Medical Affairs Studies Clause Samples
Medical Affairs Studies. Chiron may conduct Medical Affairs Studies of the Licensed Products at its sole cost and expense. Chiron shall provide to Cubist via the JCT its proposal for any Medical Affairs Study it wishes to conduct, for review and discussion purposes only. Cubist shall supply Licensed Products to be used in Medical Affairs Studies (i) at a * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION purchase price equal to the Transfer Price, and (ii) in an amount not to exceed [*], during the first complete calendar year (and any part thereof) after Commercial Launch, and for any calendar year thereafter, [*] by Chiron for the corresponding period as reflected in the forecasts of purchase quantities delivered by Chiron to Cubist pursuant to the Supply Agreement.
Medical Affairs Studies. The GDP shall allocate responsibility between the Parties for the conduct of each Development activity included in the GDP. The GDP shall also include general study design parameters, specific staffing requirements and the funding budget for each stage of clinical development for each indication in the GDP, and shall be consistent with the terms of this Agreement.
Medical Affairs Studies. If the JDC does not reach consensus on any determination related to Medical Affairs Studies to be made in accordance with Section 4.2.2 and, after escalation to the JSC and Executive Officers, the Executive Officers do not reach consensus on such matter, [***].
Medical Affairs Studies. Either Party shall have the right, at its own expense, to plan, design, recruit, monitor and conduct studies (other than Clinical Trials) relating to the Product, including surveillance studies, epidemiological studies, or other non-interventional studies where the effectiveness of the Product is not an endpoint nor are such studies used to support Regulatory Approval of the Product or expansion of the Product label (“Medical Affairs Studies”), provided that (i) such study shall be conducted in compliance with applicable Law and all applicable Professional Requirements and (ii) solely to the extent that data arising from any such study is of application exclusively to the Product, such data shall be owned by BioNTech, and Pfizer shall make such data available to BioNTech upon completion of the relevant study, and Pfizer shall be free to use and sublicense (through multiple tiers) such data (on a royalty free and irrevocable basis) for any purpose. The Party conducting such studies shall keep the other Party reasonably informed regarding the results of all such studies. In the event that the other Party desires to use the data from any such study in the Commercialization of the Product in its Commercialization Territory, the Parties shall discuss in good faith a cost-sharing arrangement with respect to costs of such studies in consideration for a license to use such data from such study.