Required Manufacturing Changes Clause Samples
The "Required Manufacturing Changes" clause establishes the obligation for a manufacturer to implement specific modifications or updates to its production processes, products, or materials as directed by the other party, typically the buyer or client. This clause details the procedures for requesting changes, the timeframe for implementation, and may address cost allocation or approval requirements. Its core practical function is to ensure that products meet evolving specifications or regulatory requirements, thereby maintaining quality and compliance throughout the manufacturing relationship.
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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. 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. 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, conditioned 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 16.1 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. 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 co-operate in making such changes promptly. NPI may not implement any Required Manufacturing Changes without receiving written agreement in advance from JDS. The cost for authorized Product or JDS- specific Required Manufacturing Changes shall be borne by JDS. Facility and NPI Equipment-related Required Manufacturing Changes shall be borne by NPI. For Product or JDS-specific Required Manufacturing Changes, JDS shall pay all the costs of all remaining obsolete stock of Products, all inventories 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 no event shall JDS be responsible for the costs of any JDS-specific Required Manufacturing Change necessitated by the failure of NPI to comply with any Laws, Rules and Regulations or Specifications. In cooperating in making such changes, JDS 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.
Required Manufacturing Changes. Subject to Section 10.4, Brickell shall bear all costs necessary to implement any changes to the Specifications or the Kaken Manufacturing process required by applicable Law outside the Territory (including changes to cGMP) or by a Regulatory Authority outside the Territory.
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”), Adolor and PII shall cooperate in making such changes and PII 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 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 of effecting Required Manufacturing Changes shall be borne by NPI; provided, however, that if such costs are material and ongoing, Celgene and NPI shall negotiate in good faith a price adjustment to compensate NPI for such material and ongoing costs. In cooperating in making such changes, Celgene shall be responsible for communicating *** - indicates material omitted pursuant to a Confidential Treatment Request and filed separately with the Securities and Exchange Commission. 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. Celgene shall be responsible for the costs associated with any required change in sourcing of the API, including any regulatory submission charges and process validation costs.