7.
REGULATORY FILINGS.
PDxwill support VTAL's FDA regulatory filings
necessary for distribution approval/release in the United States and clinical
validation work for the CT Endoscopy Application and the VC Appliance for a
period of one (1) year following the date of this Agreement (provided that PDx
will use commercially reasonably efforts to provide additional support following
such one (1) year period in the event such approval/release is not obtained in
such one (1) year period), by providing the data set forth below.
A.
PDX WILL PROVIDE ALL RELEVANT CLINICAL DATA FROM 100 VIRTUAL
COLONOSCOPY DIAGNOSTIC OR COMPARATIVE STUDIES ("THE DATA"), INCLUDING THE
INFORMED CONSENT DOCUMENTS FOR EACH STUDY TO SUPPORT AN FDA SUBMISSION FOR THE
COLON-RELATED CT ENDOSCOPY APPLICATION AND THE VC APPLIANCE, AND TO VALIDATE THE
ENDOSCOPY PROTOCOL AND VC APPLIANCE.
THE DATA WILL BE DELIVERED ON CDS
CONTAINING CT IMAGES, EXCEPT FOR THE INFORMED CONSENT DOCUMENTS AND MEDICAL
REPORTS, WHICH WILL BE DELIVERED ON PAPER.
B.
PDX WILL SEND 5 REPRESENTATIVE SETS OF CLINICAL DATA TO VTAL FOR
THE PURPOSE OF ALLOWING VTAL TO EVALUATE THE EFFICACY OF USING PDX'S DATA FOR AN
FDA SUBMISSION BY VTAL.
PDX WILL ALSO FURNISH COPIES OF THE NATIONAL SCIENCE
FOUNDATION (NSF) AND WAKE FOREST AGREEMENTS, OR OTHER REASONABLY EVIDENCE OF THE
GRANTING OF RIGHTS TO THE DATA TO PDX.
IF VTAL DETERMINES THAT THE PDX CLINICAL
DATA WILL BE SATISFACTORY IN SUPPORTING VTAL'S FDA SUBMISSION, PDX WILL PROVIDE
AN ADDITIONAL 95 COMPARABLY REPRESENTATIVE DATA SETS TO VTAL FOR USE IN VTAL'S
FDA SUBMISSION.
VTAL RESERVES THE RIGHT TO DECLINE THE PURCHASE AND USE OF THE
DATA, IF VTAL DEEMS IT INADEQUATE FOR FDA SUBMISSION.
IF VTAL DECLINES TO
PURCHASE AND USE THE DATA, PDX HAS NO OBLIGATION TO SUPPORT OR ASSIST WITH
VTAL'S FDA SUBMISSION FURTHER, AND VTAL AGREES TO PROMPTLY RETURN ALL DATA AND
DOCUMENTS RELATED TO THE FIVE TEST CASES.
C.
VTAL WILL PAY PDX $________ FOR THE DATA, WITH $______ DUE WITHIN
TEN (10) DAYS AFTER THE DATA HAVE BEEN DELIVERED TO VTAL, AND THE $______
BALANCE PAYABLE TO PDX UPON FDA CLEARANCE OF THE CT ENDOSCOPY APPLICATION OR VC
APPLIANCE, WHICHEVER IS ISSUED FIRST.
VTAL WILL NOT HAVE ANY RIGHTS TO SELL,
USE, OR DISTRIBUTE THE DATA OUTSIDE THAT USE NECESSARY TO SUPPORT THE FDA
REGULATORY FILINGS.
8.
MUTUAL REPRESENTATION AND WARRANTIES.
A.
PDX AND VTAL HEREBY EACH REPRESENT AND WARRANT TO THE OTHER AS
FOLLOWS.
1.
THAT IT IS A LEGAL ENTITY DULY ORGANIZED AND VALIDLY
EXISTING UNDER THE LAWS OF THE JURISDICTION OF ITS ORGANIZATION, HAS ALL
REQUISITE POWER AND AUTHORITY TO CARRY ON ITS BUSINESS, AND IS AUTHORIZED TO
ENTER INTO THIS AGREEMENT AND GRANT THE RIGHTS OR ACCEPT THE OBLIGATIONS HEREIN,
WHICH REPRESENTATION AND WARRANTY EXTENDS IN THE CASE OF PDX, A REPRESENTATION
AND WARRANTY THAT IT HAS THE LEGAL RIGHT AND POWER, WITHOUT ANY AUTHORIZATION
FROM ANY THIRD PARTY NOT ALREADY POSSESSED BY IT, TO GRANT THE LICENSES AND
RIGHTS TO SUBLICENSE SET FORTH IN SECTION 3 HEREOF AND HAS NOT MADE