Exclusivity of Supply of LX Bulk Drug Substance Sample Clauses

Exclusivity of Supply of LX Bulk Drug Substance. During the Exclusive Manufacturing Period(s) applicable to POZEN, POZEN will subject to Section 7.5 of this Agreement purchase from Nycomed and Nycomed will use commercially reasonable efforts to provide to POZEN, 100% of POZEN’s requirements of LX Bulk Drug Substance or Lornoxicam (or any salts, solvates or polymorphs thereof), to be provided by Nycomed in the form of LX Bulk Drug Substance, for use in the manufacture of any POZEN Product. For purposes of clarification, for any POZEN Product manufactured after the applicable Exclusive Manufacturing Period, POZEN will have the right to source LX Bulk Drug Substance or Lornoxicam (or any salt, solvate or polymorph thereof) from any entity. POZEN will ensure that either no Sublicense Agreement shall become effective unless and until the Sublicensee enters into a supply agreement with Nycomed in substantially the same form as the supply agreement attached to this Agreement as Exhibit J (attached to this Agreement and incorporated in this Agreement by reference) or, at POZEN’s election, POZEN undertakes to purchase 100% of such Sublicensee’s requirements of LX Bulk Drug Substance or Lornoxicam (or any salts, solvates or polymorphs thereof), to be provided by Nycomed in the form of LX Bulk Drug Substance, for use in the manufacture of any POZEN Product under the terms and conditions set forth in this Agreement for supply to POZEN. Nycomed will use commercially reasonable efforts to enter into such a supply agreement with each Sublicensee, and POZEN will use commercially reasonable efforts to cause each Sublicensee to enter into such a supply agreement, as promptly as practicable. In the event that a supply agreement between Nycomed and a Sublicensee is terminated for any reason other than material breach by Nycomed prior to the expiration of the applicable Exclusive Manufacturing Period(s), Nycomed shall provide POZEN with written notice of such termination, and POZEN shall promptly terminate or cause the termination of such Sublicensee’s Sublicense Agreement with respect to the Licensed Technology or any portion thereof that is sublicensed to such Sublicensee. For purposes of clarification, if a Sublicensee has entered into a supply agreement with Nycomed, POZEN, in its discretion, may supply such Sublicensee with all or any portion of such Sublicensee’s requirements of LX Bulk Drug Substance, out of POZEN’s own stock of LX Bulk Drug Substance purchased from Nycomed. *** Portion for which confidential treatmen...
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Exclusivity of Supply of LX Bulk Drug Substance. During the Exclusive Manufacturing Period(s) applicable to POZEN, POZEN will subject to Section 7.5 of this Agreement purchase from Nycomed and Nycomed will use commercially reasonable efforts to provide to POZEN, 100% of POZEN’s requirements of LX Bulk Drug Substance or Lornoxicam *** Portion for which confidential treatment requested.

Related to Exclusivity of Supply of LX Bulk Drug Substance

  • Supply of Materials The following materials will be supplied by the department Name of Materials Rate. Place of delivery 1.

  • 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.

  • AUDIT OF LICENSED PRODUCT USAGE Contractor shall have the right to periodically audit, no more than annually, at Contractor’s expense, use of licensed Product at any site where a copy of the Product resides provided that: (i) Contractor gives Licensee(s) at least thirty (30) days advance written notice, (ii) such audit is conducted during such party’s normal business hours, (iii) the audit is conducted by an independent auditor chosen on mutual agreement of the parties. Contractor shall recommend a minimum of three (3) auditing/accounting firms from which the Licensee will select one (1). In no case shall the Business Software Alliance (BSA), Software Publishers Association (SPA), Software and Industry Information Association (SIIA) or Federation Against Software Theft (FAST) be used directly or indirectly to conduct audits, or be recommended by Contractor; (iv) Contractor and Licensee are each entitled to designate a representative who shall be entitled to participate, and who shall mutually agree on audit format, and simultaneously review all information obtained by the audit. Such representatives also shall be entitled to copies of all reports, data or information obtained from the audit; and (v) if the audit shows that such party is not in compliance, Licensee shall be required to purchase additional licenses or capacities necessary to bring it into compliance and shall pay for the unlicensed capacity at the NYS Net Price in effect at time of audit, or if none, then at the Contractor’s U.S. Commercial list price. Once such additional licenses or capacities are purchased, Licensee shall be deemed to have been in compliance retroactively, and Licensee shall have no further liability of any kind for the unauthorized use of the software.

  • 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.

  • Limited Product Warranty Repair or Replacement within 12 years

  • Supply Agreement Seller and Buyer, or their Affiliates, shall have executed the Supply Agreement.

  • Storage of Materials Borrower shall cause all materials supplied for or intended to be utilized in the construction of the Improvements but not affixed to or incorporated into the Property to be stored on the Property or at such other location as may be approved by Lender in writing, with adequate safeguards to prevent loss, theft, damage or commingling with other materials not intended to be utilized in the construction of the Improvements.

  • 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.

  • Xxxxx of License Georgia Institute of Technology shall grant the Student a limited, nonexclusive, nontransferable and revocable license to use and occupy an assigned space in a Georgia Institute of Technology facility in accordance with the terms and conditions of this Contract (the “License”). The parties to this Contract do not intend that an estate, a tenancy or any other interest in property should pass from Georgia Institute of Technology to Student. Instead, it is the intention of the parties that the relationship between Georgia Institute of Technology and Student be that of licensor and licensee and the sole right of Student to use the assigned space as a living unit shall be based upon the License granted in this Contract.

  • SOURCE CODE ESCROW FOR LICENSED PRODUCT If Source Code or Source Code escrow is offered by either Contractor or Product manufacturer or developer to any other commercial customers, Contractor shall either: (i) provide Licensee with the Source Code for the Product; or (ii) place the Source Code in a third party escrow arrangement with a designated escrow agent who shall be named and identified to the State, and who shall be directed to release the deposited Source Code in accordance with a standard escrow agreement acceptable to the State; or (iii) will certify to the State that the Product manufacturer/developer has named the State, acting by and through the Authorized User, and the Licensee, as a named beneficiary of an established escrow arrangement with its designated escrow agent who shall be named and identified to the State and Licensee, and who shall be directed to release the deposited Source Code in accordance with the terms of escrow. Source Code, as well as any corrections or enhancements to such source code, shall be updated for each new release of the Product in the same manner as provided above and such updating of escrow shall be certified to the State in writing. Contractor shall identify the escrow agent upon commencement of the Contract term and shall certify annually that the escrow remains in effect in compliance with the terms of this clause. The State may release the Source Code to Licensees under this Contract who have licensed Product or obtained services, who may use such copy of the Source Code to maintain the Product.

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