EXHIBIT No. 10.91 (2)
LICENSE AGREEMENT
THIS LICENSE AGREEMENT ("Agreement") is made and entered into as
of November 20, 1998 (the "Effective Date") between MEDIMMUNE, INC., a
Delaware corporation having its principal place of business at 35 West
Watkins Mill Road, Gaithersburg, MD 20878 (hereinafter referred to as
"MEDIMMUNE"), and CONNAUGHT LABORATORIES, INC. a Delaware corporation
having its principal place of business at Route 611, P.O. Box 187,
Swiftwater, Pennsylvania 18370 (hereinafter referred to as "PMC").
RECITALS
A. MEDIMMUNE has certain proprietary rights relating to the use
of Decorin Binding Proteins (as defined below) for treatment and/or
prevention of Lyme Disease.
B. PMC desires to obtain a license to such rights and to
research, develop, manufacture, market, sell and distribute certain
vaccines for treatment and/or prevention of Lyme Disease which
incorporate Decorin Binding Proteins, all under the terms and
conditions set forth below.
NOW THEREFORE, for and in consideration of the covenants,
conditions, and undertakings hereinafter set forth, it is agreed by and
between the parties as follows:
ARTICLE 1
DEFINITIONS
1.1 "Affiliate" shall mean, with respect to any Person, (i) any
other Person of which securities or other ownership interests
representing fifty percent (50%) or more of the voting interests (or
such lesser percentage which is the maximum allowed to be owned by a
foreign corporation in a particular jurisdiction) are, at the time such
determination is being made, owned, controlled or held directly or
indirectly, by such Person, or (ii) any other Person which, at the time
such determination is being made, is Controlling, Controlled by or
under common Control with, such Person.
For the purpose of this section 1.1, "Control," whether used
as a noun or verb, refers to the possession directly or indirectly, of
the power to direct, or cause the direction of, the management or
policies of a Person, whether through the ownership of voting
securities, by contract or otherwise, and "Person" means any natural
person, corporation, firm, business trust, joint venture, association,
organization, company, partnership or other business entity, or any
government, or any agency or political subdivision thereof.
1.2 "Decorin Binding Protein" means a polypeptide that binds to
decorin and fragments thereof, which fragment may or may not bind to
decorin and/or an encoding gene therefor.
1.3 "Licensed Know-How" means MEDIMMUNE Know-How and/or
Sublicensed Know-How.
1.4 "Licensed Product" shall mean, a therapeutic and/or
prophylactic vaccine for Lyme Disease for humans and non-human animals
that infringes upon any Valid Claim of Patent Rights and/or that, in
whole or in part, incorporates, uses, or is based on Licensed Know-How.
1.5 "Licensee" shall mean a person or entity who is granted a
license to Licensed Product by PMC or an Affiliate of PMC.
1.6 "MEDIMMUNE Know-How" shall mean any biological materials, and
any research and development information, inventions, know-how, pre-
clinical, clinical and other technical data, in each case that are
owned by MEDIMMUNE, as of the Effective Date with the right to provide
the same to others, and which is necessary or useful for the research,
development, improving, making, using or selling of a Decorin Binding
Protein for use in a therapeutic and/or prophylactic vaccine for Lyme
Disease.
1.7 "MEDIMMUNE Patent Rights" shall mean:
(a) all patents and applications listed in Exhibit A; any
continuations, continuations-in-part, divisions and substitutions
thereof, or of which such an application or patent is a successor;
patents which may issue upon any of the foregoing; and all renewals,
reissues and extensions thereof; and
(b) Any foreign patents and/or applications that are
counterparts of a patent or application described in paragraph (a)
above, including any patent or application that claims subject matter
claimed in, or that takes priority from, a patent or application
described in paragraph (a) above.
1.8 "Net Sales" shall mean the gross invoice price to Third
Parties of any Licensed Product, less: (i) normal and customary trade
and quantity discounts actually allowed; (ii) returns and allowances,
all to the extent actually allowed, (iii) to the extent separately
reported on the invoice, sales or other excise taxes, duties and other
governmental charges (other than taxes on income) imposed on sales of
Licensed Product imposed upon and paid by PMC, its Affiliates or their
Licensees with respect to such sales, and (iv) transportation charges
and insurance for transportation to the extent separately invoiced or
separately reported on the invoice and paid by the seller; (v)
retroactive price reductions and rebates customary to the trade or
required by law; , all as determined and calculated in accordance with
Generally Accepted Accounting Principles. In the event that any
quantities of Licensed Product are transferred to a Third Party for
consideration other than cash or for no consideration, the fair and
reasonable market value of the applicable Licensed Product shall be
used to calculate Net Sales. Notwithstanding the foregoing, Net Sales
shall not include sales between or among Affiliates for resale by an
Affiliate, or any Licensed Product used in any clinical trial.
In the event that Licensed Product is sold in other than an arms
length transaction, then Net Sales shall be the gross invoice price
which would be received in an arms length transaction, taking into
account any deductions for items referred to in clauses (i), (ii),
(iii), (iv) and (v) of the preceding paragraph.
1.9 "Patent Right(s)" shall mean MEDIMMUNE Patent Rights and
Sublicensed Patent Rights.
1.10 "Sublicensed Know-How" means all "KNOW-HOW" (as defined in
the Texas A&M Agreement) anywhere in the world to which MEDIMMUNE has
rights under the Texas A&M Agreement.
1.11 "Sublicensed Patent Rights" shall mean any and all "PATENT
RIGHTS" (as defined in the Texas A&M Agreement) anywhere in the world
to which MEDIMMUNE has rights under the Texas A&M Agreement.
1.12 "Sublicensed Rights" shall mean the Sublicensed Patent Rights
and the Sublicensed Know-How.
1.13 "TAMUS" means Texas A&M University System.
1.14 "Territory" shall mean all countries of the world.
1.15 "Texas A&M Agreement" shall mean the License Agreement
between the Texas A&M University System and MEDIMMUNE, effective as of
June 19, 1995, and the amendment thereto, attached as Exhibit B hereto.
1.16 "Third Party" means any corporation, company, partnership or
other entity which is not a party hereto or an Affiliate of a party
hereto.
1.17 "Valid Claim" shall mean a claim of an issued and unexpired
patent which has not been held unenforceable, unpatentable or invalid
by a court or other governmental agency of competent jurisdiction from
which no appeal can be or is taken, and which has not been admitted to
be invalid or unenforceable through reissue, disclaimer or otherwise.
1.18 All dollar amounts are United States Dollars.
ARTICLE 2
GRANT OF RIGHTS
2.1 Subject to the terms and condition of this Agreement,
MEDIMMUNE grants to PMC (i)subject to Section 5.06 of the Texas A&M
agreement a sole and exclusive license under MEDIMMUNE's interest in
MEDIMMUNE Patent Rights; (ii) a sole and exclusive sublicense under
Sublicensed Rights; and (iii) subject to Section 5.06 of the Texas A&M
Agreement a sole and exclusive license under MEDIMMUNE Know-How, in
each case to make, have made, use, sell, have sold, import and export
Licensed Product in the Territory. During the term of this Agreement,
MEDIMMUNE shall not grant any rights or licenses under the MEDIMMUNE
Patent Rights, the MEDIMMUNE Know-How or the Sublicensed Rights to
make, have made, use, sell, have sold, import or export Licensed
Product in the Territory.
2.2 PMC acknowledges and agrees that the Sublicensed Rights are
subject to the terms, conditions and obligations of the Texas A&M
Agreement and that the Sublicensed Rights are no greater than the
rights granted to MEDIMMUNE under the Texas A&M Agreement.
2.3 PMC warrants, covenants and agrees that PMC is responsible
for and shall perform all of MEDIMMUNE'S obligations under the Texas
A&M Agreement, other than (i) any obligation which MEDIMMUNE may have
to pay to TAMUS any portion of the payments which MEDIMMUNE receives
from PMC hereunder and (ii) the obligations set forth in Section
5.02(f) of the Texas A&M Agreement. Such obligations include but are
not limited to the obligation to (i) pay patent expenses incurred on or
after July 10, 1998 as required by Paragraphs 3.01 and 6.03 of the
Texas A&M Agreement; (ii) the payment and reporting obligations of
Paragraphs 3.03; 3.04; 3.05, and 7.01 through 7.06 of the Texas A&M
Agreement (iii) the due diligence obligations of Article V; and (iv)
the obligations of Article XII and paragraphs 14.01 and 14.02 of the
Texas A&M Agreement; (v) and the (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED) due to TAMUS under Par. 3.07 of the Texas A&M Agreement.
With respect to the payment and reporting obligations under the
Texas A&M Agreement, PMC shall provide MEDIMMUNE with a copy of any and
all reports provided to TAMUS under the Texas A&M Agreement within
three (3) business days of the day on which such report is provided to
TAMUS, and shall provide MEDIMMUNE evidence that any payment due
thereunder has been made to TAMUS, which evidence shall be provided
within three (3) business days of the day on which such payment is
made.
2.4 With respect to the obligations of Article XII and Sections
14.01 and 14.02 of the Texas A&M Agreement, PMC shall be bound to TAMUS
as if PMC was a party to the Texas A&M Agreement, substituting PMC for
MEDIMMUNE thereunder.
2.5 With respect to the rights granted under Section 2.1 hereof,
PMC shall have the right to grant sublicenses with the prior approval
of MEDIMMUNE as to the Licensee, which approval shall not be
unreasonably denied. MEDIMMUNE hereby consents to the granting by PMC
of sublicenses to its Affiliates.
2.6 (a) In case of any sublicense by PMC of the rights and
licenses granted in this Agreement to any Third Party, the Licensee
shall agree to be bound by the terms, obligations and conditions of
Articles 6 and 10 of this Agreement (substituting the name of the
sublicensee for that of PMC) with MEDIMMUNE being expressly made a
third party beneficiary thereof, and PMC shall be responsible for the
performance by the appointed Licensee of such terms, obligations and
conditions.
(b) Each sublicense agreement concluded by PMC that grants a
sublicense under this Agreement will include a requirement that the
Licensee maintain records and permit inspection on terms essentially
identical to Section 9.4 of this Agreement. At MEDIMMUNE's request,
PMC shall arrange for an independent certified accountant selected by
MEDIMMUNE and reasonably acceptable to PMC and such Licensee to inspect
the records of its sublicensee(s) for the purpose of verifying
royalties due to MEDIMMUNE and shall cause such accountant to report
the results thereof to MEDIMMUNE.
(c) All sublicenses granted for a Licensed Product under
this Agreement shall terminate upon termination of the licenses granted
hereunder with respect to such Licensed Product.
(d) Each such sublicense shall state that no further
sublicenses are permitted.
2.7 Upon the execution of this Agreement, MEDIMMUNE shall provide
to PMC copies of all available information in tangible form that is
within the possession of or available to MEDIMMUNE and is MEDIMMUNE
Know-How or Sublicensed Know-How.
ARTICLE 3
MILESTONES AND ROYALTIES TO MEDIMMUNE
3.1 As compensation for past research and development expenses
and the MEDIMMUNE Know-How licensed to PMC under this Agreement, PMC
shall pay to MEDIMMUNE (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
within fifteen (15) days of the signing of this Agreement by the
parties hereto.
3.2 Subject to Section 9.3 hereof, PMC shall pay to MEDIMMUNE the
non-refundable and non-creditable amounts specified below within thirty
(30) days following the accomplishment by PMC its Affiliates or any of
their Licensees of the corresponding event set forth below. The
milestone payment shall be made only once for each event:
(a) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) for the
filing of the first application for licensure for sale of Licensed
Product in the United States or in a country(ies) in Europe.
(b) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) for receipt
of the first regulatory approval to sell Licensed Product in the United
States or in a country(ies) in Europe.
(c) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) for the
first calendar year in which total worldwide sales of Licensed Product
is at least (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED).
3.3 PMC shall pay to MEDIMMUNE the following royalties on all
Licensed Product sold by PMC, Affiliates of PMC and their Licensees :
(a) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) of Net Sales
of Licensed Product sold (i) in each country where the sale of Licensed
Product in such country is covered by a Valid Claim of a Patent Right,
or (ii) anywhere in the Territory, if where manufactured the Licensed
Product is covered by a Valid Claim of a Patent Right.
(b) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) of Net Sales
of all Licensed Product that is not subject to royalty under Paragraph
3.3(a).
(c) In the event that a Licensed Product is sold as part of
a vaccine that treats or prevents a disease in addition to Lyme Disease
(a "Combined Product") then Net Sales shall be the amount which is
normally received by PMC or its Affiliates or their Licensees from sale
of the Licensed Product in the applicable country in an arm's length
transaction with a Third Party other than as a Combined Product. If
the Licensed Product is 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 cost for
producing the Licensed Product and the denominator of which is the cost
for producing the Combined Product.
3.4 (a) Royalties shall be calculated and paid on a country-by-
country and Licensed Product-by-Licensed Product basis.
(b) With respect to a Licensed Product in any country, upon
the later to occur of (i) the date on which PMC is no longer obligated
to pay royalties under Section 3.3(a) for such Licensed Product for
such country or (ii) ten (10) years following the first commercial sale
of such Licensed Product in such country, PMC shall have a fully paid,
royalty-free license for such Licensed Product under the Patent Rights
and the Licensed Know-How in such country, provided that this Agreement
is still in effect at such time.
3.5 It is understood that in no event shall more than one royalty
be payable under Section 3.3 with respect to a particular unit of
Licensed Product.
3.6 PMC acknowledges and agrees that the payments to MEDIMMUNE
under this Article 3 are in addition to the payments that PMC makes or
is to make under the Texas A&M Agreement, as required by Section 2.3 of
this Agreement.
ARTICLE 4
TERM AND TERMINATION
4.1 This Agreement shall become effective as of the Effective
Date and, unless earlier terminated pursuant to the other provisions of
this Article 4, shall continue in full force and effect as long as PMC
is obligated to pay royalties on Net Sales under this Agreement, and
shall thereafter expire. PMC's license under Section 2.1 shall survive
such expiration, but not an earlier termination.
4.2 In the event of a material breach of this Agreement the
nonbreaching party in addition to any other remedy which it may have
shall be entitled to terminate this Agreement following written notice
of such breach to the breaching party. If such breach is not cured
within sixty (60) days after written notice is given by the
nonbreaching party to the breaching party specifying the breach, the
non-breaching party may terminate the Agreement forthwith upon written
notice to the breaching party after expiration of such 60-day period.
4.3
4.3.1 Termination of this Agreement for any reason shall
not release either party hereto from any liability which at the time of
such termination has already accrued to the other party.
4.3.2 In the event this Agreement is terminated for any
reason, PMC and its Affiliates and Licensees shall have the right to
sell or otherwise dispose of the stock of any Licensed Product then on
hand, all subject to the payment to MEDIMMUNE of fees and royalties
pursuant to Article 3 hereof.
4.3.3 Articles 6, 10, and 11, and Sections 4.1, 4.3,
4.4, and 5.5, shall survive the expiration and any termination of this
Agreement. Except as otherwise provided in Section 4.1 and Section
4.3, all rights and obligations of the parties under this Agreement
shall terminate upon the expiration or termination of this Agreement.
4.4. In the event that PMC's rights and licenses under this
Agreement are terminated, PMC agrees not to make, use or sell Licensed
Products except as permitted by paragraph 4.3.2.
4.5 Either party may terminate this Agreement upon written notice
if the other party makes a general assignment for the benefit of
creditors, is the subject of proceedings in voluntary or involuntary
bankruptcy or has a receiver or trustee appointed for substantially
all of its property; provided that in the case of an involuntary
bankruptcy proceeding such right to terminate shall only become
effective if the other party consents thereto or such proceeding is not
dismissed within ninety (90) days after the filing thereof. If, in
connection with bankruptcy proceedings involving a party, an election
is made by or on behalf of such party to reject the obligations of this
Agreement and the other party elects to retain its rights to
intellectual property hereunder pursuant to Section 365 n.1 of the
United States Bankruptcy Code, as amended (the "Code"), such other
party shall be entitled to enforce any rights exclusively granted to it
in respect of intellectual property hereunder by commencement of any
action it deems necessary to that effect against third-party infringes
and may do so in the name and stead of the bankrupt party. The parties
further agree that, in the event that PMC elects to retain its rights
as a licensee under the Code, PMC shall be entitled to complete access
to any technology licensed to it hereunder and all embodiments of such
technology. Such embodiments of the technology shall be delivered to
PMC not later than (a) the commencement of bankruptcy proceedings
against MEDIMMUNE, unless MEDIMMUNE elects to perform its obligations
under this Agreement, or (b) if not delivered under (a) above, upon the
rejection of this Agreement by or on behalf of MEDIMMUNE.
4.6 PMC may terminate this Agreement at any time upon ninety
(90) days' prior written notice to MEDIMMUNE.
ARTICLE 5
PATENTS AND INFRINGEMENTS
5.1 MEDIMMUNE shall have the right but not the obligation to
control the filing, prosecution and maintenance of the Patent Rights,
subject to the Texas A&M Agreement. MEDIMMUNE agrees to keep PMC
informed as to the status of the Patent Rights in the Territory and
shall provide PMC with copies of all proposed filings and
correspondence of substantive nature with respect to patents or patent
applications relating to the Patent Rights to be made or sent to the
United States Patent and Trademark Office or its counterpart in any
country (each, a "Patent Authority") of the Territory and copies of all
correspondence that MEDIMMUNE receives from such Patent Authorities
with respect to the Patent Rights. If MEDIMMUNE does not wish to
control the filing, prosecution and maintenance of the MEDIMMUNE Patent
Rights, it shall so inform PMC and PMC shall have the right but not the
obligation to control the filing, prosecution and maintenance of such
MEDIMMUNE Patent Rights. PMC shall pay all out-of-pocket costs
reasonably incurred by MEDIMMUNE on or after July 10, 1998 with respect
to filing, prosecution and maintenance of Patent Rights.
5.2 If the production, sale or use of a Licensed Product results
in any claim for infringement of a patent or other proprietary right of
a Third Party against PMC, its Affiliates or Licensees , PMC shall
promptly notify MEDIMMUNE thereof in writing. As between the parties
to this Agreement, PMC shall have the right at its own expense to
defend and control the defense of any such claim against PMC, by
counsel of PMC's own choice, and PMC shall be liable for any such
claim.
5.3 (a) In the event that any Patent Rights are infringed by a
Third Party with respect to a Licensed Product. PMC and/or its
Affiliates or Licensees shall have the right (except as provided
below), but not the obligation, to institute, and prosecute any action
or proceeding under the Patent Rights with respect to such
infringement, by counsel of its choice, including any declaratory
judgment action arising from such infringement. Any amounts recovered
from Third Parties with respect to the Patent Rights in such action
shall be applied first to reimburse the expenses of the action; then to
the extent the award is based on lost profits, MEDIMMUNE and PMC shall
divide such remaining portion such that MEDIMMUNE shall receive (a)
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) in respect of countries in
which the sale or manufacture of the Licensed Product is covered by a
Valid Claim of a Patent Right and (b) (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED) in respect of countries in which the sale or manufacture of
the Licensed product is not covered by a Valid Claim of a Patent Right.
In respect of any other recovery, the remaining amount shall be
treated as Net Sales with MEDIMMUNE receiving its royalty on such "Net
Sales." PMC shall not have the right to settle, compromise or take any
action in such litigation which diminish, limit or inhibit the scope,
validity or enforceability of the Patent Rights without the express
written permission of MEDIMMUNE. PMC shall keep MEDIMMUNE advised of
the progress of such proceedings.
5.4 In the event that a Third Party is infringing the Patent
Rights with respect to a Licensed Product and PMC does not elect to
institute an action, MEDIMMUNE shall have the right, but not the
obligation, to commence an infringement suit under the Patent Rights
against such infringer and retain any recovery, provided that it so
notifies PMC.
5.5 Each party agrees to cooperate with each other with respect
to any litigation under Sections 5.2, 5.3 or 5.4.
ARTICLE 6
CONFIDENTIALITY
6.1 Nondisclosure. Except as otherwise provided in this
Agreement, a party receiving (the "Receiving Party") any business or
technical information ("Proprietary Information") that is disclosed to
it by the other party (the "Disclosing Party") shall for a period
beginning on the Effective Date and ending five (5) years after the
termination of this Agreement hold in confidence and not disclose to
any Third Party the Proprietary Information. In addition, the
Receiving Party shall not use Proprietary Information that it receives
from the Disclosing Party, except that PMC may use Proprietary
Information of MEDIMMUNE to the extent licensed to PMC under Article 2
of this Agreement. Notwithstanding the foregoing, with the prior
written permission of MEDIMMUNE (which shall not be unreasonably
withheld), PMC may disclose information concerning the Patent Rights
and/or the MEDIMMUNE Know-How to actual or prospective sublicensees or
to other Third Parties with whom PMC is considering or has entered into
a business relationship, all of whom are similarly bound in writing
under a reasonable confidentiality agreement. Proprietary Information
of a party shall not include:
6.1.1 Information which is or was published or has become
generally available to the public through no fault of the Receiving
Party;
6.1.2 Information which the Receiving Party can document is
or was in its possession at the time of disclosure or was independently
developed by the Receiving Party; or
6.1.3 Information which is rightfully acquired by the
Receiving Party from a Third Party who is not under an obligation of
confidentiality to the Disclosing Party, and to the best of the
Receiving Party's knowledge and belief is entitled to rightfully make
such disclosure, but only to the extent the Receiving Party complies
with any restrictions imposed by the Third Party.
6.2 The Receiving Party may disclose Proprietary Information of
the other if required by applicable law or in connection with the order
of a court of law or administrative or governmental authority provided
that the Receiving Party exerts reasonable efforts to preserve the
confidentiality thereof and the Disclosing Party is given an
opportunity to protect the confidentiality thereof. PMC may disclose
Proprietary Information as is reasonably necessary in connection with
the labeling of Licensed Products that are otherwise sold in compliance
with this Agreement or as required for obtaining regulatory approval of
Licensed Product, provided that PMC protects the confidentiality
thereof to the fullest extent possible.
6.3 Notwithstanding anything else to the contrary and subject to
Section 3.4(b) in the event that PMC's rights and licenses under this
Agreement are terminated, PMC agrees not to use Patent Rights and
Licensed Know-How provided to PMC by MEDIMMUNE or any information
developed by PMC that, in whole or in part, incorporates, uses or is
based on Licensed Know-How for the research, development, making, or
using or selling of any product or process and (b) not to do any of the
foregoing while this Agreement is in force for any product other than a
Licensed Product.
ARTICLE 7
REPRESENTATIONS AND WARRANTIES AND COVENANTS
7.1 MEDIMMUNE and PMC each represents and warrants to the other
that (a) each has the full right and authority to enter into this
Agreement and grant the rights and licenses granted herein;
(b) Each is a corporation duly incorporated and validly
existing as a corporation and in good standing under the laws of
Delaware, respectively, with the corporate power to own, lease and
operate its properties and to carry on its business as now conducted;
(c) Each has all necessary corporate power and authority to
enter into this Agreement and to consummate the transactions
contemplated hereby;
(d) The execution, delivery and performance of this
Agreement by each of MEDIMMUNE and PMC does not conflict with or
contravene its articles or certificate of incorporation or by-laws,
regulations or partnership agreement (or other comparable governing
instruments with different names), nor will the execution, delivery or
performance of this Agreement conflict with or result in a breach of,
or entitle any party thereto to terminate, any material agreement or
instrument to which it is a party, or by which any of its assets or
properties is bound.
(e) This Agreement has been duly authorized, executed and
delivered by MEDIMMUNE and PMC and constitutes a legal, valid and
binding agreement of MEDIMMUNE and PMC, enforceable against MEDIMMUNE
AND PMC in accordance with its terms, except as enforceability may be
limited by bankruptcy, insolvency, moratorium, reorganization or other
similar laws affecting creditors' rights generally; and
7.2 MEDIMMUNE represents and warrants to PMC that:
(a) it has not previously granted and, prior to termination
of this Agreement, will not grant any rights in the Patent Rights or
the MEDIMMUNE Know-How that are inconsistent with the rights and
licenses granted to PMC herein and in the Texas A&M Agreement, TAMUS
has represented to MedImmune that TAMUS has not previously granted and
prior to termination of the Texas A&M Agreement, TAMUS will not grant
any rights in the Sublicensed Patent Rights that are inconsistent with
the rights and license granted to MedImmune under the Texas A&M
Agreement, and MedImmune has no reason to believe that such
representation is not true on the date hereof;
(b) MEDIMMUNE has provided to PMC a true, complete and
correct copy of the Texas A&M Agreement (including any amendments
thereto) under which MEDIMMUNE has acquired or licensed rights to the
Sublicensed Rights licensed to PMC hereunder. MEDIMMUNE has carried
out all requirements under such agreement to enable MEDIMMUNE to grant
the license granted to PMC hereunder, and there are no other
requirements necessary for MEDIMMUNE to grant such license. The Texas
A&M Agreement is in full force and effect, and MEDIMMUNE has neither
received nor delivered any notice of default thereunder. As of the
Effective Date, except for due diligence obligations of Section 7.06
and the reporting obligations of Article VII, MEDIMMUNE has not
breached any obligations under the Texas A&M Agreement that will
adversely affect the rights granted to PMC to the SubLicensed Rights
under this Agreement. MEDIMMUNE hereby covenants and agrees that it
shall not consent to any amendment thereof or terminate such agreement
without the prior written consent of PMC;
(c) The MEDIMMUNE PATENT RIGHTS listed in Exhibit A have
been filed in the United States Patent and Trademark Office and the
inventors named in such application are obligated to assign their
rights therein to MEDIMMUNE. There have been no material claims made
against MEDIMMUNE asserting the invalidity or unenforceability of, or
the misuse of, the MEDIMMUNE Patent Rights, or the Sublicensed Patent
Rights. MEDIMMUNE has not received a notice of conflict of the Patent
Rights or MEDIMMUNE Know-How with the asserted rights of others, or
otherwise challenging its rights to use any of the MEDIMMUNE Patent
Rights, MEDIMMUNE Know-How or the Sublicensed Rights.
7.3 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN
SECTION 7.1 ABOVE, 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.
ARTICLE 8
DUE DILIGENCE
8.1 PMC shall use commercially reasonable efforts to research,
develop, register, market and sell and to continue to market and sell
each Licensed Product in the United States and other countries of North
America and/or Europe for which, in PMC's reasonable judgment, there is
or would be a significant market for Licensed Product, and in which
there would be a satisfactory return on the investment required to
enter such market, with timely notice to MEDIMMUNE of such PMC
decisions.
8.2 PMC shall promptly notify MEDIMMUNE, in writing, if at any
time PMC does not intend to continue to research, develop and/or obtain
regulatory approval for and/or market and sell a Licensed Product in
the United States or in countries of the European Economic Community.
8.3 In the event that PMC provides MEDIMMUNE with notice pursuant
to Section 8.2 with respect to any Licensed Product or with respect to
any country(ies) the rights herein granted by MEDIMMUNE to PMC to such
Licensed Product in such country(ies), upon written notice from
MEDIMMUNE to PMC shall revert to MEDIMMUNE.
8.4 PMC acknowledges, agrees and understands its assumed
obligations with respect to due diligence under Article V of the Texas
A&M Agreement.
8.5 PMC shall provide written reports to MEDIMMUNE on or before
June 30th and December 31st of each year (commencing on June 30, 1999)
concerning the efforts being made in accordance with Section 8.1 with
respect to the Licensed Product. PMC shall provide MEDIMMUNE with any
additional information reasonably requested by MEDIMMUNE in this
respect. Such reports shall be considered to be Proprietary
Information of PMC.
ARTICLE 9
ACCOUNTING RECORDS AND PAYMENTS
9.1 PMC agrees to make quarterly written reports to MEDIMMUNE
within sixty (60) days after the end of each calendar quarter in which
royalties are due to MEDIMMUNE under this Agreement, stating in each
such report the number, description, and aggregate Net Sales of
Licensed Products sold during the calendar quarter and upon which a fee
or royalty is payable under Article 3 above. The report shall also
include the calculation of Net Sales all on a country by country and
Licensed Product by Licensed Product basis. The report shall be due
with respect to sales of Licensed Product sold by PMC or its AFFILIATES
sixty (60) days after the end of the calendar quarter and with respect
to sales of Licensed Product by Licensees of PMC or its AFFILIATES,
ninety (90) days after the end of a calendar quarter. All information
provided to MEDIMMUNE in such reports shall be considered Proprietary
Information.
9.2 Concurrently with the making of each such report of Section
9.1, PMC shall pay to MEDIMMUNE the royalties at the rate specified in
Article 3 above. All payments by PMC to MEDIMMUNE hereunder shall be
made in U.S. Dollars. If any currency conversion shall be required in
connection with the calculation of royalties hereunder, such conversion
shall be made by using the rate of exchange published in the Wall
Street Journal for the last business day of the applicable calendar
quarter.
9.3 Any withholding or other tax that PMC or any of its
Affiliates are required by statute to withhold and pay on behalf of
MEDIMMUNE with respect to the royalties payable to MEDIMMUNE under this
Agreement shall be deducted from said royalties and paid
contemporaneously with the remittance to MEDIMMUNE; provided, however,
that in regard to any tax so deducted PMC shall furnish MEDIMMUNE with
proper evidence of the taxes paid on its behalf. MEDIMMUNE will
furnish PMC with appropriate documents to secure application of the
most favorable rate of withholding tax under applicable tax treaties.
9.4
9.4.1 PMC shall keep complete, true and accurate books of
account and records for the purpose of determining the amounts payable
to MEDIMMUNE under this Agreement. Such books and records shall be
kept at PMC's principal place of business for at least three (3) years
following the end of the calendar quarter to which they pertain, and
will be open for inspection during such three (3) year period by an
independent certified accountant selected by MEDIMMUNE and reasonably
acceptable to PMC for the purpose of verifying PMC's royalty
statements. Such inspections may be made no more than once each
calendar year, during normal business hours and upon thirty (30) days'
prior written notice. Any such information shall be considered to be
Proprietary Information of PMC.
9.4.2 Inspections conducted under this Section 9.4 shall be
at the expense of MEDIMMUNE, unless an underpayment exceeding
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) for the period covered by
the inspection is established in the course of any such inspection,
whereupon all costs relating thereto will be paid by PMC.
9.4.3 Any underpaid royalties shall be paid to MEDIMMUNE
within thirty (30) days after requested by MEDIMMUNE.
ARTICLE 10
INDEMNIFICATION
10.1 PMC shall defend, indemnify and hold harmless MEDIMMUNE,
Affiliates of MEDIMMUNE and its licensors, and their respective
directors, officers, shareholders, agents, consultants and employees
(individually and collectively, the "Indemnitees") from and against any
and all liability, loss, damages (including, without limitation,
consequential damages) and expenses (including reasonable attorneys'
fees) as the result of claims, demands, costs or judgments which may be
made or instituted against any of the Indemnitees arising out of (i)
the research, development manufacture, design, possession,
distribution, use, testing, sale or other disposition by or through PMC
and/or Affiliates of PMC and/or Licensees of either PMC or Affiliates
of PMC of any Licensed Product and/or any product or process in
connection with or arising out of the Sublicensed Rights or MEDIMMUNE
Know-How, (ii) a breach of this Agreement (including the breach of a
representation of warranty) by PMC, or (iii) the negligence or willful
misconduct of PMC, in each case, PMC's obligation to defend, indemnify
and hold harmless shall include any and all such claims, demands, costs
or judgments, including but not limited to money damages arising from
alleged personal injury (including death) to any person or alleged
property damage,. Notwithstanding the foregoing, PMC shall have no
obligation to indemnify or hold any Indemnitee harmless (but shall
still have the obligation to defend) with respect to any claim, demand,
cost or judgment that is finally determined to result from the willful
misconduct or gross negligence of such Indemnitee.
10.2 MEDIMMUNE hereby agrees to indemnify, defend and hold
harmless PMC and its Affiliates and their respective officers,
directors, shareholders, employees and agents from and against any and
all liability, loss, damages (including, without limitation,
consequential damages) and expenses (including reasonable attorneys'
fees) arising out of, based upon or resulting from (i) a breach of this
Agreement (including the breach of a representation or warranty) by
MEDIMMUNE, or (ii) the negligence or willful misconduct of MEDIMMUNE.
10.3 (a) Any party entitled to indemnification under Section
10.1 or 10.2 hereof (an "Indemnified Party") shall promptly notify the
party potentially responsible for such indemnification (the
"Indemnifying Party") upon becoming aware of any claim or claims
asserted or threatened against such Indemnified Party which could give
rise to a right of indemnification under this Agreement; provided,
however, that the failure to give such notice shall not relieve the
Indemnifying Party of its indemnity obligation hereunder except to the
extent that such failure substantially prejudices its rights hereunder.
(b) the Indemnifying Party shall have the right to defend,
at its sole cost and expense, such claim by all appropriate
proceedings, which proceedings shall be prosecuted diligently by the
Indemnifying Party to a final conclusion or settled at the discretion
of the Indemnifying Party; provided, however, that the Indemnifying
Party may not enter into any compromise or settlement unless (x) the
Indemnified Party consents thereto, which consent shall not be
reasonably withheld, and (y) such compromise or settlement includes as
an unconditional term thereof, the giving by each claimant or plaintiff
to the Indemnified Party of a release from all liability in respect of
such claim.
(c) The Indemnified Party may participate in, but not
control, any defense or settlement of any claim controlled by the
Indemnifying Party pursuant to this Section 10.3 and shall bear its own
costs and expenses with respect to such participation; provided,
however, that the Indemnifying Party shall bear such costs and expenses
if counsel for the Indemnifying Party shall have reasonably determined
that such counsel may not properly represent both the Indemnifying
Party and the Indemnified Party.
(d) If the Indemnifying Party fails to notify the
Indemnified Party within twenty (20) days after receipt of notice of a
claim in accordance with Section 10.3(a) hereof that it elects to
defend the Indemnified Party pursuant to this Section 10.3, or if the
Indemnifying Party elects to defend the Indemnified Party but fails to
prosecute or settle the claim diligently and promptly, then the
Indemnified Party shall have the right to defend, at the sole cost and
expense of the Indemnifying Party, the claim by all appropriate
proceedings, which proceedings shall be promptly and vigorously
prosecuted by the Indemnified Party to a final conclusion or settled;
provided, however, that in no event shall the Indemnifying Party be
required to indemnify the Indemnified Party for any amount paid or
payable by the Indemnified Party in the settlement of any such claim
agreed to without the consent of the Indemnifying Party, which shall
not be unreasonably withheld.
ARTICLE 11
MISCELLANEOUS
11.1 MEDIMMUNE and PMC shall cooperate in the preparation of a
mutually agreeable press release and other publicity disclosing the
existence of this Agreement and their business relationship. Except
for information disclosed in such a mutually agreed press release or
publicity, neither PMC nor MEDIMMUNE shall disclose the existence or
any terms of this Agreement without the prior written consent of the
other party, except for such limited disclosure as may be reasonably
necessary to either party's bankers, investors, attorneys or other
professional advisors, or in connection with a merger or acquisition of
the disclosing party, or as may be required by law in the offering of
securities or in securities regulatory filings or otherwise.
11.2 It is agreed that no waiver by either party hereto of any
breach or default of any of the covenants or agreements herein set
forth shall be deemed a waiver as to any subsequent and/or similar
breach or default.
11.3 The relationship of the parties hereto is that of independent
contractors. Neither party hereto is an agent, partner or joint
venturer of the other for any purpose.
11.4 In exercising its rights under this license, PMC shall fully
comply with the requirements of any and all applicable laws,
regulations, rules and orders of any governmental body having
jurisdiction over the exercise of rights under this license.
11.5 Any notice required or permitted to be given to the parties
hereto shall be deemed to have been properly given if delivered in
person or when received if mailed by first-class certified mail, by
overnight courier or sent by facsimile to the other party at the
appropriate address as set forth below or to such other addresses as
may be designated in writing by the parties from time to time during
the term of this Agreement.
MEDIMMUNE: MEDIMMUNE, INC.
35 West Watkins Mill Road
Gaithersburg, MD 20878
Attention: President
PMC: CONNAUGHT LABORATORIES, INC.
Route 611, P.O. Box 187
Swiftwater, Pennsylvania 18370
Attention: Corporate V.P., Business
Development and
V.P. Business Development PMC USA
With Copy to: Executive V.P., Secretary & General
Counsel
at: Pasteur M,rieux Serum et Vaccins, S.A.
58, avenue Leclerc
69007 Lyon, France
11.6 It is understood and agreed between MEDIMMUNE and PMC that
this Agreement constitutes the entire agreement with respect to the
subject matter of this Agreement, both written and oral, between the
parties, and that all prior agreements respecting the subject matter
hereof, either written or oral, expressed or implied, shall be
abrogated, canceled, and are null and void and of no effect. No
amendment or change hereof or addition hereto shall be effective or
binding on either of the parties hereto unless reduced to writing and
executed by the respective duly authorized representatives of each of
the parties hereto.
11.7 In the event that any provision of this Agreement becomes or
is declared by a court of competent jurisdiction to be illegal,
unenforceable or void, this Agreement shall continue in full force and
effect without said provision and the parties shall exert commercially
reasonable efforts to amend this Agreement to include a provision which
is valid, legal and enforceable and which carries out the original
intent of the parties. In the event that such a provision cannot be
included in the Agreement and the absence thereof materially changes a
party's obligations or rights under this Agreement, such party shall
have the right to terminate this Agreement.
11.8 This Agreement may be executed in counterparts, each of which
shall be deemed to be an original and both together shall be deemed to
be one and the same agreement. All headings and any cover page or
table of contents are inserted for convenience of reference only and
shall not affect its meaning or interpretation.
11.9 All matters affecting the interpretation, validity and
performance under this Agreement shall be governed by the internal laws
of the State of Maryland without regard for its conflict of laws
principles.
11.10 If and to the extent that either party hereto is
prevented, by circumstances not now reasonably foreseeable and not
within its reasonable ability to control, from performing any of its
obligations under this Agreement (other than payment obligations) and
promptly so notifies the other party giving full particulars of the
circumstances in question, then the party affected shall be relieved of
liability to the other for failure to perform such obligations, but
shall nevertheless use commercially reasonable efforts to resume full
performance thereof without avoidable delay, and pending such
resumption shall consult with the other party and shall permit and
shall use commercially reasonable efforts to facilitate any efforts the
other party may make to effect the performance of such obligations by
other means. If such failure to perform continues for a period of more
than six (6) months, the other party may terminate this Agreement by
written notice to the non-performing party with respect to the rights
and licenses with respect to those Licensed Products and with respect
to those countries affected by such failure. The failure of PMC to
meet MEDIMMUNE's obligations under the Texas A&M Agreement shall not be
considered to be circumstances within this Section 11.10 unless such
circumstances are covered by Section 14.04 of the Texas A&M Agreement.
11.11 PMC warrants that Affiliates of PMC will comply with the
terms, obligations and conditions imposed on PMC under this Agreement
as if such Affiliates were signatories to this Agreement.
ARTICLE 12
ASSIGNMENT; SUCCESSORS
12.1 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 either party
may assign this Agreement to an Affiliate or to a successor in interest
or transferee of all or substantially all of the portion of the
business to which this Agreement relates.
12.2 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 PMC. In order for
any assignment to be effective 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.
12.3 MEDIMMUNE agrees not to assign the Texas A&M Agreement
without the prior written consent of PMC (which consent shall not be
unreasonably withheld), except that such consent shall not be required
for assignment to an Affiliate or to a successor in interest or
transferee of all or substantially all of MEDIMMUNE's business, (i)
provided that such assignment is subject to this Agreement and (ii)
such assignment does not affect the Texas A&M Agreement or MEDIMMUNE'S
rights thereunder.
IN WITNESS WHEREOF, both MEDIMMUNE and PMC have executed this
Agreement, in duplicate originals, by their respective officers
hereunto duly authorized, the day and year first above written.
MEDIMMUNE, INC CONNAUGHT LABORATORIES, INC.
By: /s/ David M. Mott By: /s/ David J. Williams
Print Name: David M. Mott Print Name: David J. Williams
Title: Vice Chairman and CFO Title: President and CEO