AMENDMENT NO. 1 TO THE COLLABORATION AND LICENSE AGREEMENT
Exhibit
10.8
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
0000 Xxxxxxx Xxxx, Xxxxx 000, Xxxxxx Xxxx, Xxxxx Xxxxxxxx (“POZEN”), and
ASTRAZENECA AB, a Swedish corporation having an office at XX-000 00, Xxxxxxx,
Xxxxxx (“AstraZeneca”). POZEN and AstraZeneca may be referred
to herein individually as a “Party,” or collectively as the
“Parties.”
RECITALS
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X.
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XXXXX
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”).
|
|
X.
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XXXXX
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:
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"(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:
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"(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.
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Milestone
Event
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Milestone
Payment
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1. Execution
of
this Amendment.
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$10,000,000
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2. Achievement
of *** ***, and achievement
of ***.
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$20,000,000
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3.
Notification by the FDA that it has accepted the first
U.S. NDA
submission for a POZEN Product in accordance with Section 4.1.1
(Regulatory Responsibilities Inside the U.S.).
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$***
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4.
Receipt of the first NDA Approval for a POZEN Product
in the
U.S.
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$***
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5.
*** of the first *** to *** a *** in
a *** that includes *** and/or *** (if
available) at an *** of the POZEN Product *** than
the *** of (a) the *** for a *** in
such ***, or (b) ***.
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$***
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"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.”
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"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.
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Milestone
Event
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Milestone
Payment
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1.End
of first calendar year during which aggregate annual Net Sales
of Products
were at least $***
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$***
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2.End
of first calendar year during which aggregate annual Net Sales
of Products
were at least $***
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$***
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3.End
of first calendar year during which aggregate annual Net Sales
of Products
were at least $***
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$***
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4.End
of first calendar year during which aggregate annual Net Sales
of Products
were at least $***
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$***
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"Each
milestone payment identified in this Section 8.3 (Sales Milestone Payments)
shall be payable one time only, and not for each time that the “annual Net
Sales” of Products exceeds a specified amount."
1.9 Amendment
to Section 8.4.1. Section 8.4.1 of the Agreement is hereby
amended and restated and replaced in its entirety with the
following:
“8.4.1
Royalty Rate. Subject to the terms and conditions of this
Agreement, AstraZeneca will pay to POZEN royalties based on the aggregate
annual
Net Sales of Products sold by AstraZeneca, its Affiliates or Sublicensees,
at
the rates set forth below:
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“(a)
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***%
of the portion of aggregate Net Sales of Products sold in the United
States during a calendar year.
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"(b) For
Net Sales of Products sold outside the United States:
"(i) For
Net Sales ***:
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“1.
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***%
of the portion of aggregate Net Sales of Products during a calendar
year
that is equal to or less than $***;
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"2.
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***%
of the portion of aggregate Net Sales of Products during a calendar
year
that is greater than $*** but equal to or less than $***;
and
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"3.
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***%
of the portion of aggregate Net Sales of Products during a calendar
year
that is greater than $***.”
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“(ii) For
Net Sales ***:
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“1.
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***%
of the portion of aggregate Net Sales of Products during a calendar
year
that is equal to or less than $***;
and
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“2.
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***%
of the portion of aggregate Net Sales of Products during a calendar
year
that is greater than $***.
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“(c)
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Notwithstanding
the foregoing provisions of this Section 8.4.1 (Royalty Rate),
if
a *** is sold in one or more countries
where ***, the total royalties owed for Products
shall be determined ***, according to the following
calculations:
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“(i)
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***
percent (***%) of the total Net Sales of the *** sold in any
country shall be added to the total Net Sales of the *** (the
resulting amount being the “Segregated Net Sales”), and
the applicable royalty rates set forth in Section 8.41(a) and (b)
shall be
applied to the Segregated Product Net Sales (the resulting amount
being
the “Segregated Royalty
Amount”);
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“(ii)
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the
applicable royalty rates set forth in Section 8.4.1(a) and (b)
shall be
applied to the remaining *** percent (***%) of the total Net
Sales of the *** (the resulting amount being the
“Remaining Royalty Amount”);
and
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“(iii)
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the
amount owed by AstraZeneca shall be equal to the Segregated Royalty
Amount
plus the Remaining Royalty Amount.
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“(iv)
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If ***
are also sold in a country where there are at least *** being
sold, then the calculations above shall be applied similarly to
each
such ***, such that *** percent (***%) of the Net
Sales of each *** shall be added to the Segregated Royalty
Amount, and the remaining *** percent (***%) of
each *** shall be combined only with the
remaining *** percent (***%) of Net Sales of the
other *** (i.e., ***) that are being sold
in other countries. The example set forth in Schedule 8.4.1
illustrates the application of this
8.4.1(c).”
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1.10 Amendment
to Section 8.4.3. Section 8.4.3 of the Agreement is hereby
amended and restated and replaced in its entirety with the
following:
"8.4.3 Rate
Step Down For Competing Product Entrants. With respect to any
particular Product and country, if in any Calendar Quarter there is a Market
Reduction of such Product (based on prescription market data published by
IMS
Health, Xxxxx-Xxxxx, or such other industry standard source as the Parties
may
agree), then the royalty rates which would otherwise apply to Net Sales of
such
Product in such country during such Calendar Quarter will be reduced
to *** percent (***%) of the rates set forth in Section 8.4.1
(Royalty Rate); provided, that in no event will *** (resulting
in *** in the ***, and *** and ***
for *** of the ***; and *** and ***
for *** of the ***). Such reduced royalty rates
will continue in effect, on a Product-by-Product and country-by-country basis,
until expiration of the applicable Royalty Term. As used in this
Section 8.4.3, the term “Market Reduction” of a Product in a
Calendar Quarter occurs when (i) *** by *** for such ***
by *** in such *** of the *** in such *** of
the *** and (ii) the *** the *** in
such *** are *** to the *** in which
the *** of a *** occurred. The example set
forth in Schedule 8.4.3 illustrates the application of this Section
8.4.3."
1.11 Amendment
to Section 12.9. Section 12.9 of the Agreement is hereby
amended and restated and replaced in its entirety with the
following:
"12.9 Post
Termination Royalties. Upon any termination of this
Agreement pursuant to (i) Section 12.4.1 (Termination for Cause)
and *** for the failure of the *** described in
the ***, to ***, or (ii) Sections 12.4.1
and *** then, for a period of *** following any such
termination, AstraZeneca shall pay POZEN a royalty on Net Sales of Products
sold
by AstraZeneca, its Affiliates or Sublicensees in an amount equal
to *** percent (***%) of the royalty amount calculated according to
Section 8.4.1 (Royalty Rate), in accordance with the terms and conditions
of
Sections 8.4 (Royalties) through 8.7 (Taxes) of this Agreement."
1.12 Amendment
to U.S. Development Plan. The U.S. Development Plan of the
Agreement is hereby amended and restated to read in its entirety as set forth
in
Exhibit B attached hereto.
1.13 Amendment
to US. Development Plan Timeline. The U.S. Development Plan
Timeline of the Agreement is hereby amended and restated to read in its entirety
as set forth in Exhibit C attached hereto.
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1.14 Amendment
to Exhibit F (TPP Profile and TPP Studies). Exhibit F of the
Agreement is hereby amended and restated to read in its entirety as set forth
in
Exhibit F attached hereto.
1.15 Amendment
to Schedules 8.4.1 and 8.4.3. Schedule 8.4.1 and Schedule
8.4.3of the Agreement is hereby amended and restated to read in its entirety
as
set forth in Schedule 8.4.1 and Schedule 8.4.3 attached
hereto.
1.16 Termination
of ***. Promptly after execution of this
Amendment, POZEN will terminate *** ***,
including ***. POZEN shall terminate these activities in a
professional manner and will use reasonable efforts to minimize termination
expenses. AstraZeneca will be responsible for the costs associated
with the termination of such activities in accordance with Section 3.3.3
(Expenses) of the Agreement. Due to the extraordinary nature of these
expenses, AstraZeneca will use commercially reasonable efforts to pay POZEN
within *** (***) days, but in any event within *** (***)
days, following receipt of invoice for such termination costs. To
allow rapid approval of the invoice, copies of vendor documentation of work
performed and billing will be included in the invoice.
1.17 New
Studies.
(a) As
promptly as practicable following the execution of this Amendment, the Parties
agree to update the U.S. Development Plan to reflect *** of
the ***, in a manner that is consistent with *** in
the ***. AstraZeneca will pay POZEN for its costs
for *** in accordance with Section 3.3.3 of the Agreement (Expenses);
provided, however, that in no event will *** for
the *** in the ***. The Parties
will ***. The Parties will use Diligent Efforts
to *** and to *** in the *** for
the *** within the ***.
(b) To
the
extent that *** in the ***, the GPT will agree
upon *** of the *** provided, however,
that *** for the *** in the ***, if any, may
include, but would not be limited to, *** and a *** of
the *** of the ***. If the *** in
the *** as an ***. AstraZeneca will
conduct *** for the *** taking into account ***
to the *** of
the ***. Assessments *** for this purpose will
include ***. Representatives from POZEN will
participate *** to the ***. AstraZeneca will be
obligated to *** if the ***. In the event that
AstraZeneca’s and POZEN’s representatives on the GPT *** of a ***
will be *** of the *** to be *** of
the ***. AstraZeneca will conduct ***, but in
any event will ***.
(c) ***
of
the *** but if ***. *** of
the ***. Promptly after execution of this Amendment by
both Parties, the Parties will *** for the *** and
will *** after the *** of
the ***. The expenses *** in
the ***.
(d) AstraZeneca
will ***, at AstraZeneca’s expense, *** with
the *** of the *** in the *** of
the *** in the ***.
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1.18 Operating
Principles. Promptly after the Amendment Effective Date, the
GPT will review, discuss and adopt new operating principles consistent with
the
draft principles attached hereto as Exhibit G that will guide the conduct
of the GPT and clinical subteam meetings. To the extent there is any
conflict between the attached operating principles and the terms and conditions
of the Agreement (as amended by this Amendment), then the Agreement will
control.
ARTICLE
2 – REFERENCE TO AND EFFECT ON THE AGREEMENT
2.1 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
hereby.
2.2 Effectiveness
of Agreement. The amendments set forth
above shall not be effective until execution and delivery of this Amendment
by
both parties. Except as specifically amended above, the Agreement, as
amended, 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.
2.3 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.
ARTICLE
3 - MISCELLANEOUS
3.1 Governing
Law; Dispute Resolution. Section 15.4
of the Agreement governs any dispute arising out of or related to this
Amendment.
3.2 Notices. All
notices or other communications that are required or permitted hereunder
will be
made according to Section 15.5 of the Agreement.
3.3 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.
3.4 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.
3.5 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 the Amendment Effective
Date.
POZEN
INC.
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POZEN
INC.
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ASTRAZENECA
AB
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By:
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/s/
Xxxx X. Xxxxxxxxx
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By:
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/s/ Xxxx Xxxxxxxxxxx | |
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Print
Name:
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Xxxx X. Xxxxxxxxx, Pharm.D. |
Print
Name:
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Xxxx Xxxxxxxxxxx | |
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Title:
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Chairman, President and Chief Executive Officer |
Title:
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Sr. Counsel, Manager Legal Department Molndal | |
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(Exhibit
A to Agreement Unchanged)
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EXHIBIT
B - U.S. DEVELOPMENT PLAN
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Study
Number
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Title
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Endpoints
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Design/Comment
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Responsibility
to Conduct/Pay
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NONCLINICAL:
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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XXXXX
0
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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XXXXX
0 ***--
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Study
Number
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Title
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Endpoints
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Design/Comment
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Responsibility
to Conduct/Pay
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XXXXX
0
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***
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· ***
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EXHIBIT
C
U.S.
DEVELOPMENT PLAN TIMELINE ***
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EXHIBIT
F
TPP
STUDIES
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EXHIBIT
G
OPERATING
PRINCIPLES
GPT
Meetings:
***.
CPT
Meetings:
***
Face-to-Face
GPT Meetings:
***.
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SCHEDULE
8.4.1
(i) For
Products sold outside the U.S.: In ***, AstraZeneca has
Net Sales for *** in country Y in the amounts of $*** for the first
Product and $*** for the ***. In *** in all
other countries of the Territory (outside the U.S.) the total Net Sales of
Products are $*** million, and Net Sales do not occur in any other country
for ***. The calculation of the Segregated Royalty Amount
would be:
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
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***
|
***
|
***
|
||||
|
***
|
***
|
The
calculation of the Remaining Royalty Amount would be:
|
***
|
***
|
***
|
***
|
***
|
|
***
|
***
|
***
|
***
|
***
|
The
total
royalty payable for all Net Sales in the Territory (outside of the US) would
be
$***
(ii) For
Products sold in the U.S.: In ***, AstraZeneca has Net
Sales for *** in the U.S. in the amounts of $*** for the first
Product and $*** for ***. The total royalty payable for all U.S. Net
Sales would be $*** (Net Sales for *** would be charged a royalty
of ***%).
***
Portion for which confidential treatment requested.
-
17
-
SCHEDULE
8.4.3
(i) For
Products sold outside the U.S.: Assume that in the *** the
total ex-U.S. Net Sales of Products are $***n. In that example the
following royalties would be payable prior to application of any Market
Reduction:
|
***
|
***
|
***
|
***
|
***
|
|
***
|
***
|
***
|
***
|
***
|
|
***
|
***
|
***
|
***
|
***
|
|
***
|
***
|
***
|
***
|
***
|
|
***
|
***
|
***
|
***
|
***
|
Assume
that in country X during the first *** a Competing Product had
commenced sales in country X, and in the first *** achieved the
criteria to trigger a Market Reduction under Section 8.4.3 (Rate Step Down
for
Competing Product Entrants). Assume that Net Sales of Products in
country X were *** in ***.
***
|
***
|
***
|
***
|
***
|
***
|
***
|
|
|
***
|
***
|
***
|
***
|
***
|
***
|
|
|
***
|
***
|
***
|
***
|
***
|
***
|
|
|
***
|
***
|
***
|
***
|
***
|
***
|
|
|
***
|
***
|
***
|
***
|
The
Market Reduction in country X would result in a reduction to royalties payable
of an amount equal to $*** ($***). Therefore the total ex-U.S.
royalty payable for Product Net Sales would be $***
(ii) For
Products sold in the United States:
Assume
that in the U.S. during the first *** a Competing Product had
commenced sales in the U.S., and in the first *** achieved the
criteria to trigger a Market Reduction under Section 8.4.3 (Rate Step Down
for
Competing Product Entrants). Assume that Net Sales of Products in the
U.S. were $*** in ***. The Market Reduction is applied to
Net Sales in the U.S. by reducing the royalty rates set forth in Section
8.4.1(a) by ***%. The total royalty payable for all U.S.
Net Sales would be $*** (net sales would be charged at a royalty
of ***%).
***
Portion for which confidential treatment requested.
-
18
-
