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EXHIBIT 10.1
 
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION

FIRST AMENDMENT TO CAPITAL EXPENDITURE AND EQUIPMENT AGREEMENT
 
THIS FIRST AMENDMENT TO CAPITAL EXPENDITURE AND EQUIPMENT AGREEMENT (this
“Amendment”) is effective as of                  , 2013 (the “Amendment
Effective Date”) between

POZEN INC.,
a corporation existing under the laws of the State of Delaware
("Pozen")

 -and-

PATHEON PHARMACEUTICALS INC.,
a corporation existing under the laws of the State of Delaware,
(“Patheon”)

BACKGROUND

Pozen and Patheon entered into a Capital Expenditure and Equipment Agreement
dated December 19, 2011 (the “Agreement”).  The purpose of this Amendment is to
revise the Agreement to include capital required for a new 81/40 mg tablet
Product and to update the capital for the 325/40 mg tablet strength Product.

AGREEMENT

NOW, THEREFORE, in consideration of the rights conferred and the obligations
assumed herein, the receipt and sufficiency of which are hereby acknowledged,
and intending to be legally bound, the parties hereby agree as follows:

1. Amendment

(a) In the Background Section, the first sentence is deleted and replaced by
this following new sentence; “Pozen and Patheon are parties to a Master
Pharmaceutical Development Agreement dated August 18, 2010 and a Manufacturing
Services Agreement (the “MSA”) dated December 19, 2011 under which Patheon will
perform certain manufacturing services (the “Services”) related to Pozen’s PA
325 and PA 81 Tablets (the “Products”).”

(b) In Section 2, Payment and Expenditures, first paragraph, line six, the
reference to “$***” is deleted and replaced with “$*** plus to-be-determined
Non-Dedicated Equipment and Facility Modification costs as shown on Schedule A
Part III.”

(c) In Section 2, Payment and Expenditures, paragraph 2 is deleted in its
entirety, and replaced with the following new paragraph.

Page 1 of 4

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION
 
Patheon has reviewed the capacity of its existing ***, which will be used for
Pozen and also for other Patheon clients, to determine if additional *** will be
required to perform the Services for Pozen. Based on the current long range
forecasts for the Product and for third party products, Patheon anticipates
being able to support most, if not all of the Pozen’s projected forecast for the
Product using the existing ***. If for some unforeseen reason, additional ***
capacity is required, the Parties will negotiate responsibility for the
additional capital in good faith.

(d) In Section 6, Term; Termination; Effect of Termination on Future Spending,
subsection (a), Term, Termination, paragraph (iii) and subsection (b), the third
paragraph, are deleted in their entirety since the Parties have entered into an
MSA, and this language is no longer relevant.

(e) Schedule A to the Agreement is deleted its entirety and is replaced with
revised Schedule A as attached hereto.

(f) The “Background” section of this document set forth above is expressly
incorporated into this Amendment.

2. General

All other terms and conditions of the Agreement shall continue unchanged and
remain in full force and effect.

IN WITNESS WHEREOF the duly authorized representatives of the parties have
executed this Agreement.

POZEN INC.
 
PATHEON PHARMACEUTICALS INC.
 
 
 
 
By:
/s/ John R. Plachetka
By:
/s/ Francis P. McCune
 
 
 
 
Name:
John R. Plachetka
Name:
Francis P. McCune
 
 
 
 
Title:
Chairman, CEO & President
Title:
Secretary

Page 2 of 4

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION
 
Schedule A
(as revised by First Amendment to Capital and Expenditure Agreement)

Part I. Required Expenditures
 
 
 
 
Pozen Funded Capital
PA 325/40
Timing
PA 81/40
Timing
Dedicated Equipment
Cost
 
Cost
 
Miscellaneous Screens and cloth Items
***
***
***
***
Compression tooling (single tip) 1set
***
***
 
 
Compression tooling (single tip) 2 sets
 
 
***
***
Packaging Change parts
 
 
***
***
Printer Change parts
***
***
***
***
Subtotal Dedicated Equipment
***
 
***
 
 
 
 
 
 
Non-Dedicated Equipment
 
 
 
 
Initial Engineering - 48" coating pan upgrade (exhaust temp control/RAFT)
***
***
Water activity equipment
***
***
***
***
Coating support equipment
 
 
***
***
Subtotal Non-Dedicated Equipment
***
 
***
 
Grand Total Phase I Pozen Funded Capital
***
 
 
 
 
 
 
 
 
 
 
 
 
 
Part II. Supply Continuity Related Expenditures
 
 
 
 
Pozen Funded Capital
PA 325/40
Timing
PA 81/40
Timing
Non-Dedicated Equipment
 
 
 
 
48" coating pan upgrade (exhaust temp control/RAFT)
 
 
***
***
Process Engineering and Qualification
 
 
***
***
***
 
 
***
***
Subtotal Non-Dedicated Equipment
 
 
***
 
Grand Total Phase II Pozen Funded Capital
***
 
 
 
 
 
 
 
 
 
 
 
 
 
Part III. Capacity (Product Volume) Related Expenditures
 
 
 
 
Pozen Funded Capital
PA 325/40
Timing
PA 81/40
Timing
Dedicated Equipment
 
 
 
 
Compression tooling (multi tip) 2 sets
 
 
***
***
Subtotal Dedicated Equipment
***
 
 
 
 
 
 
 
 
Non-Dedicated Equipment
 
 
 
 

 
Page 3 of 4

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION
 
Various capital equipment as volume increases, e.g. blender vacuum charging,
drum dumper, bins, etc.
***
***
 
 
Process Engineering and Qualification
***
***
 
 
***
***
***
 
 
Subtotal Non-Dedicated Equipment
***
 
 
 
 
 
 
 
 
Facility Modifications
 
 
 
 
Facility Study and Preliminary Design*
***
***
 
 
Facility Modifications* (estimated at $***)
***
***
 
 
Facility Engineering and Qualification*(estimated at $***)
***
***
 
 
***
***
***
 
 
Subtotal Facility Modifications
***
 
 
 
Subtotal Phase III Pozen Funded Capital
***
 
 
 
 
 
 
 
 
Patheon Funded Capital
 
 
 
 
HPLC
***
***
 
 
Dissolution Bath
***
***
 
 
Subtotal Patheon Funded Capital
***
 
 
 
 
 
 
 
 
Total Pozen Funded Capital
***
 
 
 
Grand Total Capital
***
 
 
 
 
 
 
 
 
 *Facility Modification are costs  for potential changes required to support the
increasing forecasts.    These potential modifications will be in the areas of
material handling, material flow, solution prep, printer facilities, WIP
storage, and other miscellaneous items.  Specific needs and timing will depend
on the actual Product demand and the changing demands for other products at the
site.
 

 
 
Page 4 of 4

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