Local Development Work Sample Clauses

Local Development Work. Notwithstanding Section 4.5(a), each Party shall be solely responsible for all Development Costs with respect to Development activities that are exclusively for the benefit of the country(ies) within such Party’s territory, including: (i) any and all country-specific activities (e.g., a Canada only trial for Exelixis, a Japan only trial for Collaborator, or an Expanded Access Program); (ii) all Phase 4 Clinical Trials solely benefiting such Party’s territory; (iii) any and all Development activities required for any pricing and/or reimbursement approvals in such Party’s territory (but are not required for the MAA Approval in such territory); and (iv) any and all indirect manufacturing overhead costs solely benefiting such Party’s territory. The Development work set forth in this Section 4.5(c) pertaining to Collaborator shall be deemed the “Collaborator Local Development Work” and the Development work set forth in this Section 4.5(c) pertaining to Exelixis shall be deemed the “Exelixis Local Development Work”. For clarity, only studies that are exclusively for the benefit of the Collaborator Territory shall be deemed local Development activities which constitute Collaborator Local Development Work; all other studies under the GDP, including studies with portions conducted in the Collaborator Territory, shall constitute global Development activities subject to Section 4.5(a). All planned and in-process Collaborator Local Development Work and Exelixis Local Development Work shall be included in and conducted in accordance with the GDP, to be performed reasonably and subject to the oversight of the JDC.
View SourceView Similar (2)
Local Development Work. Notwithstanding Section 4.5(a), each Party shall be solely responsible for all Development Costs with respect to Development activities that are exclusively for the benefit of the country(ies) within such Party’s territory, including: (i) any and all country-specific activities (e.g., a Canada only trial for Exelixis, a Japan only trial for Collaborator, or an Expanded Access Program); (ii) all [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
View Source

Related to Local Development Work

  • Development Work The Support Standards do not include development work either (i) on software not licensed from CentralSquare or (ii) development work for enhancements or features that are outside the documented functionality of the Solutions, except such work as may be specifically purchased and outlined in Exhibit 1. CentralSquare retains all Intellectual Property Rights in development work performed and Customer may request consulting and development work from CentralSquare as a separate billable service.

  • Staff Development As part of their induction, new staff will be made aware of this policy and will be asked to ensure compliance with its procedures at all times.

  • 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.

  • Design Development Phase 1.3.1 Based on the approved Schematic Design Documents, model(s) and any adjustments to the Program of Requirements, BIM Execution Plan or Amount Available for the Construction Contract authorized by the Owner, the Architect/Engineer shall prepare, for approval by the Owner and review by the Construction Manager, Design Development Documents derived from the model(s) in accordance with Owner’s written requirements to further define and finalize the size and character of the Project in accordance with the BIM Execution Plan, “Facility Design Guidelines” and any additional requirements set forth in Article 15. The Architect/Engineer shall review the Design Development documents as they are being modeled at intervals appropriate to the progress of the Project with the Owner and Construction Manager at the Project site or other location specified by Owner in the State of Texas. The Architect/Engineer shall utilize the model(s) to support the review process during Design Development. The Architect/Engineer shall allow the Construction Manager to utilize the information uploaded into Owner’s PMIS to assist the Construction Manager in fulfilling its responsibilities to the Owner. 1.3.2 As a part of Design Development Phase, Architect/Engineer shall accomplish model coordination, aggregation and “clash detection” to remove conflicts in design between systems, structures and components. Architect/Engineer shall utilize Owner’s PMIS to accomplish model coordination and collaborate with Construction Manager in the resolution of critical clashes identified by the Construction Manager. Architect/Engineer shall demonstrate and provide written assurance to Owner that conflicts/collisions between models have been resolved. 1.3.3 The Architect/Engineer shall review the Estimated Construction Cost prepared by the Construction Manager, and shall provide written comments. 1.3.4 Before proceeding into the Construction Document Phase, the Architect/Engineer shall obtain Owner’s written acceptance of the Design Development documents and approval of the mutually established Amount Available for the Construction Contract and schedule. 1.3.5 The Architect/Engineer shall prepare presentation materials including an animation derived from the model(s) as defined in “Facility Design Guidelines” at completion of Design Development and if so requested shall present same to the Board of Regents at a regular meeting where scheduled within the state. 1.3.6 The Architect/Engineer shall prepare preliminary recommended furniture layouts for all spaces where it is deemed important to substantiate the fulfillment of program space requirements, or to coordinate with specific architectural, mechanical and electrical elements. 1.3.7 Architect/Engineer shall assist the Owner, if requested, with seeking approval of the Project by the Texas Higher Education Coordinating Board (THECB). Such assistance shall include (i) the preparation of a listing of the rooms and square footages in the Project, and (ii) the preparation of project cost information, in accordance with THECB Guidelines. This information shall be provided at the completion of the Design Development Phase when requested by the Owner. The listing of rooms and square footages shall then be updated to reflect any changes occurring during construction and provided to the Owner at Substantial Completion. 1.3.8 At the completion of the Design Development Phase, or such other time as Owner may specify to Architect/Engineer, at Owner’s sole option and discretion, Owner will furnish Architect/Engineer with a Guaranteed Maximum Price proposal prepared by Construction Manager based upon the Design Development documents prepared by the Architect/Engineer and approved by the Owner. The Architect/Engineer shall assist the Owner and endeavor to further and advocate the Owner’s interests in Owner’s communications with the Construction Manager in an effort to develop a Guaranteed Maximum Price proposal acceptable to Owner, in Owner’s sole option and discretion. If the Owner does not accept the Construction Manager’s Guaranteed Maximum Price proposal, the Architect/Engineer shall participate with the Owner and Construction Manager in constructability reviews and shall revise the documents as necessary in order to reach an agreement. If the Construction Manager’s Guaranteed Maximum Price proposal exceeds the Schematic Design Phase Estimated Construction Cost prepared by, or otherwise accepted by the Construction Manager due to an increase in the scope of the Project caused by further development of the design documents by the Architect/Engineer to the extent that such could not be reasonably inferred by the Construction Manager from the Schematic Design documents, and Owner directs Architect/Engineer to revise the documents, the Architect/Engineer shall revise the documents at its own expense so that the Guaranteed Maximum Price proposal for constructing the Project shall not exceed the Owner’s Amount Available for the Construction Contract and any previously approved Estimated Construction Costs. If it is determined to be in the Owner’s best interest, instead of requiring the Architect/Engineer to revise the Drawings and Specifications, the Owner reserves the right to accept a Guaranteed Maximum Price proposal that exceeds the stipulated Amount Available for the Construction Contract. The Architect/Engineer shall analyze the final Guaranteed Maximum Price proposal document, together with its supporting assumptions, clarifications, and contingencies, and shall submit a detailed written analysis of the document to the Owner. Such analysis shall include, without limitation, reference to and explanation of any inaccurate or improper assumptions and clarifications. The A/E will not be required to make revisions to the documents at its own expense under the provisions of this paragraph if the Owner’s rejection of the Guaranteed Maximum Price proposal is not due to a failure of the A/E to provide the services otherwise required herein. 1.3.9 After the Guaranteed Maximum Price has been accepted, the Architect/Engineer shall incorporate necessary revisions into the Design Development documents. The A/E will not be required to make revisions to the documents at its own expense under the provisions of this paragraph if the revisions are required as the result of inaccurate assumptions and clarifications made in the development of the Guaranteed Maximum Price proposal that are not due to a failure of the A/E to provide the services otherwise required herein.

  • Professional Development Program (a) The parties agree to continue a Professional Development Program for the maintenance and development of the faculty members' professional competence and effectiveness. It is agreed that maintenance of currency of subject knowledge, the improvement of performance of faculty duties, and the maintenance and improvement of professional competence, including instructional skills, are the primary professional development activities of faculty members. (b) Information collected as part of this program shall be the sole property of the faculty member. This information or any judgments arising from this program shall not be used to determine non-renewal or termination of a faculty member's contract, suspension or dismissal of a faculty member, denial of advancement on the salary scale, nor affect any other administrative decisions pertaining to the promotion or employment status of the faculty member. (c) A joint advisory committee consisting of three regular faculty members who shall be elected by and are P.D. Committee Chairpersons and three administrators shall make recommendations for the operation, financing and management of the Professional Development Program.