APPROVAL FOR MANUFACTURING CHANGES Sample Clauses

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
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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.
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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.
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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. 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.
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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. 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: (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 the Medical Device, and (ii) pSiMedica 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 in Europe, United States or elsewhere, such changes may not be implemented until QSA receives written notice that the governmental entity or entities has or have authorized or approved the change. Each Party shall cooperate fully with the other in preparing data and information for a submission requesting prior authorization or approval of a change in materials, specifications, equipment or methods of production or testing. However, where changes are required to be made at the request of a regulatory body, pSiMedica shall not withhold their agreement to such changes.
Sample 1
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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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Related to APPROVAL FOR MANUFACTURING CHANGES

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

  • 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.

  • Program Changes Contractor agrees to inform the County of any alteration in program or service delivery at least thirty (30) days prior to the implementation of the change, or as soon as reasonably feasible.

  • 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.

  • Staffing Changes The Director’s prior written approval is required for the Consultant to remove, replace or add to any of its staffing identified in Attachment B of an Approved Service Order.

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • PRODUCT AND PRICING CHANGE REQUESTS Supplier may request Equipment, Product, or Service changes, additions, or deletions at any time. All requests must be made in writing by submitting a signed Sourcewell Price and Product Change Request Form to the assigned Sourcewell Supplier Development Administrator. This approved form is available from the assigned Sourcewell Supplier Development Administrator. At a minimum, the request must: • Identify the applicable Sourcewell contract number; • Clearly specify the requested change; • Provide sufficient detail to justify the requested change; • Individually list all Equipment, Products, or Services affected by the requested change, along with the requested change (e.g., addition, deletion, price change); and • Include a complete restatement of pricing documentation in Microsoft Excel with the effective date of the modified pricing, or product addition or deletion. The new pricing restatement must include all Equipment, Products, and Services offered, even for those items where pricing remains unchanged. A fully executed Sourcewell Price and Product Change Request Form will become an amendment to this Contract and will be incorporated by reference.

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