Common use of Development and Commercialization Clause in Contracts

Development and Commercialization. a. Orthogen undertakes to use reasonable diligence to carry out a development plan, including but not limited to, 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 the production, 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 and Services. Orthogen further undertakes to exercise due diligence and to employ its reasonable diligence to obtain or to cause its sublicensees to obtain, the appropriate approvals of the health authorities for the production, 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 FDA as complying with GMP, provided that applicable laws, rules and regulations so require. c. Orthogen undertakes to begin the regular commercial production, use, and sale of the Licensed 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. 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 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. 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 a material breach of this Agreement.

Development and Commercialization. a. Orthogen undertakes 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 diligence to carry out a development planbusiness practices and judgment and commercialize any Licensed Product that receives Regulatory Approval in the applicable country or jurisdiction. Such efforts include, including but are not limited to: (a) maintaining a continuous effort for development, the performance manufacture and sale of Licensed Products; (b) obtain 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 governmental approvals for the production, 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 and Services. Orthogen further undertakes to exercise due diligence and to employ its reasonable diligence to obtain or to cause its sublicensees to obtain, the appropriate approvals of the health authorities for the productionmanufacture, 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 ProductsAgreement; (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 each of the other countries of in the world Territory reasonably selected by Licensee in which Orthogen or good faith, consistent with Licensee’s obligation to use Commercially Reasonable Efforts hereunder. Licensee shall use its sublicensees intend Commercially Reasonable Efforts to produce, use, and/or sell Licensed Products. b. Provided that applicable laws, rules develop 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 commercialize Licensed Products on a schedule that is consistent with sound and Services shall be produced in accordance with FDA Good Manufacturing Practice (“GMP”) procedures in a facility which has been certified by the FDA as complying with GMP, provided that applicable laws, rules reasonable business practices and regulations so requirejudgment. c. Orthogen undertakes to begin the regular commercial production, use, and sale of the Licensed 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. 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 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. 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 a material breach of this Agreement.

Development and Commercialization. a. Orthogen undertakes (a) In the United States, Schering shall use Diligent Efforts to use reasonable diligence to carry out a development plan(i) market, including but not limited to, promote and sell 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 the production, 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 and Services. Orthogen further undertakes to exercise due diligence and to employ its reasonable diligence to obtain or to cause its sublicensees to obtain, the appropriate approvals of the health authorities for the production, 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 FDA as complying with GMP, provided that applicable laws, rules and regulations so require. c. Orthogen undertakes to begin the regular commercial production, usethen-current INTEGRILIN Product, and sale of (ii) perform the Licensed Products and Services in good faith and as soon as is practicable Early ACS Study in accordance with the development plan protocol as may be 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 right to continue diligently thereafter 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 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 United States through its commercial marketing, pricing and contracting strategies consistent with commercial practices it employs with respect to any other similarly situated products. (c) In Australia, Schering shall use Diligent Efforts to develop an INTEGRILIN Product and 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 Licensed Products and ServicesINTEGRILIN Product approved as of the Closing Date. d. If Orthogen (d) In the Schering Territory (except in the case of the United States which is addressed in 3.3(a) above, and Australia and Canada which are addressed in 3.3(c) above), Schering shall use commercially reasonable efforts to develop and obtain Regulatory Approval for an INTEGRILIN Product. Once such Regulatory Approval has been obtained in a country, Schering shall use commercially reasonable efforts to commercialize such INTEGRILIN Product in such country. (e) 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 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 commercialize be a breach of its obligations under this A-R Agreement and shall not require the Licensed Products or Services within a reasonable time frameconsent of GSK, unless such delay is necessitated by FDA or other regulatory agenciesbut, HJD for clarity, any modification shall notify Orthogen be made in writing of Orthogen’s failure to Portions of this Exhibit were omitted and have been filed separately compliance with the Secretary European Side Agreement. (f) Schering shall have the sole right with respect to invoicing and booking sales, establishing all terms of sale (including, without limitation, pricing and discounts), and warehousing and distributing all INTEGRILIN Products in the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933Schering Territory, as amended. commercialize and shall allow Orthogen sixty (60) days perform all related services. Schering shall also have the sole right with respect to cure its failure handling all returns, recalls or withdrawals, order processing, invoicing and collection, distribution, and inventory and receivables in the Schering Territory. If Millennium receives any orders for any INTEGRILIN Product for the Schering Territory, it shall refer such orders to commercialize. Orthogen’s failure to cure such delay to HJD’s reasonable satisfaction within such 60-day period shall be a material breach of this AgreementSchering.

Development and Commercialization. a. Orthogen undertakes 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 diligence to carry out a development planbusiness practices and judgment and commercialize any Licensed Product that receives Regulatory Approval in the applicable country or jurisdiction. Such efforts include, including but are not limited to: (a) maintaining a continuous effort for development, the performance manufacture and sale of Licensed Products; (b) obtain 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 governmental approvals for the production, 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 and Services. Orthogen further undertakes to exercise due diligence and to employ its reasonable diligence to obtain or to cause its sublicensees to obtain, the appropriate approvals of the health authorities for the productionmanufacture, 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 ProductsAgreement; (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 Vaccine Adjuvant, as applicable, Licensee shall be obligated to develop Licensed Products for such Indication or for use as 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 Vaccine Adjuvant the United States and to file all regulatory filings with applicable Regulatory Authorities in each of the other countries of in the world Territory reasonably selected by Licensee in which Orthogen or good faith, consistent with Licensee’s obligation to use Commercially Reasonable Efforts hereunder. Licensee shall use its sublicensees intend Commercially Reasonable Efforts to produce, use, and/or sell Licensed Products. b. Provided that applicable laws, rules develop 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 commercialize Licensed Products on a schedule that is consistent with sound and Services shall be produced in accordance with FDA Good Manufacturing Practice (“GMP”) procedures in a facility which has been certified by the FDA as complying with GMP, provided that applicable laws, rules reasonable business practices and regulations so requirejudgment. c. Orthogen undertakes to begin the regular commercial production, use, and sale of the Licensed 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. 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 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. 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 a material breach of this Agreement.

Development and Commercialization. a. Orthogen undertakes to (a) Schering shall use reasonable diligence to carry out a development planits diligent good faith efforts, including but not limited to, 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 the production, use and Portions of this Exhibit were omitted and have been filed separately consistent with the Secretary 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 Commission pursuant Territory where in Schering's opinion it is commercially viable to the Registrant’s application requesting confidential treatment pursuant do so; provided, however, that -------- ------- Schering shall have no obligation to Rule 406 of the Securities Act of 1933, as amended. sale of the develop and/or commercialize a Licensed Products and Services. Orthogen further undertakes to exercise due diligence and to employ its reasonable diligence to obtain or to cause its sublicensees to obtain, the appropriate approvals of the health authorities for the production, use and sale of the Licensed ProductsProduct in any country in which such development and/or commercialization is not commercially viable, in each of the other countries of the world in which Orthogen or its sublicensees intend to produce, use, and/or sell Licensed ProductsSchering's opinion. b. Provided (b) In the event Schering discontinues commercialization of a Licensed Product (a "Discontinued Product"; it being understood that applicable laws, rules 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 regulations require that is not seeking a sublicensee therefor Myriad shall have the performance right and license hereunder to either (i) pursue the commercialization of the tests, trials, studies and other activities specified such Discontinued Product alone or through licenses with one or more third parties or (ii) not pursue any further commercialization of such Discontinued Product. Myriad shall notify Schering in subsection a. above writing of its decision. Myriad 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 FDA as complying with GMP, provided that applicable laws, rules and regulations so require. c. Orthogen undertakes to begin the regular commercial production, use, and sale of the Licensed Products and Services in good faith and as soon as is practicable 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 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 plan and commercialization of the Discontinued Product. Schering and Myriad agree that the terms under which Myriad may seek a third party licensee pursuant to continue diligently thereafter this Section 3.5(b) will include provisions to commercialize protect the Licensed Products and Servicesconfidentiality of all Proprietary Information of Schering. d. (ii) If Orthogen shall Myriad initially decides not commercialize the Licensed Products or Services within a reasonable time frameto pursue commercialization of such Discontinued Product, unless such delay is necessitated by FDA or other regulatory agenciesbut later decides to begin commercialization, HJD shall it will notify Orthogen Schering in writing of Orthogen’s failure to Portions of this Exhibit were omitted and have been filed separately decision. Myriad shall provide Schering with the Secretary opportunity to re-initiate commercialization of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933such Discontinued Product and if Schering so re-initiates commercialization, as amended. commercialize such product shall no longer be considered a Discontinued Product 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 considered a material breach of this AgreementLicensed Product.