Manufacturing Process. If any process event occurs during the manufacturing of any Finished Product, which event is likely materially to affect the safety, efficacy or regulatory status of the Finished Product, then Patheon shall promptly notify Santarus. Further, Patheon shall fully and appropriately investigate and report to Santarus on all complaints and notices of quality issues concerning the Finished Products from the FDA, any Foreign Regulatory Authority or Government Authority of which Santarus shall have given Patheon notice. Santarus and Patheon shall consult with each other as to the disposition of all affected batches of such Finished Product. Patheon shall report to Santarus in writing any other atypical process event that is unlikely to materially affect the safety, efficacy or regulatory status of the Finished Product within a reasonable time after occurrence. No Bulk API or Finished Product may be reprocessed without the prior written consent of Santarus.
Manufacturing Process. The Dimerization Section converts Polymer Grade Ethylene feed to normal butenes in the presence of catalyst and co-catalyst. Butenes are separated from heavy byproducts, dried, and routed to the Metathesis Section. The Metathesis Section combines normal butenes with ethylene to produce propylene. The normal butene rich feed combines with ethylene and recycled feeds. The combined feed is first treated to remove impurities before being heated and fed to the reactor where the metathesis reaction of ethylene and butene produces propylene. A recovery section separates Polymer Grade Propylene from unreacted feed and byproducts.
Manufacturing Process. New River will use Diligent Efforts to develop a process for the Manufacture of bulk Compound and to scale up such process to a level sufficient to Manufacture and supply clinical and commercial supplies of bulk Compound for the ROW Territory. New River will undertake such development in consultation with the JSC, including the preparation of filings necessary to obtain Regulatory Approval for the Manufacture of bulk Compound for the ROW Territory and the selection of any Third Party Manufacturer. In the event that New River includes the filings referred to in this Section 5.1.1 in Drug Master Files in the US Territory, Shire may reference such Drug Master Files for countries in the ROW Territory in which Shire seeks Regulatory Approval of Collaboration Products; provided, however, that Shire will provide New River with assistance as reasonably requested by New River, and at no cost to New River, to ensure compliance with regulatory requirements in such countries. Once such filings are made, no changes to the process for the Manufacture of bulk Compound for the ROW Territory shall be made without the written consent of Shire, such consent not to be unreasonably withheld, conditioned or delayed; provided that New River will not require the prior written consent of Shire to make changes related to the process for the Manufacture of bulk Compound for the ROW Territory hereunder that are required by a Governmental Authority or applicable Law. New River’s retention of any Third Party Manufacturer to perform any activities under this Section 5.1.1 shall be subject to the prior written approval of Shire, not to be unreasonably withheld, conditioned, or delayed. All costs related to the foregoing activities set forth in this Section 5.1.1 that are additional to any activities set forth in Section 6.1.1 of the US Agreement shall be charged by New River to Shire at [*]
Manufacturing Process. Any changes to the Specifications or the Manufacturing Process for a Product shall be carried out in accordance with the Quality Agreement and Lonza’s standard operating procedures. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Manufacturing Process. Sanofi shall transfer the manufacturing process for the Licensed Products to KaloBios or its designee (which will be designated as soon as reasonably practical but in no event later than [***].
Manufacturing Process. (a) In the event that any Third Party commences any Action against either Party or any of such Party’s Affiliates alleging that the manufacture of Product (including the use of any Pfenex Technology in the manufacture of Product) infringes any Intellectual Property of such Third Party (a “Manufacturing Action”), the Party against whom such Action is commenced shall provide the other Party prompt written notice thereof. Following receipt of such notice, Hospira shall have the sole right to determine the appropriate course of action, including by way of example, assuming and controlling the defense of such Manufacturing Action and/or seeking a license from such Third Party with respect to such Third Party’s Intellectual Property. If Hospira elects to assume control over the defense of any such Manufacturing Action where Pfenex or its Affiliate is a defendant, then Pfenex or its Affiliate shall have the right to participate with counsel of its selection (at Pfenex’s sole cost and expense) and Hospira shall subject to Section 6.5(c) continue to control and defend Pfenex or its Affiliate until final judgment in such Manufacturing Action. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(b) Pfenex shall provide all cooperation and assistance reasonably requested by Hospira in connection with any Manufacturing Action, including (i) providing Hospira with detailed responses to its inquiries, (ii) providing Hospira with documents (whether in written, electronic or other form) related to the manufacturing process or the practice of the Pfenex Technology, (iii) identifying and describing any Intellectual Property that has been incorporated into the processes to manufacture Product by Pfenex, and (iv) identifying and providing witnesses who will assist in the preparation of evidence, provide written evidence, appear as witnesses in court and assist in other ways that Hospira reasonably requests.
(c) Hospira may settle, compromise or consent to any judgment with respect to any Manufacturing Action without the prior written consent of Pfenex on fifteen (15) Business Days’ notice to Pfenex (together with a complete copy of such proposed settlement, compromise, consent or judgment and such other documents as Pfenex may reasonably request); provided, that if prior to the expiration of such fifteen (15) Business Day per...
Manufacturing Process. To Pfenex’s Knowledge, the Manufacturing Strain (and the constituent components thereof) used by or on behalf of Pfenex as of the Signature Date does not infringe the Intellectual Property rights of any Third Party.
Manufacturing Process. In the event that any process event shall occur in the manufacturing of any batch of Product, which event is likely materially to affect the safety, efficacy or regulatory status of the Product, then Anthra shall notify Medeva as soon as reasonably possible. *** CONFIDENTIAL TREATMENT REQUESTED.
Manufacturing Process. Under Seragen's direction, Service Provider shall at all times perform the Technology Services and Additional Services in accordance with Seragen's manufacturing and quality control specifications. Unless Seragen directs Service Provider to do so, Service Provider shall not change its manufacturing processes, equipment or vendors relating to this Agreement or the services performed by Service Provider hereunder.
Manufacturing Process a - The Supplier shall be responsible, without limitation and at no additional cost to the Buyer:
(i) the sourcing and purchase of all raw materials for the Products;
(ii) obtaining all necessary approvals, authorizations, and licenses for the manufacture of the Products;
(iii) the provision of sufficient qualified personnel and manpower to perform the obligations under this Purchase Agreement;
(iv) the implementation and maintenance of effective inventory and production control procedures in relation to the Products; and
(v) the treatment, from time to time, of other problems at the reasonable request of the Purchaser.
b - Supplier shall not modify any process, material, component, packaging or manufacturing place without the prior express written permission of Buyer.
