Supply by BTC Sample Clauses

Supply by BTC. BTC shall be responsible for supplying or arranging for the supply of the Product suitable for use by Auxilium in Clinical Trials. All the Product shall be Manufactured in accordance with applicable specifications, all Laws, and shall be subject to the Standard Terms set forth in below. BTC will supply Auxilium, free of charge, with bulk vials containing sufficient quantities of the Product to treat up to five hundred (500) patients per year in Clinical Trials. If Auxilium requires additional clinical supplies, BTC will supply Auxilium with such clinical supplies at its Cost of Goods. Auxilium will be entitled to qualify a back up supplier for the Manufacture of clinical and commercial supplies of Product in the Field (the "Back-Up Supplier ") at any time after the Effective Date. BTC will use Commercially Reasonable Efforts to ensure that such Back-Up Supplier has sufficient know-how to Manufacture Product, including (i) providing all protocols, registration applications and other substantive regulatory documents, including, but not limited to, all data, scientific dossiers and governmental authorizations; (ii) providing access and reference to all regulatory dossiers and filings produced by BTC, its Affiliates and sublicensees relating to the Product; (iii) providing access to BTC Know-How in reasonably satisfactory form, and (iv) providing all technical assistance reasonably requested by the Back-Up Supplier related to the Manufacture of the Product. Auxilium will require that the Back-up Supplier execute a written confidentiality agreement with both Auxilium and BTC, in a form consistent with industry standards, which includes, among other things, an undertaking by the Back-up Supplier to keep confidential the manufacturing information and know-how disclosed to the Back-up Supplier by BTC. In the manufacturing information and know-how disclosed to the Back-up Supplier by BTC. In addition, Auxilium will use reasonable commercial efforts to seek the cooperation of the Back-up Supplier in sharing with BTC and Auxilium information concerning the Manufacture of the Product that Back-up Supplier may acquire in connection with such Manufacture.
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Related to Supply by BTC

  • Termination by Licensor Licensor, at its option, may immediately terminate the Agreement, or any part of Patent Rights, or any part of Field, or any part of Territory, or the exclusive nature of the license grant, upon delivery of written notice to Licensee of Licensor’s decision to terminate, if any of the following occur:

  • Termination by Licensee 10.1 Licensee will have the right at any time to terminate this Agreement in whole or as to any portion of Patent Rights by giving notice in writing to The Regents. Such Notice of Termination will be subject to Article 18. (Notices) and termination of this Agreement will be effective sixty (60) days after the effective date thereof.

  • EVENTS CONSTITUTING MATERIAL BREACH OF AGREEMENT The Applicant shall be in Material Breach of this Agreement if it commits one or more of the following acts or omissions (each a “Material Breach”):

  • Supply Agreement Seller and Buyer, or their Affiliates, shall have executed the Supply Agreement.

  • 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):

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

  • Supply of Products During the term of this Agreement and any extension hereof, the Seller shall sell and supply the products as set out in Schedule 1 hereto (“Products”) to SiPM and SiPM shall buy from the Seller such Products on a non-exclusive basis. The specifications of the Products are set out in Schedule 2 hereto. SUPPLY AGREEMENT - SiPM A Supply Agreement is a document between two parties, a Supplier and a Purchaser. The Supplier can be an individual or business and is the party that " supplies," or sells, the goods to the Purchaser. The Purchaser can also be an individual or a business and is the party that purchases for its use the goods that the Supplier provides.

  • AUDIT OF LICENSED PRODUCT USAGE Contractor shall have the right to periodically audit, no more than annually, at Contractor’s expense, use of licensed Product at any site where a copy of the Product resides provided that: (i) Contractor gives Licensee(s) at least thirty (30) days advance written notice, (ii) such audit is conducted during such party’s normal business hours, (iii) the audit is conducted by an independent auditor chosen on mutual agreement of the parties. Contractor shall recommend a minimum of three (3) auditing/accounting firms from which the Licensee will select one (1). In no case shall the Business Software Alliance (BSA), Software Publishers Association (SPA), Software and Industry Information Association (SIIA) or Federation Against Software Theft (FAST) be used directly or indirectly to conduct audits, or be recommended by Contractor; (iv) Contractor and Licensee are each entitled to designate a representative who shall be entitled to participate, and who shall mutually agree on audit format, and simultaneously review all information obtained by the audit. Such representatives also shall be entitled to copies of all reports, data or information obtained from the audit; and (v) if the audit shows that such party is not in compliance, Licensee shall be required to purchase additional licenses or capacities necessary to bring it into compliance and shall pay for the unlicensed capacity at the NYS Net Price in effect at time of audit, or if none, then at the Contractor’s U.S. Commercial list price. Once such additional licenses or capacities are purchased, Licensee shall be deemed to have been in compliance retroactively, and Licensee shall have no further liability of any kind for the unauthorized use of the software.

  • SHIPPING/RECEIPT OF PRODUCT a. Packaging Product shall be securely and properly packed for shipment, storage and stocking in appropriate, clearly labeled shipping containers and according to accepted commercial practice, without any extra charges for packing materials, cases or other types of containers. The container shall become and remain the property of the Authorized User unless otherwise specified in the Contract documents.

  • Supply Agreements For a period of three years from the consummation of the IPO, Odetics shall not unilaterally terminate or assign its guarantee obligation with respect to any supply agreement pursuant to which it has guaranteed the performance by ATL of ATL's obligations, unless such suppliers have consented to the termination or assignment of such guarantee.

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