Development and Regulatory Activities Clause Samples
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 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.
(b) In the course of its Development or manufacturing of any Dexmedetomidine Products, Orion has not conducted any activities in violation of applicable laws and regulations of the country in which and at the time such studies were conducted, including then currently applicable Good Laboratory Practices (“GLP”), current Good Clinical Practices (“GCP”), and current Good Manufacturing Practices (“cGMP”) or similar or corresponding regulations or guidelines. Specifically with respect to A▇▇▇▇▇/Hospira’s NDA for Precedex in the United States, to which Orion has a right of reference, to Orion’s Knowledge, preclinical toxicological work was conducted in accordance with then-current GLPs, all pivotal NDA clinical studies were conducted in accordance with then-current GCPs, and all manufacturing information met GMP standards. To the Knowledge of Orion as of the Effective Date, there are no problems that would reasonably require that any previous or current Development, manufacturing or Commercialization activities by Orion or its Affiliates be materially delayed, suspended or abandoned before their completion.
(c) To Orion’s Knowledge, neither ...
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.
3.2 Yitai shall bear the costs of all development and regulatory activities of the Licensed Product in the Field in the Territory. Under the Assignment and Consulting Service Agreement, in the event any clinical and non-clinical study in addition to IND Study (No.CTR20212222) is required for obtaining marketing authorization (such as more human subjects or animals need to be recruited than provided under the current clinical or non-clinical protocol), Yitai shall discuss with APN SZ before initiating these studies and the costs of such studies shall be borne by ▇▇▇▇▇ and APN SZ [***]. If APN SZ fails to pay [***] of the costs of such studies, Yitai shall have the right to pursue payment of such costs against APN JP.
Development and Regulatory Activities. As between the Parties, ARS shall have the sole right to conduct, and ALK shall not conduct or sponsor (directly or indirectly), clinical trials or other development activities with respect to the Product in the Territory, including providing support or assistance for investigator sponsored trials, cooperative studies, clinical studies, including post-approval studies, or other studies, including health economics and outcomes research and phase 4 studies, or any other research or development activities with respect to the Product. As between the Parties, ARS shall be responsible for reporting of, and shall report, regulatory matters regarding the manufacture, distribution, promotion and safety of the Product (including adverse events and product quality complaints) to or with the FDA and/or other relevant Regulatory Authorities in the Territory, as applicable. For clarity, the foregoing shall not limit ALK’s obligations under Applicable Laws to report its relevant Promotion activities under this Agreement, including ALK’s reporting obligations under Applicable Laws with respect to transparency reporting, as described in Section 5.4. If a Sales Representative receives any inquiry regarding any such matter described in this Section 3.7, ALK shall refer the Person making the inquiry to ARS, in a manner directed by ARS from time to time.
Development and Regulatory Activities. 4.1 Nonclinical and Clinical Studies and CMC Requirements
4.2 Regulatory Activities 4.3 Distributor’s Right to Use and Reference
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.
Development and Regulatory Activities. 5.1 Current Status of Development of Product. As of the Effective Date, Lilly holds the Regulatory Approval for a product containing the Compound in a certain finished form and formulation under the Lilly brand name Cialis® for treatment of erectile dysfunction, has conducted clinical trials for the Product in the Field, has submitted a New Drug Application to the FDA for Regulatory Approval for the Product in PAH in the Territory, and is conducting certain clinical trials for the Product as of the Effective Date set forth in Exhibit 5.1 (the “Ongoing Lilly Trials”).
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.
4.2. In the event that with respect to a certain milestone, any of the Parties does not timely meet the targets set in such milestone as will be agreed upon by the JCS (in case the JSC cannot reach a decision, it will be considered that such target was not timely met), such Party shall have additional three (3) months period for meeting such target milestone in the Development Plan ("First Extension"), and one additional three (3) months period if such target has not been met during the First Extension (the "Second Extension"). Either Party shall be entitled to terminate the Agreement if a certain target in a certain Development Plan has not been met until the completion of the Second Extension or in the event that the entire Development Plan is delayed by more than nine (9) months from the original approved schedule unless otherwise agreed by the JSC.
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. (a) As between the Parties, (i) ThromboGenics shall conduct all non-clinical (other than those for which EBI is responsible in the Research Collaboration) and clinical development activities for the Collaboration Products in the Field, all in accordance with the terms and conditions of this Agreement and at its sole cost and expense; (ii) ThromboGenics shall be responsible for all regulatory communications and requirements, including assembly of the eCTD and pharmacovigilance; and (iii) ThromboGenics shall file all Marketing Authorization Applications and hold all Marketing Approvals for the Collaboration Products in the Field in the Territory at its sole cost and expense. ThromboGenics shall have sole and full decision-making authority as to the pre-clinical activities for the Collaboration Products after the Research Term, and the clinical development strategy for the Collaboration Products in the Field in the Territory; provided that any activity, strategy or related decision described in this Section 4.1(a), or in Section 4.2 or 4.3(a), shall be consistent with the terms and conditions of this Agreement, and any such activity, strategy or decision may not increase EBI’s obligations, reduce EBI’s rights, expand ThromboGenics’ rights or reduce ThromboGenics’ obligations, and ThromboGenics shall determine such strategy and make such decision (x) in good faith, (y) subject to the terms and conditions of this Agreement and (z) in a commercially reasonable manner.
(b) After the JRC has been disbanded, ThromboGenics shall provide written reports to EBI at least [**] Business Days after the end of each Calendar Year, setting forth in reasonable detail ThromboGenics’ and its Affiliates’ and licensees’ activities and progress since the preceding report related to the research and development of the Collaboration Products, including information concerning clinical studies, achievement of development and regulatory milestones, filing of applications for and securing of Regulatory Approvals, and the territories (by each Major Country, if relevant, and the rest of the world) in which the foregoing activities are conducted; provided, however, that in case EBI requests an extra-ordinary update on ongoing development activities (which EBI shall not undertake more than once per Calendar Quarter), ThromboGenics shall address this request within [**] Business Days. For the avoidance of doubt, such extra-ordinary reports can be provided via email.