Starting Materials. Adams shall deliver the Starting Materials to Cardinal free of charge xx xhe Facility. Any customs duties and the like arising from importation of any Starting Material to the Facility shall be borne by Adams. The risk of loss or damage of such Starting Materials shall rexxxx with Adams until the Starting Materials are received at the Facility, at wxxxx time risk of loss or damage to the Starting Materials shall shift to Cardinal. Cardinal shall be responsible for any loss or damage to the Starting Materials while in Cardinal's custody other than as set forth herein. Adams shall be compensated for losses of any Starting Materials beyonx xxxeed upon yield tolerances, in an amount equal to Adams's actual net cost to acquire such Starting Materials.
Starting Materials. All starting materials shall be either supplied by Novartis or Unigene, or purchased by Unigene from suppliers approved by Novartis. All applicable products or raw materials used by Unigene in Manufacturing shall meet the requirements of all then-current EU Directives concerning Transmissible Spongifoam Encephalopathy (TSE). This includes all appropriate documentation and TSE Questionnaire being included with the material.
Starting Materials. 6.1.1 Water Special attention should be paid to water, since it is an important raw material. Water production equipment and water systems should supply quality water. Water systems should be sanitized according to well-established procedures. The chemical and microbiological quality of water used in production should be monitored regularly, according to written procedures and any anomaly should be followed by corrective action. The choice of method for water treatment such as deionisation, distillation or filtration depends on product requirement. The storage as well as delivery system should be properly maintained.
Starting Materials. Within forty-five (45) days of receipt by Cayman of a bulk or pre-shipment sample of a starting material provided by Aerie or an Aerie Vendor, Cayman shall perform quality control procedures to verify that all such starting materials conform fully to the specifications therefore and are otherwise suitable for use in the manufacture of Product. If Cayman determines that any starting materials fail to conform to their Specifications or are otherwise unsuitable for use in the manufacture of Product, Cayman shall notify Aerie and the vendor immediately (and, in any event, within two (2) business days of such determination), and shall provide Aerie with test results, representative samples, and any other evidence necessary to demonstrate such non-conformance or unsuitability, if requested. Cayman shall properly store and maintain all conforming starting materials to ensure they remain in compliance with Specifications and suitable for manufacture of Product. In the event a starting material from Aerie or an Aerie Vendor is rejected by Cayman, Aerie shall arrange for the return and replacement of such material and all such activities and related expenditures for such activities are at the expense of Aerie.
Starting Materials. 4.1 The Customer, or if the Starting Materials are to be provided by Nova, Nova shall ensure that:
Starting Materials. NABRIVA shall deliver the required Starting Materials from vendors that have been mutually agreed to and approved by the Parties, at no cost and of appropriate quality and quantity to HOVIONE a minimum of [**] in advance of the proposed start date for the Campaign. Where NABRIVA is aware that delivery of the Starting Materials may be delayed, it shall immediately inform HOVIONE and the Parties shall enter good faith discussions to align the delivery of the Starting Materials with the planning for the relevant Campaign. Notwithstanding the forgoing, in case of late delivery and where any good faith discussions between the Parties do not resolve the impact of late delivery of the Starting Materials, and/or in case of quality issues affecting the use of Starting Materials provided by NABRIVA in the Manufacturing of the API, HOVIONE reserves the right to reschedule the start of the relevant Campaign based on available capacity planning and to charge NABRIVA a fee up to [**] percent ([**]%) of the cost of the Campaign as compensation for any idle capacity, with HOVIONE making Commercially Reasonable Efforts to re-allocate idle capacity to other projects and, to the extent successful, reducing or waiving the fee accordingly. The value of any Starting Materials purchased by HOVIONE that cannot be used in a next Campaign and needs to be disposed of, due to shelf life or otherwise and as a direct result of the delayed delivery by NABRIVA, shall be separately invoiced to NABRIVA in addition to the up to the [**] percent ([**]%) mentioned above. HOVIONE shall keep NABRIVA informed of any exposure to import duties and value added tax that are suspended at the time of import in anticipation that the resulting API will be exported. If at any time, this export is not verified and monies for the suspended duties and VAT become due, NABRIVA shall promptly reimburse HOVIONE.
Starting Materials. Testing of Starting Materials. VIFOR shall be responsible for testing the Starting Materials (API) to be used in the Manufacture of Product for compliance with their specifications. VIFOR shall retain all related documentation for the Starting Materials for the periods consistent with GMP and applicable Laws, but in any event for (1 year + expiry date) beyond the shelf life of applicable Batch of Product. VIFOR's QP statement that suppliers of excipients and packaging materials are correctly qualified and comply with the requirements should be provided to DISTRIBUTOR upon request.
Starting Materials. The Parties agree that Novavax shall provide to Takeda certain Starting Materials specified in and pursuant to Exhibit I.
Starting Materials. 3.3.1 All Raw Materials required for the Manufacture of Product shall be acquired by NxStage from Third Parties. Axxxxx shall be promptly notified in writing of any changes in any Raw Materials or a change in suppliers which occurs after the Effective Date.
Starting Materials. API is supplied by Lxxxxxxx Labs to BMS Anagni. BMS Anagni is responsible for inspecting and testing starting materials according to approved in-house procedures and technical specifications, which are in compliance with IND 58,362.
