Development and Marketing. AUTHORIZATIONS 5.1 Shire shall use reasonable efforts within 90 days from the Effective Date: (a) to deliver to the Licensee (or its nominee) the Shire Know-How to the extent that it is reasonably necessary for the research and development of the Licensed Product by the Licensee in accordance with the Development Plan, the University Technology under Shire's possession or control; (b) to deliv▇▇ ▇▇ the Licensee (or its nominee) the Shire Materials; (c) transfer the investigational new drug application (filed with the FDA) relating to the development and use of Licensed Product to the Licensee; and (d) transfer its rights and obligations to the Licensee under the clinical research services agreements relating to the phase I clinical studies ([...***...] and [...***...]) of the Licensed Product between Shire Pharmaceutical Development Inc. and Quintiles Inc. From the Effective Date, the Licensee shall bear the cost of and risk in such phase I studies. 5.2 For a period of 3 months following the Effective Date, Shire shall provide the Licensee with a reasonable amount of access during normal business hours to [...***...], and [...***...], as is reasonably necessary to teach the Shire Know-How to the Licensee, provided that, the personnel remain employed or engaged by Shire and such access is limited to no more than an aggregate of 25 person working days and no more than 2 working days in any working week. Shire shall not terminate the employment or engagement of any of the above personnel for 3 months following the Effective Date. Shire shall promptly inform the Licensee if, during such period, any of the relevant personnel cease to work for Shire. In the event that the Licensee requires additional access to Shire personnel, the Parties shall in good faith negotiate the cost to the Licensee of such access. 5.3 The Licensee shall: (a) at [...***...], use its Reasonable Commercial Efforts to perform, or procure the performance of, the activities and services in the Development Plan; (b) perform, or procure the performance of, any such activities and services with reasonable care and skill and ensure that personnel employed or engaged by it in the provision of any such activities and services are competent and have appropriate professional qualifications, training and experience; (c) complete the Development Plan as expeditiously as reasonably possible using its Reasonable Commercial Efforts to meet and comply with the Timelines; and (d) update Shire at regular intervals, to be agreed between the Parties, on the progress of the Development Plan and submit a written report to Shire and the University every [...***...] as soon as reasonably practicable after [...***...] of each year and in any event by [...***...] respectively, detailing its progress of the research, development, registration and commercialisation of the Licensed Product and the amount of direct expenditures associated with the development of the Licensed Product for the previous [...***...] months. 5.4 Upon completion of the Development Plan, the Licensee shall, at [...***...], use, or cause its Affiliates and Sub-Licensees to use, Reasonable Commercial Efforts to prepare, file, prosecute and maintain all applications for Marketing Authorization and any other necessary licenses, permits, authorizations and approvals (or waivers) required by any Regulatory Authority for the Launch, use, promotion, import, sale, distribution or commercialisation of the Licensed Product in the Principal Markets. The Licensee shall file its application for 13 ***CONFIDENTIAL TREATMENT REQUESTED NDA in the United States of America no later than [...***...] following completion of the Development Plan with respect to that country.
Appears in 3 contracts
Sources: Patent and Know How License (SGX Pharmaceuticals, Inc.), Patent and Know How License (SGX Pharmaceuticals, Inc.), Patent and Know How License (SGX Pharmaceuticals, Inc.)