Preliminary PoC Plan; Final PoC Criteria and PoC Trial Sample Clauses

Preliminary PoC Plan; Final PoC Criteria and PoC Trial. (a) At the time of, and as part of the process of (i) nomination and determination of a Development Candidate or (ii) confirming that a Follow-On Compound determined prior to [********] continues to be a Follow-On Compound upon [********], the Parties, through the JSC or JPS, shall discuss and agree upon the appropriate preliminary development strategy and a preliminary plan for meeting the PoC Criteria, including the possible trial design and protocol for the PoC Trial and associated costs and timelines, it being understood that such trial design and timelines are merely provisional and preliminary and subject to modification (the “Preliminary PoC Plan”). Targacept shall have the right to reasonably rely on such Preliminary PoC Plan in undertaking its Phase 1 Clinical Trials of such Development Candidate or Follow-On Compound. Notwithstanding the foregoing and Targacept’s discretion in the overall conduct of the Research Programs and Early Development Programs, the final PoC Criteria and the final PoC Trial for such Development Candidate or Follow-On Compound shall be subject to the further design of the JPS and the review and approval of the JSC, and subject to Section 2.3.4(b). (b) [********], in consultation with [********], shall ensure that the design and content of the PoC Trial and the content of the PoC Criteria are presented to the JSC for approval, subject to Section 2.3.4(b), within [********] following Targacept’s completion of a Phase 1 Clinical Trial (multiple rising dose) of the applicable Development Candidate. (c) With respect to each Program, if the total [********] costs and [********] expenditures for the PoC Trial (or, with respect to a Follow-On Compound, the equivalent of a PoC Trial) exceed [********] (as [********] from [********]): (i) the portion of such costs and expenditures which exceeds such limit shall be [********] for all or any portion of such excess; (ii) with respect to the PoC Trial, the lesser of (A) [********] of such aggregate amount [********] and (B) [********] will be [********] for such Program for which such PoC Trial is being conducted, [********] for such Program; and (iii) with respect to the equivalent of a PoC Trial for a Follow-On Compound, the lesser of (A) [********] of such aggregate amount [********] and (B) [********] will be [********] toward the [********] with respect to such Follow-On Compound. As used in this Section 3.6.4(c), (1) [********] shall include [********] those costs and expenditures...
AutoNDA by SimpleDocs

Related to Preliminary PoC Plan; Final PoC Criteria and PoC Trial

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Long Term Cost Evaluation Criterion 4. READ CAREFULLY and see in the RFP document under "Proposal Scoring and Evaluation". Points will be assigned to this criterion based on your answer to this Attribute. Points are awarded if you agree not increase your catalog prices (as defined herein) more than X% annually over the previous year for the life of the contract, unless an exigent circumstance exists in the marketplace and the excess price increase which exceeds X% annually is supported by documentation provided by you and your suppliers and shared with TIPS, if requested. If you agree NOT to increase prices more than 5%, except when justified by supporting documentation, you are awarded 10 points; if 6% to 14%, except when justified by supporting documentation, you receive 1 to 9 points incrementally. Price increases 14% or greater, except when justified by supporting documentation, receive 0 points. increases will be 5% or less annually per question Required Confidentiality Claim Form This completed form is required by TIPS. By submitting a response to this solicitation you agree to download from the “Attachments” section, complete according to the instructions on the form, then uploading the completed form, with any confidential attachments, if applicable, to the “Response Attachments” section titled “Confidentiality Form” in order to provide to TIPS the completed form titled, “CONFIDENTIALITY CLAIM FORM”. By completing this process, you provide us with the information we require to comply with the open record laws of the State of Texas as they may apply to your proposal submission. If you do not provide the form with your proposal, an award will not be made if your proposal is qualified for an award, until TIPS has an accurate, completed form from you. Read the form carefully before completing and if you have any questions, email Xxxx Xxxxxx at TIPS at xxxx.xxxxxx@xxxx-xxx.xxx If the vendor is awarded a contract with TIPS under this solicitation, the vendor agrees to make any Choice of Law clauses in any contract or agreement entered into between the awarded vendor and with a TIPS member entity to read as follows: "Choice of law shall be the laws of the state where the customer resides" or words to that effect.

  • Evaluation Criteria 5.2.1. The responses will be evaluated based on the following: (edit evaluation criteria below as appropriate for your project)

  • Project/Milestones Taxpayer provides refrigerated warehousing and logistic distribution services to clients throughout the United States. In consideration for the Credit, Taxpayer agrees to invest in a new refrigeration and distribution facility in the XxXxxxxxx Park area of Sacramento, California, and hire full-time employees (collectively, the “Project”). Further, Taxpayer agrees to satisfy the milestones as described in Exhibit A (“Milestones”) and must maintain Milestones for a minimum of three (3) taxable years thereafter. In the event Taxpayer employs more than the number of full-time employees, determined on an annual full-time equivalent basis, than required in Exhibit A, for purposes of satisfying the “Minimum Annual Salary of California Full-time Employees Hired” and the “Cumulative Average Annual Salary of California Full-time Employees Hired,” Taxpayer may use the salaries of any of the full-time employees hired within the required time period. For purposes of calculating the “Minimum Annual Salary of California Full-time Employees Hired” and the “Cumulative Average Annual Salary of California Full-time Employees Hired,” the salary of any full-time employee that is not employed by Taxpayer for the entire taxable year shall be annualized. In addition, the salary of any full-time employee hired to fill a vacated position in which a full-time employee was employed during Taxpayer’s Base Year shall be disregarded.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.

  • Long Term Cost Evaluation Criterion # 4 READ CAREFULLY and see in the RFP document under "Proposal Scoring and Evaluation". Points will be assigned to this criterion based on your answer to this Attribute. Points are awarded if you agree not i ncrease your catalog prices (as defined herein) more than X% annually over the previous year for years two and thr ee and potentially year four, unless an exigent circumstance exists in the marketplace and the excess price increase which exceeds X% annually is supported by documentation provided by you and your suppliers and shared with TIP S, if requested. If you agree NOT to increase prices more than 5%, except when justified by supporting documentati on, you are awarded 10 points; if 6% to 14%, except when justified by supporting documentation, you receive 1 to 9 points incrementally. Price increases 14% or greater, except when justified by supporting documentation, receive 0 points. increases will be 5% or less annually per question Required Confidentiality Claim Form This completed form is required by TIPS. By submitting a response to this solicitation you agree to download from th e “Attachments” section, complete according to the instructions on the form, then uploading the completed form, wit h any confidential attachments, if applicable, to the “Response Attachments” section titled “Confidentiality Form” in order to provide to TIPS the completed form titled, “CONFIDENTIALITY CLAIM FORM”. By completing this process, you provide us with the information we require to comply with the open record laws of the State of Texas as they ma y apply to your proposal submission. If you do not provide the form with your proposal, an award will not be made if your proposal is qualified for an award, until TIPS has an accurate, completed form from you. Read the form carefully before completing and if you have any questions, email Xxxx Xxxxxx at TIPS at xxxx.xxxxxx@t xxx-xxx.xxx

  • Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving (either itself or through the acts of a SUBLICENSEE) the following development milestones in its diligence activities under this AGREEMENT: (a) (b).

  • Study Population ‌ Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).

  • MSAA Indicator Technical Specification Document This Agreement shall be interpreted with reference to the MSAA Indicator Technical Specifications document.

  • Commercial Operation Date Testing and Modifications Prior to the Commercial Operation Date, the Connecting Transmission Owner shall test the Connecting Transmission Owner’s Attachment Facilities and System Upgrade Facilities and System Deliverability Upgrades and Developer shall test the Large Generating Facility and the Developer Attachment Facilities to ensure their safe and reliable operation. Similar testing may be required after initial operation. Developer and Connecting Transmission Owner shall each make any modifications to its facilities that are found to be necessary as a result of such testing. Developer shall bear the cost of all such testing and modifications. Developer shall generate test energy at the Large Generating Facility only if it has arranged for the injection of such test energy in accordance with NYISO procedures.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!