Start-Up Activities. Lessor shall be responsible for all start-up activities. Lessee's personnel shall assist Lessor's engineers and technicians in performing start-up activities and the operation of all Project equipment.
Start-Up Activities. In addition to quantities of Product ordered and supplied pursuant to Section 2.4, Eyetech will purchase and Gilead will supply Product as set forth in this Section 2.10:
(a) Registration (or Clinical) Batches: The parties acknowledge that prior to the Effective Date Gilead provided Eyetech with certain batches of Product to support Product registration or for use in clinical trials (collectively, the "Registration Batches"). Each Registration Batch consists of approximately [**] units (i.e., single dose units) of Product that Gilead has tested in-process in accordance with the Specifications in the Product Supplement. Each Product in a Registration Batch consists of 0.3 mg, 1 mg or 3mg of Macugen as requested by Eyetech. To the extent that Eyetech has not already made such payments prior to the Effective Date, Eyetech will pay Gilead batch charges at $[**] (i.e., $[**] per single shift of aseptic filling) plus an additional filling charge of $[**] for each unit of Product (i.e., $[**] per single dose unit), as invoiced by Gilead. For Registration Batches packaged by Gilead, Eyetech will pay (to the extent not already paid prior to the Effective Date) Gilead an additional packaging charge of $[**] (i.e., $[**] per single shift of packaging activities) per lot. For Registration Batches tested by Gilead, Eyetech will pay (to the extent not already paid prior to the Effective Date) an additional testing batch charge of $[**] per lot. This price will be adjusted for increases due to changes to the Specifications or changes to the Product Supplement provided to Gilead after the Effective Date. Gilead will deliver entire Registration Batches of the Product, bulk packaged only, CPT to the finished packaging site designated by Eyetech (Incoterms 2000) and will deliver partial Registration Batches of the Product FCA Gilead's San Dimas facility (Incoterms 2000). Gilead will provide for storage up to 90 days following completion of production (i.e., the Batch is packaged and ready for shipment to Eyetech), with a provision for longer storage as follows: Days over 90 days: [**] [**] Room Temperature Storage per pallet/day $[**] $[**] Refrigerated Storage per pallet/day $[**] $[**]
Start-Up Activities. Review documents and conduct meetings with key stakeholders to clarify expectations, and ensure that there is consensus on what the HR requirements are for the sector. Initial start up activities will also include consultations with other stakeholders and USAID implementing partners to identify opportunities for collaboration.
Start-Up Activities. 3.1 [Reserved.]
Start-Up Activities. As used in this Agreement, “Start-Up Activities” shall mean those activities that Manufacturer and Sharp agree are necessary to commence packaging of the Products. Sharp shall complete the Start-Up Activities in accordance with the time schedule provided for in Exhibit A unless otherwise agreed to in writing by the parties. Any protocols and reports prepared by Sharp in connection with the Start-Up Activities shall be subject to Manufacturer’s prior review and approval, which approval shall not be unreasonably withheld, conditioned or delayed. Sharp shall permit a representative of Manufacturer to observe and review the Start-Up Activities at the relevant Facilities during normal business hours and upon reasonable notice. The validation reports produced in connection with the Start-Up Activities shall be deemed Confidential Information of Manufacturer subject to Article 12 of this Agreement. The costs associated with the Start-Up Activities shall be as agreed upon by the parties and shall be borne by Manufacturer.
Start-Up Activities. Household and Beneficiary Registration USAID Mega-Launch National Level Meetings
Start-Up Activities. (a) COMPANY hereby agrees that (i) by the applicable manufacturing commencement date set forth in an Addendum, it shall have complied with and completed to the full satisfaction of PFIZER all scale-up commercialization and manufacturing start-up activities with respect to new Product(s), including manufacturing trials, stability testing, validation protocols, validation, writing of validation reports and Raw Material and finished Products testing, in accordance with the applicable Addendum, (ii) it shall be responsible for managing the execution of the manufacturing trials and obtaining Raw Materials, Packaging Materials and inventory for such trials and providing technical, quality and operational resources, and (iii) it shall perform all other activities, preparations, supervision and/or training as is or becomes necessary to enable COMPANY to commence the manufacturing, packaging, labeling and shipment of Product(s) to PFIZER hereunder all in accordance with the provisions set out in an Addendum in accordance with Schedule “B” attached hereto. The activities described in clauses (i), (ii) and (iii) of this Section 2.1(a) are collectively referred to herein as the “Start-Up Activities”. Unless otherwise provided in an Addendum, COMPANY shall pay for the costs associated with such Start-Up Activities. If under an Addendum, PFIZER is to pay for all or some portion of the cost associated with Start-Up Activities, then PFIZER’s obligation with respect to the cost of such Start-Up Activities shall be no more than the estimated start-up costs identified on the applicable Addendum (“Estimated Start-Up Costs”).
(b) COMPANY shall permit a reasonable number of PFIZER employees to observe and review the Start-Up Activities at the Facility during normal business hours and on reasonable prior written notice. COMPANY shall permit a reasonable number of PFIZER employees to provide technical assistance and direction at the Facility in connection with the Start-Up Activities provided, however, that such assistance and direction shall not reduce or alter COMPANY’s obligations hereunder. The validation reports produced hereunder shall be deemed Confidential Information of PFIZER hereunder and shall not be disclosed by either party (or by any subcontractor of either party) to any third party, except as permitted under Section 12.
(c) COMPANY agrees to provide all final documentation related to Start-Up Activities to PFIZER for prior approval.
Start-Up Activities. “Start-Up Activities” means those activities required by the Medicis or Supplier that are necessary to commence the Manufacture of Products as set forth on Attachment 3 to this Product Exhibit.
Start-Up Activities. Njira activities in Q2 largely focused on preparing the foundations of the grant, such as the development of the monitoring and evaluation plan; participation in start-up workshops to develop the detailed implementation plan; ongoing recruitment, on-boarding and training of staff; partner agreements; coordination meetings; District government engagement; baseline planning; development of program systems and procedures; establishment of offices; identification of warehouses and preparation of commodity plans; development of the community mobilisation and registration strategies and mobile technology based beneficiary tracking and commodity management system); and planning for the Mega Launch. Key start- up activities are outlined below: The Country Representatives of Project Concern International (PCI), Emmanuel International (EI) and Agricane, met together with the Njira Chief of Party (COP) to discuss the role of the Njira Program Advisory Body in the leadership of the grant, and received an update on the status of project activities and upcoming events. The purpose of this Advisory Body is to collectively look at the “big picture” or, the general status of the project. As described in PCI’s Technical Narrative, it is “to meet bi-annually and focus on program strategy and impact, to ensure accountability, and establish program cohesion and accountability among consortium members” (Project Concern International, 2014). Njira staff recruitment and on-boarding continued throughout Q2. At the national level, PCI successfully recruited the Njira Commodity Manager, who will start in early April 2015, prior to the planned TOPS Commodity Management Workshop. PCI also relocated its Regional Commodity Manager from Bangladesh to Malawi in order to provide technical assistance and monitoring of Njira commodity management. Recruitment of a Knowledge Management and Learning Advisor and a Behaviour Change Communication Specialist were concluded, and the two individuals recruited will join the team in Q3. For the project implementation offices in Machinga and Balaka, all Sector Coordinators and Field Facilitators were successfully recruited for both districts and have started their work, with the exception of the Disaster Risk Management, Gender, and Village Savings and Loans (VSL) Coordinators for Xxxxxx, who will be joining the team in Q3. Five RMNCH/Nutrition Facilitators joined the team in Q2 in time for a critical training of trainers on PCI’s Care Group methodolo...
Start-Up Activities. Sharp shall complete to the reasonable satisfaction of Manufacturer the Start-Up Activities in accordance with the time schedule set forth on Exhibit D. Any protocols and reports prepared by Sharp in connection with the Start-Up Activities shall be subject to Manufacturer’s prior review and approval. Sharp shall permit a representative of Manufacturer to observe and review the Start-Up Activities at the Facilities during normal business hours and upon reasonable notice. The validation reports produced in connection with the Start-Up Activities shall be deemed Confidential Information of Sharp and Manufacturer for purposes of Article 12 of this Agreement. The costs associated with the Start-Up Activities shall be as agreed upon by the parties and shall be borne by Manufacturer.
