Common use of Study Protocols Clause in Contracts

Study Protocols. 11.1 In the event Celestial and/or BWTP proposes to sponsor or conduct any study of a Medicinal Product, it shall first draft and provide copies of the proposed study protocols for such study including all documents associated with such study protocols, including but not limited to all investigator’s brochures (“Study Protocols”) to GSK for comment and afford GSK a period of [**] Days to review such draft Study Protocols. Copies of the draft Study Protocols shall be provided by secure email or, if that is not possible, by fax. 11.2 Prior to the expiration of this [**] Days period, GSK shall have the right to provide written comments, if any, on the draft Study Protocols to Celestial and BWTP. Celestial and BWTP shall amend the draft Study Protocols to reflect all reasonable comments received from GSK. In the event that GSK determines, in its reasonable judgment, that a proposed study as designed would put any patient in safety risk, GSK may instruct Celestial and BWTP so in its written comments, and Celestial and BWTP must refrain from conducting any such study.