Development and Commercialization Activities. Arcus shall use Commercially Reasonable Efforts to Develop and Commercialize Licensed Products. Arcus shall use Commercially Reasonable Efforts to manufacture or otherwise obtain supply of its requirements of packaged and labeled Licensed Products in connection with its Development and Commercialization obligations hereunder, in accordance with all Applicable Laws, GMP (as applicable) and this Agreement. For so long as Arcus is conducting Development activities under this Agreement, Arcus shall provide to WuXi, no later than on June 30 and December 31 of each calendar year, with written summaries of the Development activities it performed, or caused to be performed, in respect of Licensed Products since the preceding report (or, with respect to the first such report, since the Effective Date), and the future Development activities it CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Development and Commercialization Activities. Arcus shall use Commercially Reasonable Efforts to Develop and Commercialize Patented Products in the Field. Notwithstanding the foregoing, Arcus is obligated to file an IND in the United States on a Patented Product no later than months from the Effective Date; provided that Stage 2 Technology Transfer, as defined in Section 3.3.1 below, is completed no later than days following the Effective Date. The deadline for Arcus to file an IND in the United States on a Patented Product shall be extended by one (1) day for each day that Abmuno is late in completing Stage 2 Technology Transfer. Any delay or postponement in the filing of an IND in the United States on a Patented Product beyond the deadline for such filing will be subject to approval by Abmuno, which approval shall not be unreasonably withheld, conditioned or delayed.
Regulatory, Manufacturing and Commercialization. After the Effective Date, # Zai Lab will be solely responsible for and control (at its own expense) all regulatory matters related to the Development and Commercialization of Compounds and/or Products in the Territory, including, without limitation, taking full responsibility for preparing and filing the relevant applications with the Regulatory Authorities for pre-clinical and clinical studies and for Regulatory Approval; and # Zai Lab will be solely responsible for and control (at its own expense) all aspects of Commercialization of Products and the Manufacturing and supply of Products (including, without limitation, the Manufacture and supply of related Compounds being Developed by Zai Lab) in the Territory and will have sole responsibility for all costs arising therefrom.
Development and Commercialization Plans. Licensee shall perform, and shall ensure that its Affiliates, sublicensees, and Third Party contractors perform, the activities described in any Development Plan for the Licensed Product in a professional manner and in compliance with, to the extent applicable, Good Laboratory Practices, Good Clinical Practices and/or Good Manufacturing Practices and in compliance with all other applicable laws, rules, and regulations.
Governance. Denali shall provide to written reports due every following the Effective Date and continuing until receipt of the first Marketing Approval for a Licensed Product summarizing Denalis research, development, manufacturing and commercialization activities for Licensed Product(s) (Development Reports) in the time since the last such report was provided to . The foregoing Development Reports will also include a forecast of any anticipated Milestone Events. Each Development Report will be Denalis Confidential Information.
review and discuss reports from the JDC and JCC and provide guidance thereto, direct the activities of such Committees, and approve each Research Plan, Early Clinical Development Plan, Late Clinical Development Plan and Joint Commercialization Plan and, in the case of all plans, amendments thereto;
Reporting. Commercializing Party shall keep Licensor reasonably informed of Commercializing Party’s and its sublicensees’ Commercialization activities concerning the Licensed Protocol, the Kaufmann Name and/or the Kaufmann Intellectual Property. Without limiting the foregoing, within thirty (30) days following the end of each calendar quarter (commencing for the calendar quarter ending December 31, 2021), Commercializing Party shall provide Licensor with a written report summarizing the significant Commercialization activities performed with respect to the Licensed Protocol, the Kaufmann Name and/or the Kaufmann Intellectual Property since the date of the last report. Such reports must be at a level of detail reasonably requested by Licensor.
Issuing Bank Reports. Unless otherwise agreed by the Administrative Agent, each Issuing Bank shall report in writing to the Administrative Agent such information as the Administrative Agent shall reasonably request as to the Letters of Credit issued by such Issuing Bank.
Records and Reports. Provider shall assist Manager and, where required by law or by legal process, provide access to records and information regarding the operation of the Biomedical Laboratories. Consistent with all applicable federal, Utah and local statutes, rules and regulations and medical ethical standards, Provider shall give Manager full access to all of its biomedical and financial records during regular business hours and upon adequate notice as
Annual Management Reports. No more than once per calendar year during the Lease Term, upon ’s request, and only to the extent the information is not already readily available to on an independent basis, shall prepare and deliver to # if the Premises are separately metered, a utilities consumption and demand report and analysis for the preceding year and # any other reports as shall, on an annual basis, reasonably request in connection with the operation, repair and maintenance of the Building Systems, which reports are generally consistent with the Management Standard.
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