PoC Trial Design Sample Clauses

The PoC (Proof of Concept) Trial Design clause defines the framework and requirements for conducting a preliminary trial to evaluate the feasibility or effectiveness of a proposed solution or product. It typically outlines the objectives, scope, methodology, and success criteria for the trial, as well as the roles and responsibilities of each party involved. By establishing clear parameters for the PoC trial, this clause ensures that both parties have a mutual understanding of expectations and deliverables, thereby reducing ambiguity and facilitating informed decision-making about future collaboration or investment.
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PoC Trial Design. Medicis shall prepare an initial PoC Trial design for the applicable Candidate Selection Compound, for review, modification and approval by the JRC. Such PoC Trial shall include the requirements of the Phase 1 Study Synopsis and PoC Trial Synopsis, attached hereto as Exhibit 5. For clarity, Anacor shall not be obligated to conduct more than [ * ] or more than [ * ].
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PoC Trial Design. The JRC shall be responsible for the design of all PoC Trials for each Collaboration Compound. Any disputes regarding the design of any PoC Trial, including with respect to content and endpoints of such PoC Trial, that are not resolved by the JRC shall be presented to GSK to make the final decision as provided in Section 3.1.4(a). Notwithstanding GSK's decision-making authority with respect to the PoC Trial design for a given Collaboration Compound, in no event shall Anacor be required to conduct a PoC Trial in which the PoC Trial design includes [***].
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PoC Trial Design. The JRC shall be responsible for the design of all PoC Trials for each Collaboration Compound. Any disputes regarding the design of any PoC Trial, [***] THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION. including with respect to content and endpoints of such PoC Trial, that are not resolved by the JRC shall be presented to GSK to make the final decision as provided in Section 3.1.4(a). Notwithstanding GSK’s decision-making authority with respect to the PoC Trial design for a given Collaboration Compound, in no event shall Anacor be required to conduct a PoC Trial in which the PoC Trial design includes [***].
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Related to PoC Trial Design

  • Final Design Provide OWNER with proposed final construction drawings and detailed opinions of probable total Project construction costs in writing for OWNER' s review, prior to completion of the final Contract Documents, so that any changes that may be necessary in accordance with Project' s budgetary schedule can be made prior to bid.

  • Study Design This includes a discussion of the evaluation design employed including research questions and hypotheses; type of study design; impacted populations and stakeholders; data sources; and data collection; analysis techniques, including controls or adjustments for differences in comparison groups, controls for other interventions in the State and any sensitivity analyses, and limitations of the study.

  • Final Design Phase A. After acceptance by Owner of the Preliminary Design Phase documents, revised opinion of probable Construction Cost as determined in the Preliminary Design Phase, and/or any other Right of Way plan documents, subject to any Owner-directed modifications or changes in the scope, extent, character, or design requirements of or for the Project, and upon written authorization from Owner, Engineer shall: 1. Prepare final Drawings and Specifications indicating the scope, extent, and character of the Work to be performed and furnished by Contractor. 2. Visit the Site as needed to assist in preparing the final Drawings and Specifications. 3. Provide technical criteria, written descriptions, and design data for Owner’s use in filing applications for permits from or approvals of governmental authorities having jurisdiction to review or approve the final design; assist Owner in consultations with such authorities; and revise the Drawings and Specifications in response to directives from such authorities, as appropriate. 4. Advise Owner of any recommended adjustments to the opinion of probable Construction Cost. 5. After consultation with Owner, include in the Construction Contract Documents any specific protocols for the transmittal of Project-related correspondence, documents, text, data, drawings, information, and graphics, in electronic media or digital format, either directly, or through access to a secure Project website. Any such protocols shall be applicable to transmittals between and among Owner, Engineer, and Contractor during the Construction Phase and Post- Construction Phase, and unless agreed otherwise shall supersede any conflicting protocols previously established for transmittals between Owner and Engineer. 6. Assist Owner in assembling known reports and drawings of Site conditions, and in identifying the technical data contained in such reports and drawings upon which bidders or other prospective contractors may rely. 7. In addition to preparing the final Drawings and Specifications, assemble drafts of other Construction Contract Documents based on specific instructions and contract forms, text, or content received from Owner. 8. Prepare or assemble draft bidding-related documents (or requests for proposals or other construction procurement documents), based on the specific bidding or procurement-related instructions and forms, text, or content received from Owner. 9. Contract shall include contractor provided changeable message signs to communication construction information. 10. Furnish for review by Owner, its legal counsel, and other advisors, 6 copies of the final drawings and Specifications, assembled drafts of other construction Contract Documents, the draft bidding-related documents (or requests for proposals or other construction procurement documents), and any other final design Phase deliverables, by the established due date, with the Final Design Phase, and review them with Owner. Owner shall submit to Engineer any comments regarding the furnished items, and any instructions for revisions. B. Engineer’s services under the Final Design Phase will be considered complete on the date when Engineer has delivered to Owner the final Drawings and Specifications, other assembled Construction Contract Documents, bidding-related documents (or requests for proposals or other construction procurement documents), and any other Final Design Phase deliverables. C. In the event that the Work designed or specified by Engineer is to be performed or furnished under more than one prime contract, or if Engineer’s services are to be separately sequenced with the work of one or more prime Contractors (such as in the case of fast- tracking), Owner and Engineer shall, prior to commencement of the Final Design Phase, develop a schedule for performance of Engineer’s services during the Final Design, Bidding or Negotiating, Construction, and Post-Construction Phases in order to sequence and coordinate properly such services as are applicable to the work under such separate prime contracts.

  • Program Design The County Human Resources Department will operate a Catastrophic Leave Bank which is designed to assist any County employee who has exhausted all paid accruals due to a serious or catastrophic illness, injury, or condition of the employee or family member. The program establishes and maintains a Countywide bank wherein any employee who wishes to contribute may authorize that a portion of his/her accrued vacation, compensatory time, holiday compensatory time or floating holiday be deducted from those account(s) and credited to the Catastrophic Leave Bank. Employees may donate hours either to a specific eligible employee or to the bank. Upon approval, credits from the Catastrophic Leave Bank may be transferred to a requesting employee's sick leave account so that employee may remain in paid status for a longer period of time, thus partially ameliorating the financial impact of the illness, injury, or condition. Catastrophic illness or injury is defined as a critical medical condition, a long-term major physical impairment or disability which manifests itself during employment.

  • 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.