License Agreement - Ixsys Inc. and MedImmune Inc.
LICENSE AGREEMENT
This License Agreement (this "Agreement") is effective as of
February 24, 1999 ("the EFFECTIVE DATE") by and between Ixsys,
Inc., a Delaware corporation, having an address at 3520 Dunhill
Road, San Diego, CA 92121 ("IXSYS"), and MedImmune, Inc., a
Delaware Corporation, having offices at 35 West Watkins Mill
Road, Gaithersburg, MD 20878 ("MEDIMMUNE").
WHEREAS, MEDIMMUNE desires to obtain from IXSYS an exclusive
worldwide right and license to certain antibodies; and
WHEREAS, IXSYS desires to grant such rights on the terms and
conditions of this Agreement.
NOW THEREFORE in consideration of the mutual promises and
other good and valuable consideration, the parties agree as
follows:
SECTION 1 - Definitions.
The terms used in this Agreement have the following meaning:
1.1 "AFFILIATE," as applied to a person or entity, means
any other person or entity controlling or controlled by or under
common control with such person or entity. The term "control"
means possession of the power to direct or cause the direction of
the management and policies whether through the ownership of
voting securities, by contract or otherwise. The ownership of
voting securities of a person, organization or entity, however,
shall not, in and of itself, constitute "control" for purposes of
this definition, unless said ownership is of a majority of the
outstanding securities entitled to vote of such person,
organization or entity. Affiliate shall also mean a limited
partnership in which a subsidiary of such person, organization or
entity is a general partner.
1.2 "ANTIBODY(IES)" means (1) an antibody that specifically
binds to (CONFIDENTIAL TREATMENT REQUESTED) (including, but not
limited to, chimeric antibodies, humanized antibodies,
recombinant antibodies, grafted antibodies, single chain
antibodies, and the like) or an antibody fragment that
specifically binds to (CONFIDENTIAL TREATMENT REQUESTED) or (2) a
polynucleotide that encodes any of the foregoing. For the
avoidance of doubt, ANTIBODY includes, but is not limited to,
derivatives of (CONFIDENTIAL TREATMENT REQUESTED) antibody,
fragments thereof and modifications, variants and derivatives
thereof, such as humanized, chimeric, grafted and CDR modified
versions thereof and fragments of such versions, including, but
not limited to, the humanized antibody referred to as VITAXIN.
Notwithstanding the foregoing, ANTIBODY shall exclude the
(CONFIDENTIAL TREATMENT REQUESTED) murine antibody produced by
the cell line (CONFIDENTIAL TREATMENT REQUESTED) deposited with
the American Type Culture Collection.
1.3 "FIRST COMMERCIAL SALE" means, in each country, (a) the
first sale of a PRODUCT by MEDIMMUNE, its AFFILIATE or
SUBLICENSEE following approval of its marketing by the
appropriate governmental agency for the country in which the sale
is to be made, or (b) when governmental approval is not required,
the first commercial sale of a PRODUCT by MEDIMMUNE, its
AFFILIATE or SUBLICENSEE in that country.
1.4 "IXSYS KNOW-HOW" means all information and data
(including, but not limited to, formulae, procedures, protocols,
techniques and results of experimentation and testing) that are
necessary or useful for MEDIMMUNE to make, use or sell an
ANTIBODY (including an ANTIBODY that constitutes a component or
ingredient of a product), in each case only to the extent owned
by or licensed to IXSYS or its AFFILIATES (with the right to
grant sublicenses) or as to which IXSYS or its AFFILIATES
otherwise has licensable rights as of the EFFECTIVE DATE or
(subject to Section 1.15) thereafter during the term of this
Agreement.
1.5 "IXSYS LICENSE AGREEMENTS" means the agreements listed
in Appendix A.
1.6 "IXSYS PATENT(S)" means any patent or patent
application (or equivalents thereof, such as extensions or other
rights that give the right to exclude others such as
Supplementary Protection Certificates) anywhere in the world, to
the extent the claims of which would be infringed by the
manufacture, use or sale of a product comprising an ANTIBODY and
only to the extent that it is either owned by or licensed to
IXSYS or its AFFILIATES (with the right to grant sublicenses) or
as to which IXSYS or its AFFILIATES otherwise has licensable
rights, in each case, as of the EFFECTIVE DATE or (subject to
Section 1.15) thereafter during the term of this Agreement
(including, but not limited to, those of Appendix B and those
licensed under the IXSYS LICENSE AGREEMENTS).
1.7 "LICENSED TERRITORY" means all countries of the world.
1.8 "MATERIALS" means ANTIBODIES, the cell lines for
producing such ANTIBODIES, the polynucleotides encoding such
ANTIBODIES, and the assays, vectors and constructs for producing
such ANTIBODIES, in each case only to the extent owned by or
licensed to IXSYS or its AFFILIATES (with the right to grant
sublicenses) or as to which IXSYS or its AFFILIATES otherwise has
transferable rights, and in the possession and control of IXSYS
or its AFFILIATES, as of the EFFECTIVE DATE or (subject to
Section 1.15) thereafter during the term of this Agreement. For
the avoidance of doubt, MATERIALS includes the existing cell line
and associated vectors for producing the humanized version of
(CONFIDENTIAL TREATMENT REQUESTED) known as VITAXIN and VITAXIN
variants in the possession and control of IXSYS as of the
EFFECTIVE DATE.
1.9 "NET SALES" means, with respect to any PRODUCT, the
invoiced sales price of such PRODUCT sold by MEDIMMUNE, its
AFFILIATES and SUBLICENSEES to independent customers who are not
AFFILIATES, less (a) actual and customary credits, allowances,
discounts and rebates to, and chargebacks from the account of,
such independent customers for spoiled, damaged, out-dated,
rejected or returned PRODUCT; (b) actual freight and insurance
costs incurred in transporting such PRODUCT to such customers;
(c) actual and customary cash, quantity and trade discounts;
(d) sales, use, value-added and taxes or governmental charges
(excluding what is commonly known as income taxes) incurred in
connection with the exportation or importation of such PRODUCT;
(e) the cost to MEDIMMUNE of the devices for dispensing or
administering such PRODUCT as well as diluents or similar
materials which accompany such PRODUCT as it is sold, and (f) a
reasonable allowance for bad debt, all in accordance with
Generally Accepted Accounting Principles. For purposes of
determining NET SALES, a sale shall have occurred when an invoice
therefor shall be generated or the PRODUCT shipped for delivery.
Sales of PRODUCTS by MEDIMMUNE, an AFFILIATE or SUBLICENSEE to
any AFFILIATE or SUBLICENSEE which is a reseller thereof shall be
excluded, and only the subsequent sale of such PRODUCTS by
AFFILIATES or SUBLICENSEES to unrelated parties shall be deemed
NET SALES hereunder.
1.10 "PRODUCT" means a product comprising (i) an ANTIBODY,
the manufacture, use or sale of which infringes a VALID PATENT
CLAIM as to which MEDIMMUNE retains a license under this
Agreement, (ii) an ANTIBODY provided and licensed to MEDIMMUNE
by IXSYS under this Agreement, or (iii) an ANTIBODY which is
derived from an ANTIBODY provided and licensed to MEDIMMUNE under
this Agreement.
1.11 "ROYALTY PERIOD" means, with respect to each PRODUCT in
each country in the LICENSED TERRITORY, (a) if the manufacture,
use, offer for sale, sale or import of such PRODUCT in such
country at the time of the FIRST COMMERCIAL SALE infringes a
VALID PATENT CLAIM (if in an issued patent) but for the license
granted by this Agreement, the royalty period continues for as
long as such VALID PATENT CLAIM remains in effect and (if in an
issued patent) is infringed thereby but for the license granted
by this Agreement, or (b) otherwise, (CONFIDENTIAL TREATMENT
REQUESTED) years from the date of the FIRST COMMERCIAL SALE of
such PRODUCT in such country.
1.12 "SUBLICENSEE" means any AFFILIATE or THIRD PARTY that
is granted a sublicense by MEDIMMUNE under the licenses and
sublicenses granted by this Agreement.
1.13 "THIRD PARTY(IES)" means a person or entity other than
IXSYS or MEDIMMUNE or any of their AFFILIATES.
1.14 The term "VALID PATENT CLAIM" shall mean either (a) a
claim of an issued and unexpired patent included within the IXSYS
PATENTS, which has not been held permanently revoked,
unenforceable or invalid by a decision of a court or other gover
nmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, and which has not
been admitted to be invalid or unenforceable through reissue or
disclaimer or otherwise or (b) a claim of a pending patent
application included within the IXSYS PATENTS, which claim was
filed in good faith and has not been abandoned or finally
disallowed without the possibility of appeal or refiling of such
application, the subject matter of which has not been pending for
more than (CONFIDENTIAL TREATMENT REQUESTED) years, including the
pendency of any prior application.
1.15 In the event of the good faith transfer or sale of all
or substantially all of IXSYS' assets (including this Agreement)
to a THIRD PARTY, or in the event of the good faith merger,
consolidation, or similar transaction with a THIRD PARTY, in
which IXSYS is not the surviving entity, (a) the subject matter
of the ANTIBODIES, IXSYS KNOW-HOW, IXSYS PATENTS and MATERIALS
shall not include any antibody or fragment, data or information,
patent or patent application or material of the surviving entity
or the purchaser of IXSYS' assets existing prior to the effective
date of such transaction or acquired or arising on or after the
effective date of such transaction, if the surviving entity or
the purchaser of IXSYS' assets, prior to such effective date. was
working on the research, development, manufacture or
commercialization of an ANTIBODY, and (b) the subject matter of
IXSYS KNOW-HOW and IXSYS PATENTS shall exclude any data or
information, or patent or patent application, regarding antibody
production generally, of the surviving entity or the purchaser of
IXSYS' assets existing prior to the effective date of such
transaction or acquired or arising on or after the effective date
of such transaction, if the surviving entity or the purchaser of
IXSYS' assets, prior to such effective date, was in the business
of commercial production of antibodies.
1.16 The use herein of the plural shall include the
singular, and the use of the masculine shall include the
feminine.
1.17 All dollars are United States Dollars.
SECTION 2 - Transfer of IXSYS KNOW-HOW and MATERIALS.
2.1 Within thirty (30) days of the EFFECTIVE DATE, IXSYS,
at the cost and expense of IXSYS, shall transfer to MEDIMMUNE the
IXSYS KNOW-HOW and MATERIALS existing as of the EFFECTIVE DATE.
Promptly after the end of each calendar quarter thereafter during
the term of this Agreement, IXSYS, at the cost and expense of
IXSYS, shall transfer to MEDIMMUNE the IXSYS KNOW-HOW and
MATERIALS not previously delivered to MEDIMMUNE.
2.2 For a period of six (6) months after the EFFECTIVE
DATE, IXSYS, at the cost and expense of IXSYS, shall provide
MEDIMMUNE with such technical assistance as reasonably requested
by MEDIMMUNE with respect to the use of the IXSYS PATENTS, IXSYS
KNOW-HOW and MATERIALS hereunder.
2.3 (a) IXSYS, at its cost and expense, shall deliver to
MEDIMMUNE (i) a (CONFIDENTIAL TREATMENT REQUESTED) liter batch of
the ANTIBODY that is a humanized form of (CONFIDENTIAL TREATMENT
REQUESTED) antibody which humanized antibody is known as VITAXIN
that is currently being produced by (CONFIDENTIAL TREATMENT
REQUESTED) for IXSYS under Good Manufacturing Practices with
delivery expected in (CONFIDENTIAL TREATMENT REQUESTED), and (ii)
the associated documentation delivered by (CONFIDENTIAL TREATMENT
REQUESTED) to IXSYS in connection therewith that is required for
use in human clinical testing and commercial development and
manufacturing of such produced VITAXIN.
(b) In the event that IXSYS does not deliver VITAXIN
in accordance with Section 2.3(a), then MEDIMMUNE shall have the
right to deduct from any and all payments due and payable to
IXSYS under this Agreement an amount equal to (CONFIDENTIAL
TREATMENT REQUESTED).
2.4 IXSYS shall have the right to publish IXSYS' KNOW-HOW;
provided, however, that IXSYS shall provide MEDIMMUNE the
opportunity to review any proposed manuscripts or any other
proposed disclosure describing such work sixty (60) days prior to
their submission for publication or other proposed disclosure.
MEDIMMUNE and IXSYS shall discuss whether or not such publication
or disclosure should occur and it is expressly understood that
MEDIMMUNE shall have the sole right to make a final determination
as to whether or not such publication or disclosure shall occur
provided that such determination is not unreasonable. It shall
not be unreasonable to deny publication on the basis that the
information proposed to be published is not generally available
to the public and may aid a competitor in developing a
competitive product.
SECTION 3 - License Grants.
3.1 (a) IXSYS hereby grants to MEDIMMUNE and MEDIMMUNE
hereby accepts from IXSYS a sole and exclusive right and license
(or sublicense, as applicable) for the LICENSED TERRITORY (i)
under and to IXSYS PATENTS and IXSYS KNOW-HOW to research,
develop, make, have made, use, import, export and sell, offer to
sell or have sold PRODUCTS and (ii) to make, have made and use
the MATERIALS for all of the purposes of 3.1(a)(i).
Notwithstanding anything to the contrary in this Agreement, the
rights and licenses granted to MEDIMMUNE under this Agreement
exclude any right or license (express or implied) under any IXSYS
patent rights or know-how regarding the generation, discovery or
modification of antibody libraries, antibodies or fragments
thereof, generally.
(b) To the extent that the rights and licenses granted
to MEDIMMUNE under Section 3.1(a) is a sublicense under an IXSYS
LICENSE AGREEMENT, the rights, and licenses granted to MEDIMMUNE
under such sublicense are limited to the extent that IXSYS is
licensed under the IXSYS LICENSE AGREEMENT and such sublicense is
subject to the terms, conditions and restrictions of the IXSYS
LICENSE AGREEMENT that are applicable to a sublicense thereunder.
MEDIMMUNE shall not take or omit to take any action the effect of
which would cause IXSYS to be in breach of IXSYS' obligations
under the IXSYS LICENSE AGREEMENTS (without regard to any
applicable cure or notice requirements thereof).
3.2 MEDIMMUNE shall have the right to grant sublicenses
under the licenses and sublicenses granted under Section 3.1 to
its AFFILIATES and THIRD PARTIES (with the right to grant further
sublicenses, subject to any terms, conditions and restrictions on
further sublicensing under IXSYS LICENSE AGREEMENTS). MEDIMMUNE
shall deliver to IXSYS a copy of each such sublicense promptly
after execution of the same. Each such sublicense shall be
subject to the terms and conditions of this Agreement.
3.3 The licenses granted hereunder include the right of
MEDIMMUNE, its AFFILIATES and SUBLICENSEES to grant to the
purchaser thereof the right to use and/or resell a purchased
PRODUCT for which a royalty has been paid hereunder on NET SALES
of such PRODUCT (determined in accordance with Section 1.9),
without payment of any further royalty to IXSYS.
3.4 The provisions of Section 11.3(b) set forth MEDIMMUNE's
only diligence obligations to IXSYS with respect to research,
development and commercialization of PRODUCT, and the sole and
exclusive remedy for failure to meet such obligations.
3.5 IXSYS acknowledges that MEDIMMUNE is in the business of
developing, manufacturing and selling of medical processes and
products and that nothing in this Agreement shall be construed as
restricting such business or imposing on MEDIMMUNE the duty to
market, and/or sell and exploit PRODUCT for which royalties are
due hereunder to the exclusion of or in preference to any other
product or process.
3.6 Subject to Section 11.3(b), MEDIMMUNE shall have sole
discretion for making all decisions relating to the
commercialization and marketing of PRODUCT.
3.7 Except as otherwise expressly provided in this
Agreement, or the parties otherwise expressly agree in writing,
neither party shall obtain any right or license in any patent
rights, know-how, materials or technology of the other party (by
implication, estoppel or otherwise) for any purpose.
3.8 IXSYS shall in good faith request that its licensor
under each IXSYS LICENSE AGREEMENT provide the consent of
Appendix C.
SECTION 4 - Confidentiality.
4.1 During the term of this Agreement, IXSYS agrees not to
provide or disclose to a THIRD PARTY any MATERIALS without the
written permission of MEDIMMUNE.
4.2 After the date of this Agreement, subject to Section
2.4, IXSYS agrees not to disclose to a THIRD PARTY any IXSYS KNOW-
HOW without the written permission of MEDIMMUNE.
4.3 During the term of this Agreement, it is contemplated
that each party will disclose to the other party confidential
information which is owned or controlled by the party providing
such information or which that party is obligated to maintain in
confidence and which is designated by the party providing such
information as confidential ("Confidential Information"). Each
party shall have the right to refuse to accept the other party's
Confidential Information. Each party agrees to retain the other
party's Confidential Information in confidence, to limit
disclosure of any such Confidential Information to its officers,
directors, employees, consultants, sublicensees and permitted
assigns on a need to know basis. Each party agrees to use the
other party's Confidential Information only as permitted by this
Agreement, and not to disclose any such Confidential Information
to any other person or entity without the prior written consent
of the party providing such Confidential Information. For the
avoidance of doubt, IXSYS KNOW-HOW and MATERIALS will be
Confidential Information of IXSYS.
4.4 The obligations of confidentiality and non-use of
Sections 4.2 and 4.3 will not apply to:
(a) Confidential Information generally known
to the public prior to its disclosure hereunder;
or
(b) Confidential Information that
subsequently becomes known to the public by some
means other than a breach of this Agreement;
(c) Confidential Information that is
subsequently disclosed to the receiving party by a
third party having a lawful right to make such
disclosure; or
(d) is approved for release by the parties.
4.5 Neither party shall disclose any terms or conditions of
this Agreement to any third party without the prior consent of
the other party; provided, however, that a party may disclose the
terms or conditions of this Agreement, (a) on a need-to-know
basis to its legal and financial advisors to the extent such
disclosure is reasonably necessary in connection with such
party's activities expressly permitted by this Agreement and
ordinary and customary business operations, and (b) to a third
party in connection with (i) an equity investment in such party,
(ii) a merger, consolidation, change in control or similar
transaction by such party, or (iii) the transfer or sale of all
or substantially all of the assets of such party.
Notwithstanding the foregoing, prior to execution of this
Agreement the parties have agreed upon the substance of
information that may be used to describe the terms and conditions
of this transaction, and each party may disclose such
information, as modified by mutual written agreement of the
parties, without the consent of the other party.
4.6 The obligations of this Section 4 shall not apply to
the extent that a party is required to disclose information by
applicable law, regulation or bona fide legal process, provided
that the party required to make the disclosure takes reasonable
steps to restrict and maintain confidentiality of such disclosure
and provides reasonable prior notice to the other party.
4.7 Notwithstanding the foregoing, MEDIMMUNE shall have the
right to disclose Confidential Information of IXSYS to a THIRD
PARTY with whom MEDIMMUNE has or proposes to enter into a
business relationship and who undertakes an obligation of
confidentiality and non-use with respect to such information, at
least as restrictive as the obligation under this Section 4.
4.8 The parties' obligations under this Section 4 shall
terminate five (5) years after the expiration or termination of
this Agreement.
SECTION 5 - Patents.
5.1 IXSYS (or its licensor) shall file, prosecute and
maintain IXSYS PATENTS through patent counsel selected by IXSYS
(or its licensor). IXSYS shall consult with and keep MEDIMMUNE
advised with respect thereto. MEDIMMUNE shall pay all reasonable
out-of-pocket costs (including reasonable attorneys' fees and
costs) incurred in connection therewith by IXSYS after the
EFFECTIVE DATE.
5.2 With respect to any IXSYS PATENTS, each patent
application, office action, response to office action, request
for terminal disclaimer, and request for reissue or reexamination
or extension of any patent issuing from such application shall be
provided to MEDIMMUNE sufficiently prior to the filing of such
application, response or request to allow for review and comment
by MEDIMMUNE. IXSYS agrees to consider such comments and follow
reasonable comments unless IXSYS believes that such comments are
adverse to the interests of IXSYS.
5.3 IXSYS shall not allow any IXSYS PATENTS licensed to
MEDIMMUNE to lapse or be surrendered, or abandoned without the
written consent of MEDIMMUNE (other than those that are abandoned
in the ordinary course of prosecution in connection with the
filing of a continuation or continuation in part application
therefor).
5.4 The obligations of IXSYS under Sections 5.1 - 5.3 with
respect to IXSYS PATENTS that are sublicensed to MEDIMMUNE shall
only be to the extent that it is permitted under the IXSYS
LICENSE AGREEMENTS.
SECTION 6 - Royalties.
6.1 Subject to Sections 6.1, 6.2, 6.3, 6.4 and 6.12(e),
during the ROYALTY PERIOD, MEDIMMUNE shall pay royalties to IXSYS
for PRODUCTS as follows:
(a) (CONFIDENTIAL TREATMENT REQUESTED) of that portion
of NET SALES of PRODUCTS in a calendar year up to (CONFIDENTIAL
TREATMENT REQUESTED);
(b) (CONFIDENTIAL TREATMENT REQUESTED) of that portion
of NET SALES of PRODUCTS in a calendar year in excess of
(CONFIDENTIAL TREATMENT REQUESTED) up to (CONFIDENTIAL TREATMENT
REQUESTED);
(c) (CONFIDENTIAL TREATMENT REQUESTED) of that portion
of NET SALES of PRODUCTS in a calendar year that exceeds
(CONFIDENTIAL TREATMENT REQUESTED).
(d) For a PRODUCT for which the ROYALTY PERIOD is
(CONFIDENTIAL TREATMENT REQUESTED) years under Section 1.11 , the
royalty rate under Section 6.1(a), (b) and (c), after taking into
account any applicable increase or decrease, shall be reduced in
each case by (CONFIDENTIAL TREATMENT REQUESTED) in any country in
which one or more THIRD PARTIES is selling ANTIBODY (other than
ANTIBODY intended for research use only), and the aggregate
dollar volume of the sales of ANTIBODY by such THIRD PARTIES
equals or exceeds (CONFIDENTIAL TREATMENT REQUESTED) of the
aggregate market for ANTIBODY and all other products labeled
for the same use in such country. Any dispute regarding the
appropriate market for purposes of such determination shall be
submitted to binding arbitration under Section 13.2.
(e) The cumulative NET SALES for a calendar year shall
be calculated based on worldwide NET SALES.
6.2 In the event that a PRODUCT is sold in combination with
a therapeutically active component that is not a PRODUCT (such
combination being a "Combination Product"), then NET SALES of
such Combination Product upon which a royalty is paid shall be
subject to the following adjustment. If the PRODUCT and the
other therapeutically active component are sold separately in a
country, then NET SALES of such Combination Product in such
country upon which a royalty is paid shall be multiplied by the
fraction A/A+B, where A equals the average sales price of such
PRODUCT sold separately in such country, and B equals the average
sales price of the other therapeutically active component sold
separately in such country. Otherwise, the parties shall enter
into good faith negotiations and attempt to reach mutual
agreement to determine an appropriate adjustment to the NET SALES
of such Combination Product in a country to reflect the relative
contributions of the PRODUCT and the other therapeutically active
component to the value of the Combination Product in such
country. If such mutual agreement is not reached within ninety
(90) days after commencement of such negotiations, then the
determination shall be submitted to binding arbitration under
Section 13.2.
6.3 With respect to any PRODUCT for which the cumulative
royalty rate owed by MEDIMMUNE to a THIRD PARTY(IES) based on
sales in any country, including the royalty rates under the IXSYS
LICENSE AGREEMENTS, exceeds (CONFIDENTIAL TREATMENT REQUESTED),
the royalty rate under Sections 6.1(b) and (c) for such PRODUCT
in such country shall be reduced by (CONFIDENTIAL TREATMENT
REQUESTED) of such excess, but in no event shall any of such
royalty rates for such PRODUCT in such country be reduced to less
than (CONFIDENTIAL TREATMENT REQUESTED).
6.4 With respect to any PRODUCT for which the cumulative
royalty rate owed by MEDIMMUNE to a THIRD PARTY(IES) based on
sales in any country, including the royalty rates under the IXSYS
LICENSE AGREEMENTS, is less than (CONFIDENTIAL TREATMENT
REQUESTED), the royalty rate under Sections 6.1(a), (b) and (c)
for such PRODUCT in such country shall be increased by
(CONFIDENTIAL TREATMENT REQUESTED) of such deficiency but in no
event shall such royalty rates for such PRODUCT in such country
be increased by more than (CONFIDENTIAL TREATMENT REQUESTED).
6.5 MEDIMMUNE additionally shall pay to IXSYS all royalties
and other amounts owed by IXSYS under the IXSYS LICENSE
AGREEMENTS that are based on development milestones, sales or
manufacturing of PRODUCT by MEDIMMUNE, its AFFILIATES and
SUBLICENSEES. IXSYS shall timely remit such amounts to the
applicable THIRD PARTY. All other payments due under IXSYS
LICENSE AGREEMENTS shall be paid by IXSYS.
6.6 MEDIMMUNE shall keep, and shall cause each of its
AFFILIATES and SUBLICENSEES to keep, full and accurate books of
account containing all particulars that may be necessary for the
purpose of calculating all royalties payable to IXSYS. Such
books of account, together with all necessary supporting data,
shall be kept at their principal place of business, and for the
three (3) years next following the end of the calendar year to
which each pertains, shall be open for inspection by an
independent certified accountant selected by IXSYS and reasonably
acceptable to MEDIMMUNE upon reasonable notice during normal
business hours at IXSYS' expense for the sole purpose of
verifying royalty statements or compliance with this Agreement,
but in no event more than once in each calendar year. All
information and data offered shall be used only for the purpose
of verifying royalties and shall be treated as MEDIMMUNE
Confidential Information subject to the obligations of this
Agreement.
6.7 With each quarterly payment, MEDIMMUNE shall deliver to
IXSYS a full and accurate accounting of the calculation of the
royalties owing hereunder to include at least the following
information:
(a) Quantity of each PRODUCT subject to royalty sold
(by country) by MEDIMMUNE, its AFFILIATES and SUBLICENSEES;
(b) NET SALES for each PRODUCT (by country);
(c) The calculation of the gross royalties (before
deductions) for each PRODUCT (by country) and any deductions,
offsets and credits therefrom; and
(d) Total royalties payable to IXSYS for each PRODUCT
(by country) and the total royalties payable to IXSYS for all
PRODUCTS (for all countries).
6.8 In each year the amount of royalty due shall be
calculated quarterly as of March 31, June 30, September 30 and
December 31 (each being the last day of an "ACCOUNTING PERIOD")
and shall be paid quarterly within the sixty (60) days next
following such date. Every such payment shall be supported by
the accounting prescribed in Section 6.7 and shall be made in
United States currency. Whenever for the purpose of calculating
royalties conversion from any foreign currency shall be required,
such conversion shall be at the average of the rate of exchange
(local currency per US$1) published in the Western Edition of The
Wall Street Journal under the caption "Currency Trading" for the
last business day of each month during the applicable ACCOUNTING
PERIOD.
6.9 If the transfer of or the conversion into United States
Dollar equivalent of any remittance due hereunder is not lawful
or possible in any country, such remittance shall be made by the
deposit thereof in the currency of the country to the credit and
account of IXSYS or its nominee in any commercial bank or trust
company located in that country, prompt notice of which shall be
given to IXSYS. IXSYS shall be advised in writing in advance by
MEDIMMUNE and provide to MEDIMMUNE a nominee, if so desired.
6.10 Any tax required to be withheld by MEDIMMUNE under the
laws of any foreign country for the account of IXSYS shall be
promptly paid by MEDIMMUNE for and on behalf of IXSYS to the
appropriate governmental authority, and MEDIMMUNE shall furnish
IXSYS with proof of payment of such tax. Any such tax actually
paid on IXSYS' behalf shall be deducted from royalty payments due
IXSYS.
6.11 Only one royalty shall be due and payable under each of
the applicable subsections under this Section 6 for the
manufacture, use and sale of a PRODUCT irrespective of the number
of patents or claims thereof which cover the manufacture, use and
sale of such PRODUCT.
6.12 (a) MEDIMMUNE shall pay to IXSYS the following
milestone payments upon the occurrence of the following events
with respect to a PRODUCT and all or a portion of such milestone
payment may be made by the purchase of common stock of IXSYS in
accordance with Section 6.12(d):
A. PRODUCT for (CONFIDENTIAL TREATMENT REQUESTED) indication
Event Payment
(1) Initiate Phase II Clinical Trial
CTR
(2) Initiate a Phase III Clinical Trial
CTR
(3) Submission of a Biologics License Application
in the United States or an equivalent for Europe
(or any country in Europe) or Japan
CTR
(4) Approval of a Biologics License Application in the
United States CTR
(5) Approval to sell in Europe (or any country in
Europe) including pricing approvals
CTR
(6) Approval to sell in Japan including pricing approvals
CTR
B. PRODUCT for (CONFIDENTIAL TREATMENT REQUESTED) indication.
Event Payment
(1) Initiate Phase II Clinical Trial
CTR
(2) Initiate a Phase III Clinical Trial
CTR
(3) Submission of a Biologics License Application
in the United States or an equivalent for Europe
(or any country in Europe) or Japan
CTR
(4) Approval of a Biologics License Application in the
United States CTR
(5) Approval to sell in Europe (or any country in
Europe) including pricing approvals
CTR
(6) Approval to sell in Japan including pricing approvals
CTR
C. Sales Milestones
Event Payment
(1) Cumulative NET SALES of PRODUCTS
in a calendar year exceeds (CONFIDENTIAL
TREATMENT REQUESTED) CTR
(2) Cumulative NET SALES of PRODUCTS
in a calendar year exceeds (CONFIDENTIAL
TREATMENT REQUESTED) CTR
(b) Each of the (CONFIDENTIAL TREATMENT REQUESTED)
milestones shall be paid (CONFIDENTIAL TREATMENT REQUESTED)
whereby the total milestone payment for all PRODUCTS is: (i)
(CONFIDENTIAL TREATMENT REQUESTED) under Section 6.12(a) A ; (ii)
(CONFIDENTIAL TREATMENT REQUESTED) under Section 6.12(a) B ; and
(iii) (CONFIDENTIAL TREATMENT REQUESTED) under Section 6.12(a) C.
(c) The milestone payments under Section 6.12(a) are due
and payable sixty (60) days after the applicable milestone
occurs.
(d) At its option, MEDIMMUNE may make the milestone payment
due under Section 6.12(a) in the form of a purchase of common
stock of IXSYS on the date the applicable milestone payment is
due in a dollar amount equal to the applicable milestone payment
that is due at a price per share equal to (CONFIDENTIAL TREATMENT
REQUESTED) per share if the milestone occurs prior to the first
anniversary of the EFFECTIVE DATE, and thereafter at a price per
share equal to the greater of (i) (CONFIDENTIAL TREATMENT
REQUESTED) per share (which (CONFIDENTIAL TREATMENT REQUESTED)
per share price shall be adjusted for stock splits that occur
after the EFFECTIVE DATE), or (ii)(A) (CONFIDENTIAL TREATMENT
REQUESTED) prior to the date the applicable milestone is
achieved, or (B) if such shares are not traded on a stock
exchange , (CONFIDENTIAL TREATMENT REQUESTED) of the most recent
share price in a good faith, arm's length sale of equity
securities of IXSYS to any THIRD PARTY (independent of an overall
transaction that includes a transfer of technology or marketing
rights and independent of a sale to employees of IXSYS pursuant
to a stock plan) or to MEDIMMUNE. Any such purchase of IXSYS
common stock shall be made pursuant to a stock purchase agreement
substantially in the form of the stock purchase agreement
described in Section 6.13. In no event shall MEDIMMUNE have the
right to purchase a number of shares by which MEDIMMUNE and its
AFFILIATES, in the aggregate, will own more than (CONFIDENTIAL
TREATMENT REQUESTED) of the total outstanding shares of IXSYS, at
the time, on a fully diluted basis. MEDIMMUNE will not have the
right to make the milestone payment in the form of a purchase of
common stock of IXSYS under this Section 6.12(d) if (i) at least
(CONFIDENTIAL TREATMENT REQUESTED) of the total outstanding
shares of IXSYS, on a fully diluted basis, is owned by a single
person or entity, (ii) there has been a good faith merger,
consolidation or similar transaction with a THIRD PARTY in which
IXSYS is not the surviving entity, or (iii) there has been the
good faith sale of all or substantially all of IXSYS' assets
(including this Agreement) to a THIRD PARTY.
(e) (CONFIDENTIAL TREATMENT REQUESTED) of all
milestone payments paid in cash under Section 6.12(a) and
(CONFIDENTIAL TREATMENT REQUESTED) of all milestone payments made
by the purchase of common stock of IXSYS under Section 6.12(d),
are creditable against up to (CONFIDENTIAL TREATMENT REQUESTED)
of each royalty payment that is to be made pursuant to Section
6.1 until the full amount of such credit has been taken.
6.13 At the option of IXSYS, this Agreement shall terminate
and be void ab initio if, by the end of the second business day
after the EFFECTIVE DATE, MEDIMMUNE shall not have purchased
common stock of IXSYS in a cumulative dollar amount equal to
(CONFIDENTIAL TREATMENT REQUESTED) at a price per share of
(CONFIDENTIAL TREATMENT REQUESTED) pursuant to a stock purchase
agreement dated as of the EFFECTIVE DATE between the parties.
SECTION 7 - Infringement.
7.1 (a) If any of the IXSYS PATENTS under which MEDIMMUNE
is licensed hereunder is infringed by the sale by a THIRD PARTY
of a PRODUCT, subject to the provisions of the IXSYS LICENSE
AGREEMENTS, MEDIMMUNE shall have the right and option but not the
obligation to bring an action for such infringement, at its sole
expense, against such THIRD PARTY in the name of IXSYS and/or in
the name of MEDIMMUNE and/or in the name of a licensor of IXSYS,
as the case may be, and to join IXSYS or its licensor as a party
plaintiff if required. MEDIMMUNE shall promptly notify IXSYS of
any such infringement and shall keep IXSYS informed as to the
prosecution of any action for such infringement. No settlement,
consent judgment or other voluntary final disposition of the suit
which adversely affects IXSYS PATENTS may be entered into without
the consent of IXSYS, which consent shall not unreasonably be
withheld.
(b) In the event that MEDIMMUNE shall undertake the
enforcement under Section 7.1(a) of the IXSYS PATENTS by
litigation, subject to the provisions of the IXSYS LICENSE
AGREEMENTS, any recovery of damages by MEDIMMUNE for any such
suit shall be applied first pro rata in satisfaction of any
unreimbursed out of pocket expenses and legal fees of MEDIMMUNE
regarding such suit. The balance remaining from any such
recovery shall be divided between MEDIMMUNE and IXSYS, as follows
(i) for that portion, if any, based on lost profits, IXSYS shall
recover the royalty IXSYS would have received under this
Agreement if such sales had been made by MEDIMMUNE; and (ii) for
any other recovery, IXSYS shall receive (CONFIDENTIAL TREATMENT
REQUESTED) of the remaining amount.
7.2 In the event that MEDIMMUNE elects not to pursue an
action for infringement, upon written notice to IXSYS by
MEDIMMUNE that an unlicensed THIRD PARTY is an infringer of a
VALID PATENT CLAIM of IXSYS PATENTS licensed to MEDIMMUNE, IXSYS
shall have the right and option, but not the obligation at its
cost and expense to initiate infringement litigation and to
retain any recovered damages.
7.3 In any infringement suit either party may institute to
enforce the IXSYS PATENTS pursuant to this Agreement, the other
party hereto shall, at the request of the party initiating such
suit, reasonably cooperate and, to the extent reasonably
possible, have its employees testify when requested and make
available relevant records, papers, information, samples,
specimens, and the like. All reasonable out-of-pocket costs
incurred in connection with rendering cooperation requested
hereunder shall be paid by the party requesting cooperation.
SECTION 8 - Warranties.
8.1 Each of IXSYS and MEDIMMUNE warrants and represents to
the other that:
(a) it has the corporate power and authority and the
legal right to enter into this Agreement and to perform its
obligations hereunder;
(b) it has taken all necessary corporate action on its
part to authorize the execution and delivery of this Agreement
and the performance of its obligations hereunder; and
(c) this Agreement has been duly executed and delivered
on its behalf, and constitutes a legal, valid, binding
obligation, enforceable against it in accordance with its terms.
8.2 IXSYS represents and warrants to MEDIMMUNE that:
(a) it has not previously granted and, prior to
expiration or termination of this Agreement, will not grant any
rights in the IXSYS PATENTS or IXSYS KNOW-HOW that conflict with
the rights and licenses granted to MEDIMMUNE herein;
(b) IXSYS has provided to MEDIMMUNE a true, complete
and correct copy of the IXSYS LICENSE AGREEMENTS (including any
amendments thereto), IXSYS has performed all obligations under
such agreements to enable IXSYS to grant the license granted to
MEDIMMUNE hereunder, and there are no other requirements
necessary for IXSYS to grant such license. IXSYS has neither
received nor delivered any written notice of default under the
IXSYS LICENSE AGREEMENTS. IXSYS hereby covenants and agrees that
(i) it shall not consent to any amendment or modification or
termination of the IXSYS LICENSE AGREEMENTS without the prior
written consent of MEDIMMUNE; (ii) shall keep the IXSYS LICENSE
AGREEMENTS in full force and effect during the respective terms
thereof; (iii) shall not assign IXSYS LICENSE AGREEMENTS without
the written consent of MEDIMMUNE (which consent shall not be
unreasonably withheld), except that such consent shall not be
required for assignment in connection with the transfer or sale
of all or substantially all of its business, or in the event of
its merger, consolidation, change in control or similar
transaction, (x) provided that such assignment is subject to this
Agreement and (y) such assignment does not adversely affect the
IXSYS LICENSE AGREEMENTS or IXSYS rights thereunder; (iv)
MEDIMMUNE will be promptly advised of any notice that IXSYS has
breached or that an IXSYS LICENSE AGREEMENT will be terminated,
and to the extent permitted under the IXSYS LICENSE AGREEMENTS,
MEDIMMUNE shall have the right but not the obligation to cure any
such breach; and (v) prior to the EFFECTIVE DATE, IXSYS has
provided to MEDIMMUNE all information and data in its possession
and control regarding the safety and efficacy of the ANTIBODY
known as VITAXIN.
(c) The IXSYS PATENTS that exist as of the Effective
Date are listed in Appendix B. IXSYS has neither received nor
delivered any written claim, nor has actual knowledge of any
claim, asserting the invalidity, unenforceability or misuse of
the IXSYS PATENTS.
8.3 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN
SECTIONS 8.1 and 8.2, NEITHER PARTY MAKES ANY REPRESENTATION OR
EXTENDS ANY WARRANTIES OF ANY KIND EITHER EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, OR VALIDITY OF
ANY PATENT RIGHTS ISSUED OR PENDING.
SECTION 9 - Indemnification.
9.1 MEDIMMUNE agrees to indemnify and hold harmless IXSYS,
its directors, officers, employees and agents (collectively, the
"Indemnitees") from and against all losses, liabilities, damages
and expenses (including reasonable attorneys' fees and costs)
incurred in connection with any claims, demands, actions or other
proceedings by any third party arising from (a) the research,
development, manufacture, use or sale of ANTIBODIES or PRODUCTS
by MEDIMMUNE, its AFFILIATES or SUBLICENSEES, (b) the use of
PRODUCTS by any purchasers thereof, (c) the use by MEDIMMUNE, its
AFFILIATES or SUBLICENSEES of the IXSYS PATENTS, IXSYS KNOW-HOW
or MATERIALS, or (d) any act or omission by MEDIMMUNE, its
AFFILIATES OR SUBLICENSEES the effect of which would cause IXSYS
to be in breach of its obligations under the IXSYS LICENSE
AGREEMENTS (without regard to any applicable cure or notice
requirements thereof).
9.2 If any such claims or actions are made, IXSYS shall be
defended at MEDIMMUNE's sole expense by counsel selected by
MEDIMMUNE and reasonably acceptable to IXSYS provided that IXSYS
may, at its own expense, also be represented by counsel of its
own choosing.
9.3 MEDIMMUNE's indemnification under Section 9.1 shall not
apply to the extent any loss, liability, damage or expense is
attributable to the gross negligence or intentional misconduct of
the Indemnitees.
9.4 MEDIMMUNE may not settle any such claim, demand, action
or other proceeding or otherwise consent to an adverse judgment
in any such action or other proceeding that diminishes the rights
or interests of the Indemnitees without the express written
consent of the Indemnitees.
9.5 IXSYS shall notify MEDIMMUNE promptly of any claim,
demand, action or other proceeding under Section 9.1 and shall
reasonably cooperate with all reasonable requests of MEDIMMUNE
with respect thereto.
SECTION 10 - Assignment; Successors.
10.1 This Agreement shall not be assigned or otherwise
transferred (in whole or in part, whether voluntarily, by
operation of law or otherwise) by either of the parties without
the prior written consent of the other party (which consent shall
not be unreasonably withheld); provided, however, that either
party may, without such consent, assign this Agreement and its
rights and obligations hereunder to an AFFILIATE or in connection
with the transfer or sale of all or substantially all of its
business, or in the event of its merger, consolidation, change in
control or similar transaction, provided that such assignment by
IXSYS does not cause the termination of the rights and licenses
granted to MEDIMMUNE under this Agreement. Any permitted
assignee shall assume all obligations of its assignor under this
Agreement. Any purported assignment or transfer in violation of
this Section 10.1 shall be void.
10.2 Subject to the limitations on assignment herein, this
Agreement shall be binding upon and inure to the benefit of said
successors in interest and assigns of MEDIMMUNE and IXSYS.
SECTION 11 - Term and Termination.
11.1 Except as otherwise specifically provided herein and
unless sooner terminated pursuant to Section 11.2 or 11.3 of this
Agreement, this Agreement and the licenses and rights granted
thereunder shall remain in full force and effect until MEDIMMUNE
has no further royalty obligation hereunder, at which time
MEDIMMUNE shall have a fully paid-up, non-cancelable,
nonexclusive license (i) under the IXSYS KNOW-HOW to research,
develop, make, have made, use, import, export and sell, offer to
sell or have sold PRODUCTS and (ii) to make, have made and use
the MATERIALS for all of the purposes of Section 11.1(i).
11.2 MEDIMMUNE shall have the right to terminate this
Agreement upon ninety (90) days prior written notice to IXSYS.
11.3 (a) In addition to the right to terminate under Section
11.3(b), IXSYS shall have the right to terminate this Agreement
if and only if MEDIMMUNE breaches its obligations under Section 6
or 9. If such a breach shall occur, IXSYS shall provide
MEDIMMUNE with written notice of such breach and if such breach
is not cured within thirty (30) days after such written notice,
IXSYS may terminate this Agreement by written notice to
MEDIMMUNE, provided such written notice is given within thirty
(30) days after the expiration of such initial thirty (30) day
period.
(b) If, in any calendar year, MEDIMMUNE (or its agent)
has not performed one of the following with respect to a PRODUCT
selected by MEDIMMUNE:
(i) expended (CONFIDENTIAL TREATMENT REQUESTED) in
the calendar year for research and/or development and/or
production which in good faith is directed to a PRODUCT;
(ii) engaged in good faith in a Phase I trial with
respect to a PRODUCT;
(iii) engaged in good faith in a Phase II trial
with respect to a PRODUCT;
(iv) engaged in good faith in a Phase III trial
with respect to a PRODUCT;
(v) good faith preparation and/or good faith review
of documents for filing a Biologics License Application (or its
equivalent) in the United States, Europe or Japan with respect to
a PRODUCT;
(vi) good faith review and/or good faith analysis
of clinical protocols and/or data with respect to a PRODUCT
including but not limited to investigating a serious adverse
event in a clinical trial;
(vii) engaged in good faith in the manufacturing of
GMP ANTIBODY for use in human clinical trials in the United
States, Europe or Japan, provided however that MEDIMMUNE shall in
good faith commence such human clinical trials of such ANTIBODY
within twelve (12) months after commencement of such
manufacturing.
(viii) a Biologics License Application (or its
equivalent) is on file in the United States, Europe or Japan for
a PRODUCT;
(ix) a Biologics License Application (or its
equivalent) has been approved for a PRODUCT in the United States,
Japan or Europe.
then in such event, as IXSYS' sole and exclusive remedy,
within sixty (60) days after the end of such calendar year, IXSYS
shall have the right to send a written notice to MEDIMMUNE that
this Agreement shall be terminated, and if within sixty (60) days
after MEDIMMUNE receives such written notice MEDIMMUNE has not
cured such failure, this Agreement shall be terminated.
(c) If MEDIMMUNE receives a notice of termination under
Section 11.3(a) or 11.3(b), MEDIMMUNE shall have the right to
contest such termination by requesting arbitration under Section
13.2, and if MEDIMMUNE requests such arbitration, this Agreement
shall be terminated only if in such arbitration there is a final
determination that IXSYS has the right to terminate this
Agreement, as provided in this Section 11.3.
11.4 Upon any termination of this Agreement, MEDIMMUNE, at
its option, shall be entitled to sell any completed inventory of
PRODUCT which remains on hand as of the date of the termination,
so long as MEDIMMUNE pays to IXSYS the royalties applicable to
said subsequent sales in accordance with the same terms and
conditions as set forth in this Agreement.
11.5 In the event that this Agreement is terminated under
Section 11.2 or under Section 11.3 :
(a) MEDIMMUNE shall take all actions necessary to
assign and deliver to IXSYS all remaining quantities of all
ANTIBODIES and PRODUCTS developed by or on behalf of MEDIMMUNE
under this Agreement, all clinical and preclinical data and
information regarding such ANTIBODIES and PRODUCTS, and all
registrations and regulatory filings regarding such ANTIBODIES
and PRODUCTS that exist as of the time of termination, in each
case to the extent that MEDIMMUNE has transferable rights
thereto.
(b) IXSYS shall agree to pay a reasonable royalty to
MEDIMMUNE to compensate MEDIMMUNE for the relative value of its
contributions to ANTIBODIES and PRODUCT. The parties shall enter
into good faith negotiations and attempt to reach mutual
agreement to determine such a reasonable royalty. If such mutual
agreement is not reached within ninety (90) days after
commencement of such negotiations, then the determination shall
be submitted to binding arbitration under Section 13.2.
(c) Any sublicense granted under this Agreement shall
remain in full force and effect as a direct license between IXSYS
and the SUBLICENSEE under the terms and conditions of the
sublicense agreement, subject to the SUBLICENSEE agreeing to be
bound to IXSYS under such terms and conditions within thirty (30)
days after IXSYS provides written notice to the SUBLICENSEE of
the termination of this Agreement. At the request of MEDIMMUNE,
IXSYS will acknowledge to a SUBLICENSEE IXSYS' obligations to the
SUBLICENSEE under this paragraph.
11.6 The provisions of Sections 4, 9, 11.1, 11.4, 11.5 and
11.6 shall survive any expiration or termination of this
Agreement.
11.7 Upon expiration or termination of this Agreement for any
reason, nothing herein shall be construed to release either party
from any obligation that matured prior to the effective date of
such expiration or termination.
11.8 All rights and licensing granted under or pursuant to
this Agreement by IXSYS to MEDIMMUNE are, and shall irrevocably
be deemed to be, "intellectual property" as defined in Section
101(56) of the Bankruptcy Code. In the event of the commencement
of a case by or against either party under any Chapter of the
Bankruptcy Code, this Agreement shall be deemed an executory
contract and all rights and obligations hereunder shall be
determined in accordance with Section 365(n) thereof. Unless a
party rejects this Agreement and the other party decides not to
retain its rights hereunder, the other party shall be entitled to
a complete duplicate of (or complete access to, as appropriate)
all intellectual property and all embodiments of such
intellectual property held by the party and the party shall not
interfere with the rights of the other party, which are expressly
granted hereunder, to such intellectual property and all
embodiments of such intellectual property from another entity.
Further, this Agreement shall be deemed, upon presentation to
another entity, to be the same as an express instruction by the
party to such other entity to provide such intellectual property
and all embodiments of such intellectual property directly to the
other party. Without limiting the foregoing provisions in this
paragraph, the other party shall be entitled to all post-
bankruptcy-petition improvements, updates, or developments of
intellectual property created hereunder. If such intellectual
property is not fully developed as of the commencement of any
bankruptcy case, the other party shall have the right to complete
development of the property.
SECTION 12 - Force Majeure.
12.1 No failure or omission by the parties hereto in the
performance of any obligation of this Agreement (other than an
obligation for the payment of money) shall be a breach of this
Agreement, nor shall it create any liability, if the same shall
arise from any cause or causes beyond the reasonable control of
the affected party, including, but not limited to, the following,
which for purposes of this Agreement shall be regarded as beyond
the control of the party in question: acts of God; acts or
omissions of any government; any rules, regulations, or orders
issued by any governmental authority or by any officer,
department, agency or instrumentality thereof; fire; storm;
flood; earthquake; accident; war; rebellion; insurrection; riot;
invasion; strikes; and lockouts or the like; provided that the
party so affected shall use its commercially reasonable efforts
to avoid or remove such causes or nonperformance and shall
continue performance hereunder with the utmost dispatch whenever
such causes are removed.
SECTION 13 - General Provisions.
13.1 The relationship between IXSYS and MEDIMMUNE is that of
independent contractors. IXSYS and MEDIMMUNE are not joint
venturers, partners, principal and agent, master and servant,
employer or employee, and have no relationship other than as
independent contracting parties. IXSYS shall have no power to
bind or obligate MEDIMMUNE in any manner. Likewise, MEDIMMUNE
shall have no power to bind or obligate IXSYS in any manner.
13.2 Any matter or disagreement under Section 6.1(d), 6.2,
11.3(c) or 11.5(b), which this Agreement specifies is to be
resolved by arbitration shall be submitted to a mutually selected
single arbitrator to so decide any such matter or disagreement.
The arbitrator shall conduct the arbitration in accordance with
the Rules of the American Arbitration Association, unless the
parties agree otherwise. If the parties are unable to mutually
select an arbitrator, the arbitrator shall be selected in
accordance with the procedures of the American Arbitration
Association. The decision and award rendered by the arbitrator
shall be final and binding. Judgment upon the award may be
entered in any court having jurisdiction thereof. Any
arbitration pursuant to this section shall be held in San Diego,
California or such other place as may be mutually agreed upon in
writing by the parties. The prevailing party in any such
arbitration shall be entitled to recover from the other party all
reasonable attorneys' fees and costs incurred by the prevailing
party in connection therewith.
13.3 This Agreement sets forth the entire agreement and
understanding between the parties as to the subject matter
thereof and supersedes all prior agreements in this respect.
There shall be no amendments or modifications to this Agreement,
except by a written document which is signed by both parties.
13.4 This Agreement shall be construed and enforced in
accordance with the laws of the State of California without
regard to the conflicts of law principles thereof.
13.5 The headings in this Agreement have been inserted for
the convenience of reference only and are not intended to limit
or expand on the meaning of the language contained in the
particular article or section.
13.6 Any delay in enforcing a party's rights under this
Agreement or any waiver as to a particular default or other
matter shall not constitute a waiver of a party's right to the
future enforcement of its rights under this Agreement, excepting
only as to an expressed written and signed waiver as to a
particular matter for a particular period of time.
13.7 Any notices given pursuant to this Agreement shall be in
writing, delivered by any means, addressed to the other party at
its address indicated below, or to such other address as the
addressee shall have last furnished in writing to the addresser
and (except as otherwise provided in this Agreement) shall be
effective upon receipt by the addressee.
To MEDIMMUNE: MedImmune, Inc.
35 West Watkins Mill Road
Gaithersburg, MD 20878
Copy to: Carella, Byrne, Bain, Gilfillan,
Cecchi, Stewart & Olstein
6 Becker Farm Road
Roseland, New Jersey 07068
Fax No. (973) 994-1744
Attn: Elliot M. Olstein, Esq.
To IXSYS: Ixsys, Inc.
3520 Dunhill Road
San Diego, CA 92121
Attention: President
Copy to: Pillsbury Madison & Sutro LLP
235 Montgomery Street, 16th Floor
San Francisco, California 94104
Attention: Thomas E. Sparks, Jr.
IN WITNESS WHEREOF, the parties have executed this Agreement
as of the date set forth above.
IXSYS, INC. MEDIMMUNE, INC.
By: /s/ Janine M. Taylor By: /s/ David M. Mott
Name: Janine M. Taylor Name: David M. Mott
Title: President & Chief Operating Title: Vice Chairman &
Officer Chief Financial Officer