[*] indicates that a confidential portion of this Agreement has been omitted and
filed separately with the Securities and Exchange Commission.
LICENSE AGREEMENT
This License Agreement (this "Agreement") is made and effective as of this
25th day of June 1999 (hereinafter referred to as the "Effective Date"), by and
among XOMA Ireland Limited, a company with limited liability organized and
existing under the laws of Ireland, having a place of business at 0 Xxxxxxxxx
Xxxxxx, Xxxxx Xxxxxx, Xxxxxx 0, Xxxxxxx ("XOMA"), and Allergan Sales, Inc., a
California corporation, having a place of business at 0000 Xxxxxx Xxxxx, Xxxxxx,
Xxxxxxxxxx 00000, Xxxxxx Xxxxxx ("ALLERGAN").
WITNESSETH THAT:
WHEREAS, XOMA owns "XOMA Know-How" (as hereinafter defined) and "Patent
Rights" (as hereinafter defined) relating to Compound (as hereinafter defined)
and/or ophthalmic pharmaceutical compositions containing Compound; and
WHEREAS, ALLERGAN desires to develop one or more anti-infective, ophthalmic
pharmaceutical compositions containing Compound; and
WHEREAS, ALLERGAN is engaged in the business of, and has the facilities
for, developing, registering, manufacturing and marketing ophthalmic
pharmaceutical products in the "Territory" (as hereinafter defined); and
WHEREAS, ALLERGAN desires to obtain from XOMA and XOMA is willing to grant
to ALLERGAN an exclusive license for the Field (as hereinafter defined) in the
Territory relating to the XOMA Know-How and Patent Rights in respect of the
Products (as hereinafter defined),
NOW, THEREFORE, in consideration of the foregoing and the mutual covenants
and considerations set forth herein, the parties hereto mutually agree as
follows:
ARTICLE I - DEFINITIONS:
The following terms shall have the meanings set forth in this Article I:
1.1 "Affiliate" of a particular party shall mean all corporations or
business entities which, directly or indirectly, are controlled by, control, or
are under common control with such party. For this purpose, the meaning of the
word "control" shall mean the ownership of fifty percent (50%) or more of the
voting shares or interest of such corporation or business entity, or any
corporation or business entity in which the party seeking to demonstrate
Affiliate status can demonstrate, even though the extent of ownership of such
shares or interest in such corporation or business entity is less than (50%),
that the operation and management of such corporation or business entity is
carried out in conformity with the particular party's standing policy; such
corporation or business entity to be deemed an Affiliate only so long as such
ownership of voting shares or interest or adherence to such standing policy
continues.
1.2 "ALLERGAN Information" shall mean all information developed or acquired
by or on behalf of or under the control of ALLERGAN or an ALLERGAN Affiliate
subsequent to the Effective Date, including pharmaceutical chemistry, analytical
chemistry and biochemistry reports, clinical trials reports, drug adverse
effects, pre-clinical reports, including toxicology, and summaries of regulatory
activities of ALLERGAN, relating to the Compound and/or Products which ALLERGAN
has access to and is free to disclose without restriction or compensation to any
Third Party.
1.3 "Antibacterial Agent" shall mean any chemical substance produced by a
microorganism or a synthetic substance (but excluding Compound and [*]) that has
the capacity to inhibit the growth of or to kill bacteria.
1.4 "Compound" shall mean any recombinant human bactericidal/permeability
increasing protein (BPI) that is: [*].
1.5 "Field" shall mean the mitigation, treatment or prevention of
ophthalmic bacterial infection in humans and other mammals.
1.6 [*]
1.7 "Major Market Country" shall mean one of the following countries:
France, Germany, Italy, Japan, Spain, United Kingdom or the United States.
1.8 "NYU License" shall mean that certain Amended and Restated License
Agreement between New York University ("NYU") and XOMA Corporation dated
September 1, 1993, which has been assigned to XOMA.
1.9 "Net Sales" shall mean the amount invoiced by ALLERGAN, its Affiliates
or sublicensees to Third Parties for the sale of Products less (i) cash
discounts and/or quantity discounts allowed; credits and allowances for returns,
rejections and recalls; (ii) charges for freight, insurance and transportation
specifically included in the amount invoiced; (iii) trade discounts, credits or
allowances; (iv) sales and use taxes, duties or other government tariffs and
similar taxes incurred and government mandated rebates; and (v) accruals for
estimated contract rebates, bid rebates, Medicaid rebates and any other similar
rebates as ALLERGAN may be required to pay from time to time, all of which shall
be determined in accordance with GAAP and ALLERGAN's standard accounting
methods. From time to time, but not less often than annually, ALLERGAN will
determine the actual amount of rebates paid under clause (v) above and any
differences between the estimates accrued under (v) above and the actual amounts
paid will be treated as adjustments to Net Sales subject to royalty in the
period in which such differences are determined by ALLERGAN.
1.10 "Patent Rights" shall mean the patents and patent applications
included in Exhibit B attached hereto and made a part hereof, and all patents
and patent applications, foreign or domestic, filed by or issued, licensed or
assigned to XOMA during the term of this Agreement in the Territory, together
with any and all patents that may issue or may have issued therefrom, including
any and all divisions, continuations, continuations-in-part, extensions,
provisionals, additions or reissues of or to any of the aforesaid patents and
patent applications, but only insofar as any of the foregoing relate to Compound
or the Products, or the manufacture, use or sale of them, in the Field.
-2-
1.11 "`Products" shall mean pharmaceutical compositions containing a
combination of Compound and an Antibacterial Agent for administration in the
Field.
1.12 "Territory" shall mean the world.
1.13 "Third Party"' shall mean any party other than XOMA, XOMA's
Affiliates, ALLERGAN, or ALLERGAN's Affiliates.
1.14 "Third Party Licenses"' shall mean any and all licenses possessed by
XOMA and its Affiliates pertaining to the Patent Rights and the XOMA Know-How
that relate to the manufacture, use or sale of Products in the Field.
1.15 "Valid Claim" shall mean a claim of an unexpired patent included
within the Patent Rights, which has not been held unenforceable, unpatentable or
invalid by a decision of a court or other governmental agency of competent
jurisdiction and which has not been admitted to be invalid or unenforceable
through reexamination, reissue or disclaimer or otherwise.
1.16 "XOMA Know-How" shall mean all scientific and medical information and
technical data invented, developed or acquired by or on behalf of or under the
control of XOMA as of the Effective Date or during the term of this Agreement
relating to the manufacture, use or sale of Compound and relevant for the
development, manufacturing, registration, marketing and/or sale of Products in
the Field, including, but not limited to, pre-clinical, pharmacological,
toxicological, analytical, stability and clinical data, Compound specifications,
the open part of Drug Master Files and health registration dossiers in the
Territory, and shall further include all Third Party data which XOMA has access
to and is free to disclose without restriction or additional compensation to
such Third Party.
ARTICLE II - REPRESENTATIONS AND WARRANTIES:
2.1 Intellectual Property. XOMA represents and warrants that it is the sole
and exclusive owner or exclusive licensee of all right, title and interest in
and to the XOMA Know-How and the Patent Rights, and that it has the right to
license the same to ALLERGAN in the Field under this Agreement without conflict
with the rights of any Third Party. XOMA further represents and warrants that to
the best of its knowledge, as of the Effective Date, the XOMA Know-How and the
Patent Rights are free of any encumbrances, liens, licenses, judgments and/or
security interests that would affect Compound or its use in the Field, and that
all patents and patent applications included in the Patent Rights are valid and
in full force and effect as of the date hereof and that none of the Patent
Rights are the current subject of any interference or opposition proceeding.
[*].
2.2 Adverse Information. As of the Effective Date, XOMA represents and
warrants that it knows of no adverse effects or other properties that may raise
objections from the Food & Drug Administration (FDA) or other health
registration authorities or may affect the use, effectiveness or merchantability
as to Compound.
2.3 Third Party Licenses. XOMA represents and warrants that the only Third
Party License for Patent Rights or XOMA Know-How as of the Effective Date is the
NYU License, and that an accurate copy of such Third Party License has been
provided to ALLERGAN. As of the Effective Date, such Third Party License is in
full force and effect and neither XOMA, or to
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XOMA's knowledge, NYU is in breach thereof. Such Third Party License is
exclusive to XOMA as is necessary to provide ALLERGAN the exclusive licenses
provided herein and, pursuant to the terms thereof, NYU does not have the right
to grant licenses in the Field of patents or technology contained in the Patent
Rights and the XOMA Know-How.
2.4 XOMA Authority. XOMA represents and warrants that it has full power and
authority to execute and deliver this Agreement and to consummate the
transactions contemplated herein. This Agreement and the provisions hereof
constitute valid and legally binding obligations upon XOMA, and do not require
the consent, approval or authorization of any person, public or governmental
authority or other entity except as specified herein.
2.5 XOMA Litigation. XOMA represents and warrants that as of the Effective
Date there is no pending, or to its knowledge threatened, litigation that would
or might adversely affect its right and ability to perform its obligations under
this Agreement.
2.6 ALLERGAN Authority. ALLERGAN represents and warrants that it has full
power and authority to execute and deliver this Agreement and to consummate the
transactions contemplated herein. This Agreement and the provisions hereof
constitute valid and legally binding obligations upon ALLERGAN, and do not
require the consent, approval or authorization of any person, public or
governmental authority or other entity except as specified herein.
2.7 ALLERGAN Litigation. ALLERGAN represents and warrants that as of the
Effective Date there is no pending, or to its knowledge threatened, litigation
that would or might adversely affect its right and ability to perform its
obligations under this Agreement.
ARTICLE III - LICENSE GRANT:
XOMA hereby grants to ALLERGAN and its Affiliates an exclusive license
(with the right to grant sublicenses) to manufacture, have made, use and sell
Products in the Territory, using the XOMA Know-How and under the Patent Rights.
The foregoing license rights are subject and subordinate to the terms and
conditions of the NYU License, including without limitation, Sections 15, 16 and
17 thereof. Notwithstanding the first sentence of this paragraph, XOMA retains
all rights to the Compound, XOMA Know-How, and Patent Rights for (i)
manufacture, use or sale of products outside the Field, (ii) manufacture, use or
sale of products other than Products inside the Field and (iii) license or
assignment to an Affiliate of XOMA in connection with any other agreement with
ALLERGAN for Compound.
ARTICLE IV - ROYALTIES:
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ALLERGAN shall pay to XOMA royalties equal to [*] of the Net Sales of the
Products sold by ALLERGAN, its Affiliates and sublicensees, the manufacture, use
or sale of which, absent this Agreement, would constitute an infringement of a
Valid Claim of the Patent Rights. Such royalty rate shall be subject to
adjustment pursuant to Sections 11.2, 11.3 and 11.5. ALLERGAN shall pay to XOMA
royalties at a percentage rate [*] of those set forth in the foregoing sentence
for Net Sales in any country in which the manufacture, use or sale of the
Product giving rise to such Net Sales would not constitute infringement of a
Valid Claim.
ARTICLE V - PAYMENT OF ROYALTIES:
5.1 Sales. A Product shall be determined to have been sold when invoiced;
provided, however, that transfers of Products between ALLERGAN and its
Affiliates or sublicensees, shall not be deemed to have been sold until it shall
have been sold to a purchaser independent of ALLERGAN and its Affiliates or
sublicensees in a bona fide, arm's length transaction between unrelated parties.
Royalties shall accrue hereunder only once in respect of the same unit of
Product.
5.2 Payment. Royalties accruing hereunder shall be reported by Product and
by country of sale, and shall be due and payable on the sixtieth (60th) day
following the close of each calendar quarter, payable in U.S. dollars. When the
currency of sale is not in U.S. dollars, the U.S. dollar equivalent will be
calculated using the same exchange rate(s) that ALLERGAN uses for its own U.S.
dollar financial statement reporting purposes prepared in accordance with GAAP.
ALLERGAN will report to XOMA the exchange rates used for conversion.
5.3 Withholding of Taxes. Any withholding of taxes levied by tax
authorities on the payments to XOMA hereunder shall be borne by XOMA and
deducted by ALLERGAN from the sums otherwise payable by it hereunder for payment
to the proper tax authorities on behalf of XOMA. ALLERGAN agrees to cooperate
with XOMA to make reasonable efforts to minimize any such taxes recognizing the
respective interests of the parties. In the event XOMA claims exemption from
such withholding under any double taxation or other similar treaty or agreement
from time to time in force, and provides ALLERGAN with appropriate documentation
of such exemption, ALLERGAN shall not withhold any such taxes. In the event of
any withholding under this Section 5.3, ALLERGAN shall provide receipts of
payment of such withheld tax or other documents reasonably available to
ALLERGAN.
5.4 Full Payment. Upon the later of the expiration of all Patent Rights in
a country or [*] years after the first sale of a Product in a country in which
no Patent Rights then exist, and upon payment of all applicable royalties, fees
and milestones due pursuant to this Agreement, and assuming that this Agreement
is not otherwise earlier terminated by either party hereto, ALLERGAN's license
hereunder shall be paid-up, perpetual and irrevocable for such country. For
purposes of this Section 5.4, all of the countries of the European Patent
Convention as listed on Exhibit C shall be considered as a single country and
such expiration shall be determined by the expiration of the last Patent Right
in such countries.
ARTICLE VI - ROYALTY REPORTS:
6.1 Records. ALLERGAN shall maintain and keep for a period of at least
three (3) years complete and accurate records in sufficient detail to enable any
royalties which shall have accrued hereunder to be determined.
6.2 Audits. Upon the request of XOMA, but not exceeding once in any one (1)
year period, ALLERGAN shall permit an independent certified accountant, selected
by XOMA and acceptable to ALLERGAN which acceptance shall not be unreasonably
withheld, to have access to such records of ALLERGAN as may be necessary to
verify the accuracy of the royalty reports and payments submitted to XOMA
hereunder. Said independent certified accountant shall verify to XOMA the amount
of royalty due hereunder and sales by country and Product, and disclose no other
information revealed in its audit. Any such audit of records shall be at XOMA's
expense; provided that in the event such examination discloses a variance of
more than five percent (5%) between the
-5-
amount of royalties due and the amount of royalties paid to XOMA, ALLERGAN shall
pay the expense of such audit. Any deficiency shall be paid promptly to XOMA,
plus interest at the commercial prime lending rate of the Bank of America from
the date such payment was originally due until the date paid.
ARTICLE VII - FEES AND MILESTONES:
7.1 Initial License Fee. In consideration for the license granted to
ALLERGAN hereunder, ALLERGAN shall pay to XOMA as an initial license fee [*]
Dollars ($[*]) promptly upon the execution of this Agreement.
7.2 Milestones. As additional consideration for the license granted to
ALLERGAN hereunder, ALLERGAN shall pay to XOMA the following amounts upon
achievement (prior to the expiration or termination of this Agreement) of each
of the applicable milestones:
[*]
7.3 Single Payment. Each of the foregoing milestone payments shall be
payable one time only, even if such milestones are subsequently again met for
another Product or variation of a Product.
7.4 Payment of Milestones. ALLERGAN shall promptly and, in any case, within
ten (10) days, notify XOMA in writing of the occurrence of the milestones set
forth above. Within fifteen (15) business days after the date of such notice,
ALLERGAN shall pay to XOMA by check, wire transfer or other means acceptable to
XOMA, the milestone payments set forth above.
ARTICLE VIII - DEVELOPMENT:
ALLERGAN shall be responsible for the development of Products at its sole
cost. ALLERGAN shall exclusively own all rights to, and bear the cost and
expense of, any submissions required to obtain pre-marketing government
approvals or any other approvals necessary to commercialize the Products in each
country of the Territory. ALLERGAN shall use reasonable efforts to develop,
register, manufacture, market, and sell the Products. Attached as Exhibit D is
ALLERGAN's preliminary research and development plan. Such plan may be changed
in such manner as ALLERGAN reasonably finds necessary in light of scientific,
technical, regulatory and commercial factors. The parties agree to meet
approximately every six to nine months, and in no event less than one time per
calendar year, to review the progress of development with attendance, in person
or by video or telephone conference, of appropriate personnel.
ARTICLE IX - TERMINATION:
9.1 Term. This Agreement, unless sooner terminated as elsewhere provided in
this Agreement, shall continue in full force and effect for the time commencing
with the Effective Date and continuing (a) with regard to the patent licenses
granted herein, until expiration of the last to expire patent (including any
modification, extension or reissue thereof) within the applicable Patent Rights,
and (b) with regard to the license granted to use the XOMA Know-How herein, for
the term of the royalty-bearing years specified in Section 5.4, subject to the
perpetual, irrevocable license set forth in such Section.
-6-
9.2 Termination of NYU License. This Agreement, to the extent it includes a
sublicense of rights under the NYU License, shall terminate upon the termination
of XOMA's rights under the NYU License; provided, that upon such termination,
ALLERGAN shall have the right to enter into a licensing agreement with NYU upon
the same terms and conditions as in the NYU License.
9.3 Breach. Upon the failure of either party hereto to comply with any of
their respective obligations and conditions contained herein, the other party
shall be entitled, without prejudice to any other rights conferred on it herein,
to terminate this Agreement upon not less than ninety (90) days notice of such
default, provided that the party in default has failed to cure such default
within such ninety (90) day period.
9.4 ALLERGAN Right to Terminate. ALLERGAN shall have the right to terminate
this Agreement in its entirety or with regards to any licenses granted herein as
to any Product in any country or countries of the Territory at any time upon
three (3) months prior written notice to XOMA. For purposes of this Section 9.4,
all of the countries of the European Patent Convention, as listed on Exhibit C,
shall be considered as a single country and such termination shall apply to all
such countries. In the event ALLERGAN terminates this Agreement pursuant to this
Section 9.4, XOMA shall be entitled to use the ALLERGAN Information for purposes
outside the Field in the country or countries in which the termination is
effective for no additional consideration. In addition, in such event, XOMA may
elect to enter into a license agreement with ALLERGAN to utilize the ALLERGAN
Information in the Field in the country or countries in which the termination is
effective in exchange for a royalty of [*] of net sales of products in the
Field. Such license shall contain terms consistent with the terms of the license
grant to ALLERGAN and the royalty payment and report provisions herein.
9.5 XOMA Right to Terminate. XOMA shall have the right to terminate this
Agreement if [*].
9.6 [*]
9.7 Sale of Inventory. In the event of any early termination of any
licenses granted herein in any country or countries of the Territory, ALLERGAN
shall promptly make an accounting to XOMA of the inventory of all Products which
it and its Affiliates and sublicensees and their respective agents and
distributors have on hand in such country or countries, if any, as of the date
of such termination and said parties shall thereafter have the right for a
period of six (6) months after said termination to sell such inventory of
Products provided that the Net Sales thereof shall be subject to the royalty
provisions of Article IV and so payable to XOMA.
9.8 Effect of Termination. Termination of this Agreement, either in whole
or in part, for any reason, shall be without prejudice to:
(1) XOMA's right to receive all royalties fees and/or milestones accrued to
it and unpaid on the effective date of such termination or thereafter in
accordance with Articles IV, V, VII, and Sections 9.5 and 9.6 of this Article
IX;
(2) the rights and obligations of the parties provided in Articles VI, X
and XV of this Agreement; and
-7-
(3) any other rights or remedies then or thereafter available to either
party under this Agreement or otherwise.
9.9 Waiver of Defaults. The rights granted either party to terminate this
Agreement, either in whole or in part, prior to the expiration of its term,
shall not be affected in any way by that party's waiver of or failure to take
action with respect to any previous default hereunder.
ARTICLE X - INFORMATION TRANSFER; COOPERATION:
10.1 Information Transfer. Promptly following execution of this Agreement,
XOMA shall provide to ALLERGAN copies of and/or access to all then existing XOMA
Know-How and, throughout the term of this Agreement, shall continue to furnish
ALLERGAN with copies of any subsequently developed XOMA Know-How which may be
useful for the development, registration, manufacturing, marketing, or sale of
Products in the Field. XOMA shall also grant ALLERGAN the right to reference any
regulatory files, including Drug Master Files that are a part of XOMA Know-How
in any country in the Territory to enable ALLERGAN to obtain pre-marketing
approval to commercialize the Products in such country.
10.2 ALLERGAN Information. ALLERGAN on an annual basis throughout the term
of this Agreement, shall provide to XOMA copies of all ALLERGAN Information.
Without limiting XOMA's rights under Section 9.4, XOMA shall have the right to
use only that ALLERGAN Information related to the safety of the Product and only
to the extent that such use is limited to and required for safety reporting to
regulatory authorities, and for no other purpose.
10.3 Confidentiality. All XOMA Know-How or ALLERGAN Information provided by
either party (hereinafter "Disclosing Party") to the other party (hereinafter
the "Receiving Party"), hereunder, shall be used by the Receiving Party only in
accordance with this Agreement and shall be kept confidential, whether so
designated or not, by the Disclosing Party for the term of this Agreement and
for a period of ten (10) years thereafter, except that the obligations of the
Receiving Party set forth in this Section 10.3 shall not extend to any
information, data and material which:
(1) Can be shown, by written records, to have been already known by the
Receiving Party at the time of its receipt by the Receiving Party from the
Disclosing Party; or
(2) Is public knowledge at the time of its receipt by the Receiving Party
from the Disclosing Party or subsequent thereto becomes public knowledge through
no fault of the Receiving Party; or
(3) Is received by the Receiving Party from a Third Party having a legal
right to disclose such information and data to others; or
(4) Is independently developed by the Receiving Party without access to the
Disclosing Party Know-How.
Further, the obligations contained herein shall not restrict, limit or
prevent the Receiving Party from disclosing information as required by law or as
can be shown to be necessary to gain government registration or approval to
market the Product in the Territory, provided that the
-8-
Receiving Party uses its commercially reasonable efforts to limit such
disclosure to the extent that the Receiving Party may legally do so.
10.4 Patent Information. XOMA shall provide to ALLERGAN a copy of each
patent and patent application within the Patent Rights.
ARTICLE XI- INFRINGEMENT:
11.1 Infringement Claims of Third Parties. XOMA and ALLERGAN shall each
give to the other prompt written notice of any claim or action made against
either of them alleging that the manufacture, use or sale of any Product in any
country(ies) of the Territory infringe the rights of a Third Party. XOMA and
ALLERGAN agree to cooperate and collaborate with each other in undertaking a
full investigation of the situation and in taking such action as they shall
agree is appropriate in the circumstances.
11.2 Expenses of Defense. In the event that any legal action is commenced
against ALLERGAN for, or based upon an alleged patent infringement relating to
the manufacture, use or sale of Compound, any costs, including outside legal
fees, and court awarded damages actually paid by ALLERGAN in connection with
such action shall be creditable against royalties due XOMA hereunder in such
country or countries; provided, however, that XOMA's liability to ALLERGAN under
this Section 11.2 shall not exceed [*] of the total amount of royalties due XOMA
hereunder in such country or countries, during the period subsequent to the
commencement of such action.
11.3 [*]
11.4 Credits. Any amounts that ALLERGAN is entitled to credit against
royalties under this Article XI shall be carried forward until all such amounts
are credited.
11.5 Infringement by Third Parties. XOMA and ALLERGAN shall promptly notify
the other in writing of any alleged or threatened infringement of any patent
included in the Patent Rights of which they become aware that would affect the
Compound or its use in the Field. Both parties shall use their best efforts in
cooperating with each other to terminate such infringement without litigation.
XOMA shall have the first right to bring and control any action or proceeding
with respect to infringement at its own expense and by counsel of its own
choice, and ALLERGAN shall have the right, at its own expense, to be represented
in such action by counsel of its own choice. If XOMA fails to bring an action or
proceeding within: (i) one hundred and twenty (120) days following the notice of
alleged infringement or (ii) ten (10) days before the time limit, if any, set
forth in the appropriate laws and regulations for the filing of such actions,
whichever comes first, and if [*], ALLERGAN shall have the right to bring and
control any such action at its own expense and by counsel of its own choice, and
XOMA shall have the right, at its own expense, to be represented in any such
action by counsel of its own choice. In the event a party brings an infringement
action, the other party shall cooperate fully, including if required to bring
such action, the furnishing of a power of attorney. Neither party shall have the
right to settle any patent infringement litigation under this Section 11.5 in a
manner that diminishes the rights or interests of the other party without the
consent of such other party. Except as otherwise agreed to by the parties as
part of a cost sharing arrangement, any recovery realized as a result of such
litigation, after reimbursement of any litigation expenses of ALLERGAN and XOMA,
shall belong to the party who
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brought the action. In the event that any such legal action is commenced by
ALLERGAN, any costs, including outside legal fees, actually paid by ALLERGAN in
connection with such action shall be creditable against royalties due XOMA
hereunder in such country or countries or reimbursed by XOMA; provided, however,
that XOMA's liability to ALLERGAN under this Section 11.5 shall not exceed [*]
of the total amount of royalties due XOMA hereunder, during the period
subsequent to the commencement of such action.
11.6 Oppositions and Appeals. ALLERGAN hereby agrees not to enter into any
non-U.S. opposition to or any non-U.S. appeal from any decision on the Patent
Rights and shall not assist or otherwise cooperate with any other party in any
such opposition or appeal.
ARTICLE XII - MAINTENANCE OF PATENT RIGHTS:
XOMA covenants that it will take all necessary steps to prevent the
abandonment of any patent or patent application included in the Patent Rights
and that during the term of the Agreement it will cooperate fully with ALLERGAN
to prevent the abandonment of any patent or patent application included in the
Patent Rights. XOMA covenants that it shall maintain all Third Party Licenses in
full force and effect during the term of this Agreement as is necessary to
provide Allergan the rights initially granted and to be granted hereunder. XOMA
shall be solely responsible for and bear the cost of the prosecution and
maintenance of the Patent Rights. In the event XOMA determines not to file,
prosecute or maintain any patent included in the Patent Rights or covering any
XOMA Know-How, in any country or countries, XOMA shall notify ALLERGAN of such
determination at least ninety (90) days prior to any applicable deadline. In
such event, ALLERGAN may elect to file, prosecute or maintain any such patent in
such jurisdiction at its own expense, and XOMA shall provide reasonable
assistance. ALLERGAN shall have an exclusive, perpetual, fully-paid up license
for all uses in the Field for any such patents and patent applications,
prosecuted or maintained at ALLERGAN's expense
ARTICLE XIII - TRANSFER OF RIGHTS AND OBLIGATIONS:
This Agreement, in whole or in part, shall not be assignable by either
party hereto to any Third Party without the prior written consent of the other
party hereto, except that either party may assign this Agreement to an Affiliate
or the successor or assignee of that portion of its business to which this
Agreement relates. In any event, ALLERGAN may assign this Agreement to Allergan
Specialty Therapeutics, Inc., a special purpose corporation of which ALLERGAN
owns 100% of the outstanding Class B Common Stock. It is expressly understood
and agreed by the parties hereto that the assignor of any rights hereunder shall
remain bound by its duties and liable for its obligations hereunder. Any
assignment or attempt at same, except as provided for herein, shall be void and
of no effect.
ARTICLE XIV - INDEMNIFICATION:
14.1 Indemnification by ALLERGAN. ALLERGAN agrees to defend, indemnify and
hold harmless XOMA, its agents and employees, against claims for loss,
liability, damage and costs for personal injury or recall attributable to the
development, manufacture, marketing use or sale of any Product by ALLERGAN or
its sublicensees or Affiliates.
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14.2 Indemnification by XOMA. XOMA agrees to defend, indemnify and hold
harmless ALLERGAN, its agents and employees, against claims for loss, liability,
damage and costs for personal injury or recall (i) attributable to the
manufacture of the Compound by XOMA or its sublicensees or Affiliates, and/or
(ii) resulting from the failure of such Compound to conform to the warranties
set forth herein.
14.3 Procedure. As to any claim or lawsuit with respect to which either
party seeks indemnification hereunder, that party shall provide prompt notice
thereof to the other party and the other party shall have the right to control
the defense of said lawsuit, including the selection of attorneys, and any
settlement thereof, provided that no settlement which impairs the rights of an
indemnified party shall be made without its prior written consent, which consent
shall not be unreasonably withheld.
ARTICLE XV- GENERAL
15.1 Public Disclosure. Except for such disclosure as is deemed necessary,
in the reasonable judgement of a party, to comply with applicable laws or
regulations, no public announcement, news release, public statement or
publication relating to the existence of this Agreement, or the terms hereof,
will be made without the other party's written approval, which approval shall
not be unreasonably withheld. The parties agree that they will use reasonable
efforts to coordinate the initial announcement of press release relating to the
existence of this Agreement in the form attached as Exhibit F, so that such
initial announcement or press release by each is made contemporaneously.
15.2 Notices. Any notice or report required or permitted to be given or
made under this Agreement by either party to the other shall be in writing, sent
by hand or by registered or express mail or courier, postage prepaid, addressed
to such other party "Attention: General Counsel" in the case of ALLERGAN and to
the Secretary in the case of XOMA, at its address indicated at the beginning of
this Agreement, or to such other address as the addressee shall have last
furnished in writing to the addressor, and shall be effective upon receipt by
the addressee.
15.3 Governing Law. This Agreement shall be governed by the laws of the
State of California, without reference to its conflicts of laws rules, and in
connection with any dispute hereunder, the parties consent to exclusive
jurisdiction and venue in the state and federal courts in the State of
California.
15.4 Severability. Whenever possible, each provision of this Agreement
shall be interpreted in such manner as to be effective and valid under
applicable law, but if any provision of this Agreement should be prohibited or
invalid under applicable law, such provision shall be ineffective to the extent
of such invalidity without invalidating the remainder of such provision or the
remaining provisions of this Agreement.
15.5 Headings. The subject headings of the Articles and Sections of this
Agreement are included for the purposes of convenience only, and shall not
affect the construction or interpretation of any of its provisions.
-11-
15.6 Entire Agreement; Amendment. This Agreement contains the entire
understanding of the parties with respect to the matters contained herein and
supersedes any previous agreements and may be altered or amended only by a
written instrument duly executed by both parties hereto.
15.7 Force Majeure. No party shall be liable for any delay or failure of
performance to the extent such delay or failure is caused by circumstances
beyond its reasonable control and that by the exercise of due diligence it is
unable to prevent, provide that the party claiming excuse uses its best efforts
to overcome the same.
15.8 Non-Waiver. The failure of a party in any one or more instances to
insist upon strict performance of any of the terms and conditions of this
Agreement shall not constitute a waiver or relinquishment, to any extent, of the
right to assert or rely upon any such terms or conditions on any future
occasion.
15.9 Disclaimer of Agency. Neither party is, or will be deemed to be, the
legal representative or agent of the other, nor shall either party have the
right or authority to assume, create, or incur any third party liability or
obligation of any kind, express or implied, against or in the name of or on
behalf of another except as expressly set forth in this Agreement.
15.10 Limitation of Liability. NO PARTY SHALL BE LIABLE TO ANOTHER FOR
INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY DAMAGES, INCLUDING BUT
NOT LIMITED TO LOST PROFITS, ARISING FROM OR RELATING TO ANY BREACH OF THIS
AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. Nothing
in this Section is intended to limit or restrict the indemnification rights or
obligations of any party.
15.11 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be an original and all of which shall
constitute together the same document.
-12-
WITNESS WHEREOF, the parties here executed this Agreement this 25th day of
June, 1999.
XOMA Ireland Limited ALLERGAN SALES, INC.
/s/ By: /s/
--------------------------------------------- ---------------------
Xxxx Xxxx, Director, Name:
duly authorized and on behalf of XOMA Ireland Title:
Limited in the presence of:
Witness:
/s/
--------------------------------------
-13-
Exhibit A - [*]
Exhibit B - Patent Rights
Exhibit C - Countries of the European Patent Convention
Exhibit D - ALLERGAN's Preliminary Research and Development Plan
Exhibit E - [*]
Exhibit F - Form of Press Release
-14-
EXHIBIT A
[*]
-15-
Exhibit B
Patent Rights
1) Title: Stable Bactericidal/Permeability-Increasing Protein Products and
Pharmaceutical Compositions Containing the Same
Inventors: Theofan, Horwitz, Burke, Baltaian, Grinna
--------------------------------------------------------------------------------
[*] PCT/US94/01235 [WO 94/18323] [*].
Country Serial No. Status/Patent No.
United States 08/013,801 Issued 5,420,019
United States 08/361,191 [*]
United States 08/430,417 Issued 5,674,834
United States 08/466,822 Issued 5,827,816
[*]
Australia 61702/94 Issued 000000
Xxxxxx 2,155,004 [*]
China 94191672.3 [*]
Europe 94908704.3 [*]
Hong Kong 98115811.8 [*]
Finland 933,658 [*]
Japan 6-518210 [*]
South Korea 703197/95 [*]
Xxxxxx 000000 [*]
Norway 953033 [*]
New Zealand 262284 Granted 262284
South Africa 94/0703 Granted 94/0703
2) Title: Pharmaceutical Compositions Containing Bactericidal Permeability
Increasing Protein and a Surfactant
Inventors: McGregor, Stubstad, Xxxxx
--------------------------------------------------------------------------------
[*] PCT/US94/01239 [WO 94/17819] [*].
Country Serial No. Status/Patent No.
United States 08/012,360 [*]
United States 08/190,869 Issued 5,488,034
United States 08/472,995 Issued 5,696,090
[*]
Australia 61330/94 Granted 000000
Xxxxxx 2,155,005 Granted 2,155,005
China 94191355.4 [*]
Europe 94907963.6 [*]
Hong Kong 98115456.8 [*]
Japan 6-518213 [*]
Mexico 942023 [*]
South Africa 94/1531 Granted 94/1531
3) Title: Improved Therapeutic Compositions Comprising Bactericidal/
Permeability-Increasing (BPI) Protein Products
Inventors: Xxxxxxx
--------------------------------------------------------------------------------
[*] PCT/US96/01095 [WO 96/21436] [*].
Country Serial No. Status/Patent No.
United States 08/372,104 [*]
[*]
Australia 47705/96 [*]
Canada 2,210,390 [*]
Europe 96903710.0 [*]
Hong Kong 99100251.6 [*]
Japan 8-521883 [*]
4) Title: Improved Methods for the Preparation of Endotoxin-Binding Proteins
Inventors: Grinna
--------------------------------------------------------------------------------
[*] PCT/US93/04752 [WO 93/23540] [*].
Country Serial No. Status/Patent No.
United States 07/885,501 [*]
United States 08/072,063 Issued 5,439,807
Australia 43820/93 Granted 000000
Xxxxxx 2,136,208 [*]
China 93109452.6 [*]
Europe 93913992.9 Granted 0642579
Austria 93913992.9 Granted EP/0642579
Belgium 93913992.9 Granted EP/0642579
Denmark 93913992.9 Granted EP/0642579
France 93913992.9 Granted EP/0642579
Germany 93913992.9 Granted EP/0642579
Great Britain 93913992.9 Granted EP/0642579
Greece 93913992.9 Granted EP/0642579
Ireland 93913992.9 Granted EP/0642579
Italy 93913992.9 Granted EP/0642579
Luxembourg 93913992.9 Granted EP/0642579
Monaco 93913992.9 Granted EP/0642579
Netherlands 93913992.9 Granted EP/0642579
Portugal 93913992.9 Granted EP/0642579
Spain 93913992.9 Granted EP/0642579
Sweden 93913992.9 Granted EP/0642579
Switzerland 93913992.9 Granted EP/0642579
Hong Kong 98115464.8 [*]
Japan 6-503617 [*]
Mexico 933651 [*]
South Africa 93/4093 Granted 93/4093
5) Title: Method of Treating Gram-Negative Bacterial Infection By
Administration of Bactericidal/Permeability-Increasing (BPI)
Protein Product and Antibiotic
Inventors: Xxxxx, Kung, Lambert, Little
--------------------------------------------------------------------------------
[*] PCT/US94/11225 [WO 95/08344] [*].
Country Serial No. Status/Patent No.
United States 08/125,651 [*]
United States 08/273,401 [*]
United States 08/311,611 Issued 5,523,288
[*]
Australia 80740/94 Granted 000000
Xxxxxx 2,172,245 [*]
Europe 94931793.7 [*]
Hong Kong 98115454.0 [*]
Japan 7-509977 [*]
Xxxxxx 000000 [*]
New Zealand 275205 Granted 275205
South Africa 94/7394 Granted 94/7394
6) Title: Anti-Gram-Positive Bacterial Methods and Materials
Inventors: Horwitz, Lambert, Little
--------------------------------------------------------------------------------
[*] PCT/US95/00656 [WO 95/19180] [*].
Country Serial No. Status/Patent No.
United States 08/274,299 [*]
United States 08/372,783 Issued 5,578,572
[*]
United States 08/758,116 Granted 5,783,561
[*]
Australia 16822/95 [*]
Canada 2,181,164 [*]
Europe 95908545.7 [*]
Hong Kong 98115461.1 [*]
Japan 7-519190 [*]
South Africa 95/0249 Granted 95/0249
7) Title: Anti-Chlamydial Methods and Materials
Inventors: Xxxxxxx
--------------------------------------------------------------------------------
[*] PCT/US97/13810 [WO 98/06415] [*].
Country Serial No. Status/Patent No.
United States 08/694,843 Issued 5,888,973
[*]
Australia 39094/97 [*]
Canada 2,263,181 [*]
China 97198452.2 [*]
Europe 97936420.5 [*]
Japan 10-509836 [*]
Mexico 991366 [*]
New Zealand 334041 [*]
8) Title: Treatment of Mycobacterial Diseases by Administration of
Bactericidal/Permeability-Increasing Protein Products
Inventors: Xxxxxxx
--------------------------------------------------------------------------------
[*] PCT/US94/02463 [WO 94/20129] [*].
Country Serial No. Status/Patent No.
United States 08/031,145 [*]
[*]
Canada 2,157,925 [*]
Hong Kong 98111614.6 [*]
Europe 94910876.5 Granted 0690721
Austria 94910876.5 Granted EP/0690721
Belgium 94910876.5 Granted EP/0690721
Denmark 94910876.5 Granted EP/0690721
France 94910876.5 Granted EP/0690721
Germany 94910876.5 Granted EP/0690721
Great Britain 94910876.5 Granted EP/0690721
Greece 94910876.5 Granted EP/0690721
Ireland 94910876.5 Granted EP/0690721
Italy 94910876.5 Granted EP/0690721
Luxembourg 94910876.5 Granted EP/0690721
Monaco 94910876.5 Granted EP/0690721
Netherlands 94910876.5 Granted EP/0690721
Portugal 94910876.5 Granted EP/0690721
Spain 94910876.5 Granted EP/0690721
Sweden 94910876.5 Granted EP/0690721
Switzerland 94910876.5 Granted EP/0690721
Mexico 941808 [*]
South Africa 94/1772 Granted 94/1772
9) Title: Bactericidal Permeability Increasing Protein (BPI) For Treating
Conditions Associated with Corneal Injury
Inventors: Scannon
--------------------------------------------------------------------------------
[*] PCT/US96/18632 [WO 97/17990] [*].
Country Serial No. Status/Patent No.
United States 08/557,289 [*]
[*]
Australia 10215/97 [*]
Canada 2,235,626 [*]
Europe 96940562.0 [*]
Hong Kong 99100828.0 [*]
Japan 9-519166 [*]
10) Title: Bactericidal/Permeability-Increasing Protein (BPI) For Treating
Conditions Associated with Corneal
Transplantation
Inventors: Scannon
-------------------------------------------------------------------------------
[*] PCT/US96/18416 [WO 97/17989] [*].
Country Serial No. Status/Patent No.
United States 08/557,287 Issued 5,686,414
Australia 77361/96 [*]
Canada 2,235,625 [*]
Europe 96940496.1 [*]
Hong Kong 99100829.9 [*]
Japan 9-519125 [*]
11) [*]
12) Title: Biologically Active Bactericidal/Permeability-Increasing Protein
Fragments
Inventors: Elsbach, Xxxxx (New York University)
--------------------------------------------------------------------------------
[*] PCT/US88/02700 [WO 89/01486] [*].
Country Serial No. Status/Patent No.
United States 07/084,355 [*]
United States 07/228,035 [*]
United States 07/762,730 [*]
United States 07/805,031 Issued 5,198,541
United States 08/007,837 Issued 5,641,874
[*]
Canada 574,398 [*]
Europe 88907884.6 Granted 0375724
Austria 88907884.6 Granted EP/0375724
Belgium 88907884.6 Granted EP/0375724
France 88907884.6 Granted EP/0375724
Germany 88907884.6 Granted EP/0375724
Great Britain 88907884.6 Granted EP/0375724
Italy 88907884.6 Granted EP/0375724
Luxembourg 88907884.6 Granted EP/0375724
Netherlands 88907884.6 Granted EP/0375724
Sweden 88907884.6 Granted EP/0375724
Switzerland 88907884.6 Granted EP/0000000
Japan 507146/88 [*]
EXHIBIT C
COUNTRIES OF THE EUROPEAN PATENT CONVENTION
Austria
Belgium
Denmark
Finland
France
Germany
Greece
Ireland
Italy
Liechtenstein
Luxembourg
Monaco
The Netherlands
Portugal
Spain
Sweden
Switzerland
United Kingdom
EXHIBIT D
ALLERGAN'S PRELIMINARY RESEARCH AND DEVELOPMENT PLAN
[*]
EXHIBIT E
[*]
EXHIBIT F
FORM OF PRESS RELEASE
Allergan:
Investor Relations: Xxxx Xxxxxxx 000-000-0000
Media Relations: Xxx Xxxxxxx 000 000-0000
XOMA:
Xxxxx Xxxxxx 000-000-0000 or 0-000-XXX-XXXX
Thomson IR: Xxxxxxx Xxxxxxx or Xxxxx Xxxxx
000-000-0000 XOMA home page @
xxxx://xxx.xxxx.xxx
XOMA LICENSES TO ALLERGAN USE OF RECOMBINANT BPI IN
COMBINATION ANTI-INFECTIVE OPHTHALMIC PRODUCTS
Antibiotic-Resistant Bacteria Targeted
Berkeley and Irvine, CA -- June 28, 1999 -- XOMA Ltd. (Nasdaq: XOMA) and
Allergan (NYSE: AGN) today announced a licensing agreement under which Allergan
will have exclusive rights to use XOMA's recombinant BPI ("rBPI") in combination
with other anti-infectives in products to treat ophthalmic infections. BPI,
bactericidal/permeability-increasing protein, is a naturally occurring human
host-defense protein with multiple anti-infective properties and XOMA's primary
drug development platform.
"XOMA's rBPI in combination with Allergan's anti-infectives may offer an
important new approach to developing products that meet the clinical need for
novel weapons against ophthalmic infections," said Xxxxx X. X. Xxxxx, President
and Chief Executive Officer of Allergan. "A number of pathogenic bacterial
strains are showing increased resistance to currently available antibiotics,
creating growing concern among the medical community. Allergan intends to
address this need by developing products that make use of rBPI's synergy with
antibiotics, including potential use against resistant strains of bacteria."
Under the terms of the agreement, XOMA will receive an upfront payment and
additional payments upon achievement of certain milestones totaling $11 million.
In addition, Allergan will pay all future development costs for any products
developed under this agreement. XOMA will be entitled to future royalties on net
sales worldwide of Allergan's anti-infective products that include rBPI. Lastly,
the relationship includes a product supply agreement, whereby a XOMA affiliate
will manufacture rBPI for Allergan.
"We are pleased to have signed our first rBPI collaboration, and delighted that
Allergan is our partner," said Xxxx Xxxxxxxx, Chairman, President and CEO of
XOMA. "Allergan represents an ideal collaborative partner for us in
ophthalmology. They have shown a willingness to make a significant financial
commitment not only in payments to XOMA, but also in future product development
spending. More importantly, they have a track record of developing products that
are successful in the marketplace. They have a number of established product
lines backed by a solid worldwide marketing and sales infrastructure."
XOMA has been researching ophthalmic applications of BPI since 1995 under its
I-PREX(TM) topical rBPI ophthalmic program. Preclinical studies at XOMA
originally demonstrated rBPI21's antibacterial and anti-angiogenic activities.
Formulations of rBPI21 were also shown to be active in additional studies done
in collaboration with Xx. Xxxx Xxxxxxx and associates at the Schepen's Eye
Research Institute, an affiliate of the Harvard Medical School. Formulations of
rBPI21 have also been shown by XOMA scientists and outside collaborators to act
synergistically with all major classes of antibiotics against many strains of
antibiotic-resistant bacteria.
XOMA Ltd. develops and manufactures biopharmaceuticals at facilities located in
Berkeley and Santa Monica, California. Medical targets include bacterial and
fungal infections, infectious complications, such as those that may follow
trauma or surgery, immunologic and inflammatory disorders. In addition to its
ongoing I-PREX(TM) program, XOMA has several BPI-derived products in
development. NEUPREX(R), a systemic anti-infective product is in Phase III
trials for two indications. Antifungal (Mycoprex(TM)) and antiangiogenic
compounds are in preclinical development. BPI was discovered in white blood
cells by Xxxxx Xxxxxxx, MD, and Xxxxxxx Xxxxx, PhD, at New York University
School of Medicine (NYU) in 1978. XOMA has collaborated with NYU since 1991 to
extend and apply BPI-related research to pharmaceutical development.
Allergan, headquartered in Irvine, California, is a technology-driven, global
health care company, providing eye care and specialty pharmaceutical products
worldwide. Allergan develops and commercializes products in eye care,
pharmaceutical, ophthalmic surgical device, over-the-counter contact lens care,
movement disorder and dermatological markets that deliver value to customers,
satisfy unmet medical needs and improve patients' lives.
Any of the above statements that refer to estimated or anticipated future
results, such as statements regarding product development and future product
marketing and sales, or that otherwise relate to future periods, are
forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such
statements reflect each company's current analysis of existing trends and
information. Actual results could differ from current expectations based on a
number of factors, including changing competitive, regulatory and market
conditions, the timing and uncertainty of the results of both research and
development and regulatory processes; uncertainties regarding the legal
standards applicable to biotechnology and pharmaceutical patents; actions by the
U.S. Food and Drug Administration or the U.S. Patent and Trademark Office; and
performance, including the approval, introduction and consumer acceptance, of
new products. Actual results could differ materially from those projected in
this release. As a result, the reader is cautioned not to rely on these
forward-looking statements. Allergan and XOMA each disclaim any intent or
obligation to update these forward-looking statements.
Additional information concerning these factors can be found in news releases as
well as in each company's public periodic filings with the Securities and
Exchange Commission, including XOMA's 1998 Form 10-K and the discussion under
the heading "Certain Factors and Trends Affecting Allergan and Its Businesses"
in Allergan's 1998 Form 10-K as well as other SEC filings. Allergan's filings
are available publicly and upon request from Allergan's Investor Relations
Department: 000-000-0000 or xxxx://xxx.xxxxxxxx.xxx. XOMA's filings are
available publicly, at xxxx://xxx.xxxx.xxx, and upon request from XOMA Investor
Relations: 000 000 0000.
