Changes to Specifications. All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.
Appears in 4 contracts
Samples: Commercial Supply Agreement, Commercial Supply Agreement (Minerva Neurosciences, Inc.), Commercial Supply Agreement (Kala Pharmaceuticals, Inc.)
Changes to Specifications. All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process Packaging process shall be deemed a Specification change. No change in the Specifications shall be implemented by CatalentPCI, whether requested by Client Client, requested by PCI or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent PCI shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent PCI shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent PCI reserves the right to postpone effecting changes to the Specifications Specifications, or in the case of changes requested or required by any Regulatory Authority postpone Packaging under this Agreement, until such time as the parties agree to and execute the required written amendment.
Appears in 3 contracts
Samples: Commercial Packaging Agreement (Blue Water Acquisition Corp.), Commercial Packaging Agreement, Commercial Packaging Agreement (Neurocrine Biosciences Inc)
Changes to Specifications. 8.1 All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.
Appears in 3 contracts
Samples: Softgel Commercial Supply Agreement, Softgel Commercial Supply Agreement (TherapeuticsMD, Inc.), Softgel Commercial Supply Agreement (TherapeuticsMD, Inc.)
Changes to Specifications. All Specifications Specifications, and any changes thereto change to the Specifications agreed to by the parties from time to time time, shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing)) and any Regulatory Approvals required by Applicable Laws have been obtained. Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good good-faith efforts to agree to the terms of such change in a timely manner. As soon as possible practicable after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changeschanges to the Specifications. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.
Appears in 2 contracts
Samples: Commercial Supply Agreement, Commercial Supply Agreement (Acadia Pharmaceuticals Inc)
Changes to Specifications. All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes[ * ]. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment. In the event the parties are unable to agree upon the terms and conditions of such written amendment, in addition to the termination rights set forth in Article 16, Client shall have the right to terminate this Agreement with [ * ] months written notice to Catalent.
Appears in 2 contracts
Samples: Commercial Manufacturing Agreement, Commercial Manufacturing Agreement (Intermune Inc)
Changes to Specifications. All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process requested in writing by Client shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changeschanges as set forth in a written amendment to the Specifications signed by the parties. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.
Appears in 2 contracts
Samples: Commercial Manufacturing Agreement (Salix Pharmaceuticals LTD), Commercial Manufacturing Agreement (Salix Pharmaceuticals LTD)
Changes to Specifications. All Specifications Specifications, and any changes thereto change to the Specifications agreed to by the parties from time to time time, shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by CatalentCoreRx, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing) and any Regulatory Approvals required by Applicable Laws have been obtained (a “Change Control”). Catalent CoreRx shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good Commercially Reasonable Efforts and good-faith efforts to agree to the terms of such change in a timely manner. As soon as possible practicable after a request is made for any change in Specifications, Catalent CoreRx shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changeschanges to the Specifications. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent CoreRx reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendmentChange Control.
Appears in 1 contract
Samples: Commercial Supply Agreement (Acadia Pharmaceuticals Inc)
Changes to Specifications. All Specifications and any changes thereto agreed to by the parties Parties from time to time shall be in writing, dated and signed by an authorized representative of each of the parties. Any change to the Process shall be deemed a Specification changeParties. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties Parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit PricingPricing necessitated by such change). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties Parties shall use commercially reasonable, reasonable and good faith efforts to agree to the terms of such change in a commercially reasonable and timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client in writing of the increase or decrease in costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Unless otherwise agreed by the Parties in writing, Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties Parties agree to and execute the required written amendment.
Appears in 1 contract
Samples: Commercial Supply Agreement (Acelrx Pharmaceuticals Inc)
Changes to Specifications. All Specifications and any changes thereto agreed to by the parties Parties from time to time shall be in writing, dated and signed by the partiesParties. Any change Impact to the Specifications from any Process change shall be deemed a Specification changeagreed in writing by the Parties, dated and signed by an authorized signatory for each of the Parties. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties Parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Batch Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties Parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties Parties agree to and execute the required written amendment.
Appears in 1 contract
Samples: Build Out and Commercial Supply Agreement (Pharmacyclics Inc)
Changes to Specifications. 8.1 All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith reasonable efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.
Appears in 1 contract
Samples: Softgel Commercial Supply Agreement (Aurinia Pharmaceuticals Inc.)
Changes to Specifications. All Specifications and any changes thereto change to the Specifications agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good good-faith efforts to agree to the terms of such change in a timely manner. As soon as possible practicable after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changeschanges to the Specifications. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.
Appears in 1 contract
Samples: Commercial Supply Agreement (Biohaven Pharmaceutical Holding Co Ltd.)
Changes to Specifications. All Specifications Specifications, and any changes thereto change to the Specifications agreed to by the parties from time to time time, shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good good-faith efforts to agree to the terms of such change in a timely manner. As soon as possible practicable after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changeschanges to the Specifications. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.
Appears in 1 contract
Samples: Manufacturing Preparation and Commercial Supply Agreement (Avadel Pharmaceuticals PLC)