Required Development Sample Clauses

Required Development. If (i) the FDA requires that additional clinical trials or other development work be conducted on the Initial Product as a condition of and prior to approving the Initial Product NDA (such required clinical trials or other development work, “Pre-Approval Required Development”) or (ii) the FDA requires additional clinical trials or other development work on the Initial Product after approval of the Initial Product NDA to obtain or maintain such Regulatory Approval in the Territory (such required clinical trials or other development work, “Post-Approval Required Development”), the holder of the Initial Product NDA (or one of its Affiliates) shall notify the other Party of such Pre-Approval Required Development or Post-Approval Required Development, as applicable, and the Parties shall, through the JDC, promptly meet to discuss in good faith and seek to agree on the Development Plan (consistent with Section 3.4) for such Pre-Approval Required Development or Post-Approval Required Development, as applicable; provided, that, unless the Parties otherwise agree in writing: (W) Arena shall be obligated to conduct, or cause one of its Affiliates to conduct, such Pre-Approval Required Development or Post-Approval Required Development, as applicable; (X) subject to Section 4.4(b), Arena shall have final decision-making authority with respect to the Development Plan for such Pre-Approval Required Development or Post-Approval Required Development, as applicable, if the Senior Executives are any unable to resolve any dispute with respect thereto pursuant to Section 4.4(b), except that the Development Expenses with respect to such Pre-Approval Required Development or Post-Approval Required Development, as applicable, shall be allocated between the Parties as set forth in clause (Y) or clause (Z) below, as applicable, and except that if Eisai does not approve the use of Arena FTEs (such approval not to be unreasonably conditioned, withheld or delayed), Arena shall have the right to use such FTEs at its own expense in conducting such development work, with the costs of such FTEs not included in Development Expenses; (Y) the Parties shall share equally the Development Expenses with respect to any Pre-Approval Required Development; and (Z) Eisai shall bear 90% and Arena shall bear 10% of the Development Expenses with respect to any Post-Approval Required Development (including any required Phase 4 clinical trial or outcomes studies), except that the Parties shall share equal...
Sample 1
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Required Development. With regards to Territory Development that is Required Development, Eisai shall be responsible for fifty percent (50%) and Company -48- 132539616_1 shall be responsible for fifty percent (50%) of all Development Costs incurred by the Parties with respect to each Eisai Collaboration Product.
Sample 1
Required Development. The Owner shall commence the construction of improvements on the Lot in accordance with approved plans and specifications within one year of his purchase of the Lot from the Developer. If the construction is not timely commenced, or once commended, not diligently pursued to completion, the Owner shall nonetheless be required to install acceptable landscaping on the entire Lot. Such landscaping shall comply with the requirements of paragraph 7 and shall include the sodding of the entire ground surface of the Lot. If the Owner fails to either install or maintain the landscaping, Developer shall have the right, privilege and license (but not the obligation) to do so, and all amounts expended by Developer, together with a surcharge of ten percent of cost for overhead shall be, upon written demand of Developer, immediately due and payable by the Owner. If not paid by the Owner with thirty days of demand, the charges shall bear interest at the rate of ten percent per annum and shall be collectible by all lawful means. The charges, together with interest thereon, shall also constitute a lien against the Lot on or for which the work was performed.
Sample 1

Related to Required Development

  • Research and Development (i) Advice and assistance in relation to research and development of Party B; (ii) Advice and assistance in strategic planning; and

  • Training and Development 3.1 Authorities will develop local 'Workforce Development Plans (see Part 4.8),' closely linked to their service delivery plans, which will provide the focus for the establishment of training and development priorities. Training and development should be designed to meet the corporate and service needs of authorities both current and in the future, taking into account the individual needs of employees. Local schemes on training and development should enable authorities to attain their strategic objectives through development of their employees. Training and development provisions should be shaped to local requirements and take account of the full range of learning methods. Such an approach should enable access to learning for all employees. The needs of part time employees and shift workers need particular consideration. 3.2 Employees attending or undertaking required training are entitled to payment of normal earnings; all prescribed fees and other relevant expenses arising. Employees are also entitled to paid leave for the purpose of sitting for required examinations. When attending training courses outside contracted daily hours, part-time employees should be paid on the same basis as full- time employees. (Assistance for other forms of learning, for example that directed at individual development, will be locally determined). Some training can be very expensive and authorities may require repayment of all or part of the costs incurred should an employee leave the authority before a reasonable time period has expired. The authority's policy in this regard should be made explicit. 3.3 Objectives for training and development programmes should include the following: • To enable Councils to attain their strategic objectives via investment in their employees. • To promote equity of access to learning. • To encourage employees to develop their skills and level of responsibility to the maximum of their individual potential. • To widen and modernise the skills profile of employees to maximise their versatility, employability and so, job security. • To enable employees to raise productivity, quality and customer service in pursuit of sustainable improvement 3.4 Authorities should establish local partnership arrangements, to include recognised trade unions, to develop their local workforce development plans. 3.5 The NJC endorses partnership provision such as the "Return to Learn" scheme. Authorities and the recognised trade unions shall encourage and support employees taking on the statutory Union Learning Representative (ULR) role. This will include agreeing facilities and paid release in accordance with statutory provisions. ULRs should be enabled to play a full part in promoting and implementing local training and development programmes.

  • Staff Development ‌ The County and the Association agree that the County retains full authority to determine training needs, resources that can be made available, and the method of payment for training authorized by the County. Nothing in this subsection shall preclude the right of an employee to request specific training.

  • Independent Development Receiving Party may currently or in the future be developing information internally, or receiving information internally, or receiving information from other parties that may be similar to the Disclosing Party's Confidential Information. Accordingly, nothing in this Agreement will be construed as a representation or inference that Receiving Party will not develop or have developed products or services, that, without violation of this Agreement, might compete with the products or systems contemplated by the Disclosing Party's Confidential Information.

  • Status as Business Development Company The Borrower is an “investment company” that has elected to be regulated as a “business development company” within the meaning of the Investment Company Act and qualifies as a RIC.

  • JOB FAMILY: APPLICATIONS DEVELOPMENT‌ Job Title: Director, Systems and Programming Job#: 1200 General Characteristics

  • Joint Development If joint development is involved, the Recipient agrees to follow the latest edition of FTA Circular 7050.1, “Federal Transit Administration Guidance on Joint Development.”

  • Business Development Provide advice and assistance in business growth and development of Party B. 业务发展。对乙方的业务发展提供建议和协助。

  • Procurement Planning Prior to the issuance of any invitations to bid for contracts, the proposed procurement plan for the Project shall be furnished to the Association for its review and approval, in accordance with the provisions of paragraph 1 of Appendix 1 to the Guidelines. Procurement of all goods and works shall be undertaken in accordance with such procurement plan as shall have been approved by the Association, and with the provisions of said paragraph 1.

  • Design Development An interim step in the design process. Design Development documents consist of plans, elevations, and other drawings and outline specifications. These documents will fix and illustrate the size and character of the entire project in its essentials as to kinds of materials, type of structure, grade elevations, sidewalks, utilities, roads, parking areas, mechanical and electrical systems, and such other work as may be required.

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