Document:

Exhibit 10.45

 

SECOND AMENDMENT TO DISTRIBUTION AGREEMENT

(Tyvaso®)

 

THIS 2ND AMENDMENT TO DISTRIBUTION AGREEMENT (this “Second Amendment”) is made and effective this 18th Day of December, 2013 (the “Second Amendment Effective Date”) by and among Accredo Health Group, Inc., a Delaware corporation having offices at 6272 Lee Vista Boulevard, Orlando FL, 32822 (“Accredo”), and 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 Distribution Agreement dated August 17, 2009, as amended by the First Amendment dated September 1, 2011 (the “Accredo Agreement”), which relates to the distribution of Tyvaso® (treprostinil) Inhalation (“UT Product”);

 

WHEREAS, UT, SP and SD are parties to that certain Amended and Restated Distribution Agreement dated as of August 21, 2009, as amended as of September 30, 2010 (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:

 

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a.                                      Section 4.13 (Tyvaso Continuing Patient Compliance, Support and Education Program) and Attachment G (Tyvaso Education & Compliance Program) are hereby deleted from the Accredo Agreement in their entireties.

 

b.                                      Section 4.15 (Device Replacement Services) and Attachment H (Tyvaso® Device Replacement Program) are hereby deleted from the Accredo Agreement in their entireties.

 

c.                                       Section 6.1 is hereby deleted in its entirety and replaced with the following:

 

Purchase Orders.  DISTRIBUTOR shall submit written purchase orders to UT by electronic mail or in accordance with written instructions provided by UT. Except as otherwise agreed 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.

 

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

 

9.3          Safety Reporting General Provisions:

 

(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

 

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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.

 

e.                                       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 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

 

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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.

 

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

 

g.                                      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.

 

h.                                      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:

 

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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, Inc.
    
	
 
    	
 
    	
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
    

 

i.                                         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.

 

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 Second Amendment to be executed as of the Second 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
    	
 
    	
 
    

 

6

 

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
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Accredo   Health Group, Inc.
    	
 
    	
CuraScript, Inc.
    	
 
    	
Accredo   Health Group, Inc.
    

 

7

 

	
6272   Lee Vista Blvd, Suite 100

Orlando,   FL 32822

888.773.7376

888.773.7386   (Fax)

DEA   BC8724557
    	
 
    	
dba   CuraScript SP Specialty Pharmacy

2   Boulden Circle, Suite 1

New   Castle, DE 19720

866.844.2469

866.844.6629   (fax)

DEA   FC0195695
    	
 
    	
2825   W. Perimeter Road, Suite 116

Indianapolis, IN  46241

800.807.6419

800.824.2642

DEA   FC2248018
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
Accredo   Health Group, Inc.

2   Boulden Circle, Suite 1

New   Castle, DE 19720

866.844.2469

866.844.6629   (fax)

DEA   TBD
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
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
    

 

8

 

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
    

 

*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

Senior Account Manager

One Express Way

St. Louis, MO 63121

Telephone: (843) 460-2473

E-mail: MHamilton2@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

 

9Exhibit 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:

 

1

 

(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

 

2

 

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.

 

3

 

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

 

4

 

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)

 

5

 

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
    	
 
    	
 
    

 

6

 

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
    	
 
    	
 

 
    

 

7

 

	
 
    	
 
    	
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
    

 

8

 

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
    

 

* 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

 

9

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