Regulatory Assistance Clause Samples

Regulatory Assistance. Upon Licensee’s reasonable request, Licensor shall provide Licensee with reasonable assistance in Licensee’s efforts to obtain and maintain Regulatory Approvals for Product in the Licensee Territory, including access to Regulatory Approvals, Regulatory Filings, and other required materials and documents in Licensor’s possession and required by Licensee or Regulatory Authorities for Regulatory Approval of Product in the Licensee Territory. Licensor shall also provide reasonable support to address questions from Licensee in preparing Regulatory Filings and communicating with Regulatory Authorities regarding Product in the Licensee Territory. Licensee shall reimburse Licensor for the costs and expenses incurred by Licensor to provide such regulatory assistance to Licensee for such cooperation.

Regulatory Assistance. Provider will permit regulators with jurisdiction over BFA or any BFA Recipient to examine Provider’s activities relating to its performance under this Agreement and the Services. Subject to Section 17.6, Provider will cooperate and provide all information reasonably requested by the regulator in connection with any such examination and provide reasonable assistance and access to all equipment, records, and systems requested by the regulator relating to the Services.

Regulatory Assistance. Upon Idorsia's reasonable request and at Idorsia's expense, Institution and Investigator shall: (i) provide assistance to support Idorsia's preparation and submission of new drug applications and any other pre-market or marketing applications relating to the Study or Study Drug, and any amendments or supplements thereto; (ii) attend meetings with Regulatory Authorities regarding such applications and the associated approvals; (iii) provide documentary and other evidence of the proper conduct of the Study in accordance with Applicable Laws as may be required in connection with such applications; and (iv) provide other assistance that Idorsia 3.4 Pomoc při plnění regulačních požadavků. Na základě odůvodněné žádosti společnosti Idorsia a na její náklady Poskytovatel a Zkoušející: (i) poskytnou společnosti Idorsia pomoc a podporu při přípravě a předkládání přihlášek hodnoceného léčiva a jakýchkoli jiných žádostí před uvedením na trh a v průběhu prodeje na trhu ve vztahu ke Klinickému hodnocení nebo k Hodnocenému přípravku, a jakýchkoli změn nebo doplnění takových přihlášek a žádostí; (ii) účastní se jednání s Regulačními orgány týkajících takových přihlášek a souvisejících povolení; (iii) poskytují dokladové a jiné důkazy o řádném provádění Klinického hodnocení v souladu s Příslušnými právními předpisy, jak se případně

Regulatory Assistance. If either Party affirmatively takes a position in the domestic regulatory environment, it will be in favor of a level playing field and in support of competition, as such Party determines in its sole discretion. The Parties shall periodically (but at least semi-annually) meet to discuss their plans and objectives with respect to the regulatory environment.

Regulatory Assistance. (a) The Parties shall cooperate in good faith to obtain any Regulatory Approvals for the use of PARI Products with INSMED Products; provided, however, that as to ROW PARI shall be provided with sufficient lead time and prior to requesting any such cooperation from PARI, INSMED shall be committed to use commercially reasonable efforts to launch the INSMED Products in the applicable country(ies). PARI shall provide regulatory and technical information relating to the Manufacture and supply of PARI Products and/or components thereof as reasonably requested by INSMED to the extent required by a Regulatory Authority or that the Parties mutually agree will be helpful for a filing with a Regulatory Authority. Alternatively, if PARI determines it is reasonably necessary to protect PARI Know-How related to eFlow or the Manufacture of PARI Products and if permitted by the applicable Regulatory Authority, PARI shall notify INSMED and make such information available to Regulatory Authorities directly (e.g. via a master file for devices or equivalent documents). INSMED shall provide regulatory and technical information and Data relating to the INSMED Products as reasonably requested by PARI to the extent required by a Regulatory Authority or that the Parties mutually agree will be helpful for a filing with a Regulatory Authority or in order for PARI to create its technical file of the CE documentation or similar documents. PARI shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the PARI Products. INSMED shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the INSMED Products. Each Party shall notify the other Party, as soon as reasonably practicable but in any event within [***] Business Days via telephone, followed by a notice in writing in the event any action is taken or threatened by a Regulatory Authority relating to the PARI Products and the INSMED Products, as applicable. (b) It is currently anticipated by the Parties that, with respect to the United States, the Device regulatory path shall not include a separate 510(k) submission to CDRH for clearance of the Device. Instead, the Parties currently anticipate proceeding with a single marketing application for the combination product (Device and INSMED Product) in the form of a New Drug Application for the INSMED Product, which single marketing applic...

Regulatory Assistance. Site agrees to assist with regulatory submissions, if necessary, subject to Sponsor paying a reasonable fee.

Regulatory Assistance. Licensee shall be solely responsible for, and shall solely own, all applications for Regulatory Approval with respect to Licensed Products. Should Licensee desire to file an IND or an application for Regulatory Approval, or equivalents of the foregoing, for a Licensed Product, SGI will use reasonable commercial efforts to provide at Licensee’s request, technical information reasonably required for Licensee, including information relating to the chemical structure of the ADC, the toxin used to create such ADC, and the linker and chemistry used to create such ADC, as well as documents necessary to compile the Chemistry Manufacturing and Controls section of any application for Regulatory Approval, or to provide other toxicity and safety data for such filings, and any other relevant information as the Parties may mutually agree. Licensee shall reimburse SGI for any out-of-pocket costs incurred by SGI in providing any such information plus an amount equal to SGI’s then current FTE Fee for SGI’s personnel engaged in such activities, as set forth in Section 6.1.2. If SGI has a drug master file with the FDA or equivalent that contains information related to Drug Conjugation Materials that is useful to support an IND or application for Regulatory Approval, Licensee shall have a right of reference or access to the contents of such drug master file on mutually agreeable terms.

Regulatory Assistance. BH shall provide all reasonably requested support and assistance to VGLNG and its subsidiaries and affiliates related to such filings or deliverables that are necessary or appropriate to submit to FERC and other regulatory authorities for the Projects, in each case, as related to BH’s scope of work, including amending any existing regulatory filings for the Projects, in accordance with the schedule set by VGLNG for submission of such filings or deliverables, [***]. VGLNG and BH acknowledge that the responsibility for FERC filings or any other regulatory or licensing filings for the Projects and successfully obtaining all necessary FERC or other regulatory or licensing approvals for the Projects are solely the responsibility and risk of VGLNG (or the applicable Purchaser).

Regulatory Assistance. At the request and expense of SPONSOR, the Institution and the Principal Investigator shall: (a) provide reasonable assistance to SPONSOR in the preparation and submission of investigational device exemption applications for the Study Device(s), device premarket notification (510(k)) submissions, premarket approval applications (PMA) for the Study Device(s), any other premarket or marketing applications relating to a Study or the Study Device(s), and any amendments or supplements to the foregoing; (b) reasonably assist SPONSOR in preparing for meetings with the FDA and other regulatory or governmental authorities regarding such applications and the associated approvals; and (c) provide such other reasonable assistance for a reasonable time period as SPONSOR may request in connection with regulatory matters relating to a Study or the Study Device(s).