Common use of Development Program Clause in Contracts

Development Program. 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 in such quantities reasonably necessary to perform such toxicity studies. Bulkwang shall promptly reimburse Triangle for [BUKWANG REDACTED] of the out-of-pocket costs (excluding all drug costs, which shall be the responsibility of Triangle) incurred by Triangle in conducting such toxicity studies, subject to reasonable substantiation by Triangle of such out-of-pocket costs. The Development Program shall be mutually discussed 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 Triangle’s sole discretion. Anything in this Agreement to the contrary notwithstanding, Triangle shall be entitled to exercise prudent and justifiable business judgment in meeting its [BUKWANG REDACTED] obligations hereunder. For purposes of this Article 6, [BUKWANG REDACTED].

Development Program. Subject to Bukwang’s timely performance of its obligations hereunder, RWJPRI shall be solely responsible for 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, have the development activities described in this Article 6. Triangle shallexclusive right, at its expensediscretion but in consultation with the JDAC, use to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its [BUKWANG REDACTED] (a) AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to conduct select a development program (LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the “Development Program”) relating to the use advice of the Licensed Product for HBV JDAC, shall have the exclusive right to develop the PRODUCT through STAGES O, I, II and (b) if III and shall have the results of the Development Program so justifyexclusive right to prepare and file, 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 in such quantities reasonably necessary to perform such toxicity studies. Bulkwang shall promptly reimburse Triangle for [BUKWANG REDACTED] of the out-of-pocket costs (excluding all drug costs, which shall be the responsibility 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 Triangle) incurred 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 Triangle in conducting such toxicity studies, subject to reasonable substantiation by Triangle RWJPRI. In the course of such outefforts 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-ofrejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-pocket costs. The Development Program shall be mutually discussed by the parties hereto at the meetings of the Joint Project Committee held pursuant rejection to Article 7 commence PHASE I, II, and shall take into consideration III clinical trials, associated studies and experiments carried out, or such other work which RWJPRI reasonably deems to be carried out byrequired for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, Bukwang reports and its licenseesrespond to all reasonable requests from the pertinent regulatory, if anyauthorities for information, outside data, samples, tests and the Territory, but the activities within the Territory comprising the Development Program shall be determined at Triangle’s sole discretion. Anything in this Agreement to the contrary notwithstanding, Triangle shall be entitled to exercise prudent and justifiable business judgment in meeting its [BUKWANG REDACTED] obligations hereunder. For purposes of this Article 6, [BUKWANG REDACTED]like.

Development Program. 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) Promptly following execution of this LICENSE AGREEMENT, ILEX shall use its best efforts based on ILEX's reasonable business judgment, to conduct a development program (execute the “Development Program”) relating DEVELOPMENT PLAN and to carry out the use activities for FULL DEVELOPMENT of the Licensed Product 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 HBV 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 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) if In carrying out the results DEVELOPMENT PLAN, ILEX shall make available the number of the Development Program so justifyqualified "full time equivalents" of its scientific, to seek Registration for such Licensed Product engineering, manufacturing and other personnel specified in the United States. As part of the Development ProgramDEVELOPMENT PLAN, 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 in such quantities reasonably necessary to perform such toxicity studies. Bulkwang shall promptly reimburse Triangle for [BUKWANG REDACTED] of the out-of-pocket costs (excluding all drug costs, which shall be the responsibility of Triangle) incurred by Triangle in conducting such toxicity studies, subject to reasonable substantiation by Triangle of such out-of-pocket costs. The Development Program shall be mutually discussed by the parties hereto at the meetings of the Joint Project Committee held pursuant to Article 7 and shall take into consideration studies 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 experiments carried outevent schedule, or in consultation with the PMT. JANS▇▇▇ shall have the right to control and direct performance of the DEVELOPMENT PLAN through the PMT, and shall have the right to approve any material agreement with third parties to be carried out by, Bukwang and its licensees, if any, outside made by ILEX related to performance of the Territory, but the activities within the Territory comprising the Development Program DEVELOPMENT PLAN hereunder which approval shall not be unreasonably withheld. (c) MARKETING AUTHORIZATION APPLICATIONS shall be determined at Triangle’s sole discretioncompiled by ILEX based on information generated during the FULL DEVELOPMENT program. Anything At JANS▇▇▇'▇ ▇▇▇ion, MARKETING AUTHORIZATION APPLICATIONS shall either be filed by JANS▇▇▇ ▇▇ filed by ILEX and transferred to JANS▇▇▇. JANS▇▇▇ ▇▇▇ll own all such MARKETING AUTHORIZATIONS. JANS▇▇▇ ▇▇▇ll exercise reasonable efforts, commensurate with the efforts it would normally exercise for products of similar potential sales volume and consistent with its overall business strategy to obtain MARKETING AUTHORIZATION for LICENSED PRODUCT in this Agreement such countries as JANS▇▇▇ ▇▇▇ms appropriate. JANS▇▇▇ ▇▇▇ll prosecute such submissions and file the necessary reports and responses to requests fromt he pertinent regulatory authorities. ILEX shall prepare supporting documentation requested by JANS▇▇▇. ▇LEX shall further assist JANS▇▇▇ ▇▇▇h the contrary notwithstanding, Triangle shall be entitled preparation of supporting data to exercise prudent apply for and justifiable business judgment in meeting its [BUKWANG REDACTED] obligations hereunder. For purposes of this Article 6, [BUKWANG REDACTED]pursue MARKETING AUTHORIZATION APPLICATIONS.

Development Program. Subject RWJPRI shall be [**] and have [**] in consultation with the JDAC, to Bukwang’s timely performance 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 obligations hereunderdecision 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 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 in such quantities reasonably necessary to perform such toxicity studies. Bulkwang shall promptly reimburse Triangle for [BUKWANG REDACTED] of the out-of-pocket costs (excluding all drug costs, which shall be the responsibility 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 Triangle) incurred 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 Triangle in conducting such toxicity studies, subject to reasonable substantiation by Triangle RWJPRI. In the course of such outefforts 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-ofrejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-pocket costs. The Development Program shall be mutually discussed by the parties hereto at the meetings of the Joint Project Committee held pursuant rejection to Article 7 commence PHASE I, II, and shall take into consideration III clinical trials, associated studies and experiments carried out, or such other work which RWJPRI reasonably deems to be carried out byrequired for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, Bukwang reports and its licenseesrespond to all reasonable requests from the pertinent regulatory, if anyauthorities for information, outside data, samples, tests and the Territory, but the activities within the Territory comprising the Development Program shall be determined at Triangle’s sole discretion. Anything in this Agreement to the contrary notwithstanding, Triangle shall be entitled to exercise prudent and justifiable business judgment in meeting its [BUKWANG REDACTED] obligations hereunder. For purposes of this Article 6, [BUKWANG REDACTED]like.

Development Program. 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. [***]A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 5.2 Subject to Bukwang’s timely performance the provisions of its obligations hereunderClause 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 in complete fulfillment sale of Triangle’s diligence obligations hereunder Candidate Product and any such obligations implied 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 lawthe withdrawing Party's lawyers), Triangle will undertakeand any other Know How, or, if applicable, will cause its Affiliates and sublicensees to undertake, held by 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”) 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 Licensed 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 HBV 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 PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. withdrawing Party, and (b) if a sub- licensee in relation to Product in ROW or any agreement between the results 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 justify(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 seek Registration 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 Licensed 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 United StatesColumbia Territory and shall have the exclusive benefit of all revenues generated in relation thereto. As part It is agreed that whilst the final decision on [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND 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 Development ProgramTerritory, Triangle 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 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 this 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-ordination, liaison and communication forum and shall not be a decision making body (all decisions about Commercialisation being reserved exclusively to Ardana in respect of the Ardana Territory and Columbia in respect of the 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. (d) shall be a channel for communication between the Parties requesting amendments to this 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 conducting 3-month toxicity studies acquiring any and all Trade Marks for Product(s) in two species their respective territory and shall have sole responsibility for selection, clearance and registration 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 said Trade Marks in such quantities reasonably necessary to perform such toxicity studiesterritory provided always that the Parties shall liaise with each other in relation thereto. Bulkwang shall promptly reimburse Triangle The Parties agree that, for [BUKWANG REDACTED] Trade Marks owned jointly by the Parties or owned by one Party and used by or on behalf of the out-of-pocket costs (excluding other Party, the Party using the ▇▇▇▇ will ensure that the manner, form, and quality of all drug costsuse of such Trade Marks will be at the approval of at least one Party owner of the Marks, 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 this shall be deemed a notice of withdrawal under Clause 5.4 and if the responsibility other Party so wishes it shall have the exclusive 90 day right to run from the date of Triangle) incurred by Triangle in conducting such toxicity studies, subject to reasonable substantiation by Triangle receipt of such out-of-pocket costs. The Development Program shall be mutually discussed written notice and exercisable 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 Triangle’s sole discretion. Anything notice in this Agreement writing to the contrary notwithstanding, Triangle shall be entitled withdrawing Party to exercise prudent and justifiable business judgment in meeting its [BUKWANG REDACTED] obligations hereunder. For purposes take over such territory on the terms of this Article 6, [BUKWANG REDACTED].Clauses 5.4.1 to 5.4.9

Development Program. Subject The following Section of Article 3 of the Agreement shall be amended: (i) SB agrees to Bukwang’s timely performance deliver to Aphton anti-GnRH conjugate manufactured under contract for SB (hereafter the "Conjugate") at no expense to Aphton within sixty (60) days of its obligations hereunderthe acceptance of an amended Development Plan by the Steering Committee (the date of said delivery hereafter termed the "Delivery Date"). The Steering Committee shall either accept or reject the amended Development Plan within thirty (30) days of submission by Aphton to the Steering Committee, which shall happen no later than sixty (60) days after the Execution Date. Such submission shall include the immunogen development program up to presentation by Aphton to the Steering Committee in accordance with Section 3.1(ii) below. SB shall deliver quantities of the Conjugate sufficient to carry out the amended Development Plan as approved by the Steering Committee, and in complete fulfillment of Triangle’s diligence obligations hereunder and any such obligations implied if so decided 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 Steering Committee SB shall deliver reasonable additional quantities of the Licensed Product for HBV and (b) if Conjugate as approved by the results Steering Committee at any later time. The parties agree to replace the Development Plan contained in Schedule B of the Agreement with the amended Development Plan, as approved by the Steering Committee. The Development Program so justify, to seek Registration Term shall be amended accordingly. Except for such Licensed Product in the United States. As part costs associated with the manufacturing of the Development ProgramConjugate, Triangle Aphton shall be responsible for conducting 3-month toxicity studies funding all costs for research and development relating to Aphton's Product (including formulations in two species of animals pursuant SB's Adjuvant Technology) to protocols be presented to the Steering Committee in accordance with paragraph (ii) below. (ii) Aphton shall present its Product to the Steering Committee for acceptance. (The date on which it develops Aphton first presents its Product to the Steering Committee shall hereafter be termed the "Presentation Date.") The Steering Committee shall have sixty (60) days to accept or approves, as applicablereject Aphton's Product. Triangle shall commence both toxicity studies as promptly as practicable [BUKWANG REDACTED] after it obtains Bulk Drug Substance of a quality and in such quantities reasonably necessary Failure by the Steering Committee to perform such toxicity studies. Bulkwang shall promptly reimburse Triangle for [BUKWANG REDACTED] either accept or reject Aphton's Product within sixty (60) days of the out-of-pocket Presentation Date shall be considered a rejection by the Steering Committee. If the Steering Committee rejects Aphton's Product, the parties may agree that Aphton will be allowed to conduct additional research and development and make a subsequent presentation to the Steering Committee for acceptance. In no event shall the Presentation Date be later than [Redacted]*. After the Steering Committee has accepted Aphton's Product (hereafter termed the "Acceptance Date"), SB shall undertake the further development of the Product under the amended Development Plan (other than the immunogen development) and shall be responsible for funding all costs (excluding all drug costs, which shall be as previously defined in the responsibility of Triangle) incurred by Triangle in conducting such toxicity studies, subject to reasonable substantiation by Triangle of such out-of-pocket costsAgreement). The Development Program can be amended and/or complemented from time to time by the Steering Committee. Section 3.1 (iv) shall be mutually discussed 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 complemented as follows: During the Development Program Term and any extension thereof Aphton undertakes to (i) use best efforts to materially perform all its activities in the Development Program (ii) and use all reasonable efforts to achieve its objectives under the Development Program. Section 3.1 (v) shall be determined at Triangle’s sole discretion. Anything in this Agreement to the contrary notwithstanding, Triangle shall be entitled to exercise prudent and justifiable business judgment in meeting its [BUKWANG REDACTED] obligations hereunder. For purposes of this Article 6, [BUKWANG REDACTED].complemented as follows:

Development Program. 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] (aA) to conduct a development program (the “Development Program”) relating to the use of the Licensed Product for HBV and (b) if the results Upon delivery of the Development Program so justifyNotification to SPECTRx set forth in Section 2.5, ABBOTT shall diligently undertake and pursue all development activities reasonably required in order to seek Registration for such Licensed submit Regulatory Filings to obtain governmental approvals to market the 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 approvesmajor European Union countries, as applicable. Triangle shall commence both toxicity studies as promptly as practicable [BUKWANG REDACTED] after it obtains Bulk Drug Substance of a quality Japan and in such quantities reasonably necessary to perform such toxicity studies. Bulkwang shall promptly reimburse Triangle for [BUKWANG REDACTED] the other countries of the out-of-pocket costs (excluding all drug costs, which shall be the responsibility of Triangle) incurred by Triangle in conducting such toxicity studies, subject to reasonable substantiation by Triangle of such out-of-pocket costs. The Development Program shall be mutually discussed 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 and in order to obtain approvals, all in accordance with ABBO▇▇'▇ ▇▇▇torical practice. All such development activity shall be at ABBO▇▇'▇ ▇▇▇ense and shall be undertaken in accordance with ABBO▇▇'▇ ▇▇▇mal procedures for evaluating development projects and the activities within exercise of its reasonable business judgment, consistent with the Territory comprising custom and practice in the industry, and ABBO▇▇'▇ ▇▇▇torical practice in filing of Regulatory Filings, conduct and completion of clinical trials, demonstration of clinical efficacy and commercial feasibility, and obtaining of regulatory approvals. (B) Any delays in, or failure to complete the Development Program (i) due to the intentional or negligent acts of SPECTRx except activities directed or required by ABBOTT or the [*] Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission. Research Committee; or (ii) because the Product is either determined not to have been shown to be safe or efficacious, or it is determined that additional material, data, or information is needed to determine safety or efficacy; or (iii) because the Product [*]; or (iv) due to events beyond the reasonable control of ABBOTT shall be determined at Triangle’s sole discretion. Anything not constitute a failure of diligence by ABBOTT under this Article, nor a breach by ABBOTT of this Agreement provided, however, that no such delay (other than as set forth in this Agreement to Section 3.1 (B)(1)) shall extend the contrary notwithstanding, Triangle shall be entitled to exercise prudent and justifiable business judgment periods of the time set forth in meeting its [BUKWANG REDACTED] obligations hereunder. For purposes Section 3.2 of this Article 6Agreement. If an event set forth in Section 3.1 (B)(1) delays the submission of a Regulatory Filing or the First Shipment Date, [BUKWANG REDACTED]ABBOTT and SPECTRx shall negotiate in good faith to extend the time periods set forth in Section 3.2(A) and (B) by a period of time commensurate with such delay.

Development Program. Subject 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 Bukwang’s timely performance 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 its obligations hereunderthe 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 a set of milestones to be agreed by the parties as part of the project plan. Angeion shall use its best efforts to complete fulfillment development of Triangle’s diligence obligations hereunder the selected concept prototype of the Linear Catheter Product in accordance with the budget and any such obligations implied by law, Triangle will undertake, or, if applicable, will cause its Affiliates milestones and sublicensees to undertakeshall 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 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 Linear Catheter Product as set forth in paragraph III.C and to terminate such activities by Angeion. Prior to such transfer of activities, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ shall give Angeion sixty (60) days written notice of its intentions. In such a case, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ shall be liable only for charges for all work done or non-cancelable costs committed by Angeion prior to such transfer. Angeion shall exercise diligent efforts 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 Licensed Product for HBV and (b) month the agreement is signed. The review will include access by ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, if the results of the Development Program so justifydesired, to seek Registration for such Licensed Product in all design documentation including the United StatesDesign History File. 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, Angeion will provide detailed monthly status reports including expenses. Angeion will not exceed a monthly expense total as applicable. Triangle shall commence both toxicity studies as promptly as practicable [BUKWANG REDACTED] after it obtains Bulk Drug Substance of a quality and in such quantities reasonably necessary to perform such toxicity studies. Bulkwang shall promptly reimburse Triangle for [BUKWANG REDACTED] of the out-of-pocket costs (excluding all drug costs, which shall be the responsibility of Triangle) incurred by Triangle in conducting such toxicity studies, subject to reasonable substantiation by Triangle of such out-of-pocket costs. The Development Program shall be mutually discussed agreed by the parties hereto at without prior written approval of ▇▇▇▇▇▇ ▇▇▇▇▇▇▇. F. Angeion shall provide overall project leadership to develop and manufacture the meetings of Spot Catheter Product and Linear Catheter Product. Product priorities for the Joint Project Committee held pursuant Spot Catheter Product, and product priorities, features and specifications for the Linear Catheter Product initially will be decided by ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, after discussions with Angeion. Any changes to Article 7 and shall take into consideration studies and experiments carried out, the project plan or to be carried out by, Bukwang and its licensees, if any, outside specifications for the Territory, but the activities within the Territory comprising the Development Program Linear Catheter Products shall be determined at Triangle’s sole discretion. Anything agreed upon by both parties in this Agreement to the contrary notwithstanding, Triangle shall be entitled to exercise prudent and justifiable business judgment in meeting its [BUKWANG REDACTED] obligations hereunder. For purposes of this Article 6, [BUKWANG REDACTED]writing.

Development Program. Subject to Bukwang’s timely performance of its obligations hereunderThe initial Development Program set forth in Exhibit C was prepared by BDSI, and in complete fulfillment shall be subject to review by and comments from Meda, as approved by the Development Committee within *** 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 the HSR Date. BDSI shall use Commercially Reasonable Efforts to undertake, the conduct pre-Governmental Approval Licensed Product development activities described in accordance with the Development Program, provided that such activities shall not include the activities of Meda with respect to Mexico and Canada contemplated by Section 2.03(b)(i). Notwithstanding the foregoing or any other provision of this Article 6. Triangle shallAgreement, at its expense, use its [BUKWANG REDACTED] Meda acknowledges and agrees that (a) to conduct a development program (the “Development Program”) relating to the use of the Licensed Product for HBV 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 results 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 in a consultative capacity. The Parties agree that it is their intent that the above-described continued development be included in the Development Program, provided that the failure of the Development Program so justify, to seek Registration for include such Licensed Product above-described development shall not limit Meda’s obligations 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 in such quantities reasonably necessary to perform such toxicity studies. Bulkwang shall promptly reimburse Triangle for [BUKWANG REDACTED] of the out-of-pocket costs (excluding all drug costs, which shall be the responsibility of Triangle) incurred by Triangle in conducting such toxicity studies, subject to reasonable substantiation by Triangle of such out-of-pocket costs. The Development Program shall be mutually discussed 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 Triangle’s sole discretion. Anything in this Agreement to the contrary notwithstanding, Triangle shall be entitled to exercise prudent and justifiable business judgment in meeting its [BUKWANG REDACTED] obligations hereunder. For purposes of this Article 6, [BUKWANG REDACTED]preceding sentence.

Development Program. Subject to Bukwang’s 's timely performance of its obligations hereunder, and in complete fulfillment of Triangle’s '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 [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 in such quantities reasonably necessary to perform such toxicity studies. Bulkwang Bukwang shall promptly reimburse Triangle for [BUKWANG REDACTED] *** of the out-of-pocket costs (excluding all drug costs, which shall be the responsibility of Triangle) incurred by Triangle in conducting such toxicity studies, subject to reasonable substantiation by Triangle of such out-of-pocket costs. The Development Program shall be mutually discussed 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 Triangle’s 's sole discretion. Anything in this Agreement to the contrary notwithstanding, Triangle shall be entitled to exercise prudent and justifiable business judgment in meeting its [BUKWANG REDACTED] *** obligations hereunder. For purposes of this Article 6, [BUKWANG REDACTED]*** .