Processes and methods. Be proficient in the Rapid Improvement Model and use daily huddles to discuss problems and build solutions.
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.
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
Processes and methods. (a) Processing of Tissue will be performed by Osteotech under applicable Processing Standards. "
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.
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
