Control of Manufacturing and Special Processes Sample Clauses

Control of Manufacturing and Special Processes. Manufacturing activities affecting the quality of the specified equipment, material, and/or service shall be prescribed by documented instructions, procedures, or drawings of a type appropriate to the circumstances and shall be accomplished in accordance with these documents. These documents shall include appropriate quantitative or qualitative criteria for determining that the prescribed manufacturing activities have been satisfactorily accomplished. The Supplier shall establish written procedures to provide controls to ensure special processes (such as welding, heat-treating, and nondestructive examination [NDE]) are accomplished under controlled conditions by qualified personnel and equipment. Both procedures and equipment shall be used in accordance with the applicable codes, standards, and specifications. The Supplier shall maintain documentation for currently qualified personnel, processes, and equipment according to the requirements of applicable codes and standards. The actual process procedures, such as welding procedures and associated qualifications, should not be a part of the quality manual. The Supplier shall have processes in place to verify controls of manufacturing equipment. The process shall establish target settings with control specification limits. The process shall include a verification process to ensure correct equipment settings prior to production runs. The process may include use of product measurement data to determine process control of the manufacturing equipment.
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Related to Control of Manufacturing and Special Processes

  • 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.

  • Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.

  • Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);

  • Required Procurement Procedures for Obtaining Goods and Services The Grantee shall provide maximum open competition when procuring goods and services related to the grant- assisted project in accordance with Section 287.057, Florida Statutes.

  • Solicitations for Subcontracts, Including Procurement of Materials and Equipment In all solicitations either by competitive bidding or negotiation made by the Local Government for work to be performed under a subcontract, including procurement of materials or leases of equipment, each potential subcontractor or supplier will be notified by the Local Government of the Local Government’s obligations under this Agreement and the Acts and Regulations relative to Nondiscrimination on the grounds of race, color, or national origin.

  • Solicitations for Subcontractors, Including Procurements of Materials and Equipment In all solicitations either by competitive bidding or negotiation made by the contractor for work to be performed under a subcontract, including procurements of materials or leases of equipment, each potential subcontractor or supplier shall be notified by the contractor of the contractor's obligations under this contract and the Regulations relative to nondiscrimination on the grounds of race, color, or national origin, sex, age, and disability/handicap.

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

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