Collaborator Compound definition
Examples of Collaborator Compound in a sentence
The term “Collaborator Clinical Trial” as used in this Agreement refers to the Collaborator Clinical Trial as a whole, including the Combination Arm(s), and any Collaborator Compound Arm(s) or MSD Compound Arm(s) that form or are intended to form a part of the Collaborator Clinical Trial.
Collaborator shall be solely responsible for taking all steps necessary to determine that MSD Compound or Collaborator Compound, as applicable, is suitable for release before making such Compounds available for human use, and MSD shall assist Collaborator as Collaborator reasonably requests in making such determination for the MSD Compound.
In the event such escalation does not result in resolution or consensus: (x) MSD shall have final decision-making authority with respect to issues related to MSD Compound (including, but not limited to PD-1 Antagonists and any biomarkers related to MSD Compound); and (y) Collaborator shall have final decision-making authority with respect to issues related to Collaborator Compound.
The sole and exclusive remedies of MSD with respect to any Collaborator Compound that is found to have a Non-Conformance at the time of Delivery shall be: [***].
Any proposed changes to: (i) the approved final Protocol (other than changes that are solely related to Collaborator Compound); or (ii) the informed consent form relating to the MSD Compound, including Sample Testing of the MSD Compound, shall be made only with MSD’s prior written consent.
In addition, the Collaborator Clinical Trial may (or may not) have a Collaborator Compound Arm(s), an MSD Compound Arm(s), or both.
Collaborator shall act as the sponsor of the Collaborator Clinical Trial under its own CTA for the Collaborator Compound with a Right of Reference to the CTA of the MSD Compound as described in Section 3.5 (Regulatory Matters); provided, however, that in no event shall Collaborator file an additional CTA for the MSD Compound Study unless required by Regulatory Authorities to do so.
Collaborator Clinical Trial, Collaborator Compound Arm(s), Combination Arm(s), MSD Compound Arm(s) and MSD Compound Study all refer to such arms as are intended to be conducted in accordance with the Protocol, including the Protocol as may be amended in accordance with Article 4 (PROTOCOL AND INFORMED CONSENT; CERTAIN COVENANTS).
Collaborator shall replace any such Collaborator Compound that has not been administered.