Regulatory Activities in the Territory Sample Clauses

Regulatory Activities in the Territory. (a) Each Party (the “Filing Party”) shall provide the other Party (the “Non-Filing Party”) with an opportunity to review and comment on all material Regulatory Materials submitted by the Filing Party to any applicable Regulatory Authority, in each case reasonably in advance of when the Filing Party intends to submit such Regulatory Materials to the Regulatory Authority. The Non-Filing Party shall provide its comments within [*], or such other period of time mutually agreed to by the Parties, but in no event shall any such review delay any such submission beyond the deadline therefore. The Filing Party shall consider in good faith any such comments of the Non-Filing Party. The Filing Party shall provide the Non-Filing Party with a copy in electronic form of all material Regulatory Materials filed with the Regulatory Authority related to the use of the Products in the Field. (b) In the Core Orphan Territory and Japan, the Filing Party shall notify the Non-Filing Party within no less than [*] of any request for a meeting or substantive telephone conference call with a Regulatory Authority with respect to any Product IND or Regulatory Approval. Upon the Non-Filing Party’s request, the Filing Party shall request that the Regulatory Authority permit at least [*] Non-Filing Party employees to participate in any such meeting or conference call as an observer and in preparatory meetings prior to any such meeting or conference call. To the extent permitted by the Regulatory Authority, the Non-Filing Party shall have the right to participate in any such meeting or conference call as an observer. The foregoing rights and obligations apply with respect to meetings or conferences initiated by the Filing Party or by the Regulatory Authority. The Filing Party shall promptly furnish the Non-Filing Party with copies of all material correspondence related to a Product the Filing Party has had with the Regulatory Authority, including (i) documents related to regulatory milestones and dates (e.g., submission, validations, agency review questions, etc.); (ii) IND annual reports and cover letters of key agency submissions; and (iii) contact reports concerning conversations or minutes from any substantive meetings with the Regulatory Authority, in each case, related to a Product.

Regulatory Activities in the Territory. MSRx and Galena shall use Commercially Reasonable Efforts, in good faith, to conduct such research and development activities, including clinical trials, necessary to maintain Regulatory Approval for the Product in the Territory and shall cooperate to take all such reasonable actions as shall be necessary or appropriate to prepare and file all documentation with the Regulatory Authorities for the maintenance of Regulatory Approval of the Product in the Territory and to furnish such information to the Regulatory Authorities in connection therewith.

Regulatory Activities in the Territory. 7.01 As of the Effective Date, based upon the Feedback and the Minutes, ARS plans to submit the application for the EU Marketing Authorization for the Strength 1 to the EMA on the legal basis of article 8(3) of the EU Directive 2001/83/EC. 7.02 Notwithstanding the provision set out in Paragraph 7.01 above, in order to avoid any possible delays after submission of the EU Marketing Authorization application for the Strength 1 to the EMA pursuant to the provision set out in Paragraph 7.03 and Paragraph 7.04(i) below, ARS, starting from the Effective Date, undertakes to promptly commence also: (i) the preparation of a Dossier and other documentation required under article 10(a) of the EU Directive 2001/83/EC; (ii) the activities necessary in order to allow the UniDose System as described in the Dossier to be compliant to the EU Regulation 2017/745 by [***] and promptly provide Recordati with the documentation necessary to evidence such compliance in accordance with the relevant EU guidelines as soon as available, and in any event by no later than [***]. 7.03 Starting from the Effective Date, ARS and Recordati undertake to discuss in good faith the most appropriate legal basis for the submission of the EU Marketing Authorization application for the Strength 1 to the EMA. ARS shall provide Recordati the comments of Rapporteur and of Co-Rapporteur on the Minutes and the final minutes and, also based on such comments, Parties shall finally determine the legal basis for the application for the EU Marketing Authorization for the Strength 1 to the EMA, which may include a different type of submission to be made in accordance with article 10(a) of the EU Directive 2001/83/EC. 7.04 ARS undertakes to: (i) submit the application for the EU Marketing Authorization for the Strength 1 to the EMA, using Commercially Reasonable Efforts to do so on [***] and in any case [***], with a view to obtaining a positive validation of such submission from the EMA; provided that should EMA raises questions during validation, ARS undertakes to take any action needed to address such questions, including promptly changing the legal basis of the submission (if needed). (ii) submit the application for the UK Marketing Authorization for the Strength 1 to the MHRA, using Commercially Reasonable Efforts to do so no later than [***], with a view to obtaining a positive validation of such submission from the MHRA; (iii) include in the applications set out in points (i) and (ii) above, 2 (two) Tra...

Regulatory Activities in the Territory. Subject to the terms of the provisions of Section 4, Dara shall use Commercially Reasonable Efforts, in good faith, to conduct such research and development activities, including clinical trials, necessary to maintain Regulatory Approval for the Product in the Territory and shall cooperate to take all such reasonable actions as shall be necessary or appropriate to prepare and file all documentation with the Regulatory Authorities for the maintenance of Regulatory Approval of the Product in the Territory and to furnish such information to the Regulatory Authorities in connection therewith.

Regulatory Activities in the Territory. Subject to Section 4.9(b), Licensee shall be solely responsible for preparing, filing, obtaining and maintaining all Product Filings for Products in the Territory, [***] and shall be the sole holder of all Product Filings for Products in the Territory, provided that Licensee shall provide English translations of final drafts of the protocol synopsis and all key points for related INDs and the key points of XXXx to Dermavant for review and comment and shall consider Dermavant’s comments thereon in good faith. Licensee shall promptly provide Dermavant with copies, and English summary descriptions, of all material documents, information and correspondence received from any Regulatory Authority in the Territory relating to Product or Compound and, at Dermavant’s request, copies of any other documents, reports and communications from or to any such Regulatory Authority relating to Product or Compound. Further, the parties understand and agree that Dermavant may require Licensee to provide accurate English translations of certain material correspondence delivered to or received from the Regulatory Authorities in the Territory relating to Product or Compound (in addition to the English summary descriptions that Licensee is required to provide pursuant to the above) and the parties agree to work in good faith (through the JDC) to determine

Regulatory Activities in the Territory. As between the Parties, Licensee shall own and hold, and have the sole right to prepare, obtain and maintain Marketing Approvals and applications therefor (including the setting of the overall regulatory strategy therefor) and other submissions, including INDs, in Licensee’s name (or the name of Licensee’s designee) and to conduct communications with the Regulatory Authorities, for Licensed Products in the Territory, [***]. Licensor will assist Licensee, including by providing copies of documentation and data in Licensee’s Control, as reasonably requested by Licensee, in order for Licensee to obtain and maintain each applicable IND and Marketing Approval for the Licensed Products in the Field in the Territory, including in connection with the preparation and filing of Licensee’s regulatory submissions for Licensed Products in the Territory (which assistance and any data provided in connection therewith must be in accordance with Applicable Law and requirements and standards by applicable Regulatory Authorities). Without limiting the generality of the foregoing, Licensor will assist Licensee as reasonably requested in connection with obtaining CMC data and the preparation and filing of regulatory submissions or portions thereof in the Territory that are related to the Manufacture of the Licensed Products.

Related to Regulatory Activities in the Territory

Regulatory Activities Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings with respect to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the Field.
Regulatory Actions The following provisions shall be applicable to the parties to the extent that they are required to be included in employment agreements between a savings bank and its employees pursuant to Section 563.39(b) of the Office of Thrift Supervision (“OTS”) Rules and Regulations, 12 C.F.R. §563.39(b), or any successor thereto, and shall be controlling in the event of a conflict with any other provision of this Agreement, including without limitation Section 5 hereof. (a) If the Executive is suspended from office and/or temporarily prohibited from participating in the conduct of the Bank’s affairs pursuant to notice served under Section 8(e)(3) or Section 8(g)(1) of the Federal Deposit Insurance Act (“FDIA”)(12 U.S.C. §§1818(e)(3) and 1818(g)(1)), the Bank’s obligations under this Agreement shall be suspended as of the date of service, unless stayed by appropriate proceedings. If the charges in the notice are dismissed, the Bank may, in its discretion: (i) pay the Executive all or part of the compensation withheld while its obligations under this Agreement were suspended, and (ii) reinstate (in whole or in part) any of its obligations which were suspended. (b) If the Executive is removed from office and/or permanently prohibited from participating in the conduct of the Bank’s affairs by an order issued under Section 8(e)(4) or Section 8(g)(1) of the FDIA (12 U.S.C. §§1818(e)(4) and (g)(1)), all obligations of the Bank under this Agreement shall terminate as of the effective date of the order, but vested rights of the Executive and the Bank as of the date of termination shall not be affected. (c) If the Bank is in default, as defined in Section 3(x)(1) of the FDIA (12 U.S.C. §1813(x)(1)), all obligations under this Agreement shall terminate as of the date of default, but vested rights of the Executive and the Bank as of the date of termination shall not be affected. (d) All obligations under this Agreement shall be terminated pursuant to 12 C.F.R. §563.39(b)(5), except to the extent that it is determined that continuation of the Agreement for the continued operation of the Bank is necessary: (i) by the Director of the OTS, or his/her designee, at the time the Federal Deposit Insurance Corporation (“FDIC”) enters into an agreement to provide assistance to or on behalf of the Bank under the authority contained in Section 13(c) of the FDIA (12 U.S.C. §1823(c)); or (ii) by the Director of the OTS, or his/her designee, at the time the Director or his/her designee approves a supervisory merger to resolve problems related to operation of the Bank or when the Bank is determined by the Director of the OTS to be in an unsafe or unsound condition, but vested rights of the Executive and the Employers as of the date of termination shall not be affected.
Marketing Activities The Borrower will not, and will not permit any of its Subsidiaries to, engage in marketing activities for any Hydrocarbons or enter into any contracts related thereto other than (i) contracts for the sale of Hydrocarbons scheduled or reasonably estimated to be produced from their proved Oil and Gas Properties during the period of such contract, (ii) contracts for the sale of Hydrocarbons scheduled or reasonably estimated to be produced from proved Oil and Gas Properties of third parties during the period of such contract associated with the Oil and Gas Properties of the Borrower and its Subsidiaries that the Borrower or one of its Subsidiaries has the right to market pursuant to joint operating agreements, unitization agreements or other similar contracts that are usual and customary in the oil and gas business and (iii) other contracts for the purchase and/or sale of Hydrocarbons of third parties (A) which have generally offsetting provisions (i.e. corresponding pricing mechanics, delivery dates and points and volumes) such that no “position” is taken and (B) for which appropriate credit support has been taken to alleviate the material credit risks of the counterparty thereto.
Regulatory Action (a) If the Executive is removed and/or permanently prohibited from participating in the conduct of the Employer’s affairs by an order issued under Section 8(e)(4) or 8(g)(l) of the Federal Deposit Insurance Act (“FDIA”) (12 U.S.C. 1818(e)(4) and (g)(l)), all obligations of the Employer under this Agreement shall terminate, as of the effective date of such order, except for the payment of Base Salary due and owing under Section 4.1 on the effective date of said order, and reimbursement under Section 4.6 of expenses incurred as of the effective date of termination. (b) If the Executive is suspended and/or temporarily prohibited from participating in the conduct of the Employer’s affairs by a notice served under Section 8(e)(3) or 8(g)(l) of the FDIA (12 U.S.C. 1818(e)(3) and (g)(l)), all obligations of the Employer under this Agreement shall be suspended as of the date of service, unless stayed by appropriate proceedings. If the charges in the notice are dismissed, the Employer shall (i) pay the Executive all or part of the compensation withheld while its contract obligations were suspended and (ii) reinstate (in whole or in part) any of its obligations which were suspended. (c) If the Employer is in default (as defined in Section 3(x)(l) of the FDIA), all obligations under this Agreement shall terminate as of the date of default, but the vested rights of the parties shall not be affected. (d) All obligations under this Agreement shall be terminated, except to the extent a determination is made that continuation of the contract is necessary for the continued operation of the Employer (i) by the director of the Federal Deposit Insurance Corporation (the “FDIC”) or his or her designee (the “Director”), at the time the FDIC enters into an agreement to provide assistance to or on behalf of the Employer under the authority contained in 13(c) of the FDIA; or (ii) by the Director, at the time the Director approves a supervisory merger to resolve problems related to operation of the Employer when the Employer is determined by the Director to be in an unsafe and unsound condition. Any rights of the Executive that have already vested, however, shall not be affected by such action.
Regulated Activities The Company shall not itself, nor shall it cause, permit or allow the Bank or any other of its Subsidiaries to (i) engage in any business or activity not permitted by all applicable laws and regulations, except where such business or activity would not reasonably be expected to have a Material Adverse Effect on the Company, the Bank and/or such of its Subsidiaries or (ii) make any loan or advance secured by the capital stock of another bank or depository institution, or acquire the capital stock, assets or obligations of or any interest in another bank or depository institution, in each case other than in accordance with applicable laws and regulations and safe and sound banking practices.
Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.
Specific Activities Please give detailed information about the specific activities of the Project promoter and the Partner(s), with budget allocations 7.1 The main tasks of [name of the Project Promoter], referred to as the ‘Project Promoter’, are summarized as follows: Name Project activities Project budget 1 .... [mention the budget allocated to Project Promoter for the respective activity] EUR.... Activity 2 .... EUR... 7.2 The main input/responsibilities of [name of the Project Partner(s)], referred to as Partner 1, 2, etc., are summarized as follows: Name Project activities Project budget Partner 1... [briefly present the project activity implemented by Partner]. Activity 1 .... [mention the budget allocated to Partner 1 for the respective activity] EUR.... Activity 2 .... EUR... Name Project activities Project budget
Proposing Integration Activities in the Planning Submission No integration activity described in section 6.3 may be proposed in a CAPS unless the Funder has consented, in writing, to its inclusion pursuant to the process set out in section 6.3(b).
Regulatory Cooperation In connection with any foreclosure, collection, sale or other enforcement of Liens granted to the Administrative Agent in the Collateral Documents, Parent will, and will cause its Restricted Subsidiaries to, reasonably cooperate in good faith with the Administrative Agent or its designee in obtaining all regulatory licenses, consents and other governmental approvals necessary or (in the reasonable opinion of the Administrative Agent or its designee) reasonably advisable to conduct all aviation operations with respect to the Collateral and will, at the reasonable request of the Administrative Agent and in good faith, continue to operate and manage the Collateral and maintain all applicable regulatory licenses with respect to the Collateral until such time as the Administrative Agent or its designee obtain such licenses, consents and approvals, and at such time Parent will, and will cause its Restricted Subsidiaries to, cooperate in good faith with the transition of the aviation operations with respect to the Collateral to any new aviation operator (including, without limitation, the Administrative Agent or its designee).
Litigation and Regulatory Cooperation During and after the Executive’s employment, the Executive shall cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company. The Executive’s full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the Executive was employed by the Company. The Company shall reimburse the Executive for any reasonable out-of-pocket expenses incurred in connection with the Executive’s performance of obligations pursuant to this Section 7(f).

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