Development and Regulatory Activities. 31 3.1 Development 31 3.2 Regulatory Activities 35 ARTICLE 4 COMMERCIALIZATION 39 4.1 In General 39 4.2 Diligence 39 4.3 Commercialization Plan 39 4.4 Booking of Sales; Distribution 40
Development and Regulatory Activities. 3.1 With the support and cooperation of APN JP and its Affiliates, Yitai shall have the sole right and responsibility, and shall use its best efforts, to conduct all clinical development and regulatory activities of the Licensed Product in the Field in the Territory, including but not limited to communicating with National Medical Products Administration (“NMPA”), preparing, applying for, and obtaining all regulatory filings and approvals in connection with the manufacturing and commercialization of the Licensed Product in the Field in the Territory.
Development and Regulatory Activities. (a) Orion and its Affiliates, and, to Orion’s Knowledge, their licensees and partners have conducted, or have caused their respective contractors or consultants to conduct, their development and manufacturing of Dexmedetomidine Products, including GLP and non-GLP preclinical studies and clinical studies for Dexmedetomidine Products, in accordance with (i) applicable laws or regulations, (ii) the standards of the relevant Regulatory Authorities, and (iii) scientific standards applicable to the conduct of such studies and activities; in each case of the country in which and at the time such studies are or were conducted. Neither Orion nor its officers, employees or subcontractors, has made an untrue statement of a material fact to any Regulatory Authority with respect to any Dexmedetomidine Product, or has knowingly failed to disclose a material fact required to be disclosed to any Regulatory Authority with respect to a Dexmedetomidine Product. During the term of this Agreement, Orion shall not, and shall cause its officers, employees and subcontractors not to, knowingly make CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***] HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. any untrue statement of material fact to any Regulatory Authority with respect to the Dexmedetomidine Product, or knowingly fail to disclose a material fact required to be disclosed to any Regulatory Authority with respect to the Dexmedetomidine Product.
Development and Regulatory Activities. Certain confidential information contained in this document, marked by [**], has been omitted because ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) is the type that ADCT customarily and actually treats as private or confidential.
Development and Regulatory Activities. MacroMed represents, warrants and covenants to Diatos that:
Development and Regulatory Activities. 4.1 Nonclinical and Clinical Studies and CMC Requirements
Development and Regulatory Activities. 13 2.1 Development 13 2.2 Regulatory Activities 14 2.3 Regulatory Data 16
Development and Regulatory Activities. 4.1. Following the date hereof the Parties will discuss and set a development plan in order to carry out the Development of Products with respect to each indication in the Field in accordance with a written plan, timetable and milestones for the Development of the Product with respect to each indication in the Field within the Territory which plan should be approved by Pluristem (the "Development Plan") a copy of which will be attached to this Agreement. The Development Plan may be modified from time to time by resolution of the JCS. All terms and conditions of this Agreement shall apply to the modified Development Plan.
Development and Regulatory Activities. The Parties will jointly be responsible for all Development activities with respect to the LRRK2 Licensed Compounds and LRRK2 Licensed Products (as further described below) for the Territory, and such activities will be conducted in accordance with the Global Development Plan/Budget (as defined below). Except as otherwise agreed by the Parties, [***]. Notwithstanding the foregoing, [***]. The Parties will reasonably cooperate and coordinate their respective regulatory interactions relating to the LRRK2 Licensed Compounds and LRRK2 Licensed Products pursuant to the procedures to be described in the Definitive LRRK2 Collaboration and Licensed Agreement. Notwithstanding any provision set forth in this Provisional Collaboration and License Agreement or the Definitive LRRK2 Collaboration and License Agreement, the Parties agree that (i) Denali shall conduct and control the Development of LRRK2 Licensed Compounds and LRRK2 Licensed Products following the Execution Date until the later of the execution of the Definitive LRRK2 Collaboration and License Agreement and the Effective Date, provided that following approval of the initial Global Development Plan/Budget by the JSC, such Development activities will be performed in accordance with such Global Development Plan/Budget; and (ii) no earlier than the date on which the initial Global Development Plan/Budget is approved Biogen shall reimburse Denali for the costs and expenses incurred in conducting Development activities for the LRRK2 Licensed Products during the period commencing on the Execution Date and ending upon the date on which the initial Global Development Plan/Budget is approved by the JSC (the “Interim Development Period”), provided that in no event will Biogen be required to reimburse Denali more than [***] in respect of such Development activities over any given [***] period during the Interim Development Period. [***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Development and Regulatory Activities. 1) Orion and its Affiliates, and, to Orion’s Knowledge, their licensees and partners have conducted, or have caused their respective contractors or consultants to conduct, their development and manufacturing of Fadolmidine Products, including GLP and non-GLP preclinical studies and clinical studies for Fadolmidine Products, in accordance with (i) applicable laws or regulations, (ii) the standards of the relevant Regulatory Authorities, and (iii) scientific standards applicable to the conduct of such studies and activities; in each case of the country in which and at the time such studies are or were conducted. Neither Orion nor its officers, employees or subcontractors, has made an untrue statement of a material fact to any Regulatory Authority with respect to any Fadolmidine Product, or has knowingly failed to disclose a material fact required to be disclosed to any Regulatory Authority with respect to a Fadolmidine Product. During the term of this Agreement, Orion shall not, and shall cause its officers, employees and subcontractors not to, knowingly make any untrue statement of material fact to any Regulatory Authority with respect to the Fadolmidine Product, or knowingly fail to disclose a material fact required to be disclosed to any Regulatory Authority with respect to the Fadolmidine Product.
