Lifecycle Management Plan definition

Lifecycle Management Plan any plans for:
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Lifecycle Management Plan the plan for further development of the Product in the Territory post-Launch covering Clinical Studies (including Phase IV Clinical Trials) for Label extensions or new NDAs, an outline of which will be submitted by the Licensee to the JSC within 90 days of the Effective Date and the detail of which will be determined by the JSC under the provisions of Clause 2.2.2 from time to time.
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Lifecycle Management Plan means (i) the plan for further development in the Territory of the Xxxxxx Product, an outline of which will be proposed by Salix to the JSC within 90 days of the Effective Date, and the detail of which will be determined by the JSC under the provisions of Section 6 from time to time; and (ii) any such plan subsequently proposed and agreed by the JSC in respect of any subsequent Product.
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Examples of Lifecycle Management Plan in a sentence

  • For clarity, responsibility for performing the Development Plan and Lifecycle Management Plan shall remain with GW Pharma.

  • The Mentor-Prote´ge´ Program Manager will recommend an award winner to the Operations Director, A/SDBU.(f) Measurement of program success.

  • Upon receipt of such notice the Parties shall discuss, through the medium of the JSC, the New Indication and the necessary changes to the Lifecycle Management Plan and GW Pharma will conduct Clinical Trials of Product of the New Indication until completion of Phase IIa Clinical Trials at its own cost and expense.

  • Within thirty (30) days of the Effective Date GW Pharma shall establish a team to oversee and manage the planning and performance of the Development Plan and Lifecycle Management Plan (the “Development Team”) on behalf of GW Pharma.

  • The JSC may add to and/or amend each Development Plan and Lifecycle Management Plan and Program Budget during the course of any Calendar Year as it considers appropriate from time to time, as long as each amendment is reduced to writing and signed and dated in accordance with the decision making process described in Clause 3.1.3 above.

  • In the event that Salix or Debiovision identifies any intellectual property rights of a Third Party which it reasonably believes that Salix might infringe upon by the conduct of any Lifecycle Management Plan or Commercialization Plan in respect of the Xxxxxx Product, any New Product or any Combination Product in the Territory it shall promptly notify the other.

  • These written records and reports shall properly reflect all the work done and the results achieved in carrying out such part of the Lifecycle Management Plan.

  • The JSC may, at the request of the Licensee only, add to and/or amend each Lifecycle Management Plan and Commercialisation Plan during the course of any Year as it considers appropriate from time to time, as long as each amendment is reduced to writing and signed and dated in accordance with the decision making process described in Clause 2.1.3 above.

  • Accordingly, the Parties shall not publish, present or otherwise disclose any material related to the Lifecycle Management Plan or the Commercialisation of the Product without the prior written consent of the JSC (such consent not to be unreasonably withheld or delayed).

  • The Lifecycle Management Plan and Commercialisation Plan shall contain reasonable target dates for major events as appropriate, and the JSC shall discuss these in good faith with reference to progress made in the current Year.

Related to Lifecycle Management Plan

  • Nutrient management plan means a plan developed or approved by the Department of Conservation and Recreation that requires proper storage, treatment and management of poultry waste, including dry litter, and limits accumulation of excess nutrients in soils and leaching or discharge of nutrients into state waters.

  • Management Plan means a plan to manage the activities and protect the special value or values in an Antarctic Specially Protected Area or an Antarctic Specially Managed Area.

  • Project Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.2 of Exhibit B to the ITP.

  • Quality Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.3 of Exhibit B to the ITP.

  • Asset Management Plan means a strategic document that states how a group of assets are to be managed over a period of time. The plan describes the characteristics and condition of infrastructure assets, the levels of service expected from them, planned actions to ensure the assets are providing the expected level of service, and financing strategies to implement the planned actions. The plan may use any appropriate format, as long as it includes the information and analysis required to be in a plan as described in Ontario’s Building Together: Guide for Asset Management Plans.

  • Forest management plan means a written plan prepared and signed by a qualified forester that prescribes measures to optimize production, utilization, regeneration, and harvest of timber. The forest management plan shall include a schedule and timetables for the various silvicultural practices used on forestlands, which shall be a maximum of 20 years in length. A forest management plan shall include all of the following:

  • Procurement Plan means the Recipient’s procurement plan for the Project, dated April 2, 2010, and referred to in paragraph 1.16 of the Procurement Guidelines and paragraph 1.24 of the Consultant Guidelines, as the same shall be updated from time to time in accordance with the provisions of said paragraphs.

  • risk management plan ’ means a risk management plan submitted to the Ad- ministrator by an owner or operator of a stationary source under subparagraph (B)(iii).

  • Virginia Stormwater Management Program or “VSMP” means a program approved by the State Board after September 13, 2011, that has been established by a locality to manage the quality and quantity of runoff resulting from land-disturbing activities and shall include such items as local ordinances, rules, permit requirements, annual standards and specifications, policies and guidelines, technical materials, and requirements for plan review, inspection, enforcement, where authorized in this article, and evaluation consistent with the requirements of this article and associated regulations.

  • Security Management Plan means the Supplier's security management plan prepared pursuant to paragraph 3 of schedule 2 an outline of which is set out in paragraph 2.7 of the Order Form as updated from time to time;

  • Adaptive management means reliance on scientific methods to test the results of actions taken so that the management and related policy can be changed promptly and appropriately.

  • Stormwater management plan means the set of drawings and other documents that comprise all the information and specifications for the programs, drainage systems, structures, BMPs, concepts and techniques intended to maintain or restore quality and quantity of stormwater runoff to pre-development levels.

  • Service Management System (SMS) means an off-line system used to access, create, modify, or update information in a Database.

  • Virginia Stormwater Management Program authority or "VSMP authority" means an authority approved by the State Board after September 13, 2011, to operate a Virginia Stormwater Management Program.

  • Procurement Management means the Director of Lee County’s Procurement Management Department or designee.

  • Database Management System (DBMS) A system of manual procedures and computer programs used to create, store and update the data required to provide Selective Routing and/or Automatic Location Identification for 911 systems. Day: A calendar day unless otherwise specified. Dedicated Transport: UNE transmission path between one of CenturyLink’s Wire Centers or switches and another of CenturyLink’s Wire Centers or switches within the same LATA and State that are dedicated to a particular customer or carrier. Default: A Party’s violation of any material term or condition of the Agreement, or refusal or failure in any material respect to properly perform its obligations under this Agreement, including the failure to make any undisputed payment when due. A Party shall also be deemed in Default upon such Party’s insolvency or the initiation of bankruptcy or receivership proceedings by or against the Party or the failure to obtain or maintain any certification(s) or authorization(s) from the Commission which are necessary or appropriate for a Party to exchange traffic or order any service, facility or arrangement under this Agreement, or notice from the Party that it has ceased doing business in this State or receipt of publicly available information that signifies the Party is no longer doing business in this State.

  • Prescription monitoring program “PMP,” or “program” means the program established pursuant to 657—Chapter 37 for the collection and maintenance of PMP information and for the provision of PMP information to authorized individuals.

  • disaster management means a continuous and integrated process of planning, organising, coordinating and implementing measures which are necessary or expedient for—

  • Quality Management System means a set of interrelated or interacting elements that organisations use to direct and control how quality policies are implemented and quality objectives are achieved;

  • Database Management System (“DBMS”) is a computer process used to store, sort, manipulate and update the data required to provide Selective Routing and ALI.

  • Network plan means a policy of group health insurance offered by an insurer under which the financing and delivery of medical care, including items and services paid for as medical care, are provided, in whole or in part, through a defined set of providers under contract with the insurer. The term does not include an arrangement for the financing of premiums.

  • Financial Crime Risk Management Activity means any action to meet Compliance Obligations relating to or in connection with the detection, investigation and prevention of Financial Crime that the Bank or members of the HSBC Group may take.

  • Project Implementation Plan means the detail plan submitted by the Developer with regard to development of Project Facilities and its operation and management thereof in accordance with this Agreement and to be appended as Schedule 9 to this Agreement.

  • Municipal Separate Storm Sewer System Management Program means a management program covering the duration of a state permit for a municipal separate storm sewer system that includes a comprehensive planning process that involves public participation and intergovernmental coordination, to reduce the discharge of pollutants to the maximum extent practicable, to protect water quality, and to satisfy the appropriate water quality requirements of the CWA and regulations, and this article and its attendant regulations, using management practices, control techniques, and system, design, and engineering methods, and such other provisions that are appropriate.

  • Executive Management means the CEO and the CFO for purposes of administering this Plan.

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.