By Santarus Sample Clauses

By Santarus. Until the earlier of (a) the fifth (5th) anniversary of the Effective Date or (b) termination of GSK’s license pursuant to Section 2.1.1 to sell, offer for sale and import Licensed Products in a given country within the GSK Territory, neither Santarus nor any of its Affiliates will directly or indirectly distribute, market, promote, detail, advertise or sell any PPI Pharmaceutical Product containing one or more PPIs which is either formulated in combination with one or more buffering agents, or which is otherwise formulated to provide, in either case, for immediate release of the PPI in or for such country in the GSK Territory. On or after the fifth (5th) anniversary of the Effective Date (for so long as GSK’s license under Section 2.1.1 is still in effect with respect to the applicable country), Santarus and any Affiliates shall have the right to directly or indirectly distribute, market, promote, detail, advertise or sell any PPI Pharmaceutical Product containing one or more PPIs which is either formulated in combination with one or more buffering agents, or which is otherwise formulated to provide, in either case, for immediate release of the PPI, in or for such country in the GSK Territory; provided that Santarus shall discuss with GSK the out-license of such product to GSK for such country; and provided further that in the event that Santarus grants the right to commercialize the product to any Third Party, or commercializes the product in its own right, in such country in the XXX Xxxxxxxxx, XXX shall be released from its obligations under Section 6.1.1 on the first commercial sale of such product in such country by such Third Party or Santarus, as the case may be. The foregoing covenants shall not restrict Santarus or any Affiliate from obtaining rights to, or engaging in research and development activities related to, products in such class during the restricted time period, so long as Santarus or its Affiliate does not engage in the activities set forth in the first sentence of this Section 6.1.2.
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By Santarus. GSK shall provide to Santarus the core regulatory file used by GSK to generate all Regulatory Filings within thirty (30) days after its initial completion and thirty (30) days after any updates thereto. In addition, from time to time or upon Santarus’ reasonable request, GSK shall provide to Santarus all Data in its Control during the Term. Santarus shall have the right to use and reference all Data and Regulatory Filings in connection with Santarus’ development, manufacture and commercialization of Licensed Products outside of the GSK Territory; provided that such core regulatory file and Data received by Santarus, together with all embodiments thereof, shall be deemed the Confidential Information of GSK, subject to the terms and conditions of Article 12. The mode that GSK provides Data and the core regulatory file under this Section 3.3.2 shall be mutually determined by Santarus and GSK in good faith with the goals of efficiency and cost-effectiveness.
By Santarus. Santarus shall indemnify, defend and hold Schering, its Affiliates, directors, employees, agents and representatives harmless from and against all liabilities, claims, demands, expenses (including, without limitation, reasonable attorneys and professional fees and other costs of litigation), losses or causes of action asserted by a Third Party (each, a “Claim”) that arise from:
By Santarus. Norgine shall provide to Santarus the core regulatory file used by Norgine to generate each Regulatory Filing within thirty (30) days after its initial submission to a Regulatory Authority in the Territory and thirty (30) days after any updates thereto is filed with a Regulatory Authority in the Territory. In addition, from time to time and upon Santarus’ reasonable request, Norgine shall provide to Santarus all Data in its Control during the Term. Santarus shall have the right to use and reference all Data and Regulatory Filings in connection with Santarus’ development, manufacture and commercialization of Licensed Products and PPI Pharmaceutical Products outside of the Territory or outside of the Field (subject to Sections 2.3 and 6.1); provided that such Regulatory Filings and Data received by Santarus, together with all embodiments thereof, shall be deemed the Confidential Information of Norgine. The mode that Norgine provides Data and the core regulatory file under this Section 3.3.2 shall be mutually determined by Santarus and Norgine in good faith.
By Santarus. GSK shall keep, and cause its Affiliates and any permitted sub-distributors to keep, complete and accurate records in sufficient detail to enable a calculation of royalties due to Santarus on account of Net Sales of PR Products in the Territory, determined in accordance with GAAP (including calculation of gross amounts invoiced for each PR Product, Net Sales of each PR Product, all itemized deductions from gross amounts invoiced taken to calculate Net Sales, and amounts payable hereunder to Santarus for each PR Product), as well as a calculation of any credits for Inter-Territory Sales. For the sole purpose of verifying amounts relating to this Agreement, Santarus shall have the right no more than [***] each calendar year, at its own expense, to have agents or representatives of Santarus or any of its licensors of Intellectual Property review such records for the [***] Calendar Quarters preceding such review in the location(s) where such records are maintained by GSK and its Affiliates upon reasonable notice and during regular business hours. Results of such review shall be made available to GSK. The records and results of such audits shall be deemed Confidential Information of GSK. In the event that such a review identifies an underpayment greater than [***] of the amounts that were otherwise due for a [***] during such period, [***]. Further, if the review reflects an underpayment to Santarus, such underpayment shall be promptly remitted to Santarus, together with interest calculated in the manner provided in Section 6.5. If the review reflects an overpayment to Santarus, such overpayment shall be credited against the next payment due Santarus. If the review reveals an underpayment of more than [***] of the amounts due for any period of [***], GSK shall reimburse Santarus for the costs of such audit.
By Santarus. GSK shall provide to Santarus the core regulatory file used by GSK to generate all Regulatory Filings within [***] after its initial completion and [***] after any updates thereto. In addition, from time to time or upon Santarus’ reasonable request, GSK shall provide to Santarus all Data in its Control during the Term. Santarus shall have the right to use and reference all Data and Regulatory Filings in connection with Santarus’ development, manufacture and commercialization of Licensed Products outside of the GSK Territory; provided that such core regulatory file and Data received by Santarus, together with all embodiments thereof, shall be deemed the Confidential Information of GSK, subject to the terms and conditions of Article 12. The mode that GSK provides Data and the core regulatory file under this Section 3.3.2 shall be mutually determined by Santarus and GSK in good faith with the goals of efficiency and cost-effectiveness.

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  • Clinical Data The descriptions of the results of any studies and tests conducted by or on behalf of, or sponsored by, the Company or its subsidiaries, or in which the Company has participated, that are described in the Disclosure Package and the Prospectus, or the results of which are referred to in the Disclosure Package and the Prospectus do not contain any misstatement of material fact or omit to state a material fact necessary to make such statements not misleading. The Company has no knowledge of any studies or tests not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Disclosure Package or Prospectus.

  • Joint Manufacturing Committee In accordance with Section 2.5(c)(iv), the Parties shall promptly establish and convene a joint Manufacturing Committee (the “JMC”) for the overall coordination and oversight of the Manufacturing of clinical and commercial supplies of the Product under this Agreement as provided in the Manufacturing Plan (including the Manufacture of API, Drug Product and Finished Product). The JMC shall consist of representatives of each Party, and shall operate by procedures, as set forth in Section 2.5. The role of the JMC shall be:

  • 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.

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  • 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.

  • Third Party Data Any statistical, industry-related and market-related data, which are included in the Disclosure Package and the Prospectus, is based on or derived from sources that the Company reasonably and in good faith believes to be reliable and accurate, and such data agrees with the sources from which it is derived, and the Company has obtained the written consent for the use of such data from such sources to the extent required.

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  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

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