Change of API Source or API Manufacturing Process Sample Clauses

Change of API Source or API Manufacturing Process. Cadence will neither change its API source nor any API Manufacturing Process unless and until such change is approved by the FDA and all other Regulating Groups in the Territory for the Product. Cadence agrees to provide written notice to Bxxxxx of any proposed change no later than Cadence’s initial notice to the FDA or any other Regulating Group. Following such written notice to Bxxxxx, Xxxxxx will timely undertake work reasonably required to support Cadence’s filings with the FDA and other Regulating Groups in the Territory to obtain approval for such change. Cadence will reimburse Bxxxxx for all reasonable costs incurred by Bxxxxx directly related to Bxxxxx work performed in support of such API source or API Manufacturing Process change, including but not limited to the cost of new stability studies, submissions to the FDA and any other Regulating Groups and return of unused (if any) API from the prior source or manufactured under prior API Manufacturing Processes. Cadence will pay Bxxxxx in accordance with Sections 4.1.4 and 4.1.6 if such change occurs during the development phase and Section 7.4 if such change occurs during the commercial phase. “API Manufacturing Process” is defined as a process used in the manufacture of API of such a type that a change in such process would require approval by the FDA or other Regulating Groups in the Territory in order to market, sell and distribute the Product in the Territory.
Sample 1
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Change of API Source or API Manufacturing Process. EKR will use commercially reasonable good faith efforts to inform Xxxxxx in writing at least two (2) years in advance of any change in its API source, or any change in its API Manufacturing Process if such change would require approval by the FDA or other Regulatory Authorities in the Territory. EKR will be responsible for requesting approval by the FDA and all other Regulatory Authorities in the Territory for such change in API or API Manufacturing Process. Following written notice to Xxxxxx, Xxxxxx will timely undertake work reasonably required to support EKR’s filings with the FDA and other Regulatory Authorities’ in the Territory to obtain approval for such change in accordance with Section 7.3. EKR will reimburse Xxxxxx in accordance with Section 7.3 for Xxxxxx’x work performed in support of such changes, including but not limited to the cost of new stability studies, submissions to the FDA and any other Regulatory Authorities, unless such change is required due to changes to the Xxxxxx Container, Xxxxxx’x negligence or misconduct, or Xxxxxx’x failure to perform its obligations under this Agreement. For any such changes “required due to Xxxxxx’x negligence or misconduct, or due to Xxxxxx’x failure to perform its obligations under this Agreement, Xxxxxx shall perform such work at its sale cost and expense.
Sample 1
Change of API Source or API Manufacturing Process. Cadence agrees to provide written notice to Xxxxxx of any proposed change to the API source, or any change in the manufacturing process for the API as soon as possible (e.g., upon receipt of notice from their supplier.) Following such written notice to Xxxxxx, the Parties will work together to promptly agree upon a Development Plan with respect to any work reasonably required of Xxxxxx to support Cadence’s filings with the Regulating Groups to obtain approval for such change. Under *** 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. any such Development Plan, Cadence will reimburse Xxxxxx for all reasonable costs incurred by Xxxxxx directly related to work performed by Xxxxxx in support of such API source or API manufacturing process change, including but not limited to the cost of new stability studies, submissions to the FDA and any other Regulating Groups and return of unused (if any) API from the prior source or manufactured under prior API manufacturing processes. Except pursuant to a Development Plan agreed upon by the Parties, Xxxxxx shall not be required to manufacture the Product using API from a new source or API that has been manufactured using an API manufacturing process that has been modified such that approval by the Regulating Groups is required in order to market, sell and distribute the Product in the Territory, unless and until such change is approved by applicable Regulating Groups.
Sample 1

Related to Change of API Source or API Manufacturing Process

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

  • Manufacturing Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.

  • Manufacturing Rights Manufacturing Rights will be governed by Attachment 6.

  • Product Changes IDSI reserves the right to make design and other modifications in the Equipment at any time but shall not be obligated to implement such modifications in Equipment that has previously been delivered.

  • Manufacture (a) Manufacturer shall only manufacture the specific number of Products as requested by Company and at no time shall manufacture excess goods or overruns. Manufacturer shall not sell any Products bearing the Trademarks to any third parties without the express written consent of Company.

  • Offering Process In connection with the Offering, each of the Co-Managers will:

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Specification Changes (a) During the Term, GSK will accept a labeling change from Prometheus as contemplated by this Section 4.2 but otherwise the Parties acknowledge and agree that GSK does not intend to make any material changes (such as packaging design, manufacturing process or similar or related changes) to the existing Product during the Term.

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