Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.
Reformulation of Products As of the Effective Date, and continuing thereafter, Products that Xxxxx directly manufactures, imports, distributes, sells, or offers for sale in California shall either: (a) be Reformulated Products pursuant to § 2.2, below; or (b) be labeled with a clear and reasonable exposure warning pursuant to §§ 2.3 and 2.4, below. For purposes of this Settlement Agreement, a “Reformulated Product” is a Product that is in compliance with the standard set forth in
Supply of Materials The following materials will be supplied by the department Name of Materials Rate. Place of delivery 1.
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.
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.
RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.
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.
Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract.
a. The contractor shall notify all potential subcontractors and suppliers and lessors of their EEO obligations under this contract.
b. The contractor will use good faith efforts to ensure subcontractor compliance with their EEO obligations.
Product Labeling The labeling of all Licensed Products sold or offered for sale under this Agreement shall expressly state that the Licensed Product is manufactured under a license from the Medicines Patent Pool.
