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.

  • Lifecycle Management Plan: Contains, asset details (including capacity, performance, condition and valuations), maintenance and renewal strategies, capital programme and asset disposal strategy.

  • Program-specific TO requirements must be identified using the TO functionality matrix, included in the program Technical Manual Contract Requirements (TMCR) and documented in the TO Lifecycle Management Plan (TOLCMP).

  • Lifecycle Management Plan: provides detail on planning to monitor the performance of the AMP, to improve asset management systems that will improve the level of confidence in the AMP, asset details (including capacity, performance condition and valuations).

  • This Post-approval Lifecycle Management Plan (PALM) would facilitate responsible product development, FDA evaluation and approval, and patient access to theBreakthrough Therapy-designated product and other expedited approval therapies with an agreed upon path forward for product-lifecycle management that is most desirable for patients seeking access to high quality, Breakthrough Therapies.

  • The Council has developed a Lifecycle Management Plan which includes a 10 years financial forecast, to illustrate a comprehensive framework consistent with asset management practices and analyses the construction, operation, maintenance and renewal of facilities.

  • It will use information in the Lifecycle Management Plan to determine if the records are what they are supposed to be.

  • This should include the use of a Post-approval Lifecycle Management Plan (PALM) that would be part of the marketing application and provide detailed timelines, deliverables, and types of regulatory filings for completing activities, such as: • Scale-up Phase III clinical lots to commercial scale for launch with a bridging comparability study • Launch from a clinical site with clinical Quality Control (QC) release, and transfer to a commercial site and commercial QC post-approval.

  • This move resulted in annual savings of around Rs. 984 crore to the patients.

  • The Parties shall meet and discuss the same in good faith and if the Parties agree the plans and protocols for such Additional Studies the Licensee may at its sole cost and expense proceed with the additional Clinical Study which shall be included as part of the Lifecycle Management Plan.

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 management plan that (i) sets out a high level workplan to describe the manner in which the Design-Builder will manage the Project, including to address related matters such as traffic management and communications, and (ii) is prepared by or for the Design-Builder and submitted to the Owner;

  • Pest Management Plan and “PMP” means the Recipient’s plan dated December 13, 2010, which: (i) addresses the concerns relating to the Project risks associated with potential increases in the use of pesticides for agricultural production, intensification and diversification and controlling disease vector populations arising from irrigation schemes; (ii) sets forth mitigation and monitoring measures to be taken during Project implementation and operation to eliminate adverse environmental and social impacts, offset them, or reduce them to acceptable levels; (iii) recommends institutional measures to strengthen national capacities to implement the mitigation and monitoring measures; and (iv) as part of the implementation arrangements, identifies national agencies and other partners that could play a vital role in the success of the Project.

  • Asset Management Plan means a plan created by the department and approved by the state transportation commission or a plan created by a local road agency and approved by the local road agency's governing body that includes provisions for asset inventory, performance goals, risk of failure analysis, anticipated revenues and expenses, performance outcomes, and coordination with other infrastructure owners.

  • 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

  • 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.

  • Storm water management plan means a comprehensive plan designed to reduce the discharge of pollutants from storm water after the site has under gone final stabilization following completion of the construction activity.

  • 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 means the electronic system within the Department of Health Professions that monitors the dispensing of certain controlled substances.

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

  • Medical cannabis card means the same as that term is defined in Section 26-61a-102.

  • 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.