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.
Appears in 3 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (BioLineRx Ltd.), Clinical Trial Collaboration and Supply Agreement (BioLineRx Ltd.), Clinical Trial Collaboration and Supply Agreement (BioLineRx Ltd.)
Labeling and Packaging; Use, Handling and Storage. 8.5.1 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 Antigen Express in the form of unlabeled vials, and BioLineRx Antigen Express 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 8.5.2. Antigen Express 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 Antigen Express 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, means except as necessary to perform its obligations under the Clinical Quality Agreement.
Appears in 2 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (Nugenerex Immuno-Oncology, Inc.), Clinical Trial Collaboration and Supply Agreement (Generex Biotechnology Corp)
Labeling and Packaging; Use, Handling and Storage. 8.5.1 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 Adaptimmune in the form of unlabeled vials*** , and BioLineRx Adaptimmune shall be responsible at its expense 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 8.5.2. Adaptimmune 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 Adaptimmune 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, means except as necessary to perform its obligations under the Clinical Quality Agreement. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
Appears in 2 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (Adaptimmune Therapeutics PLC), Clinical Trial Collaboration and Supply Agreement (Adaptimmune Therapeutics PLC)
Labeling and Packaging; Use, Handling and Storage. 8.5.1 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 FLX in the form of unlabeled vials[***], and BioLineRx FLX 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 8.5.2. FLX shall: (ia) use the Merck Compound solely for purposes of performing the Study; (iib) not use the Merck Compound in any manner that is inconsistent with this Agreement or for any commercial purpose; and (iiic) 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 FLX 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, means except as necessary to perform its obligations under the Clinical Quality Agreement.
Appears in 2 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (RAPT Therapeutics, Inc.), Clinical Trial Collaboration and Supply Agreement (RAPT Therapeutics, Inc.)
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 PDS in the form of unlabeled vials***, and BioLineRx PDS 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 PDS 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 PDS 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, means except as necessary to perform its obligations under the Clinical Quality Agreement.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Edge Therapeutics, Inc.)
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 Rexahn in the form of unlabeled vials, and BioLineRx Rexahn 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 Rexahn shall: (ia) use the Merck Compound solely for purposes of performing the Study; (iib) not use the Merck Compound in any manner that is inconsistent with this Agreement or for any commercial purpose; and (iiic) 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 Rexahn 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, means except as necessary to perform its obligations under the Clinical Quality Agreement.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Rexahn Pharmaceuticals, Inc.)
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 Company in the form of unlabeled vials, and BioLineRx Company 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 Company shall: (ia) use the Merck Compound solely for purposes of performing the Study; (iib) not use the Merck Compound in any manner that is inconsistent with this Agreement or for any commercial purpose; and (iiic) 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 MerckMerck pertaining to the Merck Compound. BioLineRx Company 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, means except as necessary to perform its obligations under the Clinical Quality Agreement.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (ONCOSEC MEDICAL Inc)
Labeling and Packaging; Use, Handling and Storage. 8.5.1 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 Company in the form of unlabeled vials, and BioLineRx Company 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 8.5.2. Company shall: (ia) use the Merck Compound solely for purposes of performing the Study; (iib) not use the Merck Compound in any manner that is inconsistent with this Agreement or for any commercial purpose; and (iiic) 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 MerckMerck pertaining to the Merck Compound. BioLineRx Company 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, means except as necessary to perform its obligations under the Clinical Quality Agreement.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (ONCOSEC MEDICAL Inc)
Labeling and Packaging; Use, Handling and Storage. 8.5.1 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 Advaxis shall provide the Merck Advaxis Compound to BioLineRx Incyte in the form of unlabeled bulk labeled vials, and BioLineRx Incyte shall be responsible for re-labeling, packaging and leafleting such Merck the Advaxis 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 8.4.2. Incyte shall (i) use the Merck Advaxis Compound solely for purposes of performing the Study; (ii) not use the Merck Advaxis 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 Advaxis Compound in compliance with Applicable Law and the Clinical Quality Agreement, as well as all written reasonable instructions of MerckAdvaxis. BioLineRx Incyte shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the Merck Advaxis Compound, and in particular shall not analyze the Merck Advaxis Compound by physical, chemical or biochemical means, means except as necessary to perform its obligations under the Clinical Quality Agreement.
Appears in 1 contract
Samples: Clinical Study Collaboration Agreement (Advaxis, Inc.)
Labeling and Packaging; Use, Handling and Storage. 8.5.1 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 MSD shall provide the Merck MSD Compound to BioLineRx Intensity in the form of unlabeled vials, and BioLineRx Intensity shall be responsible for labeling, packaging and leafleting such Merck MSD 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 8.5.2. Intensity shall: (ia) use the Merck MSD Compound supplied by MSD hereunder solely for purposes of performing the Study; (iib) not use the Merck such MSD Compound in any manner that is inconsistent with this Agreement or for any commercial purpose; and (iiic) label, use, store, transport, handle and dispose of the Merck such MSD Compound in compliance with Applicable Law and the Clinical Quality Agreement, as well as all written instructions of MerckMSD. BioLineRx Intensity shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the Merck CompoundMSD Compound supplied by MSD hereunder, and in particular shall not analyze the Merck such MSD Compound by physical, chemical or biochemical means, means except as necessary to perform its obligations under the Clinical Quality Agreement.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Intensity Therapeutics, Inc.)
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 MSD and/or its Affiliate(s) shall provide the Merck MSD Compound to BioLineRx Company in the form of unlabeled vials[***], and BioLineRx Company shall be responsible for labeling, packaging and leafleting such Merck MSD 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 Company shall: (ia) use the Merck MSD Compound solely for purposes of performing the Study; (iib) not use the Merck MSD Compound in any manner that is inconsistent with this Agreement or for any commercial purpose; and (iiic) label, use, store, transport, handle and dispose of the Merck MSD Compound in compliance with Applicable Law and the Clinical Quality Agreement, as well as all written instructions of MerckMSD. BioLineRx Company shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the Merck MSD Compound, and in particular shall not analyze the Merck MSD Compound by physical, chemical or biochemical means, means except as necessary to perform its obligations under the Clinical Quality Agreement.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (IO Biotech, Inc.)