Supply of Compound and Product Sample Clauses

Supply of Compound and Product. Any quantities of Compound and Product to be supplied by one Party to the other Party pursuant to this Section 6.5 will meet applicable Compound or Product specifications. The specifications for the Compound and Products as of the Effective Date attached hereto as Schedule 6.5.4 and shall be amended only upon agreement by the JSC. In addition, all quantities of Compound and Product supplied by one Party to the other Party pursuant to this Section 6.5 will not be misbranded or adulterated. All such Compound and/or Product will be manufactured in accordance with cGMPs; provided, however, that a Party may supply Compound not manufactured in accordance with cGMP if specifically intended for non-human testing activities allocated to the other Party under the Development Plan and as agreed to in writing in advance by such other Party. ****** - Material has been omitted and filed separately with the Commission. 42
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Supply of Compound and Product. Any quantities of Compound or Products (other than Co-Formulation Products) to be supplied by GSK to Amicus pursuant to Section 6.5.4 will meet applicable Compound or Product specifications. The specifications for the Compound and Products (other than the Co-Formulation Product) as of the Effective Date are attached hereto as Schedule 6.5.6. The specifications for the Co-Formulation Product ERT Enzyme shall be agreed upon by the Parties in advance of the conduct of Manufacturing activities for the supply of such Co-Formulation Product ERT Enzyme for use in connection with Co-Formulation Product(s). Each Party shall appoint a representative as a primary point of contact for discussions between the Parties regarding Manufacturing activities and Compound and/or Product specifications under this Agreement. Any quantities of Co-Formulation Products to be supplied by GSK to Amicus pursuant to Section 6.5.4 and/or Section 6.5.5 will meet applicable Co-Formulation Product specifications as mutually agreed upon by the Parties (such Co-Formulation Product specifications together with the Compound and Product specifications set forth on Schedule 6.5.5, the “Specifications”). Neither Party shall make any changes to the Specifications without the other Party’s prior written approval; unless such changes are requested or required by a Regulatory Authority or applicable Laws (“Required Changes”), in which case, GSK may amend the applicable Specifications for the Co-Formulation Product and, upon reasonable prior written notice to Amicus, for any Compound or Products to be supplied by GSK pursuant to Section 6.5.4, and Amicus may amend the applicable Specifications for Compound and Products (other than Co-Formulation Products) for which Amicus is responsible; in each case in order to comply with such Required Changes and provide notice thereof to the other Party; ******. In addition, all quantities of Compound and Products supplied by GSK to Amicus pursuant to this Section 6.5 will not be misbranded or adulterated. All such Compound and Products supplied by GSK to Amicus pursuant to this Section 6.5 will be manufactured in accordance with cGMPs; provided, however, that GSK may supply to Amicus ****** - Material has been omitted and filed separately with the Commission. Compound or Products not manufactured in accordance with cGMP if specifically intended for non-human testing activities allocated to Amicus under the applicable Development Plan and as agreed to in writing i...
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Supply of Compound and Product. (a) It is anticipated that timely development of the Compound and/or a Product will require the manufacture of significant amounts of the Compound and that successful worldwide commercialization of the Compound and/or a Product will require annual production of large quantities of the Compound and/or a Product. As part of the Development Program for the Compound, * the parties also agree to continue to use technically and commercially reasonably efforts to reduce the costs of manufacturing the Compound and a Product throughout the period of commercialization of the Product. The Global Joint Development Committee shall have the authority to make decisions concerning the sourcing of clinical trial supply of the Compound and Products arising out of the Development Program for cancer indications. Roche and Agouron, through the Global Joint Development Committee, agree to cooperate to identify low-cost commercial manufacturing sources for the Compound and/or Products arising out of the Development Program for cancer indications. To assure a continuous supply of the Compound and/or a Product during clinical development and commercialization, Roche and Agouron may also engage one or more third party contract manufacturers for production of the Compound and/or a Product. * (b) All Product is to be manufactured in accordance with the specifications to be determined during development and later attached hereto in Attachment 3 to this Agreement and any amendments thereto. All Product shall be furnished with a certificate of analysis. (c) Each party shall grant the other party a right of reference to the drug master file for a Product in the countries where the other party, its Affiliates or sublicensees are marketing such Product, and shall take all other steps as may be reasonably requested by a manufacturer of such Product for the limited purpose of enabling it to manufacture the Product for such other party. The manufacturer shall manufacture the Product in compliance with the Dossier for the 26
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Supply of Compound and Product. Prior to the exercise or expiration or termination of the Option Right, except as specified in the Development Plan, EVOTEC shall be solely and exclusively responsible at its own expense for, and shall use Commercially Reasonable Efforts to achieve, the clinical and commercial manufacture and supply of Compound and Product for development in the Territory, either by itself or through Third Parties, except if the Parties mutually agree otherwise and the Development Plan is amended accordingly. After the expiration or termination of the Option Right, EVOTEC shall be solely and exclusively responsible at its own expense for, and shall use Commercially Reasonable Efforts to achieve, the clinical and commercial manufacture and supply of Compound and Product for development and sale in the Territory, either by itself or through Third Parties.
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Supply of Compound and Product. Subject to the terms and conditions of this Agreement, Millennium shall exercise its rights under the Third Party Agreements to arrange for the Manufacture of Compound and Product under the terms of the applicable Third Party Agreements and shall perform the services described in the Technical Agreement. Schering shall pay to Millennium the Costs of Goods Shipped for the Manufacture of such Compound and Product.
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Supply of Compound and Product. To the extent ISLT or its Affiliate or Sublicensee is engaged in the manufacture of the Compound or Products as of the date notice of termination is given, ISLT or such Affiliate or Sublicensee shall, at BHV’s option, manufacture and supply BHV’s requirements for the Compound and/or Products from the effective date of such termination until such time as BHV secures an alternative commercial manufacturing source reasonably satisfactory to BHV, or until twenty-four (24) months after the effective date of termination, whichever is earlier. In addition, at BHV’s option, as of the effective date of such termination: (a) ISLT and its Affiliates and Sublicensees shall permit BHV to purchase all or any part of ISLT’s and ISLT’s Affiliates’ and/or Sublicensees’ worldwide unsold inventory of raw materials for the Compound and Products, work-in-progress Compound and Products and finished Compound and Products; (b) ISLT and its Affiliates and Sublicensees shall assign to BHV any Third Party manufacturing contract relating to the Compound and Products to which ISLT or any of ISLT’s Affiliates or Sublicensees is a party (or the applicable provisions thereof, as the case may be). All Products supplied to BHV by ISLT and its Affiliates and Sublicensees pursuant to this Section 17.6 shall be supplied at [***] of ISLT’s or its Affiliates’ or Sublicensees’ cost of goods (as determined in accordance with generally accepted accounting principles in the United States) or [***] of ISLT’s or its Affiliates’ or Sublicensees’ out-of-pocket procurement cost; and (c) BHV shall be responsible for all costs and expenses related to securing an alternative commercial manufacturing source, excluding ISLT’s costs and expenses related to technology transfer from ISLT to such source, which shall be borne by ISLT.
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Supply of Compound and Product 
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Related to Supply of Compound and Product

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

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

  • Product Labeling The labeling of all Licensed Products sold or offered for sale under this Agreement shall expressly state that the Licensed Product is manufactured under a license from the Medicines Patent Pool.

  • Supply of Materials The following materials will be supplied by the department Name of Materials Rate. Place of delivery 1.

  • Supply of Product 4.1 DAEWOONG shall manufacture and supply Product to AEON in a primary packaged and labeled form. Product packaging shall display the logo of DAEWOONG (to the extent required by applicable law) and AEON and the outer label shall be marked using English language in accordance with applicable laws and Product’s Regulatory Approvals. 4.2 AEON’s estimate sales forecast of the Product during the Term of Agreement in the Territory in the Field is set forth in Annex D. Within ninety (90) days after the Effective Date, AEON shall provide DAEWOONG with a non-binding twelve (12) month rolling forecast of its requirements of Product, which the Parties agree is not a commitment to buy any stated quantity. Thereafter, on at least a quarterly basis, AEON shall provide DAEWOONG with an updated twelve (12) month rolling forecast, together with a binding six (6) month forecast to the extent AEON has requested Safety Stock as described in Article 4.10 below. Each such forecast shah be referred to herein as a “Forecast.” 4.3 AEON may from time to time submit Purchase Orders to DAEWOONG for Product in accordance with the forecasting requirements in Article 4.2. Orders will be shipped on CIF Los Angeles port. 4.4 Once a Purchase Order for Product and Product Samples has been received by DAEWOONG, it shall be considered as irrevocable. 4.5 AEON agrees herein to place an Order for Product not later than [***] from receipt of Regulatory Approval. 4.6 Individual Purchase Orders of Product shall be placed at least [***] in advance of the required delivery date. 4.7 For the purpose of Commercialization, AEON will store and maintain the full quantity of Product in a clean, secured area in accordance with the reasonable directions and specifications provided by DAEWOONG in writing in connection thereof in the Territory. AEON will advise DAEWOONG on the applicable requirements specifically deriving from the laws and regulations in the Territory. 4.8 AEON agrees that DAEWOONG and its collaborators and agents, in DAEWOONG’s sole discretion, which collaborators and Agents will be subject to appropriate obligations of confidentiality, will have the right upon reasonable prior notice, to observe and to inspect and to audit AEON’s facility to ascertain compliance by AEON with the terms of this Agreement, including without limitation (a) the holding facilities for Product, and (b) AEON’s compliance with applicable law, including cGMP (if applicable). Following any such audit, DAEWOONG will discuss its observations and conclusions with AEON and corrective actions, if any, will be agreed upon by the Parties, and executed by AEON using Commercially Reasonable Efforts. 4.9 In addition to any other rights and remedies available to AEON, AEON shall have the right to recover lost profits in the event that DAEWOONG fails to deliver at least [***] in any [***] (a “Supply Default Event”). For purposes of this provision, lost profits would be equal to [***] of AEON operating profit (sales less direct expenses and the puce paid by AEON for such Products) on Products that have not been shipped against firm Purchase Orders during the period leading up to the Supply Default Event and bona fide Purchase Orders submitted by AEON that are consistent with the Forecast during the Supply Default Period (as defined below). Such payment shall be made with respect to all Product not shipped in the period giving rise to the Supply Default and for the period until DAEWOONG is again timely shipping Product to meet AEON’s needs (the “Supply Default Period”). The first such payment shall be made within [***] of the Supply Default Event, and every [***] thereafter. AEON agrees to permit full disclosure to DAEWOONG of AEON’s accounting records, solely related to the calculation of lost profits, for the [***] ending on the first day of the month in which the Supply Event Default occurred. In the event that DAEWOONG is unable to supply both AEON’s requirements of Product and its own and third parties’ requirements for Product, DAEWOONG shall allocate Product that DAEWOONG has in inventory and that DAEWOONG is able to Product, so that AEON receives its requirements of Product in priority to DAEWOONG and third parties. 4.10 At the request of AEON, DAEWOONG shall at its own cost and expense during the Term, maintain an amount of inventory of Product equal to AEON’s requirements for Product for [***] based on AEON’s most recent forecast (“Safety Stock”). The Safety Stock shall be (i) maintained for the sole benefit of AEON and its Affiliates, (ii) shall be stored at a secure facility in compliance with GMP, and (iii) shall not be used for the benefit of any other customer of DAEWOONG. DAEWOONG shall rotate the Safety Stock on a “First Expiry-First Out” basis for routine fulfillment of firm orders, subject to Article 7.

  • Existing Products Except as set forth below, Contractor shall retain all rights, title and interest in Existing Products.

  • PRICE LISTS AND PRODUCT INFORMATION Contractors should provide an electronic version of the proposed price list in an Excel format or pdf on a jump drive. Also provide a dealer list, if applicable in an Excel format with "read and write" capabilities on the same jump drive. No costs or expenses associated with providing this information in the required format shall be charged to the State of Arkansas. At the time of contract renewal contractor will furnish OSP with an updated dealer list and published price list.

  • 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.

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