Continuity of Supply The Parties agree that promptly following the date of this Agreement, they shall meet and determine appropriate measures to qualify an additional manufacturing site. PRONOVA agrees to use commercially reasonable efforts to qualify an additional manufacturing site prior to the later of (a) one (1) year following the final FDA approval of the Product for the indication HTG or (b) one (1) year following PRONOVA’s receipt of the Registration(s) from Xxxxxx. The License restrictions set out in Section 2.1 with respect to PRONOVA shall not restrict PRONOVA from establishing additional manufacturing sites in Puerto Rico or other parts of the Territory (and PRONOVA shall provide RELIANT with reasonable advance written notice thereof).
Development Schedule The schedule for design and development of the "BASE BUILDING WORK" (as defined below) and the "TENANT IMPROVEMENTS" (as defined below), including, without limitation, the time periods for preparation, delivery, review, and approval of construction documents and performance pursuant to such documents, shall be in accordance with the Development Schedule attached hereto as Schedule A, subject to adjustment as mutually agreed by the parties in writing or as provided in this Work Letter (the "DEVELOPMENT SCHEDULE").
Commercial Supply Celgene shall Manufacture and supply all Commercial Supplies.
Development Plan As defined in Section 3.2(a).
Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)
Continuity of Services If Insurance Company is subject to supervision, seizure, conservatorship or receivership, 1851 will continue to maintain any systems, programs or other infrastructure, notwithstanding such supervision, seizure, conservatorship or receivership of the Insurance Company, and will make them available to the receiver or superintendent as ordered or directed by the receiver or superintendent for so long as 1851 continues to receive timely payment for post-receivership services rendered, and unless released by the receiver, superintendent or supervising court.
Development of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.
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.
Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).
Completion of Improvements Landlord, through its general contractor (“Contractor”), shall furnish and install within the Premises those items of general design, engineering and construction, shown on the final plans and specifications approved by Landlord and Tenant pursuant to the Schedule of Approvals below, in compliance with all applicable laws, ordinances, codes, rules and regulations and matters of record, and complete any construction required in the Common Areas of the Building when such construction is required by or arises out of completion of such work (collectively the “Improvements”). The contractor constructing the Improvements in the Premises shall be selected pursuant to a procedure whereby the final Plans and Specifications (as such term is defined in this Exhibit B) are submitted to Xxxxxxx Xxxxxx Builders, Inc. (“XXX”) and Pinnacle Contracting Corporation (collectively, the “Approved Contractors”), who shall be requested to each submit to Landlord and to Tenant a sealed contract bid using such forms reasonably acceptable to Landlord in order to provide an “apples to apples” bidding process. The sealed bids shall be delivered to Tenant and Landlord and opened jointly by Landlord and Xxxxxx. Tenant, in Tenant’s sole and absolute discretion, shall select the Contractor from the two Approved Contractors (regardless of which has the lower bid). Each bid from the contractors shall specify any allowances for exclusions and shall further provide that said bids are without overtime premiums or bonuses necessary to complete the Improvements in accordance with the terms hereof. The architect engaged by Xxxxxx to prepare the Space Plan and Plans and Specifications and related design work for the Improvements shall be Xxxxxxx (the “Architect”). Landlord shall disburse amounts of the Allowance (up to the maximum specified below) to Architect within thirty (30) days after receipt of paid invoices from Architect or Tenant for Architect’s services; provided, however, notwithstanding the foregoing, Landlord shall pay $[***] for the Architect’s preparation of the Space Plan (as evidenced by the Architect’s invoice number 68045 dated October 15, 2010), at Landlord’s sole cost and expense (and without using the Allowance or any portion thereof). The definition of Improvements shall include all costs associated with completing the Improvements, including but not limited to, fees payable to Xxxxxxx, space planning, design, architectural, and engineering fees, contracting, labor and material costs, municipal fees, plan check and permit costs, and document development and/or reproduction, and all costs and expenses for any construction manager(s) engaged by Xxxxxx (provided such soft costs for architectural and engineering services charged against the Allowance shall not exceed $[***] per square feet of Usable Area in the Premises) at Tenant’s sole option. The Space Plan and the Plans and Specifications (each as defined in Section 3 of this Exhibit B) shall be subject to Landlord’s prior review and approval, which approval shall not be unreasonably withheld, conditioned or delayed. Landlord’s approval of any iteration of a Space Plan or Plans and Specifications shall be deemed granted unless Landlord provides a reasonable disapproval or approval to Tenant prior to the sixth (6th) business day after Landlord’s receipt of the Space Plan or Plans and Specifications. Without limiting Landlord’s discretion to reasonably withhold its approval, Tenant agrees that it shall be reasonable for Landlord to withhold its approval of any aspect of Tenant’s Space Plan or Plans and Specifications (or, in either case, any proposed changes thereto) which (i) adversely affect Building systems, the structure of the Building or the safety of the Building and/or its occupants, (ii) would violate any governmental laws, rules or ordinances; (iii) would require any changes that adversely impact the base, shell and core of the Building, and/or (iv) are inconsistent with the standards of first class office buildings in the vicinity of the Building, as reasonably determined by Landlord and the Contractor. Landlord shall provide a written statement of any disapproval of any Space Plan or Plans and Specifications stating the reasons for Xxxxxxxx’s disapproval. Tenant acknowledges and agrees that any change in the scope of work or details of construction after Xxxxxx’s and Landlord’s approval of the Plans and Specifications shall constitute a “Change Order”, the costs of which may be charged against any available amounts of the Allowance under this Exhibit B. To the extent the Change Order delays construction of the Improvements, the same shall be a Tenant Delay. [***] = CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THIS OMITTED INFORMATION.
