Regulatory Activities in the EU Sample Clauses

Regulatory Activities in the EU. Without limiting COMPANY's rights and responsibility for preparation of Regulatory Materials and Pricing Materials under Section 4.1.(a) and the draft version of the transition plan attached hereto as EXHIBIT 17, MorphoSys shall use Commercially Reasonable Efforts to continue to (i) prepare Regulatory Materials for Product in the European Region and to prepare the MAA in the name of COMPANY or its designated Affiliate and (ii) be the primary contact point for the EMA, including leading the registration procedure and all meetings with rapporteurs, EMA and CHMP; for the first submission of a MAA in the European Region based on the L-MIND (MOR208C203) Trial, RE-MIND Trial and RE-MIND2 Trial until the grant of such Marketing Authorization for the EU. Such continuation shall be made in close cooperation and alignment with COMPANY and COMPANY representatives shall be permitted to attend key meetings and scheduled calls between MorphoSys and the Regulatory Authorities to the extent permitted by applicable Laws, and subject to Section 9.2(e)(ii). It is the shared objective of both Parties to file the EU MAA in COMPANY’s (or its Affiliate’s) name no later than [***] (assuming Regulatory Authority feedback is supportive). In the event that the Parties determine that it is not reasonably possible to file the EU MAA in COMPANY’s name [***], the Chief Medical Officers (or equivalent functions) of both companies shall discuss in good faith the pros and cons of delaying the MAA filing (to file at a later date in COMPANY’s name) or to file in MorphoSys’ name on or [***]. In the event of disagreement, the matter shall be referred to the Parties’ Chief Executive Officers who shall discuss in good faith and shall reach agreement (without recourse to external Experts as described in Section 9.2(e)) whether to: (a) file the MAA with the EMA in the name of MorphoSys (or its Affiliate) on or before [***], or (b) file the MAA with the EMA in the name of COMPANY CONFIDENTIAL (or its Affiliate) after [***]. In the event that the Parties’ Chief Executive Officers agree on option (a) as the preferred course, MorphoSys will exercise Commercially Reasonable Efforts to transfer the MAA to COMPANY (or its designated Affiliate) as soon as possible after filing. COMPANY shall be responsible for preparing and submitting all future Marketing Authorizations in COMPANY Territory.
Sample 1
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Related to Regulatory Activities in the EU

  • 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.

  • Regulatory Action (a) If Executive is removed and/or permanently prohibited from participating in the conduct of the Bank’s affairs by an order issued under Section 8(e)(4) or 8(g)(1) of the Federal Deposit Insurance Act (“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 such order.

  • 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.

  • Other Related Activities (a) The Administrator and Affiliates thereof shall have the right to engage in the following activities (subject to compliance with laws and intellectual property rights of third parties) in exchange for the payment of an annual royalty of $10.00 per annum:

  • Regulatory Agreements List any exceptions to the representation and warranty in Section 2.19

  • 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.

  • Cooperation with Regulatory Authorities The parties to this Agreement each agree to cooperate in a reasonable manner with each other in the event that any of them should become involved in a legal, administrative, judicial or regulatory action, claim, or suit as a result of performing its obligations under this Agreement.

  • OTHER ACTIVITIES OF CONSULTANT The Company recognizes that the Consultant now renders and may continue to render consulting and other services to other companies that may or may not conduct business and activities similar to those of the Company. The Consultant shall not be required to devote his full time and attention to the performance of his duties under this Agreement, but shall devote only so much of his time and attention as it deems reasonable or necessary for such purposes.

  • 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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