Processes and methods Sample Clauses

Processes and methods. Be proficient in the Rapid Improvement Model and use daily huddles to discuss problems and build solutions.
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Processes and methods. ADP will determine the methodologies and parameters to be used for measuring service levels and ADP shall use commercially reasonable procedures to fulfill the requirements hereunder. For the avoidance of doubt ADP will consider the feasibility of any additional processes and/or methodologies requested by the Client; however, ADP shall make the sole determination to incorporate such processes.
Sample 1
Processes and methods. (a) Processing of Tissue will be performed by Osteotech under applicable Processing Standards. (b) In the event the FDA implements new or additional regulations applicable to Tissue, Osteotech and ARC shall each implement such changes to its SOPs as are necessary to comply with such FDA regulations. In the event Osteotech is unable or unwilling to implement such changes, ARC shall have the remedy set forth in Section 6.5. (c) Osteotech will grant designated ARC personnel access to its facilities to observe all steps of Processing for the purpose of conducting a standard ARC inspection of the Processing Standards. As part of this inspection, all Processing Standards will be made available to the inspectors. If such personnel require access to Osteotech's cleanrooms, the personnel must have on file with Osteotech appropriate blood serum test results and such other tests as Osteotech may require prior to such personnel being granted access to Osteotech's cleanrooms. Osteotech may, at its sole discretion, refuse any individual access to Osteotech cleanrooms for cause. Such denial of access will not be a violation of this Agreement.
Sample 1
Processes and methods. (a) Processing of Tissue will be performed by Osteotech under applicable Processing Standards. "Processing Standards" shall mean all standards, guidelines, rules, regulations and laws applicable to the Processing, storage, packag- ing, labeling, and shipping of Tissue by Osteotech. The Processing Standards shall include (i) applicable laws, regulations, and guidelines of the FDA; (ii) applicable standards and guidelines promulgated by the AATB; (iii) applicable laws and regulations of other U.S. federal, state and local government agencies with jurisdiction over the processing and distribution of human musculoskeletal tissue; (iv) applicable laws and regulations of non-U.S. jurisdiction where Tissue processed by Osteotech is procured or distributed by or on behalf of MTF; (v) MTF's SOPs, as may be amended from time to time by MTF and as provided to Osteotech in advance of their effectiveness; and (vi) Osteotech's SOPs. If interpretation of the Processing Standards is required or if there is a disagreement about the inter- pretation of the Processing Standards, MTF and Osteotech will attempt to negotiate a resolution in good faith. If such interpretations or disagreements are not resolved by the parties, the parties will mutually agree to a third
Sample 1
Processes and methods. 10 1.2.3 PROCESSING CONSIDERATIONS...................................10 2. STORAGE, SHIPPING, REGULATORY COMPLIANCE AND LABELING.....................12 2.1 POSSESSION AND STORAGE OF TISSUE.....................................12 2.2 SHIPPING.............................................................13
Sample 1
Processes and methods. (a) Processing of Tissue will be performed by Osteotech under applicable Processing Standards. "
Sample 1

Related to Processes and methods

  • Currency and method of payments All payments to be made by the Lenders or by the Borrower under a Finance Document shall be made to the Agent or to the Security Trustee, in the case of an amount payable to it:

  • Payment for Labor and Materials The Contractor agrees and binds itself to pay for all labor done, and for all the materials used in the construction of the work to be completed pursuant to this contract.

  • 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.

  • 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.

  • Technical Information The Employer agrees to provide to the Union such information that is available relating to employees in the bargaining unit, as may be required by the Union for collective bargaining purposes.

  • Technology Discoveries, innovations, Know-How and inventions, whether patentable or not, including computer software, recognized under U.S. law as intellectual creations to which rights of ownership accrue, including, but not limited to, patents, trade secrets, maskworks and copyrights developed under this Agreement.

  • Combination Products If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.

  • 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.

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