Phase I/II Batches. 3.1.1 A first batch of Product manufactured from [ * ] litres of Plasma ready for shipping on or before [ * ].
Phase I/II Batches Sample Clauses
Related to Phase I/II Batches
Phase II The parties acknowledge that this Agreement is not exclusive and GPPC shall have the right to provide consulting services regarding the marketing of the DCC services of Member, GPPC, any of GPPC’s Affiliates, or of any third party, subject to the provisions of Section 5.4 above. During the Term of this Agreement, GPPC may choose to develop the functionality of its own processing platform, or use a third person’s processing platform to enable GPPC to support certain functions in the clearing and settlement of DCC Transactions (“Phase II”). At such time as it is ready to begin implementing Phase II, GPPC shall inform Planet Payment of its plans and the parties shall discuss how Phase II may be integrated into the Acquirer Program. Nothing herein shall prohibit GPPC from implementing Phase II, and Planet Payment agrees that it will use its commercially reasonable efforts to provide assistance to GPPC to implement Phase II, provided that Planet Payment shall not have any obligation whatsoever to assist GPPC in any way in specifying, designing or implementing functions similar to any of Planet Payment’s functions provided hereunder relating to the conversion, calculation, reporting or reconciliation of cross-currency Transactions. Nothing herein shall oblige Planet Payment to disclose, transfer or license any of its IP to GPPC for the purposes of Phase II. Planet Payment shall not charge GPPC for such assistance, unless GPPC requests modifications or enhancements to the Planet Payment Platform to facilitate Phase II, in which case Planet Payment shall only charge GPPC for its actual and out of pocket costs incurred in connection with such modifications or enhancements. The parties shall use good faith efforts to modify the parties’ respective obligations under this Agreement relating to processing of Transactions (but without any change to their respective Revenue Shares) to reflect the reallocation of their respective functions following implementation of Phase II.
Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
PHASE Phase means any individual Phase of the Project, as more particularly described in the definition of Project.
Phase I A copy of the existing “Phase I” environmental assessment of the Project, if any, in Seller’s possession; and
Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput through the Pipelines, nor will Operator be obligated to accept Product that fails to meet the applicable quality specifications for the Berths under the BAUTA and any Terminal Service Orders issued thereunder.
Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.
Product Quality (a) Tesoro warrants that all Products delivered under this Agreement or any Purchaser Order shall meet the latest applicable pipeline specifications for that Product upon receipt at the applicable Terminal and contain no deleterious substances or concentrations of any contaminants that may make it or its components commercially unacceptable in general industry application. Tesoro shall not deliver to any of the Terminals any Products which: (a) would in any way be injurious to any of the Terminals; (b) would render any of the Terminals unfit for the proper storage of similar Products; (c) would contaminate or otherwise downgrade the quality of the Products stored in commingled storage; (d) may not be lawfully stored at the Terminals; or (e) otherwise do not meet applicable Product specifications for such Product that are customary in the location of the Terminal. If, however, there are Products that do not have such applicable specifications, the specifications shall be mutually agreed upon by the Parties. Should Tesoro's commingled Products not meet or exceed the minimum quality standards set forth in this Agreement or any applicable Purchase Order, Tesoro shall be liable for all loss, damage and cost incurred thereby, including damage to Products of third parties commingled with Tesoro's unfit Products.
Acceptance Testing The MCP must have the capability to report all elements in the Minimum Data Set as set forth in the ODJFS Encounter Data Specifications and must submit a test file in the ODJFS-specified medium in the required formats prior to contracting or prior to an information systems replacement or update. Acceptance testing of encounter data is required as specified in Section 29(a)(v) of this Appendix.
Technical Specifications Each Bloom System is an integrated system comprised of a fuel cell stack assembly and associated balance of plant components that converts a fuel into electricity using electrochemical means that (i) has a Nameplate Capacity of at least 0.5 kilowatts of electricity using an electrochemical process and (ii) has an electricity-only generation efficiency greater than thirty percent (30%).
Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).
