Updating the Strategic Plan Sample Clauses

Updating the Strategic Plan. The Parties will review, evaluate progress, augment, and/or update the Strategic Plan with any changes as needed (but at least once every year), through the Joint Steering Committee, taking into consideration a number of relevant factors, including emerging data, and any changes in the regulatory, medical environment and the competitive landscape. Akcea has primary responsibility for preparing each proposed updated Strategic Plan. Akcea will submit such proposed updated plan to Isis at least fifteen days prior to the next JSC meeting. Any changes to the Strategic Plan altering a Product’s target patient population, key end points or approximate size of the key Clinical Studies, timelines for approval, budget or timing of Product approvals for each patient population (each, a “Material Change”) must be mutually agreed to by the Parties via the JSC.
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Updating the Strategic Plan. 6.3.1. Novartis will review and update the Strategic Plan every [***] months and the Parties will meet or hold a telephone conference to review such updates. Novartis will be responsible for coordinating and scheduling such meetings or telephone conferences, and the Parties will mutually determine the location of meetings. Each Party will be responsible for the costs of its own representatives attending such meetings. At such meeting or telephone conference, as applicable, the Parties will discuss, among other things: (i) Material updates to the Strategic Plan; (ii) Relevant new data and results from ongoing or completed Clinical Studies and non-clinical studies; (iii) Technology advancements (including platform technology) potentially relevant to the Products; (iv) Key elements of the manufacturing planning and strategy to support Development, Regulatory Approvals and Commercialization for the Products; and (v) The evolving competitive landscape (including [***], [***] and [***]) and its potential impact on the Products and strategy.
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Updating the Strategic Plan. Following the JSC’s approval of the initial Strategic Plan, each Party (including through the Regulatory Sub-Committee) will develop updates to those sections of the Strategic Plan for which it is responsible every six months to account for the progression of Development, Manufacturing, and Commercialization of each Product, which updates will include an update to the Strategic Plan prior to completion of the first Phase 1 Clinical Trial for IONIS-TTR-LRx and an update in September of each Calendar Year (to enable each Party to timely complete its internal annual budget process). Akcea will also be responsible, following Ionis’ development of such section in the initial Strategic Plan, for updating the Strategic Plan to include (a) the strategy for Manufacturing and supply of API and Drug Product (i) of inotersen sufficient to support Commercialization (and any Akcea Non-Commercial Activities), and (ii) of IONIS-TTR-LRx,following receipt of Approval therefor in the U.S., and (b) a sequence of activities and associated timelines for the orderly transition from Ionis to Akcea of CMC activities for IONIS-TTR-LRx following receipt of Approval therefor in the U.S. Ionis will remain responsible for updating such strategy for the Manufacturing and supply of IONIS-TTR-LRx through receipt of Approval therefor in the U.S. Without limiting the generality of the foregoing, the Parties will discuss (through the JSC), and Ionis will take into consideration and not unreasonably refuse to implement Akcea’s comments relating to aspects of Development (including designs and protocols of Clinical Trials) of IONIS-TTR-LRx that are likely to affect Commercializing of IONIS-TTR-LRx, such as trial site selection, health economic outcomes, quality of life measures, endpoints, market access, and optimal reimbursement. In addition, at the appropriate time, but no later than at the completion of the first Phase 1 Clinical Trial for IONIS-TTR-LRx, Akcea will update the Development section of the Strategic Plan to account for Akcea Non-Commercial Activities for IONIS-TTR-LRx and the Commercial section of the Strategic Plan to account for Commercial activities for IONIS-TTR-LRx.Each Party or the Regulatory Sub-Committee, as applicable, will submit those sections of the proposed updated Strategic Plan developed by it to the other Party at least 15 days prior to the next JSC meeting. Subject to Section 3.4.4, the JSC must determine whether to approve any material changes to the Strategic...
Sample 1
Updating the Strategic Plan. 6.3.1. Novartis will review and update the Strategic Plan every [***] months and the Parties will meet or hold a telephone conference to review such updates. Novartis will be responsible for coordinating and scheduling such meetings or telephone conferences, and the Parties will mutually determine the location of meetings. Each Party will be responsible for the costs of its own representatives attending such meetings. At such meeting or telephone conference, as applicable, the Parties will discuss, among other things:
Sample 1
Updating the Strategic Plan. The initial Development activities performed by Bayer and Isis under the Strategic Plan will be designed to support market Approval and Commercialization of the First Indication of ISIS-FXIRx. 1.3.1. Bayer will review and update the Strategic Plan every [***] months and the Parties will meet with one another or hold a telephone conference to review such updates. In addition, the Parties may meet or hold a telephone conference more often as mutually agreed on an ad-hoc basis to address any urgent matters that arise with respect to Products. Each Party will ensure that its representatives at such meetings are senior development and/or commercial executives or have similar experience and expertise. Bayer will be primarily responsible for coordinating and scheduling such meetings or telephone conferences, and the Parties will mutually determine the location of meetings. Each Party will be responsible for the costs of its own representatives attending such meetings. At such meeting or telephone conference, as applicable, the Parties will discuss inter alia: (i) any available new data and results from ongoing or completed Clinical Studies and non-clinical studies; (ii) available updates regarding the progress of ongoing Clinical Studies and any New Drug Option Programs; (iii) technology advancements potentially relevant to the Products; (iv) changes proposed by either Party to the Strategic Plan; (v) upcoming scientific, development or commercial events that may impact the Products; (vi) publication plan (including the strategy for scientific publications and presentations at medical meetings); and (vii) the evolving competitive landscape [***] and its impact on the Products and strategy.
Sample 1
Updating the Strategic Plan. 6.3.1. Novartis will review and update the Strategic Plan every [***] months and the Parties will meet or hold a telephone conference to review such updates. Novartis will be responsible for coordinating and scheduling such meetings or telephone conferences, and the Parties will mutually determine the location of meetings. Each Party will be responsible for the costs of its own representatives attending such meetings. At such meeting or telephone conference, as applicable, the Parties will discuss, among other things: (i) Material updates to the Strategic Plan; (ii) Relevant new data and results from ongoing or completed Clinical Studies and non-clinical studies; (iii) Technology advancements (including platform technology) potentially relevant to the Products; (iv) Key elements of the manufacturing planning and strategy to support Development, Regulatory Approvals and Commercialization for the Products; and (v) The evolving competitive landscape (including [***], [***] and [***]) and its potential impact on the Products and strategy. 6.3.2. Material Changes to the Strategic Plan. Novartis is responsible for preparing each updated Strategic Plan and the agenda for each meeting or telephone conference of the Parties to discuss such update, and will submit such updated * ***Confidential Treatment Requested 25 plan and agenda to Akcea at least [***] ([***]) calendar days prior to the date of such next scheduled meeting or telephone conference, as applicable. The Parties’ goal is to mutually agree on changes to the Strategic Plan materially changing the CVRR Indication, the details or timing of the CVOT for a Product (each, a “Material Change”). If, however, after good faith discussions, the Parties cannot mutually agree on a Material Change to the Strategic Plan, then Novartis will have final decision-making authority regarding [***].
Sample 1
Updating the Strategic Plan. Novartis will review and update the Strategic Plan every [***] and, if requested by Xxxxx following receipt of such update, the Parties will meet (in person or virtually) to review such update, which meeting may be held as part of a JSC meeting if the JSC is still in existence. The Parties will mutually determine the location of such meetings. Each Party will be responsible for the costs of its own representatives attending such meetings.
Sample 1
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Related to Updating the Strategic Plan

  • Scope of the Services UNOPS intends to retain the Contractor for the implementation of the Services, and the Contractor intends to provide the Services. The Contractor has represented to UNOPS that it has the appropriate experience, expertise, licences, and resources to undertake the Services and has agreed to undertake the Services in accordance with the Contract. In reliance on the Contractor’s representations UNOPS has entered into the Contract. The Contract sets out the terms and conditions upon which the Contractor will undertake the Services.

  • Description of the Services 1.1 The scope of the service to be rendered is described more fully in the Annexures and Schedules referred to below: ❑ Annexure A – Scope / Specification ❑ Annexure C – Pricing Schedule The Deliverables, due for completion by and governed by this Schedule 1. In the event that the Service Provider fails to meet the delivery dates as agreed, the following penalties will be imposed:

  • Performance of the Services In addition to the Common Articles, it is specified that:

  • Access to the Services ID’s for access to Vendor Core Research and Analyst Inquiry may not be shared. Access to the Services is restricted to the number of named individuals (each a “Licensed User”) as identified in the Customer Purchase Order.

  • REPORTS TO THE SUB-ADVISER The Fund will provide the Sub-Adviser with such periodic reports concerning the status of the Portfolio Account as the Sub-Adviser may reasonably request.

  • Compliance Program of the Sub-Adviser The Sub-Adviser hereby represents and warrants that: (a) in accordance with Rule 206(4)-7 under the Investment Advisers Act of 1940, as amended (the “Advisers Act”), the Sub-Adviser has adopted and implemented and will maintain written policies and procedures reasonably designed to prevent violation by the Sub-Adviser and its supervised persons (as such term is defined in the Advisers Act) of the Advisers Act and the rules the SEC has adopted under the Advisers Act; and (b) to the extent that the Sub-Adviser’s activities or services could affect a Fund, the Sub-Adviser has adopted and implemented and will maintain written policies and procedures that are reasonably designed to prevent violation of the “federal securities laws” (as such term is defined in Rule 38a-1 under the 0000 Xxx) by the Funds and the Sub-Adviser (the policies and procedures referred to in this Paragraph 7(b), along with the policies and procedures referred to in Paragraph 7(a), are referred to herein as the Sub-Adviser’s “Compliance Program”).

  • B1 The Services The Contractor shall supply the Services during the Contract Period in accordance with the Authority’s requirements as set out in the Specification and the provisions of the Contract in consideration of the payment of the Contract Price. The Authority may inspect and examine the manner in which the Contractor supplies the Services at the Premises during normal business hours on reasonable notice.

  • Financial Planning Services The Executive shall receive financial planning services, on an in-kind basis, for a period of eighteen (18) months following the Date of Termination. Such financial planning services shall include expert financial and legal resources to assist the Executive with financial planning needs and shall be limited to (i) current investment portfolio management, (ii) tax planning, (iii) tax return preparation, and (iv) estate planning advice and document preparation (including xxxxx and trusts); provided, however, that the Company shall provide such financial planning services during any taxable year of the Executive only to the extent the cost to the Company for such taxable year does not exceed $25,000. The Company shall provide such financial planning services through a financial planner selected by the Company, and shall pay the fees for such financial planning services. The financial planning services provided during any taxable year of the Executive shall not affect the financial planning services provided in any other taxable year of the Executive. The Executive’s right to financial planning services shall not be subject to liquidation or exchange for any other benefit. Such financial planning services shall be provided in a manner that complies with Treasury Regulation Section 1.409A-3(i)(1)(iv).

  • Notification and Consultation 1. A Party shall promptly notify the other Party in writing upon: (a) initiating a bilateral safeguard proceeding under this Section; (b) applying a provisional bilateral safeguard measure; and (c) taking a final decision to apply or extend a bilateral safeguard measure. 2. A Party shall provide to the other Party a copy of the public version of the report of its competent investigating authority in accordance with Article 8.4.1. 3. Upon request of a Party whose good is subject to a bilateral safeguard proceeding under this Section, the Party conducting that proceeding shall enter into consultations with the requesting Party to review a notification under paragraph 1 or any public notice or report that the competent investigating authority has issued in connection with the proceeding. 4. All notifications during any bilateral safeguard investigation shall be exchanged in English.

  • INFORMATION AND CONSULTATION 8.1 You are entitled under the General Data Protection Regulation to access personal data we hold on you in our housing files. We will provide you with a copy of any such information we hold within one calendar month of your request. You may have other rights under the General Data Protection Regulation in relation to your personal data, which we will honour. You are entitled to check information you have provided in connection with your housing application free of charge. 8.2 We will publish an annual report on our housing management performance which, you may obtain from us on request. We will give you information about our complaints procedure. 8.3 On request, we will provide you with free information relating to: ▪ The terms of your tenancy; ▪ Our policy and procedures on setting rent and service charges; ▪ Our policy and rules about; o Admission to the housing lists; o Allocations; o Transfer of tenants between houses; o Exchanges of houses between our tenants, and tenants of other landlords; o Repairs and maintenance; o Our tenant participation strategy; o Our arrangements for taking decisions about housing management and services. 8.4 We will consult you about making or changing: ▪ Policies regarding housing management, repairs and maintenance if the proposal is likely to significantly affect you; ▪ Proposals for changes in rent and service charges where they affect all or a class of tenants (and you are to be affected); ▪ Proposals for the sale or transfer of your house to another landlord; ▪ Decisions about the information to be provided relating to our standards of housing management and performance; ▪ Performance standards or targets in relation to housing management repairs and maintenance; ▪ Our tenant participation strategy. We will take into account any views that you have before making a final decision. Any consultation with you will include giving you comprehensive information in an accessible form and reasonable time to express views.

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