EXHIBIT 10.47

***Text Omitted and Filed Separately with the Securities and Exchange
Commission.

Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Execution Copy

AMENDMENT NO. 1 TO AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT FOR
THE UNITED STATES

This AMENDMENT NO. 1 TO AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT
FOR THE UNITED STATES (the “Amendment”) is made by and between POZEN Inc., a
Delaware corporation (“POZEN”), and Horizon Pharma USA, Inc., a Delaware
corporation (“Horizon,” and together with POZEN, the “Parties”). Reference is
made to that certain Amended and Restated Collaboration and License Agreement
for the United States, dated as of November 18, 2013, by and between POZEN and
Horizon, as successor in interest to AstraZeneca AB (“AZ”) (the “Agreement”).
All capitalized terms not herein defined shall have the meaning ascribed to them
in the Agreement. This Amendment shall be effective automatically as of the
Amended and Restated Effective Date.

WHEREAS, subject to that certain (i) Letter Agreement, dated as of the date
hereof, by and among POZEN, Horizon and AZ, and (ii) Supply Agreement, dated as
of the date hereof by and between Horizon and AZ, Horizon is acquiring all of
AZ’s rights, title and interest in and to the Agreement, including, except as
otherwise explicitly provided in the Agreement or the Amended and Restated
Collaboration and License Agreement (the “ROW License Agreement”), by and
between AstraZeneca and POZEN, all of AZ’s rights and obligations under the
Agreement (the “Divestiture”);

WHEREAS, it is a condition precedent that POZEN consent to the Divestiture;

WHEREAS, POZEN has conditioned its consent to the Divestiture upon the
simultaneous execution of this Amendment; and

WHEREAS, in consideration for POZEN’s consent, the Parties agree that
simultaneously with the consummation of the Divestiture, the Agreement shall be
amended pursuant to the terms and conditions of this Amendment.

NOW THEREFORE, in consideration of the mutual promises and covenants hereinafter
set forth, the parties hereto agree to amend the Agreement as follows:

 

  1.

Amendment to Section 8.1.1. Section 8.1.1 is hereby amended and restated to read
in its entirety as follows:

“8.1.1             Royalty Rate. Subject to the terms and conditions of this
Agreement, Licensee will pay to POZEN royalties based on the aggregate annual
Net Sales of Products sold by Licensee, its Affiliates or Sublicensees, at the
rate of 10% of aggregate Net Sales of Products sold in the Territory. In
addition, effective only upon completion of the Divestiture, and only for each
calendar year during which (i) the manufacture, use, sale, offer for sale,
import or export of Products in the Territory would, without a license from
POZEN to the Licensed Patents, infringe one or more Valid Claims of the Licensed
Patents; and (ii) there are no Competing Products in the Territory, Licensee
shall be required to pay POZEN the following minimum annual royalties (each a
“Minimum Annual Royalty Amount”):

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(a)        for calendar year 2014 (January 1, 2014 – December 31, 2014),
Licensee shall pay POZEN a minimum royalty payment of Five Million Dollars
($5,000,000); and

(b)        for each calendar year beginning after January 1, 2015, Licensee
shall pay POZEN a minimum royalty payment of Seven Million Five Hundred Thousand
Dollars ($7,500,000).”

 

  2.

Amendment to Section 8.2.1. Section 8.2.1 is hereby amended and restated to read
in its entirety as follows:

“8.2.1             Sales Reporting.

(a)        Licensee will provide POZEN, within (i) […***…] ([…***…]) of the end
of each of the first, second and third Calendar Quarters in each calendar year,
and (ii) […***…] ([…***…]) of the end of the fourth Calendar Quarter in each
calendar year, with a preliminary report setting forth for such Calendar Quarter
and, with respect to the fourth Calendar Quarter, the calendar year, on a
Product-by-Product basis, the amount of gross sales of each Product in the
Territory, a calculation of Net Sales and a calculation of the amount of royalty
payment due on such Net Sales, subject to the Minimum Annual Royalty Amounts set
forth in Section 8.1.1 (Royalties), provided such report shall be based on
preliminary financials of Licensee and Licensee shall be permitted to revise
such reports as reasonably necessary in light of its review process at any time
up to (i) […***…] ([…***…]) following the end of the relevant Calendar Quarter
(with respect to the first, second and third Calendar Quarters); and
(ii) […***…] ([…***…]) following the end of the fourth Calendar Quarter. If any
payment reduction is claimed by Licensee under this Agreement from the full
royalty rates set forth in Section 8.1.1 (Royalties), then the report will set
forth in detail the claimed reduction and the related facts.

(b)        Licensee will provide POZEN, within (i) […***…] ([…***…]) of the end
of each of the first, second and third Calendar Quarters in each calendar year,
and (ii) […***…] ([…***…]) of the end of the fourth Calendar Quarter in each
calendar year, with a final report setting forth for such Calendar Quarter and,
with respect to the fourth Calendar Quarter, the calendar year, on a
Product-by-Product basis, the amount of gross sales of each Product in the
Territory, a calculation of Net Sales and a calculation of the amount of royalty
payment due on such Net Sales, subject to the Minimum Annual Royalty Amounts set
forth in Section 8.1.1 (Royalties), provided that Licensee shall use reasonable
efforts to provide such report as soon as practicable to accommodate POZEN’s SEC
filing requirements and to provide such reports in a shorter time period than
the periods specified above if Licensee has such reports available for its own
internal purposes. If any payment reduction is claimed by Licensee under this
Agreement from the full royalty rates set forth in Section 8.1.1 (Royalties),
then the report will set forth in detail the claimed reduction and the related
facts.

(c)        At the request of POZEN, Licensee will, within (i) […***…] ([…***…])
[…***…] of the end of each of the first, second and third Calendar Quarters in
each calendar

 

 

***Confidential Treatment Requested

 

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year, and (ii) […***…] ([…***…]) of the end of the fourth Calendar quarter in
each calendar year, conduct a teleconference with POZEN (the “Quarterly Update
Call”) in order to report, on a Product-by-Product basis, the commercial results
for the Calendar Quarter. These results will include gross sales and Net Sales
and […***…] for Products. These results will also include other information
available to Licensee that would be relevant to explaining the results, for
example, […***…]. During that call, Licensee will also provide POZEN with an
update concerning […***…], as well as any […***…]. Licensee will provide POZEN
with a reasonable opportunity to comment on such plans and agrees to reasonably
consider all POZEN comments and suggestions with respect to such matters.

(d)        POZEN acknowledges and agrees that all information disclosed by
Licensee pursuant to […***…] shall be subject to the restrictions set forth in
Section 11 (Confidentiality) and […***…] of the […***…] on a […***…] or […***…]
to be […***…] and […***…]. Notwithstanding the foregoing, Licensee and POZEN
[…***…] to […***…] of all […***…] in […***…], to the […***…] or […***…].”

 

  3.

Amendment to Section 8.2.2. Section 8.2.2 is hereby amended and restated to read
in its entirety as follows:

“8.2.2 Payment Timing. Licensee will make royalty payments to POZEN within
[…***…] ([…***…]) […***…] of the last day of each Calendar Quarter for which
such payments are due under Section 8.1 (Royalties). Such quarterly payments
shall be equal to the greater of (i) the applicable portion of the Minimum
Annual Royalty Amount (i.e., Q1 = 25%; Q2 = 50%; Q3 = 75%; Q4 = 100%), minus the
aggregate royalty amount paid by Licensee to POZEN during the then-current
calendar year through the immediately preceding Calendar Quarter, or (ii) the
actual royalty amount payable under the Section 8.1 (Royalties), calculated
year-to-date, minus the aggregate royalty amount paid by Licensee to POZEN
during the then-current calendar year through the immediately preceding Calendar
Quarter. For purposes of clarity, the Parties agree with the following examples
which assume the 2014 Minimum Annual Royalty Amount is applicable:

 

***Confidential Treatment Requested

 

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(a)        If Net Sales in the first Calendar Quarter of 2014 equal $10 million,
then the royalty payment to be made by Licensee to POZEN under this
Section 8.2.2 shall equal $1,250,000 (i.e., the applicable Minimum Annual
Royalty Amount ($1,250,000) exceeded the actual royalty payment ($1,000,000 (10%
of $10,000,000 of Net Sales) for the Calendar Quarter).

(b)        If year-to-date Net Sales in the second Calendar Quarter of 2014
equal $40 million ($10 million in Q1 and $30 million in Q2), then the royalty
payment to be made by Licensee to POZEN under this Section 8.2.2 for Q2 shall
equal $2,750,000 (i.e., the actual royalty payment, calculated year-to-date, for
the second Calendar Quarter ($4,000,000 (10% of $40,000,000 of Net Sales)),
minus the aggregate royalty amount paid by Licensee to POZEN during the
then-current calendar year ($1,250,000)).”

 

  4.

Amendment to Section 9.10.2. Section 9.10.2 is hereby amended and restated to
read in its entirety as follows:

“9.10.2           Hatch-Waxman Act. Notwithstanding Section 9.6.1 (Infringement
by Third Parties) above, each Party will immediately give notice to the other
Party of any notice it receives of certification filed under the Hatch-Waxman
Act claiming that any of the Licensed Patents is invalid, unenforceable or that
any infringement will not arise from the manufacture, use or sale of the POZEN
Product by a Third Party. With regard to litigation arising out of or related to
the submission of Abbreviated New Drug Applications to FDA referencing NDA
#22-511 (the “Vimovo Litigation”), Licensee, at its cost and expense and with
counsel selected by Licensee, controls and directs the Vimovo Litigation with
respect to the Licensed Patents (including Joint Patents). POZEN shall cooperate
with regard to the Vimovo Litigation in accordance with this Section 9.10.2, and
POZEN’s litigation counsel may participate in the Vimovo Litigation with respect
to the Licensed Patents (including Joint Patents) (without in any way limiting
Licensee’s control thereof), at POZEN’s cost and expense; provided that Licensee
will reimburse POZEN for the reasonable legal fees of POZEN’s litigation counsel
incurred for the Vimovo Litigation from and after the Amended and Restated
Effective Date, up to a maximum of […***…] for calendar year 2014 and […***…]
for any other calendar year during the Term of this Agreement (pro-rated for any
period less than a full calendar year), such reimbursement to be made within
[…***…] ([…***…]) days after receipt of invoices with reasonably detailed
supporting information for such fees. The Parties agree that settlement of any
action hereunder will be controlled as set forth in Section 9.6.3 (Cooperation).
Any recovery realized as a result of an action hereunder will be allocated in
accordance with Section 9.6.4 (Recovery). For purposes of clarity any other
litigation matters with respect to the Licensed Patents (including Joint
Patents) that in any way relate to the Hatch-Waxman Act shall be subject to the
terms of this Section 9.10.2 and all other litigation matters related to
infringement of the Licensed Patents and the Joint Patents shall be covered by
Section 9.6. Any suit hereunder may be in the name of either or both Parties, as
may be required by law and each Party agrees to cooperate fully in the
prosecution of such action, including, if required to bring or maintain such
action, the furnishing of a power-

 

 

***Confidential Treatment Requested

 

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of-attorney or the joining of such action as a necessary party, executing all
papers and instruments, or requiring its employees or contactors, to execute
such papers and instruments so as to successfully prosecute any such action. For
clarity, any Patent with Valid Claims solely directed to any product containing
acetyl salicylic acid (including salts and derivatives thereof) is not a
Licensed Patent; therefore, Licensee will have no right to bring infringement
proceedings of such Patent under this Section 9.10.2. Notwithstanding anything
in this Section 9.10.2 to the contrary, Licensee shall not have the right to
bring an infringement proceeding under this Section 9.10.2 unless such
proceeding involves a POZEN Product.”

 

  5.

Amendment to Section 10.1. Section 10.1 is hereby amended by inserting this
section 10.1A in its entirety as follows:

“10.1A     Additional POZEN Representations and Warranties. POZEN hereby
warrants and represents to Licensee as of the Amended and Restated Execution
Date and the Amended and Restated Effective Date that, except with respect to
the Vimovo Litigation, none of the Licensed Patents, including the Joint
Patents, is involved in any litigation, claim, proceeding, inventorship
challenge, reissue, interference, reexamination or opposition in the Territory.”

 

  6.

Amendment to Section 15.5. Section 15.5 is hereby amended and restated to read
in its entirety as follows:

“15.5     Notices. All notices or other communications that are required or
permitted hereunder will be in writing and delivered personally, sent by
facsimile (and promptly confirmed by personal delivery or overnight courier as
provided herein), or sent by internationally-recognized overnight courier
addressed as follows:

If to POZEN, to:

POZEN Inc.

1414 Raleigh Road, Suite 400

Chapel Hill, NC 27517

USA

Attention: President and CEO

Facsimile: (919) 913-1039

With a copy to:

DLA Piper LLP (US)

51 John F. Kennedy Parkway, Suite 120

Short Hills, New Jersey 07078

USA

Attention: Andrew P. Gilbert

Facsimile: (973) 520-2575

 

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If to Licensee, to:

Horizon Pharma USA, Inc.

520 Lake Cook Rd.

Suite 520

Deerfield, IL 60015

Attention: President and CEO

With a copy to:

Horizon Pharma USA, Inc.

520 Lake Cook Rd.

Suite 520

Deerfield, IL 60015

Attention: Brian K. Beeler

or to such other address as the Party to whom notice is to be given may have
furnished to the other Party in writing in accordance herewith. Any such
communication will be deemed to have been given (i) when delivered, if
personally delivered or sent by facsimile on a Business Day, and (ii) on the
second Business Day after dispatch, if sent by nationally-recognized overnight
courier. It is understood and agreed that this Section 15.5 (Governing Law;
Dispute Resolution) is not intended to govern the day-to-day business
communications necessary between the Parties in performing their duties, in due
course, under the terms of this Agreement.”

 

  7.

Reference to Agreement. Upon and after the effectiveness of this Amendment, each
reference in the Agreement to “this Agreement,” “hereunder,” “hereof” or words
of like import referring to the Agreement shall mean and be a reference to the
Agreement as modified and amended by this Amendment; provided nothing herein
shall affect the Three-Party Agreement, which shall remain in full force and
effect in accordance with its terms.

 

  8.

Effectiveness of Agreement. The Amendment set forth above shall not be effective
until execution and delivery of this Amendment by both Parties. Except as
specifically amended above, the Agreement is and shall continue to be in full
force and effect and is hereby in all respects ratified and confirmed and shall
constitute the legal, valid, binding and enforceable obligations of the Parties;
provided nothing herein shall affect the Three-Party Agreement, which shall
remain in full force and effect in accordance with its terms.

 

  9.

No Waiver. The execution, delivery and effectiveness of this Amendment shall not
operate as a waiver of any right, power or remedy of either Party under the
Agreement, nor constitute a waiver of any provision of the Agreement.

 

  10.

Governing Law; Dispute Resolution. Section 15.4 of the Agreement governs any
dispute arising out of or related to this Amendment.

 

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  11.

Notices. All notices or other communications that are required or permitted
hereunder will be made according to Section 15.5 of the Agreement.

 

  12.

Headings. The headings for each Article and Section in this Amendment have been
inserted for convenience of reference only and are not intended to limit or
expand on the meaning of the language contained in the particular Article or
Section.

 

  13.

Counterparts. This Amendment may be executed in two (2) or more counterparts,
each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.

 

  14.

No Strict Construction. This Amendment has been submitted to the scrutiny of,
and has been negotiated by, both Parties and their counsel, and will be given a
fair and reasonable interpretation in accordance with its terms, without
consideration or weight being given to any such terms having been drafted by any
Party or its counsel. No rule of strict construction will be applied against
either Party.

 

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IN WITNESS WHEREOF, the Parties have executed this Amendment in duplicate
originals by their duly authorized representatives as of November 18, 2013.

 

POZEN INC. /s/ John R. Plachetka

Name:  John R. Plachetka

Title:  Chairman, President & CEO

 

HORIZON PHARMA USA, INC. /s/ Timothy P. Walbert

Name:  Timothy P. Walbert

Title:   Chairman, President & Chief Executive Officer

 

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