EACH SUCH PAYMENT, AND A COPY OF SUCH REPORT SHALL ALSO BE MAILED TO
PHS AT ITS ADDRESS FOR NOTICES INDICATED ON THE SIGNATURE PAGE OF THIS
AGREEMENT.
9.07
LICENSEE SHALL BE SOLELY RESPONSIBLE FOR DETERMINING IF ANY TAX ON
ROYALTY INCOME IS OWED OUTSIDE THE UNITED STATES AND SHALL PAY ANY SUCH TAX AND
BE RESPONSIBLE FOR ALL FILINGS WITH APPROPRIATE AGENCIES OF FOREIGN GOVERNMENTS.
THE TAXES PAID BY LICENSEE ON BEHALF OF PHS MAYBE DEDUCTED FROM THE EARNED
ROYALTY DUE UNDER PARAGRAPH 6.03.
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9.08
INTEREST AND PENALTIES MAY BE ASSESSED BY PHS ON ANY OVERDUE
PAYMENTS IN ACCORDANCE WITH THE FEDERAL DEBT COLLECTION ACT. THE PAYMENT OF SUCH
LATE CHARGES SHALL NOT PREVENT PHS FROM EXERCISING ANY OTHER RIGHTS IT MAY HAVE
AS A CONSEQUENCE OF THE LATENESS OF ANY PAYMENT.
9.09
ALL PLANS AND REPORTS REQUIRED BY THIS ARTICLE 9 AND MARKED
"CONFIDENTIAL" BY LICENSEE SHALL, TO THE EXTENT PERMITTED BY LAW, BE TREATED BY
PHS AS COMMERCIAL AND FINANCIAL INFORMATION OBTAINED FRONT A PERSON AND AS
PRIVILEGED AND CONFIDENTIAL, AND ANY PROPOSED DISCLOSURE OF SUCH RECORDS BY THE
PHS UNDER THE FREEDOM OF INFORMATION ACT (FOIA), 5 U.S.C: §552 SHALL BE SUBJECT
TO THE PREDISCLOSURE NOTIFICATION REQUIREMENTS OF 45 CFR PART 5.65(D).
10.
PERFORMANCE
10.01
LICENSEE SHALL USE ITS REASONABLE COMMERCIAL EFFORTS TO BRING THE
LICENSED PRODUCT(S) AND LICENSED PROCESS(ES) TO PRACTICAL APPLICATION.
"REASONABLE COMMERCIAL EFFORTS" FOR THE PURPOSES OF THIS PROVISION SHALL INCLUDE
ADHERENCE TO THE COMMERCIAL DEVELOPMENT PLAN AT APPENDIX F AND PERFORMANCE OF
THE BENCHMARKS AT APPENDIX E. THE EFFORTS OF A SUBLICENSEE SHALL BE CONSIDERED
THE EFFORTS OF LICENSEE.
10.02
UPON THE FIRST COMMERCIAL SALE, UNTIL THE EXPIRATION OF THIS
AGREEMENT, LICENSEE SHALL USE ITS REASONABLE COMMERCIAL EFFORTS TO MAKE LICENSED
PRODUCT(S) AND LICENSED PROCESS(ES) REASONABLY ACCESSIBLE TO THE UNITED STATES
PUBLIC.
10.03
LICENSEE AGREES, AFTER ITS FIRST COMMERCIAL SALE, TO MAKE REASONABLE
QUANTITIES OF LICENSED PRODUCT(S) OR MATERIALS PRODUCED THROUGH THE USE OF
LICENSED PROCESS(ES) AVAILABLE ON A COMPASSIONATE USE BASIS TO PATIENTS, EITHER
THROUGH THE PATIENT'S PHYSICIAN(S) AND/OR THE MEDICAL CENTER TREATING THE
PATIENT.
10.04
LICENSEE FURTHER AGREES, AFTER ITS FIRST COMMERCIAL SALE AND AS PART
OF ITS MARKETING ARID PRODUCT PROMOTION, TO DEVELOP WRITTEN EDUCATIONAL
MATERIALS (E.G., BROCHURES, ADVERTISEMENTS, ETC.) DIRECTED TO PATIENTS AND
PHYSICIANS DETAILING THE LICENSED PRODUCT(S) AND ITS USE TO TREAT CANCER.
10.05
PHS ACKNOWLEDGES THAT INFORMATION AND MATERIALS RELATED TO THE
LICENSED PATENT RIGHTS MAY BE OF ASSISTANCE TO LICENSEE IN ITS COMMERCIALIZATION
EFFORTS. ACCORDINGLY, PHS, AT ITS DISCRETION, WILL CONSIDER REASONABLE REQUESTS
BY LICENSEE FOR ACCESS TO THE INVENTORS OF THE LICENSED PATENT RIGHTS WITH
REGARD TO THIS INFORMATION AND MATERIALS. MORE SPECIFICALLY, PHS AGREES TO
PROVIDE LICENSEE WITH INFORMATION AND MATERIALS, IF AVAILABLE, RELATED TO THE
CDNA, MRNA, SEQUENCE DATA. ETC., THAT MIGHT BE NECESSARY FOR THE DEVELOPMENT AND
COMMERCIALIZATION OF THE LICENSED PRODUCT(S) AND/OR THE LICENSED PROCESS(ES) IN
THE LICENSED FIELDS OF USE.
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11.
INFRINGEMENT AND PATENT ENFORCEMENT
11.01
PHS AND LICENSEE AGREE TO NOTIFY EACH OTHER PROMPTLY