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EXHIBIT 10.32
CONFIDENTIAL TREATMENT REQUESTED BY ABGENIX, INC.
EXCLUSIVE WORLDWIDE PRODUCT LICENSE
THIS PRODUCT LICENSE AGREEMENT (the "Agreement") effective the ____ day
of November, 1997, is made by and between XENOTECH, L.P., a California limited
partnership ("XT"), and ABGENIX, INC., a Delaware corporation ("Licensee").
RECITALS
XT desires to grant to Licensee and Licensee desires to acquire from XT
an exclusive worldwide license or sublicense, as the case may be, under the
Licensed Technology to commercialize Products, on the terms and conditions
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.
For purposes of this Agreement, the terms set forth in this Article
shall have the meanings set forth below.
1.1 "ABX" shall mean Abgenix, Inc.
1.2 "Affiliate" shall mean any entity which controls, is
controlled by or is under common control with any one of ABX, JTI or XT. An
entity shall be regarded as in control of another entity if it owns or controls
at least fifty percent (50%) of the shares of the subject entity entitled to
vote in the election of directors (or, in the case of an entity that is not a
corporation, for the election of the corresponding managing authority);
provided, however, XT shall not be an Affiliate of ABX or JTI under this
Agreement and XT shall not be considered controlled by ABX or JTI for purposes
of determining Affiliates of ABX or JTI.
1.3 "Antibody" shall mean a composition comprising a whole
antibody or a fragment thereof, said antibody or fragment having been derived
from the Licensed Technology and/or generated from the Mice or the Future
Generation Mice or having been derived from nucleotide sequences encoding, or
amino acid sequences of, such an antibody or fragment.
1.4 "Antibody Product" shall mean any product comprising an
Antibody or Genetic Material encoding an Antibody wherein, in respect of each
Antibody Product, said Genetic Material does not encode multiple Antibodies.
1.5 "Antibody-Secreting Cell" shall mean a cell that secretes an
Antibody, except where such cell is part of a mammal.
1.6 "Antigen Technology" shall mean (i) all U.S. patent
applications and patents listed on Schedule 1 and patents issuing on such patent
applications owned by or licensed to XT
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which relate to the Product Antigen, in each case to the extent XT has the right
to license or sublicense the same; (ii) any continuations, divisionals,
reexaminations, reissues or extensions of any of (i) above; (iii) any foreign
counterparts issued or issuing on any of (i) or (ii) above; and (iv) materials
as set forth in Schedule 1.
1.7 "CGI" shall mean Cell Genesys, Inc.
1.8 "Effective Date" shall mean the date this Agreement is
executed by XT and Licensee.
1.9 "Future Generation Mice" shall have the meaning defined in
the Master Research License and Option Agreement, as amended.
1.10 "Genetic Material" shall mean a nucleotide sequence,
including DNA, RNA, and complementary and reverse complementary nucleotide
sequences thereto, whether coding or noncoding and whether intact or a fragment.
1.11 "GenPharm Cross License" shall mean that certain Cross
License Agreement, effective as of March 26, 1997, entered into by and among the
parties, GenPharm International, Inc. ("GenPharm") and the other parties named
therein, as the same may be amended from time to time.
1.12 "IND" shall mean an Investigational New Drug Exemption for a
Product, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations
promulgated thereunder, or its non-U.S. equivalent.
1.13 "JTI" shall mean Japan Tobacco Inc.
1.14 "License Fee" shall have the meaning set forth in Article 3
hereof.
1.15 "Licensed Field" shall mean all human medical uses.
1.16 "Licensed Technology" shall mean the Antigen Technology, the
XenoMouse Technology, and XT-Controlled Rights.
1.17 "Master Research License and Option Agreement" shall mean
that certain Master Research License and Option Agreement entered into by CGI,
JTI and XT as of June 28, 1996 (and subsequently assigned by CGI to ABX), as it
may be amended.
1.18 "Mice" shall have the meaning defined in the Master Research
License and Option Agreement, as amended.
1.19 "Net Sales" shall mean the gross sales price charged by
Licensee or its Affiliates and Sublicensees for sales of Product to
non-Affiliate customers, less: (i) normal and customary rebates, cash and trade
discounts, and credits for returns and allowances, (ii) sales
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consumption or other excise taxes or duties imposed upon and paid by Licensee
and its Affiliates or Subsidiaries with respect to such sales, and (iii)
reasonable reserves for uncollectible accounts, as reflected in financial
statements of Licensee and its Affiliates or Sublicensees, to the extent such
accounts are not actually collected. "Net Sales" for [***] shall mean [***] of
Gross Sales, where Gross Sales shall mean the [***]. Notwithstanding the
foregoing, Gross Sales shall include [***], but notwithstanding any of the
foregoing, shall not include [***]. Notwithstanding the foregoing, "Net Sales"
for Universal Donor Cell Products shall be [***] of Gross Sales.
1.20 "Product" and "Products" shall mean one or more Antibody
Products which incorporate (i) an Antibody which binds to the Product Antigen or
(ii) Genetic Material encoding such an Antibody wherein said Genetic Material
does not encode multiple antibodies.
1.21 "Product Antigen" shall mean Epidermal Growth Factor
Receptor (EGFR).
1.22 "Sublicensee" shall mean a third party that is not an
Affiliate (provided, however, that CGI may be a Sublicensee of ABX, whether or
not CGI is an Affiliate of ABX) to whom Licensee has granted a sublicense under
the Licensed Technology to make, use and/or sell Products to the extent of the
rights of Licensee therein. "Sublicensee" shall also include a third party to
whom Licensee has granted the right to distribute Products under the Licensed
Technology to the extent of the rights of Licensee therein, provided that such
third party is responsible for the marketing and promotion of Products within
the applicable country.
1.23 "Territory" shall mean all the countries of the world.
1.24 "Transgenic Product" shall mean any product constituting (i)
Mice or Future Generation Mice, (ii) Genetic Material from Mice or Future
Generation Mice, or (iii) an Antibody-Secreting Cell.
1.25 "Universal Receptor Product" shall mean a substance that is
developed utilizing both (i) an Antibody and (ii) Universal Receptor
Technology.
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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1.26 "Universal Receptor Technology" shall mean technology for
universal receptors [***]. As used herein: (i) "universal receptor" shall mean a
receptor [***].
1.27 "Valid Claim" shall mean a claim of a pending or issued, and
unexpired patent included within the Licensed Technology, which has not been
held unenforceable, unpatentable or invalid by a court or other governmental
agency of competent jurisdiction, and which has not been admitted to be invalid
or unenforceable through reissue, disclaimer or otherwise.
1.28 "XenoMouse Technology" shall mean (i) all U.S. patent
applications and patents listed on Schedule 2 and patents issuing on such
applications; (ii) any continuations, divisionals, reexaminations, reissues or
extensions of any of (i) above; (iii) any foreign counterparts issued or issuing
on any of (i) or (ii) above; and (iv) the Mice (as such term is defined in the
Master Research License and Option Agreement) and other materials as set forth
on Schedule 2.
1.29 "XT-Controlled Rights" shall mean all rights to patents or
technology that are licensed to XT pursuant to the agreements listed on Schedule
4 or any other license or similar agreement granting XT rights to patents or
technology (each such agreement an "XT In-License"), to the extent that XT has
the right under the terms of the applicable XT In-License to further license or
sublicense such rights during the Term of this Agreement.
1.30 "XT In-License" shall have the meaning set forth in Section
1.29 above.
2. LICENSE GRANT; USE OF MICE BY THIRD PARTIES.
2.1 Subject to the terms and conditions of this Agreement, XT
hereby grants to Licensee an exclusive license or sublicense, as the case may
be, under the Licensed Technology, to make and have made Products anywhere in
the world and to use, sell, lease, offer to sell or lease, import, export,
otherwise transfer physical possession of or otherwise transfer title to such
Products
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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in the Licensed Field in the Territory. Such license or sublicense shall be
exclusive even as to XT, and shall include the exclusive right to grant and
authorize sublicenses for exploitation worldwide; provided, however, that
Licensee may not, under this license, grant sublicenses to any rights to the
Mice except as provided in Section 2.2 of this Agreement.
2.2 In connection with the grant of a sublicense under this
Agreement to a third party, and notwithstanding any provision to the contrary in
the Master Research License and Option Agreement or any Material Transfer
Agreement entered into between the parties under Sections 2.1, 2.2 or 2.3 of the
Master Research License and Option Agreement, Licensee shall have the right to
grant a sublicense to use Mice and Future Generation Mice transferred to the
third party pursuant to the terms of Section 2.7 of the Master Research License
and Option Agreement, and Transgenic Products other then Mice or Future
Generation Mice, to research, develop, make, have made, use, import, export,
sell, lease, offer to sell or lease or otherwise distribute or commercialize
Products, with the proviso that the sublicense described in this Section 2.2
shall not exceed the Licensee's rights conferred in accordance with the Master
Research License and Option Agreement or this Product License.
2.3 It is understood and agreed that, as to all XT-Controlled
Rights, the grant of rights under this Article 2 shall be subject in all
respects to the applicable XT In-License(s) pursuant to which such XT-Controlled
Rights were granted to XT.
3. LICENSE FEE.
Licensee shall pay to XT within thirty days of the Effective Date a
license fee of [***].
4. ROYALTIES.
4.1 Royalty Rates. In consideration for the license and rights
granted herein, Licensee agrees to pay to XT royalties of [***] of Net Sales of
Products by it and its Affiliates and Sublicensees.
4.2 Royalty Offsets. In the event that (i) Licensee, its
Affiliate or Sublicensee is required to pay a non-Affiliate third party amounts
with respect to Products under agreements for patent rights or other
technologies with Licensee, its Affiliate or Sublicensee, in its reasonable
judgment, determines are necessary or desirable to license or acquire with
respect to such Products (excluding any such payments made to Licensee by its
Affiliates), or (ii) any reimbursement payments are due to XT pursuant to
Section 5.1 below, then Licensee may deduct the aggregate of any such amounts
from any royalty amount owing to XT for the sale of such Products pursuant to
Section 4.1 above; provided, however, that payments from Licensee to a third
party that is an Affiliate, or was an Affiliate at any time within two (2) years
prior to the Effective Date, may not be offset under this Section 4.2.
Notwithstanding the foregoing provisions of this Section 4.2, in no event shall
the royalties due to XT pursuant to Section 4.1 above be so reduced to less than
[***] of the amount that would otherwise be due to XT thereunder. [***]
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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[***].
4.3 Single Royalty; Non-Royalty Sales. Only one royalty shall be
payable with respect to any Product, regardless of how many claims or patents
within the Licensed Technology cover such Product. In addition, no royalty shall
be payable under this Article 4 with respect to sales of Products among Licensee
and its Affiliates and/or Sublicensees and their Affiliates or for use in
research and/or development or clinical trials.
4.4 No Patent Protection. Royalties shall be payable at the rates
specified in Section 4.1 or 4.2 above only with respect to sales of Products
that would infringe a Valid Claim in the country in which such Products are
sold. In the event that such Products are not covered by a Valid Claim in such
country, XT shall be paid a royalty on such sales in accordance with this
Article 4, but the royalty due XT with respect to Net Sales in such country will
equal [***] of the royalty set forth in Section 4.1 or as it may be offset under
Section 4.2.
4.5 Combination Products. In the event that a Product is sold in
combination as a single product with another product or component, Net Sales
from such combination sales for purposes of calculating the amounts due under
this Article 4 shall be calculated by multiplying the Net Sales of that
combination by the fraction A/(A+B), where A is the gross selling price of the
Product sold separately and B is the gross selling price of the other product
sold separately. In the event that no such separate sales are made in the same
quarter by Licensee, Net Sales for royalty determination shall be as reasonably
allocated by Licensee, between such Product and such other product, based upon
their relative importance and proprietary protection.
4.6 Termination of Royalties. Royalties under Section 4.1, 4.2,
or 4.4 will be due until the later of (i) ten years from the first commercial
sale of Products in any country or (ii) on a country-by-country basis, the
expiration of the last-to-expire patent within the Licensed Technology covering
the Products in such country.
5. THIRD PARTY ROYALTIES.
5.1 Royalties Payable by XT. XT will be responsible for the
payment of any royalties, license fees and milestone and/or other payments due
to third parties under licenses or similar agreements entered into by XT
necessary to allow the manufacture, use or sale of Products. Licensee shall
reimburse XT for any royalties paid by XT to third parties under licenses or
similar agreements covering Products necessary to allow the manufacture, use or
sale or other exploitation of Products anywhere in the world. Licensee shall
continue any such reimbursement payments to XT until XT's obligation to pay
royalties to a third party under any license covering Products expires or
terminates. XT agrees not to enter into any license or similar agreement after
the Effective Date which would obligate Licensee to make any payments under this
Section 5.1 without the prior written consent of Licensee.
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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5.2 Royalties Payable by Licensee. Xenotech shall have no
responsibility under the terms of this Agreement for the payment of any
royalties, license fees or milestone or other payments due to third parties
under licenses or similar agreements entered into by Licensee, its Affiliates,
or its Sublicensees to allow the manufacture, use or sale of Products.
6. ACCOUNTING AND RECORDS.
6.1 Royalty Reports and Payments. After the first commercial sale
of Products on which royalties are required, Licensee agrees to make quarterly
written reports to XT within eighty days after the end of each calendar quarter,
stating in each such report the number, description, and aggregate Net Sales of
Products sold during the calendar quarter upon which a royalty is payable under
Article 4 above. Concurrently with the making of such reports, Licensee shall
pay to XT royalties at the applicable rate specified in Section 4.1, 4.2 or 4.4
above and all royalties payable pursuant to Section 5.1 above, and any
adjustment to Net Sales for a prior period in accordance with the definition of
Net Sales in Section 1.11 hereof. All payments to XT hereunder shall be made in
U.S. Dollars to a bank account designated by XT.
6.2 Early Third Party License Payments. If XT is obligated to pay
royalties to a third party prior to ninety days after the end of the calendar
quarter, XT shall so notify Licensee and Licensee shall provide the reports and
payments set forth in Section 6.1 above not later than ten days before the date
such payments are due to the third party. Up to thirty-five days before such
payments are due, XT may provide Licensee with an invoice by facsimile setting
forth the royalties XT must pay third parties with respect to Licensee's
activities in the Territory in the preceding quarter, and Licensee shall pay
such invoices within thirty days of receipt of such invoice.
6.3 Records; Inspection. Licensee shall keep (and cause its
Affiliates and Sublicensees to keep) complete, true and accurate books of
account and records for the purpose of determining the royalty amounts payable
to XT under this Agreement. Such books and records shall be kept at the
principal place of business of Licensee or its Affiliates or Sublicensees, as
the case may be, for at least three years following the end of the calendar
quarter to which they pertain. Such records of Licensee or its Affiliates will
be open for inspection during such three-year period by a representative of XT
for the purpose of verifying the royalty statements. Licensee shall require each
of its Sublicensees to maintain similar books and records and to open such
records for inspection during the same three-year period by a representative of
Licensee reasonably satisfactory to XT on behalf of, and as required by, XT for
the purpose of verifying the royalty statements. All such inspections may be
made no more than once each calendar year, at reasonable times mutually agreed
by XT and Licensee. The XT representative will be obliged to execute a
reasonable confidentiality agreement prior to commencing any such inspection.
Inspections conducted under this Section 6.3 shall be at the expense of XT,
unless a variation or error producing an increase exceeding [***] of the amount
stated for the period covered by the inspection is established in the course of
any such inspection, whereupon all costs relating thereto will be paid by
Licensee. Upon the expiration of three years following the end of any fiscal
year, the calculation of royalties payable with respect to
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respect to the omitted portions.
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such year shall be binding and conclusive, and Licensee shall be released from
any liability or accountability with respect to royalties for such year.
6.4 Currency Conversion. If any currency conversion shall be
required in connection with the calculation of royalties hereunder, such
conversion shall be made using the selling exchange rate for conversion of the
foreign currency into U.S. Dollars, quoted for current transactions reported in
The Wall Street Journal for the last business day of the calendar quarter to
which such payment pertains.
6.5 Late Payments. Any payments due from Licensee that are not
paid on the date such payments are due under this Agreement shall bear interest
to the extent permitted by applicable law at the prime rate as reported by the
Bank of America in San Francisco, California on the date such payment is due,
plus an additional [***] percent, calculated on the number of days such payment
is delinquent. This Section 6.5 shall in no way limit any other remedies
available to any party.
6.6 Withholding Taxes.
6.6.1 Unless immediately reimbursable under Section 6.6.2
below, all payments required to be made pursuant to Articles 3, 4 and 5 hereof
shall be without deduction or withholding for or on account of any taxes (other
than taxes imposed on or measured by net income) or similar governmental charge
imposed by a jurisdiction. Such taxes are referred to herein as "Withholding
Taxes" and such Withholding Taxes shall be the sole responsibility of the
withholding party. The withholding party shall provide a certificate evidencing
payment of any Withholding Taxes hereunder.
6.6.2 XT agrees to elect to claim a tax credit for
Withholding Taxes with respect to which it is entitled so to elect, and further
agrees not to amend such election for the full carry-forward period with respect
to such credit. At the time that XT realizes a reduction in U.S. tax liability
by actually utilizing the Withholding Taxes as a credit against regular U.S. tax
liability (determined on a "first-in-first-out" basis pro rata with other
available foreign tax credits) , then the amount of such reduction attributable
to such credit shall immediately be reimbursed to the withholding party. For
these purposes, a reduction in U.S. tax liability shall include both a direct
reduction in XT's own tax liability and a reduction in the U.S. tax liability of
any of its partners.
6.7 Tax Indemnity. Except as provided in Section 6.6, each party
(the "Tax Indemnitor") shall indemnify and hold harmless the other party hereto
(each a "Tax Indemnitee") from and against any tax or similar governmental
charge assessed solely because of this Agreement with respect to and directly
attributable to the income or the assets of the Tax Indemnitor. In the event
that any governmental agency shall make a claim against a party hereto which
could give rise to an indemnity hereunder, such potential Tax Indemnitee shall
give reasonably prompt notice to the potential Tax Indemnitor of the assertion
of such claim. If the transmission of such notice is unreasonably deferred and
has a material, adverse affect on the ability of the potential Tax Indemnitor to
challenge such claim, such potential Tax Indemnitor shall be released from
liability hereunder. The Tax Indemnitor alone shall (at its own expense) control
the defense or compromise
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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of any such claim. The Tax Indemnitee shall execute any documents required to
enable Tax Indemnitor to defend such claim, provide any information necessary
therefor, and cooperate with Tax Indemnitor in such defense.
6.8 XT Tax Indemnity. XT shall indemnify and hold harmless
Licensee and its Affiliates from and against any increase to its country of
incorporation income tax liability directly attributable to a positive
adjustment to the amount of gross receipts (an "Adjustment") reported or
reportable by such party from the income, including the royalty income, received
from Licensee on Covered Products. The amount payable hereunder shall be equal
to the difference between (a) the product of (i) the amount of the Adjustment,
and (ii) the highest combined marginal corporate tax rate in the country of
incorporation in effect for the taxable year for which such Adjustment is made,
and (b) the reduction in the party's foreign tax liability, which for purposes
of this Agreement shall be equal to the product of (i) the amount of any
correlative adjustment to its foreign taxable income, and (ii) the highest
combined marginal foreign corporate tax rate in effect for the taxable year for
which the correlative adjustment is made. No indemnification payment shall be
required hereunder until comprehensive efforts to obtain a correlative
adjustment to Licensee's or its Affiliates', as the case may be, taxable income
in a foreign state (which may include, for example invoking competent authority
provisions under the U.S. Japanese Income Tax Treaty (if applicable) or other
applicable bilateral tax treaty) have, to the extent reasonable to do so, been
exhausted.
7. RESEARCH AND DEVELOPMENT.
7.1 Funding and Conduct. Licensee shall independently furnish and
be responsible for funding and conducting all of its preclinical and clinical
research and development of Products, at its own expense.
7.2 Biomaterials. In the case of Previously Selected Antigens as
defined in the Master Research License and Option Agreement, at the reasonable
request of Licensee, XT shall make available as part of the license granted
hereunder to Licensee [***]. Such hybridomas, reagents and materials, as well as
the related data thus made available will be used only by Licensee and its
Affiliates and Sublicensees and manufacturing subcontractors.
8. DUE DILIGENCE.
8.1 Reasonable Commercial Efforts: [***] Milestone.
8.1.1 Licensee agrees to use commercially reasonable
efforts consistent with prudent business judgment to commercialize Products, by
the [***] by Licensee, or its Affiliate or Sublicensee, in the United States or
Japan within such period of time as may be agreed upon by the parties after good
faith negotiations taking into account factors relating to the Product Antigen
or, if no such period is agreed upon, three years from the Effective Date.
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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8.1.2 Notwithstanding the foregoing, Licensee shall be
required actively and continually to [***] by Licensee, or its Affiliate or
Sublicensee, as soon as producible after the Effective Date using reasonable
commercial efforts consistent with prudent business judgment. After [***]
Licensee, or its Affiliate or Sublicensee, shall be required to have [***] and
to be actively conducting clinical trials in pursuit of regulatory approval for
the Products in the United States or Japan.
8.2 Failure to Meet Due Diligence Obligation.
8.2.1 If the diligence requirements set forth in Section
8.1 are not met by Licensee (or its Affiliates or Sublicensees) in the United
States or in Japan, Licensee's rights hereunder shall terminate upon written
notice by XT to Licensee and subject to Sections 8.3, 8.4 and 13.3 below.
8.2.2 Notwithstanding Section 8.2.1, the license granted
hereunder to Licensee shall not terminate by reason of a delay in meeting the
[***] milestone set forth in Section 8.1.1, to the extent that prudent business
judgment, based on circumstances outside of Licensee's reasonable control,
reasonably justifies such delay.
8.3 Dispute Resolution. In the event that a dispute arises
whether the diligence requirements in Article 8 have been met or circumstances
exist which Licensee believes justifies a failure on its part to meet such
obligation, the parties will attempt to resolve any dispute by mutual agreement
during a period of 30 days following Licensee's receipt of the notice under
Section 8.2.1.
8.4 Arbitration. In the event that the parties are unable to
resolve such dispute pursuant to Section 8.3 above, such dispute shall be
settled between XT and Licensee by binding arbitration as set forth in Section
14.12. If the arbitrator determines that the party acted in good faith, but
failed to meet its obligations under Section 8.1 above, the license granted to
such party shall not terminate unless the nonperforming party fails to cure such
non-performance within a reasonable period of time, as determined by the
arbitrator.
9. PATENTS.
9.1 XenoMouse Technology.
(a) XT or its licensor, as they may agree, shall have
responsibility for preparing, filing, prosecuting and maintaining patents and
patent applications worldwide relating to the XenoMouse Technology and
conducting any interferences, oppositions, reexaminations, or requesting
reissues or patent term extensions with respect to the XenoMouse Technology. XT
shall keep Licensee reasonably informed as to the status of such patent matters,
including without limitation, by providing Licensee the opportunity to review
and comment on any substantive documents which will be filed in any patent
office, and providing Licensee copies of any substantive documents received by
XT from such patent offices including notice of all interferences,
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respect to the omitted portions.
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reexaminations, oppositions or requests for patent term extensions. Licensee
shall cooperate with and assist XT in connection with such activities, at XT's
request and expense.
(b) In the event that Licensee becomes aware that any
XenoMouse Technology necessary for the practice of the license granted herein is
infringed or misappropriated by a third party or is subject to a declaratory
judgment action arising from such infringement, Licensee shall promptly notify
XT and XT shall thereafter promptly notify the owner of such intellectual
property. XT or its licensor, as they may agree, shall have the exclusive right
to enforce, or defend any declaratory judgment action, at its expense, involving
any XenoMouse Technology. In such event, XT shall keep Licensee reasonably
informed of the progress of any such claim, suit or proceeding. Any recovery
received by XT as a result of any such claim, suit or proceeding shall be used
first to reimburse XT for all expenses (including attorneys, and professional
fees) incurred in connection with such claim, suit or proceeding, and the
remainder divided [***] between XT and Licensee, only to the extent that such
recovery is related to the Products.
9.2 Antigen Technology.
9.2.1 Licensee shall, at its expense, have the initial
worldwide responsibility for preparing, filing, prosecuting and maintaining
patent applications and conducting any interferences, oppositions,
reexaminations, or requesting reissues or patent term extensions with respect to
Antigen Technology, except to the extent XT may not have the right to do so.
Licensee shall give XT the opportunity to review the status of all such pending
patent applications and actions and shall keep XT fully informed of the progress
of such applications and actions, including, without limitation, by promptly
providing XT with copies of all substantive worldwide correspondence sent to and
received from patent offices, and providing notice of all interferences,
reexaminations, oppositions or requests for patent term extensions. In the event
that Licensee declines or fails to prepare, file, prosecute or maintain such
patent applications or patents or take such other actions, relating to the
Products in any country, it shall promptly and in no event later than ninety
days prior to any filing deadline, provide notice to XT. XT shall have the right
to assume such responsibilities at its own expense, using counsel of its choice.
9.2.2 In the event that Licensee becomes aware that any
Antigen Technology is infringed or misappropriated by a third party in any
country of the world, or is subject to a declaratory judgment action arising
from such infringement in any country, Licensee shall promptly notify XT and XT
shall thereafter promptly notify the owner of such intellectual property.
Licensee shall have the exclusive right to enforce, or defend any declaratory
judgment action, in any country of the world, at its expense, involving any
Antigen Technology. In such event, Licensee shall keep XT reasonably informed of
the progress of any such claim, suit or proceeding. Any recovery by Licensee
received as a result of any such claim, suit or proceeding shall be used first
to reimburse Licensee for all expenses (including attorneys, and professional
fees) incurred in connection with such claim, suit or proceeding, and the
remainder divided [***] between Licensee and XT.
9.3 Infringement Claims. If the production, sale or use of
Products pursuant to this Agreement results in any claim, suit or proceeding
alleging patent infringement against Licensee
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(or its Affiliates or Sublicensees), Licensee shall promptly notify XT thereof
in writing setting forth the facts of such claim in reasonable detail. [***],
Licensee shall have the exclusive right to defend and control the defense of any
such claim, suit or proceeding, at its own expense, using counsel of its choice.
Licensee shall keep XT reasonably informed of all material developments in
connection with any such claim, suit or proceeding as it relates to the Licensed
Technology, Licensee shall have the right to deduct any damages and expenses
(including attorneys' and professional fees) against any amounts due, or which
may become due, to XT pursuant to this Agreement. Notwithstanding the above,
Licensee shall not be able to settle any such claim, suit or proceeding that
involves any admission of the invalidity of the Licensed Technology.
9.4 Patent Marking. Licensee agrees to xxxx and have its
Affiliates and Sublicensees xxxx all Products sold pursuant to this Agreement in
accordance with the applicable statutes or regulations in the country or
countries of manufacture and sale thereof.
10. CONFIDENTIALITY.
10.1 Confidential Information. Except as expressly provided
herein, the parties agree that, for the term of this Agreement and for five
years thereafter, the receiving party shall keep completely confidential and
shall not publish or otherwise disclose and shall not use for any purpose any
information furnished to it by another party hereto pursuant to this Agreement
except to the extent that it can be established by the receiving party by
competent proof that such information:
(a) was already known to the receiving party, other than
under an obligation of confidentiality, at the time of disclosure;
(b) was generally available to the public or otherwise
part of the public domain at the time of its disclosure to the receiving party;
(c) became generally available to the public or otherwise
part of the public domain after its disclosure and other than through any act or
omission of the receiving party in breach of this Agreement; or
(d) was subsequently lawfully disclosed to the receiving
party by a person other than a party or developed by the receiving party without
reference to any information or materials disclosed by the disclosing party.
10.2 Permitted Disclosures. Notwithstanding Sections 10.1 above
and 14.16 below, each party hereto may disclose the other party's information to
the extent such disclosure is reasonably necessary in filing or prosecuting
patent applications, prosecuting or defending litigation, complying with
applicable governmental regulations or otherwise submitting information to tax
or
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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other governmental authorities, making a permitted sublicense or other exercise
of its rights hereunder or conducting clinical trials, provided that if a party
is required to make any such disclosure of the other party's secret or
confidential information, other than pursuant to a confidentiality agreement, it
will give reasonable advance notice to the latter party of such disclosure
requirement and, save to the extent inappropriate in the case of patent
applications, will use efforts consistent with prudent business judgment to
secure confidential treatment of such information prior to its disclosure
(whether through protective orders or otherwise). Notwithstanding the foregoing,
XT shall not disclose to third parties, clinical data or regulatory filings
received from Licensee except as agreed in writing by Licensee.
11. SUBLICENSES.
Pursuant to Article 2 herein, Licensee will have the right to grant and
authorize sublicenses to third parties; provided, however, the Licensee shall
remain responsible for any payments due XT for Net Sales of Products by any
Sublicensee. Licensee may retain any amounts received from Sublicensees in
excess of the amounts owed to XT pursuant to Articles 4 and 5. Any sublicense
granted by Licensee pursuant to this Agreement shall provide that the
Sublicensee will be subject to the applicable terms of this Agreement. Licensee
shall provide XT with a copy of relevant portions of each sublicense agreement,
as reasonably required by XT.
12. REPRESENTATIONS AND WARRANTIES.
12.1 XT. XT represents and warrants that:
(i) it has the full right and authority to enter into this
Agreement and grant the rights and licenses granted herein;
(ii) it has not previously granted and will not grant any
rights inconsistent or in conflict with the rights and licenses granted to
Licensee herein;
(iii) there are no existing or threatened actions, suits
or claims pending against XT with respect to the Licensed Technology or the
right of XT to enter into and perform its obligations under this Agreement;
(iv) it has not previously granted, and will not grant
during the term of this Agreement, any right, license or interest in and to the
Licensed Technology, or any portion thereof, with respect to the Products, or
their manufacture or use;
(v) Schedule 3 hereto sets forth all royalties, license
fees, milestone payments and similar payments due to third parties for which
Licensee is obligated to reimburse XT under Section 5.1 above as of the
Effective Date; and
(vi) the Licensed Technology is all the technology owned
by or licensed to XT as of the Effective Date.
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12.2 Licensee. Licensee represents and warrants that:
(i) it has the full right and authority to enter into
this Agreement,
(ii) to its knowledge, there are no existing or threatened
actions, suits or claims pending with respect to the subject matter hereof or
the right of Licensee to enter into and perform its obligations under this
Agreement; and
(iii) it has not entered and during the term of this
Agreement will not enter any other agreement inconsistent or in conflict with
this Agreement.
12.3 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS
AGREEMENT, XT MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND,
EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND VALIDITY OF LICENSED
TECHNOLOGY CLAIMS, ISSUED OR PENDING.
12.4 Effect of Representations and Warranties. It is understood
that if the representations and warranties under this Article 12 are not true
and accurate and a party incurs liabilities, costs or other expenses as a result
of such falsity, the party at fault shall indemnify, defend and hold the injured
party harmless from and against any such liabilities, costs or expenses
incurred, provided that the party at fault receives prompt notice of any claim
against the injured party resulting from or related to such falsity and the sole
right to control the defense or settlement thereof.
13. TERM AND TERMINATION.
13.1 Effectiveness. This Agreement shall become effective as of
the Effective Date and the license rights granted by XT under Article 2 above
shall be in full force and effect as of such date.
13.2 Term. Unless earlier terminated pursuant to the other
provisions of this Article 13, this Agreement shall continue in full force and
effect until the later of
(i) the expiration of the last to expire patent within the
Licensed Technology claiming Products; or
(ii) the twentieth anniversary of the Effective Date.
The licenses granted under Article 2 shall survive the expiration (but not an
earlier termination) of this Agreement; provided that such licenses shall in
such event become nonexclusive.
13.3 Termination for Breach. Either party to this Agreement may
terminate this Agreement in the event the other party shall have materially
breached or defaulted in the
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performance of any of its material obligations hereunder, and such shall have
continued for sixty days after written notice thereof was provided to the
breaching party by the nonbreaching party that terminates the Agreement as to
such party. Any termination shall become effective at the end of such sixty day
period unless the breaching party has cured any such breach or default prior to
the expiration of the sixty day period. However, if the party alleged to be in
breach of this Agreement disputes such breach within such sixty day period, the
non-breaching party shall not have the right to terminate this Agreement unless
it has been determined by an arbitration proceeding in accordance with Section
14.12 below that this Agreement was materially breached, and the breaching party
fails to cure such breach within thirty days following the final decision of the
arbitrators or such other time as directed by the arbitrators.
13.4 Other Termination Rights. Licensee may terminate this Agreement and
the license granted herein, in its entirety or as to any particular patent
within the Licensed Technology in a particular country, at any time, by
providing XT ninety-days written notice. In the event of termination as to a
particular country, the subject patent in such country shall cease to be within
the Licensed Technology for all purposes of this Agreement.
13.5 Effect of Termination.
13.5.1 Termination of this Agreement for any reason shall not
release either party hereto from any liability which at the time of such
termination has already accrued to the other party or which is attributable to a
period prior to such termination.
13.5.2 In the event this Agreement is terminated for any reason,
Licensee and its Affiliates and Sublicensees shall have the right to sell or
otherwise dispose of the stock of any Products subject to this Agreement then on
hand. Upon termination of this Agreement by XT for any reason, any sublicense
granted by Licensee hereunder shall survive, provided that upon request by XT,
such Sublicensee promptly agrees in writing to be bound by the applicable terms
of this Agreement.
13.5.3 This Agreement, including, without limitation, any
licenses or sublicenses granted pursuant to this Agreement, shall survive any
dissolution, liquidation or acquisition of XT. Such licenses shall remain in
full force and effect even after any distribution, following dissolution, of the
intellectual property owned or licensed to XT, to any entity. Any transfer of
such intellectual property prior to or following dissolution shall be subject to
the licenses granted herein.
13.5.4 This Agreement, including the license granted in Article
2, is independent of, and shall not be affected by, any breach or termination of
the Master Research License and Option Agreement or any other agreement between
the parties or their Affiliates. In the event of the termination of the Master
Research License and Option Agreement, the rights and obligations of the parties
hereto under Article 12 thereof shall be deemed to be part of this Agreement.
13.5.5 Sections 6.3, 6.5, 6.6, 6.7 and 6.8 and Articles 10, 12,
13 and 14 shall survive the expiration and any termination of this Agreement for
any reason.
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14. MISCELLANEOUS.
14.1 Governing Laws. This Agreement shall be interpreted and
construed in accordance with the laws of the State of California, without regard
to conflicts of law principles.
14.2 Waiver. It is agreed that no waiver by any party hereto of
any breach or default of any of the covenants or agreements herein set forth
shall be deemed a waiver as to any subsequent and/or similar breach or default.
14.3 Assignment. This Agreement and the license granted hereunder
may not be assigned by Licensee to any third party without the written consent
of XT, and XT may not assign this Agreement to a third party without the consent
of Licensee; except any party may assign this Agreement without such consent to
(a) an Affiliate (provided that such Affiliate is two-thirds or greater owned
directly or indirectly) or (b) an entity that acquires substantially all of the
assets of the monoclonal antibody business segment of the assigning party. The
terms and conditions of this Agreement shall be binding on and inure to the
benefit of the permitted successors and assigns of the parties.
14.4 Independent Contractors. The relationship of the parties
hereto is that of independent contractors. The parties hereto are not deemed to
be agents, partners or joint venturers of the others for any purpose as a result
of this Agreement or the transactions contemplated thereby.
14.5 Compliance with Laws. In exercising their rights under this
license, the parties shall fully comply with the requirements of any and all
applicable laws, regulations, rules and orders of any governmental body having
jurisdiction over the exercise of rights under this license.
14.6 No Implied Obligations. Except as expressly provided in
Article 8 above, nothing in this Agreement shall be deemed to require Licensee
to exploit the Licensed Technology nor to prevent Licensee from commercializing
products similar to or competitive with any Products, in addition to or in lieu
of such Products.
14.7 Notices. Any notice required or permitted to be given to the
parties hereto shall be given in writing and shall be deemed to have been
properly given if delivered in person or when received if mailed by first class
certified mail to the other party at the appropriate address as set forth below
or to such other addresses as may be designated in writing by the parties from
time to time during the term of this Agreement.
XT: Xenotech, L.P.
000 Xxxxxxxx Xxxxx
Xxxxxx Xxxx, Xxxxxxxxxx 00000
Attn: Chief Financial Officer
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Japan Tobacco Inc.: Japan Tobacco Inc.
JT Xxxxxxxx
0-0 Xxxxxxxxx 0-xxxxx
Xxxxxx-xx, Xxxxx 000
Xxxxx
Attn: Vice President
Pharmaceutical Division
with a copy to: JT America Inc.
0000 Xxxxx Xxxxx Xxxxxx, Xxxxx 000
Xxx Xxxxx, XX 00000
Attn: President
and to: Xxxxxxx, Xxxxxx and Xxxxx LLP
000 Xxxx Xxxxxx
Xxx Xxxx, XX 00000
Attn: Xxxx X. Xxxxxx, Esq.
Abgenix, Inc.: Abgenix, Inc.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attn: President
with a copy to: Xxxxxx Xxxxxxx Xxxxxxxx & Xxxxxx, P.C.
000 Xxxx Xxxx Xxxx
Xxxx Xxxx, Xxxxxxxxxx 00000
Attn: Xxxxxxx X. Xxxxx, Esq.
14.8 Export Laws. Notwithstanding anything to the contrary
contained herein, all obligations of XT and Licensee are subject to prior
compliance with United States export regulations and such other United States
laws and regulations as may be applicable, and to obtaining all necessary
approvals required by the applicable agencies of the government of the United
States. Licensee shall use efforts consistent with prudent business judgment to
obtain such approvals. XT shall cooperate with Licensee and shall provide
assistance to Licensee as reasonably necessary to obtain any required approvals.
14.9 Severability. In the event that any provision of this
Agreement becomes or is declared by a court of competent jurisdiction to be
illegal, unenforceable or void, this Agreement shall continue in full force and
effect without said provision and the parties shall discuss in good faith
appropriate revised arrangements.
14.10 Force Majeure. Nonperformance of any party (except for
payment obligations) shall be excused to the extent that performance is rendered
impossible by strike, fire, earthquake, flood, governmental acts or orders or
restrictions, failure of suppliers, or any other
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reason where failure to perform, is beyond the reasonable control and not caused
by the negligence, intentional conduct or misconduct of the nonperforming party.
14.11 No Consequential Damages. IN NO EVENT SHALL ANY PARTY
HERETO BE LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF
THIS
AGREEMENT OR THE EXERCISE OF RIGHTS HEREUNDER.
14.12 Dispute Resolution; Arbitration. The parties will attempt
to resolve any dispute under this Agreement by mutual agreement, and, if
required, there shall be a face-to-face meeting between senior executives of the
parties. Any dispute under this Agreement which is not settled after such
meeting, shall be finally settled by binding arbitration, conducted in
accordance with the Rules of Arbitration of the International Chamber of
Commerce by three arbitrators appointed in accordance with said rules. The
arbitration proceedings and all pleadings and written evidence shall be in the
English language. Any written evidence originally in a language other than
English shall be submitted in English translation accompanied by the original or
a true copy thereof. The costs of the arbitration, including administrative and
arbitrators' fees, shall be shared equally by the parties. Each party shall bear
its own costs and attorneys' and witness' fees. The prevailing party in any
arbitration, as determined by the arbitration panel, shall be entitled to an
award against the other party in the amount of the prevailing party's costs and
reasonable attorneys, fees. The arbitration shall be held in San Francisco,
California. A disputed performance or suspended performances pending the
resolution of the arbitration must be completed within thirty days following the
final decision of the arbitrators. Any arbitration shall be completed within six
months from the filing of notice of a request for such arbitration.
14.13 Complete Agreement. It is understood and agreed between XT
and Licensee that this Agreement constitutes the entire agreement, both written
and oral, between the parties with respect to the subject matter hereof, and
that all prior agreements respecting the subject matter hereof, either written
or oral, expressed or implied, shall be abrogated, canceled, and are null and
void and of no effect. No amendment or change hereof or addition hereto shall be
effective or binding on either of the parties hereto unless reduced to writing
and executed by the respective duly authorized representatives of XT and
Licensee.
14.14 Counterparts. This Agreement may be executed in
counterparts, each of which shall be deemed to be an original and both together
shall be deemed to be one and the same agreement.
14.15 Headings. The captions to the several Articles and Sections
hereof are not a part of this Agreement, but are included merely for convenience
of reference only and shall not affect its meaning or interpretation.
14.16 Nondisclosure. Except as provided in Article 10, each of
the parties hereto agrees not to disclose to any third party the terms of this
Agreement without the prior written consent of each other party hereto, except
to advisors, investors, licensees, sublicensees and others on a need to know
basis under circumstances that reasonably ensure the confidentiality thereof, or
to the extent
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required by law; provided, however, that the royalty rate specified in Section
4.1 of this executed Product License shall be redacted before the terms of this
executed Product License are disclosed to potential licensees and sublicensees.
Without limitation upon any provision of this Agreement, each of the parties
hereto shall be responsible for the observance by its employees, consultants and
contractors of the foregoing confidentiality obligations.
14.17 Conformity with GenPharm Cross-License. The rights and
licenses granted to Licensee hereunder shall be subject to the GenPharm Cross
License, and to the extent that this Agreement purports to grant greater rights
to Licensee than is permitted under the GenPharm Cross License, such rights
shall be granted only to the extent permitted under the GenPharm Cross License,
and the terms of the GenPharm Cross License shall control.
IN WITNESS WHEREOF, the parties have executed this Agreement, through
their respective officers hereunto duly authorized, as of the day and year first
above written.
XENOTECH, INC. (as General LICENSEE
Partner of XENOTECH, L.P.)
By: /s/ XXXXXXX XXXXX By: /s/ R. XXXXX XXXXX
-------------------------------------- --------------------------
Name: Xxxxxxx Xxxxx Name: R. Xxxxx Xxxxx
------------------------------------ ------------------------
Title: President and CEO, Xenotech, Inc. Title: President and CEO
----------------------------------- -----------------------
and By: /s/ XXXXXXX X. XXXXX
----------------------------------
Name: Xxxxxxx X. Xxxxx
------------------------------------
Title: Chairman, Xenotech, Inc.
-----------------------------------
Schedule 1: Patents [***] Technology"
Schedule 2: Patents [***] Technology"
Schedule 3: Payments Due to Third Parties
Schedule 4: XT In-Licenses
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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20
SCHEDULE 1 PATENTS
None.
21
SCHEDULE 1
None.
22
Schedule 2 - Patents
Docket No. Filing Date Serial No. Title Inventors
[***]
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
23
Schedule 2 - Patents
(Continued)
Docket No. Filing Date Serial No. Title Inventors
[***]
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
24
Schedule 2
[***]
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
25
Schedule 2
(Continued)
[***]
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
26
Schedule 2
(Continued)
[***]
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
27
Schedule 2
(Continued)
[***]
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
28
Schedule 3
Royalties Payable by Xenotech
[***]
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
29
Schedule 4
Xenotech Controlled Rights
[***]
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
