Development and Regulatory Matters. A. Somaxon shall be solely responsible for conducting and paying for all clinical trials and for all regulatory filings/interactions, including pharmacovigilance related to the Licensed Product(s).
B. Synchroneuron shall provide reasonable and appropriate assistance to Somaxon on the design and implementation of the clinical trials and such other matters relating to the Licensed IP as may be mutually agreeable to the parties. Somaxon shall promptly reimburse Synchroneuron, Advisor and Dr. Steven K. Gold for all expenses reasonably incurred by them durixx xxxxxxxxxxe of such assistance or for other services approved by Somaxon in advance of performance upon presentation of receipts.
C. Somaxon shall file for and hold any related NDA and other similar foreign regulatory filings related to the Licensed Product(s) in its name. Synchroneuron shall be entitled to have a representative attend and participate in (i) each meeting during which Somaxon's strategy with respect to meetings with the FDA or other like foreign government body is discussed and (ii) each meeting with the FDA or other like foreign government body during the conduct of Phase 2 Clinical Trials and Phase 3 Clinical Trials.
Development and Regulatory Matters. 12.1 Promptly following the Effective Date, the JOC shall prepare a detailed plan of all Development activities to be performed by the parties under this Agreement, including the estimated budget for such activities required to obtain and/or maintain Regulatory Approval in any applicable country in the Territory. The JSC shall review and approve the initial Development Plan and on a regular basis review and approve the amended Development Plan (including the related budget if shared by both parties).
12.2 The parties shall perform their respective obligations under the Development Plan in a good scientific manner and in accordance with the terms and conditions of this Agreement, current Good Clinical Practices (as issued by ICH) and all Applicable Laws.
12.3 The Parties shall maintain records of their Development activities under the Development Plan in sufficient detail in good scientific manner appropriate for Patent application and regulatory purposes and in accordance with all Applicable Laws and otherwise in a manner that reflects all work done and results achieved in the performance of the Development Plan.
12.4 The activities under the Development Plan relating to obtaining or maintaining Regulatory Approval, will be allocated between the parties as follows:
12.4.1 in the EEA:
(i) Licensor shall be responsible for conducting any pre-authorization study or test and provide all data as required to EMA prior to the Commission decision to grant a (standard or conditional) marketing authorisation. To the extent practicable in view of the timelines granted to communicate with EMA or other Regulatory Authorities, Licensor shall take into consideration Licensee’s comments on the protocol of any study or test, including any comments relating to a potential impact on activities relating to the Product outside the respective country;
(ii) Studies and tests required to convert a conditional marketing authorisation into a standard marketing authorisation shall be under the responsibility of Licensor if conducted prior to the transfer of the conditional marketing authorisation to Licensee, or under responsibility of Licensee if conducted after the transfer of the conditional marketing authorisation to Licensee. Each party shall take into consideration the other party’s comments on the protocol of any study or test;
(iii) After having obtained a standard marketing authorisation and after transfer of such marketing authorisation to Licensee, Licensee shall be respo...
Development and Regulatory Matters. 22 4.1 Exchange of Data and Know-How...............................22 4.2 Product Registrations.......................................22 4.3 Scope of Clinical Development Plans and Clinical Budget.....
Development and Regulatory Matters. 3.1 (a) The Parties acknowledge that Argyll Biotech is in the process of preparing to submit an initial regulatory registration application for use of SF-1019 with respect to a Licensed Use with one or more regulatory bodies, such as the United States Food and Drug Administration or a foreign regulatory bodies (the “Initial Regulatory Filing”). Until the Initial Regulatory Filing is made and continuing indefinitely thereafter, Argyll Biotech shall be solely responsible for conducting clinical studies and all other regulatory matters, manufacturing matters and/or pre-clinical studies necessary to support, prepare and file the Initial Regulatory Filing, and Argyll Biotech shall use all commercially reasonable efforts necessary to make such Initial Regulatory Filing. Argyll Biotech shall keep Immunosyn informed as to the status of such efforts, shall permit Immunosyn to review and privately to Argyll Biotech comment on the Initial Regulatory Filing and each subsequent regulatory filing during each filing’s preparation, and shall consult with Immunosyn regarding the preparation of the Initial Regulatory Filing and each subsequent filing.
Development and Regulatory Matters. As for Product A:
7.1 Licensee acknowledges that Licensor has completed a phase II clinical trial for the scope of Regulatory Approval for Product A both in the US and Europe for induction of remission of mild to moderate Ulcerative Colitis. Licensee acknowledges that it has been provided data on the outcome of such phase II clinical trials.
7.2 Licensee acknowledges that Licensor has currently phase III clinical trials ongoing in Europe and US for the scope of Regulatory Approval for Product A in such territories and that it has been provided with information on clinical trials design and accepts such design.
7.3 Licensor shall be in charge of conducting such US phase III clinical trial for induction of remission of mild to moderate Ulcerative Colitis including the conduct of any extension trial, but Licensee shall have a right to supervise and manage all the activities related to the US phase III clinical trial. Licensee acknowledges that management of the phase III clinical trial in Europe and US could be optimized in the interest of both Parties, through the supervision by the Steering Committee (SC) set forth by Section 7.13. The SC shall be in charge of setting such optimization process with the objective to speed up Regulatory Approval. Independently from this optimization, however, Licensor and Licensee undertake to provide each other at no charge with all information that each one possesses or to which each one has access that is related to the Product and is reasonably necessary to support Licensor or Licensee’s application for Regulatory Approvals including: as for what pertains Licensor (or its licensees in other territories), all information and data related to the EU phase III clinical trial; as for what pertains Licensee, all information and data related to the US phase III clinical trial; and agree that each Party shall have a right of mutual reference at no-cost to the data the other Party shall gather for the purpose of Product A Regulatory Approval.
7.4 As soon as practically possible following completion of the ongoing phase III clinical trial, Licensor shall transfer to Licensee all regulatory materials (and all rights thereto, including the right to reference any drug master file) to allow Licensee to file an NDA for the Territory. Notwithstanding the foregoing, Licensor shall promptly share any development and/or regulatory data and information generated in connection with Product A from time to time so as not to delay Licensee in fi...
Development and Regulatory Matters. The parties acknowledge that Product manufactured under the Current Product Specifications uses HA sourced from avian tissue. The parties further acknowledge that, in some markets, the customer, regardless of regulatory requirements, prefers products using HA sourced from bacterial fermentation. In recognition of this fact, upon the Effective Date, Seller shall, at *** expense, use its *** efforts to begin qualifying a source of bacterial-fermented raw material that will meet the Current Product Specifications on Exhibit A1 and the regulatory requirements of those countries where Buyer, in its discretion, desires to sell bacterial fermented HA products. *** *** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED WITH ASTERISKS.
Development and Regulatory Matters. 4.1 Exchange of Data and Know-How.................................................................... 4.2
Development and Regulatory Matters. 3.1.1 Dermata shall, at its own expense, be solely responsible for conducting all development activities for the Licensed Products, including formulation optimization, manufacturing, packaging, non-clinical studies, and clinical trials, and for obtaining and maintaining all Regulatory Approvals and interactions with Regulatory Authorities for any Licensed Product in the Territory.
3.1.2 During the Term, upon the request of Dermata, Licensor shall provide Dermata (or Dermata’s designee) with the assistance of Licensor’s employees and access to Licensor’s other internal resources and facilities to provide Dermata with a reasonable level of assistance and consultation to facilitate the development and Regulatory Approval of the Licensed Products, including assigning to Dermata any relevant Regulatory Filings, and the prosecution of the Licensed Patents.
3.1.3 Beginning July 1, 2018 and annually thereafter, and ending on the date of the First Commercial Sale, Dermata shall submit to Licensor a written progress report covering Dermata’s (and any Affiliate’s and Sublicensee’s) activities for the preceding year to develop and obtain Regulatory Approval for any Licensed Product. Such annual reports shall include a summary of work completed, summary of work in progress and schedule of anticipated development milestones. In addition, beginning October 1, 2018 and quarterly thereafter, and ending on the date of the First Commercial Sale, Dermata shall submit to Licensor a brief summary of development activities covering the preceding quarter.
Development and Regulatory Matters. 3.1 Development in the Clinical Development Plan ASTELLAS shall remain responsible for and shall bear all Clinical Plan Development Costs in relation to completing, and shall perform in accordance with the terms of this Agreement and in particular, Sections 2.1(b), 2.1(f) and 3.5, all activities and all studies in each case as specified in the Clinical Development Plan and as detailed more specifically in Section 3.5 below subject to Sections 2.1(c) and 2.1(d).
Development and Regulatory Matters. 3.1 Current Status of Development; Development Activities 54
3.2 Long-Term Development Plan; Annual Development Plan and Budget 55 3.3 Clinical and Regulatory Matters 60 3.4 Allocation of Development Costs 64 3.5 Overruns with Respect to Development Costs 67
3.6 Opt‑In Rights for Other Compounds 68
3.7 Development of Additional Indications and Additional Formulations within the Field 76 3.8 Delegation; Subcontracting 77
