Exhibit 10.3


 


Pursuant
to 17 C.F.R. § 240.24b-2, confidential information (indicated by [***]) has
been omitted and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed with the
Commission. 


 


EXECUTION VERSION


 


MANUFACTURING AND SUPPLY AGREEMENT


 


BY AND BETWEEN


 


ELI LILLY AND COMPANY,


 


LILLY DEL CARIBE, INC.


 


AND


 


UNITED THERAPEUTICS CORPORATION


 


DATED


 


NOVEMBER 14, 2008


 

















 


TABLE OF CONTENTS


 


	
   

  	
   

  	
   

  	
   

  	
  Page

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE 1  Definitions

  	
   

  	
  1

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.1

  	
   

  	
  “Effective Date”

  	
   

  	
  1

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.2

  	
   

  	
  “Manufacturing Facility”

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.3

  	
   

  	
  “Manufacturing Responsibility Document” or “MRD”

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.4

  	
   

  	
  “Modification”

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.5

  	
   

  	
  “Product”

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.6

  	
   

  	
  “Purchase Price”

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.7

  	
   

  	
  “Quality Agreement”

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.8

  	
   

  	
  “Specifications”

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.9

  	
   

  	
  “Term”

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.10

  	
   

  	
  “Wholesaler”

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE 2  Manufacture and
  Supply

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.1

  	
   

  	
  General

  	
   

  	
  2

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.2

  	
   

  	
  The Product Prior to Modification

  	
   

  	
  3

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.3

  	
   

  	
  Subcontractors

  	
   

  	
  3

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.4

  	
   

  	
  Product for Development and Promotion

  	
   

  	
  4

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.5

  	
   

  	
  Notice of Impact on Supply

  	
   

  	
  4

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.6

  	
   

  	
  Manufacturing Facility

  	
   

  	
  4

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.7

  	
   

  	
  Product Packaging & Labeling

  	
   

  	
  5

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.8

  	
   

  	
  Supply Lead Contacts

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE 3  Modifications

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.1

  	
   

  	
  Packaging and Labeling

  	
   

  	
  6

  
							



 


i

















 


	
  3.2

  	
   

  	
  Manufacturing Facility

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.3

  	
   

  	
  Compound and its Specifications and Manufacturing Process

  	
   

  	
  6

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.4

  	
   

  	
  Product, its Specifications and Manufacturing Process

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.5

  	
   

  	
  Modifications Required Under Applicable Law

  	
   

  	
  7

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.6

  	
   

  	
  Terms Applicable to All Modifications

  	
   

  	
  8

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE 4  Costs of
  Modifications

  	
   

  	
  8

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4.1

  	
   

  	
  Graphics and Artwork into Packaging

  	
   

  	
  8

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4.2

  	
   

  	
  Required Under Applicable Law

  	
   

  	
  9

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4.3

  	
   

  	
  Lilly Modifications

  	
   

  	
  9

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4.4

  	
   

  	
  United Therapeutics’ Modifications

  	
   

  	
  9

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE 5  Remedies

  	
   

  	
  10

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5.1

  	
   

  	
  Failure to Make Modifications

  	
   

  	
  10

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5.2

  	
   

  	
  Modifications to Comply with Laws or Approvals

  	
   

  	
  10

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5.3

  	
   

  	
  Failure to Supply

  	
   

  	
  11

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE 6  Price and Payment

  	
   

  	
  11

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.1

  	
   

  	
  Payment to Lilly del Caribe

  	
   

  	
  11

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.2

  	
   

  	
  Distribution Process

  	
   

  	
  11

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.3

  	
   

  	
  Purchase Price

  	
   

  	
  12

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.4

  	
   

  	
  Invoices from Lilly to United Therapeutics

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.5

  	
   

  	
  Payment of Invoices

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.6

  	
   

  	
  Taxes

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.7

  	
   

  	
  Wire Transfers/Electronic Transfers

  	
   

  	
  13

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.8

  	
   

  	
  Late Payments

  	
   

  	
  14

  



 


ii

















 


	
  6.9

  	
   

  	
  Cash Collection

  	
   

  	
  14

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.10

  	
   

  	
  Service Costs

  	
   

  	
  14

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE 7  Forecasts, Orders,
  and Shipment

  	
   

  	
  14

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7.1

  	
   

  	
  Forecasts

  	
   

  	
  14

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7.2

  	
   

  	
  Purchase Orders

  	
   

  	
  15

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7.3

  	
   

  	
  Conflicts

  	
   

  	
  15

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7.4

  	
   

  	
  Raw Materials

  	
   

  	
  15

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7.5

  	
   

  	
  Shipment; Title

  	
   

  	
  16

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7.6

  	
   

  	
  Reporting Regarding Lilly Distribution and Lilly Shipments to
  Wholesalers (or Third Parties)

  	
   

  	
  17

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7.7

  	
   

  	
  Financial Matters

  	
   

  	
  17

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE 8  Quality and Safety

  	
   

  	
  18

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8.1

  	
   

  	
  Inspections and Audits

  	
   

  	
  18

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8.2

  	
   

  	
  GMP Compliance

  	
   

  	
  19

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8.3

  	
   

  	
  Quality Agreement

  	
   

  	
  20

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8.4

  	
   

  	
  Shelf Life

  	
   

  	
  20

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8.5

  	
   

  	
  Lot Numbering

  	
   

  	
  20

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8.6

  	
   

  	
  Lilly Obligations to Meet Specifications

  	
   

  	
  20

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE 9  Representations,
  Warranties and Indemnification

  	
   

  	
  20

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  9.1

  	
   

  	
  Incorporation by Reference of Warranties and Indemnification

  	
   

  	
  20

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  9.2

  	
   

  	
  Further Representations and Warranties of Lilly

  	
   

  	
  21

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE 10  Decision Making

  	
   

  	
  21

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  10.1

  	
   

  	
  Dispute Resolution

  	
   

  	
  21

  



 


iii

















 


	
  ARTICLE 11  Term and
  Termination

  	
   

  	
  21

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  11.1

  	
   

  	
  Term, Expiry and Termination of the Agreement

  	
   

  	
  21

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  11.2

  	
   

  	
  Consequences of Expiry or Termination

  	
   

  	
  21

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  11.3

  	
   

  	
  Survival

  	
   

  	
  22

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  11.4

  	
   

  	
  No Waiver of Remedies

  	
   

  	
  22

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE 12  Confidentiality

  	
   

  	
  22

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE 13  General Provisions

  	
   

  	
  22

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  13.1

  	
   

  	
  Assignment

  	
   

  	
  22

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  13.2

  	
   

  	
  Subcontracting

  	
   

  	
  22

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  13.3

  	
   

  	
  Compliance with Laws

  	
   

  	
  23

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  13.4

  	
   

  	
  Incorporation by Reference of Miscellaneous Terms

  	
   

  	
  23

  



 


iv

















 


EXHIBITS


 


	
  Exhibit 1.3

  	
   

  	
  Manufacturing Responsibility Document Table of Contents

  
	
   

  	
   

  	
   

  
	
  Exhibit 1.7

  	
   

  	
  Quality Agreement Table of Contents

  
	
   

  	
   

  	
   

  
	
  Exhibit 1.8

  	
   

  	
  Specifications

  
	
   

  	
   

  	
   

  
	
  Exhibit 2.3(b)

  	
   

  	
  Lilly Del Caribe Guarantee

  
	
   

  	
   

  	
   

  
	
  Exhibit 6.2

  	
   

  	
  Schematic of Distribution of Product

  
	
   

  	
   

  	
   

  
	
  Exhibit 6.3(a)

  	
   

  	
  Purchase Price

  
	
   

  	
   

  	
   

  
	
  Exhibit 6.7

  	
   

  	
  Wire Instructions

  



 


v

















 


MANUFACTURING AND SUPPLY AGREEMENT


 


THIS MANUFACTURING AND SUPPLY AGREEMENT
(the “Agreement”) is made and
entered into as of November 14, 2008 (the “Execution Date”), effective as of the Effective Date, by and
between Eli Lilly and Company, an Indiana corporation, having its principal
place of business at Lilly Corporate Center, Indianapolis, Indiana 46285, (“Lilly”) and 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 1110 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, as of the
Execution Date, Lilly is manufacturing and selling its proprietary active
pharmaceutical ingredient, tadalafil, under the brand name Cialis® for
treatment of erectile dysfunction;


 


WHEREAS, Lilly is
developing and seeking regulatory approval for, and intends to manufacture and
sell, tadalafil under a separate Lilly brand name for treatment of pulmonary
hypertension, and owns or otherwise controls certain related intellectual
property rights;


 


WHEREAS, Lilly and
United Therapeutics have entered into a separate License Agreement as of the
Execution Date (the “License Agreement”)
pursuant to which United Therapeutics has received a license to Develop and
Commercialize, under such separate Lilly brand name, Lilly’s proprietary
pharmaceutical product consisting of tadalafil for the treatment of pulmonary
hypertension; and


 


WHEREAS, United
Therapeutics desires to purchase, and Lilly desires to sell to United
Therapeutics, United Therapeutics’ requirements of such Lilly proprietary
pharmaceutical product in its final finished form, subject to, and in
accordance with, the terms and conditions set forth in this Agreement and the
License Agreement.


 


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:


 


ARTICLE 1


DEFINITIONS


 


The terms in this Agreement with initial letters capitalized, whether
used in the singular or plural, shall have the meanings set forth in this Article 1
or elsewhere in this Agreement, or if not otherwise defined in this Agreement,
shall have the meanings set forth in the License Agreement.


 


1.1          “Effective
Date” shall mean the Effective Date as defined in the
License Agreement.


 

















 


1.2          “Manufacturing
Facility” shall mean Lilly’s manufacturing facilities
used by Lilly or such other facilities used for Lilly’s benefit in the
production of the Compound or the Product, as may be designated from time to
time in writing by Lilly.


 


1.3          “Manufacturing
Responsibility Document” or “MRD” shall mean additional written instructions regarding
the manufacture and supply of the Product. Sections of the MRD may be modified
from time to time through the issuance of a revised section signed on behalf of
each of the Parties by an authorized representative incorporating the
modification and stating the effective date and revision number of the
modification. An example of the table of contents of an MRD is attached hereto
as Exhibit 1.3.


 


1.4          “Modification”
shall mean changes or modifications to the Product in the Field or to the
process for manufacturing the Product for use in the Field as made in
accordance with the terms and conditions of this Agreement.


 


1.5          “Product”
shall mean that prescription pharmaceutical product, the active ingredient of
which is the Compound, in finished form and formulation, as further described
on Exhibit 1.45 (Product) of the License Agreement, which may be modified
from time to time in accordance with the terms of this Agreement.


 


1.6          “Purchase
Price” shall mean the price for the Product set forth
on Exhibit 6.3(a).


 


1.7          “Quality
Agreement” shall have the meaning set forth in Section 8.3.  An example of the table of contents of a
Quality Agreement is attached hereto as Exhibit 1.7.


 


1.8          “Specifications”
shall mean the specifications for the Product set forth on Exhibit 1.8, as
may be modified from time to time pursuant to ARTICLE 3.


 


1.9          “Term”
shall have the meaning set forth in Section 11.1.


 


1.10        “Wholesaler”
shall mean a wholesale distributor or reseller of the Product that (a) does
not engage in any marketing or promotion of the Product and (b) is
approved by Lilly.


 


ARTICLE 2


MANUFACTURE AND SUPPLY


 


2.1          General.
During the Term, and subject to the terms and
conditions of this Agreement, United Therapeutics agrees to purchase its and
its Affiliates’ and sublicensees’ requirements of the Product for the Territory
exclusively from Lilly, and Lilly agrees to sell to United Therapeutics the
requirements of the Product for the Territory of United Therapeutics and its
Affiliates and sublicensees.  Notwithstanding anything to the contrary, Lilly’s efforts to supply
the Product to United Therapeutics for use in the Field in the Territory under
this Agreement and the License Agreement will be consistent with Lilly’s
efforts to supply the Product for use in the Field outside the Territory.


 


2

















 


2.2          The
Product Prior to Modification.


 


(a)           Lilly
represents and warrants that, as of the Effective Date, it does not anticipate
making any material Modification that would increase the Purchase Price or
delay launch of the Product in the Field in the Territory.


 


(b)           The
Parties anticipate making certain minor Modifications to the Product which will
not be subject to the decision-making process referred to in ARTICLE 3 in
preparation for the launch of the Product in United Therapeutics’ Domain,
including:


 


(i)                identifying the
Lilly Product Mark, distinct from the brand name Cialis®, used in connection
with the marketing and sale of the Product in the Field, anticipated as of the
Execution Date to be [***]TM; or its replacement, subject to
Regulatory Approval, and any identifying design mark to be associated with the
Product in the Field in the Territory; and 


 


(ii)               adding a
Corporate Mark of United Therapeutics as identified by United Therapeutics to
the packaging for the Product in accordance with Section 2.7(b).


 


2.3          Subcontractors.


 


(a)           Lilly
shall have the right to subcontract all or any portion of its exclusive
manufacturing and supply activities under this Agreement to a Lilly Affiliate
or a Lilly authorized Third Party. In the event that any such subcontractor will
perform cGMP manufacturing, distribution, invoicing or collections activities
under such subcontract with respect to the Product to be supplied under this
Agreement, Lilly shall provide United Therapeutics with prompt notice of such
subcontract. If the activities under such subcontract are intended to relate:


 


(i)                to
distribution, invoicing or collections with respect to the Product and not to
other products Lilly distributes and sells directly for Lilly’s own benefit; or


 


(ii)               primarily to
the manufacture of the Product to be supplied to United Therapeutics under this
Agreement and not to other products Lilly distributes and sells directly for
Lilly’s own benefit;


 


then Lilly may
not subcontract its rights or obligations under this Agreement in respect of
such activities to any subcontractor or consultant without prior written
consent of United Therapeutics, which shall not unreasonably be withheld;
provided that, if such a subcontract is intended to relate to the manufacture
of Product for supply to United Therapeutics under this Agreement for United
Therapeutics’ Domain and also for Lilly for outside the Field in the Territory
or in any field outside the Territory, Lilly will not require prior written
consent of United Therapeutics.


 


(b)           With
respect to any provision of this Manufacturing and Supply Agreement relating to
supply obligations, any reference to “Lilly” shall be deemed to include a reference
to Lilly del Caribe. References to Lilly shall also be deemed to include Lilly’s


 


3

















 


Affiliates. Lilly shall cause Lilly del Caribe to perform its
obligations hereunder and shall execute the guarantee attached as Exhibit 2.3(b).


 


2.4          Product
for Development and Promotion. The Parties acknowledge
and agree that the Product and placebo 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), 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 (a) the Product to United Therapeutics for such purposes
at the Purchase Price for such Product and (b) placebo at Lilly’s cost, to
be agreed upon by the Parties in each instance in advance in writing. Lilly
will have no obligation to manufacture or supply samples of the Product
specially packaged for sampling unless otherwise agreed by the Parties in writing.


 


2.5          Notice
of Impact on Supply. Lilly shall notify United
Therapeutics promptly upon Lilly’s discovery of any event or condition that
Lilly expects may have the potential to materially adversely affect Lilly’s
ability to supply the Product for Development or Commercialization in the Field
in the Territory under this Agreement and the License Agreement. The Parties
shall meet within seven (7) days after such notice to assess the potential
impact of such event or condition on Lilly’s ability to supply the Product for
Commercialization in the Field in the Territory under this Agreement and the
License Agreement. Notwithstanding
anything to the contrary, in the event of any inability by Lilly to
supply Product for Development or Commercialization in the Field in the
Territory under this Agreement and the License Agreement, Lilly shall allocate raw materials, Compound,
components, and available production capacity such that Lilly’s efforts to
supply Product to United Therapeutics for such use will take priority
over the supply of Cialis®.


 


2.6          Manufacturing
Facility.


 


(a)                   Lilly
shall manufacture the Compound and the Product supplied to United Therapeutics
under this Agreement at the Manufacturing Facilities approved by the relevant
Regulatory Authorities to manufacture the Product.


 


(b)                   If
Lilly intends to change the Manufacturing Facility at which Lilly manufactures
the Compound and the Product supplied to United Therapeutics under this
Agreement, or adds additional Manufacturing Facilities at which Lilly manufactures
the Compound and the Product (including, if applicable, Manufacturing
Facilities of a Third Party) supplied to United Therapeutics under this
Agreement, Lilly shall provide United Therapeutics with at least six (6) months
prior written notice to that effect and shall deliver to United Therapeutics a
copy of each relevant Regulatory Authority’s approval of such Manufacturing
Facility upon receipt thereof. If Lilly changes the Manufacturing Facility or
adds additional


 


4
















 


Manufacturing Facilities, and there are incremental costs associated
with such change or addition that may be recovered by Lilly from United
Therapeutics pursuant to this Agreement, Lilly shall ensure that the costs of
same are not borne disproportionately in United Therapeutics’ Domain, as
opposed to Lilly’s Domain.


 


(c)                   Lilly shall provide to United
Therapeutics at least six (6) months prior written notice of any scheduled
shutdown at a Manufacturing Facility that would materially adversely affect
Lilly’s ability to manufacture and timely deliver the Product to United
Therapeutics under this Agreement.


 


2.7           Product Packaging & Labeling.


 


(a)                   Subject to Section 2.7(b),
Applicable Law and consistent with industry practices, the Parties shall
collaborate on preparing the design of the packaging and labeling for the
Product, including packaging and labeling alternatives for uses in accordance
with Section 2.4, and each Party shall allow the other Party reasonable
time to provide comments and recommendations with respect to same.


 


(b)                   The Parties shall act reasonably and
in good faith in considering each other’s comments on the packaging and
labeling for the Product, including giving the Corporate Mark of United
Therapeutics identified by United Therapeutics pursuant to Section 2.2(b)(ii) prominence
over Lilly’s Corporate Mark to the extent permitted under Applicable Law;
provided that, subject to Applicable Law and consistent with industry
standards, Lilly shall have final decision-making authority regarding such
packaging and labeling in accordance with the terms of Section 3.4(c) (Decision
Making) of the License Agreement.  In
connection with the exercise of such final decision-making authority, Lilly
shall comply with Section 3.4(c)(ii) of the License Agreement.


 


(c)                   Subject to Applicable Law, Section 2.7(b),
and industry practices, the Parties, acting reasonably, shall determine the
positioning and appearance of each Party’s trademarks on such packaging and
labeling.


 


(d)                   Each unit of the Product shall be
packaged and labeled with language, indications, labeling and regulatory
disclosures in accordance with the Specifications and in compliance with
Applicable Law, including Regulatory Approvals, GMP, the MRD, and the Quality
Agreement.


 


(e)                   The Parties shall act reasonably to
design the packaging and labeling of the Product to prevent the unauthorized
sale of the Product outside the Field in the Territory and outside the
Territory.  Lilly shall act reasonably to
design the packaging and labeling of products containing the Compound for sale
outside the Field in the Territory and outside the Territory to prevent the
unauthorized sale of such products in the Field in the Territory.


 


(f)                    Each unit of the Product shall bear
a label and be contained in an outer package, and/or carton and, if applicable,
be accompanied by a package insert, which label, outer package, and/or carton
and/or package insert shall comply with all Applicable Law and Article 9
(Trademark Usage and Maintenance) of the License Agreement.  United Therapeutics, at its


 


5

















 


expense, shall provide Lilly with graphics and artwork for such
packaging materials for use by Lilly in the manufacture of the Product, subject
to Applicable Laws and in accordance with the provisions set forth in the MRD
and the Quality Agreement.  Such
packaging materials shall carry a legend clearly indicating that the Product
was manufactured by Lilly and exclusively sold by United Therapeutics or its
Affiliates, unless it is reasonable and allowed under Applicable Law under the
circumstances to delete Lilly’s name.


 


2.8          Supply Lead
Contacts. Each Party shall appoint a lead contact for the activities
contemplated by this Agreement (each, a “Supply
Lead Contact”).  The Supply
Lead Contact for each Party shall be identified to the other Party not later
than ten (10) days after the Effective Date.  A Party may change its Supply Lead Contact
upon written notice to the other Party. 
Each Supply Lead Contact shall be charged with creating and maintaining
a collaborative work environment between the Parties.  Each Supply Lead Contact will also:  (a) be the point of first referral in
all matters of conflict resolution under this Agreement; (b) provide a
single point of communication for seeking consensus both within the respective
Parties’ organizations and between the Parties regarding key issues; (c) identify
and bring disputes to the attention of the Parties in a timely manner for
resolution under Section 3.4(c) (Decision Making) of the License
Agreement; and (d) coordinate agreement between the Parties on the
definitive MRD and definitive Quality Agreement.


 


ARTICLE 3

MODIFICATIONS


 


3.1          Packaging
and Labeling. Each Party shall have the right to propose
Modifications to packaging and labeling for the Product in the Field in the
Territory consistent with the process set out in Section 2.7.  Lilly’s review and approval of any labeling
shall not cause Lilly to be liable or otherwise responsible for the compliance
with Applicable Law of the form and contents of any labeling and packaging
proposed by United Therapeutics.


 


3.2          Manufacturing
Facility. In respect of any change in or addition to a Manufacturing
Facility contemplated by Section 2.6(b), Lilly will give United
Therapeutics prompt advance written notice and an opportunity to provide
comments to Lilly in writing for Lilly’s good faith consideration; provided,
however, that Lilly, after such good faith consideration of United Therapeutics’
comments, will have final decision-making authority regarding the Manufacturing
Facility(ies) at which Lilly will manufacture Compound and/or Product, so long
as such change or modification would not be reasonably likely to materially
adversely affect the Product in the Field in the Territory.


 


3.3          Compound and its Specifications and Manufacturing
Process.


 


(a)           Lilly shall provide United Therapeutics with
written notice soon as reasonably possible and at least sixty (60) days in
advance of the effective date of a Modification to the specifications for the Compound
or process for the manufacture of the Compound, unless impractical for
regulatory reasons, in which case such notice shall be provided promptly after
the need for such Modification arises, subject to the terms of the Quality
Agreement.


 


6

















 


(b)           Notwithstanding anything to the contrary,
Lilly, acting reasonably and in good faith, shall have the right to make any
Modification proposed under Section 3.3(a), without the consent of United
Therapeutics.


 


3.4          Product, its Specifications and Manufacturing Process.


 


(a)           Each Party shall have the right to propose
Modifications to the Product, its Specifications and the manufacturing process.
The Modifications contemplated by this Section 3.4 include changes to the
number of tablets in a package, type or design of the bottle, blister
packaging, the Product insert, counterfeiting measures, and the like.


 


(b)           Notwithstanding anything to the contrary, in
addition to Lilly’s rights under Sections 3.3 and 3.5, but subject to Lilly’s
obligations under Sections 2.2(b), 3.1 and the rest of this Section 3.4,
Lilly, acting reasonably and in good faith, shall have the right to make
Modifications to the Product, its Specifications and manufacturing process,
without the consent of United Therapeutics.


 


(c)           Except with respect to Modifications that
Lilly believes in good faith are reasonably necessary to promote patient safety
or for ethical or quality reasons, or which are required by Applicable Law,
Lilly shall not make and shall not be obliged to make, unless mutually agreed
to between the Parties, any Modification to:


 


(i)                the size, shape
and the Lilly Identicode® of the Product, unless such change is required to
conform to changes made by Lilly to Cialis® produced at the same Manufacturing
Facility; and


 


(ii)               changes to the
dosage form of the Product.


 


3.5          Modifications
Required Under Applicable Law.


 


(a)           Prior to the obtaining Regulatory Approval
for the Product in the Territory, Lilly shall modify the Product as necessary
to comply with Applicable Law or Regulatory Approvals specific to the Product
in the Field in the Territory.


 


(b)           After obtaining Regulatory Approval for the
Product in the Territory, if Lilly is required to modify the Product for use in
the Field to comply with Applicable Law or Regulatory Approvals specific to the
Product in the Field in the Territory, Lilly shall provide United Therapeutics
with written notice as soon as reasonably possible and at least sixty (60) days
in advance of the effective date of such Modification, unless impractical for
regulatory reasons, in which case such notice shall be provided promptly after
the need for such Modification arises.


 


(c)           Notwithstanding anything to the contrary,
Lilly, acting reasonably and in good faith, shall have the right to make any
Modification necessary to comply with Applicable Law or Regulatory Approvals
specific to the Product in the Field in the Territory, without the consent of
United Therapeutics.


 


7

















 


3.6          Terms
Applicable to All Modifications.  All
Modifications shall be subject to the following terms and conditions:


 


(a)           Every Modification proposed by Lilly or
United Therapeutics will be treated separately.


 


(b)           Subject to Lilly’s rights as set forth in Sections
3.3(b) and 3.5(c), the Parties shall collaborate regarding the reasons and
merits for implementation of any significant (as described in the Quality
Agreement and the MRD)  Modification
and, to the full extent practicable, each Party shall allow the other Party
reasonable time to provide comments and recommendations with respect to
same.  Lilly shall keep United
Therapeutics informed of the progress of implementing any significant (as
described in the Quality Agreement and the MRD) Modification on a timely basis.


 


(c)           Each Party shall act reasonably and in good
faith in considering proposals by the other Party for any Modification.


 


(d)           In no event shall Lilly be required to make
any Modification that is prohibited by Applicable Law or by a Regulatory
Authority.


 


(e)           Lilly shall use Commercially Reasonable
Efforts to implement any Modification at the lowest practical cost.


 


(f)            Lilly shall have sole responsibility for
obtaining any and all necessary Regulatory Approvals for any and all
Modifications, and for reporting any Modification and any modification to the
Regulatory Approvals to the Regulatory Authority, as appropriate.


 


(g)           If Lilly exercises its decision-making
authority under this Agreement, Lilly will, if such decision might materially
adverse effect the Product in United Therapeutics’ Domain, prior to making such
decision, provide to United Therapeutics a reasonably detailed written
explanation of the basis for such decision and provide United Therapeutics with
an opportunity to discuss the matter.


 


(h)           Section 4.1 (Conduct of the Parties) of
the License Agreement is hereby incorporated herein and made part of this
Agreement.


 


(i)            Lilly shall have no obligation to give
notice or obtain the consent of United Therapeutics for any Modification or any
change or modification with respect to the Manufacturing Facility that is not
significant (as described in the Quality Agreement and the MRD).


 


ARTICLE 4

COSTS OF MODIFICATIONS


 


4.1          Graphics
and Artwork into Packaging.  United
Therapeutics shall reimburse Lilly for any reasonable costs associated incurred
by Lilly as a consequence of implementing United Therapeutics’ graphics and
artwork into packaging materials in accordance with Section


 


8

















 


3.1 in accordance with a prior written estimate of such costs,
including reasonable costs of Lilly associated with the destruction of printed
components rendered obsolete as a result of the transactions contemplated
hereby.


 


4.2          Required
Under Applicable Law.  If Lilly
modifies the Product as necessary to comply with changes in Applicable Law or
Regulatory Approvals specific to the Product in the Field in the Territory
prior to the initial Regulatory Approval in the Territory, then Lilly shall be
solely responsible for the costs and expenses (including capital expenditures,
regulatory costs, and any other costs) incurred by Lilly as a consequence of
implementing any such Modification, and there will be an increase in the
Purchase Price to permit Lilly to recover such costs and expenses; provided
that, if Lilly implements any such Modification for the Product outside of the
Field in the Territory or outside of the Territory, then such increase in the
Purchase Price shall be on a pro rata basis.


 


4.3          Lilly Modifications.  If:


 


(a)           Lilly proposes a Modification that is not
required by Applicable Law, then Lilly shall be solely responsible for the
costs and expenses (including capital expenditures, regulatory costs, and any
other costs) incurred by Lilly as a consequence of implementing any such
Modification, and the Purchase Price shall not be adjusted as a result of such
costs and expenses;


 


(b)           a Modification is attributable to products
in Lilly’s Domain and not required in United Therapeutics’ Domain, or a
Modification is required to comply with changes in Applicable Law or Regulatory
Approvals outside the Territory, then Lilly shall be solely responsible for the
costs and expenses (including capital expenditures, regulatory costs, and any
other costs) incurred by Lilly as a consequence of implementing any such
Modification, and the Purchase Price shall not be adjusted as a result of such
costs and expenses; or


 


(c)           in respect of any change in or addition to a
Manufacturing Facility contemplated by Section 2.6(b), the incremental
costs and expenses incurred by Lilly as a consequence of such change or
addition, including any start-up costs, capital expenditures, or regulatory
costs related to such change or addition shall be borne by Lilly and, subject
to Section 2.6(b), there will be an increase in the Purchase Price to
permit Lilly to recover such costs and expenses.  In no event shall the Purchase Price be
increased by more than forty percent (40%) of the then-current Purchase Price
as a result of Lilly’s decision to use a different Manufacturing Facility
pursuant to Section 2.6.


 


4.4          United
Therapeutics’ Modifications.


 


(a)           If United Therapeutics requests a
Modification, or a Modification is required under Applicable Law specific to
the Product in the Field in the Territory after the initial Regulatory Approval
in the Territory, then Lilly shall initially bear the reasonable costs and
expenses (including capital expenditures, regulatory costs, and any other
costs) incurred by the Parties as a consequence of implementing any such
Modification; provided that the Purchase Price shall be adjusted to permit
Lilly to recoup such costs and expenses as described in this Section 4.4.


 


9

















 


(b)           Within forty-five (45) days of receipt of
United Therapeutics’ request, or as soon as reasonably possible after notice
that such a Modification is required under Applicable Law, Lilly shall provide
United Therapeutics with a written explanation of any incremental costs and
expenses (including capital expenditures, regulatory costs and any other costs
applied consistently with other divisions) and any incremental increase in
ongoing the Product manufacturing costs (as reflected in Lilly’s cost of
manufacturing the Product as calculated by Lilly for internal accounting
purposes, such calculation to be performed consistently with the practice
across Lilly’s divisions,) estimated to be incurred by Lilly due to any such
Modification.  Within forty-five (45)
days of receipt of such explanation, United Therapeutics may notify Lilly that
United Therapeutics is not willing to pay for such Modification, and thereafter
such Modification will not be implemented unless Lilly, in its discretion,
chooses to implement such Modification and advises United Therapeutics of such
decision within a reasonable period of time. 
For the purpose of calculating the responsibility for the costs of any
such Modification that Lilly chooses to implement, such Modification shall be
deemed to be a Modification proposed by Lilly and paid for pursuant to Section 4.3(a).
Any calculation or payment of such incremental costs and expenses of any such
Modification shall be based on the incremental costs and expenses attributable
solely to such Modification with respect to the Product in the Field in the
Territory, and shall not include any costs or expenses attributed to any
modification of products in Lilly’s Domain. 
Lilly may increase the Purchase Price to reflect any such incremental
costs and expenses (including capital expenditures, regulatory costs and any
other costs applied consistently with other divisions) and such incremental
increase in ongoing Product manufacturing costs.


 


(c)           United Therapeutics may propose the addition
of one or more Wholesalers to Lilly’s distribution and shipment process
described in this Agreement, and Lilly shall act reasonably and in good faith
in considering such proposal.  United
Therapeutics shall be solely responsible for the Reasonable Costs incurred by
Lilly as a consequence of implementing any such proposal.


 


ARTICLE 5

REMEDIES


 


5.1          Failure to
Make Modifications.  In the
event that Lilly is unable or fails to implement a Modification after
exercising Commercially Reasonable Efforts, then Lilly will use Commercially
Reasonable Efforts to employ a capable Third Party to perform such
manufacturing.


 


5.2          Modifications
to Comply with Laws or Approvals.  If
United Therapeutics is not willing to pay for a Modification necessary to
comply with Applicable Law or Regulatory Approvals specific to the Product in
the Field in the Territory, then, at United Therapeutics’ request, Lilly and
United Therapeutics shall use Commercially Reasonable Efforts to purchase the
Product from a Third Party manufacturer or find a mutually acceptable solution
to the problem, and in the absence of such a solution, in addition to its rights available under this
Agreement, the License Agreement and Applicable Law, United Therapeutics
may, at its option, terminate
this Agreement and the License Agreement as of the earlier of (A) the
date Applicable Laws require the implementation of such Modification, or (B) thirty
(30) days after written


 


10

















 


notice from United Therapeutics to Lilly, pursuant, in either case (A) or
(B), to Section 13.2
(Unilateral Termination by United Therapeutics) of the License Agreement, with
the consequences of such a termination as set out therein.


 


5.3          Failure to
Supply.  If Lilly fails, in
two (2) or more calendar months in any twelve (12) calendar month period,
to supply an amount of Product equal to the lesser of (a) eighty percent
(80%) of the aggregate Product ordered by Wholesalers for such calendar month
and (b) eighty percent (80%) of the Product set forth in the applicable
Forecast for such calendar month, and as a result, United Therapeutics is
significantly harmed in its ability to meet the demand at the retail level for
the Product in the Field in the Territory, then at United Therapeutics’
request, Lilly and United Therapeutics shall use Commercially Reasonable Efforts
to purchase the Product from a Third Party manufacturer.  The applicable
Forecast for Section 5.3(b) shall be the Forecast for the calendar
month in question that was contained in the United Therapeutics’ Forecast
delivered to Lilly four (4) months in advance of the applicable calendar
month. 
If United
Therapeutics and Lilly, using Commercially Reasonable Efforts, are unable to
purchase the Product from a Third Party manufacturer, United Therapeutics shall
be permitted to exercise any of its other rights available under this
Agreement, the License Agreement and Applicable Law.


 


ARTICLE 6

PRICE AND PAYMENT


 


6.1          Payment to
Lilly del Caribe. In consideration of Lilly del Caribe’s agreement
to manufacture and have Lilly supply the Product to United Therapeutics at the
purchase price set forth in Section 6.2 for sale by United Therapeutics,
United Therapeutics, within ten (10) days after the Effective Date shall
pay to Lilly del Caribe a one-time only, non-refundable (except as provided by Section 13.5(c) (Upon
Termination of this Agreement by Lilly Pursuant to Section 13.4(a)) of the
License Agreement), non creditable payment of One Hundred Twenty-Five Million
Dollars ($125,000,000) as prepayment for a portion of the price for the Product
to be supplied by Lilly to United Therapeutics.


 


6.2          Distribution
Process.


 


(a)           United Therapeutics will purchase Product
from Lilly and Lilly, acting as agent for United Therapeutics, will distribute
such Product to Wholesalers, on behalf of United Therapeutics, in accordance
with the terms of this Agreement.  A
schematic description of the distribution of Product under this Agreement,
solely for purposes of clarification and not limitation, is set forth in Exhibit 6.2.  In particular, based on a standing Purchase
Order from United Therapeutics, Lilly will manufacture and ship Product to a
Lilly distribution center, using shipment arrangements consistent with those
Lilly uses for products Lilly distributes and sells directly for Lilly’s own
benefit, as further described in Section 7.5(a).  The Parties will establish a joint committee
through the Supply Lead Contacts to facilitate the use by United Therapeutics
of Lilly’s distribution processes as contemplated by this Agreement. The
Parties will agree on a minimum inventory level of Product to be maintained in
Lilly distribution centers in the MRD. 
Lilly shall use Commercially Reasonable Efforts to maintain a quantity
of Product in inventory in Lilly’s distribution center equal to or greater than
the agreed-upon minimum inventory level;


 


11

















 


provided that the minimum replenishment quantity will be one (1) then-standard
Lilly manufacturing lot of Product; provided further that, if a batch is split,
United Therapeutics shall be responsible only for the portion of such a split
batch that is allocated to United Therapeutics’ Domain and no portion of such a
split batch that is allocated to Lilly’s Domain.  As of the Effective Date, one (1) standard
manufacturing lot of Product is equal to [***] ([***]) tablets.  Lilly will invoice United Therapeutics in
accordance with Section 6.4 for Product shipped by Lilly to Lilly
distribution centers at the time of shipment to distribution center, and United
Therapeutics will make payment to Lilly against such invoices in accordance
with Sections 6.3, 6.4, 6.5, 6.6, 6.7 and 6.8.


 


(b)           As an agent for United Therapeutics, Lilly
will (i) store Product in its distribution centers, (ii) receive,
through its distribution centers, orders for Product from Wholesalers, (iii) ship
ordered Product to Wholesalers, (iv) bill/invoice Wholesalers, (v) process
invoice remittances from Wholesalers, and (vi) receive payments from
Wholesalers.  Upon shipment of Product to
a Wholesaler, Lilly shall invoice the Wholesaler for the selling price at Lilly’s
then-current standard terms and the terms of Lilly’s agreements with its
Wholesalers.


 


(c)           The intent of the arrangement described in
Sections 6.2(a) and 6.2(b) is to permit the Parties to take advantage
of Lilly’s internal processes and Lilly’s existing relationships with
Wholesalers but, if there are subsequent changes in Lilly’s internal processes
and/or Lilly’s existing relationships with Wholesalers, or there are other
changes and circumstances that otherwise make such arrangement not feasible or
desirable, the Parties shall discuss in good faith amending this Agreement.


 


6.3          Purchase Price.


 


(a)           In addition to the amount paid to Lilly del
Caribe by United Therapeutics as a prepayment for supply of the Product in the amount
set forth in Section 6.1, and in consideration for supply of the Product
under this Agreement, United Therapeutics shall pay to Lilly the Purchase Price
for such Products sold by Lilly to United Therapeutics, as set forth in Exhibit 6.3(a),
subject to adjustment in accordance with Section 6.3(b) and/or
6.3(c), or as otherwise adjusted pursuant to this Agreement.


 


(b)           The Purchase Price for supply of the Product
shall be adjusted annually at the beginning of each Calendar Year upon sixty
(60) days prior written notice from Lilly to United Therapeutics, and
Lilly shall apply the new price only in respect of Purchase Orders received on
or after the effective date of such price change.  Such adjustment shall be based on: (a) actual
increases or decreases in the most recent Calendar Year Producer Price Index,
Industry: Pharmaceutical Preparations, as published by the U.S. Department of
Labor, Bureau of Labor Statistics, or any replacement index, and (b) changes
contemplated by ARTICLE 4.


 


(c)           In the event that Lilly determines that
Lilly’s standard cost of manufacturing the Product (including Lilly’s cost of
its distribution system, including the costs of transportation, and insurance
during transport, to Lilly’s distribution center, storage in warehouse facilities,
and insurance during such storage, at Lilly’s distribution center, and
transportation, and insurance during transport, to the Wholesaler pursuant to
Lilly’s relationship with such Wholesaler) as calculated by Lilly for internal
accounting purposes, such calculation


 


12

















 


performed consistently with the practice across Lilly’s divisions, is
greater than the Purchase Price, then Lilly will give notice of same to United
Therapeutics and disclose to United Therapeutics such standard cost of
manufacturing the Product. Lilly may thereafter increase the Purchase Price for
the Product sold to United Therapeutics to Lilly’s standard cost of
manufacturing the Product.  Lilly will
give United Therapeutics at least ninety (90) days notice of any such increase,
and such notice shall be given no more than once in any twelve (12) month
period.  Any overheads forming a part of
Lilly’s standard cost of manufacture shall be shared pro-rata based on volume
of the Product in the Field in the Territory, and the total of the volume of
product manufactured between the Product in the Field in the Territory versus
the volume of products containing the Compound outside the Field in the
Territory and in fields outside the Territory.


 


6.4          Invoices
from Lilly to United Therapeutics. At the time of shipment by Lilly
from the factory to a Lilly distribution center, Lilly shall deliver an invoice
(electronically using Electronic Data Interchange (“EDI”) standard methods) to United Therapeutics after shipment
of the Product in accordance with Section 7.5(a) and delivery of the
corresponding Purchase Order.  All
invoices issued by Lilly shall show:


 


(a)                   the actual quantity of the Product
shipped;


 


(b)                   the lot number and expiration date
of each batch of the Product shipped; and


 


(c)                   the Purchase Price for the quantity
of the Product shipped, based on the Purchase Price for the Product as in
effect at the time of shipment;


 


or as otherwise set forth in the MRD. 
If United Therapeutics disputes for any reason the amounts set forth in
any invoice submitted by Lilly, United Therapeutics shall notify Lilly of such
dispute within thirty (30) days after the date of such invoice, and the Parties
shall promptly attempt to resolve the dispute.


 


6.5          Payment of
Invoices.  Each invoice issued
by Lilly to United Therapeutics under Section 6.4, to the extent accurate,
shall be paid in full by United Therapeutics to Lilly within thirty (30) days
after the date of such invoice.


 


6.6          Taxes. The
Parties acknowledge and agree that it is their mutual objective and intent to
minimize, to the extent feasible, taxes payable with respect to the payment
under Section 6.1 and that they shall each use Commercially Reasonable
Efforts to cooperate and coordinate with each other to achieve such
objective.  If Applicable Law requires
that taxes be deducted and withheld from any payment, United Therapeutics shall
(a) deduct such taxes from the payment; (b) pay such taxes to the
proper taxing authority; and (c) send evidence of such obligation together
with proof of such payment to Lilly within sixty (60) days following such
payment.


 


6.7          Wire
Transfers/Electronic Transfers. All payments for invoices delivered
under this Agreement that are not associated with the transfer of the Product
shall be made to Lilly or Lilly del Caribe, as applicable, by bank wire
transfer in immediately available funds to


 


13

















 


Lilly or Lilly del Caribe, as applicable, in accordance with the wire
instructions set forth in Exhibit 6.7, which may be changed by written
notice to United Therapeutics in accordance with Section 15.7 (Notice) of
the License Agreement.  All payments for
all other invoices delivered under this Agreement shall be made to Lilly or
Lilly del Caribe, as applicable, electronically using EDI standard methods or
wire transfer.


 


6.8          Late
Payments. Subject to the terms of this Agreement, payments not made
to Lilly or Lilly del Caribe, as applicable, within the time period set forth
in Section 6.1 or 6.5, as applicable, shall bear interest at a rate of two
percent (2%) per month or the highest rate allowed under Applicable Law,
whichever is lower, until paid in full. 
The payment of such interest shall not limit Lilly from exercising any
other rights it may have as a consequence of the lateness of any payment.


 


6.9          Cash
Collection. Any receipt by Lilly under Section 6.2(b), acting
as an agent for United Therapeutics, of the receivables due from the
Wholesaler, shall be consistent with those practices that Lilly uses for the
collection of receivables owed Lilly for its own product sales.  Lilly shall transfer any such receivables
collected by Lilly on a monthly basis to United Therapeutics (via EFT/ACH or
wire transfer).  Lilly shall use
Commercially Reasonable Efforts, consistent with Lilly’s usual collection
practices, to collect payments due from Wholesalers with respect to Products
delivered to such Wholesalers under this Agreement; provided, however, that
Lilly does not guarantee any such collections. For purposes of clarification,
United Therapeutics shall bear the risk of any and all uncollected receivables
and bear ultimate responsibility for collecting same.


 


6.10       Service Costs.
In consideration for start-up services provided by Lilly in connection
with the distribution process to be utilized by the Parties under the terms of
this Agreement, as mutually agreed by the Parties and as further described in Section 6.2(a),
United Therapeutics will reimburse Lilly for the costs and expense incurred by
Lilly to establish such start-up services. 
The amount to be reimbursed to Lilly by United Therapeutics will be
determined based upon actual amounts paid to Third Parties and, with respect to
Lilly employees by the number of full time equivalents (FTEs) spent by Lilly to
establish such start-up services at an annual rate of [***] Dollars ($[***])
(adjusted annually based on CPI) per full time equivalent.  Lilly will provide an invoice to United
Therapeutics after such start-up services have been established, and United
Therapeutics will make payment to Lilly against such invoice in accordance with
Sections 6.5, 6.6, 6.7 and 6.8.


 


ARTICLE 7

FORECASTS, ORDERS, AND SHIPMENT


 


7.1          Forecasts. Commencing
on or before the later of: (a) the first day of the month that commences
at least nine (9) calendar months in advance of the anticipated launch
date for the Product, as agreed between the Parties; and (b) January 2,
2009; United Therapeutics will provide to Lilly:  (i) on or before the first day of each
month thereafter, United Therapeutics’ good faith estimate of the total
quantity of the Product, on a stock keeping unit basis, expected to be ordered
by all Wholesalers for the following twenty-four (24) calendar months, broken
down into calendar months (each, the “Forecast”),
and (ii) on or before April 15th of each year, United


 


14
















 


Therapeutics’ good faith estimate of the total quantity of the Product,
on a stock keeping unit basis, expected to be ordered by all Wholesalers for
the current year and the following two (2) years, broken down into
years.  The Parties agree that such Forecasts
and such estimates will be for general planning purposes only, and will not be
binding on Lilly or United Therapeutics except as otherwise set out in Section 5.3.


 


7.2                               Purchase
Orders.


 


(a)                                                          Lilly
will receive purchase orders from Wholesalers (each such separate purchase
order, a “Purchase Order”) for
fulfillment.  Lilly, using efforts
consistent with those Lilly puts forth to fill orders for products Lilly
distributes and sells directly for Lilly’s own benefit, shall fill the orders
corresponding to such Purchase Orders and ship the Product directly to the
Wholesalers.  A schematic description of
distribution of Product under this Agreement, solely for purposes of
clarification and not limitation, is set forth in Exhibit 6.2.


 


(b)                                                          Notwithstanding
the foregoing, Lilly, using efforts consistent with those Lilly puts forth to
fill orders for products Lilly distributes and sells directly for Lilly’s own
benefit, shall: (i) meet any request of Wholesalers for delivery of the
Product; and (ii) accommodate any cancellations of Purchase Orders or
changes in delivery schedules for the Product requested by Wholesalers
following Lilly’s receipt of Purchase Orders from Wholesalers.


 


7.3                               Conflicts.  Each United Therapeutics’ Forecast, any
Purchase Order, and each Lilly invoice shall be governed by the terms of this
Agreement, the License Agreement, the MRD, and the Quality Agreement, and no
terms or conditions of United Therapeutics’ Forecasts and Purchase Orders,
Lilly’s acknowledgement forms or invoices, or any other forms shall be
applicable except those specifying quantity ordered (subject to the quantity
restrictions) and shipment locations. 
For clarity, no term or condition added by United Therapeutics to a
Forecast or Purchase Order or by Lilly to an invoice shall be binding on Lilly
or United Therapeutics, respectively, unless such term or condition is
specifically agreed to in writing by a duly authorized officer of Lilly and
United Therapeutics.  In the event of a
conflict between the terms of the MRD on the one hand, and the terms of the
License Agreement, this Agreement, or the Quality Agreement, on the other, the
terms of the License Agreement, this Agreement, or the Quality Agreement, as
applicable, shall govern.


 


7.4                               Raw
Materials.


 


(a)                                                          Reasonable
quantities of unique components or raw materials, including the Compound, that
are used in the manufacture of the Product, shall be purchased or manufactured
by Lilly, at its own cost and expense, for use in supplying United Therapeutics’
requirements for the Product under this Agreement based on the Forecast.  If United Therapeutics’ change to the
quantities of the Product previously forecasted for a calendar month in a
Forecast causes any material obsolescence of any quantities of the Product, or
any such components or materials purchased by Lilly and allocated for the
supply of such Product to United Therapeutics hereunder, and such components or
materials cannot reasonably be used by Lilly in the manufacture of other
products, United Therapeutics shall bear the reasonable and direct costs and
expenses actually incurred by the Parties associated with such change
(including


 


15

















 


any costs related to returning such components or material to the
vendor or otherwise disposing thereof). Lilly shall not make any claim under
this Section 7.4(a) for such costs and expenses until such costs and
expenses exceed twenty-five thousand Dollars ($25,000) in the aggregate in any
Calendar Quarter. Lilly shall keep United Therapeutics reasonably advised as to the
quantities of such excess unique components or materials used in the
manufacture of the Product that are purchased by Lilly.


 


(b)                                                          If
the available supply of the Compound or other inputs to the Product, including
production time, for purposes of manufacturing the Product is in short supply
such that Lilly is unable to fulfill completely United Therapeutics’
outstanding Purchase Orders, Lilly shall allocate such available supply of the
Compound and such other inputs to the Product for: the Product in the Field in
the Territory for United Therapeutics; and the Product in the Field outside the
Territory for Lilly; on a pro rata basis based on aggregate unit sales of the
Product in the Territory and outside the Territory in the two most recent
Calendar Quarters for which such information is available. Lilly shall inform
United Therapeutics of the expected duration of the shortage of the Compound or
other inputs to the Product and shall keep United Therapeutics informed on a
timely basis of the status of the supply of the Compound or other such inputs
to the Product while such shortage is occurring. The Parties shall cooperate to
expedite the manufacture of the Product by Lilly when the shortage of the
Compound or other inputs to the Product has been alleviated.  Lilly agrees to: (i) carry in “safety
stock” inventory a minimum three (3) months’ supply of the Compound and a
supply of the Product to accommodate United Therapeutics’ orders of the Product
for use in the Field in the Territory consistent with the supply of products
distributed and sold by Lilly and maintained by Lilly for other products for
similar purposes; and (ii) consistent with Section 2.1, in the event
of a shortage of the Compound or other inputs to the Product, favor the supply
of the Product for use in the Field in the Territory over the supply of
Cialis®.


 


7.5                               Shipment;
Title.


 


(a)                                                          Lilly
will ship Product from the Manufacturing Facility to a Lilly distribution
center, utilizing Lilly’s ordinary course of business shipment methods and
procedures.  Title and risk of loss of
Product will transfer from Lilly to United Therapeutics on delivery of such
Product by Lilly to a carrier at the Manufacturing Facility for shipment.  Lilly shall select the carrier to be used for
shipment of the Product from the Manufacturing Facility to a Lilly distribution
center and Lilly, as agent for United Therapeutics, will (i) arrange for
transportation of the Product from the Manufacturing Facility to a Lilly
distribution center and (ii) procure on behalf of United Therapeutics
insurance coverage on Product during shipment to a Lilly distribution center
and warehousing at the Lilly distribution center; in either case at no
additional cost to United Therapeutics, except as may be incorporated into the
Purchase Price in accordance with the terms of this Agreement.


 


(b)                                                          Lilly,
concurrently with each shipment of Product to a Lilly distribution center,
shall provide to United Therapeutics for the Product included in such shipment:
(i) normal and customary documentation, including bill of lading; (ii) a
certificate of compliance that such lot meets the Specifications; and (iii) a
certificate of analysis.


 


16

















 


(c)                                                          Lilly,
as agent for United Therapeutics, will ship Product from a Lilly distribution
center to the Wholesaler, utilizing Lilly’s ordinary course of business
shipment methods and procedures.  Title
and risk of loss of Product will transfer from United Therapeutics to
Wholesaler on delivery of such Product by Lilly to a carrier at the Lilly
distribution center for shipment.  To the
extent consistent with Lilly’s standard practices in effect at the time, Lilly
shall select the carrier to be used for shipment of the Product from a Lilly
distribution center to Wholesalers. Lilly, as agent for United Therapeutics,
will (i) arrange for transportation of the Product from the Lilly
distribution center to the Wholesaler, and (ii) procure, on behalf of
Wholesaler or United Therapeutics, insurance coverage on all Product until
received by the Wholesaler; in either case at no additional cost to United
Therapeutics, except as may be incorporated into the Purchase Price in
accordance with the terms of this Agreement. 
Lilly shall include normal and customary documentation in any and all
shipments to Wholesalers, which documentation shall be specified in the MRD.


 


7.6                               Reporting
Regarding Lilly Distribution and Lilly Shipments to Wholesalers (or Third
Parties).  Unless superseded by the
MRD, the Parties agree that the following terms will apply:


 


(a)                                  Inventory
Reports. 
Within three (3) Business Days after each month end,
Lilly shall provide United Therapeutics with an inventory detailing current
approved product in Lilly’s distribution system.


 


(b)                                  Shipping
Report.  Within three (3) Business
Days after each month end, Lilly shall provide United Therapeutics with a
report, detailing by shipping date, the batch(s), including quantity of each
batch, shipped during the month to Wholesalers or other Third Parties.


 


(c)                                  Receipt
of Goods Notifications.  Upon United
Therapeutics’ request, Lilly shall provide to United Therapeutics the shipper’s
acknowledgment of the date on which the delivery was received by the
Wholesaler.


 


(d)                                  Additional
Reports.  On United Therapeutics’
reasonable request, Lilly shall use reasonable efforts to provide to United
Therapeutics additional reports in a form to be agreed between the Parties,
including, for cash receipts, a listing of invoices paid that match the cash
being remitted to United Therapeutics monthly, and a listing of all outstanding
invoices to Wholesalers at the end of each month.  In the event that Lilly agrees to provide any
such additional report to United Therapeutics, other than any additional report
previously provided to and paid for by United Therapeutics pursuant to Section 6.10,
United Therapeutics will reimburse Lilly for Lilly’s expenses in connection
with such additional report at an annual rate of [***] Dollars ($[***])
(adjusted annually based on CPI) per full time equivalent.


 


7.7                               Financial
Matters.


 


(a)                                  Wholesaler
Claims.  Lilly, working in its
capacity as agent for United Therapeutics, will process any claims filed by
wholesalers related to their purchase of Product.  If a Wholesaler files any claim with United
Therapeutics regarding: (i) a discrepancy between what was delivered and
the bill of lading; (ii) any quality concern; (iii) any dating
concerns; or


 


17

















 


(iv) any other issue; United Therapeutics will provide a copy of
such claim, together with all available information relating to such claim, to
Lilly as soon as practicable but in no event later than five (5) days
after receipt of such claim by United Therapeutics.  The resolution of any claim respecting Product
will be based on the outcome of Lilly’s investigation.  If resolution of any claim respecting any
Product results in a refund to the Wholesaler, and Lilly has paid United
Therapeutics in respect of the sale to a Wholesaler for such Product, United
Therapeutics will reimburse Lilly within thirty (30) days after the date of an
invoice from Lilly respecting same, and, where appropriate, credit United
Therapeutics with the Purchase Price paid by United Therapeutics for such
Product (e.g., where Product did not meet Specifications).  Alternatively, Lilly may deduct these amounts
from future payments due to United Therapeutics.  If the claim is not resolved, the Purchase
Price for replacement material will be shared between Lilly and United
Therapeutics, less any contribution recovered from the Wholesaler.


 


(b)                                  Returns.  United Therapeutics shall be responsible for,
and bear all costs and expenses associated with, any and all returns by
customers and by Wholesalers (except as otherwise provided in Section 7.7(a))
of Product in the Field in the Territory.


 


(c)                                  Audit
Right.  Upon no less than sixty (60)
days’ written notice to Lilly and no more than one (1) time each Calendar
Year, Lilly shall permit an independent certified public accountant appointed
by United Therapeutics and approved by Lilly, such approval not to be
unreasonably withheld, to audit Lilly’s processes, procedures and records and
Lilly’s invoicing, and collections systems during regular business hours for
the purpose of ensuring compliance with the terms of this Agreement.  Any such United Therapeutics representatives
shall be advised of the confidentiality obligations of ARTICLE 12, and shall
follow such security and facility access procedures as are reasonably
designated by Lilly.


 


ARTICLE 8


QUALITY AND SAFETY


 


8.1                               Inspections
and Audits.


 


(a)                                  Prior
to  obtaining Regulatory Approval
for the Product in the Territory, Lilly shall notify United Therapeutics within
one (1) Business Day after Lilly learns that an inspection of the
Manufacturing Facility with respect to the Product by FDA has been scheduled by
FDA or, if such an inspection occurs without prior notice to Lilly, within one (1) Business
Day after such inspection is conducted by FDA. 
Lilly shall provide United Therapeutics a summary of the findings
contained in a Form 483 resulting from such inspection specific to the
Product and a summary of Lilly’s response to such Form 483.


 


(b)                                  After  obtaining Regulatory Approval for the
Product in the Territory, if a Regulatory Authority conducts an inspection of
the Manufacturing Facility with respect to the Product and, as a result of such
inspection, Lilly receives a FDA Form 483 that would reasonably be
expected to affect the supply of the Product, Lilly shall promptly provide
United Therapeutics a summary of the findings contained in such FDA Form 483
and a summary of Lilly’s response to such Form 483.


 


18

















 


(c)                                  Upon
no less than sixty (60) days’ written notice to Lilly and no more than one (1) time
each Calendar Year, Lilly shall permit United Therapeutics or its appointed
representatives (such representatives to be reasonably acceptable to Lilly) to
audit Lilly’s processes, procedures and records at or in respect of the
Manufacturing Facility and Lilly’s distribution systems during regular business
hours for the purpose of making quality control inspections to ensure
compliance with Applicable Law of the Manufacturing Facility and distribution
systems used in the manufacturing, receiving, sampling, analyzing, storing,
handling, packaging and shipping of the Product, including, but not limited to,
in the receipt, storage and issuance of raw materials, labeling and packaging
components, and ingredients thereof; provided that United Therapeutics shall
have no access to any areas of the Manufacturing Facility where such access
would be likely to result in the disclosure of any of Lilly’s trade secrets.
Notwithstanding the foregoing sentence, in the event of a material breach of
this Agreement, a rejection of the Product by United Therapeutics pursuant to Section 8.6
because of a failure to meet the Specifications, or a material regulatory issue
or series of issues at any time, United Therapeutics shall have an additional
right to conduct an audit under the provisions of this Section 8.1(a).  Any such United Therapeutics representatives
shall be advised of the confidentiality obligations of ARTICLE 12, and shall
follow such security and facility access procedures as are reasonably
designated by Lilly.  Lilly may require
that the United Therapeutics representatives be accompanied by a Lilly
representative at all times and that the United Therapeutics representatives
enter areas of the facility used in production of the Product at times only
when the production of the Product is not occurring where necessary to ensure
protection of Lilly Confidential Information or the confidential information of
a Third Party.  Lilly shall respond to
any written audit observations provided by United Therapeutics within sixty
(60) days.


 


(d)                                  Without
limiting the Parties’ obligations under the License Agreement, (i) each
Party shall closely consult with the other Party about all regulatory
activities affecting the Manufacturing Facility with respect to the Product and
Lilly’s ability to manufacture and supply the Product in the Field in the
Territory, and shall keep the other Party closely informed about all regulatory
activities and developments affecting the Manufacturing Facility with respect
to the Product and its ability to manufacture and supply the Product in the
Field in the Territory; and (ii) where possible, Lilly shall consult with
United Therapeutics in advance of any such regulatory activities or
developments, and in any event report on same to United Therapeutics as soon as
reasonably possible after any relevant occurrence.


 


(e)                                                          Lilly
shall, with respect to each lot of the Product produced by it hereunder, for
the longer of (i) any period required by Applicable Laws, or (ii) a
period of one (1) year after the expiry of the expiration dating of such
lot, keep retained samples and accurate records of the manufacture and testing
of the Product produced by it hereunder, including all such records required
under Applicable Laws.


 


8.2                               GMP
Compliance. Lilly shall ensure that the Manufacturing Facility (including
equipment, systems, record keeping and utilities) complies with Applicable Law
and is operated in accordance with GMPs and the conditions set forth in
Regulatory Approvals.  Lilly shall store
all components and raw materials (including the Compound) and the Product until
shipment in accordance with the Specifications and Applicable Laws.  Lilly shall manufacture the Product in


 


19

















 


compliance with Applicable Law and the Specifications.  Lilly shall perform quality control testing
and quality oversight on the Product to be delivered hereunder in accordance
with Applicable Law, Specifications, cGMPs, the MRD, and the Quality Agreement.  Lilly shall ship the Product in compliance
with Applicable Law and the Specifications.


 


8.3                               Quality
Agreement. Prior to the first shipment of the Product, the Parties shall
enter into an agreement that describes certain quality and regulatory
responsibilities relating to the manufacture and release for sale of the
Product by Lilly (the “Quality Agreement”).  The Quality Agreement shall be subject to and
not inconsistent with the terms of this Agreement and the License Agreement,
and in the event of conflict between the terms of this Agreement or the License
Agreement, as applicable, on one hand, and the Quality Agreement on the other,
this Agreement or the License Agreement, as applicable, shall govern.  Sections of the Quality Agreement may be
modified from time to time through the issuance of a revised Quality Agreement
signed on behalf of each of the Parties by an authorized representative
incorporating the modification and stating the effective date and revision
number of the modification.


 


8.4                               Shelf
Life. At the time of delivery of the Product to the Wholesaler by Lilly,
the Product shall have a minimum of [***] ([***]) months shelf life remaining;
provided that [***] ([***]) year dating is granted by the FDA at the time
Regulatory Approval is obtained for the Product in the Field in the Territory.
Lilly will use Commercially Reasonable Efforts to supply Product with a minimum
shelf life at delivery equal to at least two-thirds of the shelf life for the
Product approved by the Regulatory Authority. 
Lilly may deliver the Product with a shelf life shorter than noted above
if agreed by Parties upon the written request of United Therapeutics.


 


8.5                               Lot
Numbering. Lilly’s lot numbers shall be affixed on the containers for the
Product and on each shipping carton in accordance with Applicable Laws.


 


8.6                               Lilly
Obligations to Meet Specifications.


 


(a)                                  All
Product sold to United Therapeutics shall meet the Specifications as of the
date of delivery to the Wholesaler. 
Lilly shall test or cause to be tested, in accordance with the test
methods and procedures in the Specifications as set forth in Exhibit 1.8,
each lot of Product before shipment to a Lilly distribution center.  Lilly shall ensure that its quality control
department approves each lot of the Product for release promptly following
successful completion of release testing and does not release any lot of the
Product that does not meet the requirements set out in the Specifications.


 


(b)                                  If
any Product is rejected prior to entering United Therapeutics’ inventory for
any reason, Lilly shall replace rejected Product with Product that meets the
Specifications within a commercially reasonable time.


 


ARTICLE 9


REPRESENTATIONS, WARRANTIES AND
INDEMNIFICATION


 


9.1                               Incorporation
by Reference of Warranties and Indemnification.  The terms of Article 10 (Representations,
Warranties, and Covenants) (excluding Section 10.3) and Article 12
(Indemnification) (excluding Section 12.4) of the License Agreement are
hereby incorporated


 


20

















 


herein and made part of this Agreement. The disclaimer in Section 10.4
(Disclaimer) of the License Agreement shall apply to the warranties in Article 10
of the License Agreement and Section 9.2 of this Agreement.


 


9.2                               Further
Representations and Warranties of Lilly. Lilly hereby represents and warrants
and covenants to United Therapeutics that:


 


(a)                                                          Lilly
shall conduct its work under this Agreement in a competent, workmanlike fashion
using qualified personnel;


 


(b)                                                          all
Product supplied by Lilly under this Agreement shall be delivered by it free
and clear of any security interests, liens, claims, pledges or encumbrances of
any kind or nature except for such as are created by United Therapeutics;


 


(c)                                                          all
analytical work performed by or for Lilly shall be performed in a manner and in
a laboratory which complies with GMPs and all related testing procedures and
all equipment shall have been validated prior to the testing of any Product
under this Agreement;


 


(d)                                                          all
records and reports required to be maintained by Lilly under GMPs shall be
accurate and complete in all material respects; and


 


(e)                                                          all
Product delivered by Lilly to United Therapeutics hereunder shall at the time
it is delivered: (i) conform to the Specifications then in effect, (ii) shall
have been manufactured in accordance with cGMP in effect at the time of
manufacture, (iii) shall not be adulterated or misbranded within the
meaning of the FDCA or any equivalent local legislation, and (iv) shall
not have been manufactured, sold or shipped in violation of any Applicable Laws
in any material respect.


 


ARTICLE 10


DECISION MAKING


 


10.1                        Dispute
Resolution. Except as expressly set out in this Agreement, any disagreement
between the designees of United Therapeutics and Lilly shall be first submitted
to the Alliance Managers in order to facilitate a resolution and then, if not
resolved, at the election of either Party, be referred for resolution pursuant
to and in accordance with Section 3.4(c) (Decision Making) and Article 14
(Dispute Resolution) of the License Agreement.


 


ARTICLE 11


TERM AND TERMINATION


 


11.1                        Term,
Expiry and Termination of the Agreement. 
Subject to the terms of the License Agreement, the term of this
Agreement (the “Term”) shall
commence on the Effective Date and shall continue in full force and effect
until expiry or earlier termination of the License Agreement.


 


11.2                        Consequences
of Expiry or Termination.  The
consequences of expiry or earlier termination of this Agreement shall be as set
out in the License Agreement.


 


21

















 


11.3                        Survival.  The rights and obligations of the Parties
under the following provisions of this Agreement shall survive any expiration
or termination of this Agreement: 
ARTICLE 1, ARTICLE 6 (to the extent that any amounts payable remain
unpaid), ARTICLE 7 (to the extent that Purchase Orders are outstanding as the
effective date of termination, and provided that Section 7.7(c) shall
survive for a period of one (1) year after the expiration or termination
of this Agreement), ARTICLE 8 (solely with respect to Product shipped by under
this Agreement), Section 10.4 (Disclaimer) of the License Agreement to the
extent it is incorporated by reference into this Agreement, ARTICLE 10, ARTICLE
11, ARTICLE 12 (for the term set forth in Section 11.1 of the License
Agreement) and ARTICLE 13.


 


11.4                        No Waiver
of Remedies.  Termination of this
Agreement shall not preclude either Party from (a) claiming any other
damages, compensation or relief that it may be entitled to upon such
termination, (b) any right to receive any amounts accrued under this
Agreement prior to the termination date but which are unpaid or become payable
thereafter and (c) any right to obtain performance of any obligation
provided for in this Agreement which shall survive termination.


 


ARTICLE 12


CONFIDENTIALITY


 


The terms of Article 11 (Confidentiality) of the License Agreement
are hereby incorporated herein and made part of this Agreement.


 


ARTICLE 13


GENERAL PROVISIONS


 


13.1                        Assignment.
A Party may not assign this Agreement or any rights or obligations
hereunder without the prior written consent of the non-assigning Party, and any
attempted assignment without such consent shall be null and void.  Notwithstanding the foregoing, this Agreement
shall be assigned by a Party only as part of that Party’s interest in the License
Agreement if such assignment
occurs as part of an assignment of a Party’s interest in the License Agreement
permitted thereby, and such assignee agrees to be bound by the assignor’s
obligations contained in this Agreement.


 


13.2                        Subcontracting.


 


(a)                                  United
Therapeutics may not subcontract any or all of its rights or obligations under
this Agreement to any subcontractor or consultant without prior written consent
of Lilly, which shall not unreasonably be withheld.


 


(b)                                  Lilly
may subcontract any or all of its rights or obligations under this Agreement in
accordance with the terms of Section 2.3.


 


(c)                                  Subject
to the terms of Sections 13.2(a) and 13.2(b), as applicable, a Party
subcontracting any portion of the services to be performed by such Party shall
be and shall remain fully responsible to the other Party for the performance of
the subcontractor or consultant


 


22

















 


to the same extent as if the subcontracted portion of the services was
performed directly by the subcontracting Party.


 


13.3                        Compliance
with Laws. Each Party shall at all times comply with all Applicable Law
relating to its activities under this Agreement.


 


13.4                        Incorporation
by Reference of Miscellaneous Terms. The terms of Article 15 (Miscellaneous)
of the License Agreement are hereby incorporated herein and made part of this
Agreement.


 


[Signature
Page Follows]


 


23

















 


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


 


	
  ELI LILLY AND COMPANY

  	
   

  	
  UNITED THERAPEUTICS CORPORATION

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ John C. Lechleiter

  	
   

  	
  By:

  	
  /s/ Roger A. Jeffs

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name: 

  	
  John C. Lechleiter

  	
   

  	
  Name: 

  	
  Roger A. Jeffs

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title: 

  	
  President & Chief Executive Officer

  	
   

  	
  Title: 

  	
  President & Chief Operating Officer

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  LILLY DEL CARIBE, INC.

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By: 

  	
  /s/ John D. Huesing

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name: 

  	
  John D. Huesing

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title: 

  	
  Asst. Treasurer – del Caribe

  	
   

  	
   

  	
   

  
									



 


[Signature Page to Manufacturing and Supply
Agreement]


 
















 


EXHIBIT 1.3


MANUFACTURING RESPONSIBILITY DOCUMENT TABLE
OF CONTENTS


 


	
  A.

  	
  Purpose

  
	
   

  	
   

  
	
  B.

  	
  Revision and Reason For Revision

  
	
   

  	
   

  
	
  C.

  	
  Abbreviations and Definitions

  
	
   

  	
   

  
	
  D.

  	
  Key Contracts and Contact Numbers

  
	
   

  	
   

  
	
  E.

  	
  Organization Chart

  
	
   

  	
   

  
	
  F.

  	
  Supply Chain Flow Chart Diagram

  
	
   

  	
   

  
	
  G.

  	
  Forecasting Rules

  
	
   

  	
   

  
	
  H.

  	
  Inventory Policy

  
	
   

  	
   

  
	
  I.

  	
  Supply Performance and Forecasting
  Performance

  
	
   

  	
   

  
	
  J.

  	
  Ordering Policies

  
	
   

  	
   

  
	
  K.

  	
  Transport and Storage Conditions

  
	
   

  	
   

  
	
  L.

  	
  Transport Packaging Design

  
	
   

  	
   

  
	
  M.

  	
  Paperwork to Accompany Shipments

  
	
   

  	
   

  
	
  N.

  	
  Invoicing Procedures

  
	
   

  	
   

  
	
  O.

  	
  Inspection of Shipment Upon Arrival

  
	
   

  	
   

  
	
  P.

  	
  Communication of Shipping Discrepancies

  
	
   

  	
   

  
	
  Q.

  	
  Wholesaler Concerns

  
	
   

  	
   

  
	
  R.

  	
  Shipping Terms

  
	
   

  	
   

  
	
  S.

  	
  Purchase Price

  
	
   

  	
   

  
	
  T.

  	
  Financial

  



 

















 


EXHIBIT 1.7


QUALITY AGREEMENT TABLE OF CONTENTS


 


	
  A.

  	
  Purpose

  
	
   

  	
   

  
	
  B.

  	
  Revision Number and Reason For Revision

  
	
   

  	
   

  
	
  C.

  	
  Definitions

  
	
   

  	
   

  
	
  D.

  	
  GMP Commitments

  
	
   

  	
   

  
	
  E.

  	
  Key Quality Contacts and Organization

  
	
   

  	
   

  
	
  F.

  	
  Specifications

  
	
   

  	
   

  
	
  G.

  	
  Analytical Methods

  
	
   

  	
   

  
	
  H.

  	
  Batch Disposition

  
	
   

  	
   

  
	
  I.

  	
  Manufacturing Facilities

  
	
   

  	
   

  
	
  J.

  	
  Labeling and Packaging Materials

  
	
   

  	
   

  
	
  K.

  	
  Modifications to the Product

  
	
   

  	
   

  
	
  L.

  	
  Product Returns

  
	
   

  	
   

  
	
  M.

  	
  Record Retention

  
	
   

  	
   

  
	
  N.

  	
  Stability Data

  
	
   

  	
   

  
	
  O.

  	
  Sub-Contracting

  
	
   

  	
   

  
	
  P.

  	
  Transportation and Storage

  
	
   

  	
   

  
	
  Q.

  	
  Notification of Regulatory Inspections

  
	
   

  	
   

  
	
  R.

  	
  Quality Audits

  
	
   

  	
   

  
	
  S.

  	
  Investigation of Product Complaints

  
	
   

  	
   

  
	
  T.

  	
  Recalls and Withdrawals

  
	
   

  	
   

  
	
  U.

  	
  Special Security Substance Management

  
	
   

  	
   

  
	
  V.

  	
  Paperwork to Accompany Shipments

  
	
   

  	
   

  
	
  W.

  	
  Marketing and Sales

  
	
   

  	
   

  
	
  X.

  	
  Management of Termination (when
  appropriate)

  



 

















 


EXHIBIT 1.8


PROPOSED(1) SPECIFICATIONS FOR PRODUCT ([***] TABLETS)


 


	
  Test

  	
   

  	
  Analytical

  Procedure

  	
   

  	
  Acceptance Criteria

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Identification Test

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Identification

  	
   

  	
  IR

  	
   

  	
  The infrared spectrum must [***]  with
  that of the
  reference sample obtained under the same  conditions.

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Potency Tests

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Assay

  	
   

  	
  LC

  	
   

  	
  NLT [***]% and NMT [***]% of label claim as
  determined by
  liquid chromatography

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Uniformity of Dosage Units

  	
   

  	
  USP

  	
   

  	
  Meets USP requirements

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Purity Tests

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total Degradation Products

  	
   

  	
  LC

  	
   

  	
  NMT [***]% as determined by liquid
  chromatography

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Any Unspecified Degradation  Product

  	
   

  	
  LC

  	
   

  	
  NMT [***]% as determined by liquid
  chromatography

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Other Tests

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Physical Appearance(2)

  	
   

  	
  Visual

  	
   

  	
  [***], [***]-shaped tablet debossed with “[***]”

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Dissolution

  	
   

  	
  USP

  	
   

  	
  Meets USP requirements;  

  Q = [***]% at [***]  and
  

  Q = [***]% at [***]

  



 






NLT = Not less than; NMT = Not more than


 


(1)  Pending regulatory agency
approval


 


(2)  Physical Appearance is
equivalent to the ICH term “Description.”


 

















 


EXHIBIT 2.3(b)


LILLY DEL CARIBE GUARANTEE


 


GUARANTEE


 


THIS GUARANTEE (the
“Guarantee”) is made and entered into as
of November 14, 2008 (the “Execution Date”),
effective as of the Effective Date, by and between Eli Lilly and Company, an
Indiana corporation, having its principal place of business at Lilly Corporate
Center, Indianapolis, Indiana 46285, (“Lilly”) and
United Therapeutics Corporation, a Delaware corporation, having its principal
place of business at 1110 Spring Street, Silver Spring, Maryland 20910 (“United Therapeutics”). 
Lilly and United Therapeutics are referred to individually as a “Party” and collectively as the “Parties.”


 


RECITALS


 


WHEREAS,
Lilly and United Therapeutics have entered into as of the Execution Date a
separate License Agreement (the “License Agreement”);
and


 


WHEREAS,
contemporaneously with the execution of this Guarantee, Lilly, United
Therapeutics and 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”)
are entering into a manufacturing and supply agreement (the “Manufacturing and Supply Agreement”) pursuant to which Lilly
and/or its Affiliates, including Lilly del Caribe, will supply a product
containing tadalafil to United Therapeutics for commercialization purposes; and


 


WHEREAS,
under the terms of the Manufacturing and Supply Agreement, any reference
relating to supply obligations of Lilly thereunder is deemed to include a
reference to Lilly del Caribe; and Lilly has agreed to cause Lilly del Caribe
to perform its obligations thereunder and to execute and deliver a guarantee in
favor of United Therapeutics.


 


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:


 


ARTICLE 1

DEFINITIONS


 


The terms in
this Guarantee with initial letters capitalized, whether used in the singular
or plural, shall have the meanings set forth in this Article 1 or
elsewhere in this Guarantee, or if not otherwise defined in this Guarantee,
shall have the meanings set forth in the Manufacturing and Supply Agreement or
License Agreement, as applicable.


 


1.1                          “Effective
Date” shall mean the Effective Date as defined in the License Agreement.


 


1.2                          “Guaranteed Obligations” shall mean any and all
indebtedness, obligations and liabilities of Lilly del Caribe to United
Therapeutics under the Manufacturing and Supply Agreement, as same may be
amended from time to time by the parties thereto, to the extent that such
indebtedness, obligations and liabilities have not been satisfied in accordance
with the terms and conditions of the Manufacturing and Supply Agreement.  For clarity, any material breach of


 

















 


a term of the Manufacturing and Supply Agreement shall not be deemed a
Guaranteed Obligation until the applicable period for curing such material
breach expires and such material breach remains uncured.


 


ARTICLE 2

REPRESENTATIONS AND WARRANTIES


 


2.1                          Mutual
Representations and Warranties. 
Each Party represents and warrants to the other Party that:


 


(a)           the entering into, execution and delivery
of, and the performance and observance by such Party of, this Guarantee, has
been duly authorized by all necessary corporate action of such Party;


 


(b)           no consent, approval, authorization,
license, order or permit of any governmental authority, court or arbitrator and
no filing with, notice to or registration by such Party with any governmental
authority, court or arbitrator is required in order for such Party to execute
and deliver this Guarantee;


 


(c)           neither the execution and delivery of this
Guarantee nor the due observance and performance by such Party of its covenants
and obligations herein will conflict with or result in a breach of or a default
under any provision, term or condition of the organizing documents of such
Party or will conflict with or result in a breach of or a default under (or
with the giving of notice or lapse of time, or both, will conflict with or
result in a breach of or default under) or violate any provision, term or
condition of:


 


(i)            any law, regulation, bylaw or rule of any governmental authority applicable to such Party;


 


(ii)           any order, declaration, injunction, decree,
writ, judgment or award of any governmental authority, or any court or
arbitrator to which such Party is subject; or


 


(iii)          any agreement, instrument or other document
to which such Party is a party or from which such Party derives benefit, except
those agreements with respect to which a consent or waiver has been received by
such Party; and


 


(d)           there are no actions, suits or proceedings
pending or, to the knowledge of such Party, threatened against or affecting
such Party (nor, to the knowledge of such Party, any basis therefor) which
could reasonably be expected to have a material adverse effect on the ability
of such Party to comply with the terms of this Guarantee.


 


2

















 


2.2                          Representations
and Warranties by Lilly.  Lilly
represents and warrants to United Therapeutics that:


 


(a)           this Guarantee constitutes a legal, valid
and binding obligation of Lilly enforceable against Lilly in accordance with
its terms; and


 


(b)           no consent, approval, authorization,
license, order or permit of any governmental authority, court or arbitrator and
no filing with, notice to or registration by Lilly with any governmental
authority, court or arbitrator is required in order for Lilly to: (i) incur
and perform its obligations pursuant to, this Guarantee;  or
(ii) render this Guarantee legal, valid, binding and enforceable against
Lilly in accordance with its terms.


 


Article 3

GUARANTEE


 


3.1                          Guarantee.
Lilly hereby unconditionally, absolutely and irrevocably guarantees to United
Therapeutics, effective as of the Effective Date, the full and punctual
performance, observance, satisfaction, and payment, of any and all of the
Guaranteed Obligations. If any default shall be made in the due performance,
observance, satisfaction and payment of any of the Guaranteed Obligations,
Lilly covenants and agrees with United Therapeutics, promptly following written
demand by United Therapeutics, to perform, observe, satisfy and pay to United
Therapeutics any and all of the Guaranteed Obligations in respect of which such
default will have occurred.


 


3.2                          Nature
of Guarantee. Lilly covenants and agrees with United Therapeutics that:


 


(a)           the Guaranteed Obligations shall not be
subject to any counterclaim, set off, deduction or defense based upon any claim
Lilly may have against Lilly del Caribe, whether in connection with this
Guarantee or any other transaction, that Lilly del Caribe would not have been
entitled to assert against United Therapeutics;


 


(b)           until there has been full and punctual
performance, observance, satisfaction and payment of all of the Guaranteed
Obligations, the rights of United Therapeutics and the obligations of Lilly
under this Guarantee shall remain in full force and effect without regard to,
and shall not be released, discharged or in any way affected or impaired by,
any occurrence, matter, circumstance or condition whatsoever (whether or not
Lilly has any knowledge or notice thereof or has consented thereto), and
without limiting the generality of the foregoing, shall remain in full force
and effect without regard to, and shall not be released, discharged or in any
way affected or impaired, terminated or prejudiced by:


 


(i)            the dissolution, winding-up or other
cessation of existence of Lilly del Caribe or Lilly or the institution of any
proceeding relating thereto, any continuance or reorganization or any change in
the business, capital 


 


3

















 


structure, directorate, management, members, name, objects,
organization, partners, powers or shareholders of Lilly del Caribe or Lilly,
the amalgamation of Lilly del Caribe or Lilly with another corporation, the
sale or disposal of or appointment of a custodian, liquidator, receiver or
trustee in respect of the assets or undertaking, in whole or in part, of Lilly
del Caribe or Lilly, any distribution of the assets, in whole or in part, of
Lilly del Caribe or Lilly upon any arrangement, bankruptcy, composition,
insolvency, liquidation, readjustment, receivership, reorganization or other
similar proceeding or occurrence relating to Lilly del Caribe or Lilly, any
assignment by Lilly del Caribe or Lilly for the benefit of creditors, any other
marshalling of any of the assets of Lilly del Caribe or Lilly or any other act
or event which would constitute a novation of any obligation or liability of
Lilly del Caribe in respect of any of the Guaranteed Obligations whether by
substitution of the obligations or liabilities of any other person in place of
those of Lilly del Caribe or otherwise;


 


(ii)           any issue or levy by any administrative,
governmental, judicial or other authority or arbitrator of any award,
execution, injunction, judgment, order, warrant of attachment, writ or similar
process against Lilly del Caribe, whether in respect of any of the Guaranteed
Obligations or otherwise, or against Lilly, whether in respect of any of its
obligations or liabilities under this Guarantee or otherwise, or against any
other person who is or may become liable in respect of any of the Guaranteed
Obligations (except to the extent any of the foregoing changes the Guaranteed
Obligations);


 


(iii)          any activity, conduct, matter or thing
authorized by Lilly under Section 3.3 below (except to the extent any of
the foregoing changes the Guaranteed Obligations);


 


(iv)          any extension of time for compliance with or
payment of any of the Guaranteed Obligations (in which case the Guaranteed
Obligations shall be so extended);


 


(v)           any waiver, consent, extension, granting of
time, forbearance, indulgence, renewal or other action or inaction under or in
respect of the Manufacturing and Supply Agreement or any of the Guaranteed
Obligations, or any exercise or non-exercise of any right, remedy or power in
respect thereof (except to the extent any of the foregoing changes the Guaranteed
Obligations);


 


(vi)          any lack or limitation of capacity, status,
power or authority, or any incapacity or disability, of Lilly del Caribe or
Lilly or any of their respective directors, officers, employees, trustees,
partners or agents acting or purporting to act on their behalf, and any defect
or any failure to 


 


4

















 


comply with a formal legal requirement in the execution or delivery of
this Guarantee;


 


(vii)         any misrepresentation by Lilly del Caribe under
the Manufacturing and Supply Agreement;


 


(viii)        any action or other proceeding brought by any
beneficiaries or creditors of, or by, Lilly del Caribe or any other person for
any reason whatsoever, including without limitation any action or proceeding in
any way attacking or involving any issue in respect of the Manufacturing and
Supply Agreement, any of the Guaranteed Obligations, or any other agreement or
instrument (except to the extent any of the foregoing changes the Guaranteed
Obligations); or


 


(ix)           any occurrence or non-occurrence of any
other act or event which, by operation of law or equity or otherwise, would
directly or indirectly now or hereafter result in the determination, discharge,
extinction, limitation, merger, novation, reduction or release, pro tanto or
otherwise, of Lilly or of any of its obligations or liabilities hereunder or
which would otherwise prejudice or impair any right of United Therapeutics
hereunder except for payment, performance or satisfaction of the Guaranteed
Obligations, it being understood and agreed that this Guarantee guarantees, but
does not expand the scope of, the Guaranteed Obligations;


 


(c)           the Guaranteed Obligations shall constitute
obligations and liabilities of payment and not of collection and shall be
absolute and independent of and not in consideration of or conditional or
contingent upon any other obligation or liability of Lilly, any obligation or
liability of Lilly del Caribe (other than the Guaranteed Obligations), or any
obligation or liability of any other person who is or may become liable in
respect of any of the Guaranteed Obligations, or any prior notice or protest
to, demand upon or action, suit or other proceeding against Lilly del Caribe or
any such other person other than the demand required by Section 3.1, and
United Therapeutics may bring or prosecute a separate action, suit or other
proceeding against Lilly whether such action, suit or other proceeding is
brought or prosecuted against Lilly del Caribe or any such other person or
whether Lilly del Caribe or any such other person (including United
Therapeutics) is joined in such action, suit or other proceeding; and


 


(d)           any part performance or part payment by
Lilly del Caribe of any of the Guaranteed Obligations or other circumstance
which operates to toll any statute of limitations or law of prescription as to
Lilly del Caribe shall operate to toll such statute of limitations or law of
prescription as to Lilly.


 


3.3                          Authorizations.
Lilly authorizes United Therapeutics, at the sole discretion of United
Therapeutics, without notice to or demand upon Lilly, and without in any
manner, releasing, discharging, or in any way affecting any obligation or
liability of Lilly hereunder or 


 


5

















 


prejudicing or impairing any right of United Therapeutics hereunder
(except to the extent of any resulting change in the Guaranteed Obligations),
from time to time to:


 


(a)           to the extent permitted by the Manufacturing
and Supply Agreement or otherwise agreed by Lilly del Caribe, accelerate,
adjust, compromise, extend, modify, renew or otherwise change the time, form or
manner for performance of or any term in respect of any of the Guaranteed
Obligations; and


 


(b)           compromise, release or settle with or
substitute or delay or waive the exercise of any right or remedy against Lilly
del Caribe, Lilly or any other person who is or may become liable in respect of
any of the Guaranteed Obligations.


 


3.4                          Waivers.
Lilly unconditionally waives:


 


(a)           any right to require United Therapeutics to:


 


(i)            proceed against Lilly del Caribe, Lilly or
any other person who is or may become liable in respect of any of the
Guaranteed Obligations;


 


(ii)           first apply any property or assets of Lilly
del Caribe or any other person who is or may become liable in respect of any of
the Guaranteed Obligations to the discharge of the Guaranteed Obligations or
marshal in favor of Lilly; or


 


(iii)          pursue or exercise or exhaust any other right
or remedy of United Therapeutics whatsoever before proceeding against and
enforcing its rights and remedies against Lilly under this Guarantee;


 


(b)           so long as any of the Guaranteed Obligations
shall remain unperformed, unsatisfied or unpaid, including such part thereof,
if any, as shall exceed the liability of Lilly hereunder, any right to claim
repayment against Lilly del Caribe or to exercise any right of subrogation to
or any right to enforce any right or remedy which United Therapeutics now has
or hereafter may have against or in respect of Lilly del Caribe, any other person
who is or may become liable in respect of any of the Guaranteed Obligations; or


 


(c)           any defense arising out of or in connection
with:


 


(i)            any absence, impairment or loss of any
right of contribution, reimbursement or subrogation or any other right or
remedy of Lilly against or in respect of Lilly del Caribe, any other person who
is or may become liable in respect of any of the Guaranteed Obligations; or


 


(ii)           any disability, incapacity, or defense
available to Lilly del Caribe (other than a defense available to Lilly del
Caribe under the terms of the Manufacturing and Supply Agreement) or any other
person who is or may 


 


6

















 


become liable in respect of any of the Guaranteed Obligations or any
cessation from any cause whatsoever of any obligation or liability of Lilly del
Caribe or any such other person in respect of any of the Guaranteed Obligations
(other than any cessation under the terms of the Manufacturing and Supply
Agreement).


 


3.5                          Bankruptcy,
etc.  In the event of any
distribution of the assets, in whole or in part, of  Lilly del Caribe, Lilly or any other person
who is or may become liable in respect of any of the Guaranteed Obligations,
upon any arrangement, bankruptcy, composition, execution sale, insolvency,
liquidation, readjustment, receivership, reorganization or other similar
proceeding or occurrence relating to any such person, any proceeding for the
dissolution, liquidation, winding-up or other cessation of existence of any
such person, voluntary or involuntary, whether or not involving bankruptcy or
insolvency proceedings, any assignment by any such person for the benefit of
creditors or any other marshalling of any of the assets of any such person, no
obligation or liability of Lilly hereunder shall be determined or in any manner
affected, and no right of United Therapeutics hereunder shall in any manner be
prejudiced or impaired, by any omission by United Therapeutics to prove its
claim or to prove its full claim and United Therapeutics may prove such claim
as it sees fit and may refrain from proving any claim and may value as it sees
fit or refrain from valuing any security held by United Therapeutics.


 


3.6                          New
Manufacturing and Supply Agreement. If the Manufacturing and Supply
Agreement shall be cancelled or terminated by reason of disclaimer by a trustee
in bankruptcy or the incapacity of Lilly del Caribe, before the Guaranteed
Obligations have otherwise been fully performed, observed, satisfied and paid,
Lilly covenants and agrees with United Therapeutics, at the option and request
of United Therapeutics, to enter into, execute and deliver a new agreement
between United Therapeutics and Lilly whereby Lilly shall assume and covenant
and agree to observe, perform and be bound by the Guaranteed Obligations as it
was at the time immediately before such cancellation, determination or
termination.


 


3.7                          Continuing
Guarantee.  The obligations of Lilly
under this Guarantee constitute a continuing guarantee and shall remain in full
force and effect until all the Guaranteed Obligations have been fully
performed, observed, satisfied and paid. No recovery under this Guarantee, and
no action or proceeding brought or instituted under this Guarantee, and no
recovery in pursuance of such action or proceeding, shall be a bar or defense
to any further action or proceeding under this Guarantee or to any further
recovery.


 


ARTICLE 4

GENERAL PROVISIONS


 


4.1                          Assignment.  A Party may not assign this Guarantee or any
rights or obligations hereunder without the prior written consent of the
non-assigning Party, and any attempted assignment without such consent shall be
null and void.


 


7

















 


4.2                          Incorporation
by Reference of Miscellaneous Terms. 
The terms of Article 11 (Confidentiality), Article 14 (Dispute
Resolution) and Article 15 (Miscellaneous) of the License Agreement are
hereby incorporated herein and made part of this Guarantee.


 


[Signature Page Follows]


 


8

















 


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


 


	
  ELILILLY AND COMPANY

  	
  UNITED THERAPEUTICS CORPORATION

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
  Name:

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
  Title:

  	
   

  
								



 

















 


EXHIBIT 6.2


SCHEMATIC OF DISTRIBUTION OF PRODUCT


 





 

















 


EXHIBIT 6.3(a)


PURCHASE PRICE


 


$[***] per tablet, each tablet containing [***] ([***]) milligrams the
Compound, supplied in [***] ([***]) count bottles


 

















 


EXHIBIT 6.7


WIRE INSTRUCTIONS


 


Lilly del Caribe Inc


 


Acct:


 


Swift: