REGULATORY ACTIVITIES AND PRICING ACTIVITIES Sample Clauses

REGULATORY ACTIVITIES AND PRICING ACTIVITIES. 4.1 Diligence; Ownership of Regulatory Approvals and Pricing Approvals. (a) General Regulatory Activities and Pricing Activities in COMPANY Territory. COMPANY shall be responsible for all Regulatory Activities and Pricing Activities and shall use Commercially Reasonable Efforts in preparing all Regulatory Materials and Pricing Materials necessary or desirable for obtaining and maintaining Regulatory Approvals and Pricing Approvals, as applicable, in the COMPANY Territory in the Field (including in connection with Labelling and Packaging for the Product in the COMPANY Territory) in accordance with the Development Plan and the COMPANY Commercialization Plan. MorphoSys shall have the right to review any essential Regulatory Materials and [***] related to the Licensed Antibody and Product and may provide advice to COMPANY on the proposed strategy and documentation for submission in the COMPANY Territory and COMPANY shall reasonably consider such comments in good faith in preparing such materials. COMPANY shall, subject to Section 4.1(c), prepare and submit such Regulatory Materials, XXXx and Pricing Materials, as applicable, to the applicable Governmental Authorities in the COMPANY Territory. Subject to Section 5.2(b), COMPANY shall use Commercially Reasonable Efforts toward obtaining and maintaining Regulatory Approvals and Pricing Approvals, as applicable, for Product as a therapeutic, prophylactic or palliative product in the countries and regulatory jurisdictions in the COMPANY Territory, in its own name, in a commercially reasonable time and manner. To the extent not prohibited by applicable Laws and feasible based on scheduling timelines, MorphoSys shall be entitled, [***], to attend key meetings and scheduled calls with the relevant Governmental Authorities in the COMPANY Territory with respect to obtaining or maintaining the Regulatory Approvals and [***], as applicable, for the Product in the Field. COMPANY shall be responsible for and [***] the Product in the COMPANY Territory and, for clarity, shall [***] to the extent MorphoSys is performing [***] or supporting [***] as agreed between the Parties. For the avoidace of doubt, the exercise of MorphoSys’ rights to review materials and provide advice to COMPANY as described above shall [***].
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Related to REGULATORY ACTIVITIES AND PRICING ACTIVITIES

  • 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.

  • 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.

  • 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

  • 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.

  • 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.

  • Market Activities The Company will not, directly or indirectly, (i) take any action designed to cause or result in, or that constitutes or would reasonably be expected to constitute, the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of Common Stock or (ii) sell, bid for, or purchase Common Stock in violation of Regulation M, or pay anyone any compensation for soliciting purchases of the Placement Shares other than the Agent.

  • Lobbying Activities [Added] A. Pursuant to 31 U.S.C. § 1352, and any regulations promulgated thereunder, the Contractor hereby assures and certifies, to the best of its knowledge and belief, that no federally appropriated funds have been paid, or will be paid, by or on behalf of the Contractor, to any person for influencing or attempting to influence an officer or employee of any agency, a member of Congress, an officer or employee of Congress, or an employee of a member of Congress, in connection with the awarding of any federal contract, the making of any federal grant, the making of any federal loan, the entering into of any cooperative agreement, and the extension, continuation, renewal, amendment, or modification of any federal contract, grant, loan or cooperative agreement. B. If any funds other than federally appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a member of Congress, an officer or employee of Congress, or an employee of a member of Congress in connection with this Contract, the Contractor shall complete and submit Standard Form-LLL, “Disclosure Form to Report Lobbying”. If the Contractor is required to submit Standard Form-LLL, the form and instructions for preparation of the form may be obtained from the State. C. The Contractor shall require that the language of this certification be included in any subcontracts and that all subcontractors shall certify and disclose accordingly. D. The foregoing certification is a material representation of fact upon which reliance was or will be placed when entering into this Contract and any transactions with the State. Submission of this certification is a prerequisite for making or entering into any transaction as imposed by 31 U.S.C. § 1352. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000.00 and not more than $100,000.00 for each such failure.

  • Competing Activities Notwithstanding any duty otherwise existing at law or in equity, (i) neither a Member nor a Manager of the Company, or any of their respective affiliates, partners, members, shareholders, directors, managers, officers or employees, shall be expressly or impliedly restricted or prohibited solely by virtue of this Agreement or the relationships created hereby from engaging in other activities or business ventures of any kind or character whatsoever and (ii) except as otherwise agreed in writing or by written Company policy, each Member and Manager of the Company, and their respective affiliates, partners, members, shareholders, directors, managers, officers and employees, shall have the right to conduct, or to possess a direct or indirect ownership interest in, activities and business ventures of every type and description, including activities and business ventures in direct competition with the Company.

  • EXTRA-CURRICULAR ACTIVITIES 1. In this Agreement, extra-curricular programs and activities include all those that are beyond the provincially prescribed and locally determined curricula of the school district. 2. The Board and the Association consider it desirable that teachers participate in extra-curricular activities, and recognize that participation in extra-curricular activities by the individual teacher is on a voluntary basis.

  • Extracurricular Activities Effective July 1, 2009, stipends for participation in extracurricular activities which are authorized by the appointing authority shall be: Inland $950/year Sailing $400/year Art Club Advisor $300/year Drama Club Advisor $300/year Cross Country Skiing $150/year Boys’ Basketball $1000/year Girls’ Basketball (if class D) $1000/year Asst. Boys’ Basketball $750/year Asst. Girls’ Basketball (if class D) $750/year Scorekeeper/Timekeeper $10/game Soccer $400/year Track $400/year Cross County Running $400/year Girls’ Basketball (if not class D) $400/year Sports Activity Director $400/year Athletic Director $200/year

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