Personnel Participant Conditions The Subrecipient shall include the following clauses in every Subcontract or purchase order, specifically or by reference, so that such provisions will be binding upon each subcontractor or vendor.
Participant Information My address is: My Social Security Number is:
B4 Key Personnel The Contractor acknowledges that the Key Personnel are essential to the proper provision of the Services to the Authority.
Sharing of Participant Information 20 7.4 REPORTING AND DISCLOSURE AND COMMUNICATIONS TO PARTICIPANTS..................................................20 7.5 NON-TERMINATION OF EMPLOYMENT; NO THIRD-PARTY BENEFICIARIES.................................................20 7.6
Contractor Key Personnel The Contractor shall assign a Corporate OASIS SB Program Manager (COPM) and Corporate OASIS SB Contract Manager (COCM) as Contractor Key Personnel to represent the Contractor as primary points-of-contact to resolve issues, perform administrative duties, and other functions that may arise relating to OASIS SB and task orders solicited and awarded under OASIS SB. Additional Key Personnel requirements may be designated by the OCO at the task order level. There is no minimum qualification requirements established for Contractor Key Personnel. Additionally, Contractor Key Personnel do not have to be full-time positions; however, the Contractor Key Personnel are expected to be fully proficient in the performance of their duties. The Contractor shall ensure that the OASIS SB CO has current point-of-contact information for both the COPM and COCM. In the event of a change to Contractor Key Personnel, the Contractor shall notify the OASIS SB CO and provide all Point of Contact information for the new Key Personnel within 5 calendar days of the change. All costs associated with Contractor Key Personnel duties shall be handled in accordance with the Contractor’s standard accounting practices; however, no costs for Contractor Key Personnel may be billed to the OASIS Program Office. Failure of Contractor Key Personnel to effectively and efficiently perform their duties will be construed as conduct detrimental to contract performance and may result in activation of Dormant Status and/or Off-Ramping (See Sections H.16. and H.17.).
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) 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. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for up to 12 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 days starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before dosing • If dosing under fed conditions (Part A), you must not eat or drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed during • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Contractor’s Project Manager and Key Personnel Contractor shall appoint a Project Manager to direct the Contractor’s efforts in fulfilling Contractor’s obligations under this Contract. This Project Manager shall be subject to approval by the County and shall not be changed without the written consent of the County’s Project Manager, which consent shall not be unreasonably withheld. The Contractor’s Project Manager shall be assigned to this project for the duration of the Contract and shall diligently pursue all work and services to meet the project time lines. The County’s Project Manager shall have the right to require the removal and replacement of the Contractor’s Project Manager from providing services to the County under this Contract. The County’s Project manager shall notify the Contractor in writing of such action. The Contractor shall accomplish the removal within five (5) business days after written notice by the County’s Project Manager. The County’s Project Manager shall review and approve the appointment of the replacement for the Contractor’s Project Manager. The County is not required to provide any additional information, reason or rationale in the event it The County is not required to provide any additional information, reason or rationale in the event it requires the removal of Contractor’s Project Manager from providing further services under the Contract.
Authorized Employees Contractor acknowledges that Section285.530, RSMo, prohibits any business entity or employer from knowingly employing, hiring for employment, or continuing to employ an unauthorized alien to perform work within the State of Missouri. Contractor therefore covenants that is not knowingly in violation of subsection 1 or Section 285.530, RSMo, and that it will not knowingly employ, hire for employment, or continue to employ any unauthorized aliens to perform work on the Project, and that its employees are lawfully to work in the United States.
Key Personnel 11.1 Each party shall appoint the persons named as such in Schedule 4 as the individuals who shall be responsible for the matters allocated to such Key Personnel. The Key Personnel shall be those people who are identified by each party as being key to the success of the implementation and/or operation of the Services and who shall be retained on the implementation and/or operation of the Services for such time as a person is required to perform the role which has been allocated to the applicable Key Personnel. The Key Personnel shall have the authority to act on behalf of their respective party on the matters for which they are expressed to be responsible.
11.2 The Supplier shall not remove or replace any of the Key Personnel unless:
(a) requested to do so by the Authority;
(b) the person is on long-term sick leave;
(c) the element of the Services in respect of which the individual was engaged has been completed to the Authority's satisfaction;
(d) the person resigns from their employment with the Supplier; or
(e) the Supplier notifies the Authority within 5 working days of any change.
11.3 The Supplier shall inform the Authority of the identity and background of any replacements for any of the Key Personnel as soon as a suitable replacement has been identified.
11.4 Each party shall ensure that the role of each of its Key Personnel is not vacant (in terms of a permanent representative) for more than 15 consecutive Working Days. Any replacement shall be as, or more qualified and experienced as the previous incumbent and fully competent to carry out the tasks assigned to the Key Personnel whom they have replaced. A temporary replacement shall be identified with immediate effect from the Supplier or the Authority becoming aware of the role becoming vacant.
11.5 The Authority may require the Supplier to remove, or procure the removal of, any of its Key Personnel whom it considers, in its reasonable opinion, to be unsatisfactory for any reason which has a material impact on such person's responsibilities.
11.6 If the Supplier replaces the Key Personnel as a consequence of this clause 11, the cost of effecting such replacement shall be borne by the Supplier.
DESIGNATED PERSONNEL The Contractor will provide the Designated Personnel listed below for the duration of the Contract at no charge to the State. Information regarding the Designated Personnel is set forth in Appendix D – Contractor and Reseller Information. Contractor must notify OGS within five (5) business days if any of the Designated Personnel change, and provide an interim contact person until the position is filled. Contractor may submit a Designated Personnel change by submission electronically via e-mail of a revised Appendix D – Contractor and Reseller Information to the OGS Contract Administrator. The Designated Personnel must have the authority to act on behalf of the Contractor: Account Manager The Account Manager is responsible for the overall relationship with the State during the course of the Contract and shall act as the central point of contact. Contract Administrator The Contract Administrator is responsible for the updating and management of the Contract on a timely basis. Sales Manager The Sales Manager is responsible for the overall relationship with the Authorized Users for matters relating to RFQs.
