Investigational Agent Sample Clauses

Investigational Agent. ‌ VTX-2337 is comprised of an active pharmaceutical ingredient (API) formulated at neutral pH in Captisol® (a cyclodextrin-based solubilizing agent). The API of VTX-2337 is VTX-378: a novel, small, organic molecule TLR8 agonist with a molecular weight of 458.6. VTX-2337 a lyophilized cake is supplied in sterile, single-use vials and is administered via subcutaneous injection. The selectivity of this compound has been assessed in peripheral mononuclear cells (PBMC) and in cells engineered to express only a single TLR. In both PBMC and cell transfectants, VTX-2337 is highly selective for TLR8 with an EC50 of approximately 70 nM. VTX-2337 shows minimal activity for TLR7 (with an EC50 of approximately 3 μM), but does not stimulate other TLRs.[16] Placebo contains Captisol and citric acid, the same excipient ingredients of the VTX-2337 formulation, but does not include the API VTX-378.
Sample 1
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Investigational Agent. Cysteamine Bitartrate Delayed-release Capsules (RP103) are a beaded, enteric-coated, delayed-release form of the bitartrate salt of cysteamine (an aminothiol, β- mercaptoethylamine), the microspheronized beads are further hard gelatin encapsulated and intended for oral administration. Cysteamine Bitartrate Delayed- release Capsules (RP103) will be available for use in this Study in 25 mg and 75 mg capsules (expressed as cysteamine free-base).
Sample 1

Related to Investigational Agent

  • Complaints Investigation The employee who complains of harassment under the provisions of the Human Rights Code must first comply with the Employer’s harassment policy procedures before filing a grievance or human rights complaint.

  • Credit Investigation In conjunction with your application for credit and, if approved, maintenance of your Account, you agree that we have the right to investigate your credit and employment history, to verify your credit references, to request and use credit reports, and to report the way you pay your Account to credit bureaus and other interested parties.

  • Safety Representative On every job site, workers may elect a Workers’ Safety Representative in accordance with the Act.

  • COMPLAINTS AND INVESTIGATIONS 1. This article applies to complaints or allegations made externally and not from normal supervisory activities. 2. A department head shall be responsible for ensuring that all allegations of misconduct or other complaints against an employee on which any action is to be taken or a record is to be made shall be investigated. The investigator shall be allowed to interview the complainant prior to notifying the employee.

  • Investigation To make investigation about the accuracy of representations, warranties or other obligations of the Issuer under the Transaction Documents.

  • Background Investigation The BOARD is prohibited from knowingly employing a person who has been convicted of committing or attempting to commit certain criminal offenses. If the required criminal background investigation is not completed at the time this Contract is signed, and the subsequent investigation report reveals that there has been a prohibited conviction, this Contract shall immediately become null and void.

  • Grievance Investigation The Employer agrees to supply to the Union the names of all applicants for a vacancy, or new position in the course of a grievance investigation.

  • Due Diligence Investigation Pubco shall be reasonably satisfied with the results of its due diligence investigation of the Company in its sole and absolute discretion.

  • Grievance Investigations Where an employee has asked or is obliged to be represented by the Institute in relation to the presentation of a grievance and an employee acting on behalf of the Institute wishes to discuss the grievance with that employee, the employee and the representative of the employee will, where operational requirements permit, be given reasonable leave with pay for this purpose when the discussion takes place in the headquarters area of such employee and leave without pay when it takes place outside the headquarters area of such employee.

  • Investigations 15.1 The Contractor agrees to cooperate fully and faithfully with any investigation, audit or inquiry conducted by a State or City governmental agency or authority that is empowered, directly or by designation, to compel the attendance of witnesses and to examine witnesses under oath, or conducted by the Inspector General of a governmental agency that is a party in interest to the transaction, submitted proposal, contract, lease, permit, or license that is the subject of the investigation, audit or inquiry. 15.2 If:‌ 15.2.1 any person who has been advised that her or his statement, and any information from such statement, will not be used against her or him in any subsequent criminal proceeding refuses to testify before a grand jury or other governmental agency or authority empowered directly or by designation to compel the attendance of witnesses and to examine witnesses under oath concerning the award of, or performance under, any transaction, agreement, lease, permit, contract, or license entered into with the City, the State, or any political subdivision or public authority thereof, or PANYNJ, or the Owner, or any local development Owner within the City, or any public benefit Owner organized under the laws of the State of New York, or 15.2.2 any person refuses to testify for a reason other than the assertion of her or his privilege against self- incrimination in an investigation, audit or inquiry conducted by a City or State governmental agency or authority empowered directly or by designation to compel the attendance of witnesses and to take testimony under oath, or by the Inspector General of the governmental agency that is a party in interest in, and is seeking testimony concerning the award of, or performance under, any transaction, agreement, lease, permit, contract, or license entered into with the City, the State, or any political subdivision thereof, or the Owner, or any local development Owner within the City, then the commissioner or agency head (each of which is hereinafter referred to as the “Commissioner”) whose agency is a party in interest to the transaction, submitted Proposal, submitted proposal, contract, lease, permit, or license involved in such investigation, audit or inquiry shall convene a hearing, upon not less than five (5) days written Notice to the parties involved, to determine if any penalties should attach for the failure of a person to testify. 15.3 If any non-governmental party to the hearing convened in accordance with the final clause of Section 15.2 requests an adjournment, the Commissioner who convened the hearing or the Owner may, upon the Commissioner granting the adjournment, suspend any contract, lease, permit, or license pending the final determination pursuant to Subsection 15.4.3 below without the City or the Owner incurring any penalty or damages for delay or otherwise. 15.4 The Owner or the City may impose the following penalties after a final determination by the Commissioner that penalties should attach for the failure of a person to testify: 15.4.1 the disqualification for a period not to exceed five (5) years from the date of an adverse determination of any person, or any entity of which such person was a member at the time the testimony was sought, from submitting Proposals for, or transacting business with, or entering into or obtaining any contract, lease, permit or license with or from the City or the Owner, as the case may be; and/or 15.4.2 the cancellation or termination of any and all such existing City or Owner contracts, leases, permits or licenses that the refusal to testify concerns and that have not been assigned as permitted under this Contract, nor the proceeds of which pledged, to an unaffiliated and unrelated institutional lender for fair value prior to the issuance of the Notice scheduling the hearing, without the City or the Owner incurring any penalty or damages on account of such cancellation or termination; monies lawfully due for goods delivered, work done, rentals, or fees accrued prior to the cancellation or termination shall be paid by the City or the Owner, as the case may be. 15.4.3 The Commissioner shall consider and address, in reaching her or his determination, and the Owner and the Commissioner shall consider and address, in assessing an appropriate penalty, the factors in Subsections 15.4.3.1 and

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