Medical Affairs; Information Sample Clauses

Medical Affairs; Information. For Shared Products in the US Territory, the Parties will discuss the implementation of medical and scientific affairs and programs, including for professional symposia and other educational activities, and medical affairs studies based upon approved protocols, medical information support and medical communications and publishing activities, and the allocation of each Party to such activities in the US Territory, provided that Celgene, following consultation with the JCC, shall have the final decision-making authority to the conduct of such activities in the US Territory (it being understood and agreed that [***] shall be permitted to contribute [***] percent ([***]%) of the medical science liaisons on an equitable basis in the US Territory). The Parties acknowledge that in the US Territory each Party may receive requests for medical information concerning any Shared Product from members of the medical professions and consumers. Celgene will have the exclusive right to respond to questions and requests for information about Shared Products received from Persons in the Territory that warrant a response beyond the understanding of the sales representatives or that are beyond the scope of the Shared Product labels and inserts (each such request, an “Information Request”) and that are solely applicable to Shared Products for ROW Administration. Any Information Request that is applicable to Shared Products for U.S. Administration or throughout the Territory shall be referred to the JCC.
AutoNDA by SimpleDocs
Medical Affairs; Information. For Co-Co Products in the United States, the Parties will discuss the implementation of medical and scientific affairs and programs, including for professional symposia and other educational activities, and medical affairs studies based upon approved protocols, medical information support and medical communications and publishing activities, and the allocation of each Party to such activities in the United States, provided Jounce shall have the final decision-making authority to the conduct of such activities in the United States. The Parties acknowledge that in the United States each Party may receive requests for medical information concerning the Co-Co Product from members of the medical professions and consumers. Celgene will have the exclusive right to respond to questions and requests for information about Co-Co Product received from Persons in the Territory that warrant a response beyond the understanding of the sales representatives or that are beyond the scope of the Co-Co Product labels and inserts (each such request, an “Information Request”) and that are solely applicable to Co-Co Product for U.S. Administration. Any Information Request that is applicable to Co-Co Product throughout the Territory shall be referred to the JCC.
Medical Affairs; Information. For Co-Co Products in the United States, the Parties will discuss the implementation of medical and scientific affairs and programs, including for professional symposia and other educational activities, and medical affairs studies based upon approved protocols, medical information support and medical communications and publishing activities, and the allocation of each Party to such activities in the United States, provided Jounce shall have the final decision-making authority to the conduct of such activities in the United States. The Parties acknowledge that in the United States each Party may receive requests for medical information concerning the Co-Co Product from members of the medical professions and consumers. Jounce will have the exclusive right to respond to questions and requests for information about Co-Co Product received from such Persons that warrant a response beyond the understanding of the sales representatives or that are beyond the scope of the Co-Co Product labels and inserts (each such request, an “Information Request”) and that are solely applicable to Co-Co Product for U.S. Administration. For clarity, Celgene will have the exclusive right to respond to an Information Request that is applicable to Co-Co Product for ROW Administration. Any Information Request that is applicable to Co-Co Product throughout the Territory shall be referred to the JCC.
Medical Affairs; Information. The Parties will discuss the execution of medical and scientific affairs and programs, including professional symposia and other educational activities, and medical affairs studies based upon approved protocols, including medical information support and medical communications and publishing activities, which may include [***]. The Parties acknowledge that each Party may receive requests for medical information concerning the Co-Co Product from members of the medical professions and consumers. [***] will have the [***] right to respond to questions and requests for information about Co-Co Product received from such Persons that (i) [***] or (ii) are [***] (each such request, an “Information Request”). If Information Requests are received by [***], the request will be [***] to which [***] Information Requests.
Medical Affairs; Information. For Juno Program Co-Co Products in countries in which the non-Commercialization Lead Party provides Commercialization support to the Commercialization Lead Party, the Parties will discuss the execution of medical and scientific affairs and programs, including for professional symposia and other educational activities, and medical affairs studies based upon approved protocols, medical information support and medical communications and publishing activities, and the allocation of each Party to such activities in the Territory, provided [***] to the conduct of such activities in the Commercialization Lead Party’s territory. The Parties acknowledge that in such countries each Party may receive requests for medical information concerning the Juno Program Co-Co Product from members of the medical professions and consumers. [***] will have the [***] right to respond to questions and requests for information about Juno Program Co-Co Product received from such Persons that [***] or that are [***] (each such request, an “Information Request”) and that are [***], and [***] will have the [***] right to respond to an Information Request that is [***]. Any Information Request that is applicable to [***].
Medical Affairs; Information. For Celgene Program Co-Co Products in countries in which Juno provides Commercialization support to Celgene, the Parties will discuss the execution of medical and scientific affairs and programs, including professional symposia and other educational activities, and medical affairs studies based upon approved protocols, including medical information support and medical communications and publishing activities, and the allocation of each Party to such activities in the Territory, provided that [***] to the conduct of such activities. The Parties acknowledge that in such countries each Party may receive requests for medical information concerning the Celgene Program Co-Co Product from members of the medical professions and consumers. [***] will have the [***] right to respond to questions and requests for information about Celgene Program Co-Co Product received from such Persons that [***] or that are [***] of the Celgene Program Co-Co Product [***] (each such request, an “Information Request”).

Related to Medical Affairs; Information

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Information/Cooperation Executive shall, upon reasonable notice, furnish such information and assistance to the Bank as may be reasonably required by the Bank, in connection with any litigation in which it or any of its subsidiaries or affiliates is, or may become, a party; provided, however, that Executive shall not be required to provide information or assistance with respect to any litigation between Executive and the Bank or any other subsidiaries or affiliates.

  • Information and Cooperation Each Party that has responsibility for filing and prosecuting any Patent Rights under this Section 7.4 (a “Filing Party”) shall (a) regularly provide the other Party (the “Non-Filing Party”) with copies of all patent applications filed hereunder and other material submissions and correspondence with the patent offices, in sufficient time to allow for review and comment by the Non-Filing Party; and (b) provide the Non-Filing Party and its patent counsel with an opportunity to consult with the Filing Party and its patent counsel regarding the filing and contents of any such application, amendment, submission or response. The advice and suggestions of the Non-Filing Party and its patent counsel shall be taken into consideration in good faith by such Filing Party and its patent counsel in connection with such filing. Each Filing Party shall pursue in good faith all reasonable claims and take such other reasonable actions, as may be requested by the Non-Filing Party in the prosecution of any Patent Rights covering any Program Technology under this Section 7.4; provided, however, if the Filing Party incurs any additional expense as a result of any such request, the Non-Filing Party shall be responsible for the cost and expenses of pursuing any such additional claim or taking such other actions. In addition, Company agrees that if Licensor claims any action taken under Section 7.4(d)(i) would be detrimental to Patent Rights covering Licensor Technology, Licensor shall provide written notice to Company and the Patent Coordinators shall, as promptly as possible thereafter, meet to discuss and resolve such matter and, if they are unable to resolve such matter, the Parties shall refer such matter to a mutually agreeable outside patent counsel for resolution.

  • Joint Development All inventions, know-how, trade secrets, data or information which result from joint development by the Parties hereto shall be jointly owned by the Parties. The Parties hereby agree to cooperate in good faith in the filing of any and all patent applications in all jurisdictions.

  • PROCESS INFORMATION Describe planned use, and include brief description of manufacturing processes employed.

  • Product Information Galapagos recognizes that by reason of, inter alia, Xxxxxx’x status as an exclusive licensee pursuant to the grants under Section 5.2, Xxxxxx has an interest in Galapagos’ retention in confidence of certain information of Galapagos. Accordingly, during the Term, Galapagos shall, and shall cause its Affiliates and its and their respective officers, directors, employees, and agents to, keep completely confidential, and not publish or otherwise disclose, and not use directly or indirectly for any purpose other than to fulfill Galapagos’ obligations hereunder any Information owned or otherwise Controlled by Galapagos or any of its Affiliates specifically relating to any Licensed Compound or Licensed Product, or the Exploitation of any of the foregoing (the “Product Information”); except to the extent (x) the Product Information is in the public domain through no fault of Galapagos, its Affiliates or any of its or their respective officers, directors, employees, or agents; (y) such disclosure or use is expressly permitted under Section 9.3, or (z) such disclosure or use is otherwise expressly permitted by the terms of this Agreement. For purposes of Section 9.3, Xxxxxx shall be deemed to be the disclosing Party with respect to Product Information under Section 9.3 and Galapagos shall be deemed to be the receiving Party with respect thereto. For further clarification, (i) without limiting this Section 9.1, to the extent Product Information is disclosed by Galapagos to Xxxxxx pursuant to this Agreement, such information shall, subject to the other terms and conditions of this Article 9, also constitute Confidential Information of Galapagos with respect to the use and disclosure of such Information by Galapagos (and Galapagos shall be deemed to be the disclosing Party with respect to Product Information under Section 9.3 and Xxxxxx shall be deemed to be the receiving Party with respect thereto), but (ii) the disclosure by Galapagos to Xxxxxx of Product Information shall not cause such information to cease to be subject to the provisions of this Section 9.1 with respect to the use and disclosure of such Confidential Information by Galapagos. If this Agreement is terminated in its entirety or with respect to the Terminated Territory, this Section 9.1 shall have no continuing force or effect with respect to the use or disclosure of such information solely in connection with the Exploitation of the Licensed Compound or Licensed Product for the benefit of the Terminated Territory, but the Product Information, to the extent disclosed by Xxxxxx to Galapagos hereunder, shall continue to be Confidential Information of Xxxxxx, subject to the terms of Sections 9.2, 9.3, and 9.7 for purposes of the surviving provisions of this Agreement.

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Confidential Supervisory Information Notwithstanding any other provision of this Agreement, no disclosure, representation or warranty shall be made (or other action taken) pursuant to this Agreement that would involve the disclosure of confidential supervisory information (including confidential supervisory information as defined in 12 C.F.R. § 261.2(c)) of a Government Authority by any party to this Agreement to the extent prohibited by applicable Law. To the extent legally permissible, appropriate substitute disclosures or actions shall be made or taken under circumstances in which the limitations of the preceding sentence apply.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

Time is Money Join Law Insider Premium to draft better contracts faster.