Procurement and Approval of Product Materials Sample Clauses

Procurement and Approval of Product Materials. Subject to Sections 5.4(c) and 2.4(f), Gilead shall order sufficient quantities of all Product Materials to enable Gilead to Manufacture, and to deliver, the Product in accordance with Orders placed by Eyetech and accepted by Gilead pursuant to Section 2.4(e). All Product Materials used in the Manufacture of the Product and the supplier(s) thereof shall have been approved in writing by Eyetech. Gilead shall issue and pay all purchase orders for such Product Materials. Gilead may not substitute or otherwise replace any Product Materials and/or any supplier thereof without the prior written consent of Eyetech. Gilead agrees to provide Eyetech, on a timely basis, all information that Eyetech may reasonably request in order to comply with internal Eyetech procedures regarding approval of a change in Product Materials and/or any supplier thereof. The costs of Product Materials and the management and procurement of such Product Materials shall be included in the Price in accordance with the terms of Section 4.1 hereof. If Eyetech designates certain suppliers, Gilead shall obtain Product Materials from such suppliers and the Price shall be adjusted to account for any cost savings or increased costs resulting from obtaining Product Materials from such suppliers.
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Procurement and Approval of Product Materials. Subject to Section 3.5, COMPANY shall order sufficient quantities of all Product Materials to enable COMPANY to manufacture, and to deliver, the Product(s) in accordance with PFIZER’s delivery requirements, as communicated pursuant to Section 3.5 All Product Materials used in the manufacture of the Product(s) and the supplier(s) thereof must be approved in advance in writing by PFIZER which shall not be unreasonably withheld or delayed. COMPANY may not substitute or otherwise replace any ingredient, Raw Material, Packaging Material and/or any supplier thereof without the prior written consent of PFIZER. COMPANY agrees to provide PFIZER, on a timely basis, all information that PFIZER may reasonably request in order to comply with internal PFIZER procedures regarding approval of a change in Product Material and/or any supplier thereof. In the event PFIZER designates certain suppliers, COMPANY shall obtain materials from such suppliers. The costs of (a) such Product Materials and (b) the management and procurement of such Product Materials shall be included in the Price in accordance with the terms of Section 4.1 hereof. PFIZER may choose to, at its own expense, or for a cost, supply COMPANY with sufficient quantities of Product Materials as described in Schedule “E” attached hereto as may be amended from time to time, needed for the manufacture of the Product(s) specified in the forecasts and Purchase Orders in order to meet PFIZER’s requirements for commercial and/or developmental quantities of Product(s) in finished dosage form. At PFIZER’s election, the Raw Materials may be delivered directly from PFIZER’s vendor to COMPANY at the vendor’s or PFIZER’s expense. PFIZER or its vendor shall supply COMPANY with a copy of the Certificate of Analysis for the Raw Materials no later than the date of delivery of the Raw Materials to COMPANY. At PFIZER’s option, PFIZER may elect to supply COMPANY with any, Raw Materials and/or Packaging Materials for the Product(s). In the event PFIZER elects to do so, PFIZER shall notify COMPANY and COMPANY shall decrease the Price to reflect the reduction in the cost of the Product(s) associated with such Raw Materials and/or Packaging Materials. In addition, such PFIZER supplied Raw Materials and/or Packaging Materials shall be the sole property of PFIZER and shall be appropriately handled and stored by COMPANY at no additional cost. PFIZER supplied Raw Materials and/or Packaging Materials shall be held in accordance with PFIZER ...
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Related to Procurement and Approval of Product Materials

  • Development of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

  • 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.

  • Manufacture of Product Prior to commercialization of the Product, the Parties may, if appropriate for both parties, negotiate in good faith a manufacturing and supply agreement to provide for Licensor to fulfill the manufacturing requirements of Licensee for Product for sale in the European market. The cost of such manufacturing shall not be greater than * percent (*%) of the cost of any competitor cGMP contract manufacturing facility that proposes to manufacturer the Product for Licensee. * Confidential information has been omitted and filed confidentially with the Securities and Exchange Commission.

  • Supply of Products TheraSense shall be responsible for the ------------------ manufacture of FreeStyle Products for sale to Nipro.

  • Supply of Product The JDC shall be responsible for determining the sources of, and arrangements for, the manufacture and supply of Products that the JDC believes will result in long-term profit maximization for such Products. The JDC shall endeavor to [ * ].

  • Regulatory Filings and Approvals Copies of all necessary governmental and third party approvals, registrations, and filings in respect of the transactions contemplated by this Agreement;

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Regulatory Approvals All Requisite Regulatory Approvals shall have been obtained and shall remain in full force and effect and all statutory waiting periods in respect thereof shall have expired, and no such Requisite Regulatory Approval shall have resulted in the imposition of any Materially Burdensome Regulatory Condition.

  • Regulatory Approvals; Efforts (a) Prior to the Closing, Parent, Merger Sub and the Company shall use their respective reasonable best efforts to take, or cause to be taken, all actions, and to do, or cause to be done, all things necessary, proper or advisable under any applicable Laws to consummate and make effective the Merger including (i) the preparation and filing of all forms, registrations and notices required to be filed to consummate the Merger, (ii) the satisfaction of the conditions to consummating the Merger, (iii) taking all reasonable actions necessary to obtain (and cooperating with each other in obtaining) any consent, authorization, Order or approval of, or any exemption by, any third party, including any Governmental Entity (which actions shall include furnishing all information and documentary material required under the HSR Act) required to be obtained or made by Parent, Merger Sub, the Company or any of their respective Subsidiaries in connection with the Merger or the taking of any action contemplated by this Agreement, and (iv) the execution and delivery of any additional instruments necessary to consummate the Merger and to fully carry out the purposes of this Agreement. Additionally, each of Parent, Merger Sub and the Company shall use reasonable best efforts to fulfill all conditions precedent to the Merger and shall not take any action after the date of this Agreement that would reasonably be expected to materially delay the obtaining of, or result in not obtaining, any permission, approval or consent from any such Governmental Entity necessary to be obtained prior to Closing. To the extent that transfers of any permits issued by any Governmental Entity are required as a result of the execution of this Agreement or the consummation of the Merger, the parties hereto shall use reasonable best efforts to effect such transfers.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

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