Development decisions Sample Clauses

Development decisions. Subject to the obligations set forth in Section 5.7(a) to meet and cooperate with respect to Severe Adverse Events, ViaCell shall have final decision-making authority with respect to Development activities relating to all Cell Therapy Products, after reasonably considering in good faith any concerns raised or comments promptly provided by Amgen. Subject to the obligations set forth in Section 5.7(a) to meet and cooperate with respect to Severe Adverse Events, Amgen shall have final decision-making authority with respect to Development activities relating to all Collaboration Products, after reasonably considering in good faith any concerns raised or comments promptly provided by ViaCell.
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Development decisions. The Managing Member shall monitor the --------------------- completion of all work at the Properties Under Development in conformance with a development budget ("Development Budget"), in accordance with a schedule ("Development Schedule") and pursuant to plans and specifications ("Development Plans and Specifications"), which have been approved by NYSTRS and which are attached hereto as part of the Business Plan attached as Exhibit E. Any Undeveloped Properties that the Company may decide to develop from time to time shall be considered "New Projects" and shall henceforth be considered Properties Under Development for all intents and purposes of this Agreement. Likewise, Properties Under Development which are completed shall henceforth be considered Developed Properties for all intents and purposes of this Agreement. The Company from time to time, with the approval of the Management Committee, may decide to acquire new properties, and upon acquisition such new properties shall be considered Properties for all intents and purposes of this Agreement. Depending upon the circumstances, such newly acquired properties may be Developed Properties, Properties Under Development or Undeveloped Properties. The Management Committee shall approve all future Development Budgets, Development Schedules and Development Plans and Specifications relating to the Properties Under Development or New Projects. All Properties Under Development shall be constructed in accordance with existing construction contracts which have been approved by NYSTRS. All new construction contracts for Properties under Development or New Projects must be guaranteed maximum price contracts, stipulated sum contracts or otherwise approved by the Management Committee. All requisitions for payment or periodic reports required to be delivered by the developer to the Company or its representative under the Development Agreements shall, at the option of NYSTRS, be delivered also to NYSTRS and/or its construction consultant, it being understood that such construction consultant shall have no independent approval rights but shall review the requisitions for the benefit of NYSTRS. Additional costs attributable to change orders, cost overruns or other obligations of the Company shall be covered by borrowings of the Company or through Additional Capital Contributions, as proposed by the Managing Member and, if the applicable modification to any Development Budgets, Development Schedules and Development Plans an...
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Development decisions. If any proposed activity of HPPI relating to the Product at the IND enabling or clinical stages would be outside the scope of cGLP, cGCP or customary practices for drug development or is reasonably likely to have a material adverse impact outside the Field, then Mayne Pharma has the right to veto such proposed activity by notice to HPPI, in which case HPPI agrees not to engage in such activity. In all other cases, HPPI has the right to make decisions regarding research, development and registration activities relating to the exploitation of the Product in the Field in the Territory, provided that, for any material decisions, it first consults with the JDC.
Sample 1
Development decisions. Roche will solely determine whether or not to develop a Ribozyme Product, Non-Ribozyme Product, or no Product against a Validated Target. Confidential portions ([ ]) have been omitted pursuant to regulation 240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed separately with the Commission.
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Development decisions. 31 SECTION 6.6. Business Plan.............................................................. 33 SECTION 6.7. Duties and Conflicts....................................................... 33 SECTION 6.8. Company's Counsel.......................................................... 34 SECTION 6.9. Exculpation................................................................ 34 SECTION 6.10. Intentionally Deleted...................................................... 35 SECTION 6.11. Indebtedness; UBTI......................................................... 35 SECTION 6.12. Removal of the Managing Member............................................. 35 SECTION 6.13. Substitution of Managing Member............................................ 36 SECTION 6.14. Rights of Members upon Removal of Managing Member.......................... 37 SECTION 6.15. Dispute Resolution......................................................... 37 SECTION 6.16. Indebtedness............................................................... 38
Sample 1
Development decisions. Other than as set forth in this Section 2.4(b)(i), Hyseq shall have final decision-making authority with respect to the generation and implementation of the Development Plan, after reasonably considering in good faith any concerns raised or comments provided by Amgen. This authority shall apply to all Development decisions, with the exception of the following issues, which will at all times require [***] consent of the Steering Committee: setting product specifications and product forecasts (as detailed in the Development Plan and/or Commercial Plan sections of the Program Plan); setting the [***] charged to the Operating Profit or Loss account; and deciding whether to [***] for the generation of sufficient clinical data to file for and obtain Regulatory Approval of a first Collaboration Product.
Sample 1
Development decisions. Vanda shall have the final discretion with respect to Development decisions for Licensed Products subject to and in accordance with this Section 5. Vanda shall Develop the Compound and Licensed Products in compliance with all applicable Law, including but not limited to, all legal and regulatory requirements pertaining to the design and conduct of clinical studies.
Sample 1
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Related to Development decisions

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Development Plan As defined in Section 3.2(a).

  • Development Diligence Pfizer will use its Commercially Reasonable Efforts to Develop and seek Regulatory Approval for [ * ] Product [ * ] in the Field [ * ]. Pfizer will [ * ] with respect to the Development or Regulatory Approval of Products under this Agreement.

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • 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).

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

  • Development Work Do, or cause to be done, such development and other work as may be reasonably necessary to protect from diminution and production capacity of the Mortgaged Property and each producing well thereon.

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