Clinical Development and Marketing. The preclinical and clinical development of Licensed Compounds shall be the responsibility of Sankyo. For each Licensed Compound, Sankyo shall use reasonable diligence and scientific judgment to evaluate and develop such Licensed Compounds in a timely manner in accordance with industry standards and Sankyo's internal practices and advise MTI as to the status of such Licensed Compounds. Sankyo agrees to conduct such preclinical and human clinical trials as are necessary to obtain all regulatory approvals to manufacture and market Products in each Primary Country in the Territory, and diligently, consistent with industry standards generally, develop, obtain necessary approval to market and commence marketing each such Product in Primary Countries unless in its reasonable business judgment such development and marketing is not practical or is strategically inadvisable. For the purposes of this Agreement, "Primary Countries" shall mean Australia, the Benelux countries, Canada, France, Germany, Italy, Japan, the Scandinavian countries, Spain, Switzerland, the United Kingdom and the United States. Sankyo shall use reasonable diligence, consistent with industry standards generally, to develop and market Products in other countries (the "non-Primary Countries") in the Territory unless in its reasonable business judgment such development and marketing is not practical or strategically inadvisable. Notwithstanding anything to the contrary in this Agreement, if Sankyo does not diligently develop and market a Product incorporating a Licensed Compound in a Primary Country or in a non-Primary Country where Sankyo has not made a reasonable business judgment that to develop and market such Product is not practical or strategically inadvisable, then following [***] written notice by MTI to Sankyo if such decision has not been reversed by Sankyo, (a) the license and other rights granted to Sankyo with respect to such Licensed Compound and such country shall [***] and (b) Sankyo [***] as necessary to develop, make, use, import and sell Products incorporating such Licensed Compound in such country.
Clinical Development and Marketing. Except as otherwise ------------ ----------------------------------- provided in this Agreement or as LILLY and MEGABIOS may agree in writing, LILLY, at its sole discretion, shall have the exclusive right (and the funding and other responsibilities related thereto) to handle either directly or through third parties of its choice (subject to Sections 2.10 and 4.3 below) all matters related to the Product after pre-clinical development including, but not limited to, clinical development, regulatory registrations and filings, manufacturing and commercialization of any Product under the terms of this Agreement. LILLY may also, in its sole discretion, conduct further preclinical studies (including toxicology studies) beyond those provided for in the Research Plan. LILLY agrees to provide MEGABIOS with all data and information generated in such further preclinical studies conducted by LILLY on Products, subject to the confidentiality provisions of Article VII. For avoidance of any doubt, LILLY may, in its sole discretion, discontinue clinical development and the obligations related thereto if it deems it appropriate at anytime, subject to the terms of this Agreement, including but not limited to Section 5.2(b) and Articles III and VIII. LILLY shall notify MEGABIOS upon its decision to discontinue development or commercialization efforts with respect to any Product, and Lilly's license under Section 5.1 shall terminate with respect to any such Product.
Clinical Development and Marketing. The clinical development of a CDK Development Compound starting with the commencement of human clinical trials for such CDK Development Compound and continuing through obtaining regulatory approvals of any resulting CDK Product shall be the sole responsibility of DuPont Merck and shall be conducted at the sole expense of DuPont Merck, with input from Mitotix through the Collaborative Policy Setting Committee. Subject to Mitotix’s co-promotion option set forth in Article 8, DuPont Merck shall have sole responsibility for and shall bear all expenses associated with the marketing and sale of all CDK Products. For each CDK Development Compound, DuPont Merck shall use its good faith commercially reasonable efforts to evaluate and develop such compound or CDK Product in a timely manner in accordance with industry standards and DuPont Merck internal practices and shall advise the Collaborative Policy Setting Committee as to the status of the development of each CDK Development Compound. Consistent with industry standards and DuPont Merck internal practices, DuPont Merck shall use its good faith commercially reasonable efforts to conduct at its own expense, such human clinical trials as are necessary to obtain all regulatory approvals to manufacture and market CDK Products and to seek and obtain all necessary regulatory approvals to market and promptly commence worldwide marketing of each CDK Product.
