Authorized Generic Product Sample Clauses

Authorized Generic Product. Par shall be permitted, without requiring license or approval from IntelGenx, to enter into an agreement with the owner of the Brand Product under which Par may sell an AG Product (an “AG Agreement”), and Par may thereafter acquire, use, sell and otherwise market such AG Product pursuant to such AG Agreement in the Territory. Par shall be allowed to sell the AG Product in place of, or in addition to, the Product; provided, however, that in the event that Par enters into an AG Agreement, Par shall continue to be bound by its royalty obligations to IntelGenx under Section 5.5.1 during the Term, and will pay the applicable percentage of Net Profits as set forth in Section 5.5 on the sales of both AG Product and Product.
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Authorized Generic Product. Par shall be permitted, without requiring license or approval from IntelGenx, to enter into an agreement with the owner of any Brand Product under which Par may sell an AG Product (an "AG Agreement"), and Par may thereafter acquire, use, sell and otherwise market such AG Product pursuant to such AG Agreement in the Territory. Par shall be allowed to sell such AG Product in place of, or in addition to, the Product to which such AG Product relates; provided, however, that in the event that Par enters into an AG Agreement, Par shall continue to be bound by its royalty obligations to IntelGenx under Section 5.5.1 during the Term, and will pay the applicable percentage of Net Profits as set forth in Section 5.5 on the sales of both AG Product and Product. For purposes of clarification, if Par enters into an AG Agreement related to a Product, Par shall remain obligated to pay any unpaid development fees in respect of such Product that were earned by IntelGenx in accordance with Section 5.1 prior to Par’s entry into such AG Agreement.
Authorized Generic Product. After December 31, 2010, PURDUE will have the right to enter into an agreement or sublicense with one or more third parties or Affiliates to Distribute an Authorized Generic in the Territory." 17. Section 15.4(a). Section 15.4(a) of the Agreement is hereby deleted in its entirety and replaced by the following new Section 15.4(a) of the Agreement: (a) From and after the Effective Date, LEL will defend, indemnify and hold the PURDUE Indemnitees harmless from and against any and all Damages (only until December 31, 2010 for Damages in respect of the enforcement or defense of intellectual property), which the PURDUE Indemnitees may incur, or suffer, or with which any of them may be faced arising out of the LEL Intellectual Property, or the development, design, and regulatory submission for the Licensed Product; provided, however, that, in each such case, LEL will not be liable hereunder to the extent such Damages arise from willful misconduct or negligence of, or a violation of any Applicable Law, or from the breach of the provisions of this Agreement by PURDUE, its Affiliates, agents, employees or contractors. Notwithstanding the foregoing or any other provision to the contrary, in no event will (x) LEL have any liability to PURDUE Indemnitees or any other person for Damages arising on or after January 1, 2011 in respect of the enforcement or defense of intellectual property (i.e., the Licensed Product Patents, the LEL Intellectual Property or the Purdue Intellectual Property), including, without limitation, patent enforcement matters under the Cost Shing" (REDACTED) Letter, the OMI Letter Agreement, this Agreement, the Supply Agreement, and any other agreement related to the Licensed Product or an Authorized Generic thereof, or (y) LEL's liability to PURDUE Indemnitees for Damages resulting from product liability claims in respect of the Licensed Product and/or the Authorized Generic arising on or after January 1, 2011 exceed, in the aggregate, US$5 million; provided, however, such $5 million cap will not apply to such Damages arising (i) prior to January 1, 2011, or (ii) from or caused by LEL's gross negligence, or intentional or willful misconduct, whether arising prior to, on or after January 1, 2011." 18. Section 15.4(b). Section 15.4(b) of the Agreement is hereby deleted in its entirety and replaced by the following new Section 15.4(b) of the Agreement:
Authorized Generic Product. 3.1. The Original Agreement is hereby amended by the replacement of the term “Product” where it is used in each of the following instances with the phrase “Product and the Authorized Generic Product”: 3.1.1. Clauses (c) and (d) of the recitals; 1.1 in the definitions ofApplicable Laws” and “Commercialisation Plan”; 2.1.3(iii); 2.1.3(iv)(a); 3.
Authorized Generic Product. As used herein, “Authorized Generic Product” means a pharmaceutical product containing treprostinil sodium as the active ingredient and manufactured, used, offered for sale, imported, distributed and/or sold, by or under the authority of UTC or its Affiliates, for use in the Territory under NDA No. 21-272 as a generic version of any of the Remodulin® Drug Products.

Related to Authorized Generic Product

  • 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.

  • Combination Product The term “

  • Combination Products If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.

  • 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 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.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Territory 33.1 This Agreement applies to the territory in which CenturyLink operates as an ILEC in the State. CenturyLink shall be obligated to provide services under this Agreement only within this territory. 33.2 Notwithstanding any other provision of this Agreement, CenturyLink may terminate this Agreement as to a specific operating territory or portion thereof pursuant to Section 6.7 of this Agreement.

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