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.
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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: (i) a breach of a representation, warranty or covenant in this Agreement by Santarus; or (ii) a negligent act or omission or willful misconduct by Santarus, its Affiliates or sublicensees in the performance of its obligations under this Agreement; except, in all cases, to the extent that such Claim arises out of the negligence or willful misconduct of Schering, its Affiliates or Sublicensees or a breach by Schering of a representation, warranty or covenant in this Agreement.
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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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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.
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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.
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