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 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. [ * ]. 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: Quality Agreement, Quality Agreement (Intermune 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 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.EXECUTION VERSION

Appears in 1 contract

Samples: Commercial Supply Agreement (Minerva Neurosciences, 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. 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.ARTICLE9

Appears in 1 contract

Samples: Softgel Commercial Supply Agreement (Aurinia 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. 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 1 contract

Samples: Build Out and Commercial Supply Agreement (Pharmacyclics 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 changes 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. In * Confidential treatment requested; certain information omitted and filed separately with 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.SEC. EXECUTION COPY

Appears in 1 contract

Samples: Commercial Manufacturing Agreement (Salix Pharmaceuticals LTD)

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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 changechange (“Change Date”), and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing) (“Change Costs”). 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; provided, however, that in the case of any change that is requested by Client in response to (i) requirements imposed by a Regulatory Authority or Applicable Laws, or (ii) a safety or toxicity issue, the only terms of such change that Catalent may object to are the Change Date, the Change Costs and any requested change that would reasonably be expected to affect Catalent’s other customers or regulatory status, and Catalent shall use commercially reasonable, good faith efforts to resolve any such objection in an expedited 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 reasonable 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 1 contract

Samples: Supply Agreement (Phathom 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. 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 1 contract

Samples: Supply Agreement (Acelrx Pharmaceuticals Inc)

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