Development Product. The following terms and conditions apply to Products that are in the development stage:
Development Product. “Development Product” shall mean Product not intended for commercial sale.
Development Product. The development of the Product and the Development Product and the production of the Transferred Inventory have been carried out in accordance with all applicable Laws in all material respects, including GLP, GCP and GMP, as applicable. As of the date hereof, Seller has not received any written notice or other communication indicating that there are any material safety issues, including any facts, data, finding, analysis, information, or belief that there is a substantial risk that (a) the Product presents an unacceptable (i) risk of death, (ii) a life-threatening condition, or (iii) a serious safety or health concern to patients, (b) Regulatory Approval for the Product has been terminated or suspended in any country, or (c) a Regulatory Authority with jurisdiction over the Product has directed or requested discontinuance of development, distribution, use, sale, or importation of the Product, and to the Knowledge of Seller, there is no reasonable basis for any findings related to any of the foregoing (a)-(c).
Development Product. The Parties acknowledge that any Product to be used in connection with the conduct of clinical studies shall be provided to Takeda pursuant to the Collaboration and License Agreement.
Development Product. Pursuant to Section 4.2(b)(vii) of the Collaboration and License Agreement, the costs for any Product and/or placebo used in connection with the conduct of clinical studies shall be deemed to be included within Development costs and any such costs therefore shall be paid by SPI or Takeda as provided in the Collaboration and License Agreement. The Parties acknowledge the price [**] of such Product is U.S.$[**]. The price for any placebo [**] supplied by RTU for use in connection with the conduct of clinical studies shall be US $[**] equal to [**] percent ([**]%) of Product). RTU shall supply and Takeda and SPI shall purchase their entire requirements for the Product from RTU in the standard order quantities of standard case lots (i.e. [**] per lot). RTU shall keep the Product and placebo in appropriate condition until the Product and placebo are required for use.
Development Product. Certain of the Products are designated in the Work Plan as “Development Products”. Product resulting from Engineering Runs shall be considered as Development Product. Notwithstanding any other provision herein set forth, the following terms and conditions apply to Development Products:
Development Product. From time to time, COMPANY may request, in writing, that DPT evaluate, develop, manufacture, test or provide price quotations for certain new items which may become Product (hereinafter referred to as “Development Product”) on behalf of COMPANY. If DPT agrees to perform such services, DPT shall so notify COMPANY within thirty (30) days of its receipt of COMPANY’s proposal. To the extent that DPT agrees to perform any services hereunder for COMPANY, DPT shall only be obligated to act in good faith and to use reasonable efforts to accomplish the desired results as outlined in the relevant Project Protocol. Nothing herein shall obligate DPT to achieve any specific results and DPT makes no warranties or representations that it will be able to achieve the desired results.
Development Product. 5.1 With respect to each DEVELOPMENT PRODUCT in the CO-PROMOTION TERRITORY, the CLINICAL STEERING COMMITTEE shall determine the work to be performed by NOVARTIS for preclinical, clinical development and regulatory approval thereof.
Development Product. If Seller has made commercially reasonable efforts to effect a Technology Transfer and the Technology Transfer has not been accomplished at the end of the two year period from the commencement of efforts (i.e., the delivery to Buyer of relevant Know-How documentation) to effect said Technology Transfer, then (a) if the Technology Transfer has not occurred solely due to regulatory issues, then the Technology Transfer Payments shall be made upon the earlier of (i) completion of the Technology Transfer, or (ii) six months after the aforementioned two year period; or (b) if there are no regulatory issues then impeding said Technology Transfer, then the Technology Transfer Payments shall be due and payable two years from the commencement of efforts (i.e., the delivery to Buyer of relevant Know-How documentation) to effect said Technology Transfer. Notwithstanding the foregoing, if Buyer does not acquire the Xxxxxxx Product pursuant to Section 3.10, then Buyer shall not be obligated for the Technology Transfer Payment for the Xxxxxxx Product.
Development Product. Peerless hereby grants Kyocera the worldwide, non-exclusive right to reproduce, distribute, market, sell and sublicense the Licensed Software, as those terms are defined in the Addendum to this Agreement.
