GRANT SUBLICENSES,
UNDER THE LICENSED PATENT RIGHTS AND LICENSED TECHNOLOGY TO MAKE, DISTRIBUTE,
USE AND SELL LICENSED PRODUCTS WITHIN THE FIELD AND IN THE TERRITORY.
2.2
RETAINED RIGHTS OF ILI.
SUBJECT TO THE
TERMS AND CONDITIONS OF THIS AGREEMENT, ILI HEREBY RETAINS THE RIGHT (A) TO USE
THE LICENSED TECHNOLOGY AND PRACTICE THE LICENSED PATENT RIGHTS FOR ANY AND ALL
USES, INCLUDING (I) TO PERFORM ITS OBLIGATIONS UNDER THIS AGREEMENT; (II) TO
DEVELOP, HAVE DEVELOPED, MAKE, HAVE MADE, USE, HAVE USED, SELL, HAVE SOLD, OFFER
FOR SALE, IMPORT, HAVE IMPORTED, EXPORT AND HAVE EXPORTED LICENSED PRODUCTS,
BOTH WITHIN AND OUTSIDE OF THE FIELD; AND (B) TO GRANT ADDITIONAL LICENSES TO
ANY THIRD PARTY TO DO ANY OR ALL OF THE FOREGOING.
2.3
LICENSE TO ILI.
SUBJECT TO THE TERMS AND
CONDITIONS OF THIS AGREEMENT, ORAL DNA HEREBY GRANTS TO ILI A NON-EXCLUSIVE,
WORLDWIDE, FULLY-PAID, IRREVOCABLE, ROYALTY-FREE LICENSE UNDER ORAL DNA'S
INTEREST IN ANY IMPROVEMENTS CONTROLLED BY ORAL DNA (A) TO DEVELOP, MAKE, HAVE
MADE, USE, SELL, HAVE SOLD, OFFER FOR SALE, IMPORT, HAVE IMPORTED, EXPORT AND
HAVE EXPORTED LICENSED PRODUCTS; AND (B) TO OTHERWISE EXPLOIT SUCH IMPROVEMENTS
FOR ALL USES WITHIN THE FIELD AND TERRITORY.
IN CONNECTION THEREWITH, ORAL DNA
SHALL PROMPTLY NOTIFY ILI OF THE CONCEPTION OR REDUCTION TO PRACTICE OF ANY SUCH
IMPROVEMENT.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
6
3.
COMMERCIALIZATION OF LICENSED PRODUCTS
3.1
COMMERCIALIZATION.
3.1.1
RESPONSIBILITY.
FROM AND AFTER THE EFFECTIVE DATE,
ORAL DNA SHALL HAVE AUTHORITY OVER THE MARKETING AND COMMERCIALIZATION OF
LICENSED PRODUCTS IN THE FIELD IN THE TERRITORY, INCLUDING, WITHOUT LIMITATION
(A) THE CONDUCT OF THE INITIAL MARKETING ACTIVITIES; (B) ALL ACTIVITIES RELATING
TO MANUFACTURE AND SUPPLY OF LICENSED PRODUCTS (INCLUDING ANY REQUIRED PROCESS
DEVELOPMENT AND SCALE UP WORK WITH RESPECT THERETO); (C) ALL MARKETING,
PROMOTION, SALES, MARKETING, DISTRIBUTION, CUSTOMER SERVICE, IMPORT AND EXPORT
ACTIVITIES RELATING TO LICENSED PRODUCTS; (D) THE MAKING AND/OR OBTAINING OF
REQUIRED REGULATORY APPROVALS RELATING TO ANY OF THE FOREGOING; AND (E) THE
PROCESSING OF DNA SAMPLES SUPPLIED BY PATIENTS FOR THE PST® GENETIC RISK
ASSESSMENT TEST INCLUDED IN THE LICENSED PRODUCT.
ORAL DNA SHALL (A) PERFORM
ALL SUCH ACTIVITIES (I) AT ITS SOLE COST AND EXPENSE AND (II) IN COMPLIANCE WITH
ALL APPLICABLE LAWS, INCLUDING WITHOUT LIMITATION HIPAA, ALL APPLICABLE CLIA
REGULATIONS AND ALL REGULATIONS OF ANY STATE AGENCIES WITHIN ANY STATE IN WHICH
ORAL DNA IS MARKETING PST® GENETIC RISK ASSESSMENT TESTS THAT APPLY TO THE
CONDUCT OF GENETIC TESTING AND (B) OBTAIN ALL REGULATORY APPROVALS REQUIRED FROM
ANY APPLICABLE REGULATORY AUTHORITY IN CONNECTION WITH ITS PERFORMANCE OF SUCH
ACTIVITIES.
ORAL DNA FURTHER AGREES THAT ALL TESTING OF LICENSED PRODUCTS UNDER
THIS AGREEMENT SHALL BE PERFORMED IN A CLIA-CERTIFIED LABORATORY IN ACCORDANCE
WITH CLIA-GUIDELINES.
3.1.2
LABORATORY INSPECTION.
(A)
ACCESS.
ORAL DNA SHALL PROVIDE ILI WITH
ACCESS TO ITS TESTING FACILITY, OR ANY TESTING FACILITY