SCALE-UP OF THE MANUFACTURING PROCESS BY ALKERMES Sample Clauses

SCALE-UP OF THE MANUFACTURING PROCESS BY ALKERMES. (A) Alkermes shall be responsible for, and shall use its commercially reasonable efforts to, scale up the process for producing Licensed Product for both clinical and (unless Genentech manufactures commercial Licensed Product pursuant to Section 5) commercial requirements provided that Genentech supplies sufficient quantities of human growth hormone (at Genentech's expense) to enable Alkermes to do so. Exhibit C attached hereto sets forth the anticipated timeline, requirements and costs for scaling-up the manufacturing process for making Licensed Product for clinical and commercial use to treat pediatric GHD. Genentech shall not be responsible for any of Alkermes' capital cost of its facilities except as otherwise set forth in Exhibit C or approved by the JDC for the facility in which commercial Licensed Product is to be manufactured. The Parties will prepare and agree upon a separate document setting forth the anticipated timeline, requirements and costs for scaling-up the manufacturing process for other applications of the Licensed Product. (B) Genentech will reimburse the costs incurred by Alkermes pursuant to Section 4.3(a) above at Alkermes' actual cost of performing the obligations set forth in that section, as determined by Alkermes in accordance with an FTE rate established as set forth above as consistently applied by Alkermes. Alkermes shall submit a reasonably detailed invoice to Genentech at the end of each quarter during which it incurs costs under Section 4.3(a) setting forth activities completed and costs for such activities, which shall be reasonably in accordance with amounts previously agreed upon by the JDC for such activities. Genentech shall reimburse Alkermes' costs within thirty (30) days of receiving each invoice.
Sample 1
AutoNDA by SimpleDocs
SCALE-UP OF THE MANUFACTURING PROCESS BY ALKERMES. Alkermes shall be responsible for, and shall use its commercially reasonable efforts to, scale up the process for producing the 1st and 2nd Generation Formulations of Licensed Product for both clinical and (unless Genentech manufactures commercial Licensed Product pursuant to Section 5) commercial requirements, provided that Genentech supplies sufficient quantities of human growth hormone (at Genentech's expense) to enable Alkermes to do so. Exhibit B attached hereto sets forth the anticipated timeline, requirements and costs for scaling-up the manufacturing process for making the 2nd Generation Formulation of Licensed Product for clinical and commercial use. Genentech shall not be responsible for any of Alkermes' capital cost of its facilities except as otherwise set forth in Exhibit B or approved by the JDC for the facility in which commercial Licensed Product(s) are to be manufactured. The Parties will prepare and agree upon a separate document setting forth the anticipated timeline, requirements and costs for scaling-up the manufacturing process for other applications of the Licensed Product.
Sample 1

Related to SCALE-UP OF THE MANUFACTURING PROCESS BY ALKERMES

  • Loop Provisioning Involving Integrated Digital Loop Carriers 2.6.1 Where Freedom has requested an Unbundled Loop and BellSouth uses IDLC systems to provide the local service to the End User and BellSouth has a suitable alternate facility available, BellSouth will make such alternative facilities available to Freedom. If a suitable alternative facility is not available, then to the extent it is technically feasible, BellSouth will implement one of the following alternative arrangements for Freedom (e.g. hairpinning): 1. Roll the circuit(s) from the IDLC to any spare copper that exists to the customer premises. 2. Roll the circuit(s) from the IDLC to an existing DLC that is not integrated. 3. If capacity exists, provide "side-door" porting through the switch. 4. If capacity exists, provide "Digital Access Cross Connect System (DACS)- door" porting (if the IDLC routes through a DACS prior to integration into the switch). 2.6.2 Arrangements 3 and 4 above require the use of a designed circuit. Therefore, non- designed Loops such as the SL1 voice grade and UCL-ND may not be ordered in these cases. 2.6.3 If no alternate facility is available, and upon request from Freedom, and if agreed to by both Parties, BellSouth may utilize its Special Construction (SC) process to determine the additional costs required to provision facilities. Freedom will then have the option of paying the one-time SC rates to place the Loop.

  • Computer Equipment Recycling Program If this Contract is for the purchase or lease of computer equipment, then Contractor certifies that it is in compliance with Subchapter Y, Chapter 361 of the Texas Health and Safety Code related to the Computer Equipment Recycling Program and the Texas Commission on Environmental Quality rules in 30 TAC Chapter 328.

  • RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.

  • SOURCE CODE ESCROW FOR LICENSED PRODUCT If Source Code or Source Code escrow is offered by either Contractor or Product manufacturer or developer to any other commercial customers, Contractor shall either: (i) provide Licensee with the Source Code for the Product; or (ii) place the Source Code in a third party escrow arrangement with a designated escrow agent who shall be named and identified to the State, and who shall be directed to release the deposited Source Code in accordance with a standard escrow agreement acceptable to the State; or (iii) will certify to the State that the Product manufacturer/developer has named the State, acting by and through the Authorized User, and the Licensee, as a named beneficiary of an established escrow arrangement with its designated escrow agent who shall be named and identified to the State and Licensee, and who shall be directed to release the deposited Source Code in accordance with the terms of escrow. Source Code, as well as any corrections or enhancements to such source code, shall be updated for each new release of the Product in the same manner as provided above and such updating of escrow shall be certified to the State in writing. Contractor shall identify the escrow agent upon commencement of the Contract term and shall certify annually that the escrow remains in effect in compliance with the terms of this clause. The State may release the Source Code to Licensees under this Contract who have licensed Product or obtained services, who may use such copy of the Source Code to maintain the Product.

  • Third Party Components The Products and Services may contain third party components (including open source software) subject to separate license agreements. To the limited extent a third party license expressly supersedes this XXXX, such third party license governs Customer’s use of that third party component.

  • Manufacturing Rights (a) If QED fails to supply Product ordered by ViewRay in accordance with the terms of this Agreement regarding the quantity or quality of Products supplied to ViewRay, then QED shall within fifteen (15) Business Days of said failure present ViewRay with a plan to remedy the problem and shall use Commercially Reasonable Efforts to execute such plan and remedy the problem or QED shall secure an alternative source of supply within a reasonable time at no additional cost to ViewRay. Any such alternative source of supply shall be on terms substantially identical with the terms of this Agreement. If QED is unable to provide a plan to remedy the problem or secure an alternative source of supply within [***] after its initial failure to supply, then QED shall consult with ViewRay and the parties shall work together to remedy the problem. If QED is unable to remedy the supply problem after [***] (or longer as agreed in writing by the parties), commencing with the date upon which such failure to supply began, then ViewRay may at its option, and upon notice to QED, manufacture the Products itself or through a third party in accordance with the provisions of Section 3.10(b). [***] 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) If ViewRay notifies QED pursuant to Section 3.10(a), above, that ViewRay will manufacture the Products itself or through a third party, QED shall (i) deliver to ViewRay within thirty (30) days media embodying or disclosing all Program technology and Program proprietary or intellectual property rights necessary to enable ViewRay or its designee to manufacture Products conforming with the Specifications; and (ii) provide ViewRay or its designee, upon request, with reasonable assistance in establishing a back-up manufacturing line. ViewRay shall require any third party ViewRay designates to manufacture Products pursuant to this Section 3.10, to agree in writing to observe the terms of this Agreement relating to confidentiality and the manufacture of Products. Notwithstanding any provision of this Section 3.10 to the contrary, in no case shall QED be required to pay ViewRay in respect of any Products purchased by ViewRay from a third party operating a back-up manufacturing line established pursuant to this Section 3.10 or manufactured by ViewRay or its Affiliates pursuant to this Section 3.10.

  • Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract. a. The contractor shall notify all potential subcontractors and suppliers and lessors of their EEO obligations under this contract. b. The contractor will use good faith efforts to ensure subcontractor compliance with their EEO obligations.

  • Manufacturing Technology Transfer Except as the Committee ------------ --------------------------------- may otherwise agree in writing, in order to effectuate an orderly transition of the uninterrupted availability of Product to LILLY for purposes contemplated under this Agreement, MEGABIOS, at least ninety (90) days prior to completion of the Project or completion of Phase I Clinical Trials, whichever is earlier, shall transfer to LILLY all information and instructions concerning the manufacturing process and related matters in MEGABIOS' possession which may be necessary for LILLY to manufacture Product (including information regarding obtaining necessary Lipids related thereto) for clinical trials and commercialization as contemplated hereunder including, but not limited to, analytical and manufacturing methods. MEGABIOS shall also provide assistance (in the form of consultation) to LILLY with respect to manufacturing matters for a period of [ * ] months after completion of the initial transfer of information and instructions as provided below. Such transfer and assistance by MEGABIOS will be referred to herein as the "Manufacturing Transfer." All such information, methods and instructions transferred to LILLY under this Section 4.3 shall be referred to herein as the "Manufacturing Information," and shall be maintained in confidence by LILLY pursuant to Section 7.1, except that LILLY's obligation to maintain in confidence such Manufacturing Information shall survive for ten (10) years following expiration or termination of this Agreement. LILLY agrees that it will use all such transferred Manufacturing Information only for the manufacture of the Products and shall not disclose or transfer such Manufacturing Information to any third party manufacturer except as provided in Section 2.10. MEGABIOS shall provide, and bear its costs for, up to [ * ] FTEs for a period of up to [ * ] months [ * ] in aggregate) to accomplish the Manufacturing Transfer. Such FTEs, at LILLY's request, shall include visits to LILLY's facilities by MEGABIOS personnel including up to [ * ] from MEGABIOS' head of manufacturing. MEGABIOS shall furnish any additional reasonable assistance beyond the assistance described above regarding manufacturing matters that LILLY may request and that MEGABIOS is able to provide, for up to [ * ] after the initial transfer of Manufacturing Information, providing that LILLY [ * ] incurred with respect to such additional assistance.

  • 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. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • Particular Methods of Procurement of Goods and Works International Competitive Bidding. Goods and works shall be procured under contracts awarded on the basis of International Competitive Bidding.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!