3. Institution Agrees that if Institution is selected by the Sponsor or CRO for participation in this Study;
3.1 that SMO will negotiate the Contract and Budget on behalf of the Institution with the Sponsor or CRO. However, Institution will be encouraged to provide input throughout negotiations and provide final approval of the contract and budget. Institution is not obligated to sign the contract if the budget does not cover site costs.
3.2 that SMO will be Party to the Contract and the Institution will not conduct this Study directly with the Sponsor or CRO without written permission from SMO.
3.3 that SMO will be Payee on the Contract.
3.4 that SMO will make payment to Institution within five (5) business days of receipt of funds and corresponding payment details from CRO or Sponsor. SMO assumes no financial liability in the event funds are not made available by CRO or Sponsor. In the event of non-payment by CRO and Sponsor, Institution, and Principal Investigator’s exclusive cause of action for non-payment shall be against CRO and/or Sponsor.
4. Institution Agrees that neither the Institution, its employees, contracted personnel or PI, to the best of its knowledge after diligent inquiry, has been:
4.1 charged or convicted with a federal or state offense,
4.2 been debarred or disqualified from participating in clinical research by any regulatory authority, state or federal agency (21 U.S.C. §335a),
4.3 excluded by the Office of Inspector General or any state agency from participation in any federal or state health care program (42 U.S.C. §1320a-7 and 21 C.F.R. 312.70).
4.4 SMO reserves the right to remove any Institution and/or Investigator from the network at any time and for any reason deemed by SMO to be potentially detrimental to SMO's business.
5.1 Willful misrepresentation of Institution and PI information in terms of previous trial experience, potential patient population, PI experience, staff credentials, or other related information.
5.2 Institution’s failure to refund unearned study monies to SMO within 30 business days of notice pursuant to Section 11.
5.3 Institution’s failure to attend a Pre-Study Visit without prior notification.
5.4 Institution’s regular display of lack of timely response to email or phone communications.
5.5 Any proceedings related to Section 4 in terms of debarment or disqualification at the Institution.
6. Institution Agrees that the Start-Up Fee will be subject to a flat rate fee proportionate to the Amount paid by the Sponsor or CRO as shown below. The SMO uses this fee to cover the time and expense associated with finding studies, submitting site information and documentation, and providing contract and budget negotiation expertise.
Total Start-Up Amount Portion Paid to SMO
$0 - $999……………….…………...… $0
$1,000 - $1,500…………………….. $250
$1,501 - $2,000…………………….. $500
$2,001 - $3,000…………………….. $1,000
$3,001 - $4,000…………………….. $1,500
$4,001 - $5,000…………………….. $2,000
$5,001 - $7,000…………………….. $2,500
$7,001 - $9,000…………………….. $3,000
$9,001 - and up…………………….. $3,500
7. Institution Agrees that SMO will apply an 8% standard margin to the Budget that SMO negotiates with the Sponsor. SMO will apply this margin prior to payment to the Institution on the following items:
7.1 Per-Patient Visit Procedures and Payments (hereinafter referred to as “Visit Costs”)
7.2 Unscheduled Visits when costs are calculated from procedures that are itemized as Budget Line Items in the Visit Costs
7.3 Screen Failures when costs are calculated from procedures that are itemized as Budget Line Items in the Visit Costs
7.4 Invoiceable Expenses when costs are calculated from procedures that are itemized as Budget Line Items in the Visit Costs
7.5 Pass-through Fees with Overhead
8. Institution Agrees that the below fees are exempt from the 8% margin and will be paid 100% to the Institution:
8.1 Any Invoiceable Procedures that are not itemized as Budget line items in the Visit Costs and are not paid with overhead:
8.1.1 Imaging procedures (MRI, XRay, CT Scan, etc.) that are not itemized as Budget line items in the Visit Costs and are not paid with overhead
8.1.2 Significant medical procedures (colonoscopy, sigmoidoscopy. e TVU, etc.) that are not itemized as Budget line items in the Visit Costs and are not paid with overhead
8.1.3 All pass-through 3rd Party Vendor Costs (Advertising, Dry Ice, etc.)
8.1.4 All other pass-through expenses (Pharmacy, Close Out, Archiving Fees, etc.)
8.1.5 Subject Stipends, including travel and meal stipends
8.2 Screen Failures that are paid at a flat rate less than the screening visit rates, and are not itemized as Budget line items in the Visit Costs and are not paid with overhead
8.3 Unscheduled Visits that are paid at a flat rate and are not itemized as Budget line items in the Visit Costs and are not paid with overhead