Product Manufacture and Supply. Except for the initial supply set forth in Section 4.2 above, ZAI shall be solely responsible for, either by itself or through its Affiliates or Third Party contact manufactures, the manufacture and supply of all necessary clinical and commercial supply of the Licensed Compounds and Licensed Products, in conformance with the applicable specifications thereof and all Applicable Laws, for both Development and Commercialization of the Licensed Compounds and Licensed Products in the ZAI Territory. To the extent necessary for the Development of the Licensed Compounds and Licensed Products in the ZAI Territory in accordance with this Agreement, ZAI shall obtain all other clinical supplies, and acknowledges and agrees that (a) such clinical supplies shall be manufactured and supplied in accordance with the Good Manufacturing Practice for Drugs (药品生产质量管理规范) promulgated by CFDA, and (b) ZAI shall be responsible for labeling of such supplies and distribution to clinical sites. Notwithstanding the foregoing, ZAI shall not use any contract manufacturer or materials supplier listed on Schedule 7.1, for the purposes of manufacturing Licensed Compounds or Licensed Products, without the prior written consent of TESARO.
Product Manufacture and Supply. 6.1 Within six (6) months of the Effective Date or such longer period as may otherwise be agreed in writing (including by email), the Parties shall agree a detailed Manufacturing and Supply Plan for the supply of the Drug Product through the JSC. The Manufacturing and Supply Plan shall be based on the following principles:
Product Manufacture and Supply. (a) AVI shall use reasonably diligent efforts to manufacture and supply Product as required by SuperGen. SuperGen shall exclusively obtain from AVI or from its designated Third Party manufacturer(s), and AVI shall exclusively supply to SuperGen (or shall cause or its designated Third Party manufacturer(s) to supply exclusively to SuperGen), SuperGen's requirements for the Product in the U.S. Territory.
Product Manufacture and Supply. Except as set forth in Section 4.2 above, ZAI shall be responsible for providing, either by itself or through its Affiliates or Third Part contact manufactures, all necessary clinical and commercial supply of the Licensed Product and placebo in conformance with specifications therefor and all Applicable Laws for both Development and Commercialization of the Licensed Product (including fulfilling purchase orders for Licensed Products and placebo) in the Partner Territory. To the extent necessary for the Development of the Licensed Product for the Partner Territory in accordance with this Agreement, ZAI shall obtain all other clinical supplies, and acknowledges and agrees that (i) such clinical supplies shall be manufactured and supplied in accordance with the Good Manufacturing Practice for Drugs (药品生产质量管理规范) promulgated by CFDA, and (ii) ZAI shall be responsible for labeling of such supplies and distribution to clinical sites.
Product Manufacture and Supply. 14 6. CONSIDERATION........................................................................................... 18 7.
Product Manufacture and Supply. 5.1 During the term of this Agreement, Medicis shall purchase or otherwise obtain exclusively from Ipsen or from any Affiliate or Third Party appointed by Ipsen, all of the Product requirements for the Products Medicis, its Affiliates, or appointed distributors distribute under this Agreement.
Product Manufacture and Supply. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Confidential Treatment Requested by Puma Biotechnology, Inc. Puma agrees to Manufacture Products as provided in Section 5.1 and to supply Products to Pint pursuant to a Supply Agreement to be entered into by the Parties as provided in Section 5.2.
Product Manufacture and Supply. 5.1 Puma shall have the sole right and responsibility to Manufacture or have Manufactured and supply to Pint the Product for Development, Commercialization and Use in the Territory.
Product Manufacture and Supply. A. Manufacture and Supply B&L agrees to manufacture the Product(s) in Appendix C at its facility located at 0000 Xxxxxx Xxxxx Xxxxxxx, Xxxxx, Xxxxxxx (or other locations as the parties mutually agree upon), in accordance with cGMPs, Applicable Laws, and B&L policies and procedures that do not conflict with any terms or conditions of this Agreement, and to meet the mutually agreed upon product specifications and test methods, respectively. During the Term of this Agreement and for a period of five (5) years thereafter, B&L agrees that it shall not manufacture or supply to any third party any product containing the AERIE proprietary compounds, specifically AR-13324. With respect to manufacture of Product(s) under this Agreement, B&L and AERIE will also enter into a separate Quality Agreement. If the terms of this Agreement and the Quality Agreement conflict, the terms of this Agreement shall control for the explicit purposes of Supply of Product(s).
Product Manufacture and Supply. A. Manufacture and Supply B&L agrees to manufacture the Product(s) in Appendix C at its facility located at 0000 Xxxxxx Xxxxx Xxxxxxx, Xxxxx, Xxxxxxx (or other locations as the parties mutually agree upon), in accordance with cGMPs, Applicable Laws, and B&L policies and procedures that do not conflict with any terms or conditions of this Agreement, and to meet the mutually agreed upon product specifications and test methods, respectively. During the Term of this Agreement and for a period of five (5) years thereafter, B&L agrees that it shall not manufacture or supply to any third party any product containing the AERIE proprietary compounds, specifically AR-13324. With respect to manufacture of Product(s) under this Agreement, B&L and AERIE will also enter into a separate Quality Agreement. If the terms of this Agreement and the Quality Agreement conflict, the terms of this Agreement shall control for the explicit purposes of Supply of Product(s). B. Ingredients, Supplies and Packaging Materials. B&L agrees to supply at its expense all of the raw materials (excluding the active ingredient, AR-13324 which will be supplied by AERIE), in accordance with the Specifications for the Product that are necessary to manufacture and supply the Product(s). B&L agrees to supply at its expense all of the packaging materials necessary to manufacture and supply the Product(s) as set forth in Appendix C. C. Testing and Inspection of Materials. B&L shall analyze and evaluate all materials to confirm that they satisfy the mutually agreed upon material specifications. The cost of all such analyses and evaluations shall be borne by B&L. AERIE shall be liable for all obsolete materials due to forecasting errors, FDA changes or changes required by the customer. D. Testing and Inspection of Product. B&L shall conduct all quality control and other tests required to ensure that the Product(s) as manufactured meet the mutually agreed upon product specifications. The cost of all such analyses and evaluations shall be borne by B&L. During the commercial phase of the project, B&L shall conduct stability testing on one (1) lot for each fill size of the Product(s) annually, and shall provide AERIE with on-going stability reports. The cost of all such analyses and evaluations shall be borne by B&L. B&L will place each of the Validation Batches into AERIE defined stability studies and will provide interim stability reports to AERIE, including statistical analyses where appropriate, as requ...
