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 


 

















 


                                                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.


 

















 


(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-


 

















 


                                                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 


 

















 


                                                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 


 

















 


                                                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 


 

















 


                                                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.


 

















 


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 


 

















 


                                                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-


 

















 


                                                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


 






 










 


                                                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 


 

















 


                                                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, 


 

















 


                                                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.


 

















 


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 


 

















 


                                                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 


 

















 


                                                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 


 

















 


                                                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.


 

















 


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 


 

















 


                                                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 


 

















 


                                                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.


 






 










 


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 


 

















 


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 


 

















 


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.


 

















 


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 


 

















 


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;


 

















 


(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 


 

















 


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.


 

















 


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

  



 

















 


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


 





 

















 





 














 


Exhibit 2


 


Monthly Medicaid Utilization
Report


 





 














 


Exhibit 3


 


340B Covered Entity
Reconciliation Report


 





 














 





 


Exhibit 4


 


Product Forecast (example):


 





 














 


Attachment G


 


Tyvaso Education &
Compliance Program


 


THIS CHART NEEDS TO BE
UPDATED TO MATCH TEXT


 





 














 


The TyvasoTM 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 TyvasoTM 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