Required Manufacturing Changes. Each Party shall give the other Party reasonable written notice prior to any changes to the process of Manufacturing Supplied Product for sale in the Buyer Territory that are required by cGMP or other applicable Law (collectively, “Required Manufacturing Changes”). The Party required by cGMP or other applicable Law to make Required Manufacturing Changes shall use commercially reasonable efforts to carry out such Required Manufacturing Changes and the other Party shall, where required, reasonably assist in carrying out such changes.
Required Manufacturing Changes. For changes to the Specifications or manufacturing processes that are required by Applicable Laws (collectively “Required Manufacturing Changes”), Aventis and Purchaser shall cooperate in making such changes and use commercially reasonable efforts to implement such changes in compliance with such Applicable Laws and as promptly as practicable. Notwithstanding the foregoing, Aventis’ standard change control procedures shall be utilized in reviewing such changes.
Required Manufacturing Changes. Provided that GTX furnishes Orion with evidence of Required Manufacturing Changes, Orion shall commence the implementation of Required Manufacturing Changes as soon as practicable, but in no event later than (i) ninety (90) days after receipt of GTX’s request (or within such other longer time period as may be mutually agreed upon by the Parties if implementation within ninety (90) days is impossible or reasonably impractical, such agreement not to be unreasonably withheld, condition or delayed by GTX) or (ii) earlier if required by the U.S. FDA or any corresponding regulatory authority in a Major Country. If Orion does not commence the implementation of Required Manufacturing Changes within the time period referenced in the preceding sentence or does not notify GTX in writing that Orion disputes whether GTX’s requested changes are Required Manufacturing Changes, then GTX shall have the option to exercise standby manufacturing rights for Toremifene and Product pursuant to Section 15.1 until such time as Orion implements such Required Manufacturing Changes. If Orion notifies GTX in writing that Orion disputes whether GTX’s requested changes are Required Manufacturing Changes, the Parties shall resolve such dispute by reference to a mutually agreed upon independent Third Party regulatory expert as soon as possible for a binding determination of whether the requested changes are Required Manufacturing Changes. If such independent Third Party regulatory expert determines that GTX’s requested changes are Required Manufacturing Changes, Orion shall implement such changes as soon as possible. Any modification to the Specifications that is necessary to implement or reflect a Required Manufacturing Change shall be deemed to be included in the Specifications, and any Products manufactured thereunder by Orion shall be deemed Orion Products.
Required Manufacturing Changes. Each Party shall notify the other Party of any Technical Change which is required by cGMPs or Applicable Laws (a “Required Manufacturing Change”). Upon approval by Client, WuXi Biologics shall use Commercially Reasonable Efforts to promptly implement Required Manufacturing Changes in accordance with the change control provisions set forth in the Quality Agreement.
Required Manufacturing Changes. Each Party shall give the other Party reasonable written notice prior to any changes to the Specifications, process of Manufacturing, or other change, as applicable, with respect to the Supplied Materials, in each case that are required by cGMPs or Applicable Laws or a Regulatory Authority (collectively, “Required Manufacturing Changes”). PharmaZell shall use commercially reasonable efforts to promptly implement such Required Manufacturing Changes. PharmaZell shall ensure that any change in any of the foregoing shall, in each case, comply with cGMPs and all Applicable Laws. PharmaZell and Intercept will jointly discuss the cost resulting from such changes.
Required Manufacturing Changes. With respect to changes to the Specifications or manufacturing process which are required by applicable Laws, Rules and Regulations or by action (or inaction) of any legally-competent government or other regulatory body or authority, or by medical or scientific concerns as to the toxicity, safety, and/or efficacy of the products (collectively, “Required Manufacturing Changes”), the Parties shall cooperate in making such changes promptly. The cost for Product or Allendale-specific Required Manufacturing Changes shall be borne by the Allendale. Facility and NPI Equipment-related Required Manufacturing Changes shall be borne by NPI. For Product or Allendale-specific Required Manufacturing changes, Allendale shall pay all the costs of all remaining obsolete stock of Products, all inventory of affected raw materials (at NPI actual acquisition cost plus 15%), and all remaining obsolete work in process of products resulting from any such changes. In cooperating in making such changes, Allendale shall be responsible for communicating with regulatory agencies with respect to the health registrations and marketing authorizations for the Products. Required Manufacturing Changes: (i) do not include changes to the labeling only (which are dealt with in Section 5.3 hereof), and (ii) do include changes resulting from or arising out of changes to or withdrawal of third party Materials. Allendale shall be responsible for the costs associated with any required change in sourcing of the active pharmaceutical ingredient, including any regulatory submission charges and process validation costs.
Required Manufacturing Changes. In the event that: (a) the FDA (or other appropriate regulatory authority for countries outside of the United States) or other federal, state or local governmental agency requires changes to NaPro's manufacturing facility or manufacturing process of the Bulk Drug; or (b) changes are required to NaPro's manufacturing facility or manufacturing process of the Bulk Drug to comply with applicable laws and regulations (together with the matters referred to in clause (a), the "Required Changes"), NaPro shall promptly notify Abbott of any such Required Changes. In consultation with Abbott and xxxx Xbbott's prior written approval, which approval shall xxx xe unreasonxxxx xxxhheld or delayed, NaPro shall make all such Required Changes by the date specified by the FDA or other regulatory authority and, if no such date is specified, no later than sixty (60) days after the date of notice of the Required Change. NaPro shall consult with Abbott in connection with Required Changes to coordinate changes with: (x) the other aspects of the Development Program; (ii) the Regulatory Approval; and (iii) the finishing of the Finished Product or marketing of the Finished Product so as to avoid any business interruptions. In the event that NaPro fails to make the Required Changes by the time specified in this Section 8.5.4, Abbott shall have the right to acquire Bulk Drug from a Stand-By Manuxxxxxxing Source. All costs of any Required Changes (including, but not limited to FDA and other regulatory authority approval costs described in Section 8.5.6 and manufacturing and stability runs) shall be the sole responsibility of NaPro.
Required Manufacturing Changes. For changes to the Specifications that are required by a Governmental Authority, the Marketing Authorization or applicable Laws (collectively “Required Manufacturing Changes”), Client and CRL shall cooperate in making such changes and CRL shall implement such changes in compliance with such applicable Laws and as promptly as practicable.
Required Manufacturing Changes. With respect to changes to the Specifications or manufacturing process (but not changes to the labeling only) which are required by the FDA Rules or other applicable laws, rules and regulations, or by action (or inaction) of any Regulatory Authority, or by medical or scientific concerns as to the toxicity, safety, and/or efficacy of the Product (collectively, “Required Manufacturing Changes”), the Parties shall cooperate in reviewing the proposed Required Manufacturing Changes in accordance with the Quality Agreement and shall, thereafter, implement any agreed upon Required Manufacturing Changes in accordance with the Third Party Manufacturer’s change control procedures. ONXEO may not implement major Required Manufacturing Changes without receiving the prior written agreement of DARA. The cost of DARA-specific Required Manufacturing Changes shall be borne by DARA to the extent that such Required Manufacturing Changes are being required as a result of changes in the FDA Rules, any other laws, rules and regulations or conditions affecting the Territory only and no other market. In the event that DARA-specific Required Manufacturing Changes are also required to be made in any other markets of the Product outside of the Territory, ONXEO shall make commercially reasonable efforts to appropriately allocate the cost of such Required Manufacturing Changes to ONXEO’s partners who market and sell the Product in such markets. The cost of facility and/or ONXEO equipment-related Required Manufacturing Changes shall be borne by DARA. For DARA-specific Required Manufacturing changes, DARA shall pay all the costs of all remaining obsolete stock of the Product, all inventory of affected raw materials (at ONXEO’s actual acquisition cost), and all remaining obsolete work in process of the Product resulting from any such changes for the amount of the Product listed in the binding Manufacturing Forecast. In no event shall DARA be responsible for the costs of any DARA-specific Required Manufacturing Change necessitated by the failure of ONXEO or any Third Party Manufacturer to comply with any laws, rules, regulations or Specifications. In cooperating in making such changes, DARA shall be responsible for communicating with Regulatory Authorities with respect to the NDA or other marketing authorizations for the Product in the Territory.
Required Manufacturing Changes. In the event that a Manufacturing Change is requested or required (i) due to a requirement of a Regulatory Authority, or (ii) as necessary to obtain or maintain Regulatory Approval for a Product for use in the Field (each, a “Required Manufacturing Change”), the Parties shall work together in good faith, and Alnylam, or, in the case of the Roche Territory following the Technology Transfer Completion Date, Roche, as applicable, shall use commercially reasonable efforts to make, or cause the applicable CMO to make, such Manufacturing Change.
