Manufacturing Assistance. From and after completion of the POC Trial, Bayer shall be responsible for the manufacture of the Licensed GT Products for clinical or commercial use, including any process development and scale up. Notwithstanding the foregoing, in sufficient advance of any Phase II/III Trial by Bayer (including prior to completion of the POC Trial), Dimension and Bayer shall meet and discuss and, if Bayer considers it appropriate, engage ReGenX and any other necessary Third Parties for purposes of developing processes necessary to enable Bayer’s commercial manufacturing of the Licensed GT Product for use in the Field.
Manufacturing Assistance. FAILURE ANALYSIS/SILICON DEBUGGING - other support service mutually agreed between the parties
Manufacturing Assistance. Many SBDCs partner with the Department of Commerce, National Institute of Standards and Technology’s Manufacturing Extension Partnerships (MEPs) to provide specialized services to small manufacturers. Through this partnership, a small manufacturer can receive business management assistance from the SBDC and engineering assistance from the MEPs. Most SBDCs and MEPs view the partnership as significant. All SBDCs that are partnering with the NIST MEPs are encouraged to continue this valuable assistance to small business manufacturers. SBDCs without a working partnership with the NIST MEPs may wish to pursue one. The nature of any participation with MEPs must be reported in the semiannual and annual reports to SBA.
Manufacturing Assistance. Following delivery of the POC Trial Material in accordance with the Transition Plan and that certain Quality Agreement entered into by and between the Parties or any of their Affiliates, dated on or about April 25, 2018 (the “Quality Agreement”), Bayer shall be responsible for the manufacture of the Licensed GT Products for clinical or commercial use, including any process development and scale up. Notwithstanding the foregoing, Dimension shall provide the support outlined in Exhibit D-4, and shall negotiate in good faith an agreement to provide reasonable additional support and assistance as Bayer might consider to be necessary in connection with the manufacturing process. Dimension shall not be obligated to provide any such additional support prior to the Parties entering into a written agreement with respect to the same, which shall provide for reasonable compensation to be paid.
Manufacturing Assistance. Luoxin may, during the Term, at its own discretion, exercise the right to manufacture the Licensed Compound and/or Licensed Products in the Luoxin Territory. In order to facilitate Luoxin’s exercise of such right, Synergy shall, following its receipt of a written request by Luoxin during such time, provide such documents, Information, technical assistance and support necessary or reasonably useful for Luoxin to manufacture or have manufactured by a third party contractor engaged by Luoxin, Licensed Compound or Licensed Product, to the extent Controlled by Synergy as of such date in a timely manner to be reasonably requested by Luoxin. Luoxin shall pay Synergy’s direct and reasonable external costs and expenses (including travel and accommodation costs) incurred in connection with providing such Information or assistance pursuant to this Section 7.5. [*] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portion. Prior to providing such Information or assistance, Synergy shall provide Luoxin an estimate of any external costs and expenses related thereto and shall not incur any such external costs and expenses without Luoxin’s prior written consent. Notwithstanding the foregoing, Luoxin’s right to manufacture API for the Licensed Compound or Licensed Product in the Luoxin Territory shall be exercisable only after receipt of MAA approval for the first Licensed Product by the applicable Regulatory Authority in mainland China.
Manufacturing Assistance. The JDC will oversee the transition of manufacturing responsibilities from SGX to Novartis for Collaboration Compounds and Products for which an IND is to be filed. SGX shall fully cooperate with and provide assistance to Novartis or its designee, at Novartis’ expense, through documentation, consultation, training and face-to-face meetings, to enable Novartis or its designee to proceed with manufacturing of the Collaboration Compounds and the Products and to obtain all appropriate Marketing Authorizations for manufacturing (including qualification by the applicable Regulatory Authority of manufacturing sites). Promptly after the Effective Date, SGX shall disclose and provide to Novartis all relevant SGX Know-How to enable Novartis to promptly prepare for the transition of manufacturing responsibilities.
Manufacturing Assistance. Should Seller notify Buyer that Seller is unable to supply Buyer with Products or Exclusive Parts pursuant to this Agreement, Buyer agrees to inform Seller of the purchase orders that exist as of the date of notification. Seller agrees to use its commercially reasonable efforts to assist Buyer in the fulfillment of its obligations under such purchase orders, until such time as Buyer is able to procure an acceptable alternative source for such Products or Exclusive Parts. Buyer agrees to use its commercially reasonable efforts to procure an acceptable alternative source as soon as possible after Buyer's receipt of notice of such inability to perform.
Manufacturing Assistance. Without limiting the generality of Section 3.2 (Assistance and Costs), during the Technology Transfer Period upon CASI’s reasonable request, Black Belt will provide CASI with introductions to all Third Party contract manufacturers and other vendors that as of the Effective Date have provided Black Belt or its Affiliates with products or services relating to the Licensed Compounds or Licensed Products, and will make available to CASI such appropriate employees and representatives of Black Belt that are most familiar with the Licensed Compounds and Licensed Products, and cause such employees and representatives of Black Belt, to meet with employees or representatives of CASI (or its Affiliate or designated Third Party contract manufacturers, as applicable) at the applicable manufacturing facility at mutually convenient times to provide reasonable technical advice and assistance to facilitate the transfer of all Black Belt Know-How related to the Manufacture of the Licensed Compounds and Licensed Products, to the extent reasonably necessary to enable CASI (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Black Belt Know-How. Notwithstanding any provision in this Agreement to the contrary, CASI will reimburse Black Belt for all out-of-pocket expenses (including travel expenses) incurred by Black Belt in connection with any assistance provided by Black Belt under this Section 3.2.2 (Manufacturing Assistance).
Manufacturing Assistance. (1) During the term of this Agreement, at the written request of Universal, USA will send competent representatives to visit Universal’s manufacturing plant or plants for the purpose of assisting and advising Universal in connection with the Deck Process. The identity and number of such representatives and the date and duration of each such visit shall be such as USA and Universal may mutually agree to be necessary. USA shall not be required to provide more than twenty days of personnel support per Annual Year. Universal shall pay a daily assistance fee of $600.00 per person for such advisory services, plus all reasonable traveling, living and other costs and expenses of such representatives.
Manufacturing Assistance. Each Party shall initially provide the other Party with all current design and related documentation concerning its respective products in its possession which may be useful to the other Party in exercising its manufacturing rights hereunder. Each Party shall use commercially reasonable best efforts to complete such transfer as soon as practical after the Parties have reached an Agreement to Commercialize for each Collaboration Product. Thereafter, each Party shall periodically provide the other with all relevant information and materials regarding any updates, modifications, improvements or corrections to any Collaboration Products which may be made by such Party. The Parties shall discuss and mutually agree upon any NANOGEN or HITACHI requirements that cause changes to be made to the Collaboration Products and the impact such changes may have on schedules and any additional costs related to such changes. Existing production and test equipment currently located at NANOGEN facilities which can be utilized in the development and/or manufacture of HITACHI Products, any Other Products (that HITACHI is to develop and/or manufacture pursuant to any Development Plan), and any NANOGEN Products (that HITACHI is to manufacture pursuant to Section 5.5) which HITACHI cannot purchase from outside vendors, will be made available free of charge and transferred at NANOGEN's expense to HITACHI's facility for HITACHI's use in connection with HITACHI's performance of its obligations under this Agreement, upon HITACHI'S request. In the event of expiration or earlier termination of this Agreement, all such production and test equipment shall be returned to NANOGEN's facility at HITACHI's expense upon the expiration of HITACHI's right to manufacture hereunder as set forth in Section 12.8.
