Common use of Development Program Clause in Contracts

Development Program. RWJPRI shall be [**] and have [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.

Development Program. RWJPRI shall be [**] solely responsible for and have [**] the exclusive right, at its discretion but in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] exclusive right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] exclusive right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.

Development Program. RWJPRI Subject to Bukwang’s timely performance of its obligations hereunder, and in complete fulfillment of Triangle’s diligence obligations hereunder and any such obligations implied by law, Triangle will undertake, or, if applicable, will cause its Affiliates and sublicensees to undertake, the development activities described in this Article 6. Triangle shall, at its expense, use its [BUKWANG REDACTED] (a) to conduct a development program (the “Development Program”) relating to the use of the Licensed Product for HBV and (b) if the results of the Development Program so justify, to seek Registration for such Licensed Product in the United States. As part of the Development Program, Triangle shall be responsible for conducting 3-month toxicity studies in two species of animals pursuant to protocols which it develops or approves, as applicable. Triangle shall commence both toxicity studies as promptly as practicable [**BUKWANG REDACTED] after it obtains Bulk Drug Substance of a quality and have in such quantities reasonably necessary to perform such toxicity studies. Bulkwang shall promptly reimburse Triangle for [**BUKWANG REDACTED] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDACout-of-pocket costs (excluding all drug costs, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and which shall be the owner responsibility of Triangle) incurred by Triangle in conducting such toxicity studies, subject to reasonable substantiation by Triangle of such out-of, all applications for MARKETING AUTHORIZATION throughout the world-pocket costs. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may The Development Program shall be mutually agreed, discussed by the parties hereto at RWJPRI's expense, in chemical development, formulation development, production the meetings of labeled material the Joint Project Committee held pursuant to Article 7 and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated into consideration studies and such other work which RWJPRI reasonably deems experiments carried out, or to be required for subsequent inclusion carried out by, Bukwang and its licensees, if any, outside the Territory, but the activities within the Territory comprising the Development Program shall be determined at Triangle’s sole discretion. Anything in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions this Agreement to the contrary notwithstanding, Triangle shall be entitled to exercise prudent and file all reasonably necessaryjustifiable business judgment in meeting its [BUKWANG REDACTED] obligations hereunder. For purposes of this Article 6, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like[BUKWANG REDACTED].

Development Program. RWJPRI (a) Promptly following execution of this LICENSE AGREEMENT, ILEX shall use its best efforts based on ILEX's reasonable business judgment, to execute the DEVELOPMENT PLAN and to carry out the activities for FULL DEVELOPMENT of the LICENSED PRODUCT so that JANS▇▇▇ ▇▇▇ launch the LICENSED PRODUCT in the United States and Europe no later than the 13 second quarter of the year 2000. In the course of such efforts ILEX shall, under the direction of JANS▇▇▇ ▇▇ coordinated by the PMT as set forth in Article 3.1.2 hereto, take appropriate steps including the following: (i) Establish and maintain a program reasonably designed, funded and resourced to complete PHASE III trials on the LICENSED PRODUCT for the LEAD INDICATION; (ii) Proceed following successful completion of PHASE III trials, other associated studies and all other work which the PMT reasonably deems to be [**] required, to prepare and have [**] compile the necessary regulatory documentation for inclusion in a filing of MARKETING AUTHORIZATION APPLICATIONS in the United States and Europe for the LICENSED PRODUCT for the LEAD INDICATION. In the case of Europe, the filing may be based on the EC multistate procedure or individual filings in at least the EUROPEAN MAJOR MARKET COUNTRIES. (b) In carrying out the DEVELOPMENT PLAN, ILEX shall make available the number of qualified "full time equivalents" of its scientific, engineering, manufacturing and other personnel specified in the DEVELOPMENT PLAN, and shall take such steps as it deems necessary, in order to perform its obligations in accordance with the terms hereof. ILEX shall use its best based on its reasonable business judgment efforts to carry out the DEVELOPMENT PLAN in accordance with the agreed upon time 14 and event schedule, in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATESPMT. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, JANS▇▇▇ shall have the [**] right to develop control and direct performance of the PRODUCT DEVELOPMENT PLAN through STAGES Othe PMT, I, II and III and shall have the [**] right to prepare and file, and approve any material agreement with third parties to be made by ILEX related to performance of the DEVELOPMENT PLAN hereunder which approval shall not be unreasonably withheld. (c) MARKETING AUTHORIZATION APPLICATIONS shall be compiled by ILEX based on information generated during the owner ofFULL DEVELOPMENT program. At JANS▇▇▇'▇ ▇▇▇ion, all applications for MARKETING AUTHORIZATION throughout the worldAPPLICATIONS shall either be filed by JANS▇▇▇ ▇▇ filed by ILEX and transferred to JANS▇▇▇. During JANS▇▇▇ ▇▇▇ll own all such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studiesMARKETING AUTHORIZATIONS. RWJPRI shall JANS▇▇▇ ▇▇▇ll exercise diligent reasonable efforts, commensurate with the efforts it would normally exercise for products with of similar potential sales volume and consistent with its overall business strategy, in developing such strategy to obtain MARKETING AUTHORIZATION for LICENSED PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRIsuch countries as JANS▇▇▇ ▇▇▇ms appropriate. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed JANS▇▇▇ ▇▇▇ll prosecute such submissions and file all reasonably necessary, the necessary reports and respond responses to all reasonable requests from fromt he pertinent regulatory authorities. ILEX shall prepare supporting documentation requested by JANS▇▇▇. ▇LEX shall further assist JANS▇▇▇ ▇▇▇h the pertinent regulatory, authorities preparation of supporting data to apply for information, data, samples, tests and the likepursue MARKETING AUTHORIZATION APPLICATIONS.

Development Program. RWJPRI 1.1 Fuisz and Kos shall jointly undertake using reasonable best efforts a Development Program to develop one or more Products for Commercial Sale. It is understood that this Development Program is primarily for the purposes of developing and producing Products and shall be [carried out generally in accordance with Appendix B. 1.2 Each party shall appoint a Program Manager for overall management of the Development Program and such Program Managers shall by mutual agreement provide the direction of the program and the scope of work to be undertaken under the Development Program; provided, however, that Kos shall determine the focus of work which the Program Managers mutually agree can be carried out under the Development Program, within the guidelines set forth in Appendix B. The initial Program Manager for Kos shall be designated within thirty (30) days and the initial Program Manager for Fuisz shall be Martynn Sheehan. ▇▇▇▇ ▇▇▇▇▇ ▇▇▇ change the designated Program Manager upon written notice to the other party of such change. 1.3 During the term of the Development Program Fuisz shall periodically provide to Kos samples of materials for evaluation by Kos. Kos shall promptly evaluate such samples and provide guidance to Fuisz for further work based on the results of such evaluations. During the Development Program term, Program Managers or representatives of the parties shall meet from time to time to discuss planning and progress of the Development Program to carry out efficient and effective activities. Fuisz shall provide project updates to Kos verbally and/or in written form every four (4) weeks during the Development Program, and shall provide a written report upon completion of the Development Program. All such discussions and activities shall be considered as carried out under the Development Program. 1.4 Kos shall supply to Fuisz, at Kos's cost and expense, materials including IS-5-MN which Kos believes are essential for carrying out the Development Program. All such materials supplied by Kos shall be materials approved for human uses unless otherwise specifically designated and Kos shall supply MSDS sheets where necessary for the processing of such materials. Fuisz shall advise Kos from time to time of its requirements for such materials for the Development Program. 1.5 Upon termination of each Phase of the Development Program, Fuisz shall provide to Kos quantities of prototype Products processed using Technology which demonstrate the best results obtained under the Development Program. Kos shall provide to Fuisz all data, information and conclusions generated during the Development Program relating to the Development Program and/or Technology including without limitation **] and have [**] in consultation with the JDAC**************** and any other mutually agreed pre-defined data, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, Fuisz shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right ************** to prepare use all such data, information and fileconclusions; provided, however, that Fuisz shall not utilize such data, information and conclusions to the detriment of the competitive position of Kos or inappropriately identify Kos in any publicity concerning same. 1.6 In the event special processing or manufacturing equipment specifically modified or adapted for use with Technology is requested by Kos to be used under the Development Program, Kos shall provide such equipment to Fuisz for the duration of the Development Program. 1.7 All activities in connection with the Development Program shall be carried out by each party in strict compliance with any applicable federal, state or local laws, regulations or guidelines governing such activities. 1.8 In addition to the funding under Article 3, Kos shall pay for the cost of all materials including IS-5-MN used in the Development Program and approved by Kos (to the extent such materials are not provided and fully paid by Kos), and Kos shall pay for the costs of all shipping, packing, customs, duties and customs clearances associated with shipment of materials and/or equipment to or from Fuisz or for, or resulting from work under, the Development Program. In addition, Kos shall pay for the reasonable costs of travel of Fuisz personnel at the prior request and approval of Kos in connection with meetings, activities or reviews of activities under the Development Program. 1.9 All equipment, supplies and other items purchased by either party for the conduct of the Development Program, shall be the owner ofsole and exclusive property of the purchasing party. For purposes hereof, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may items purchased by Fuisz with funds provided by Kos shall be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material deemed to be items purchased and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established owned by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT***. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.

Development Program. RWJPRI shall be [**] solely responsible for and have [**] the exclusive right, at its discretion but in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] exclusive right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] exclusive right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's ’s expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.

Development Program. RWJPRI 5.1 As soon as practicable following an Ardana Positive Election and a Columbia Positive Election the Parties shall cause the DC to meet to agree the detailed work program for the Second Development Program and the Development Budget for the first Year of the Second Development Program. The Parties agree that in relation to any Clinical Trials to be carried out as part of the Second Development Program: 5.1.1 Ardana shall be the sole sponsor of and for organising any such Clinical Trials to be carried out in the Ardana Territory and for the Development Costs to be paid in respect thereof (recouping the appropriate share of such Development Costs under the provisions of Clause 5.3) and Ardana shall make all Regulatory Applications in respect of such Clinical Trials or in respect of any subsequent Marketing Authorisation in the Ardana Territory in its own name; 5.1.2 Columbia shall be the sole sponsor of and for organising any such Clinical Trials to be carried out in the Columbia Territory and for the Development Costs to be paid in respect thereof (recouping the appropriate share of such Development Costs under the provisions of Clause 5.3) and Columbia shall make all Regulatory Applications in respect of such Clinical Trials or in respect of any subsequent Regulatory Approval in the Columbia Territory in its own name. [**] and have [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT ]A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 5.2 Subject to the provisions of Clause 5.1 each Party shall carry out those tasks and parts of the work program for the Second Development Program allocated to it by the DC provided always that neither Party shall be obliged to commit more FTE to the Second Development Program in any Year than determined under Clause 2.2.4. 5.3 The Parties shall be jointly responsible on a 50:50 basis for all Development Costs incurred by them in carrying out the Second Development Program. Within thirty (30) days of the end of each Quarter each party shall supply the other with a report of the Development Costs paid by it during that Quarter which report shall set out the tasks undertaken (which tasks shall be cross-referenced to the Second Development Program) and the Development Costs paid in relation to such task. Within forty-five (45) days of the end of each Quarter there shall be a reconciliation prepared of the Development Costs incurred during such Quarter by the Parties which reconciliation shall be in the form of an invoice from one Party to the other Party and a balancing payment as necessary by such Party to the other shall be made so that each Party has borne 50% of the Development Cost for that Quarter. For the avoidance of doubt it is declared and agreed that the sharing of Development Costs shall commence from the point that each Party makes a positive election pursuant to Clause 4 and the Parties acknowledge and agree that subject to the provisions of Clause 3.3 any costs and expenses incurred prior to that date are not chargeable to Development Costs. 5.4 If at the time that the DC seeks ratification of the Development Budget for any Year during the Second Development Program or the FTE commitment for any Year it is not so ratified by either Party's Chief Executive Officer in writing within 3 months of the commencement of the Year to which it relates (such Party's reasonable request for changes to the Second Development Program and consequential changes to the Development Budget or FTE commitment having been acceded to by the other Party) this shall be deemed notice of withdrawal from the Second Development Program by the Party refusing to ratify. Upon any such notice of withdrawal: 5.4.1 the provisions of Clauses 4.3 and 4.4 shall be deemed to apply such that the continuing Party shall have the fully paid up royalty free worldwide right to continue alone with development, commercialization, marketing, and sale of Candidate Product and any resulting Product; [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 5.4.2 the withdrawing Party shall upon the continuing Party's written request deliver up to the continuing Party all Documents containing any Know How (save for a single copy to be retained for evidential purposes by the withdrawing Party's lawyers), and any other Know How, held by the withdrawing Party relating to the Candidate Product and/or the resultant Product; 5.4.3 the withdrawing Party shall not use or otherwise exploit in any way, either directly or indirectly the Joint Program IP as it relates to the Candidate Product or any resulting Product in either case for all indications; 5.4.4 only the continuing Party shall be free to use and exploit all Joint Program IP as it relates to the Candidate Product or any resulting Product in either case for all indications as it sees fit with no obligation to the withdrawing Party in respect thereof provided however that both Parties shall be free to use and exploit all Joint Program IP, except as it relates to the Candidate Product or any resulting Product in either case for all indications, as each sees fit with no obligation to the withdrawing Party in respect thereof; 5.4.5 if the withdrawing Party is Columbia the licences granted by Columbia to Ardana pursuant to Clause 13.6 shall continue in full force and effect and shall be extended to the Columbia Territory and ROW and Columbia shall do all such acts and things as may be necessary to perfect this obligation and the provisions of Clauses 14.1, 14.3, 14.4, 14.6, and 14.7 shall continue to apply and shall be deemed expanded in scope to place similar obligations on Columbia in relation to non-European Columbia IP owned by Columbia at Ardana's request and sole reasonable expense. In such circumstances Ardana shall assume sole responsibility for the prosecution, maintenance, defence and enforcement of Joint Program IP at its own cost and expense, under the same terms, obligations, and consequences, and the same standards for maintaining exclusive rights, as set forth in Clause 4.3; 5.4.6 if the withdrawing Party is Ardana the licence granted by Ardana to Columbia pursuant to Clause 13.7 shall continue in full force and effect and shall be extended to the Ardana Territory and ROW and Ardana shall do all [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. such acts and things as may be necessary to perfect this obligation and the provisions of Clauses 14.3, 14.6, and 14.7 shall continue to apply. In such circumstances Columbia shall assume sole responsibility for the prosecution, maintenance, defence and enforcement of Joint Program IP at its own cost and expense, under the same terms, obligations, and consequences, and the same standards for maintaining exclusive rights, as set forth in Clause 4.4; 5.4.7 if the withdrawing Party is Columbia and it has obligations to manufacture and supply CTM and Finished Product under the terms of a Manufacturing and Supply Agreement entered into pursuant to Clause 9 these shall continue; 5.4.8 the withdrawing Party shall commensurate with legislative and regulatory requirements, transfer to the continuing Party or its nominee all Regulatory Approvals, Marketing Authorisations, Regulatory Applications and other regulatory filings and approvals for Candidate Product or resultant Product in all countries of the territory of the withdrawing Party and any country in the ROW Territory in relation to which the withdrawing Party has been appointed the Responsible Party pursuant to Clause 8. In the event that in any country such a transfer is not possible, the withdrawing Party shall use reasonable endeavours to ensure that the continuing Party has the benefit of the relevant Regulatory Approvals, Marketing Authorisations, Regulatory applications and other regulatory filings and approvals and, to this end, consents to any Governmental Authority cross-referencing to the data and information on file with any Governmental Authority as may be necessary to facilitate the granting of second Marketing Authorisations, applications, regulatory filings and approvals to the continuing Party, and the withdrawing Party agrees to complete whatever other procedures are reasonably necessary in relation to the same to enable the continuing Party (either itself or in conjunction with a third party) freely to develop and sell the Product in substitution for the withdrawing Party; and 5.4.9 the withdrawing Party shall use its reasonable endeavours to assign to the continuing Party the benefit of any agreement made between the [***] A CONFIDENTIAL TREATMENT PORTION OF THE MATERIAL HAS BEEN REQUESTED OMITTED AND FILED SEPARATELY WITH RESPECT TO THE SECURITIES AND EXCHANGE COMMISSION. withdrawing Party, and a sub- licensee in relation to Product in ROW or any agreement between the withdrawing Party and an agent or distributor in any country to which Clause 8.1 relates. 5.5 In the event that during the course of the Development Program the DC identifies a strategic, legal, commercial, safety, efficacy, formulation, scientific or technical reason which means that both Parties wish to abandon the development of the Candidate Product, then this Agreement shall terminate by their mutual agreement to do so (such mutual agreement being said decision of the DC ratified by both the CEO of Ardana and the CEO of Columbia). Following any such termination Ardana shall not use or exploit in any way whatsoever the Columbia IP, and both Parties shall not use or exploit the Joint Program IP in relation to the Candidate Product or resultant Product in either case for any indication without the other Party's prior written consent. 5.6 In the event that the Second Development Program continues to its satisfactory conclusion and filings for Regulatory Approval are made in the Columbia Territory and filings for Marketing Authorisation are made in the Ardana Territory as specified in Clause 5.1 and subsequently such Regulatory Approvals and/or Marketing Authorisations are granted: 5.6.1 Columbia shall own and hold the Regulatory Approvals for the Columbia Territory and thereafter shall be solely responsible for ensuring that all Applicable Laws and other regulatory or other obligations arising as a result thereof or in relation thereto are met. 5.6.2 Ardana shall own and hold the Marketing Authorisations for the Ardana Territory and thereafter shall be solely responsible for ensuring that all Applicable Laws and other regulatory or other obligations arising as a result thereof or in relation thereto are met. 5.6.3 Columbia shall be solely responsible (as between Columbia and Ardana) at its own cost and expense for the Commercialisation of the Product in the Columbia Territory and shall have the exclusive benefit of all revenues generated in relation thereto. It is agreed that whilst the final decision on [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED PORTIONSAND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Packaging and Labelling shall be Columbia's, the Packaging and Labeling will be marked with all relevant patent numbers in each country of the Territory, as may be required by local patent law or practice or otherwise permitted under Applicable Law and the MAs. 5.6.4 Ardana shall be solely responsible (as between Ardana and Columbia) at its own cost and expense for the Commercialisation of the Product in the Ardana Territory and shall have the exclusive benefit of all revenues generated in relation thereto. It is agreed that whilst the final decision on Packaging and Labelling shall be Ardana's, the Packaging and Labeling will be marked with all relevant patent numbers in each country of the Territory, as may be required by local patent law or practice or otherwise permitted under Applicable Law and the MAs. 5.6.5 As and when any variation to any Regulatory Approval or Marketing Authorisation is made each Party shall supply a copy thereof to the other evidence required Party. 5.6.6 The Parties shall co-ordinate and liaise with each other in connection with Commercialisation of the Product in the Ardana Territory and Columbia Territory respectively and shall establish a separate committee for IND nonthis purpose. In particular but not limiting the foregoing each party shall supply details of its Commercialisation Know How to the other. The Commercialisation Committee: (a) shall be constituted as specified in Clause 2.1.1; (b) shall be purely a co-rejection ordination, liaison and communication forum and shall not be a decision making body (all decisions about Commercialisation being reserved exclusively to commence Ardana in respect of the Ardana Territory and conduct human clinical trials Columbia in respect of such PRODUCTthe Columbia Territory); (c) shall meet as specified in Clauses 2.2.1 and 2.1.3; and [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. (iiid) proceed following IND non-rejection shall be a channel for communication between the Parties requesting amendments to commence PHASE Ithis Agreement (if any such requests are made) so that Commercialisation by such Party can occur in the most tax efficient manner for such Party. 5.7 Each Party shall be responsible for acquiring any and all Trade Marks for Product(s) in their respective territory and shall have sole responsibility for selection, IIclearance and registration of said Trade Marks in such territory provided always that the Parties shall liaise with each other in relation thereto. The Parties agree that, for Trade Marks owned jointly by the Parties or owned by one Party and used by or on behalf of the other Party, the Party using the ▇▇▇▇ will ensure that the manner, form, and III clinical trialsquality of all use of such Trade Marks will be at the approval of at least one Party owner of the Marks, associated studies which approval shall not be unreasonably withheld. 5.8 If at any time following First Commercial Sale by Columbia in the Columbia Territory or by Ardana in the Ardana Territory either of them should decide to withdraw the Product from such territory on a permanent basis for whatever reason they shall give 90 days written notice of the same to the other Party and such this shall be deemed a notice of withdrawal under Clause 5.4 and if the other work which RWJPRI reasonably deems Party so wishes it shall have the exclusive 90 day right to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests run from the pertinent regulatory, authorities for information, data, samples, tests date of receipt of such written notice and exercisable by notice in writing to the like.withdrawing Party to take over such territory on the terms of Clauses 5.4.1 to 5.4.9

Development Program. RWJPRI A. Angeion shall complete at no additional charge development of the Spot Catheter Product in accordance with the specification as set forth in Exhibit A for clinical studies to support a Pre-Market Approval ("PMA") submission. Any changes to the specification for the Spot Catheter Product reasonably requested by ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ after the Effective Date shall be completed by Angeion and paid for by ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ on a time and materials basis at the Development Rates as set forth in Exhibit B. B. Angeion shall develop Linear Catheter Product concept prototypes in accordance with a project plan to be agreed upon by the parties. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ shall select a Linear Catheter Product from the concept prototypes and the parties shall agree upon a project plan and specifications for the selected concept prototype of the Linear Catheter Product. Development of the selected concept prototypes of the Linear Catheter Product shall include design, building and testing of prototypes and clinical units for PMA submission, equipment modifications and in vitro testing, when required. C. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ will fund Angeion for reasonable costs incurred commencing January 1, 1998 to produce the concept prototypes and develop the selected concept prototype for the Linear Catheter Product (including not more than [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]incurred as of the Effective Date as set forth in the invoice attached as Exhibit C) in accordance with a budget of up to [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] and have a set of milestones to be agreed by the parties as part of the project plan. Angeion shall use its best efforts to complete development of the selected concept prototype of the Linear Catheter Product in accordance with the budget and milestones and shall not incur additional charges or costs above the agreed upon budget without prior written approval of ▇▇▇▇▇▇ ▇▇▇▇▇▇▇; however, the budget shall be based funding Angeion on a time and materials basis at the Development Rates as set forth in Exhibit B. Angeion does not guarantee or warrant that the development work related to the selected concept prototype of the Linear Catheter Product can be completed [**] *CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]. All sums paid pursuant to subparagraph C of this section will be paid upon receipt of a statement of services performed. Angeion shall keep accurate records reflecting the development work related to the Linear Catheter Product. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ shall have the right to audit the invoices and to inspect such records of Angeion no more than twice a year during normal business hours and upon reasonable notice. D. Notwithstanding the provisions of paragraph III.C above, it is understood that during the term of this Agreement ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ may elect to bring within the ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ organization certain or all of the development and manufacturing activities relating to the Linear Catheter Product as set forth in consultation with the JDACparagraph III.C and to terminate such activities by Angeion. Prior to such transfer of activities, to select LICENSED COMPOUNDS which ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with give Angeion sixty (60) days written notice of its decision to select intentions. In such a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENTcase, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ shall be the owner of, liable only for charges for all applications for MARKETING AUTHORIZATION throughout the worldwork done or non-cancelable costs committed by Angeion prior to such transfer. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI Angeion shall exercise diligent effortsefforts to minimize any such non-cancelable costs. E. Project reviews will be conducted on a quarterly basis or more frequently upon request by ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ commencing the month the agreement is signed. The review will include access by ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategyif desired, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps all design documentation including the following: (i) in consultation with Design History File. Angeion will provide detailed monthly status reports including expenses. Angeion will not exceed a monthly expense total as agreed by the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials parties without prior written approval of such PRODUCT▇▇▇▇▇▇ ▇▇▇▇▇▇▇. (iii) proceed following IND non-rejection F. Angeion shall provide overall project leadership to commence PHASE I, IIdevelop and manufacture the Spot Catheter Product and Linear Catheter Product. Product priorities for the Spot Catheter Product, and III clinical trialsproduct priorities, associated studies features and such other work which RWJPRI reasonably deems specifications for the Linear Catheter Product initially will be decided by ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, after discussions with Angeion. Any changes to the project plan or specifications for the Linear Catheter Products shall be required for subsequent inclusion agreed upon by both parties in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the likewriting.

Development Program. RWJPRI 3.1 Commencing on the EFFECTIVE DATE, the PARTIES shall conduct the COLLABORATION for the development, evaluation, testing and optimization of the DEVELOPED-PRODUCTS. 3.2 The PARTIES will collaborate on developing [processing] and application tests to evaluate the DEVELOPED-PRODUCTS. 3.3 BASF and ASPEN shall use best efforts to develop, evaluate and test the DEVELOPED PRODUCTS within a reasonable time after the EFFECTIVE DATE, but in no event later than two (2) consecutive years from the EFFECTIVE DATE. 3.4 The execution of the COLLABORATION shall take place, with respect to the research, development, design and formulation of the DEVELOPED-PRODUCTS on BASF’s premises at BASF’s site in Trostberg and/or the sites of its AFFILIATES BASF Wall Systems GmbH & Co. KG, and/or Elastogran GmbH and/or BASF SE in each case in close contact and exchange between BASF and ASPEN. BASF-PRODUCTS to be tested by BASF within the scope of the COLLABORATION shall be selected by BASF, and BASF shall specify these BASF-PRODUCTS with regard Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. to their possible qualities and under the specifications as defined in Annex 3, respectively. ASPEN-PRODUCTS to be tested by BASF within the scope of the COLLABORATION shall be selected by ASPEN, and ASPEN shall specify these ASPEN-PRODUCTS with regard to their possible qualities and under the specifications as defined in Annex 2, respectively. 3.5 BASF shall evaluate, test and report on the DEVELOPED-PRODUCTS’ suitability and effectiveness in [**] and have [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES]. RWJPRI BASF shall provide KOSAN designated representatives of ASPEN with periodic written notice reports of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with BASF’s progress in the advice testing of the JDACASPEN-PRODUCTS provided by ASPEN in DEVELOPED-PRODUCTS. BASF shall provide a final written report upon the completion of the COLLABORATION setting forth in detail the evaluations and tests conducted and all results obtained, as well as all conclusions which BASF reaches with respect to the effectiveness of the DEVELOPED-PRODUCTS. BASF agrees to provide ASPEN access to all testing and evaluation data BASF obtains during the period of exclusivity referenced herein, if any. 3.6 BASF shall have in its sole discretion determine the [**] right feasibility of commercially producing the DEVELOPED-PRODUCTS. 3.7 BASF and ASPEN shall identify any product they provide under the COLLABORATION for testing that is a commercial product of BASF or ASPEN, respectively. 3.8 With respect to develop the PRODUCT through STAGES Oapplication, I, II marketing and III initial commercialization of DEVELOPED-PRODUCTS BASF and shall have ASPEN will jointly negotiate and agree to a separate agreement in due time. The PARTIES undertake to use their best efforts to start a commercial exploitation of the [**] right to prepare and fileDEVELOPED-PRODUCTS as soon as the said DEVELOPED-PRODUCTS will be definitely validated by the PARTIES, and shall provided that the said DEVELOPED-PRODUCTS will be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established specifications of the present AGREEMENT. 3.9 The PARTIES are each allowed to inspect each other’s RESULTS as appropriate and shall inform each other on a regular basis of the progress of the COLLABORATION according to the milestone plannings as defined in Annex 1 but not later than by RWJPRIthe end of each quarter. In RESULTS shall be made available to each other by the course PARTIES after completion of such efforts RWJPRI shallthe COLLABORATION at its latest in an appropriate form. 3.10 It is agreed that the PARTIES shall exchange RESULTS and/or arrange additional steps at least once a quarter, either directly or through an AFFILIATE or SUBLICENSEE within the scope of a work meeting, regarding RESULTS, the progress of the work and future measures with respect to which the license COLLABORATION. If necessary, the PARTIES shall jointly modify the COLLABORATION in accordance with Articles 1 and 3.1, having regard to the respectively obtained RESULTS. The Portions of this Exhibit were omitted and have been extended, take appropriate steps including the following: (i) in consultation filed separately with the JDACSecretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced as amended. PARTIES reserve their right to obtain information adequate propose changes to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests COLLABORATION and the likeDEVELOPED-PRODUCTS at any time and this AGREEMENT may be modified accordingly with the approval of each PARTY.

Development Program. RWJPRI 4.1.1 The Parties shall be [**] and have [**] in consultation with undertake the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice development of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT Licensed Product in accordance with the DEVELOPMENT PLAN established terms and conditions set forth in this Agreement and the Development Plan. SLI shall furnish, maintain and preserve suitable and sufficient facilities and personnel for the work to be accomplished by RWJPRISLI hereunder, use its reasonable commercial efforts to accomplish the Development Plan within the time described therein in a commercially reasonable, diligent and workmanlike manner and in compliance in all material respects with the standards, laws, rules and regulations of the FDA [*] over SLI’s activities. 4.1.2 Each Development Plan shall include a budget for the proposed development activities set forth in such plan, which shall be determined prior to the anticipated commencement of the proposed development activities. For activities to be performed by SLI, Indevus shall pay to SLI the sums set out in the Development Plan on a mutually agreed upon schedule payable within 30 days of Indevus’ receipt of SLI’s invoice detailing the tasks carried out by SLI pursuant to the Development Plan; provided, however, that in no event shall Indevus be responsible for or be required to reimburse SLI for activities not mutually agreed upon in writing. Indevus shall be responsible for all reasonable out of pocket costs and/or expenses associated with the Development Plan upon submission of appropriate back-up documentation and provided, however, that no expenses in excess of [*], or such other amount as may be subsequently agreed to by the Parties, shall be incurred by SLI or reimbursed by Indevus unless SLI obtained Indevus’ written consent prior to incurring such expense. Such costs and expenses shall include required raw materials, excipients, supplies, columns, standards, chemicals, travel and shipping expenses. 4.1.3 Indevus shall be responsible for providing adequate supplies of the Compound, which will be supplied to SLI free of charge in accordance with the Development Plan and in accordance with cGMP. In the course of such efforts RWJPRI shallevent that the active ingredient is not delivered to SLI or not provided within the required timescale the Development Plan will be extended accordingly. SLI shall be responsible for and shall manufacture and supply Licensed Product to Indevus, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extendedat Indevus’ expense, take appropriate steps including the following: (i) in consultation accordance with the JDAC, select certain LICENSED COMPOUNDS Development Plan for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE Iconducted under a Development Plan, II, in accordance with the Specifications and III clinical trials, associated studies in compliance with cGMP and all other applicable laws and regulations and such other work which RWJPRI reasonably deems terms to be required for subsequent inclusion mutually agreed upon between the Parties. 4.1.4 Should Indevus or any Indevus Affiliate or any Sublicensee elect to pursue any development that requires any change in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file the formulation of the Licensed Product, SLI will conduct all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the likefuture development activities under a mutually agreed upon Development Plan.

Development Program. RWJPRI 1.1 Fuisz and Kos shall jointly undertake using reasonable best efforts a Development Program to develop one or more Products for Commercial Sale. It is understood that this Development Program is primarily for the purposes of developing and producing Products and shall be [carried out generally in accordance with Appendix B. 1.2 Each party shall appoint a Program Manager for overall management of the Development Program and such Program Managers shall by mutual agreement provide the direction of the program and the scope of work to be undertaken under the Development Program; provided, however, that Kos shall determine the focus of work which the Program Managers mutually agree can be carried out under the Development Program, within the guidelines set forth in Appendix B. The initial Program Manager for Kos shall be designated within thirty (30) days and the initial Program Manager for Fuisz shall be Martynn Sheehan. ▇▇▇▇ ▇▇▇▇▇ ▇▇▇ change the designated Program Manager upon written notice to the other party of such change. 1.3 During the term of the Development Program Fuisz shall periodically provide to Kos samples of materials for evaluation by Kos. Kos shall promptly evaluate such samples and provide guidance to Fuisz for further work based on the results of such evaluations. During the Development Program term, Program Managers or representatives of the parties shall meet from time to time to discuss planning and progress of the Development Program to carry out efficient and effective activities. Fuisz shall provide project updates to Kos verbally and/or in written form every four (4) weeks during the Development Program, and shall provide a written report upon completion of the Development Program. All such discussions and activities shall be considered as carried out under the Development Program. 1.4 Kos shall supply to Fuisz, at Kos's cost and expense, materials including Captopril which Kos believes are essential for carrying out the Development Program. All such materials supplied by Kos shall be materials approved for human uses unless otherwise specifically designated and Kos shall supply MSDS sheets where necessary for the processing of such materials. Fuisz shall advise Kos from time to time of its requirements for such materials for the Development Program. 1.5 Upon termination of each Phase of the Development Program, Fuisz shall provide to Kos quantities of prototype Products processed using Technology which demonstrate the best results obtained under the Development Program. Kos shall provide to Fuisz all data, information and conclusions generated during the Development Program relating to the Development Program and/or Technology including without limitation **] and have [**] in consultation with the JDAC**************** and any other mutually agreed pre-defined data, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, Fuisz shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right ************** to prepare use all such data, information and fileconclusions; provided, however, that Fuisz shall not utilize such data, information and conclusions to the detriment of the competitive position of Kos or inappropriately identify Kos in any publicity concerning same. 1.6 In the event special processing or manufacturing equipment specifically modified or adapted for use with Technology is requested by Kos to be used under the Development Program, Kos shall provide such equipment to Fuisz for the duration of the Development Program. 1.7 All activities in connection with the Development Program shall be carried out by each party in strict compliance with any applicable federal, state or local laws, regulations or guidelines governing such activities. 1.8 In addition to the funding under Article 3, Kos shall pay for the cost of all materials including Captopril used in the Development Program and approved by Kos (to the extent such materials are not provided and fully paid by Kos), and Kos shall pay for the costs of all shipping, packing, customs, duties and customs clearances associated with shipment of materials and/or equipment to or from Fuisz or for, or resulting from work under, the Development Program. In addition, Kos shall pay for the reasonable costs of travel of Fuisz personnel at the prior request and approval of Kos in connection with meetings, activities or reviews of activities under the Development Program. 1.9 All equipment, supplies and other items purchased by either party for the conduct of the Development Program, shall be the owner ofsole and exclusive property of the purchasing party. For purposes hereof, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may items purchased by Fuisz with funds provided by Kos shall be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material deemed to be items purchased and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established owned by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT***. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.

Development Program. RWJPRI 3.1 Commencing on the EFFECTIVE DATE, the PARTIES shall conduct the COLLABORATION for the development, evaluation, testing and optimization of the DEVELOPED-PRODUCTS. 3.2 The PARTIES will collaborate on developing [processing] and application tests to evaluate the DEVELOPED-PRODUCTS. 3.3 BASF and ASPEN shall use best efforts to develop, evaluate and test the DEVELOPED PRODUCTS within a reasonable time after the EFFECTIVE DATE, but in no event later than two (2) consecutive years from the EFFECTIVE DATE. 3.4 The execution of the COLLABORATION shall take place, with respect to the research, development, design and formulation of the DEVELOPED-PRODUCTS on BASF’s premises at BASF’s site in Trostberg and/or the sites of its AFFILIATES BASF Wall Systems GmbH & Co. KG, and/or Elastogran GmbH and/or BASF SE in each case in close contact and exchange between BASF and ASPEN. BASF-PRODUCTS to be tested by BASF within the scope of the COLLABORATION shall be selected by BASF, and BASF shall specify these BASF-PRODUCTS with regard Portions of this Exhibit, indicated by the ▇▇▇▇ “[**] *],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. to their possible qualities and under the specifications as defined in Annex 3, respectively. ASPEN-PRODUCTS to be tested by BASF within the scope of the COLLABORATION shall be selected by ASPEN, and ASPEN shall specify these ASPEN-PRODUCTS with regard to their possible qualities and under the specifications as defined in Annex 2, respectively. 3.5 BASF shall evaluate, test and report on the DEVELOPED-PRODUCTS’ suitability and effectiveness in [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES*]. RWJPRI BASF shall provide KOSAN designated representatives of ASPEN with periodic written notice reports of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with BASF’s progress in the advice testing of the JDACASPEN-PRODUCTS provided by ASPEN in DEVELOPED-PRODUCTS. BASF shall provide a final written report upon the completion of the COLLABORATION setting forth in detail the evaluations and tests conducted and all results obtained, as well as all conclusions which BASF reaches with respect to the effectiveness of the DEVELOPED-PRODUCTS. BASF agrees to provide ASPEN access to all testing and evaluation data BASF obtains during the period of exclusivity referenced herein, if any. 3.6 BASF shall have in its sole discretion determine the [**] right feasibility of commercially producing the DEVELOPED-PRODUCTS. 3.7 BASF and ASPEN shall identify any product they provide under the COLLABORATION for testing that is a commercial product of BASF or ASPEN, respectively. 3.8 With respect to develop the PRODUCT through STAGES Oapplication, I, II marketing and III initial commercialization of DEVELOPED-PRODUCTS BASF and shall have ASPEN will jointly negotiate and agree to a separate agreement in due time. The PARTIES undertake to use their best efforts to start a commercial exploitation of the [**] right to prepare and fileDEVELOPED-PRODUCTS as soon as the said DEVELOPED-PRODUCTS will be definitely validated by the PARTIES, and shall provided that the said DEVELOPED-PRODUCTS will be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established specifications of the present AGREEMENT. 3.9 The PARTIES are each allowed to inspect each other’s RESULTS as appropriate and shall inform each other on a regular basis of the progress of the COLLABORATION according to the milestone plannings as defined in Annex 1 but not later than by RWJPRIthe end of each quarter. In RESULTS shall be made available to each other by the course PARTIES after completion of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) COLLABORATION at its latest in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate form. 3.10 It is agreed that the PARTIES shall exchange RESULTS and/or arrange additional steps at least once a quarter, within the scope of a work meeting, regarding RESULTS, the progress of the work and properly empowered national regulatory authority all necessary documentationfuture measures with respect to the COLLABORATION. If necessary, data the PARTIES shall jointly modify the COLLABORATION in accordance with Articles 1 and 3.1, having regard to the respectively obtained RESULTS. The Portions of this Exhibit, indicated by the ▇▇▇▇ “[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION*],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection PARTIES reserve their right to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection propose changes to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests COLLABORATION and the likeDEVELOPED-PRODUCTS at any time and this AGREEMENT may be modified accordingly with the approval of each PARTY.

Development Program. RWJPRI Subject to Bukwang's timely performance of its obligations hereunder, and in complete fulfillment of Triangle's diligence obligations hereunder and any such obligations implied by law, Triangle will undertake, or, if applicable, will cause its Affiliates and sublicensees to undertake, the development *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. activities described in this Article 6. Triangle shall, at its expense, use its *** (a) to conduct a development program (the "Development Program") relating to the use of the Licensed Product for HBV and (b) if the results of the Development Program so justify, to seek Registration for such Licensed Product in the United States. As part of the Development Program, Triangle shall be [responsible for conducting 3-month toxicity studies in two species of animals pursuant to protocols which it develops or approves, as applicable. Triangle shall commence both toxicity studies as promptly as practicable **] * after it obtains Bulk Drug Substance of a quality and have [in such quantities reasonably necessary to perform such toxicity studies. Bukwang shall promptly reimburse Triangle for **] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice * of the JDACout-of-pocket costs (excluding all drug costs, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and which shall be the owner responsibility of Triangle) incurred by Triangle in conducting such toxicity studies, subject to reasonable substantiation by Triangle of such out-of, all applications for MARKETING AUTHORIZATION throughout the world-pocket costs. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may The Development Program shall be mutually agreeddiscussed by the parties hereto at the meetings of the Joint Project Committee held pursuant to Article 7 and shall take into consideration studies and experiments carried out, or to be carried out by, Bukwang and its licensees, if any, outside the Territory, but the activities within the Territory comprising the Development Program shall be determined at RWJPRITriangle's expensesole discretion. Anything in this Agreement to the contrary notwithstanding, Triangle shall be entitled to exercise prudent and justifiable business judgment in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with meeting its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION* obligations hereunder. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials For purposes of such PRODUCTthis Article 6, *** . (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.

Development Program. RWJPRI 1.1 Fuisz and Kos shall jointly undertake using reasonable best efforts a Development Program to develop one or more Products for Commercial Sale. It is understood that this Development Program is primarily for the purposes of developing and producing Products and shall be [carried out generally in accordance with Appendix B. 1.2 Each party shall appoint a Program Manager for overall management of the Development Program and such Program Managers shall by mutual agreement provide the direction of the program and the scope of work to be undertaken under the Development Program; provided, however, that Kos shall determine the focus of work which the Program Managers mutually agree can be carried out under the Development Program, within the guidelines set forth in Appendix B. The initial Program Manager for Kos shall be designated within thirty (30) days and the initial Program Manager for Fuisz shall be **] and have [**] in consultation with ***********. Each party may change the JDAC, designated Program Manager upon written notice to select LICENSED COMPOUNDS which the other party of such change. 1.3 During the term of the Development Program Fuisz shall then be designated PRODUCTS periodically provide to Kos samples of materials for evaluation by Kos. Kos shall promptly evaluate such samples and provide guidance to Fuisz for further DEVELOPMENT by RWJPRI work based on the results of such evaluations. During the Development Program term, Program Managers or representatives of the parties shall meet from time to time to discuss planning and marketing by ORTHO progress of the Development Program to carry out efficient and its AFFILIATESeffective activities. RWJPRI Fuisz shall provide KOSAN with project updates to Kos verbally and/or in written notice form ******************** during the Development Program, and shall provide a written report upon completion of the Development Program. All such discussions and activities shall be considered as carried out under the Development Program. 1.4 Kos shall supply to Fuisz, at Kos's cost and expense, materials including Captopril which Kos believes are essential for carrying out the Development Program. All such materials supplied by Kos shall be materials approved for human uses unless otherwise specifically designated and Kos shall supply MSDS sheets where necessary for the processing of such materials. Fuisz shall advise Kos from time to time of its decision to select a LICENSED COMPOUND requirements for DEVELOPMENT. Once a PRODUCT has been selected such materials for further DEVELOPMENT, RWJPRI, with the advice Development Program. 1.5 Upon termination of each Phase of the JDACDevelopment Program, Fuisz shall provide to Kos quantities of prototype Products processed using Technology which demonstrate the best results obtained under the Development Program. Kos shall provide to Fuisz all data, information and conclusions generated during the Development Program relating to the Development Program and/or Technology including without limitation ******************** and any other mutually agreed pre-defined data, and Fuisz shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right ************** to prepare use all such data, information and fileconclusions; provided, however, that Fuisz shall not utilize such data, information and conclusions to the detriment of the competitive position of Kos or inappropriately identify Kos in any publicity concerning same. 1.6 In the event special processing or manufacturing equipment specifically modified or adapted for use with Technology is requested by Kos to be used under the Development Program, Kos shall provide such equipment to Fuisz for the duration of the Development Program. 1.7 All activities in connection with the Development Program shall be carried out by each party in strict compliance with any applicable federal, state or local laws, regulations or guidelines governing such activities. 1.8 In addition to the funding under Article 3, Kos shall pay for the cost of all materials including Captopril used in the Development Program and approved by Kos (to the extent such materials are not provided and fully paid by Kos), and Kos shall pay for the costs of all shipping, packing, customs, duties and customs clearances associated with shipment of materials and/or equipment to or from Fuisz or for, or resulting from work under, the Development Program. In addition, Kos shall pay for the reasonable costs of travel of Fuisz personnel at the prior request and approval of Kos in connection with meetings, activities or reviews of activities under the Development Program. 1.9 All equipment, supplies and other items purchased by either party for the conduct of the Development Program, shall be the owner ofsole and exclusive property of the purchasing party. For purposes hereof, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may items purchased by Fuisz with funds provided by Kos shall be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material deemed to be items purchased and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established owned by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT***. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.

Development Program. RWJPRI shall be [**] and have [**] The initial Development Program set forth in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT Exhibit C was prepared by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and fileBDSI, and shall be subject to review by and comments from Meda, as approved by the owner of, all applications for MARKETING AUTHORIZATION throughout Development Committee within *** of the worldHSR Date. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI BDSI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT use Commercially Reasonable Efforts to conduct pre-Governmental Approval Licensed Product development activities in accordance with the DEVELOPMENT PLAN established Development Program, provided that such activities shall not include the activities of Meda with respect to Mexico and Canada contemplated by RWJPRISection 2.03(b)(i). In Notwithstanding the course foregoing or any other provision of this Agreement, Meda acknowledges and agrees that (a) the Development Program is experimental in nature; and (b) BDSI does not guarantee that the Development Program will be successful or that Governmental Approval will be obtained for any Licensed Product or indication therefor. During the Term, BDSI may revise the Development Program at any time and from time to time, provided, to the extent reasonably practicable, BDSI provides the Development Committee with a reasonable opportunity to review and comment (which opportunity shall not be required to be any longer than ***). Meda shall, notwithstanding anything to the contrary, use Commercially Reasonable Efforts to continue development of the Fentanyl Product for each of the First Indication and Non-Cancer Indication following receipt of Governmental Approval therefor, and, if Commercially Reasonable, develop the Fentanyl Product for and seek Governmental Approval of the Fentanyl Product for such other indications as the Parties agree to pursue in addition to the First Indication and Non-Cancer Indication, in a Commercially Reasonable manner intended to maximize the Parties’ collective economic benefit with respect to the Fentanyl Product, including the conduct of post-approval Phase IIIB and Phase IV studies concerning the Fentanyl Product for the First Indication and, if approved by FDA, the Non-Cancer Indication; Meda shall include BDSI in such efforts RWJPRI shallin a consultative capacity. The Parties agree that it is their intent that the above-described continued development be included in the Development Program, either directly or through an AFFILIATE or SUBLICENSEE provided that the failure of the Development Program to which include such above-described development shall not limit Meda’s obligations in the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCTpreceding sentence. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.

Development Program. RWJPRI 1.1 Fuisz and Kos shall jointly undertake using reasonable best efforts a Development Program to develop one or more Products for Commercial Sale. It is understood that this Development Program is primarily for the purposes of developing and producing Products and shall be [carried out generally in accordance with Appendix B. 1.2 Each party shall appoint a Program Manager for overall management of the Development Program and such Program Managers shall by mutual agreement provide the direction of the program and the scope of work to be undertaken under the Development Program; provided, however, that Kos shall determine the focus of work which the Program Managers mutually agree can be carried out under the Development Program, within the guidelines set forth in Appendix B. The initial Program Manager for Kos shall be designated within thirty (30) days and the initial Program Manager for Fuisz shall be **] and have [**] in consultation with ***********. Each party may change the JDAC, designated Program Manager upon written notice to select LICENSED COMPOUNDS which the other party of such change. 1.3 During the term of the Development Program Fuisz shall then be designated PRODUCTS periodically provide to Kos samples of materials for evaluation by Kos. Kos shall promptly evaluate such samples and provide guidance to Fuisz for further DEVELOPMENT by RWJPRI work based on the results of such evaluations. During the Development Program term, Program Managers or representatives of the parties shall meet from time to time to discuss planning and marketing by ORTHO progress of the Development Program to carry out efficient and its AFFILIATESeffective activities. RWJPRI Fuisz shall provide KOSAN with project updates to Kos verbally and/or in written notice form ******************** during the Development Program, and shall provide a written report upon completion of the Development Program. All such discussions and activities shall be considered as carried out under the Development Program. 1.4 Kos shall supply to Fuisz, at Kos's cost and expense, materials including IS-5-MN which Kos believes are essential for carrying out the Development Program. All such materials supplied by Kos shall be materials approved for human uses unless otherwise specifically designated and Kos shall supply MSDS sheets where necessary for the processing of such materials. Fuisz shall advise Kos from time to time of its decision to select a LICENSED COMPOUND requirements for DEVELOPMENT. Once a PRODUCT has been selected such materials for further DEVELOPMENT, RWJPRI, with the advice Development Program. 1.5 Upon termination of each Phase of the JDACDevelopment Program, Fuisz shall provide to Kos quantities of prototype Products processed using Technology which demonstrate the best results obtained under the Development Program. Kos shall provide to Fuisz all data, information and conclusions generated during the Development Program relating to the Development Program and/or Technology including without limitation ******************** and any other mutually agreed pre-defined data, and Fuisz shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right ************** to prepare use all such data, information and fileconclusions; provided, however, that Fuisz shall not utilize such data, information and conclusions to the detriment of the competitive position of Kos or inappropriately identify Kos in any publicity concerning same. 1.6 In the event special processing or manufacturing equipment specifically modified or adapted for use with Technology is requested by Kos to be used under the Development Program, Kos shall provide such equipment to Fuisz for the duration of the Development Program. 1.7 All activities in connection with the Development Program shall be carried out by each party in strict compliance with any applicable federal, state or local laws, regulations or guidelines governing such activities. 1.8 In addition to the funding under Article 3, Kos shall pay for the cost of all materials including IS-5-MN used in the Development Program and approved by Kos (to the extent such materials are not provided and fully paid by Kos), and Kos shall pay for the costs of all shipping, packing, customs, duties and customs clearances associated with shipment of materials and/or equipment to or from Fuisz or for, or resulting from work under, the Development Program. In addition, Kos shall pay for the reasonable costs of travel of Fuisz personnel at the prior request and approval of Kos in connection with meetings, activities or reviews of activities under the Development Program. 1.9 All equipment, supplies and other items purchased by either party for the conduct of the Development Program, shall be the owner ofsole and exclusive property of the purchasing party. For purposes hereof, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may items purchased by Fuisz with funds provided by Kos shall be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material deemed to be items purchased and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established owned by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT***. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.

Development Program. RWJPRI LICENSEE shall be [**] solely responsible for and have [**] the exclusive right, at its discretion but in consultation with the JDAC, to select LICENSED COLLABORATION COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI LICENSEE and marketing by ORTHO LICENSEE and its AFFILIATESAFFILIATE(S) or SUBLICENSEE(S). RWJPRI LICENSEE shall provide KOSAN SKI with written notice of its decision to select a LICENSED COLLABORATION COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRILICENSEE, with the advice of the JDAC, shall have the [**] exclusive right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] exclusive right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN SKI will assist RWJPRI LICENSEE as may be mutually agreed, at RWJPRILICENSEE's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI LICENSEE shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRILICENSEE. In the course of such efforts RWJPRI LICENSEE shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COLLABORATION COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded funded, and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data data, and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI LICENSEE reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION;; and (iv) after such submissions are filed filed, prosecute such submissions and file all reasonably necessary, necessary reports and respond to all reasonable requests from the pertinent regulatory, regulatory authorities for information, data, samples, tests tests, and the like.