During the Study Sample Clauses

The "During the Study" clause outlines the obligations, procedures, and conduct expected of parties while a study or research project is ongoing. It typically details requirements such as data collection methods, reporting intervals, participant management, and compliance with ethical or regulatory standards throughout the study period. By clearly defining these expectations, the clause ensures that all parties understand their responsibilities and helps maintain the integrity and smooth operation of the study.
During the Study. The events below will take place throughout the study. If you would like to know when exactly these will take place, please ask the study staff.  You will be asked about any updates to your medical history. This includes medication, drug, alcohol, and tobacco usePhysical exam  The use of proper birth control will be confirmed/reviewed  ▇▇▇▇▇ ▇▇▇▇▇ will be measured. Your oral temperature will also be measured  You will be swabbed for COVID-19  ECGs (triplicate measurements) will be collected o It may be necessary to shave or trim hair on your chest so that the patches for the ECGs will stick to your skin o Your chest may be marked with a pen to identify the correct areas for ECG patch placement  Continuous heart monitoring will be done for at least 12 hours after dosing. There will also be a period of at least 2 hours where monitoring will be done before the first dosing. o This involves the attachment of a small box like unit (transmitter) to your chest o The box is attached by a few wires (similar to those of an ECG) o The monitor sends information about your heart’s activity by a radio signal to a monitor o You may not sleep during the 2 hours of continuous monitoring done before dosing o You will need to stay in the procedure room for at least 4 hours after the last dosing on Day 1 while attached to the monitor o You will need to keep the box with you during the monitoring period o You will be asked to minimize activity while attached to the monitor  An intravenous (IV) catheter may be placed in a vein in one of your arms for blood collection  The study investigator may decide to do an alcohol breath test at any time  Blood and urine samples will be collected at various times throughout the study o Safety Labs: The blood and urine samples will be used for safety labs including the following:  Urine samples to test for drugs of abuse  Blood samples for pregnancy testing (females able to have children). Pregnancy tests may be performed at the discretion of the study investigator in all females o Any leftover blood from the safety lab samples may be stored and used to assess exploratory safety biomarkers or unexpected safety findings. Biomarkers are natural substances in your body that can be used to show how your body works.  Samples to be used for this purpose will be kept for up to 1 year following completion of this study o Banked Biospecimen: A sample of your blood will be collected and sent to Pfizer’s biobank. Pfizer calls this sample...
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During the Study. The events below will take place throughout the study. If you would like to know when exactly these will take place, please ask the study staff. • You will be asked about any updates to your medical history. This includes medication, drug, alcohol, and tobacco use • Physical exams, including skin exam o Photographs of the skin may be taken if the study clinician thinks it is needed. Photographs are photographic images of the skin that the study team may take of you during the study. You will not be identified in these photographs. However, if you have any markings on the area of your skin photographed, like a tattoo, those markings may appear in the photographs. Pfizer will own these photographs. The photographs will be used and shared along with your study records, as described in this consent document. In addition, the photographs may be used in publications, presentations, brochures, or other ways. The photographs may be used along with text, graphics, or audio materials. You will not be identified by name in any use of the photographs. By signing this consent document, you are giving permission for the study staff to take these types of photographic images and for the uses described above. • The use of proper birth control will be confirmed/reviewed (males only) • ▇▇▇▇▇ ▇▇▇▇▇. Your oral temperature may also be measured • Weight will be measured (Part B only) • ECGs will be collected o It may be necessary to shave or trim hair on your chest so that the patches for the ECGs will stick to your skin o Your chest may be marked with a pen to identify the correct areas for ECG patch placement • Continuous heart monitoring will be done for at least 8 hours after each dose (Part A only, except for Japanese dosing group, if done). There will also be a period of at least 2 hours (Day -1, Period 1 only) where monitoring will be done before the first dose o This involves the attachment of a small box like unit (transmitter) to your chest o The box is attached by a few wires (similar to those of an ECG) o The monitor sends information about your heart’s activity by a radio signal to a monitor o You may not sleep during the 2 hours of continuous monitoring done before dosing o You will need to stay in the procedure room for at least 4 hours after dosing while attached to the monitor o You will need to keep the box with you during the monitoring period o You will be asked to minimize activity while attached to the monitor • You will be asked: “How do you feel?” each d...
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During the Study. Study progress reports, detailing the number of sites who have signed the contract as well as the dates of initiation of the sites, financial information, status of monitoring, status of data entry, data query generation and query resolution Any publication on the Study whether in a journal, lay press, website, scientific meeting as in section 15.4.1 Any updates to the documents mentioned above Before Data Base Lock: Study Results Dissemination Plan
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During the Study. Continue your routine cleansing regimen • Continue your routine cosmetics and skin care products • Avoid exposing your target and non-target SKs to excessive natural or artificial ultraviolet radiation (e.g., sunlight, tanning beds) and use sunscreen on the target or non-target SKs, if excessive exposure cannot be avoided • The use of the following therapies to treat any of the target or non-target lesions are prohibited o Retinoids (topical) o Corticosteroids (topical) o LASER, light or other energy-based therapy o Liquid nitrogen, electrodesiccation, curettage, imiquimod, ingenol mebutate o Microdermabrasion or superficial chemical peels o Antibiotics (topical) • Use of self-▇▇▇▇▇▇ lotions/sprays are prohibited during the study • Bring this subject instruction sheet with you to each visit
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During the Study. HOST Card Matriculation certificate Canteen (Mensa)/ Cafeteria Library Internet/ Computer Labs
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Related to During the Study

  • Conduct of the Study 3.1 Athenex shall act as the sponsor of the Study and shall hold the IND/CTA relating to the Study; provided, however, that in no event shall Athenex file a separate IND/CTA for the Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests a separate IND/CTA for the Study the Parties will meet and mutually agree on an approach to address such requirement. 3.2 Athenex shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. 3.3 Athenex shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Further, Athenex shall ensure that all Regulatory Approvals from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are obtained prior to initiating performance of the Study. Athenex shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that Lilly shall have the right (but no obligation) to participate in any discussions with a Regulatory Authority, and prior review and approval of any written communications with a Regulatory Authorty, regarding matters related to the Lilly Compound. 3.4 Athenex shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law. Athenex shall provide any Study information and documentation reasonably requested to enable Lilly to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or such the Lilly Compound, (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether the Study has been performed by Athenex in accordance with this Agreement. 3.5 Athenex shall ensure that all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection with the Study, permit the use and sharing of the Clinical Data as set forth in this Agreement, including the sharing of Clinical Data with Lilly. 3.6 All Clinical Data, including raw data and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and related to the Lilly Compound, shall be jointly owned by Lilly and Athenex.

  • Transition Period Due to the nature of our purchasing process, the District often requires an existing service provider to continue to provide goods and/or services while the District is in the process of advertising, evaluating, and awarding a contract for the provision of the same goods and/or services in the future. To accommodate this process, the Contractor shall agree to maintain the same terms and conditions set forth in this Agreement for a period up to ninety (90) days after the automatic termination of this Agreement at the end of its term, if requested by the District, as a transition period. In addition, if the Contractor is not the successful bidder for a future solicitation for the same or similar services, he or she shall agree to provide the same goods and/or services provided in this Agreement for a period up to ninety (90) days to allow for an orderly transition to the new provider. The District and the Contractor may mutually agree to a longer transition period.

  • Development Period The Contractor may commence pre-construction activities like utility shifting, boundary wall construction or any other activity assigned to the Contractor by the Authority to enable construction of the Project Highway immediately after signing of the Agreement, to the extent that such work is ready for execution. The Parties agree that these works may be taken up and completed to the extent feasible by the Contractor, before declaration of the Appointed Date, but no claim against the Authority for delay shall survive during this period and that the undertaking of these works by the Contractor shall not count towards the Scheduled Construction Period of the project which starts counting only from the Appointed Date. No construction activity of the Project Highway shall be undertaken during the development period.

  • Exclusivity Period During the Exclusivity Period, each Party: (a) shall and shall cause its respective Affiliates and Representatives to, work exclusively with the other Parties to implement the Transaction, including to (i) evaluate the Target; (ii) formulate any amendments to the terms of the Proposal, if applicable; (iii) prepare and submit to the Target the Merger Agreement; (iv) conduct negotiations, prepare and finalize the Documentation in the forms to be agreed by the Parties and (v) vote, or cause to be voted, at every shareholder meeting (whether by written consent or otherwise) all Securities against any Competing Proposal or matter that would facilitate a Competing Proposal and in favor of the Transaction; (b) shall not, without the written consent of the other Parties, directly or indirectly, either alone or with or through any of its Affiliates or Representatives: (i) make a Competing Proposal or join with, or invite, any other person to be involved in the making of any Competing Proposal (including through any rollover investment therein); (ii) provide any information to any third party with a view to the third party or any other person pursuing or considering to pursue a Competing Proposal; (iii) finance or offer to finance any Competing Proposal, including by offering any equity or debt finance, or contribution of Securities or provision of a voting agreement, in support of any Competing Proposal; (iv) enter into any written or oral agreement, arrangement or understanding (whether legally binding or not) regarding, or do, anything which is directly inconsistent with the Transaction as contemplated under this Agreement; (v) acquire (other than pursuant to share incentive plans of the Target) or dispose of any Securities, or directly or indirectly (A) sell, offer to sell, give, pledge, encumber, assign, grant any option for the sale of or otherwise transfer or dispose of, or enter into any agreement, arrangement or understanding to sell or otherwise transfer or dispose of, an interest in any Securities (“Transfer”) or permit the Transfer by any of their respective Affiliates of an interest in any Securities, in each case, except as expressly contemplated under this Agreement and the Documentation, (B) enter into any contract, option or other arrangement or understanding with respect to a Transfer or limitation on voting rights of any of the Securities, or any right, title or interest thereto or therein, or (C) deposit any Securities into a voting trust or grant any proxies or enter into a voting agreement, power of attorney or voting trust with respect to any Securities, (vi) take any action that would have the effect of preventing, disabling or delaying the Party from performing its obligations under this Agreement; or (vii) solicit, encourage, facilitate, induce or enter into any negotiation, discussion, agreement or understanding (whether or not in writing) with any other person regarding the matters described in Section 5.01(a) or (b); (c) shall immediately cease and terminate, and cause to be ceased and terminated, all existing activities, discussions, conversations, negotiations and other communications (whether conducted by it or any of its Affiliates or Representatives) with all persons conducted heretofore with respect to a Competing Proposal; and (d) shall promptly notify the other Parties if it, its Affiliates or any of its Representatives receives any approach or communication with respect to any Competing Proposal, promptly disclose to the other Parties the identity of any other persons involved and the nature and content of such approach or communication and promptly provide copies of any such written Competing Proposal.

  • License Period a. The License is hereby granted in favour of the Licensee for a total period of 15 (fifteen) years from the Commencement Date subject to unless otherwise terminated by Maha-Metro or surrendered by the Successful Bidder/Licensee, in term of provisions of License Agreement. b. The tenure of License Agreement shall commence from the date of handing over of the property business space. c. Tenure of the License Period of any additional space handed over subsequently shall be co- terminus with above period irrespective of date of actual handing over for such additional space. d. There shall be a lock in period of five (05) years from the date of commencement of agreement/ handing over of licensed space. e. Licensee shall have option to exit from the License Agreement immediately after completion of lock in period of 5 (Five) years. For it, Licensee shall have to issue 180 days prior notice to Maha-Metro. Such prior notice intimation can be given after four and half (4 ½) years however option to exit will be available only after five (05) years. f. At no time during the license tenure, the Licensee shall be allowed to surrender partial Licensed Space which has been handed over to the Licensee by Maha-Metro. g. At the end of License period or in the event of termination of this agreement prior to completion of license tenure, for any reason whatsoever, all rights given under this License Agreement shall cease to have effect and the premises shall revert to Maha-Metro, without any obligation to Maha-Metro to pay or adjust any consideration or other payment to the Licensee. h. The tenure shall be inclusive of fitment period as applicable for the tendered space. i. On completion/ termination of License Agreement, the Licensee shall hand over the space with normal wear & tear. The Licensee shall be allowed to remove its assets like temporary structure, furniture, almirahs, air-conditioners, DG sets, equipments, etc. without causing damage to the existing structure. However, the Licensee shall not be allowed to remove any facility, equipment, fixture, etc. which has become an integral part of the development plan of the space. j. At the end of the License Period or sooner determination of this Agreement for any reason whatsoever all rights given under this License Agreement shall cease to have effect and the Licensed Area with all the furniture and fixtures and other assets permanently attached to the Licensed Area shall revert to Maha-Metro without any obligation on part of Maha-Metro to pay or adjust any consideration or other payment to the Licensee. The Licensee voluntarily gives Maha-Metro the right to seal the said Licensed Space(s) and remarket the same as part on its discretion upon Termination of this Agreement. No claim, compensation or damages will be entertained by Maha-Metro on this account.