APPROVAL FOR MANUFACTURING CHANGES Sample Clauses

APPROVAL FOR MANUFACTURING CHANGES. Third Party Manufacturing. RIBI agrees not to make changes in any materials, equipment or methods of production or testing used in the Manufacture of the Product that would affect Health Registrations or Product without Schering's prior written approval, which will not be unreasonably withheld or delayed. RIBI shall notify Schering promptly of any such changes that may be required by GMPs or other applicable law, rule or regulation in the Territory or the country of Manufacture. RIBI agrees not to [*] without the prior written consent of Schering, which shall not be unreasonably withheld. Manufacture of Product shall comply with all of the representations and warranties given by RIBI in this Agreement.
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APPROVAL FOR MANUFACTURING CHANGES. Nordion agrees that no changes will be made to any materials, Specifications, equipment or methods of production or testing of any Labelled Drug, without Coulxxx'x xxxor written approval, not to be unreasonably withheld. Subsequent to such approval of Coulxxx, Xxrdion may then make such approved changes in manufacturing procedures, so long as, in any event, (i) such changes are permitted by applicable government regulations and the terms of any licenses, registrations, authorizations, or approvals previously granted by the applicable governmental entity in the United States or Canada with respect to such Labelled Drug and (ii) Coulxxx xxxeives copies of all documentation relating to such approved changes. If the changes require the additional license, registration, authorization, or approval of any applicable governmental entity in the United States or Canada, Nordion may not implement the changes until it receives written notice from Coulxxx xxxt the governmental entity in the United States or Canada has authorized or approved the change. Nordion shall cooperate fully with Coulxxx xx preparing, and will provide all necessary data and information for, a submission requesting authorization or approval of a change in materials, specifications, equipment or methods of production or testing of the Labelled Drug.
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APPROVAL FOR MANUFACTURING CHANGES. Supplier shall ensure that no change is made to the materials, equipment or methods of production or testing used in the Manufacture of API to be supplied to Tonix (including changes therein that would require changes to any regulatory approvals), without Tonix’s prior written approval.
Sample 1
APPROVAL FOR MANUFACTURING CHANGES. APC agrees that no material changes will be made to any materials, Specifications, equipment, methods or protocol of production or testing for the Product, including the Batch Production Record, without Revance’s prior written approval. Subsequent to the prior written approval of the change control request by Revance, APC may then make those changes in manufacturing procedures permitted under Regulatory Standards and this Agreement. In the event that Regulatory Standards enacted after the Effective Date require a change in the manufacturing procedures for Product, the parties will meet
Sample 1
APPROVAL FOR MANUFACTURING CHANGES. I3 agrees that no changes will be made to any materials, Requirements, equipment, Processing or Quality Control Tests without NeoRx's prior written approval. Subsequent to such approval from NeoRx, I3 may then make such approved changes, so long as, in any event, (i) such changes are permitted by applicable governmental regulations and the terms of any licenses, registrations, authorizations or approvals previously granted by the applicable governmental entity with respect to the Product and (ii) NeoRx receives copies of all documentation relating to such approved changes. If the changes require the additional license, registration, authorization, or approval of any applicable governmental entity, I3 may not implement the changes until it receives written notice from NeoRx that the governmental entity has authorized or approved the change. I3 shall cooperate fully with NeoRx in preparing, and will provide all necessary data and information for, a submission requesting authorization or approval of a change in materials, Requirements, equipment, Processing or Quality Control Tests.
Sample 1
APPROVAL FOR MANUFACTURING CHANGES. HCC agrees that no changes will be made to any materials, specifications, equipment or methods of production or testing of any Drug Substance, without Pharmacyclics' prior written approval. Subsequent to such approval of Pharmacyclics, HCC may then make such approved changes in manufacturing procedures, so long as, in any event, (i) such changes are permitted by applicable government regulations and the terms of any licenses, registrations, authorizations, or approvals previously granted by the applicable Governmental Entity with respect to such Drug Substance and (ii) Pharmacyclics receives copies of all documentation relating to such approved changes. If the changes require the additional license, registration, authorization, or approval of any applicable Governmental Entity, HCC may not implement the changes until it receives written notice from Pharmacyclics that the Governmental Entity has authorized or approved the change. HCC shall cooperate fully with Pharmacyclics in preparing, and will provide all necessary data and information for, a submission requesting prior authorization or approval of a change in materials, specifications, equipment or methods of production or testing of the Drug Substance.
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APPROVAL FOR MANUFACTURING CHANGES. QSA agrees that no changes will be made to any materials, Specifications, Equipment, Hot Cell(s) or methods of production or testing the Sources, without pSiMedica's prior written approval. Subsequent to such approval by pSiMedica, QSA may then make such approved changes in manufacturing procedures, so long as in any event:
Sample 1
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APPROVAL FOR MANUFACTURING CHANGES. Becton agrees that no changes will be made to any materials, specifications, equipment or methods of production or testing for the Instrument without Biocircuits' prior written approval. Subsequent to the prior written approval of Biocircuits, such approval not to be unreasonably withheld, Becton may then make those changes in manufacturing procedures permitted by applicable regulations. In the event that government regulations or regulatory authorities enacted after the Effective Date require a change in the manufacturing procedures for the Instrument, the parties will meet promptly to discuss a mutually agreeable way to implement such change.
Sample 1

Related to APPROVAL FOR MANUFACTURING CHANGES

  • Product Changes IDSI reserves the right to make design and other modifications in the Equipment at any time but shall not be obligated to implement such modifications in Equipment that has previously been delivered.

  • Engineering Changes Customer may request that Flextronics incorporate engineering changes into the Product by providing Flextronics with a description of the proposed engineering change sufficient to permit Flextronics to evaluate its feasibility and cost. Flextronics will proceed with engineering changes when the parties have agreed upon the changes to the Specifications, delivery schedule and Product pricing and the Customer has issued a purchase order for the implementation costs.

  • Term SOFR Conforming Changes In connection with the use or administration of Term SOFR, the Administrative Agent will have the right to make Conforming Changes from time to time and, notwithstanding anything to the contrary herein or in any other Loan Document, any amendments implementing such Conforming Changes will become effective without any further action or consent of any other party to this Agreement or any other Loan Document. The Administrative Agent will promptly notify the Borrower and the Lenders of the effectiveness of any Conforming Changes in connection with the use or administration of Term SOFR.

  • Benchmark Replacement Conforming Changes In connection with the use, administration, adoption or implementation of a Benchmark Replacement, the Administrative Agent will have the right to make Conforming Changes from time to time and, notwithstanding anything to the contrary herein or in any other Loan Document, any amendments implementing such Conforming Changes will become effective without any further action or consent of any other party to this Agreement or any other Loan Document.

  • Conforming Changes In connection with the use, administration, adoption or implementation of a Benchmark Replacement, the Administrative Agent will have the right to make Conforming Changes from time to time and, notwithstanding anything to the contrary herein or in any other Loan Document, any amendments implementing such Conforming Changes will become effective without any further action or consent of any other party to this Agreement or any other Loan Document.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Specification Changes (a) During the Term, GSK will accept a labeling change from Prometheus as contemplated by this Section 4.2 but otherwise the Parties acknowledge and agree that GSK does not intend to make any material changes (such as packaging design, manufacturing process or similar or related changes) to the existing Product during the Term.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Regulatory Milestones Celgene shall make the following approval milestone payments to Jounce that are set forth below upon the first achievement by or on behalf of Celgene, its Affiliates or Sublicensees of the regulatory milestone events (“Regulatory Milestone Events”) set forth below with respect to the first Co-Co Product that achieves such event. For clarity, each milestone set forth below shall be due and payable one time only (regardless of the number of Co-Co Products to achieve any such Regulatory Milestone Event). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Regulatory Milestone Event (For the first Co-Co Product that achieves such event) Milestone Payments (in $ millions) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] For each of Paragraphs (1) - (3) of this Exhibit C-1, the Parties understand and agree that in no event will more than one (1) milestone payment be paid with respect to any specific event triggering a payment under this Jounce Lead Co-Co Agreement.

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