Regulatory Assistance Clause Samples

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. 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 reasonably requests with respect to regulatory matters relating to the Study or Study Drug. 3.4 Pomoc ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇. ▇▇ ▇▇▇▇▇▇▇ 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. 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. Site agrees to assist with regulatory submissions, if necessary, subject to Sponsor paying a reasonable fee.

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 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. (a) During each Program and for a period of [***] years following Completion, Fujifilm will provide all reasonably necessary assistance to aTyr in respect of aTyr’s regulatory filing activities for the applicable Drug Product or Process, subject to (except as may be expressly agreed in a Scope of Work) payment by aTyr of a reasonable commercial rate for such assistance and Fujifilm’s reasonable expenses. No advice or assistance given by Fujifilm shall be deemed to be or construed as a guarantee that a Drug Product will receive regulatory approval. Fujifilm will provide an electronic (PDF) copy of any documents which may be reasonably required by aTyr in support of such regulatory filing activities. If aTyr requires copies of the laboratory notebooks, provision of these will be subject to agreement of an additional fee associated with copying. (b) aTyr shall have the sole right and responsibility for determining regulatory strategy, decisions and actions relating to each Program and any Product and/or Drug Product, provided that Fujifilm shall have the right and responsibility for determining regulatory strategy, decisions and actions solely to the extent relating to (i) the Facility; (ii) Fujifilm’s quality systems; (iii) any requirement imposed on Fujifilm by a Regulatory Authority or (iv) any other commitments made by Fujifilm prior to the commencement date of the applicable Program; (each a “Fujifilm Regulatory Responsibility”). aTyr shall therefore consult with Fujifilm in relation to in the Chemistry, Manufacturing and Controls (CMC) Clause of any submissions to Regulatory Authorities before submission to such Regulatory Authorities and aTyr shall not make any change to its regulatory filings, including without limitation its IND, which may in the reasonable judgment of aTyr have an impact on any such Fujifilm Regulatory Responsibility without [***] days written notification to Fujifilm.

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.