Migration MCK shall provide all requisite assistance as is reasonably requested by NewCo in order to migrate the Services from MCK’s personnel, facilities and environment to NewCo’s (or its designee’s) personnel, facilities and environment, provided, that, other than as expressly set forth in the Service Schedule, NewCo shall be responsible for all third-party costs incurred by MCK and its Affiliates to migrate such Services and, provided further, that, NewCo shall be responsible for all costs associated with operational decisions made by NewCo for its set-up costs and costs to procure items (e.g., selection of Customer Relationship Management software). For the avoidance of doubt, NewCo will be responsible for migration to any new NewCo Data Center, including design, implementation and testing. MCK will provide reasonable support in such efforts. MCK will provide to NewCo an electronic copy in the then-current format of all data that is owned by NewCo (a) a written description of processes and procedures used by MCK in connection with the provision of Services to the Core MTS Business to the extent such descriptions exist, (b) a written description of all system documentation, architecture diagrams and business process diagrams for the systems, processes and controls used in the Core MTS Business to the extent such descriptions exist and (c) written training and onboarding materials used in the Core MTS Business to the extent such materials exist. In addition, MCK will, upon NewCo’s reasonable request, make available knowledgeable MCK personnel for knowledge transfer and discussion at a mutually agreed upon time with respect to the Services and the processes, procedures and systems used in the provision of the Services. The parties will meet in person to establish, within two (2) weeks following the Closing Date, a planning process for the migration of the Services from MCK’s personnel, facilities and environment to NewCo’s (or its designee’s) personnel, facilities and environment. During such meetings, the parties will identify workstreams and workstream leaders, staff project teams for each workstream, identify roles and responsibilities for project team members and create a project charter that will serve collectively as the basis for developing more detailed timelines and specific deliverables for each of the workstreams. At a minimum, there will be a workstream for each functional area that is the subject of Schedules. Each workstream will report to the Project Managers. The parties will meet (in person or by telephone) as often as is reasonably necessary to develop such detailed timelines and specific deliverables for each workstream.
Regulatory Affairs Each Party shall advise the other Party of any regulatory action of which it is aware which would affect the Product in any country of the Territory.
Transition Planning 28 4.5. Control of Other Party's Business . . . . . . . . . 28
Initial Development Plan Not later than the Effective Date, Licensee shall have provided Merck with an initial Development plan for the Licensed Product in the Field in the Territory, which shall be incorporated as part of this Agreement as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the “Development Plan”). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
Transition Seller will not take any action that is designed or intended to have the effect of discouraging any lessor, licensor, customer, supplier, or other business associate of the Company from maintaining the same business relationships with the Company after the Closing as it maintained with the Company prior to the Closing. The Seller will refer all customer inquiries relating to the business of the Company to the Purchaser from and after the Closing.
Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.
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.
Disaster Recovery and Business Continuity Company has developed and implemented a contingency planning program to evaluate the effect of significant events that may adversely affect the customers, assets, or employees of Company and Company Bank. To Company’s Knowledge, such program ensures that Company can recover its mission critical functions, and complies in all material respects with the requirements of the FFIEC and the FDIC.
Scope of Cooperation 1) Party A authorizes Party B as the sole distribution agent of the “Case edition” and “Channel edition” of China Marketing and China Business and Trade in the territory of Hunan Province (not including post offices) and Party B is responsible for the distribution matter within such area. Party A will support Party B to achieve a good performance in the regional marketing and promotion and guarantee the legitimate rights and interests of Party B during the term of this agreement.
Pharmacovigilance No later than [***] prior to (a) [***] or (b) [***], the Parties will negotiate in good faith and finalize the actions that the Parties will employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports and any other information concerning the safety of any Licensed Product, including recall and withdrawal responsibilities, processes, and procedures. Such guidelines and procedures will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Law. Furthermore, such agreed procedure will be consistent with relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will prevail. Lian will be responsible for reporting quality complaints, Adverse Events, and safety data related to the Licensed Products in the Field to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Field in the Territory. Lyra will be responsible for reporting quality complaints, Adverse Events, and safety data related to Licensed Product to applicable Regulatory Authorities outside the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the Territory. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Lyra at its sole cost and expense, which worldwide safety database will be accessible by Lian and its Affiliates, Sublicensees, and contractors to the full extent necessary for Lian to exercise its rights under this Agreement, comply with its obligations under this Agreement, and comply with all applicable Law. Each Party will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligations.
