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 a. PCT and Client shall permit Regulatory Agencies to conduct inspections of the Facility(ies) where Services are performed as may reasonably be requested during normal business hours and PCT shall cooperate, at Client’s cost, with such Regulatory Agencies (to the extent such inspections or audits relate primarily to Product or Services set forth in this Agreement). Each Party shall give the other prior written notice, to the extent practicable, of such inspections and keep the other Party informed about the progress, results and conclusions of each regulatory inspection. If prior notice is not possible, PCT shall, within *** Business Days of said inspections, inform Client of a regulatory inspection relating to or that may reasonably affect Services under the Agreement. In the event that an inspection/audit by a Regulatory Agency of a Facility where Services are being performed relates solely to the Product or Services provided to Client in this Agreement, and such inspection/audit is not the result of the negligence or willful misconduct of PCT, then Client agrees that PCT may charge Client the standard hourly rates for the PCT staff involved (in accordance with the table of hourly rates set forth in Section 17(m) below, as such rates may be adjusted from time to time) with such audit/inspection. b. PCT shall, within *** Business Days, promptly provide to Client copies of correspondence received from any Regulatory Agencies in connection with such inspections or relating to any Product, the Facility (if it relates to or affects the Services and/or Product) or the Manufacturing Process, including, but not limited to, FDA Form 483 notices or warning letters. PCT will consult with, and obtain approval from, Client (which approval will not be unreasonably withheld or delayed) before responding to each such communication from a Regulatory Agency that relates to the Product or the Manufacturing Process. Client will be given the opportunity to have a representative, at Client’s cost and expense, present during an FDA or other Regulatory Agency inspection relating to or that may reasonably affect Services under the Agreement. In the event that an inspection/audit by the Regulatory Agency of the Facility solely relates to the Product or Services provided to Client in the Agreement, and such inspection/audit is not the result of the negligence or willful misconduct of PCT, then Client agrees that PCT may charge Client the standard hourly rates for the PCT staff in...

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 3.4 Pomoc při plnění regulačních požadavků. Na základě 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 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. 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 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. 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. 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. 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.