Supply Plans. Prepare a contingency supply plan that considers the potential loss of the City’s largest supply source due to groundwater contamination including options to use interties from the Cities of Vancouver and Washougal and use of the Camas surface water diversions on Boulder and Xxxxx creeks. ▪ Prepare Notification Letters. Prepare notification letters that will need to be sent to hazardous waste handlers, first responders, and regulatory agencies as required by WAC 000-000-000. The letters will include maps showing the locations of the wellhead protection capture zones, transportation corridors where spills might be of concern, and waste storage and handling sites. It is assumed that the City will transmit the letters using their letterhead. Electronic versions of the documents and mailing lists will be provided to the City for their transmittal. Copies of the letters will be provided for inclusion in the WSP. ▪ Provide Assistance with Xxxxxxxxxxx Wellfield Supply Options and Analysis. Xxxx XxxXxxxxx will assist with integrating information from the Xxxxxxxxxxx water supply work that we have completed to date as needed for the 2015 WSP. Up to 2 days of staff time have been included in the budget. ▪ Prepare Wellhead Protection Plan Summary Report. Prepare a letter report which summarizes the findings of Subtasks 1 through 5. The document will serve as an appendix to the City’s WSP document which will be submitted to DOH. ▪ Xxxx XxxXxxxxx Project Management. Conduct internal communication and management of personnel in accomplishing the project tasks. Xxxx XxxXxxxxx will communicate regularly with City staff and other project team members to keep them informed on project status and will solicit input, as needed. Xxxx XxxXxxxxx will prepare and submit invoices on a monthly basis. Prepare draft Chapter 8 for City’s review and approval. City comments and Consultant responses will be tracked in the Comment Response Log. Comments on this chapter will be incorporated into the final WSP.
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. 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.
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.
