Additional Manufacturer Sample Clauses

Additional Manufacturer. If an additional site pursuant to Section 3.5(c)(i) does not resolve the Supply Interruption, then CyDex shall use its good faith efforts to qualify one or more alternate suppliers for the manufacture of Captisol as soon as practicable, but in any event within 90 days from the first day of the Supply Interruption.
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Additional Manufacturer. If an additional site pursuant to Section 3.6(c)(i) does not resolve the Supply Interruption, then CyDex shall use its good faith efforts to qualify or re-qualify one or more alternate suppliers at its own cost for the manufacture of Commercial Grade Captisol as soon as practicable, but in any event within [***] ([***]) days from the first day of the Supply Interruption. If CyDex is unable to resolve such Supply Interruption within [***] ([***]) days after the first day of the Supply Interruption or has not taken steps within such time period likely to resolve such Supply Interruption pursuant to Sections 3.6(c)(i) or (ii), then Spectrum shall additionally have the non-exclusive right and license, notwithstanding Section 2.1(c) of the License Agreement, to make (by Spectrum or its Affiliates) or have made (by a Contract Manufacturer via sublicense, other than the Third Party Manufacturer) quantities of Captisol, necessary to replace quantities of Commercial Grade Captisol not provided by CyDex due to the Supply Interruption, for use in the Licensed Product. After CyDex resumes manufacture and supply of Captisol, Spectrum shall use its best efforts to resume purchase of up to [***] of its requirements of Captisol from CyDex but in no event shall Spectrum have any obligation to terminate the supply arrangement with any such Third Party. Any transfer of CyDex’s Captisol manufacturing technology (which shall not include technology which is proprietary to the Third Party Manufacturer or Pfizer) to Spectrum or its Contract Manufacturer shall be subject to contractual covenants reasonably satisfactory to CyDex regarding confidentiality, limitations on use and non-competition. In the event of a dispute between the parties as to whether or not a Supply Interruption has occurred, such dispute shall be finally resolved by short-form arbitration in accordance with Section 14.4(b) of the License Agreement.
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Related to Additional Manufacturer

  • Additional Products Upon satisfying the minimum order requirements above, Enrolled Affiliate may order Additional Products.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Equipment, Etc Each Grantor shall, (i) within ten (10) days after a written request by the Administrative Agent, in the case of Equipment now owned, and (ii) following a request by the Administrative Agent pursuant to subclause (i) above, within ten (10) days after acquiring any other Equipment, deliver to the Administrative Agent, any and all certificates of title, and applications therefor, if any, of such Equipment and shall cause the Administrative Agent to be named as lienholder on any such certificate of title and applications. No Grantor shall permit any such items to become a fixture to real estate or an accession to other personal property unless such real estate or personal property is the subject of a fixture filing (as defined in the UCC) creating a first priority perfected Lien in favor of the Administrative Agent.

  • Product Quality 4.1 The following provisions shall apply to Product after Production:

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • 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.

  • Additional Equipment Additional Equipment may from time to time be added as the subject matter of this Agreement as agreed on by the parties. Any additional property will be added in an amendment describing the property, the monthly rental, security deposit, and stipulated loss value of the additional Equipment. All amendments must be in writing and signed by both parties. Other than by this amendment procedure, this Agreement may not be amended, modified, or altered in any manner except in writing signed by both parties.

  • Product Supply The Parties shall reasonably cooperate and assist each other in transferring ownership of Product drug product and/or Product drug substance (such material, CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. collectively, the “Product Lots”) set forth in Exhibit A attached hereto as promptly as reasonably practicable following the Effective Date; provided, however, that neither Party shall be required to pay money to any Third Party, commence any litigation with, or offer or grant any accommodation (financial or otherwise) to any Third Party. Such Product Lots shall be delivered EXW (Ex Works) (Incoterms 2010) AMGEN, Thousand Oaks, California. Any expense for shipment shall be borne by AKERO (including any import or export duties or taxes). Subject to the terms of this Section 5.4 and Section 6.2 (Additional AMGEN Warranties), AMGEN transfers the Product Lots to AKERO “as is”, and makes no other representation to AKERO in connection therewith. The Parties have entered into a Quality Agreement substantially in the form attached hereto as Exhibit F, dated as of the date hereof, governing the quality of the Product Lots to be supplied pursuant to this Section 5.4. For the avoidance of doubt, Product Lots consisting of drug product as set forth in Exhibit A supplied pursuant to this Section 5.4 shall be labeled for their intended clinical use as set forth in Exhibit A and the labeling of any Product drug product manufactured after the Effective Date shall be the responsibility of AKERO. Except for the Licensed Materials and such Product Lots to be transferred to AKERO, AKERO shall be responsible for, and shall bear the cost of, obtaining (whether by manufacturing or causing to be manufactured) research, clinical and commercial supplies of the Product. From and after the Effective Date, AKERO shall be responsible for all costs and expenses in connection with the storage of, and any stability studies performed on, the Product Lots.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time.

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