For Client using a print version of this Agreement please complete this section: This Agreement for clinical research support services ("Agreement") is made and entered into on
between Exodon, LLC of 111 Howard Blvd, Mt. Arlington, NJ 07856 ("Exodon") and
("Client").
For Web-based Clients: 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.
WHEREAS, through Exodon's Validate SystemŽ 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 uses de-identified medical records of the Client and/or the Client's site metrics listed in Exodon's Investigator Enrollment Database Form (IEDF), and matches these data to all actively enrolling and soon to be enrolling clinical trials listed in Exodon's clinical trials database which contains approximately 50,000 trials. Exodon does not guarantee a specific number of clinical research studies will be delivered to Client, as Exodon is not responsible for site selection, only the matching of sites to actively or soon to be enrolling studies.
Exodon and Client agree as follows:
1. Definitions: For the purpose of this Agreement:
1.1 "Get Me Clinical TrialsTM Subscriber" shall mean each individual clinical research site that pays Exodon a monthly subscription fee in return for delivering clinical trials to Client.
1.2 Trials Management Organization ("TMO") shall mean a Client who belongs to Exodon's Validate SystemŽ network of sites where Exodon is authorized to act as an agent with the Client delivering clinical trials to the Client and providing contract and budget negotiations as well as patient recruitment services for the Client.
1.3 Site Management Organization ("SMO") shall mean a Client who belongs to Exodon's Validate SystemŽ network of sites where Exodon is authorized to act as an agent with the Client delivering clinical trials to the Client and providing contract and budget negotiations as well as patient recruitment and site support services for Client.
2. Exodon's Responsibilities: Exodon will perform the following services for Client when acting as a business associate:
i. Exodon will identify clinical research studies where the inclusion/exclusion criteria matches sets of data in the Client's Validate SystemŽ de-identified patient database and/or IEDF, and will deliver these studies to Client,
ii. Free enrollment into Exodon's Validate SystemŽ for TMO and SMO Clients,
iii. Get Me Clinical TrialsTM Subscriber will receive a weekly list of enrolling or soon to be enrolling clinical trials including contact information for a representative of the study and relevant study start up documents for each trial such as: a sponsor's Confidentiality Agreement, Protocol Synopsis and Site Information Questionnaire.
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.
vi. Exodon will attempt to obtain funding from a sponsor for investigator initiated research projects upon submission and a decisional review of a study proposal submitted by Client.
3. Client Responsibilities: For TMO and SMO Clients: Client acknowledges and agrees to:
i. Import de-identified medical records and/or site metric data by completing Exodon's on-line IEDF into Exodon's VALIDATE SystemŽ database. These data are used to identify clinical research trials matching the Client's patient population or site metrics to enrolling or soon to be enrolling clinical trials,
ii. Complete all necessary VALIDATE SystemŽ enrollment documents such as an IEDF.
iii. When required, pre-consent and pre-qualify patients for participation in upcoming clinical research studies.
4. Trial Management and Site Support Services: For TMO and SMO Clients, if selected to participate in an Exodon delivered clinical research study, additional clinical research support services will be made available to the Client. All TMO and SMO Clients acknowledge and agree that all contract and budget negotiations must occur directly with and only with Exodon for each clinical trial delivered to TMO and SMO Client by Exodon. Contracts and budgets for each clinical trial will be reviewed by TMO and SMO Client and sent back directly to Exodon. All TMO and SMO Clients will receive patient recruitment services from Exodon. If SMO services are requested by Client; these are offered on a study by study basis per the terms and conditions of the Client's SMO Contract that will 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).
5. Payments :
i. Each individual Get Me Clinical TrialsT Subscriber shall pay Exodon a monthly subscription fee as stipulated by the terms and conditions in Exhibit C.
ii. Payments to TMO Clients are based on each clinical research study's reimbursement schedules and are delivered to Client directly by Exodon. In general the more pre-qualified and pre-consented patients matching a study's requirements the higher the per patient reimbursement rate paid to Client.
iii. Payments to SMO Clients are based on each clinical research study's reimbursement schedules and are delivered to Client directly by Exodon after the deduction of fees for SMO services requested by Client.
iv. 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 may be sent by Exodon to Client asking Client for permission to contact that patient to assess if patient is interested in participating in that study. Client has the option of receiving payments as a screening center for identifying patients where Client is not acting as an investigator in that specific study.
6. Intellectual Property: Ownership and all rights, title, and interest in the Validate SystemŽ 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 SystemŽ.
7. 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.
If this Agreement is terminated with or without cause, the terms stipulated in any separate existing agreement for any pending or ongoing clinical trials project delivered to Client by Exodon will override paragraph 7 of this Agreement and Client is bound by the terms and conditions specific to that clinical research trial(s).
c. Effect of Termination.
Termination of this Agreement shall nullify all obligations of Exodon. Medical reports in Exodon's Validate SystemŽ database will be deleted or 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. Termination of the Agreement shall not nullify Client's obligation to pay any outstanding charges owed to Exodon. If Client continues to use an Exodon affiliated EMR, the Validate SystemŽ application will be removed and Client agrees not to attempt to replicate, reproduce, copy or otherwise use this proprietary system created by Exodon.
8. 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.
9. Limitation of Liability
NOT WITHSTANDING ANYTHING TO THE CONTRARY HEREIN, THE LIABILITY OF 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 EXODON. THIS LIMITATION IS CUMULATIVE; SUM OF MULTIPLE CLAIMS MAY NOT EXCEED THIS LIMIT. IN NO EVENT WILL EXODON BE LIABLE TO CLIENT FOR: ANY LOSS OF PROFITS, ANY INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES OF ANY KIND; OR ANY CLAIMS OR DEMANDS BROUGHT AGAINST CLIENT BY ANY THIRD PARTY, EVEN IF 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 PERFORMANCE OR NONPERFORMANCE OF OBLIGATIONS PROPOSED BY THIS AGREEMENT OR FROM NEGLIGENCE, ACTIVE OR OTHERWISE, OF EXODON, ITS AFFILIATES OR EMPLOYEES. CLIENT WAIVES ALL REMEDIES THAT MAY OTHERWISE BE AVAILABLE UNDER THE LAWS BY ANY JURISDICTION. BECAUSE SOME JURISDICTIONS DO NOT ALLOW THE EXECUTION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, THE ABOVE LIMITATION MAY NOT APPLY TO CLIENT.
10. 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.
Please indicate which Exodon clinical research support services you are requesting. You may request more then one service. For example, you can be a Get Me Clinical TrialsT Subscriber and be considered for TMO clinical trials with Exodon.
If you are using a Print version of this Agreement please circle one or more of the following choices:
Get Me Clinical Trials Subscriber, TMO or SMO.
If you are completing this Agreement on the web please tic off the boxes below which services you are requesting:
GMCTTM Subscription
TMO
SMO
IN WITNESS WHEREOF, the parties have executed this Agreement as of the Effective Date first set forth below.
CLIENT
Printed Name:
Title:
Date:
Phone :
www.Exodon.com
If using a print version of this Agreement fax back to 973.710.9142
