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. WuXi Biologics will provide assistance to Licensee, and any sublicensee, in respect of Licensee’s or such sublicensee’s regulatory filing activities for the Client Product and/or Drug Product, at Licensee’s or such sublicensee’s reasonable cost and expense on [***] rate.
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. 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 reasonably requests with respect to regulatory matters relating to the Study or Study Drug. 3.4 Pomoc xxx xxxxxx xxxxxxxxxxx xxxxxxxxx. Xx xxxxxxx odůvodněné žádosti společnosti Idorsia a na její náklady Zdravotnické zařízení a Zkoušející: (i) poskytnou společnosti Idorsia pomoc a podporu při přípravě a předkládání přihlášek nových léčiv 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 se 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 požadují v souvislosti s takovými přihláškami a žádostmi; a (iv) poskytují jakoukoli jinou pomoc, kterou společnost Idorsia odůvodněně požaduje ve vztahu k regulačním záležitostem souvisejícím s Klinickým hodnocením nebo s Hodnoceným přípravkem.
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).
Regulatory Assistance. Site agrees to assist with regulatory submissions, if necessary, subject to Sponsor paying a reasonable fee. 1.3.5
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. Upon request of BI, Zealand Pharma shall provide, and shall cause its Affiliates to provide such reasonable assistance as may be required by BI, its Affiliates, Sublicensees or Recognized Agents where liaison between the Parties is, or may be, necessary to enable BI, its Affiliates, Sublicensees or Recognized Agents to fulfill its responsibilities hereunder. BI shall reimburse Zealand Pharma and its Affiliates for reasonable and properly justified (i) internal costs (charged on an hourly basis) at the FTE Rate and (ii) internal expenses as well as (iii) reasonable out-of-pocket costs and expenses incurred by Zealand Pharma in providing such assistance.
Regulatory Assistance. Aerogen shall be responsible for creating and maintaining design history files for the Device and for obtaining and maintaining all applicable regulatory and safety certifications for the Device including those set forth in the Product Requirements (e.g., CE Xxxx) for the Device at Dance’s cost. In the event that Aerogen uses the Device outside of the Field, Aerogen will be responsible for the cost of maintaining regulatory and safety certifications from the Device for so long as it continues to use the Device outside of the Field. In addition, Aerogen shall, at Dance’s expense, cooperate with Dance in providing all information (including Information) and reasonable assistance, and taking all actions reasonably requested by Dance, that are necessary or desirable to enable Dance to comply with its obligations under this Agreement including those obligations relating to obtaining Regulatory Approvals for the Drug Device Combination in the Territory. Without limiting the generality of the foregoing, Aerogen shall (i) provide Dance with copies of correspondence received from and to be provided to Regulatory Authorities concerning the Device, including XX xxxxx and manufacturing inspections; (ii) consider in good faith all reasonable suggestions and comments provided by Dance with respect to such correspondence and other communications with Regulatory Authorities; and (iv) not voluntarily take any action or fail to take any action which would be reasonable likely to have an adverse effect on the development of the Drug Device Combination or Dance’s ability to obtain Regulatory Approvals for the Drug Device Combination, including with respect to the milestones and timelines set forth in the Device Development Plan. In addition to the foregoing, Aerogen shall (a) assist Dance with and accompany Dance in its interactions with Regulatory Authorities as requested by Dance and at Dance’s expense and (b) obtain and maintain all applicable regulatory and safety certifications for the Device including those set forth in the Product Requirements. Dance shall provide Aerogen with copies of all correspondence received from and to be provided to Regulatory Authorities concerning the Device and access to all regulatory documentation relating to the Drug Device Combination if so requested.
Regulatory Assistance. If Lucent affirmatively takes a position in the United States regulatory environment, it will be in favor of a level playing field and in support of competition. Lucent agrees to meet and consult with WinStar regarding United States regulatory issues, including with regard to WinStar's licensed spectrum and Equal Access II concerns. Outside of the United States, Lucent shall assist and support all of WinStar's regulatory- related efforts in connection with obtaining required licenses, approvals or otherwise in connection with WinStar's implementation of its network.
