Exhibit 10.47

 

DISTRIBUTION AGREEMENT

 

THIS DISTRIBUTION AGREEMENT (“Agreement”) is made as of August 17, 2009 (the
“Effective Date”), by and between United Therapeutics Corporation (“UT”), a
Delaware corporation, with offices at 1110 Spring Street, Silver Spring,
Maryland and Accredo Health Group, Inc (“DISTRIBUTOR”), a Delaware corporation,
with offices at 1640 Century Center Parkway, Memphis, Tennessee 38134.

 

Recitals

 

A.                                   WHEREAS, DISTRIBUTOR has represented that
it possesses the necessary expertise, financial resources and marketing
organization to dispense and distribute UT Product (as hereinafter defined) and
desires to acquire from UT the right to sell, market, distribute and maintain UT
Product in the Territory (as hereinafter defined);

 

B.                                     WHEREAS, UT is willing to appoint
DISTRIBUTOR and DISTRIBUTOR is willing to accept appointment, as a distributor
of UT Product in the Territory on the terms and conditions contained herein; and

 

C.                                     WHEREAS, the Parties hereto believe that
the business relationship regarding UT Product and related support will be
mutually advantageous.

 

NOW, THEREFORE, in consideration of the mutual promises and covenants
hereinafter set forth, the Parties agree as follows:

 

ARTICLE 1:  INTRODUCTORY PROVISIONS

 

1.1                                 DEFINED TERMS.   THE FOLLOWING TERMS, WHEN
USED IN CAPITALIZED FORM IN THIS AGREEMENT, SHALL HAVE THE MEANINGS SET FORTH
BELOW:

 

(A)                                  “AGREEMENT” SHALL MEAN THIS DISTRIBUTION
AGREEMENT ENTERED INTO BY AND BETWEEN UT AND DISTRIBUTOR AS OF THE EFFECTIVE
DATE.

 

(B)                                 “ADVERSE EVENT” SHALL MEAN ANY “ADVERSE DRUG
EXPERIENCE” AS DEFINED IN 21 CFR 310.305, 21 CFR 314.80 AND/OR 21 CFR 600.80 (AS
APPLICABLE) OR ANY REPLACEMENTS THERETO.

 

(C)                                  “AFFILIATE” WHEN USED WITH REFERENCE TO
EITHER PARTY SHALL MEAN ANY CORPORATION CONTROLLING, CONTROLLED BY OR UNDER
COMMON CONTROL WITH THE SAID PARTY AND ANY OFFICER, DIRECTOR OR EMPLOYEE OF SUCH
CORPORATION, AS THE CASE MAY BE.  FOR PURPOSES HEREOF, “CONTROL” SHALL MEAN
OWNERSHIP, DIRECTLY OR INDIRECTLY, OF MORE THAN FIFTY PERCENT (50%) OF THE
SECURITIES HAVING THE RIGHT TO VOTE FOR THE ELECTION OF DIRECTORS, IN THE CASE
OF A CORPORATION, AND MORE THAN FIFTY PERCENT (50%) OF THE BENEFICIAL INTEREST
IN THE CAPITAL, IN THE CASE OF A BUSINESS ENTITY OTHER THAN A CORPORATION.

 

(D)                                 “APPLICABLE LAWS” SHALL MEAN ALL LAWS,
STATUTES, ORDINANCES, CODES, RULES, AND REGULATIONS THAT HAVE BEEN ENACTED BY A
GOVERNMENT AUTHORITY AND WHICH ARE IN FORCE AS OF THE EFFECTIVE DATE OR COME
INTO FORCE DURING THE TERM OF THIS AGREEMENT, IN EACH CASE TO THE EXTENT THAT
THE SAME ARE APPLICABLE TO THE PERFORMANCE BY THE PARTIES OF THEIR RESPECTIVE
OBLIGATIONS UNDER THIS AGREEMENT, INCLUDING, WITH RESPECT TO THE UNITED STATES,
THE PRESCRIPTION DRUG MARKETING ACT, THE FEDERAL FOOD, DRUG AND COSMETICS ACT OF
1938, AS AMENDED, THE HEALTH

 

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                                                INSURANCE PORTABILITY AND
ACCOUNTABILITY ACT, THE FEDERAL ANTI-KICKBACK STATUTE, AND ANY APPLICABLE FDA
REGULATIONS.

 

(E)                                  “CLEAN PRESCRIPTION” SHALL MEAN A REFERRAL
FOR WHICH BENEFITS HAVE BEEN VERIFIED AND THAT INCLUDES A VALID PRESCRIPTION
THAT DOES NOT: (I) REQUIRE PHYSICIAN, PATIENT, OR ANY THIRD PARTY INTERVENTION
OR INFORMATION; (II) INVOLVE BACKORDER, SHORT SUPPLY, ALLOCATION, OR RECALL; OR
(III) INVOLVE A REFERRAL THAT IS SUBSEQUENTLY CANCELED OR REQUESTED TO BE HELD
FOR FUTURE PROCESSING.

 

(F)                                    “COMMERCIALLY REASONABLE EFFORTS” SHALL
MEAN WITH RESPECT TO EACH PARTY, COMMERCIALLY REASONABLE EFFORTS IN ACCORDANCE
WITH THE BUSINESS, LEGAL, MEDICAL AND SCIENTIFIC JUDGMENT OF A SIMILARLY
SITUATED COMPANY, AND IN ACCORDANCE WITH THE EFFORTS AND RESOURCES A SIMILARLY
SITUATED COMPANY WOULD USE TAKING INTO ACCOUNT REASONABLE COMMERCIAL JUDGMENT
AND OTHER RELEVANT FACTORS.

 

(G)                                 “CONFIDENTIAL INFORMATION” SHALL MEAN ALL
INFORMATION DISCLOSED BY ONE PARTY (“DISCLOSING PARTY”) TO THE OTHER PARTY
(“RECEIVING PARTY”), REGARDLESS OF THE FORM IN WHICH IT IS DISCLOSED, INCLUDING
INFORMATION RELATING TO THE DISCLOSING PARTY’S MARKETS, PRODUCT SPECIFIC PAYER
POLICIES, DATABASES, CUSTOMERS, PRODUCTS, PATENTS, INVENTIONS, PROCEDURES,
METHODS, DESIGNS, STRATEGIES, PLANS, ASSETS, LIABILITIES, PRICES, COSTS,
REVENUES, PROFITS, ORGANIZATION, EMPLOYEES, AGENTS, RESELLERS OR BUSINESS IN
GENERAL, AND WITH RESPECT TO UT AS DISCLOSING PARTY, INFORMATION EMBODIED IN UT
PRODUCT.  THE FOLLOWING SHALL NOT BE CONSIDERED CONFIDENTIAL INFORMATION:

 

(I.)                                  INFORMATION WHICH IS OR BECOMES IN THE
PUBLIC DOMAIN THROUGH NO FAULT OR ACT OF THE RECEIVING PARTY;

 

(II.)                               INFORMATION WHICH WAS INDEPENDENTLY
DEVELOPED BY THE RECEIVING PARTY WITHOUT THE USE OF OR RELIANCE ON CONFIDENTIAL
INFORMATION;

 

(III.)                            INFORMATION WHICH WAS PROVIDED TO THE
RECEIVING PARTY BY A THIRD PARTY UNDER NO DUTY OF CONFIDENTIALITY TO THE
DISCLOSING PARTY; OR

 

(IV.)                           INFORMATION THAT IS REQUIRED TO BE DISCLOSED BY
APPLICABLE LAWS, PROVIDED, HOWEVER, PROMPT PRIOR NOTICE THEREOF SHALL BE GIVEN
TO THE DISCLOSING PARTY.

 

(H)                                 “CUSTOMER” SHALL MEAN ANY HOSPITAL,
PHYSICIAN, HEALTH CARE COMPANY, INCLUDED PATIENT, DISTRIBUTOR OR OTHER PERSON OR
ENTITY THAT IS LEGALLY ENTITLED TO PURCHASE THE UT PRODUCT FOR USE IN THE
TERRITORY.

 

(I)                                     “DESIGNATED SHIPMENT LOCATION” SHALL
MEAN THE DESIGNATED STORAGE LOCATION(S) TO WHICH UT HAS AGREED TO SHIP UNITS OF
UT PRODUCT AS SET FORTH IN ATTACHMENT E ATTACHED HERETO.

 

(J)                                     “DESIGNATED STORAGE LOCATION” SHALL MEAN
THE LOCATIONS OF DISTRIBUTOR’S FACILITIES OR PHARMACIES OWNED BY DISTRIBUTOR OR
ITS AFFILIATE(S) FOR THE STORAGE OF THE UNITS OF UT PRODUCT SHIPPED TO
DISTRIBUTOR’S DESIGNATED STORAGE LOCATIONS AS SET FORTH IN ATTACHMENT E ATTACHED
HERETO.

 

(K)                                  “DISTRIBUTOR” SHALL MEAN ACCREDO HEALTH
GROUP, INC. AND ITS WHOLLY OWNED SUBSIDIARIES.

 

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(L)                                     “EFFECTIVE DATE” SHALL MEAN THE DATE
FIRST ABOVE WRITTEN.

 

(M)                               “FORCE MAJEURE” SHALL MEAN ANY EVENT, NOT
EXISTING AS OF THE EFFECTIVE DATE AND NOT REASONABLY WITHIN THE CONTROL OF THE
PARTIES AS OF SUCH DATE, WHICH, IN WHOLE OR IN MATERIAL PART, PREVENTS OR MAKES
COMMERCIALLY UNREASONABLE ONE PARTY’S PERFORMANCE OF ITS OBLIGATIONS UNDER THIS
AGREEMENT.  FORCE MAJEURE SHALL INCLUDE, WITHOUT LIMITATION:  FIRE, STORM,
EARTHQUAKE, FLOOD, ACTS OF STATE, WAR OR CIVIL UNREST, LABOR DISPUTE, INABILITY
TO OBTAIN LABOR OR MATERIALS, AND PROLONGED SHORTAGE OF ENERGY OR ANY OTHER
SUPPLIES.

 

(N)                                 “GOOD DISTRIBUTION PRACTICE” SHALL MEAN THAT
PRACTICE OF PURCHASING, STORING AND SHIPPING A REGULATED PHARMACEUTICAL PRODUCT
AND BILLING TO AND COLLECTING FROM CUSTOMERS FOR A REGULATED PHARMACEUTICAL
PRODUCT IN ACCORDANCE WITH LEGAL REQUIREMENTS AND THE STANDARDS AND CUSTOMARY
INDUSTRY COMMERCIAL PRACTICES.

 

(O)                                 “INCLUDED PATIENT” SHALL MEAN AN INDIVIDUAL
DIAGNOSED WITH PULMONARY ARTERIAL HYPERTENSION (“PAH”) WHO IS PRESCRIBED UT
PRODUCT.

 

(P)                                 “LEVEL 1 APPEAL” SHALL MEAN AN APPEAL OF A
REIMBURSEMENT CLAIM DENIAL BY A THIRD PARTY PAYER DUE TO AN INCOMPLETE OR
IMPROPERLY SUBMITTED REIMBURSEMENT CLAIM OR OTHER SIMILAR ADMINISTRATIVE
OVERSIGHT.

 

(Q)                                 “LEVEL 2 APPEAL” SHALL MEAN AN APPEAL OF A
REIMBURSEMENT CLAIM DENIAL BY A THIRD PARTY PAYER, WHETHER SUCH DENIAL IS FIRST
ASSERTED UPON VERIFICATION OF REIMBURSEMENT OR FOLLOWING SUBMISSION OF A
REIMBURSEMENT CLAIM, BECAUSE: (I) THE APPLICABLE POLICY COVERING THE INCLUDED
PATIENT DOES NOT INCLUDE UT PRODUCT AS A COVERED BENEFIT, OR (II) THE INCLUDED
PATIENT FALLS WITHIN A CLASS OF PERSONS WHO ARE ALL DENIED COVERAGE FOR UT
PRODUCT AS THE RESULT OF THE APPLICATION OF A GENERAL POLICY.

 

(R)                                    “PAP PATIENT” SHALL MEAN ANY INCLUDED
PATIENT WHO IS ENROLLED IN THE PATIENT ASSISTANCE PROGRAM AS ESTABLISHED BY UT
FROM TIME TO TIME AND OPERATED IN ACCORDANCE WITH ATTACHMENT C HERETO.  UT SHALL
PROVIDE DISTRIBUTOR WITH THE ELIGIBILITY CRITERIA FOR THIS PROGRAM.

 

(S)                                  “PRICE” SHALL MEAN THE WHOLESALE
ACQUISITION COST FOR UT PRODUCT AS SET FORTH ON ATTACHMENT A HERETO.

 

(T)                                    “UT TRADEMARKS” SHALL MEAN ANY OF THE UT
TRADEMARKS, LOGOTYPES AND TRADE NAMES LISTED ON ATTACHMENT B HERETO, AS SUCH
ATTACHMENT MAY BE MODIFIED FROM TIME TO TIME BY UT DURING THE TERM OF THIS
AGREEMENT.

 

(U)                                 “PARTIES” SHALL MEAN UT AND DISTRIBUTOR
COLLECTIVELY.

 

(V)                                 “PARTY” SHALL MEAN EITHER UT OR DISTRIBUTOR.

 

(W)                               “TERRITORY” SHALL MEAN THE UNITED STATES,
INCLUDING ITS TERRITORIES AND POSSESSIONS, THE FIFTY STATES AND THE DISTRICT OF
COLUMBIA ONLY, UNLESS OTHERWISE EXPRESSLY AGREED IN WRITING BY THE PARTIES.

 

(X)                                   “THIRD-PARTY PAYERS” SHALL MEAN MANAGED
CARE PROVIDERS, HEALTH MAINTENANCE ORGANIZATIONS, INSURANCE COMPANIES,
SELF-INSURANCE PROGRAMS OF EMPLOYERS, THIRD-

 

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                                                PARTY ADMINISTRATORS, THE UNITED
STATES MEDICARE AND MEDICAID PROGRAMS, AND OTHER SIMILAR ENTITIES.

 

(Y)                                 “TYVASO INHALATION SYSTEM” SHALL MEAN THE
OPTINEB® PORTABLE NEBULIZER SYSTEM AND ALL RELATED SUPPLIES AND ACCESSORIES.

 

(Z)                                   “UNIT OF UT PRODUCT” SHALL MEAN THE
COMBINATION OF UT PRODUCT, PACKAGE INSERT AND OTHER ITEMS AS MAY BE DETERMINED
AND SUPPLIED BY UT TO DISTRIBUTOR, IN EACH INSTANCE CONTAINED WITHIN A STANDARD
OUTER PACKAGE SUPPLIED BY UT AND LABELED IN ACCORDANCE WITH APPLICABLE LEGAL
REQUIREMENTS.

 

(AA)                            “UT PRODUCT” OR “PRODUCT” SHALL MEAN
TREPROSTINIL SODIUM FOR INHALATION ONLY, A PHARMACEUTICAL PRODUCT ADMINISTERED
BY THE TYVASO INHALATION SYSTEM FOR THE TREATMENT OF PAH TO BE MARKETED IN THE
TERRITORY UNDER THE BRAND NAME TYVASO®.

 

(BB)                          “WAC” SHALL MEAN THE THEN-CURRENT WHOLESALE
ACQUISITION COST OF UT PRODUCT AS DETERMINED BY UT.

 

1.2                                 OTHER RULES OF INTERPRETATION. UNLESS THE
CONTEXT OTHERWISE REQUIRES, (I) WORDS OF ANY GENDER INCLUDE EACH OTHER GENDER;
(II) WORDS USING THE SINGULAR OR PLURAL NUMBER ALSO INCLUDE THE PLURAL OR
SINGULAR NUMBER, RESPECTIVELY; (III) THE TERMS “HEREOF,” “HEREIN,” “HEREBY” AND
DERIVATIVE OR SIMILAR WORDS REFER TO THIS ENTIRE AGREEMENT; (IV) THE TERMS
“ARTICLE” OR “SECTION” REFER TO THE SPECIFIED ARTICLE OR SECTION OF THIS
AGREEMENT; (V) THE WORD “INCLUDING” SHALL MEAN “INCLUDING, WITHOUT LIMITATION;”
(VI) THE WORD “CONSENT” SHALL MEAN “CONSENT, NOT TO BE UNREASONABLY WITHHELD OR
DELAYED”; (VII) THE WORD “OR” SHALL BE DISJUNCTIVE BUT NOT EXCLUSIVE; (VIII) THE
WORDS “MADE AVAILABLE” SHALL MEAN THAT THE INFORMATION REFERRED TO HAS BEEN MADE
AVAILABLE IF REQUESTED BY THE PARTY TO WHOM SUCH INFORMATION IS TO BE MADE
AVAILABLE; AND (IX) ALL REFERENCES HEREIN TO “DAYS” SHALL MEAN CALENDAR DAYS.

 

ARTICLE 2:  MUTUAL REPRESENTATIONS AND WARRANTIES

 

2.1                                 AUTHORITY.  EACH PARTY REPRESENTS AND
WARRANTS THAT IT POSSESSES ALL CORPORATE POWER AND AUTHORITY NECESSARY TO ENTER
INTO THIS AGREEMENT AND TO PERFORM ITS OBLIGATIONS UNDER THIS AGREEMENT.  ALL
CORPORATE ACTS AND OTHER PROCEEDINGS REQUIRED TO BE TAKEN BY OR ON THE PART OF
EACH PARTY TO AUTHORIZE IT TO PERFORM ITS OBLIGATIONS UNDER THIS AGREEMENT HAVE
BEEN DULY AND PROPERLY TAKEN.  THIS AGREEMENT HAS BEEN DULY EXECUTED AND
DELIVERED BY EACH PARTY AND CONSTITUTES LEGAL, VALID AND BINDING OBLIGATIONS OF
EACH PARTY ENFORCEABLE IN ACCORDANCE WITH ITS TERMS, SUBJECT TO THE APPLICATION
OF GENERAL PRINCIPLES OF EQUITY.

 

2.2                                 NO CONFLICTS.  EACH PARTY REPRESENTS AND
WARRANTS THAT THE EXECUTION AND PERFORMANCE OF THIS AGREEMENT WILL NOT CONFLICT
WITH OR VIOLATE ANY OTHER AGREEMENT OR OBLIGATION BINDING ON IT.

 

2.3                                 APPROVALS.  EXCEPT AS EXPRESSLY PROVIDED
HEREIN, EACH PARTY REPRESENTS AND WARRANTS THAT NO APPROVAL, AUTHORIZATION,
CONSENT OR OTHER ORDER OR ACTION OF OR FILING WITH ANY COURT, ADMINISTRATIVE
AGENCY OR OTHER GOVERNMENTAL AUTHORITY IS REQUIRED FOR THE EXECUTION AND
DELIVERY BY SUCH PARTY OF THIS AGREEMENT OR ITS CONSUMMATION OF THE TRANSACTIONS
CONTEMPLATED BY THIS AGREEMENT.

 

2.4                                 DEBARMENT AND EXCLUSION CERTIFICATION
REQUIREMENTS.  EACH PARTY CERTIFIES THAT IT HAS NOT BEEN DEBARRED UNDER THE
PROVISIONS OF THE GENERIC DRUG ENFORCEMENT ACT OF 1992, 21 U.S.C. § 335(A) AND
(B), AND DOES NOT APPEAR ON THE “LIST OF EXCLUDED

 

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                                                INDIVIDUALS/ENTITIES” (“LEIE”)
MAINTAINED BY THE OFFICE OF THE INSPECTOR GENERAL OF THE U.S. DEPARTMENT OF
HEALTH & HUMAN SERVICES, AVAILABLE AT
HTTP://OIG.HHS.GOV/FRAUD/EXCLUSIONS/LISTOFEXCLUDED.HTML.  IN THE EVENT THAT,
DURING THE TERM OF THIS AGREEMENT, EITHER PARTY (I) BECOMES DEBARRED, (II) IS
PLACED ON THE LEIE, OR (III) RECEIVES NOTICE OF AN ACTION OR THREAT OF AN ACTION
WITH RESPECT TO ITS DEBARMENT OR PLACEMENT ON THE LEIE, SUCH PARTY SHALL NOTIFY
THE OTHER PARTY IMMEDIATELY.  EACH PARTY HEREBY CERTIFIES THAT IT HAS NOT AND
WILL NOT USE IN ANY CAPACITY THE SERVICES OF ANY INDIVIDUAL, CORPORATION,
PARTNERSHIP OR ASSOCIATION THAT HAS BEEN DEBARRED UNDER 21 U.S.C. § 335(A) AND
(B) OR THAT APPEARS ON THE LEIE.  IN THE EVENT THAT EITHER PARTY BECOMES AWARE
OF THE DEBARMENT, THREATENED DEBARMENT, APPEARANCE OR THREATENED PLACEMENT ON
THE LEIE OF ANY INDIVIDUAL, CORPORATION, PARTNERSHIP OR ASSOCIATION PROVIDING
SERVICES TO THE OTHER PARTY THAT DIRECTLY OR INDIRECTLY RELATE TO ACTIVITIES
UNDER THIS AGREEMENT, THE OTHER PARTY SHALL BE IMMEDIATELY NOTIFIED.  IN THE
EVENT OF AN ACTUAL DEBARMENT OR EXCLUSION OF DISTRIBUTOR OR ITS OWNERS DURING
THE TERM OF THIS AGREEMENT, THIS AGREEMENT SHALL, AS OF, OR PRIOR TO, THE
EFFECTIVE DATE OF SUCH DEBARMENT OR EXCLUSION, AUTOMATICALLY TERMINATE.  IN THE
EVENT OF AN ACTUAL DEBARMENT OR EXCLUSION OF ANY DISTRIBUTOR EMPLOYEE, AGENT OR
CONTRACTOR DURING THE TERM OF THIS AGREEMENT, SUCH EMPLOYEE, AGENT OR CONTRACTOR
MUST IMMEDIATELY CEASE PROVIDING ANY SERVICES TO UT UNDER THIS AGREEMENT, AND UT
SHALL HAVE THE OPTION OF IMMEDIATELY TERMINATING THIS AGREEMENT.

 

ARTICLE 3:  APPOINTMENT

 

3.1                                 SCOPE; NON-EXCLUSIVE.  UT HEREBY APPOINTS
DISTRIBUTOR, AND DISTRIBUTOR HEREBY ACCEPTS SUCH APPOINTMENT, AS A DISTRIBUTOR
OF UT PRODUCT DURING THE TERM OF THIS AGREEMENT, SUBJECT TO THE TERMS AND
CONDITIONS OF THIS AGREEMENT.  THIS APPOINTMENT IS NON-EXCLUSIVE, AND UT
RESERVES THE RIGHT TO APPOINT ADDITIONAL DISTRIBUTORS IN THE TERRITORY AND TO
DISTRIBUTE UT PRODUCT IN THE TERRITORY ON ITS OWN BEHALF.

 

3.2                                 SUB-DISTRIBUTORS.  DISTRIBUTOR SHALL NOT,
WITHOUT THE PRIOR WRITTEN APPROVAL OF UT, APPOINT ANY DISTRIBUTORS OR AGENTS TO
ACT ON BEHALF OF DISTRIBUTOR (COLLECTIVELY, “SUB-DISTRIBUTORS”) TO DISTRIBUTE UT
PRODUCT WITHIN THE TERRITORY, OTHER THAN ANY OF ITS AFFILIATES.  DISTRIBUTOR
SHALL AT ALL TIMES REMAIN FULLY LIABLE FOR THE PERFORMANCE OF ANY APPROVED
SUB-DISTRIBUTORS AND DISTRIBUTOR SHALL PROVIDE UT WITH A WRITTEN ACKNOWLEDGEMENT
EXECUTED BY EACH SUB-DISTRIBUTOR THAT IT HAS READ THIS AGREEMENT AND AGREES TO
BE BOUND BY ITS TERMS AND CONDITIONS, INCLUDING THOSE CONTAINED IN THE
ATTACHMENTS HERETO.

 

3.3                                 SALES OUTSIDE THE TERRITORY.  DISTRIBUTOR
SHALL NOT DISTRIBUTE, SELL OR OTHERWISE PROVIDE UT PRODUCT OUTSIDE OF THE
TERRITORY AND SHALL NOT ADVERTISE, PROMOTE OR SOLICIT CUSTOMERS FOR UT PRODUCT
OUTSIDE THE TERRITORY.

 

ARTICLE 4:  OBLIGATIONS OF DISTRIBUTOR

 

4.1                                 MARKETING.  DISTRIBUTOR SHALL USE
COMMERCIALLY REASONABLE EFFORTS TO FUND AND SUPPORT ONGOING MARKETING OF ITS
DISTRIBUTION OF UT PRODUCT, CONSISTENT WITH DISTRIBUTOR’S NORMAL FUNDING AND
SUPPORT FOR ITS OVERALL DISTRIBUTION ACTIVITIES.  IN ADDITION, DISTRIBUTOR SHALL
USE ITS COMMERCIALLY REASONABLE  EFFORTS TO FUND AND SUPPORT ONGOING SALE OF UT
PRODUCT.  SUCH COMMERCIALLY REASONABLE EFFORTS  SHALL INCLUDE, BUT NOT BE
LIMITED TO:

 

(A)                                  MAINTAINING THROUGHOUT THE TERRITORY
ADEQUATE MARKETING, SALES, AND ORDER-FULFILLMENT STAFF WHO ARE ADEQUATELY
TRAINED ON PAH AND UT PRODUCT.  THE

 

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                                                PARTIES ACKNOWLEDGE THAT THIS
OBLIGATION REQUIRES DISTRIBUTOR TO HAVE THE CAPABILITY TO PROVIDE THE FOREGOING
SERVICES THROUGHOUT THE TERRITORY, BUT DOES NOT REQUIRE DISTRIBUTOR TO HAVE A
PHYSICAL OFFICE WITHIN EACH JURISDICTION WITHIN THE TERRITORY;

 

(B)                                 PROMPTLY RESPONDING TO ALL INQUIRIES FROM
CUSTOMERS, INCLUDING RESPONDING TO COMPLAINTS, PROCESSING ALL ORDERS AND
EFFECTING ALL SHIPMENTS OF UT PRODUCT FOR INCLUDED PATIENTS IN ACCORDANCE WITH
THE TIMELINES AND OTHER TERMS AND CONDITIONS CONTAINED WITHIN THIS AGREEMENT;

 

(C)                                  PROVIDING UT PRODUCT TO INCLUDED PATIENTS
PURSUANT TO PHYSICIAN ORDERS;

 

(I.)                                  EXHIBITING AT CONVENTIONS, TRADE SHOWS,
PRODUCT FAIRS OR OTHER COMPARABLE EVENTS INVOLVING PATIENTS, INCLUDED PATIENTS
AND/OR PHYSICIAN SPECIALISTS WHO HAVE A HIGH PROPENSITY TO DIAGNOSE AND TREAT
PATIENTS SUFFERING FROM PAH FOR THE PURPOSE OF PROVIDING INFORMATION ON UT
PRODUCT AND/OR EDUCATING ATTENDEES.

 

(D)                                 DILIGENTLY INVESTIGATING AND PURSUING ALL
LEADS AND INQUIRIES OF POTENTIAL CUSTOMERS REFERRED TO DISTRIBUTOR BY UT AND
REPORTING WITHIN 7 DAYS ON THE STATUS OF ALL SUCH LEADS AND INQUIRIES. 
NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS
REQUIRING DISTRIBUTOR TO ADMIT TO ITS SERVICE, OR PROVIDE UT PRODUCT TO, ANY
PARTICULAR INDIVIDUAL(S) OR TYPES OF INDIVIDUAL(S).  ADDING INCLUDED PATIENTS TO
ITS SERVICE IS IN DISTRIBUTOR’S SOLE DISCRETION.

 

4.2                                 POLICIES AND PROCEDURES.  DISTRIBUTOR SHALL
USE COMMERCIALLY REASONABLE EFFORTS TO COMPLY WITH UT’S POLICIES AND PROCEDURES
AS PROVIDED AND UPDATED BY UT FROM TIME TO TIME AND AS ACCEPTED BY DISTRIBUTOR. 
IF ANY SUCH POLICIES AND PROCEDURES CONTRADICT THIS AGREEMENT, THE TERMS OF THIS
AGREEMENT SHALL CONTROL.

 

4.3                                 WRITTEN ASSURANCE.  DISTRIBUTOR HEREBY
ASSURES UT THAT DISTRIBUTOR SHALL NOT EXPORT UT PRODUCT FROM THE TERRITORY TO
ANY DESTINATION TO WHICH RE-EXPORT REQUIRES A LICENSE UNDER THE UNITED STATES
EXPORT ADMINISTRATION REGULATIONS.

 

4.4                                 PRODUCT SPECIFICATIONS.  DISTRIBUTOR SHALL
STORE UT PRODUCT IN ACCORDANCE WITH ALL DIRECTIONS ACCOMPANYING UT PRODUCT IN
ORDER TO MAINTAIN UT PRODUCT IN ACCORDANCE WITH UT- AND FDA-APPROVED
SPECIFICATIONS.  DISTRIBUTOR SHALL DISPENSE UT PRODUCT AS PRESCRIBED, IN
ACCORDANCE WITH ALL APPLICABLE PHARMACY REQUIREMENTS.  THE PARTIES ACKNOWLEDGE
THAT UT SHALL NOT HAVE ANY RIGHTS, OBLIGATIONS, RESPONSIBILITIES, OVERSIGHT OR
ROLE OF ANY KIND OR NATURE CONCERNING DISTRIBUTOR’S PRACTICE OF PHARMACY IN
COMPLIANCE WITH ALL APPLICABLE STATE PHARMACY REGULATIONS AND CONSISTENT WITH
DISTRIBUTOR’S THEN CURRENT PRACTICES.

 

4.5                                 PHARMACY AND HOME HEALTH CARE SERVICES. 
DISTRIBUTOR MAY CREATE ITS OWN EDUCATIONAL MATERIALS CONCERNING UT PRODUCT OR
PAH (“EDUCATIONAL MATERIALS”) FOR DISTRIBUTION BY DISTRIBUTOR IN ACCORDANCE WITH
THIS AGREEMENT AND DISTRIBUTOR’S OBLIGATIONS AS A HEALTH CARE PROVIDER AND
PHARMACY; PROVIDED, HOWEVER, THAT ALL SUCH EDUCATIONAL MATERIALS SHALL: (I) BE
CONSISTENT WITH THE CONTENTS OF UT PRODUCT PACKAGE INSERT APPROVED BY THE FDA;
(II) COMPLY WITH THE CONDITIONS AND REQUIREMENTS OF ALL APPLICABLE STATE
PHARMACY REGULATIONS MANDATING THE PROVISION OF PATIENT EDUCATIONAL MATERIALS ON
PRESCRIPTION DRUGS AND THEIR ADMINISTRATION, AND (III) NOT BE USED BY
DISTRIBUTOR TO PROMOTE, MARKET OR SELL UT PRODUCT. FURTHER, TO THE EXTENT

 

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                                                THAT ANY UT TRADEMARKS ARE
INCLUDED IN SUCH EDUCATIONAL MATERIALS, THEN DISTRIBUTOR SHALL NOTIFY UT IN
WRITING PRIOR  TO USE OF SUCH MATERIALS.

 

4.6                                 COMPLAINTS., DISTRIBUTOR SHALL PROCESS ANY
AND ALL COMPLAINTS RECEIVED FROM CUSTOMERS IN THE TERRITORY REGARDING THE UT
PRODUCT IN ACCORDANCE WITH SECTION 9.3 OF THIS AGREEMENT.

 

4.7                                 INVENTORY.  DISTRIBUTOR SHALL MAINTAIN AT
ALL TIMES ADEQUATE INVENTORY OF UNITS OF UT PRODUCT (THE “INVENTORY”) AS ARE
MUTUALLY CONSIDERED BY UT AND DISTRIBUTOR TO BE SUFFICIENT TO MEET CUSTOMERS’
ANTICIPATED DEMANDS FOR UT PRODUCT.  SUCH REQUIREMENTS MAY BE ADJUSTED BY UT AND
DISTRIBUTOR FROM TIME TO TIME. NOTWITHSTANDING THE FOREGOING, DISTRIBUTOR SHALL
MAINTAIN A MINIMUM INVENTORY LEVEL AT ALL TIMES BETWEEN THE FOLLOWING MINIMUM
AND MAXIMUM:

 

(A)                                  AT A MINIMUM: NO LESS THAN THIRTY (30)
DAYS’ INVENTORY ON HAND AT ANY TIME BASED ON CURRENT DEMAND AND USAGE OF UT
PRODUCT BY DISTRIBUTOR’S CUSTOMERS; AND

 

(B)                                 AT A MAXIMUM NO GREATER THAN SEVENTY-FIVE
(75) DAYS’ INVENTORY ON HAND BASED ON CURRENT DEMAND AND USAGE OF UT PRODUCT BY
DISTRIBUTOR’S CUSTOMERS; AND

 

(C)                                  CALCULATIONS OF INVENTORY LEVELS SHALL BE
BASED ON THE CURRENT MONTHLY AVERAGE USAGE OF UT PRODUCT BY INCLUDED PATIENTS
(“USAGE”). USAGE SHALL BE EQUAL TO THE ROLLING AVERAGE NUMBER OF UNITS OF UT
PRODUCT DISTRIBUTED BY DISTRIBUTOR EACH MONTH FOR THE PREVIOUS THREE (3) MONTHS.

 

DISTRIBUTOR shall ensure that it purchases enough Inventory each month to meet
Usage demand for UT Product in addition to the thirty (30) day minimum Inventory
level requirement.  From time to time, UT and DISTRIBUTOR may mutually agree to
reasonably change the above-listed minimum and maximum requirements and
DISTRIBUTOR shall adjust its Inventory accordingly.

 

4.8                                 STORAGE OF UT PRODUCT. DISTRIBUTOR SHALL
STORE AND MAINTAIN UT PRODUCT SOLELY AT THE DESIGNATED STORAGE LOCATIONS
DESCRIBED IN ATTACHMENT E HERETO.  DISTRIBUTOR SHALL STORE, MAINTAIN AND HANDLE
THE PRODUCT IN ACCORDANCE WITH GOOD DISTRIBUTION PRACTICE, APPLICABLE LAWS, THE
UT PRODUCT PACKAGE INSERT AND UT’S WRITTEN INSTRUCTIONS, INCLUDING ANY
REQUIREMENTS WITH RESPECT TO RACKING, TEMPERATURE, LIGHT, DARKNESS, VIBRATION
AND ROTATION. THE UT PRODUCT MUST BE STORED AT THE TEMPERATURE RANGE SPECIFIED
BY UT TO ENSURE SAFETY AND RELIABILITY, AND ROTATED SO THAT THE OLDEST UNEXPIRED
UNITS OF UT PRODUCT ARE SHIPPED BEFORE NEWER UNEXPIRED UNITS OF UT PRODUCT,
UNLESS UT SPECIFIES OTHERWISE.  DISTRIBUTOR SHALL PROMPTLY NOTIFY UT OF ANY
MATERIAL OR SIGNIFICANT CHANGE IN ITS STORAGE CONDITIONS OR SHIPPING PROCEDURES
FOR UT PRODUCT.  DISTRIBUTOR SHALL MAINTAIN COMPLETE AND ACCURATE RECORDS FOR
INSPECTION BY UT OR ITS REPRESENTATIVES, UPON TEN (10) BUSINESS DAYS’ PRIOR
NOTICE DURING REGULAR BUSINESS HOURS, OF ALL MOVEMENTS AND TRANSACTIONS
INVOLVING UT PRODUCT.  SUCH RECORDS SHALL REFLECT UNIT, LOT NUMBER AND CUSTOMER
INFORMATION, INCLUDING DEFECTIVE OR RETURNED UNITS OF UT PRODUCT, SUCH THAT THE
UNITS OF UT PRODUCT MAY BE TRACED FOR PURPOSES OF STOCK RECONCILIATION, RECALL
AND GENERAL MARKETING AND SHIPPING REVIEW.  UT SHALL ALSO HAVE THE RIGHT TO
INSPECT DISTRIBUTOR’S STORAGE CONDITIONS AND SHIPPING PROCEDURES FOR UT PRODUCT
UPON TEN (10) BUSINESS DAYS’ PRIOR NOTICE, DURING REGULAR BUSINESS HOURS.
DISTRIBUTOR SHALL NOT MANUFACTURE, MIX, PROCESS, COMBINE OR INCORPORATE UT
PRODUCT ALONE OR INTO ANY OTHER SUBSTANCE.

 

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4.9                                 DISTRIBUTOR EXPENSES.  DISTRIBUTOR SHALL
BEAR ALL OF ITS OWN COSTS AND EXPENSES INCURRED IN CARRYING OUT ITS OBLIGATIONS
UNDER THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ALL RENTS, SALARIES,
COMMISSIONS, DEMONSTRATION, TRAVEL AND ACCOMMODATION.

 

4.10                           DISTRIBUTOR REPORTING.  DISTRIBUTOR SHALL
COMPLETE A SERIES OF REGULAR REPORTS AS DESCRIBED IN ATTACHMENT F HERETO.  THE
REPORTS ARE DUE NO LATER THAN THE 10TH OF EACH MONTH FOLLOWING THE END OF THE
RESPECTIVE REPORTING PERIODS AND CONSTITUTE CONFIDENTIAL INFORMATION OF
DISTRIBUTOR. THE PARTIES ACKNOWLEDGE THAT APPLICABLE LAWS OR EXISTING
CONTRACTUAL RELATIONSHIPS WITH THIRD-PARTY PAYERS MAY RESTRICT DISTRIBUTOR’S
ABILITY TO COLLECT, USE, INCLUDE AND/OR DISCLOSE AS DATA CERTAIN PATIENT- AND
PHYSICIAN-SPECIFIC DATA. DISTRIBUTOR WARRANTS THAT IT WILL NOT PROVIDE PATIENT-
AND PHYSICIAN-SPECIFIC DATA AND INFORMATION WHERE SO LIMITED BY SUCH EXISTING
CONTRACTUAL RELATIONSHIPS OR APPLICABLE LAWS. NEW CONTRACTS WITH THIRD PARTY
PAYERS AND THE ENACTMENT OF NEW APPLICABLE LAWS WHICH FURTHER LIMIT THE
DISCLOSURE OF PATIENT- AND PHYSICIAN-SPECIFIC DATA AND INFORMATION SHALL NOT BE
DEEMED TO BE A CHANGE IN A LAW FOR PURPOSES OF THIS AGREEMENT. NEITHER PARTY MAY
RESELL DATA TO IMS, WOLTERS KLUWER, OR ANY OTHER DATA AGGREGATION SERVICE
WITHOUT THE EXPRESS WRITTEN CONSENT OF THE OTHER PARTY.

 

4.11                           DISTRIBUTOR REPRESENTATIONS.

 

(A)                                  DISTRIBUTOR ACKNOWLEDGES THAT UT PRODUCT
CONSTITUTES A SENSITIVE THERAPEUTIC DRUG, AND THAT DISTRIBUTION AND HANDLING OF
THE UT PRODUCT REQUIRES SPECIALIZED TRAINING AND DEDICATION TO CUSTOMER NEEDS. 
DISTRIBUTOR REPRESENTS AND WARRANTS THAT IT WILL TRAIN AND DEPLOY ITS AGENTS AND
EMPLOYEES IN THE MANNER NECESSARY TO MEET THESE SPECIAL REQUIREMENTS.

 

(B)                                 DISTRIBUTOR REPRESENTS AND WARRANTS THAT IT
AND ITS OFFICERS, DIRECTORS, AGENTS AND/OR EMPLOYEES AS APPLICABLE ARE QUALIFIED
TO PERFORM THE SERVICES AND ACTIVITIES DESCRIBED IN THIS AGREEMENT AND THAT ALL
LICENSES AND/OR APPROVALS NECESSARY TO CONDUCT SUCH SERVICES AND ACTIVITIES HAVE
BEEN OBTAINED AND SHALL BE MAINTAINED THROUGHOUT THE TERM OF THIS AGREEMENT.

 

4.12                           DISTRIBUTOR PROVIDES APPROPRIATE PHARMACY
SERVICES AS REQUIRED BY APPLICABLE LAWS. DISTRIBUTOR SHALL ALSO PERFORM THE
FOLLOWING ACTIVITIES IN SUPPORT OF THE DISTRIBUTION OF THE UT PRODUCT:

 

(A)                                  INHALATION DEVICE:  DISTRIBUTOR SHALL
ENSURE THAT ITS PERSONNEL ARE TRAINED ON THE USE OF THE TYVASO INHALATION SYSTEM
AND CAPABLE OF PROVIDING SUCH TRAINING TO CUSTOMERS. TRAINING AND EDUCATION FOR
USE MUST COMPLY WITH THE TECHNICAL AND ADMINISTRATIVE REQUIREMENTS SPECIFIED IN
THE PACKAGE INSERT FOR TYVASO AND THE INSTRUCTIONS FOR USE MANUAL FOR THE TYVASO
INHALATION SYSTEM.

 

(B)                                 INCLUDED PATIENT BENEFIT VERIFICATION:
DISTRIBUTOR SHALL HANDLE INCLUDED PATIENT ENROLLMENT, INITIAL PROCESSING,
INSURANCE ELIGIBILITY AND BENEFITS VERIFICATION. IF DISTRIBUTOR IS UNABLE TO
SERVICE A PATIENT, THEN DISTRIBUTOR SHALL IMMEDIATELY, I.E., NO MORE THAN FIVE
(5) BUSINESS DAYS FROM THE INITIAL RECEIPT OF THE REFERRAL, RE-DIRECT THE
REFERRAL TO AN APPROPRIATE SPECIALTY PHARMACY PARTICIPATING IN THE TYVASO
DISTRIBUTION NETWORK.

 

(I.)                                  UPON RECEIPT OF A PRESCRIPTION FOR UT
PRODUCT, DISTRIBUTOR SHALL IMMEDIATELY FAX THE PRESCRIBING PHYSICIAN TO CONFIRM
RECEIPT OF THE PRESCRIPTION. NO MORE THAN ONE (1) BUSINESS DAY FROM RECEIPT OF
THE PRESCRIPTION, DISTRIBUTOR SHALL PERFORM VERIFICATION OF INSURANCE

 

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                                                COVERAGE FOR UT PRODUCT. IF THE
PRESCRIPTION IS RECEIVED AFTER 2 P.M. EASTERN TIME, DISTRIBUTOR MAY HAVE UNTIL
THE END OF THE NEXT BUSINESS DAY TO PERFORM VERIFICATION OF INSURANCE COVERAGE
FOR UT PRODUCT.

 

(II.)                               DISTRIBUTOR SHALL TAKE ALL NECESSARY ACTIONS
TO VERIFY, OR ASSIST CUSTOMERS IN VERIFYING, INSURANCE COVERAGE FOR UT PRODUCT
INCLUDING, WITHOUT LIMITATION, RESEARCHING AND ATTEMPTING TO DETERMINE: (1) ALL
CUSTOMER INFORMATION AND COVERAGE PARAMETERS, INCLUDING ALL RELEVANT CLINICAL
DOCUMENTATION; (2) IF UT PRODUCT IS COVERED, UNDER WHAT TYPE OF PLAN (E.G., A
“MEDICAL PLAN” OR A “PHARMACY PLAN”), THE INCLUDED PATIENT COST SHARE AMOUNT, IF
ANY, AND THE RATE OF REIMBURSEMENT, IF AVAILABLE; (3) WHETHER PRIOR
AUTHORIZATION IS REQUIRED FOR REIMBURSEMENT; (4) IF PRIOR AUTHORIZATION IS
REQUIRED, WHAT INFORMATION THE CUSTOMER MUST SUBMIT IN ORDER TO RECEIVE SUCH
AUTHORIZATION; AND (5) WHETHER ANY OTHER ACTIVITIES, SUBMISSIONS OR APPROVALS
ARE REQUIRED TO OBTAIN REIMBURSEMENT PROMPTLY AND TO THE FULLEST EXTENT
PERMITTED BY THE THIRD-PARTY PAYER. DURING THE PROCESS OF BENEFIT VERIFICATION,
DISTRIBUTOR SHALL COMMUNICATE WITH THE REFERRAL SOURCE AND PROVIDE INFORMATION
TO THE PRESCRIBING PHYSICIAN IN A TIME AND MANNER SUFFICIENT FOR THE
CIRCUMSTANCES.

 

(III.)                            DISTRIBUTOR SHALL RECORD THE RESULTS OF ITS
RESEARCH ON THE FOREGOING AND SHALL REPORT SUCH INFORMATION TO THE CUSTOMER
WITHIN ONE (1) BUSINESS DAY FROM RECEIPT. [RACHEL & MIKE ARE OK WITH THIS]

 

(IV.)                           IF THE THIRD-PARTY PAYER REQUIRES PRIOR
AUTHORIZATION, THEN DISTRIBUTOR SHALL, WITHIN ONE (1) BUSINESS DAY, NOTIFY AND
ASSIST THE CUSTOMER WITH QUESTIONS RELATING TO THE REQUIREMENTS FOR PRIOR
AUTHORIZATION.

 

(V.)                              IF, PRIOR TO THE SUBMISSION OF A CLAIM FOR
REIMBURSEMENT, A THIRD-PARTY PAYER INFORMS DISTRIBUTOR THAT THE CUSTOMER OR UT
PRODUCT IS NOT ELIGIBLE FOR COVERAGE, THEN, WITHIN ONE (1) BUSINESS DAY,
DISTRIBUTOR SHALL MAKE SUCH INQUIRIES OF THE THIRD-PARTY PAYER AS SHALL BE
NECESSARY TO DETERMINE THE REQUIREMENTS FOR SUBMISSION OF AN APPEAL OF THE
DENIAL OF COVERAGE. DISTRIBUTOR SHALL PROMPTLY  RECORD THE RESULTS OF THIS
INQUIRY AND REPORT SUCH INFORMATION TO THE CUSTOMER AND TO THE UT MANAGED
MARKETS DESIGNEE.

 

(VI.)                           IF A CUSTOMER NOTIFIES DISTRIBUTOR OF A DENIAL
OF COVERAGE AND DISTRIBUTOR DETERMINES THAT AN APPEAL OF THE DENIAL OF COVERAGE
WOULD REQUIRE A LEVEL 1 APPEAL, THEN DISTRIBUTOR SHALL IMMEDIATELY NOTIFY THE
CUSTOMER.  THE CUSTOMER, AT ITS OPTION, MAY ELECT TO PURSUE THE LEVEL 1 APPEAL
DIRECTLY OR REQUEST DISTRIBUTOR’S ASSISTANCE. IF THE CUSTOMER ELECTS TO HAVE
DISTRIBUTOR ASSIST WITH THE LEVEL 1 APPEAL, DISTRIBUTOR, AT ITS COST, SHALL USE
REASONABLE EFFORTS TO ASSIST CUSTOMER, AND IF AN INCLUDED PATIENT IS PURSUING
THE LEVEL 1 APPEAL ON HIS/HER OWN BEHALF, DISTRIBUTOR, AT ITS COST, SHALL
PROMPTLY INITIATE (AT THE LATEST WITHIN ONE (1) BUSINESS DAY) AND PURSUE SUCH
LEVEL 1 APPEAL IN ACCORDANCE WITH THE THIRD-PARTY PAYER’S PROCESSES.  UPON
REQUEST, UT SHALL PROVIDE REASONABLE ASSISTANCE TO DISTRIBUTOR, INCLUDING
ASSISTANCE WITH PREPARING APPLICATIONS AND PARTICIPATION IN TELEPHONE
CONFERENCES AND MEETINGS WITH REPRESENTATIVES OF THE THIRD-

 

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                                                PARTY PAYER. DISTRIBUTOR SHALL
NOTIFY THE CUSTOMER IMMEDIATELY FOLLOWING ANY INTERIM AND FINAL DETERMINATIONS
BY THE THIRD PARTY PAYER IN RESPONSE TO ANY LEVEL 1 APPEAL.  ALL DOCUMENTS
PREPARED AS PART OF A LEVEL 1 APPEAL, AND ANY INFORMATION OBTAINED IN CONNECTION
THEREWITH, SHALL BE PROMPTLY RECORDED.

 

(VII.)                        IF DISTRIBUTOR DETERMINES THAT AN APPEAL OF THE
DENIAL OF COVERAGE WOULD REQUIRE A LEVEL 2 APPEAL, DISTRIBUTOR SHALL NOTIFY THE
CUSTOMER, THE INCLUDED PATIENT, AND UT (IF DISTRIBUTOR DEEMS NECESSARY AND IF
THE INCLUDED PATIENT CONSENTS) IMMEDIATELY OF SUCH DETERMINATION.  THE INCLUDED
PATIENT, AT HIS OR HER OPTION, MAY ELECT TO PURSUE THE LEVEL 2 APPEAL DIRECTLY
OR TO REQUEST THAT CUSTOMER ASSIST WITH PURSUIT OF THE LEVEL 2 APPEAL.  IF
CUSTOMER ASSISTS WITH THE PURSUIT OF A LEVEL 2 APPEAL, DISTRIBUTOR SHALL PROVIDE
REASONABLE ASSISTANCE TO CUSTOMER, INCLUDING ASSISTANCE WITH PREPARING
APPLICATIONS AND PARTICIPATION IN TELEPHONE CONFERENCES AND MEETINGS WITH
REPRESENTATIVES OF THE THIRD-PARTY PAYER.

 

(C)                                  DISPENSING ACTIVITIES:

 

(I.)                                  UPON COMPLETION OF BENEFITS INVESTIGATION
AND, IF NECESSARY, AFTER PRIOR AUTHORIZATION, DISTRIBUTOR SHALL PROCESS
CUSTOMER’S ORDER FOR UT PRODUCT IF CUSTOMER CHOOSES TO PLACE AN ORDER.  IF
CUSTOMER ELECTS NOT TO PLACE AN ORDER AT THE TIME THAT INCLUDED PATIENT BENEFITS
ARE REPORTED, DISTRIBUTOR SHALL ATTEMPT TO DETERMINE THE REASON FOR CUSTOMER’S
CHOICE (E.G., “INCLUDED PATIENT TO RECEIVE UT PRODUCT AT AN ALTERNATE FACILITY”,
“PHYSICIAN ELECTED NOT TO ORDER UT PRODUCT”, OR “INCLUDED PATIENT ELECTED NOT TO
RECEIVE UT PRODUCT”).  DISTRIBUTOR SHALL IMMEDIATELY RECORD THIS INFORMATION.

 

(II.)                               WHEN THE PRESCRIBER IS THE CUSTOMER,
DISTRIBUTOR SHALL ATTEMPT TO CONTACT THE INCLUDED PATIENT ON THE SAME DAY THAT
THE BENEFIT VERIFICATION HAS BEEN COMPLETED FOR THE INCLUDED PATIENT IN ORDER TO
INFORM THE INCLUDED PATIENT OF HIS OR HER COST SHARE AMOUNT, IF ANY, AND TO MAKE
ARRANGEMENTS WITH THE INCLUDED PATIENT FOR COLLECTION SUCH COST SHARE AMOUNT, IF
ANY, AND TO INTRODUCE THE INCLUDED PATIENT TO THE DISTRIBUTOR’S SERVICES. 
DISTRIBUTOR MAY DELAY SHIPMENT OF UT PRODUCT UNTIL THE INCLUDED PATIENT’S COST
SHARE AMOUNT IS SATISFIED IN FULL.  DISTRIBUTOR SHALL BE SOLELY RESPONSIBLE FOR
SUBMITTING CLAIMS FOR REIMBURSEMENT DIRECTLY TO THE THIRD-PARTY PAYER FOR THE
APPLICABLE REIMBURSABLE AMOUNT (DEDUCTING ANY INCLUDED PATIENT COST SHARE
AMOUNT).

 

(III.)                            DISTRIBUTOR SHALL DISPENSE THE UNIT(S) OF UT
PRODUCT (ALONG WITH A CURRENT PACKAGE INSERT) TO INCLUDED PATIENTS PURSUANT TO A
VALID PRESCRIPTION AND IN ACCORDANCE WITH APPLICABLE LAWS.  UPON RECEIPT OF A
CLEAN PRESCRIPTION, DISTRIBUTOR SHALL ENSURE THAT THE INCLUDED PATIENT RECEIVES
UT PRODUCT WITHIN ONE (1) BUSINESS DAY FROM RECEIPT OF SUCH PRESCRIPTION, OR AT
SUCH OTHER TIME AS THE INCLUDED PATIENT MAY REQUEST.

 

(D)                                 FOLLOW UP ACTIVITY GENERALLY: UNLESS
DISTRIBUTOR IS OTHERWISE REQUIRED TO CONTACT CUSTOMER SOONER OR MORE OFTEN,
DISTRIBUTOR SHALL CONTACT CUSTOMER

 

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                                                TWO (2) BUSINESS DAYS AFTER
RECEIPT OF A PRESCRIPTION/REFERRAL AND EVERY TWO (2) BUSINESS DAYS THEREAFTER TO
UPDATE CUSTOMER ON THE STATUS OF A BENEFITS INVESTIGATION/PRIOR
AUTHORIZATION/APPEAL OR OTHER RELATED MATTER. WHEN REQUIRED TO OBTAIN ADDITIONAL
INFORMATION TO COMPLETE A VALID PRESCRIPTION/COVERAGE DETERMINATION/PRIOR
AUTHORIZATION/APPEAL OR RELATED MATTER, DISTRIBUTOR SHALL COMMUNICATE ALL
REQUIRED INFORMATION TO THE APPROPRIATE PARTY AND CONTINUE TO CONTACT SUCH PARTY
EVERY BUSINESS DAY UNTIL THE NEEDED INFORMATION IS RECEIVED OR THE MATTER IS
OTHERWISE CLOSED.

 

(A)                                  SOCIAL SERVICES: DISTRIBUTOR SHALL ENGAGE
IN PATIENT ADVOCACY AND UPON RECEIPT OF INQUIRIES FROM OR CUSTOMERS, PROVIDE
NOTICE TO SUCH CUSTOMERS OF ALTERNATE FUNDING SOURCES, CERTAIN HARDSHIP
REIMBURSEMENT SUPPORT, AND CERTAIN INDIGENT AND PATIENT ASSISTANCE PROGRAMS,
INCLUDING UT’S PAP AS DESCRIBED IN ATTACHMENT C HERETO. DISTRIBUTOR SHALL SEND
AN APPLICATION TO ALL ELIGIBLE INCLUDED PATIENTS WHO REQUEST TO PARTICIPATE IN
THE PAP WITHIN ONE (1) BUSINESS DAY FROM THE DATE OF SUCH REQUEST, WITH NOTICE
TO THE REFERRAL SOURCE (VIA FAX, EMAIL OR MAIL) AS WELL.

 

(B)                                 PRODUCT & ANCILLARY SUPPLY DISTRIBUTION:
DISTRIBUTOR SHALL MAKE AVAILABLE AND/OR DISPENSE WITH UT PRODUCT, AS NECESSARY
AND APPROPRIATE FOR THE APPLICABLE SITE OF SERVICE (E.G., HEALTH CARE
PROVIDER/PHYSICIAN OFFICE, CLINIC, HOSPITAL OUTPATIENT SETTING, PHARMACY-OWNED
FACILITY, HOME), THE CONTENTS OF THE UT PRODUCT PACKAGE AND SUPPLIES NECESSARY
FOR UT PRODUCT ADMINISTRATION.

 

(C)                                  EDUCATION: DISTRIBUTOR SHALL PROVIDE ITS
STANDARD EDUCATIONAL SUPPORT (INCLUDING THE PROVISION OF ANY UT MATERIALS OR
EDUCATIONAL MATERIALS) REGARDING UT PRODUCT ADMINISTRATION AND SAFETY TO
CUSTOMERS AND CAREGIVERS INVOLVED IN TREATING INCLUDED PATIENTS. DISTRIBUTOR
SHALL PROMPTLY RESPOND TO QUESTIONS FROM MANAGED CARE ORGANIZATIONS AND OTHER
THIRD-PARTY PAYERS ABOUT UT PRODUCT. NOTWITHSTANDING THE FOREGOING, THE
PROVISION OF SUCH EDUCATIONAL SERVICES SHALL BE PERFORMED IN ACCORDANCE WITH THE
OBLIGATIONS CONTAINED IN THIS AGREEMENT INCLUDING THOSE WITH RESPECT TO
TRAINING.

 

(E)                                  NURSING SERVICES:

 

(I.)                                  DISTRIBUTOR SHALL MAKE AVAILABLE ON AN
AS-NEEDED BASIS ITS STANDARD TELEPHONIC NURSING SERVICES IN ACCORDANCE WITH ITS
STANDARD POLICIES AND PROCEDURES. IF DISTRIBUTOR RECEIVES REQUESTS FOR
ADMINISTRATION FOR UT PRODUCT, IT SHALL FACILITATE SUCH REQUESTS IN ACCORDANCE
WITH ITS STANDARD BUSINESS PRACTICES. DISTRIBUTOR’S STANDARD TELEPHONIC NURSING
SERVICES SHALL BE RENDERED BY NURSES WHO HAVE THE REQUISITE AND NECESSARY
TRAINING, EXPERIENCE, LICENSES AND PERMITS IN ACCORDANCE WITH APPLICABLE LAWS.
DISTRIBUTOR MAY NOT SEEK REIMBURSEMENT FOR ITS STANDARD TELEPHONIC NURSING
SERVICES DIRECTLY FROM UT OR  FROM THE INCLUDED PATIENT.

 

(I.)                                  THE PARTIES SHALL WORK TOGETHER IN GOOD
FAITH TO DEVELOP AN INTEGRATED NURSING PROGRAM TO ADEQUATELY SUPPORT UT PRODUCT,
INCLUDED PATIENTS AND CUSTOMERS WITH THE FOLLOWING ELEMENTS:

 

(A)                                  ALL NURSES SHALL BE TRAINED BY DISTRIBUTOR
WITH RESPECT TO UT PRODUCT AND PAH PRIOR TO ANY INTERACTION WITH AN INCLUDED
PATIENT OR CUSTOMER. ALL NURSES (INCLUDING PER DIEM NURSES) SHALL

 

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                                                PASS COMPETENCY TESTING ON THE
FOLLOWING TOPICS (AT A MINIMUM): PAH AND PAH DRUG CLASSES; UT PRODUCT; PATIENT
NEEDS WHETHER NAÏVE OR EXPERIENCED; ADMINISTRATION OF UT PRODUCT; TRAINING
PATIENTS ON ADMINISTRATION OF UT PRODUCT; RELEVANT NURSING STANDARDS OF CARE FOR
ADMINISTRATION OF UT PRODUCT; ANY AND ALL DEVICES/PUMPS THAT ARE TO BE USED WITH
UT PRODUCT; AN “IDEAL PATIENT ENCOUNTER”; AND HIPAA, PATIENT PRIVACY AND ANY
OTHER APPLICABLE LEGAL REQUIREMENTS;

 

(B)                                 DISTRIBUTOR SHALL PROVIDE UPDATED TRAINING
AS NECESSARY FOR NURSES TO EXCEL IN THE FOREGOING COMPETENCY AREAS;

 

(C)                                  DISTRIBUTOR SHALL UPDATE AND REFRESH
TRAINING AND REQUIRE REGULARLY UPDATED CERTIFICATION TESTING WHEN NEW
INFORMATION BECOMES AVAILABLE OR WHEN A NURSE HAS NOT PROVIDED SERVICES FOR AN
EXTENDED PERIOD OF TIME;

 

(D)                                 DISTRIBUTOR SHALL MAKE AVAILABLE TO UT UPON
REQUEST, FOR UT’S REVIEW AND COMMENT, TRAINING MATERIALS RELATED TO UT PRODUCT
AND THE ADMINISTRATION AND SUPPORT OF UT PRODUCT;

 

(E)                                  DISTRIBUTOR SHALL MAKE AVAILABLE TO UT
RECORDS OF COMPLETION OF RELATED TRAINING UPON UT’S REQUEST;

 

(F)                                    DISTRIBUTOR SHALL MANAGE NONPERFORMANCE
OF NURSES (INCLUDING PER DIEM NURSES) THROUGH APPROPRIATE MEASURES, INCLUDING
RE-TRAINING, DISCIPLINE OR REMOVAL; AND

 

(G)                                 DISTRIBUTOR SHALL REASONABLY PROVIDE NURSES
WHO ARE ABLE TO SPEAK THE SAME LANGUAGE AS THE INCLUDED PATIENT OR A TRANSLATION
SERVICE.

 

(F)                                    ADDITIONAL PERFORMANCE REQUIREMENTS:  AS
PART OF THE OVERALL ACTIVITIES PERFORMED IN SUPPORT OF THE DISTRIBUTION OF UT
PRODUCT, DISTRIBUTOR AGREES TO KEEP CAREFUL RECORDS OF THE FOLLOWING DATA POINTS
AND MAINTAIN THE REQUISITE LEVELS OF COMPETENCY FOR EACH DATA POINT AND SHALL
PROVIDE SUCH DATA IN REPORTS TO UT AS UT REASONABLY REQUESTS, BUT NO LESS THAN
QUARTERLY:

 

(I.)                                  ASA: MEANING THE AVERAGE SPEED DISTRIBUTOR
TAKES TO ANSWER A CALL MEASURED OVER A CALENDAR MONTH.  DISTRIBUTOR SHALL USE
ITS BEST EFFORTS TO ENSURE THAT THE ASA DOES NOT EXCEED 15 SECONDS, AND IN ANY
EVENT, AT LEAST 95% OF ALL CALLS TO DISTRIBUTOR SHALL BE ANSWERED BY A LIVE
PERSON WITHIN FIFTEEN (15) SECONDS;

 

(II.)                               CALLS DROPPED: MEANING THE PERCENTAGE OF
CALLS THAT ARE DROPPED BEFORE BEING ANSWERED OVER THE COURSE OF A CALENDAR
MONTH.  DISTRIBUTOR SHALL USE ITS BEST EFFORTS TO ENSURE THAT THE CALLS DROPPED
DOES NOT EXCEED 2%; AND

 

(III.)                            AHT: MEANING THE AVERAGE HOLD TIME EXPERIENCED
BY A CALLER AS MEASURED OVER THE COURSE OF A CALENDAR MONTH.  DISTRIBUTOR SHALL
USE ITS BEST EFFORTS TO ENSURE THAT THE AHT DOES NOT EXCEED 45 SECONDS,

 

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                                                AND IN ANY EVENT, AT LEAST 95%
OF CALLS PLACED ON HOLD WILL BE ON HOLD FOR LESS THAN FORTY-FIVE (45) SECONDS.

 

4.13                           TYVASO CONTINUING PATIENT COMPLIANCE, SUPPORT AND
EDUCATION PROGRAM. AS SET FORTH IN ATTACHMENT G HERETO AND IN ACCORDANCE WITH
THIS SECTION 4.13, DISTRIBUTOR AGREES TO PERFORM ALL REQUIRED SERVICES UNDER THE
CONTINUING PATIENT COMPLIANCE, SUPPORT AND EDUCATION PROGRAM FOR TYVASO (“CPCSEP
SERVICES”) AND UT AGREES TO PAY DISTRIBUTOR A FEE FOR SUCH CPCSEP SERVICES
(“SERVICE FEE”).

 

(A)                                  DISTRIBUTOR WARRANTS THAT IT WILL PERFORM
THE CPCSEP SERVICES IN A PROFESSIONAL MANNER, IN COMPLIANCE WITH INDUSTRY
STANDARDS, AND IN ACCORDANCE WITH THE DESCRIPTIONS AND REPRESENTATIONS SET FORTH
ON ATTACHMENT G HERETO OR AS OTHERWISE MUTUALLY AGREED BY THE PARTIES FROM TIME
TO TIME.

 

(B)                                 DISTRIBUTOR SHALL SUBMIT DETAILED MONTHLY
INVOICES TO UT SETTING FORTH A DESCRIPTION OF THE CPCSEP SERVICES ACTUALLY
PERFORMED AND THE CORRESPONDING SERVICE FEE DUE.  THE FOREGOING INVOICES ARE DUE
TO UT WITHIN TEN (10) DAYS OF THE END OF EACH CALENDAR MONTH.  UT’S SHALL PAY
DISTRIBUTOR WITHIN SIXTY (60) DAYS FROM RECEIPT OF EACH INVOICE.

 

(C)                                  THE PARTIES AGREE AND ACKNOWLEDGE THAT THE
SERVICE FEE PAID HEREUNDER HAS BEEN DETERMINED THROUGH GOOD FAITH AND
ARMS-LENGTH NEGOTIATION TO BE THE FAIR MARKET VALUE OF THE CPCSEP SERVICES TO BE
RENDERED.  NO AMOUNT PAID OR REIMBURSED HEREUNDER IS INTENDED TO BE, NOR SHALL
IT BE CONSTRUED AS, AN OFFER OR PAYMENT MADE, WHETHER DIRECTLY OR INDIRECTLY, TO
INDUCE THE REFERRAL OF PATIENTS, THE PURCHASE, LEASE OR ORDER OF ANY ITEM OR
SERVICE, OR THE RECOMMENDING OF THE PURCHASE, LEASE OR ORDER OF ANY ITEM OR
SERVICE.

 

(D)                                 BY ACCEPTING PAYMENT OF THE SERVICE FEE FROM
UT, DISTRIBUTOR REPRESENTS AND WARRANTS TO UT THAT DISTRIBUTOR HAS ACTUALLY
PERFORMED THE CPCSEP SERVICES AS INVOICED AND WAS OBLIGATED TO PERFORM THE
CPCSEP SERVICES (OR ANY SUBSTANTIALLY SIMILAR ACTIVITY) SOLELY PURSUANT TO THE
OBLIGATIONS IN THIS SECTION 4.13 AND ATTACHMENT G HERETO.   THE PARTIES EACH
AGREE THAT THE SERVICE FEE IS NOT A DISCOUNT BUT INSTEAD REPRESENTS A FAIR
AMOUNT IN CONSIDERATION FOR THE CPCSEP SERVICES DESCRIBED IN THIS SECTION 4.13
AND ATTACHMENT G HERETO.  FURTHER, IN RECOGNITION OF THE FOREGOING, DISTRIBUTOR
WARRANTS THAT IT WILL RETAIN THE SERVICE FEE FOR ITS OWN ACCOUNT.

 

(E)                                  THE CPCSEP SERVICES AND CORRESPONDING
SERVICE FEES WILL BE EVALUATED BY UT ON AN ANNUAL BASIS AND UT MAY TERMINATE ALL
OR A PORTION OF THE CPCSEP SERVICES AT ANY TIME UPON THIRTY (30) DAYS PRIOR
WRITTEN NOTICE TO DISTRIBUTOR WITHOUT ANY ADDITIONAL FEE OR EXPENSE.

 

4.14                           DISTRIBUTOR AGREES TO MAKE AVAILABLE ALL
PERSONNEL RESPONSIBLE FOR OVERSEEING/MANAGING THE ACTIVITIES RELATED TO THE
DISTRIBUTION OF UT PRODUCT FOR QUARTERLY MEETINGS WITH UT PERSONNEL AT
REASONABLY AGREED UPON TIMES AND PLACES IN ORDER TO REVIEW AND ASSESS
DISTRIBUTOR PERFORMANCE RELATIVE TO THE VARIOUS OBLIGATIONS DESCRIBED IN THIS
ARTICLE 4 AND ELSEWHERE IN THIS AGREEMENT.

 

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ARTICLE 5:  OBLIGATIONS OF UT

 

5.1                                 TRAINING.  UT MAY IN ITS DISCRETION PROVIDE
TRAINING TO DISTRIBUTOR FOR UT PRODUCT AT A TIME AND IN A MANNER AS DETERMINED
BY DISTRIBUTOR.

 

5.2                                 UT MATERIALS.  UT SHALL PROVIDE DISTRIBUTOR,
UPON DISTRIBUTOR’S REQUEST, WITH REASONABLE QUANTITIES OF SALES AND MARKETING
MATERIALS FOR UT PRODUCT AS THEY ARE DEVELOPED BY UT, INCLUDING BUT NOT LIMITED
TO REPRINTS, BROCHURES, PACKAGE INSERTS, PEER REVIEWED ARTICLES AND OTHER
SCIENTIFIC AND MEDICAL INFORMATION REGARDING UT PRODUCT, INFORMATIONAL MATERIAL
AND OTHER MARKETING LITERATURE (“UT MATERIALS”), FOR USE AND DISTRIBUTION BY
DISTRIBUTOR IN ACCORDANCE WITH THIS AGREEMENT.  DISTRIBUTOR SHALL USE THE UT
MATERIALS IN ACCORDANCE WITH UT’S WRITTEN DIRECTIONS, INCLUDING PROVIDING THE
PACKAGE INSERT TO CUSTOMERS UNTIL SUCH TIME AS THE PACKAGE INSERT IS INCLUDED
WITH UT PRODUCT. DISTRIBUTOR SHALL NOT REVISE, ALTER, CHANGE, SUPPLEMENT OR
REPRODUCE IN ANY MANNER THE UT MATERIALS AND THEIR CONTENT AS PROVIDED BY UT
WITHOUT UT’S ADVANCE WRITTEN PERMISSION.  NOTHING IN THIS PROVISION REQUIRES UT
TO CREATE ANY SPECIFIC MATERIALS.

 

ARTICLE 6:   ORDERS FOR PRODUCTS

 

6.1                                 PURCHASE ORDERS.  DISTRIBUTOR SHALL SUBMIT
WRITTEN PURCHASE ORDERS TO UT BY ELECTRONIC MAIL OR IN ACCORDANCE WITH WRITTEN
INSTRUCTIONS PROVIDED BY UT. PURCHASE ORDERS SHALL BE SUBMITTED ONCE PER MONTH
BY THE 10TH DAY OF THE MONTH. EACH SUCH ORDER SHALL SET FORTH: (A) THE PACKAGE
REFERENCE FOR THE UT PRODUCT ORDERED (I.E. “STARTER KIT”, “RE-SUPPLY KIT”, OR
“SUPPLEMENTAL REFILL”), INCLUDING ITEM NUMBERS; (B) QUANTITIES IN MULTIPLES OF
TEN (10) PER PACKAGE REFERENCE; (C) REQUESTED DELIVERY DATES; (D) SPECIFIC
SHIPPING INSTRUCTIONS; AND (E) IF APPLICABLE, ANY RELEVANT EXPORT CONTROL
INFORMATION OR DOCUMENTATION TO ENABLE UT TO COMPLY WITH APPLICABLE LAWS. 
EXCEPT AS OTHERWISE AGREED BY UT, DISTRIBUTOR SHALL SUBMIT SUCH PURCHASE ORDERS
AT LEAST FIVE (5) BUSINESS DAYS PRIOR TO THE REQUESTED DELIVERY DATES.
DISTRIBUTOR IS RESPONSIBLE FOR GOOD INVENTORY MANAGEMENT PROCESSES AND
SUBSEQUENT PURCHASES SHOULD NOT DEVIATE NEGATIVELY BY MORE THAN 15% FROM THE
PREVIOUS PO UNLESS UNEXPECTED EVENTS OCCUR AND ARE COMMUNICATED TO UT IN ADVANCE
IN WRITING. DISTRIBUTOR MAY ONLY PURCHASE UT PRODUCT FROM UT OR THROUGH THE
ACQUISITION OF ALL OR PART OF A PHARMACY AUTHORIZED TO DISPENSE PRODUCT.
DISTRIBUTOR MAY ONLY SELL UT PRODUCT FOR USE BY AN INCLUDED PATIENT AND MAY NOT
SELL, TRANSFER OR DISTRIBUTE UT PRODUCT TO ANY ENTITY THAT DISTRIBUTOR KNOWS IS
LIKELY TO RESELL THE UT PRODUCT.

 

6.2                                 ACCEPTANCE OF ORDERS. EACH PURCHASE ORDER
SHALL BE GOVERNED BY THE TERMS AND CONDITIONS SET FORTH IN THIS AGREEMENT WITH
RESPECT TO SUCH ORDER TO THE EXCLUSION OF ANY ADDITIONAL OR CONTRARY TERMS SET
FORTH IN THE DISTRIBUTOR PURCHASE ORDER.  ANY TERMS OR CONDITIONS OF SUCH
PURCHASE ORDER THAT CONFLICT WITH THE TERMS AND CONDITIONS OF THIS AGREEMENT
SHALL BE NULL AND VOID.  NOTWITHSTANDING THE FOREGOING, IN THE EVENT OF EXIGENT
CIRCUMSTANCES, UT SHALL USE ITS BEST EFFORTS TO ACCEPT AN EMERGENCY PURCHASE
ORDER FROM DISTRIBUTOR TWO (2) BUSINESS DAYS PRIOR TO THE REQUESTED DELIVERY
DATE

 

6.3                                 DELIVERY TERMS.  UNITS OF UT PRODUCT ORDERED
BY DISTRIBUTOR AND ACCEPTED BY UT SHALL BE PACKED FOR SHIPMENT AND STORAGE IN
ACCORDANCE WITH UT’S STANDARD COMMERCIAL SHIPPING PRACTICES. UT SHALL USE ITS
BEST EFFORTS TO DELIVER UNITS OF UT PRODUCT INTO THE POSSESSION OF A COMMON
CARRIER FOR DELIVERY WITHIN A REASONABLE PERIOD OF TIME AFTER ACCEPTANCE OF A
PURCHASE ORDER BY UT.  UNLESS MUTUALLY AGREED UPON BY DISTRIBUTOR AND UT, NO UT
PRODUCT SHALL BE SHIPPED ON A FRIDAY, SATURDAY OR SUNDAY.  EACH ORDER MAY ONLY
BE SHIPPED, AND SHALL BE ADDRESSED FOR SHIPMENT, TO THE DESIGNATED SHIPMENT

 

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                                                LOCATION SPECIFIED IN ATTACHMENT
E.  UNLESS UT AND DISTRIBUTOR OTHERWISE AGREE IN WRITING, ALL DELIVERIES OF UT
PRODUCT SHALL BE F.O.B. DISTRIBUTOR’S DESIGNATED SHIPMENT LOCATION.  UT SHALL
INSURE EACH SHIPMENT OF UT PRODUCT WITH A REPUTABLE INSURER FOR THE FULL INVOICE
PRICE OF SUCH SHIPMENT.  RISK OF LOSS AND TITLE TO UT PRODUCT SHALL PASS TO
DISTRIBUTOR UPON DELIVERY AT ITS DESIGNATED SHIPMENT LOCATION.  UT SHALL HAVE NO
LIABILITY FOR ANY LOSS, THEFT, DESTRUCTION OR DAMAGE TO THE UNITS OF UT PRODUCT
ONCE THEY HAVE BEEN DELIVERED TO A DESIGNATED SHIPMENT LOCATION AND THE EXTERIOR
HAS BEEN INSPECTED BY DISTRIBUTOR FOR VISIBLE DAMAGEWITHOUT NECESSITY OF OPENING
.  EACH INDIVIDUAL PACKAGE OF UT PRODUCT.  SHALL BE INSPECTED WITHIN FIVE
(5) BUSINESS DAYS OF DELIVERY TO DISTRIBUTOR’S DESIGNATED SHIPMENT LOCATIONS. 
DISTRIBUTOR SHALL, AT ITS SOLE COST AND EXPENSE, INSURE THE PRODUCTS FROM THE
TIME OF DELIVERY AT DISTRIBUTOR’S DESIGNATED SHIPMENT LOCATION UNTIL DELIVERY OF
THE UNITS OF UT PRODUCT BY DISTRIBUTOR TO CUSTOMER HAS BEEN COMPLETED.  IN EACH
CASE SUCH INSURANCE OR SELF-INSURANCE SHALL BE FOR THE UT PRODUCT’S FULL
REPLACEMENT VALUE (I.E., MARKET VALUE) AGAINST FIRE, THEFT, LOSS OR DESTRUCTION,
AND SUCH OTHER RISKS AS ARE CUSTOMARILY INSURED AGAINST BY PRUDENT PERSONS IN A
SIMILAR LINE OF BUSINESS.  AT UT’S REQUEST, DISTRIBUTOR SHALL FURNISH TO UT
CERTIFICATES OF INSURANCE EVIDENCING THE TYPES AND AMOUNTS OF COVERAGE.

 

6.4                                 MODIFICATION OF ORDERS.  NO ACCEPTED
PURCHASE ORDER SHALL BE MODIFIED OR CANCELED EXCEPT UPON THE WRITTEN AGREEMENT
OF BOTH PARTIES.

 

6.5                                 CHANGE ORDER CHARGES.  IF DISTRIBUTOR
REQUESTS MODIFICATIONS TO AN ACCEPTED ORDER PRIOR TO THE SCHEDULED DELIVERY DATE
PROVIDED IN SUCH ORDER, THEN, IN CONSIDERATION FOR ACCEPTING SUCH CHANGE ORDER,
UT MAY EXTEND THE SCHEDULED DELIVERY DATE AND/OR REQUIRE DISTRIBUTOR TO PAY A
CHANGE ORDER CHARGE EQUAL TO THE SUM OF THE ACTUAL DOCUMENTED NON-RECOVERABLE
COSTS INCURRED BY UT BY REASON OF SUCH CHANGE ORDER.

 

6.6                                 PRODUCT CHANGES.  SUBJECT TO APPLICABLE
REGULATORY APPROVAL, UT RESERVES THE RIGHT, IN ITS SOLE DISCRETION AND WITHOUT
INCURRING ANY LIABILITY TO DISTRIBUTOR EXCEPT AS OTHERWISE PROVIDED IN THIS
AGREEMENT, TO: (A) ALTER UT PRODUCT; (B) DISCONTINUE THE MANUFACTURE OF UT
PRODUCT; OR (C) COMMENCE THE MANUFACTURE AND SALE OF NEW PRODUCTS HAVING
FEATURES WHICH MAKE UT PRODUCT OBSOLETE.  UT ALSO RESERVES THE RIGHT, IN ITS
SOLE DISCRETION AND WITHOUT INCURRING ANY LIABILITY TO DISTRIBUTOR EXCEPT AS
OTHERWISE PROVIDED IN THIS AGREEMENT, IMMEDIATELY TO ALTER THE SPECIFICATIONS OR
THE MANUFACTURING PROCESS FOR UT PRODUCT FOR REASONS OF HEALTH OR SAFETY.  UT
SHALL FILL ALL ACCEPTED PURCHASE ORDERS FROM DISTRIBUTOR FOR ALTERED OR
DISCONTINUED UT PRODUCT FOR WHICH MANUFACTURING AND COMMERCIAL DELIVERIES HAVE
COMMENCED PRIOR TO THE EFFECTIVE DATE OF SUCH A CHANGE BUT OTHERWISE SHALL HAVE
NO OBLIGATION TO DO SO UNLESS THE DELIVERY DATE REQUESTED IN THE RELEVANT
PURCHASE ORDER IS PRIOR TO THE EFFECTIVE DATE OF SUCH A CHANGE. UT SHALL NOTIFY
DISTRIBUTOR IN WRITING WHEN SUCH MODIFICATIONS OR CHANGES OCCUR.

 

6.7                                 ROLLING FORECASTS.  DISTRIBUTOR SHALL
PROVIDE UT WITH AN ANNUAL, NON-BINDING TWELVE (12) MONTH FORECAST PROJECTING
DISTRIBUTOR’S INTENDED PURCHASES OF UT PRODUCT FOR THE COMING TWELVE (12)
MONTHS, AS WELL AS SUCH OTHER MUTUALLY AGREEABLE INFORMATION.  UT SHALL RECEIVE
THIS ANNUAL FORECAST NO LATER THAN JANUARY 10TH OF EACH CALENDAR YEAR. 
DISTRIBUTOR SHALL ALSO UPDATE UT ON A ROLLING BASIS EACH CALENDAR QUARTER, AND
EACH UPDATED FORECAST SHALL BE RECEIVED BY UT NO LATER THAN THE 10TH DAY OF THE
MONTH FOLLOWING THE END OF EACH CALENDAR QUARTER.

 

6.8                                 CHARGEBACK PRICING.  SUBJECT TO UT’S
REIMBURSEMENT OF THE “CHARGEBACKS” (AS DESCRIBED BELOW) DISTRIBUTOR SHALL
PROVIDE WHOLESALE DISTRIBUTION TO CERTAIN ENTITIES ELIGIBLE FOR DISCOUNTED
GOVERNMENT PRICING (E.G., FSS, VA, PHS (340B)) (“DISCOUNTED

 

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                                                ENTITY”) AS DESCRIBED HEREIN. 
THE DISCOUNTED GOVERNMENT PRICING IS LESS THAN THE PRICE AT WHICH DISTRIBUTOR
PURCHASES UT PRODUCT (I.E., LESS THAN THE PRICE SET FORTH IN ATTACHMENT A). 
DISTRIBUTOR SHALL CREATE AN ACCOUNT FOR EACH DISCOUNTED ENTITY PURCHASING UT
PRODUCT FROM DISTRIBUTOR.  AS PART OF THIS PROCESS, DISTRIBUTOR SHALL USE
COMMERCIALLY REASONABLE EFFORTS TO IDENTIFY WHETHER THE PROPOSED DISCOUNTED
ENTITY IS ELIGIBLE FOR DISCOUNTED GOVERNMENT PRICING THROUGH DIRECT
DOCUMENTATION FROM THE PROPOSED DISCOUNTED ENTITY OR THROUGH REVIEW OF DATA ON
THE HRSA ELIGIBILITY WEBSITE OR OTHER DATABASE RESOURCE.  AS AN ORDER FOR
PRODUCT IS RECEIVED FROM THE DISCOUNTED ENTITY, DISTRIBUTOR SHALL PROVIDE
PRODUCT TO THE DISCOUNTED ENTITY AT THE DISCOUNTED GOVERNMENT PRICE.  THE
DIFFERENCE BETWEEN THE DISCOUNTED GOVERNMENT PRICE AND THE LIST PRICE FOR THE
PRODUCT IS REFERRED TO AS THE “CHARGEBACK.” THE CHARGEBACK SHALL BE PAID BY UT
TO DISTRIBUTOR BY CHECK. WHEN SUBMITTING A CHARGEBACK REQUEST TO UT, DISTRIBUTOR
SHALL INCLUDE THE FOLLOWING INFORMATION: (I) DATE OF SALE TO DISCOUNTED ENTITY,
(II) THE DISCOUNTED ENTITY’S NAME AND ADDRESS, (III) PRODUCT(S) PURCHASED FROM
DISTRIBUTOR (IV) UT’S PRICE TO DISTRIBUTOR FOR THE PRODUCT, (V) DISTRIBUTOR’S
PRICE TO THE DISCOUNTED ENTITY FOR THE PRODUCT, AND (VI) THE AMOUNT OF
CHARGEBACK REQUESTED.  CHARGEBACK REQUEST(S) SHALL BE SUBMITTED TO UT BY THE
10TH OF EACH MONTH FOR ALL ACTIVITY IN THE PREVIOUS CALENDAR MONTH. UT SHALL
PROCESS CHARGEBACK CREDITS DUE DISTRIBUTOR WITHIN THIRTY (30) DAYS OF RECEIPT OF
THE CHARGEBACK SUBMISSION.  DISTRIBUTOR SHALL NOT SET OFF CHARGEBACKS OWED BY UT
AGAINST ANY AMOUNTS OWED BY DISTRIBUTOR TO UT. UPON TERMINATION OF THIS
AGREEMENT, IF THERE ARE ANY UNAPPLIED CREDITS FOR A CHARGEBACK, UT SHALL ISSUE A
CHECK IN THE AMOUNT THEREOF TO DISTRIBUTOR. CHARGEBACKS PAID HEREUNDER
CONSTITUTE REIMBURSEMENT TO DISTRIBUTOR FOR DEBITS INCURRED IN ADMINISTERING UT
DISCOUNTS TO DISCOUNTED ENTITIES, AND ARE NOT, AND SHOULD NOT BE CONSTRUED AS,
REMUNERATION INTENDED TO INDUCE DISTRIBUTOR TO PURCHASE, ORDER, LEASE, OR
RECOMMEND ANY UT PRODUCT.

 

ARTICLE 7:  PRICES AND PAYMENTS

 

7.1                                 PRICES.  DISTRIBUTOR SHALL PAY THE PRICES
FOR UT PRODUCT PURCHASED UNDER THIS AGREEMENT THAT ARE IN EFFECT AT THE TIME OF 
SUBMISSION OF A RELEVANT PURCHASE ORDER BY DISTRIBUTOR, EXCEPT AS PROVIDED IN
SECTION 7.2 BELOW.

 

7.2                                 PRICE CHANGES.  AT ANY TIME DURING THE TERM
OF THIS AGREEMENT, UT MAY INCREASE OR DECREASE ITS PRICES FOR UT PRODUCT WITH
NOTICE TO DISTRIBUTOR OF THE EFFECTIVE DATE OF THE PRICE CHANGE. ANY SUCH PRICE
CHANGE SHALL NOT APPLY TO PURCHASE ORDERS SUBMITTED PRIOR TO THE EFFECTIVE DATE
OF THE APPLICABLE PRICE CHANGE.

 

7.3                                 COSTS. ALL COSTS RELATED TO SHIPPING,
INSURING, PACKING, HANDLING AND DELIVERING UT PRODUCT TO DISTRIBUTOR’S FACILITY
SHALL BE AT THE SOLE EXPENSE OF UT.  ALL SUCH COSTS INCURRED AFTER THE INSTANT
OF DELIVERY TO THE DESIGNATED SHIPMENT LOCATION SHALL BE THE RESPONSIBILITY OF
DISTRIBUTOR. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, UT MAY,
IN ITS SOLE DISCRETION, CHARGE DISTRIBUTOR FOR ANY AND ALL SHIPPING, PACKING,
HANDLING OR DELIVERY CHARGES ASSOCIATED WITH EMERGENCY PURCHASE ORDERS, OR IF
DISTRIBUTOR PLACES THREE OR MORE ORDERS IN A ONE MONTH PERIOD.

 

7.4                                 PAYMENT TERMS; INVOICES.  DISTRIBUTOR SHALL
MAKE PAYMENTS FOR UT PRODUCT WITHIN SIXTY (60) DAYS OF ITS RECEIPT OF AN
APPLICABLE INVOICE FROM UT.  DISTRIBUTOR SHALL BE ELIGIBLE FOR A TWO PERCENT
(2%) PROMPT PAY DISCOUNT IF

 

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                                                PAYMENT IS RECEIVED BY UT WITHIN
THIRTY (30) DAYS OF THE DATE OF INVOICE. ALL PAYMENTS SHALL BE MADE IN UNITED
STATES DOLLARS.

 

7.5                                 PROVISION OF INVOICES TO GOVERNMENT PAYERS.
UPON THE REQUEST OF ANY FEDERAL OR STATE AGENCY WITH JURISDICTION OVER CLAIMS
FOR REIMBURSEMENT OF UT PRODUCT, DISTRIBUTOR MAY PROVIDE SUCH AGENCY WITH
INVOICES RECEIVED FROM UT THAT ACCURATELY REFLECT THE ACTUAL CHARGE TO
DISTRIBUTOR FOR UT PRODUCT PURCHASED PURSUANT TO THIS AGREEMENT WITH PROMPT
WRITTEN NOTICE TO UT OF SUCH REQUEST.

 

7.6                                 OVERDUE PAYMENTS.  IF AND FOR SO LONG AS ANY
PAYMENT FROM DISTRIBUTOR TO UT OR UT TO DISTRIBUTOR UNDER THIS AGREEMENT SHALL
BE OVERDUE:

 

(A)                                  INTEREST SHALL BE DUE AND PAYABLE AT THE
RATE OF TWELVE PERCENT (12%) PER ANNUM, OR SUCH LOWER RATE AS MAY BE THE MAXIMUM
LEGALLY PERMISSIBLE RATE OF INTEREST, ON ALL BALANCES OUTSTANDING FROM THE FIRST
DATE SUCH PAYMENT IS DUE UNTIL FULLY PAID;

 

(B)                                 EACH PARTY SHALL HAVE THE RIGHT TO RECOVER
ITS COLLECTION COSTS AND EXPENSES (INCLUDING REASONABLE ATTORNEYS’ FEES) FOR
LATE PAYMENTS.  UT RESERVES THE RIGHT TO WITHHOLD OR SUSPEND SHIPMENT OF UT
PRODUCT IF THERE IS ANY UNSETTLED OR OUTSTANDING BALANCE OWED OR CAUSED BY
DISTRIBUTOR TO UT AND TO REVOKE ANY CREDIT TERMS IT MAY OFFER DISTRIBUTOR; AND

 

(C)                                  OVERDUE PAYMENTS AUTOMATICALLY FORFEIT ANY
PROMPT PAY DISCOUNTS REFERENCED IN SECTION 7.3.

 

7.7                                 TAX PAYMENTS.  EACH PARTY SHALL PAY ALL
TAXES, DUTIES, IMPORT DEPOSITS, ASSESSMENTS AND OTHER GOVERNMENTAL CHARGES,
HOWEVER DESIGNATED, THAT ARE NOW OR HEREAFTER IMPOSED UPON SUCH PARTY BY ANY
GOVERNMENTAL AUTHORITY OR AGENCY IN CONNECTION WITH THE PERFORMANCE OF ITS
OBLIGATIONS UNDER THIS AGREEMENT.

 

7.8                                 RESALE PRICES.  THE PARTIES ACKNOWLEDGE THAT
DISTRIBUTOR MAY OFFER THE UT PRODUCT IN THE TERRITORY AT SUCH PRICES OR
DISCOUNTS AS DISTRIBUTOR, IN ITS SOLE DISCRETION, MAY DETERMINE.

 

7.9                                 DRUG FORMULARY.  THE PARTIES ACKNOWLEDGE AND
AGREE THAT NO PAYMENT MADE PURSUANT TO THIS AGREEMENT IS INTENDED IN ANY WAY AS
A PAYMENT RELATED TO A DRUG FORMULARY OR DRUG FORMULARY ACTIVITIES.  THE PARTIES
ACKNOWLEDGE AND AGREE THAT NO DRUG FORMULARY OR DRUG FORMULARY ACTIVITIES HAVE
BEEN NEGOTIATED OR DISCUSSED BETWEEN THE PARTIES IN CONNECTION WITH THIS
AGREEMENT.

 

ARTICLE 8:  ACCEPTANCE, WARRANTY AND PRODUCTS SUPPORT

 

8.1                                 ACCEPTANCE OF UT PRODUCT.  DISTRIBUTOR SHALL
PROMPTLY INSPECT EACH SHIPMENT OF UT PRODUCT.  IN THE EVENT OF ANY SHORTAGE,
DAMAGE, EXPIRATION OR DISCREPANCY IN A SHIPMENT OF UT PRODUCT ON THE EXTERIOR OF
THE SHIPMENT OF UT PRODUCT THAT IS PATENTLY OBVIOUS, DISTRIBUTOR SHALL PROMPTLY
REPORT THE SAME TO UT AND FURNISH SUCH WRITTEN EVIDENCE OR OTHER DOCUMENTATION
AS UT MAY REASONABLY REQUEST.  DISTRIBUTOR SHALL BE DEEMED TO HAVE ACCEPTED A
SHIPMENT AND UT SHALL NOT BE LIABLE FOR ANY SUCH SHORTAGE, DAMAGE, EXPIRATION OR
DISCREPANCY IN SUCH SHIPMENT UNLESS DISTRIBUTOR PROVIDES UT WITH SUCH NOTICE AND
SUBSTANTIATING EVIDENCE WITHIN FIVE (5) DAYS OF RECEIPT OF THE UT PRODUCT AT
DISTRIBUTOR’S DESIGNATED SHIPMENT LOCATION.  UPON RECEIPT OF REASONABLE
SUBSTANTIATING EVIDENCE OF SUCH SHORTAGE, DAMAGE OR DISCREPANCY, UT SHALL
PROMPTLY PROVIDE ADDITIONAL UT PRODUCT OR SUBSTITUTE PRODUCTS TO DISTRIBUTOR.

 

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8.2                                 PRODUCT WARRANTY.  UT HEREBY AUTHORIZES
DISTRIBUTOR TO PASS ON THE UT STANDARD WARRANTY SET FORTH IN ATTACHMENT D TO
DISTRIBUTOR’S CUSTOMERS IN THE TERRITORY, WHICH MAY BE REVISED BY UT UPON
WRITTEN NOTICE TO DISTRIBUTOR.

 

8.3                                 EXCLUDED CLAIMS.  UT SHALL NOT HAVE ANY
ADDITIONAL WARRANTY OBLIGATIONS TO DISTRIBUTOR OR CUSTOMERS UNDER SECTION 8.2
ABOVE OR OTHERWISE TO THE EXTENT THAT DISTRIBUTOR HAS MADE ANY WARRANTIES, ORAL
OR WRITTEN, BEYOND THOSE EXPRESSLY SET FORTH IN THE STANDARD UT WARRANTY, SET
FORTH IN ATTACHMENT D HERETO. DISTRIBUTOR SHALL NOT OFFER ITS CUSTOMERS ANY
WARRANTIES DIFFERENT FROM OR IN ADDITION TO THOSE GIVEN BY UT HEREUNDER.

 

8.4                                 LIMITED WARRANTY.   THE WARRANTIES SET FORTH
IN THE UT WARRANTY, ATTACHMENT D HERETO, AND THE OTHER TERMS AND CONDITIONS OF
THIS AGREEMENT, ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, WHICH
ARE HEREBY DISCLAIMED AND EXCLUDED BY UT, INCLUDING, WITHOUT LIMITATION, ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE.  THE
SOLE AND EXCLUSIVE REMEDIES FOR BREACH OF UT’S STANDARD WARRANTIES SHALL BE
LIMITED TO THE REMEDIES PROVIDED IN UT’S STANDARD WARRANTIES SET FORTH ON
ATTACHMENT D HERETO AND AS OTHERWISE PROVIDED IN THIS AGREEMENT.

 

8.5                                 LIMITED REMEDY.  UT SHALL NOT BE LIABLE TO
DISTRIBUTOR OR ANY OF ITS CUSTOMERS FOR LOSS OR DAMAGE CAUSED BY DISTRIBUTOR’S
DELAY IN FURNISHING THE PRODUCTS UNDER THIS AGREEMENT. UT SHALL NOT BE LIABLE TO
DISTRIBUTOR OR ANY OF ITS AFFILIATES, EMPLOYEES, AGENTS OR CONTRACTORS FOR ANY
SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL LOSSES OR DAMAGES, EVEN IF UT
SHALL HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH POTENTIAL LOSS OR DAMAGE BY
DISTRIBUTOR OR SUCH THIRD PARTY.      NOTWITHSTANDING THE FOREGOING, IN CASE OF
ANY CONFLICT BETWEEN THE PROVISIONS OF THIS SECTION AND SECTION 12.3,
SECTION 12.3 AND SECTION 12.4 SHALL CONTROL.

 

ARTICLE 9:  REGULATORY APPROVALS, COMPLIANCE AND AUDITS

 

9.1                                 COMPLIANCE WITH APPLICABLE LAWS.  UT SHALL
BE SOLELY RESPONSIBLE FOR, AND COMPLY WITH, APPLICABLE LAWS GOVERNING THE
REGULATION OF THE MANUFACTURE, IMPORTATION, DESIGN, TESTING, INSPECTION,
LABELING, SALE, WARNING AND INSTRUCTIONS FOR USE OF UT PRODUCT IN THE TERRITORY,
OR OTHERWISE APPLICABLE TO THE PERFORMANCE OF ITS OBLIGATIONS UNDER THIS
AGREEMENT.  DISTRIBUTOR SHALL COMPLY WITH ALL APPLICABLE LAWS GOVERNING ITS
DISTRIBUTION AND SALE OF UT PRODUCT IN THE TERRITORY, OR OTHERWISE APPLICABLE TO
THE PERFORMANCE OF ITS OBLIGATIONS HEREUNDER.  EACH PARTY SHALL COMPLY WITH
APPLICABLE LAWS INTENDED TO PREVENT FRAUD, WASTE AND ABUSE IN FEDERAL HEALTH
CARE PROGRAMS, INCLUDING BUT NOT LIMITED TO MEDICARE AND MEDICAID, AND SHALL
CONDUCT ITS ACTIVITIES HEREUNDER IN AN ETHICAL AND PROFESSIONAL MANNER.

 

9.2                                 GOVERNMENT INQUIRIES.  IN THE EVENT THAT
DISTRIBUTOR RECEIVES AN INQUIRY, OR SIMILAR NOTICE FROM A GOVERNMENT AGENCY OR
ENTITY FOR INFORMATION OR AN INSPECTION (A “NOTICE”) WHICH RELATES TO UT PRODUCT
OR THIS AGREEMENT, DISTRIBUTOR SHALL: (A) NOTIFY AND PROVIDE A COPY TO UT OF
SUCH NOTICE PROMPTLY WITHIN THREE (3) BUSINESS DAYS OF RECEIPT OF SUCH NOTICE;
(B) UNLESS EXPRESSLY PROHIBITED BY THE NOTICE, CONSULT WITH UT REGARDING ITS
RESPONSE TO THE NOTICE TO DETERMINE, AMONG OTHER THINGS, WHETHER ANY OF UT’S

 

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                                                CONFIDENTIAL INFORMATION SHALL
BE DISCLOSED (WHICH IN ALL EVENTS SHALL BE SUBJECT TO DISTRIBUTOR’S OBLIGATIONS
SPECIFIED IN ARTICLE 10 OF THIS AGREEMENT); (C) KEEP UT INFORMED OF THE PROGRESS
OF ANY INSPECTION AND PROVIDE UT WITH PRIOR NOTICE OF ANY DOCUMENTS RELATED TO
UT PRODUCT OR UT TO BE PROVIDED TO SUCH GOVERNMENT ENTITY; AND (D) PROVIDE UT
WITH A COPY OF ANY DOCUMENTS RELATED TO UT PRODUCT OR UT ULTIMATELY PRODUCED
PURSUANT TO SUCH NOTICE.  FURTHER, DISTRIBUTOR SHALL PROVIDE UT WITH A SUMMARY
OF THE RESULTS OF ANY INSPECTION AND SUCH ACTIONS, IF ANY, TAKEN TO REMEDY
CONDITIONS CITED IN SUCH INSPECTIONS.  DISTRIBUTOR FURTHER AGREES TO COOPERATE
WITH ANY INSPECTION OF A SHIPMENT OF UT PRODUCT BY A GOVERNMENTAL AGENCY.

 

9.3                                 ADVERSE EVENT REPORTING.  DISTRIBUTOR SHALL
NOT BE RESPONSIBLE FOR FDA REPORTING OF ADVERSE EVENTS. DISTRIBUTOR SHALL
ATTEMPT TO WARM TRANSFER A CALLER WITH POTENTIAL ADVERSE EVENT INFORMATION TO A
PHONE NUMBER DESIGNATED BY UT.  OTHERWISE, DISTRIBUTOR SHALL NOTIFY UT BY FAX TO
(919) 313-1297 OR E-MAIL AT DRUGSAFETY@UNITHER.COM IMMEDIATELY, OR AT THE LATEST
WITHIN THREE (3) BUSINESS DAYS, OF ANY COMPLAINT OF A POTENTIAL ADVERSE EVENT
FROM A THIRD PARTY BEING REPORTED TO DISTRIBUTOR.  AS DIRECTED BY UT, SUCH FAX
OR E-MAIL REPORT SENT BY DISTRIBUTOR SHALL INCLUDE INFORMATION AS REQUIRED BY UT
IN ORDER TO ADEQUATELY REPORT SUCH ADVERSE EVENT TO FDA.

 

9.4                                 WITHDRAWAL OR RECALL OF PRODUCT.  ANY
RECALLS OF UT PRODUCT SHALL BE CONDUCTED IN COMPLIANCE WITH FDA REQUIREMENTS AND
THE UT STANDARD OPERATING PROCEDURE FOR RECALLS (“UT RECALL SOP”) AS PROVIDED TO
AND ACCEPTED BY DISTRIBUTOR. DISTRIBUTOR SHALL PREPARE AND MAINTAIN A WRITTEN
STANDARD OPERATING PROCEDURE THAT PROVIDES PROCESSES FOR CONDUCTING
RECALL-RELATED ACTIVITIES FOR UT PRODUCT AS DIRECTED BY UT AND IN ACCORDANCE
WITH THE UT RECALL SOP.  THE DECISION TO RECALL UT PRODUCT SHALL BE MADE SOLELY
BY UT, UNLESS OTHERWISE DICTATED BY A GOVERNMENTAL AUTHORITY. UT SHALL BE
RESPONSIBLE FOR THE EXPENSES RELATED TO RECALL ACTIVITIES AS DESCRIBED BELOW,
UNLESS THE RECALL RESULTS FROM A BREACH OF ANY OF DISTRIBUTOR’S REPRESENTATIONS
AND WARRANTIES UNDER THIS AGREEMENT OR DISTRIBUTOR’S NEGLIGENCE OR WILLFUL
MISCONDUCT, IN WHICH EVENT DISTRIBUTOR SHALL BE RESPONSIBLE FOR ALL OF
RECALL-RELATED EXPENSES.  FOR PURPOSES OF THIS AGREEMENT, THE EXPENSES OF THE
ACTIVITIES SHALL BE: (I) THE REASONABLE EXPENSES OF NOTIFICATION AND RETURN OR
DESTRUCTION (IF AUTHORIZED BY UT) OF UT PRODUCT, (II) THE COST TO REPLACE UT
PRODUCT,  (III) THE COSTS DIRECTLY ASSOCIATED WITH THE DISTRIBUTION OF
REPLACEMENT UT PRODUCT INCLUDING PHARMACIST AND DISPENSING LABOR, COLD PACKS AND
LABELS; (IV.) REASONABLE COMMUNICATIONS TO INCLUDED PATIENTS SUCH AS PATIENT
LETTERS, PATIENT PHONE CALLS AND FOLLOW-UP CUSTOMER SERVICE; (V.) LABOR
ASSOCIATED WITH MANAGING THE RECALL PROCESS; (VI.) ANY EXPENSES ASSOCIATED WITH
DISPENSING ACTIVITY MISSED BY DISTRIBUTOR AS A RESULT OF UT’S PROVISION OF
PRODUCT TO INCLUDED PATIENTS BEYOND THAT IS NECESSARY TO REPLACE RECALLED
PRODUCT; AND (VII.) SHIPPING AND INSURANCE COSTS ASSOCIATED WITH RETURNING
RECALLED UT PRODUCT. DISTRIBUTOR AND UT SHALL COOPERATE FULLY WITH ONE ANOTHER
IN CONDUCTING ANY ACTIVITY CONTEMPLATED BY THIS SECTION 9.4.  DESTRUCTION OF
RECALLED PRODUCT SHALL BE CONDUCTED IN ACCORDANCE WITH THE RECALL PLAN, AS
APPROVED BY UT UNDER THE UT RECALL SOP AND BY ANY APPLICABLE GOVERNMENTAL
AUTHORITIES.  IF INSTRUCTED BY UT, DISTRIBUTOR MAY RETURN RECALLED UT PRODUCT TO
UT AT UT’S EXPENSE WITHIN THIRTY (30) DAYS FROM COMPLETION OF THE RECALL AND UT
SHALL REPLACE THE UT PRODUCT RECALLED OR REFUND THE COST OF SUCH RETURNED UT
PRODUCT. ANY UT PRODUCT RETURNED TO UT UNDER THIS SECTION 9.4 SHALL BE SHIPPED
BY COMMON CARRIER IN A MANNER THAT PRESERVES THE INTEGRITY OF THE UT PRODUCT
SHIPPED, AS INSTRUCTED BY UT.  TITLE TO THE RECALLED UT PRODUCT AND RISK OF
LOSS, THEFT, DESTRUCTION OR DAMAGE TO UT PRODUCT DURING SHIPMENT AS DESCRIBED
ABOVE SHALL PASS FROM DISTRIBUTOR TO UT UPON DELIVERY OF RECALLED UT PRODUCT AT
UT’S FACILITY.  DISTRIBUTOR’S OBLIGATION TO INSURE UT

 

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                                                PRODUCT SHALL CONTINUE WITH
RESPECT TO RECALLED UT PRODUCT UNTIL UT’S RECEIPT OF SUCH RECALLED UT PRODUCT.

 

9.5                                 VISITS BY PARTIES.  DISTRIBUTOR SHALL PERMIT
UT TO VISIT ITS PLACE OF BUSINESS AND INSPECT ITS RECORDS, INVENTORIES AND OTHER
RELEVANT MATERIALS AND RECORDS RELATING SOLELY TO ITS PERFORMANCE OF THIS
AGREEMENT, UPON REASONABLE ADVANCE NOTICE AND DURING NORMAL BUSINESS HOURS.

 

9.6                                 NO RETURNS.  UT WILL NOT ACCEPT THE RETURN
OF ANY UT PRODUCT, UNLESS AGREED IN WRITING BY UT, EXCEPT IF RETURNED PURSUANT
TO A RECALL UNDER SECTION 9.4 ABOVE.

 

ARTICLE 10:  PROPERTY OWNERSHIP; CONFIDENTIALITY

 

ALL CONFIDENTIAL INFORMATION AND OTHER PROPRIETARY MATERIALS, DOCUMENTS,
INFORMATION, DATABASES, COMPLETE AND INCOMPLETE CASE REPORT FORMS AND ALL DATA
THAT ONE PARTY (“DISCLOSING PARTY”) SUPPLIES TO THE OTHER PARTY (“RECEIVING
PARTY”) SHALL BE THE SOLE AND EXCLUSIVE PROPERTY OF THE DISCLOSING PARTY
(“DISCLOSING PARTY PROPERTY”). ALL CONFIDENTIAL INFORMATION SHALL BE DEEMED
CONFIDENTIAL AND PROPRIETARY TO THE DISCLOSING PARTY. DURING THE TERM OF THIS
AGREEMENT AND FOR A PERIOD OF FIVE (5) YEARS FOLLOWING THEREAFTER, THE RECEIVING
PARTY SHALL: (A) NOT DISCLOSE OR PROVIDE ANY CONFIDENTIAL INFORMATION TO ANY
THIRD PARTY, AND (B) TAKE REASONABLE MEASURES TO PREVENT ANY UNAUTHORIZED
DISCLOSURE OF CONFIDENTIAL INFORMATION BY ITS EMPLOYEES, AGENTS, CONTRACTORS OR
CONSULTANTS DURING THE TERM HEREOF INCLUDING ADVISING SUCH INDIVIDUALS OF
APPLICABLE CONFIDENTIALITY OBLIGATIONS.  UPON TERMINATION OF THIS AGREEMENT, THE
RECEIVING PARTY SHALL RETURN OR DESTROY TO THE DISCLOSING PARTY, AT THE
DISCLOSING PARTY’S REQUEST AND EXPENSE, ALL UNUSED DISCLOSING PARTY PROPERTY,
EXCEPT THE RECEIVING PARTY MAY KEEP ONE (1) COPY OF SUCH DISCLOSING PARTY
PROPERTY FOR LEGAL ARCHIVAL PURPOSES.

 

ARTICLE 11:  TRADEMARKS

 

11.1                           TRADEMARK LICENSE GRANT.  UT HEREBY GRANTS TO
DISTRIBUTOR, AND DISTRIBUTOR HEREBY ACCEPTS FROM UT, A NONEXCLUSIVE,
NONTRANSFERABLE, AND ROYALTY-FREE RIGHT AND LICENSE, DURING THE TERM OF THIS
AGREEMENT, TO REPRODUCE AND USE THE UT TRADEMARKS IN CONNECTION WITH THE
DISTRIBUTION, MARKETING AND SALE OR OTHER DISTRIBUTION OF UT PRODUCT IN THE
TERRITORY AND IN ACCORDANCE WITH UT’S STANDARDS AND INSTRUCTIONS AND FOR NO
OTHER PURPOSE.  DISTRIBUTOR SHALL NOT USE ANY OTHER MARKS OR TRADE NAMES IN
CONNECTION WITH THE MARKETING AND DISTRIBUTION OF UT PRODUCT, EXCEPT THAT
DISTRIBUTOR MAY USE ITS MARKS OR TRADE NAMES IN A MANNER CONSISTENT WITH ITS
NORMAL COURSE OF BUSINESS, SUCH AS ADDING A LABEL ON THE PACKAGING IDENTIFYING
DISTRIBUTOR AS A DISTRIBUTOR OF UT PRODUCT, AND SUCH USE SHALL NOT CONFER ON UT
ANY RIGHTS OR LICENSE IN DISTRIBUTOR’S MARKS OR TRADE NAMES.  UT MAY INSPECT AND
MONITOR DISTRIBUTOR’S USE OF THE UT TRADEMARKS.  DISTRIBUTOR SHALL NOT REMOVE OR
ALTER ANY UT TRADE NAMES, TRADEMARKS, COPYRIGHT NOTICES, SERIAL NUMBERS, LABELS,
TAGS OR OTHER IDENTIFYING MARKS, SYMBOLS OR LEGENDS AFFIXED TO ANY UT PRODUCT,
DOCUMENTATION OR CONTAINERS OR PACKAGES.

 

11.2                           REGISTRATION.  IN ITS SOLE DISCRETION, UT MAY
REGISTER THE UT TRADEMARKS IN THE TERRITORY IF UT DETERMINES THAT REGISTRATION
IS NECESSARY OR USEFUL TO THE SUCCESSFUL DISTRIBUTION OF UT PRODUCT.  IN
ADDITION, IF UT BELIEVES THAT IT IS ADVISABLE TO EFFECT ANY FILING OR OBTAIN ANY
GOVERNMENTAL APPROVAL OR SANCTION FOR THE USE BY DISTRIBUTOR OF ANY OF UT
TRADEMARKS PURSUANT TO THIS AGREEMENT, THE PARTIES SHALL COOPERATE TO DO SO.
 ALL EXPENSES RELATING TO THE REGISTRATION OF THE UT TRADEMARKS IN THE TERRITORY
AS WELL AS THE MAKING OF ANY FILING OR OBTAINING ANY GOVERNMENTAL APPROVALS FOR
THE USE BY DISTRIBUTOR OF THE TRADEMARKS SHALL BE BORNE BY UT.

 

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11.3                           TERMINATION OF USE.  IMMEDIATELY UPON TERMINATION
OF THIS AGREEMENT, DISTRIBUTOR’S LICENSE AND RIGHT GRANTED IN SECTION 11.1 SHALL
BE REVOKED AND DISTRIBUTOR SHALL CEASE AND DESIST FROM USE OF ANY UT TRADEMARK
IN ANY MANNER, OTHER THAN TO LIQUIDATE ITS THEN-EXISTING INVENTORY OF UT PRODUCT
WITHIN SIX MONTHS OF SUCH TERMINATION. DISTRIBUTOR HEREBY GRANTS TO UT OR ITS
DESIGNEE, IN THE EVENT OF SUCH TERMINATION, FULL POWER OF ATTORNEY, WITH THE
RIGHT OF SUBSTITUTION, TO CANCEL, REVOKE OR WITHDRAW ANY GOVERNMENTAL
REGISTRATION OR AUTHORIZATION PERMITTING DISTRIBUTOR TO USE ANY UT TRADEMARK IN
THE TERRITORY, AND DISTRIBUTOR SHALL PROVIDE SUCH FURTHER DOCUMENTATION AND
ASSISTANCE AS UT MAY REASONABLY REQUEST IN CONNECTION THEREWITH.

 

11.4                           RESERVATION OF RIGHTS.

 

(A)                                  DISTRIBUTOR ACKNOWLEDGES UT’S PROPRIETARY
RIGHTS IN AND TO ANY UT TRADEMARK, SUBJECT TO THE LICENSE AND RIGHT GRANTED IN
SECTION 11.1.  DISTRIBUTOR SHALL NOT ADOPT, USE OR REGISTER ANY WORDS, PHRASES
OR SYMBOLS THAT ARE IDENTICAL TO OR CONFUSINGLY SIMILAR TO ANY UT TRADEMARK AND
SHALL NOT USE ANY UT TRADEMARK AS PART OF DISTRIBUTOR’S CORPORATE OR TRADE NAME
OR PERMIT ANY THIRD PARTY TO DO SO.

 

(B)                                 UT ACKNOWLEDGES DISTRIBUTOR’S PROPRIETARY
RIGHTS IN AND TO ANY OF DISTRIBUTOR’S TRADEMARKS. UT SHALL NOT ADOPT, USE OR
REGISTER ANY WORDS, PHRASES OR SYMBOLS THAT ARE IDENTICAL TO OR CONFUSINGLY
SIMILAR TO ANY OF DISTRIBUTOR’S TRADEMARKS AND SHALL NOT USE ANY SUCH TRADEMARK
AS PART OF UT’S CORPORATE OR TRADE NAME OR PERMIT ANY THIRD PARTY TO DO SO.

 

11.5                           INFRINGEMENTS.  EACH PARTY SHALL PROMPTLY NOTIFY
THE OTHER PARTY IN WRITING IF IT BECOMES AWARE OF ANY USE IN THE TERRITORY BY
ANY THIRD PARTY OF TRADEMARK OR OF ANY SIMILAR MARK, WHICH MAY CONSTITUTE AN
INFRINGEMENT OF A UT TRADEMARK OR DISTRIBUTOR’S TRADEMARKS. SUBJECT TO THE
PROVISIONS OF THIS ARTICLE 11,  EACH PARTY SHALL HAVE THE EXCLUSIVE RIGHT, IN
ITS SOLE DISCRETION, TO INSTITUTE PROCEEDINGS AGAINST THIRD-PARTY INFRINGERS OF
ITS TRADEMARKS.

 

ARTICLE 12:  INSURANCE AND INDEMNIFICATION

 

12.1                           INSURANCE.  DISTRIBUTOR SHALL MAINTAIN IN EFFECT
DURING THE TERM OF THIS AGREEMENT A COMPREHENSIVE GENERAL LIABILITY POLICY
(WHICH MAY BE IN THE FORM OF PRIMARY OR EXCESS COVERAGE) IN AN AMOUNT NOT LESS
THAN TWO MILLION DOLLARS ($2,000,000) PER OCCURRENCE AND THREE MILLION DOLLARS
($3,000,000) IN THE AGGREGATE.  THE DEDUCTIBLE FOR SUCH POLICY SHALL BE NO MORE
THAN ONE HUNDRED THOUSAND DOLLARS ($100,000) DISTRIBUTOR AGREES TO PROVIDE UT
WITH A CERTIFICATE OF INSURANCE EVIDENCING COMPLIANCE WITH THIS SECTION  UPON
WRITTEN REQUEST OF UT.

 

12.2                           CLAIMS.  FOR THE PURPOSES OF THIS ARTICLE 12 A
“CLAIM” SHALL MEAN ANY LIABILITIES, DAMAGES, COSTS OR EXPENSES, INCLUDING,
WITHOUT LIMITATION, REASONABLE ATTORNEYS’ FEES ARISING FROM ANY CLAIM, LAWSUIT,
DEMAND OR OTHER ACTION BY A THIRD PARTY.

 

12.3                           DISTRIBUTOR INDEMNIFICATION OF UT.  EXCEPT AS
PROVIDED IN SECTION 12.4, DISTRIBUTOR SHALL INDEMNIFY, DEFEND AND HOLD HARMLESS
UT, ITS AFFILIATES, AND THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES, AGENTS,
SUCCESSORS AND ASSIGNS FROM AND AGAINST ANY CLAIM TO THE EXTENT SUCH CLAIM
RELATES TO OR IS BASED ON: (A) PROPERTY DAMAGE, PERSONAL INJURY OR DEATH
RESULTING FROM DISTRIBUTOR’S NEGLIGENT OR RECKLESS PROVISION OR MAINTENANCE OF
UT PRODUCT (EXCEPT TO THE EXTENT THE SAME RESULTS FROM ANY WRONGFUL

 

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ACT OR OMISSION OF UT); (B) DISTRIBUTOR’S VIOLATION OF APPLICABLE LAWS; OR
(C) ANY BREACH BY DISTRIBUTOR OF ANY OF ITS REPRESENTATIONS, WARRANTIES,
COVENANTS OR AGREEMENTS UNDER THIS AGREEMENT.

 

12.4                           UT INDEMNIFICATION OF DISTRIBUTOR FOR UT
PRODUCT.  EXCEPT AS PROVIDED IN SECTION 12.3, UT SHALL INDEMNIFY, DEFEND AND
HOLD HARMLESS DISTRIBUTOR AND ITS AFFILIATES, AND THEIR RESPECTIVE OFFICERS,
DIRECTORS, EMPLOYEES, AGENTS AND SUCCESSORS AND ASSIGNS FROM AND AGAINST ANY
CLAIM TO THE EXTENT SUCH CLAIM RELATES TO OR IS BASED ON: (A) PROPERTY DAMAGE,
PERSONAL INJURY OR DEATH RESULTING FROM USE OF UT PRODUCT (EXCEPT TO THE EXTENT
THE SAME RESULTS FROM ANY WRONGFUL ACTION OR OMISSION OF DISTRIBUTOR); (B) UT’S
VIOLATION OF APPLICABLE LAWS; OR (C)  ANY BREACH BY UT OF ANY OF ITS
REPRESENTATIONS, WARRANTIES, COVENANTS OR AGREEMENTS UNDER THIS AGREEMENT.

 

12.5                           INDEMNIFICATION PROCEDURE.  A PARTY SEEKING
INDEMNIFICATION UNDER THIS ARTICLE 12 (“INDEMNIFIED PARTY”) SHALL GIVE PROMPT
WRITTEN NOTICE TO THE INDEMNIFYING PARTY (“INDEMNIFYING PARTY”) OF ANY CLAIM
COVERED BY THE INDEMNIFICATION OBLIGATIONS HEREUNDER; PROVIDED, HOWEVER, THAT A
DELAY IN SUCH NOTICE SHALL NOT TERMINATE THE INDEMNIFYING PARTY’S
INDEMNIFICATION OBLIGATIONS HEREUNDER, UNLESS SUCH DELAY SHALL HAVE MATERIALLY
IMPAIRED THE DEFENSE OF SUCH CLAIM.   SUCH INDEMNIFYING PARTY SHALL HAVE SOLE
AND EXCLUSIVE CONTROL OF THE DEFENSE OF ANY SUCH CLAIM, INCLUDING THE CHOICE AND
DIRECTION OF ANY LEGAL COUNSEL; PROVIDED, HOWEVER, IF INDEMNIFYING PARTY’S
CHOICE OF LEGAL COUNSEL WOULD BE SUBJECT TO A MATERIAL CONFLICT OF INTEREST
UNDER THE APPLICABLE RULES OF PROFESSIONAL CONDUCT GOVERNING SUCH COUNSEL, THE
INDEMNIFIED PARTY SHALL NOT BE OBLIGATED TO WAIVE SUCH CONFLICT AND MAY REQUEST
SEPARATE LEGAL COUNSEL AT THE INDEMNIFYING PARTY’S EXPENSE.  THE INDEMNIFYING
PARTY MAY NOT SETTLE OR COMPROMISE ANY SUCH CLAIM WITHOUT THE WRITTEN CONSENT OF
THE INDEMNIFIED PARTY, WHICH CONSENT SHALL NOT BE UNREASONABLY WITHHELD.

 

12.6                           LITIGATION SUPPORT.  IN THE EVENT AND FOR SO LONG
AS AN INDEMNIFYING PARTY ACTIVELY IS CONTESTING OR DEFENDING AGAINST ANY CLAIM
UNDER THIS ARTICLE 12, THE INDEMNIFIED PARTY SHALL COOPERATE WITH THE
INDEMNIFYING PARTY AND ITS LEGAL COUNSEL IN THE CONTEST OR DEFENSE OF SUCH
CLAIM, MAKE AVAILABLE ITS PERSONNEL, AND PROVIDE SUCH TESTIMONY AND ACCESS TO
ITS BOOKS AND RECORDS AS SHALL BE REASONABLY NECESSARY IN CONNECTION WITH THE
CONTEST OR DEFENSE OF SUCH CLAIM, ALL AT THE SOLE COST AND EXPENSE OF THE
INDEMNIFYING PARTY.

 

12.7                           SUBROGATION.  THE INDEMNIFYING PARTY SHALL BE
SUBROGATED TO THE RIGHTS OF THE INDEMNIFIED PARTY AGAINST ANY THIRD PARTY
BRINGING A CLAIM, AND SUCH INDEMNIFIED PARTY HEREBY ASSIGNS TO THE INDEMNIFYING
PARTY ALL CLAIMS, CAUSES OF ACTION AND OTHER RIGHTS THAT THE INDEMNIFIED PARTY
MAY THEN HAVE AGAINST SUCH THIRD PARTY.  CONVERSELY, AND WITHOUT IN ANY WAY
LIMITING THE OBLIGATION OF EITHER PARTY TO INDEMNIFY THE OTHER PARTY AS HEREIN
PROVIDED, TO THE EXTENT THAT AN INDEMNIFYING PARTY FAILS TO PERFORM ITS
INDEMNIFICATION OBLIGATIONS UNDER SECTION 12.3 OR SECTION 12.4 ABOVE, THE
INDEMNIFYING PARTY HEREBY ASSIGNS TO THE INDEMNIFIED PARTY ALL CLAIMS, CAUSES OF
ACTION AND OTHER RIGHTS WHICH THE INDEMNIFYING PARTY MAY THEN HAVE AGAINST ANY
THIRD PARTY WITH RESPECT TO ANY CLAIM FOR WHICH INDEMNIFICATION IS PROVIDED
HEREUNDER.

 

ARTICLE 13:  ARTICLE 13  JOINT PUBLICITY

 

13.1                           PUBLIC DISCLOSURE.  IF EITHER PARTY WISHES TO
MAKE A PUBLIC DISCLOSURE CONCERNING THIS AGREEMENT OR THE RELATIONSHIP
ESTABLISHED HEREUNDER AND SUCH DISCLOSURE MENTIONS THE OTHER PARTY BY NAME OR
DESCRIPTION, SUCH OTHER PARTY SHALL BE PROVIDED WITH AN ADVANCE COPY OF THE
DISCLOSURE AND SHALL HAVE TWO (2) BUSINESS DAYS WITHIN WHICH TO APPROVE OR

 

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DISAPPROVE SUCH USE OR ITS NAME OF DESCRIPTION (INCLUDING MENTION OF THE NAME OF
THE PRODUCT); PROVIDED, HOWEVER: (A) APPROVAL SHALL NOT BE UNREASONABLY WITHHELD
BY EITHER PARTY; (B) FAILURE TO RESPOND WITHIN TWO (2) BUSINESS DAYS SHALL BE
DEEMED APPROVAL; AND (C) IF APPROVAL IS DENIED, NO DISCLOSURE SHALL USE THE NAME
OF OR OTHERWISE DESCRIBE SUCH PARTY EXCEPT TO THE EXTENT REQUIRED BY APPLICABLE
LAWS, OR THE EXTENT THAT THE DESCRIPTION OF THE OTHER PARTY IS LIMITED TO PUBLIC
INFORMATION ABOUT THE AVAILABILITY OF UT PRODUCT.

 

13.2                           FILINGS WITH SECURITIES AND EXCHANGE COMMISSION. 
NOTWITHSTANDING THE FOREGOING, EACH PARTY ACKNOWLEDGES THAT BOTH PARTIES ARE, OR
ARE AFFILIATES OF, A PUBLICLY TRADED COMPANY AND EACH PARTY HEREBY CONSENTS TO
THE DISCLOSURE OF THIS AGREEMENT AND THE RELATIONSHIP BETWEEN THE PARTIES IN
THEIR RESPECTIVE FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION AND
DISCLOSURES TO THEIR STOCKHOLDERS; PROVIDED, HOWEVER, THAT EACH PARTY SHALL USE
COMMERCIALLY REASONABLE EFFORTS NOT TO DISCLOSE THE SPECIFIC FINANCIAL TERMS AND
CONDITIONS OF THIS AGREEMENT EXCEPT WHEN SUCH DISCLOSURE IS REQUIRED BY
APPLICABLE LAWS OR BY THIS AGREEMENT.

 

ARTICLE 14:  FORCE MAJEURE

 

14.1                           NOTICE.  A PARTY AFFECTED BY AN EVENT OF FORCE
MAJEURE SHALL PROMPTLY PROVIDE THE OTHER PARTY WITH WRITTEN NOTICE DESCRIBING
THE EVENT, ITS CAUSE AND FORESEEABLE DURATION, AND ITS POSSIBLE CONSEQUENCES
UPON PERFORMANCE UNDER THIS AGREEMENT.

 

14.2                           SUSPENSION OF PERFORMANCE.  AFTER AN AFFECTED
PARTY HAS GIVEN NOTICE UNDER SECTION 15.1, THAT PARTY SHALL BE RELIEVED OF ANY
PERFORMANCE OBLIGATION UNDER THIS AGREEMENT FOR OBLIGATIONS WHICH THE FORCE
MAJEURE EVENT PREVENTS, BUT ONLY TO THE EXTENT AND ONLY FOR SO LONG AS THE FORCE
MAJEURE PREVENTS PERFORMANCE.  THE OTHER PARTY MAY LIKEWISE SUSPEND THE
PERFORMANCE OF ALL OR PART OF ITS OBLIGATIONS, EXCEPT FOR THE OBLIGATION TO PAY
ANY AMOUNT DUE AND OWING AND THOSE OBLIGATIONS SPECIFIED IN SECTION 16.4(C) OF
THIS AGREEMENT. NOTWITHSTANDING THE FOREGOING, UT SHALL USE COMMERCIALLY
REASONABLE EFFORTS TO ALLOCATE AVAILABLE UT PRODUCT TO DISTRIBUTOR AT LEAST IN
PROPORTION TO DISTRIBUTOR’S HISTORICAL PURCHASES.

 

14.3                           SUBSTITUTE PERFORMANCE.  IF DISTRIBUTOR IS
DELAYED BY AN EVENT OF FORCE MAJEURE, UT SHALL, AT ITS SOLE OPTION, ALLOW A
THIRD PARTY TO COVER THE SERVICES RELATED TO THE DISTRIBUTION OF UT PRODUCT THAT
DISTRIBUTOR WAS UNABLE TO COMPLETE DUE TO ITS DELAY AND SUCH THIRD PARTY SHALL
RECEIVE THE FEES DISTRIBUTOR WOULD HAVE RECEIVED DURING ITS PERIOD OF DELAY.

 

14.4                           TERMINATION.  IF THE PERIOD OF FORCE MAJEURE
CONTINUES FOR MORE THAN SIXTY (60) DAYS, EITHER PARTY MAY TERMINATE THIS
AGREEMENT UPON GIVING NOTICE TO THE OTHER PARTY WITHOUT INCURRING LIABILITY
OTHER THAN THE OBLIGATION TO MAKE PAYMENTS DUE UP TO AND INCLUDING SUCH DATE OF
TERMINATION.

 

ARTICLE 15:  TERM AND TERMINATION

 

15.1                           TERM.  THE INITIAL TERM OF THIS AGREEMENT SHALL
BEGIN ON THE EFFECTIVE DATE AND SHALL CONTINUE IN FORCE FOR ONE (1) YEAR FROM
THE EFFECTIVE DATE.  THEREAFTER, THIS AGREEMENT SHALL AUTOMATICALLY RENEW FOR
ADDITIONAL PERIODS OF ONE (1) YEAR EACH, UNLESS EITHER OF THE PARTIES SHALL HAVE
GIVEN THE OTHER PARTY WRITTEN NOTICE OF ITS NON-RENEWAL OF THIS AGREEMENT NO
LATER THAN NINETY (90) DAYS PRIOR TO THE END OF THE INITIAL OR ANY RENEWAL TERM
HEREOF.

 

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15.2                           TERMINATION.  THIS AGREEMENT MAY BE TERMINATED
PRIOR TO THE EXPIRATION OF THE THEN CURRENT TERM AS FOLLOWS:

 

(A)                                  EITHER PARTY MAY TERMINATE THIS AGREEMENT
IMMEDIATELY UPON WRITTEN NOTICE TO THE OTHER PARTY IF THE OTHER PARTY FILES A
PETITION OF ANY TYPE AS TO ITS BANKRUPTCY, IS DECLARED BANKRUPT, BECOMES
INSOLVENT, MAKES AN ASSIGNMENT FOR THE BENEFIT OF CREDITORS, GOES INTO
LIQUIDATION OR RECEIVERSHIP, A PROCEEDING IS COMMENCED AGAINST IT WHICH WILL
SUBSTANTIALLY IMPAIR ITS ABILITY TO PERFORM HEREUNDER OR SUCH PARTY OTHERWISE
LOSES LEGAL CONTROL OF ITS BUSINESS;

 

(B)                                 EITHER PARTY MAY TERMINATE THIS AGREEMENT
UPON THE OCCURRENCE OF A MATERIAL BREACH BY THE OTHER PARTY (INCLUDING, BUT NOT
LIMITED TO, DISTRIBUTOR’S FAILURE TO PROMPTLY PAY SUMS OWING TO UT), WHICH
BREACH HAS NOT BEEN CURED WITHIN THIRTY (30) DAYS OF WRITTEN NOTICE OF SUCH
BREACH FROM THE NON-BREACHING PARTY;

 

(C)                                  EITHER PARTY MAY TERMINATE THIS AGREEMENT
UPON WRITTEN NOTICE IF AN EVENT OF FORCE MAJEURE CONTINUES FOR MORE THAN SIXTY
(60) DAYS AS PROVIDED IN SECTION 15.4;

 

(D)                                 THE PARTIES MAY AGREE IN WRITING TO
TERMINATE THIS AGREEMENT FOR THEIR MUTUAL CONVENIENCE AT ANY TIME AND FOR ANY
REASON, SUBJECT TO SUCH TERMS AND CONDITIONS AS THEY MAY THEN ADOPT;

 

(E)                                  EITHER PARTY MAY TERMINATE THIS AGREEMENT
AT ANY TIME, WITH OR WITHOUT CAUSE, BY WRITTEN NOTICE TO THE OTHER PARTY, WHICH
SHALL BE EFFECTIVE ONE HUNDRED AND EIGHTY DAYS (180) DAYS AFTER ITS DATE; AND

 

(F)                                    IF AT ANY TIME IN THE FUTURE, A CHANGE IN
THE REIMBURSEMENT OF UT PRODUCT OR LEGAL REQUIREMENTS OF PAYERS WOULD
(A) REQUIRE THE PARTIES TO RENEGOTIATE OR ALTER SIGNIFICANT TERMS OF THIS
AGREEMENT, OR (B) RESULT IN A SUBSTANTIAL ADVERSE CHANGE IN THE RESPECTIVE
FINANCIAL BENEFITS OR BURDENS ACCRUING TO ANY PARTY UNDER THE TERMS OF THIS
AGREEMENT, THEN UPON WRITTEN REQUEST BY EITHER PARTY IN THE CASE OF (A), OR THE
AFFECTED PARTY IN THE CASE OF (B), THE PARTIES SHALL ENDEAVOR IN GOOD FAITH TO
RENEGOTIATE AND MODIFY THE TERMS OF THIS AGREEMENT TO COMPLY WITH SUCH NEW
REQUIREMENTS OR AVOID SUCH SUBSTANTIAL ADVERSE CHANGE.  IF THE PARTIES ARE
UNABLE TO AGREE TO SUCH MODIFICATIONS WITHIN ONE HUNDRED TWENTY (120) DAYS OF
RECEIPT OF THE WRITTEN REQUEST, THEN EITHER PARTY (IN THE CASE OF (A)), OR THE
ADVERSELY AFFECTED PARTY (IN THE CASE OF (B)) MAY TERMINATE THIS AGREEMENT
IMMEDIATELY UPON EXPIRATION OF THE ONE HUNDRED TWENTY (120) DAY PERIOD.

 

15.3                           PARTIAL TERMINATION.  IN THE EVENT THAT  EITHER
PARTY SHALL HAVE THE RIGHT PURSUANT TO THE PROVISIONS OF SECTION 15.2 TO
TERMINATE THIS AGREEMENT IN ITS ENTIRETY, THAT PARTY MAY ELECT, IN ITS SOLE
DISCRETION, TO TERMINATE THIS AGREEMENT SOLELY AS IT APPLIES TO A PORTION OF THE
TERRITORY, OR, IF APPLICABLE, ANY CATEGORY OF CUSTOMER.

 

15.4                           RIGHTS AND OBLIGATIONS ON TERMINATION.  IF THIS
AGREEMENT IS TERMINATED FOR ANY REASON, THE PARTIES SHALL HAVE THE FOLLOWING
RIGHTS AND OBLIGATIONS:

 

(A)                                  TERMINATION OF THIS AGREEMENT SHALL NOT
RELEASE EITHER PARTY FROM THE OBLIGATION TO MAKE PAYMENTS OF ALL AMOUNTS THEN OR
THEREAFTER DUE AND PAYABLE, AND SHALL NOT RELEASE UT FROM ITS OBLIGATIONS TO
PROVIDE UT PRODUCT TO DISTRIBUTOR AT DISTRIBUTOR’S REQUEST TO SERVICE ITS
EXISTING PATIENTS AS OF THE EFFECTIVE TERMINATION DATE AND UNTIL SUCH EXISTING
PATIENTS ARE TRANSITIONED TO ANOTHER

 

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DISTRIBUTOR. DISTRIBUTOR AND UT SHALL USE THEIR BEST EFFORTS TO ACHIEVE SUCH
TRANSITION AS EXPEDITIOUSLY AS POSSIBLE AFTER THE EFFECTIVE TERMINATION DATE;

 

(B)                                 EACH PARTY’S RESPECTIVE OBLIGATIONS OF
CONFIDENTIALITY UNDER ARTICLE 13 AND RECORD RETENTION UNDER ARTICLE 18 SHALL
SURVIVE AS PROVIDED IN SUCH ARTICLES;

 

(C)                                  EACH PARTY’S RESPECTIVE OBLIGATIONS UNDER
SECTION 7.3, ‘PAYMENT TERMS; INVOICES,’ SECTION 9.2, ‘COMPLIANCE WITH LAWS,’ THE
INDEMNIFICATION PROVISIONS OF ARTICLE 12, THIS ARTICLE 16 AND ARTICLE 17,
‘DISPUTE RESOLUTION,’ SHALL SURVIVE TERMINATION OF THIS AGREEMENT; AND

 

(D)                                 UT SHALL CAUSE OTHER ENTITIES TO UNDERTAKE,
OR SHALL OTHERWISE RELIEVE DISTRIBUTOR OF ITS OBLIGATIONS AND ALL COSTS RELATING
TO ALL PAP PATIENTS, AND SHALL COMPLETE SUCH TRANSITION OR RELIEF WITH RESPECT
TO SUCH PATIENTS NO LATER THAN ONE HUNDRED AND EIGHTY (180) DAYS FROM THE
TERMINATION DATE.  DISTRIBUTOR AGREES TO USE ITS BEST EFFORTS TO COOPERATE WITH
SUCH TRANSFER.

 

ARTICLE 16:  DISPUTE RESOLUTION

 

16.1                           NEGOTIATION.  THE PARTIES AGREE TO CONSULT AND
NEGOTIATE IN GOOD FAITH TO TRY TO RESOLVE ANY DISPUTE, CONTROVERSY OR CLAIM THAT
ARISES OUT OF OR RELATES TO THIS AGREEMENT.  EXCEPT AS PROVIDED IN SECTION 16.2,
NO FORMAL DISPUTE RESOLUTION SHALL BE USED BY EITHER PARTY UNLESS AND UNTIL
SENIOR EXECUTIVE OFFICERS OF EACH PARTY SHALL HAVE ATTEMPTED TO MEET IN PERSON
TO ACHIEVE SUCH AN AMICABLE RESOLUTION.

 

16.2                           RESERVATION FOR LITIGATION.  NOTWITHSTANDING
SECTION 16.3 BELOW, EACH PARTY EXPRESSLY RESERVES THE RIGHT TO SEEK JUDICIAL
RELIEF FROM A COURT OF COMPETENT JURISDICTION IF THE OTHER PARTY IS OR APPEARS
TO BE IN VIOLATION OF SUCH OTHER PARTY’S OBLIGATIONS OF NON-USE AND
NON-DISCLOSURE UNDER ARTICLE 10 ABOVE AND  EACH PARTY EXPRESSLY RESERVES THE
RIGHT TO SEEK INJUNCTIVE OR SIMILAR EQUITABLE RELIEF FOR ANY VIOLATION OR BREACH
HEREUNDER.

 

16.3                           ARBITRATION.  SUBJECT TO THE RESERVATION OF THE
PARTIES UNDER SECTION 16.2 ABOVE, ANY DISPUTE, CONTROVERSY OR CLAIM THAT ARISES
OUT OF OR RELATES TO THIS AGREEMENT THAT IS NOT RESOLVED UNDER SECTION 16.1
SHALL BE SETTLED BY FINAL AND BINDING ARBITRATION IN ACCORDANCE WITH THE
COMMERCIAL ARBITRATION RULES OF THE AMERICAN ARBITRATION ASSOCIATION (“AAA”) IN
EFFECT ON THE EFFECTIVE DATE, AS MODIFIED BY SECTION 16.4 BELOW.  JUDGMENT UPON
THE AWARD RENDERED BY THE ARBITRATORS MAY BE ENTERED IN ANY COURT OF COMPETENT
JURISDICTION.  THE PLACE OF ARBITRATION SHALL NEW YORK, NEW YORK, U.S.A.  THE
ARBITRATION SHALL BE CONDUCTED IN THE ENGLISH LANGUAGE BY THREE (3) NEUTRAL
ARBITRATORS SELECTED BY MUTUAL AGREEMENT OF THE PARTIES OR, IF THAT IS NOT
POSSIBLE WITHIN THIRTY (30) DAYS OF THE INITIAL DEMAND FOR SUCH ARBITRATION, BY
THE AAA.

 

16.4                           SPECIAL RULES.  NOTWITHSTANDING ANY PROVISION TO
THE CONTRARY IN THE AAA’S RULES, THE PARTIES HEREBY STIPULATE THAT ANY
ARBITRATION HEREUNDER SHALL BE SUBJECT TO THE FOLLOWING SPECIAL RULES:

 

(A)                                  EACH PARTY SHALL HAVE THE RIGHT TO REQUEST
FROM THE ARBITRATORS, AND THE ARBITRATORS SHALL ORDER UPON GOOD CAUSE SHOWN,
REASONABLE AND LIMITED PRE-HEARING DISCOVERY, INCLUDING (I) EXCHANGE OF WITNESS
LISTS, (II) DEPOSITIONS UNDER OATH OF NAMED WITNESSES, (III) WRITTEN
INTERROGATORIES, AND (IV) DOCUMENT REQUESTS;

 

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(B)                                 UPON CONCLUSION OF THE PRE-HEARING
DISCOVERY, THE ARBITRATORS SHALL PROMPTLY HOLD A HEARING UPON THE EVIDENCE TO BE
PRESENTED BY THE PARTIES AND SHALL PROMPTLY RENDER A WRITTEN OPINION AND AWARD;

 

(C)                                  THE ARBITRATORS MAY NOT AWARD OR ASSESS
PUNITIVE DAMAGES AGAINST EITHER PARTY; AND

 

(D)                                 EACH PARTY SHALL BEAR ITS OWN COSTS AND
EXPENSES OF THE ARBITRATION AND ONE-HALF (1/2) OF THE FEES AND COSTS OF THE
ARBITRATORS, SUBJECT TO THE POWER OF THE ARBITRATORS, IN THEIR SOLE DISCRETION,
TO AWARD ALL SUCH REASONABLE COSTS, EXPENSES AND FEES TO THE PREVAILING PARTY.

 

ARTICLE 17:  RECORDS

 

DURING THE TERM HEREOF AND FOR THREE (3) YEARS THEREAFTER, OR SUCH LONGER PERIOD
AS MAY BE REQUIRED BY APPLICABLE LAWS, DISTRIBUTOR SHALL MAINTAIN ACCURATE
RECORDS AS REQUIRED TO MEET APPLICABLE LAWS.  EXCEPT AS OTHERWISE REQUIRED BY
APPLICABLE LAWS, DISTRIBUTOR SHALL PROVIDE UT WITH ACCESS TO ANY REASONABLY
REQUESTED DOCUMENTATION RELATED SOLELY TO THIS AGREEMENT DURING REASONABLE
BUSINESS HOURS.  UT SHALL GIVE DISTRIBUTOR SEVEN (7) DAYS’ PRIOR WRITTEN NOTICE
OF SUCH EXAMINATIONS, WHICH WILL NOT OCCUR MORE THAN ONCE ANNUALLY, AND SUCH
EXAMINATIONS SHALL BE UNDERTAKEN ONLY TO SUCH EXTENT NECESSARY TO VERIFY THAT
THE DISTRIBUTOR HAS COMPLIED WITH THE TERMS OF THIS AGREEMENT.

 

ARTICLE 18:  ARTICLE 18  GENERAL PROVISIONS

 

18.1                           ENTIRE AGREEMENT.  THIS AGREEMENT CONSTITUTES THE
ENTIRE AGREEMENT OF THE PARTIES   WITH RESPECT TO THE SUBJECT MATTER HEREOF AND
SUPERSEDES ALL THE PARTIES’ PREVIOUS OR CONTEMPORANEOUS CORRESPONDENCE, TERM
SHEETS, UNDERSTANDINGS, AGREEMENTS AND REPRESENTATIONS, ORAL OR WRITTEN BETWEEN
THE PARTIES.

 

18.2                           ASSIGNMENT.  NEITHER PARTY SHALL ASSIGN OR
OTHERWISE TRANSFER ITS RIGHTS OR OBLIGATIONS UNDER THIS AGREEMENT EXCEPT WITH
THE PRIOR WRITTEN CONSENT OF THE OTHER PARTY, WHICH SHALL NOT BE UNREASONABLY
WITHHELD OR DELAYED; PROVIDED, HOWEVER, THAT NO SUCH CONSENT SHALL BE REQUIRED
AND  EITHER PARTY MAY TRANSFER ALL RIGHTS AND OBLIGATIONS ARISING HEREUNDER TO
AN ENTITY IF IT IS: (A) AN AFFILIATE; (B) THE SUCCESSOR IN INTEREST BY REASON OF
SALE, MERGER OR OPERATION OF LAW; OR (C) HAS ACQUIRED ALL OR SUBSTANTIALLY ALL
OF THE ASSETS AND BUSINESS.  ANY UNAUTHORIZED ATTEMPTED ASSIGNMENT OR DELEGATION
SHALL BE NULL AND VOID AND OF NO FORCE OR EFFECT.

 

18.3                           SUBCONTRACTING. DISTRIBUTOR SHALL NOT, WITHOUT
THE PRIOR WRITTEN APPROVAL OF UT, APPOINT ANY DISTRIBUTORS OR AGENTS TO ACT ON
BEHALF OF DISTRIBUTOR (COLLECTIVELY, “SUB-DISTRIBUTORS”) TO DISTRIBUTE UT
PRODUCT WITHIN THE TERRITORY, OTHER THAN ANY OF ITS AFFILIATES.  DISTRIBUTOR
SHALL AT ALL TIMES REMAIN FULLY LIABLE FOR THE PERFORMANCE OF ANY APPROVED
SUB-DISTRIBUTORS AND DISTRIBUTOR SHALL PROVIDE UT WITH A WRITTEN ACKNOWLEDGEMENT
EXECUTED BY EACH SUB-DISTRIBUTOR THAT IT HAS READ THIS AGREEMENT AND AGREES TO
BE BOUND BY ITS TERMS AND CONDITIONS, INCLUDING THOSE CONTAINED IN THE
ATTACHMENTS HERETO. NOTWITHSTANDING THE FORGOING, DISTRIBUTOR MAY SUBCONTRACT
PORTIONS OF CERTAIN LIMITED FUNCTIONS AND RESPONSIBILITIES OF THIS AGREEMENT,
PROVIDED THAT THE SUBCONTRACTOR PERFORMS IN A MANNER CONFORMING TO THIS
AGREEMENT, SUBCONTRACTOR ENTERS INTO A CONFIDENTIALITY AGREEMENT NO LESS
EXTENSIVE THAN REQUIRED BY THIS AGREEMENT; AND DISTRIBUTOR RETAINS FULL
RESPONSIBILITY AND LIABILITY FOR THE PERFORMANCE OF THE SUBCONTRACTED SERVICE.
 AT NO TIME SHALL DISTRIBUTOR SUBCONTRACT

 

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ALL OR SUBSTANTIALLY ALL OF ANY GIVEN FUNCTION TO A THIRD PARTY WITHOUT THE
PRIOR WRITTEN CONSENT OF UT.

 

18.4                           AMENDMENT.  THIS AGREEMENT MAY NOT BE MODIFIED OR
AMENDED, IN WHOLE OR IN PART, EXCEPT BY A WRITTEN AGREEMENT SIGNED BY BOTH
PARTIES, AND SPECIFICALLY STATING THAT IT MODIFIES OR AMENDS THIS AGREEMENT.

 

18.5                           SEVERABILITY.  IF ONE OR MORE OF THE PROVISIONS
OF THIS AGREEMENT IS SUBSEQUENTLY DECLARED INVALID OR UNENFORCEABLE, THIS
AGREEMENT SHALL BE TREATED AS THOUGH THAT PROVISION WERE NOT IN THIS AGREEMENT,
AND THIS SHALL NOT AFFECT THE VALIDITY OR ENFORCEABILITY OF THE REMAINING
PROVISIONS OF THIS AGREEMENT (UNLESS THOSE PROVISIONS THAT ARE INVALIDATED OR
UNENFORCEABLE ARE CLEARLY MATERIAL AND INSEPARABLE FROM THE OTHER PROVISIONS). 
THE AGREEMENT AS MODIFIED SHALL BE APPLIED AND CONSTRUED TO REFLECT
SUBSTANTIALLY THE GOOD FAITH INTENT OF THE PARTIES AND TO ACHIEVE THE ECONOMIC
EFFECTS ORIGINALLY INTENDED BY THE TERMS HEREOF.

 

18.6                           NOTICES; LANGUAGE.  EXCEPT AS MAY BE OTHERWISE
PROVIDED IN THIS AGREEMENT, ANY NOTICE, DEMAND OR REQUEST GIVEN, MADE OR
REQUIRED TO BE MADE SHALL BE IN WRITING AND SHALL BE EFFECTIVE, UNLESS OTHERWISE
PROVIDED HEREIN, EITHER (A) WHEN DELIVERED IN PERSON TO THE OTHER PARTY, OR
(B) ON THE SAME BUSINESS DAY THAT IT IS TRANSMITTED BY FACSIMILE TO THE
FACSIMILE NUMBER (S) SET FORTH BELOW, WITH ELECTRONIC CONFIRMATION OF RECEIPT,
IF TRANSMITTED PRIOR TO 5:00 P.M. EASTERN TIME ON SUCH BUSINESS DAY, OR ON THE
FIRST BUSINESS DAY FOLLOWING SUCH TRANSMISSION IF TRANSMITTED AFTER 5:00 P.M.
EASTERN TIME OR IF TRANSMITTED ON A DAY OTHER THAN A BUSINESS DAY; PROVIDED A
HARD COPY IS DEPOSITED WITHIN ONE (1) DAY AFTER SUCH TRANSMISSIONS IN THE U.S.
MAIL, POSTAGE PREPAID, AND ADDRESSED AS SET FORTH BELOW FOR NOTICES BY U.S.
MAIL; OR (C) ON THE THIRD BUSINESS DAY FOLLOWING ITS DEPOSIT IN THE U.S. MAIL,
POSTAGE AND ADDRESSED AS FOLLOWS:

 

If to UT:

 

United Therapeutics Corporation

 

 

1110 Spring Street

 

 

Silver Spring, Maryland 20910

 

 

Attention: John Ferrari, Chief Financial Officer

 

 

Telefax: 301-608-9291

 

 

 

 

 

With a copy to:

 

 

United Therapeutics Corporation

 

 

1735 Connecticut Ave. NW

 

 

Washington, DC 20009

 

 

Attention: Paul Mahon, EVP & General Counsel

 

 

Telefax: 202-483-4005

 

 

 

If to DISTRIBUTOR:

 

Accredo Health Group

 

 

1640 Century Center Parkway

 

 

Memphis, TN 38134

 

 

Attention: Michael R. Hess, Chief Counsel Accredo

 

 

Telefax:  901-261-6840

 

18.7                           WAIVER.  EITHER PARTY’S FAILURE OR DELAY IN
EXERCISING ANY REMEDY FOR DEFAULT SHALL NOT BE DEEMED A WAIVER OF THAT OR ANY
SUBSEQUENT DEFAULTS OF THAT PROVISION OR OF ANY OTHER PROVISION HEREOF.  NO
WAIVER SHALL BE EFFECTIVE UNLESS MADE IN WRITING WITH SPECIFIC REFERENCE TO THE
RELEVANT PROVISION(S) OF THIS AGREEMENT AND SIGNED BY A DULY AUTHORIZED
REPRESENTATIVE OF THE PARTY GRANTING THE WAIVER.

 

--------------------------------------------------------------------------------

 

18.8                           COUNTERPARTS.  THIS AGREEMENT SHALL BE EXECUTED
IN TWO (2) OR MORE COUNTERPARTS IN THE ENGLISH LANGUAGE, EACH OF WHICH SHALL BE
DEEMED AN ORIGINAL, WHICH TAKEN TOGETHER SHALL CONSTITUTE ONE AND THE SAME
INSTRUMENT.

 

18.9                           GOVERNING LAW.  EXCEPT AS PROVIDED BY FEDERAL
LAW, THIS AGREEMENT SHALL BE GOVERNED BY, AND INTERPRETED AND CONSTRUED IN
ACCORDANCE WITH, THE LAWS OF THE STATE OF NEW YORK, EXCLUDING (A) ANY
CONFLICT-OF-LAWS RULE OR PRINCIPLE THEREIN CONTAINED UNDER WHICH ANY OTHER LAW
WOULD BE MADE APPLICABLE

 

18.10                     RELATIONSHIP.  THIS AGREEMENT DOES NOT MAKE EITHER
PARTY THE EMPLOYEE, AGENT OR LEGAL REPRESENTATIVE OF THE OTHER PARTY FOR ANY
PURPOSE WHATSOEVER.  NEITHER PARTY IS GRANTED ANY RIGHT OR AUTHORITY TO ASSUME
OR TO CREATE ANY OBLIGATION OR RESPONSIBILITY, EXPRESS OR IMPLIED, ON BEHALF OF
OR IN THE NAME OF THE OTHER PARTY.  IN FULFILLING ITS OBLIGATIONS PURSUANT TO
THIS AGREEMENT EACH PARTY SHALL BE ACTING AS AN INDEPENDENT CONTRACTOR AND SHALL
NOT BE DEEMED TO HAVE FORMED ANY PARTNERSHIP, JOINT VENTURE OR OTHER
RELATIONSHIP

 

18.11                     HEADINGS.  THE HEADINGS CONTAINED IN THIS AGREEMENT
ARE FOR REFERENCE PURPOSES ONLY AND SHALL NOT AFFECT IN ANY WAY THE MEANING OR
INTERPRETATION OF THIS AGREEMENT.

 

18.12                     SIGNATURE AUTHORITY.  EACH SIGNATORY TO THIS AGREEMENT
HAS SIGNATURE AUTHORITY AND, IS EMPOWERED ON BEHALF OF HIS OR HER RESPECTIVE
PARTY TO EXECUTE THIS AGREEMENT.

 

18.13                     CUMULATIVE REMEDIES.  EXCEPT AS EXPRESSLY PROVIDED IN
THIS AGREEMENT, AND TO THE EXTENT PERMITTED BY APPLICABLE LAWS, ANY REMEDIES
DESCRIBED IN THIS AGREEMENT ARE CUMULATIVE AND NOT ALTERNATIVE TO ANY OTHER
REMEDIES AVAILABLE AT LAW OR EQUITY.

 

18.14                     ANTI-KICKBACK LAW COMPLIANCE. EACH PARTY AGREES THAT
IT SHALL NOT VIOLATE THE FEDERAL ANTI-KICKBACK STATUTE, SET FORTH AT 42 U.S.C §
1320A-7B(B) (“ANTI-KICKBACK STATUTE”), THE FEDERAL “STARK LAW,” SET FORTH AT 42
U.S.C § 1395NN, OR THE PUBLIC CONTRACTS ANTI-KICKBACK LAW WITH RESPECT TO THE
PERFORMANCE OF ITS OBLIGATIONS UNDER THIS AGREEMENT. THE PARTIES INTEND TO TREAT
ALL DISCOUNTS (INCLUDING, BUT NOT LIMITED TO, PROMPT PAYMENT DISCOUNTS) PAYABLE
BY UT HEREUNDER AS “DISCOUNTS OR OTHER REDUCTIONS IN PRICE” PURSUANT TO THE
ANTI-KICKBACK STATUTE, AND TO COMPLY WITH THE DISCOUNT SAFE HARBOR SET FORTH AT
42 C.F.R. § 1001.952(H).  ACCORDINGLY, THE PARTIES AGREE THAT: (I) DISTRIBUTOR
SHALL, AS APPROPRIATE, DISCLOSE ALL DISCOUNTS RECEIVED HEREUNDER TO
REPRESENTATIVES OF MEDICARE, MEDICAID, ANY GOVERNMENTAL AUTHORITY, AND FEDERAL
HEALTH CARE PROGRAMS (AS DEFINED UNDER 42 U.S.C. 1320A-7B(F)) (COLLECTIVELY,
“GOVERNMENTAL ENTITIES”) UPON REQUEST IN 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 (WWW.MEDCO.COM).

 

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 Safety Box

·                  2 Sets of Safety Plugs

 

NDC 66303-206-02 Tyvaso Re-Supply Kit includes

·                  28 ampoules of Tyvaso

·                  1 Set of Autoclavable Parts

·                  32 Medicine Cups

·                  64 Filter Membranes

 

NDC 66302-206-03 Tyvaso Supplemental Refill includes

·                  4 ampoules of Tyvaso

 

UT shall notify the DISTRIBUTOR in writing of any change (and the amount of the
change) in the Price of any respective UT Product during the term of this
Agreement in the same time and manner as it notifies other similarly situated
distributors.

 

UT shall provide DISTRIBUTOR with a current list of Tyvaso prices to Discounted
Entities, including FSS prices, Federal Ceiling Prices, and prices to section
340B entities, and shall promptly notify Distributor of any and all changes in
such prices as well as the effective dates of such changes.

 

--------------------------------------------------------------------------------

 

Attachment  B

 

UT Trademarks Logotypes and Trade Names

 

UNITED THERAPEUTICS

 

UNITED THERAPEUTICS CORPORATION LOGO

 

REMODULIN

 

MEDICINES FOR LIFE

 

--------------------------------------------------------------------------------

 

Attachment  C
Patient Assistance Program Guidelines

 

The PAP will be administered in accordance with UT SOPs that will require at a
minimum the activities described in this Agreement and this Attachment C.
DISTRIBUTOR is responsible for collecting the necessary patient demographics,
financial, and clinical information and the oversight of the completion of the
PAP enrollment form application. In addition, the DISTRIBUTOR will follow these
guidelines and associated SOPs (as developed by UT) and will make the necessary
decisions for patient acceptance into the PAP. DISTRIBUTOR will maintain a
detailed and retrievable record of all communications, correspondence, and
activities related to the PAP including dispensing of UT Product, supplies, and
equipment without charge to the PAP Included Patient, and will use reasonable
attempts to aid in securing third party payer benefits for each PAP Included
Patient where applicable. In addition, DISTRIBUTOR shall take all necessary
steps to preserve the confidentiality of Included Patient information gathered
under the PAP in accordance with all federal, state and local laws relating to
patient privacy, except as such confidentiality may otherwise be expressly
waived by Included Patients.  If and when Included Patients are presented to
DISTRIBUTOR who do not meet the designated UT criteria, then DISTRIBUTOR will
consult with UT prior to any decision regarding PAP acceptance.

 

Indigent Patients

 

Included Patients who meet the UT PAP criteria for indigent patients will
qualify for the PAP for a period up to one (1) year from the date of acceptance
into the PAP.  DISTRIBUTOR will reevaluate Included Patient household income
information, health insurance status, and out-of-pocket medication and supply
expenses each quarter to assure continued eligibility.  At the end of the one
(1) year period, the PAP Included Patient will be required to re-enroll (as they
did with the initial application) and provide proof of income or lack of third
party payer information eligibility.

 

Under-Insured/”GAP” Coverage Patients

 

Included Patients who meet the under-insured/GAP coverage patient criteria will
qualify for the PAP for a period up to a maximum of six (6) months or until
he/she is able to obtain third party payer or similar reimbursement capabilities
(whichever comes first).  DISTRIBUTOR will reevaluate Included Patient household
income information, health insurance status, and out-of-pocket medication and
supply expenses each quarter to assure continued eligibility.

 

Potential Exhaustion of Insurance Coverage

 

Included Patients who meet the PAP criteria for potential exhaustion of
insurance coverage will qualify for the PAP program for a period up to one
(1) year from the date of acceptance into the PAP, except that eligibility will
terminate at any earlier time that the Included Patient obtains a new source of
insurance coverage (including supplemental coverage) and no longer meets the
applicable criteria. DISTRIBUTOR will reevaluate Included Patient household
income information, health insurance status, and out-of-pocket medication and
supply expenses each quarter to assure continued eligibility.

 

Further DISTRIBUTOR Responsibilities:

 

DISTRIBUTOR will use Best Efforts to secure all information to support
eligibility of PAP Included Patients PRIOR to any commitments for start of care.
However, it may not always be possible to secure all information in the event of
a medical need which could cause delays with the start of care. Therefore,
DISTRIBUTOR may obtain at the very minimum a completed and

 

--------------------------------------------------------------------------------

 

signed enrollment form and use its best judgment as to the Included Patient’s
eligibility for acceptance prior to receiving all required supporting
documentation. This will constitute a 28-30 day grace period for which the
DISTRIBUTOR will not be liable for UT Product, pumps/devices, and supporting
pump/device supplies from the initial start of care for a PAP Included Patient.
At the end of the grace period, UT will not provide or reimburse for additional
UT Product (or related supplies) unless DISTRIBUTOR obtains the required
supporting documentation and determines that the PAP Included Patient is
eligible for the PAP.

 

--------------------------------------------------------------------------------

 

Attachment  D
UT Warranty

 

UT warrants that all of its Product shall as of the date such Product arrives at
DISTRIBUTOR’s Designated Shipment Location: (i) be free from defects in design,
material and workmanship; (ii) be in compliance with all applicable law and
regulation, including without limitation all regulatory requirements of the FDA,
including those related to the adulteration or misbranding of Product within the
meaning of Section 501 and 502 of the Food Drug and Cosmetics Act; (iii) not be
articles which may not be introduced into interstate commerce pursuant to the
requirements of Sections 505, 514, 515, 516 or 520 thereof; (iv) be manufactured
in accordance with current FDA Good Manufacturing Practice as required by 21
C.F.R. 210 and 820; (v) are fit for the ordinary purposes for which such
Products are intended; and (vi) are not infringing upon the patents or
trademarks of any third party.

 

--------------------------------------------------------------------------------

 

Attachment E

 

Designated Shipment Locations and Designated Storage Locations

 

Name/Address/Phone/Fax

 

Name/Address/Phone/Fax

 

Name/Address/Phone/Fax

 

 

 

 

 

Accredo Health Group, Inc.
2100 Riverchase Center, Suite 405
Hoover, AL  35244
205-987-0778
800-442-7202
205-987-0332 (Fax)

 

Accredo Health Group, Inc.
12900 Foster, Suite 120
Overland Park, KS  66213
913-339-7100
800-569-5451
913-339-7440 (Fax)

 

Accredo Health Group, Inc.
45 Route, 46 East, Suite 609
Pine Brook, NJ  07058
973-276-0794
800-549-2654
973-276-0998 (Fax)

 

 

 

 

 

Accredo Health Group, Inc.
10400 North 25th Avenue, Suite 120
Phoenix, AZ  85021
602-944-1199
800-232-1199
602-944-1787 (Fax)

 

Accredo Health Group, Inc.
2115 Stanley Gault Parkway, #150
Louisville, KY 40223
502-244-2400
800-553-8832
502-244-5590 (Fax)

 

Accredo Health Group, Inc.
11A Commerce Way
Totowa, NJ  07512
973-256-1870
800-526-5113
973-256-5346 (Fax)

 

 

 

 

 

Accredo Health Group, Inc.
1831 Commerce Street, Suite 104
Corona, CA  92880
951-737-2355
800-622-1820
951-737-2553 (Fax)

 

Accredo Health Group, Inc.
520 Elmwood Park Blvd. Suite 145
Jefferson, LA 70123-6827
504-731-6113
800-250-5278
504-731-6112 (Fax)

 

Accredo Health Group, Inc.
505 East Capovilla, Suite 103
Las Vegas, NV   89119
702-895-8990
800-234-7044
702-895-8992 (Fax)

 

 

 

 

 

Accredo Health Group, Inc.
1660 Riverside Drive, Suite 101
Los Angeles, CA  90031
323-953-4500
888-709-6004
323-665-5123 (Fax)

 

Accredo Health Group, Inc.
261 Cedar Hill Street, Bldg. C
Marlboro, MA  01752
508-460-9813
800-343-9813
508-460-0072 (Fax)

 

AHG of New York, Inc.
500 Executive Blvd.
Elmsford, NY  10523-1109
914-592-0333
800-680-6843
914-592-5859 (Fax)

 

 

 

 

 

Accredo Health Group, Inc.
3069 Research Drive
Richmond, CA  94806
510-223-1360
800-842-3399
510-758-1235 (Fax)

 

Accredo Health Group, Inc.
39625 Lewis Drive, Suite 800
Novi, MI  48377
248-489-0300
800-688-2024
248-489-1126 (Fax)

 

Accredo Health Group, Inc.
4901 West Reno Rd, Ste 950
Oklahoma City, OK  73127
405-942-3961
800-999-9376
405-949-2689 (Fax)

 

 

 

 

 

Accredo Health Group, Inc.
361 Iverness Drive South, Suite F
Englewood, CO  80112
303-799-6550
800-488-0290
303-799-6551 (Fax)

 

Accredo Health Group, Inc.
2915 Waters Road, Suite 109
Eagan, MN  55121-1562
651-681-0885
800-955-3121
651-681—0977 (Fax)

 

Home HealthCare Resources, Inc.
800 Clarmont Avenue
Bensalem, PA  19020
215-245-7003
800-626-4427
215-245-9038 (Fax)

 

 

 

 

 

Accredo Health Group, Inc.
5249 N.W. 33rd Avenue, Bldg. 6
Ft. Lauderdale, FL  33309-6301
954-777-1685
800-955-5909
954-730-0129 (Fax)

 

Accredo Health Group, Inc.
749 Goddard Avenue
Chesterfield, MO  63005
636-530-1514
800-285-7384
636-530-1508 (Fax)

 

Accredo Health Group, Inc.
3000 Ericsson Drive, Ste 100
Warrendale, PA  15086 -7502
724-772-6000
888-200-2811
724-742-2450 (Fax)

 

 

 

 

 

Accredo Health Group, Inc.
5300 Oakbrook Parkway, Suite 320
Norcross, GA 30093
770-935-2510
800-310-7995
800-554-5545 (Fax)

 

Accredo Health Group, Inc.
4000-E  Spring Garden Street
Greensboro, NC  27407
336-854-3128
800-887-9253
336-854-3147 (Fax)

 

Accredo Health Group, Inc.
1620 Century Center Parkway, Ste 109
Memphis, TN  38134
901-385-3600
800-235-8498
901-385-3780 (Fax)

 

 

 

 

 

Accredo Health Group, Inc.
2415 Heinz Road
Iowa City, IA  52240-2661
319-354-7844
800-288-3752
319-354-6808 (Fax)

 

Accredo Health Group, Inc.
7866 Thorndike Road
Greensboro, NC 27409
336-393-0555
800-866-0566
866-832-3709 (Fax)

 

Accredo Health Group, Inc.
201 Great Circle Road
Nashville, TN  37228
615-352-2500
800-800-6606
615-850-5100 (Fax)

 

 

 

 

 

Accredo Health Group, Inc.
650 West Grand Avenue, Suite 102
Elmhurst, IL  60126
630-249-7390
800-753-5554
630-279-8464 (Fax)

 

Hemophilia Resources of America, Inc.
4000-E  Spring Garden Street
Greensboro, NC  27407
336-854-3128
800-887-9253
336-854-6033 (Fax)

 

Accredo Health Group, Inc.
9307 Kirby Drive
Houston, TX  77054
713-791-1552
800-878-7690
713-791-9411 (Fax)

 

 

 

 

 

BioPartners in Care, Inc.
11411 Strangline Road
Lenexa, KS  66215
913-451-2919
800-662-2922
913-451-2939 (Fax)

 

Accredo Health Group, Inc.
422 E. Gallimore Dairy Road
Suite A
Greensboro, NC 27409-9725
336-393-0555
866-832-3709 (Fax)

 

Accredo Health Group, Inc.
4343 West Royal Lane, Suite 124
Irving, TX  75063
972-929-6800
800-878-1254
972-929-6945 (Fax)

 

 

 

 

 

Accredo Health Group, Inc.
14111 Strang Line, Suite A
Lenexa, KS  66215
913-451-2919
913-451-2939 (Fax)

 

Accredo Health Group, Inc.
11329 — P Street, Suite 118 & 119
Omaha, NE 68137
402-597-2330
800-569-5451
402-597-2333 (Fax)

 

Accredo Health Group, Inc.
3488 South Main Street
Salt Lake City, UT  84115
801-832-0222
800-729-5984
801-832-0333 (Fax)

 

--------------------------------------------------------------------------------

 

 

Name/Address/Phone/Fax

 

Name/Address/Phone/Fax

 

Name/Address/Phone/Fax

 

 

 

 

 

Accredo Health Group, Inc.
4125 Lafayette Drive, Suite 400
Chantilly, VA  20151
703-817-7707
800-366-1824
888-445-4581 (Fax)

 

Critical Care Systems, Inc.
2985 Gateway Drive, Suite 150
Norcross, GA  30071
(Atlanta)
770.209.9728
770.209.9695 (Fax)

 

Critical Care Systems, Inc.
3631 44th Street, Suite C
Grand Rapids, MI  49512
616.458.1400
616.458.1481 (Fax)

 

 

 

 

 

Accredo Health Group, Inc.
22623 — 68th Avenue South
Kent, WA  98032
253-872-2121
800-647-2448
253-872-5663 (Fax)

 

Critical Care Systems, Inc.
12301 W. Explorer Drive, Suite 126
Boise, ID  83713
208.322.8868
208.322.3330 (Fax)

 

Critical Care Systems, Inc.
46998 Magellan Drive, Suite 300
Wixom, MI 48393
(Detroit)
248.960.8095
248.960.9172 (Fax)

 

 

 

 

 

Critical Care Systems, Inc.
4100 Colonnade Parkway, Suite 175
Birmingham, AL  35243
205.969.1006
205.969.1107 (Fax)

 

Critical Care Systems, Inc.
655 W. Grand Ave
Elmhurst, IL 60126
(Chicago)
630.833.3427
630.833.8020 (Fax)

 

Critical Care Systems, Inc.
1850 Lackland Hill Parkway
St. Louis, MO  63146
314.991.2400
314.991.2401 (Fax)

 

 

 

 

 

Critical Care Systems, Inc.
820 S. University Boulevard
Suite D-E, Building 1
Mobile, AL 36609
251.344.4452
251.344.4451 (Fax)

 

Critical Care Systems, Inc.
3700 Vanguard Drive, Suite D
Fort Wayne, IN 46809
260.747.0552
260.747.2126 (Fax)

 

Critical Care Systems, Inc.
505 East Capovilla Ave, Suite 103
Las Vegas, NV  89119
702.992.4007
702.992.4015 (fax)

 

 

 

 

 

Critical Care Systems, Inc.
4645 S. Ash Avenue, Suite 1-6
Tempe, AZ 85282
480.897.2927
480.897.8533 (Fax)

 

Critical Care Systems, Inc.
5648 West 74th Street
Indianapolis, IN 46278
317.291.1700
317.291.1777 (Fax)

 

Critical Care Systems, Inc.
5401 Longley Lane
Building B, Suite 34
Reno, NV 89511
775.829.2100
775.829.2151 (Fax)

 

 

 

 

 

Critical Care Systems, Inc.
5880 North La Cholla Blvd, Suite 126
Tucson, AZ 85741
520.297.1351
520.297.5760 (Fax)

 

Critical Care Systems, Inc.
11382 Aurora Avenue
Urbandale, IA  50322
(Des Moines)
515.276.1660
515.276.1933 (Fax)

 

Critical Care Systems, Inc.
10 Commerce Park North, # 4
Bedford, NH 03110
603.625.8880
603.625.8881 (Fax)

 

 

 

 

 

Critical Care Systems, Inc.
1326 W. Winton Avenue
Hayward, CA 94545
(San Francisco)
510.670.1384
510.670.0879 (Fax)

 

Critical Care Systems, Inc.
8053 Bond Street
Lenexa, KS 66214
(Kansas City)
913.894.0090
913.894.0095 (Fax)

 

Critical Care Systems, Inc.
20 World’s Fair Drive, Unit D
Somerset, NJ 08873
732.748.4690
732.748.4695 (Fax)

 

 

 

 

 

Critical Care Systems, Inc.
1950 Rosaline Avenue, Suite C
Redding, CA 96001
530.241.4727
530.241.4600 (Fax)

 

Critical Care Systems, Inc.
10 Donald B. Dean Drive
S. Portland, ME 04106
207.775.3600
207.775.3636 (Fax)

 

Critical Care Systems, Inc.
15 Technology Place, Suite 2
East Syracuse, NY  13057
315.434.1980
315.434.1985 (Fax)

 

 

 

 

 

Critical Care Systems, Inc.
14661 Myford Road, Suite B
Tustin, CA 92780
(LA/Orange County)
714.508.2990
714.508.2992 (Fax)

 

Critical Care Systems, Inc.
806 Cromwell Park Drive, Suite N
Glen Burnie, MD  21061
(Baltimore)
410.768.0711
410.768.0712 (Fax)

 

Critical Care Systems, Inc.
215J Industrial Avenue
Greensboro, NC  27406
336.273.2993
336.273.2994 (Fax)

 

 

 

 

 

Critical Care Systems, Inc.
176 Bolton Road
Vernon, CT  06066
(Hartford)
860.872.9337
860.872.9155 (Fax)

 

Critical Care Systems, Inc.
191 Bay State Drive
Braintree, MA  02184
(Boston South)
781.843.6688
781.843.4719 (Fax)

 

Critical Care Systems, Inc.
6185 Shamrock Court
Dublin, OH 43016
(Columbus)
614.791.8700
614.791.0754 (Fax)

 

 

 

 

 

Critical Care Systems, Inc.
4854 Woodbine Road, Suite 5
Pace, FL 32571
(Pensacola)
850.994.2333
850.994.0650 (Fax)

 

Critical Care Systems, Inc.
1 North Avenue
Burlington, MA  01803
(Boston North)
781.270.5565
781.270.5575 (Fax)

 

Critical Care Systems, Inc.
6380 Flank Drive, Suite 600
Harrisburg, PA  17112
717.540.6800
717.540.6805 (Fax)

 

 

 

 

 

Critical Care Systems, Inc.
3901 Columbia Avenue, Suite 100
Linwood, PA 19061
(Philadelphia)
610.485.9900
610.485.9903 (Fax)

 

Critical Care Systems, Inc.
246 Boston Turnpike
Shrewsbury, MA 01545
(Boston West)
508.363.3665
508.363.3666 (Fax)

 

Critical Care Systems, Inc.
3243 Old Frankstown Road
Pittsburgh, PA 15239
724.325.9977
724.325.9949 (Fax)

 

--------------------------------------------------------------------------------

 

Name/Address/Phone/Fax

 

Name/Address/Phone/Fax

 

Name/Address/Phone/Fax

 

 

 

 

 

Critical Care Systems, Inc.
253 Benner Pike, Suite D
State College, PA  16801
814.867.4100
814.867.4004 (Fax)

 

Critical Care Systems, Inc.
1801 Royal Lane, Suite 1006
Dallas, TX 75229
214.574.4700
214.574.8700 (Fax)

 

Critical Care Systems, Inc.
2233 S. Presidents Drive, Suite B
Salt Lake City, UT  84120
801.978.9600
801.978.0020 (Fax)

 

 

 

 

 

Critical Care Systems, Inc.
70 Catamore Boulevard
E. Providence, RI  02914
401.435.4030
401.435.4035 (Fax)

 

Critical Care Systems, Inc.
900 S. Loop West, Suite 170
Houston, TX  77054
713.440.0200
713.440.0400 (Fax)

 

Critical Care Systems, Inc.
527B Branchway Road
Richmond, VA  23236
804.378.8005
804.378.8043 (Fax)

 

--------------------------------------------------------------------------------

 

Attachment F

 

Inventory Data Reports

 

The following reports will be completed timely as indicated herein and provided
to UT Management via electronic mail in Microsoft Word® or Excel® file formats
or comma delimited (“CSV”) files and without cost or fee charges to UT.

 

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DEFINITIONS

 

Reports

 

Written reports as described in this Attachment F.

 

Patient Starts

 

The initiation of commercial Product on an Included Patient for treatment.

 

Patient Discontinuations

 

When UT Product is no longer required by the Included Patient for any variety of
medical or physical reasons.

 

Patient Assistance Program (PAP)

 

A US based program for Included Patients receiving UT Product who are either
indigent, under insured, or in jeopardy of losing insurance due to therapy
costs. The program allows for access to Product at no charge and demonstration
of financial hardships through an enrollment process is required prior coverage.
US Distributors are designated administrators of the program on behalf of UT in
accordance with this Agreement.

 

Product Forecasts

 

Non-binding detailed reports by product size with reasonable estimates of use
over a period of no less than 12 calendar months spanning January through
December.  Forecasts are updated each quarter during the year with revised 12
month calendar forecasts occurring annually.  Forecasts may also include planned
purchases of equipment or supplies to support the UT Product, where applicable
and requested by UT.

 

Purchase Orders

 

An official and binding document, generated by the Distributor, to guarantee a
request to purchase and pay at a contractual rate for the UT Products.

 

PROCEDURES: REPORTS

 

Reports will be provided to UT on a monthly and quarterly basis based on the
type of the Report and data collected. These Reports are outlined below and are
referenced as Attachments elsewhere in Attachment F (listed as Exhibits 1-4).
Reports will consist of:

 

Report Name

 

Frequency

 

Due Following
Reporting Period

 

Exhibits

 

 

 

 

 

 

 

Product Utilization Report

 

Monthly

 

10th of each month

 

1

 

 

 

 

 

 

 

Medicaid Utilization Report

 

Monthly

 

10th of each month

 

2

340B Covered Entity Reconciliation Report

 

Monthly

 

10th of each month

 

3

Product Forecast

 

Quarterly

 

10th of month after each quarter

 

4

 

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Product Utilization Report

 

The monthly Product Utilization Report provides details of Product dispensing
activities to commercial (reimbursable) and PAP Included Patients for the
Territory. Exhibit 1 contains a sample Report form.

 

The Product Utilization Reports will be provided to UT by the DISTRIBUTOR no
later than the 10th of each month using only the UT approved electronic form.

 

The Report contains the following three sections:

 

Product Utilization Data (by size) & Ordering Patients / Month

 

·                  Total Number of Tyvaso Starter Kits, Tyvaso Re-Supply Kits,
Tyvaso Supplemental Refill  dispensed/sold during the reporting period.

·                  Total number of orders for the package sizes dispensed/sold
accessing the UT Product.

 

Commercial Inventory On Hand Summary values:

 

·                  An Inventory count of UT Product by package size at the end
(last day) of the reporting period month.

·                  A realistic average dispensing/sold quantity of UT Product (a
previous 3 month average is recommended).

·                  Actual Inventory days on hand which is automatically
calculated by the Inventory count and average dispensing/sold quantities. The
Inventory days on hand are measured based on a 28 day period.

·                  Purchase Order (PO) Requests for quantities expected to be
purchased in order to meet both regular commercial activity and maintain a
contractual on hand Inventory balance. (Note: An actual Purchase Order should
accompany the Report)

·                  An Adjusted Inventory quantity is automatically calculated as
the sum of the physical Inventory count plus the expected purchases from the PO.

·                  The Adjusted Inventory Days on Hand. This automatically
calculated field is based on the previous data entries and will confirm if the
new purchases plus actual Inventory, divided by the average dispensing/sold
product will maintain the contractually required Inventory levels.

 

Patient Assistance Program for consigned inventory to support PAP Included
Patients:

 

·                  The total Included Patient census on PAP at the beginning of
the reporting period.

·                  The total Included Patient census on PAP at the end of the
reporting period.

·                  Consignment PAP Inventory count of UT Product by package size
at the end (last day) of the reporting period month.

 

--------------------------------------------------------------------------------

 

·                  A realistic average estimate of Consigned PAP Inventory
dispensed of UT Product (a previous 3 month average is recommended).

·                  Actual PAP Consigned Inventory days on hand which is
automatically calculated by the PAP Consigned Inventory count and average
dispensing/sold quantities. The PAP Consignment Inventory days on hand are
measured based on a 28 day period.

·                  PAP Consignment Purchase Order (PO) Requests (if needed for
the next period). It is recommended to request a PO for approximately of a 3 to
4 months worth of Consigned Product based on current use. (Note: An actual PO
for Consigned Product should accompany the report).

·                  An Adjusted PAP Consigned Inventory quantity is automatically
calculated as the sum of the PAP Consigned physical inventory count plus any
expected Consigned Products from the PO.

·                  The Adjusted PAP Consignment Inventory Days on Hand. This
automatically calculated field is based on the previous data entries and will
confirm if the new purchases plus actual Inventory, divided by the average
dispensing of PAP Consignment product levels.

 

Medicaid Utilization Report

 

The monthly Medicaid Utilization Report provides the information necessary for
UT to manage its Medicaid-related programs. UT is a participant in the Federal
Fee Schedule (“FFS”) and for the Centers of Medicare and Medicaid Services
(“CMS”). Participation requirements are for provisions of rebates to CMS for
those patients receiving UT Products who are covered by individual State
Medicaid programs. Exhibit 2 contains a sample Report form.

 

The Medicaid Utilization Report will be provided to UT by the DISTRIBUTOR no
later than the 10th of each month using only the UT approved electronic form.

 

The Report includes summary of activity for the reporting period (month) that
includes a unique patient identifier number (HIPAA compliant), the UT Product
size), the quantity dispensed during the reporting period, the Distributor’s
internal State Medicaid identification number/description, the State of the
Program (abbreviated), and any other descriptions or comments to support the
data.

 

340B Covered Entity Reconciliation Report

 

The monthly 340B Covered Entity Reconciliation Report provides the records that
are required in order for the Distributor to recover the loss on Product cost
incurred due to UT’s participation in the FFS and CMS. Exhibit 3 contains a
sample Report form.

 

The 340B Covered Entity Reconciliation Report will be provided to UT by the
DISTRIBUTOR no later than the 10th of each month IF any transactions to 340B
Covered Entities occurred. Any Reports filed for previous months not reported to
UT will be denied for refund. If no activity of 340B sales occurs during the
month, no Report submission will be required.

 

--------------------------------------------------------------------------------

 

Public Health Services (“PHS”) pricing programs as part of FFS participation
requires discounted pricing to be offered under the FFS program title known as
340B with whom 340B eligible hospitals or clinics (known as 340B covered
entities) are entitled to receive products from FFS/PHS Participating
manufactures at reduced price.

 

In order to facilitate 340B covered entities to obtain the reduced prices,
DISTRIBUTOR will offer 340B prices at rates regularly updated and provided by UT
when a 340B covered entity identifies itself and requests such prices. If the
DISTRIBUTOR purchased UT Product from UT at transfer prices higher than the 340B
price, UT will provide payment to the DISTRIBUTOR for the difference between the
DISTRIBUTOR’s transfer price and the 340B price sold to a 340B covered entity.

 

The Report must include the following elements:

 

·                  340B Covered Entity Name

·                  340B Identification Number

·                  Date of UT Product Sale

·                  Quantity of UT Product Sold

·                  340B Ceiling Price (per product NDC /sold) — provided by UT

·                  Total 340B Sales (unit 340B Ceiling price times quantity
sold)

·                  Distributor Transfer price (per product NDC/ sold)

·                  Transfer price extension (Transfer price time the unit
quantity sold)

·                  Refund due

 

PROCEDURES: FORECASTS

 

Forecasts

 

The non-binding forecasts will be based on reasonable estimates of expected
purchases and be presented in Excel Spreadsheet or similar electronic format
listed by month and totaled for the calendar year. The forecasts will list each
UT Product size for a particular drug category and may include medical devices
(such as Infusion Pumps) or supplies needed from UT contracted equipment
distributors to support the Product.

 

At the end of each Calendar quarter, DISTRIBUTOR will revise and update its
twelve (12) month rolling non-binding forecasts for future quarters for that
twelve (12) month period based on changes in demand and the market. These
revised non-binding Forecasts will be provided to UT no later than the 10th day
of first month in the new calendar quarter unless otherwise specified in this
Agreement using the UT approved electronic format (refer to Exhibit 4).

 

--------------------------------------------------------------------------------

 

EXHIBITS TO ATTACHMENT F

 

--------------------------------------------------------------------------------

 

Exhibit 1

 

Monthly Product Utilization Report

 

[g359532kg13i001.jpg]

 

--------------------------------------------------------------------------------

 

[g359532kg13i002.jpg]

 

--------------------------------------------------------------------------------

 

Exhibit 2

 

Monthly Medicaid Utilization Report

 

[g359532kg15i001.jpg]

 

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Exhibit 3

 

340B Covered Entity Reconciliation Report

 

[g359532kg17i001.jpg]

 

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[g359532kg19i001.gif]

 

Exhibit 4

 

Product Forecast (example):

 

[g359532kg19i002.jpg]

 

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Attachment G

 

Tyvaso Education & Compliance Program

 

THIS CHART NEEDS TO BE UPDATED TO MATCH TEXT

 

[g359532kg21i001.gif]

 

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The Tyvaso™ Continuing Patient Compliance,
Support and Education Program

 

TIME

 

ACTIVITY

 

 

 

Day Zero

 

· Pre — teach (as needed)*

 

 

 

Day 1 – 3

 

· Teaching RN initiation visit*

 

 

 

Day 2 – 3

 

· RN post start telephonic status check/assessment*

 

 

 

Day 4 – 14

 

· RN visit within first 3 to 14 days post-start. Evaluation and review.

 

 

 

Week 1,2,3

 

· RN telephonic status check/assessment minimum of weekly contact.

 

 

 

Week 4/Month 1

 

· Telephonic status check/assessment with transfer to PAH RN/RPh** as required.
(Reorder Call)

 

 

 

Week 6/Month 1.5

 

· PAH RN/RPh telephonic status check/assessment

 

 

 

Week 8/Month 2

 

· Telephonic status check/assessment with transfer to PAH RN/RPh** (Reorder
Call)

 

 

 

Week 10/Month 2.5

 

· PAH RN/RPh telephonic status check/assessment

 

 

 

Week 12/Month 3

 

· Telephonic status check/assessment with transfer to PAH/RNRPh** (Reorder Call)

· 90 day Risk Stratification Review

 

 

 

Month 4,5

 

Telephonic status check/assessment with transfer to PAH RN/RPh** (Reorder Call)

 

 

 

Month 6

 

· Telephonic status check/assessment PAH RN/RPh** (Reorder Call)

· Clinical Team Evaluation and Treatment Goal Planning

 

 

 

Months 7 thru 11

 

· Telephonic status check/assessment with transfer to PAH RN/RPh** (Reorder
Call)

 

 

 

Month 12

 

· Telephonic status check/assessment PAH RN/RPh** (Reorder Call)

· Clinical Team Evaluation and Treatment Goal Planning

 

 

 

Months 13 plus

 

· Follows format of months 7 through 12

 

--------------------------------------------------------------------------------

 

--------------------------------------------------------------------------------

*These activities are considered standard activities for a specialty pharmacy
and should be included under this Agreement at no additional charge.

 

**In each case throughout this Exhibit G, the reference to “PAH RN/RPh” means
that such activity requires a Registered Nurse or Registered Pharmacist with the
required expertise and training in PAH.

 

The Tyvaso™ Continuing Patient Compliance,
Support and Education Program

Description of Activities

 

Subject to patient’s consent, the Teaching RN will complete a minimum of two (2
teaching sessions within the first fourteen (14) days of therapy.  Additionally,
a clinicianwill contact the patient telephonically in weeks one, two, and three
of therapy. During these teaching visits and telephonic touch points, the
clinician will review with the patient in detail:

 

·                  TYVASO

·                  Education Tools — (Example 1 of Exhibit A to this Attachment
G). Includes UT/Lung Rx materials that can be used to supplement
DISTRIBUTOR-developed educational materials. Exhibit A will be updated as
needed.

·                  Disease information

·                  Dosing and Administration

·                  Use of one ampule per day

·                  Daily documentation in Patient Diary

·                  Daily disposal of unused drug

·                  Titration schedule (prescribed per breath)

·                  Missed Doses

·                  Managing Side Effects

·                  Establish treatment goals

·                  Storage/Handling/Cleaning

·                  TYVASO Inhalation System

·                  Education Tools - Information For Use Manual, Patient DVD,
Patient Breath Counter, Patient Diary and Quick Start Mat

·                  Preparing for treatment

·                  Using the TYVASO Inhalation System

·                  Assembly

·                  Use of distilled water only

·                  Inhaling Technique

·                  Audiovisual prompts

·                  Cleaning and maintenance

·                  Use of distilled water only

·                  Alarms/Troubleshooting

·                  Recording number of breaths per treatment sessions

·                  Use of Breath Counter/Patient Diary

·                  Fitting 4 treatment sessions into your day

·                  DISTRIBUTOR Services

·                  Refills services

·                  Monthly Touch points (Clinical Risk/Assessments & Medication
Resupply)

·                  Emergency/After Hours Support

 

--------------------------------------------------------------------------------

 

·                  Reimbursement Services

 

After the first month of therapy, the patient should be competent in the
administration of TYVASO and use of the TYVASO Inhalation System.  From this
point in the Continuing Patient Compliance, Support and Education Program,
Accredo will continue to monitor the patient telephonically on a bi-weekly basis
in the second and third month of the program, and monthly there after.  These
ongoing telephonic touch points will include a Risk Stratification Review.

 

A typical Risk Stratification Review call should cover the following topics:

 

·                  Disease:  Assess changes in signs and symptoms of disease

·                  Dose:  Confirm the current dose

·  Confirm use of one ampule per day and discard of any remaining solution

·  Confirm proper breath tracking per treatment session

·  Review titration schedule, if applicable

·                  Side effects:  Assess extent and duration of side effects.

Develop solution to minimize side effects.

Consult with prescribing physician if necessary.

·                  Device:  Confirm proper use of the TYVASO Inhalation System.

Confirm use of distilled water only

·                  Goals:  Measure attainment for treatment goals

·                  Support:  Encourage patient to use educational/support tools
provided by the manufacturer

(PEER/Integrated Persistency Program).  Increase patient awareness of PAH
support groups.

 

Based on information received from the Risk Stratification Review the patient
will be identified as one of the following:

 

1) Compliant

2) Compliant risk — requires clinical intervention

3) Non-compliant - requires clinical intervention

 

·        Compliant: With minimal side effects, the patient is showing benefit
from TYVASO and taking treatments 4x a day, between 3 - 9 breaths per session,
discarding any remaining solution at the end of each day.

 

·        Compliant Risk: The PAH RN/RPh has documented interventions for device
management issues, non-compliant, side effect management, or lack of efficacy.

 

·        Non-compliant: The PAH RN/RPh has multiple documented interventions for
non-compliance in addition to lack of efficacy.

 

If it is determined that a patient is in the compliant risk or non-compliant
category, the PAH RN/RPh will intervene appropriately.  Intervention may require
a home visit and include the following:

 

·                  Additional disease education

·                  Continued education on the use of the TYVASO Inhalation
Device

·                  Review proper Inhalation technique

·                  Side effect management

·                  Dose escalation/titration

·                  Strategies to fit four inhalation sessions into a day

 

--------------------------------------------------------------------------------

 

·                  Reassessment of treatment goals

·                  Consultation with the prescribing physician

 

Upon reaching the 180th day of therapy, DISTRIBUTOR’s clinical team will perform
a Clinical Team Evaluation and Treatment Goal Plan for the patient. This will
include a clinical contact (either PAH RN or RPh) contacting the patient for
assessment. After the assessment, the physician will be contacted to review the
patients progress to date and therapeutic goals for the next six months.

 

In addition to the clinical support outlined above, DISTRIBUTOR will contact the
patient telephonically on a monthly basis to process refills, ensure the patient
is using one ampule per day, confirm the patient is properly tracking number of
breaths per treatment session, using distilled water only and resolve
reimbursement issues.

 

--------------------------------------------------------------------------------

 

--------------------------------------------------------------------------------

 

Service Fees

 

Description of CPCSEP Service

 

Service Fee

Teaching RN visit within 4 to 14 days post-start

 

$250 per visit

Teaching RN telephonic status check/assessment weeks 1, 2 and 3

 

$52 per completed call

PAH RN/RPh telephonic status check/assessment

 

$52 per completed call

Clinical Team Evaluation and Treatment Goal Planning

 

$150 per session (including completed communication with physician)

 

The Parties agree that the activities described in Attachment G occurring from
Day Zero through Day 3 (including the initial visit from the Teaching RN and the
post start telephonic status check/assessments) are considered standard
activities for a specialty pharmacy and should be included under this Agreement
at no additional charge.

 

Note: The CPCSEP Services and corresponding Service Fees will be evaluated by UT
on an annual basis and UT may terminate all or a portion of the CPCSEP Services
at any time upon thirty (30) days prior written notice to DISTRIBUTOR without
any additional fee or expense.

 

--------------------------------------------------------------------------------

 

Attachment G “Exhibit A”

 

Education Theme

 

Education Tool Description

 

Item #

The welcome letter provides on overview of the TYVASO Patient Tool Kit
components.

 

TYVASO Patient Tool Kit Welcome Letter (Tool kit contains: Patient Video,
Patient Brochure, Treatment Tracker, Breath Counter & Quick Start Mat)

 

TBD

Educational video designed to:

 

 

 

 

 

 

 

 

 

1.               Teach the patient how to clean, assemble and store the
inhalation system.

 

TYVASO Patient Video

 

TBD

2.               Proper inhalation technique and use of the inhalation system.

 

 

 

 

Disease overview: what is PAH, causes and symptoms of PAH, and treatment
options. TYVASO overview: what is TYVASO, how does TYVASO help, and how do I
take TYVASO.

 

TYVASO Patient Brochure

 

TBD

A daily diary to assist the patient with tracking breathes and cycles.

 

TYVASO Treatment Tracker

 

TBD

A table top tool to assist the patient with tracking breaths and cycles.

 

TYVASO Breath Counter

 

TBD

Reinforce important information such as: inhalation technique, treatment
sessions and how to operate the inhalation system.

 

TYVASO Inhalation System Quick Start Mat

 

TBD

 

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