Common use of Development and Commercialization Clause in Contracts

Development and Commercialization. 3.1 Commercially Reasonable Efforts. Licensee shall be solely responsible for the development and commercialization of Licensed Products in the Field in the Territory, at its own cost and expense, including all non-clinical and clinical studies and collection of CMC Information, as necessary to obtain Regulatory Approval for Licensed Products (i) in the United States and (ii) in the other countries in the Territory reasonably selected by Licensee in good faith, consistent with Licensee’s obligation to use Commercially Reasonable Efforts hereunder. Licensee shall use its Commercially Reasonable Efforts to develop and commercialize Licensed Products on a schedule that is consistent with sound and reasonable business practices and judgment and commercialize any Licensed Product that receives Regulatory Approval in the applicable country or jurisdiction. Such efforts include, but are not limited to: (a) maintaining a continuous effort for development, manufacture and sale of Licensed Products; (b) obtain all necessary governmental approvals for the manufacture, use and sale of Licensed Products in the Territory, in compliance with this Agreement and under supervision of the Licensor; (c) reasonably filling the market demand for Licensed Products following commencement of marketing at any time during the term of the Licensed Agreement; (d) implementing and conducting technology transfer as required for the manufacture of Licensed Product in the Territory. Upon exercise of the Exclusive Option for an Indication or for use as a Vaccine Adjuvant, as applicable, Licensee shall be obligated to develop Licensed Products for such Indication or for use as a Vaccine Adjuvant and to file all regulatory filings with FDA as necessary to obtain Regulatory Approval for such Licensed Product for such Indication or for use as a Vaccine Adjuvant the United States and to file all regulatory filings with applicable Regulatory Authorities in the other countries in the Territory reasonably selected by Licensee in good faith, consistent with Licensee’s obligation to use Commercially Reasonable Efforts hereunder. Licensee shall use its Commercially Reasonable Efforts to develop and commercialize Licensed Products on a schedule that is consistent with sound and reasonable business practices and judgment.

Development and Commercialization. 3.1 Commercially Reasonable Efforts. Licensee shall be solely responsible for the a. Orthogen undertakes to use reasonable diligence to carry out a development and commercialization of Licensed Products in the Field in the Territory, at its own cost and expenseplan, including all non-clinical and clinical studies and collection of CMC Information, as necessary to obtain Regulatory Approval for Licensed Products (i) in the United States and (ii) in the other countries in the Territory reasonably selected by Licensee in good faith, consistent with Licensee’s obligation to use Commercially Reasonable Efforts hereunder. Licensee shall use its Commercially Reasonable Efforts to develop and commercialize Licensed Products on a schedule that is consistent with sound and reasonable business practices and judgment and commercialize any Licensed Product that receives Regulatory Approval in the applicable country or jurisdiction. Such efforts include, but are not limited to: (a) maintaining a continuous effort , the performance of all efficacy, pharmaceutical, safety, toxicological and clinical tests, trials and studies and all other activities necessary in order to obtain the approval of the FDA for developmentthe production, manufacture use and 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. sale of the Licensed Products; (b) Products and Services. Orthogen further undertakes to exercise due diligence and to employ its reasonable diligence to obtain all necessary governmental or to cause its sublicensees to obtain, the appropriate approvals of the health authorities for the manufactureproduction, use and sale of the Licensed Products, in each of the other countries of the world in which Orthogen or its sublicensees intend to produce, use, and/or sell Licensed Products. b. Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in subsection a. above shall be carried out in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities, Orthogen shall carry out such tests, trials, studies and other activities in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities. Furthermore, the Licensed Products and Services shall be produced in accordance with FDA Good Manufacturing Practice (“GMP”) procedures in a facility which has been certified by the TerritoryFDA as complying with GMP, in compliance with this Agreement provided that applicable laws, rules and under supervision of regulations so require. c. Orthogen undertakes to begin the Licensor; (c) reasonably filling the market demand for Licensed Products following commencement of marketing at any time during the term regular commercial production, use, and sale of the Licensed Agreement;Products and Services in good faith and as soon as is practicable in accordance with the development plan and to continue diligently thereafter to commercialize the Licensed Products and Services. (d) implementing d. If Orthogen shall not commercialize the Licensed Products or Services within a reasonable time frame, unless such delay is necessitated by FDA or other regulatory agencies, HJD shall notify Orthogen in writing of Orthogen’s failure to Portions of this Exhibit were omitted and conducting technology transfer as required for have been filed separately with the manufacture of Licensed Product in the Territory. Upon exercise Secretary of the Exclusive Option for an Indication or for use as a Vaccine AdjuvantCommission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as applicable, Licensee amended. commercialize and shall allow Orthogen sixty (60) days to cure its failure to commercialize. Orthogen’s failure to cure such delay to HJD’s reasonable satisfaction within such 60-day period shall be obligated to develop Licensed Products for such Indication or for use as a Vaccine Adjuvant and to file all regulatory filings with FDA as necessary to obtain Regulatory Approval for such Licensed Product for such Indication or for use as a Vaccine Adjuvant the United States and to file all regulatory filings with applicable Regulatory Authorities in the other countries in the Territory reasonably selected by Licensee in good faith, consistent with Licensee’s obligation to use Commercially Reasonable Efforts hereunder. Licensee shall use its Commercially Reasonable Efforts to develop and commercialize Licensed Products on a schedule that is consistent with sound and reasonable business practices and judgmentmaterial breach of this Agreement.

Development and Commercialization. 3.1 Commercially Reasonable Efforts. Licensee (a) In the United States, Schering shall use Diligent Efforts to (i) market, promote and sell the then-current INTEGRILIN Product, and (ii) perform the Early ACS Study in accordance with the protocol as may be solely responsible amended by Schering in its sole discretion from time to time; PROVIDED, HOWEVER, it is understood that Schering shall not have any obligation to develop any new INTEGRILIN Product or to develop the Existing INTEGRILIN Product for any new indications; and PROVIDED FURTHER that Schering shall have the development and commercialization of Licensed right to terminate or modify the Early ACS Study, Add On Studies or Clinical Development Plan in its sole discretion at any time. (b) Schering shall not implement a commercial pricing strategy for INTEGRILIN Products in the Field United States (including discounts, rebates, etc.) that would (i) economically disadvantage the INTEGRILIN Products in favor of any other group of products in Schering's U.S. product portfolio, or (ii) economically advantage any other product or group of products in Schering's U.S. product portfolio at the expense of the INTEGRILIN Products. Schering will use Diligent Efforts to maximize Net Sales of the then-current INTEGRILIN Product in the TerritoryUnited States through its commercial marketing, at its own cost pricing and expensecontracting strategies consistent with commercial practices it employs with respect to any other similarly situated products. (c) In Australia, including all non-clinical Schering shall use Diligent Efforts to develop an INTEGRILIN Product and clinical studies obtain Regulatory Approval. Once such Regulatory Approval has been obtained in Australia, Schering shall use Diligent Efforts to commercialize such INTEGRILIN Product in Australia. In Canada, Schering shall use Diligent Efforts to commercialize the INTEGRILIN Product approved as of the Closing Date. (d) In the Schering Territory (except in the case of the United States which is addressed in 3.3(a) above, and collection of CMC InformationAustralia and Canada which are addressed in 3.3(c) above), as necessary Schering shall use commercially reasonable efforts to develop and obtain Regulatory Approval for Licensed Products (i) an INTEGRILIN Product. Once such Regulatory Approval has been obtained in the United States and (ii) in the other countries in the Territory reasonably selected by Licensee in good faitha country, consistent with Licensee’s obligation to use Commercially Reasonable Efforts hereunder. Licensee Schering shall use its Commercially Reasonable Efforts commercially reasonable efforts to develop and commercialize Licensed Products on a schedule that is consistent with sound and reasonable business practices and judgment and commercialize any Licensed such INTEGRILIN Product that receives Regulatory Approval in the applicable country or jurisdiction. Such efforts include, but are not limited to:such country. (ae) maintaining In this A-R Agreement, the use of commercially reasonable efforts can be satisfied by less than the level of efforts associated with the use of Diligent Efforts. The Parties acknowledge that development activities pursuant to Sections 3.3(a) are limited to performance of the ongoing Early ACS Study or any other registration study undertaken by Schering pursuant to a continuous effort future Clinical Development Plan. For clarity, any decision by Schering to terminate or modify the Early ACS Study, an Add On Study or any other registration study prior to its completion shall not be a breach of its obligations under this A-R Agreement and shall not require the consent of GSK, but, for developmentclarity, manufacture and sale of Licensed Products;any modification shall be made in compliance with the European Side Agreement. (bf) obtain Schering shall have the sole right with respect to invoicing and booking sales, establishing all necessary governmental approvals for the manufactureterms of sale (including, use without limitation, pricing and sale of Licensed discounts), and warehousing and distributing all INTEGRILIN Products in the Schering Territory, and shall perform all related services. Schering shall also have the sole right with respect to handling all returns, recalls or withdrawals, order processing, invoicing and collection, distribution, and inventory and receivables in compliance with this Agreement and under supervision of the Licensor; (c) reasonably filling the market demand Schering Territory. If Millennium receives any orders for Licensed Products following commencement of marketing at any time during the term of the Licensed Agreement; (d) implementing and conducting technology transfer as required INTEGRILIN Product for the manufacture of Licensed Product in the Schering Territory. Upon exercise of the Exclusive Option for an Indication or for use as a Vaccine Adjuvant, as applicable, Licensee it shall be obligated refer such orders to develop Licensed Products for such Indication or for use as a Vaccine Adjuvant and to file all regulatory filings with FDA as necessary to obtain Regulatory Approval for such Licensed Product for such Indication or for use as a Vaccine Adjuvant the United States and to file all regulatory filings with applicable Regulatory Authorities in the other countries in the Territory reasonably selected by Licensee in good faith, consistent with Licensee’s obligation to use Commercially Reasonable Efforts hereunder. Licensee shall use its Commercially Reasonable Efforts to develop and commercialize Licensed Products on a schedule that is consistent with sound and reasonable business practices and judgmentSchering.

Development and Commercialization. 3.1 Commercially Reasonable Efforts(a) Schering shall use its diligent good faith efforts, consistent with the usual practice followed by Schering in pursuing the commercialization and marketing of its other pharmaceutical products of similar potential, value and status, at its own expense, to develop and commercialize a Licensed Product on a commercially reasonable basis in such countries in the Territory where in Schering's opinion it is commercially viable to do so; provided, however, that -------- ------- Schering shall have no obligation to develop and/or commercialize a Licensed Product in any country in which such development and/or commercialization is not commercially viable, in Schering's opinion. (b) In the event Schering discontinues commercialization of a Licensed Product (a "Discontinued Product"; it being understood that a Licensed Product not being commercially pursued by Schering which is similar in function to a Licensed Product being commercially pursued by Schering shall not be considered a "Discontinued Product") and is not seeking a sublicensee therefor Myriad shall have the right and license hereunder to either (i) pursue the commercialization of such Discontinued Product alone or through licenses with one or more third parties or (ii) not pursue any further commercialization of such Discontinued Product. Licensee Myriad shall notify Schering in writing of its decision. Myriad shall exercise its rights in accordance with the following: (i) If Myriad decides to pursue the commercialization of such Discontinued Product, Myriad and Schering agree to meet, in good faith, to discuss and agree upon what Proprietary Information of Schering related to the Discontinued Product may be solely responsible for utilized by Myriad and any third party licensee(s) in connection with their commercialization efforts with respect to such Discontinued Product. If Schering, in its sole discretion, agrees to permit Proprietary Information of Schering related to the Discontinued Product to be used in such commercialization efforts, Myriad and Schering shall agree upon an equitable division of royalties and milestone payments paid to Myriad by such licensee, based on the relative contributions of Schering, Myriad and the third party licensee to the development and commercialization of Licensed Products in the Field in Discontinued Product. Schering and Myriad agree that the Territory, at its own cost and expense, including terms under which Myriad may seek a third party licensee pursuant to this Section 3.5(b) will include provisions to protect the confidentiality of all non-clinical and clinical studies and collection Proprietary Information of CMC Information, as necessary to obtain Regulatory Approval for Licensed Products (i) in the United States and Schering. (ii) in the other countries in the Territory reasonably selected by Licensee in good faith, consistent with Licensee’s obligation If Myriad initially decides not to use Commercially Reasonable Efforts hereunder. Licensee shall use its Commercially Reasonable Efforts to develop and commercialize Licensed Products on a schedule that is consistent with sound and reasonable business practices and judgment and commercialize any Licensed Product that receives Regulatory Approval in the applicable country or jurisdiction. Such efforts includepursue commercialization of such Discontinued Product, but are not limited to: (a) maintaining later decides to begin commercialization, it will notify Schering in writing of this decision. Myriad shall provide Schering with the opportunity to re-initiate commercialization of such Discontinued Product and if Schering so re-initiates commercialization, such product shall no longer be considered a continuous effort for development, manufacture Discontinued Product and sale of Licensed Products; (b) obtain all necessary governmental approvals for the manufacture, use and sale of Licensed Products in the Territory, in compliance with this Agreement and under supervision of the Licensor; (c) reasonably filling the market demand for Licensed Products following commencement of marketing at any time during the term of the Licensed Agreement; (d) implementing and conducting technology transfer as required for the manufacture of Licensed Product in the Territory. Upon exercise of the Exclusive Option for an Indication or for use as a Vaccine Adjuvant, as applicable, Licensee shall be obligated to develop considered a Licensed Products for such Indication or for use as a Vaccine Adjuvant and to file all regulatory filings with FDA as necessary to obtain Regulatory Approval for such Licensed Product for such Indication or for use as a Vaccine Adjuvant the United States and to file all regulatory filings with applicable Regulatory Authorities in the other countries in the Territory reasonably selected by Licensee in good faith, consistent with Licensee’s obligation to use Commercially Reasonable Efforts hereunder. Licensee shall use its Commercially Reasonable Efforts to develop and commercialize Licensed Products on a schedule that is consistent with sound and reasonable business practices and judgmentProduct.

Development and Commercialization. 3.1 Commercially Reasonable Efforts. Licensee shall be solely responsible for the development and commercialization of Licensed Products in the Field in the Territory, at its own cost and expense, including all non-clinical and clinical studies and collection of CMC Information, as necessary to obtain Regulatory Approval for Licensed Products (i) in the United States and (ii) in the other countries in the Territory reasonably selected by Licensee in good faith, consistent with Licensee’s obligation to use Commercially Reasonable Efforts hereunder. Licensee shall use its Commercially Reasonable Efforts to develop and commercialize Licensed Products on a schedule that is consistent with sound and reasonable business practices and judgment and commercialize any Licensed Product that receives Regulatory Approval in the applicable country or jurisdiction. Such efforts include, but are not limited to: (a) maintaining a continuous effort for development, manufacture and sale of Licensed Products; (b) obtain all necessary governmental approvals for the manufacture, use and sale of Licensed Products in the Territory, in compliance with this Agreement and under supervision of the Licensor; (c) reasonably filling the market demand for Licensed Products following commencement of marketing at any time during the term of the Licensed Agreement; (d) implementing and conducting technology transfer as required for the manufacture of Licensed Product in the Territory. Upon exercise of the Exclusive Option for an Indication or for use as a Vaccine Adjuvant, as applicable, Licensee shall be obligated to develop Licensed Products for such Indication or for use as a Vaccine Adjuvant and to file all regulatory filings with FDA as necessary to obtain Regulatory Approval for such Licensed Product for such Indication or for use as a Vaccine Adjuvant the United States and to file all regulatory filings with applicable Regulatory Authorities in the other countries in the Territory reasonably selected by Licensee in good faith, consistent with Licensee’s obligation to use Commercially Reasonable Efforts hereunder. Licensee shall use its Commercially Reasonable Efforts to develop and commercialize Licensed Products on a schedule that is consistent with sound and reasonable business practices and judgment.