CHANGES IN SPECIFICATIONS Sample Clauses

CHANGES IN SPECIFICATIONS. If at any time, Client desires to make any changes or variations from the script(s) or storyboard(s) in the Specified Media(s) or from any material or work in progress, and such changes result in additional costs to Producer, Producer agrees to notify the Client of the amount before any such additional costs are incurred and Producer shall proceed only after receiving approval (written or oral) from Authorized Representative, approval by Client shall be binding and incorporated into the terms of this Agreement. Reimbursement for such additional costs shall be payable in accordance with the terms of this Agreement for final payment.

CHANGES IN SPECIFICATIONS. If at any time, the Client desires to make any changes or variations from the completed project, script(s) or storyboard(s) in the Outputs or from any material or work in progress, and such changes result in additional costs to the Company, including person hours, reimbursement for such additional costs shall be payable in accordance with the terms for final payment.

CHANGES IN SPECIFICATIONS. (i) Alexza may, without Teva’s approval, but in any event with notification to Teva, change the Specifications to reflect any changes currently in process as of the Effective Date. Thereafter, Alexza may request a change in the Specifications; provided that, Alexza shall not make any changes to the Specifications without Teva’s prior written approval, which approval shall not be unreasonably withheld or delayed. In the event that such proposed change requires the [ * ] of the [ * ], the Parties shall coordinate and collaborate in [ * ] and Alexza shall not implement any such change unless and until [ * ] is [ * ]. Notwithstanding the foregoing, if any change to the Specification requested by Alexza would not require any change to the Product NDA or any Regulatory Approvals in the U.S. or require the submission of a Regulatory Approval application supplement in the U.S., Alexza shall promptly notify Teva of such change through the Manufacturing JPT. [ * ] shall be solely responsible for all costs (including both implementation and [ * ] costs and expenses) incurred in connection with any changes requested by Alexza, except to the extent otherwise agreed by the Parties. (ii) Each Party shall promptly notify the other Party of any change of the Specifications that is required by the FDA or in order to comply with any Regulatory Requirement applicable to the Product for use or sale in the Field in the U.S. Any such changes shall be implemented at Teva’s sole expense unless such Specification changes are also CMC changes and such CMC changes would apply to other APIs and not the Drug specifically, in which case, such CMC changes shall be implemented at Alexza’s sole expense. In consultation with Teva, Alexza shall, promptly make all such regulatory required changes to the Specifications and the Parties shall coordinate and collaborate in making all necessary Regulatory Filings with the FDA to effect such change. Alexza shall compile and provide to Teva the necessary information required to support any such Regulatory Filing in the format reasonably requested by Teva, and shall provide all necessary technical assistance and services to Teva. Teva shall be responsible for making such Regulatory Filing and paying filing fees required for such Regulatory Filing. [ * ] = 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, a...

CHANGES IN SPECIFICATIONS. In case AHM notifies Researchers that AHM desires to change the Research, Researchers shall use their reasonable efforts to accommodate the requested changes.

CHANGES IN SPECIFICATIONS. Each Party shall promptly notify the other Party of (i) any change of the Specifications as well as any analytical methods that is required by any Regulatory Authority or in order to comply with any Regulatory Requirement, and/or (ii) any other material modifications to the Manufacturing process, applicable to the Product for use in the Field in the Territory, and the Parties shall discuss such change of Specifications, analytical methods and/or other material modification to the Manufacturing process prior to its implementation. (i) Prior to the receipt of the first Marketing Approval of the Product for the Territory, [ * ]. (ii) After the receipt of the first Marketing Approval of the Product for the Territory, such regulatory required Specification changes that are not conditions to the receipt of the first Marketing Approval of the Product for the Territory shall, [ * ] and the Parties shall coordinate and collaborate in making all necessary Regulatory Filings with the application Regulatory Authority in the Territory to effect such change. Grünenthal shall be responsible for making such Regulatory Filing in the Territory and paying filing fees required for such Regulatory Filing.

CHANGES IN SPECIFICATIONS. 4.6.1 TRANSMEDICS shall have the right to make other changes to the Product Specifications, the Material Specifications, and the Testing Specifications (collectively, the “Specifications”) at any time. Any increase in costs for the manufacture of the Products by FRESENIUS as a result of such changes in the Specifications as well as any FRESENIUS internal and out-of-pocket cost to implement said changes by FRESENIUS shall be borne by TRANSMEDICS. FRESENIUS shall advise TRANSMEDICS of such cost prior to implementation of the changes to the Specifications requested by TRANSMEDICS and FRESENIUS shall not commence to implement any such changes or incur any costs until TRANSMEDICS has given its written authorization to do so. The Parties shall further agree on a reasonable time schedule for the implementation of said changes. 4.6.2 TRANSMEDICS shall reimburse FRESENIUS for the reasonable costs related to new labels, package inserts or packaging materials or changes to existing labels, package inserts, or packaging materials that are requested by TRANSMEDICS. 4.6.3 TRANSMEDICS shall reimburse FRESENIUS for direct costs of inventories and for costs of destruction thereof, of manufacturing materials, including printed materials, which become obsolete due to changes in Specifications made at the request of TRANSMEDICS. 4.6.4 FRESENIUS may make changes to the Manufacturing Process only with the prior written consent of TRANSMEDICS. Any increased costs resulting from any changes to the Manufacturing Process arising from a request from FRESENIUS shall be borne by FRESENIUS. Unless subject to section 14.1, any benefit arising from a request by FRESENIUS shall be to the benefit of FRESENIUS. 4.6.5 The Parties shall cooperate to determine an appropriate qualification protocol for all changes to Product Specifications. 4.6.6 The Parties shall determine an appropriate inventory level of pre-change Products in order to cover on-going requirements during the qualification process.

CHANGES IN SPECIFICATIONS. If at any time, Client desires to make any changes or variations from the script(s) or storyboard(s) in the Specified Media(s) or from any material or work in progress, and such changes result in additional costs to Producer, reimbursement for such additional costs shall be payable in accordance with the terms of this Agreement for final payment.

CHANGES IN SPECIFICATIONS. All Products shipped by Triax to OMP shall conform to the existing Specifications. The Specifications may be amended or otherwise changed from time to time only by written agreement of Triax and OMP.

CHANGES IN SPECIFICATIONS. Buyer reserves the right at any time to make changes in drawings and specifications as to any material and/or work covered by this offfer. Any difference in price or time for performance resulting from such changes shall be adjusted to a mutually agreed upon amount and the Contract shall be modified in writing accordingly. Any claim by Seller for adjustment under this clause shall be deemed waived unless asserted in writing within thirty (30) days from receipt by Seller of the change. Any changes must be issued in writing and signed by an authorized representative of Buyer. Seller must notify Buyer if there will be any additional costs or delays on account of such changes.

CHANGES IN SPECIFICATIONS. In the event that an amendment to the Specifications, the Manufacturing process, or the test methods for the Crofelemer Animal API is (i) required in writing by any Regulatory Authority, or (ii) requested by Jaguar, Jaguar promptly shall provide Glenmark with appropriate documentation relating to any such changes to the Specifications or Manufacturing process to the extent that such changes affect Glenmark’s Manufacturing of the Crofelemer Animal API hereunder. If the requested changes can be made without modification to the existing process capability, Glenmark shall implement such changes in accordance with the change control procedures applicable under GMP and per agreement between the Parties regarding the timing of the changes. It shall be within Glenmark’s sole discretion to determine whether or not the requested change can be made without modification to the existing process capability. In the event that Glenmark determines that the requested change cannot be made without modification to the existing process capability, then Glenmark, in its sole discretion, shall have the right to reject any request for changes to the Specifications or Manufacturing process. Glenmark shall not, in any respect, amend, modify or supplement the Specifications, the Manufacturing process, or the test methods for the Crofelemer Animal API or any Jaguar-Supplied CPL or sources of Jaguar-Supplied CPL used in connection with Manufacturing the Crofelemer Animal API without the prior written consent of Jaguar.