Development Responsibilities From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.
Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.
Regulatory Responsibilities 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof.
6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement.
6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities.
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).
Licensee Responsibilities Licensee is responsible for Licensee’s Users’ compliance with this Agreement. Licensee is responsible for all of Licensee’s uses and accounts. Licensee will be responsible for maintaining the security of Licensee’s accounts, passwords and files. Licensee and Users cannot share Licensee’s accounts or passwords or allow any third party to use Licensee’s accounts or passwords. Licensee will exercise reasonable precautions to prevent unauthorized use of the Software.
Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.
Specific Responsibilities Without limiting the responsibilities of the Manager, the Manager will:
1. Maintain office facilities (which may be in the offices of the Manager or a corporate affiliate but shall be in such location as the Trust reasonably determines).
2. Furnish statistical and research data, clerical services and stationery and office supplies.
3. Compile data for, prepare for execution by the Fund and file all the Fund’s federal and state tax returns and required tax filings other than those required by this Agreement to be made by the Fund’s custodian and transfer agent.
4. Prepare compliance filings pursuant to state securities laws with the advice of the Trust’s counsel.
5. Prepare the Trust’s Annual and Semi-Annual Reports to Shareholders and amendments to its Registration Statements (on Form N-1A or any replacement therefor).
6. Compile data for, prepare and file timely Notices to the SEC required pursuant to Rule 24f-2 under the 1940 Act.
7. Determine the daily pricing of the portfolio securities and computation of the net asset value and the net income of Fund in accordance with the Prospectus, resolutions of the Trust’s Board of Trustees, and the procedures set forth in EXHIBIT A: NET ASSET VALUE CALCULATIONS.
8. Keep and maintain the financial accounts and records of the Fund and provide the Trust with certain reports, as needed or requested by the Fund.
9. Provide officers for the Trust as requested by the Trust’s Board of Trustees.
10. Perform fund accounting services for the Fund as set forth in EXHIBIT B: FUND ACCOUNTING FUNCTIONS.
11. Generally assist in all aspects of the operations of the Fund.
Joint Responsibilities The relationship between SAE ITC, the Activities and its Members shall be, and at all times, advisory only, and no party shall have the authority to enter into any contract or commitment in the name of, or on behalf of, any other party. Nothing in this Agreement shall be construed to confer upon either party the status of employee, agent, partner, joint venturer or legal representative of the other, it being intended by all parties to remain independent legal entities solely responsible for its own actions.
University Responsibilities 4.1 The University will provide a room accommodation to The Resident for a period of one academic year or the portion of the academic year remaining when occupancy begins (limited to the subsequent fall and spring semesters) exclusive of the Winter Recess period unless The Resident is assigned to a facility that remains open during this time or is approved to live on-campus during Winter Recess. Services provided by the University begin on the official check-in dates for the specific area and include access to the assigned building and room.
4.2 In accordance with University policy, the University will provide staff that will help facilitate a living experience that complements the academic mission of the University.
4.3 Exclusive of unanticipated weather events and building system failures that may disrupt service and subject to the availability of applicable resources, the University will provide adequate light, heat, electricity, hot water and telecommunication services (limited to video and internet connection) to residents. Student rooms shall be furnished.
Licensee’s Responsibilities Licensee will be responsible for any and all damage to or relocation of existing facilities. Further, Licensee shall reimburse the City for all costs of replacing or repairing any property of the City, or of others, that is damaged by or on behalf of Licensee as a result of activities under this Agreement.
