ACCORDANCE WITH 42 C.F.R. 1001.952(H);
AND (II) UT SHALL, IF REQUIRED AND AS APPROPRIATE, PROPERLY REPORT ALL DISCOUNTS
PAID HEREUNDER TO THE APPROPRIATE GOVERNMENTAL ENTITIES FOR PURPOSES OF
DETERMINING "BEST PRICE" UNDER THE MEDICAID REBATE PROGRAM AND FOR PURPOSES OF
DETERMINING AMP OR ASP UNDER MEDICARE, IF APPLICABLE. DURING THE TERM OF THIS
AGREEMENT, EACH PARTY SHALL TAKE ALL ACTIONS NECESSARY AND APPROPRIATE TO ENSURE
THAT IT COMPLIES WITH ALL APPLICABLE LAWS, INCLUDING, WITHOUT LIMITATION, THE
ANTI-KICKBACK STATUTE, THE STARK LAW AND HIPAA AS SET FORTH ABOVE; AND ANY LAWS
AND REGULATIONS RELATING TO THE TERMS OF THIS ARRANGEMENT AS REQUIRED. IN
ADDITION, ACCREDO IS SUBJECT TO MEDCO HEALTH SOLUTION'S CODE OF CONDUCT AND ITS
POLICIES AND PROCEDURES RELATING TO COMPLIANCE WITH THE ABOVE-NAMED LAWS. THESE
POLICES AND PROCEDURES, ALONG WITH THE CODE OF CONDUCT, ARE AVAILABLE ON MEDCO'S
INTERNET SITE ().
18.15
HIPAA COMPLIANCE.
DISTRIBUTOR SHALL ONLY PROVIDE
INFORMATION TO UT IN A MANNER CONSISTENT WITH THE HEALTH INSURANCE PORTABILITY
AND ACCOUNTABILITY ACT OF 1996, AS AMENDED, 42 U.S.C. § 1320D, ET SEQ., AND THE
IMPLEMENTING REGULATIONS PROMULGATED THEREUNDER (COLLECTIVELY REFERRED TO HEREIN
AS "HIPAA"). ACCORDINGLY, THE PARTIES AGREE
THAT DISTRIBUTOR SHALL ONLY PROVIDE UT WITH INFORMATION THAT IS DE-IDENTIFIED IN
ACCORDANCE WITH HIPAA'S DE-IDENTIFICATION PROVISION, 45 C.F.R. § 164.514(B)(2),
UNLESS DISTRIBUTOR: (I) HAS ON FILE A VALID, HIPAA-COMPLIANT AUTHORIZATION FOR
EACH PATIENT WHOSE PROTECTED HEALTH INFORMATION ("PHI") IS SOUGHT TO BE
DISCLOSED; OR (II) AUTHORIZATION IS NOT REQUIRED UNDER APPLICABLE LAWS IN ORDER
TO DISCLOSE THE PHI.
18.16
NOTHING HEREIN SHALL BE CONSTRUED TO LIMIT DISTRIBUTOR
FROM ENTERING INTO OTHER AGREEMENTS WITH OTHER MANUFACTURERS OR WHOLESALERS THAT
ALLOW DISTRIBUTOR TO DISPENSE PRODUCTS THAT COMPETE WITH UT'S PRODUCTS.
NOTWITHSTANDING THE PRECEDING SENTENCE, DISTRIBUTOR WARRANTS AND REPRESENTS THAT
IT WILL NOT DISPARAGE UT OR UT PRODUCT
18.17
EACH PARTY SHALL PROMPTLY NOTIFY THE OTHER PARTY UPON
LEARNING OF ANY ACTIVITY THAT APPEARS TO IMPROPERLY OR INAPPROPRIATELY PORTRAY
OR AFFECT THE OTHER PARTY, ITS PRODUCTS OR AFFILIATES.
18.18
THE PARTIES DO NOT INTEND FOR THIS AGREEMENT TO
BENEFIT ANY THIRD PARTY AND, THEREFORE, THERE ARE NO THIRD PARTY BENEFICIARIES
TO THIS AGREEMENT.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives as of the Effective Date.
UNITED THERAPEUTICS
ACCREDO HEALTH GROUP
CORPORATION
By
/s/ Jay A. Watson
By
/s/ Michael R. Hess
Jay A, Watson, Pharm.D.
Michael R. Hess
Vice President, Strategic Operations
Chief Counsel, Accredo
and Logistics
Attachment
A
Prices
UT PRODUCT
UT Product Name
NDC
Strength
Price
Tyvaso Starter Kit
66302-206-01
0.6 mg/ml
TBA
Tyvaso Re-Supply Kit
66302-206-02
0.6 mg/ml
TBA
Tyvaso Supplemental Refill (4ct)
66302-206-03
0.6 mg/ml
TBA
NDC 66302-206-01 Tyvaso Starter Kit includes:
·
28 ampoules of Tyvaso
·
2 Sets of Autoclavable Parts
·
2 Tyvaso Inhalation Devices
·
2 AC Power Adapters
·
1 Rechargeable Battery Pack
·
1 Car Power Cord
·
1 Leather Carrying Case
·
32 Medicine Cups
·
64 Filter Membranes
·
1 Nose Clip
·
1 Measuring Cup
·
1