Product Manufacture and Supply Sample Clauses
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:
6.1.1 the Parties shall develop a detailed forecasting, supply, access and implementation plan for the supply of the Drug Product and define related operational supply chain management processes to ensure availability and access of the Drug Product in the Field with the consultation, as appropriate, of one or more funding agencies or partners, e.g., the World Health Organisation; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
6.1.2 the Parties will use commercially reasonable endeavours to optimize production costs and will seek opportunities to jointly appoint Manufacturing Sublicensee(s) where possible;
6.1.3 the Parties will give due consideration to the need to ensure continued efficacy and responsible use of the Drug Product and will therefore seek to minimize the number of Sublicensees for Manufacturing;
6.1.4 if the appointment of joint Manufacturing Sublicensee(s) is not possible, each Party will have the right to Manufacture the Drug Product anywhere in the world (and subject to Clauses 7.6 and 7.8 appoint a Sublicensee to do so) and to Commercialise the Drug Product in the countries in its respective Territory for which a Marketing Authorization has been obtained;
6.1.5 each Party shall make reasonably available to nominated representatives of the other Party appropriate personnel to educate and train such representatives in relation to Know How that may be required to Manufacture the Drug Product;
6.1.6 each Party will ensure that any Drug Product is supplied with appropriate instructions for use and neither Party will promote the Drug Product for any use or indication other than those specified in the Marketing Authorisation in the Territory or part thereof from time to time or make any medical or promotional claims regarding the Drug Product other than permitted by law;
6.1.7 each Party will use commercially reasonable endeavours to ensure that the Drug Product is made available at price which is affordable and sustainable in its respective T...
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.
(b) SuperGen shall obtain Finished Product for the U.S. Territory from AVI or from its designated Third Party manufacturer(s).
(c) The Parties shall cooperate to determine manufacturing strategy and objectives for the supply of Compound, Product, and Finished Product consistent with the terms of this Agreement, including but not limited to agreeing in writing on the Specifications within 120 days of the Effective Date, and to qualifying a second manufacturer for the Compound, acceptable to both Parties, as soon as possible after the Effective Date.
(d) Within 12 months prior to the agreed projected Launch of the Product in the U.S. Territory, the U.S. Marketing Board shall establish a sales forecast for such Product specifying the Parties' anticipated requirements of the Finished Product in the U.S. Territory for the 18 months commencing approximately 6 months prior to the anticipated date of Launch (the "U.S. Sales Forecast"). The U.S. Marketing Board shall be responsible for establishing, preparing and updating the U.S. Sales Forecast.
(e) Such Sales Forecasts for the U.S. Territory shall be updated on a quarterly basis so that at the beginning of each calendar quarter, AVI shall have been provided with rolling Sales Forecasts for the twelve (12) month period commencing with the third (3rd) calendar quarter after the date on which such Sales Forecasts are submitted (i.e. approximately 270 days). By way of example only, at the end of the first quarter of a calendar year (assuming the Product has been Launched), the U.S. Marketing Board shall provide AVI with a Sales Forecast of the anticipated requirements of Finished Product for the U.S. Territory for the twelve (12) months consisting of the four quarters of the next calendar year.
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. 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.
5.2 The Parties shall execute a Supply Agreement within [***] in relation to the Product. The Supply Agreement will contain terms consistent with those terms included in Exhibit 5.2 and other commercially reasonable terms mutually agreed to by the Parties.
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...
Product Manufacture and Supply. 14 6. CONSIDERATION........................................................................................... 18 7.
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.
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