Use of Combined Therapy Study Data by BMS Sample Clauses

The 'Use of Combined Therapy Study Data by BMS' clause defines the rights and limitations for Bristol Myers Squibb (BMS) regarding access to and use of data generated from studies involving combined therapies. Typically, this clause outlines the specific types of study data BMS can utilize, such as efficacy or safety results, and may set conditions on how BMS can share or apply this information in its own research, regulatory submissions, or product development. Its core function is to clarify data ownership and usage rights, ensuring both parties understand how combined study results can be leveraged while protecting proprietary interests.
Use of Combined Therapy Study Data by BMS. BMS, [ ]* and their respective Affiliates and (sub)licensees shall have the right to use and analyze the Combined Therapy Study Data (i) in connection with the independent development, commercialization or other exploitation of the BMS Study Drug (alone or in combination with other drugs and/or other pharmaceutical agents) and/or for inclusion in the safety database for the BMS Study Drug, in each case without the consent of, or any obligation to account to, the Recipient, and (ii) to conduct studies with Samples pursuant to Section 8.5. Subject to Section 8.5, the results of all such analyses or uses shall be owned by BMS, including any intellectual property arising out of same, unless the Parties shall have agreed otherwise in a writing separate from this Agreement. BMS, [ ]*, and their respective Affiliates and (sub)licensees shall also be entitled to use the Combined Therapy Study Data during and following the Term to (1) make regulatory filings, meet regulatory requirements, and seek approvals for the BMS Study Drug, either alone or as part of the Combined Therapy, (2) evaluate the safety and efficacy of the Combined Therapy and the BMS Study Drug, (3) promote indications based on, and to disseminate, the Combined Therapy Study Data for the benefit of the BMS Study Drug, either alone or as part of the Combined Therapy, where permitted by and in accordance with Applicable Law; provided that nothing in the foregoing is intended or shall be construed as granting BMS any right or license, expressly or impliedly to make, have made, use, sell, offer for sale, or import the Recipient Study Drug; and (4) include in Patent Rights filings made in the course of the prosecution of BMS Independent Patent Rights that do not Cover both the composition of matter of the Recipient Study Drug, its manufacture or formulation, method of use and the BMS Study Drug. The Recipient grants BMS, [ ]*, their respective Affiliates and (sub)licensees (of rights to the BMS Study Drug) a Right of Cross-Reference to the Recipient Regulatory Documentation Controlled by Recipient for the Recipient Study Drug and the Combined Therapy Clinical Trial Regulatory Documentation for the Recipient Study Drug or the Combined Therapy for the sole purpose of enabling BMS, [ ]* and their Affiliates and sublicensees to exercise its rights under clause (1) of this Section 8.3(b), which right shall survive any expiration or termination of this Agreement.
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Use of Combined Therapy Study Data by BMS. (a) Subject to the restrictions on disclosure of the Combined Therapy Study Data to Third Parties as set forth below in this Section 7.4, BMS shall have the right to use and analyze the Combined Therapy Study Data for any purpose. (b) The Combined Therapy Study Data shall not be disclosed to Third Parties by BMS except as follows (and otherwise as expressly permitted under the Agreement). (i) BMS may disclose the Combined Therapy Study Data to a Bona Fide Collaborator, solely for purposes of the development, regulatory approval and commercialization of the one or more compounds or products that are the subject of a bona fide contractual licensing arrangement with such Bona Fide Collaborator; provided that such Bona Fide Collaborator shall be subject to the same restrictions on use and disclosure of such Combined Therapy Study Data as BMS under this Agreement; and provided further that disclosure of such Combined Therapy Study Data does not grant to such Bona Fide Collaborator any intellectual property rights in and to the Company Technology, Company Inventions, Company Study Data or the Company Compound or any Right of Cross-Reference to Company Regulatory Documentation. (ii) BMS may disclose the Combined Therapy Study Data to its contractors under confidentiality obligations similar to BMS’s obligations under the Agreement, solely for purposes and to the extent required for such contractors to provide services for BMS for the development, regulatory approval and/or commercialization of the BMS Compound. (iii) BMS may disclose the Combined Therapy Study Data (1) to Regulatory Authorities in connection with regulatory filings, (2) to investigators as necessary in connection with the Combined Therapy Study (provided that BMS shall provide the Company with at least [Redacted] Business Days’ notice prior to any such disclosure) or (3) as may be required by Applicable Law and/or the rules or regulations of any securities exchange on which BMS’s stock is listed. (iv) To the extent that the Combined Therapy Study Data includes Safety Information and BMS needs to disclose to Third Parties such Safety Information of the Combined Therapy in its studies of the BMS Compound with other bispecific antibodies in order to ensure patient safety, BMS may disclose such Safety Information. For clarity, BMS shall not disclose Safety Information related solely to the Company Compound. (v) BMS may use and disclose to a Third Party the Combined Therapy Study Data, under obligatio...
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Use of Combined Therapy Study Data by BMS. (a) Subject to the restrictions on disclosure of the Combined Therapy Study Data to Third Parties as set forth below in this Section 8.5, BMS shall have the right to use and analyze the Combined Therapy Study Data for any purpose. (b) The Combined Therapy Study Data shall not be disclosed to Third Parties by BMS except as follows (and otherwise as expressly permitted under the Agreement). (i) BMS may disclose the Combined Therapy Study Data to its contractors under confidentiality obligations similar to BMS’ obligations under the Agreement, solely for purposes and to the extent required for such contractors to provide services for BMS for the development, regulatory approval and/or commercialization of the BMS Study Drug. (ii) BMS may disclose the Combined Therapy Study Data (x) to Regulatory Authorities in connection with regulatory filings, (y) to investigators as necessary in connection with the Combined Therapy Clinical Trial and/or (y) as may be required by Applicable Law. (iii) To the extent that the Combined Therapy Study Data includes safety information and BMS needs to disclose to Third Parties such safety information of the Combined Therapy in its studies of the BMS Study Drug with other cell based therapy in order to ensure patient safety, BMS may disclose such safety information. For clarity, BMS shall not disclose safety information related solely to the Recipient Study Drug. (iv) BMS may use and disclose to a Third Party the Combined Therapy Study Data, under obligations of confidentiality consistent with this Agreement, to the extent such Third Party is developing or commercializing a biomarker or diagnostic test for use with its Study Drug and/or the Combined Therapy.
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Use of Combined Therapy Study Data by BMS. BMS, Ono and their respective Affiliates and (sub)licensees of the BMS Compound shall have the right to use and analyze the Combined Therapy Study Data for any and all purposes without the consent of, or any obligation to account to, Exelixis, including (x) in connection with their independent development, commercialization or other exploitation of the BMS Compound(s) (alone or in combination with the Exelixis Compound and/or other pharmaceutical agents) and/or for inclusion in the safety [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. database for the BMS Compound, and (y) to conduct studies with Samples pursuant to Section 8.5. Subject to Section 8.5, the results of all such uses or analyses shall be owned by BMS, including any intellectual property arising out of same, unless the Parties shall have agreed otherwise in writing.
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Use of Combined Therapy Study Data by BMS. As between BMS and Recipient, BMS, [***] shall have the right to: (A) use, analyze and exploit the Combined Therapy Study Data in connection with the independent development, commercialization or other exploitation of the BMS Study Drug (alone or in combination with other drugs and/or other pharmaceutical agents) in the Territory, and (B) analyze the safety information within the Combined Therapy Study Data in connection with the independent development, commercialization or other exploitation of the BMS Study Drug (alone or in combination with other drugs and/or other pharmaceutical agents other than Recipient Study Drug) outside the Territory, and include such safety information in the safety database for the BMS Study Drug for use outside the Territory, in each case (A) or (B) above without the consent of, or any obligation to account to, the Recipient; provided that nothing in any case (A) or (B) above shall grant, or is intended or shall be construed as granting, BMS [***] any right or license, expressly or impliedly, to make, have made, use, sell, offer for sale, or import the Recipient Study Drug or a Recipient Class Drug within or outside the Territory. Subject to Section 8.5, the results of all such analyses or uses shall be owned by BMS, including any intellectual property arising out of same, unless the Parties shall have agreed otherwise in a writing separate from this Agreement. Subject to Applicable Law, BMS agrees that it (and its Affiliates and (sub)licensees, including [***]) will not use or exploit the Combined Therapy Study Data for itself or in collaboration with a Third Party for any purpose outside the Territory except as provided in Section 8.3(b) above.
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Use of Combined Therapy Study Data by BMS. (a) Subject to the restrictions on disclosure of the Combined Therapy Study Data to Third Parties as set forth below in this Section 8.5, BMS shall have the right to use and analyze the Combined Therapy Study Data for any purpose. [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
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Related to Use of Combined Therapy Study Data by BMS

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement or the Prospectus, or the results of which are referred to in the Registration Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMA, Health Canada and other comparable regulatory agencies outside of the U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Registration Statement or 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 Registration Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • LIMITATIONS ON REVERSE ENGINEERING, DECOMPILATION AND DISASSEMBLY You may not reverse engineer, decompile, or disassemble the Software, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation.

  • Updated Information Submission by Interconnection Customer The updated information submission by the Interconnection Customer, including manufacturer information, shall occur no later than one hundred eighty (180) Calendar Days prior to the Trial Operation. The Interconnection Customer shall submit a completed copy of the Electric Generating Unit data requirements contained in Appendix 1 to the LGIP. It shall also include any additional information provided to the Participating TO and the CAISO for the Interconnection Studies. Information in this submission shall be the most current Electric Generating Unit design or expected performance data. Information submitted for stability models shall be compatible with the Participating TO and CAISO standard models. If there is no compatible model, the Interconnection Customer will work with a consultant mutually agreed to by the Parties to develop and supply a standard model and associated information.