Exhibit 10.3

 

SECOND AMENDMENT TO MANUFACTURING AND SUPPLY AGREEMENT

 

THIS SECOND AMENDMENT TO MANUFACTURING AND SUPPLY AGREEMENT (the “Amendment”) is
made and entered into as of May 17, 2017 (the “Execution Date”), effective as of
the Effective Date, by and among Eli Lilly and Company, an Indiana corporation,
having its principal place of business at Lilly Corporate
Center, Indianapolis, Indiana 46285, (“Lilly”), Lilly del Caribe, Inc., a Cayman
Island corporation, having its principal place of business at Km 12.6
65th Infantry Avenue, Carolina, PR  00985 (“Lilly del Caribe) and United
Therapeutics Corporation, a Delaware corporation, having its principal place of
business at 1040 Spring Street, Silver Spring, Maryland 20910 (“United
Therapeutics”).  Lilly, Lilly del Caribe and United Therapeutics are referred to
individually as a “Party” and collectively as the “Parties.”

 

RECITALS

 

WHEREAS, the Lilly, Lilly del Caribe and United Therapeutics are parties to that
certain Manufacturing and Supply Agreement dated as of November 14, 2008, as
amended as of October 5, 2011 (the “Supply Agreement”);

 

WHEREAS, the Parties desire to amend the Supply Agreement to reflect the
Parties’ agreement with respect to certain terms and conditions as set forth
herein;

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements
contained herein and for other good and valuable consideration, the receipt and
adequacy of which are hereby acknowledged, the Parties agree as follows:

 

AGREEMENT

 

1.             Section 2.4 Product for Development and Promotion is hereby
deleted in its entirety and replaced with the following:

 

The Parties acknowledge and agree that the Product may be required by United
Therapeutics for the Development of the Product, including use in clinical
trials (including Phase 4 clinical trials and label expansion studies and
externally sponsored research), complying with GMPs in accordance with the
License Agreement and the Quality Agreement (including conducting release
testing, stability testing and maintaining retention samples), and the Product
may be required by United Therapeutics for complimentary distribution for
patient assistance, compassionate use programs, and United Therapeutics’
sampling program.  Such Product shall not be sold to end-users. The Parties
anticipate that United Therapeutics’ sampling program will involve providing
samples of the commercial version of the Product in limited quantities at key
centers for the treatment of indications in the Field in accordance with
industry practices.  Lilly shall use Commercially Reasonable Efforts to supply
the commercial version of the Product to United Therapeutics for such purposes
at the Purchase Price for such Product.  Lilly will have no obligation to
manufacture clinical trial material (containing active ingredient of which is
the

 

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compound or placebo) or supply samples of the Product specially packaged for
sampling unless otherwise agreed by the Parties in writing.

 

Section 6.1 Payment to Lilly del Caribe.  The reference to “Section 6.2” is
deleted and replaced with “Section 6.3”.

 

2.             Section 6.3 Purchase Price.  Exhibit 6.3(a) is deleted in its
entirety and replaced with the following attached hereto.

 

3.             Full Force and Effect.  Except as specifically modified or
amended by the terms of this Amendment, the Supply Agreement and all provisions
contained therein are, and shall continue, to be in full force and effect and
are hereby ratified and confirmed.

 

4.             Counterparts.  This Amendment may be executed in counterparts,
each of which shall be deemed an original and both of which together shall
constitute one and the same instrument.

 

[Signature Page Follows]

 

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IN WITNESS WHEREOF, the Parties, intending to be bound hereby, have executed
this Amendment by their duly authorized representatives as of the Execution
Date.

 

ELI LILLY AND COMPANY

 

UNITED THERAPEUTICS CORPORATION

 

 

 

By:

/s/ David A. Ricks

 

By:

/s/ Michael Benkowitz

 

 

 

Name:

David A. Ricks

 

Name:

Michael Benkowitz

 

 

 

Title:

President & Chief Executive Officer

 

Title:

President & Chief Operating Officer

 

 

LILLY DEL CARIBE, INC.

 

 

 

 

 

By:

/s/ Eric Zinn

 

 

 

 

 

Name:

Eric Zinn

 

 

 

 

 

Title:

Vice President

 

 

 

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EXHIBIT 6.3(a)

 

PURCHASE PRICE

 

$0.30 per tablet, each tablet containing twenty (20) milligrams the Compound,
supplied in sixty (60) count bottles.

 

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