Common use of Purchase and Supply Commitment Clause in Contracts

Purchase and Supply Commitment. AstraZeneca hereby appoints FibroGen as its exclusive supplier of Product (drug substance and drug product) for the Territory for use in accordance with the terms of this Agreement. AstraZeneca agrees to purchase, and FibroGen agrees to supply, all of AstraZeneca’s and its Affiliates’ and their respective Sublicensees’ requirements of Product (as bulk drug product and drug substance) for Development and Commercialization in the Territory under the terms of this Article 6. AstraZeneca shall have the exclusive right to perform (itself or through its Affiliates, Sublicensees or Distributors) and shall be solely responsible for final product labeling and secondary packaging for sale to end users in the Territory. To the extent that such labeling and packaging are relevant to FibroGen’s activities to seek and obtain Regulatory Approval for the Product, AstraZeneca will reasonably and timely cooperate with FibroGen, in a manner sufficient to enable FibroGen to receive Regulatory Approval and to provide materials and Information as requested by FibroGen. The right of FibroGen to manufacture on behalf of AstraZeneca contemplates that at a time to be determined by the JSC, and in any event before the point in time when [*] in any twelve (12) month period, AstraZeneca will have the right to select, or obligate FibroGen to select, a second supplier (which may be AstraZeneca itself), and FibroGen will have the obligation to complete activities to undertake technology transfer in order for such secondary source to establish and secure regulatory approval as a second source for drug substance for Product, which shall in any event not limit FibroGen’s right to continue to ensure that a source of Product be maintained in the U.S. in order to satisfy FibroGen’s obligations under the Astellas Agreements and the DFCI Agreement. For clarity, FibroGen shall have the right to manufacture Product outside the Territory to fulfill its supply obligations under this Agreement. For clarity, subject to the terms of this Agreement, FibroGen shall have the right to satisfy its obligations under this Article 6 through a Third Party contract manufacturer. In connection with FibroGen’s manufacture of Products for use under this Agreement, FibroGen shall have the right to manufacture in the Territory for supply of Products under the Astellas Agreements.

Appears in 2 contracts

Samples: Development and Commercialization Agreement (Fibrogen Inc), Development and Commercialization Agreement (Fibrogen Inc)

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Purchase and Supply Commitment. AstraZeneca hereby appoints FibroGen as its exclusive supplier of Product (drug substance and drug product) for the Territory for use in accordance with the terms of this Agreement. AstraZeneca agrees to purchase, and FibroGen agrees to supply, all of AstraZeneca’s and its Affiliates’ and their respective Sublicensees’ requirements of Product (as bulk drug product and drug substance) for Development and Commercialization in the Territory under the terms of this Article 6. AstraZeneca shall have the exclusive right to perform (itself or through its Affiliates, Sublicensees or Distributors) and shall be solely responsible for final product labeling and secondary packaging for sale to end users in the Territory. To the extent that such labeling and packaging are relevant to FibroGen’s activities to seek and obtain Regulatory Approval for the Product, AstraZeneca will reasonably and timely cooperate with FibroGen, in a manner sufficient to enable FibroGen to receive Regulatory Approval and to provide materials and Information as requested by FibroGen. The right of FibroGen to manufacture on behalf of AstraZeneca contemplates that at a time to be determined by the JSC, and in any event before the point in time when [*[ * ] in any twelve (12) month period, AstraZeneca will have the right to select, or obligate FibroGen to select, a second supplier (which may be AstraZeneca itself), and FibroGen will have the obligation to complete activities to undertake technology transfer in order for such secondary source to establish and secure regulatory approval as a second source for drug substance for Product, which shall in any event not limit FibroGen’s right to continue to ensure that a source of Product be maintained in the U.S. in order to satisfy FibroGen’s obligations under the Astellas Agreements and the DFCI Agreement. For clarity, FibroGen shall have the right to manufacture Product outside the Territory to fulfill its supply obligations under this Agreement. For clarity, subject to the terms of this Agreement, FibroGen shall have the right to satisfy its obligations under this Article 6 through a Third Party contract manufacturer. In connection with FibroGen’s manufacture of Products for use under this Agreement, FibroGen shall have the right to manufacture in the Territory for supply of Products under the Astellas Agreements.

Appears in 2 contracts

Samples: License, Development and Commercialization Agreement, Development and Commercialization Agreement (Fibrogen Inc)

Purchase and Supply Commitment. AstraZeneca hereby appoints FibroGen as its exclusive supplier of Product (drug substance and drug product) for the Territory for use in accordance with the terms of this Agreement. AstraZeneca agrees to purchase, and FibroGen XxxxxXxx agrees to supply, all of AstraZeneca’s and its Affiliates’ and their respective Sublicensees’ requirements of Product (as bulk drug product and drug substance) for Development and Commercialization in the Territory under the terms of this Article 6. AstraZeneca shall have the exclusive right to perform (itself or through its Affiliates, Sublicensees or Distributors) and shall be solely responsible for final product labeling and secondary packaging for sale to end users in the Territory. To the extent that such labeling and packaging are relevant to FibroGen’s activities to seek and obtain Regulatory Approval for the Product, AstraZeneca will reasonably and timely cooperate with FibroGen, in a manner sufficient to enable FibroGen to receive Regulatory Approval and to provide materials and Information as requested by FibroGen. The right of FibroGen to manufacture on behalf of AstraZeneca contemplates that at a time to be determined by the JSC, and in any event before the point in time when [*[ * ] in any twelve (12) month period, AstraZeneca will have the right to select, or obligate FibroGen to select, a second supplier (which may be AstraZeneca itself), and FibroGen will have the obligation to complete activities to undertake technology transfer in order for such secondary source to establish and secure regulatory approval as a second source for drug substance for Product, which shall in any event not limit FibroGen’s right to continue to ensure that a source of Product be maintained in the U.S. in order to satisfy FibroGen’s obligations under the Astellas Agreements and the DFCI Agreement. For clarity, FibroGen shall have the right to manufacture Product outside the Territory to fulfill its supply obligations under this Agreement. For clarity, subject to the terms of this Agreement, FibroGen shall have the right to satisfy its obligations under this Article 6 through a Third Party contract manufacturer. In connection with FibroGen’s manufacture of Products for use under this Agreement, FibroGen shall have the right to manufacture in the Territory for supply of Products under the Astellas Agreements.

Appears in 1 contract

Samples: License, Development and Commercialization Agreement

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Purchase and Supply Commitment. AstraZeneca hereby appoints FibroGen as its exclusive supplier of Product (drug substance and drug product) for the Territory for use in accordance with the terms of this Agreement. AstraZeneca agrees to purchase, and FibroGen agrees to supply, all of AstraZeneca’s and its Affiliates’ and their respective Sublicensees’ requirements of Product (as bulk drug product and drug substance) for Development and Commercialization in the Territory under the terms of this Article 6. AstraZeneca shall have the exclusive right to perform (itself or through its Affiliates, Sublicensees or Distributors) and shall be solely responsible for final product labeling and secondary packaging for sale to end users in the Territory. To the extent that such labeling and packaging are relevant to FibroGen’s activities 42. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed. EXECUTION VERSION to seek and obtain Regulatory Approval for the Product, AstraZeneca will reasonably and timely cooperate with FibroGen, in a manner sufficient to enable FibroGen to receive Regulatory Approval and to provide materials and Information as requested by FibroGen. The right of FibroGen to manufacture on behalf of AstraZeneca contemplates that at a time to be determined by the JSC, and in any event before the point in time when [*[ * ] in any twelve (12) month period, AstraZeneca will have the right to select, or obligate FibroGen to select, a second supplier (which may be AstraZeneca itself), and FibroGen will have the obligation to complete activities to undertake technology transfer in order for such secondary source to establish and secure regulatory approval as a second source for drug substance for Product, which shall in any event not limit FibroGen’s right to continue to ensure that a source of Product be maintained in the U.S. in order to satisfy FibroGen’s obligations under the Astellas Agreements and the DFCI Agreement. For clarity, FibroGen shall have the right to manufacture Product outside the Territory to fulfill its supply obligations under this Agreement. For clarity, subject to the terms of this Agreement, FibroGen shall have the right to satisfy its obligations under this Article 6 through a Third Party contract manufacturer. In connection with FibroGen’s manufacture of Products for use under this Agreement, FibroGen shall have the right to manufacture in the Territory for supply of Products under the Astellas Agreements.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Fibrogen Inc)

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