License Agreement - Loyola University of Chicago and MedImmune Inc.
LICENSE AGREEMENT
This Agreement is effective December 3, 1997 ("the EFFECTIVE DATE") by
and between LOYOLA UNIVERSITY OF CHICAGO, an Illinois not for profit
corporation, with offices at 820 North Michigan Avenue, Chicago, IL 60611
("UNIVERSITY"), and MEDIMMUNE, INC., a Delaware Corporation having offices
at 35 West Watkins Mill Road, Gaithersburg, MD 20878 ("MEDIMMUNE").
WHEREAS, MEDIMMUNE desires to obtain an exclusive license in and to
certain patents owned by UNIVERSITY;
WHEREAS, UNIVERSITY is willing to grant the exclusive license desired
by MEDIMMUNE.
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 The term "AFFILIATE" as applied to MEDIMMUNE shall mean a related
company of MEDIMMUNE, the voting stock of which is directly or indirectly
at least fifty percent (50%) owned or controlled by MEDIMMUNE, or an
organization which directly or indirectly controls at least fifty percent
(50%) of the voting stock or ownership of MEDIMMUNE, and an organization, a
majority ownership of which is directly or indirectly common to the
ownership of MEDIMMUNE.
1.2 The term "FIELD" shall mean products and processes directed to the
treatment, prevention or diagnosis of human diseases or infections related
to human papilloma virus ("HPV").
1.3 The term "FIRST COMMERCIAL SALE" shall mean in each country the
first sale of any PRODUCT by MEDIMMUNE, its AFFILIATES or SUBLICENSEES,
following approval of its marketing by the appropriate governmental agency
for the country in which the sale is to be made and when governmental
approval is not required, the first sale in that country.
1.4 The term "INVENTIONS" shall mean new and useful improvements in
the construction of Papillomavius hybrid particles conceived and reduced to
practice by Lutz Grissman, Jian Zhou, Martin Muller, and Jeanette
Painstill, all employees of UNIVERSITY, and disclosed to UNIVERSITY in
Loyola University Invention Disclosure dated September 28, 1994, and
December 16, 1996, and as amended from time to time.
1.5 The term "NET SALES" means the total amount received by MEDIMMUNE
or its AFFILIATES from sales of PRODUCT, less transportation charges and
insurance, sales taxes, use taxes, excise taxes, value added taxes, customs
duties or other imposts, normal and customary quantity and cash discounts,
rebates (to the extent actually granted) and disallowed reimbursements and
allowances and credit on account of rejection or return of PRODUCT.
(PAGE 1)
1.6 The term "PATENT RIGHTS" shall mean the following: (CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED)
1.7 The term "PRODUCT" shall mean any article, composition, apparatus,
substance, chemical, material, method or service, the manufacture, use or
sale of which, but for the license granted hereunder, would infringe a
VALID CLAIM of PATENT RIGHTS.
1.8 The term "SUBLICENSEE" shall mean any non-AFFILIATE third party
licensed by MEDIMMUNE to make, have made, import, use or sell any PRODUCT
under PATENT RIGHTS.
1.9 The term "TERRITORY" shall mean all countries of the world.
1.10 The term "VALID CLAIM" shall mean a claim of an issued patent
which has not lapsed or become abandoned or been declared invalid or
unenforceable by a court of competent jurisdiction or an administrative
agency from which no appeal can be or is taken.
1.11 The use herein of the plural shall include the singular, and the
use of the masculine shall include the feminine.
SECTION 2 - GRANT.
2.1 (a)UNIVERSITY hereby grants to MEDIMMUNE and MEDIMMUNE hereby
accepts from UNIVERSITY a sole and exclusive, royalty-bearing right and
license for the TERRITORY under PATENT RIGHTS to make, have made, use,
import, offer to sell, sell or have sold on its behalf PRODUCT in the
FIELD, including the right to sublicense third parties. MEDIMMUNE shall
have the right to extend such license to its AFFILIATES.
(b) MEDIMMUNE, at UNIVERSITY's request, shall grant to a third party a
royalty bearing, sublicense under PATENT RIGHTS in the field defined
by MEDIMMUNE and the third party. MEDIMMUNE shall be required to
grant only one sublicense under this Par 2.1(b).
2.2 MEDIMMUNE agrees to forward to UNIVERSITY a copy of all fully
executed sublicense agreements (with financial terms redacted) within
thirty (30) days of signing thereof.
2.3 The above licenses to sell any PRODUCT includes the right of
MEDIMMUNE, its AFFILIATES and SUBLICENSEES to grant to the purchaser of a
PRODUCT for which a royalty has been paid under this Agreement the right to
use and/or resell such purchased PRODUCT without payment of an additional
royalty, provided that such purchaser does not combine PRODUCT with other
products or otherwise add significant value to the PRODUCT. If so, such
transactions should be sublicenses rather than sales transactions.
(PAGE 2)
2.4 (a) Taking into account the complexity, and stage of
development of the PRODUCT and the science related thereto,
MEDIMMUNE shall select and use reasonable best efforts under the
circumstances to research, develop and then commercialize a
selected PRODUCT. The efforts of a SUBLICENSEE, collaborator
and/or an AFFILIATE shall be considered as efforts of MEDIMMUNE.
(b) MEDIMMUNE and UNIVERSITY agree that the following
commercialization milestones are reasonable, taking into account
the complexity and stage of development of the PATENT RIGHTS and
the science related thereto and that the achievement of such
milestones shall conclusively establish reasonable best efforts
under Par. 2.4(a).
1. Phase I clinical trials on any Product initiated by MEDIMMUNE an
AFFILIATE or a SUBLICENSEE anywhere in the World by the beginning of
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED).
2. Phase II clinical trials on any Product initiated by MEDIMMUNE an
AFFILIATE, or a SUBLICENSEE anywhere in the World by the beginning
of the (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED), or two years
after Milestone 1, whichever is later.
3. Phase III clinical trials on any Product initiated by MEDIMMUNE an
AFFILIATE, or a SUBLICENSEE anywhere in the World by the beginning
of (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED), or two years after
Milestone 2, whichever is later.
4. A product license application submitted by MEDIMMUNE an AFFILIATE,
or a SUBLICENSEE in any territory of the world by beginning of
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED), or two years after
Milestone 3, whichever is later.
5. Granting an approval for sale by MEDIMMUNE an AFFILIATE, or a
SUBLICENSEE of any PRODUCT in any territory of the world by the
beginning of (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED), or one
year after Milestone 4, whichever is later.
(c) If MEDIMMUNE an AFFILIATE, or a SUBLICENSEE fails to
achieve a Milestone by the Milestone date, then MEDIMMUNE may
request a meeting with UNIVERSITY within ten (10) days of the
Milestone date to discuss the reasons for the failure to meet the
Milestone, and to propose corrective actions and a revised
schedule for future milestones. Within thirty (30) days of the
Milestone date if the Milestone has not been achieved, as its
sole and exclusive remedy,
UNIVERSITY may give notice that the license granted
hereunder is no longer exclusive (but only if the failure to
achieve the milestone was within the control of MEDIMMUNE) or
agree to a revised schedule of future milestones.
(PAGE 3)
2.5 UNIVERSITY acknowledges that MEDIMMUNE is in the business of
developing, manufacturing and selling of medical processes and products and
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.
2.6 Subject to Section 2.4, MEDIMMUNE shall have sole discretion for
making all decisions relating to the commercialization and marketing of
PRODUCT, and will bear the cost of preparing such PRODUCT for market and
for obtaining governmental approvals (except with respect to PATENT RIGHTS)
where required.
SECTION 3. CONFIDENTIALITY.
3.1 Subject to the exceptions set forth in Sections 3.2 and 3.3, during
the term of this Agreement, UNIVERSITY may disclose to MEDIMMUNE
proprietary and confidential technology, inventions, technical information,
material, reagents, biological materials and the like which are owned or
controlled by UNIVERSITY and which is designated by UNIVERSITY as
confidential ("Confidential Information"). MEDIMMUNE agrees to retain such
Confidential Information in confidence and not to disclose any such
Confidential Information to a third party without the prior written consent
of UNIVERSITY and to use such Confidential Information only for the
purposes of this Agreement.
3.2 The obligations of confidentiality and non-use will not apply to
Confidential Information which:
(i) was known to MEDIMMUNE or generally known to
the public prior to its disclosure hereunder; or
(ii)subsequently becomes known to the public by
some means other than a breach of this Agreement;
(iii) is subsequently disclosed to MEDIMMUNE by
a third party having a lawful right to make such
disclosure;
(iv)is disclosed to obtain regulatory approval for
PRODUCT or for the purpose of making, using, selling or
licensing of PRODUCT, provided that MEDIMMUNE takes all
reasonable steps to restrict and maintain the
confidentiality of the disclosure;
(v) is required by law, rule, regulation or bona
fide legal process to be disclosed, provided that
MEDIMMUNE takes all reasonable steps to restrict and
maintain confidentiality of such disclosure and provides
reasonable notice to UNIVERSITY; or
(vi)is approved for release by the parties.
(PAGE 4)
3.3 Notwithstanding anything to the contrary, MEDIMMUNE shall have the
right to transfer Confidential Information to a third party including
MEDIMMUNE'S AFFILIATES and SUBLICENSEES for the purpose of researching,
developing and making PRODUCT, provided that such third party agrees to be
bound by obligations of confidentiality and non-use similar to those set
forth in this Agreement.
SECTION 4. PATENT PROSECUTION.
4.1 UNIVERSITY shall take responsibility for the preparation, filing,
prosecution and maintenance of any and all PATENT RIGHTS PATENT
APPLICATIONS and PATENTS RIGHTS PATENTS, included in PATENT RIGHTS,
provided however that UNIVERSITY shall first consult with MEDIMMUNE as to
the preparation, filing prosecution and maintenance of such PATENT RIGHTS
PATENT APPLICATIONS and PATENT RIGHTS PATENTS and shall furnish to
MEDIMMUNE copies of office actions, cited prior art, responses to office
actions, requests for terminal disclaiming, and requests for reissue or
reexamination, other documents relevant to any such preparation, filing,
prosecution or maintenance. UNIVERSITY and MEDIMMUNE shall cooperate fully
in the preparation, filing, prosecution and maintenance of PATENT RIGHTS
and of all PATENT RIGHTS PATENTS and PATENT RIGHTS PATENT APPLICATIONS
licensed to MEDIMMUNE hereunder, executing all papers and instruments so as
to enable UNIVERSITY to apply for, to prosecute and to maintain PATENT
RIGHTS PATENT APPLICATIONS and PATENTS RIGHTS PATENTS in its name in any
country. Each party shall provide to the other prompt notice as to all
matters which come to its attention and which may affect the preparation,
filing, prosecution or maintenance of any such PATENT RIGHTS PATENT
APPLICATIONS or PATENT RIGHTS PATENTS. Patent attorneys chosen by
UNIVERSITY shall handle patent filings and prosecutions on behalf of
UNIVERSITY, provided, however, MEDIMMUNE shall be entitled to review and
comment upon all actions undertaken in the prosecution of all PATENT RIGHTS
PATENTS and PATENT RIGHTS PATENT APPLICATIONS.
4.2 MEDIMMUNE shall reimburse UNIVERSITY for patent fees and
application costs incurred with respect to PATENT RIGHTS prior to the
EFFECTIVE DATE, provided such reimbursement shall not exceed (CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED).
4.3 After the EFFECTIVE DATE, MEDIMMUNE shall reimburse UNIVERSITY for
all reasonable expenses incurred by UNIVERSITY for the preparation, filing,
prosecution and maintenance of PATENT RIGHTS upon receipt of invoices from
UNIVERSITY.
4.4 In the event UNIVERSITY decides not to apply for, prosecute or
maintain any such PATENT RIGHTS PATENT APPLICATIONS and PATENT RIGHTS
PATENTS, UNIVERSITY shall give sufficient and timely notice to MEDIMMUNE so
as to permit MEDIMMUNE to apply for, prosecute and maintain such PATENT
RIGHTS PATENT APPLICATIONS and PATENT RIGHTS PATENTS. MEDIMMUNE shall
have the right to pursue same in UNIVERSITY's name and at MEDIMMUNE's
expense, and MEDIMMUNE shall not pay royalties on sales of PRODUCTS in such
territories.
(PAGE 5)
4.5 In the event MEDIMMUNE elects to no longer pay the expenses of a
PATENT RIGHT PATENT APPLICATION or PATENT RIGHT PATENT included within
PATENT RIGHTS, MEDIMMUNE shall notify UNIVERSITY not less than sixty (60)
days prior to such action and shall thereby surrender its rights under such
patent or patent application.
SECTION 5. ROYALTIES AND OTHER COMPENSATION
5.1 (A) MEDIMMUNE shall pay to UNIVERSITY:
a royalty of (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
of the NET SALES of PRODUCTS which are sold by MEDIMMUNE or its
AFFILIATES and which are covered by a VALID CLAIM of any PATENT
RIGHT licensed to LICENSEE hereunder in the country where sold;
or (ii) a royalty of the lesser of (CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED) of the running royalty received by LICENSEE from
its SUBLICENSEES for the sale of PRODUCTS or (CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED) of the NET SALES of PRODUCT sold by
the SUBLICENSEE.
(B) In the event that MEDIMMUNE'S license is converted to a non-
exclusive license pursuant to Section 2.4(c), the royalties under
Paragraph 5.1 (A) shall be reduced by (CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED).
(C) In the event that a PRODUCT includes both component(s) covered by
a VALID CLAIM of a PATENT RIGHT ("Patented Component(s)") and a
component which is therapeutically active and such component is not
covered by a VALID CLAIM of a PATENT RIGHT ("Unpatented Component(s)
(s)") (such PRODUCT being a "Combined Product"), then NET SALES
shall be the amount which is normally received by MEDIMMUNE or its
AFFILIATES from the sale of the Patented Component(s) in an arm's
length transaction with an unaffiliated third party. If the
Patented Component (s) are not sold separately, then NET SALES
upon which a royalty is paid shall be the NET SALES of the Combined
Product multiplied by a fraction, the numerator of which is the
number of Patented Components in the Combined Product and the
denominator of which is the total number of therapeutically active
Components (Patented) Components plus Unpatented Components) in the
Combined Product.
(D) In the event that royalties are to be paid by MEDIMMUNE to a party
who is not an AFFILIATE of MEDIMMUNE for PRODUCT for which royalties
are also due to UNIVERSITY pursuant to Paragraph 5.1 (such royalties
to such party are hereinafter "Other Royalties"), then the royalties
to be paid to UNIVERSITY by MEDIMMUNE pursuant to Paragraph 5.1 (A)
or (B) shall be reduced by (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED) of the amount of such Other Royalties, but in no event
shall any royalities payable under Paragraph 5.1 be reduced by more
than (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED).
(PAGE 6)
5.2 (a) Upon execution of this Agreement, MEDIMMUNE shall pay
UNIVERSITY a license fee of (CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED).
(b) MEDIMMUNE shall also pay the following amounts within
thirty (30) days of achieving the milestones set forth herein.
(i) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) on
initiation of Phase II clinical trials on any PRODUCT
initiated by MEDIMMUNE an AFFILIATE, or a SUBLICENSEE in the
United States or Europe.
(ii) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) on
initiation of Phase III clinical trials on any PRODUCT
initiated by MEDIMMUNE, an AFFILIATE, or a SUBLICENSEE in
the United States or Europe.
(iii)(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) on
submission of a product license application by MEDIMMUNE, an
AFFILIATE or a SUBLICENSEE in the United States or Europe.
(iv) (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED) on approval of the first Biologics License
Application for a PRODUCT with the U.S. Food and Drug
Administration.
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 UNIVERSITY. Such books of account shall be kept at
their principal place of business and, with all necessary supporting data
shall, for the three (3) years next following the end of the calendar year
to which each shall pertain be open for inspection by its designee upon
reasonable notice during normal business hours at UNIVERSITY's 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 In each year the amount of royalty due shall be calculated
semi-annually as of June 30 and December 31 (each as being the last day of
an "Accounting Period") and shall be paid semi-annually within the sixty
(60) days next following such date, every such payment shall be supported
by the accounting prescribed in Paragraph 5.5 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 rate of exchange thereafter published in the Wall Street
Journal for the last business day of the applicable Accounting Period.
5.5 With each semi-annual payment, MEDIMMUNE shall deliver to
UNIVERSITY a full and accurate accounting to include at least the following
information:
(PAGE 7)
(a) Quantity of each PRODUCT subject to royalty sold (by
country) by MEDIMMUNE and its AFFILIATES and SUBLICENSEES;
(b) Total receipts for each PRODUCT subject to royalty (by
country);
(c) Taxes paid (by country)
(d) Royalties due to third parties (identifying the party and
the royalty rate)
(e) Total royalties payable to UNIVERSITY
(f) Royalties received from SUBLICENSEES
(g) Actual exchange rates applied to foreign funds
5.6 Any tax required to be withheld by MEDIMMUNE under the laws of any
foreign country for the account of UNIVERSITY, shall be promptly paid by
MEDIMMUNE for and on behalf of UNIVERSITY to the appropriate governmental
authority, and MEDIMMUNE shall furnish UNIVERSITY with proof of payment of
such tax. Any such tax actually paid on UNIVERSITY's behalf shall be
deducted from royalty payments due UNIVERSITY.
5.7 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 UNIVERSITY or its
nominee in any commercial bank or trust company located in that country,
prompt notice of which shall be given to UNIVERSITY. UNIVERSITY shall be
advised in writing in advance by MEDIMMUNE and provide to MEDIMMUNE a
nominee, if so desired.
5.8 Only one royalty shall be due and payable 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.
SECTION 6 - INFRINGEMENT
6.1 Infringement of UNIVERSITY'S PATENT RIGHTS by third parties:
6.1.1 MEDIMMUNE shall inform UNIVERSITY promptly in writing of any
alleged infringement and of any available evidence of infringement
by a third party of any patents within the PATENT RIGHTS, and
UNIVERISITY shall inform MEDIMMUNE promptly in writing of any
alleged infringement and of any available evidence of infringement
by a third party of any patents within the PATENT RIGHTS.
6.1.2 During the term of this Agreement, UNIVERSITY shall have the
right, but shall not be obligated, to prosecute at its own expense
any such infringements of the PATENT RIGHTS and, in furtherance of
such right, UNIVERSITY hereby agrees that MEDIMMUNE may join
UNIVERSITY as a party plaintiff in any such suit without expense to
UNIVERSITY. The total cost of any such
(PAGE 8)
6.1.3 infringement action commenced or defended solely by UNIVERSITY
shall be borne by UNIVERSITY. Any recovery of damages by UNIVERSITY
for any infringement shall be applied first in satisfaction of any
unreimbursed expenses and attorneys' fees of UNIVERSITY relating to
the suit, and second toward reimbursement of MEDIMMUNE's reasonable
expenses, including reasonable attorneys' fees, relating to the
suit. The balance remaining from any such recovery shall be
distributed to UNIVERSITY.
6.1.3. If within three (3) months after having been notified of any
alleged infringement, UNIVERSITY shall have been unsuccessful in
persuading the alleged infringer to desist and shall not have
brought and shall not be diligently prosecuting an infringement
action; or if UNIVERSITY shall notify MEDIMMUNE at any time prior
thereto of its intention not to bring suit against any alleged
infringer, then MEDIMMUNE in its sole discretion shall have the
right, but shall not be obligated, to either:
(a) settle the infringement dispute by sublicensing the
alleged infringer or by other means; or
(b) prosecute at its own expense any infringement of the
PATENT RIGHTS. In the event MEDIMMUNE prosecutes such
infringement, MEDIMMUNE may, for such purposes, request to
use the name of UNIVERSITY as party plaintiff. Subject to
the approval of the Board of Trustees of Loyola University
of Chicago, the UNIVERSITY may agree to become a party
plaintiff.
6.1.4 In the event that MEDIMMUNE shall undertake the enforcement
and/or defense of the PATENT RIGHTS by litigation, including any
declaratory judgment action, MEDIMMUNE may withhold an amount equal
to up to (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) from future
royalties due under Section 5 of this Agreement for legal expenses,
including reasonable attorneys' fees, in connection with such
litigation. Any recovery of damages by MEDIMMUNE for any such suit
shall be applied first to reimburse UNIVERSITY for any royalties due
but withheld under this paragraph 6.1.4 and any unreimbursed legal
expenses of UNIVERSITY, and second in satisfaction of any
unreimbursed expense and attorney's fees of MEDIMMUNE relating to
the suit. The balance remaining from any such recovery shall be
distributed to MEDIMMUNE, provided that MEDIMMUNE shall pay to
UNIVERSITY such royalties as would otherwise be applicable under
Section 5 hereof for that portion of MEDIMMUNE's recovery
attributable to lost sales. MEDIMMUNE shall be entitled to settle
any such litigation by agreement, consent, judgment, voluntary
dismissal, or otherwise.
6.1.5 MEDIMMUNE shall have the right in accordance with the terms
and conditions herein to sublicense any alleged infringer under
(PAGE 9)
6.1.6 the PATENT RIGHTS for future infringements.
6.1.6 In any infringement suit either party may institute to enforce
the PATENT RIGHTS pursuant to this Agreement, the other party hereto
shall, at the request of the party initiating such suit, cooperate
in all respects and, to the extent 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.
6.1.7 Any of the foregoing notwithstanding, if at any time during
the term of this Agreement any of the PATENT RIGHTS are declared
invalid or unenforceable, by a court of competent jurisdiction or an
administrative agency from which no appeal can be or is taken,
MEDIMMUNE, shall have no further obligation to UNIVERSITY with
respect to its future use or sale of any product or process covered
by such PATENT RIGHTS, including the obligation of paying royalties.
Nevertheless, MEDIMMUNE shall not have a damage claim or a claim for
refund or reimbursement against the UNIVERSITY.
6.2 Alleged infringement of a third party's patent rights.
6.2.1 In the event that litigation against MEDIMMUNE is initiated
by a third-party charging MEDIMMUNE with infringement of a patent of
the third party as a result of the manufacture, use or sale by
MEDIMMUNE of PRODUCT covered by a PATENT RIGHT, MEDIMMUNE shall
promptly notify UNIVERSITY in writing thereof. MEDIMMUNE's costs as
to any such defense shall be creditable against any and all payments
due and payable to UNIVERSITY under Section 5 of this Agreement but,
no royalty payment after taking into consideration any such credit
under this Section 6.2.1 shall be reduced by more than
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) provided, however,
that if said claim of infringement does not pertain to a PATENT
RIGHT of UNIVERSITY, but to other patent rights used in the
manufacture or sale of the PRODUCT, then this credit shall not be
made against royalities due and payable to UNIVERSITY.
6.2.2 In the event of a judgment in any suit in which a court of
competent jurisdiction rules that the manufacture, use or sale by
MEDIMMUNE of PRODUCT covered by a PATENT RIGHT has infringed on a
third-party's patent requiring MEDIMMUNE to pay damages or a royalty
to said third party, or in the event of a settlement of such suit
requiring damages or royalty payments to be made, payments due to
UNIVERSITY under Section 5 of this Agreement arising from the
applicable PRODUCT shall be correspondingly reduced by the amounts
due under the requirement of such judgment or under the terms of
such settlement. However, subject to Section 5.1(c), the royalty
payment after taking into consideration any such reduction under
this Section 6.2.2 shall not be reduced by more than (CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED);
(PAGE 10)
6.2.3 provided, however that if said judgment does not
pertain to a PATENT RIGHT of UNIVERSITY, but to other patent rights
used in the manufacture or sale of the PRODUCT, then this credit
shall not be made against royalties due and payable to the
UNIVERSITY.
6.2.3 UNIVERSITY shall give MEDIMMUNE assistance in the defense
of any such infringement charge or lawsuit, as may be
reasonably required.
SECTION 7 - WARRANTIES.
7.1 UNIVERSITY and MEDIMMUNE warrant and represent to the other that it
has the full right and authority to enter into this Agreement, and that it
is not aware of any impediment which would inhibit its ability to perform
the terms and conditions imposed on it by this Agreement.
7.2 UNIVERSITY warrants and represents that the named inventors of
PATENT RIGHTS and any assignees thereof have assigned all right, title and
interest to the PATENT RIGHTS to UNIVERSITY, that UNIVERSITY has not
licensed or assigned any right or interest in or to PATENT RIGHTS to any
third party; and that it has the right to grant the rights granted
hereunder.
7.3 UNIVERSITY covenants, warrants and represents that (i) UNIVERSITY
has not received any information with respect to any challenge by another
as to the validity of the PATENT RIGHTS (ii) UNIVERSITY has not received
any information that any of the PATENT RIGHTS is involved in an
interference action; (iii) except with respect to the filing by Medigene,
Inc. for foreign protection in States, including Germany, UNIVERSITY has
not received any information with respect to any challenge by another to
UNIVERSITY's rights of sole ownership; and (iv) UNIVERSITY represents that
it is taking all steps necessary to secure its exclusive title to the
properties in all countries.
7.4 Except as otherwise expressly set forth in this Section 7, LOYOLA
MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND EITHER
EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND VALIDITY OF PATENT
RIGHTS CLAIMS ISSUED OR PENDING.
SECTION 8 - INDEMNIFICATION.
8.1 MEDIMMUNE, its AFFILIATES and SUBLICENSEES shall at all times
during the term of this Agreement indemnify, defend and hold UNIVERSITY its
affiliates and subsidiaries and their Trustees, Officers, Faculty, Medical
and Professional Staff, Employees, Agents and their representatives,
successors, assignees and heirs harmless against all third party claims and
expenses, including legal expenses and reasonable attorneys' fees, arising
out of the death of or injury to any person or persons or out of any damage
to property and against any other claim, proceeding, demand, expense and
liability of any kind whatsoever resulting from utilization of the PATENT
RIGHTS in the research, development, evaluations, production, manufacture,
(PAGE 11)
sale, use, lease, consumption or advertisement of the PRODUCTS by
MEDIMMUNE, its AFFILIATES and SUBLICENSEES except for any claims or
expenses arising out of the negligence or willful misconduct of UNIVERSITY
or its affiliates and subsidiaries and their Trustees, Officers, Faculty,
Medical and Professional Staff, Employees, Agents and their
representatives, successors, assignees and heirs.
8.2 MEDIMMUNE and its SUBLICENSEES shall maintain reasonable levels of
product liability insurance available at commercially reasonable rates, at
its expense, to comply with its obligations to UNIVERSITY under this
section as soon as it has commercialized PRODUCT(s). UNIVERSITY shall have
the right to require such insurance policies to be made available for the
UNIVERSITY's inspection.
SECTION 9 - ASSIGNMENT; SUCCESSORS.
9.1 This Agreement shall not be assignable by either of the parties
without the prior written consent of the other party (which consent shall
not be unreasonably withheld), except that MEDIMMUNE without the consent of
UNIVERSITY may assign this Agreement to an AFFILIATE or to a successor in
interest or transferee of all or substantially all of its human papilloma
virus business. Any other assignment by MEDIMMUNE without UNIVERSITY'S
approval will be null and void.
9.2 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 UNIVERSITY. Any such successor or
assignee of a party's interest shall expressly assume in writing the
performance of all the terms and conditions of this Agreement to be
performed by said party and such Assignment shall not relieve the Assignor
of any of its obligations under this Agreement.
SECTION 10 - TERMINATION.
10.1 Except as otherwise specifically provided herein and unless sooner
terminated pursuant to Paragraph 10.2 or 10.3 of this Agreement, this
Agreement and the licenses and rights granted thereunder shall remain in
full force and effect until the expiration of the last to expire PATENT
RIGHT at which time MEDIMMUNE shall have a fully paid-up noncancellable
license.
10.2 Except as qualified by Paragraph 10.7, MEDIMMUNE shall have the
right to terminate this Agreement or terminate its license under this
Agreement, in one or more countries, upon sixty (60) days prior written
notice.
10.3 Upon material breach of any material provisions of this Agreement
by either party to this Agreement, in the event the breach is not cured
within sixty (60) days after written notice to the breaching party by the
other party, in addition to any other remedy it may have, the other party
at its sole option may terminate this Agreement, provided that such other
party is not then in breach of this Agreement.
(PAGE 12)
10.4 If MEDIMMUNE shall cease to carry on its business, this Agreement
shall terminate upon notice by UNIVERSITY. or: In the event that
MEDIMMUNE shall become insolvent, shall make an assignment for the benefit
of creditors, or shall have a petition in bankruptcy filed for or against
it, UNIVERSITY shall have the right to terminate this entire Agreement
immediately upon giving MEDIMMUNE written notice of such termination.
10.5 Except as provided in Section 10.4, in the event there is a
disagreement between the parties as to whether or not a material breach has
occurred, this Agreement shall not terminate until such disagreement has
been finally determined by arbitration as provided in Section 11.2 herein.
10.6 Upon any termination of this Agreement MEDIMMUNE shall be entitled
to but not be obligated to finish any work-in-progress which is completed
within six (6) months of termination of this Agreement and to sell any
completed inventory of a PRODUCT covered by this Agreement which remains on
hand as of the date of the termination, so long as MEDIMMUNE pays to
UNIVERSITY the royalties applicable to said subsequent sales in accordance
with the same terms and conditions as set forth in this Agreement.
10.7 In the event that this Agreement is terminated, any sublicense
granted by MEDIMMUNE under this Agreement shall remain in full force and
effect between the SUBLICENSEE and UNIVERSITY, except that UNIVERSITY's
obligations thereunder shall be no greater than UNIVERSITY's obligations
under this Agreement. At the request of MEDIMMUNE, UNIVERSITY shall
acknowledge to a SUBLICENSEE UNIVERSITY's obligations to the SUBLICENSEE
under this paragraph 10.6.
10.8 The obligations of Sections 3 and 8, as well as Paragraphs 2.4,
10.5, 10.6, 10.7, 10.8 and 11.4 shall survive any termination of this
Agreement.
10.9 Upon 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 termination.
SECTION 11 - GENERAL PROVISIONS.
11.1 The relationship between UNIVERSITY and MEDIMMUNE is that of
independent contractors. UNIVERSITY 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.
UNIVERSITY shall have no power to bind or obligate MEDIMMUNE in any manner.
Likewise, MEDIMMUNE shall have no power to bind or obligate UNIVERSITY in
any manner.
11.2 Any matter or disagreement under this Agreement, which cannot be
resolved by the parties shall be submitted to a mutually selected single
arbitrator to so decide any such matter or disagreement. The arbitrator
shall conduct the arbitration in English in accordance with the Rules of
the American Arbitration Association ("AAA"). If the parties are unable to
mutually select an arbitrator, the arbitrator shall be selected in
accordance with the procedures of the AAA. The arbitrator shall have no
power to add to, subtract from or modify the terms of this Agreement. The
(PAGE 13)
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
Washington, D.C. or such other place as may be mutually agreed upon in
writing by the parties.
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 Illinois, U.S.A. without reference to its choice
of law principles.
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 Notices. Any notices given pursuant to this Agreement shall be in
writing and shall be deemed delivered upon the earlier of (i) when received
at the address set forth below, or (ii) three (3) business days after
mailed by certified or registered mail postage prepaid and properly
addressed, with return receipt requested, or (iii) when sent, if sent, by
facsimile, as confirmed by certified or registered mail. Notices shall be
delivered to the respective parties as indicated:
<TABLE>
<CAPTION>
<S> <C>
To MEDIMMUNE: MEDIMMUNE, Inc.
35 West Watkins Mill Road
Gaithersburg, MD 20878
Attn: Office of Business Development
Copy to: Carella, Byrne, Bain, Gilfillan,
Cecchi, Stewart & Olstein
6 Becker Farm Road
Roseland, New Jersey 07068
Fax No.: (201) 994-1744
Attn: Elliot M. Olstein, Esq.
To UNIVERSITY: Office of University Research Services
Loyola University of Chicago
820 North Michigan Avenue
Chicago, IL 60611
</TABLE>
(PAGE 14)
11.8 MEDIMMUNE shall not use the name of Loyola University of Chicago,
or of any of their employees in conjunction with such employee's positions
with UNIVERSITY, or any adaptation thereof, in any advertising,
promotional, or sales literature without prior written consent obtained
from an authorized officer of the UNIVERSITY in each case, except that
MEDIMMUNE may state that it has received from UNIVERSITY one or more of the
patents and/or applications comprising the PATENT RIGHTS. Failure by
MEDIMMUNE to comply with this restriction shall be deemed a material breach
of this Agreement. Such material breach shall be deemed cured if the
offending use is terminated within ninety (90) days of MEDIMMUNE'S receipt
of a written notice from UNIVERSITY.
11.9 All terms and conditions of this Agreement regarding business
matters, including but not limited to payments and royalty rates shall be
held in confidence by each party to the extent permitted by law unless
authorized in writing by the other party, except as may be required by law,
rule or regulation or in connection with a governmental filing or
financing.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date
set forth above.
<TABLE>
<CAPTION>
<S> <C>
MEDIMMUNE, INC. LOYOLA UNIVERSITY OF CHICAGO
By:/s/David M. Mott By:/s/John J. Piderit, S.J.
Name: David M. Mott Name: John J. Piderit, S.J.
Title: President Title: President
</TABLE>
(PAGE 15)