EXHIBIT
10.41
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and are requested to be treated confidentially.
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (the
“Agreement”) is made and entered into effective this
day of October 2003 (the
“Effective Date”) between aaiPharma LLC, a Delaware
limited liability company having an address at 2320 Scientific Park
Drive, Wilmington, NC 28405, aaiPharma Inc., a Delaware corporation
having an address at 2320 Scientific Park Drive, Wilmington, NC
28405 (hereinafter referred to collectively with aaiPharma LLC as
“aaiPharma”), and Salix Pharmaceuticals, Inc., a
California corporation having an address at 8540 Colonnade Center
Drive, Suite 501, Raleigh, NC 27615 (hereinafter referred to as
“Salix”).
WITNESSETH
WHEREAS, aaiPharma has developed an
azathioprine product in several strengths (the “Licensed
Product,” as defined in more detail below).; and
WHEREAS, Salix seeks an exclusive
license to market, promote, sell, and distribute the
“Licensed Product” in the Territory, and is willing to
expend its reasonable efforts and resources to do so if it can
obtain a license under the terms and conditions set forth herein;
and
WHEREAS, aaiPharma wishes to grant
to Salix such a license, subject to the terms and conditions set
forth herein.
NOW, THEREFORE, for and in
consideration of the covenants, conditions, and undertakings
hereinafter set forth, it is agreed by and between the parties as
follows:
1. Definitions
1.1 “Competing Product”
with respect to any country in the Territory shall mean a
bioequivalent pharmaceutical product for human use approved by any
national, federal, state or local regulatory agency, department,
bureau or other government entity within the Territory, including
but not limited to the United States’ Food & Drug
Administration, that contains 25 mg, 75 mg, or 100 mg of
azathioprine.
1.2 “GI Product” means
any product indicated or developed for the treatment of
gastrointestinal disease owned, developed, or licensed by
aaiPharma, or any parent, subsidiary, or affiliate, other than (i)
those containing omeprazole or S-omeprazole, or any derivatives
thereof as an active ingredient or (ii) any 50 mg formulation of
azathioprine sold by aaiPharma.
1.3 “Licensed Field”
means all indications and uses for humans.
1.4 “Licensed Know-How”
means (i) all know-how, trade secrets, formulations, methods of
manufacture, and scientific, clinical and other data and
information, whether or not patented or patentable, and any
intellectual property rights, pertaining to Licensed Products for
use in the Licensed Field, or pertaining to the manufacture or use
of such formulations and (ii) any pharmacological, toxicological,
pharmacokinetic, non-clinical data, and clinical data regarding
Licensed Products available to aaiPharma and required by Salix to
maintain current
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regulatory approvals or seek and obtain
regulatory approvals or intellectual property rights protection for
additional indications for Licensed Products or with respect to
additional jurisdictions in the Territory and which, in each case,
aaiPharma has the right to disclose, license, sublicense, and/or
assign, as applicable, as of the Effective Date and during the Term
of this Agreement or to which aaiPharma subsequently acquires the
right to disclose, license, sublicense, or assign during the Term
of this Agreement in the Territory.
1.5 “Licensed Products”
means any and all products for use in the Licensed Field in the
Territory that incorporate 25 mg, 75 mg, or 100 mg dosage
formulations of azathioprine, including but not limited to such
products as are currently sold by aaiPharma for human therapeutic
use. For purposes of clarification, “Licensed Products”
does not include the 50 mg formulation currently sold by
aaiPharma.
1.6 “Licensed
Trademarks” means AZASAN and any related trade dress and
domain names (including but not limited to azasan.com or
azathioprine.com) used or registered for use by aaiPharma with
respect to any Licensed Products or their active
ingredient(s).
1.7 “Net Sales” means
the total sales price invoiced to a third party by Salix or any
Salix Affiliate for the Licensed Products, after deducting (a)
sales taxes or other taxes separately stated on the invoice, (b)
shipping charges (including but not limited to related insurance)
actually paid and separately stated on the invoice, (c) actual
allowances, rebates, credits and refunds for returned or defective
goods, (d) chargeback payments and rebates (or the equivalent
thereof) granted to managed health care organizations or to
federal, state/provincial, local and other governments, including
their agencies, purchasers, and/or reimbursers, or to trade
customers, (e) normal and customary trade and quantity discounts,
retroactive price reductions, or other allowances actually allowed
or granted from the billed amount and taken, and (f) any import or
export duties, tariffs, or similar charges incurred with respect to
the import or export of Licensed Products into or out of a country
in the Territory, provided that Net Sales shall not include amounts
received from Salix Affiliates with respect to the sale or transfer
of Licensed Products unless such Salix Affiliates are the end users
of such Licensed Products.
1.8 “Product Approvals”
means any approvals, licenses, registrations or authorizations
granted by, or applications therefor made to, any national,
federal, state or local regulatory agency, department, bureau or
other government entity within the Territory, including but not
limited to the United States’ Food & Drug Administration,
necessary for the marketing, manufacture, use, storage, import,
transport, or sale of Licensed Products in a regulatory
jurisdiction in the Territory, including but not limited to those
listed on Appendix A , attached hereto and incorporated
herein by reference, and all correspondence, filings, and documents
related thereto.
1.9 “Affiliate” means
any firm, person or company which controls, is controlled by or is
under common control with a party to this Agreement; as used in
this definition, “control” means the possession,
directly or indirectly, of the power to direct or cause the
direction of the management and policies of such firm, person or
company, whether through the ownership of voting securities, by
contract or otherwise.
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1.10 “Supply Agreement”
means the separate Supply Agreement, dated as of the Effective
Date, between Salix and aaiPharma under which aaiPharma shall
supply, and Salix shall purchase, all of Salix’s and the
Salix Affiliates’ needs for Licensed Product.
1.11 “Territory” means
Canada, Mexico, and the United States of America and its
territories and possessions, including the Commonwealth of Puerto
Rico.
2. Effectiveness; Grant of License; Term;
Options .
2.1 Effectiveness . This
Agreement shall only be effective upon the execution of the Supply
Agreement and Quality & Compliance Agreement by each party
hereto.
2.2 Exclusive License . Upon
execution of this License Agreement, Salix shall pay aaiPharma
[ * ] United States Dollars ($ [ * ] ).
Upon receipt thereof, aaiPharma grants to Salix an exclusive
royalty -bearing license to make and have made (solely (i) as
permitted by the terms of Sections 3.1 and 3.10 of the Supply
Agreement or (ii) upon expiration or termination of the Supply
Agreement), use, offer for sale, market, promote, sell, import and
export (solely among jurisdictions within the Territory), and
distribute, and, for purposes of clarification but not limitation,
enter into agreements with third parties, including Salix
Affiliates, to co-promote and distribute within the Territory, the
Licensed Products in the Territory under the Licensed Trademarks,
or any other trademarks owned or licensed by Salix or its
Affiliates, for all uses in the Licensed Field upon the terms and
conditions set forth in this Agreement (the “Distribution and
Trademark License”). In addition to the Distribution and
Trademark License, aaiPharma grants Salix the right to use the
marketing or advertising materials provided hereunder to market,
offer for sale, sell, promote and distribute the Licensed Products
in the Territory. Except with respect to existing inventories of
Licensed Products no longer in aaiPharma’s reasonable control
as of the Effective Date, aaiPharma shall no longer sell any
Licensed Products. This Distribution and Trademark License is not
intended to expand aaiPharma’s manufacturing and supply
obligations, which are fully described in the Supply
Agreement.
2.3 License Term . This
agreement is effective as of the Effective Date and shall continue
in perpetuity, unless otherwise terminated pursuant to Sections
2.4(b)(2), 10, or 11 below (the “Term”).
2.4 Assignment Option
.
(a) Grant of Assignment
Option . If, at any time during the Term but after the date
[ * ] months following the Effective Date, (i)
aaiPharma terminates its obligation to supply Licensed Products to
Salix pursuant to the Supply Agreement, (ii) aaiPharma otherwise
ceases, absent proper notice, to supply Licensed Products to Salix
pursuant to the Supply Agreement, or (iii) either Salix or
aaiPharma, respectively, sells, transfers, or otherwise disposes of
all or substantially all of its assets to, or merges or
consolidates into, in a single transaction or series of related
transactions, an entity that is not controlled, directly or
indirectly,
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by the stockholders of Salix or
aaiPharma, respectively, immediately prior thereto (a “Salix
Acquisition” and “aaiPharma Acquisition,”
respectively), Salix has the option to cause aaiPharma to assign to
Salix all of aaiPharma’s right, title, and interest to (i)
Licensed-Know How, (ii) Licensed Products, (iii) Licensed
Trademarks, (iv) Product Approvals, and (v) any intellectual
property rights (including but not limited to patent rights),
licenses, or other agreements or rights held by aaiPharma and
necessary for the manufacture, supply, and sale of Licensed
Products in the Territory, free and clear of any liens, claims, or
encumbrances (the “Assignment Option”). The parties
acknowledge and agree that the Assignment Option shall not include
the assignment of any aaiPharma rights, title or interest outside
the Territory.
(b) Exercise of Assignment
Option
(1) aaiPharma shall (i) provide
written notice to Salix regarding the cessation of its supply
obligations to Salix pursuant to the Supply Agreement and (ii)
provide written notice to Salix as soon as reasonably possible, but
not later than [ * ] days, in advance of any
aaiPharma Acquisition (collectively, “aaiPharma
Notice”). Salix shall provide written to aaiPharma as soon as
reasonably possible, but no later than [ * ] days, in
advance of any Salix Acquisition (“Salix Notice”). The
Assignment Option may be exercised by Salix by written notice to
aaiPharma and payment of the Option Fee pursuant to Section 3.2 at
any time within one (1) year following (i) its receipt of the
aaiPharma Notice, (ii) aaiPharma’s failure, absent proper
notice, to supply Licensed Products to Salix pursuant to the Supply
Agreement, or (iii) its sending the Salix Notice. aaiPharma agrees
to reasonably cooperate with Salix in its evaluation of the
Assignment Option and respond to any questions Salix reasonably may
have regarding such evaluation, including but not limited to
details concerning the aaiPharma Acquisition as it relates to the
Licensed Products, Licensed Trademarks, and any intellectual
property rights (including but not limited to patent rights),
licenses, or other agreements or rights necessary for the use,
manufacture, supply, and sale of Licensed Products in the
Territory.
(2) In the event that Salix
exercises its Assignment Option, (i) aaiPharma shall immediately
assign all of aaiPharma’s right, title, and interest to the
(i) Licensed Know-How, (ii) Licensed Products, (iii) Licensed
Trademarks, (iv) Product Approvals, and (v) any intellectual
property rights (including but not limited to patent rights),
licenses, or other agreements or rights held by aaiPharma and
necessary for the use, manufacture, supply, and sale of Licensed
Products in the Territory to Salix and provide Salix with copies of
all books, records, and correspondence in its possession regarding
the foregoing and (ii) this Agreement shall immediately terminate,
subject to the further provisions of Section 12.3. Upon such
exercise, aaiPharma and Salix shall negotiate in good faith a
definitive asset purchase agreement providing for the assignment
and transfer of such intellectual property and other materials,
which agreement shall include representations and warranties and
other terms and provisions customary in similar
agreements.
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2.5 Right of First Discussion -
GI Products .
(a) Grant of Right .
aaiPharma grants to Salix the, first option to discuss (i) an
exclusive license to any GI Product, with exclusive rights of
sublicense, and (ii) an exclusive license to any Licensed Products
for jurisdictions outside the Territory, with exclusive rights of
sublicense, as described below (the “GI Product
Option”). aaiPharma shall notify Salix in writing of the
availability of any such GI Product, including reasonably
sufficient detail, as determined in aaiPharma’s sole
reasonable discretion, to enable Salix to evaluate its interest in
licensing such GI Product, and Salix shall have a period of
[ * ] days from the receipt of such disclosure (the
“Evaluation Period”) within which to exercise such
option in writing with respect to such GI Product.
(b) Exercise of Right . If
Salix exercises its option with respect to a particular GI Product,
the parties shall have an additional [ * ] day period
following Salix’s exercise of its GI Product Option within
which to negotiate in good faith during the Evaluation Period the
terms of the license (the “Negotiation Period”). If
Salix declines its option or fails to exercise its option with
respect to such GI Product within the Evaluation Period, or the
parties are unable to reach material agreement on the terms of a
license agreement during the Negotiation Period with respect to
such GI Product, aaiPharma shall be free to license its rights in
such GI Product to any third party.
(c) 50 mg Formulation
.
(1) aaiPharma grants to Salix the
exclusive, first option to acquire an exclusive license, with
exclusive rights of sublicense, to any 50 mg formulation of
azathioprine (“50 mg Product”) if aaiPharma seeks to
license such product to a third party, as described below (the
“50 mg Option”). aaiPharma shall notify Salix in
writing of the availability of any 50 mg Product, including
reasonably sufficient detail, as determined in aaiPharma’s
sole discretion, to enable Salix to evaluate its interest in
licensing such 50 mg Product, and Salix shall have a period of
[ * ] days from the receipt of such disclosure (the
“50 mg Evaluation Period”) within which to exercise
such option in writing with respect to such 50 mg Product.
aaiPharma shall not offer, discuss, negotiate, or enter into a
commercial license with any third party with respect to any 50 mg
Product without first complying with the terms of the option
described in this Section 2.5(c). The 50 mg Option shall be
exercisable during the term of this Agreement and, if Salix
exercises its Assignment Option pursuant to Section 2.4(b) above
and is assigned the rights, titles, and interests to be assigned
upon such exercise, for a period of [ * ] years
following such assignment.
(2) If Salix exercises its option
with respect to a 50 mg Product, the parties shall have an
additional [ * ] day period following Salix’s
exercise of its 50 mg Option within which to negotiate in good
faith the terms of the license (the “50 mg Negotiation
Period”), which terms shall be commercially reasonable and
fairly reflect the relative contributions of both parties. If Salix
declines its option or fails to exercise its option with
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respect to such 50 mg Product within
the 50 mg Evaluation Period, or the parties are unable to reach
material agreement on the terms of a license agreement during the
50 mg Negotiation Period with respect to such 50 mg Product,
aaiPharma shall be free to license its rights in such 50 mg Product
to any third party.
3. Royalties and Option Fee
3.1 Royalties . Beginning on
the first commercial sale of the Licensed Product in the Territory
by Salix or a Salix Affiliate, Salix will pay earned royalties on
all Net Sales of Licensed Product(s) purchased during the Term by
Salix or Salix Affiliates pursuant to subsections (a) and (b)
below.
(a) Prior to the marketing or sale
of a Competing Product in the Territory during the Term of the
Agreement, the royalty rate payable by Salix shall be [ *
] percent ( [ * ] %) of Net Sales.
(b) Following the marketing or sale
of a Competing Product in the Territory during the Term of the
Agreement, the royalty rate payable by Salix for sales within the
country in which such Competing Product is sold shall be [ *
] percent ( [ * ] %) of Net Sales in the
relevant country and shall remain at [ * ] percent (
[ * ] %) of Net Sales in all other countries within
the Territory in which no Competing Product is sold.
3.2 Option Fee . Upon
exercise of the Assignment Option pursuant to Section 2.5, Salix
shall pay aaiPharma an amount equal to the difference between (i)
[ * ] times total Net Sales for the [ *
] month period (represented by the last [ * ]
quarterly reports provided by Salix pursuant to Section 3.3) prior
to the month in which Salix provides written notice of its exercise
of the Assignment Option and (ii) [ * ] Dollars ($
[ * ] ), provided that, in any event, the amount
payable hereunder shall not exceed [ * ] Dollars ($
[ * ] ). The amount denoted above shall be the total
consideration paid to aaiPharma by Salix in connection with the
exercise of such Assignment Option and for the assignments and
transfers associated therewith; Salix shall not be required to pay
any additional amounts of any kind in connection with its exercise
of the Assignment Option, the assignment and transfer of all
rights, materials, and assets to be acquired upon such exercise, or
the undertaking of any related activities by aaiPharma as necessary
to effect the exercise of the Assignment Option and all such
assignments and transfers.
3.3 Reporting . Salix shall
make quarterly written reports to aaiPharma, within thirty (30)
days after the first day in each January, April, July, and October
during the Term, stating the number, description, and aggregate Net
Sales of Licensed Products sold or transferred during the preceding
three calendar months and calculating the royalty payable as
provided in Section 3.1. Until Salix or a Salix Affiliate has
achieved the first commercial sale of a Licensed Product, a report
shall be submitted by Salix at the end of each January and July
after the Effective Date of
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this Agreement describing Salix’s
marketing efforts made towards such first commercial sale in the
Territory for all Licensed Products.
3.4 Payment . Concurrently
with the delivery of the reports under Section 3.3, Salix shall pay
to aaiPharma royalties on the Net Sales of the Licensed Products
included therein or due for that period, in U.S. dollars at the
royalty rates specified in Section 3.1, with the rate of exchange
for any Net Sales of Licensed Product denominated in a currency
other than U.S. dollars being the exchange rate which is the
arithmetic mean of the opening telegraphic transfer selling and
buying rate published by the American edition of the Wall Street
Journal. U.S.-dollar equivalence shall be calculated on a quarterly
basis, using the average of the exchange rate on the first and last
business day of the quarter during the Term of this Agreement for
each of the currencies in which Net Sales of Licensed Product(s)
were made during the quarter. All payments due to aaiPharma under
this Agreement shall be made in full without deduction for taxes,
assessments or other charges of any kind or description; provided
that Salix may only deduct any existing or future withholding taxes
for taxes based on aaiPharma’s income which Salix is required
to pay or withhold in the Territory on behalf of aaiPharma from any
payment and royalty due hereunder as long as Salix provides
aaiPharma with such documents as may reasonably be necessary to
enable or assist aaiPharma to claim any available exemption
therefrom.
3.5 Records; Audits . Salix
shall keep, and shall ensure that the Salix Affiliates keep,
complete, true and accurate books of account and records showing
Net Sales and the derivation of all amounts payable to aaiPharma in
connection with this Agreement. Such books of record shall be
preserved for a period not less than two (2) years after their
creation. Salix agrees to make these books of record available for
audit by a nationally-recognized, independent accounting firm
designated by aaiPharma, upon reasonable prior written notice and
during normal business hours, but no more than once every twelve
(12) months, for purposes of confirming proper payment of royalties
under this Agreement. The records shall be treated as confidential,
except as may be required in connection with the royalty
obligations of this Agreement or aaiPharma’s royalty
obligations to its licensors (if any). Such audits shall be at the
expense of aaiPharma, unless an underpayment in excess of [
* ] percent ( [ * ] %) is discovered in the
course of any such audit, whereupon all reasonable, documented
costs relating thereto shall be paid by Salix. Salix will promptly
pay to aaiPharma the full amount of any underpayment determined by
an audit under this section as well as any audit costs due pursuant
to the immediately preceding sentence; aaiPharma will promptly pay
to Salix the full amount of any overpayment determined by an audit
under this section.
4. Adverse Event Reporting; Product
Approvals .
4.1 Upon execution of this Agreement
and from time to time, as reasonably requested by Salix, aaiPharma
shall, provide Salix with (i) copies of Product Approvals and (ii)
Licensed Know-How, including the availability of data and results
obtained from non-clinical and clinical
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studies of the Licensed Products performed by
aaiPharma, its consultants, contractors, agents, or other
representatives. Upon the reasonable request of Salix, aaiPharma
shall provide Salix with copies of such data and results that
aaiPharma is legally entitled to disclose. Additionally, aaiPharma
shall assist Salix in any reasonable manner with respect to Product
Approvals (including but not limited to those that Salix may pursue
with respect to additional indications or jurisdictions), as shall
be reasonably requested by Salix as necessary to enable Salix to
manufacture, sell, use, offer for sale, distribute, and market
Licensed Products to the extent permitted by this Agreement,
including but not limited to the assignment of any Product
Approvals and provision and/or obtaining of appropriate
correspondence, clearance or transfer letters, or any other form of
authorization, license, permit, or the like from regulatory
authorities with respect to Product Approvals, provided that Salix
shall keep aaiPharma fully informed of such efforts and shall
provide aaiPharma with copies of such correspondence. [ *
]
4.2. Salix shall have the right, so
long as such actions are not inconsistent with the terms of this
Agreement and the Supply Agreement, to make amendments to the
Product Approvals, make additional applications thereunder, conduct
such studies, or undertake any and all such actions as are
necessary in order to maintain and apply for any marketing or
product approvals, licenses, registrations or authorizations in the
Territory with respect to Licensed Products, including but not
limited to any such approvals with respect to (i) additional
indications for Licensed Products or (ii) additional jurisdictions
in the Territory, provided that Salix shall keep aaiPharma fully
informed of such efforts, and shall provide aaiPharma with copies
of such correspondence.
4.3 Each party shall report to the
other in writing the occurrence or reporting of any adverse event
occurring with respect to a Licensed Product to the other party
immediately following a party’s receiving notice or otherwise
becoming aware thereof for so long as aaiPharma owns any right,
title, and interest to any product approvals, licenses,
registrations or authorizations regarding Licensed Products. The
recorded owner of the Product Approval in the relevant portion of
the Territory shall be responsible for reporting to the appropriate
regulatory authorities all adverse events related to the use of
Licensed Products.
5. Generic Relabeling; Marketing Materials;
Existing Agreements .
5.1 Upon execution of this
Agreement, aaiPharma shall, [ * ] .
5.2 Upon execution of this
Agreement, aaiPharma shall cease to use the Licensed Trademarks,
and trade dress associated therewith. Notwithstanding the
foregoing, aaiPharma shall not be required to remove or relabel any
50 mg azathioprine product that has already been sent to a third
party for distribution as of the Effective Date.
5.3 aaiPharma agrees to supply Salix
with marketing and advertising materials, including but not limited
to sales training materials, non-confidential customer
information,
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promotional and marketing books and records,
pamphlets, and other promotional items, in its possession
pertaining to the Licensed Products, and to destroy any marketing
and advertising materials in its possession that use or incorporate
the Licensed Trademarks for products other than Licensed
Products.
5.4 aaiPharma shall, in addition to,
and without limitation of, any legal or equitable remedies
available to Salix as a result of any breach by aaiPharma of this
Agreement, be fully responsible and liable for any and all returns,
rebates, chargebacks, discounts, other claims made by any third
party, or any other financial liability or other liability of any
kind related to Licensed Products manufactured and distributed by
aaiPharma. Similarly, Salix shall, in addition to, and without
limitation of, any legal or equitable remedies available to
aaiPharma as a result of any breach by Salix of this Agreement, be
fully responsible and liable for any and all returns, rebates,
chargebacks, discounts, other claims made by any third party, or
any other financial liability or other liability of any kind
related to Licensed Products distributed by Salix, excluding only
any liability (i) arising as a result of breach of this Agreement
by aaiPharma or the negligence or willful misconduct of aaiPharma
or (ii) otherwise indemnified by aaiPharma under this Agreement or
the Supply Agreement.
5.5 As requested by Salix, aaiPharma
shall use commercially reasonable efforts to (i) promptly assign,
terminate, or remove the Licensed Products from, any existing
agreements between aaiPharma and third parties that relate to the
sale, marketing, o