Change in Manufacturing Process. XOMA shall obtain Onyx's prior written approval before it implements any change in the materials, equipment, process or procedures used to manufacture Drug Substance that would constitute a major change under cGMP.
Change in Manufacturing Process. PPG shall obtain GWM’s prior written approval before implementing any planned change in the materials, equipment, process, or procedures used to manufacture the Product that would constitute a change under cGMP, would impact the validation status of the process, or would constitute noncompliance with the manufacturing process set forth in the Contract Manufacturing Manual. PPG shall disclose all proposed changes in such manufacturing materials, equipment, process, or procedure to GWM at a level sufficient to allow GWM to practice such changed manufacturing process. GWM shall notify PPG in writing with reasonable notice of any change in the materials, equipment, process, analytical methods, specifications, or procedures to be used in the manufacture of the Product whether such changes are to be reflected as updates to the Contract Manufacturing Manual or otherwise. PPG shall provide GWM with an authentic copy of the current Master Batch Record for the preparation of the Product. The cost of implementing any amendment or change of whatever nature to the procedures or specifications described in the Contract Manufacturing Manual as it exists on the Effective Date of this Agreement, as well as any extra costs resulting from the implementation of such change, shall be borne by [*] through an [*] which the Parties shall negotiate in good faith.
Change in Manufacturing Process. AFP shall provide prior written notice to MannKind before AFP implements any change in the materials, suppliers, contract laboratories, equipment, processes, procedures, or test methods used to manufacture the Product, but only to the extent that such changes affect AFP’s United States Drug Master File of the Product or any other regulatory filing throughout the Territory. If MannKind does not notify AFP of an objection within ten (10) business days of receipt of AFP’s notice and, as far as AFP is aware having made due inquiry, such change would not require approval or notification of the applicable regulatory authorities with respect to the MannKind Product, then AFP may proceed with the change without the prior written approval of MannKind. If MannKind notifies AFP ***Confidential Treatment Requested within such ten (10) business day period that such change would require approval or notification of the applicable regulatory authorities with respect to the MannKind Product, then AFP shall not make such change without the prior written consent of MannKind, which prior written consent shall not be unreasonably withheld. With respect to any changes that would not require approval or notification of the applicable regulatory authorities in connection with the MannKind Product, if MannKind notifies AFP of an objection to such change within such ten (10) business day period, the Parties will discuss the change in good faith for up to an additional ten (10) business days (or longer, if agreed by the Parties) in the interest of reaching a mutually agreeable resolution; provided, that if agreement is not reached on such change (and that change does not require notification or approval of the applicable regulatory authorities with respect to the MannKind Product) then AFP may proceed with such change following such discussions.
Change in Manufacturing Process. Supplier shall obtain Purchaser’s prior written approval, which shall not be unreasonably withheld, before Supplier implements any change in the Materials, equipment, processes or procedures used to manufacture Materials. Supplier shall disclose all such proposed changes in such manufacturing Materials, equipment, processes or procedures to Purchaser at a level sufficient to allow Purchaser to reasonably evaluate the effect of such changes.
Change in Manufacturing Process. PharmaChem will obtain GWM’s prior written approval before implementing any planned change (including substantial improvements) in the materials, equipment, process, raw material suppliers, analytical methods, or procedures used to manufacture the Product that would constitute a major change under cGMP, would impact the validation status of the process, or may be interpreted to be noncompliant with the manufacturing process set forth in the RAAs or the Contract Manufacturing Manual. PharmaChem will disclose all proposed changes in such manufacturing materials, equipment, process, or procedure to GWM at a level reasonably sufficient to enable GWM to practice such changed manufacturing process. GWM will notify PharmaChem in writing with reasonable notice of any change (including substantial improvements) in the materials, equipment, process, raw material suppliers, analytical methods, specifications, or procedures to be used in the manufacture of the Product whether such changes are to be reflected as updates to the Contract Manufacturing Manual or otherwise, and PharmaChem will implement within a reasonable time as agreed by the Parties. PharmaChem will provide GWM with an authentic copy of the current Master Batch Record for the preparation of the Product. [ * ] will bear any increased costs of implementing any amendment or change of whatever nature to the procedures or specifications described in the RAAs or the Contract Manufacturing Manual as they exist on the Effective Date of this Agreement, as well as any extra costs resulting from the implementation of such change, through an [ * ] which the Parties will negotiate in good faith.
Change in Manufacturing Process. SUPPLIER shall notify McDATA immediately in writing of any proposed significant change which would impact any manufacturing process, or use of equipment. McDATA requires advance written notice of and must approve any and all changes that will affect Product quality or field reliability. Notwithstanding the foregoing, notice of emergency changes not deemed to be significant changes, and which do not affect Product quality, form, fit or function or field reliability, but deemed necessary by SUPPLIER to accommodate manufacturing processes during SUPPLIER’s normal business hours, may be provided to McDATA within [***] ([***])[***]of SUPPLIER’s implementation of such emergency change.
Change in Manufacturing Process. SUPPLIER shall notify Dot Hill immediately in writing of any proposed change in manufacturing process, raw materials, suppliers or other processes or circumstances which has the potential to impact the manufacturing process of the Products, testing of the Products or the Products themselves (“Changed Circumstance”). Dot Hill requires advance notice of and must approve any and all such Changed Circumstances. In Dot Hill’s discretion, Dot Hill may re-qualify the Products in light of the Changed Circumstance(s). If Dot Hill chooses to re-qualify the Products, SUPPLIER will, upon Dot Hill’s request: [...***...].
Change in Manufacturing Process. Organon shall, in accordance with the Quality/Technical Agreement, provide prior written notice to MannKind before Organon implements any major change in the materials, equipment, processes or procedures used to manufacture the Product.
Change in Manufacturing Process. Oakwood shall obtain Edge’s prior written approval before it implements any change in the materials, equipment, facilities, process or procedures used in the Manufacture of Products that would constitute a major change under cGMPs. Oakwood shall disclose all proposed changes in such manufacturing materials, equipment, process or procedure to Edge at a level sufficient to allow Edge to assess the impact of such changes on Edge’s regulatory filings and to update and maintain such regulatory filings accordingly.
Change in Manufacturing Process. Patheon shall notify Gilead if Patheon wishes to make, and obtain Gilead’s prior written approval before Patheon implements, any of the following: (a) a major change (as defined in applicable regulations) including without limitation, major or regulatory changes relating to (i) the Facility that would constitute a change under cGMPs, would impact the validation status of the process, or would constitute noncompliance with the Patheon Manufacturing Responsibilities, (ii) the Materials, (iii) the Specifications, (iv) any quantitative formulae and any other aspect of Drug Product Processing, or (v) testing methods with respect to the Drug Product; and (b) changes that require regulatory submission, relating to the Materials, Specifications, Facility, equipment, process, testing methods or other procedures used to Process any Drug Product. Gilead’s consent with respect to such changes shall not be unreasonably withheld, or unduly delayed; provided, however, that with respect to such changes affecting a particular Drug Product, Patheon acknowledges that Gilead may be required to obtain its licensee’s consent to such changes prior to providing consent to Patheon.
