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. No change in the Specifications shall be implemented by Cardinal Health, whether requested by Reliant 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. Cardinal Health shall respond promptly to any request made by Reliant 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. If after initial Product qualification, Reliant requests a change in the Specifications for its own benefit or to comply with the requirements of a Regulatory Authority, the Specifications shall be amended as soon as [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. possible after a request is made for any change in Specifications, and Cardinal Health shall notify Reliant of the costs associated with such change and shall provide such supporting documentation as Reliant may reasonably require. Reliant shall pay all costs associated with such Reliant-requested changes or changes required by a Regulatory Authority as may be agreed upon by the Parties. Changes, agreed to between the Parties, for the benefit of Cardinal Health, shall be at the expense of Cardinal Health. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control.

Appears in 4 contracts

Samples: Manufacturing and Packaging Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing and Packaging Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing and Packaging Agreement (Reliant Pharmaceuticals, Inc.)

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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. No change in the Specifications shall be implemented by Cardinal Health, whether requested by Reliant 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. Cardinal Health shall respond promptly to any request made by Reliant 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. If after initial Product qualification, Reliant requests a change in the Specifications for its own benefit or to comply with the requirements of a Regulatory Authority, the Specifications shall be amended as soon as [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. possible after a request is made for any change in Specifications, and Cardinal Health shall notify Reliant of the costs associated with such change and shall provide such supporting documentation as Reliant may reasonably require. Reliant shall pay all costs associated with such Reliant-requested changes or changes required by a Regulatory Authority as may be agreed upon by the Partiesparties. Changes, agreed to between the Partiesparties, for the benefit of Cardinal Health, shall be at the expense of Cardinal Health. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

Appears in 3 contracts

Samples: Manufacturing and Packaging Agreement, Manufacturing and Packaging Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing and Packaging Agreement (Reliant Pharmaceuticals, 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. No change in the Specifications shall be implemented by Cardinal HealthPROVIDER, whether requested by Reliant CUSTOMER 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. Cardinal Health PROVIDER shall respond promptly to any request made by Reliant CUSTOMER 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. If after initial Product qualification, Reliant CUSTOMER requests a change in the Specifications for its own benefit or to comply with the requirements of a Regulatory Authority, the Specifications shall be amended as soon as [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. possible after a request is made for any change in Specifications, and Cardinal Health PROVIDER shall notify Reliant CUSTOMER of the costs associated with such change and shall provide such supporting documentation as Reliant CUSTOMER may reasonably require. Reliant CUSTOMER shall pay all costs associated with such Reliant-CUSTOMER's requested changes or changes required by a Regulatory Authority as may be agreed upon by the Parties. Changes, agreed to between the Parties, for the benefit or at the request of Cardinal HealthPROVIDER, shall be at the expense of Cardinal HealthPROVIDER. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall controlprevail.

Appears in 2 contracts

Samples: Tech Transfer, Manufacturing and Supply Agreement (RedHill Biopharma Ltd.), Tech Transfer, Manufacturing and Supply Agreement (RedHill Biopharma Ltd.)

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. No change in the Specifications shall be implemented by Cardinal HealthCatalent, whether requested by Reliant 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 changechange (including any change to Unit Pricing). Cardinal Health Catalent shall respond promptly to any request made by Reliant 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. If after initial Product qualification, Reliant requests a change in the Specifications for its own benefit or to comply with the requirements of a Regulatory Authority, the Specifications shall be amended as As soon as [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. possible after a request is made for any change in Specifications, and Cardinal Health Catalent shall notify Reliant Client of the costs associated with such change and shall provide such supporting documentation as Reliant Client may reasonably require. Reliant Client shall pay all costs associated with such Reliant-requested changes or changes required by a Regulatory Authority as may be agreed upon by changes except to the Parties. Changes, agreed extent such change is primarily attributable to between the Parties, for the benefit of Cardinal Health, shall be at the expense of Cardinal HealthCatalent’s own business needs. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment; provided, however, Catalent agrees to effectuate such changes promptly after such amendment.

Appears in 1 contract

Samples: Commercial Supply Agreement (Adamas Pharmaceuticals Inc)

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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. No change in the Specifications shall be implemented by Cardinal HealthAQUA THIRST, whether requested by Reliant PROTON 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. Cardinal Health AQUA THIRST shall respond promptly to any request made by Reliant PROTON 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. If after initial Product qualification, Reliant requests qualification PROTON requires a change in the Specifications for its own benefit or to comply with the requirements of a any Regulatory Authority, the Specifications shall be amended and as soon as [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. possible after a request is made for any change in Specifications, and Cardinal Health AQUA THIRST shall notify Reliant PROTON of the costs associated with such change and shall provide such supporting documentation as Reliant PROTON may reasonably require. Reliant PROTON shall pay all costs associated with such ReliantPROTON-requested or regulatory required changes. Agreed changes or changes required by a Regulatory Authority as may be agreed upon by to the Parties. Changes, agreed to between the Parties, Specifications for the benefit of Cardinal Health, PROTON shall be at the expense of Cardinal HealthPROTON. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control.

Appears in 1 contract

Samples: Manufacturing and Packaging Agreement (Proton Laboratories Inc)

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