Development decisions Clause Samples
The 'Development decisions' clause defines how choices regarding the direction, scope, or methods of a project's development are made. Typically, this clause outlines which party or parties have authority to make key decisions, the process for resolving disagreements, and any required approvals or consultations. For example, it may specify that the client must approve major design changes or that a steering committee will resolve disputes. Its core function is to ensure clarity and efficiency in the decision-making process, reducing the risk of misunderstandings or project delays.
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.
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...
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
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.
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.
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.
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.