Examples of Roche Compound in a sentence
Derivatives made as part of a Collaboration Medicinal Chemistry Program from compounds originating from the Roche Bioscience Screening Library shall be considered part of the Roche Compound Library.
Roche shall own the Study Data that relates exclusively to the Roche Compound (“Roche Study Data”), Exelixis shall own the Study Data that relates exclusively to the Exelixis Compound (“Exelixis Study Data”), and the Parties shall jointly and equally own all other Study Data (“Combined Therapy Study Data”).
Roche shall Manufacture or have Manufactured the Roche Compound in drug product and/or drug substance form (as necessary) in reasonable quantities and at the points in time as agreed by the JSC for each Combined Therapy Trial and each Independent Combined Therapy Trial.
Where a cohort of a Combined Therapy Trial is a monotherapy cohort with just the Exelixis Compound or with just the Roche Compound, then the Study Data from such cohort will be Exelixis Study Data in the case where such cohort is a monotherapy cohort with just the Exelixis Compound and Roche Study Data in the case where such cohort is a monotherapy cohort with just the Roche Compound.
Reasonable out-of-pocket costs incurred by Exelixis in packaging and labeling the Roche Compound for use in the Combined Therapy Trials shall be included in the Shared Costs under the Agreement.
Roche shall deliver to Exelixis certificates of analysis, and any other documents specified in the Quality Agreement for the Roche Compound provided under this Agreement.
The Roche Compound shall be manufactured in accordance with Applicable Law (including GMP) and shall be of equivalent quality to the Roche Compound used by Roche for its other clinical trials of the Roche Compound.
Within [ * ] after the Effective Date (for the Initial Trials) or within [ * ] of finalizing a protocol for a Combined Therapy Trial, and in no event later than the date on which the first shipment of bulk Exelixis Compound or bulk Roche Compound is supplied for use in a Combined Therapy Trial, the Parties shall enter into a supply agreement with respect to such supply (a “Supply Agreement”), substantially in the form attached as Exhibit C.
Roche shall inform Exelixis as to the GMP Manufacturing and testing site of bulk drug substance for the Roche Compound, as well as the Roche Compound drug product GMP Manufacturing and testing site, prior to the start of the Combined Therapy Trials and provide [ * ] written notice if there is any change to any such site.
If Roche is the Non-Conducting Party for a Combined Therapy Trial (or the Responding Party for an Independent Combined Therapy Trial), it shall supply such Roche Compound to Exelixis or its designee for use in such Combined Therapy Trial, and Exelixis shall package and label the Roche Compound for use in such Combined Therapy Trial.