A
1	DEVELOPMENT AGREEMENT
2
3	MEDISORB TECHNOLOGIES INTERNATIONAL L.P. ("Medisorb"), a Delaware limited partnership, doing business at 6954 Cornell Road, Cincinnati, Ohio 45242, and
4	JANSSEN PHARMACEUTICA INTERNATIONAL, a division of Cilag International AG, ("Janssen"), a Swiss business corporation, doing business at Kollerstrasse 38,
5	CH-6300 Zug 6, Switzerland, agree this 23 rd day of December, 1993 to jointly develop the products described herein under the following terms and conditions:
6
7	1. Background
8	Janssen desires to develop a depot formulation of [ ]. Medisorb possesses technology and expertise relating to bioabsorbable polymer technologies and
9	drug delivery systems for biologically active compounds based on such polymers. In light of these facts, Medisorb and Janssen's Affiliate entered
10	into a preliminary Development Agreement (dated 9 June 1992) in order to collaborate in determining the feasibility of developing a depot
11	formulation of [ ]. Janssen has executed the option as specified in the said preliminary Development Agreement and both parties agree to continue
12	the development of Product under the terms and conditions specified hereinafter.
13
14	2. Definitions
15	A) Affiliate: shall mean any company controlling, controlled by, or under common control with a party by ownership, directly or
16	indirectly, of fifty percent (50%) or more of the total ownership or by the power to control the policies and actions of such company.
17
18	B) Field: shall mean human [ ] products comprising polymers of lactic and glycolic acids. In this regard [ .]
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20	C) International Registration Dossier ("IRF"):
21	shall mean the Product registration file compiled by Janssen Pharmaceutica N.V., Beerse, Belgium on behalf of Janssen, the
22	contents and format being such that it can be submitted as such to national health authorities or be used as a basis for a
23	national application for marketing authorization for the Products in the specific format required by such national health authorities.
24
25	D) Patents: shall mean (i) any and all existing issued patents and patent applications or parts thereof which describe and claim a depot
26	formulation of [ ], or any chemical analogues of [ ] with similar physiological activity, based on polymers of lactic and glycolic
27	acids and the production and use thereof; (ii) any other patents and patent applications filed by or on behalf of Medisorb, or under which Medisorb has the
28	rights to grant licenses, which are needed to practice the inventions; and (iii) any reissues, extensions, substitutions, confirmations, registrations,
29	revalidations, additions, continuations, continuations-in-part, or divisions of or to any of the foregoing which are granted hereafter or any additional
30	protection certificate granted with respect thereto.
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32	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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35	DEVELOPMENT AGREEMENT
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37	E) Products: shall mean any and all depot formulations of [ ], or any chemical analogues of [ ] with similar physiological
38	activity, based on polymers of lactic and glycolic acids which are designed to deliver [ ], or any of its chemical analogues, over an extended period.
39
40	3. Development Program
41	A) "Development Program" shall mean the development activities conducted by the parties as contemplated hereunder. The Development Program is
42	to be mutually agreed upon from time to time as the parties find necessary. Medisorb shall (i) carry out its development activities in
43	the Development Program to the currently accepted standards of Good Laboratory Practice, and (ii) manufacture human clinical supplies to
44	cGMP standards. The Development Program is attached hereto as Exhibit A and incorporated herein.
45
46	B) Janssen will fund Medisorb's activities under the Development Program at a cost not to exceed the following projected development costs
47	without prior written authorization from Janssen:
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49	[ ]
50	[ ]
51	[ ]
52
53	Medisorb will invoice Janssen monthly according to Medisorb's standard rates and practices for the actual costs of work performed during the
54	immediately preceding month. Payment will be due 30 days from the end of the month in which the invoice is received; a late fee of 1.5% per
55	month will be added to any outstanding balance not paid when due.
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57	C) Medisorb will provide Janssen monthly brief written descriptions of the work performed during the preceding month. Upon Janssen's request
58	Medisorb will promptly provide Janssen with detailed reports of the work already undertaken, in order for Janssen and its Affiliates to
59	prepare the health registration applications and the IRF. Medisorb will provide to Janssen a final detailed written report on the work
60	performed under the Development Program within 30 days of completion of the Development Program.
61
62	D) Janssen will disclose to Medisorb as soon as reasonably practicable during the term of this Agreement the following test results from
63	experiments employing materials supplied to Janssen by Medisorb: (i) bioavailability and bioactivity assays from in vivo tests and (ii) any
64	results which reasonably suggest potential adverse consequences in humans associated with such materials.
65
66	4. Term and Termination
67	A) The initial term of this Agreement shall commence upon the date first above written and continue thereafter until the earlier of (i) the
68	completion of the Development Program at the moment of finalization of the IRF, which is expected during the [ ], or (ii) [
69	], unless earlier terminated pursuant to the provisions of this Section 4 or according to the terms of Section 16 below. However, in
70	the event that the IRF has not been completed by [ ], if Janssen can show due diligence, this Agreement shall not
71	terminate and will be extended for such period as Janssen requires to finalize the IRF, provided that during such extension Janssen
72	continues to show due diligence. Due diligence, amongst other factors, shall mean the timely filing of required regulatory applications,
73
74	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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78	including, without limitation, a CTX (clinical trial exemption certificate) and/or IND, and continuing to fund the Development
79	Program in a commercially reasonable manner.
80
81	B) Janssen may terminate this Agreement upon 30 days written notice, provided that Janssen must fulfill all obligations to Medisorb
82	actually incurred prior to the notice of termination.
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84	C) Medisorb may only terminate this Agreement upon 30 days written notice for cause, which shall include:
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86	1. Any material breach of this Agreement by Janssen which has not been cured within 30 days of written notice of the breach; and
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88	2. The failure of Janssen to provide within 60 days of a request by Medisorb reasonably sufficient quantities of [
89	] as will be required by Medisorb to fulfill its obligations hereunder.
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91	D) Articles 8, 9, 10, 11, 12 and 17 shall survive termination of this Agreement.
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93
94	5. Exclusivity and Right of First Refusal
95
96	A) This Agreement shall be exclusive with respect to both parties obligations in the Field.
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98	B) With respect to Products in the Field intended to treat [ ] the development of which is not being currently pursued and/or
99	funded by Janssen shall be subject to the following right of first refusal. With respect to products in the Field which are subject to
100	this right of first refusal, Medisorb shall provide written notice to Janssen of Medisorb's intent to enter into substantive negotiations
101	with a third party for the development of such a product. Medisorb's notice shall, to the fullest permissible extent, disclose to Janssen
102	the details of the proposed product and its application(s). Medisorb shall not be required to disclose the identity of the third party.
103	Janssen shall have 60 days following the notice required above from Medisorb to inform Medisorb of its intent to enter into substantive
104	negotiations with Medisorb for the development of a product in the same application(s). In the event that Janssen does not elect to
105	enter into such negotiations with Medisorb within the 60 day period, Medisorb shall thereafter be free to enter into development, licensing
106	and/or supply contracts with third parties respecting the product which was the subject of Medisorb's original notice to Janssen. In
107	the event that Janssen elects to enter into substantive negotiations with Medisorb and the parties are unable, despite their mutual good
108	faith efforts, to negotiate and enter into the subject agreements within 120 days from Medisorb's original notice to Janssen, Medisorb
109	shall thereafter be free to enter into development, licensing and/or supply contracts with third parties respecting the product which was
110	the subject of Medisorb's original notice to Janssen. Medisorb agrees that whenever it would not have been possible to execute such an
111	agreement with such third party within a period of twelve months, the right of first refusal granted to Janssen will be restored.
112
113	6. Option
114
115	A) Medisorb hereby grants to Janssen an option, exercisable at any time during the period beginning with the finalization of the IRF and 30
116	days thereafter (except as modified by Section 6(B) below), to enter into the License Agreements (i.e., the first a worldwide license,
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118	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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123	excluding the United States, and the second a license encompassing only the United States) attached hereto as Exhibits B & C, respectively.
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125	B) The option granted to Janssen under Section 6(A) above shall be immediately exercisable upon the termination of this Agreement by Janssen due to material breach by Medisorb.
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127	7. Future Supply
128	A) In the event that Janssen and Medisorb enter into the License Agreements referred to in Section 6 above, the parties agree that it
129	is likely that either Janssen or Medisorb will manufacture Product(s) for commercial sale. Therefore the parties are negotiating the
130	definitive terms of two Product Manufacturing Agreements (i.e., the first a worldwide agreement, excluding the United States, and the
131	second encompassing only the United States) which shall be appended hereto as Exhibits D & E respectively, and which will be executed at
132	the moment of executing the License Agreements, unless Janssen elects to manufacture the Product itself as specified hereafter. The parties
133	each covenant to use their best efforts to expeditiously negotiate the definitive Manufacturing Agreements referred to in this Section 7(A).
134
135	It is understood and agreed upon that Janssen and its Affiliates shall retain sole discretion at the time of entering in to the License
136	Agreements under Section 6 to choose to manufacture or have manufactured Product(s). In the event that Janssen determines to
137	manufacture Product(s) itself or have Product(s) manufactured by a third party, the terms of the License Agreements (Appendices B and C
138	to this Agreement) shall control the transfer of the required technology from Medisorb to Janssen.
139
140	B) With respect to third party suppliers, except as limited by the Product Manufacturing Agreements, Medisorb will have a right of first
141	refusal as to the manufacture and supply to Janssen of all Product(s), and component bioabsorbable polymers thereof, developed under this
142	Agreement. Medisorb will have a period of thirty days following written notice from Janssen of terms it is offering to, or prepared to
143	accept from, third parties to notify Janssen of its intention to exercise its right of first refusal to supply Product or component
144	bioabsorbable polymers thereof to Janssen, its Affiliates and Licensees on terms no less favorable to Janssen than those offered by
145	such third party supplier.
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147	8. Proprietary Rights
148
149	A) Medisorb will retain title to and ownership of all technology (including, without limitation, all patents, inventions, and data
150	relating thereto) relating to absorbable polymers, controlled release of active agents, and/or manufacturing methods or processes relating
151	to such polymers and the controlled delivery systems for active agents based on such polymers previously owned by Medisorb or developed by
152	Medisorb as a result of the Development Program or otherwise. Medisorb will pay its own costs and expenses in connection with the protection
153	of any such technology, including all patent application and maintenance costs and Janssen agrees to provide Medisorb with any necessary utility information.
154
155	Medisorb shall inform Janssen of any patent application it wishes to file to protect proprietary rights defined in Article 8, resulting
156	from either the Development Program or the preliminary
157
158	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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163	Development Program and shall forward a copy of any such patent application to Janssen at least one month prior to filing.
164
165	Medisorb shall consider any suggestions made by Janssen for amplifying such application and shall accordingly amend the application where in
166	Medisorb's opinion it is appropriate.
167
168	Nine months after the first filing, Medisorb shall propose a list of countries in which it intends to file foreign equivalents. Janssen
169	shall be given the opportunity to propose further countries to be added to the list. In case the adding of some or all of these further
170	countries is unacceptable to Medisorb, Janssen shall have the right to file patent applications in those countries, in Medisorb's name and
171	at Janssen expense. Medisorb shall assist in the transfer of rights for the latter patent applications and shall provide all information
172	necessary to file and prosecute such patent applications.
173
174	Medisorb shall not abandon part or whole of any of the patents or patent applications without having first consulted Janssen, which
175	shall have the right to further pursue any patents or patent applications which Medisorb wishes to abandon, or parts thereof, in
176	its own name and at its own expense.
177
178	B) Janssen and/or its Affiliate will retain title to and ownership of all technology (including, without limitation, all patents, inventions,
179	and data relating thereto) relating to [ ] or any chemical analogues of [ ] with similar physiological
180	activity previously owned by Janssen and/or its Affiliate or developed by Janssen as a result of this Agreement or otherwise. Janssen and/or
181	its Affiliate will pay its own costs and expenses in connection with the protection of any such technology, including all patent
182	application and maintenance costs and Medisorb agrees to provide Janssen with any necessary utility information.
183
184	C) Any inventions, other than those falling under either section 8(A) or 8(B) hereof, having an inventorship jointly between at least one
185	employee of Janssen or an Affiliate of Janssen and one employee of Medisorb or an Affiliate of Medisorb shall be jointly-owned by Janssen
186	and Medisorb. Each party will cooperate fully in the filing and prosecution of such patent applications.
187
188	Janssen and Medisorb shall agree on which of both shall be responsible for the filing, prosecution and maintenance of any such joint patent
189	applications and patents (hereinafter referred to as the "Responsible Party"). In principle, the party having contributed the most to the
190	invention to be protected shall be the responsible party, unless agreed upon differently. Upon mutual consent, the responsible party
191	may select an agent for drafting, filing and prosecuting a joint application. However, both parties shall agree who shall be the agent
192	and to what extent this agent shall be used.
193
194	The Responsible Party shall consult the other party when drafting any new jointly owned patent application. The final draft shall be
195	forwarded to the other party at least one month prior to filing to give the opportunity to make final comments.
196
197	The Responsible Party shall propose a list of countries in which it intends to file such patent applications. The other party shall be
198	given the opportunity to propose further countries to be added to the list. In case the adding of some or all of these further countries is
199	unacceptable to the Responsible Party, the other party shall have the right to file patent applications in those countries, in its own name
200	and at its own expense. The Responsible Party shall assist in the
201
202	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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205	DEVELOPMENT AGREEMENT
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207	transfer of rights for the latter patent applications and shall provide all information necessary to file and prosecute such patent applications.
208
209	The Responsible Party shall not abandon part or whole of any of the patents or patent applications without having first consulted the
210	other party, which shall have the right to further pursue any patents or patent applications which the responsible party wishes to abandon,
211	or parts thereof, in its own name and at its own expense.
212
213	All out-of-pocket costs made in relation to joint patent applications and patents shall be shared equally by Janssen and Medisorb. A
214	statement of costs shall be made up on a quarterly basis and invoiced to the other party.
215
216	Medisorb shall grant to Janssen an exclusive fully-paid up royalty free license with the right to sublicense to make, have made, use and
217	sell under any such patents or patent applications for the duration of the patents, any continuations, continuations in part, divisions,
218	patents of addition, reissues, renewals or extensions thereof or any supplementary protection certificates granted with respect thereto,
219	in respect of any claims concerning the application of [ ] or any chemical analogues of [ ] with similar
220	physiological activity. However, nothing contained in this paragraph shall obviate Janssen's obligation to pay royalties under Section 6
221	hereof with respect to any Products developed hereunder.
222
223	Janssen shall grant to Medisorb an exclusive fully paid-up royalty free license with the right to sublicense to make, have made, use and
224	sell under any such patents or patent applications for the duration of the patents, any continuations, continuations in part, divisions,
225	patents of addition, reissues, renewals or extensions thereof or any supplementary protection certificates granted with respect thereto, in
226	respect of any claims concerning the application of bioabsorbable polymers in the field of human and/or veterinary medicine.
227
228	D) In addition, each party will retain exclusive title to its respective Confidential Information (as defined in Section 11 below)
229
230	9. Patent Infringement
231
232	A) In the event that either party becomes aware that any third party is infringing any patents included within the Patents in any country or
233	countries, the party becoming aware of such infringement shall promptly give notice of such infringement to the other party. Any
234	possible action against such alleged infringement of the Patents will be carried out by either or both of the parties in accordance with the
235	provisions specified hereinafter in paragraphs B), C), D) and E).
236
237	B) Whenever it would concern a patent or patent application falling within the definition of Patents and of which Medisorb retains full
238	title and ownership pursuant to Article 8 A), Medisorb shall use all reasonable efforts to take action against such infringement in its own
239	name, at its own expense and on its own behalf.
240
241	If Medisorb fails to take action against such infringement, or if Medisorb does not use reasonable efforts in carrying out such action
242	after commencement thereof, within thirty (30) days after the notice referred to in paragraph A) above or after having become aware of such
243	infringement, Janssen shall be entitled at its own discretion and at its own expense, to take
244
245	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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250	immediate action against such infringement in its own name, at its own expense and on its own behalf. If Janssen commences or assumes such
251	action, Janssen may credit [ ] of any royalty otherwise due to Medisorb for sales in such country or countries
252	against the amount of the expenses and costs of such action, including without limitation, attorney fees actually incurred by Janssen.The
253	amount of expenses so deducted shall be paid to Medisorb out of the recoveries, if any, received by Janssen as a result of such action.
254	Except for such repayment of royalties deducted, Janssen shall be entitled to retain all recoveries therefrom.
255
256	In no event shall Medisorb settle with such infringing third party in the Field without the prior written consent of Janssen.
257
258	C) Whenever it would concern a patent or patent application falling within the definition of Patents and of which Janssen retains full
259	title and ownership pursuant to Article 8 B), Janssen shall have the right but not the obligation to take action against such infringement
260	in its own name, at its own cost and on its own behalf. If Janssen fails to take action against such infringement, or if Janssen does not
261	use reasonable efforts in carrying out such action after commencement thereof, within thirty (30) days after the notice referred to in
262	paragraph A) above or after having become aware of such infringement, Medisorb shall be entitled at its own discretion and at its own
263	expense, to take action against such infringement. Medisorb shall be entitled to retain all recoveries, if any, therefrom.
264
265	D) Whenever it would concern a patent or patent application falling within the definition of Patents and of which Janssen and Medisorb
266	jointly retain full title and ownership pursuant to Article 8 C), and whenever in such case the infringing product would be a drug product
267	falling within the definition of the Field, Janssen shall have the right but not the obligation to take action against such infringement
268	in its own name, at its own cost and on its own behalf. If Janssen fails to take action against such infringement, or if Janssen does not
269	use reasonable efforts in carrying out such action after commencement thereof, within thirty (30) days after the notice referred to in
270	paragraph A) above or after having become aware of such infringement, Medisorb shall be entitled at its own discretion and at its own
271	expense, to take action against such infringement, it being understood that Janssen will have a continuing right to take over any such action
272	at its own expense and shall pay to Medisorb from any recoveries Janssen receives (i) Medisorb's expenses and (ii) from any sums
273	remaining after deduction of Medisorb's and Janssen's expenses, an amount proportionate to Medisorb's expenses in relation to Janssen's expenses.
274
275	Whenever it would concern a patent or patent application falling within the definition of Patents and of which Janssen and Medisorb
276	jointly retain full title and ownership pursuant to Article 8C), and whenever in such case the infringing product would be a drug product
277	falling outside the definition of the Field, Medisorb shall have the right but not the obligation to take action against such infringement
278	in its own name, at its own cost and on its own behalf.If Medisorb fails to take action against such infringement, or if Medisorb does
279	not use reasonable efforts in carrying out such action after commencement thereof, within thirty (30) days after the notice
280	referred to in paragraph A) above or after having become aware of such infringement, Janssen shall be entitled at its own discretion and at
281	its own expense, to take action against such infringement, it being understood that Medisorb will have a continuing right to take over any
282	such action at its own expense. If Janssen commences or assumes such action, Janssen may credit [ ] of any royalty
283	otherwise payable to Medisorb payable hereunder against the amount of the expenses and costs of such action, including without limitation,
284	attorney fees actually incurred by Janssen. The amount of expenses so
285
286	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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291	deducted shall be paid to Medisorb out of the recoveries, if any, received by Janssen as a result of such action. Except for such
292	repayment of royalties deducted, Janssen shall be entitled to retain all recoveries therefrom.
293
294	E) Each party agrees to cooperate reasonably with the other party in such litigation, including making available to the other party records,
295	information, and evidence relevant to the infringement of the Patent.
296
297
298	10. Third Party Intellectual Property Rights
299
300	A) Medisorb warrants that to the best of its current knowledge and belief the Products to be developed hereunder will not infringe the patent
301	rights of any third party.
302
303	B) In the event that the manufacture, use or sale of the Product would constitute an infringement of the rights of a third party in a country
304	because of the use of the Patents or Medisorb's know how, each party shall, as soon as it becomes aware of the same, notify the other
305	thereof in writing, giving in the same notice full details known to it of the rights of such third party and the extent of any alleged
306	infringement. The parties shall after receipt of such notice meet to discuss the situation, and, to the extent necessary attempt to agree
307	on a course of action in order to permit Janssen to practice the license granted hereunder. Such course of action may include: (a)
308	modifying the Product or its manufacture so as to be noninfringing; (b) obtaining an appropriate license from such third party; or ©
309	fight the claimor suit. In the event that within a short period of time, the parties fail to agree on an appropriate course of action
310	Janssen may decide upon the course of action in the interest of the further development, manufacturing or commercialization of the Product.
311
312	C) In the event that the parties cannot agree on modifying the Product or in the case that such modification would not be economically viable or
313	regulatorily feasible, Janssen, whenever it relates to know how, whether patented or not, owned by Janssen in accordance with the
314	provisions of Article 8 B) and C), or Medisorb, whenever it relates to know how, whether patented or not, owned by Medisorb in accordance
315	with the provisions of Article 8 A), will have the right to negotiate with such third party for such license. Both parties hereto will in
316	any event in good faith consult with each other with respect to such negotiations and the party negotiating such license as indicated
317	above, will make every effort to minimize the amount of license fees and royalties payable thereunder. In no event shall either party as a
318	result of such settlement, grant a sublicense or cross license to the third party to settle the suit, without the prior written approval of
319	the other party. In the event that such negotiations result in a consummated agreement, any license fee and/or royalties to be paid
320	thereunder shall be paid by the party responsible for the negotiations as indicated above, [ ] of any license fees or
321	royalties paid by Janssen under such license will be creditable against royalties due to Medisorb with respect to such country or countries.
322
323	D) In the event that either or both parties would further to such notification under Paragraph 10 B) decide to defend such suit or claim
324	in which a third party alleges that the manufacture, use or selling of the Product infringes said third party's patent in a country, Janssen
325	shall have the right to apply [ ] of the royalties due to Medisorb on the sales of the allegedly infringing Product
326	against its litigation expenses.
327
328	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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333	11. Confidentiality and Disclosure
334
335	A) Each party agrees to keep confidential and to not use for any purpose other than as set forth herein all technical information and materials
336	supplied by the other hereunder and any information a party may acquire about the other or its activities as a result of entering into
337	this Agreement, provided that such obligation shall not apply to technical information or material which: (i) was in the receiving
338	party's possession without restriction prior to receipt from the other party or its Affiliates; (ii) was in the public domain at the time of
339	receipt; (iii) becomes part of the public domain through no fault of the receiving party; (iv) shall be lawfully received from a third
340	party with a right of further disclosure; (v) shall be required to be disclosed by law, by regulation or by the rules of any securities exchange.
341
342	B) Except as may be otherwise provided herein, the confidentiality obligations as set out in this Section shall continue so long as this
343	Agreement remains in force and for 10 years thereafter.
344
345	C) Licensee shall cause its Affiliates and Sublicensees to enter into similar obligations of confidentiality with respect to unpublished
346	information within the Patents and Technical Information.
347
348
349	12. Disclaimer of Warranty
350	Medisorb makes no representations or warranties, express or implied, other than those specified in section 13 below, with respect to any services,
351	technology, products or materials supplied to Janssen hereunder, including without limitation any warranties of merchantability or fitness for a particular purpose.
352
353	13. Liability
354
355	A) Janssen agrees to indemnify, defend and hold harmless Medisorb from and against any liability, loss, damages and expenses (including
356	reasonable attorney fees) Medisorb may suffer as the result of claims, demands, costs or judgments which may be made or instituted against
357	Medisorb by reason of personal injury or damage to property arising out or caused by Janssen's clinical testing of the Product, except
358	where such liabilities claims, demands, costs or judgments are caused by any sole negligence on behalf of Medisorb in manufacturing the
359	clinical trial samples, its failure to supply such samples in accordance with the mutually agreed written specifications or its
360	failure to provide Janssen with any information as specified in Article 13(B). Medisorb will notify Janssen as soon as it becomes
361	aware of any such claim or action and agrees to give reasonable assistance in the investigation and defense of such claim or action it
362	being understood that it shall allow Janssen to control the disposition of the same.
363
364	B) Medisorb agrees to indemnify, defend and hold harmless Janssen from and against any liability, loss, damages and expenses (including
365	reasonable attorney fees) Janssen may suffer as the result of claims, demands, costs or judgments which may be made or instituted against
366	Janssen by reason of personal injury or damage to property arising out or caused by Medisorb's sole negligence in manufacturing the clinical
367	trial samples or its failure to supply such samples in accordance with the mutually agreed written specifications.
368
369	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
370
371	JANSSEN-MEDISORB PAGE 10
372	DEVELOPMENT AGREEMENT
373
374	C) In no event shall either party be liable for loss of profits, loss of goodwill or any consequential or incidental damages of any kind of the other party.
375
376	D) This indemnification shall not apply with respect to any Product which would be commercialized under the terms of the License Agreement or
377	manufactured under the terms of the Product Manufacture Agreement with respect to which the indemnification clause of such Agreements will apply.
378
379	14. Product Information and Adverse Drug Events
380
381	A) As Janssen has superior knowledge of the end-use applications to which Products developed hereunder will be put, Janssen is responsible for
382	providing third parties with adequate information as to the medical profile of the Product. Janssen will provide Medisorb with copies of
383	the IPID (International Product Information Document) and the IPPI (International Patient Package Insert), which are all part of the IRF
384	for the Product. For the purpose of this Agreement IPID refers to the document that summarizes all medically relevant features of the
385	Product, including the instructions for use meant to inform the medical profession, whereas the IPPI is a patient-oriented document,
386	based upon the IPID that summarizes all relevant information on the Product in lay language. Janssen will keep Medisorb informed of any
387	revisions or amendments in the IPID and IPPI of the Product.
388
389	B) Medisorb will provide to Janssen promptly after its discovery by Medisorb, any information in its possession which indicates adverse
390	effects in humans associated with the Products developed hereunder. For the purpose of this Agreement "adverse event" shall mean an
391	experience which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of a
392	disease or for the modification or physiological functioning and any report of an overdose.
393
394	15. Government Approvals
395
396	A) Janssen shall be responsible for conducting all necessary testing as well as determining what, if any, government approvals are required
397	for the use and sale of Products developed hereunder and shall comply with all such requirements prior to and following the sale or
398	distribution of such Products.
399
400	Medisorb shall cooperate fully with Janssen in obtaining regulatory approvals for Products developed hereunder and shall, at Janssen's
401	request, provide appropriate regulatory authorities with any and all information concerning Medisorb's technology, Medisorb polymers and
402	manufacturing methods for such Products.
403
404	In this respect Medisorb undertakes that it has submitted or will as soon as possible submit a type IV Drug Master File to the FDA
405	identifying Medisorb's method of manufacture, release specifications and testing methods used in the manufacture of its bioabsorbable
406	polymers and a type I Drug Master File of Medisorb's manufacturing facilities where Product may be manufactured.
407
408	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
409
410	JANSSEN-MEDISORB PAGE 11
411	DEVELOPMENT AGREEMENT
412
413	16. Warranties and Covenants
414
415	A) Each party hereto covenants with the other to use its best efforts, consistent with reasonable business practice, to perform its
416	obligations hereunder in a timely fashion. In the event that Janssen determines not to pursue the commercialization of Products, it will
417	promptly inform Medisorb of such decision and this Agreement will automatically terminate.
418
419	B) Medisorb warrants to the best of its knowledge that Medisorb bioabsorbable polymers are suitable for chronic human use in
420	parenteral drug delivery systems similar to Products to be developed hereunder.
421
422	C) Medisorb warrants that to the best of its knowledge the use of Medisorb's bioabsorbable polymers in Products will not infringe the
423	patent rights of any third parties.
424
425	17. Force Majeure
426
427	Neither party shall be liable for its failure to perform any of its obligations hereunder if such failure is occasioned by a contingency beyond
428	its reasonable control including, but not limited to, occurrences such as strikes or other labor disturbances, lock out, riot, war, default by a
429	common carrier, fire, flood, storm, earthquake, other acts of God, inability to obtain raw materials, failure of plant facilities or
430	government regulation, act or failure to act. Each party shall notify the other immediately upon occurrence or cessation of any such contingencies.
431	If such contingency continues unabated for at least 180 consecutive days, either party shall have the right to terminate this Agreement without
432	further obligation beyond those actually incurred prior to such termination.
433
434	18. Dispute Resolution
435
436	Should any dispute arise under this Agreement, the parties shall first meet in an attempt to amicably resolve the situation. In the event that the
437	parties are unable to resolve any contested issues, then both parties hereby agree to submit said disputes to the jurisdiction of the competent
438	Courts of Zurich, Switzerland, and agree that any litigation in any way related to this Agreement shall be submitted to such Courts and that same
439	shall be subject to Swiss law.
440
441	19. Assignment
442
443	This Agreement shall not be assigned by either party without the prior written consent of the other party; provided, however, that assignment
444	shall be permitted without such consent to any party, not less than 50% of the total interest of which owns, is owned by, or is under common control
445	with the assigning party. In the event of any such permitted assignment the assignee shall be subject to and shall agree in writing to be bound by the
446	terms and conditions of this Agreement.
447
448	20. Severability
449
450	In the event that any one or more of the provisions of this Agreement should for any reason be held by any court or authority having jurisdiction
451	over this Agreement or any of the parties hereto to be invalid, illegal or unenforceable such provision or provisions shall be validly reformed to as
452	nearly approximate
453
454	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
455
456	JANSSEN-MEDISORB PAGE 12
457	DEVELOPMENT AGREEMENT
458
459	the intent of the parties as possible and, if unreformable; shall be divisible and deleted in such jurisdiction, elsewhere this Agreement shall
460	not be affected, except to the extent such applicability would substantially burden only one of the parties to this Agreement.
461
462	21. Separate Entities
463
464	Nothing contained herein shall be construed to constitute the parties hereto as partners or joint venturers, or as agents or representatives of the other.
465
466	22. Captions
467
468	The captions of this Agreement are for convenience only, and shall not be deemed of any force or effect whatsoever in construing this Agreement.
469
470	23. Waiver
471
472	Any waiver by either party of a breach of any provision of this Agreement shall not operate as or be construed to be a waiver of any further breach
473	of the same or other provisions of this Agreement. The failure of a party to insist upon strict adherence to any term of this Agreement on one or
474	more occasions shall not be considered a waiver or deprive that party of the right thereafter to insist upon strict adherence to that term or any
475	other term of this Agreement. Any waiver must be in writing.
476
477	24. Press Communications
478
479	Neither Party shall originate any publicity, news release or public announcement, written or oral relating to this Agreement, including its
480	existence, without the prior written approval of the other party.
481
482	25. Notices
483
484	Any legal notice required or permitted hereunder shall be considered properly given if in writing and sent by first class mail, certified mail
485	or by telefacsimile to the party being notified at the respective address of such party as follows:
486
487	If to Medisorb: Medisorb Technologies International L.P.
488	6954 Cornell Road
489	Cincinnati, OH 45242
490	USA
491	Facsimile: 513-489-2348
492
493	If to Janssen: Janssen Pharmaceutica
494	Kollerstrasse 38
495	6300 Zug 6
496	Switzerland
497	Facsimile: 00-41-42449565
498
499	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
500
501	JANSSEN-MEDISORB PAGE 13
502	DEVELOPMENT AGREEMENT
503
504	Such notice shall be effective upon receipt or upon refusal to accept such notice. In any case, notice shall be presumed effective no later than five
505	(5) days after such notice is sent.
506
507	Neither party shall originate any publicity, news release or public announcement, written or oral, relating to this Agreement, including its
508	existence, without the written approval of the other party.
509
510
511	26. Entire Understanding
512
513	This Agreement may be executed by the parties hereto in counterparts, each of which when so executed and delivered shall be considered to be an
514	original, but all such counterparts shall together constitute but one and the same instrument. This Agreement constitutes the entire understanding
515	between the parties with respect to the subject matter hereof and supersedes all previous agreements related thereto, provided, however, that
516	no variation or modification of this Agreement or any of the terms hereof shall be valid unless in writing and signed by the parties hereto.
517
518	WITNESS the signature of both parties by their duly authorized officers:
519
520	JANSSEN PHARMACEUTICA INTERNATIONAL
521	A division of Cilag International AG
522
523
524	By: /s/ Erik Rombouts
525	-----------------------------
526	Name: Erik Rombouts
527	-----------------------
528	Title: Business Manager
529	-----------------------
530	Date: January 4, 1994
531	-------------------------
532
533
534	{Second Janssen Signatory}
535	- --------------------------
536
537
538	By: /s/ Heinz Schmid
539	----------------------------
540	Name: Heinz Schmid
541	------------------------
542	Title: General Manager
543	-------------------------
544	Date: January 4, 1994
545	------------------------------
546
547	MEDISORB TECHNOLOGIES INTERNATIONAL L.P.
548
549	by: Medisorb Technologies
550	International, Inc.,
551	its General Partner
552
553
554	By: /s/ David R. Lohr
555	----------------------------------
556	Name: David R. Lohr
557	-------------------------------
558	Title: President
559	-----------------------------------
560	Date: December 6, 1993
561	---------------------------------
562
563	11299302
564
565	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
566	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
567	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
568
569	EXHIBIT A
570	---------
571
572	DEVELOPMENT PROGRAM
573
574	[
575
576
577
578	]
579
580	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
581	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
582	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
583
584	DEVELOPMENT PROGRAM
585	Page 2
586
587
588
589	[
590
591
592
593	]
594
595	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
596	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
597	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
598
599	EXHIBIT B
600
601
602	To Development Agreement
603	dated December 23, 1993
604	between
605	Janssen Pharmaceutica International
606	and
607	Medisorb Technologies International L.P.
608
609
610	License Agreement, ex. United States of America
611	Following 16 Pages
612
613
614
615	[Note: This exhibit supercedes the previous Exhibit B, document number
616	07069402.doc.]
617
618
619
620	/s/ Erik Rombouts 12/12/95
621	- -------------------------------- --------
622	For JANSSEN Date
623
624
625	/s/ David R. Lohr December 6, 1995
626	- ------------------------------- ----------------
627	For MEDISORB Date
628
629
630
631	1205902.doc
632
633	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
634
635	LICENSE AGREEMENT
636
637
638	This Agreement is made as of the __ day ______ of 19___, between MEDISORB TECHNOLOGIES INTERNATIONAL L.P., a Delaware limited partnership
639	(hereinafter "Medisorb") and JANSSEN PHARMACEUTICA INTERNATIONAL, a division of Cilag International AG, a Swiss business corporation ("Janssen").
640
641	WHEREAS, the parties have entered into a certain Development Agreement, dated December 23, 1993 (the "Development Agreement"), for the
642	development of a Product (as described below); and
643
644	WHEREAS, Janssen has an option under the Development Agreement to enter into this License Agreement for the Medisorb technology required to make,
645	use and sell the Product, which option Janssen has elected to exercise; and
646
647	WHEREAS, the parties believe that it is in their mutual best interest for Medisorb to license to Janssen on an exclusive basis in the Territory,
648	Medisorb Patents and Technical Information within the Field, upon the terms and conditions set forth herein;
649
650	NOW, IT IS HEREBY AGREED AS FOLLOWS:
651
652	(1) Definitions: The following terms shall have the meanings ascribed to them herein, unless the context otherwise requires:
653
654	(a) "Affiliate" shall mean any company controlling, controlled by, or under common control with a party by ownership, directly or indirectly, of
655	fifty percent (50%) or more of the total ownership or by the power to control the policies and actions of such company.
656
657	(b) "Development Program" shall mean the development activities conducted by the parties pursuant to the Development Agreement.
658
659	(c) "Field" shall mean the treatment of [ ].
660
661	(d) "Improvements" shall mean any improvements or developments to or of the Patents and Technical Information in the Field which Medisorb may
662	acquire, discover, invent, originate, make, conceive or have a right to, in whole or in part, during the term of this Agreement, whether or not such
663	improvement or development is patentable.
664
665	(e) "International Registration Dossier" ("IRF") shall mean the Product registration file compiled by Janssen Pharmaceutica N.V., Beerse,
666	Belgium on behalf of Janssen, the contents and format being such that it can be submitted as such to national health authorities or be used as a basis for a
667	national application for marketing authorization for the Products in the specific format required by such national health authorities.
668
669	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
670
671	Janssen-Medisorb Page 2
672	License Agreement
673
674	(f) "Medisorb Polymers" shall mean bioresorbable aliphatic polyesters based on glycolide, lactide, caprolactone and combinations of such
675	polymers, which are manufactured by Medisorb and utilized in Product(s) licensed under this Agreement.
676
677	(g) "Net Sales" shall mean the gross amounts received from sales of Products during a calendar quarter to third parties by Janssen, its
678	Sublicensees or any Affiliate of either, less any: (i) applicable sales taxes; (ii) cash trade or quantity discounts; (iii) amounts repaid or credited by
679	reason of rejections or return of goods; or (iv) freight, postage and duties paid for. No deduction from the gross sales price shall be made for any item of
680	cost incurred by the seller in its own operations incident to the manufacture, sale or shipment of the product sold. For purposes hereof, Net Sales shall not
681	include sales of a Product from Janssen or an Affiliate of Janssen to any Affiliate or Sublicensee of either; it being intended that Net Sales shall only
682	include sales to unrelated third-parties.
683
684	(h) "Patents" shall mean (i) any and all existing issued patents and patent applications or parts thereof which describe and claim a depot
685	formulation of [ ], or any chemical analogues of [ ] with similar physiological activity, based on polymers of lactic and glycolic acids and the production and
686	use thereof; (ii) any other patents and patent applications filed by or on behalf of Medisorb, or under which Medisorb has the rights to grant licenses,
687	which are needed to practice the inventions; and (iii) any reissues, extensions, substitutions, confirmations, registrations, revalidations, additions,
688	continuations, continuations-in-part, or divisions of or to any of the foregoing which are granted hereafter or any additional protection certificate granted
689	with respect thereto.
690
691	(i) "Product(s)" shall mean any and all depot formulations of [ ], or any chemical analogues of [ ] with similar physiological
692	activity, based on polymers of lactic and glycolic acids which are designed to deliver [ ], or any of its chemical analogues,
693	over an extended period.
694
695	(j) "Sublicensees" shall mean any company or companies, other than Janssen's Affiliates, sublicensed by Janssen.
696
697	(k) "Technical Information" shall mean all unpatented information, know-how, practical experience, procedures, methodology, specifications,
698	formulae and data whether or not the same shall be patentable which have been heretofore developed or acquired by Medisorb prior to the date of this Agreement
699	and which are necessary in order to use, manufacture or sell Products in the Field.
700
701	(l) "Territory" shall mean worldwide with the exception of the United States, its Territories, Protectorates, Commonwealths, and all other
702	political subdivisions of the United States.
703
704	(2) License Grant
705
706	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
707
708	Janssen-Medisorb Page 3
709	License Agreement
710
711	(a) Medisorb hereby grants to Janssen in the Territory an exclusive license under the Patents and Technical Information existing prior to
712	the effective date of this Agreement, with the right to grant sublicenses thereunder, for all purposes within the Field to practice and use the Patents
713	and Technical Information, including the rights to manufacture and have manufactured, to use and have used, and to sell and have sold Products. Medisorb
714	exclusively retains all rights under the Patents and Technical Information outside the Field and for use other than in Products. The right to grant
715	sublicenses granted hereunder is exclusive to Janssen and shall not extend to Janssen Affiliates or Sublicensees.
716
717	(b) Medisorb shall offer to Janssen for incorporation into this License Agreement on reasonable terms and conditions, Medisorb Improvements in
718	the Field which, if incorporated into Janssen's then current commercial Product(s), would: (i) result in significant changes in either the
719	specifications for such Product(s) or the processes for producing such Product(s), and (ii) would reasonably be expected to result in enhanced market
720	value and/or profitability of such Product(s). Examples of such Improvements would include: (i) the development by Medisorb of a non-aqueous injection
721	vehicle which offers significant advantages with respect to ease of administration and (ii) the development by Medisorb of technology enabling[ ]. It is the parties'
722	understanding that the effect of any such license amendment would, in general, be either an extension of the term of this Agreement for a mutually agreed
723	period or a marginal increase in the then current royalty rate . All other Medisorb Improvements shall be made available to Janssen for its use without
724	further agreement. Proprietary rights to Improvements jointly developed by Medisorb and Janssen shall be governed by the terms of Section 5(c) of this Agreement.
725
726	(c) In the event that at any time during the term of this Agreement Medisorb is unable for any reason whatsoever to supply the Medisorb
727	Polymers required by Janssen for use in Products, then the license granted under paragraph 2(a) above shall be expanded to include the Medisorb Technology
728	required to make and use the Medisorb Polymers.
729
730	(3) Royalties:
731
732	(a) Janssen shall pay or cause to be paid to Medisorb a running royalty with respect to all Products sold to customers by Janssen, its
733	Affiliates and Sublicensees, payable quarter-annually in arrears within sixty (60) days following the end of each three (3) month period ending on March 31,
734	June 30, September 30 or December 31 in any year during the term hereof, as follows: (i) [ ]% of the Net Sales of each unit of Product sold during the
735	preceding calendar quarter during the term hereof, if such unit of Product was manufactured by Medisorb pursuant to a written contract for the supply of
736	Product; or (ii) [ ]% of the Net Sales of each unit of Product sold during the preceding calendar quarter during the term hereof, if such unit of Product
737	was not manufactured by Medisorb pursuant to a written contract for the supply of Product. Any withholding or other tax that Janssen or any of its Affiliates
738	are required by statute to withhold and pay on behalf of Medisorb with respect to the royalties payable to Medisorb under this Agreement shall be deducted from
739	said royalties and paid contemporaneously with the remittance to Medisorb; provided, however, that in regard to any tax so deducted Janssen shall furnish
740	Medisorb with proper evidence of the taxes paid on its behalf.
741
742	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
743
744	Janssen-Medisorb Page 4
745	License Agreement
746
747	(b) In the event that, in a country where Product is not claimed in a valid Patent, a similar product obtains a market share greater than [ ]% of
748	the total market revenues for Products and similar products in such country, the parties agree to meet and negotiate in good faith an appropriate reduction in
749	the royalty rate then in effect. In no event shall a reduction in royalty rates pursuant to this section result in royalty rates [ ] of the rates specified
750	under Section 3(a)(i) and 3(a)(ii) of this Agreement. For the purposes of this section, "similar product" shall mean a generic version of the Product(s) where:
751	(i) the active agent is [ ], or a chemical analogue thereof and (ii) the excipient is comprised of lactic and/or glycolic acids. In the event that patent
752	protection for Product(s) becomes available subsequent to a royalty reduction pursuant to this section, the parties agree to (i) reinstitute the royalty
753	otherwise applicable, and (ii) in the event that any recovery is obtained for prior infringement of the subsequently issued patent, the parties will first
754	apply such recoveries to reimbursing Medisorb for royalties it would otherwise have received.
755
756	(c) Janssen shall keep complete and adequate records with respect to the proceeds of Products on which it has to pay royalties payable hereunder
757	for at least two (2) years after expiry of the year they concern. Medisorb shall have the right to have such records of Janssen inspected and examined, at
758	Medisorb's expense, for the purpose of determining the correctness of royalty payments made hereunder.
759
760	Such inspection shall be made by an independent, certified public accountant to whom Janssen shall have no reasonable objection. Such accountant shall not
761	disclose to Medisorb any information other than that necessary to verify the accuracy of the reports and payments made pursuant to this Agreement. It is
762	understood that such examination with respect to any quarterly accounting period shall take place not later than two (2) years following the expiration of said
763	period. Not more than one examination per year shall take place.
764
765	Based upon the verification of such reports and whenever there is reasonable doubt about the accuracy of the sales of Product realized by an Affiliate or
766	sublicensee, Medisorb may reasonably request Janssen to audit the books of such Affiliate or such sublicensee in accordance with any applicable contractual
767	provision, in order to confirm the accuracy of such reports.
768
769	(4) Production of Product/Technology Transfer:
770
771	(a) Janssen shall use its reasonable efforts to commercialize and market Product, or to have the same commercialized and marketed.
772
773	(b) In the event that Janssen determines to manufacture Product itself or have Product manufactured by a third party, Medisorb shall transfer to
774	Janssen all relevant Technical Information, and provide such technical assistance, upon mutually agreed terms and conditions, as is required by Janssen
775	in order to enable the manufacture of Product by Janssen or its designated third party manufacturer. However, with respect to such third party manufacturers,
776	except as limited by a written Product manufacturing agreement between Janssen and Medisorb, Medisorb will have a right of first refusal as to the manufacture
777	and supply to Janssen of all Product(s), and component bioabsorbable polymers utilized in such Product(s). Medisorb will have a period of thirty (30) days
778
779	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
780
781	Janssen-Medisorb Page 5
782	License Agreement
783
784	following written notice from Janssen of terms it is offering to, or prepared to accept from, a third party manufacturer to notify Janssen of its intention to
785	exercise its right of first refusal to supply Product and/or component bioabsorbable polymers thereof to Janssen, its Affiliates and Licensees on terms
786	no less favorable to Janssen than those offered by such third party manufacturer. Such third party manufacturer cannot be an in-kind competitor to
787	Medisorb and must be reasonably acceptable to Medisorb with respect to confidential protection of Medisorb's Technical Information. In the event that
788	at any time during the term of this Agreement Medisorb is unable for any reason whatsoever to supply the Medisorb Polymers required by Janssen for use in
789	Products, then the right of first refusal under this paragraph respecting the supply of the component bioabsorbable polymers shall be eliminated. For the
790	purposes of this section, an "in-kind" competitor shall mean any organization which regularly engages in the contract development and/or contract manufacture
791	of injectable controlled release drug delivery systems comprising a polymeric excipient based on lactic and/or glycolic acids and/or other closely related
792	monomers. This Section 4(b) specifically supercedes Section 7(B) of the Development Agreement, which Section 7(B) shall be of no further force or effect.
793
794	(c) The right of first refusal granted to Medisorb pursuant to Section 4(b) above shall be contingent upon: (i) Medisorb and Janssen reaching
795	an agreement concerning the financing, scheduling and construction in Europe of a Medisorb manufacturing facility within twelve (12) months of the date first
796	above written or the initiation of Phase III human clinical trials, whichever is later, and (ii) prior to the qualification of Medisorb's European manufacturing
797	facility, Medisorb using reasonable efforts to supply from its United States manufacturing facilities all of Janssen's commercial requirements for Product
798	pursuant to the Product Supply Agreement anticipated by Section 7(A) of the Development Agreement.
799
800	(5) Proprietary Rights
801
802	(a) Medisorb will retain title to and ownership of all technology (including, without limitation, all patents, inventions, and data relating
803	thereto) relating to absorbable polymers, controlled release of active agents, and/or manufacturing methods or processes relating to such polymers and the
804	controlled delivery systems for active agents based on such polymers previously owned by Medisorb or developed by Medisorb as a result of the Development
805	Program or otherwise. Medisorb will pay its own costs and expenses in connection with the protection of any such technology, including all patent application and
806	maintenance costs and Janssen agrees to provide Medisorb with any necessary utility information.
807
808	Medisorb shall inform Janssen of any patent application it wishes to file to protect proprietary rights defined in Article 5, resulting from either
809	the Development Program or the preliminary Development Program and shall forward a copy of any such patent application to Janssen at least one month prior to filing.
810
811	Medisorb shall consider any suggestions made by Janssen for amplifying such application and shall accordingly amend the application where in Medisorb's
812	opinion it is appropriate.
813
814	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
815
816	Janssen-Medisorb Page 6
817	License Agreement
818
819	Nine months after the first filing, Medisorb shall propose a list of
820	countries in which it intends to file foreign equivalents. Janssen shall be
821	given the opportunity to propose further countries to be added to the list. In
822	case the adding of some or all of these further countries is unacceptable to
823	Medisorb, Janssen shall have the right to file patent applications in those
824	countries, in Medisorb's name and at Janssen expense. Medisorb shall assist in
825	the transfer of rights for the latter patent applications and shall provide all
826	information necessary to file and prosecute such patent applications.
827
828	Medisorb shall not abandon part or whole of any of the patents or
829	patent applications without having first consulted Janssen, which shall have the
830	right to further pursue any patents or patent applications which Medisorb wishes
831	to abandon, or parts thereof, in its own name and at its own expense.
832
833	(b) Janssen and/or its Affiliate will retain title to and
834	ownership of all technology (including, without limitation, all patents,
835	inventions, and data relating thereto) relating to [ ] or any chemical analogues
836	of [ ] with similar physiological activity previously owned by Janssen and/or
837	its Affiliate or developed by Janssen as a result of this Agreement or
838	otherwise. Janssen and/or its Affiliate will pay its own costs and expenses in
839	connection with the protection of any such technology, including all patent
840	application and maintenance costs and Medisorb agrees to provide Janssen with
841	any necessary utility information.
842
843	(c) Any inventions, other than those falling under either section
844	5(a) or 5(b) hereof, having an inventorship jointly between at least one
845	employee of Janssen or an Affiliate of Janssen and one employee of Medisorb or
846	an Affiliate of Medisorb shall be jointly-owned by Janssen and Medisorb. Each
847	party will cooperate fully in the filing and prosecution of such patent
848	applications.
849
850	Janssen and Medisorb shall agree on which of both shall be responsible
851	for the filing, prosecution and maintenance of any such joint patent
852	applications and patents (hereinafter referred to as the "Responsible Party").
853	In principle, the party having contributed the most to the invention to be
854	protected shall be the responsible party, unless agreed upon differently. Upon
855	mutual consent, the responsible party may select an agent for drafting, filing
856	and prosecuting a joint application. However, both parties shall agree who shall
857	be the agent and to what extent this agent shall be used.
858
859	The Responsible Party shall consult the other party when drafting any
860	new jointly owned patent application. The final draft shall be forwarded to the
861	other party at least one month prior to filing to give the opportunity to make
862	final comments.
863
864	The Responsible Party shall propose a list of countries in which it
865	intends to file such patent applications. The other party shall be given the
866	opportunity to propose further countries to be added to the list. In case the
867	adding of some or all of these further countries is unacceptable to the
868	Responsible Party, the other party shall have the right to file patent
869	applications in those countries, in its own name and at its own expense. The
870	Responsible Party shall assist in the transfer of rights for the latter patent
871	applications and shall provide all information necessary to file and prosecute
872	such patent applications.
873
874	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
875	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
876	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
877	<PAGE>
878
879	Janssen-Medisorb Page 7
880	License Agreement
881
882	The Responsible Party shall not abandon part or whole of any of the
883	patents or patent applications without having first consulted the other party,
884	which shall have the right to further pursue any patents or patent applications
885	which the responsible party wishes to abandon, or parts thereof, in its own name
886	and at its own expense.
887
888	All out-of-pocket costs made in relation to joint patent applications
889	and patents shall be shared equally by Janssen and Medisorb. A statement of
890	costs shall be made up on a quarterly basis and invoiced to the other party.
891
892	Medisorb shall grant to Janssen an exclusive fully-paid up royalty
893	free license with the right to sublicense to make, have made, use and sell under
894	any such patents or patent applications for the duration of the patents, any
895	continuations, continuations in part, divisions, patents of addition, reissues,
896	renewals or extensions thereof or any supplementary protection certificates
897	granted with respect thereto, in respect of any claims concerning the
898	application of [ ] or any chemical analogues of [
899	] with similar physiological activity. However, nothing contained in this
900	paragraph shall obviate Janssen's obligation to pay royalties under Section 3
901	hereof with respect to any Products developed hereunder.
902
903	Janssen shall grant to Medisorb an exclusive fully paid-up royalty
904	free license with the right to sublicense to make, have made, use and sell under
905	any such patents or patent applications for the duration of the patents, any
906	continuations, continuations in part, divisions, patents of addition, reissues,
907	renewals or extensions thereof or any supplementary protection certificates
908	granted with respect thereto, in respect of any claims concerning the
909	application of bioabsorbable polymers in the field of human and/or veterinary
910	medicine.
911
912	(d) In addition, each party will retain exclusive title to its
913	respective confidential information in accordance with the provisions of Article
914	9 below.
915
916	(6) Patent Infringement
917	-------------------
918
919	(a) In the event that either party becomes aware that any third
920	party is infringing any patents included within the Patents in any country or
921	countries, the party becoming aware of such infringement shall promptly give
922	notice of such infringement to the other party. Any possible action against such
923	alleged infringement of the Patents will be carried out by either or both of the
924	parties in accordance with the provisions specified hereinafter in paragraphs
925	(b), (c), (d) and (e).
926
927	(b) Whenever it would concern a patent or patent application
928	falling within the definition of Patents and of which Medisorb retains full
929	title and ownership pursuant to Article 5 a), Medisorb shall use all reasonable
930	efforts to take action against such infringement in its own name, at its own
931	expense and on its own behalf.
932
933	If Medisorb fails to take action against such infringement, or if
934	Medisorb does not use reasonable efforts in carrying out such action after
935	commencement thereof, within thirty (30) days after the notice referred to in
936	paragraph (a) above or after having become aware of such infringement, Janssen
937	shall be entitled at its own discretion and at its own expense, to take
938	immediate action against
939
940	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
941	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
942	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
943	<PAGE>
944
945	Janssen-Medisorb Page 8
946	License Agreement
947
948	such infringement in its own name, at its own expense and on its own behalf. If
949	Janssen commences or assumes such action, Janssen may credit [
950	] of any royalty otherwise due to Medisorb for sales in such country or
951	countries against the amount of the expenses and costs of such action, including
952	without limitation, attorney fees actually incurred by Janssen. The amount of
953	expenses so deducted shall be paid to Medisorb out of the recoveries, if any,
954	received by Janssen as a result of such action. Except for such repayment of
955	royalties deducted, Janssen shall be entitled to retain all recoveries
956	therefrom.
957
958	In no event shall Medisorb settle with such infringing third party in
959	the Field without the prior written consent of Janssen.
960
961	(c) Whenever it would concern a patent or patent application
962	falling within the definition of Patents and of which Janssen retains full title
963	and ownership pursuant to Article 5 B), Janssen shall have the right but not the
964	obligation to take action against such infringement in its own name, at its own
965	cost and on its own behalf. If Janssen fails to take action against such
966	infringement, or if Janssen does not use reasonable efforts in carrying out such
967	action after commencement thereof, within thirty (30) days after the notice
968	referred to in paragraph (a) above or after having become aware of such
969	infringement, Medisorb shall be entitled at its own discretion and at its own
970	expense, to take action against such infringement. Medisorb shall be entitled to
971	retain all recoveries, if any, therefrom.
972
973	(d) Whenever it would concern a patent or patent application
974	falling within the definition of Patents and of which Janssen and Medisorb
975	jointly retain full title and ownership pursuant to Article 5 (c), and whenever
976	in such case the infringing product would be a drug product falling within the
977	definition of the Field, Janssen shall have the right but not the obligation to
978	take action against such infringement in its own name, at its own cost and on
979	its own behalf. If Janssen fails to take action against such infringement, or if
980	Janssen does not use reasonable efforts in carrying out such action after
981	commencement thereof, within thirty (30) days after the notice referred to in
982	paragraph (a) above or after having become aware of such infringement, Medisorb
983	shall be entitled at its own discretion and at its own expense, to take action
984	against such infringement, it being understood that Janssen will have a
985	continuing right to take over any such action at its own expense and shall pay
986	to Medisorb from any recoveries Janssen receives (i) Medisorb's expenses and
987	(ii) from any sums remaining after deduction of Medisorb's and Janssen's
988	expenses, an amount proportionate to Medisorb's expenses in relation to
989	Janssen's expenses.
990
991	Whenever it would concern a patent or patent application falling
992	within the definition of Patents and of which Janssen and Medisorb jointly
993	retain full title and ownership pursuant to Article 5 (c), and whenever in such
994	case the infringing product would be a drug product falling outside the
995	definition of the Field, Medisorb shall have the right but not the obligation to
996	take action against such infringement in its own name, at its own cost and on
997	its own behalf. If Medisorb fails to take action against such infringement, or
998	if Medisorb does not use reasonable efforts in carrying out such action after
999	commencement thereof, within thirty (30) days after the notice referred to in
1000	paragraph (a) above or after having become aware of such infringement, Janssen
1001	shall be entitled at its own discretion and at its own expense, to take action
1002	against such infringement, it being understood that Medisorb will have a
1003	continuing right to take over any such action at its own
1004
1005	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1006	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1007	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1008	<PAGE>
1009
1010	Janssen-Medisorb Page 9
1011	License Agreement
1012
1013	expense. If Janssen commences or assumes such action, Janssen may credit [
1014	] of any royalty otherwise payable to Medisorb payable hereunder against the
1015	amount of the expenses and costs of such action, including without limitation,
1016	attorney fees actually incurred by Janssen. The amount of expenses so deducted
1017	shall be paid to Medisorb out of the recoveries, if any, received by Janssen as
1018	a result of such action. Except for such repayment of royalties deducted,
1019	Janssen shall be entitled to retain all recoveries therefrom.
1020
1021	(e) Each party agrees to cooperate reasonably with the other party
1022	in such litigation, including making available to the other party records,
1023	information, and evidence relevant to the infringement of the Patent.
1024
1025	(7) Third Party Intellectual Property Rights
1026	----------------------------------------
1027
1028	(a) Medisorb warrants that to the best of its current knowledge
1029	and belief the Products to be developed hereunder will not infringe the patent
1030	rights of any third party.
1031
1032	(b) In the event that the manufacture, use or sale of the Product
1033	would constitute an infringement of the rights of a third party in a country
1034	because of the use of the Patents or Medisorb's know how, each party shall, as
1035	soon as it becomes aware of the same, notify the other thereof in writing,
1036	giving in the same notice full details known to it of the rights of such third
1037	party and the extent of any alleged infringement. The parties shall after
1038	receipt of such notice meet to discuss the situation, and, to the extent
1039	necessary attempt to agree on a course of action in order to permit Janssen to
1040	practice the license granted hereunder. Such course of action may include: (a)
1041	modifying the Product or its manufacture so as to be noninfringing; (b)
1042	obtaining an appropriate license from such third party; or (c) fight the claimor
1043	suit. In the event that within a short period of time, the parties fail to
1044	agree on an appropriate course of action Janssen may decide upon the course of
1045	action in the interest of the further development, manufacturing or
1046	commercialization of the Product.
1047
1048	(c) In the event that the parties cannot agree on modifying the
1049	Product or in the case that such modification would not be economically viable
1050	or regulatorily feasible, Janssen, whenever it relates to know how, whether
1051	patented or not, owned by Janssen in accordance with the provisions of Article 5
1052	(b) and (c), or Medisorb, whenever it relates to know how, whether patented or
1053	not, owned by Medisorb in accordance with the provisions of Article 5 (a), will
1054	have the right to negotiate with such third party for such license. Both
1055	parties hereto will in any event in good faith consult with each other with
1056	respect to such negotiations and the party negotiating such license as indicated
1057	above, will make every effort to minimize the amount of license fees and
1058	royalties payable thereunder. In no event shall either party as a result of
1059	such settlement, grant a sublicense or cross license to the third party to
1060	settle the suit, without the prior written approval of the other party. In the
1061	event that such negotiations result in a consummated agreement, any license fee
1062	and/or royalties to be paid thereunder shall be paid by the party responsible
1063	for the negotiations as indicated above, [ ] of any license
1064	fees or royalties paid by Janssen under such license will be creditable against
1065	royalties due to Medisorb with respect to such country or countries.
1066
1067	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1068	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1069	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1070	<PAGE>
1071
1072	Janssen-Medisorb Page 10
1073	License Agreement
1074
1075	(d) In the event that either or both parties would further to such
1076	notification under Paragraph 7 (b) decide to defend such suit or claim in which
1077	a third party alleges that the manufacture, use or selling of the Product
1078	infringes said third party's patent in a country, Janssen shall have the right
1079	to apply [ ] of the royalties due to Medisorb on the
1080	sales of the allegedly infringing Product against its litigation expenses.
1081
1082	(8) Term:
1083	----
1084
1085	(a) Except as otherwise provided herein, this Agreement and the
1086	term of the license granted to Janssen hereunder shall commence on the date
1087	first written above and shall expire (i) upon expiration of the last to expire
1088	Patent in such country or (ii) fifteen (15) years after the date of the first
1089	commercial sale of Product in such country, whichever is later; provided, that
1090	in no event shall the license granted hereunder expire later than the twentieth
1091	anniversary of the first commercial sale of Product in any country with the
1092	exception of the following countries where the fifteen (15) year minimum shall
1093	pertain regardless: Canada, France, Germany, Italy, Japan, Spain and the United
1094	Kingdom. After expiration of the license granted to Janssen hereunder, Janssen
1095	shall retain a fully paid-up non-exclusive license to manufacture, use and sell
1096	Products in the Field in the Territory.
1097
1098	(b) Medisorb may convert the exclusive license granted under this
1099	Agreement to non-exclusive if Janssen does not maintain the following minimum
1100	annual royalty payments to Medisorb:
1101
1102	(i) With respect to the entire Territory, excluding Japan, the
1103	minimum royalty obligation will first apply to the twelve month period following
1104	the anniversary of the end of the ;month in which the Product was launched in
1105	the third major country. For the purpose of this Article only, major country
1106	shall mean France, Germany, United Kingdom or Italy. During the first twelve
1107	month period that such minimum royalty obligation is applicable, the minimum
1108	royalty amount to be paid by Janssen will be calculated by multiplying the
1109	applicable royalty rate by [ ] percent of the actual aggregate net sales of
1110	other [ ] products during such twelve month period in the three major countries
1111	referred to above.
1112
1113	As from the subsequent twelve month period the minimum annual royalty amount to
1114	be paid by Janssen will be calculated by multiplying the applicable royalty rate
1115	by [ ]% of the aggregate net sales of other [ ] products
1116	during such period in all countries where Product has been launched and marketed
1117	for a period of minimally twelve months prior to the actual reference twelve
1118	month period; and
1119
1120	(ii) In Japan the minimum royalty obligation will be first
1121	applied to the twelve month period following the anniversary of the end of the
1122	month in which the Product was launched. The minimum annual royalty amount to be
1123	paid by Janssen will be calculated by multiplying the applicable royalty rate by
1124	an amount representing [ ]% of the aggregate net sales of other [ ] products in
1125	Japan during such period.
1126
1127	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1128	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1129	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1130	<PAGE>
1131
1132	Janssen-Medisorb Page 11
1133	License Agreement
1134
1135	Janssen shall have the right to make up any shortfall in minimum royalty
1136	payments from Product sales, both in Japan and in the rest of the Territory
1137	provided, such make-up payment is made at the same time and in the same manner
1138	as required for the underlying minimum royalty obligation.
1139
1140	Janssen may elect to have its exclusive rights converted into non-exclusive
1141	rights on a country by country basis. As a consequence thereof, such country's
1142	other [ ] products sales will no longer be taken into account
1143	for calculating the above minimum royalty obligation.
1144
1145	(c) In the event that either party shall enter or be put into
1146	voluntary or compulsory liquidation or have a receiver appointed or default in
1147	the observance or performance of its obligations under this Agreement and shall
1148	fail to remedy such default within ninety (90) days after the delivery of
1149	written notice from the other party, the other party shall be entitled upon
1150	giving written notice to terminate this Agreement.
1151
1152	(d) Janssen may terminate this Agreement without cause upon 30
1153	days prior written notice. Thereafter, Janssen shall have no further rights or
1154	privileges with respect to the use of Medisorb Technology in Products and
1155	Medisorb shall be under no further obligation of non-competition or exclusive
1156	dealing.
1157
1158	(e) Any early termination of the Agreement shall be without
1159	prejudice to the rights of either party against the other accrued under this
1160	Agreement prior to termination.
1161
1162	(f) Upon any termination of this Agreement, any remaining
1163	inventory of Product may be sold, provided all royalties otherwise due hereunder
1164	are paid with respect to such sales.
1165
1166	(9) Confidentiality:
1167	---------------
1168
1169	(a) Each party agrees to keep confidential and to not use for any
1170	purpose other than as set forth herein all technical information and materials
1171	supplied by the other hereunder and any information a party may acquire about
1172	the other or its activities as a result of entering into this Agreement,
1173	provided that such obligation shall not apply to technical information or
1174	material which: (i) was in the receiving party's possession without restriction
1175	prior to receipt from the other party or its Affiliates; (ii) was in the public
1176	domain at the time of receipt; (iii) becomes part of the public domain through
1177	no fault of the receiving party; (iv) shall be lawfully received from a third
1178	party with a right of further disclosure; (v) shall be required to be disclosed
1179	by law, by regulation or by the rules of any securities exchange.
1180
1181	(b) Except as may be otherwise provided herein, the
1182	confidentiality obligations as set out in this Section shall continue so long as
1183	this Agreement remains in force and thereafter for a period of seven (7) years.
1184
1185	(c) Janssen shall cause its Affiliates and Sublicensees to abide
1186	by the obligations of confidentiality with respect to unpublished information
1187	within the Patents and Technical Information.
1188
1189	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1190	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1191	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1192	<PAGE>
1193
1194	Janssen-Medisorb Page 12
1195	License Agreement
1196
1197	(d) Any confidential information relating to the subject matter of
1198	this Agreement imparted to the other party prior to the execution of this
1199	Agreement shall be considered to fall under the terms of this Agreement.
1200
1201	(10) Disclaimer of Warranty: Medisorb makes no representations or
1202	----------------------
1203	warranties, express or implied, with respect to the Medisorb Patents and
1204	Technical Information licensed to Janssen hereunder, including without
1205	limitation any warranties of merchantability or fitness for a particular
1206	purpose.
1207
1208	(11) Liability
1209	---------
1210
1211	(a) Janssen agrees to indemnify, defend and hold harmless Medisorb
1212	from and against any liability, loss, damages and expenses (including reasonable
1213	attorney fees) Medisorb may suffer as the result of claims, demands, costs or
1214	judgments which may be made or instituted against Medisorb by reason of personal
1215	injury or damage to property arising out or caused by Janssen's promotion, use
1216	and sale of the Product, except where such liabilities claims, demands, costs or
1217	judgments are caused by Medisorb's failure to provide Janssen with any
1218	information as specified in Section 12 (c) and Article 13. Medisorb will notify
1219	Janssen as soon as it becomes aware of any such claim or action and agrees to
1220	give reasonable assistance in the investigation and defense of such claim or
1221	action it being understood that it shall allow Janssen to control the
1222	disposition of the same.
1223
1224	(b) Medisorb agrees to indemnify, defend and hold harmless Janssen
1225	from and against any liability, loss, damages and expenses (including reasonable
1226	attorney fees) Janssen may suffer as the result of claims, demands, costs or
1227	judgments which may be made or instituted against Janssen by reason of personal
1228	injury or damage to property arising out or caused by Medisorb's failure to
1229	provide Janssen with any information as specified in Section 12 (c) and Article
1230	13
1231
1232	(c) In no event shall either party be liable for loss of profits,
1233	loss of goodwill or any consequential or incidental damages of any kind of the
1234	other party.
1235
1236	(12) Product Information and Adverse Drug Events
1237	-------------------------------------------
1238
1239	(a) As Janssen has superior knowledge of the end-use applications
1240	to which Products licensed hereunder will be put, Janssen is responsible for
1241	providing third parties with adequate information as to the medical profile of
1242	such Products. Janssen will provide Medisorb with copies of the IPID
1243	(International Product Information Document) and the IPPI (International Patient
1244	Package Insert), which are all part of the IRF for the Product. For the purpose
1245	of this Agreement IPID refers to the document that summarizes all medically
1246	relevant features of the Product, including the instructions for use meant to
1247	inform the medical profession, whereas the IPPI is a patient-oriented document,
1248	based upon the IPID that summarizes all relevant information on the Product in
1249	lay language. Janssen will keep Medisorb informed of any revisions or amendments
1250	in the IPID and IPPI of the Product.
1251
1252	(b) Medisorb does not claim the expertise to judge whether
1253	Product(s) will perform acceptably in Janssen's application(s). Janssen is the
1254	sole judge as to whether Product(s) will
1255
1256	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1257	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1258	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1259	<PAGE>
1260
1261	Janssen-Medisorb Page 13
1262	License Agreement
1263
1264	perform acceptably in Janssen's application(s). Janssen represents and warrants
1265	on an on-going basis during the term of this agreement that it has the
1266	capability to assess the suitability of Product(s) in Janssen's application(s)
1267	and agrees to conduct adequate testing to confirm the safety and efficacy of
1268	Products prior to commercialization.
1269
1270	(c) Medisorb will provide to Janssen promptly after its discovery
1271	by Medisorb, any information in its possession which indicates adverse effects
1272	in humans associated with the Products, including the bioabsorbable polymeric
1273	components thereof, licensed hereunder. For the purpose of this Agreement
1274	"adverse event" shall mean an experience which is noxious and unintended and
1275	which occurs at doses normally used in man for the prophylaxis, diagnosis or
1276	therapy of a disease or for the modification of a physiological function and any
1277	report of an overdose.
1278
1279	(13) Government Approvals
1280	--------------------
1281
1282	Janssen shall be responsible for conducting all necessary testing as
1283	well as determining what, if any, government approvals are required for the use
1284	and sale of Product licensed hereunder and shall comply with all such
1285	requirements prior to and following the sale or distribution of such Products.
1286
1287	Medisorb shall cooperate fully with Janssen in obtaining regulatory
1288	approvals for Product licensed hereunder and shall, at Janssen's request,
1289	provide appropriate regulatory authorities with any and all information
1290	concerning Medisorb's technology, Medisorb polymers and Medisorb's manufacturing
1291	process for such Product.
1292
1293	In this respect Medisorb undertakes that it has submitted or will as
1294	soon as possible submit a type IV Drug Master File to the FDA identifying
1295	Medisorb's method of manufacture, release specifications and testing methods
1296	used in the manufacture of its bioabsorbable polymers and a type I Drug Master
1297	File of Medisorb's manufacturing facilities where Product may be manufactured.
1298	Medisorb will authorize Janssen at its request to cross-reference any Medisorb
1299	Drug Master Files relating to the Medisorb Polymers.
1300
1301	(14) Force Majeure: Neither party shall be liable for its failure to
1302	-------------
1303	perform any of its obligations hereunder if such failure is occasioned by a
1304	contingency beyond its reasonable control including, but not limited to,
1305	occurrences such as strikes or other labor disturbances, lock out, riot, war,
1306	default by a common carrier, fire, flood, storm, earthquake, other acts of God,
1307	inability to obtain raw materials, failure of plant facilities or government
1308	regulation, act or failure to act. Each party shall notify the other immediately
1309	upon occurrence or cessation of any such contingencies. If such contingency
1310	continues unabated for at least 180 consecutive days, either party shall have
1311	the right to terminate this Agreement without further obligation beyond those
1312	actually incurred prior to such termination.
1313
1314	(15) Press Communications: Neither party shall originate any
1315	--------------------
1316	publicity, news release or public announcement, written or oral relating to this
1317	Agreement, including its existence, without the prior written approval of the
1318	other party.
1319
1320	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1321	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1322	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1323	<PAGE>
1324
1325	Janssen-Medisorb Page 14
1326	License Agreement
1327
1328	(16) Notices: Any legal notice required or permitted hereunder shall
1329	-------
1330	be considered properly given if in writing and sent by first class mail,
1331	certified mail or by telefacsimile to the party being notified at the respective
1332	address of such party as follows:
1333
1334	If to Medisorb:
1335
1336	Medisorb Technologies International L.P.
1337	6954 Cornell Road
1338	Cincinnati, OH 45242
1339	USA
1340	Facsimile: 513-489-2348
1341
1342	If to Janssen:
1343
1344	Janssen Pharmaceutica
1345	Kollerstrasse 38
1346	6300 Zug 6
1347	Switzerland
1348	Facsimile: 00-41-42449565
1349
1350	Such notice shall be effective upon receipt or upon refusal to accept such
1351	notice. In any case, notice shall be presumed effective no later than five (5)
1352	days after such notice is sent.
1353
1354	Neither party shall originate any publicity, news release or public
1355	announcement, written or oral, relating to this Agreement, including its
1356	existence, without the written approval of the other party.
1357
1358	(17) Assignment: This Agreement shall not be assigned by either party
1359	----------
1360	without the prior written consent of the other party; provided, however, that
1361	assignment shall be permitted without such consent to any party, not less than
1362	50% of the total interest of which owns, is owned by, or is under common control
1363	with the assigning party. In the event of any such permitted assignment the
1364	assignee shall be subject to and shall agree in writing to be bound by the terms
1365	and conditions of this Agreement.
1366
1367	(18) Dispute Resolution: The parties shall amicably discuss and
1368	------------------
1369	negotiate any matters which arise under this Agreement and are not specifically
1370	set forth hereunder. If any disputes arise under this Agreement, the parties
1371	shall use their best efforts to meet and resolve such disputes. In the event
1372	that the parties are unable to resolve any such disputes, then both parties
1373	hereby agree to submit said disputes to the jurisdiction of the competent Courts
1374	of Zurich, Switzerland, and agree that any litigation in any way related to this
1375	Agreement shall be submitted to such Courts and that same shall be subject to
1376	Swiss law.
1377
1378	(19) Severability: In the event any one or more of the provisions of
1379	------------
1380	this Agreement should for any reason be held by any court or authority having
1381	jurisdiction over this Agreement or any of the parties hereto to be invalid,
1382	illegal or unenforceable such provision or
1383
1384	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1385	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1386	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1387	<PAGE>
1388
1389	Janssen-Medisorb Page 15
1390	License Agreement
1391
1392	provisions shall be validly reformed to as nearly approximate the intent of the
1393	parties as possible and, if unreformable; shall be divisible and deleted in such
1394	jurisdiction, elsewhere this Agreement shall not be affected.
1395
1396	(20) Captions: The captions of this Agreement are for convenience
1397	--------
1398	only, and shall not be deemed of any force or effect whatsoever in construing
1399	this Agreement.
1400
1401	(21) Waiver: The failure on the party of a party to exercise or
1402	------
1403	enforce any right conferred upon it hereunder shall not be deemed to be a waiver
1404	of any such right, nor operate to bar the exercise or enforcement thereof at any
1405	time thereafter.
1406
1407	(22) Survival: The following Articles of this Agreement shall survive
1408	--------
1409	the termination or expiration of this Agreement: 5, 9, 10, 11, 15, 17, and 18.
1410
1411	(23) Miscellaneous: This Agreement may be executed by the parties
1412	-------------
1413	hereto in counterparts, each of which when so executed and delivered shall be
1414	considered to be an original, but all such counterparts shall together
1415	constitute but one and the same instrument. This Agreement is the complete
1416	agreement of the parties and supersedes all previous understandings and
1417	agreements relating to the subject matter hereof. Neither this Agreement nor
1418	any of the terms hereof may be terminated, amended, supplemented, waived or
1419	modified orally , but only by an instrument in writing signed by the party
1420	against whom enforcement of the termination, amendment, supplement, waiver or
1421	modification is sought.
1422
1423	IN WITNESS WHEREOF, the duly authorized representatives of the parties
1424	hereto have executed this Agreement as of the day and year first above written.
1425
1426
1427	JANSSEN PHARMACEUTICA INTERNATIONAL
1428	A division of Cilag International AG
1429
1430
1431	By: _________________________
1432	Name: _______________________
1433	Title: ______________________
1434	Date: _______________________
1435
1436
1437	{Second Janssen Signatory}
1438	- --------------------------
1439
1440
1441	By: _________________________
1442	Name: _______________________
1443	Title: ______________________
1444	Date: _______________________
1445
1446	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1447	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1448	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1449	<PAGE>
1450
1451	Janssen-Medisorb Page 16
1452	License Agreements
1453
1454	MEDISORB TECHNOLOGIES INTERNATIONAL L.P.
1455
1456
1457	by: Medisorb Technologies
1458	International, Inc.,
1459	its General Partner
1460
1461
1462	By: __________________________
1463	Name: David R. Lohr
1464	------------------------
1465	Title: President
1466	-----------------------
1467	Date: ________________________
1468
1469	12059504.doc
1470	12/5/1995
1471
1472	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1473	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1474	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1475	<PAGE>
1476
1477	EXHIBIT C
1478
1479
1480	To Development Agreement
1481	dated December 23, 1993
1482	between
1483	Janssen Pharmaceutica International
1484	and
1485	Medisorb Technologies International L.P.:
1486
1487
1488	License Agreement, United States of America
1489	Following 16 Pages
1490
1491
1492
1493	/s/ Paul F. Costa 12/12/95
1494	- ----------------- --------
1495	For JANSSEN Date
1496
1497
1498	/s/ David R. Lohr December 6, 1995
1499	- ------------------ ----------------
1500	For MEDISORB Date
1501
1502	12059503.doc
1503
1504	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1505	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1506	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1507	<PAGE>
1508
1509	LICENSE AGREEMENT
1510
1511	This Agreement is made as of the __ day ______ of 19___, between
1512	MEDISORB TECHNOLOGIES INTERNATIONAL L.P., a Delaware limited partnership
1513	(hereinafter "Medisorb") and JANSSEN PHARMACEUTICA INC., a New Jersey
1514	corporation ("Janssen US").
1515
1516	WHEREAS, Medisorb and Janssen Pharmaceutica International, an
1517	affiliate of Janssen US, have entered into a certain Development Agreement,
1518	dated December 23, 1993 (the "Development Agreement"), for the development of a
1519	Product (as described below); and
1520
1521	WHEREAS, Janssen Pharmaceutica International has an option under the
1522	Development Agreement to enter into this License Agreement for the Medisorb
1523	technology required to make, use and sell the Product, which option Janssen
1524	Pharmaceutica International has assigned to Janssen US with the consent of
1525	Medisorb and which option Janssen US has elected to exercise; and
1526
1527	WHEREAS, the parties believe that it is in their mutual best interest
1528	for Medisorb to license to Janssen US on an exclusive basis in the Territory,
1529	Medisorb Patents and Technical Information within the Field, upon the terms and
1530	conditions set forth herein;
1531
1532	NOW, IT IS HEREBY AGREED AS FOLLOWS:
1533
1534	(1) Definitions: The following terms shall have the meanings ascribed
1535	-----------
1536	to them herein, unless the context otherwise requires:
1537
1538	(a) "Affiliate" shall mean any company controlling, controlled by,
1539	or under common control with a party by ownership, directly or indirectly, of
1540	fifty percent (50%) or more of the total ownership or by the power to control
1541	the policies and actions of such company.
1542
1543	(b) "Development Program" shall mean the development activities
1544	conducted by the parties pursuant to the Development Agreement.
1545
1546	(c) "Field" shall mean the treatment of [
1547
1548
1549
1550	].
1551
1552	(d) "Improvements" shall mean any improvements or developments to
1553	or of the Patents and Technical Information in the Field which Medisorb may
1554	acquire, discover, invent, originate, make, conceive or have a right to, in
1555	whole or in part, during the term of this Agreement, whether or not such
1556	improvement or development is patentable.
1557
1558	(e) "Medisorb Polymers" shall mean bioresorbable aliphatic
1559	polyesters based on glycolide, lactide, caprolactone and combinations of such
1560	polymers, which are manufactured by Medisorb and utilized in Product(s) licensed
1561	under this Agreement.
1562
1563	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1564	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1565	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1566	<PAGE>
1567
1568	Janssen US-Medisorb Page 2
1569	License Agreement
1570
1571	(f) "NDA" shall mean a New Drug Application and all supplements
1572	filed pursuant to the requirements of the United States Food and Drug
1573	Administration, including all documents, data and other information concerning
1574	Product which are necessary for, or included in, FDA approval to market a
1575	Product as more fully defined in 21 C.F.R. 314.5 et seq. or any other similar
1576	application for marketing authorization filed with the appropriate regulatory
1577	authorities in other countries of the Territory (as defined hereinafter).
1578
1579	(g) "Net Sales" shall mean the gross amounts received from sales
1580	of Products during a calendar quarter to third parties by Janssen US, its
1581	Sublicensees or any Affiliate of either, less any: (i) applicable sales taxes;
1582	(ii) cash trade or quantity discounts; (iii) amounts repaid or credited by
1583	reason of rejections or return of goods; or (iv) freight, postage and duties
1584	paid for. No deduction from the gross sales price shall be made for any item of
1585	cost incurred by the seller in its own operations incident to the manufacture,
1586	sale or shipment of the product sold. For purposes hereof, Net Sales shall not
1587	include sales of a Product from Janssen US or an Affiliate of Janssen US to any
1588	Affiliate or Sublicensee of either; it being intended that Net Sales shall only
1589	include sales to unrelated third-parties.
1590
1591	(h) "Patents" shall mean (i) any and all existing issued patents
1592	and patent applications or parts thereof which describe and claim a depot
1593	formulation of [ ], or any chemical analogues of [ ] with similar
1594	physiological activity, based on polymers of lactic and glycolic acids and the
1595	production and use thereof; (ii) any other patents and patent applications filed
1596	by or on behalf of Medisorb, or under which Medisorb has the rights to grant
1597	licenses, which are needed to practice the inventions; and (iii) any reissues,
1598	extensions, substitutions, confirmations, registrations, revalidations,
1599	additions, continuations, continuations-in-part, or divisions of or to any of
1600	the foregoing which are granted hereafter or any additional protection
1601	certificate granted with respect thereto.
1602
1603	(i) "Product(s)" shall mean any and all depot formulations of [
1604	], or any chemical analogues of [ ] with similar physiological
1605	activity, based on polymers of lactic and glycolic acids which are designed to
1606	deliver [ ], or any of its chemical analogues, over an extended period.
1607
1608	(j) "Sublicensees" shall mean any company or companies, other than
1609	Janssen US's Affiliates, sublicensed by Janssen US.
1610
1611	(k) "Technical Information" shall mean all unpatented information,
1612	know-how, practical experience, procedures, methodology, specifications,
1613	formulae and data whether or not the same shall be patentable which have been
1614	heretofore developed or acquired by Medisorb prior to the date of this Agreement
1615	and which are necessary in order to use, manufacture or sell Products in the
1616	Field.
1617
1618	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1619	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1620	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1621	<PAGE>
1622
1623	Janssen US-Medisorb Page 3
1624	License Agreement
1625
1626	(l) "Territory" shall mean the United States, its Territories,
1627	Protectorates, Commonwealths, and all other political subdivisions of the United
1628	States.
1629
1630	(2) License Grant
1631	-------------
1632
1633	(a) Medisorb hereby grants to Janssen US in the Territory an
1634	exclusive license under the Patents and Technical Information existing prior to
1635	the effective date of this Agreement, with the right to grant sublicenses
1636	thereunder, for all purposes within the Field to practice and use the Patents
1637	and Technical Information, including the rights to manufacture and have
1638	manufactured, to use and have used, and to sell and have sold Products. Medisorb
1639	exclusively retains all rights under the Patents and Technical Information
1640	outside the Field and for use other than in Products. The right to grant
1641	sublicenses granted hereunder is exclusive to Janssen US and shall not extend to
1642	Janssen US Affiliates or Sublicensees.
1643
1644	(b) Medisorb shall offer to Janssen US for incorporation into this
1645	License Agreement on reasonable terms and conditions, Medisorb Improvements in
1646	the Field which, if incorporated into Janssen US's then current commercial
1647	Product(s), would: (i) result in significant changes in either the
1648	specifications for such Product(s) or the processes for producing such
1649	Product(s), and (ii) would reasonably be expected to result in enhanced market
1650	value and/or profitability of such Product(s). Examples of such Improvements
1651	would include: (i) the development by Medisorb of a non-aqueous injection
1652	vehicle which offers significant advantages with respect to ease of
1653	administration and (ii) the development by Medisorb of technology enabling [
1654	]. It is the parties'
1655	understanding that the effect of any such license amendment would, in general,
1656	be either an extension of the term of this Agreement for a mutually agreed
1657	period or a marginal increase in the then current royalty rate . All other
1658	Medisorb Improvements shall be made available to Janssen US for its use without
1659	further agreement. Proprietary rights to Improvements jointly developed by
1660	Medisorb and Janssen US or any of its Affiliates shall be governed by the terms
1661	of Section 5(c) of this Agreement.
1662
1663	(c) In the event that at any time during the term of this
1664	Agreement Medisorb is unable for any reason whatsoever to supply the Medisorb
1665	Polymers required by Janssen U.S. for use in Products, then the license granted
1666	under paragraph 2(a) above shall be expanded to include the Medisorb Technology
1667	required to make and use the Medisorb Polymers.
1668
1669	(3) Royalties:
1670	----------
1671
1672	(a) Janssen US shall pay or cause to be paid to Medisorb a running
1673	royalty with respect to all Products sold to customers in the Territory by
1674	Janssen
1675
1676	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1677	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1678	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1679	<PAGE>
1680
1681	Janssen US-Medisorb Page 4
1682	License Agreement
1683
1684	US, its Affiliates and Sublicensees, payable quarter-annually in arrears within
1685	sixty (60) days following the end of Janssen US's regular fiscal quarters in any
1686	year during the term hereof, as follows: (i) [ ]% of the Net Sales of each
1687	unit of Product sold during the preceding calendar quarter during the term
1688	hereof, if such unit of Product was manufactured by Medisorb pursuant to a
1689	written contract for the supply of Product; or (ii) [ ] % of the Net Sales of
1690	each unit of Product sold during the preceding calendar quarter during the term
1691	hereof, if such unit of Product was not manufactured by Medisorb pursuant to a
1692	written contract for the supply of Product. Any withholding or other tax that
1693	Janssen US or any of its Affiliates or Sublicensees are required by statute to
1694	withhold and pay on behalf of Medisorb with respect to the royalties payable to
1695	Medisorb under this Agreement shall be deducted from said royalties and paid
1696	contemporaneously with the remittance to Medisorb; provided, however, that in
1697	regard to any tax so deducted Janssen US shall furnish Medisorb with proper
1698	evidence of the taxes paid on its behalf.
1699
1700	(b) In the event that Product is not claimed in a valid Patent
1701	effective in the Territory and a similar product obtains a market share greater
1702	than [ ]% of the total market revenues for Products and similar products in
1703	such country, the parties agree to meet and negotiate in good faith an
1704	appropriate reduction in the royalty rate then in effect. In no event shall a
1705	reduction in royalty rates pursuant to this section result in royalty rates [
1706	] of the rates specified under Section 3(a)(i) and 3(a)(ii) of this Agreement.
1707	For the purposes of this section, "similar product" shall mean a generic version
1708	of the Product(s) where: (i) the active agent is [ ], or a
1709	chemical analogue thereof and (ii) the excipient is comprised of lactic and/or
1710	glycolic acids. In the event that patent protection in the Territory for
1711	Product(s) becomes available subsequent to a royalty reduction pursuant to this
1712	section, the parties agree to (i) reinstitute the royalty otherwise applicable,
1713	and (ii) in the event that any recovery is obtained for prior infringement of
1714	the subsequently issued patent, the parties will first apply such recoveries to
1715	reimbursing Medisorb for royalties it would otherwise have received.
1716
1717	(c) Janssen US shall keep complete and adequate records with
1718	respect to the proceeds of Products on which it has to pay royalties payable
1719	hereunder for at least two (2) years after expiry of the year they concern.
1720	Medisorb shall have the right to have such records of Janssen US inspected and
1721	examined, at Medisorb's expense, for the purpose of determining the correctness
1722	of royalty payments made hereunder.
1723
1724	Such inspection shall be made by an independent, certified public accountant to
1725	whom Janssen US shall have no reasonable objection. Such accountant shall not
1726	disclose to Medisorb any information other than that necessary to verify the
1727	accuracy of the reports and payments made pursuant to this Agreement. It is
1728	understood that such examination with respect to any quarterly accounting period
1729	shall take place not later than two (2) years following the expiration of said
1730	period. Not more than one examination per year shall take place.
1731
1732	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1733	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1734	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1735	<PAGE>
1736
1737	Janssen UA-Medisorb Page 5
1738	License Agreement
1739
1740	Based upon the verification of such reports and whenever there is reasonable
1741	doubt about the accuracy of the sales of Product realized by an Affiliate or
1742	sublicensee, Medisorb may reasonably request Janssen US to audit the books of
1743	such Affiliate or such sublicensee in accordance with any applicable contractual
1744	provision, in order to confirm the accuracy of such reports.
1745
1746	(4) Production of Product/Technology Transfer:
1747	-----------------------------------------
1748
1749	(a) Janssen US shall use its reasonable efforts consistent with
1750	its overall business practices and strategies to commercialize and market
1751	Product, or to have the same commercialized and marketed in the Territory.
1752
1753	(b) In the event that Janssen US determines to manufacture Product
1754	itself or through an Affiliate or have Product manufactured by a third party,
1755	Medisorb shall transfer to Janssen US and/or Affiliate all relevant Technical
1756	Information, and provide such technical assistance, upon mutually agreed terms
1757	and conditions, as is required by Janssen US in order to enable the manufacture
1758	of Product by Janssen US, its Affiliate or its designated third party
1759	manufacturer. However, with respect to such third party manufacturers, except
1760	as limited by a written Product manufacturing agreement between Janssen US and
1761	Medisorb, Medisorb will have a right of first refusal as to the manufacture and
1762	supply to Janssen US of all Product(s), and component bioabsorbable polymers
1763	utilized in such Product(s). Medisorb will have a period of thirty (30) days
1764	following written notice from Janssen US of terms it is offering to, or prepared
1765	to accept from, a third party manufacturer to notify Janssen US of its intention
1766	to exercise its right of first refusal to supply Product and/or component
1767	bioabsorbable polymers thereof to Janssen US, its Affiliates and Licensees on
1768	terms no less favorable to Janssen US than those offered by such third party
1769	manufacturer. Such third party manufacturer cannot be an in-kind competitor to
1770	Medisorb and must be reasonably acceptable to Medisorb with respect to
1771	confidential protection of Medisorb's Technical Information. In the event that
1772	at any time during the term of this Agreement Medisorb is unable for any reason
1773	whatsoever to supply the Medisorb Polymers required by Janssen U.S. for use in
1774	Products, then the right of first refusal under this paragraph respecting the
1775	supply of the component bioabsorbable polymers shall be eliminated. For the
1776	purposes of this section, an "in-kind" competitor shall mean any organization
1777	which regularly engages in the contract development and/or contract manufacture
1778	of injectable controlled release drug delivery systems comprising a polymeric
1779	excipient based on lactic and/or glycolic acids and/or other closely related
1780	monomers. This Section 4(b) specifically supersedes Section 7(B) of the
1781	Development Agreement, which Section 7(B) shall be of no further force or
1782	effect.
1783
1784	(5) Proprietary Rights
1785	------------------
1786
1787	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1788	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1789	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1790	<PAGE>
1791
1792	Janssen US-Medisorb Page 6
1793	License Agreement
1794
1795	(a) Medisorb will retain title to and ownership of all technology
1796	(including, without limitation, all patents, inventions, and data relating
1797	thereto) relating to absorbable polymers, controlled release of active agents,
1798	and/or manufacturing methods or processes relating to such polymers and the
1799	controlled delivery systems for active agents based on such polymers previously
1800	owned by Medisorb or developed by Medisorb as a result of the Development
1801	Program or otherwise. Medisorb will pay its own costs and expenses in connection
1802	with the protection of any such technology, including all patent application and
1803	maintenance costs and Janssen US agrees to provide Medisorb with any necessary
1804	utility information.
1805
1806	Medisorb shall inform Janssen US of any patent application it wishes
1807	to file to protect proprietary rights defined in Article 5, resulting from
1808	either the Development Program or the preliminary Development Program and shall
1809	forward a copy of any such patent application to Janssen US at least one month
1810	prior to filing.
1811
1812	Medisorb shall consider any suggestions made by Janssen US for
1813	amplifying such application and shall accordingly amend the application where in
1814	Medisorb's opinion it is appropriate.
1815
1816	Medisorb shall not abandon part or whole of any of the patents or
1817	patent applications without having first consulted Janssen US, which shall have
1818	the right to further pursue any patents or patent applications which Medisorb
1819	wishes to abandon, or parts thereof, in its own name and at its own expense.
1820
1821	(b) Janssen US and/or its Affiliate will retain title to and
1822	ownership of all technology (including, without limitation, all patents,
1823	inventions, and data relating thereto) relating to [ ] or any chemical
1824	analogues of [ ] with similar physiological activity previously owned by
1825	Janssen US and/or its Affiliate or developed by Janssen US and/or affiliate as a
1826	result of this Agreement or otherwise. Janssen US and/or its Affiliate will pay
1827	its own costs and expenses in connection with the protection of any such
1828	technology, including all patent application and maintenance costs and Medisorb
1829	agrees to provide Janssen US with any necessary utility information.
1830
1831	(c) Any inventions, other than those falling under either section
1832	5(a) or 5(b) hereof, having an inventorship jointly between at least one
1833	employee of Janssen US or an Affiliate of Janssen US and one employee of
1834	Medisorb or an Affiliate of Medisorb shall be jointly-owned by Janssen US or
1835	Janssen US Affiliate as the case may be and Medisorb. Each party will cooperate
1836	fully in the filing and prosecution of such patent applications.
1837
1838	Janssen US and Medisorb shall agree on which of both shall be
1839	responsible for the filing, prosecution and maintenance of any such joint patent
1840	applications
1841
1842	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1843	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1844	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1845	<PAGE>
1846
1847	Janssen US-Medisorb Page 7
1848	License Agreement
1849
1850	and patents (hereinafter referred to as the "Responsible Party") in Territory.
1851	In principle, the party having contributed the most to the invention to be
1852	protected shall be the responsible party, unless agreed upon differently. Upon
1853	mutual consent, the responsible party may select an agent for drafting, filing
1854	and prosecuting a joint application. However, both parties shall agree who shall
1855	be the agent and to what extent this agent shall be used.
1856
1857	The Responsible Party shall consult the other party when drafting any
1858	new jointly owned patent application. The final draft shall be forwarded to the
1859	other party at least one month prior to filing to give the opportunity to make
1860	final comments.
1861
1862	The Responsible Party shall not abandon part or whole of any of the
1863	patents or patent applications without having first consulted the other party,
1864	which shall have the right to further pursue any patents or patent applications
1865	which the responsible party wishes to abandon, or parts thereof, in its own name
1866	and at its own expense.
1867
1868	All out-of-pocket costs made in relation to joint patent applications
1869	and patents in the Territory shall be shared equally by Janssen US and Medisorb.
1870	A statement of costs shall be made up on a quarterly basis and invoiced to the
1871	other party.
1872
1873	Medisorb shall grant to Janssen US an exclusive fully-paid up royalty
1874	free license with the right to sublicense to make, have made, use and sell under
1875	any such patents or patent applications for the duration of the patents, any
1876	continuations, continuations in part, divisions, patents of addition, reissues,
1877	renewals or extensions thereof or any supplementary protection certificates
1878	granted with respect thereto, in respect of any claims concerning the
1879	application of [ ] or any chemical analogues of [
1880	] with similar physiological activity. However, nothing contained in this
1881	paragraph shall obviate Janssen US's obligation to pay royalties under Section 3
1882	hereof with respect to any Products developed hereunder.
1883
1884	Janssen US shall grant to Medisorb an exclusive fully paid-up royalty
1885	free license with the right to sublicense to make, have made, use and sell under
1886	any such patents or patent applications for the duration of the patents, any
1887	continuations, continuations in part, divisions, patents of addition, reissues,
1888	renewals or extensions thereof or any supplementary protection certificates
1889	granted with respect thereto, in respect of any claims concerning the
1890	application of bioabsorbable polymers in the field of human and/or veterinary
1891	medicine.
1892
1893	(d) In addition, each party will retain exclusive title to its
1894	respective confidential information in accordance with the provisions of Article
1895	9 below.
1896
1897	(6) Patent Infringement
1898	-------------------
1899
1900	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1901	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1902	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1903	<PAGE>
1904
1905	Janssen US-Medisorb Page 8
1906	License Agreement
1907
1908	(a) In the event that either party becomes aware that any third
1909	party is infringing in the Territory any patents included within the Patents,
1910	the party becoming aware of such infringement shall promptly give notice of such
1911	infringement to the other party. Any possible action against such alleged
1912	infringement of the Patents will be carried out by either or both of the parties
1913	in accordance with the provisions specified hereinafter in paragraphs (b), (c),
1914	(d) and (e).
1915
1916	(b) Whenever it would concern a patent or patent application
1917	falling within the definition of Patents and of which Medisorb retains full
1918	title and ownership pursuant to Article 5 a), Medisorb shall use all reasonable
1919	efforts to take action against such infringement in its own name, at its own
1920	expense and on its own behalf.
1921
1922	If Medisorb fails to take action against such infringement, or if
1923	Medisorb does not use reasonable efforts in carrying out such action after
1924	commencement thereof, within thirty (30) days after the notice referred to in
1925	paragraph (a) above or after having become aware of such infringement, Janssen
1926	US shall be entitled at its own discretion and at its own expense, to take
1927	immediate action against such infringement in its own name, at its own expense
1928	and on its own behalf. Medisorb will give all reasonable assistance to Janssen
1929	in taking such action in accordance with Article 6(e), including giving Janssen
1930	the authority to file and prosecute such suit and, if necessary, being named a
1931	party in such action. If Janssen US commences or assumes such action, Janssen
1932	US may credit [ ] of any royalty otherwise due to
1933	Medisorb for sales in such country or countries against the amount of the
1934	expenses and costs of such action, including without limitation, attorney fees
1935	actually incurred by Janssen US. The amount of expenses so deducted shall be
1936	paid to Medisorb out of the recoveries, if any, received by Janssen US as a
1937	result of such action. Except for such repayment of royalties deducted, Janssen
1938	US shall be entitled to retain all recoveries therefrom.
1939
1940	In no event shall Medisorb settle with such infringing third party in
1941	the Field without the prior written consent of Janssen US.
1942
1943	(c) Whenever it would concern a patent or patent application
1944	falling within the definition of Patents and of which Janssen US or any of its
1945	Affiliates retains full title and ownership pursuant to Article 5 B), Janssen US
1946	shall have the right but not the obligation to take action against such
1947	infringement in its own name, at its own cost and on its own behalf. If Janssen
1948	US fails to take action against such infringement, or if Janssen US does not use
1949	reasonable efforts in carrying out such action after commencement thereof,
1950	within thirty (30) days after the notice referred to in paragraph (a) above or
1951	after having become aware of such infringement, Medisorb shall be entitled at
1952	its own discretion and at its own expense, to take action against such
1953	infringement. Medisorb shall be entitled to retain all recoveries, if any,
1954	therefrom.
1955
1956	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
1957	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
1958	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1959	<PAGE>
1960
1961	Janssen US-Medisorb Page 9
1962	License Agreement
1963
1964	(d) Whenever it would concern a patent or patent application
1965	falling within the definition of Patents and of which Janssen US or any of its
1966	Affiliates and Medisorb jointly retain full title and ownership pursuant to
1967	Article 5 (c), and whenever in such case the infringing product would be a drug
1968	product falling within the definition of the Field, Janssen US shall have the
1969	right but not the obligation to take action against such infringement in its own
1970	name, at its own cost and on its own behalf. If Janssen US fails to take action
1971	against such infringement, or if Janssen US does not use reasonable efforts in
1972	carrying out such action after commencement thereof, within thirty (30) days
1973	after the notice referred to in paragraph (a) above or after having become aware
1974	of such infringement, Medisorb shall be entitled at its own discretion and at
1975	its own expense, to take action against such infringement, it being understood
1976	that Janssen US will have a continuing right to take over any such action at its
1977	own expense and shall pay to Medisorb from any recoveries Janssen US receives
1978	(i) Medisorb's expenses and (ii) from any sums remaining after deduction of
1979	Medisorb's and Janssen US's expenses, an amount proportionate to Medisorb's
1980	expenses in relation to Janssen US's expenses.
1981
1982	Whenever it would concern a patent or patent application falling
1983	within the definition of Patents and of which Janssen US or any of its
1984	Affiliates and Medisorb jointly retain full title and ownership pursuant to
1985	Article 5 (c), and whenever in such case the infringing product would be a drug
1986	product falling outside the definition of the Field, Medisorb shall have the
1987	right but not the obligation to take action against such infringement in its own
1988	name, at its own cost and on its own behalf. If Medisorb fails to take action
1989	against such infringement, or if Medisorb does not use reasonable efforts in
1990	carrying out such action after commencement thereof, within thirty (30) days
1991	after the notice referred to in paragraph (a) above or after having become aware
1992	of such infringement, Janssen US shall be entitled at its own discretion and at
1993	its own expense, to take action against such infringement, it being understood
1994	that Medisorb will have a continuing right to take over any such action at its
1995	own expense. If Janssen US commences or assumes such action, Janssen US may
1996	credit [ ] of any royalty otherwise payable to
1997	Medisorb payable hereunder against the amount of the expenses and costs of such
1998	action, including without limitation, attorney fees actually incurred by Janssen
1999	US. The amount of expenses so deducted shall be paid to Medisorb out of the
2000	recoveries, if any, received by Janssen US as a result of such action. Except
2001	for such repayment of royalties deducted, Janssen US shall be entitled to retain
2002	all recoveries therefrom.
2003
2004	(e) Each party agrees to cooperate reasonably with the other party
2005	in such litigation, including making available to the other party records,
2006	information, and evidence relevant to the infringement of the Patent.
2007
2008	(7) Third Party Intellectual Property Rights
2009	----------------------------------------
2010
2011	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2012	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
2013	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2014	<PAGE>
2015
2016	Janssen US-Medisorb Page 10
2017	License Agreement
2018
2019	(a) Medisorb warrants that to the best of its current knowledge
2020	and belief the Products to be developed hereunder will not infringe the patent
2021	rights of any third party.
2022
2023	(b) In the event that the manufacture, use or sale of the Product
2024	would constitute an infringement of the rights of a third party in the Territory
2025	because of the use of the Patents or Medisorb's know how, each party shall, as
2026	soon as it becomes aware of the same, notify the other thereof in writing,
2027	giving in the same notice full details known to it of the rights of such third
2028	party and the extent of any alleged infringement. The parties shall after
2029	receipt of such notice meet to discuss the situation, and, to the extent
2030	necessary attempt to agree on a course of action in order to permit Janssen US
2031	to practice the license granted hereunder. Such course of action may include:
2032	(a) modifying the Product or its manufacture so as to be noninfringing; (b)
2033	obtaining an appropriate license from such third party; or (c) fight the claim
2034	or suit. In the event that within a short period of time, the parties fail to
2035	agree on an appropriate course of action Janssen US may decide upon the course
2036	of action in the interest of the further development, manufacturing or
2037	commercialization of the Product.
2038
2039	(c) In the event that the parties cannot agree on modifying the
2040	Product or in the case that such modification would not be economically viable
2041	or regulatory feasible, Janssen US, whenever it relates to know how, whether
2042	patented or not, owned by Janssen US in accordance with the provisions of
2043	Article 5 (b) and (c), or Medisorb, whenever it relates to know how, whether
2044	patented or not, owned by Medisorb in accordance with the provisions of Article
2045	5 (a), will have the right to negotiate with such third party for such license.
2046	Both parties hereto will in any event in good faith consult with each other with
2047	respect to such negotiations and the party negotiating such license as indicated
2048	above, will make every effort to minimize the amount of license fees and
2049	royalties payable thereunder. In no event shall either party as a result of
2050	such settlement, grant a sublicense or cross license to the third party to
2051	settle the suit, without the prior written approval of the other party. In the
2052	event that such negotiations result in a consummated agreement, any license fee
2053	and/or royalties to be paid thereunder shall be paid by the party responsible
2054	for the negotiations as indicated above, [ ] of any license
2055	fees or royalties paid by Janssen US under such license will be creditable
2056	against royalties due to Medisorb hereunder.
2057
2058	(d) In the event that either or both parties would further to such
2059	notification under Paragraph 7 (b) decide to defend such suit or claim in which
2060	a third party alleges that the manufacture, use or selling of the Product in the
2061	Territory infringes said third party's patent in, Janssen US shall have the
2062	right to apply [ ] of the royalties due to Medisorb on the
2063	sales of the allegedly infringing Product against its litigation expenses.
2064
2065	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2066	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
2067	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2068	<PAGE>
2069
2070	Janssen US-Medisorb Page 11
2071	License Agreement
2072
2073	(8) Term:
2074	----
2075
2076	(a) Except as otherwise provided herein, this Agreement and the
2077	term of the license granted to Janssen US hereunder shall commence on the date
2078	first written above and shall expire (i) upon expiration of the last to expire
2079	Patent or (ii) fifteen (15) years after the date of the first commercial sale of
2080	Product in the Territory, whichever is later; provided, that in no event shall
2081	the license granted hereunder expire later than the twentieth anniversary of the
2082	first commercial sale of Product. After expiration of the license granted to
2083	Janssen US hereunder, Janssen US shall retain a fully paid-up non-exclusive
2084	license to manufacture, use and sell Products in the Field in the Territory.
2085
2086	(b) Medisorb may convert the exclusive license granted under this
2087	Agreement to non-exclusive if Janssen US does not maintain the following minimum
2088	annual royalty payments to Medisorb. With respect to the entire Territory, the
2089	minimum royalty obligation will first apply to the twelve month period following
2090	the anniversary of the end of the month in which the Product was launched.
2091	During the first twelve month period and each subsequent twelve month period
2092	that such minimum royalty obligation is applicable, the minimum royalty amount
2093	to be paid by Janssen US will be calculated by multiplying the applicable
2094	royalty rate by [ ] percent of the actual aggregate net sales of other
2095	[ ] products in the Territory during such twelve month period.
2096
2097	Janssen US shall have the right to make up any shortfall in minimum royalty
2098	payments from Product sales in the Territory provided, such make-up payment is
2099	made at the same time and in the same manner as required for the underlying
2100	minimum royalty obligation.
2101
2102	(c) In the event that either party shall enter or be put into
2103	voluntary or compulsory liquidation or have a receiver appointed or default in
2104	the observance or performance of its obligations under this Agreement and shall
2105	fail to remedy such default within ninety (90) days after the delivery of
2106	written notice from the other party, the other party shall be entitled upon
2107	giving written notice to terminate this Agreement.
2108
2109	(d) Janssen US may terminate this Agreement without cause upon 30
2110	days prior written notice. Thereafter, Janssen US shall have no further rights
2111	or privileges with respect to the use of Medisorb Technology in Products and
2112	Medisorb shall be under no further obligation of non-competition or exclusive
2113	dealing.
2114
2115	(e) Any early termination of the Agreement shall be without
2116	prejudice to the rights of either party against the other accrued under this
2117	Agreement prior to termination.
2118
2119	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2120	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
2121	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2122	<PAGE>
2123
2124	Janssen US-Medisorb Page 12
2125	License Agreement
2126
2127	(f) Upon any termination of this Agreement, any remaining
2128	inventory of Product may be sold, provided all royalties otherwise due hereunder
2129	are paid with respect to such sales.
2130
2131	(g) All rights and licenses granted under or pursuant to this
2132	Agreement by Medisorb to Janssen U.S. are, and shall otherwise be deemed to be,
2133	for purposes of Section 365(n) of Title 11, U.S. Code (the "Bankruptcy Code"),
2134	licenses to "intellectual property" as defined under section 101(60) of the
2135	Bankruptcy Code. The parties agree that Janssen, as a licensee of such rights
2136	under this Agreement, shall retain and may fully exercise all of its rights and
2137	elections under the Bankruptcy Code.
2138
2139	(9) Confidentiality:
2140	---------------
2141
2142	(a) Each party agrees to keep confidential and to not use for any
2143	purpose other than as set forth herein all technical information and materials
2144	supplied by the other hereunder and any information a party may acquire about
2145	the other or its activities as a result of entering into this Agreement,
2146	provided that such obligation shall not apply to technical information or
2147	material which: (i) was in the receiving party's possession without restriction
2148	prior to receipt from the other party or its Affiliates; (ii) was in the public
2149	domain at the time of receipt; (iii) becomes part of the public domain through
2150	no fault of the receiving party; (iv) shall be lawfully received from a third
2151	party with a right of further disclosure; (v) shall be required to be disclosed
2152	by law, by regulation or by the rules of any securities exchange.
2153
2154	(b) Except as may be otherwise provided herein, the
2155	confidentiality obligations as set out in this Section shall continue so long as
2156	this Agreement remains in force and thereafter for a period of seven (7) years.
2157
2158	(c) Janssen US shall cause its Affiliates and Sublicensees to
2159	abide by the obligations of confidentiality with respect to unpublished
2160	information within the Patents and Technical Information.
2161
2162	(d) Any confidential information relating to the subject matter of
2163	this Agreement imparted to the other party prior to the execution of this
2164	Agreement shall be considered to fall under the terms of this Agreement.
2165
2166	(10) Disclaimer of Warranty: Medisorb makes no representations or
2167	----------------------
2168	warranties, express or implied, with respect to the Medisorb Patents and
2169	Technical Information licensed to Janssen US hereunder, including without
2170	limitation any warranties of merchantability or fitness for a particular
2171	purpose.
2172
2173	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2174	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
2175	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2176	<PAGE>
2177
2178	Janssen US-Medisorb Page 13
2179	License Agreement
2180
2181	(11) Liability
2182	---------
2183
2184	(a) Janssen US agrees to indemnify, defend and hold harmless
2185	Medisorb from and against any liability, loss, damages and expenses (including
2186	reasonable attorney fees) Medisorb may suffer as the result of claims, demands,
2187	costs or judgments which may be made or instituted against Medisorb by reason of
2188	personal injury or damage to property arising out or caused by Janssen US's
2189	promotion, use and sale of the Product, except where such liabilities claims,
2190	demands, costs or judgments are caused by Medisorb's failure to provide Janssen
2191	US with any information as specified in Section 12 (c) and Article 13. Medisorb
2192	will notify Janssen US as soon as it becomes aware of any such claim or action
2193	and agrees to give reasonable assistance in the investigation and defense of
2194	such claim or action it being understood that it shall allow Janssen US to
2195	control the disposition of the same.
2196
2197	(b) Medisorb agrees to indemnify, defend and hold harmless Janssen
2198	US from and against any liability, loss, damages and expenses (including
2199	reasonable attorney fees) Janssen US may suffer as the result of claims,
2200	demands, costs or judgments which may be made or instituted against Janssen US
2201	by reason of personal injury or damage to property arising out or caused by
2202	Medisorb's failure to provide Janssen US with any information as specified in
2203	Section 12 (c) and Article 13.
2204
2205	(c) In no event shall either party be liable for loss of profits,
2206	loss of goodwill or any consequential or incidental damages of any kind of the
2207	other party.
2208
2209	(12) Product Information and Adverse Drug Events
2210	-------------------------------------------
2211
2212	(a) As Janssen US has superior knowledge of the end-use
2213	applications to which Products licensed hereunder will be put, Janssen US is
2214	responsible for providing third parties with adequate information as to the
2215	medical profile of such Products. Janssen US will provide Medisorb with copies
2216	of the product information document which is part of the NDA for the Product.
2217
2218	(b) Medisorb does not claim the expertise to judge whether
2219	Product(s) will perform acceptably in Janssen US's application(s). Janssen US is
2220	the sole judge as to whether Product(s) will perform acceptably in Janssen US's
2221	application(s). Janssen US represents and warrants on an on-going basis during
2222	the term of this agreement that it has the capability to assess the suitability
2223	of Product(s) in Janssen US's application(s) and agrees to conduct adequate
2224	testing to confirm the safety and efficacy of Products prior to
2225	commercialization.
2226
2227	(c) Medisorb will provide to Janssen US promptly after its
2228	discovery by Medisorb, any information in its possession which indicates adverse
2229	effects in
2230
2231	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2232	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
2233	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2234	<PAGE>
2235
2236	Janssen US-Medisorb Page 14
2237	License Agreement
2238
2239	humans associated with the Products, including the bioabsorbable polymeric
2240	components thereof, licensed hereunder. For the purpose of this Agreement
2241	"adverse event" shall mean an experience which is noxious and unintended and
2242	which occurs at doses normally used in man for the prophylaxis, diagnosis or
2243	therapy of a disease or for the modification of a physiological function and any
2244	report of an overdose.
2245
2246	(13) Government Approvals
2247	--------------------
2248
2249	Janssen US shall be responsible for conducting all necessary testing
2250	as well as determining what, if any, government approvals are required for the
2251	use and sale of Product licensed hereunder and shall comply with all such
2252	requirements prior to and following the sale or distribution of such Products.
2253
2254	Medisorb shall cooperate fully with Janssen US in obtaining regulatory
2255	approvals for Product licensed hereunder and shall, at Janssen US's request,
2256	provide appropriate regulatory authorities with any and all information
2257	concerning Medisorb's technology, Medisorb polymers and Medisorb's manufacturing
2258	process for such Product.
2259
2260	In this respect Medisorb undertakes that it has submitted or will as
2261	soon as possible submit a type IV Drug Master File to the FDA identifying
2262	Medisorb's method of manufacture, release specifications and testing methods
2263	used in the manufacture of Medisorb Polymers and a type I Drug Master File of
2264	Medisorb's manufacturing facilities where Product may be manufactured. Medisorb
2265	will authorize Janssen U.S. at its request to cross-reference any Drug Master
2266	Files relating to the Medisorb Polymers.
2267
2268	(14) Force Majeure: Neither party shall be liable for its failure to
2269	-------------
2270	perform any of its obligations hereunder if such failure is occasioned by a
2271	contingency beyond its reasonable control including, but not limited to,
2272	occurrences such as strikes or other labor disturbances, lock out, riot, war,
2273	default by a common carrier, fire, flood, storm, earthquake, other acts of God,
2274	inability to obtain raw materials, failure of plant facilities or government
2275	regulation, act or failure to act. Each party shall notify the other immediately
2276	upon occurrence or cessation of any such contingencies. If such contingency
2277	continues unabated for at least 180 consecutive days, either party shall have
2278	the right to terminate this Agreement without further obligation beyond those
2279	actually incurred prior to such termination.
2280
2281	(15) Press Communications: Neither party shall originate any
2282	--------------------
2283	publicity, news release or public announcement, written or oral relating to this
2284	Agreement, including its existence, without the prior written approval of the
2285	other party.
2286
2287	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2288	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
2289	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2290	<PAGE>
2291
2292	Janssen US-Medisorb Page 15
2293	License Agreement
2294
2295	(16) Notices: Any legal notice required or permitted hereunder shall
2296	-------
2297	be considered properly given if in writing and sent by first class mail,
2298	certified mail or by telefacsimile to the party being notified at the respective
2299	address of such party as follows:
2300
2301	If to Medisorb:
2302
2303	Medisorb Technologies International L.P.
2304	6954 Cornell Road
2305	Cincinnati, OH 45242
2306
2307	Facsimile: 513-489-2348
2308
2309	If to Janssen US:
2310
2311	Janssen U.S.
2312	1125 Trenton-Harbourton Road
2313	P.O. Box 200
2314	Titusville, New Jersey 08560-0200
2315
2316	Facsimile: 609-630-2616
2317
2318	with a copy to Janssen Pharmaceutica International
2319	Kollerstrasse 38
2320	6300 Zug 6
2321	Switzerland
2322	Facsimile: 00-41-42449565
2323
2324	Such notice shall be effective upon receipt or upon refusal to accept such
2325	notice. In any case, notice shall be presumed effective no later than five (5)
2326	days after such notice is sent.
2327
2328	Neither party shall originate any publicity, news release or public
2329	announcement, written or oral, relating to this Agreement, including its
2330	existence, without the written approval of the other party.
2331
2332	(17) Assignment: This Agreement shall not be assigned by either party
2333	----------
2334	without the prior written consent of the other party; provided, however, that
2335	assignment shall be permitted without such consent to any party, not less than
2336	50% of the total interest of which owns, is owned by, or is under common control
2337	with the assigning party. In the event of any such permitted assignment the
2338	assignee shall be subject to and shall agree in writing to be bound by the terms
2339	and conditions of this Agreement.
2340
2341	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2342	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
2343	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2344	<PAGE>
2345
2346	Janssen US-Medisorb Page 16
2347	License Agreement
2348
2349	(18) Dispute Resolution: The parties shall amicably discuss and
2350	------------------
2351	negotiate any matters which arise under this Agreement and are not specifically
2352	set forth hereunder. If any disputes arise under this Agreement, the parties
2353	shall use their reasonable efforts to meet and resolve such disputes. In the
2354	event that the parties are unable to resolve any such disputes, then both
2355	parties hereby agree to submit said disputes to the jurisdiction of the
2356	competent courts of the State of New Jersey and agree that any litigation in any
2357	way related to this Agreement shall be submitted to such courts and that same
2358	shall be subject to the laws of the State of New Jersey without regard to its
2359	rules respecting choice of law.
2360
2361	(19) Severability: In the event any one or more of the provisions of
2362	------------
2363	this Agreement should for any reason be held by any court or authority having
2364	jurisdiction over this Agreement or any of the parties hereto to be invalid,
2365	illegal or unenforceable such provision or provisions shall be validly reformed
2366	to as nearly approximate the intent of the parties as possible and, if
2367	unreformable; shall be divisible and deleted in such jurisdiction, elsewhere
2368	this Agreement shall not be affected.
2369
2370	(20) Captions: The captions of this Agreement are for convenience
2371	--------
2372	only, and shall not be deemed of any force or effect whatsoever in construing
2373	this Agreement.
2374
2375	(21) Waiver: The failure on the party of a party to exercise or
2376	------
2377	enforce any right conferred upon it hereunder shall not be deemed to be a waiver
2378	of any such right, nor operate to bar the exercise or enforcement thereof at any
2379	time thereafter.
2380
2381	(22) Survival: The following Articles of this Agreement shall survive
2382	--------
2383	the termination or expiration of this Agreement: 5, 9, 10, 11, 15, 17, and 18.
2384
2385	(23) Miscellaneous: This Agreement may be executed by the parties
2386	-------------
2387	hereto in counterparts, each of which when so executed and delivered shall be
2388	considered to be an original, but all such counterparts shall together
2389	constitute but one and the same instrument. This Agreement is the complete
2390	agreement of the parties and supersedes all previous understandings and
2391	agreements relating to the subject matter hereof. Neither this Agreement nor
2392	any of the terms hereof may be terminated, amended, supplemented, waived or
2393	modified orally , but only by an instrument in writing signed by the party
2394	against whom enforcement of the termination, amendment, supplement, waiver or
2395	modification is sought.
2396
2397	IN WITNESS WHEREOF, the duly authorized representatives of the parties
2398	hereto have executed this Agreement as of the day and year first above written.
2399
2400
2401	JANSSEN PHARMACEUTICA INC.
2402
2403	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2404	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
2405	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2406	<PAGE>
2407
2408	Janssen US-Medisorb Page 17
2409	License Agreement
2410
2411	By: _________________________
2412	Name: _______________________
2413	Title: ______________________
2414	Date: _______________________
2415
2416
2417	{Second Janssen Signatory}
2418	- ---------------------------
2419
2420
2421	By: _________________________
2422	Name: _______________________
2423	Title: ______________________
2424	Date: _______________________
2425
2426
2427	MEDISORB TECHNOLOGIES INTERNATIONAL L.P.
2428	by: Medisorb Technologies
2429	International, Inc.,
2430	its General Partner
2431
2432
2433	By: __________________________
2434	Name: David R. Lohr
2435	------------------------
2436	Title: President
2437	-----------------------
2438	Date: ________________________
2439
2440	12059501.doc
2441
2442	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2443	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
2444	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2445	</TEXT>
2446	</DOCUMENT>
2447	<DOCUMENT>
2448	<TYPE>EX-10.18(A)
2449	<SEQUENCE>4
2450	<DESCRIPTION>FIRST AMENDMENT TO DEVELOPMENT AGREEMENT
2451	<TEXT>
2452
2453	<PAGE>
2454
2455
2456	FIRST AMENDMENT TO DEVELOPMENT AGREEMENT
2457
2458
2459	This First Amendment to that certain Development Agreement, dated 23 December
2460	---------------------
2461	1993 (hereinafter "the Development Agreement"), by and between MEDISORB
2462	TECHNOLOGIES INTERNATIONAL L.P. ("Medisorb"), a Delaware limited partnership,
2463	doing business at 6954 Cornell Road, Cincinnati, Ohio 45242, and JANSSEN
2464	PHARMACEUTICA INTERNATIONAL, a division of Cilag International AG, ("Janssen"),
2465	a Swiss business corporation, doing business at Kollerstrasse 38, CH-6300 Zug 6,
2466	Switzerland, is agreed this 6th day of December, 1995.
2467	--- --------
2468
2469	WHEREAS, the Parties desire to amend certain terms of the Development Agreement
2470	respecting the timing of Janssen's right to exercise its option to license MTI
2471	technology and, further, respecting, certain milestone dates;
2472
2473	NOW THEREFORE, the parties agree to amend the Development Agreement as follows:
2474
2475	(A) Section 4(A) of the Development Agreement is hereby amended in its entirety
2476	to read as follows:
2477
2478	The initial term of this Agreement shall commence upon the date first above
2479	written and continue thereafter until the earlier of (i) the completion of
2480	the Development Program at the moment of finalization of the IRF, which is
2481	expected during the [ ], or (ii) [
2482	], unless earlier terminated pursuant to the provisions of this Section 4
2483	or according to the terms of Section 16 below. However, in the event that
2484	the IRF has not been completed by [ ], if Janssen can
2485	show due diligence, this Agreement shall not terminate and will be extended
2486	for such period as Janssen requires to finalize the IRF, provided that
2487	during such extension Janssen continues to show due diligence. Due
2488	diligence, amongst other factors, shall mean the timely filing of required
2489	regulatory applications, including, without limitation, a CTX (clinical
2490	trial exemption certificate) and/or IND, and continuing to fund the
2491	Development Program in a commercially reasonable manner.
2492
2493	(B) Section 6(A) of the Development Agreement is hereby amended in its entirety
2494	to read as follows:
2495
2496	Medisorb hereby grants to Janssen an option, exercisable at any time during
2497	the term of this Agreement and continuing for a period of thirty (30) days
2498	thereafter to enter into the License Agreements (i.e., the first a
2499	worldwide license, excluding the United States, and the second a license
2500	encompassing only the United States) attached hereto as Exhibits B & C,
2501	respectively.
2502
2503	All capitalized terms used in this First Amendment shall have the same meanings
2504	as defined in the Development Agreement. Other than the foregoing, all other
2505	terms of the Development Agreement remain in full force and effect.
2506
2507	WITNESS the signature of both parties by their duly authorized officers:
2508
2509	JANSSEN PHARMACEUTICA INTERNATIONAL
2510	A division of Cilag International AG
2511
2512	By: /s/ Erik Rombouts
2513	----------------------------------------
2514	Name: Erik Rombouts
2515	--------------------------------------
2516	Title: Operations Director
2517	-------------------------------------
2518	Date: 12/12/95
2519	--------------------------------------
2520
2521
2522	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2523	TREATMENT REQUEST. REDACTED MATERIALS IS BRACKETED AND HAS BEEN FILED
2524	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2525	<PAGE>
2526
2527	DEVELOPMENT AGREEMENT
2528	AMENDMENT
2529	JANSSEN-MEDISORB
2530
2531	[Second Janssen Signatory]
2532	- -------------------------
2533
2534
2535	By: /s/ Heinz Schmid
2536	-----------------------------------
2537	Name: Heinz Schmid
2538	---------------------------------
2539	Title: General Manager
2540	--------------------------------
2541	Date: 12/12/95
2542	---------------------------------
2543
2544
2545	MEDISORB TECHNOLOGIES INTERNATIONAL L.P.
2546
2547	by: Medisorb Technologies
2548	International, Inc.,
2549	its General Partner
2550
2551
2552	By: /s/ David R. Lohr
2553	---------------------------------
2554	Name: David R. Lohr
2555	-------------------------------
2556	Title: President
2557	------------------------------
2558	Date: December 6, 1995
2559	-------------------------------
2560
2561
2562
2563	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2564	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
2565	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2566	</TEXT>
2567	</DOCUMENT>
2568	<DOCUMENT>
2569	<TYPE>EX-10.19
2570	<SEQUENCE>5
2571	<DESCRIPTION>LICENSE AGREEMENT DATED 2/13/96
2572	<TEXT>
2573
2574	<PAGE>
2575
2576	LICENSE AGREEMENT
2577
2578	This Agreement is made as of the 13 day February of 1996, between MEDISORB
2579	-- -------- ----
2580	TECHNOLOGIES INTERNATIONAL L.P., a Delaware limited partnership (hereinafter
2581	"Medisorb") and JANSSEN PHARMACEUTICA INC., a New Jersey corporation ("Janssen
2582	US").
2583
2584	WHEREAS, Medisorb and Janssen Pharmaceutica International, an affiliate of
2585	Janssen US, have entered into a certain Development Agreement, dated December
2586	23, 1993 (the "Development Agreement"), for the development of a Product (as
2587	described below); and
2588
2589	WHEREAS, Janssen Pharmaceutica International has an option under the
2590	Development Agreement to enter into this License Agreement for the Medisorb
2591	technology required to make, use and sell the Product, which option Janssen
2592	Pharmaceutica International has assigned to Janssen US with the consent of
2593	Medisorb and which option Janssen US has elected to exercise; and
2594
2595	WHEREAS, the parties believe that it is in their mutual best interest for
2596	Medisorb to license to Janssen US on an exclusive basis in the Territory,
2597	Medisorb Patents and Technical Information within the Field, upon the terms and
2598	conditions set forth herein;
2599
2600	NOW, IT IS HEREBY AGREED AS FOLLOWS:
2601
2602	(1) Definitions: The following terms shall have the meanings ascribed to
2603	-----------
2604	them herein, unless the context otherwise requires:
2605
2606	(a) "Affiliate" shall mean any company controlling, controlled by, or
2607	under common control with a party by ownership, directly or indirectly, of fifty
2608	percent (50%) or more of the total ownership or by the power to control the
2609	policies and actions of such company.
2610
2611	(b) "Development Program" shall mean the development activities
2612	conducted by the parties pursuant to the Development Agreement.
2613
2614	(c) "Field" shall mean the treatment of [
2615
2616	].
2617
2618	(d) "Improvements" shall mean any improvements or developments to or of
2619	the Patents and Technical Information in the Field which Medisorb may acquire,
2620
2621	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2622	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
2623	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2624	<PAGE>
2625
2626	Janssen US-Medisorb Page 2
2627	License Agreement
2628
2629	discover, invent, originate, make, conceive or have a right to, in whole or in
2630	part, during the term of this Agreement, whether or not such improvement or
2631	development is patentable.
2632	(e) "Medisorb Polymers" shall mean bioresorbable aliphatic polyesters
2633	based on glycolide, lactide, caprolactone and combinations of such polymers,
2634	which are manufactured by Medisorb and utilized in Product(s) licensed under
2635	this Agreement.
2636
2637	(f) "NDA" shall mean a New Drug Application and all supplements filed
2638	pursuant to the requirements of the United States Food and Drug Administration,
2639	including all documents, data and other information concerning Product which are
2640	necessary for, or included in, FDA approval to market a Product as more fully
2641	defined in 21 C.F.R. 314.5 et seq. or any other similar application for
2642	marketing authorization filed with the appropriate regulatory authorities in
2643	other countries of the Territory (as defined hereinafter).
2644
2645	(g) "Net Sales" shall mean the gross amounts received from sales of
2646	Products during a calendar quarter to third parties by Janssen US, its
2647	Sublicensees or any Affiliate of either, less any: (i) applicable sales taxes;
2648	(ii) cash trade or quantity discounts; (iii) amounts repaid or credited by
2649	reason of rejections or return of goods; or (iv) freight, postage and duties
2650	paid for. No deduction from the gross sales price shall be made for any item of
2651	cost incurred by the seller in its own operations incident to the manufacture,
2652	sale or shipment of the product sold. For purposes hereof, Net Sales shall not
2653	include sales of a Product from Janssen US or an Affiliate of Janssen US to any
2654	Affiliate or Sublicensee of either; it being intended that Net Sales shall only
2655	include sales to unrelated third-parties.
2656
2657	(h) "Patents" shall mean (i) any and all existing issued patents and
2658	patent applications or parts thereof which describe and claim a depot
2659	formulation of [ ], or any chemical analogues of [ ] with similar
2660	physiological activity, based on polymers of lactic and glycolic acids and the
2661	production and use thereof; (ii) any other patents and patent applications filed
2662	by or on behalf of Medisorb, or under which Medisorb has the rights to grant
2663	licenses, which are needed to practice the inventions; and (iii) any reissues,
2664	extensions, substitutions, confirmations, registrations, revalidations,
2665	additions, continuations, continuations-in-part, or divisions of or to any of
2666	the foregoing which are granted hereafter or any additional protection
2667	certificate granted with respect thereto.
2668
2669	(i) "Product(s)" shall mean any and all depot formulations of [ ],
2670	or any chemical analogues of [ ] with similar physiological activity,
2671	based on polymers of lactic and glycolic acids which are designed to deliver
2672	[ ], or any of its chemical analogues, over an extended period.
2673
2674
2675	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2676	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
2677	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2678	<PAGE>
2679
2680	Janssen US-Medisorb Page 3
2681	License Agreement
2682
2683
2684	(j) "Sublicensees" shall mean any company or companies, other than
2685	Janssen US's Affiliates, sublicensed by Janssen US.
2686
2687	(k) "Technical Information" shall mean all unpatented information,
2688	know-how, practical experience, procedures, methodology, specifications,
2689	formulae and data whether or not the same shall be patentable which have been
2690	heretofore developed or acquired by Medisorb prior to the date of this Agreement
2691	and which are necessary in order to use, manufacture or sell Products in the
2692	Field.
2693
2694	(l) "Territory" shall mean the United States, its Territories,
2695	Protectorates, Commonwealths, and all other political subdivisions of the United
2696	States.
2697
2698	(2) License Grant
2699	-------------
2700
2701	(a) Medisorb hereby grants to Janssen US in the Territory an exclusive
2702	license under the Patents and Technical Information existing prior to the
2703	effective date of this Agreement, with the right to grant sublicenses
2704	thereunder, for all purposes within the Field to practice and use the Patents
2705	and Technical Information, including the rights to manufacture and have
2706	manufactured, to use and have used, and to sell and have sold Products.
2707	Medisorb exclusively retains all rights under the Patents and Technical
2708	Information outside the Field and for use other than in Products. The right to
2709	grant sublicenses granted hereunder is exclusive to Janssen US and shall not
2710	extend to Janssen US Affiliates or Sublicensees.
2711
2712	(b) Medisorb shall offer to Janssen US for incorporation into this
2713	License Agreement on reasonable terms and conditions, Medisorb Improvements in
2714	the Field which, if incorporated into Janssen US's then current commercial
2715	Product(s), would: (i) result in significant changes in either the
2716	specifications for such Product(s) or the processes for producing such
2717	Product(s), and (ii) would reasonably be expected to result in enhanced market
2718	value and/or profitability of such Product(s). Examples of such Improvements
2719	would include: (i) the development by Medisorb of a non-aqueous injection
2720	vehicle which offers significant advantages with respect to ease of
2721	administration and (ii) the development by Medisorb of technology enabling [
2722	].
2723	It is the parties' understanding that the effect of any such license amendment
2724	would, in general, be either an extension of the term of this Agreement for a
2725	mutually agreed period or a marginal increase in the then current royalty rate.
2726	All other Medisorb Improvements shall be made available to Janssen US for its
2727	use without further agreement. Proprietary rights to Improvements jointly
2728	developed by Medisorb and Janssen US or any of its Affiliates shall be governed
2729	by the terms of Section 5(c) of this Agreement.
2730
2731
2732
2733	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2734	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
2735	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2736	<PAGE>
2737
2738	Janssen US-Medisorb Page 4
2739	License Agreement
2740
2741
2742
2743	(c) In the event that at any time during the term of this Agreement
2744	Medisorb is unable for any reason whatsoever to supply the Medisorb Polymers
2745	required by Janssen U.S. for use in Products, then the license granted under
2746	paragraph 2(a) above shall be expanded to include the Medisorb Technology
2747	required to make and use the Medisorb Polymers.
2748
2749	(3) Royalties:
2750	----------
2751
2752	(a) Janssen US shall pay or cause to be paid to Medisorb a running
2753	royalty with respect to all Products sold to customers in the Territory by
2754	Janssen US, its Affiliates and Sublicensees, payable quarter-annually in arrears
2755	within sixty (60) days following the end of Janssen US's regular fiscal quarters
2756	in any year during the term hereof, as follows: (i) [ ]% of the Net Sales of
2757	each unit of Product sold during the preceding calendar quarter during the term
2758	hereof, if such unit of Product was manufactured by Medisorb pursuant to a
2759	written contract for the supply of Product; or (ii) [ ]% of the Net Sales of
2760	each unit of Product sold during the preceding calendar quarter during the term
2761	hereof, if such unit of Product was not manufactured by Medisorb pursuant to a
2762	written contract for the supply of Product. Any withholding or other tax that
2763	Janssen US or any of its Affiliates or Sublicensees are required by statute to
2764	withhold and pay on behalf of Medisorb with respect to the royalties payable to
2765	Medisorb under this Agreement shall be deducted from said royalties and paid
2766	contemporaneously with the remittance to Medisorb; provided, however, that in
2767	regard to any tax so deducted Janssen US shall furnish Medisorb with proper
2768	evidence of the taxes paid on its behalf.
2769
2770	(b) In the event that Product is not claimed in a valid Patent
2771	effective in the Territory and a similar product obtains a market share greater
2772	than [ ]% of the total market revenues for Products and similar products in
2773	such country, the parties agree to meet and negotiate in good faith an
2774	appropriate reduction in the royalty rate then in effect. In no event shall a
2775	reduction in royalty rates pursuant to this section result in royalty rates
2776	[ ] of the rates specified under Section 3(a)(i) and 3(a)(ii) of this
2777	Agreement. For the purposes of this section, "similar product" shall mean a
2778	generic version of the Product(s) where: (i) the active agent is
2779	[ ], or a chemical analogue thereof and (ii) the excipient is
2780	comprised of lactic and/or glycolic acids. In the event that patent protection
2781	in the Territory for Product(s) becomes available subsequent to a royalty
2782	reduction pursuant to this section, the parties agree to (i) reinstitute the
2783	royalty otherwise applicable, and (ii) in the event that any recovery is
2784	obtained for prior infringement of the subsequently issued patent, the parties
2785	will first apply such recoveries to reimbursing Medisorb for royalties it would
2786	otherwise have received.
2787
2788	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2789	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
2790	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2791	<PAGE>
2792
2793	Janssen US-Medisorb Page 5
2794	License Agreement
2795
2796
2797	(c) Janssen US shall keep complete and adequate records with respect to
2798	the proceeds of Products on which it has to pay royalties payable hereunder for
2799	at least two (2) years after expiry of the year they concern. Medisorb shall
2800	have the right to have such records of Janssen US inspected and examined, at
2801	Medisorb's expense, for the purpose of determining the correctness of royalty
2802	payments made hereunder.
2803
2804	Such inspection shall be made by an independent, certified public accountant to
2805	whom Janssen US shall have no reasonable objection. Such accountant shall not
2806	disclose to Medisorb any information other than that necessary to verify the
2807	accuracy of the reports and payments made pursuant to this Agreement. It is
2808	understood that such examination with respect to any quarterly accounting period
2809	shall take place not later than two (2) years following the expiration of said
2810	period. Not more than one examination per year shall take place.
2811
2812	Based upon the verification of such reports and whenever there is reasonable
2813	doubt about the accuracy of the sales of Product realized by an Affiliate or
2814	sublicensee, Medisorb may reasonably request Janssen US to audit the books of
2815	such Affiliate or such sublicensee in accordance with any applicable contractual
2816	provision, in order to confirm the accuracy of such reports.
2817
2818	(4) Production of Product/Technology Transfer:
2819	-----------------------------------------
2820
2821	(a) Janssen US shall use its reasonable efforts consistent with its
2822	overall business practices and strategies to commercialize and market Product,
2823	or to have the same commercialized and marketed in the Territory.
2824
2825	(b) In the event that Janssen US determines to manufacture Product
2826	itself or through an Affiliate or have Product manufactured by a third party,
2827	Medisorb shall transfer to Janssen US and/or Affiliate all relevant Technical
2828	Information, and provide such technical assistance, upon mutually agreed terms
2829	and conditions, as is required by Janssen US in order to enable the manufacture
2830	of Product by Janssen US, its Affiliate or its designated third party
2831	manufacturer. However, with respect to such third party manufacturers, except as
2832	limited by a written Product manufacturing agreement between Janssen US and
2833	Medisorb, Medisorb will have a right of first refusal as to the manufacture and
2834	supply to Janssen US of all Product(s), and component bioabsorbable polymers
2835	utilized in such Product(s). Medisorb will have a period of thirty (30) days
2836	following written notice from Janssen US of terms it is offering to, or prepared
2837	to accept from, a third party manufacturer to notify Janssen US of its intention
2838	to exercise its right of first refusal to supply Product and/or component
2839	bioabsorbable polymers thereof to Janssen US, its Affiliates and Licensees on
2840	terms no less favorable to Janssen US than those offered by such
2841
2842
2843	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2844	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
2845	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2846	<PAGE>
2847
2848	Janssen US-Medisorb Page 6
2849	License Agreement
2850
2851
2852
2853	third party manufacturer. Such third party manufacturer cannot be an in-kind
2854	competitor to Medisorb and must be reasonably acceptable to Medisorb with
2855	respect to confidential protection of Medisorb's Technical Information. In the
2856	event that at any time during the term of this Agreement Medisorb is unable for
2857	any reason whatsoever to supply the Medisorb Polymers required by Janssen U.S.
2858	for use in Products, then the right of first refusal under this paragraph
2859	respecting the supply of the component bioabsorbable polymers shall be
2860	eliminated. For the purposes of this section, an "in-kind" competitor shall mean
2861	any organization which regularly engages in the contract development and/or
2862	contract manufacture of injectable controlled release drug delivery systems
2863	comprising a polymeric excipient based on lactic and/or glycolic acids and/or
2864	other closely related monomers. This Section 4(b) specifically supersedes
2865	Section 7(B) of the Development Agreement, which Section 7(B) shall be of no
2866	further force or effect.
2867
2868	(5) Proprietary Rights
2869	------------------
2870
2871	(a) Medisorb will retain title to and ownership of all technology
2872	(including, without limitation, all patents, inventions, and data relating
2873	thereto) relating to absorbable polymers, controlled release of active agents,
2874	and/or manufacturing methods or processes relating to such polymers and the
2875	controlled delivery systems for active agents based on such polymers previously
2876	owned by Medisorb or developed by Medisorb as a result of the Development
2877	Program or otherwise. Medisorb will pay its own costs and expenses in connection
2878	with the protection of any such technology, including all patent application and
2879	maintenance costs and Janssen US agrees to provide Medisorb with any necessary
2880	utility information.
2881
2882	Medisorb shall inform Janssen US of any patent application it wishes to
2883	file to protect proprietary rights defined in Article 5, resulting from either
2884	the Development Program or the preliminary Development Program and shall forward
2885	a copy of any such patent application to Janssen US at least one month prior to
2886	filing.
2887
2888	Medisorb shall consider any suggestions made by Janssen US for amplifying
2889	such application and shall accordingly amend the application where in Medisorb's
2890	opinion it is appropriate.
2891
2892	Medisorb shall not abandon part or whole of any of the patents or patent
2893	applications without having first consulted Janssen US, which shall have the
2894	right to further pursue any patents or patent applications which Medisorb wishes
2895	to abandon, or parts thereof, in its own name and at its own expense.
2896
2897	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2898	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
2899	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2900	<PAGE>
2901
2902	Janssen US-Medisorb Page 7
2903	License Agreement
2904
2905
2906	(b) Janssen US and/or its Affiliate will retain title to and ownership
2907	of all technology (including, without limitation, all patents, inventions, and
2908	data relating thereto) relating to [ ] or any chemical analogues of
2909	[ ] with similar physiological activity previously owned by Janssen US
2910	and/or its Affiliate or developed by Janssen US and/or affiliate as a result of
2911	this Agreement or otherwise. Janssen US and/or its Affiliate will pay its own
2912	costs and expenses in connection with the protection of any such technology,
2913	including all patent application and maintenance costs and Medisorb agrees to
2914	provide Janssen US with any necessary utility information.
2915
2916	(c) Any inventions, other than those falling under either section 5(a)
2917	or 5(b) hereof, having an inventorship jointly between at least one employee of
2918	Janssen US or an Affiliate of Janssen US and one employee of Medisorb or an
2919	Affiliate of Medisorb shall be jointly-owned by Janssen US or Janssen US
2920	Affiliate as the case may be and Medisorb. Each party will cooperate fully in
2921	the filing and prosecution of such patent applications.
2922
2923	Janssen US and Medisorb shall agree on which of both shall be responsible
2924	for the filing, prosecution and maintenance of any such joint patent
2925	applications and patents (hereinafter referred to as the "Responsible Party") in
2926	Territory. In principle, the party having contributed the most to the invention
2927	to be protected shall be the responsible party, unless agreed upon differently.
2928	Upon mutual consent, the responsible party may select an agent for drafting,
2929	filing and prosecuting a joint application. However, both parties shall agree
2930	who shall be the agent and to what extent this agent shall be used.
2931
2932	The Responsible Party shall consult the other party when drafting any new
2933	jointly owned patent application. The final draft shall be forwarded to the
2934	other party at least one month prior to filing to give the opportunity to make
2935	final comments.
2936
2937	The Responsible Party shall not abandon part or whole of any of the patents
2938	or patent applications without having first consulted the other party, which
2939	shall have the right to further pursue any patents or patent applications which
2940	the responsible party wishes to abandon, or parts thereof, in its own name and
2941	at its own expense.
2942
2943	All out-of-pocket costs made in relation to joint patent applications and
2944	patents in the Territory shall be shared equally by Janssen US and Medisorb. A
2945	statement of costs shall be made up on a quarterly basis and invoiced to the
2946	other party.
2947
2948	Medisorb shall grant to Janssen US an exclusive fully-paid up royalty free
2949	license with the right to sublicense to make, have made, use and sell under any
2950	such patents or patent applications for the duration of the patents, any
2951	continuations, continuations in part,
2952
2953
2954	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
2955	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
2956	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2957	<PAGE>
2958
2959	Janssen US-Medisorb Page 8
2960	License Agreement
2961
2962
2963	divisions, patents of addition, reissues, renewals or extensions thereof or any
2964	supplementary protection certificates granted with respect thereto, in respect
2965	of any claims concerning the application of [ ] or any chemical
2966	analogues of [ ] with similar physiological activity. However, nothing
2967	contained in this paragraph shall obviate Janssen US's obligation to pay
2968	royalties under Section 3 hereof with respect to any Products developed
2969	hereunder.
2970
2971	Janssen US shall grant to Medisorb an exclusive fully paid-up royalty free
2972	license with the right to sublicense to make, have made, use and sell under any
2973	such patents or patent applications for the duration of the patents, any
2974	continuations, continuations in part, divisions, patents of addition, reissues,
2975	renewals or extensions thereof or any supplementary protection certificates
2976	granted with respect thereto, in respect of any claims concerning the
2977	application of bioabsorbable polymers in the field of human and/or veterinary
2978	medicine.
2979
2980	(d) In addition, each party will retain exclusive title to its
2981	respective confidential information in accordance with the provisions of Article
2982	9 below.
2983
2984	(6) Patent Infringement
2985	-------------------
2986
2987	(a) In the event that either party becomes aware that any third party
2988	is infringing in the Territory any patents included within the Patents, the
2989	party becoming aware of such infringement shall promptly give notice of such
2990	infringement to the other party. Any possible action against such alleged
2991	infringement of the Patents will be carried out by either or both of the parties
2992	in accordance with the provisions specified hereinafter in paragraphs (b), (c),
2993	(d) and (e).
2994
2995	(b) Whenever it would concern a patent or patent application falling
2996	within the definition of Patents and of which Medisorb retains full title and
2997	ownership pursuant to Article 5 a), Medisorb shall use all reasonable efforts to
2998	take action against such infringement in its own name, at its own expense and on
2999	its own behalf.
3000
3001	If Medisorb fails to take action against such infringement, or if Medisorb
3002	does not use reasonable efforts in carrying out such action after commencement
3003	thereof, within thirty (30) days after the notice referred to in paragraph (a)
3004	above or after having become aware of such infringement, Janssen US shall be
3005	entitled at its own discretion and at its own expense, to take immediate action
3006	against such infringement in its own name, at its own expense and on its own
3007	behalf. Medisorb will give all reasonable assistance to Janssen in taking such
3008	action in accordance with Article 6(e), including giving Janssen the authority
3009	to file and prosecute such suit and, if necessary, being named a party in such
3010	action. If Janssen US commences or assumes such action, Janssen US may credit
3011	[ ] of
3012
3013
3014	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3015	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
3016	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3017	<PAGE>
3018
3019	Janssen US-Medisorb Page 9
3020	License Agreement
3021
3022
3023	any royalty otherwise due to Medisorb for sales in such country or countries
3024	against the amount of the expenses and costs of such action, including without
3025	limitation, attorney fees actually incurred by Janssen US. The amount of
3026	expenses so deducted shall be paid to Medisorb out of the recoveries, if any,
3027	received by Janssen US as a result of such action. Except for such repayment of
3028	royalties deducted, Janssen US shall be entitled to retain all recoveries
3029	therefrom.
3030
3031	In no event shall Medisorb settle with such infringing third party in the
3032	Field without the prior written consent of Janssen US.
3033
3034	(c) Whenever it would concern a patent or patent application falling
3035	within the definition of Patents and of which Janssen US or any of its
3036	Affiliates retains full title and ownership pursuant to Article 5 B), Janssen US
3037	shall have the right but not the obligation to take action against such
3038	infringement in its own name, at its own cost and on its own behalf. If Janssen
3039	US fails to take action against such infringement, or if Janssen US does not use
3040	reasonable efforts in carrying out such action after commencement thereof,
3041	within thirty (30) days after the notice referred to in paragraph (a) above or
3042	after having become aware of such infringement, Medisorb shall be entitled at
3043	its own discretion and at its own expense, to take action against such
3044	infringement. Medisorb shall be entitled to retain all recoveries, if any,
3045	therefrom.
3046
3047	(d) Whenever it would concern a patent or patent application falling
3048	within the definition of Patents and of which Janssen US or any of its
3049	Affiliates and Medisorb jointly retain full title and ownership pursuant to
3050	Article 5 (c), and whenever in such case the infringing product would be a drug
3051	product falling within the definition of the Field, Janssen US shall have the
3052	right but not the obligation to take action against such infringement in its own
3053	name, at its own cost and on its own behalf. If Janssen US fails to take action
3054	against such infringement, or if Janssen US does not use reasonable efforts in
3055	carrying out such action after commencement thereof, within thirty (30) days
3056	after the notice referred to in paragraph (a) above or after having become aware
3057	of such infringement, Medisorb shall be entitled at its own discretion and at
3058	its own expense, to take action against such infringement, it being understood
3059	that Janssen US will have a continuing right to take over any such action at its
3060	own expense and shall pay to Medisorb from any recoveries Janssen US receives
3061	(i) Medisorb's expenses and (ii) from any sums remaining after deduction of
3062	Medisorb's and Janssen US's expenses, an amount proportionate to Medisorb's
3063	expenses in relation to Janssen US's expenses.
3064
3065	Whenever it would concern a patent or patent application falling within the
3066	definition of Patents and of which Janssen US or any of its Affiliates and
3067	Medisorb jointly retain full title and ownership pursuant to Article 5 (c), and
3068	whenever in such case the
3069
3070
3071	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3072	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
3073	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3074	<PAGE>
3075
3076	Janssen US-Medisorb Page 10
3077	License Agreement
3078
3079
3080	infringing product would be a drug product falling outside the definition of the
3081	Field, Medisorb shall have the right but not the obligation to take action
3082	against such infringement in its own name, at its own cost and on its own
3083	behalf. If Medisorb fails to take action against such infringement, or if
3084	Medisorb does not use reasonable efforts in carrying out such action after
3085	commencement thereof, within thirty (30) days after the notice referred to in
3086	paragraph (a) above or after having become aware of such infringement, Janssen
3087	US shall be entitled at its own discretion and at its own expense, to take
3088	action against such infringement, it being understood that Medisorb will have a
3089	continuing right to take over any such action at its own expense. If Janssen US
3090	commences or assumes such action, Janssen US may credit
3091	[ ] of any royalty otherwise payable to Medisorb
3092	payable hereunder against the amount of the expenses and costs of such action,
3093	including without limitation, attorney fees actually incurred by Janssen US. The
3094	amount of expenses so deducted shall be paid to Medisorb out of the recoveries,
3095	if any, received by Janssen US as a result of such action. Except for such
3096	repayment of royalties deducted, Janssen US shall be entitled to retain all
3097	recoveries therefrom.
3098
3099	(e) Each party agrees to cooperate reasonably with the other party in
3100	such litigation, including making available to the other party records,
3101	information, and evidence relevant to the infringement of the Patent.
3102
3103	(7) Third Party Intellectual Property Rights
3104	----------------------------------------
3105
3106	(a) Medisorb warrants that to the best of its current knowledge and
3107	belief the Products to be developed hereunder will not infringe the patent
3108	rights of any third party.
3109
3110	(b) In the event that the manufacture, use or sale of the Product
3111	would constitute an infringement of the rights of a third party in the Territory
3112	because of the use of the Patents or Medisorb's know how, each party shall, as
3113	soon as it becomes aware of the same, notify the other thereof in writing,
3114	giving in the same notice full details known to it of the rights of such third
3115	party and the extent of any alleged infringement. The parties shall after
3116	receipt of such notice meet to discuss the situation, and, to the extent
3117	necessary attempt to agree on a course of action in order to permit Janssen US
3118	to practice the license granted hereunder. Such course of action may include:
3119	(a) modifying the Product or its manufacture so as to be noninfringing; (b)
3120	obtaining an appropriate license from such third party; or (c) fight the claim
3121	or suit. In the event that within a short period of time, the parties fail to
3122	agree on an appropriate course of action Janssen US may decide upon the course
3123	of action in the interest of the further development, manufacturing or
3124	commercialization of the Product.
3125
3126
3127	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3128	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
3129	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3130	<PAGE>
3131
3132	Janssen US-Medisorb Page 11
3133	License Agreement
3134
3135
3136	(c) In the event that the parties cannot agree on modifying the
3137	Product or in the case that such modification would not be economically viable
3138	or regulatory feasible, Janssen US, whenever it relates to know how, whether
3139	patented or not, owned by Janssen US in accordance with the provisions of
3140	Article 5 (b) and (c), or Medisorb, whenever it relates to know how, whether
3141	patented or not, owned by Medisorb in accordance with the provisions of Article
3142	5 (a), will have the right to negotiate with such third party for such license.
3143	Both parties hereto will in any event in good faith consult with each other with
3144	respect to such negotiations and the party negotiating such license as indicated
3145	above, will make every effort to minimize the amount of license fees and
3146	royalties payable thereunder. In no event shall either party as a result of such
3147	settlement, grant a sublicense or cross license to the third party to settle the
3148	suit, without the prior written approval of the other party. In the event that
3149	such negotiations result in a consummated agreement, any license fee and/or
3150	royalties to be paid thereunder shall be paid by the party responsible for the
3151	negotiations as indicated above, [ ] of any license fees
3152	or royalties paid by Janssen US under such license will be creditable against
3153	royalties due to Medisorb hereunder.
3154
3155	(d) In the event that either or both parties would further to such
3156	notification under Paragraph 7 (b) decide to defend such suit or claim in which
3157	a third party alleges that the manufacture, use or selling of the Product in the
3158	Territory infringes said third party's patent in, Janssen US shall have the
3159	right to apply [ ] of the royalties due to Medisorb
3160	on the sales of the allegedly infringing Product against its litigation
3161	expenses.
3162
3163	(8) Term:
3164	----
3165
3166	(a) Except as otherwise provided herein, this Agreement and the term
3167	of the license granted to Janssen US hereunder shall commence on the date first
3168	written above and shall expire (i) upon expiration of the last to expire Patent
3169	or (ii) fifteen (15) years after the date of the first commercial sale of
3170	Product in the Territory, whichever is later; provided, that in no event shall
3171	the license granted hereunder expire later than the twentieth anniversary of the
3172	first commercial sale of Product. After expiration of the license granted to
3173	Janssen US hereunder, Janssen US shall retain a fully paid-up non-exclusive
3174	license to manufacture, use and sell Products in the Field in the Territory.
3175
3176	(b) Medisorb may convert the exclusive license granted under this
3177	Agreement to non-exclusive if Janssen US does not maintain the following minimum
3178	annual royalty payments to Medisorb. With respect to the entire Territory, the
3179	minimum royalty obligation will first apply to the twelve month period following
3180	the anniversary of the end of the month in which the Product was launched.
3181	During the first twelve month period and each subsequent twelve month period
3182	that such minimum royalty obligation is applicable, the
3183
3184
3185	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3186	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
3187	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3188	<PAGE>
3189
3190	Janssen US-Medisorb Page 12
3191	License Agreement
3192
3193
3194	minimum royalty amount to be paid by Janssen US will be calculated by
3195	multiplying the applicable royalty rate by [ ] percent of the actual aggregate
3196	net sales of other [ ] products in the Territory during such twelve month
3197	period.
3198
3199	Janssen US shall have the right to make up any shortfall in minimum royalty
3200	payments from Product sales in the Territory provided, such make-up payment is
3201	made at the same time and in the same manner as required for the underlying
3202	minimum royalty obligation.
3203
3204	(c) In the event that either party shall enter or be put into
3205	voluntary or compulsory liquidation or have a receiver appointed or default in
3206	the observance or performance of its obligations under this Agreement and shall
3207	fail to remedy such default within ninety (90) days after the delivery of
3208	written notice from the other party, the other party shall be entitled upon
3209	giving written notice to terminate this Agreement.
3210
3211	(d) Janssen US may terminate this Agreement without cause upon 30 days
3212	prior written notice. Thereafter, Janssen US shall have no further rights or
3213	privileges with respect to the use of Medisorb Technology in Products and
3214	Medisorb shall be under no further obligation of non-competition or exclusive
3215	dealing.
3216
3217	(e) Any early termination of the Agreement shall be without prejudice
3218	to the rights of either party against the other accrued under this Agreement
3219	prior to termination.
3220
3221	(f) Upon any termination of this Agreement, any remaining inventory of
3222	Product may be sold, provided all royalties otherwise due hereunder are paid
3223	with respect to such sales.
3224
3225	(g) All rights and licenses granted under or pursuant to this
3226	Agreement by Medisorb to Janssen U.S. are, and shall otherwise be deemed to be,
3227	for purposes of Section 365(n) of Title 11, U.S. Code (the "Bankruptcy Code"),
3228	licenses to "intellectual property" as defined under section 101(60) of the
3229	Bankruptcy Code. The parties agree that Janssen, as a licensee of such rights
3230	under this Agreement, shall retain and may fully exercise all of its rights and
3231	elections under the Bankruptcy Code.
3232
3233	(9) Confidentiality:
3234	---------------
3235
3236	(a) Each party agrees to keep confidential and to not use for any
3237	purpose other than as set forth herein all technical information and materials
3238	supplied by the other hereunder and any information a party may acquire about
3239	the other or its activities as a result of entering into this Agreement,
3240	provided that such obligation shall not apply to
3241
3242	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3243	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
3244	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3245	<PAGE>
3246
3247	Janssen US-Medisorb Page 13
3248	License Agreement
3249
3250
3251	technical information or material which: (i) was in the receiving party's
3252	possession without restriction prior to receipt from the other party or its
3253	Affiliates; (ii) was in the public domain at the time of receipt; (iii) becomes
3254	part of the public domain through no fault of the receiving party; (iv) shall be
3255	lawfully received from a third party with a right of further disclosure; (v)
3256	shall be required to be disclosed by law, by regulation or by the rules of any
3257	securities exchange.
3258
3259	(b) Except as may be otherwise provided herein, the confidentiality
3260	obligations as set out in this Section shall continue so long as this Agreement
3261	remains in force and thereafter for a period of seven (7) years.
3262
3263	(c) Janssen US shall cause its Affiliates and Sublicensees to abide by
3264	the obligations of confidentiality with respect to unpublished information
3265	within the Patents and Technical Information.
3266
3267	(d) Any confidential information relating to the subject matter of
3268	this Agreement imparted to the other party prior to the execution of this
3269	Agreement shall be considered to fall under the terms of this Agreement.
3270
3271	(10) Disclaimer of Warranty: Medisorb makes no representations or
3272	----------------------
3273	warranties, express or implied, with respect to the Medisorb Patents and
3274	Technical Information licensed to Janssen US hereunder, including without
3275	limitation any warranties of merchantability or fitness for a particular
3276	purpose.
3277
3278
3279	(11) Liability
3280	---------
3281
3282	(a) Janssen US agrees to indemnify, defend and hold harmless Medisorb
3283	from and against any liability, loss, damages and expenses (including reasonable
3284	attorney fees) Medisorb may suffer as the result of claims, demands, costs or
3285	judgments which may be made or instituted against Medisorb by reason of personal
3286	injury or damage to property arising out or caused by Janssen US's promotion,
3287	use and sale of the Product, except where such liabilities claims, demands,
3288	costs or judgments are caused by Medisorb's failure to provide Janssen US with
3289	any information as specified in Section 12 (c) and Article 13. Medisorb will
3290	notify Janssen US as soon as it becomes aware of any such claim or action and
3291	agrees to give reasonable assistance in the investigation and defense of such
3292	claim or action it being understood that it shall allow Janssen US to control
3293	the disposition of the same.
3294
3295
3296
3297	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3298	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
3299	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3300	<PAGE>
3301
3302	Janssen US-Medisorb Page 14
3303	License Agreement
3304
3305
3306	(b) Medisorb agrees to indemnify, defend and hold harmless Janssen US
3307	from and against any liability, loss, damages and expenses (including reasonable
3308	attorney fees) Janssen US may suffer as the result of claims, demands, costs or
3309	judgments which may be made or instituted against Janssen US by reason of
3310	personal injury or damage to property arising out or caused by Medisorb's
3311	failure to provide Janssen US with any information as specified in Section 12
3312	(c) and Article 13.
3313
3314	(c) In no event shall either party be liable for loss of profits, loss
3315	of goodwill or any consequential or incidental damages of any kind of the other
3316	party.
3317
3318	(12) Product Information and Adverse Drug Events
3319	-------------------------------------------
3320
3321	(a) As Janssen US has superior knowledge of the end-use applications
3322	to which Products licensed hereunder will be put, Janssen US is responsible for
3323	providing third parties with adequate information as to the medical profile of
3324	such Products. Janssen US will provide Medisorb with copies of the product
3325	information document which is part of the NDA for the Product.
3326
3327	(b) Medisorb does not claim the expertise to judge whether Product(s)
3328	will perform acceptably in Janssen US's application(s). Janssen US is the sole
3329	judge as to whether Product(s) will perform acceptably in Janssen US's
3330	application(s). Janssen US represents and warrants on an on-going basis during
3331	the term of this agreement that it has the capability to assess the suitability
3332	of Product(s) in Janssen US's application(s) and agrees to conduct adequate
3333	testing to confirm the safety and efficacy of Products prior to
3334	commercialization.
3335
3336	(c) Medisorb will provide to Janssen US promptly after its discovery
3337	by Medisorb, any information in its possession which indicates adverse effects
3338	in humans associated with the Products, including the bioabsorbable polymeric
3339	components thereof, licensed hereunder. For the purpose of this Agreement
3340	"adverse event" shall mean an experience which is noxious and unintended and
3341	which occurs at doses normally used in man for the prophylaxis, diagnosis or
3342	therapy of a disease or for the modification of a physiological function and any
3343	report of an overdose.
3344
3345	(13) Government Approvals
3346	--------------------
3347
3348	Janssen US shall be responsible for conducting all necessary testing as
3349	well as determining what, if any, government approvals are required for the use
3350	and sale of Product licensed hereunder and shall comply with all such
3351	requirements prior to and following the sale or distribution of such Products.
3352
3353
3354	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3355	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
3356	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3357	<PAGE>
3358
3359	Janssen US-Medisorb Page 15
3360	License Agreement
3361
3362
3363	Medisorb shall cooperate fully with Janssen US in obtaining regulatory
3364	approvals for Product licensed hereunder and shall, at Janssen US's request,
3365	provide appropriate regulatory authorities with any and all information
3366	concerning Medisorb's technology, Medisorb polymers and Medisorb's manufacturing
3367	process for such Product.
3368
3369	In this respect Medisorb undertakes that it has submitted or will as soon
3370	as possible submit a type IV Drug Master File to the FDA identifying Medisorb's
3371	method of manufacture, release specifications and testing methods used in the
3372	manufacture of Medisorb Polymers and a type I Drug Master File of Medisorb's
3373	manufacturing facilities where Product may be manufactured. Medisorb will
3374	authorize Janssen U.S. at its request to cross-reference any Drug Master Files
3375	relating to the Medisorb Polymers.
3376
3377	(14) Force Majeure: Neither party shall be liable for its failure to
3378	-------------
3379	perform any of its obligations hereunder if such failure is occasioned by a
3380	contingency beyond its reasonable control including, but not limited to,
3381	occurrences such as strikes or other labor disturbances, lock out, riot, war,
3382	default by a common carrier, fire, flood, storm, earthquake, other acts of God,
3383	inability to obtain raw materials, failure of plant facilities or government
3384	regulation, act or failure to act. Each party shall notify the other immediately
3385	upon occurrence or cessation of any such contingencies. If such contingency
3386	continues unabated for at least 180 consecutive days, either party shall have
3387	the right to terminate this Agreement without further obligation beyond those
3388	actually incurred prior to such termination.
3389
3390	(15) Press Communications: Neither party shall originate any publicity,
3391	--------------------
3392	news release or public announcement, written or oral relating to this Agreement,
3393	including its existence, without the prior written approval of the other party.
3394
3395	(16) Notices: Any legal notice required or permitted hereunder shall be
3396	-------
3397	considered properly given if in writing and sent by first class mail, certified
3398	mail or by telefacsimile to the party being notified at the respective address
3399	of such party as follows:
3400
3401	If to Medisorb:
3402
3403	Medisorb Technologies International L.P.
3404	6954 Cornell Road
3405	Cincinnati, OH 45242
3406
3407	Facsimile: 513-489-2348
3408
3409	If to Janssen US:
3410
3411
3412	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3413	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
3414	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3415	<PAGE>
3416
3417	Janssen US-Medisorb Page 16
3418	License Agreement
3419
3420
3421
3422	Janssen U.S.
3423	1125 Trenton-Harbourton Road
3424	P.O. Box 200
3425	Titusville, New Jersey 08560-0200
3426
3427	Facsimile: 609-630-2616
3428
3429	with a copy to Janssen Pharmaceutica International
3430	Kollerstrasse 38
3431	6300 Zug 6
3432	Switzerland
3433	Facsimile: 00-41-42449565
3434
3435	Such notice shall be effective upon receipt or upon refusal to accept such
3436	notice. In any case, notice shall be presumed effective no later than five (5)
3437	days after such notice is sent.
3438
3439	Neither party shall originate any publicity, news release or public
3440	announcement, written or oral, relating to this Agreement, including its
3441	existence, without the written approval of the other party.
3442
3443	(17) Assignment: This Agreement shall not be assigned by either party
3444	----------
3445	without the prior written consent of the other party; provided, however, that
3446	assignment shall be permitted without such consent to any party, not less than
3447	50% of the total interest of which owns, is owned by, or is under common control
3448	with the assigning party. In the event of any such permitted assignment the
3449	assignee shall be subject to and shall agree in writing to be bound by the terms
3450	and conditions of this Agreement.
3451
3452	(18) Dispute Resolution: The parties shall amicably discuss and
3453	------------------
3454	negotiate any matters which arise under this Agreement and are not specifically
3455	set forth hereunder. If any disputes arise under this Agreement, the parties
3456	shall use their reasonable efforts to meet and resolve such disputes. In the
3457	event that the parties are unable to resolve any such disputes, then both
3458	parties hereby agree to submit said disputes to the jurisdiction of the
3459	competent courts of the State of New Jersey and agree that any litigation in any
3460	way related to this Agreement shall be submitted to such courts and that same
3461	shall be subject to the laws of the State of New Jersey without regard to its
3462	rules respecting choice of law.
3463
3464	(19) Severability: In the event any one or more of the provisions of
3465	------------
3466	this Agreement should for any reason be held by any court or authority having
3467	jurisdiction over this Agreement or any of the parties hereto to be invalid,
3468	illegal or unenforceable such provision or provisions shall be validly reformed
3469	to as nearly approximate the intent of the
3470
3471
3472	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3473	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
3474	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3475	<PAGE>
3476
3477	Janssen US-Medisorb Page 17
3478	License Agreement
3479
3480
3481	parties as possible and, if unreformable; shall be divisible and deleted in such
3482	jurisdiction, elsewhere this Agreement shall not be affected.
3483
3484	(20) Captions: The captions of this Agreement are for convenience
3485	--------
3486	only, and shall not be deemed of any force or effect whatsoever in construing
3487	this Agreement.
3488
3489	(21) Waiver: The failure on the party of a party to exercise or
3490	------
3491	enforce any right conferred upon it hereunder shall not be deemed to be a waiver
3492	of any such right, nor operate to bar the exercise or enforcement thereof at any
3493	time thereafter.
3494
3495	(22) Survival: The following Articles of this Agreement shall survive
3496	--------
3497	the termination or expiration of this Agreement: 5, 9, 10, 11, 15, 17, and 18.
3498
3499	(23) Miscellaneous: This Agreement may be executed by the parties
3500	-------------
3501	hereto in counterparts, each of which when so executed and delivered shall be
3502	considered to be an original, but all such counterparts shall together
3503	constitute but one and the same instrument. This Agreement is the complete
3504	agreement of the parties and supersedes all previous understandings and
3505	agreements relating to the subject matter hereof. Neither this Agreement nor
3506	any of the terms hereof may be terminated, amended, supplemented, waived or
3507	modified orally , but only by an instrument in writing signed by the party
3508	against whom enforcement of the termination, amendment, supplement, waiver or
3509	modification is sought.
3510
3511	IN WITNESS WHEREOF, the duly authorized representatives of the parties
3512	hereto have executed this Agreement as of the day and year first above written.
3513
3514
3515	JANSSEN PHARMACEUTICA INC.
3516
3517	By: /s/ Paula F. Costa
3518	------------------------------
3519	Name: Paula F. Costa
3520	----------------------------
3521	Title: President
3522	---------------------------
3523	Date: 2/13/96
3524	----------------------------
3525
3526
3527	(Second Janssen Signatory)
3528	- ---------------------------
3529
3530
3531	By: /s/ Bruce D. Given
3532	------------------------------
3533	Name: Bruce D. Given
3534	----------------------------
3535	Title: Group Vice President
3536	---------------------------
3537
3538
3539	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3540	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
3541	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3542	<PAGE>
3543
3544	Janssen US-Medisorb Page 18
3545	License Agreement
3546
3547
3548
3549	Date: 2/16/96
3550	----------------------------
3551
3552
3553	MEDISORB TECHNOLOGIES INTERNATIONAL L.P.
3554	by: Medisorb Technologies
3555	International, Inc.,
3556	its General Partner
3557
3558
3559	By: /s/ David R. Lohr
3560	------------------------------
3561	Name: David R. Lohr
3562	----------------------------
3563	Title: President
3564	---------------------------
3565	Date: January 31, 1996
3566	----------------------------
3567
3568
3569
3570
3571
3572
3573
3574
3575
3576
3577
3578	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3579	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN
3580	FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3581	</TEXT>
3582	</DOCUMENT>
3583	<DOCUMENT>
3584	<TYPE>EX-10.20
3585	<SEQUENCE>6
3586	<DESCRIPTION>LICENSE AGREEMENT DATED 2/21/96
3587	<TEXT>
3588
3589	<PAGE>
3590
3591	LICENSE AGREEMENT
3592
3593
3594	This Agreement is made as of the 21 day February of 1996, between
3595	-- -------- ----
3596	MEDISORB TECHNOLOGIES INTERNATIONAL L.P., a Delaware limited partnership
3597	(hereinafter "Medisorb") and JANSSEN PHARMACEUTICA INTERNATIONAL, a division of
3598	Cilag International AG, a Swiss business corporation ("Janssen").
3599
3600	WHEREAS, the parties have entered into a certain Development
3601	Agreement, dated December 23, 1993 (the "Development Agreement"), for the
3602	development of a Product (as described below); and
3603
3604	WHEREAS, Janssen has an option under the Development Agreement to
3605	enter into this License Agreement for the Medisorb technology required to make,
3606	use and sell the Product, which option Janssen has elected to exercise; and
3607
3608	WHEREAS, the parties believe that it is in their mutual best interest
3609	for Medisorb to license to Janssen on an exclusive basis in the Territory,
3610	Medisorb Patents and Technical Information within the Field, upon the terms and
3611	conditions set forth herein;
3612
3613	NOW, IT IS HEREBY AGREED AS FOLLOWS:
3614
3615	(1) Definitions: The following terms shall have the meanings ascribed
3616	-----------
3617	to them herein, unless the context otherwise requires:
3618
3619	(a) "Affiliate" shall mean any company controlling, controlled by,
3620	or under common control with a party by ownership, directly or indirectly, of
3621	fifty percent (50%) or more of the total ownership or by the power to control
3622	the policies and actions of such company.
3623
3624	(b) "Development Program" shall mean the development activities
3625	conducted by the parties pursuant to the Development Agreement.
3626
3627	(c) "Field" shall mean the treatment of [
3628
3629
3630	].
3631
3632	(d) "Improvements" shall mean any improvements or developments to
3633	or of the Patents and Technical Information in the Field which Medisorb may
3634	acquire,
3635
3636
3637	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3638	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
3639	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3640	<PAGE>
3641
3642	Janssen-Medisorb
3643	License Agreement
3644	Page 2
3645
3646
3647
3648	discover, invent, originate, make, conceive or have a right to, in whole or in
3649	part, during the term of this Agreement, whether or not such improvement or
3650	development is patentable.
3651
3652	(e) "International Registration Dossier" ("IRF") shall mean the
3653	Product registration file compiled by Janssen Pharmaceutica N.V., Beerse,
3654	Belgium on behalf of Janssen, the contents and format being such that it can be
3655	submitted as such to national health authorities or be used as a basis for a
3656	national application for marketing authorization for the Products in the
3657	specific format required by such national health authorities.
3658
3659	(f) "Medisorb Polymers" shall mean bioresorbable aliphatic
3660	polyesters based on glycolide, lactide, caprolactone and combinations of such
3661	polymers, which are manufactured by Medisorb and utilized in Product(s) licensed
3662	under this Agreement.
3663
3664	(g) "Net Sales" shall mean the gross amounts received from sales
3665	of Products during a calendar quarter to third parties by Janssen, its
3666	Sublicensees or any Affiliate of either, less any: (i) applicable sales taxes;
3667	(ii) cash trade or quantity discounts; (iii) amounts repaid or credited by
3668	reason of rejections or return of goods; or (iv) freight, postage and duties
3669	paid for. No deduction from the gross sales price shall be made for any item of
3670	cost incurred by the seller in its own operations incident to the manufacture,
3671	sale or shipment of the product sold. For purposes hereof, Net Sales shall not
3672	include sales of a Product from Janssen or an Affiliate of Janssen to any
3673	Affiliate or Sublicensee of either; it being intended that Net Sales shall only
3674	include sales to unrelated third-parties.
3675
3676	(h) "Patents" shall mean (i) any and all existing issued patents
3677	and patent applications or parts thereof which describe and claim a depot
3678	formulation of [ ] or any chemical analogues of [ ] with
3679	similar physiological activity, based on polymers of lactic and glycolic acids
3680	and the production and use thereof; (ii) any other patents and patent
3681	applications filed by or on behalf of Medisorb, or under which Medisorb has the
3682	rights to grant licenses, which are needed to practice the inventions; and (iii)
3683	any reissues, extensions, substitutions, confirmations, registrations,
3684	revalidations, additions, continuations, continuations-in-part, or divisions of
3685	or to any of the foregoing which are granted hereafter or any additional
3686	protection certificate granted with respect thereto.
3687
3688	(i) "Product(s)" shall mean any and all depot formulations of [
3689	] or any chemical analogues of [ ] with similar physiological
3690	activity, based on polymers of lactic and glycolic acids which are designed to
3691	deliver [ ], or any of its chemical analogues, over an extended period.
3692
3693
3694
3695	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3696	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
3697	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3698	<PAGE>
3699
3700	Janssen-Medisorb
3701	License Agreement
3702
3703	Page 3
3704
3705
3706	(j) "Sublicensees" shall mean any company or companies, other
3707	than Janssen's Affiliates, sublicensed by Janssen.
3708
3709	(k) "Technical Information" shall mean all unpatented information,
3710	know-how, practical experience, procedures, methodology, specifications,
3711	formulae and data whether or not the same shall be patentable which have been
3712	heretofore developed or acquired by Medisorb prior to the date of this Agreement
3713	and which are necessary in order to use, manufacture or sell Products in the
3714	Field.
3715
3716	(l) "Territory" shall mean worldwide with the exception of the
3717	United States, its Territories, Protectorates, Commonwealths, and all other
3718	political subdivisions of the United States.
3719
3720	(2) License Grant
3721	-------------
3722
3723	(a) Medisorb hereby grants to Janssen in the Territory an
3724	exclusive license under the Patents and Technical Information existing prior to
3725	the effective date of this Agreement, with the right to grant sublicenses
3726	thereunder, for all purposes within the Field to practice and use the Patents
3727	and Technical Information, including the rights to manufacture and have
3728	manufactured, to use and have used, and to sell and have sold Products. Medisorb
3729	exclusively retains all rights under the Patents and Technical Information
3730	outside the Field and for use other than in Products. The right to grant
3731	sublicenses granted hereunder is exclusive to Janssen and shall not extend to
3732	Janssen Affiliates or Sublicensees.
3733
3734	(b) Medisorb shall offer to Janssen for incorporation into this
3735	License Agreement on reasonable terms and conditions, Medisorb Improvements in
3736	the Field which, if incorporated into Janssen's then current commercial
3737	Product(s), would: (i) result in significant changes in either the
3738	specifications for such Product(s) or the processes for producing such
3739	Product(s), and (ii) would reasonably be expected to result in enhanced market
3740	value and/or profitability of such Product(s). Examples of such Improvements
3741	would include: (i) the development by Medisorb of a non-aqueous injection
3742	vehicle which offers significant advantages with respect to ease of
3743	administration and (ii) the development by Medisorb of technology enabling[
3744	]. It is the parties'
3745	understanding that the effect of any such license amendment would, in general,
3746	be either an extension of the term of this Agreement for a mutually agreed
3747	period or a marginal increase in the then current royalty rate . All other
3748	Medisorb Improvements shall be made available to Janssen for its use without
3749	further agreement. Proprietary rights to Improvements jointly developed by
3750	Medisorb and Janssen shall be governed by the terms of Section 5(c) of this
3751	Agreement.
3752
3753
3754	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3755	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
3756	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3757	<PAGE>
3758
3759	Janssen-Medisorb
3760	License Agreement
3761
3762
3763	Page 4
3764
3765
3766
3767	(c) In the event that at any time during the term of this
3768	Agreement Medisorb is unable for any reason whatsoever to supply the Medisorb
3769	Polymers required by Janssen for use in Products, then the license granted under
3770	paragraph 2(a) above shall be expanded to include the Medisorb Technology
3771	required to make and use the Medisorb Polymers.
3772
3773	(3) Royalties:
3774	----------
3775
3776	(a) Janssen shall pay or cause to be paid to Medisorb a running
3777	royalty with respect to all Products sold to customers by Janssen, its
3778	Affiliates and Sublicensees, payable quarter-annually in arrears within sixty
3779	(60) days following the end of each three (3) month period ending on March 31,
3780	June 30, September 30 or December 31 in any year during the term hereof, as
3781	follows: (i) [ ]% of the Net Sales of each unit of Product sold during the
3782	preceding calendar quarter during the term hereof, if such unit of Product was
3783	manufactured by Medisorb pursuant to a written contract for the supply of
3784	Product; or (ii) [ ]% of the Net Sales of each unit of Product sold during
3785	the preceding calendar quarter during the term hereof, if such unit of Product
3786	was not manufactured by Medisorb pursuant to a written contract for the supply
3787	of Product. Any withholding or other tax that Janssen or any of its Affiliates
3788	are required by statute to withhold and pay on behalf of Medisorb with respect
3789	to the royalties payable to Medisorb under this Agreement shall be deducted from
3790	said royalties and paid contemporaneously with the remittance to Medisorb;
3791	provided, however, that in regard to any tax so deducted Janssen shall furnish
3792	Medisorb with proper evidence of the taxes paid on its behalf.
3793
3794	(b) In the event that, in a country where Product is not claimed
3795	in a valid Patent, a similar product obtains a market share greater than
3796	[ ]% of the total market revenues for Products and similar products in such
3797	country, the parties agree to meet and negotiate in good faith an appropriate
3798	reduction in the royalty rate then in effect. In no event shall a reduction
3799	in royalty rates pursuant to this section result in royalty rates [
3800	] of the rates specified under Section 3(a)(i) and 3(a)(ii) of this Agreement.
3801	For the purposes of this section, "similar product" shall mean a generic version
3802	of the Product(s) where: (i) the active agent is [ ], or a chemical
3803	analogue thereof and (ii) the excipient is comprised of lactic and/or glycolic
3804	acids. In the event that patent protection for Product(s) becomes available
3805	subsequent to a royalty reduction pursuant to this section, the parties agree to
3806	(i) reinstitute the royalty otherwise applicable, and (ii) in the event that any
3807	recovery is obtained for prior infringement of the subsequently issued patent,
3808	the parties will first apply such recoveries to reimbursing Medisorb for
3809	royalties it would otherwise have received.
3810
3811
3812	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3813	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
3814	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3815	<PAGE>
3816
3817	Janssen-Medisorb
3818	License Agreement
3819
3820	Page 5
3821
3822
3823	(c) Janssen shall keep complete and adequate records with respect
3824	to the proceeds of Products on which it has to pay royalties payable hereunder
3825	for at least two (2) years after expiry of the year they concern. Medisorb shall
3826	have the right to have such records of Janssen inspected and examined, at
3827	Medisorb's expense, for the purpose of determining the correctness of royalty
3828	payments made hereunder.
3829
3830	Such inspection shall be made by an independent, certified public accountant to
3831	whom Janssen shall have no reasonable objection. Such accountant shall not
3832	disclose to Medisorb any information other than that necessary to verify the
3833	accuracy of the reports and payments made pursuant to this Agreement. It is
3834	understood that such examination with respect to any quarterly accounting period
3835	shall take place not later than two (2) years following the expiration of said
3836	period. Not more than one examination per year shall take place.
3837
3838	Based upon the verification of such reports and whenever there is reasonable
3839	doubt about the accuracy of the sales of Product realized by an Affiliate or
3840	sublicensee, Medisorb may reasonably request Janssen to audit the books of such
3841	Affiliate or such sublicensee in accordance with any applicable contractual
3842	provision, in order to confirm the accuracy of such reports.
3843
3844	(4) Production of Product/Technology Transfer:
3845	-----------------------------------------
3846
3847	(a) Janssen shall use its reasonable efforts to commercialize and
3848	market Product, or to have the same commercialized and marketed.
3849
3850	(b) In the event that Janssen determines to manufacture Product
3851	itself or have Product manufactured by a third party, Medisorb shall transfer to
3852	Janssen all relevant Technical Information, and provide such technical
3853	assistance, upon mutually agreed terms and conditions, as is required by Janssen
3854	in order to enable the manufacture of Product by Janssen or its designated third
3855	party manufacturer. However, with respect to such third party manufacturers,
3856	except as limited by a written Product manufacturing agreement between Janssen
3857	and Medisorb, Medisorb will have a right of first refusal as to the manufacture
3858	and supply to Janssen of all Product(s), and component bioabsorbable polymers
3859	utilized in such Product(s). Medisorb will have a period of thirty (30) days
3860	following written notice from Janssen of terms it is offering to, or prepared to
3861	accept from, a third party manufacturer to notify Janssen of its intention to
3862	exercise its right of first refusal to supply Product and/or component
3863	bioabsorbable polymers thereof to Janssen, its Affiliates and Licensees on terms
3864	no less favorable to Janssen than those offered by such third party
3865	manufacturer. Such third party manufacturer cannot be an in-kind competitor to
3866	Medisorb and must be reasonably acceptable to Medisorb with respect to
3867	confidential protection of
3868
3869
3870	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3871	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
3872	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3873	<PAGE>
3874
3875	Janssen-Medisorb
3876	License Agreement
3877
3878	Page 6
3879
3880
3881
3882	Medisorb's Technical Information. In the event that at any time during the term
3883	of this Agreement Medisorb is unable for any reason whatsoever to supply the
3884	Medisorb Polymers required by Janssen for use in Products, then the right of
3885	first refusal under this paragraph respecting the supply of the component
3886	bioabsorbable polymers shall be eliminated. For the purposes of this section, an
3887	"in-kind" competitor shall mean any organization which regularly engages in the
3888	contract development and/or contract manufacture of injectable controlled
3889	release drug delivery systems comprising a polymeric excipient based on lactic
3890	and/or glycolic acids and/or other closely related monomers. This Section 4(b)
3891	specifically supercedes Section 7(B) of the Development Agreement, which Section
3892	7(B) shall be of no further force or effect.
3893
3894	(c) The right of first refusal granted to Medisorb pursuant to
3895	Section 4(b) above shall be contingent upon: (i) Medisorb and Janssen reaching
3896	an agreement concerning the financing, scheduling and construction in Europe of
3897	a Medisorb manufacturing facility within twelve (12) months of the date first
3898	above written or the initiation of Phase III human clinical trials, whichever is
3899	later, and (ii) prior to the qualification of Medisorb's European manufacturing
3900	facility, Medisorb using reasonable efforts to supply from its United States
3901	manufacturing facilities all of Janssen's commercial requirements for Product
3902	pursuant to the Product Supply Agreement anticipated by Section 7(A) of the
3903	Development Agreement.
3904
3905	(5) Proprietary Rights
3906	------------------
3907
3908	(a) Medisorb will retain title to and ownership of all technology
3909	(including, without limitation, all patents, inventions, and data relating
3910	thereto) relating to absorbable polymers, controlled release of active agents,
3911	and/or manufacturing methods or processes relating to such polymers and the
3912	controlled delivery systems for active agents based on such polymers previously
3913	owned by Medisorb or developed by Medisorb as a result of the Development
3914	Program or otherwise. Medisorb will pay its own costs and expenses in connection
3915	with the protection of any such technology, including all patent application and
3916	maintenance costs and Janssen agrees to provide Medisorb with any necessary
3917	utility information.
3918
3919	Medisorb shall inform Janssen of any patent application it wishes to
3920	file to protect proprietary rights defined in Article 5, resulting from either
3921	the Development Program or the preliminary Development Program and shall forward
3922	a copy of any such patent application to Janssen at least one month prior to
3923	filing.
3924
3925
3926	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3927	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
3928	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3929	<PAGE>
3930
3931	Janssen-Medisorb
3932	License Agreement
3933
3934	Page 7
3935
3936
3937	Medisorb shall consider any suggestions made by Janssen for amplifying
3938	such application and shall accordingly amend the application where in Medisorb's
3939	opinion it is appropriate.
3940
3941	Nine months after the first filing, Medisorb shall propose a list of
3942	countries in which it intends to file foreign equivalents. Janssen shall be
3943	given the opportunity to propose further countries to be added to the list. In
3944	case the adding of some or all of these further countries is unacceptable to
3945	Medisorb, Janssen shall have the right to file patent applications in those
3946	countries, in Medisorb's name and at Janssen expense. Medisorb shall assist in
3947	the transfer of rights for the latter patent applications and shall provide all
3948	information necessary to file and prosecute such patent applications.
3949
3950	Medisorb shall not abandon part or whole of any of the patents or
3951	patent applications without having first consulted Janssen, which shall have the
3952	right to further pursue any patents or patent applications which Medisorb wishes
3953	to abandon, or parts thereof, in its own name and at its own expense.
3954
3955	(b) Janssen and/or its Affiliate will retain title to and
3956	ownership of all technology (including, without limitation, all patents,
3957	inventions, and data relating thereto) relating to [ ] or
3958	any chemical analogues of [ ] with similar physiological
3959	activity previously owned by Janssen and/or its Affiliate or developed by
3960	Janssen as a result of this Agreement or otherwise. Janssen and/or its
3961	Affiliate will pay its own costs and expenses in connection with the
3962	protection of any such technology, including all patent application and
3963	maintenance costs and Medisorb agrees to provide Janssen with any necessary
3964	utility information.
3965
3966	(c) Any inventions, other than those falling under either section
3967	5(a) or 5(b) hereof, having an inventorship jointly between at least one
3968	employee of Janssen or an Affiliate of Janssen and one employee of Medisorb or
3969	an Affiliate of Medisorb shall be jointly-owned by Janssen and Medisorb. Each
3970	party will cooperate fully in the filing and prosecution of such patent
3971	applications.
3972
3973	Janssen and Medisorb shall agree on which of both shall be responsible
3974	for the filing, prosecution and maintenance of any such joint patent
3975	applications and patents (hereinafter referred to as the "Responsible Party").
3976	In principle, the party having contributed the most to the invention to be
3977	protected shall be the responsible party, unless agreed upon differently. Upon
3978	mutual consent, the responsible party may select an agent for drafting, filing
3979	and prosecuting a joint application. However, both parties shall agree who shall
3980	be the agent and to what extent this agent shall be used.
3981
3982	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
3983	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
3984	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3985	<PAGE>
3986
3987	Janssen-Medisorb
3988	License Agreement
3989
3990
3991	Page 8
3992
3993
3994	The Responsible Party shall consult the other party when drafting any
3995	new jointly owned patent application. The final draft shall be forwarded to the
3996	other party at least one month prior to filing to give the opportunity to make
3997	final comments.
3998
3999	The Responsible Party shall propose a list of countries in which it
4000	intends to file such patent applications. The other party shall be given the
4001	opportunity to propose further countries to be added to the list. In case the
4002	adding of some or all of these further countries is unacceptable to the
4003	Responsible Party, the other party shall have the right to file patent
4004	applications in those countries, in its own name and at its own expense. The
4005	Responsible Party shall assist in the transfer of rights for the latter patent
4006	applications and shall provide all information necessary to file and prosecute
4007	such patent applications.
4008
4009	The Responsible Party shall not abandon part or whole of any of the
4010	patents or patent applications without having first consulted the other party,
4011	which shall have the right to further pursue any patents or patent applications
4012	which the responsible party wishes to abandon, or parts thereof, in its own name
4013	and at its own expense.
4014
4015	All out-of-pocket costs made in relation to joint patent applications
4016	and patents shall be shared equally by Janssen and Medisorb. A statement of
4017	costs shall be made up on a quarterly basis and invoiced to the other party.
4018
4019	Medisorb shall grant to Janssen an exclusive fully-paid up royalty
4020	free license with the right to sublicense to make, have made, use and sell under
4021	any such patents or patent applications for the duration of the patents, any
4022	continuations, continuations in part, divisions, patents of addition, reissues,
4023	renewals or extensions thereof or any supplementary protection certificates
4024	granted with respect thereto, in respect of any claims concerning the
4025	application of [ ] or any chemical analogues of [ ]
4026	with similar physiological activity. However, nothing contained in this
4027	paragraph shall obviate Janssen's obligation to pay royalties under Section 3
4028	hereof with respect to any Products developed hereunder.
4029
4030	Janssen shall grant to Medisorb an exclusive fully paid-up royalty
4031	free license with the right to sublicense to make, have made, use and sell under
4032	any such patents or patent applications for the duration of the patents, any
4033	continuations, continuations in part, divisions, patents of addition, reissues,
4034	renewals or extensions thereof or any supplementary protection certificates
4035	granted with respect thereto, in respect of any claims concerning the
4036	application of bioabsorbable polymers in the field of human and/or veterinary
4037	medicine.
4038
4039
4040
4041	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
4042	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
4043	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
4044	<PAGE>
4045
4046	Janssen-Medisorb
4047	License Agreement
4048
4049
4050	Page 9
4051
4052	(d) In addition, each party will retain exclusive title to its
4053	respective confidential information in accordance with the provisions of Article
4054	9 below.
4055
4056	(6) Patent Infringement
4057	-------------------
4058
4059	(a) In the event that either party becomes aware that any third
4060	party is infringing any patents included within the Patents in any country or
4061	countries, the party becoming aware of such infringement shall promptly give
4062	notice of such infringement to the other party. Any possible action against such
4063	alleged infringement of the Patents will be carried out by either or both of the
4064	parties in accordance with the provisions specified hereinafter in paragraphs
4065	(b), (c), (d) and (e).
4066
4067	(b) Whenever it would concern a patent or patent application
4068	falling within the definition of Patents and of which Medisorb retains full
4069	title and ownership pursuant to Article 5 a), Medisorb shall use all reasonable
4070	efforts to take action against such infringement in its own name, at its own
4071	expense and on its own behalf.
4072
4073	If Medisorb fails to take action against such infringement, or if
4074	Medisorb does not use reasonable efforts in carrying out such action after
4075	commencement thereof, within thirty (30) days after the notice referred to in
4076	paragraph (a) above or after having become aware of such infringement, Janssen
4077	shall be entitled at its own discretion and at its own expense, to take
4078	immediate action against such infringement in its own name, at its own expense
4079	and on its own behalf. If Janssen commences or assumes such action, Janssen may
4080	credit [ ] of any royalty otherwise due to Medisorb
4081	for sales in such country or countries against the amount of the expenses and
4082	costs of such action, including without limitation, attorney fees actually
4083	incurred by Janssen. The amount of expenses so deducted shall be paid to
4084	Medisorb out of the recoveries, if any, received by Janssen as a result of such
4085	action. Except for such repayment of royalties deducted, Janssen shall be
4086	entitled to retain all recoveries therefrom.
4087
4088	In no event shall Medisorb settle with such infringing third party in
4089	the Field without the prior written consent of Janssen.
4090
4091	(c) Whenever it would concern a patent or patent application
4092	falling within the definition of Patents and of which Janssen retains full title
4093	and ownership pursuant to Article 5 B), Janssen shall have the right but not the
4094	obligation to take action against such infringement in its own name, at its own
4095	cost and on its own behalf. If Janssen fails to take action against such
4096	infringement, or if Janssen does not use reasonable efforts in carrying out such
4097	action after commencement thereof, within thirty (30) days after the notice
4098	referred to
4099
4100	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
4101	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
4102	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
4103	<PAGE>
4104
4105	Janssen-Medisorb
4106	License Agreement
4107
4108	Page 10
4109
4110
4111
4112	in paragraph (a) above or after having become aware of such infringement,
4113	Medisorb shall be entitled at its own discretion and at its own expense, to take
4114	action against such infringement. Medisorb shall be entitled to retain all
4115	recoveries, if any, therefrom.
4116
4117	(d) Whenever it would concern a patent or patent application
4118	falling within the definition of Patents and of which Janssen and Medisorb
4119	jointly retain full title and ownership pursuant to Article 5 (c), and whenever
4120	in such case the infringing product would be a drug product falling within the
4121	definition of the Field, Janssen shall have the right but not the obligation to
4122	take action against such infringement in its own name, at its own cost and on
4123	its own behalf. If Janssen fails to take action against such infringement, or if
4124	Janssen does not use reasonable efforts in carrying out such action after
4125	commencement thereof, within thirty (30) days after the notice referred to in
4126	paragraph (a) above or after having become aware of such infringement, Medisorb
4127	shall be entitled at its own discretion and at its own expense, to take action
4128	against such infringement, it being understood that Janssen will have a
4129	continuing right to take over any such action at its own expense and shall pay
4130	to Medisorb from any recoveries Janssen receives (i) Medisorb's expenses and
4131	(ii) from any sums remaining after deduction of Medisorb's and Janssen's
4132	expenses, an amount proportionate to Medisorb's expenses in relation to
4133	Janssen's expenses.
4134
4135	Whenever it would concern a patent or patent application falling
4136	within the definition of Patents and of which Janssen and Medisorb jointly
4137	retain full title and ownership pursuant to Article 5 (c), and whenever in such
4138	case the infringing product would be a drug product falling outside the
4139	definition of the Field, Medisorb shall have the right but not the obligation to
4140	take action against such infringement in its own name, at its own cost and on
4141	its own behalf. If Medisorb fails to take action against such infringement, or
4142	if Medisorb does not use reasonable efforts in carrying out such action after
4143	commencement thereof, within thirty (30) days after the notice referred to in
4144	paragraph (a) above or after having become aware of such infringement, Janssen
4145	shall be entitled at its own discretion and at its own expense, to take action
4146	against such infringement, it being understood that Medisorb will have a
4147	continuing right to take over any such action at its own expense. If Janssen
4148	commences or assumes such action, Janssen may credit [ ]of any
4149	royalty otherwise payable to Medisorb payable hereunder against the amount of
4150	the expenses and costs of such action, including without limitation, attorney
4151	fees actually incurred by Janssen. The amount of expenses so deducted shall be
4152	paid to Medisorb out of the recoveries, if any, received by Janssen as a result
4153	of such action. Except for such repayment of royalties deducted, Janssen shall
4154	be entitled to retain all recoveries therefrom.
4155
4156
4157
4158	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
4159	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
4160	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
4161	<PAGE>
4162
4163	Janssen-Medisorb
4164	License Agreement
4165
4166
4167	Page 11
4168
4169
4170	(e) Each party agrees to cooperate reasonably with the other party
4171	in such litigation, including making available to the other party records,
4172	information, and evidence relevant to the infringement of the Patent.
4173
4174	(7) Third Party Intellectual Property Rights
4175	----------------------------------------
4176
4177	(a) Medisorb warrants that to the best of its current knowledge
4178	and belief the Products to be developed hereunder will not infringe the patent
4179	rights of any third party.
4180
4181	(b) In the event that the manufacture, use or sale of the Product
4182	would constitute an infringement of the rights of a third party in a country
4183	because of the use of the Patents or Medisorb's know how, each party shall, as
4184	soon as it becomes aware of the same, notify the other thereof in writing,
4185	giving in the same notice full details known to it of the rights of such third
4186	party and the extent of any alleged infringement. The parties shall after
4187	receipt of such notice meet to discuss the situation, and, to the extent
4188	necessary attempt to agree on a course of action in order to permit Janssen to
4189	practice the license granted hereunder. Such course of action may include: (a)
4190	modifying the Product or its manufacture so as to be noninfringing; (b)
4191	obtaining an appropriate license from such third party; or (c) fight the claimor
4192	suit. In the event that within a short period of time, the parties fail to
4193	agree on an appropriate course of action Janssen may decide upon the course of
4194	action in the interest of the further development, manufacturing or
4195	commercialization of the Product.
4196
4197	(c) In the event that the parties cannot agree on modifying the
4198	Product or in the case that such modification would not be economically viable
4199	or regulatorily feasible, Janssen, whenever it relates to know how, whether
4200	patented or not, owned by Janssen in accordance with the provisions of Article 5
4201	(b) and (c), or Medisorb, whenever it relates to know how, whether patented or
4202	not, owned by Medisorb in accordance with the provisions of Article 5 (a), will
4203	have the right to negotiate with such third party for such license. Both
4204	parties hereto will in any event in good faith consult with each other with
4205	respect to such negotiations and the party negotiating such license as indicated
4206	above, will make every effort to minimize the amount of license fees and
4207	royalties payable thereunder. In no event shall either party as a result of
4208	such settlement, grant a sublicense or cross license to the third party to
4209	settle the suit, without the prior written approval of the other party. In the
4210	event that such negotiations result in a consummated agreement, any license fee
4211	and/or royalties to be paid thereunder shall be paid by the party responsible
4212	for the negotiations as indicated above, [ ] of any
4213	license fees or royalties paid by Janssen under such license will be creditable
4214	against royalties due to Medisorb with respect to such country or countries.
4215
4216
4217
4218	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
4219	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
4220	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
4221	<PAGE>
4222
4223	Janssen-Medisorb
4224	License Agreement
4225
4226	Page 12
4227
4228
4229
4230	(d) In the event that either or both parties would further to such
4231	notification under Paragraph 7 (b) decide to defend such suit or claim in which
4232	a third party alleges that the manufacture, use or selling of the Product
4233	infringes said third party's patent in a country, Janssen shall have the right
4234	to apply [ ] of the royalties due to Medisorb on
4235	the sales of the allegedly infringing Product against its litigation expenses.
4236
4237	(8) Term:
4238	----
4239
4240	(a) Except as otherwise provided herein, this Agreement and the
4241	term of the license granted to Janssen hereunder shall commence on the date
4242	first written above and shall expire (i) upon expiration of the last to expire
4243	Patent in such country or (ii) fifteen (15) years after the date of the first
4244	commercial sale of Product in such country, whichever is later; provided, that
4245	in no event shall the license granted hereunder expire later than the twentieth
4246	anniversary of the first commercial sale of Product in any country with the
4247	exception of the following countries where the fifteen (15) year minimum shall
4248	pertain regardless: Canada, France, Germany, Italy, Japan, Spain and the United
4249	Kingdom. After expiration of the license granted to Janssen hereunder, Janssen
4250	shall retain a fully paid-up non-exclusive license to manufacture, use and sell
4251	Products in the Field in the Territory.
4252
4253	(b) Medisorb may convert the exclusive license granted under this
4254	Agreement to non-exclusive if Janssen does not maintain the following minimum
4255	annual royalty payments to Medisorb:
4256
4257	(i) With respect to the entire Territory, excluding Japan, the
4258	minimum royalty obligation will first apply to the twelve month period following
4259	the anniversary of the end of the month in which the Product was launched in the
4260	third major country. For the purpose of this Article only, major country shall
4261	mean France, Germany, United Kingdom or Italy. During the first twelve month
4262	period that such minimum royalty obligation is applicable, the minimum royalty
4263	amount to be paid by Janssen will be calculated by multiplying the applicable
4264	royalty rate by [ ] percent of the actual aggregate net sales of other
4265	[ ] products during such twelve month period in the three major
4266	countries referred to above.
4267
4268	As from the subsequent twelve month period the minimum annual royalty amount to
4269	be paid by Janssen will be calculated by multiplying the applicable royalty rate
4270	by [ ]% of the aggregate net sales of other [ ] products
4271	during such period in all countries where Product has been launched and marketed
4272	for a period of minimally twelve months prior to the actual reference twelve
4273	month period; and
4274
4275
4276
4277	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
4278	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
4279	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
4280	<PAGE>
4281
4282	Janssen-Medisorb
4283	License Agreement
4284
4285
4286	Page 13
4287
4288
4289
4290	(ii) In Japan the minimum royalty obligation will be first
4291	applied to the twelve month period following the anniversary of the end of the
4292	month in which the Product was launched. The minimum annual royalty amount to
4293	be paid by Janssen will be calculated by multiplying the applicable royalty
4294	rate by an amount representing [ ]% of the aggregate net sales of other
4295	[ ] products in Japan during such period.
4296
4297	Janssen shall have the right to make up any shortfall in minimum royalty
4298	payments from Product sales, both in Japan and in the rest of the Territory
4299	provided, such make-up payment is made at the same time and in the same manner
4300	as required for the underlying minimum royalty obligation.
4301
4302	Janssen may elect to have its exclusive rights converted into non-exclusive
4303	rights on a country by country basis. As a consequence thereof, such country's
4304	other [ ] products sales will no longer be taken into account for
4305	calculating the above minimum royalty obligation.
4306
4307	(c) In the event that either party shall enter or be put into
4308	voluntary or compulsory liquidation or have a receiver appointed or default in
4309	the observance or performance of its obligations under this Agreement and shall
4310	fail to remedy such default within ninety (90) days after the delivery of
4311	written notice from the other party, the other party shall be entitled upon
4312	giving written notice to terminate this Agreement.
4313
4314	(d) Janssen may terminate this Agreement without cause upon 30
4315	days prior written notice. Thereafter, Janssen shall have no further rights or
4316	privileges with respect to the use of Medisorb Technology in Products and
4317	Medisorb shall be under no further obligation of non-competition or exclusive
4318	dealing.
4319
4320	(e) Any early termination of the Agreement shall be without
4321	prejudice to the rights of either party against the other accrued under this
4322	Agreement prior to termination.
4323
4324	(f) Upon any termination of this Agreement, any remaining
4325	inventory of Product may be sold, provided all royalties otherwise due hereunder
4326	are paid with respect to such sales.
4327
4328	(9) Confidentiality:
4329	---------------
4330
4331	(a) Each party agrees to keep confidential and to not use for any
4332	purpose other than as set forth herein all technical information and materials
4333	supplied by the
4334
4335
4336
4337
4338	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
4339	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
4340	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
4341	<PAGE>
4342
4343	Janssen-Medisorb
4344	License Agreement
4345
4346
4347	Page 14
4348
4349
4350
4351	other hereunder and any information a party may acquire about the other or its
4352	activities as a result of entering into this Agreement, provided that such
4353	obligation shall not apply to technical information or material which: (i) was
4354	in the receiving party's possession without restriction prior to receipt from
4355	the other party or its Affiliates; (ii) was in the public domain at the time of
4356	receipt; (iii) becomes part of the public domain through no fault of the
4357	receiving party; (iv) shall be lawfully received from a third party with a right
4358	of further disclosure; (v) shall be required to be disclosed by law, by
4359	regulation or by the rules of any securities exchange.
4360
4361	(b) Except as may be otherwise provided herein, the
4362	confidentiality obligations as set out in this Section shall continue so long as
4363	this Agreement remains in force and thereafter for a period of seven (7) years.
4364
4365	(c) Janssen shall cause its Affiliates and Sublicensees to abide
4366	by the obligations of confidentiality with respect to unpublished information
4367	within the Patents and Technical Information.
4368
4369	(d) Any confidential information relating to the subject matter of
4370	this Agreement imparted to the other party prior to the execution of this
4371	Agreement shall be considered to fall under the terms of this Agreement.
4372
4373	(10) Disclaimer of Warranty: Medisorb makes no representations or
4374	----------------------
4375	warranties, express or implied, with respect to the Medisorb Patents and
4376	Technical Information licensed to Janssen hereunder, including without
4377	limitation any warranties of merchantability or fitness for a particular
4378	purpose.
4379
4380	(11) Liability
4381	---------
4382
4383	(a) Janssen agrees to indemnify, defend and hold harmless Medisorb
4384	from and against any liability, loss, damages and expenses (including reasonable
4385	attorney fees) Medisorb may suffer as the result of claims, demands, costs or
4386	judgments which may be made or instituted against Medisorb by reason of personal
4387	injury or damage to property arising out or caused by Janssen's promotion, use
4388	and sale of the Product, except where such liabilities claims, demands, costs or
4389	judgments are caused by Medisorb's failure to provide Janssen with any
4390	information as specified in Section 12 (c) and Article 13. Medisorb will notify
4391	Janssen as soon as it becomes aware of any such claim or action and agrees to
4392	give reasonable assistance in the investigation and defense of such claim or
4393	action it being understood that it shall allow Janssen to control the
4394	disposition of the same.
4395
4396
4397
4398	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
4399	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
4400	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
4401	<PAGE>
4402
4403	Janssen-Medisorb
4404	License Agreement
4405
4406
4407	Page 15
4408
4409
4410	(b) Medisorb agrees to indemnify, defend and hold harmless Janssen
4411	from and against any liability, loss, damages and expenses (including reasonable
4412	attorney fees) Janssen may suffer as the result of claims, demands, costs or
4413	judgments which may be made or instituted against Janssen by reason of personal
4414	injury or damage to property arising out or caused by Medisorb's failure to
4415	provide Janssen with any information as specified in Section 12 (c) and Article
4416	13
4417
4418	(c) In no event shall either party be liable for loss of profits,
4419	loss of goodwill or any consequential or incidental damages of any kind of the
4420	other party.
4421
4422	(12) Product Information and Adverse Drug Events
4423	-------------------------------------------
4424
4425	(a) As Janssen has superior knowledge of the end-use applications
4426	to which Products licensed hereunder will be put, Janssen is responsible for
4427	providing third parties with adequate information as to the medical profile of
4428	such Products. Janssen will provide Medisorb with copies of the IPID
4429	(International Product Information Document) and the IPPI (International Patient
4430	Package Insert), which are all part of the IRF for the Product. For the purpose
4431	of this Agreement IPID refers to the document that summarizes all medically
4432	relevant features of the Product, including the instructions for use meant to
4433	inform the medical profession, whereas the IPPI is a patient-oriented document,
4434	based upon the IPID that summarizes all relevant information on the Product in
4435	lay language. Janssen will keep Medisorb informed of any revisions or amendments
4436	in the IPID and IPPI of the Product.
4437
4438	(b) Medisorb does not claim the expertise to judge whether
4439	Product(s) will perform acceptably in Janssen's application(s). Janssen is the
4440	sole judge as to whether Product(s) will perform acceptably in Janssen's
4441	application(s). Janssen represents and warrants on an on-going basis during the
4442	term of this agreement that it has the capability to assess the suitability of
4443	Product(s) in Janssen's application(s) and agrees to conduct adequate testing to
4444	confirm the safety and efficacy of Products prior to commercialization.
4445
4446	(c) Medisorb will provide to Janssen promptly after its discovery
4447	by Medisorb, any information in its possession which indicates adverse effects
4448	in humans associated with the Products, including the bioabsorbable polymeric
4449	components thereof, licensed hereunder. For the purpose of this Agreement
4450	"adverse event" shall mean an experience which is noxious and unintended and
4451	which occurs at doses normally used in man for the prophylaxis, diagnosis or
4452	therapy of a disease or for the modification of a physiological function and any
4453	report of an overdose.
4454
4455	(13) Government Approvals
4456	--------------------
4457
4458
4459	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
4460	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
4461	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
4462	<PAGE>
4463
4464	Janssen-Medisorb
4465	License Agreement
4466
4467
4468	Page 16
4469
4470
4471	Janssen shall be responsible for conducting all necessary testing as
4472	well as determining what, if any, government approvals are required for the use
4473	and sale of Product licensed hereunder and shall comply with all such
4474	requirements prior to and following the sale or distribution of such Products.
4475
4476	Medisorb shall cooperate fully with Janssen in obtaining regulatory
4477	approvals for Product licensed hereunder and shall, at Janssen's request,
4478	provide appropriate regulatory authorities with any and all information
4479	concerning Medisorb's technology, Medisorb polymers and Medisorb's manufacturing
4480	process for such Product.
4481
4482	In this respect Medisorb undertakes that it has submitted or will as
4483	soon as possible submit a type IV Drug Master File to the FDA identifying
4484	Medisorb's method of manufacture, release specifications and testing methods
4485	used in the manufacture of its bioabsorbable polymers and a type I Drug Master
4486	File of Medisorb's manufacturing facilities where Product may be manufactured.
4487	Medisorb will authorize Janssen at its request to cross-reference any Medisorb
4488	Drug Master Files relating to the Medisorb Polymers.
4489
4490	(14) Force Majeure: Neither party shall be liable for its failure to
4491	-------------
4492	perform any of its obligations hereunder if such failure is occasioned by a
4493	contingency beyond its reasonable control including, but not limited to,
4494	occurrences such as strikes or other labor disturbances, lock out, riot, war,
4495	default by a common carrier, fire, flood, storm, earthquake, other acts of God,
4496	inability to obtain raw materials, failure of plant facilities or government
4497	regulation, act or failure to act. Each party shall notify the other immediately
4498	upon occurrence or cessation of any such contingencies. If such contingency
4499	continues unabated for at least 180 consecutive days, either party shall have
4500	the right to terminate this Agreement without further obligation beyond those
4501	actually incurred prior to such termination.
4502
4503	(15) Press Communications: Neither party shall originate any
4504	--------------------
4505	publicity, news release or public announcement, written or oral relating to this
4506	Agreement, including its existence, without the prior written approval of the
4507	other party.
4508
4509	(16) Notices: Any legal notice required or permitted hereunder shall
4510	-------
4511	be considered properly given if in writing and sent by first class mail,
4512	certified mail or by telefacsimile to the party being notified at the respective
4513	address of such party as follows:
4514
4515
4516
4517	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
4518	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
4519	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
4520	<PAGE>
4521
4522	Janssen-Medisorb
4523	License Agreement
4524
4525
4526
4527	Page 17
4528
4529	If to Medisorb:
4530
4531	Medisorb Technologies International L.P.
4532	6954 Cornell Road
4533	Cincinnati, OH 45242
4534	USA
4535	Facsimile: 513-489-2348
4536
4537	If to Janssen:
4538
4539	Janssen Pharmaceutica
4540	Kollerstrasse 38
4541	6300 Zug 6
4542	Switzerland
4543	Facsimile: 00-41-42449565
4544
4545	Such notice shall be effective upon receipt or upon refusal to accept such
4546	notice. In any case, notice shall be presumed effective no later than five (5)
4547	days after such notice is sent.
4548
4549	Neither party shall originate any publicity, news release or public
4550	announcement, written or oral, relating to this Agreement, including its
4551	existence, without the written approval of the other party.
4552
4553	(17) Assignment: This Agreement shall not be assigned by either party
4554	----------
4555	without the prior written consent of the other party; provided, however, that
4556	assignment shall be permitted without such consent to any party, not less than
4557	50% of the total interest of which owns, is owned by, or is under common control
4558	with the assigning party. In the event of any such permitted assignment the
4559	assignee shall be subject to and shall agree in writing to be bound by the terms
4560	and conditions of this Agreement.
4561
4562	(18) Dispute Resolution: The parties shall amicably discuss and
4563	------------------
4564	negotiate any matters which arise under this Agreement and are not specifically
4565	set forth hereunder. If any disputes arise under this Agreement, the parties
4566	shall use their best efforts to meet and resolve such disputes. In the event
4567	that the parties are unable to resolve any such disputes, then both parties
4568	hereby agree to submit said disputes to the jurisdiction of the competent Courts
4569	of Zurich, Switzerland, and agree that any litigation in any way related to this
4570	Agreement shall be submitted to such Courts and that same shall be subject to
4571	Swiss law.
4572
4573
4574
4575	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
4576	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
4577	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
4578	<PAGE>
4579
4580	Janssen-Medisorb
4581	License Agreement
4582
4583
4584	Page 18
4585
4586
4587	(19) Severability: In the event any one or more of the provisions of
4588	------------
4589	this Agreement should for any reason be held by any court or authority having
4590	jurisdiction over this Agreement or any of the parties hereto to be invalid,
4591	illegal or unenforceable such provision or provisions shall be validly reformed
4592	to as nearly approximate the intent of the parties as possible and, if
4593	unreformable; shall be divisible and deleted in such jurisdiction, elsewhere
4594	this Agreement shall not be affected.
4595
4596	(20) Captions: The captions of this Agreement are for convenience
4597	--------
4598	only, and shall not be deemed of any force or effect whatsoever in construing
4599	this Agreement.
4600
4601	(21) Waiver: The failure on the party of a party to exercise or
4602	------
4603	enforce any right conferred upon it hereunder shall not be deemed to be a waiver
4604	of any such right, nor operate to bar the exercise or enforcement thereof at any
4605	time thereafter.
4606
4607	(22) Survival: The following Articles of this Agreement shall survive
4608	--------
4609	the termination or expiration of this Agreement: 5, 9, 10, 11, 15, 17, and 18.
4610
4611	(23) Miscellaneous: This Agreement may be executed by the parties
4612	-------------
4613	hereto in counterparts, each of which when so executed and delivered shall be
4614	considered to be an original, but all such counterparts shall together
4615	constitute but one and the same instrument. This Agreement is the complete
4616	agreement of the parties and supersedes all previous understandings and
4617	agreements relating to the subject matter hereof. Neither this Agreement nor
4618	any of the terms hereof may be terminated, amended, supplemented, waived or
4619	modified orally , but only by an instrument in writing signed by the party
4620	against whom enforcement of the termination, amendment, supplement, waiver or
4621	modification is sought.
4622
4623
4624
4625	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
4626	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
4627	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
4628	<PAGE>
4629
4630	Janssen-Medisorb
4631	License Agreement
4632
4633
4634	Page 19
4635
4636
4637	IN WITNESS WHEREOF, the duly authorized representatives of the parties
4638	hereto have executed this Agreement as of the day and year first above written.
4639
4640
4641	JANSSEN PHARMACEUTICA INTERNATIONAL
4642	A division of Cilag International AG
4643
4644
4645	By: /s/ Erik Rombouts
4646	---------------------------------------
4647	Name: Erik Rombouts
4648	-------------------------------------
4649	Title: Operations Director
4650	------------------------------------
4651	Date: February 21, 1996
4652	-------------------------------------
4653
4654
4655	[Second Janssen Signatory]
4656	- -------------------------
4657
4658
4659	By: /s/ Heinz Schmid
4660	---------------------------------------
4661	Name: Heinz Schmid
4662	-------------------------------------
4663	Title: General Manager
4664	------------------------------------
4665	Date: February 21, 1996
4666	-------------------------------------
4667
4668
4669	MEDISORB TECHNOLOGIES INTERNATIONAL L.P.
4670
4671	by: Medisorb Technologies
4672	International, Inc.,
4673	its General Partner
4674
4675
4676	By: /s/ David R. Lohr
4677	---------------------------------------
4678	Name: David R. Lohr
4679	-------------------------------------
4680	Title: President
4681	------------------------------------
4682	Date: January 31, 1996
4683	-------------------------------------
4684
4685
4686
4687
4688	THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
4689	TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
4690	SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.