Common use of Changes to Specifications Clause in Contracts

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 Packaging process shall be deemed a Specification change. No change in the Specifications shall be implemented by PCI, whether requested by 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 Pricing). 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, 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. PCI reserves the right to postpone effecting changes to the 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)

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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 Packaging process Process shall be deemed a Specification change. No change in the Specifications shall be implemented by PCICatalent, whether requested by Client, requested by PCI 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). PCI 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, PCI 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. PCI Catalent reserves the right to postpone effecting changes to the Specifications, or in the case of changes requested or required by any Regulatory Authority postpone Packaging under this Agreement, Specifications until such time as the parties agree to and execute the required written amendment.

Appears in 3 contracts

Samples: Commercial Supply Agreement, Commercial Supply Agreement (Kala Pharmaceuticals, Inc.), Commercial Supply Agreement (Kala Pharmaceuticals, 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 Packaging process shall be deemed a Specification change. No change in the Specifications shall be implemented by PCICatalent, whether requested by Client, requested by PCI 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. PCI 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, PCI 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. PCI Catalent reserves the right to postpone effecting changes to the Specifications, or in the case of changes requested or required by any Regulatory Authority postpone Packaging under this Agreement, 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 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 Packaging process Process shall be deemed a Specification change. No change in the Specifications shall be implemented by PCICatalent, whether requested by Client, requested by PCI 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). PCI 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, PCI 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. PCI Catalent reserves the right to postpone effecting changes to the Specifications, or in the case of changes requested or required by any Regulatory Authority postpone Packaging under this Agreement, Specifications until such time as the parties agree to and execute the required written amendment.

Appears in 1 contract

Samples: Zydis® 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 Packaging process Process shall be deemed a Specification change. No change in the Specifications shall be implemented by PCICatalent, whether requested by Client, requested by PCI 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). PCI 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, PCI 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. PCI Catalent reserves the right to postpone effecting changes to the Specifications, or in the case of changes requested or required by any Regulatory Authority postpone Packaging under this Agreement, Specifications until such time as the parties agree to and execute the required written amendment.

Appears in 1 contract

Samples: Supply Agreement (Avadel Pharmaceuticals PLC)

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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 Packaging process shall be deemed a Specification change. No change in the Specifications shall be implemented by PCICoreRx, whether requested by Client, requested by PCI 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”). PCI 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, PCI 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. PCI CoreRx reserves the right to postpone effecting changes to the Specifications, or in the case of changes requested or required by any Regulatory Authority postpone Packaging under this Agreement, 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 from time to time shall be in writing, dated and signed by the parties. Any change to the Packaging process Process requested in writing by Client shall be deemed a Specification change. No change in the Specifications shall be implemented by PCICatalent, whether requested by Client, requested by PCI 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). PCI 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, PCI 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. PCI Catalent reserves the right to postpone effecting changes to the Specifications, or in the case of changes requested or required by any Regulatory Authority postpone Packaging under this Agreement, Specifications until such time as the parties agree to and execute the required written amendment.. * Confidential treatment requested; certain information omitted and filed separately with the SEC. EXECUTION COPY ARTICLE 9

Appears in 1 contract

Samples: Commercial Manufacturing Agreement (Salix Pharmaceuticals LTD)

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