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. 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. 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. 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 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. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
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 Current Material or Commercial Materials, equipment, processes or procedures used to manufacture the Current Material or Commercial Materials. Supplier shall disclose all such proposed changes in such manufacturing Current Material or Commercial 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. 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. 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. SSCI shall notify McDATA immediately in writing of any proposed change which would materially impact any manufacturing process, or use of equipment. McDATA requires advance notice of and must approve any and all changes that will affect Product quality or field reliability.
Change in Manufacturing Process. Supplier shall obtain SGI’s prior written approval, which approval shall not be unreasonably withheld, before it implements any change in the materials, equipment, process or procedures used to manufacture Products that would constitute a significant deviation under cGMP as described in the Quality Understanding Document. Supplier shall disclose all proposed changes in such manufacturing materials, equipment, process or procedure to SGI at a level sufficient to allow SGI to practice such changed manufacturing process.
Change in Manufacturing Process. AFC shall obtain GSL’s prior written approval, per the Notification Policy (October 5, 2001), before implementing any planned change in the materials, equipment, process, or procedures used to manufacture the Product that would constitute a major change under cGMP, or that would constitute noncompliance with the manufacturing process set forth in the Contract Manufacturing Manual. AFC shall disclose all proposed changes in such manufacturing materials, equipment, process, or procedure to GSL at a level sufficient to allow GSL to practice such changed manufacturing process. GSL shall notify AFC of any change in the materials, equipment, process, analytical methods, specifications, or procedures to be used in the manufacture of the Product in writing, by means of timely updates to the Contract Manufacturing Manual, identical copies of which reside at AFC and GSL. AFC shall provide GSL 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 described in the Contract Manufacturing Manual, as well as any extra costs resulting from the implementation of such change, shall be borne by [*]. However, the Parties recognize the pricing agreed in Exhibit A reflect implementation of the process developed by AFC and GSL during 2007-2008, which, at the time of this agreement, is not represented in the Contract Manufacturing Manual. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
