Development Supply at No Cost Sample Clauses

Development Supply at No Cost. Pluristem shall supply the Development supplies of the Product and placebo supplied under this Section ‎6.1 at no cost to UTC; provided that, in respect of any supply of Products and placebo required due to loss of prior supply by UTC resulted from non-compliance by UTC with its obligations under the Quality Agreement or Section ‎4.8, UTC shall reimburse Pluristem for the Cost of Goods Sold for same.
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Related to Development Supply at No Cost

  • Product Supply 5.1 In the event that Eisai notifies Radius of its desire to purchase bulk substance of Compound from Radius, Radius shall supply Eisai with all amount of such bulk substance of Compound, which meets specifications for the Product determined by Radius in the course of its Development activities pursuant to this Agreement, required by Eisai for commercial sales of Product in Japan With respect to Eisai clinical development activities for Product in Japan, upon Eisai’s request, Radius shall supply Eisai the bulk substance of Compound for * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. the conduct of the Eisai Development activities in the amounts and at the times determined by the SC, having reference to the quantity of the bulk substance of Compound required for clinical trials in Japan. Radius shall charge [*] for applicable bulk substance of Compound. Radius shall ship such bulk substance of Compound, FOB point of manufacturing. 5.2 In the event that Eisai notifies Radius of its desire to purchase Semi-Product from Radius which meets specifications determined by Radius in the course of its Development activities pursuant to this Agreement, Radius shall supply Eisai with all amount of Semi-Product required by Eisai for commercial sales of Product in Japan. With respect to Eisai clinical development activities for Product in Japan, upon Eisai’s request, Radius shall supply Eisai Semi-Product for the conduct of the Eisai Development activities in the amounts and at the times determined by the SC, having reference to the quantity of Semi-Product required for clinical trials in Japan. Radius shall charge [*] for Semi-Product. Radius shall ship such Semi-Product, FOB point of manufacturing. 5.3 The Parties agree that they shall, in good faith, discuss, negotiate and execute necessary agreements containing mutually acceptable terms, including but not limited to, a supply agreement for either bulk substance of Compound or Semi-Product as well as a quality control agreement of either bulk substance of Compound or Semi-Product, in the event that Eisai notifies Radius as set forth in Article 5.1 or 5.2. 5.4 As manufacturer of the Product, Radius shall be responsible for: (a) the control of the quality of the Product promoted and sold under the Radius trademarks; as provided in Article 2.3; and (b) ensuring that all bulk substance of Compound or Semi-Product supplied to Eisai pursuant to this Article 5 shall be manufactured in accordance with the applicable good manufacturing practices (GMP) and shall meet the then applicable specifications for the bulk substance of Compound or Semi-Product; and Radius warrants that all bulk substance of Compound or Semi-Product supplied to Eisai pursuant to this Article 5 shall be manufactured in accordance with the applicable GMP and * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. shall meet the then applicable specifications for the bulk substance of Compound or Semi-Product and will be free from defects in material and workmanship. Radius shall resolve any product liability issues in the Territory relating to the Product and shall resolve any product liability issues in Japan relating to the Product or the bulk substance of Compound or Semi-Product, as the case may be, supplied to Eisai pursuant to this Article 5 in the event and to the extent related to a breach of the warranty set forth in Article 5.4(b) at its own expense and subject to Article 5.5. 5.5 Radius’ obligations with respect to product liability in the Territory and Japan shall include the following responsibilities, each to be taken at Radius’ expense: (a) Radius shall report, at its expense, to appropriate authorities, in accordance with local requirements, all adverse events related to use of the Product in the Territory or Japan. Eisai shall provide to Radius, upon Radius’ request, reasonable assistance in connection with the reporting of all of adverse events, responding to safety queries and assessing safety issues, in each case, to the extent related to the Product in Japan. Adverse events shall be recorded in a single, centralized database, which shall be held and owned by Radius. Radius will provide, upon request by Eisai, any safety information in Radius’ control and reasonably required by Eisai in connection with the development and commercialization of the Product in Japan and all reasonable assistance in responding to safety queries related to the Product and in assessing safety issues related to the Product in Japan. Details of safety reporting activities relating to the Product will be addressed in a pharmacovigilance contract, which the Parties shall enter into after the Effective Date. (b) In the event that (i) Radius determines that an event, incident, or circumstance may result in the need for a recall or other removal of the Product or any lot or lots thereof from the market; (ii) any regulatory authority in the Territory threatens to remove a Product from the market; or (iii) any regulatory authority in the Territory requires distribution of a “Dear Doctor” letter or its equivalent regarding the use of Product, Radius shall promptly advise Eisai in writing, and shall provide Eisai with copies of all relevant correspondence, notices and the like. Notwithstanding anything the contrary herein, Radius shall have final authority to make all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product in the Territory. After establishing SC pursuant to Article 3.5, all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product shall be decided by the SC as set forth in Article 3.6; provided that in the event that the Parties take different positions with respect to recall, market withdrawal or other corrective action with respect to the Product, then Radius shall have the right to cease supplying bulk substance of Compound or Semi-Product to Eisai for Japan if, after good faith discussions with Eisai, Radius reasonably believes that that continued supply to Eisai exposes Radius to liability as a result of its decision with respect to the Territory. If Radius elects to cease supply, it will terminate supply in an orderly manner, as soon as practical and in accordance with a schedule agreed to by Eisai and Radius. In the event of a recall, market withdrawal or other corrective action with respect to the Product in Japan, and at Radius’ request, Eisai shall provide reasonable assistance to Radius, at Radius’ cost and expense, in conducting any such recall, market withdrawal or other corrective action with respect to the Product in Japan. 5.6 THE WARRANTY IN SECTION 5.4(b) IS IN LIEU OF ANY OTHER WARRANTY WITH RESPECT TO THE PRODUCT, BULK SUBSTANCE OF COMPOUND OR SEMI-PRODUCT SUPPLIED BY RADIUS HEREUNDER, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL (INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE).

  • Development License Subject to the terms and conditions of this XXXX, You are licensed to perform an installation of the SOFTWARE for an unlimited use in designing, testing and creating Developed Software by unlimited Developers on one or more computers.

  • Third Party Suppliers If Licensee wishes to obtain the Compound, Product and/or Licensed Product from a Third Party source, Licensee shall notify Pfizer through MPP of the intended source prior to making any commitments to purchase the Compound, Product and/or Licensed Product. Pfizer will determine at its sole discretion whether and on what terms to grant a license to the intended source to produce the Compound, Product and/or Licensed Product or inform Licensee whether such license already exists.

  • Patent License For patent claims including, without limitation, method, process, and apparatus claims which You or Your Affiliates own, control or have the right to grant, now or in the future, You grant to Us a perpetual, worldwide, non-exclusive, transferable, royalty-free, irrevocable patent license, with the right to sublicense these rights to multiple tiers of sublicensees, to make, have made, use, sell, offer for sale, import and otherwise transfer the Contribution and the Contribution in combination with the Material (and portions of such combination). This license is granted only to the extent that the exercise of the licensed rights infringes such patent claims; and provided that this license is conditioned upon compliance with Section 2.3.

  • End User License Agreement This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported License. xxxx://xxxxxxxxxxxxxxx.xxx/licenses/by-nc-nd/3.0/ You are free to: Share: to copy, distribute and transmit the work Under the following conditions: Attribution: You must attribute the work in the manner specified by the author (but not in any way that suggests that they endorse you or your use of the work).

  • SOFTWARE PRODUCT LICENSE The SOFTWARE PRODUCT is protected by copyright laws and international copyright treaties, as well as other intellectual property laws and treaties. The SOFTWARE PRODUCT is licensed, not sold.

  • Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall xxxx, and shall cause its Affiliates and Sublicensees to xxxx, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.

  • Alternate or Supplemental Pricing Documents No response Optional. If when completing Pricing Form 1 & Pricing Form 2 you direct TIPS to view additional, alternate, or supplemental pricing documentation, you may upload that documentation.

  • Sublicense to Use the Scudder Trademarks As exclusive licensee of the rights to use anx xxxxxcense the use of the "Scudder," "Scudder Investments" and "Scudder, Stevens & Clark, Inx." xxxdemaxxx (xxgether, the "Scuddex Xxxxx"), xxx xerexx xxant the Trust a nonexclusive right xxx xxxlicense to use (i) the "Scudder" name and mark as part of the Trust's name (the "Fund Namx"), xxd (ii) the Scudder Marks in connection with the Trust's investment products xxx xxxvices, in each case only for so long as this Agreement, any other investment management agreement between you or any organization which shall have succeeded to your business as investment manager ("your Successor") and the Trust, or any extension, renewal or amendment hereof or thereof remains in effect, and only for so long as you are a licensee of the Scudder Marks, provided however, that you agree to use your best xxxxxxx to maintain your license to use and sublicense the Scudder Marks. The Trust agrees that it shall have no right to suxxxxxxxe or assign rights to use the Scudder Marks, shall acquire no interest in the Scudder Marks othxx xxxx the rights granted herein, that all of txx Xxxxt's uses of the Scudder Marks shall inure to the benefit of Scudder Trust Company xx xxxer and licensor of the Scudder Marks (xxx "Xrademark Owner"), and that the Trust shall nxx xxxxlenge the validity of the Scudder Marks or the Trademark Owner's ownership thereof. The Truxx xxxxher agrees that all services and products it offers in connection with the Scudder Marks shall meet commercially reasonable standards of duaxxxx, xs may be determined by you or the Trademark Owner from time to time, provided that you acknowledge that the services and products the Trust rendered during the one-year period preceding the date of this Agreement are acceptable. At your reasonable request, the Trust shall cooperate with you and the Trademark Owner and shall execute and deliver any and all documents necessary to maintain and protect (including but not limited to in connection with any trademark infringement action) the Scudder Marks and/or enter the Trust as a registered user thereof. Xx xxch time as this Agreement or any other investment management agreement shall no longer be in effect between you (or your Successor) and the Trust, or you no longer are a licensee of the Scudder Marks, the Trust shall (to the extent that, and as soon ax, xx xawfully can) cease to use the Fund Name or any other name indicating that it is advised by, managed by or otherwise connected with you (or your Successor) or the Trademark Owner. In no event shall the Trust use the Scudder Marks or any other name or mark confusingly similar therexx (xxxluding, but not limited to, any name or mark that includes the name "Scudder") if this Agreement or any other investment advisory agrexxxxx xetween you (or your Successor) and the Fund is terminated.

  • Monopolies and Exclusive Service Suppliers 1. Each Party shall ensure that any monopoly supplier of a service in its territory does not, in the supply of the monopoly service in the relevant market, act in a manner inconsistent with that Party's Schedule of specific commitments. 2. Where a Party's monopoly supplier competes, either directly or through an affiliated company, in the supply of a service outside the scope of its monopoly rights and which is subject to that Party's Schedule of specific commitments, the Party shall ensure that such a supplier does not abuse its monopoly position to act in its territory in a manner inconsistent with such commitments. 3. If a Party has reason to believe that a monopoly supplier of a service of the other Party is acting in a manner inconsistent with paragraphs 1 or 2 above, it may request that Party establishing, maintaining or authorising such supplier to provide specific information concerning the relevant operations. 4. The provisions of this Article shall also apply to cases of exclusive service suppliers, where a Party, formally or in effect: (a) authorises or establishes a small number of service suppliers; and (b) substantially prevents competition among those suppliers in its territory.

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