Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have taken any medications, dietary or herbal supplements that are inhibitors or inducers of certain enzymes or proteins within 14 days or 5 half-lives (which is drug dependent); before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You must not have a history of sensitivity reactions to midazolam or any of the components of the liquid formulation • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) ...
Participant Responsibilities. The SFS scholarship participant agrees to the following:
Participant Responsibilities. 7.1 The Participant shall comply with the terms of this Agreement including, for certainty, any schedule attached hereto, as applicable.
7.2 The Participant acknowledges and agrees that it has the responsibility to protect its own information network, at its own expense. The Participant further agrees that, notwithstanding any other provision hereof, CANARIE shall not be liable in any way whatsoever for loss (of any kind whatsoever) or damage (of any kind whatsoever) caused by a breach, compromise or malfunction in the Participant’s information network, whether caused by CANARIE or not.
Participant Responsibilities. In order for Company to be obligated to provide the Services to Participant, the Participant agrees to take the following actions:
4.1 Contact the IRS and/or state (with the assistance of Company) per the notice received to request an extension of the deadline for responding,
4.2 Notify Company of any IRS and/or state correspondence or notice regarding the Return within thirty (30) days from the date of such notice along with a complete copy of the Return.
4.3 Provide Company any further assistance or documents as requested that support claims made on the Return.
Participant Responsibilities. Participant covenants and agrees to do the following during the term of this Agreement in addition to any other obligations specified herein:
a. Employ software in conformance with the document, “InCommon Federation Software Guidelines,” available on the InCommon website;
b. Support and make use of the identity attributes described in the document “InCommon Federation Attribute Overview” available on the InCommon website;
c. Provide InCommon with accurate technical and administrative data elements that describe the participating system entities and their properties, support and facilitate the Federation’s policy and operational goals (collectively, “Metadata”).
Participant Responsibilities. To ensure a successful initiative, the Participant agrees to: • Allow periodic site visits by NYSERDA staff and contractors to assess heat pump functionality and material related to the Initiative • Allow signage and a good faith effort to keep signage visible and clean • Allow Site information such as name, address, type of business and relevant event or promotion information to be posted on a public website and in event notices • Make a good faith effort to participate in promotional campaigns including social media promotions • Make staff available for initial training • Make a good faith effort to have staff promote signage and promote heat pump(s) • Make staff available for evaluation interviews/questionnaires • Follow guidelines in the Experience Clean Heat Program Manual for marketing, contests, social media interactions and overall program participation • Provide a general certificate of insurance meeting required coverages under Insurance section below.
Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, St. John’s Wort, minerals, or vitamins) within 7 days before the first dose or at any time during the study o Hormonal methods of birth control are allowed o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study You must not have taken any medications or substances that are strong inducers of CYP3A4 (a gene that alters enzyme activity in the body) within 28 days of the first dose, or take any strong inhibitors of CYP3A4 during the study and for at least 4 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you You must not take any investigational drugs within 30 days before the first dose of this study You must not have a history of sensitivity to ritonavir, or any of the components of the study drug or ritonavir You must not have received the COVID-19 vaccine within 7 days before screening or admission to the CRU or be scheduled to be vaccinated at any time while confined to the CRU for the study You may be asked to provide documentation of your childbearing status You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. of beer, 3 oz. of wine, or 1 oz. of hard liquor You must not use tobacco or nicotine containing products in exce...
Participant Responsibilities a. Participant will immediately notify Company upon becoming aware of any failure by any Authorized User to comply with this Agreement, the Policies and Procedures, or any additional terms of use applicable to CliniSync or other Services, and will assist Company in ensuring this Agreement, the Policies and Procedures, and any additional terms of use are followed by each Authorized User.
b. Participant will be solely responsible, at Participant’s own expense, for acquiring, installing and maintaining all hardware, software and other equipment as may be necessary for Participant and each Authorized User to connect to, access, or use CliniSync or any other Services. Participant will be solely liable for any failure in its hardware, software, and other equipment, including any such failure resulting in Participant’s breach of this Agreement or violation of Laws, except where that failure was due to a qualifying event under the terms of Force Majeure as defined in Section 18.1 below. Participant will be solely liable for any failure in its hardware, software and other equipment, resulting in Participant’s violation of Laws.
Participant Responsibilities. 2 3.2 NASA RESPONSIBILITIES..................................................3 4.0 SCHEDULE AND MILESTONES.......................................................5
Participant Responsibilities. A. Participating Institutions agree to abide by the Bylaws of CIFNAL/ICBFN, which are attached as Appendix D. Participating Institutions are expected to adhere to the terms and conditions set forth in any and all participant agreements, subscription licenses, or project guidelines and expectations that the Participating Institution has voluntarily and willingly joined.
