Clinical Research Support Services Agreement
By clicking the Accept button at the end of this Agreement you are acknowledging and accepting to agree to all of the terms and conditions of this clinical research support services ("Agreement") between Exodon, LLC (“Exodon”) and you as the “Client”.
WHEREAS, Exodon is engaged as a business associate of Client (Exhibit A HIPAA Compliance Agreement) for the business of delivering clinical research studies on behalf of Client.
WHERAS, through Exodon’s VALIDATE System® which shall mean a proprietary system that validates a clinical research site’s ability to complete trials by minimizing research subject recruitment costs and subject screening failures. This system de-identifies medical records, pre-consents patients for participation in upcoming clinical research studies and imports de-identified medical records into Exodon’s Clinical Research Database which is a diagnostic and treatment repository containing patient data from clinicians around the globe who are part of Exodon’s network of investigators.
Exodon and Client agree as follows:
1. General Services: Exodon will perform the following services for Client when acting as a business associate:
i. Free enrollment into Exodon’s VALIDATE System®,
ii. Exodon will identify clinical research studies where the inclusion/exclusion criteria matches sets of data in the Client’s pre-consented patient database, and will deliver these studies to Client at no charge to the Client,
iii. Client will have access to Exodon’s worldwide Clinical Research Database to conduct novel investigational research at no charge to Client, and if contracted with Client will attempt to obtain funding from a sponsor for a given research project,
iv. Client will be part of Exodon’s affiliated researcher network of consultants for the pharmaceutical, medical device and biotechnology sponsors at no charge to Client and,
v. Offer free support to Client if Client decides to organize a consortium of clinical research sites as reviewed in Schedule A.
A. Trial Services: Once a study begins, additional clinical research support services are available if requested by Client on a study by study basis that include: supporting Client in starting, coordinating, managing, and completing clinical research trials. If and when needed, these services are supplied by Exodon or one of Exodon’s SMO affiliates or subsidiary (Exhibit B).
2. Compensation: Clinical research studies and their reimbursement schedules are delivered to Client via a number of methods such as directly by Exodon when Exodon is the acting contract research organization (CRO), one of our CRO or site management organizations (SMO) affiliates, an independent 3rd party CRO, patient recruitment and biotechnology companies, as well as, directly from the study’s sponsor(s). Exodon does not guarantee that any specific number of research studies will be delivered to Client.
i. In most cases the above mentioned organizations will contact Client directly with opportunities to participate in a research study. If Client does not participate in a specific study of which a patient of Client may be eligible for, a written request to contact patient will be sent by Exodon to Client and Client has the option of receiving payment as a diagnostic courtesy fee for every patient enrolled in a study where Client is not acting as an investigator in that specific study.
3. Intellectual Property: Ownership and all rights, title, and interest in the VALIDATE System® are and shall remain vested solely in Exodon. Client acknowledges and agrees that it does not claim and will not claim any rights, title or interest in the VALIDATE System®.
4. Termination:
a. Termination without cause. This Agreement may be terminated at any time by either party without cause by given written notice not less than thirty (30) days to the other party.
b. Termination with cause. Either party hereto may terminate this Agreement for cause at any time if (i) the other party breaches any material hereof and fails to cure such breach in ninety (90) days (or thirty (30) days in case of a failure to pay any sum due hereunder) after receipt of written notice of such breach or (ii) the other party shall be or will become insolvent.
c. Effect of Termination. Termination of this Agreement shall nullify all obligations of Exodon. Medical reports in the eCast Corp. data center of Exodon’s EMR affiliate on the last effective day of this Agreement will be delivered to Client in some acceptable medium agreed upon by both parties. Patients currently being enrolled in studies at the time of termination of this Agreement will complete the enrollment process and all de-identified data of Client stored in Exodon’s repository will be deleted. Termination of the Agreement shall not nullify Client’s obligation to pay any outstanding charges owed to Exodon. If Client continues to use an EMR, the VALIDATE System™ application will be removed and Client agrees not to attempt to replicate, reproduce, copy or otherwise use this proprietary system created by Exodon.
5. Indemnification Client and Exodon each agree, to the extent allowed under the governing law to indemnify and hold the other party harmless of any claim, demand, suit, loss, or liability which the indemnified party may sustain as a result of the indemnifying party’s breach of duties or the indemnifying party’s errors or omissions and within the reasonable expenses of the indemnified party, including attorney’s fees incurred in connection with sum claims and damages (collectively “Damages”). As a condition precedent to asserting a right of indemnity, the party seeking indemnification shall have given the indemnified party timely written notice of the assertion of the claim to which the right of indemnification is claimed to exist. The Client hereby acknowledges that Exodon is performing an outsourcing activity for Client and Client is solely responsible for the content of each medical report and other types of reports transmitted to Exodon’s research repository. Accordingly, without limiting the generality of the foregoing, Exodon shall not be obligated to indemnify and hold harmless Client for any Damages resulting from the content of any medical report or other data transmitted to Exodon research repository and any errors contained therein or omissions.
6. Limitation of Liability
NOT WITHSTANDING ANYTHING TO THE CONTRARY HERIN, THE LIABILITY OF CALIBRATED-EXODON TO CLIENT FOR ANY AND ALL CLAIMS WHATSOEVER RELATED TO THIS AGREEMENT OR RELATED TO SERVICES PROVIDED UNDER THIS AGREEMENT WILL NOT EXCEED THE TOTAL AMOUNT OF ALL PAYMENTS MADE UNDER THIS AGREEMENT BY CLIENT TO CALIBRATED-EXODON. THIS LIMITATION IS CUMMULATIVE; SUM OF MULTIPLE CLAIMS MAY NOT EXCEED THIS LIMIT. IN NO EVENT WILL CALIBRATED-EXODON BE LIABLE TO CLIENT FOR: ANY LOSS OF PROFITS, ANY INCIDENTIAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES OF ANY KIND; OR ANY CLAIMS OR DEMANDS BROUGHT AGAINST CLIENT BY ANY THIRD PARTY, EVEN IF CALIBRATED-EXODON HAS BEEN ADVISED OF THE POSSIBLITY OF SUCH CLAIMS OR DEMANDS. THE PROVISIONS OF THIS PARAGRAPH WILL APPLY IF LOSS, DAMAGE OR INJURY, IRRESPECTIVE OF CAUSE OF ORIGIN, RESULTS DIRECTLY OR INDIRECTLY TO PERSON OR PROPERTY FROM PERFOMANCE OR NONPERFORMANCE OF OBLIGATIONS PROPOSED BY THIS AGREEMENT OR FROM NEGLIGANCE, ACTIVE OR OTHERWISE, OF CALIBRATED-EXODON, ITS AFFILIATES OR EMPLOYEES. CLIENT WAIVES ALL REMEDIES THE MAY OTHERWISE BE AVAILABLE UNDER THE LAWS ANY JURISDICTION. BECAUSE SOME JURISDICTIONS DO NOT ALLOW THE EXECUTION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTIAL DAMAGES, THE ABOVE LIMITATION MAY NOT APPLY TO CLIENT.
7. Entire Agreement
This Agreement, including all Exhibits and any attachments and amendments hereto, constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes any and all prior and contemporaneous representations, proposals, agreements, negotiations, advertisements, statements, or understandings, whether oral or written and fully and finally sets forth the rights, duties and obligations of each party to the other as of its date. The provisions of this Agreement shall take precedence and have priority over any subsequent conflicting or other non-identical terms dealing with the same subject matter described herein set forth in any purchase order or similar document generated by Client.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the Effective Date first set forth above.