Labeling and Packaging; Use, Handling and Storage. 8.5.1. The Parties’ obligations with respect to the labeling and packaging of the Compounds shall be as set forth in the Clinical Quality Agreement. Notwithstanding the foregoing or anything to the contrary contained herein, Company shall provide the Company Compound to Merck in the form of unlabeled bottles, and Merck shall be responsible for labeling, secondary packaging and leafleting such Company Compound in accordance with the terms and conditions of the Clinical Quality Agreement and otherwise in accordance with all Applicable Law, including cGMP, GCP, and health, safety and environmental protections (and promptly following Company’s request, Merck shall provide Company with representative samples of such labeling (i.e. clinical label proof), packaging (i.e. component specifications), and leafleting (if applicable) for Company’s review). 8.5.2. Merck shall: (i) use the Company Compound solely for purposes of performing the Study in accordance with the terms hereof; (ii) not use the Company Compound in any manner that is inconsistent with this Agreement or for any commercial purpose; and (iii) label, use, store, transport, handle and dispose of the Company Compound in compliance with Applicable Law and the Clinical Quality Agreement, as well as all instructions of Company with respect thereto. Notwithstanding anything to the contrary herein, Merck shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the Company Compound, and in particular shall not analyze the Company Compound by physical, chemical or biochemical means except to the extent expressly described in and necessary to perform its obligations under the Clinical Quality Agreement.
Appears in 1 contract
Sources: Clinical Trial Collaboration and Supply Agreement (Array Biopharma Inc)
Labeling and Packaging; Use, Handling and Storage. 8.5.1INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
8.4.1 The Parties’ obligations with respect to the labeling and packaging of the Compounds shall be are as set forth in the Clinical Quality AgreementAgreements. Notwithstanding the foregoing or anything to the contrary contained herein, Company the Alliance shall provide the Company Alliance Compound to Merck Syndax in the form of unlabeled bottlesvials, and Merck Syndax shall be responsible for labeling, secondary packaging and leafleting such Company Alliance Compound in accordance with the terms and conditions of the Clinical Quality Agreement Agreements and otherwise in accordance with all Applicable Law, including cGMP, GCP, and health, safety and environmental protections (and promptly following Company’s request, Merck shall provide Company with representative samples of such labeling (i.e. clinical label proof), packaging (i.e. component specifications), and leafleting (if applicable) for Company’s review)protections.
8.5.2. Merck shall: 8.4.2 Syndax shall (i) use the Company Alliance Compound solely for purposes of performing the Study in accordance with the terms hereofStudy; (ii) not use the Company Alliance Compound in any manner that is inconsistent with this Agreement or for any commercial purposepurpose other than conduct of the Study; and (iii) label, use, store, transport, handle and dispose of the Company Alliance Compound in compliance with Applicable Law and the Clinical Quality Agreement, as well as all instructions of Company with respect theretoAgreements. Notwithstanding anything to the contrary herein, Merck Syndax shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the Company Alliance Compound, and in particular shall not analyze the Company Alliance Compound by physical, chemical or biochemical means except to the extent expressly described in and as necessary to perform its obligations under the Clinical Quality AgreementAgreements.
Appears in 1 contract
Sources: Clinical Trial Collaboration and Supply Agreement (Syndax Pharmaceuticals Inc)