INVESTIGATIONAL PRODUCTS Sample Clauses

INVESTIGATIONAL PRODUCTS. Parties acknowledge and agree that the Institution’s pharmacy, or such other pharmacy as appointed by Sponsor the Principal Investigator and the Institution, will be responsible for certain tasks in relation with the handling of the Investigational Product. Any agreements between the pharmacy and any of the Parties will be in writing and must be in accordance with the Institution’s internal policies. Any such agreements will be annexed to this Agreement as applicable. Subject to the foregoing, the Sponsor and/or CRO will provide the Principal Investigator and the pharmacy with all necessary information on the Investigational Product(s), quality and handling instructions thereof and sufficient quantities needed to conduct the Clinical Trial free of charge. The Site Parties shall not use or permit the Research Staff or any third party to use the Investigational Product for any purpose other than the conduct of the Clinical Trial and upon termination or expiration of this Agreement all unused Investigational Product shall, at the Sponsor’s option, either be returned to the Sponsor or disposed of in accordance with the Protocol or the Sponsor’s written instructions.
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INVESTIGATIONAL PRODUCTS. 7.1. Parties acknowledge and agree that the Institution’s pharmacist, or such other pharmacist as appointed by Sponsor the Principal Investigator and the Institution, will be responsible for certain tasks in relation with the handling of the Investigational Product. Any agreements between the pharmacist and any of the Parties will be in writing and must be in accordance with the Institution’s internal policies. Any such agreements will be annexed to this Agreement as Annex 4. 7.2. Subject to the foregoing, the Sponsor will provide the Principal Investigator and the pharmacist with all necessary information on the Investigational Product(s), quality and handling instructions thereof and sufficient quantities needed to conduct the Clinical Trial. 7.3. The Principal Investigator shall not use or permit the Research Staff or any third party to use the Investigational Product for any purpose other than the conduct of the Clinical Trial and upon termination or expiration of this Agreement all unused Investigational Product shall, at the Sponsor’s option, either be returned to the Sponsor or disposed of in accordance with the Protocol or the Sponsor’s written instructions. 7.4. In case Sponsor has provided any equipment, such equipment to be further described in Annex 5 attached to this Agreement, to Institution or the Principal Investigator for the conduct of the Clinical Trial at the Trial Site, such equipment shall remain the property of Sponsor and shall be treated in accordance with the provisions as described in more detail in said Annex 5.
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INVESTIGATIONAL PRODUCTS. Parties acknowledge and agree that the Institution’s pharmacy, or such other pharmacy as appointed by Sponsor, the Principal Investigator and the Institution, will be responsible for certain tasks in relation to the handling of the Investigational Product. Any agreements between the pharmacy and any of the Parties will be in writing and must be in accordance with the Institution’s internal policies. Any such agreements will be annexed to this Agreement as Annex 4, if applicable. Subject to the foregoing, the Sponsor and/or CRO will provide the Principal Investigator and the pharmacy with all necessary information on the Investigational Product(s), quality and handling instructions thereof and sufficient quantities needed to conduct the Clinical Trial free of charge. The Site Parties shall not use or permit the Research Staff or any third party to use the Investigational Product for any purpose other than the conduct of the Clinical Trial and upon termination or expiration of this Agreement all unused Investigational Product shall, at the Sponsor’s option, either be returned to the Sponsor or disposed of in accordance with the Protocol or the Sponsor’s written instructions.
Sample 1
INVESTIGATIONAL PRODUCTS. 7.1. The Parties acknowledge and agree that the Sponsor’s pharmacy will be responsible for certain tasks in relation to the handling of the Investigational Product. Any agreements between the pharmacy and any of the Parties will be in writing and must be in accordance with the Sponsor’s internal policies. 7.2. Subject to the foregoing, the Company will provide the Principal Investigator and the pharmacy with all necessary information on the Investigational Product(s), quality and handling instructions thereof and sufficient quantities needed to conduct the Clinical Trial free of charge. 7.3. The Site Parties shall not use or permit the Research Staff or any third party to use the Investigational Product for any purpose other than the conduct of the Clinical Trial and upon termination or expiration of this Agreement all unused Investigational Product shall, at the Company’s option, either be returned to the Company or disposed of in accordance with the Protocol or the Company’s written instructions.
Sample 1
INVESTIGATIONAL PRODUCTS. Test Article: ACRYSOF IQ PanOptix Presbyopia-Correcting IOL Model TFNT00 The TFNT00 IOL is a CE Marked device that is commercially available in the countries of the participating Investigators as well as other countries across the globe. The lens is an ultraviolet and blue-light filtering foldable multifocal IOL of single-piece design with a central optic and two open-loop haptics. The optic is 6.0 mm in diameter and the lens has an overall diameter of 13.0 mm. The optic consists of a proprietary high refractive index hydrophobic acrylic material with a blue light filtering chromophore which filters light in a manner that approximates the human crystalline lens in the 400-475 nm blue light wavelength range (Xxxxxxxx 1962). It is biconvex and consists of a soft acrylic material capable of being folded prior to insertion, allowing placement through an incision smaller than the optic diameter of the lens. After surgical insertion into the eye, the lens gently unfolds to its intended shape. The optic diffractive structure is in the central 4.5 mm portion of the optic zone and divides the incoming light to create a +2.17 D intermediate and a +3.25 D near add power. The anterior surface is designed with negative spherical aberration to compensate for the positive spherical aberration of the cornea. The lens is available in a diopter range of 13.0 – 30.0 D in 0.5 D increments and 31.0 D –
Sample 1
INVESTIGATIONAL PRODUCTS. The study drugs that will be used are as follows: AT-752 tablet 250 mg of AT-281, free base of the drug substance AT-752 Matching placebo tablet 0 mg of AT-281, free base of the drug substance AT-752 Further information on the study drug can be found in the investigator’s brochure (Atea Pharmaceuticals).
Sample 1
INVESTIGATIONAL PRODUCTS. Extra replacement lenses will not be given to the subject upon leaving the site. In the event a lens needs to be replaced, the subject must return to the site for a replacement lens. Test Product soft contact lenses (LID018869) ( Manufacturer Alcon Laboratories, Inc. 0000 Xxxxx Xxxxxxx Xxxx Xxxxx, Xxxxx 00000-0000 XXX Indication for Use and Intended Purpose in the Current Study The intended use of this contact lens is for vision correction. Product Description and Parameters Available for this Study • • Water content: 55% ± 2% (target) • Power range: -1.00 to -6.00 D (0.25 D steps) • Base curve: 8.4 (±0.2 mm) (target) • Diameter: 14.2 mm (±0.2 mm) (target) Formulation Silicone Hydrogel. Additional details can be found in the IB. Usage • Wear: o Up to 6 nights/7 days of continuous wear o Contralateral • Exposure: up to 1 week • Additional details can be found in the Manual of Procedures Number/Amount of Product to be Provided to the Subject Only one test lens will be dispensed to the subject on Visit 1. Packaging Description Blister foil pack Labeling Description • Lens Foil label includes: - material name and/or identifier - base curve - diameter - manufacturing protocol number - packing solution - power - lot number - expiration date - content statement - investigational device statement - Sponsor information • Provided in packages of up to 20 lenses per power per box, identified with the following: - a color-coded label stating the protocol number - material identifier - power - an investigational use only statement - tracking number Storage Conditions Stored at room temperature. Supply All test lenses will be provided to the site. The site will dispense the test lens to each subject at Visit 1.
Sample 1
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Related to INVESTIGATIONAL PRODUCTS

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

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