INDEPENDENT CONTRACTOR AGREEMENT
FOR COMPOUND STUDY INVESTIGATORS (CSI)
THIS INDEPENDENT CONTRACTOR AGREEMENT ("Agreement") is made and entered into as of this day of , 20 (the "Effective Date") by and between:
SAS Research LLC (hereinafter referred to as, “SAS”), a New Jersey company located at
101 Eisenhower Pkwy, Suite 300, Roseland, New Jersey, 07068, “NOTICES” below
-And-
, a medical practitioner licensed to prescribe pharmaceutical compounds in the United States and being registered with the National Provider
Identifier (NPI) of (hereinafter referred to as "CSI") located at ______set out under “NOTICES” below.
WHEREAS, SAS is a New Jersey based company engaged in providing Data Collection services, as set forth below, for the benefit of SAS’s clients, for purpose of conducting ongoing studies on various compounded prescriptions and other pharmaceutical products; and
WHEREAS, CSI warrants that he/she is licensed to practice medicine and seeks to contract with SAS to provide such services;
NOW, THEREFORE, in consideration of the mutual covenants contained in this Agreement, and other good and valuable consideration, the receipt of which is hereby acknowledged, the parties hereto, intending to be legally bound, agree as follows:
IT IS THEREFORE AGREED BY AND BETWEEN THE PARTIES THAT:
v RESPONSIBILITIES OF CSI
During the term of this Agreement, CSI will perform the duties and obligations set forth hereinafter and such additional duties and obligations as are set forth in Exhibit A attached hereto and made a part hereof.
v INDEPENDENT CONTRACTOR
It is understood that CSI is acting as an independent contractor, and CSI will be not considered an employee of SAS. It is agreed and acknowledged by the Parties that, as an independent contractor, CSI retains the right to engage in the private practice of medicine, and nothing in this Agreement will be interpreted as limiting or restricting that right in any way. In no event will this Agreement be construed as establishing a partnership or joint venture or similar relationship between the Parties hereto, and nothing herein contained will be construed to authorize either Party to act as agent for the other.
v TERM
This Agreement shall become effective as of the Effective Date and shall conclude in one year from anniversary date of signing, unless terminated earlier as hereinafter provided. This Agreement may be amended or modified from time to time as requested by the lead investigator, (to be named on each study by SAS), or legal counsel. This agreement shall be for a one year and shall automatically renew for successive one (1) year terms unless either SAS or CSI gives written notice to the other of such Party's intention not to renew this Agreement at least 30 days prior to the Renewal Date or, if given during a renewal term, then at least thirty (30) days prior to the annual anniversary of the Renewal Date.
v TERMINATION
a. Termination for Breach. Either party may terminate this Agreement upon breach by the other party of any material provision of this Agreement, provided such breach remains uncured for fifteen (15) continuous days after receipt by the breaching party of written notice of such breach from the non-breaching party.
b. Immediate Termination. This Agreement may be terminated, immediately, by written notice to the non-terminating party upon the occurrence of any of the following events:
(1) By SAS upon the denial, suspension, revocation, termination, restriction, lapse, or voluntary relinquishment (under threat of disciplinary action) of CSI's license to practice medicine:
(2) Upon the death or permanent disability of CSI;
(3) By SAS upon the termination, revocation, restriction, or relinquishment of CSI's DEA and/or DPS registration;
(4) By SAS if the conduct of CSI, in the sole discretion of SAS, could affect the quality of professional care provided to SAS's patients, or the performance of duties required hereunder, or be prejudicial or adverse to the best interest and welfare of SAS or its patients;
(5) By either party upon a breach of the confidentiality provisions in this Agreement;
(6) By CSI upon closure of SAS, cessation of the SAS's patient care operations, sale of SAS, or sale of substantially all of SAS's assets;
(7) By either party upon the other's conviction of a felony or of an offense related to healthcare, or a party's listing by a federal agency as being debarred, excluded, or otherwise ineligible for federal program participation;
(8) Upon either party's becoming insolvent, making assignment for the benefit of creditors, being declared a bankruptcy or having his/her assets administered in any type of creditor's proceeding;
(9) Upon the mutual agreement in writing by the SAS and CSI;
(10) In the event there is a change of law or interpretation of the law that would render the arrangement illegal and the arrangement cannot be restructured to comply with the law;
c. Termination Without Cause. Either party may, without cause and upon 30-day prior written notice, terminate this Agreement, however, if such termination occurs prior to the end of one year the parties agree not to contract with another for the same or similar services until the expiration of the original term.
v COMPENSATION
a. THE CSI shall be recompensed for accurate and complete data collection and case study patient administration services twice monthly, during the term of this agreement, after each case study patient’s collected data is confirmed and verified to be true and accurate by SAS and all duties and procedures as set out in Exhibit A, hereto are complete to the satisfaction of SAS.
b. THE CSI shall be compensated one hundred and twenty five dollars ($125.00) per month for each case study patient who participates in any month and for which the requirements set forth in Paragraph A, immediately above have been fully met.
c. No compensation will be paid to CSI for any Services for which CSI has not submitted a completed Activity Log in the same format as Exhibit B of this Agreement attached hereto and made a part hereof or as may from time to time be determined by SAS and notice of any change to such Activity Log provided to CSI before the last of the month for use in that month. Both parties hereby acknowledge that any scheme of “pay-per-script” is strictly prohibited and forbidden and shall not constitute any part of this agreement.
N.B. – Further, no Medicare/Medicaid/TriCare patients shall be included in the CSI’s time or Activity Log for any services rendered and CSI will never be compensated by SAS for any time or effort spent with any patient with such coverage.
ASSIGNMENT OF CSI COMPENSATION:
CSI may notify SAS to pay any compensation due under this contract to any legally constituted entity or individual with which the CSI is associated in the conduct of the CSI’s medical services. (E. G. – Clinic, Hospital, Medical Practice, etc). CSI will provide SAS with a W9 form containing the required information on any such assignee.
v CONFIDENTIALITY
a. CSI recognizes and acknowledges that by virtue of entering into this Agreement and providing services to SAS hereunder, CSI may have access to certain information of SAS that is confidential and constitutes valuable, special and unique property of SAS. CSI will not at any time, either during or subsequent to the term of this Agreement, disclose to others, use, copy or permit to be copied without SAS's express prior written consent, except pursuant to CSI's duties hereunder, any confidential or proprietary information of SAS including, but not limited to, information that concerns SAS's costs, prices and treatment methods at any time used, developed, or made by SAS and that is not otherwise available to the public.
b. Terms of this Agreement. Except for disclosure to CSI's legal counsel, accountant, or other advisors, CSI will not disclose the terms of this Agreement to any third party, unless disclosure thereof is required by law or otherwise authorized by this Agreement or consented to by SAS. Unauthorized disclosure of the terms of this Agreement will be a material breach of this Agreement and will provide SAS with the option of pursuing remedies for breach or immediate termination of this Agreement in accordance with this Agreement.
c. INVESTIGATOR SITE INFORMATION CSI agrees to provide all information as requested in the Investigator Site Information Form in the same format as Exhibit C of this Agreement attached hereto and made a part hereof.
d. Patient Information. CSI will not disclose to any third party, except where permitted or required by law or where such disclosure is expressly approved by SAS in writing, any patient or medical record information regarding patients, and CSI will comply with all federal and State laws and regulations, and all rules, regulations, and policies of SAS, regarding the confidentiality of such information.
e. HIPAA and State Confidentiality Compliance. CSI will comply with the applicable provisions of the Administrative Simplification section of the Health Insurance Portability and Accountability Act of 1996, as codified at 42 U.S.C. § 1320d through d-8 ("HIP AA"), and the requirements of any regulations promulgated thereunder including, without limitation, the federal privacy regulations as contained in 45 CPR Part 164 (the "Federal Privacy Regulations") and the federal security standards as contained in 45 CPR Part 142 (the "Federal Security Regulations"). CSI will not use or further disclose any protected health information, as defined in 45 CFR 164.504, or individually identifiable health information, as defined in 42 U.S.C. § 1320d (collectively, the "Protected Health Information"), concerning a patient other than as permitted by this Agreement and the requirements of HIPAA or regulations promulgated under HIPAA including, without limitation, the Federal Privacy Regulations and the Federal Security Regulations. CSI will implement appropriate safeguards to prevent the use or disclosure of a patient's Protected Health Information other than as provided for by this Agreement. CSI will promptly report to SAS any use or disclosure of a patient's Protected Health Information not provided for by this Agreement or in violation of HIPAA, the Federal Privacy Regulations, the Federal Security Regulations, confidentiality laws of which CSI becomes aware. In the event CSI, with SAS’s approval, contracts with any agents to whom CSI provides a patient's Protected Health Information, CSI will include provisions in such agreements whereby CSI and agent agree to the same restrictions and conditions that apply to CSI with respect to such patient's Protected Health Information. CSI will make its internal practices, books, and records relating to the use and disclosure of a patient's Protected Health Information available to the Secretary of Health and Human Services to the extent required for determining compliance with the Federal Privacy Regulations and the Federal Security Regulations. Notwithstanding the foregoing, no attorney-client, accountant-client, or other legal privilege will be deemed waived by CSI or SAS by virtue of this agreement.
REQUIRED DISCLOSURES
a. CSI will notify SAS in writing within three (3) days after any of the following events occur:
(1) CSI's license to practice medicine is denied, suspended, revoked, terminated, relinquished, or made subject to terms of probation or other restriction;
(2) CSI's medical staff privileges at any health care facility are denied, suspended, revoked, terminated, voluntarily relinquished (under threat of disciplinary action), or made subject to terms of probation or other restriction;
(3) CSI becomes the subject of an investigatory, disciplinary, or other proceeding or action before any governmental, professional, licensing board, medical staff, or peer review body;
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v REQUIRED DISCLOSURES (continued)
(4) CSI's DEA or DPS registration is revoked, terminated, restricted, or relinquished, placed on terms of probation, or restricted in any way;
(5) CSI's conviction of a felony or an offense related to health care or CSI's listing by a federal or State agency as being debarred, excluded, or otherwise ineligible for federal or State program participation.
b. SAS will provide a full disclosure of each state where they are licensed to ship.
SAS licenses are set forth in Exhibit D attached hereto and made a part hereof.
c. SAS will notify CSI in writing within three (3) days if the following event occurs:
(1) SAS licenses and certifications lapses or are denied, suspended, revoked, terminated, relinquished, or made subject to terms of probation or other restriction;
v ENTIRE AGREEMENT; MODIFICATION
This Agreement contains the entire understanding of the Parties with respect to the subject matter hereof and supersedes all prior agreements, oral or written, and all other communications between the Parties relating to such subject matter. This Agreement may not be amended or modified except by mutual written agreement.
v GOVERNING LAW
This Agreement will be construed in accordance with the laws of the State of Florida. Venue shall be in TAMPA BAY FLORIDA.
v NOTICES
All notices hereunder will be in writing, delivered personally, or delivered by certified or registered mail return receipt requested, or by overnight courier, and will be deemed to have been duly given when delivered personally or when deposited in the United States mail, postage prepaid, or deposited with the overnight courier addressed as follows:
CRO
SAS Research LLC
101 Eisenhower Pkwy, Suite 300,
Roseland, New Jersey, 07068
CSI:
Practitioner Name: ______
Address: ______
City/ST/Zip: ______
v REFERRALS
The Parties acknowledge that none of the benefits granted CSI hereunder are conditioned on any requirement that CSI make referrals to, be in a position to make or influence referrals to, or otherwise generate business for any pharmacy. The Parties further acknowledge that CSI is not restricted from referring any patient to, or otherwise generating any business for any other facility or pharmacy of CSI's choosing.
I hereby agree to the participation of data collection for the compound cream study mentioned above. Furthermore I desire to enroll (50) or (100) or other amount of non-Medicare case study patients. (Please circle a number or fill in the blank above).
CSI:
BY: ______
Signature
Printed Name: ______
Date: ______