MAY BE NECESSARY TO COMPLY WITH THE REQUESTING PARTY'S
OBLIGATIONS UNDER APPLICABLE LAW OR WITH A REQUEST MADE BY ANY GOVERNMENTAL
AUTHORITY, IN EITHER CASE WITH RESPECT TO ANY CALENDAR YEAR ENDING NOT MORE THAN
SEVEN (7) YEARS PRIOR TO SUCH PARTY'S REQUEST.
RESULTS OF ANY SUCH EXAMINATION
SHALL BE (I) MADE AVAILABLE TO BOTH PARTIES, (II) LIMITED TO INFORMATION
RELATING TO THE LICENSED PRODUCTS AND (III) SUBJECT TO ARTICLE 12. THE PARTY
REQUESTING THE AUDIT SHALL BEAR THE FULL COST OF THE PERFORMANCE OF ANY SUCH
AUDIT, UNLESS SUCH AUDIT DISCLOSES A VARIANCE OF MORE THAN [*] FROM THE AMOUNT
OF THE ORIGINAL REPORT, ROYALTY OR PAYMENT CALCULATION.
IN SUCH CASE, THE PARTY
BEING AUDITED SHALL BEAR THE FULL COST OF THE PERFORMANCE OF SUCH AUDIT.
11.2.
PUBLICATIONS. NEITHER PARTY SHALL PUBLISH OR PRESENT THE RESULTS OF
STUDIES CARRIED OUT UNDER THIS AGREEMENT WITHOUT THE OPPORTUNITY FOR PRIOR
REVIEW BY THE OTHER PARTY IN ACCORDANCE WITH THE PROVISIONS SET FORTH IN THIS
SECTION 11.2.
SUBJECT TO SECTION 12.2, EACH PARTY AGREES TO PROVIDE THE OTHER
PARTY THE OPPORTUNITY TO REVIEW ANY PROPOSED ABSTRACTS, MANUSCRIPTS OR
PRESENTATIONS (INCLUDING VERBAL PRESENTATIONS) WHICH RELATE TO ANY LICENSED
PRODUCT AT LEAST SIXTY (60) DAYS PRIOR TO THEIR INTENDED SUBMISSION FOR
PUBLICATION AND AGREES, UPON REQUEST, NOT TO SUBMIT ANY SUCH ABSTRACT OR
MANUSCRIPT FOR PUBLICATION, OR TO MAKE SUCH PRESENTATION, UNTIL THE OTHER PARTY
IS GIVEN A REASONABLE PERIOD OF TIME TO SECURE PATENT PROTECTION FOR ANY
MATERIAL IN SUCH PUBLICATION OR PRESENTATION THAT IS OWNED BY THE REQUESTING
PARTY (EITHER INDIVIDUALLY OR JOINTLY WITH THE NON-REQUESTING PARTY) AND WHICH
THE REQUESTING PARTY BELIEVES TO BE PATENTABLE.
IN THE EVENT THAT THE NATURE OF
THE CONTENT OF ANY PROPOSED PUBLICATION OR PRESENTATION IS SUCH THAT A PARTY IS
ENTITLED TO REQUEST THAT SUBMISSION OF SUCH PUBLICATION OR DELIVERY OF SUCH
PRESENTATION BE DELAYED PURSUANT TO THE FOREGOING PROVISIONS OF THIS SECTION
11.2, THEN BOTH PARTIES UNDERSTAND THAT A REASONABLE COMMERCIAL STRATEGY MAY
REQUIRE DELAY OF PUBLICATION OR PRESENTATION OF
* CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE
COMMISSION
68
INFORMATION OR FILING OF PATENT APPLICATIONS.
THE PARTIES AGREE TO REVIEW AND
CONSIDER DELAY OF PUBLICATION OR PRESENTATION AND FILING OF PATENT APPLICATIONS
UNDER CERTAIN CIRCUMSTANCES. NEITHER PARTY SHALL HAVE THE RIGHT TO PUBLISH OR
PRESENT CONFIDENTIAL INFORMATION OF THE OTHER PARTY, AND EACH PARTY SHALL REMOVE
THE CONFIDENTIAL INFORMATION OF THE OTHER PARTY FROM ANY PROPOSED PUBLICATION OR
PRESENTATION UPON REQUEST BY SUCH OTHER PARTY.
NOTHING CONTAINED IN THIS
SECTION 11.2 SHALL PROHIBIT THE INCLUSION OF INFORMATION NECESSARY TO FILE A
PATENT APPLICATION WITH A GOVERNMENT AUTHORITY, EXCEPT FOR CONFIDENTIAL
INFORMATION OF THE NON-FILING PARTY, PROVIDED THE NON-FILING PARTY IS GIVEN A
REASONABLE OPPORTUNITY TO REVIEW THE INFORMATION TO BE INCLUDED PRIOR TO
SUBMISSION OF SUCH PATENT APPLICATION.
NOTWITHSTANDING THE FOREGOING, THE
PARTIES RECOGNIZE THAT INDEPENDENT INVESTIGATORS HAVE BEEN ENGAGED, AND WILL BE
ENGAGED IN THE FUTURE, TO CONDUCT CLINICAL TRIALS OF LICENSED PRODUCTS.
INDEPENDENT INVESTIGATORS THAT