Supply of Compound and Product Sample Clauses

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. *
Sample 1Sample 2
AutoNDA by SimpleDocs
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
Sample 1
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:
Sample 1
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.
Sample 1
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.
Sample 1
Supply of Compound and Product. Vanda shall supply Compound and Product to Novartis under the following conditions:
Sample 1
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...
Sample 1
AutoNDA by SimpleDocs
Supply of Compound and Product 
Sample 1Sample 2Sample 3

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 “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • 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 3.1 In accordance with the terms of this Agreement, GENSIA SICOR (through SICOR) shall supply all of PURCHASER'S ordered requirements for Product in bulk form for use by PURCHASER in the Territories in accordance with the provisions of this Agreement. The right and license of PURCHASER to obtain, use and distribute Product (including, without limitation, the right to make or have made Product) from GENSIA SICOR and SICOR shall be (i) non-exclusive in the Non-exclusive Territory, and (ii exclusive in the Exclusive Territory; provided, however, that the rights and licenses set forth in clause (ii) above shall be co-exclusive in each jurisdiction in which GENSIA SICOR (or ALCO or SICOR, as the case may be) has binding written agreements, or binding written commitments that will lead to binding written agreements, to sell Product on the Restatement Date (which is limited to only those [ * ] and the [ * ] with whom GENSIA SICOR has commitments that are in existence on the Restatement Date), but only with respect to such third parties and only until the earlier of expiration or termination of such agreements; and provided, further that GENSIA SICOR shall use all diligent efforts (without any obligation to violate or alter the terms of such agreements existing on the Restatement Date) to provide PURCHASER with exclusive rights and licenses to sell the Products in the Territory as soon as possible. All Product hereunder shall be manufactured at SICOR's GMP facilities at Rho, Italy, the facility identified in Exhibit 9 hereto, the Santxx Xxxility and additional (as necessary and as provided in Section 6 below) GMP qualified facilities that are approved in advance by PURCHASER (which approval will not be unreasonably withheld). In addition, all Product shall be manufactured (A) in accordance with drug substance manufacturing and quality control procedures existing on the Effective Date, which drug substance manufacturing and quality control procedures have been included in manufacturer's Abbreviated Antibiotic Drug Application ("AADA") submitted to the FDA in 1996, and that will be submitted to other Regulatory Authorities in the Territory (which AADA shall include at least the elements set forth in the Drug Master File) in accordance with U.S. FDA current Good Manufacturing Practices, and (B) to the Q/C Specifications. GENSIA SICOR shall cause SICOR to use its diligent efforts to [ * ] in order to produce and supply all Product ordered by Purchaser hereunder and to meet the Product [ * ] that will be set forth in Schedule 1 hereto within [ * ] after the Restatement Date. In addition, GENSIA SICOR agrees to the following (and GENSIA SICOR agrees to cause SICOR to undertake):

  • Existing Products 1. Hardware - Title and ownership of Existing Hardware Product shall pass to Authorized User upon Acceptance.

  • 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.

Time is Money Join Law Insider Premium to draft better contracts faster.