Manufacture of R&D Supplies. Subject to the terms of Section 3.2 (Functions),the manufacture of all supplies of the Product required for research anddevelopment purposes shall be as provided for in the Collaboration andDevelopment Plan.
Manufacture of R&D Supplies Sample Clauses
Related to Manufacture of R&D Supplies
Manufacture of Products All Products marketed through Grantor's Web ------------------------- Site shall be manufactured, packaged, prepared, and shipped in accordance with the specifications and requirements described on Exhibit A hereto as it may be modified from time to time. Quality control standards relating to the Product's weight, color, consistency, micro-biological content, labeling and packaging are also set forth on Exhibit A. In the event that Exhibit A is incomplete, Products shall be manufactured and shipped in accordance with industry standards.
PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.
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 [***].
Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.
Manufacture 2.1. The LED(s) on the LED module shall be equipped with suitable fixation elements.
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 (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.
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.
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.
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):
