SUPPLY OF BULK DRUG SUBSTANCE AND DRUG PRODUCT Sample Clauses

SUPPLY OF BULK DRUG SUBSTANCE AND DRUG PRODUCT. The Joint Commercialization Agreement between the Parties shall, at Nippon Kayaku's option, provide for Nippon Kayaku to supply bulk drug substance on a worldwide basis for a percentage of Net Sales of Products on commercially reasonable terms to be negotiated in good faith by the Parties. In anticipation of this supply arrangement, Nippon Kayaku will provide compounds and formulations of Research Leads for all pre-clinical and clinical studies (including toxicology studies) at a price and on such other commercially reasonable terms to be negotiated in good faith by the Parties, and Nippon Kayaku will ensure that its facilities meet all GMP and GLP standards, maintain DMFs and comply with all regulatory requirements necessary to obtain regulatory and marketing approvals. In the event that Nippon Kayaku does not provide such bulk drug substance and such drug product for all pre-clinical and clinical studies (including toxicology studies), then the foregoing option to supply bulk drug substance on a worldwide basis for a percentage of Net Sales of Products shall lapse and be of no further force or effect.
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SUPPLY OF BULK DRUG SUBSTANCE AND DRUG PRODUCT. NOVARTIS will be responsible for manufacturing and supply of all Bulk Drug Substance, Drug Product Candidates and Drug Product as necessary for the conduct of the Development Plan and for all commercial purposes in the Territory. Pursuant to the provisions of Section 4.7 of the Research Agreement, the parties will agree on reasonable and appropriate measures by which manufacturing previously being undertaken by VERTEX shall be transitioned to NOVARTIS following the exercise of its Development Election with respect to a particular Drug Product Candidate. The objective of both parties will be to accomplish a smooth and timely transition. Any Bulk Drug Substance provided to NOVARTIS during the transition period will be supplied at VERTEX's reasonable Manufacturing Cost.
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SUPPLY OF BULK DRUG SUBSTANCE AND DRUG PRODUCT. With respect to Products developed for indications in the PNS Field, the Parties hereby agree that Nippon Kayaku shall have the exclusive right to manufacture and supply bulk drug substance and finished drug product on a worldwide basis. For purposes of determining the transfer price of bulk drug substance and finished drug product supplied by Nippon Kayaku hereunder, such transfer price shall [***]. Nippon Kayaku's unit transfer price for commercial bulk drug substance and finished drug product shall be no more than [***]. Signal further agrees to grant Nippon Kayaku exclusive manufacturing rights for Products developed for indications in the CNS Field, provided the granting of such rights to Nippon Kayaku does not limit the Parties' ability to obtain collaboration partners for indications in the CNS Field in the Rest of the World.
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SUPPLY OF BULK DRUG SUBSTANCE AND DRUG PRODUCT. If, at the time the parties desire to enter into a manufacturing and supply arrangement for bulk drug substance and/or finished drug product for clinical development and commercialization of Products, LG Chem can reasonably demonstrate that it has the capacity and is otherwise able to meet the parties' supply requirements hereunder at a price competitive with bids submitted to the parties by reputable contract manufacturers of pharmaceutical products, then Elitra agrees that LG Chem shall have the right to supply such bulk drug substance and/or finished drug product at [...***...] with respect thereto for so long as LG Chem remains able to meet the parties' supply requirements hereunder on competitive terms. If the parties do not agree that LG Chem will be * CONFIDENTIAL TREATMENT REQUESTED 20. manufacturer, the parties shall cooperate to identify a single manufacturing source for the worldwide supply of bulk drug substance and finished drug product for clinical development and commercialization of Products.
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Related to SUPPLY OF BULK DRUG SUBSTANCE AND DRUG PRODUCT

  • 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):

  • Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.

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

  • 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.

  • 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.

  • 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 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.

  • Manufacture 2.1. The LED(s) on the LED module shall be equipped with suitable fixation elements.

  • NON-COMPLYING PRODUCT WATER & SEDIMENT CONTENT – PRICE DEDUCTION When the delivered fuel oil’s water and sediment content is found to be greater than three hundredths (0.03%) of a percent for Xxxxxxxx, Xx. 0 and No. 2, a deduction from the contracted price shall be taken at the rate of one (1%) percent for every two hundredths (0.02%) of a percent above the specified limit. (i.e., 0.02% above limit equals a 1% deduction, 0.04% above limit equals a 2% deduction, 0.06% above equals a 3% deduction) No. 4 fuel oil shall have an excess water and sediment content adjustment at the rate of one-tenth percent (0.1%) of invoice for every one-tenth (0.1%) in excess of five-tenths (0.5%) up to and including one percent (1.0%) and at the rate of two-tenths percent (0.2%) of invoice for every one-tenth percent (0.1%) in excess of one percent (1.0%).

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

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