Common use of Records Reports Clause in Contracts

Records Reports. ILDONG shall (a) maintain records of its Commercialization activities under this Article 5 in sufficient detail, which shall fully and properly reflect all work done and results achieved in the Commercialization of Products and (b) following the commencement of Commercialization of the Products provide SUBLICENSOR with annual written reports (each, a “Commercialization Report”) which shall (i) summarize ILDONG’s efforts to Commercialize Products, (ii) identify the Regulatory Filings and Drug Approval Applications with respect to such Product that ILDONG or any of its Affiliates or Sublicensees have filed, sought or obtained in the prior twelve (12) month period or reasonably expect to make, seek or attempt to obtain in the following twelve (12) month period and (iii) summarize all Clinical Data generated by ILDONG with respect to Products. Commencing no later than ninety (90) days from the date of receipt by ILDONG of the first Marketing Authorization for each Product and on each anniversary thereof until the expiration of the Royalty Term applicable to such Product, each such Commercialization Report shall also include (i) an outline of the key sales and marketing activities that ILDONG reasonably expects to conduct with respect to Product in the Territory, (ii) a non-binding estimate of projected sales of Product in the Territory for the subsequent three (3) Calendar Year period and (iii) such additional information that it has in its possession as may be reasonably requested by SUBLICENSOR regarding the Commercialization of any Product, which request shall not be made more than once each Calendar Year. The Commercialization Plan and Commercialization Report can be provided as one document. * Confidential material redacted and filed separately with the Commission.

Appears in 2 contracts

Samples: Sublicense Agreement (Tg Therapeutics, Inc.), Sublicense Agreement (Tg Therapeutics, Inc.)

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Records Reports. ILDONG rEVO and/or its Affiliates, Sublicensees, Distributors shall (a) maintain records of its Commercialization activities under this Article 5 the Development program in sufficient detaildetail and in good scientific manner appropriate for patent and regulatory purposes, which shall fully and properly reflect all work done performed and results achieved in the Commercialization performance of Products the Development activities and (b) following the commencement of Commercialization keep LFB USA regularly informed of the progress of its efforts to Develop CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Products provide SUBLICENSOR in the Territory, including without limitation, providing LFB USA with an annual written reports development report (each, a “Commercialization Development Report”) which shall (ito be delivered with each annual update to the Development Plan) summarize ILDONG’s efforts that summarizes: (a) significant Development activities conducted during the preceding Calendar Year and results obtained with respect to Commercialize Compounds and Products (including the status of all Clinical Trials), (b) Significant Development Events applicable to the Compounds and/or Products, (iic) identify the Regulatory Filings and Drug Approval Applications with respect a summary of all Program Technology conceived or reduced to practice by rEVO over such Product that ILDONG or any of its Affiliates or Sublicensees have filed, sought or obtained in the prior twelve (12) month period or reasonably expect to make, seek or attempt to obtain in the following twelve (12) month period and (iii) summarize all Clinical Data generated by ILDONG with respect to Products. Commencing no later than ninety (90) days from the date of receipt by ILDONG of the first Marketing Authorization for each Product and on each anniversary thereof until the expiration of the Royalty Term applicable to such Product, each such Commercialization Report shall also include (i) an outline of the key sales and marketing activities that ILDONG reasonably expects to conduct with respect to Product in the Territoryperiod, (iid) a non-binding estimate of projected sales the expected timing of Product in the Territory for the subsequent three (3) Calendar Year period any milestone events with respect to Products and (iiie) such additional other information that it rEVO has in its possession as may be reasonably requested from time to time by SUBLICENSOR regarding the Commercialization of any Product, which request shall not be made more than once each Calendar YearLFB USA. The Commercialization Plan and Commercialization Development Report can shall be provided as one document. * deemed rEVO Confidential material redacted and filed separately with the CommissionInformation.

Appears in 2 contracts

Samples: Exclusive License Agreement (rEVO Biologics, Inc.), Exclusive License Agreement (rEVO Biologics, Inc.)

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Records Reports. ILDONG TG shall (a) maintain records of its Commercialization activities under this Article 5 in sufficient detail, which shall fully and properly reflect all work done and results achieved in the Commercialization of Products and (b) following the commencement of Commercialization of the Products provide SUBLICENSOR LICENSOR with annual written reports (each, a “Commercialization Report”) which shall (i) summarize ILDONGTG’s efforts to Commercialize Products, (ii) identify the Regulatory Filings and Drug Approval Applications with respect to such Product that ILDONG TG or any of its Affiliates or Sublicensees have filed, sought or obtained in the prior twelve (12) month period or reasonably expect to make, seek or attempt to obtain in the following twelve (12) month period and (iii) summarize all Clinical Data generated by ILDONG TG with respect to Products. Commencing no later than ninety (90) days from the date of receipt by ILDONG TG of the first Marketing Authorization for each Product and on each anniversary thereof until the expiration of the Royalty Term applicable to such Product, each such Commercialization Report shall also include (i) an outline of the key sales and marketing activities that ILDONG TG reasonably expects to conduct with respect to Product in the Territory, (ii) a non-binding estimate of projected sales of Product in the Territory for the subsequent three (3) Calendar Year period and (iii) such additional information that it has in its possession as may be reasonably requested by SUBLICENSOR LICENSOR regarding the Commercialization of any Product, which request shall not be made more than once each Calendar Year. The Commercialization Plan and Commercialization Report can be provided as one document. * Confidential material redacted and filed separately with the Commission.

Appears in 1 contract

Samples: Exclusive License Agreement (Manhattan Pharmaceuticals Inc)

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