Manufacture and Supply of Licensed Products Sample Clauses

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”). (b) Cardium may by written notice to BioZone, request changes to Product or Process Specifications for one or more Products. BioZone shall notify Cardium in writing (a “Change Report”) within ten days after receipt of notice of any request for changes to such Specifications, of the cost and lead time required to incorporate the requested changes. If Cardium wishes to proceed with the change, it shall sign and return to BioZone a copy of the Change Report. If the change proceeds, the cost of the associated Product shall reflect the modification as provided in the Change Report. (c) Unless otherwise agreed to for a particular Product or component thereof, all manufacture, fill and finish processing, and testing will be performed solely by qualified personnel at BioZone’s accredited manufacturing facility located at 000 Xxxxxx Xxx., Pittsburg, CA. (the “Manufacturing Location”). BioZone will not alter the Manufacturing Location, the sources of any Product components, or any Product or Process Specifications without Cardium’s prior written approval. (d) All purchases of Manufactured Products by Cardium under this Agreement shall be under the terms and conditions of Cardium’s purchase order form (“PO”), the minimum terms of which shall be as shown on the attached Exhibit 4, with such other terms as Cardium may specify, which may be delivered by facsimile, courier or other means providing a record of receipt (the “Date of PO Receipt”). The terms and conditions of the PO shall be in addition to and not in limitation of the terms and conditions of this Agreement. Any conflict between the terms and conditions of the PO and the provisions of this Agreement shall be resolved i...
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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.)
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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
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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. (b) MBI shall use *** to manufacture and supply to Chugai *** quantity of FS069 and ORALEX-Registered Trademark- solely for use in the preclinical tests and clinical trials to be conducted as part of the Chugai Development Program, in each case until such time as Chugai obtains Marketing Authorization in Japan for FS069 and ORALEX or such time as Chugai is able itself or through one or more Affiliates or Third Parties to manufacture or have manufactured FS069 and ORALEX-Registered Trademark- that can be used in clinical trials, in each case whichever occurs first. (c) If requested in writing by the other party, MBI and Chugai shall discuss the terms under which each party would provide backup manufacturing capabilities for the other. The parties acknowledge that any backup manufacturing arrangement would need to be mutually acceptable, and that neither party shall have any liability hereunder in the event the parties are not able to agree on the terms for such an...
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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.
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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. (b) After First Commercial Sale of the Licensed Product in the Territory, Licensee shall have the right, but not the obligation, [***]; provided, however, that if Licensee chooses to exercise its [***] it shall also [***]. If Licensee wishes to exercise this right, it shall so notify Akebia, and [***]. For the avoidance of doubt, Licensee shall not be permitted to [***]. Upon the execution of a [***], which shall include the Parties’ respective obligations and responsibilities relating to matters of [***]. If Licensee wishes to [***] pursuant to this Section 7.01(b), Licensee may do so only with Akebia’s prior written consent, not to be unreasonably withheld or delayed, and all other terms of this Section 7.01(b) shall apply.
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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.
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Manufacture and Supply of Licensed Products. 5.1 Responsibilities for Licensed Product Supply.
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Related to Manufacture and Supply of Licensed Products

  • Manufacture and Supply As between the Parties, Otsuka shall be responsible for, shall bear all costs associated with, and shall have all decision-making authority over, all Manufacturing Activities (subject to discussion of CMC matters with Acucela through the JDC or applicable Operating Team as discussed below); provided, that Otsuka shall supply Licensed Product to Acucela or its permitted subcontractors for use in clinical trials conducted in accordance with each Development Plan and, if applicable, Commercialization Plan (i.e., Phase 3b Clinical Trials or Post-Approval Studies, if any), free of charge and in such quantities as are agreed by the JDC or the JCC (as applicable) or are otherwise required to seek or obtain Regulatory Approval. In addition, if and after Acucela exercises an Opt-In Right under Section 3.1, Otsuka shall supply promotional samples of Licensed Product to Acucela for use in its performance of Co-Promotion, in such quantities and on such terms as are determined by the JCC. The cost of promotional samples of Licensed Product, which shall be included in Commercialization Costs, shall be established by the JCC based on Otsuka’s per-unit cost to manufacture such promotional samples (but, for the avoidance of doubt, Otsuka shall have no obligation to disclose any information relating to its manufacturing costs), but in no event shall such promotional sample cost exceed * per promotional sample unless mutually agreed otherwise by the Parties. Acucela’s and its permitted subcontractors’ obligations to conduct Development activities, and upon Acucela’s exercise of its Opt-in Right pursuant to Section 3.1, to conduct Development and Commercialization activities, shall be expressly conditioned upon Otsuka fulfilling its Licensed Product supply obligations as set forth in the Development Plan or the Commercialization Plan, as applicable. To the extent that Otsuka reasonably believes is necessary for performance of Development or Commercialization, Otsuka agrees to keep Acucela reasonably informed from time to time, through the JDC, JCC or applicable Operating Team, regarding the general status of Manufacturing Activities related to the Licensed Product (including Other Indication Product(s), as applicable) and from time to time shall update Acucela on any foreseeable delays and/or other material issues relating to Manufacturing the Licensed Product (including Other Indication Product(s), as applicable). Through the JDC or applicable Operating Team, Otsuka and Acucela shall confer and discuss CMC matters, and Otsuka agrees to consider suggestions of Acucela regarding CMC matters.

  • 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.

  • 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.

  • Supply of Products ‌‌ 3.1 The Supplier warrants that the Products shall: (a) correspond with their description and any applicable Product Specification; (b) conform in all respects with the Order and any relevant sample; (c) be of satisfactory quality and fit for any purpose held out by the Supplier or made known to the Supplier by Ornua, expressly or by implication, and in this respect Ornua relies on the Supplier's skill and judgement; (d) be manufactured by properly trained and qualified personnel using all reasonable skill, care and diligence and in a good and workmanlike manner;‌ (e) where they are manufactured products, be free from defects in design, materials and workmanship and remain so for the period set out in the Product Specification or, if none is specified, for at least 12 months after delivery; (f) comply with all applicable statutory and regulatory requirements relating to the manufacture, labelling, packaging, storage, handling and delivery of the Products;‌ (g) comply with all relevant standards including any UK Standards, European Standards or International Standards applicable in the UK and the country or State where the Products are to be used; and (h) in the case of Products containing food stuffs, when delivered to Ornua, comply with all applicable food and hygiene legislation and regulations and best industry practice.‌ 3.2 The Supplier shall ensure that at all times it has and maintains all licences, permissions, authorisations, consents and permits needed to carry out its obligations under the Contract in respect of the supply of Products. Breach of this Condition shall be deemed a material breach of the Contract. 3.3 Ornua may inspect and test the Products at any time before delivery. The Supplier shall remain fully responsible for the Products despite any such inspection or testing and any such inspection or testing shall not reduce or otherwise affect the Supplier's obligations under the Contract. 3.4 If following such inspection or testing Ornua considers that the Products do not comply or are unlikely to comply with the Supplier's undertakings at clause 3.1, Ornua shall inform the Supplier and the Supplier shall immediately take such remedial action as is necessary to ensure compliance.‌ 3.5 Ornua may conduct further inspections and tests after the Supplier has carried out its remedial actions.

  • Manufacture of Products All Products marketed through Grantor's Web ------------------------- Site shall be manufactured, packaged, prepared, and shipped in accordance with the specifications and requirements described on Exhibit A hereto as it may be modified from time to time. Quality control standards relating to the Product's weight, color, consistency, micro-biological content, labeling and packaging are also set forth on Exhibit A. In the event that Exhibit A is incomplete, Products shall be manufactured and shipped in accordance with industry standards.

  • Supply of Product 4.1 DAEWOONG shall manufacture and supply Product to AEON in a primary packaged and labeled form. Product packaging shall display the logo of DAEWOONG (to the extent required by applicable law) and AEON and the outer label shall be marked using English language in accordance with applicable laws and Product’s Regulatory Approvals. 4.2 AEON’s estimate sales forecast of the Product during the Term of Agreement in the Territory in the Field is set forth in Annex D. Within ninety (90) days after the Effective Date, AEON shall provide DAEWOONG with a non-binding twelve (12) month rolling forecast of its requirements of Product, which the Parties agree is not a commitment to buy any stated quantity. Thereafter, on at least a quarterly basis, AEON shall provide DAEWOONG with an updated twelve (12) month rolling forecast, together with a binding six (6) month forecast to the extent AEON has requested Safety Stock as described in Article 4.10 below. Each such forecast shah be referred to herein as a “Forecast.” 4.3 AEON may from time to time submit Purchase Orders to DAEWOONG for Product in accordance with the forecasting requirements in Article 4.2. Orders will be shipped on CIF Los Angeles port. 4.4 Once a Purchase Order for Product and Product Samples has been received by DAEWOONG, it shall be considered as irrevocable. 4.5 AEON agrees herein to place an Order for Product not later than [***] from receipt of Regulatory Approval. 4.6 Individual Purchase Orders of Product shall be placed at least [***] in advance of the required delivery date. 4.7 For the purpose of Commercialization, AEON will store and maintain the full quantity of Product in a clean, secured area in accordance with the reasonable directions and specifications provided by DAEWOONG in writing in connection thereof in the Territory. AEON will advise DAEWOONG on the applicable requirements specifically deriving from the laws and regulations in the Territory. 4.8 AEON agrees that DAEWOONG and its collaborators and agents, in DAEWOONG’s sole discretion, which collaborators and Agents will be subject to appropriate obligations of confidentiality, will have the right upon reasonable prior notice, to observe and to inspect and to audit AEON’s facility to ascertain compliance by AEON with the terms of this Agreement, including without limitation (a) the holding facilities for Product, and (b) AEON’s compliance with applicable law, including cGMP (if applicable). Following any such audit, DAEWOONG will discuss its observations and conclusions with AEON and corrective actions, if any, will be agreed upon by the Parties, and executed by AEON using Commercially Reasonable Efforts. 4.9 In addition to any other rights and remedies available to AEON, AEON shall have the right to recover lost profits in the event that DAEWOONG fails to deliver at least [***] in any [***] (a “Supply Default Event”). For purposes of this provision, lost profits would be equal to [***] of AEON operating profit (sales less direct expenses and the puce paid by AEON for such Products) on Products that have not been shipped against firm Purchase Orders during the period leading up to the Supply Default Event and bona fide Purchase Orders submitted by AEON that are consistent with the Forecast during the Supply Default Period (as defined below). Such payment shall be made with respect to all Product not shipped in the period giving rise to the Supply Default and for the period until DAEWOONG is again timely shipping Product to meet AEON’s needs (the “Supply Default Period”). The first such payment shall be made within [***] of the Supply Default Event, and every [***] thereafter. AEON agrees to permit full disclosure to DAEWOONG of AEON’s accounting records, solely related to the calculation of lost profits, for the [***] ending on the first day of the month in which the Supply Event Default occurred. In the event that DAEWOONG is unable to supply both AEON’s requirements of Product and its own and third parties’ requirements for Product, DAEWOONG shall allocate Product that DAEWOONG has in inventory and that DAEWOONG is able to Product, so that AEON receives its requirements of Product in priority to DAEWOONG and third parties. 4.10 At the request of AEON, DAEWOONG shall at its own cost and expense during the Term, maintain an amount of inventory of Product equal to AEON’s requirements for Product for [***] based on AEON’s most recent forecast (“Safety Stock”). The Safety Stock shall be (i) maintained for the sole benefit of AEON and its Affiliates, (ii) shall be stored at a secure facility in compliance with GMP, and (iii) shall not be used for the benefit of any other customer of DAEWOONG. DAEWOONG shall rotate the Safety Stock on a “First Expiry-First Out” basis for routine fulfillment of firm orders, subject to Article 7.

  • 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. 2.2. The fixation elements shall be strong and firmly secured to the LED(s) and the LED module.

  • 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.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

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