Research and Assignment and License Agreement - Ixsys Inc. and MedImmune Inc.
RESEARCH AND ASSIGNMENT AND LICENSE AGREEMENT
This Research and Assignment and 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 that IXSYS perform certain
research and development to modify a certain antibody; and
WHEREAS, IXSYS desires to perform such work 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" means an antibody that specifically binds to
(CONFIDENTIAL TREATMENT REQUESTED) (including, but not limited
to, variants, chimeric antibodies, humanized antibodies,
recombinant antibodies, grafted antibodies, single chain
antibodies, and the like) developed by IXSYS during the term of
the PROGRAM or a fragment of such an antibody.
1.3 "ASSIGNED MATERIALS AND INFORMATION" means all
ANTIBODIES, cell lines used by IXSYS for producing ANTIBODIES,
polynucleotides encoding ANTIBODIES, assays, vectors and
constructs for producing ANTIBODIES, sequence information
regarding such ANTIBODIES and polynucleotides, and the results of
the testing and evaluation of such ANTIBODIES and information and
data useful for the manufacture, making and use of ANTIBODY, in
each case which is developed by IXSYS during the term of the
PROGRAM, and only in the case of assays, vectors and constructs,
only to the extent IXSYS or its AFFILIATES has the right during
the term of the PROGRAM to assign such to MEDIMMUNE.
1.4 "ASSIGNED 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 a claim thereof would be infringed by the manufacture,
use, or sale of a product comprising an ANTIBODY and that is
based on ANTIBODY and/or ASSIGNED MATERIALS AND INFORMATION.
1.5 "DESIGNATED AMOUNT" means the total worldwide sales of
products comprising the EXISTING ANTIBODY sold by or on behalf of
MEDIMMUNE for the twelve-month period prior to the time a PRODUCT
receives all licensing and pricing approvals for sale of PRODUCT
in a country.
1.6 (CONFIDENTIAL TREATMENT REQUESTED) means (CONFIDENTIAL
TREATMENT REQUESTED).
1.7 "EXISTING 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 (with the right to grant sublicenses) or as to which IXSYS
otherwise has licensable rights, in each case, as of the
EFFECTIVE DATE.
1.8 "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.
1.9 "FTE" means one full time equivalent scientific
investigator, together with all reasonably necessary materials,
equipment and facilities used thereby.
1.10 "MATERIALS" means ANTIBODIES, cell lines used or
developed by IXSYS for producing ANTIBODIES, polynucleotides
encoding ANTIBODIES, and the assays, vectors and constructs for
producing ANTIBODIES, in each case only to the extent owned by or
licensed to IXSYS (with the right to grant sublicenses) or as to
which IXSYS otherwise has transferable rights, and in the
possession and control of IXSYS, in each case, that exists as of
the EFFECTIVE DATE.
1.11 "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)
reasonable allowance for bad debt, all of the above 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.
1.12 "PRODUCT" means a product comprising (i) an ANTIBODY,
the manufacture, use or sale of which infringes a VALID PATENT
CLAIM under the ASSIGNED PATENTS or under the EXISTING IXSYS
PATENTS as to which MEDIMMUNE retains a license under this
Agreement, (ii) an ANTIBODY assigned to MEDIMMUNE by IXSYS under
this Agreement, or (iii) an ANTIBODY which is derived from an
ANTIBODY assigned to MEDIMMUNE under this Agreement.
1.13 "PROGRAM" means the research and development program
described generally in Section 2.1.
1.14 "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.
1.15 (CONFIDENTIAL TREATMENT REQUESTED)
1.16 "SUBLICENSEE" means any AFFILIATE or THIRD PARTY that
is granted a sublicense by MEDIMMUNE under this Agreement.
1.17 "THIRD PARTY(IES)" means a person or entity other than
IXSYS or MEDIMMUNE or any of their AFFILIATES.
1.18 The term "VALID PATENT CLAIM" shall mean either (a) a
claim of an issued and unexpired patent included within the
ASSIGNED PATENTS or the EXISTING IXSYS PATENTS, which has not
been held permanently revoked, unenforceable or invalid by a
decision of a court or other governmental 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
ASSIGNED PATENTS or the EXISTING IXSYS PATENTS, which claim was
filed in good faith and has not been abandoned or finally dis
allowed without the possibility of appeal or refiling of such
application, the subject matter of which has not been pending for
more than five (5) years, including the pendency of any prior
application.
1.19 The use herein of the plural shall include the
singular, and the use of the masculine shall include the
feminine.
1.20 All dollars are United States Dollars.
SECTION 2 - The PROGRAM
2.1 (a) IXSYS shall perform a program of research and
development in accordance with this Section 2 to produce modified
antibodies to the (CONFIDENTIAL TREATMENT REQUESTED), and shall
use its commercially reasonable efforts to produce a modified
antibody of the (CONFIDENTIAL TREATMENT REQUESTED) that
(CONFIDENTIAL TREATMENT REQUESTED) as compared to (CONFIDENTIAL
TREATMENT REQUESTED), as measured in the (CONFIDENTIAL TREATMENT
REQUESTED) model.
(b) The parties shall prepare a mutually acceptable
written workplan for the PROGRAM. Any such workplan shall be
modified and supplemented from time to time only by the mutual
written agreement of the parties.
(c) The research and development work to be performed
by IXSYS under the PROGRAM shall not be performed by a THIRD
PARTY without the written approval of MEDIMMUNE.
(d) IXSYS shall allocate not less than (CONFIDENTIAL
TREATMENT REQUESTED) FTEs to conduct the PROGRAM and at the
request of MEDIMMUNE upon sixty (60) days' prior written notice,
IXSYS shall be required to allocate up to (CONFIDENTIAL TREATMENT
REQUESTED) FTEs to conduct the PROGRAM, provided that once the
FTEs are increased, MEDIMMUNE will not have the right to decrease
the number of FTEs.
(e) The PROGRAM shall commence on the date thirty (30)
days after the EFFECTIVE DATE and continue for a term of
(CONFIDENTIAL TREATMENT REQUESTED) thereafter provided however at
the request of MEDIMMUNE, and upon sixty (60) days' prior written
notice to IXSYS, the term shall be extended for up to
(CONFIDENTIAL TREATMENT REQUESTED) in (CONFIDENTIAL TREATMENT
REQUESTED) increments.
2.2 It is understood that MEDIMMUNE intends to measure the
potency of ANTIBODY obtained from IXSYS in the (CONFIDENTIAL
TREATMENT REQUESTED) model to determine the potency thereof with
a view toward developing and commercializing such an ANTIBODY. It
is further understood and agreed that ANTIBODY obtained from
IXSYS that is tested, if any, shall be determined by MEDIMMUNE,
within its sole and absolute discretion, that MEDIMMUNE, within
its sole and absolute discretion, shall determine whether or not
to develop and/or commercialize a PRODUCT and which, if any,
PRODUCT shall be developed and commercialized and in which, if
any, countries it should be developed and commercialized.
2.3 (a) MEDIMMUNE shall pay IXSYS at the rate equal to
(CONFIDENTIAL TREATMENT REQUESTED) per FTE required to be
allocated to the PROGRAM as set forth above, payable in equal
quarterly installments of (CONFIDENTIAL TREATMENT REQUESTED) per
FTE per quarter in advance on the EFFECTIVE DATE and each three
(3) month anniversary thereof during the term of the PROGRAM for
the period of Section 2.1(e) which amount covers both direct and
indirect expenses. If the number of FTEs is increased in any
quarter, the pro-rata amount for such quarter for such increase
shall be paid for the remainder of such quarter (and provided
that such payment shall be due on the effective date of such
increase if the notice and effective date of such increase is in
the same calendar quarter).
(b) MEDIMMUNE shall not be required to make any
payments to IXSYS for research that exceeds the aggregate amount
described in Section 2.3(a), and IXSYS shall not be required to
perform research or development under the PROGRAM that exceeds
such aggregate amount, unless agreed to in writing by both
parties.
2.4 Within ten (10) days after the EFFECTIVE DATE,
MEDIMMUNE shall provide IXSYS with such quantity (as reasonably
sufficient to enable IXSYS to conduct the PROGRAM) of the
(CONFIDENTIAL TREATMENT REQUESTED), polynucleotides encoding the
(CONFIDENTIAL TREATMENT REQUESTED) and (CONFIDENTIAL TREATMENT
REQUESTED), the (CONFIDENTIAL TREATMENT REQUESTED) and together
with any other information and data which the parties mutually
agree is reasonably necessary for IXSYS to conduct the PROGRAM.
Additionally, during the term of the PROGRAM, MEDIMMUNE shall
provide IXSYS, at MEDIMMUNE's sole cost, with such technical
assistance as IXSYS reasonably requests regarding the use of such
assay under the PROGRAM.
2.5 During the term of the PROGRAM, IXSYS shall permit
representatives of MEDIMMUNE, upon reasonable notice during
normal business hours at MEDIMMUNE's expense, to visit the
facilities where IXSYS is conducting the PROGRAM and during such
visits shall make employees of IXSYS, who are performing research
and development under the PROGRAM, reasonably available to
representatives of MEDIMMUNE to discuss such research and
development and the results thereof.
2.6 Not later less than once each calendar quarter during
the term of the PROGRAM, and not more than thirty (30) days after
conclusion of the term of the PROGRAM, IXSYS, at the cost and
expense of IXSYS, shall transfer to MEDIMMUNE the ASSIGNED
MATERIALS AND INFORMATION and any other MATERIALS not previously
transferred to MEDIMMUNE hereunder.
2.7 For a period of six (6) months after the conclusion of
the term of the PROGRAM, 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
ASSIGNED MATERIALS AND INFORMATION, and MATERIALS hereunder.
2.8 Except as permitted by MEDIMMUNE, during the term of
the PROGRAM and for a period of (CONFIDENTIAL TREATMENT
REQUESTED) years thereafter, IXSYS and its AFFILIATES shall not
(1) research, develop, make, have made, use or sell any antibody
or any antibody fragment directed to (CONFIDENTIAL TREATMENT
REQUESTED) or any polynucleotide encoding the foregoing, (2)
perform research or development work for a THIRD PARTY with
respect to any such antibody, fragment or polynucleotide , or (3)
research, develop, make, have made, use or sell or grant rights
to a THIRD PARTY with respect to any such antibody, fragment or
polynucleotide that was conceived or reduced to practice during
the term of the PROGRAM or within a period of (CONFIDENTIAL
TREATMENT REQUESTED) years thereafter.
2.9 IXSYS shall have the right to publish the results of
IXSYS' work under the PROGRAM; 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 - Assignment and License Grants.
3.1 (a) IXSYS hereby grants to MEDIMMUNE and MEDIMMUNE
hereby accepts from IXSYS a sole and exclusive worldwide right
and license (or sublicense, as applicable) (1) under and to
EXISTING IXSYS PATENTS to research, develop, make, have made,
use, import, export and sell, offer to sell or have sold PRODUCTS
and (2) to make, have made and to use MATERIALS for all the
purposes of Section 3.1(a)(1). 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 a license
agreement between IXSYS and a THIRD PARTY, the rights and
licenses granted to MEDIMMUNE under such sublicense are limited
to the extent that IXSYS has the right to grant sublicenses under
such license agreement and such sublicense is subject to the
terms, conditions and restrictions of such license agreement that
are applicable to a sublicensee 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 such 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
(with the right to grant further sublicenses, subject to any
terms, conditions and restrictions on further sublicensing under
any license agreement under which MEDIMMUNE is a sublicensee) to
its AFFILIATES and THIRD PARTIES. 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 1.11),
without payment of any further royalty to IXSYS.
3.4 (a) IXSYS agrees to assign and hereby assigns to
MEDIMMUNE all right, title and interest in and to the ASSIGNED
MATERIALS AND INFORMATION together with all ASSIGNED PATENTS and
other intellectual property rights arising therefrom.
(b) IXSYS agrees to cooperate with MEDIMMUNE and cause
its employees to cooperate with MEDIMMUNE and to perform all
acts, at MEDIMMUNE's request on reasonable notice and during
normal business hours, as reasonably necessary (i) to perfect
MEDIMMUNE's ownership interest in and to the ASSIGNED MATERIALS
AND INFORMATION together with all ASSIGNED PATENTS and other
intellectual property rights arising therefrom, and (ii) to
facilitate the preparation, filing, prosecution and enforcement
of the ASSIGNED PATENTS. MEDIMMUNE shall reimburse IXSYS on
demand for the reasonable cost to IXSYS (at the rate set forth in
Section 2.3(a) plus all out-of-pocket expenses) incurred in
connection therewith.
(c) IXSYS hereby reserves the nonexclusive,
nontransferable right to use information and data that are
included in ASSIGNED MATERIALS AND INFORMATION for its own
internal research use; provided, however, that IXSYS shall not
use the ASSIGNED MATERIALS AND INFORMATION to make, have made,
use or sell any antibody directed to (CONFIDENTIAL TREATMENT
REQUESTED), or perform research or development work for a THIRD
PARTY with respect to any such antibody.
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
2.9, IXSYS agrees not to provide or disclose to a THIRD PARTY any
ASSIGNED MATERIALS AND INFORMATION 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, to use the other party's
Confidential Information only for the purposes of 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 ASSIGNED MATERIALS AND INFORMATION are Confidential
Information of MEDIMMUNE.
4.4 The obligations of confidentiality and non-use of
Sections 4.1, 4.2 and 4.3 will not apply to:
(i) Confidential Information generally known
to the public prior to its disclosure hereunder;
or
(ii) Confidential Information that
subsequently becomes known to the public by some
means other than a breach of this Agreement;
(iii) Confidential Information that is
subsequently disclosed to the receiving party by a
third party having a lawful right to make such
disclosure; or
(iv) 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 - Royalties.
5.1 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 the DESIGNATED
AMOUNT;
(b) (CONFIDENTIAL TREATMENT REQUESTED) of that portion
of NET SALES of PRODUCTS in a calendar year above the DESIGNATED
AMOUNT.
The cumulative NET SALES for a calendar year shall be
calculated based on worldwide NET SALES.
5.2 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 NET
SALES of such Combination Product in such country shall be
determined by binding arbitration under Section 11.2.
5.3 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, 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.
5.4 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).
5.5 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 5.4 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.
5.6 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.
5.7 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.
5.8 Only one royalty shall be due and payable under each of
the applicable subsections under this Section 5 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.
5.9 (a) MEDIMMUNE shall pay to IXSYS the following
milestone payments upon the occurrence of the following events
with respect to a PRODUCT:
Event Payment
(i) Demonstration in the (CONFIDENTIAL TREATMENT
REQUESTED) model that a PRODUCT has a (CONFIDENTIAL
TREATMENT REQUESTED) as compared to (CONFIDENTIAL
TREATMENT REQUESTED) $ (CTR)
(ii) Demonstration in the (CONFIDENTIAL TREATMENT
REQUESTED) model that a PRODUCT has a (CONFIDENTIAL
TREATMENT REQUESTED) as compared to (CONFIDENTIAL
TREATMENT REQUESTED) $ (CTR)
(iii) Filing an IND (or its foreign equivalent)
for a PRODUCT $ (CTR)
(iv) Obtains approval of a Biologics License
Application (or its foreign equivalent) for a
PRODUCT $ (CTR)
(b) The milestone payments under Section 5.9(a) are
due and payable sixty (60) days after the applicable milestone
occurs.
(c) (CONFIDENTIAL TREATMENT REQUESTED) of all
milestone payments paid under Section 5.9(a) are creditable
against up to (CONFIDENTIAL TREATMENT REQUESTED) of each royalty
payment that is to be made pursuant to Section 5.1 until the full
amount of such credit has been taken..
(d) The total payment under Section 5.9(a)(i) and
5.9(a)(ii) shall not exceed (CONFIDENTIAL TREATMENT REQUESTED),
and the total milestone payments for any and all PRODUCT shall
not exceed (CONFIDENTIAL TREATMENT REQUESTED).
SECTION 6 - Warranties.
6.1 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.
6.2 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 EXISTING IXSYS PATENTS, ASSIGNED PATENTS,
MATERIALS, and ASSIGNED MATERIALS AND INFORMATION that conflict
with the rights and licenses granted to MEDIMMUNE herein;
(b) all persons performing research by or on behalf of
IXSYS under the PROGRAM will be obligated to assign to IXSYS (for
re-assignment to MEDIMMUNE hereunder), the ownership of ASSIGNED
MATERIALS AND INFORMATION, the ASSIGNED PATENTS and all other
intellectual property rights arising therefrom.
6.3 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN
SECTIONS 6.1 and 6.2, 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 7 - Indemnification.
7.1 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 EXISTING IXSYS PATENTS, the
ASSIGNED MATERIALS AND INFORMATION or the ASSIGNED PATENTS,
(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 license agreements described
in Section 3.1(b) (without regard to any applicable cure or
notice requirements thereof, or (e) patent infringement by IXSYS
during the PROGRAM based on a claim that an ANTIBODY or ligand or
assay provided by MEDIMMUNE to IXSYS infringes a patent of a
THIRD PARTY.
7.2 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.
7.3 MEDIMMUNE's indemnification under Section 7.1 shall not
apply to the extent any loss, liability, damage or expense is
attributable to the gross negligence or intentional misconduct of
the Indemnitees.
7.4 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.
7.5 IXSYS shall notify MEDIMMUNE promptly of any claim,
demand, action or other proceeding under Section 7.1 and shall
reasonably cooperate with all reasonable requests of MEDIMMUNE
with respect thereto.
SECTION 8 - Assignment; Successors.
8.1 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 8.1 shall be void.
8.2 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 9 - Term and Termination.
9.1 Except as otherwise specifically provided herein and
unless sooner terminated pursuant to Section 9.2 or 9.3 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 to make, have made and use MATERIALS to
research, develop, make, have made, use, import, export, sell,
offer to sell, or have sold PRODUCTS.
9.2 MEDIMMUNE shall have the right to terminate this
Agreement upon ninety (90) days prior written notice to IXSYS.
9.3 IXSYS shall have the right to terminate this Agreement
if and only if MEDIMMUNE breaches its obligations under Section
5 or 7. 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.
9.4 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.
9.5 In the event that this Agreement is terminated under
Section 9.2 or 9.3, 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.
9.6 The provisions of Sections 2.8, 2.9, 3.4(c), 4, 7, 9.4,
9.5 and 9.6 shall survive any expiration or termination of this Agreement.
9.7 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.
9.8 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 10 - Force Majeure.
10.1 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 11 - General Provisions.
11.1 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.
11.2 Any matter or disagreement under Section 5.2, 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.
11.3 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.
11.4 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.
11.5 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.
11.6 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.
11.7 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 addressor
and (except as otherwise provided in this Agreement) shall be
effective upon receipt by the addressee.
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