Confidential Treatment has been requested for portions of this
exhibit. The copy filed herewith omits the information
subject to the confidentiality request. Omissions are
designated as “ ***”. A complete version of
this exhibit has been filed separately with the Securities and
Exchange Commission.
AMENDMENT NO. 1 TO THE COLLABORATION AND LICENSE
AGREEMENT
This Amendment No. 1 to
the Collaboration and License Agreement (this “
Amendment ”) is made effective as of September
6, 2007 (the “ Amendment
Effective Date ”) by and between POZEN INC., a
Delaware corporation having offices at 1414 Raleigh Road,
Suite 400, Chapel Hill, North Carolina (“
POZEN” ), and ASTRAZENECA AB, a Swedish
corporation having an office at SE-431 83, Mölndal,
Sweden (“ AstraZeneca ”). POZEN
and AstraZeneca may be referred to herein individually as a
“ Party ,” or collectively as the “
Parties .”
RECITALS
|
A.
|
POZEN
and AstraZeneca entered into that certain Collaboration and License
Agreement, dated as of August 1, 2006, and effective as of
September 7, 2006 (as amended hereby, the “ Agreement
”).
|
|
B.
|
POZEN
and AstraZeneca desire to amend the Agreement.
|
NOW, THEREFORE, in
consideration of the mutual promises and covenants
hereinafter set forth, the parties hereto agree to amend the
Agreement as follows:
Capitalized terms used
herein have the respective meanings assigned to them as
defined in this Amendment. Other capitalized terms
not otherwise defined herein have the meaning ascribed
thereto in the Agreement.
ARTICLE 1 - AMENDMENTS
1.1
Amendment to Section 1.77. Section 1.77 of the
Agreement is hereby amended and restated to read in its entirety as
follows:
"
"***, ***, ***,
and *** Studies" means
the ***, ***, ***,
and *** Studies described in the U.S. Development
Plan, each of which may be referred to individually (e.g., the
"*** Study") to describe that particular study in the U.S.
Development Plan."
1.2
Amendment to Section 1.82(b). Section 1.82(b)
of the Agreement is hereby amended and restated to read in its
entirety as follows:
*** Portion for which confidential treatment
requested.
" (b)
the
receipt of notice from the FDA, EMEA or other Regulatory
Authority in the EU that successful completion of
the Budgeted Development Activities and Core
Development Activities would be insufficient to achieve NDA
Approval of the Initial POZEN Product without the performance
of Additional Development Activities that are not included in
the Budgeted Development Activities and that would be
reasonably expected, in the aggregate, to either (i) delay
the anticipated date of NDA Approval of the Initial POZEN
Product by more than *** *** past the
dates set forth in the Initial U.S. Development Plan Timeline
or for any country of the EU set forth in the Initial ROW
Development Plan Timeline, or (ii) require AstraZeneca to
spend more than an aggregate of $*** to perform; provided
that, the cost of any such Additional Development Activities
conducted pursuant to the *** Study
or *** Study shall not be counted toward such $***
limit;"
1.3
Amendment to Section 1.104. Section 1.104 of
the Agreement is hereby amended and restated to read in its
entirety as follows:
“
1.104 “TPP Studies”
means the studies
entitled ***, ***, *** in the
U.S. Development Plan.”
1.4
Amendment to Section 2.2.1(a). Section
2.2.1(a) of the Agreement is hereby amended and restated to read in
its entirety as follows:
" (a)
Membership. In addition to
members designated by AstraZeneca, the GPT shall have up to
three (3) representatives designated by POZEN, attending,
observing and participating in meetings of the GPT at
POZEN’s expense, such representatives having the
relevant experience and skill appropriate for service on such
team. Attendance of POZEN representatives at GPT
meetings shall be agenda-driven, as determined in the sole
discretion of AstraZeneca. AstraZeneca shall be
entitled to have as many representatives serve as members of
the GPT as it desires. POZEN may replace its
representatives on the GPT at any time upon written notice to
AstraZeneca. AstraZeneca shall provide POZEN with
office space at its facilities for such representatives to
facilitate such participation; provided, that such
representatives shall comply with all policies and reasonable
restrictions imposed by AstraZeneca and provided to POZEN in
writing. Upon prior written consent of
AstraZeneca, which consent will not be unreasonably withheld,
a reasonable number of employees, consultants,
representatives or advisors of POZEN who are not
POZEN’s GPT representatives may attend GPT meetings as
observers; provided, that such persons shall comply with all
policies and reasonable restrictions imposed by AstraZeneca
and provided to POZEN in writing."
1.5
Amendment to Section 2.2.1(c). Section
2.2.1(c) of the Agreement is hereby amended and restated to read in
its entirety as follows:
*** Portion for which confidential treatment
requested.
" (c)
Meetings. The GPT will hold
meetings when called by the GPT Chair. Meetings
may be held in person or by means of telecommunication
(telephone, video, or web
conference). Face-to-face GPT meetings that
require POZEN attendance will be convened on an as-needed
basis as mutually agreed by AstraZeneca and POZEN, but in any
event, at least twice per annum. The location of
these meetings, will be based on business requirements and
determined by mutual agreement between AstraZeneca and
POZEN. Following any GPT meeting, the GPT Chair
will be responsible for preparing and issuing minutes of such
meeting within fifteen (15) Business Days
thereafter. When POZEN has participated in the
meeting, such minutes will not be finalized until a
representative of the GPT designated by each Party has
reviewed and confirmed the accuracy of such minutes in
writing. If a disagreement regarding the accuracy
of such minutes cannot be resolved, the minutes will reflect
such disagreement."
1.6
Amendment to Section 3.3.3. In Section 3.3.3
of the Agreement, the phrase "(including upon finalization of the
scope of the *** and *** studies)" is hereby
deleted and replaced with the following:
"(including
upon the finalization of the design of
the ***, ***, ***,
and *** Studies, and any agreed Additional New
Studies referenced in Section 1.15 of this
Amendment)"
1.7
Amendment to Section 8.2 . Section 8.2 of the
Agreement is hereby amended and restated to read in its entirety
with the following:
“8.2 Development Milestone Payments.
Subject to the terms and conditions of this Agreement,
including without limitation the last paragraph of this Section 8.2
(Development Milestone Payments), AstraZeneca will pay to POZEN the
following one-time, non-creditable, non-refundable payments with
respect to the first achievement of the corresponding events with a
POZEN Product.
*** Portion for which confidential treatment
requested.
|
Milestone
Event
|
Milestone
Payment
|
|
1. Execution of this
Amendment.
|
$10,000,000
|
|
2. Achievement of *** ***, and
achievement of ***.
|
$20,000,000
|
|
3. Notification by the FDA that it has accepted the first
U.S. NDA submission for a POZEN Product in accordance with Section
4.1.1 (Regulatory Responsibilities Inside the U.S.).
|
$***
|
|
4. Receipt of the first NDA Approval for a POZEN Product
in the U.S.
|
$***
|
|
5. *** of the first *** to *** a ***
in a *** that includes ***
and/or *** (if available) at an *** of the
POZEN Product *** than the *** of (a)
the *** for a *** in such ***, or
(b) ***.
|
$***
|
"POZEN
shall notify AstraZeneca in writing upon the achievement of
Milestones Events 3 and 4 above, and shall provide AstraZeneca
with reasonable evidence that such Milestone Events have been
achieved. The payments due with respect to
achievement of each Milestone Event shall be due and payable
within *** (***) days after (i) AstraZeneca
receives notification from POZEN of the achievement of
Milestone Events #3 and 4, and (ii) the occurrence of the
Milestone Event #5. The Parties agree that
Milestone Event #2 above has been achieved as of the Amendment
Effective Date, and that development Milestone Event #1
previously set forth in Section 8.2 the Agreement will be
deemed to have been achieved through the performance and
achievement of Milestone Event #2 above. Milestone
Events #1 and 2 shall be payable within *** (***)
Business Days after the execution of this
Amendment. The date on which any such milestone
payment is due and payable in accordance with the preceding
sentence is hereinafter referred to as the
“Milestone Due Date .
”
*** Portion for which confidential treatment
requested.
"Each
milestone payment identified in this Section 8.2 (Development
Milestone Payments) shall be payable one time only,
irrespective of the number of POZEN Products that achieve the
applicable Milestone Event. Notwithstanding the
foregoing, if a Milestone Event for which a payment would be
due under this Section 8.2 (Development Milestone Payments) is
achieved, but AstraZeneca provides notice to POZEN that it is
exercising its right to terminate this Agreement pursuant to
Section 12.3 (Termination for Material Breach), 12.4
(Termination for Cause) or 12.5 (Termination at Will) prior to
the applicable Milestone Due Date for such Milestone Event,
then such milestone payment will not be payable; provided,
that AstraZeneca complies with its obligations under Section
12.6.3(b) (Effect of Termination for Cause or Material Breach)
or 12.6.4 (Effect of Termination at Will) if
applicable.”
1.8
Amendment to Section 8.3 . Section 8.3 of the
Agreement is hereby amended and restated and replaced in its
entirety with the following:
“
8.3 Sales Milestone Payments.
Subject to the terms and conditions of this
Agreement, AstraZeneca will pay to POZEN the following
one-time, non-creditable, non-refundable payments within
thirty (30) days following the achievement of the
corresponding events described in the table
below.
|
Milestone
Event
|
Milestone
Payment
|
|
1. End of first calendar year during which aggregate
annual Net Sales of Products were at least $***
|
$***
|
|
2. End of first calendar year during which aggregate
annual Net Sales of Products were at least $***
|
$***
|
|
3. End of first calendar year during which aggregate
annual Net Sales of Products were at least $***
|
$***
|
|
4.End
of first calendar year during which aggregate annual Net Sales
of Products were at least $***
|
$***
|
"Each
milestone payment identified in this Section 8.3 (Sales
Milestone Payments) shall be payable one time o
