Custom Products Effective upon creation of Custom Products, Contractor hereby conveys, assigns and transfers to Authorized User the sole and exclusive rights, title and interest in Custom Product(s), whether preliminary, final or otherwise, including all trademark and copyrights. Contractor hereby agrees to take all necessary and appropriate steps to ensure that the Custom Products are protected against unauthorized copying, reproduction and marketing by or through Contractor, its agents, employees, or Subcontractors. Nothing herein shall preclude the Contractor from otherwise using the related or underlying general knowledge, skills, ideas, concepts, techniques and experience developed under a Purchase Order, project definition or work order in the course of Contractor’s business. Authorized User may, by providing written notice thereof to the Contractor, elect in the alternative to take a non-exclusive perpetual license to Custom Products in lieu of Authorized User taking exclusive ownership and title to such Products. In such case, Licensee on behalf of all Authorized Users shall be granted a non-exclusive perpetual license to use, execute, reproduce, display, perform, adapt and distribute Custom Product as necessary to fully effect the general business purpose(s) as stated in paragraph (b)(i)(2), above.
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.
Additional Products and Services Subject to the allocation of funds, the CPO may add similar equipment, supplies, services, or locations, within the scope of this Agreement, to the list of equipment, supplies, services, or locations to be performed or provided by giving written notification to Contractor. For purposes of this Section, the “Effective Date” means the date specified in the notification from the CPO. As of the Effective Date, each item added is subject to this Agreement, as if it had originally been a part, but the charge for each item starts to accrue only on the Effective Date. In the event the additional equipment, supplies, services, or locations are not identical to the items(s) already under this Agreement, the charges therefor will then be Contractor’s normal and customary charges or rates for the equipment, supplies, services, or locations classified in the Fees and Costs (Exhibit “F”).
Product Sales Subject to Sections 10.3(c) and 10.3(d), Licensee agrees that it will not sell, offer for sale, or assist third parties (including Affiliates) in selling Product except for the sale and offer for sale of (A) TAF Product, TAF Combination Product, TDF Product and TDF Combination Product for use in the Field and in the countries of the TDF-TAF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, and (C) EVG Product, EVG Combination Product and Quad Product for use in the Field and in the countries of the EVG-Quad Territory. (i) Licensee agrees that during the period in which the Patents are valid and enforceable (on a Product-by-Product basis) it will prohibit its Distributors from selling Product (A) to any other wholesaler or distributor, (B) outside the Territory for which Licensee is licensed for sale of such Product pursuant to Section 2.2, or (C) for any purpose outside the Field. (ii) Licensee agrees that it will not administer the TAF Quad to humans, or sell the TAF Quad until Gilead has obtained marketing approval for the TAF Quad from the FDA. Licensee agrees that it will not administer EVG to humans, or sell Products containing EVG until Gilead has obtained marketing approval for an EVG Product from the FDA. Licensee agrees that it will not administer COBI to humans, or sell Products containing COBI until Gilead has obtained marketing approval for a COBI Product from the FDA. Licensee agrees that it will not administer TAF to humans, or sell Products containing TAF until Gilead has obtained marketing approval for a TAF Product from the FDA. If Gilead obtains marketing approval from the FDA for any Quad Product or a Combination Product containing TAF, COBI or EVG (“Approved Combination Product”) prior to obtaining marketing approval for a TAF Product, EVG Product or COBI Product from the FDA, then Licensee will be allowed to administer such Quad Product or such Approved Combination Product to humans, and sell such Quad Product or such Approved Combination Product from and after the date of such marketing approval from the FDA, but will not (A) administer to humans or sell Combination Products containing EVG other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for an EVG Product, or (B) administer to humans or sell Combination Products containing COBI other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for a COBI Product or (C) administer to humans or sell Combination Products containing TAF other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for a TAF Product.
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.
Product Recalls (a) If either Party reasonably decides or is required by any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning such action. The Parties will assist each other in investigating any such situation and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by HSL and LMI. (b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. For the purposes of this Agreement, the expenses of any recall, withdrawal, field correction or seizure shall include, without limitation, the out-of-pocket expenses of notification and destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c).
PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.
API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.
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.
Supply of Materials The following materials will be supplied by the department Name of Materials Rate. Place of delivery 1.