Exhibit 10.49

 

1ST AMENDMENT TO AMENDED AND RESTATED DISTRIBUTION AGREEMENT

(Remodulin®)

 

THIS 1ST AMENDMENT TO AMENDED AND RESTATED DISTRIBUTION AGREEMENT (this “First
Amendment”) is made and effective this 18th Day of December, 2013 (the “First
Amendment Effective Date”), by and among Accredo Health Group, Inc., a Delaware
corporation having offices at 6272 Lee Vista Boulevard, Orlando FL, 32822,
(“Accredo”), United Therapeutics Corporation, a Delaware corporation, having
offices at 1040 Spring Street, Silver Spring, Maryland (“UT”), CuraScript, Inc.,
a Delaware corporation having offices at 6272 Lee Vista Boulevard, Orlando FL,
32822(“SP”) and Priority Healthcare Distribution, Inc., doing business as
CuraScript SD Specialty Distribution, a Florida corporation with offices at 255
Technology Park, Lake Mary, Florida, 32746 (“SD”). SP, SD and Accredo are
collectively referred to herein as the “Distributor”.

 

WHEREAS, UT and Accredo are parties to that certain Amended and Restated
Distribution Agreement dated February 21, 2011 (the “Accredo Agreement”), which
relates to the distribution of Remodulin® (treprostinil) Injection (“UT
Product”);

 

WHEREAS, UT, SP and SD are parties to that certain Amended and Restated
Distribution Agreement dated as of December 1, 2011 (the “CuraScript
Agreement”), which also related to the distribution of UT Product;

 

WHEREAS, SP, SD, and Accredo are now affiliates of one another, as both are
wholly-owned subsidiaries (directly or indirectly) of Express Scripts Holding
Company;

 

WHEREAS, the Parties wish to amend the Accredo Agreement to add SP and SD as
parties, and terminate the CuraScript Agreement, in order to provide for one
Distribution Agreement among the parties relating to UT Product, and to
otherwise amend the Accredo Agreement as provided herein;

 

WHEREAS, pursuant to Section 18.4 of the Accredo Agreement, the Accredo
Agreement may be amended by the parties by a written instrument signed by a duly
authorized representative of each of the Parties; and

 

WHEREAS, capitalized terms used but not defined herein shall have the meanings
ascribed to them in the Accredo Agreement.

 

NOW THEREFORE, in consideration of the mutual agreements and covenants contained
herein, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties hereto, intending to
be legally bound, hereby agree as follows:

 

1.              Joinder.  SP and SD each hereby agrees that, from and after the
Amendment Effective Date, it shall be a party to the Accredo Agreement (as
amended hereby), and shall be deemed, jointly with Accredo, to be the
“DISTRIBUTOR” as defined under the Accredo Agreement, subject, jointly and
severally with Accredo, to all of the covenants, terms and conditions of the
Accredo Agreement as though an original party thereto.

 

2.              Termination of CuraScript Agreement.  SP, SD, Accredo and UT
hereby agree that, effective as of the Amendment Effective Date, the CuraScript
Agreement is terminated in its entirety, provided that any liability, obligation
or provision which survives termination pursuant to Section 15.4 of the
CuraScript Agreement shall survive as an obligation of SP, SD and Accredo as
“DISTRIBUTOR” under the Accredo Agreement, as amended hereby.

 

3.              Amendments to Accredo Agreement.  The Parties agree that the
Accredo Agreement is hereby amended with effect from the Amendment Effective
Date as follows:

 

a.                                      Section 9.3 is hereby deleted in its
entirety and replaced with the following:

 

9.3          Safety Reporting General Provisions:

 

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(a)               Definitions.  As used in this Section 9.3, the following terms
shall have the following meanings:

 

(i.)               “Adverse Drug Reaction” or “ADR” shall mean any adverse
experience in response to a medicinal product which is noxious and unintended,
including without limitation an ADR occurring in the course of the use of a drug
product in professional practice; drug overdose whether accidental or
intentional; drug abuse; drug withdrawal; occupational exposure and any failure
of expected pharmacological action. Pregnancy is not considered ADR, for the
purpose of this Agreement; UT requires to collect Pregnancy where the embryo or
fetus may have been exposed to medicinal products (either through maternal
exposure or transmission of a medicinal product via semen following paternal
exposure).

 

(ii.)           “Day 0 (Zero)”. The date on which DISTRIBUTOR or any of its
representatives (including Affiliates and contracted Sub-Distributors) is made
aware of information containing the minimum reporting criteria (medicinal
product, reporter, event/reaction, patient), irrespective of whether the
information is received during a weekend or public holiday.

 

(iii.)       “Product Complaint” or “PC” shall mean any written, electronic, or
oral communication that alleges deficiencies of the identity, quality,
durability, reliability, safety, effectiveness, or performance of UT Product.

 

(iv.) Additional terms used but not defined in this Section 9.3 and Attachment G
shall have the meanings as described to them in the Code of Federal Regulations,
Section 314.80, Postmarketing reporting of adverse drug experiences.

 

(b)               UT has responsibility for all post-market pharmacovigilance
and safety regulatory reporting for UT Product in the Territory, including all
reporting obligations to the applicable regulatory authorities, and shall comply
with all Applicable Laws in carrying out those activities.

 

(c)                DISTRIBUTOR agrees to have and maintain suitable
pharmacovigilance policies, procedures, systems, and resources (including staff
training on the definitions and timelines provided in Attachment G) to ensure
compliance with all Applicable Law in the Territory, including maintaining
adequate written procedures to address the receipt, evaluation, and reporting of
Postmarketing Adverse Drug Experience (PADE) activities that are being performed
under this Agreement.

 

(d)          DISTRIBUTOR shall identify and notify UT of any potential ADR
and/or PC in accordance with Attachment G.  Either Party may update its contact
information for purposes of Attachment G from time to time by providing written
notice to the other Party.

 

b.                                      Section 9.5 is hereby deleted in its
entirety and replaced with the following:

 

9.5                               Visits by Parties.  DISTRIBUTOR shall permit
UT to visit its place of business and inspect its facilities, systems, records,
inventories and other relevant materials and records relating solely to its
performance under this Agreement, at DISTRIBUTOR’s expense. Such inspections may
be made no more than once each calendar year, at reasonable times during normal
business hours and on

 

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not less than upon thirty (30) business days’ notice, accompanied by a detailed
scope.  UT shall have the right to conduct additional “for cause” audits as
needed to address specific quality problems and/or if issues arise that need
inspection to ensure DISTRIBUTOR’s compliance with and ability to comply with
the terms of this Agreement. “For cause” audits may be performed with less than
thirty (30) days’ notice, but with as much notice is as reasonably practicable
taking into account the level of urgency associated with a “for cause” audit. 
If a designated agent of UT conducts the audit, the designated agent shall enter
into a confidentiality agreement with Accredo. Audits during the months of
December and January are limited to regulatory needs.

 

UT may choose to share a confidential audit report summarizing all audit
observations with DISTRIBUTOR.  DISTRIBUTOR will issue responses to all
observations in writing to UT’s Quality Assurance unit within 30 calendar days
of receipt.

 

UT will evaluate the acceptability of the audit observation responses (as
acceptable, incomplete response, inadequate response and/or other).  Both
parties shall bring to resolution any audit response deemed unacceptable by UT.
DISTRIBUTOR will incorporate in its commitment tracking system any corrective
actions and related timelines committed to by DISTRIBUTOR.

 

c.                                       Attachment G to this Amendment is
hereby added to the Agreement as Attachment G.

 

d.                                      Section 12.1 is hereby deleted in its
entirety and replaced with the following:

 

12.1 Insurance Requirements.

 

(a)                                 Distributor 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. DISTRIBUTOR shall provide thirty
(30) days’ written notice to UT in the event of any modifications, cancellations
or terminations thereof. If such policies are written on a claims made policy
form, DISTRIBUTOR shall maintain coverage for claims arising out of this
agreement for a period of at least Five (5) years following termination of this
agreement or any renewal thereof or any renewal thereof.  DISTRIBUTOR agrees to
provide UT with a certificate of insurance evidencing compliance with this
section within ten (10) days of execution of this Agreement and prior to the
policy’s renewal date each year thereafter.

 

(b)                                 UT Insurance. UT 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 and a product liability policy (which may be in
the form of primary or excess coverage) in an amount not less than Ten Million
Dollars ($10,000,000) per occurrence and in the aggregate.  These policies shall
provide for thirty (30) days’ written notice to UT in the event of any
modifications, cancellations or terminations thereof.  If such policies are
written on a claims made policy form, UT shall maintain coverage for claims
arising out of this agreement for a period of at least Five (5) years following
termination of this agreement or any renewal thereof. DISTRIBUTOR agrees to
provide UT with a certificate of insurance evidencing compliance with this
section within ten (10) days of execution of this Agreement and prior to the
policy’s renewal date each year thereafter.

 

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e.                                       Section 18.6 is hereby deleted in its
entirety and replaced with the following:

 

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

 

 

1040 Spring Street

 

 

Silver Spring, Maryland 20910

 

 

Attention: Chief Financial Officer

 

 

Telefax: 301-608-9291

 

 

 

 

With a copy to:

 

 

 

United Therapeutics Corporation

 

 

1735 Connecticut Ave. NW

 

 

Washington, DC 20009

 

 

Attention: General Counsel

 

 

Telefax: 202-483-4005

 

 

 

 

If to DISTRIBUTOR:

Express Scripts, Inc.

 

 

c/o Accredo Health Group

 

 

One Express Way

 

 

St. Louis, MO 63121

 

 

Attention: Legal Department

 

 

 

 

With a copy to:

 

 

 

Accredo Health Group, Inc.

 

 

6272 Lee Vista Boulevard

 

 

Orlando, FL 32822

 

 

Attention: Specialty Contract Management

 

 

 

 

 

Priority Healthcare Distribution, Inc.

 

 

255 Technology Park

 

 

Lake Mary, FL 32746

 

 

Attention: General Manager

 

f.                                        Attachment E, Designated Shipment
Locations and Designated Storage Locations, is hereby deleted in its entirety
and replaced with the revised Attachment E, Designated Shipment Locations and
Designated Storage Locations, attached hereto.

 

g.                                      Attachment C,  United Therapeutics/
Patient Assistance Program Guidelines, is hereby amended to add the following
sentence at the end:

 

“United Therapeutics agrees to reimburse DISTRIBUTOR at its reasonable, actual
cost for ancillary supplies utilized in supplying Product to PAP Patients,
including but not

 

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limited to Alchohol Prep pads, Flolan Diluent, Minimed shower pack, Opsite IV
prep, Soft-Set Sub Cut Admin Set and Tape.”

 

4.              Except as specifically set forth herein, all other provisions of
the Accredo Agreement shall continue unchanged.

 

(SIGNATURE PAGE TO FOLLOW)

 

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IN WITNESS WHEREOF, the parties hereto have caused this First Amendment to be
executed as of the First Amendment Effective Date set forth above by their duly
authorized representatives.

 

 

ACCREDO HEALTH GROUP, INC.

 

UNITED THERAPEUTICS CORPORATION

 

 

 

 

 

 

 

 

 

 

By:

/s/ Bill Martin

 

By:

/s/ Jay A. Watson

 

 

 

 

 

Name:

Bill Martin

 

Name:

Jay A. Watson, Pharm.D

 

 

 

 

 

Title:

VP

 

Title:

EVP Strategic Operations & Logistics

 

 

 

 

 

Date:

12/18/13

 

Date:

07/Jan/2014

 

 

 

 

 

 

CURASCRIPT, INC.

 

 

 

 

 

 

 

 

 

 

By:

/s/ Bill Martin

 

 

 

 

 

 

Name:

Bill Martin

 

 

 

 

 

 

Title:

VP

 

 

 

 

 

 

Date:

12/18/13

 

 

 

 

 

 

 

 

PRIORITY HEALTHCARE DISTRIBUTION, INC.

 

 

 

 

 

 

 

 

By:

/s/ Gayle Johnston

 

 

 

 

 

 

Name:

Gayle Johnston

 

 

 

 

 

 

Title:

President

 

 

 

 

 

 

Date:

12/18/13

 

 

 

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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)

DEA BA9439490

 

Accredo Health Group, Inc.

10400 North 25th Avenue, Suite 120

Phoenix, AZ  85021

602-944-1199

800-232-1199

602-944-1787 (Fax)

DEA BA 9437042

 

Accredo Health Group, Inc.

1831 Commerce Street, Suite 104

Corona, CA  92880

951-737-2355

800-622-1820

951-737-2553 (Fax)

DEABA9751050

 

 

 

 

 

Accredo Health Group, Inc.

361 Iverness Drive South, Suite F

Englewood, CO  80112

303-799-6550

800-488-0290

303-799-6551 (Fax)

DEA BA9492555

 

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)

DEA BA9495905

 

Accredo Health Group, Inc.

5300 Oakbrook Parkway, Suite 320

Norcross, GA 30093

770-935-2510

800-310-7995

800-554-5545 (Fax)

DEA BA9579890

 

 

 

 

 

Accredo Health Group, Inc.

2415 Heinz Road

Iowa City, IA  52240-2661

319-354-7844

800-288-3752

319-354-6808 (Fax)

DEA BA9481817

 

Accredo Health Group, Inc.

650 West Grand Avenue, Suite 102

Elmhurst, IL  60126

630-249-7390

800-753-5554

630-279-8464 (Fax)

DEA BA9411214

 

Accredo Health Group, Inc.

11411 Strang Line Rd, Suite A

Lenexa, KS 66215

913-451-2919

800-662-2922

913-451-2939 (Fax)

 

 

 

 

 

 

BioPartners in Care, Inc.

11411 Strang Line Rd, Suite A

Lenexa, KS 66215

913-451-2919

800-662-2922

913-451-2939 (Fax)

DEA BB9471549

 

Accredo Health Group, Inc.

520 Elmwood Park Blvd. Suite 145

Jefferson, LA 70123-6827

504-731-6113

800-250-5278

504-731-6112 (Fax)

DEA BA9735599

 

Accredo Health Group, Inc.

261 Cedar Hill Street, Bldg. C

Marlboro, MA  01752

508-460-9813

800-343-9813

508-460-0072 (Fax)

DEA BA9612208

 

 

 

 

 

Accredo Health Group, Inc.

39625 Lewis Drive, Suite 800

Novi, MI  48377

248-489-0300

800-688-2024

248-489-1126 (Fax)

DEA BA9444477

 

Accredo Health Group, Inc.

2915 Waters Road, Suite 109

Eagan, MN  55121-1562

651-681-0885

800-955-3121

651-681—0977 (Fax)

DEA BA9562679

 

Accredo Health Group, Inc.

749 Goddard Avenue

Chesterfield, MO  63005

636-530-1514

800-285-7384

636-530-1508 (Fax)

DEA BA9432612

 

 

 

 

 

Accredo Health Group, Inc.

422 E. Gallimore Dairy Rd Suite A

Greensboro, NC 27409

336-393-0555

800-866-0566

866-832-3709 (Fax)

DEA BA9513905

 

Accredo Health Group, Inc.

11329 — P Street, Suite 118 & 119

Omaha, NE 68137

402-597-2330

800-569-5451

402-597-2333 (Fax)

DEA BA9481502

 

Accredo Health Group, Inc.

45 Route, 46 East, Suite 609

Pine Brook, NJ  07058

973-276-0794

800-549-2654

973-276-0998 (Fax)

DEA BA9943829

 

 

 

 

 

Accredo Health Group, Inc.

505 East Capovilla, Suite 103

Las Vegas, NV   89119

702-895-8990

800-234-7044

702-895-8992 (Fax)

DEA BA9455254

 

AHG of New York, Inc.

500 Executive Blvd.

Elmsford, NY  10523-1109

914-592-0333

800-680-6843

914-592-5859 (Fax)

DEA BP9431747

 

Accredo Health Group, Inc.

4901 West Reno Rd, Ste 950

Oklahoma City, OK  73127

405-942-3961

800-999-9376

405-949-2689 (Fax)

DEA BA9439882

 

 

 

 

 

Accredo Health Group, Inc.

3000 Ericsson Drive, Ste 100

Warrendale, PA  15086 -7502

724-772-6000

888-200-2811

724-742-2450 (Fax)

DEA BA9505554

 

Accredo Health Group, Inc.

1620 Century Center Parkway, Ste 109

Memphis, TN  38134

901-385-3600

800-235-8498

901-385-3780 (Fax)

DEA BA9451167

 

Accredo Health Group, Inc.

(wholesale facility)

1680 Century Center Parkway, Ste 8

Memphis, TN  38134

901-385-3600

800-235-8498

866-628-8942 (Fax)

DEA RA0401416

 

 

 

 

 

Accredo Health Group, Inc.

201 Great Circle Road

Nashville, TN  37228

615-352-2500

800-800-6606

615-850-5100 (Fax)

DEA BA9451193

 

Accredo Health Group, Inc.

9307 Kirby Drive

Houston, TX  77054

713-791-1552

800-878-7690

713-791-9411 (Fax)

DEA BA9419525

 

Accredo Health Group, Inc.

4343 West Royal Lane, Suite 124

Irving, TX 75063

972-929-6800

800-878-1254

866-435-8451 (Fax)

DEA BA9584699

 

 

 

 

 

Accredo Health Group, Inc.

3488 South Main Street

Salt Lake City, UT  84115

801-832-0222

800-729-5984

801-832-0333 (Fax)

DEA BA9434022

 

Accredo Health Group, Inc.

22623 68th Avenue South

South Kent, WA  98032

253-872-2121

800-647-2448

253-872-5663 (Fax)

DEA BA9444554

 

 

 

 

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CuraScript, Inc.

dba CuraScript SP Specialty Pharmacy

2 Boulden Circle, Suite 1

New Castle, DE 19720

866.844.2469

866.844.6629 (fax)

DEA FC0195695

 

 

 

 

 

 

 

Accredo Health Group, Inc

6272 Lee Vista Blvd, Suite 100

Orlando, FL 32822

888.773.7376

888.773.7386 (Fax)

FEIN 11-3358535

NCPDP 1085667

NPI 1043309735

 

Accredo Health Group, Inc

2 Boulden Circle, Suite 1

New Castle, DE 19720

866.844.2469

866.844.6629 (fax)

DEA TBD

 

Accredo Health Group, Inc

2825 W. Perimeter Road, Suite 116

Indianapolis, IN  46241

800.807.6419

800.824.2642

FEIN 11-3358535

NCPDP 1531706

NPI 1639375066

 

 

 

 

 

Lynnfield Drug, Inc.

dba Hemophilia of the Sunshine State

4035 Tampa Road, #6500

Oldmar, FL 34677

800.684.2966

813.855.6972 (Fax)

DEA BL7787279

 

Lynnfield Compounding Center, Inc.

dba Freedom FP Fertility Pharmacy

12 Kent  Way, Suite 120-E

Byfield, MA 01922

800.660.4283

888.660.4283 (Fax)

DEA BL9566754

 

Lynnfield Drug, Inc.

dba Freedom Fertility Pharmacy

12 Ken Way, Suite 120-F

Byfield, MA 01922

800.660.4283

888.660.4283 (Fax)

DEA BL9566742

 

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Attachment G

 

1.              Timelines for delivery of reports from DISTRIBUTOR to UT (Post
Marketing)

 

Type of Report

 

Timeline from
DISTRIBUTOR to
UT Following
Day 0*

 

Format

 

Means of Delivery**

ADR/PC

 

As soon as possible but no later than 3 days

 

Source Data in English — MedWatch or CIOMS I form

 

Secure E-Mail, FAX as set forth in Exhibit A

 

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* After DISTRIBUTOR acknowledgement of delays in ADR/PC reporting, DISTRIBUTOR
will notify UT within 1 business day..

 

2.              Contact information for the parties to this Agreement

 

United Therapeutics Corporation

 

DISTRIBUTOR

 

 

 

Pharmacovigilance Contact

 

Adrian Johnson RN, BSN

Vendor Operations Lead

United Therapeutics

55 TW Alexander Drive

RTP, NC 27709

P: 919-425-5867 |

agjohnson@unither.com

 

Maria Litzinger

Director, Pharmacovigilance Operations

United Therapeutics

55 TW Alexander Drive

RTP, NC 27709

Office: 919-425-5596

MLitzinger@unither.com

 

Pharmacovigilance Contact or designee

 

Scott Ziesmer

Account Manager

6272 Lee Vista Blvd

Orlando, FL 32822

Telephone: (407) 816-9864

E-mail: SZiesmer@express-scripts.com

 

and

 

 

Amy Watts

Director Account Management

One Express Way

St. Louis, MO 63121

Telephone: (843) 460-2473

E-mail: AGWatts@express-scripts.com

 

 

 

Safety and General Correspondence

 

DrugSafety@unither.com

 

Safety and General Correspondence

 

Scott Ziesmer

Account Manager

Telephone: (407) 816-9864

E-mail: SZiesmer@express-scripts.com

 

 

 

Product Complaint Correspondence

 

DrugSafety@unither.com

 

Product Complaint Correspondence

 

Scott Ziesmer

Account Manager

Telephone: (407) 816-9864

E-mail: SZiesmer@express-scripts.com

 

3.              Reference:

 

·                  Food and Drug Administration - Code of Federal Regulations,
TITLE 21 CHAPTER I - SUBCHAPTER D -PART 314 -Subpart B Sec. 314.80 Postmarketing
reporting of adverse drug experiences

 

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