Preview | Clinical Trial Agreement |

THIS AGREEMENT, effective as of August 19, 2003 (the Effective Date), is by and between BIOLOK International, Inc. a corporation organized and existing under the laws of the State of Florida and having its offices at 312 South Military Trail, Deerfield Beach, Florida 33442 ("Sponsor") and New York University College of Dentistry, an administrative unit of New York University an education corporation organized and existing under the laws of New York, having its offices at 345 East Twenty-fourth Street, New York, NY 10010 ("NYUCD").

WHEREAS, Sponsor desires to conduct clinical trails with respect to such Protocols as "A study to compare the BioLok implant system vs. three other dental implant systems with regards to changes in marginal bone level", which will guide the performance of this Agreement and which has been written by the Sponsor and accepted by NYUCD and Principal Investigator.

WHEREAS, the research program contemplated by this Agreement is of mutual interest and benefit to NYUCD and to the Sponsor, and will further NYUCD's instructional and research objectives in a manner consistent with its status as a non-profit, tax-exempt educational institution.

This Agreement shall be effective as of the Effective Date and shall remain in full force and effect until it expires or is terminated in accordance with Section 15 hereof

NYUCD shall perform the study described in the Protocol entitled: "A study to compare the BioLok implant system vs. three other dental implant systems with regards to changes in marginal bone level" and attached hereto as Appendix A and which is hereby incorporated into and made part of this Agreement ("the Study") subject to and in accordance with the provisions hereof.

A. The Study will be conducted by and under the direction of NYUCD's Dr. Dennis Tarnow, (hereafter referred to as "Principal Investigator"). The Principal Investigator will be responsible for the direction of the Study in accordance with all applicable NYUCD policies and all applicable State and Federal laws and regulations. If, during the Performance Period (as hereafter defined) the Principal Investigator shall cease to supervise the Study, then NYUCD shall so notify Sponsor and shall endeavor to find from among the faculty of NYUCD a Principal Investigator or Principal Investigators acceptable to Sponsor, which acceptance shall not unreasonably be withheld, this Agreement may be terminated by either party upon written notice to the other party.

B. Principal Investigator, or, Investigators responsible to the Principal Investigator and who are identified within the proposal shall distribute the test article to subjects. The Principal Investigator shall not commence the Study until NYU's Institutional Review Board has given its written approval to the Study and to a written informed consent form with respect to the Study. The Principal Investigator will promptly forward a copy of such approval to Sponsor.

C. The Principal Investigator shall not distribute the Study product except to subjects who have given informed consent in writing upon the form approved by NYU's Institutional Review Board.

D. The Principal Investigator shall promptly notify the Sponsor by telephone of any serious or unexpected adverse reaction experienced by a patient or subject in the Study, whether or not such has been determined to be attributable to the test product. NYU's Institutional Review Board must also be notified of such reactions. All adverse reactions shall be reported on the appropriate case report forms.

The study shall be performed during the period of October 10, 2003 to September 31, 2007 ("Performance Period"). If at anytime the Principal Investigator has reason to believe work will not be completed within the Performance Period, the Principal Investigator will advise Sponsor of the reason(s) and the length of time required to complete the study.

Sponsor shall make available sufficient quantities of test product to carryout the Study. The Principal Investigator shall take responsible steps to handle, store, and use such materials in accordance with Appendix A. All such unused materials will be returned to the Sponsor at the conclusion of the work, unless written authorization to destroy them is given by the Sponsor.

i.	Payment of $5,000 due upon execution of contract.
ii.	Payments of $5,000 per month for the period of October through December of 2003 due upon the first of each month (total $15,000).
iii.	Payments of $7,500 per month for the period of January through December of 2004 due upon the first of each month (total $90,000).
iv.	Payments of $7,500 per month for the period of January through December of 2005 due upon the first of each month (total $90,000).
v.	Payment of $20,000 due upon December 1, 2006.
vi.	Payment of $37,139 will be paid when the investigator has signed the final report.
vii.	Invoicable Items are due upon receipt of invoice.

The total payments which SPONSOR will be obligated to make or cause to be made to NYUCD to complete Study with the number of subjects specified in the Protocol for Study shall be set forth in the Budget which shall be attached to this Agreement and which shall be deemed incorporated herein and subject to all terms and conditions of this Agreement (the "Budget"). In no event shall payments hereunder exceed the amount set forth in the Budget, without the prior written consent of SPONSOR. If fewer than the anticipated number of subjects complete a Study, then the aforementioned payments will be reasonably prorated.