Value dossiers Sample Clauses

Value dossiers. La Jolla and the Licensors shall, at no additional cost, disclose to Paion and Licensed Subsidiaries any Know-how and/or Programme Data in La Jolla's, Licensors and/or their Affiliates' possession or control that is necessary or useful for the exploitation of the Licensed Rights in the Territory and that La Jolla, Licensors and/or their Affiliates may develop, have developed or acquire during the Term, including without limitation all such Know-how and/or Programme Data which it may obtain from any of its licensees outside the Territory (unless prevented from so doing by the terms of its agreement with any licensee) and that is necessary or useful for Paion and Licensed Subsidiaries to manufacture, have manufactured, sell, offer to sell, import, conduct clinical trials and studies and obtain regulatory approvals, market, distribute, supplying, offer for sale and use the Licensed Products under this Agreement, within thirty (30) days of developing or acquiring such Know-how and/or Programme Data, all of the foregoing of which will be deemed to be included in the Licensed Rights that are granted to Paion and Licensed Subsidiaries in accordance with this Agreement (in the case of Know-how and/or Programme Data obtained from any of La Jolla and/or Licensors' licensees outside the Territory, subject any limitations on the use thereof imposed under any agreements with such licensees). Where reasonably requested by Paion or any Licensed Subsidiary, La Jolla and Licensors shall use good faith to (a) seek consent from La Jolla's and/or Licensors' licensees outside the Territory and (b) secure amendments to any agreements with La Jolla's and/or Licensors' licensees outside the Territory to the extent necessary to provide Paion and Licensed Subsidiaries all such Know-how and/or Programme Data that is obtained from any of La Jolla and/or Licensors' licensees outside the Territory and which is necessary or useful for Paion and Licensed Subsidiaries to manufacture, have manufactured, sell, offer to sell, import, conduct clinical trials and studies and obtain regulatory approvals, market, distribute, supplying, offer for sale and use the Licensed Products under this Agreement.
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Related to Value dossiers

  • 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.

  • Procurement of Goods Part A: General Goods shall be procured in accordance with the provisions of Section I of the "Guidelines for Procurement under IBRD Loans and XXX Credits" published by the Bank in January 1995 and revised in January 1996 (the Guidelines) and the following provisions of this Section, as applicable. Part B: International Competitive Bidding

  • Procurement of Goods and Services (a) If the HSP is subject to the procurement provisions of the BPSAA, the HSP will abide by all directives and guidelines issued by the Management Board of Cabinet that are applicable to the HSP pursuant to the BPSAA. (b) If the HSP is not subject to the procurement provisions of the BPSAA, the HSP will have a procurement policy in place that requires the acquisition of supplies, equipment or services valued at over $25,000 through a competitive process that ensures the best value for funds expended. If the HSP acquires supplies, equipment or services with the Funding it will do so through a process that is consistent with this policy.

  • 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 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.

  • Promotional Material In the event that the Fund or the Investment Adviser makes available any promotional materials related to the Securities or the transactions contemplated hereby intended for use only by registered broker-dealers and registered representatives thereof by means of an Internet web site or similar electronic means, the Investment Adviser will install and maintain or will cause to be installed and maintained, pre-qualification and password-protection or similar procedures which are reasonably designed to effectively prohibit access to such promotional materials by persons other than registered broker-dealers and registered representatives thereof.

  • 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.

  • QUALITY OF GOODS 5.1 Voip Unlimited warrants that on delivery, the Goods shall: (a) conform in all material respects with the Goods Specification; (b) be free from material defects in design, material and workmanship; (c) be of satisfactory quality (within the meaning of the Sale of Goods Act 1979); and (d) be fit for any purpose held out by Voip Unlimited. 5.2 Subject to clause 5.3, if: (a) the Customer gives notice in writing within a reasonable time of discovery that some or all of the Goods do not comply with the warranty set out in clause 5.1; (b) Voip Unlimited is given a reasonable opportunity of examining such Goods; and (c) the Customer (if asked to do so by Voip Unlimited) returns such Goods to Voip Unlimited's place of business at Voip Unlimited's cost, Voip Unlimited shall, at its option, repair or replace the defective Goods, or refund the price of the defective Goods in full. 5.3 Voip Unlimited shall not be liable for the Goods' failure to comply with the warranty in clause 5.1 if: (a) the Customer makes any further use of such Goods after giving a notice in accordance with clause 5.2; (b) the defect arises because the Customer failed to follow Voip Unlimited's oral or written instructions as to the storage, installation, commissioning, use or maintenance of the Goods or (if there are none) good trade practice; (c) the defect arises as a result of Voip Unlimited following any drawing, design or Goods Specification supplied by the Customer; (d) the Customer alters or repairs such Goods without the written consent of Voip Unlimited; (e) the defect arises as a result of fair wear and tear, wilful damage, negligence, or abnormal working conditions; (f) the Goods differ from the Goods Specification as a result of changes made to ensure they comply with applicable statutory or regulatory standards. 5.4 Except as provided in this clause 5, Voip Unlimited shall have no liability to the Customer in respect of the Goods' failure to comply with the warranty set out in clause 5.1. 5.5 The terms of these Conditions shall apply to any repaired or replacement Goods supplied by Voip Unlimited under clause 5.2.

  • XXXXEAS Employer is engaged in the telephone and telecommunication installation and service, and manufacture sale and installation of highway signs and traffic control products.

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