Records Reports. rEVO and/or its Affiliates, Sublicensees, Distributors shall (a) maintain records of its activities under the Development program in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall fully and properly reflect all work performed and results achieved in the performance of the Development activities and (b) 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 in the Territory, including without limitation, providing LFB USA with an annual development report (each, a “Development Report”) (to be delivered with each annual update to the Development Plan) that summarizes: (a) significant Development activities conducted during the preceding Calendar Year and results obtained with respect to Compounds and Products (including the status of all Clinical Trials), (b) Significant Development Events applicable to the Compounds and/or Products, (c) a summary of all Program Technology conceived or reduced to practice by rEVO over such period, (d) a non-binding estimate of the expected timing of any milestone events with respect to Products and (e) such other information that rEVO has in its possession as may be reasonably requested from time to time by LFB USA. The Development Report shall be deemed rEVO Confidential Information.
Appears in 2 contracts
Samples: Exclusive License Agreement (rEVO Biologics, Inc.), Exclusive License Agreement (rEVO Biologics, Inc.)
Records Reports. rEVO and/or its Affiliates, Sublicensees, Distributors ILDONG shall (a) maintain records of its Commercialization activities under the Development program this Article 5 in sufficient detail and in good scientific manner appropriate for patent and regulatory purposesdetail, which shall fully and properly reflect all work performed done and results achieved in the performance Commercialization of the Development activities Products and (b) keep LFB USA regularly informed following the commencement of Commercialization 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 in the Territory, including without limitation, providing LFB USA provide SUBLICENSOR with an annual development report written reports (each, a “Development Commercialization Report”) which shall (i) summarize ILDONG’s efforts to be delivered with each annual update to Commercialize Products, (ii) identify the Development Plan) that summarizes: (a) significant Development activities conducted during the preceding Calendar Year Regulatory Filings and results obtained Drug Approval Applications with respect to Compounds 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 Products (including the status of iii) summarize all Clinical Trials)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, (b) Significant Development Events applicable to the Compounds and/or Products, (c) a summary of all Program Technology conceived or reduced to practice by rEVO over such period, (dii) a non-binding estimate of projected sales of Product in the expected timing of any milestone events with respect to Products Territory for the subsequent three (3) Calendar Year period and (eiii) such other additional information that rEVO it has in its possession as may be reasonably requested from time to time by LFB USASUBLICENSOR regarding the Commercialization of any Product, which request shall not be made more than once each Calendar Year. The Development Commercialization Plan and Commercialization Report shall can be deemed rEVO provided as one document. * Confidential Informationmaterial redacted and filed separately with the Commission.
Appears in 2 contracts
Samples: Sublicense Agreement (Tg Therapeutics, Inc.), Sublicense Agreement (Tg Therapeutics, Inc.)
Records Reports. rEVO and/or its Affiliates, Sublicensees, Distributors TG shall (a) maintain records of its Commercialization activities under the Development program this Article 5 in sufficient detail and in good scientific manner appropriate for patent and regulatory purposesdetail, which shall fully and properly reflect all work performed done and results achieved in the performance Commercialization of the Development activities Products and (b) keep LFB USA regularly informed following the commencement of Commercialization 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 in the Territory, including without limitation, providing LFB USA provide LICENSOR with an annual development report written reports (each, a “Development Commercialization Report”) which shall (i) summarize TG’s efforts to be delivered with each annual update to Commercialize Products, (ii) identify the Development Plan) that summarizes: (a) significant Development activities conducted during the preceding Calendar Year Regulatory Filings and results obtained Drug Approval Applications with respect to Compounds such Product that 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 Products (including the status of iii) summarize all Clinical Trials)Data generated by TG with respect to Products. Commencing no later than ninety (90) days from the date of receipt by 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 TG reasonably expects to conduct with respect to Product in the Territory, (b) Significant Development Events applicable to the Compounds and/or Products, (c) a summary of all Program Technology conceived or reduced to practice by rEVO over such period, (dii) a non-binding estimate of projected sales of Product in the expected timing of any milestone events with respect to Products Territory for the subsequent three (3) Calendar Year period and (eiii) such other additional information that rEVO it has in its possession as may be reasonably requested from time to time by LFB USALICENSOR regarding the Commercialization of any Product, which request shall not be made more than once each Calendar Year. The Development Commercialization Plan and Commercialization Report shall can be deemed rEVO Confidential Informationprovided as one document.
Appears in 1 contract
Samples: Exclusive License Agreement (Manhattan Pharmaceuticals Inc)