Manufacture and Supply of Licensed Products Sample Clauses

Manufacture and Supply of Licensed Products. (a) Subject to the terms and conditions of this Agreement, Akebia shall be responsible for manufacturing or having manufactured and supplying all reasonable requirements of Licensed Product for clinical and commercial use in the Territory in accordance with GCP and GMP at the same level of diligence [***]. If necessary, the Parties shall agree upon a supply agreement for the clinical supply of the Licensed Product by Akebia to Licensee in the Territory pursuant to which Akebia shall supply Licensed Products at [***]. Prior to commercial launch of the Licensed Product, the Parties shall agree upon a supply agreement for the commercial supply of the Licensed Product by Akebia to Licensee in the Territory, which shall include provisions regarding long-range forecasting of Licensee’s requirements for the Licensed Product. Promptly after the execution of a supply agreement, the Parties will enter into a mutually acceptable quality agreement, which shall include the Parties’ respective obligations and responsibilities relating to quality assurance requirements for Licensed Products.
Sample 1Sample 2
AutoNDA by SimpleDocs
Manufacture and Supply of Licensed Products. Following the Option Exercise Date and subject to completion of the required Technology Transfer under Section 5.3 (Technology Transfer Activities), Galapagos, either itself or with or through Third Party(ies), will be solely responsible for, at its own cost and expense, the Manufacture of the Licensed TCR Vector and the Licensed Products for the Exploitation of the Licensed Products (including for use in Clinical Trials) in the Field in the Territory. For the Manufacture of the Licensed TCR Vector, Galapagos may elect to either Manufacture the Licensed TCR Vector itself or by any of its Affiliates or, subject to Section 4.3 (Subcontracting), to have the Licensed TCR Vector Manufactured by a Third Party contract manufacturer selected by Galapagos and reasonably acceptable to Adaptimmune (such acceptance not to be unreasonably withheld, conditioned, or delayed). Approval of such Third Party contract manufacturer may be requested by Galapagos as part of the Pre-Technology Transfer Activities. Notwithstanding anything herein to the contrary, Adaptimmune will retain the right to conduct and remain responsible for all manufacturing activities necessary for the exploitation of its Adaptimmune Product Rights.
Sample 1
Manufacture and Supply of Licensed Products. Unless otherwise agreed to by the Parties, DS shall be responsible, at its sole expense, for manufacturing, either by itself, its Affiliates or by a Third Party contract manufacturing organization, each Licensed Product that is Developed and Commercialized under this Agreement. DS shall report regularly to the JEC on CMC plans and activities, development of manufacturing processes and any plans for outsourcing (including the identity of any Third Party to which any part of manufacture of Licensed Products is outsourced.)
Sample 1
Manufacture and Supply of Licensed Products. 21 7.1 Manufacture and Supply of Licensed Products. . . . . . . . . . . . 21 7.2 Orders for Clinical Supplies . . . . . . . . . . . . . . . . . . . 22 7.3 Delivery of Clinical Supplies. . . . . . . . . . . . . . . . . . . 22 7.4
Sample 1
Manufacture and Supply of Licensed Products. (a) Chugai may manufacture or have manufactured the Licensed Products pursuant to the license granted under Section 2.1 above. MBI shall provide reasonable assistance to Chugai in connection with the manufacture of the Licensed Products, which assistance shall include, if reasonably requested by Chugai, reasonable assistance to Chugai in identifying and communicating with suppliers of components of Licensed Products, and Chugai shall reimburse MBI for the reasonable lodging, meal and travel expenses (and all other travel-related expenses) incurred in providing the assistance to Chugai within thirty (30) days of receipt of an invoice for such travel expenses. MBI's obligation to provide reasonable assistance to Chugai pursuant to the preceding sentence shall not exceed *** of assistance for each of the Licensed Products. In the event that Chugai requests additional assistance in excess of the *** provided for above, MBI will use reasonable efforts to provide such additional assistance to Chugai on terms mutually agreed upon by MBI and Chugai. In the event that the parties are not able to agree on the terms under which such assistance will be provided to Chugai, MBI shall use *** to provide such assistance to Chugai ***. Chugai's right to appoint a Third Party supplier to manufacture any of the Licensed Products for Chugai shall be subject to the Third Party supplier executing a binding contract between MBI and the Third Party supplier to manufacture the Licensed Products on terms acceptable to MBI.
Sample 1
Manufacture and Supply of Licensed Products. (a) BioZone shall exclusively manufacture and supply Schedule A Products and any Manufactured Schedule B Products (collectively “Manufactured Products”) to Cardium in strict compliance with (i) the product specifications developed for each Manufactured Product (the “Product Specifications”); (ii) the process specifications developed for the manufacturing and testing of products in general, the “Standard Process Specifications” which are attached as Exhibit 3, together with individual specifications and proposed batch records for the manufacture and testing of specific products, the “Individual Process Specifications” (all of which are referred to individually and collectively as the “Process Specifications”), and (iii) all applicable laws and governmental regulations (“Governmental Standards”).
Sample 1
Manufacture and Supply of Licensed Products. Throughout the Term, each Nuance Entity shall have Verona supply to such Nuance Entity all quantities of Licensed Product that such Nuance Entity needs for the Development or Commercialization of Licensed Product in the Field in the Territory. In connection therewith, at a Nuance Entity’s written request (“Supply Request”), but in no event later than one hundred and eighty (180) days following the Effective Date of this Agreement, Nuance and Verona will negotiate in good faith and enter into a supply agreement for clinical and/or commercial supply of Licensed Product and a related quality agreement (collectively with the aforementioned supply agreement between Nuance and Verona, the “Supply Agreement”). The Supply Agreement will be consistent with the terms set forth in this Section 7.01 (Manufacture and Supply of Licensed Products). From and after the execution of the Supply Agreement, and subject to the terms of such Supply Agreement, Verona will use Commercially Reasonable Efforts, either itself or through Third Parties, to supply to the applicable Nuance Entity Licensed Product in quantities that are requested by Nuance for the conduct of Development and Commercialization of Licensed Product in the Field and in the Territory. The purchasing Nuance Entity shall pay Verona the Supply Price for any Licensed Product supplied by Verona pursuant to this Section 7.01 (Manufacture and Supply of Licensed Products). Nuance shall be responsible for, and shall pay directly for, all import-related requirements, expenses or taxes related to importing Licensed Product into the Territory. In addition, if Verona will be required to engage in any product development work specifically needed in order to supply Licensed Product to Nuance for Development or Commercialization by Nuance in the Territory, Nuance shall agree in advance to reimburse Verona for the costs of all such work.
Sample 1
AutoNDA by SimpleDocs
Manufacture and Supply of Licensed Products. 5.1 Responsibilities for Licensed Product Supply.
Sample 1

Related to Manufacture and Supply of Licensed Products

  • Manufacture and Supply Subject to the terms and conditions of this Agreement, Collaboration Products shall be manufactured and supplied for preclinical and clinical testing and for commercial sale upon the following terms and conditions:

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Supply of Product Salix shall use reasonable efforts to supply the Product during the Co-Promotion Period in sufficient quantities to satisfy the levels of Product sales forecasted in the then current Marketing Plan. Salix shall maintain reasonable inventory levels of the Product in order to ensure their ability to fulfill this obligation. Salix shall have the sole responsibility and right to fill orders with respect to the Product. Altana shall not solicit orders for the Product but, if for any reason, Altana shall receive an order for the Product, Altana shall promptly forward to Salix any such orders. All orders for Product shall be subject to acceptance by Salix, in its sole discretion, which acceptance shall not be unreasonably withheld. Salix may cancel any order for Product at any time after acceptance without incurring any liability to Altana. Salix shall be solely responsible for responding to requests from Target Physicians for individual patients who need the Product but are unable to afford it. Any such request shall be forwarded by Altana to Salix for processing. Salix shall have the sole right and responsibility for establishing and modifying the terms and conditions of the sale of the Product, including (a) the price at which the Product will be sold, (b) whether the Product will be subject to trade or quantity discounts, (c) whether any discount will be provided for payments on accounts receivable, (d) whether the Product will be subject to rebates, returns and allowances or retroactive price reductions, (e) the channels of distribution of the Product, and (f) whether credit [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. is to be granted or refused in connection with any sale of Product. In the event that Salix fails to supply the Product as required pursuant to this Agreement for any reason other than a Force Majeure, which such failure results in lost sales for Altana, the Parties shall meet and attempt to negotiate a mutually agreeable and commercially reasonable solution. If the Parties cannot reach such an agreement within a reasonable period of time, the issue will be dealt with as contemplated under Section 4.4 of this Agreement.

  • Manufacture of Product Prior to commercialization of the Product, the Parties may, if appropriate for both parties, negotiate in good faith a manufacturing and supply agreement to provide for Licensor to fulfill the manufacturing requirements of Licensee for Product for sale in the European market. The cost of such manufacturing shall not be greater than * percent (*%) of the cost of any competitor cGMP contract manufacturing facility that proposes to manufacturer the Product for Licensee. * Confidential information has been omitted and filed confidentially with the Securities and Exchange Commission.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • Manufacture 2.1. The LED(s) on the LED module shall be equipped with suitable fixation elements.

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!