Co-Promotion Agreement - Abbott Laboratories and MedImmune Inc.
CO-PROMOTION AGREEMENT
This CO-PROMOTION AGREEMENT effective as of the 26th day of November,
1997 between ABBOTT LABORATORIES, through its ROSS PRODUCTS DIVISION, a
corporation organized and existing under the laws of the State of Illinois
and having its principal office at 100 Abbott Park Road, Abbott Park,
Illinois 60064 (hereinafter individually and collectively referred to as
"ABBOTT") and MEDIMMUNE, INC., a corporation organized and existing under
the laws of the State of Delaware and having its principal office at 35
West Watkins Mill Road, Gaithersburg, Maryland 20878 ("MEDIMMUNE").
W I T N E S S E T H:
WHEREAS, the parties hereto desire to enter into a Co-Promotion
Agreement with respect to PRODUCT (as hereinafter defined) in the TERRITORY
(as hereinafter defined).
NOW, THEREFORE, the PARTIES agree that the following terms and
conditions shall apply with respect to the Co-Promotion of PRODUCT in the
TERRITORY:
1. GENERAL
(a) "AFFILIATE" shall mean any corporation or other business entity
that directly or indirectly controls, is controlled by, or is under
common control with a PARTY. Control means ownership or other
beneficial interest in fifty percent (50%) or more of the voting stock
or other voting interest of a corporation or other business entity.
(b) "COMMITTEE" shall mean the advisory marketing committee as set
forth in Section 2.3(a).
(c) "FIRST COMMERCIAL SALE" of PRODUCT shall mean the first sale to a
THIRD PARTY of PRODUCT in the TERRITORY after approval of the PRODUCT
has been granted by the U.S. Food & Drug Administration ("FDA").
(d) "GAAP" shall mean, as of any applicable date of determination,
Generally Accepted Accounting Principles consistently applied.
(e) "MARKETING PLAN" shall mean a plan for marketing and detailing of
PRODUCT, including monthly PRODUCT sales forecasts for the TERRITORY
and a marketing budget.
(f) "NET SALES" shall mean with respect to PRODUCT that sum
determined by deducting from the gross amount invoiced for PRODUCT by
MEDIMMUNE in the TERRITORY in an arms length transaction to customers
who are not AFFILIATES of MEDIMMUNE: (i) transportation charges to the
extent included in the billing; (ii) trade, quantity or cash
discounts, to the extent allowed; (iii) credits or allowances, if any,
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given or made on account of price adjustments, or returns, to the
extent made; (iv) any and all Federal, state or local government
rebates, whether in existence now, or enacted at any time during the
term of this Agreement, to the extent made; (v) any tax, excise or
other governmental charge upon or measured by the production, sale,
transportation, delivery or use of the PRODUCT to the extent
separately billed; (vi) a reasonable allowance for bad debt; in each
case determined in accordance with MEDIMMUNE's normal internal
accounting practices and GAAP.
(g) "PARTY(IES)" shall mean ABBOTT and/or MEDIMMUNE, as the case may
be.
(h) "PRODUCT" shall mean the humanized antibody directed against
respiratory syncytial virus ("RSV") and known as MEDI-493
(palivizumab).
(i) "TERRITORY" shall mean the United States of America, including
its territories and possessions, Puerto Rico and excluding the State
of Maine and the Commonwealth of Massachusetts; provided that if
MEDIMMUNE reacquires rights to the PRODUCT in Maine and Massachusetts
the TERRITORY shall from that point forward include the State of Maine
and the Commonwealth of Massachusetts.
(j) "THIRD PARTY" shall mean a party other than ABBOTT, MEDIMMUNE or
their AFFILIATES.
(k) "YEAR" shall mean the 12-month period beginning on July 1, 1998
and ending June 30, 1999 and each 12 month-period thereafter.
2. CO-PROMOTION
2.1 (a) MEDIMMUNE hereby appoints ABBOTT as the co-promoter of PRODUCT in
the TERRITORY. ABBOTT accepts such appointment and agrees to
co-promote the PRODUCT with MEDIMMUNE in a manner consistent with this
Agreement and the directions of MEDIMMUNE for the PRODUCT. Neither
PARTY shall authorize any third party to sell or co-promote the
PRODUCT in the TERRITORY other than authorized distributors that
resell the PRODUCT. ABBOTT shall have the exclusive right to
co-promote PRODUCT in the TERRITORY.
(b) At ABBOTT's cost and expense, ABBOTT agrees to maintain at least
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) sales representatives
whose primary call responsibility includes pediatricians (office and
hospital based), neonatologists, pediatric infectious disease
specialists and other pediatric support personnel, to train such sales
force with respect to selling of PRODUCT and to use such sales force
to actively promote PRODUCT each YEAR with special emphasis on such
promotion during the months of September through March of each YEAR,
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with such promotion including but not limited to sales presentations
to the target audience, and participation in conventions, and
symposia.
(c) At MEDIMMUNE's cost and expense, MEDIMMUNE agrees to maintain at
least (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) sales
representatives whose primary call responsibility includes hospital
based physicians, neonatologists, pediatric infectious disease
specialists and other pediatric support personnel, to train such sales
force with respect to selling of PRODUCT and to use such sales force
to actively promote PRODUCT each YEAR with special emphasis on such
promotion during the months of September through March of each YEAR,
with such promotion including but not limited to sales presentations
to the target audience, and participation in conventions, and
symposia.
(d) ABBOTT and MEDIMMUNE shall be responsible for causing their
respective sales forces to co-promote PRODUCT in accordance with the
MARKETING PLAN only with promotional materials provided or approved by
MEDIMMUNE and in accordance with all applicable laws, rules and
regulations.
2.2 Sale and Manufacture of the PRODUCT.
(a) During the term of this Agreement, MEDIMMUNE shall be responsible
for:
(i) Manufacturing (or having manufactured), packaging,
labeling, warehousing and distributing PRODUCT in the
TERRITORY.
(ii) Accepting of orders, invoicing customers and
collecting receivables.
(iii)Training materials, territory sales reports and
promotional materials for both PARTIES field sales forces.
(iv) Providing customer service activities, medical
information services and regulatory filings and activities.
(v) Preparation of a MARKETING PLAN for the PRODUCT
for each YEAR which may be amended by MEDIMMUNE during the
YEAR, after prior consultation with the COMMITTEE.
(b) All sales of the PRODUCT in the TERRITORY shall be invoiced by
MEDIMMUNE.
(c) All terms of sale including, without limitation, policies
concerning pricing, credit terms, cash discounts and returns and
(PAGE 3)
allowances shall be set by MEDIMMUNE consistent with MEDIMMUNE's
normal internal selling practices and in accordance with GAAP,
consistently applied.
(d) All customer orders for the PRODUCT shall be received and
executed by MEDIMMUNE or its designee. If ABBOTT receives any orders
it shall refer such to MEDIMMUNE. MEDIMMUNE, or its designee, shall
use reasonable efforts to fill PRODUCT orders.
(e) PRODUCT shall be marketed by the PARTIES hereto under a single
trademark selected, registered and maintained by MEDIMMUNE and owned
by MEDIMMUNE.
(f) ABBOTT shall give MEDIMMUNE notice of any PRODUCT complaint,
including but not limited to any adverse drug experience (as defined
in 21 CFR 314.80 or any successor provision thereto) which ABBOTT
obtains information in accordance with the following procedure:
(i) information concerning any adverse drug experience
associated with the PRODUCT shall be reported to MEDIMMUNE's
designated medical liaison by telefax within twenty-four
(24) hours and by hard copy in writing within three (3) days
after initial receipt of such information;
(ii) ABBOTT's report to MEDIMMUNE shall contain (a) the
date the report was received by ABBOTT; (b) the name of the
reporter; (c) the address and telephone number of the
reporter; and (d) an indication of the adverse drug
experience; and
(iii) all other PRODUCT complaints not covered by (i)
above shall be reported to MEDIMMUNE in writing at least
once each month.
MEDIMMUNE shall investigate all adverse drug experiences and
non-clinical complaints associated with the PRODUCT, including those
reported to MEDIMMUNE by ABBOTT, and as appropriate report such
information to the FDA. In addition, so long as ABBOTT is a
co-promoter of PRODUCT, MEDIMMUNE shall provide ABBOTT with a summary
of all adverse drug experiences and clinical complaints received by
MEDIMMUNE, during each calendar quarter and all material comments of
the FDA with respect thereto within thirty (30) days after the end of
such calendar quarter; provided, however, MEDIMMUNE shall provide
ABBOTT prompt written notice of any adverse side effect experienced in
response to the use of PRODUCT.
(g) MEDIMMUNE warrants that the PRODUCT (i) shall be manufactured in
conformance with all applicable federal, state and local statutes,
ordinances and regulations, (including, without limitation, the
Federal Food Drug and Cosmetic Act (FD&C) and the regulations
(PAGE 4)
thereunder such as current Good Manufacturing Practices), as the same
may be amended from time to time, (ii) at the time of shipment by
MEDIMMUNE shall not be adulterated or misbranded within the meaning of
the FD&C, and (iii) at the time of shipment by MEDIMMUNE shall not be
a product which would violate any section of the FD&C if introduced
into interstate commerce.
(h) MEDIMMUNE agrees that MEDIMMUNE will not without ABBOTT's written
consent discount the selling price of PRODUCT in order to promote the
sales of other products of MEDIMMUNE and that it will conduct all
price negotiations in good faith on an arms length basis.
(i) In addition to MEDIMMUNE's obligations set forth in Section
2.3(h) above, MEDIMMUNE shall, after the first YEAR, advise and
consult with ABBOTT prior to any reduction of the price at which the
PRODUCT shall be marketed, promoted and sold in the TERRITORY to the
extent such proposed reduced price is less than the average selling
price per unit of PRODUCT achieved during the first YEAR; provided,
however, MEDIMMUNE shall make the final decision regarding such price
reduction.
(j) If there is a change in market conditions which affects the
economics of this Agreement, both PARTIES will discuss modifications
to this Agreement to address such changed market conditions. However,
neither party shall be obligated to agree to such modifications to the
terms of this Agreement.
2.3 Advisory Marketing Committee.
(a) So long as ABBOTT continues as a co-promoter of PRODUCT, there
shall be a joint committee to advise MEDIMMUNE with respect to the
marketing and selling of PRODUCT in the TERRITORY (the "COMMITTEE").
The COMMITTEE shall be composed of three members appointed by ABBOTT
and three members appointed by MEDIMMUNE, with one of the members
appointed by MEDIMMUNE being Chairman of the COMMITTEE. The COMMITTEE
shall consider PRODUCT supply issues.
(b) The COMMITTEE shall meet at the call of the Chairman, but not
less than once each calendar quarter, at the offices of MEDIMMUNE or
such other place in the TERRITORY designated by the Chairman to advise
as to the coordination and implementation of a MARKETING PLAN for the
PRODUCT. A quorum for the conduct of business at any meeting of the
COMMITTEE shall consist of at least two representatives of ABBOTT and
at least two MEDIMMUNE representatives. If the COMMITTEE fails to
agree on a matter, the matter shall be referred to the President of
MEDIMMUNE and the President of the Ross Products Division. MEDIMMUNE
will consider ABBOTT's input, but shall have the final authority with
respect to any recommendations of the COMMITTEE.
(PAGE 5)
(c) The COMMITTEE shall assist and advise MEDIMMUNE in the
development of a MARKETING PLAN for each YEAR PRODUCT will be sold in
the TERRITORY.
(d) In the event a decision is made by ABBOTT to sample the PRODUCT,
ABBOTT shall pay for its samples at MEDIMMUNE's fully allocated cost
therefor.
(e) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
(f) MEDIMMUNE shall prepare or approve all promotional materials for
PRODUCT. Such promotional material will identify both PARTIES.
MEDIMMUNE shall be responsible for all costs associated with
developing promotional materials.
(g) MEDIMMUNE shall supply ABBOTT with such promotional materials at
MEDIMMUNE's fully allocated direct cost. Each PARTY shall be
responsible for the costs and expenses of its sales force and for all
of its selling expenses, including but not limited to sales training
and sales meetings. The PARTIES agree to cooperate with each other
with respect to such sales training.
2.4 Reporting and Payment.
(a) In each YEAR, in which ABBOTT is co-promoting PRODUCT, in lieu of
any other compensation, ABBOTT shall receive the following payment on
NET SALES of PRODUCT sold for use in the TERRITORY by MEDIMMUNE or its
AFFILIATES as follows:
(x) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
(y) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
(z) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
(b) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
(c) All sums due under this Agreement shall be payable in U.S.
Dollars by federal funds wire transfer or by check as instructed in
writing by the party to receive such payment from time to time. All
amounts due under Section 2.4 shall be paid on a calendar quarter
basis, within forty-five (45) days after the end of the quarter. With
each quarterly payment, MEDIMMUNE shall deliver to ABBOTT a full and
accurate accounting to include at least the following information:
(i) Quantity of PRODUCT sold by MEDIMMUNE,
(ii) Total amount invoiced for PRODUCT,
(PAGE 6)
(iii)Calculation of NET SALES,
(iv) Total compensation payable to ABBOTT.
(e) Each PARTY shall keep complete and accurate records as are
required to verify compliance with this Agreement. Such records shall
be retained and made available for reasonable review by an independent
public accounting firm acceptable to both PARTIES upon reasonable
notice, during normal business hours and no more than once each YEAR,
and at the reviewing PARTY's expense, for the purposes of verifying
the accuracy of the accounting. Each document from which the reports
and statements are prepared pursuant to this Agreement shall be
retained for two (2) years, and the right of inspection and the right
of audit hereunder shall terminate with respect thereto at the end of
such two (2) year period. In the event that such inspection shall
indicate that in any calendar year that the payments which should have
been paid by MEDIMMUNE are at least five percent (5%) greater than
those which were actually paid by MEDIMMUNE, then MEDIMMUNE shall pay
the cost of such inspection. All underpayments are immediately due
and payable.
2.6 (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
2.7 Each PARTY shall promptly notify the other PARTY in writing of any
facts relating to the advisability of the recall, destruction or
withholding from the market of the PRODUCT anywhere in the world
(collectively, "Recall"). If at any time (a) any governmental or
regulatory authority in the TERRITORY issues a request, directive or
order for a Recall; (b) a court of competent jurisdiction orders a
Recall in the TERRITORY; or (c) MEDIMMUNE determines, following
consultation with ABBOTT (except in emergency situations in which
there is insufficient time for such consultation), that a Recall in
the TERRITORY is necessary or advisable, MEDIMMUNE shall take all
appropriate corrective actions, at MEDIMMUNE's expense, to effect the
Recall and ABBOTT shall provide MEDIMMUNE with such cooperation in
connection with the Recall as MEDIMMUNE may reasonably request.
3. INDEMNITY
3.1 (a) MEDIMMUNE shall defend, indemnify and hold harmless ABBOTT,
AFFILIATES of ABBOTT and their respective directors, officers, agents
and employees, from and against any and all liability, loss, damages
and expenses (including attorneys' fees) as the result of THIRD PARTY
claims, demands, costs or judgments which may be made or instituted
against any of them arising out of (i) any negligent act or omission
or willful misconduct of MEDIMMUNE, AFFILIATES of MEDIMMUNE or any of
their respective officers, directors, agents or employees with
respect to PRODUCT, (ii) any violation of approved labeling or any
applicable statute or regulation with respect to PRODUCT, or breach of
(PAGE 7)
this Agreement or any representation or warranty hereunder, by
MEDIMMUNE, AFFILIATES of MEDIMMUNE or any of their respective
officers, directors, agents or employees, (iii) the manufacture,
possession, packaging, distribution (except for the distribution of
PRODUCT samples by ABBOTT representatives), use, testing, sale or
other disposition of the PRODUCT, or (iv) any claim against ABBOTT for
patent or trademark infringement in connection with the manufacture,
use or sale of the PRODUCT. MEDIMMUNE shall not be obligated to
indemnify an indemnified party to the extent that any claims against
an indemnified party result from (i) any negligent act or omission or
willful misconduct of ABBOTT, AFFILIATES of ABBOTT or any of their
respective officers, directors, agents, or employees with respect to
the PRODUCT, or (ii) any violation of approved labeling or any
applicable statute or regulation with respect to PRODUCT (provided
that ABBOTT shall not be deemed to be in violation of this provision
by using promotional materials provided by MEDIMMUNE), or breach of
this Agreement or any representation or warranty hereunder, by ABBOTT,
AFFILIATES of ABBOTT or any of their respective officers, directors,
agents, or employees with respect to the PRODUCT, or (iii) marketing
of the PRODUCT or any other action with respect to PRODUCT by ABBOTT,
AFFILIATES of ABBOTT or any of their respective officers, directors,
agents or employees, in each case which is not in compliance with
applicable law, rules or regulation, (ABBOTT shall not be deemed to be
in violation of this provision for using promotional materials
provided by MEDIMMUNE) or (iv) any claim warranty or representation by
ABBOTT, AFFILIATES of ABBOTT or any of their respective officers,
directors, agents or employees with respect to PRODUCT which has not
been approved in advance by MEDIMMUNE. MEDIMMUNE shall have the
exclusive right to control the defense of any action which is to be
indemnified in whole by MEDIMMUNE hereunder, including the right to
select counsel reasonably acceptable to ABBOTT to defend ABBOTT, and
to settle any claim, provided that, without the written consent of
ABBOTT (which shall not be unreasonably withheld or delayed),
MEDIMMUNE shall not agree to settle any claim against ABBOTT. The
provisions of this paragraph shall survive and remain in full force
and effect after any termination, expiration or cancellation of this
Agreement and MEDIMMUNE'S obligation hereunder shall apply whether or
not such claims are rightfully brought.
(b) ABBOTT shall defend, indemnify and hold harmless MEDIMMUNE,
AFFILIATES of MEDIMMUNE, and their respective directors, officers,
agents and employees, from and against any and all liability, loss,
damages and expenses (including attorneys' fees) as the result of
THIRD PARTY claims, demands, costs or judgments which may be made or
instituted against any of them arising out of (i) any negligent act or
omission or willful misconduct of ABBOTT, AFFILIATES or ABBOTT or any
of their respective officers, directors, agents or employees, with
respect to the Product or (ii) any violation of approved labeling or
any applicable statute or regulation with respect to PRODUCT (ABBOTT
(PAGE 8)
shall not be deemed to be in violation of this provision by using
promotional material provided by MEDIMMUNE), or breach of this
Agreement or any representation or warranty hereunder, by ABBOTT,
AFFILIATES of ABBOTT or any of their respective officers, directors,
agents or employees, or (iii) the marketing of the PRODUCT, or any
other action of ABBOTT, AFFILIATES of ABBOTT or any of their
respective officers, directors, agents or employees, with respect to
PRODUCT in each case which is not in compliance with applicable law,
rules or regulation (provided that ABBOTT shall not be deemed to be in
violation of this provision by using promotional materials provided by
MEDIMMUNE), or (iv) from any claim, warranty or representation of
ABBOTT, AFFILIATES of ABBOTT or any of their respective officers,
directors, agents or employees, with respect to PRODUCT which has not
been approved in advance by MEDIMMUNE. ABBOTT shall not be obligated
to indemnify an indemnified party to the extent that any claims
against an indemnified party result from (i) any negligent act or
omission or willful misconduct of MEDIMMUNE, or Affiliates of
MEDIMMUNE or any of their respective officers, directors, agents or
employees with respect to the PRODUCT, (ii) any violation of approved
labeling or any applicable statute or regulation with respect to
PRODUCT, or breach of this Agreement or any representation or warranty
hereunder, by MEDIMMUNE, AFFILIATES of MEDIMMUNE or any of their
respective officers, directors, agents or employees, (iii) the
manufacture, possession, packaging, distribution (except for the
distribution of PRODUCT samples by ABBOTT representatives), use,
testing, sale or other disposition of the PRODUCT, or (iv) any claim
against ABBOTT for patent or trademark infringement in connection with
the manufacture, use or sale of the PRODUCT. ABBOTT shall have the
exclusive right to control the defense of any action which is to be
indemnified in whole by ABBOTT hereunder, including the right to
select counsel reasonably acceptable to MEDIMMUNE to defend MEDIMMUNE,
and to settle any claim, provided that, without the written consent of
MEDIMMUNE (which shall not be unreasonably withheld or delayed),
ABBOTT shall not agree to settle any claim against MEDIMMUNE. The
provisions of this paragraph shall survive and remain in full force
and effect after any termination, expiration or cancellation of this
Agreement and ABBOTT'S obligation hereunder shall apply whether or not
such claims are rightfully brought.
3.2 A person or entity that intends to claim indemnification under this
Article 6 (the "Indemnitee") shall promptly notify the other PARTY
(the "Indemnitor") of any loss, claim, damage, liability or action in
respect of which the Indemnitee intends to claim such indemnification,
and the Indemnitor, after it determines that indemnification is
required of it, shall assume the defense thereof with counsel mutually
satisfactory to the PARTIES; provided, however, that an Indemnitee
shall have the right to retain its own counsel, with the fees and
expenses to be paid by the Indemnitor if Indemnitor does not assume
the defense, or if representation of such Indemnitee by the counsel
(PAGE 9)
retained by the Indemnitor would be inappropriate due to actual or
potential differing interests between such Indemnitee and any other
person represented by such counsel in such proceedings. The indemnity
agreement in this Article shall not apply to amounts paid in
settlement of any loss, claim, damage, liability or action if such
settlement is effected without the consent of the Indemnitor, which
consent shall not be withheld or delayed unreasonably. The failure to
deliver notice to the Indemnitor within a reasonable time after the
commencement of any such action, if prejudicial to its ability to
defend such action, shall relieve such Indemnitor of any liability to
the Indemnitee under this Article, but the omission so to deliver
notice to the Indemnitor will not relieve it of any liability that it
may have to any Indemnitee otherwise than under this Article. The
Indemnitee under this Article, its employees and agents, shall
cooperate fully with the Indemnitor and its legal representatives in
the investigations of any action, claim or liability covered by this
indemnification. In the event that each PARTY claims indemnity from
the other and one PARTY is finally held liable to indemnify the other,
the Indemnitor shall additionally be liable to pay the reasonable
legal costs and attorneys' fees incurred by the Indemnitee in
establishing its claim for indemnity.
4. TERM AND TERMINATION
4.1 Except if sooner terminated as provided herein, this Agreement shall
be effective as of the date hereof and shall continue for so long as
MEDIMMUNE or its AFFILIATE is selling PRODUCT in the TERRITORY.
4.2 Expiration or termination of this Agreement shall not relieve the
PARTIES of any obligation accruing prior to such expiration or
termination nor preclude either PARTY from pursuing all rights and
remedies it may have hereunder or at law or in equity with respect to
any breach of this Agreement nor prejudice either PARTY's right to
obtain performance of any obligation provided for in this Agreement
which expressly survives expiration or termination. The provisions of
Article 3 and Sections 4.2, 4.5, 5.7, 5.11, 5.12, and 5.15 shall
survive the expiration or termination of this Agreement as well as any
other provision which by its intent is meant to survive expiration or
termination of this Agreement.
4.3 Notwithstanding any other provision of this Agreement, either PARTY
may terminate this Agreement by notice in writing to the other upon or
at any time after the occurrence of any of the following events:
(i) if the other commits a material breach of this
Agreement which (a) in the case of a breach capable of a remedy,
shall not have been remedied within sixty (60) days of the
receipt by the other of written notice identifying the breach and
requiring its remedy and (b) continues to exist at the time of
notice of
(PAGE 10)
termination; or
(ii) if the other is unable to pay its debts, becomes
bankrupt or insolvent, or enters into liquidation whether
compulsorily or voluntarily, or compound with or convenes a
meeting of its creditors, or has a receiver appointed over all or
part of its assets, or takes or suffers any similar action in
consequence of a debt, or ceases for any reason to carry on
business.
4.4 If the THRESHOLD set forth in Section 2.4 has not been or is not going
to be achieved in a YEAR, after the first YEAR, either PARTY shall
have the right to terminate this Agreement by written notice to the
other PARTY no earlier than April 1 and no later than April 30th of
the applicable YEAR effective at the end of such YEAR, provided,
however, that by written notice to MEDIMMUNE given within twenty (20)
days following ABBOTT's receipt of MEDIMMUNE's termination notice,
ABBOTT may elect to pay MEDIMMUNE (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED) of the difference between the THRESHOLD for the applicable
YEAR and the NET SALES of PRODUCT for the applicable YEAR, in which
case the Agreement shall not be terminated. Such amount shall be paid
within (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) days after the end
of the subject YEAR. The provisions of this Section 4.4 shall not be
applicable if the failure by ABBOTT to reach the THRESHOLD results
from an inability of MEDIMMUNE to timely deliver PRODUCT.
4.5 Upon termination of this Agreement, ABBOTT shall have no further
rights whatsoever in the PRODUCT in the TERRITORY, including but not
limited to any rights to co-promote the PRODUCT or to the payment set
forth hereunder.
4.6 Notwithstanding any other provision of this Agreement, MEDIMMUNE may
suspend or terminate sale of PRODUCT if the FDA takes any action the
result of which is to prohibit or restrict the manufacture or sale or
introduction into interstate commerce of the PRODUCT. Such
termination or suspension shall not be deemed a termination of this
Agreement. MEDIMMUNE shall promptly notify ABBOTT of any such action
by the FDA.
4.7 Notwithstanding any other provision of this Agreement, upon six (6)
months prior written notice to ABBOTT, MEDIMMUNE may terminate,
manufacture, and/or use, and/or sale of PRODUCT in the TERRITORY,
within its sole discretion and thereby terminate this Agreement. Such
termination shall not be deemed a breach of this Agreement.
5. MISCELLANEOUS
5.1 Independent Contractor. The relationship between MEDIMMUNE and ABBOTT
is that of independent contractors. MEDIMMUNE and ABBOTT are not
joint venturers, partners, principal and agent, master and servant,
(PAGE 11)
employer or employee, and have no relationship other than as
independent contracting parties. MEDIMMUNE shall have no power to
bind or obligate ABBOTT in any manner. Likewise, ABBOTT shall have no
power to bind or obligate MEDIMMUNE in any manner. Except as
permitted in Section 2.3(e), neither PARTY shall have any
responsibility for the hiring, firing, compensation or employee's
benefits of the other PARTY'S employees.
5.2 Nonassignability. This Agreement may not be assigned or otherwise
transferred by either PARTY without the consent of the other PARTY;
provided, however, that either PARTY may, without such consent, assign
this Agreement and its rights and obligations hereunder to its
AFFILIATES or in connection with the transfer or sale of all or
substantially all of its business to which this Agreement relates, or
in the event of its merger or consolidation or change in control or
similar transaction. Any purported assignment in violation of the
preceding sentences shall be void. Any permitted assignee shall
assume all obligations of its assignor under this Agreement, provided
that such assigning party shall remain primarily liable hereunder in
the case of an assignment to an AFFILIATE.
5.3 Modification. This Agreement constitutes the entire agreement among
the PARTIES with respect to the subject matter hereof and supersedes
all prior agreements, understandings, and discussions, whether oral or
written of the PARTIES with respect to the subject matter hereof. Any
modification of this Agreement shall be effective only when in writing
and signed by the PARTIES and specifically states that it is an
amendment to this Agreement.
5.4 Notices. Any notices expressly provided for under this Agreement
shall be in writing, shall be given either manually or by mail,
facsimile message, telegram, telex or other written means, and shall
be deemed sufficiently given if and when received by the PARTY to be
notified at its address set forth below, or if and when mailed by
certified or registered mail, postage prepaid, addressed to the PARTY
at such address stated below. Either PARTY may, by notice to the
other PARTY, change its address for receiving such notices.
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To MEDIMMUNE: MedImmune, Inc.
35 West Watkins Mill Road
Gaithersburg, MD 20878
Attn: CEO
Telephone No.: 301-417-0770
Fax No.: 301-527-4201
(PAGE 12)
To ABBOTT: Ross Products Division
625 Cleveland Avenue
Columbus, OH 43215
Attn: President
Telephone No.: 614-624-7677
Fax No.: 614-624-7030
with copy to: Abbott Laboratories
D-364, AP6D
100 Abbott Park Road
Abbott Park, IL 60064
Attn: General Counsel
Telephone No.: 847-937-5210
Fax No.: 847-938-1342
</TABLE>
5.5 Severability. If any provision(s) of this Agreement are or become
invalid, are ruled illegal by any court of competent jurisdiction or
are deemed unenforceable under then current applicable law from time
to time in effect during the term hereof, it is the intention of the
PARTIES that the remainder of this Agreement shall not be affected
thereby provided that a PARTY's rights under this Agreement are not
materially affected. It is further the intention of the PARTIES that
in lieu of each such provision which is invalid, illegal, or
unenforceable, there be substituted or added as part of this Agreement
a provision which shall be as similar as possible in economic and
business objectives as intended by the PARTIES to such invalid,
illegal or unenforceable provision, but shall be valid, legal and
enforceable. In the event a party's rights are materially affected as
a result of a change in this Agreement under this Section, such PARTY
may terminate this Agreement.
5.6 Public Announcements. MEDIMMUNE and ABBOTT each agrees not to
disclose any terms or conditions of this Agreement to any third party
or to make any public statement about this Agreement or wherein the
name of the other PARTY is used without the prior written consent of
the other PARTY (which shall not be unreasonably withheld or delayed),
except as is required by applicable law, rule or regulation; provided
(i) that if this Agreement is required to be filed as part of any
public document the filing PARTY shall, to the fullest extent
permitted under such law, rule or regulation, request that
confidential treatment be afforded to this Agreement; or (ii) that
either PARTY may allow a third party to review this Agreement as part
of an overall due diligence examination of such PARTY in connection
with any potential financing, acquisition, disposition or other
business combination; provided that such third party is under
obligation of confidentiality. In the event of a disclosure permitted
(PAGE 13)
under this Section, the disclosing PARTY shall nonetheless provide
the non-disclosing PARTY with notice of such disclosure prior to
disclosure, and will, to the extent reasonably possible, provide the
non-disclosing PARTY with an opportunity to correct same. A PARTY
shall not be required to provide the other PARTY with a disclosure
which has been previously provided to a PARTY.
5.7 Applicable Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of Maryland with regard to
choice of law principles.
5.8 Force Majeure. Neither PARTY shall be held liable or responsible to
the other PARTY nor be deemed to have defaulted under or breached this
Agreement for failure or delay in fulfilling or performing any term of
this Agreement other than a payment provision when such failure or
delay is caused by or results from causes beyond the reasonable
control of the affected PARTY including but not limited to fire,
floods, embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other
labor disturbances, acts of God or acts, omissions or delays in acting
by any governmental authority or the other PARTY. Upon the occurrence
of such event, the affected PARTY shall give prompt written notice of
such event to the other PARTY.
5.9 Waiver. 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.
5.10 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument.
5.11 Nondisclosure Obligations.
(a) During the term of this Agreement, it is contemplated that a
PARTY will disclose to the other PARTY proprietary and confidential
technology, specifications, technical information and the like which
are owned or controlled by a PARTY ("Confidential Information"). The
receiving PARTY agrees to retain the disclosing PARTY's Confidential
Information in confidence and not to disclose any such Confidential
Information to a THIRD PARTY without the prior written consent of the
disclosing PARTY and to use the disclosing PARTY's Confidential
Information only for the purposes of this Agreement. The obligations
of confidentiality will not apply to Confidential Information which:
(PAGE 14)
(i) was known to the receiving PARTY or generally
known to the public prior to its disclosure hereunder;
(ii) subsequently becomes known to the public by some
means other than a breach of this Agreement;
(iii)is subsequently disclosed to the receiving PARTY
by a third party having a lawful right to make such
disclosure;
(iv) is required by law or bona fide legal process to
be disclosed provided that the receiving PARTY takes all
reasonable steps to restrict and maintain confidentiality of
such disclosure and provides reasonable prior notice to the
disclosing PARTY; or
(v) is approved for release by the PARTIES.
(b) Upon termination or expiration of this Agreement, each PARTY
shall return to the other PARTY all tangible forms of confidential
information furnished by the other PARTY, including all copies thereof
and all memoranda of oral disclosure, except that each PARTY may
retain one copy in its files to ensure compliance with any legal
obligations.
(c) This Section shall survive until the tenth anniversary of the
termination or expiration of this Agreement.
5.12 Non-Compete.
(a) During the period that ABBOTT is co-promoting PRODUCT under this
Agreement and for (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED), ABBOTT
agrees that neither ABBOTT nor an AFFILIATE of ABBOTT shall promote,
market or sell directly or indirectly or assist another PARTY in
marketing or selling in the TERRITORY any biological and/or
pharmaceutical product for prevention and/or treatment of respiratory
syncytial virus disease that competes with the PRODUCT.
(b) During the first (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED),
MEDIMMUNE agrees that neither MEDIMMUNE nor an AFFILIATE of MEDIMMUNE
shall promote, market or sell directly or indirectly or assist another
PARTY in marketing or selling in the TERRITORY any biological and/or
pharmaceutical product for prevention and/or treatment of respiratory
syncytial virus disease that competes with the PRODUCT, except
RESPIGAM and any product of which RESPIGAM is a component.
5.13 Authority. The PARTIES warrant and represent to each other that each
has the full right and authority to enter into this Agreement, that
each is not aware of any impediment which would inhibit its ability to
(PAGE 15)
perform the terms and conditions imposed on it by this Agreement, and
that there are no and will be no outstanding agreements, licenses,
assignments or encumbrances inconsistent with the provisions of and
the rights granted under this Agreement, or which are inconsistent
with or would prevent a PARTY from performing all of its obligations
under this Agreement.
5.14 No Grant of License. Nothing contained herein shall be deemed to
grant ABBOTT either expressly or impliedly, a license or other right
or interest in any patent, trademark, trade name or logo or other
similar property of MEDIMMUNE, except as may be necessary for ABBOTT
to co-promote the PRODUCT as provided hereunder.
5.15 No Consequential Damages. Except for a PARTY's obligations under
Section 3.1, neither PARTY shall be liable to the other for any
consequential, special, incidental or indirect charges.
5.16 Representations and Warranties. MEDIMMUNE represents and warrants to
ABBOTT, as of the date hereof, that to the best of its knowledge, the
manufacture, use, sale or offer to sell of PRODUCT in the TERRITORY
does not infringe or violate any granted patent. In no event shall
MEDIMMUNE's liability for a breach of this representation and warranty
exceed $250,000.
IN WITNESS WHEREOF, this Agreement has been duly executed effective on
the date first above written.
<TABLE>
<CAPTION>
<S> <C>
By:/s/Thomas M. McNally By:/s/David M. Mott
Thomas M. McNally David M. Mott
Senior Vice President President
</TABLE>
(PAGE 16)