Participant See Section 7(a) hereof.
Deferred Retirement a. An employee who is eligible for paid retirement at the time he or she separates from County service, but elects deferred retirement, may defer participation in the Grant until such time as he or she becomes an active retiree.
b. An otherwise eligible employee who is not eligible for paid retirement at the time he or she separates from County service but is eligible for and elects deferred retirement shall not become eligible for participation in the Grant.
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, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which may put your safety at risk or could have an effect on the study results • You may be eligible to participate if you have well controlled hypertension or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • 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 have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 days plus 5 half-lives 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 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 o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary or herbal supplements that are sensitive CYP3A, BCRP, P-gp/MDRI, OATP1B, or UGT1A1 and UGT1A4 substrates after Day -1 of the study. o The study investigator or study staff will review a list of these medications and substances with you • You must have taken a GLP-1R agonist within 90 days before the first dose of Saxenda • You must not have a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • 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 24 days starting with check-in o 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 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 • You may drink water freely while in the CRU • You must not eat anything for at least 10 hours before eating breakfast • If dosing when an OGTT will be done you must not eat anything for at least 10 hours before dosing and/or OGTT • 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 • 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.
Death of Participant Any distribution or delivery to be made to Participant under this Award Agreement will, if Participant is then deceased, be made to Participant’s designated beneficiary, or if no beneficiary survives Participant, the administrator or executor of Participant’s estate. Any such transferee must furnish the Company with (a) written notice of his or her status as transferee, and (b) evidence satisfactory to the Company to establish the validity of the transfer and compliance with any laws or regulations pertaining to said transfer.
Limitation upon Participant Rights A Participant shall not be entitled to receive any greater payment under Section 3.01 or 3.04 than the applicable Lender would have been entitled to receive with respect to the participation sold to such Participant, unless the sale of the participation to such Participant is made with the Borrower’s prior written consent. A Participant that would be a Foreign Lender if it were a Lender shall not be entitled to the benefits of Section 3.01 unless the Borrower is notified of the participation sold to such Participant and such Participant agrees, for the benefit of the Borrower, to comply with Section 3.01(e) as though it were a Lender.
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.
Participants The Lender and its participants, if any, are not partners or joint venturers, and the Lender shall not have any liability or responsibility for any obligation, act or omission of any of its participants. All rights and powers specifically conferred upon the Lender may be transferred or delegated to any of the Lender's participants, successors or assigns.
Participant Representations (a) The Participant represents, warrants and agrees that it will not make any representations concerning the Funds, the Creation Units or the Shares other than those consistent with the then current Prospectus or any promotional or sales literature furnished to the Participant by the Distributor or the Trust, or any such materials permitted by clause (b) of this Section 6.
(b) The Participant agrees not to furnish or cause to be furnished by Participant or its employees to any person or display or publish any information or materials relating to the Funds (including, without limitation, promotional materials and sales literature, advertisements, press releases, announcements, statements, posters, signs or other similar materials, but not including any materials prepared and used for Participant’s internal use only or brokerage communications prepared by the Participant in the normal course of its business and consistent with the Trust’s then current Prospectus and in accordance with applicable laws and regulations) (“Marketing Materials”), except such Marketing Materials as may be furnished to the Participant by the Distributor or the Trust and such other Marketing Materials as are consistent with the Trust’s then current Prospectus and have been approved by the Distributor in writing prior to use; provided that such Marketing Materials clearly indicate that such Marketing Materials are prepared and distributed by Participant. All Marketing Materials prepared by the Participant shall be filed with FINRA or the SEC, as applicable, by the Participant, and shall comply with all applicable rules and regulations of FINRA and the SEC.
(c) The Participant understands that the Trust will not be advertised or marketed as an open-end investment company, i.e., as a mutual fund, which offers redeemable securities, and that any advertising materials will prominently disclose that Shares are redeemable only in Creation Unit size by or through a Participant and on an in-kind basis, as applicable, as described in the Prospectus. In addition, the Participant understands that any advertising material that addresses redemptions of Shares, including the Prospectus, will disclose that the owners of Shares may acquire Shares and tender Shares for redemption to the Fund in Creation Unit aggregations only.
(d) Notwithstanding anything to the contrary in this Agreement, the Participant and its affiliates may prepare and circulate in the regular course of their businesses research reports that include information, opinions or recommendations relating to Shares (i) for public dissemination; provided that such research reports compare the relative merits and benefits of Shares with other products and are not used for the purpose of marketing shares and comply with all applicable rules and regulations of FINRA or the SEC, or (ii) for internal use by the Participant and other materials that include information, opinions or recommendations relating to Shares.
Sharing of Participant Information 22 7.4 REPORTING AND DISCLOSURE AND COMMUNICATIONS TO PARTICIPANTS............................22 7.5 NON-TERMINATION OF EMPLOYMENT; NO THIRD-PARTY BENEFICIARIES............................23 7.6
Participant Contributions If Participant contributions are permitted, complete (a), (b), and (c). Otherwise complete (d).
