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.

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.

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.

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.

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

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 Coul▇▇▇'▇ ▇▇▇or written approval, not to be unreasonably withheld. Subsequent to such approval of Coul▇▇▇, ▇▇rdion 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) Coul▇▇▇ ▇▇▇eives 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 Coul▇▇▇ ▇▇▇t the governmental entity in the United States or Canada has authorized or approved the change. Nordion shall cooperate fully with Coul▇▇▇ ▇▇ 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.

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.

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.