Labeling and Packaging; Use, Handling and Storage. 8.5.1 The Parties’ obligations with respect to the labeling and packaging of the Compounds are as set forth in the Clinical Quality Agreement. Notwithstanding the foregoing or anything to the contrary contained herein, Merck shall provide the Merck Compound to BioLineRx in the form of unlabeled vials, and BioLineRx shall be responsible for labeling, packaging and leafleting such Merck 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.
8.5.2 BioLineRx shall (i) use the Merck Compound solely for purposes of performing the Study; (ii) not use the Merck 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 Merck Compound in compliance with Applicable Law and the Clinical Quality Agreement, as well as all written instructions of Merck. BioLineRx shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the Merck Compound, and in particular shall not analyze the Merck Compound by physical, chemical or biochemical means, except as necessary to perform its obligations under the Clinical Quality Agreement.
Labeling and Packaging; Use, Handling and Storage. 9.4.1 The Parties’ obligations with respect to the labeling and packaging of the Compounds are as set forth in the Quality Agreement. Notwithstanding the foregoing or anything to the contrary contained herein, Pfizer shall provide the Pfizer Compound to Ideaya in the U.S. commercial presentation or as agreed to by the Joint Development Committee, and Ideaya shall be responsible for labeling, packaging and leafleting such Pfizer Compound, at Ideaya’s sole expense, in accordance with the terms and conditions of the Quality Agreement and otherwise in accordance with all Applicable Law, including cGMP, GCP, and health, safety and environmental protections.
9.4.2 Ideaya shall (i) use the Pfizer Compound solely for purposes of performing the Study; (ii) not use the Pfizer Compound in any manner inconsistent with this Agreement or for any commercial purpose; and (iii) use, store, transport, handle and dispose of the Pfizer Compound in compliance with Applicable Law and the Quality Agreement. Ideaya shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the Pfizer Compound, and in particular shall not analyze the Pfizer Compound by physical, chemical or biochemical means except as necessary to perform its obligations under the Quality Agreement.
Labeling and Packaging; Use, Handling and Storage. 8.4.1 The Parties’ obligations with respect to the labeling and packaging of the Compounds are as set forth in the Clinical Quality Agreements. Notwithstanding the foregoing or anything to the contrary contained herein, Merck shall provide Merck Compound to Vaccinex in the form of released unlabeled vials, and Vaccinex shall be responsible for labeling, packaging and leafleting such Merck Compound in accordance with the terms and conditions of the Clinical Quality Agreements and otherwise in accordance with all Applicable Law, including cGMP, GCP, and health, safety and environmental protections. Labeling, packaging, and leafleting of Merck Compound and Vaccinex Compound shall be considered Study Costs and shall be handled in accordance with Section 7.1.
8.4.2 Vaccinex shall (i) use Merck Compound solely for purposes of performing the Study; (ii) not use Merck Compound in any manner inconsistent with this Agreement or for any commercial purpose other than conduct of the Study; and (iii) use, store, transport, handle and dispose of Merck Compound in compliance with Applicable Law and the Clinical Quality Agreements. Vaccinex shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of Merck Compound, and in particular shall not analyze Merck Compound by physical, chemical or biochemical means except as necessary to perform its obligations under the Clinical Quality Agreements.
Labeling and Packaging; Use, Handling and Storage. 8.4.1 The Parties’ obligations with respect to the labeling and packaging of the Compounds are as set forth in the Clinical Quality Agreement. Notwithstanding the foregoing or anything to the contrary contained herein, Merck shall provide unlabeled Merck Compound to Syndax in accordance with all Applicable Law, including cGMP, GCP, and health, safety and environmental protections.
8.4.2 Syndax shall (i) use the Merck Compound solely for purposes of performing the Study; (ii) not use the Merck Compound in any manner inconsistent with this Agreement or for any purpose other than conduct of the Study; and (iii) label, use, store, transport, handle and dispose of the Merck Compound in compliance with Applicable Law and the Clinical Quality Agreement. Syndax shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the Merck Compound, and in particular shall not analyze the Merck Compound by physical, chemical or biochemical means except as necessary to perform its obligations under the Clinical Quality Agreement and/or any testing described in Section 8.7.
Labeling and Packaging; Use, Handling and Storage. 8.6.1. The Parties’ obligations with respect to the labeling and packaging of the MSD Compound are as set forth in the Clinical Quality Agreement. MSD shall provide the MSD Compound to Collaborator in the form of [***].
8.6.2. Collaborator shall: (i) use the MSD Compound solely for purposes of performing the MSD Compound Study; and (ii) not use the MSD Compound in any manner that is inconsistent with this Agreement or for any commercial purpose. Collaborator shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the MSD Compound, and in particular shall not analyze the MSD Compound by physical, chemical or biochemical means except as necessary to perform its obligations under the Clinical Quality Agreement.
Labeling and Packaging; Use, Handling and Storage. 8.6.1. The Parties’ obligations with respect to the labeling and packaging of the MSD Compound are as set forth in the Clinical Quality Agreement. MSD shall provide the MSD Compound to Collaborator in the form of unlabeled vials, and Collaborator shall label, package, use, store, transport, handle and dispose of the MSD Compound in accordance with MSD’s instructions and the terms and conditions of the Clinical Quality Agreement and Applicable Law.
8.6.2. Collaborator shall: (i) use the MSD Compound solely for purposes of performing the MSD Compound Study; and (ii) not use the MSD Compound in any manner that is inconsistent with this Agreement or for any commercial purpose. Collaborator shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the MSD Compound, and in particular shall not analyze the MSD Compound by physical, chemical or biochemical means except as necessary to perform its obligations under the Clinical Quality Agreement.
Labeling and Packaging; Use, Handling and Storage. INDICATES 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 are as set forth in the Clinical Quality Agreements. Notwithstanding the foregoing or anything to the contrary contained herein, the Alliance shall provide the Alliance Compound to Syndax in the form of unlabeled vials, and Syndax shall be responsible for labeling, packaging and leafleting such Alliance Compound in accordance with the terms and conditions of the Clinical Quality Agreements and otherwise in accordance with all Applicable Law, including cGMP, GCP, and health, safety and environmental protections.
8.4.2 Syndax shall (i) use the Alliance Compound solely for purposes of performing the Study; (ii) not use the Alliance Compound in any manner inconsistent with this Agreement or for any commercial purpose other than conduct of the Study; and (iii) use, store, transport, handle and dispose of the Alliance Compound in compliance with Applicable Law and the Clinical Quality Agreements. Syndax shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the Alliance Compound, and in particular shall not analyze the Alliance Compound by physical, chemical or biochemical means except as necessary to perform its obligations under the Clinical Quality Agreements.
Labeling and Packaging; Use, Handling and Storage. 8.5.1. The Parties’ obligations with respect to the labeling and packaging of the MSD Compound is set forth in the Clinical Quality Agreement. Notwithstanding the foregoing or anything to the contrary contained herein, MSD shall provide the MSD Compound to Company in the form of [***].
8.5.2. Company shall: (a) use the MSD Compound solely for purposes of performing the Study; (b) not use the MSD Compound in any manner that is inconsistent with this Agreement or for any commercial purpose; and (c) label, use, store, transport, handle and dispose of the MSD Compound in compliance with Applicable Law and the Clinical Quality Agreement, as well as all instructions of MSD. Company shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the MSD Compound, and in particular shall not analyze the MSD Compound by physical, chemical or biochemical means except as necessary to perform its obligations under the Clinical Quality Agreement.
Labeling and Packaging; Use, Handling and Storage. The Parties respectively shall label and package the units and Batch(es) of a Licensed Product in compliance with Applicable Law and otherwise as set forth in the Quality Agreement. NeuroBo shall use, store, transport, handle and dispose of units and Batch(es) of a Licensed Product in compliance with the Specifications, Applicable Law and the Quality Agreement.
Labeling and Packaging; Use, Handling and Storage. 8.4.1 The Parties’ obligations with respect to the labeling and packaging of the Compounds are as set forth in the Quality Agreements. Notwithstanding the foregoing or anything to the contrary contained herein, the Alliance shall provide the Alliance Compound and Checkmate shall provide the Checkmate Compound to Pfizer in the form of unlabeled vials, and Pfizer shall be responsible for labeling, packaging and leafleting such Alliance Compound and Checkmate Compound and the Pfizer Compound, as applicable, in accordance with the terms and conditions of the Quality Agreements and otherwise in accordance with all Applicable Law, including cGMP, GDP, GCP, and health, safety and environmental protections.
8.4.2 Pfizer shall (i) use the Alliance Compound and Checkmate Compound, as applicable, solely for purposes of performing the Study; (ii) not use the Alliance Compound or Checkmate Compound, as applicable, in any manner inconsistent with this Agreement or for any commercial purpose other than conduct of the Study; and (iii) use, store, transport, handle and dispose of the Alliance Compound and Checkmate Compound, as applicable, in compliance with Applicable Law and the Quality Agreements. Pfizer shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the Alliance Compound or Checkmate Compound, as applicable, and in particular shall not analyze the Alliance Compound and Checkmate Compound, as applicable, by physical, chemical or biochemical means except as necessary to perform its obligations under the Quality Agreements and/or the Protocol.
