Supply Plans Sample Clauses

Supply Plans. On a Product-by-Product basis, by [***], Myovant shall prepare and submit to the JMC, for its review and discussion, a proposed supply chain management plan for the Products being Manufactured under this Agreement by the Existing CMO to the extent Myovant is responsible for the supply of such Products, such plan to be designed to provide reasonable assurance that Myovant, utilizing the Existing CMO, is able to satisfy the then-current forecast for the Products in the Field in the Co-Promotion Territory (each such plan once determined in accordance with this Section 9.2, a “Supply Plan”). Each Supply Plan shall include (a) a plan for producing launch quantities for each such Product, including appropriate capacity and inventory and safety stock levels, (b) a [***] year high-level non-binding forecast for capacity planning purposes and short-term forecasts meeting the requirements established by the JMC, and (c) inventory requirements (for the Products and key raw materials) in order to satisfy supply requirements. After the submission of the initial Supply Plan for the Product, Myovant shall prepare and submit to the JMC for its review and discussion, an updated copy of such Supply Plan periodically as determined by the JMC. The JMC shall submit each updated Supply Plan to the JSC for review and approval on an annual basis. Following Option Closing (if it occurs), the Parties shall update the Supply Plan to include the Products in the Field in the Pfizer Territory, for so long as Myovant is supplying Pfizer such Products.
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Supply Plans. By [**] of each Calendar Year during the Term, the Parties shall together prepare and submit to the JMC, for its review and discussion, a proposed supply chain management plan for the Licensed Products being Manufactured under this Agreement by the existing CMOs, such plan to be designed to provide reasonable assurance that the Parties, utilizing the existing CMOs, are able to satisfy the then-current forecast for the Licensed Products for the Clinical Trials and Joint Development Plan for the Territory, and [**] prior to the projected First Commercial Sale of the Licensed Product, the Parties will prepare and submit to the JMC, for its review and discussion and approval by the JSC, a [**] supply chain and management plan (each such plan once determined in accordance with this Section 6.5(a), a “Supply Plan”). Each Supply Plan shall include, where applicable, (i) a plan for producing sufficient quantities of the Licensed Products for each Clinical Trial set forth in the then-current Joint Development Plan and quantities of the Licensed Products for Commercialization demand as set forth in the then-current Joint Commercialization Plan, as applicable, including appropriate capacity and inventory and safety stock levels, (ii) a [**] or [**] year high-level non-binding forecast for capacity planning purposes and short-term forecasts meeting the requirements established by the JMC, (iii) life cycle planning, including capacity needs, (iv) information regarding yields and batch sizes, (v) inventory requirements (for the Licensed Products and key raw materials) in order to satisfy supply requirements and (iv) the associated budget of the Manufacturing Costs for the supply of the Licensed Products in connection with the foregoing. After the submission of the initial Supply Plan for the Licensed Products, Pfizer shall prepare and submit to the JMC for its review and discussion, an updated copy of such Supply Plan periodically as determined by the JMC. The JMC shall submit each updated Supply Plan to the JSC for review and approval on an annual basis.
Supply Plans. The JSC shall establish the pre-clinical, clinical and commercial supply strategy for Joint Compounds, Joint Products and Diagnostic Products for Joint Compounds or Joint Products in the United States, including Manufacturing plans with respect thereto. BII or its Affiliates, or its or their Contractors or Sublicensees. shall Manufacture (a) all pre-clinical and clinical requirements of Joint Compounds, Joint Products (including placebo or other comparators) and Diagnostic Products for Joint Compounds or Joint Products, with respect to each, for use by the Parties in connection with Development activities as contemplated in the Joint Development Plan and Budget and (b) all commercial requirements of Joint Compounds, Joint Products and Diagnostic Products for Joint Compounds or Joint Products, with respect to each, for use by the Parties in connection with Commercialization activities as contemplated in the Joint Commercialization Plan and Budget, with respect to (a)-(b), in accordance with the JSC-approved supply strategy and Manufacturing plans. If, pursuant to the Joint Development Plan and Budget, the JSC appoints Epizyme to Conduct a Clinical Trial for a Joint Product, then BII and Epizyme shall promptly enter into a (i) supply agreement for the supply and Manufacture of the Joint Compounds, Joint Products or Diagnostic Products for Joint Compounds or Joint Products that are the subject of such Clinical Trial and (ii) a quality agreement related to such Manufacture and supply, which will set forth the applicable quality, release and approval procedures.

Related to Supply Plans

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • Marketing Plans Contractor and the Exchange recognize that Enrollees and other health care consumers benefit from efforts relating to outreach activities designed to increase heath awareness and encourage enrollment. The parties shall share marketing plans on an annual basis and with respect to periodic updates of material changes. The marketing plans of the Exchange and Contractor shall include proposed and actual marketing approaches, messaging and channels and provide samples of any planned marketing materials and related collateral as well as planned, and when completed, expenses for the marketing budget. The Contractor shall include this information for both the Exchange and the outside individual market. The Exchange shall treat all marketing information provided under this Section as confidential information consistent with Section 1.4.1. The obligation of the Exchange to maintain confidentiality of this information shall survive termination or expiration of this Agreement.

  • Project Plans The Contractor: must carry out the Contractor's Activities in accordance with, and otherwise implement, the Project Plans; and for the purposes of subparagraph (i), must: prepare Project Plans based, where applicable, on the draft Project Plans lodged by the Contractor in its tender for the Contractor's Activities, and otherwise in accordance with the requirements of the Contract and submit them to the Contract Administrator so as to ensure that there is no delay or disruption to the Contractor's Activities and in any event no later than the number of days specified in the Contract Particulars after the Award Date for each Project Plan; not commence any of the Contractor's Activities to which any Project Plan applies, unless the Contract Administrator has had the number of days specified in the Contract Particulars for each Project Plan to review the Project Plan and has not rejected the Project Plan; if any Project Plan is rejected, submit an amended Project Plan to the Contract Administrator; in any event, finalise each Project Plan so as to ensure that there is no delay or disruption to the Contractor's Activities and in any event in accordance with the requirements of the Contract to the satisfaction of the Contract Administrator; after each Project Plan has been finalised: regularly review, update and amend each Project Plan in accordance with the process set out in each Project Plan (and otherwise at least on each anniversary of the Award Date); update or amend a Project Plan on request of the Contract Administrator; and continue to correct any defects in or omissions from a Project Plan (whether identified by the Contract Administrator or the Contractor), and submit an updated or amended Project Plan to the Contract Administrator, after which: the Contractor must continue to comply with the requirements of the then current Project Plan until the process in subparagraph (ii) has been completed in respect of the updated or amended Project Plan; and subsubparagraphs B - E will apply (to the extent applicable); and document and maintain detailed records of all: reviews, updates, amendments and submissions of each Project Plan; audits or other monitoring of each Project Plan; and training and awareness programs and communications provided to Contractor and subcontractor personnel in respect of each Project Plan (including each updated or amended Project Plan). The Contractor will not be relieved from compliance with any of its obligations under the Contract or otherwise at law or in equity as a result of: the implementation of, and compliance with, the requirements of any Project Plan; any direction by the Contract Administrator concerning a Project Plan or the Contractor's compliance or non-compliance with a Project Plan; any audit or other monitoring by the Contract Administrator or anyone else acting on behalf of the Commonwealth of the Contractor's compliance with a Project Plan; or any failure by the Contract Administrator, or anyone else acting on behalf of the Commonwealth, to detect any defect in or omission from a Project Plan including where any such failure arises from any negligence on the part of the Contract Administrator or other person.

  • Medical Plans The Employer will maintain the current health (including vision) and dental insurance programs and practices. The Employer shall contribute 80% of the premium charge for PPO plans, 83% of premium for the POS plan, 85% of premium for the HMO plan, 80% for the prescription drug plan and 50% for the dental plan. There shall be no change in the State’s premium subsidy for health benefits plans in Fiscal Year 2012.

  • Safety Plan Developer’s safety plan specifically adapted for the Project. Developer's Safety Plan shall comply with all provisions regarding Project safety, including all applicable provisions in these Construction Provisions.

  • Work Plans Tenant shall prepare and submit to Landlord for approval schematics covering the Tenant Improvements prepared in conformity with the applicable provisions of this Work Letter (the “Draft Schematic Plans”). The Draft Schematic Plans shall contain sufficient information and detail to accurately describe the proposed design to Landlord and such other information as Landlord may reasonably request. Landlord shall notify Tenant in writing within ten (10) business days after receipt of the Draft Schematic Plans whether Landlord approves or objects to the Draft Schematic Plans and of the manner, if any, in which the Draft Schematic Plans are unacceptable. Landlord’s failure to respond within such ten (10) business day period shall be deemed approval by Landlord. If Landlord reasonably objects to the Draft Schematic Plans, then Tenant shall revise the Draft Schematic Plans and cause Landlord’s objections to be remedied in the revised Draft Schematic Plans. Tenant shall then resubmit the revised Draft Schematic Plans to Landlord for approval, such approval not to be unreasonably withheld, conditioned or delayed. Landlord’s approval of or objection to revised Draft Schematic Plans and Tenant’s correction of the same shall be in accordance with this Section until Landlord has approved the Draft Schematic Plans in writing or been deemed to have approved them. The iteration of the Draft Schematic Plans that is approved or deemed approved by Landlord without objection shall be referred to herein as the “Approved Schematic Plans.”

  • Service Plans 2.1 Standard Price Service Standard Price Term Home Basic Broadband 100 HK$168 Monthly Plan 24 consecutive months HomeFibre 500 HK$178 Monthly Plan 24 consecutive months HomeFibre 1000 HK$198 Monthly Plan 24 consecutive months

  • Benefits Plans During the Employment Period, You will be eligible to participate in all benefit plans in effect for executives and employees of the Company, subject to the terms and conditions of such plans.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Payment Plans Employees covered by the Samaritan Choice medical insurance plan who have outstanding balances that are payable to Samaritan Health Services for in network, covered, and authorized (if medically necessary) services will be provided payment plan offerings upon request from the employee. The request will be made to Patient Financial Services, and may be directed through the Hospital Patient Financial Counselor. Patient Financial Services will work with employees to identify the appropriate payment arrangement based on the employee financial needs/eligibility. Within 120 days from first patient statement, employees must contact Patient Financial Services and identify themselves as a SHS SEIU member and ask for a payment plan arrangement that does not exceed six percent (6%) of their household income. Such requests will be granted using the existing SHS payment options and funding programs. To be eligible for a payment plan, employees must comply with all requirements for establishing appropriate payment options/eligibility, including the completion of a financial assistance application with supporting documentation. Employees who comply with all terms of the payment plan(s) will not be subject to collections or wage garnishment.

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