COMPANY Protocol definition
Examples of COMPANY Protocol in a sentence
GCAR shall retain and preserve, or cause COMPANY Sites to retain and preserve, a copy of all Clinical Data, including copies of signed consent forms, the COMPANY Protocol and information relating to the COMPANY Compound, correspondence and investigator files for at least 15 years from COMPANY Arm Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of COMPANY.
GCAR and COMPANY will collaborate on an Arm of the Study to evaluate the safety and efficacy of the COMPANY Compound in the Indication in accordance with the COMPANY Protocol (the “COMPANY Arm”).
Through the JDC, GCAR shall (a) provide any Material Amendments to the COMPANY Protocol to COMPANY for COMPANY’s review and comment, which COMPANY shall provide, if any, within thirty (30) days of receiving notification of such proposed Material Amendment; and (b) subject to Section 4.1.5, below, GCAR will consider in good faith, but is not obligated to accept, any such comments proposed by COMPANY.
This Agreement, together with the Appendices and Exhibits hereto (including the COMPANY Protocol as amended from time to time) and the Related Agreements, constitutes the sole, full and complete agreement by and between the Parties with respect to the subject matter of this Agreement, and all prior agreements, understandings, promises and representations, whether written or oral, with respect thereto are superseded by this Agreement.
The JDC will also review Material Amendments to the COMPANY Protocol in accordance with Section 4.1.
GCAR will ensure an adequate number of appropriately qualified personnel are available to perform the Study for the foreseen duration of the Study and ensure that such personnel are adequately informed about the COMPANY Protocol, COMPANY Compound, and their Study related duties and functions.
If the COMPANY Protocol is modified in accordance with Article 4 in such a manner that may affect the quantities of COMPANY Compound to be provided or the timing for providing such quantities, the Parties shall amend Exhibit B to reflect any changes required to be consistent with the COMPANY Protocol.
GCAR shall file the COMPANY Protocol as an amendment to its master IND for the Study, which will cross-reference the INDs for the COMPANY Compound and other compounds included in the Study.
The initial COMPANY Protocol is attached hereto as Exhibit A and the Master Protocol attached hereto as Exhibit F.
In addition, through the JDC, GCAR shall provide all other amendments to the COMPANY Protocol to COMPANY for COMPANY’s information.