License Agreement - Eli Lilly & Co. and Cubist Pharmaceuticals Inc.
License Agreement
This Agreement is made this 7th day of November, 1997 (the "Effective Date"),
by and between ELI LILLY & COMPANY having its principal place of business at
Lilly Corporate Center, Indianapolis, Indiana 46285 and its Affiliates
(collectively, "ELI LILLY") and Cubist Pharmaceuticals Incorporated, a
Delaware corporation having its principal place of business at 24 Emily
Street, Cambridge, MA, 02139 and its Affiliates (collectively "CUBIST") as
follows:
Article 1
Definitions
As used throughout this Agreement, the following terms shall have the
meanings indicated in this Article.
"Affiliate" means any corporation or other entity which directly or
indirectly controls, is controlled by or is under common control with a party
to this Agreement. A corporation or other entity shall be regarded as in
control of another corporation or entity if it owns or directly or indirectly
controls more than [ ]* of the outstanding voting stock or other
ownership interest of the other corporation or entity, or if it possesses,
directly or indirectly, the power to manage, direct or cause the direction of
the management and policies of the corporation or other entity or the power
to elect or appoint [ ]* or more of the members of the governing body
of the corporation or other entity. Any such other relationship as in fact
results in actual control over the management, business and affairs of a
corporation or other entity shall also be deemed to constitute control.
"Average Market Price" shall mean the average closing price for CUBIST common
stock for twenty consecutive trading days, the last day of which is
immediately prior to five days prior to the event that triggered such payment
of CUBIST common stock to ELI LILLY.
"Compound" means [ ]* or a pharmaceutically acceptable salt thereof
or a pharmaceutically acceptable formulation thereof which is in Lilly's
possession on the Effective Date.
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* Confidential Treatment requested: material has been omitted and filed
separately with the Commission.
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"Confidential Information" means any information and data received by a party
from the other party, as well as the terms of this Agreement. Notwithstanding
the foregoing, Confidential Information shall not include any part of such
Confidential Information that: (1) is or becomes part of the public domain
other than by unauthorized acts of the party obligated not to disclose such
Confidential Information; (ii) can be shown by written documents to have been
disclosed to the receiving party by a third party, provided such Confidential
Information was not obtained by such third party directly or indirectly from
the disclosing party with an obligation for such third party to maintain the
confidentiality of such information; (iii) prior to disclosure under this
Agreement, was already in the possession of the receiving party and such
possession can be evidenced by written documents, provided such Confidential
Information was not obtained directly or indirectly from the disclosing party
with an obligation to maintain the confidentiality of such information, (iv)
can be shown by written documents to have been independently developed by the
receiving party without breach of any of the provisions of this Agreement and
such independent development can be evidenced by written documents', or (v)
is disclosed by the receiving party pursuant to interrogatories, requests for
information or documents, subpoena, civil investigative demand issued by a
court or governmental agency or as otherwise required by law, provided,
however, that the receiving party notifies the disclosing party immediately
upon receipt thereof, giving such disclosing party sufficient advance notice
to permit it to seek a protective order or other similar order with respect
to such Confidential Information and provided, further, that the receiving
party furnishes only that portion of the Confidential Information which it is
advised by counsel is legally required whether or not a protective order or
other similar order is obtained by the disclosing party.
"ELI LILLY Program" shall mean a research, development and/or marketing
project that ELI LILLY, its Affiliates, and/or a third party, pursuant to an
Agreement with ELI LILLY, have been committing non-trivial financial and/or
human resources to advance.
"Field" shall mean the treatment of infectious diseases except, [ ]*
"Know-How" means all information and data reasonably useful for the
development, process development, regulatory approval, manufacture,
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* Confidential Treatment requested: material has been omitted and filed
separately with the Commission.
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use, formulation or sale of Compound in the Field which (i) is in the
possession of ELI LILLY as of the Effective Date or is created by ELI LILY
after the Effective Date, (ii) ELI LILLY can provide using reasonble efforts
and (iii) ELI LILLY is free to provide without obligation to any third party.
Such Know-How may include information that is secret, whether or not
patentable, relating to materials, methods, processes, procedures, protocols,
techniques, formulae and data reasonably useful for the development,
regulatory approval, manufacture or use of Compound in the Field.
"Major Market Country" shall mean the United States, Canada, Japan, the
United Kingdom, Germany, France, Italy, Spain, Switzerland, Netherlands and
Belgium.
"Net Sales" means the amounts received by CUBIST and/or its sublicensees on
sales or other transfers for commercial use of Compound, and products
incorporating Compound, to independent third parties in bona fide arms length
transactions, less the following deductions actually allowed and taken by
such independent third parties and not otherwise recovered by or reimbursed
by CUBIST or its sublicensees:
(a) [ ]*;
(b) [ ]*;
(c) [ ]*; and
(d) [ ]*.
If CUBIST or its sublicensees sell or transfer Compound, or any products
incorporating Compound for commercial use, other than (i) reasonable
quantities of promotional samples or (ii) to an independent third party in a
bona fide arm's length transaction, Net Sales shall be determined based upon
the resale or other retransfer to an independent third party in an arm's
length transaction by the entity to whom such Compound, or product, was sold
or transferred by Cubist or its sublicensee. If there is no such resale or
retransfer, Net Sales shall be determined based on the average Net Sales
price as determined in the immediately preceding royalty accounting period as
set forth in Section 4.02.
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* Confidential Treatment requested: material has been omitted and filed
separately with the Commission.
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In the event Compound is sold as a component of a combination of functional
elements, Net Sales for purposes of determining royalty payments on such
combination shall be calculated by multiplying the Net Sales price of such
combination by the fraction [ ]* In the event no separate sale of
either such above-designated Compound or such above-designated non-Compound
portion of the combination is made during the accounting period in which the
sale of the combination was made, Net Sales shall be calculated by
multiplying the Net Sales price of the combination by the fraction [ ]
*.
"Patent(s)" means any of ELI LILLY's patents, pending patent applications,
and future. patent applications, including, but not limited to, those set
forth on Exhibit 3 attached hereto, which claim Compound, formulations of
Compound, processes for preparing Compound or use of Compound in the Field,
any United States or foreign counterpart patents and applications, and any
continuing, divisional, reissue, re-examination and substitute patents and
applications based, in whole or in part, on any of the foregoing patents and
patent applications, together with all continuations, continuations-in-part,
divisions, patents of addition, reissues, renewals, extensions, supplementary
protection certificates and complementary protection certificates of any of
the foregoing which are owned by ELI LILLY and under which ELI LILLY has
rights to grant a sublicenses.
"Phase II Clinical Trial" shall mean clinical studies conducted in accordance
with Good Clinical Practices ("GCPs") in a small number of healthy volunteers
to establish efficacy and obtain a preliminary indication of the dosage of
Compound.
"Phase III Clinical Trial" shall mean large scale clinical studies in
patients conducted in accordance with GCPs primarily to establish safety and
efficacy of Compound.
"Valid Claim" shall mean a claim of an issued and unexpired Patent which has
not been withdrawn, canceled, revoked, disclaimed, or held invalid,
unenforceable or unpatentable by a final and unappealed (within the time
allowed for appeals) or unappealable judgment or decision of a court or other
governmental agency of competent jurisdiction.
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* Confidential Treatment requested: material has been omitted and filed
separately with the Commission.
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Article 2
License Grant
2.00 ELI LILLY grants to CUBIST the following worldwide, exclusive licenses
subject to the conditions set forth herein below in Section 2.01:
(a) Under the Patents, to develop, manufacture, formulate, have
manufactured, import, use, distribute for sale, market and sell Compound in
the Field; and
(b) To use the Know-How for the development, manufacture, formulation,
use, distribution for sale, marketing, and sale of Compound consistent with
the terms of this Agreement.
2.01 (i) Subject to Section 2.01(ii) below, CUBIST shall have the right to
grant sub-licenses under the Patents and Know-How, for use in the Field,
provided that the terms and conditions of such sub-licenses are consistent
with and no less restrictive than the terms and conditions of this Agreement,
and any such disclosure or transfer of Compound shall be limited to use
solely in the Field.
(ii) In the event that, during the term of this Agreement, CUBIST
actively seeks to grant a sub-license to a third party for the development of
the Compound in the Field which sublicense includes, but is not necessarily
limited to, the right to develop and/or commercialize an oral or intravenous
formulation of the Compound, CUBIST agrees to inform ELI LILLY of such
determination by written notice, which notice shall include (a) a description
in reasonable detail of the subject matter of the proposed sub-license and
(b) the terms on which CUBIST would be willing to grant ELI LILLY such rights
(the "Sublicense Notice"). ELI LILLY shall thereupon have a period of
[ ]* (the "Notice Period") to either accept CUBIST's terms in writing
or to make a written counter-proposal. If ELI LILLY accepts CUBIST's
proposal or makes a counter-proposal, the parties will, for a period of up to
[ ]* from receipt by ELI LILLY of the Sublicense Notice (the
"Negotiation Period"), seek in good faith to enter into a definitive
agreement for such rights. If ELI LILLY does not by the expiration of the
Notice Period either accept CUBIST's proposal or make a counter-proposal, or
the parties negotiate in
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* Confidential Treatment requested: material has been omitted and
filed separately with the Commission.
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good faith and fail to reach agreement by the expiration of the Negotiation
Period, CUBIST shall be free to enter into a sub-license for such rights with
a third party,[ ]*.
2.02 CUBIST shall notify ELI LILLY within [ ]* of the identity of
each sublicensee together with a summary of the principal terms of any
sub-license, and shall take all reasonable steps in the event of a breach of
any sub-license by the sub-licensee to enforce the same.
2.03 CUBIST acknowledges that ELI LILLY has disclosed certain Know-How to
CUBIST prior to the execution of this Agreement and CUBIST shall treat such
Know-How in accordance with the terms of this Agreement. During the term of
this Agreement, ELI LILLY shall disclose to CUBIST such other Know-How as is
directly related to CUBIST's activities under the license granted in Article
2.00 and which ELI LILLY can provide to CUBIST using reasonable efforts.
2.04 Promptly after the Effective Date, ELI LILLY may provide CUBIST with
reasonable access to consult with pertinent ELI LILLY employees that have had
prior experience working with Compound in the Field at ELI LILLY to enhance
the preclinical or clinical development and manufacturing of the Compound,
provided that such consultation shall occur at a mutually agreeable time and
place and that ELI LILLY will only provide such access to current employees
which are reasonably able to provide CUBIST with ELI LILLY Know-How relating
to the scale-up, manufacture, or formulation of Compound for use in the
Field. CUBIST shall be responsible for all reasonable expenses its own
personnel and ELI LILLY personnel incur in association with any such
consultations. Upon CUBIST's request, ELI LILLY shall provide CUBIST and its
sublicensees with all Know-How, information and data owned by ELI LILLY which
ELI LILLY can provide using reasonable efforts to the extent such Know-How,
information and data is reasonably required to further CUBIST's or its
sub-licensees' ability to develop, scale-up, obtain regulatory approval for,
manufacture, distribute, use, formulate or sell Compound for use in the
Field. CUBIST agrees to treat all Know-How disclosed to it as Confidential
Information of ELI LILLY.
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* Confidential Treatment requested: material has been omitted and
filed separately with the Commission.
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2.05 ELI LILLY shall deliver to CUBIST, ELI LILLY's available inventory of
Compound. ELI LILLY shall not be required to perform any manufacturing of
Compound for CUBIST.
Article 3
Diligence and
Regulatory
3.00 CUBIST shall use commercially reasonable efforts to develop and test
the Compound in the Field, to perform all pre-clinical, clinical and other
studies of such Compound necessary to obtain regulatory approval for the
manufacture, use and sale of Compound, and to market and sell Compound in the
Field in all countries in which it is commercially reasonable to market such
Compound. CUBIST shall fully fund these efforts, as well as any other work
that is required for CUBIST to develop and market Compound in the Field.
CUBIST has prepared and provided to ELI LILLY a preliminary development plan
attached hereto as Exhibit 2, which contains CUBIST's estimate, based upon
data currently available to CUBIST concerning the subject matter of this
Agreement, of the probable course of Compound development hereunder. As
Compound development progresses, CUBIST will revise the plan from time to
time to reflect the development and evolution of its plans regarding
development, regulatory approvals, manufacturing and formulation, and
clinical trials, and will provide ELI LILLY with a copy of any such
materially revised plan as soon as reasonably possible after such revision
occurs. [ ]*. The terms under which ELI LILLY shall acquire back
all such rights shall be the subject of a separate agreement to be negotiated
in good faith by the parties.
3.01 CUBIST represents that it intends to conduct clinical testing of
Compounds to the extent that such testing is supported by safety and efficacy
data required by the applicable regulatory agency.
3.02 Within thirty (30) days of the Effective Date, ELI LILLY shall deliver
to CUBIST a copy of the Investigational New Drug Application filed with the
United States Food and Drug Administration and foreign equivalents, if any
relating to the Compound, and as soon thereafter as is commercially
practicable, ELI LILLY shall transfer all other reasonably
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* Confidential Treatment requested: material has been omitted and
filed separately with the Commission.
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transferable information used in regulatory filings, laboratory data,
clinical data, toxicology data, and scale-up, manufacturing and formulation
information relating to Compound to CUBIST in a commercially reasonable time
frame.
3.03 Both ELI LILLY and CUBIST shall submit information and file reports to
various governmental agencies to the extent they are lawfully required on
compounds under clinical investigation, compounds proposed for marketing, or
marketed drugs. Information must be submitted at the time of initial filing
for investigational use in humans and at the time of a request for market
approval of a new drug. In addition, supplemental information must be
provided on compounds at periodic intervals and adverse drug experiences must
be reported at more frequent intervals depending on the severity of the
experience. Consequently, ELI LILLY and CUBIST agree, to the extent required
by applicable law or regulations, to:
1) provide to one another for initial and/or periodic submission to
governmental agencies significant information on Compound from pre-clinical
laboratory, animal toxicology and pharmacology studies, as well as serious or
unexpected adverse experience reports from clinical trials and marketed
commercial experiences with Compound.
2) report to one another in such a manner and time so as to enable
each party to comply with all governmental laws and regulations in
territories for which registration is or will be sought.
Serious adverse experience means any experience that suggests a
significant hazard, contraindication, side effect or precaution, or any
experience that is fatal or life threatening, is permanently disabling,
requires or prolongs inpatient hospitalization, or is a congenital anomaly,
cancer or overdose.
Unexpected adverse experience is one not identified in nature,
specificity, severity or frequency in a current investigator brochure for
Compound, or in CUBIST's labeling for Product.
3.04 CUBIST also agrees that if it contracts with a third party for
research to be performed by such third party on Compound or if it sublicenses
its rights herein to a third party, it will require such third party to
comply with the reporting obligations (both to ELI LILLY and to regulatory
agencies) set forth in this Section.
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3.05 CUBIST shall comply with all applicable laws and regulations regarding
the care and use of experimental animals, in a country where the development
is carried out. All animals used to evaluate Compound shall be provided
humane care and treatment in accordance with the most acceptable veterinary
practices.
Article 4
Payments
4.00 Cubist will pay [ ]* to ELI LILLY as a license fee upon the
Effective Date of this Agreement.
4.01 CUBIST will also pay to ELI LILLY the following payments:
(a) [ ]* as a license fee, to be paid upon the earlier of (i)
completion of CUBIST or CUBIST's sub-licensee's first Phase II Clinical Trial
in a Major Market Country or (ii) upon the initiation of CUBIST or CUBIST's
sub-licensees of patient dosing in the first Phase III Clinical Trial in a
Major Market Country; said license fee to be paid in CUBIST common stock
based on the Average Market Price for such CUBIST common stock;
(b) [ ]* as a license fee, to be paid upon the date of
CUBIST's or CUBIST's sub-licensee's first regulatory submission in a Major
Market Country for a license to market Compound, said license fee to be paid
in CUBIST common stock, based on the Average Market Price for such CUBIST
Common Stock; and
(c) [ ]* as a license fee, to be paid upon the date of
CUBIST's or CUBIST's sub-licensee's first regulatory approval in a Major
Market Country for their application to market Compound, said license fee to
be paid in CUBIST common stock, based on the Average Market Price for such
CUBIST Common Stock.
4.02 During the first [ ]* after the first commercial sale of
Compound in a Major Market Country, CUBIST will pay ELI LILLY royalties of
[ ]* on the first [ ]* of aggregate annual Net Sales of
Compounds and [ ]* on aggregate Net Sales between [ ]* and
[ ]* and [ ]* on aggregate annual Net Sales in excess of
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* Confidential Treatment requested: material has been omitted and
filed separately with the Commission.
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$150,000,000 in all countries ("Protected Countries") for so long as (a) the
manufacture, use or sale of Compound is covered by a Valid Claim, or (b)
there is no significant generic competition which causes a reduction of Net
Sales of Compound by [thirty (30) percent]* or more in any [twelve month]*
period.
After the expiration of the first [ ]* after first commercial sale in
a Major Market Country, CUBIST will pay ELI LILLY royalties of [ ]*
on the first [ ]* of aggregate annual Net Sales of Compound and
[ ]* on aggregate annual Net Sales between [ ]* and
[ ]* and [ ]* on aggregate annual Net Sales in excess of
[ ]* in all countries ("Protected Countries") for so long as (a) the
manufacture, use or sale of a Compound is covered by a Valid Claim, or (b)
there is no significant generic competition which causes a reduction of Net
Sales of Compound by [ ]* or more in any [twelve month]* period.
4.03 For a period of [ ]* following first commercial sale in a
Major Market Country, CUBIST will pay ELI LILLY royalties of [ ]* of
aggregate annual Net Sales in all countries that are not Protected Countries,
but where the manufacture, use, sale or transfer of Compound utilizes
Know-How provided to CUBIST by ELI LILLY. [ ]* of Net Sales in
countries that are not Protected Countries shall be included in aggregate
annual Net Sales of Compound calculated pursuant to Section 4.02 for purposes
of determining the appropriate royalty percentage in Section 4.02.
4.04 In the event that CUBIST can demonstrate that external factors beyond
its control (such as government-imposed price controls) have materially
reduced CUBIST's profitability on sales of Compound in any Country, ELI LILLY
agrees to consider in good faith an equitable reduction in the royalty rate
applicable to such country under Section 4.02 or 4.03, as applicable.
4.05 The first payment under Articles 4.04 and 4.05 shall be due within
[ ]* after December 31 or June 30, whichever such date occurs first
after the first commercial sale or transfer of Compound. Thereafter,
payments under Articles 4.04 and 4.05 shall be made within [ ]* of
each of December 31 and June 30 of each year. Payments shall be
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* Confidential Treatment requested: material has been omitted and
filed separately with the Commission.
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accompanied by a report showing all facts necessary to the calculation of
amounts due.
4.06 All royalty payments to ELI LILLY shall be in United States dollars.
Royalty payments based on Net Sales in currencies other than United States
dollars shall be converted to US dollars according to the average official
rate of exchange for that currency as published in the Wall Street Journal on
the first and last days of the six-month period in which that royalty accrued
(or, if not published on that day, the first and last publication days for
the Wall Street Journal during that six month period). If such exchange rate
is not published in the Wall Street Journal, then the rate shall be
determined using average conversion rates that are accepted in the industry
on the first and last days of the six month period in which the royalty
accrued. All payments that are not to be made in CUBIST common stock, as
specified herein. shall be paid in United States dollars.
4.07 If by law, regulation, or fiscal policy of a particular country,
conversion into United States dollars or transfer of funds of a convertible
currency to the United States is restricted or forbidden, CUBIST shall give
ELI LILLY prompt written notice and shall pay the royalty due under this
Article 4 through such means or methods as are lawful in such country as ELI
LILLY may reasonably designate. Failing the designation by ELI LILLY of such
lawful means or methods within thirty (30) days after such written notice is
given to ELI LILLY, CUBIST shall deposit such royalty payment in local
currency to the credit of ELI LILLY in a recognized banking institution
designated by ELI LILLY, or if none is designated by ELI LILLY within the
thirty (30) day period described above, in a recognized banking institution
selected by CUBIST In and identified in a written notice to ELI LILLY by
CUBIST, and such deposit shall fulfill all obligations of CUBIST with respect
to such royalties.
4.08 CUBIST and its sub-licensees, if any, shall maintain complete and
accurate books and records with respect to sale and use of Compound and all
other information necessary to permit calculation and verification of amounts
due under this Article 4 and Article 5 and Article 6, set forth below. Upon
reasonable prior written notice to CUBIST, ELI LILLY may cause an independent
agent to audit the books and records of CUBIST and its sub-licensees, if any,
pertaining to the payment to ELI LILLY hereunder, for the sole purpose of
confirming the amounts due, and the accuracy of the payments and reports;
provided that no such audit shall
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be permitted for periods exceeding [ ]* prior to the date CUBIST
receives such written notice. Any such audit shall be performed at ELI
LILLY's expense during normal business hours and shall, if so required by
CUBIST, be performed by a firm of independent public accountants reasonably
acceptable to CUBIST. The independent agent shall report only such
information as would properly be included in such a report. In the event of
an underpayment, CUBIST shall promptly remit to ELI LILLY all amounts due.
CUBIST shall require any sublicensee to agree to comply with all of the terms
of this paragraph, including but not limited to making such report,
maintaining such records, and permitting such audit.
[ ]*
4.09 Any late payments due to ELI LILLY shall be subject to interest
charges which rate shall be established at [ ]* above the prime
interest rate in effect on the date that such payment was first due to ELI
LILLY.
Article 5
Minimum Royalties
5.00 [ ]* after December 31 or June 30, whichever date occurs
first, following the first twelve (12) month period after the first
commercial sale of Compound in a Major Market Country, CUBIST will pay ELI
LILLY [ ]* as a minimum royalty.
5.01 [ ]* after December 31 or June 30, whichever date occurs
first, following the second twelve (12) month period after the first
commercial sale of Compound in a Major Market Country, CUBIST will pay to ELI
LILLY [ ]* as a minimum royalty.
5.02 [ ]* after December 31 or June 30, whichever date occurs
first, following the third twelve (12) month period after the first
commercial sale of Compound in a Major Market Country, CUBIST will pay ELI
LILLY [ ]* as a minimum royalty.
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* Confidential Treatment requested: material has been omitted and
filed separately with the Commission.
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5.03 CUBIST shall deduct any withholding taxes from the payments agreed
upon under this Agreement and pay them to the proper tax authorities as
required by applicable law. CUBIST shall maintain official receipts of any
withholding taxes and forward these receipts to ELI LILLY. The parties will
exercise their best efforts to ensure that any withholding taxes imposed are
reduced as far as legally possible under the provisions of any treaties
applicable to any payment made hereunder.
Article 6
Indemnification, Insurance and Limitation of Damages
6.00 CUBIST shall indemnify ELI LILLY and its directors, officers,
employees and agents, as set forth in Article 6.02, with respect to (a) any
third party claim or action against ELI LILLY based on CUBIST's or CUBIST's
sublicensee's developing, making, distributing, selling, marketing, using or
otherwise transferring Compound and (b) breach of any representation or
warranty contained in Article 7 by CUBIST, provided, however that CUBIST
shall have no duty to indemnify ELI LILLY to the extent that any such claim
or action is subject to ELI LILLY's duty of indemnification set forth in
Article 6.01.
6.01 ELI LILLY shall indemnify CUBIST, as set forth in Article 6.02, with
respect to (a) any third party claim or action against CUBIST based on (i)
activities of ELI LILLY, Its employees, or its agents with respect to
Compound prior to the Effective Date, (ii) the negligence or willful
misconduct of ELI LILLY, its employees and agents, and (b) breach of any
representation or warranty contained in Article 7 by ELI LILLY, provided,
however, that ELI LILLY shall have no duty to indemnify CUBIST to the extent
that any such claim or action Is subject to CUBIST's duty of indemnification
set forth in Article 6.00.
6.02 With respect to the claims and actions referenced in Articles 6.00 and
6.01 above, the indemnifying party shall defend any such claim or action
against the indemnified party and shall pay all damages, judgments, costs,
expenses (including attorneys' fees, but only to the extent that the
indemnifying party fails to promptly assume the defense of such claims and
actions) and liability awarded against the indemnified party, or settlements
entered into, with respect to such claim or action, provided that the
indemnified party (a) provides prompt written notice to the indemnifying
party of any such claim or action, (b) allows the indemnifying party to
assume the defense and settlement thereof, with counsel of its choice, and
(c) provides reasonable assistance to the indemnifying party in connection
with the defense and settlement thereof.
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6.03 Prior to administration of Compound to any human, CUBIST shall provide
to ELI LILLY an endorsement verifying customary levels of insurance for
damages, judgments, costs, expenses (including attorneys' fees) and liability
with respect to any third party claim or action based on CUBIST's or CUBIST's
sublicensee's manufacture, distribution, use, marketing or sale of Compound,
naming ELI LILLY, its directors, officers and employees as additional
insureds on the policy, and shall have copies of such insurance policies
delivered to ELI LILLY as soon as reasonably practical. In addition,
evidence of insurance in the form of such endorsement shall be furnished to
ELI LILLY at the inception of each subsequent phase of human clinical trials,
as well as upon granting of NDA and PLA, but in no event less than annually
upon the insurance policy renewal date. Such insurance shall remain in
effect at customary levels throughout the term of this Agreement. ELI LILLY
shall be informed thirty (30) days prior to any cancellation of or material
decrease in the amount of coverage of such insurance by CUBIST or any other
action that CUBIST reasonably should believe will result in decrease or
cancellation of such insurance, or immediately upon receipt by CUBIST of a
notice of cancellation of such insurance, on the effective date of which
cancellation or decrease, clinical use of Compound must immediately cease,
subject to CUBIST obtaining adequate replacement insurance. The foregoing
shall not be interpreted to limit the scope or amount of CUBIST's
indemnification obligation under Article 6.00.
Notwithstanding the foregoing, CUBIST shall be entitled to adopt an insurance
program containing self insurance elements, to the extent that CUBIST is able
to demonstrate to the reasonable satisfaction of ELI LILLY that such a
program is not unusual in the industry for companies similarly situated
(including financial condition to support such a program) or with respect to
products with a risk profile similar to products licensed hereunder.
6.04 Other than as set forth elsewhere in this Agreement, in no event shall
either party be liable for any special, consequential, indirect, or
incidental damages, however caused and on any theory of liability, arising
out of this Agreement. These limitations shall apply notwithstanding any
failure of essential purpose of any limited remedy.
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Article 7
Representations, Warranties And Disclaimer
7.00 Each party represents and warrants to the other party that (a) it has
the right to enter into this Agreement; (b) this Agreement has been duly
authorized by all necessary action of such party and (c) the execution of
this Agreement by the party will not conflict with or breach any other
agreement to which it is a party or by which it is bound.
7.01 ELI LILLY represents that (a) it is party to an agreement with
Ophidian which Agreement includes a covenant not to compete (b) if CUBIST
notifies ELI LILLY that it desires to develop Compound for the treatment of
clostridium difficile-induced colitis, ELI LILLY shall notify CUBIST if such
covenant has expired or is terminated, (c) there is no other agreement known
to ELI LILLY to which it is a party and by which it is bound that would
conflict with or be breached by ELI LILLY granting the license in Article 2,
(d) except as previously disclosed in writing to CUBIST, no other person or
entity has claimed, or to ELI LILLY's knowledge has, any rights to or
interest in the Patents and the Know- How in the Field to be licensed
hereunder, and that to its knowledge, the manufacture, use, distribution,
marketing or sale of the Compound(s) can be performed without infringing the
patent rights of any third party, and (e) as of the Effective Date ELI LILLY
is conducting no development program relating to analogs or derivatives of
the Compound, provided that ELI LILLY shall be free to commence and conduct
any such program at any time hereafter.
7.02 ELI LILLY makes no representation or warranty that Compound made,
used, or sold under the licenses granted herein is or will be free of claims
of infringement of the patent rights of any third party (although it
represents and warrants that it has no knowledge of (i) such infringement not
heretofore disclosed to Cubist and (ii) any payment obligations that CUBIST
will have to third parties in connection with CUBIST's development,
manufacturing, marketing or sale of Compound) and makes no warranty or
representation that any of the Patents to be licensed hereunder are valid or
enforceable.
7.03 EXCEPT AS SET FORTH IN ARTICLES 7.00 AND 7.01 ABOVE, ELI LILLY
EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
OR NON-INFRINGEMENT.
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7.04 CUBIST acknowledges that the Compound(s) are highly experimental in
nature [ ]*.
7.05 CUBIST warrants that all CUBIST common stock to be paid to ELI LILLY
pursuant to this Agreement shall be properly issued and all legal
requirements associated with such issuance to ELI LILLY shall be fulfilled.
The number of shares of CUBIST common stock payable to ELI LILLY shall be
determined by dividing the payment amount by the Average Market Price to
determine the number of shares.
For illustration purposes only, upon completion of CUBIST's first Phase II
Clinical Trial, CUBIST shall pay ELI LILLY [ ]* in CUBIST common
stock. The number of shares to be transferred to ELI LILLY shall be
determined by dividing [ ]* by the Average Market Price.
Article 8
Patents And Know-How
8.00 In the event either of the parties shall learn of the infringement, or
a challenge to the validity, enforceability, or title of any Patent
(including any action for a declaratory Judgment) right licensed hereunder,
or an action for unauthorized use or misappropriation of Know-How licensed
hereunder, such party shall promptly notify the other party thereof in
writing and shall provide the other party with any evidence in its possession
of such infringement, challenge or action.
8.01 Actions Affecting Other ELI LILLY Programs.
(i) During the term of this Agreement, ELI LILLY shall have the sole
right, but no obligation, to bring or defend any suit or action relative to
the patenting or patent enforcement directly relating to Compound,
manufacture, use, distribution, marketing or sale of Compound in the Field
which suit or action also materially affects intellectual property rights of
ELI LILLY that relate to an active ELI LILLY Program, including the fight to
recover for past infringement, or the unauthorized use or misappropriation of
Know-How in the Field. If ELI LILLY finds it necessary or desirable to join
CUBIST in such suit or action, CUBIST
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* Confidential Treatment requested: material has been omitted and
filed separately with the Commission.
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shall execute all papers and perform such other acts as may reasonably be
required, at ELI LILLY's expense, to join CUBIST in such suit or action.
CUBIST may, at its option, join as a party to such suit and be, at its
expense, represented by counsel of its choice, provided that ELI LILLY shall
continue to control the prosecution or defense of such suit. Unless CUBIST
and ELI LILLY otherwise agree, any amount recovered in any such action,
whether by judgment or settlement, after deducting ELI LILLY's reasonable
expenses (including attorneys' fees), and payment to CUBIST of damages in
respect of CUBIST's lost profits for which ELI LILLY recovers payment and
CUBIST's reasonable expenses (including attorneys' fees) incurred in
connection with an action or suit in which ELI LILLY requested that CUBIST be
Joined or in which CUBIST voluntarily joined, shall be paid to or retained by
ELI LILLY.
(ii) In the event ELI LILLY faIls to take action with respect to such
infringement, or challenge to validity, enforceability or title, or action
for unauthorized use or misappropriation of Know-How in the Field which
materially affect intellectual property rights of ELI LILLY that relate to an
active ELI LILLY program, within a reasonable period, no less than three (3)
months, following receipt by ELI LILLY of reliable evidence of infringement,
CUBIST shall have the right, but no obligation, to bring, or defend any such
suit or action. ELI LILLY may, at its option, join as a party to such suit
and be, at its expense, represented by counsel of its choice, provided that
CUBIST shall continue to control the prosecution or defense of such suit. If
CUBIST finds it necessary to join ELI LILLY in such suit or action, ELI LILLY
shall execute all papers and perform such other acts as may be reasonably
required at CUBIST's expense. Unless CUBIST and ELI LILLY otherwise agree,
any amount recovered in any such action or suit, whether by judgment or
settlement, after deducting CUBIST's reasonable expenses (including
attorneys' fees) and payment to ELI LILLY of damages in respect of ELI
LILLY's lost royalties for which CUBIST recovers payment and after payment to
ELI LILLY of its reasonable expenses (including attorneys' fees) incurred in
connection with an action or suit in which CUBIST requested that ELI LILLY be
joined or which ELI LILLY voluntarily owned, shall be paid to or retained
entirely by CUBIST.
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8.02 Actions Not Affecting Other Lilly Programs.
(i) During the term of this Agreement, CUBIST shall have the sole
right, but no obligation, to bring or defend any suit or action relative to
the patenting or patent enforcement directly relating to Compound,
manufacture, use, distribution, marketing or sale of Compound in the Field
which suit or action does not materially affect intellectual property rights
of ELI LILLY that relate to an active ELI LILLY Program, including the right
to recover for past infringement, or the unauthorized use or misappropriation
of Know-How in the Field. If CUBIST finds it necessary or desirable to join
ELI LILLY in such suit or action, CUBIST shall execute all papers and perform
such other acts as may reasonably be required, at CUBIST's expense, to join
ELI LILLY in such suit or action. ELI LILLY may, at its option, join as a
party to such suit and be, at its expense, represented by counsel of its
choice, provided that CUBIST shall continue to control the prosecution or
defense of such suit. Unless CUBIST and ELI LILLY otherwise agree, any
amount recovered in any such action or suit, whether by Judgment or
settlement, after deducting CUBIST's reasonable expenses (including
attorneys' fees) and payment to ELI LILLY of damages in respect of ELI
LILLY's lost royalties for which CUBIST recovers payment and after payment to
ELI LILLY of its reasonable expenses (including attorneys' fees) in
connection with an action or suit in which CUBIST requested that ELI LILLY be
joined or which ELI LILLY voluntarily joined, shall be paid to or retained
entirely by CUBIST.
(ii) In the event CUBIST faIls to take action with respect to such
infringement, or challenge to validity, enforceability or title, or action
for unauthorized use or misappropriation of Know-How in the Field which does
not materially affect intellectual property rights of ELI LIILLY that relate
to an active ELI LILLY program, within a reasonable period, no less than
three (3) months, following receipt by CUBIST of reliable evidence of
infringement, ELI LILLY shall have the right, but no obligation, to bring, or
defend any such suit or action. If ELI LILLY finds it necessary to join
CUBIST in such suit or action, CUBIST shall execute all papers and perform
such other acts as may be reasonably required at ELI LILLY's expense. CUBIST
may, at its option, join as a party to such suit and be, at its expense,
represented by counsel of its choice, provided that ELI LILLY shall continue
to control the prosecution or defense of such suit. Unless CUBIST and ELI
LILLY otherwise agree, any amount recovered in any such action, whether by
judgment or settlement, after deducting ELI LILLY's reasonable expenses
(including attorneys' fees), and payment to CUBIST of damages in respect of
CUBIST's lost profits
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for which ELI LILLY recovers payment and CUBIST's reasonable expenses
(including attorneys' fees) incurred in connection with an action or suit in
which ELI LILLY requested that CUBIST be joined or in which CUBIST
voluntarily joined, shall be paid to or retained by ELI LILLY.
8.03 If CUBIST determines in good faith in consultation with ELI LILLY that
the manufacture, use or sale of Compound in the Field would infringe the
intellectual property rights of a third party unaffiliated with either CUBIST
or ELI LILLY, and it therefore becomes necessary to pay a royalty, license
fee or other compensation to that party to avoid a claim of infringement,
then CUBIST and ELI LILLY shall each bear [ ]* provided that ELI
LILLY's share of such obligation shall be deducted from CUBIST's royalty
payments due to ELI LILLY, and further provided that CUBIST's payment,
pursuant to this Agreement, to ELI LILLY in any one (1) year would never be
reduced by more than [ ]*. If, as a result of the preceding
sentence, CUBIST bears more than [ ]* of the royalty, license fee or
other compensation due to a third party under this Section 8.04, the amount
of the excess may be carried forward and used by CUBIST as a credit against
royalties due ELI LILLY in subsequent royalty periods, provided that in no
event shall CUBIST's royalty payments to ELI LILLY be reduced by more than
[ ]*.
8.04 Each party agrees to cooperate with the other in legal action taken to
enforce, defend or maintain a Patent licensed hereunder or concerning
Know-How licensed hereunder, including litigation proceedings.
8.05 ELI LILLY shall take all steps necessary to maintain the Patents in
the Field, including without limitation the preparation, filing and
prosecution of new patent applications, through an attorney of their choice.
CUBIST shall reimburse ELI LILLY for one half (1/2) of its reasonable
out-of-pocket expenses incurred after the Effective Date paid to third
parties for patent preparation, reasonable attorney fees, patent filing fees,
applications for patent term extensions and SPC's, translation fees for
patent purposes, and patent maintenance fees for Patents licensed hereunder
within thirty (30) days of receipt of an itemized expense report from ELI
LILLY for such patent related expenses.
(a) If CUBIST reasonably believes that ELI LILLY is failing to maintain
one or more of its Patents in the Field, CUBIST shall provide
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* Confidential Treatment requested: material has been omitted and
filed separately with the Commission.
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<PAGE>
ELI LILLY sixty (60) days written notice of its intent to assume maintenance
of such Patents itself If ELI LILLY fails to resume maintenance of the
Patents in the Field that CUBIST reasonably believes that ELI LILLY is
failing to maintain or to provide reasonable evidence demonstrating that ELI
LILLY is maintaining these Patents in the Field at the expiration of such
sixty (60) day period, CUBIST may, through an attorney of their choice, take
all necessary actions to maintain the Patents, and shall be entitled to
deduct [ ]* of the costs and expenses incurred from any of CUBIST's
payments pursuant to Article 4.04. In such event, ELI LILLY shall complete
all acts and execute and deliver all instruments and other documents and
render CUBIST assistance as is necessary or desirable for CUBIST to assume
the filing, prosecution and maintenance of such Patents in the Field that ELI
LILLY has not resumed maintenance of or demonstrated that it is maintaining.
(b) ELI LILLY shall keep CUBIST currently advised as to the status of all
patents and patent applications which relate to Patents and to supply CUBIST
promptly with copies of all patents, patent applications, substantive patent
office actions, substantive responses received or filed in connection with
such applications. CUBIST may itself or through its attorney offer comments
and suggestions with respect to the matters that are the subject of this
Article 8.06, and ELI LILLY agrees to consider carefully such comments and
suggestions; however, nothing herein shall obligate ELI LILLY to follow such
comments or suggestions.
(c) ELI LILLY shall notify CUBIST of their intention to abandon a patent
or patent application which relates to Patents (either a total series of
Patents or patent applications or on a country by country basis). At CUBIST's
option, CUBIST may maintain such patent or patent application relating to
Patent that ELI LILLY plans to abandon either a total series of Patents or
patent applications or on a country by country basis) at CUBIST's sole
expense, and CUBIST shall receive title to such patent or patent application
and such patent shall no longer then be considered a Patent for purposes of
this Agreement.
8.06 CUBIST shall take all steps necessary to maintain its patents and
patents relating to Compound in the Field, including without limitation the
preparation, filing and prosecution of new patent applications through
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* Confidential Treatment requested: material has been omitted and
filed separately with the Commission.
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<PAGE>
an attorney of its choice, provided that a copy of any new patent
applications relating to Compound in the Field, to be filed by CUBIST or a
sub-licensee of CUBIST, will be supplied to ELI LILLY at least thirty (30)
days prior to the filing date of such patent application.
CUBIST shall keep ELI LILLY currently advised as to the status of all
patents and patent applications which relate to patents filed by CUBIST in
the Field and to supply ELI LILLY promptly with copies of all patents, patent
applications, patent office actions, responses and other papers received or
filed in connection with such applications. ELI LIILLY may itself or through
its attorney offer the other comments and suggestions with respect to the
matters that are the subject of this Article 8.06, and CUBIST agrees to
consider carefully such comments and suggestions, however, nothing herein
shall obligate CUBIST to follow such comments or suggestions.
Article 9
Assignment
9.00 Neither party may assign or delegate any of its rights or duties under
this Agreement without the prior written consent of the other, except that
either party may assign this Agreement to a person or party that has
purchased or succeeded to all or substantially all of the business and assets
of the assignor to which the Agreement relates, and that has assumed in
writing or by operation of law such party's obligations under this Agreement,
provided that CUBIST shall be permitted to sub-license its rights hereunder
as provided under Section 2.01 above. This Agreement shall inure to the
benefit of, and shall be binding upon, the parties hereto and their
respective successors and assigns insofar as this Agreement is assignable.
The assignor of this Agreement shall guarantee the performance of the
obligation of this Agreement by such successor or assigns. Nothing herein is
intended to confer on any person other than the parties hereto or their
respective successors and assigns any rights, remedies, obligations, or
liabilities under or by reason of this Agreement.
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Article 10
Term And Termination
10.00 The term of this Agreement shall be for the period commencing as of
the Effective Date and ending on the later of [ ]* unless and until
earlier terminated as provided in this Article. Upon the expiration of this
Agreement, CUBIST shall retain a fully paid-up, royalty free license under
the Know-How for purposes consistent with this Agreement and limited to use
in the Field.
10.01 If either party defaults in the performance of its material
obligations hereunder, including but not limited to CUBIST's failure to use
commercially reasonable efforts to develop Compound (provided, however, that
this shall not be construed as a guarantee that any Compound will be
successfully developed), and if any such default is not corrected within
[ ]* after it shall have been called to the attention of the
defaulting party, in writing, by the other party, then the other party, at
its option, may, in addition to any other remedies it may have, thereupon
terminate this Agreement by giving written notice of termination to the
defaulting party.
10.02 This Agreement may be terminated by either party, on notice, (i) upon
the institution by the other party of insolvency, receivership or bankruptcy
proceedings, (ii) upon the institution of such proceedings against the other
party, which are not dismissed or otherwise resolved in such party's favor
within sixty (60) days thereafter, and (iii) upon the other party's
dissolution or ceasing to do business in the normal course.
10.03 CUBIST may terminate this Agreement at any time, upon thirty (30) days
prior written notice to ELI LILLY and upon a reasonable determination by
CUBIST that continued development of the Compound hereunder is not
commercially reasonable. [ ]*.
10.04 Termination of this Agreement for any reason shall not result in any
obligation by ELI LILLY to repay any payments made to it by CUBIST prior to
such termination.
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* Confidential Treatment requested: material has been omitted and
filed separately with the Commission.
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<PAGE>
10.05 Upon termination of this Agreement for any reason, the sub-licenses
shall be automatically assigned to ELI LILLY, and ELI LILLY shall be bound by
the terms of such sub-licenses provided that the sub-licensees continue to
perform in accordance with their respective sublicense agreements.
Notwithstanding the foregoing, ELI LILLY's obligations to any such
sublicensee shall not be interpreted to extend beyond any obligations to
CUBIST hereunder with respect to the subject matter of the sub-license.
10.06 Upon termination of this Agreement for any reason, except for
termination caused by material breach by ELI LILLY, all licenses granted to
CUBIST pursuant to Article 2 shall terminate, Cubist furthermore shall
transfer to ELI LILLY all regulatory filings and regulatory correspondence,
patent filings and patent office correspondence, any and all other clinical
and non-clinical data, records and tabulations related to the Compound; and
shall execute any and all documents of such patent offices and/or patent
receiving offices, and/or regulatory agencies, including the US FDA, so as to
allow ELI LILLY to make immediate use of such data, records, patent
applications and/or patents and regulatory filings. ELI LILLY shall not be
obligated to treat such information received pursuant to this Section 10.06
as Confidential Information and may use such information, data and know-how
for any purpose at ELI LILLY's discretion.
If CUBIST terminates this Agreement due to ELI LILLY's material
breach, CUBIST's licenses pursuant to Article 2 shall continue for so long as
CUBIST continues to fulfill their payment obligations pursuant to Articles 4
and 5.
10.07 Termination of this Agreement for any reason shall not terminate the
provisions set forth in Article 6 with respect to actions arising with
respect to periods prior to termination, as well as Articles 7, 10, 13, 15,
and 17 hereof The obligations of those Articles shall continue in full force
and effect following any such termination.
10.08 Upon termination of this Agreement for any reason, neither party shall
be relieved of obligations with respect to periods prior thereto, including
any obligation to make payments, including but not limited to obligations
pursuant to Articles 4, 5, 6 or 10, or reports regarding sale prior to such
termination.
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10.09 If CUBIST determines that it will not develop or market Compound in
one or more countries, either by itself or through the efforts of a
sublicensee, or if ELI LILLY makes written request to CUBIST to develop or
sell Compound in one or more countries and in which countries CUBIST either
by itself or through the efforts of a sublicensee, has taken no action, all
rights including rights to develop, market and sell Compound in that
country(ies) shall revert to ELI LILLY [ ]* after CUBIST receives
written notice of ELI LILLY's intent to pursue those rights is received by
CUBIST if CUBIST either by itself or through the efforts of a sublicensee,
has taken no action toward such development or marketing prior to the end of
that year.
Article II
Force Majeure
11.00 If the performance of this Agreement or any obligations hereunder,
except the making of payments, is prevented, restricted or interfered with by
reason of fire or other casualty or accident, earthquake, supplier delay,
strikes or labor disputes, war or other violence, any law, order,
proclamation, regulations, ordinance, demand or requirement of any government
agency, or any other act or condition beyond the reasonable control of the
parties hereto ("Event of Force Majeure"), the party so affected upon giving
prompt notice to the other party shall be excused from such performance to
the extent of such prevention, restriction, or interference; provided that
the party so affected shall use its reasonable best efforts to avoid or
remove such causes of nonperformance and shall continue performance hereunder
with the utmost dispatch and that such party exercises due diligence to
overcome such circumstances.
11.01 The party suffering an Event of Force Majeure shall notify the other
party within fifteen (15) days of the occurrence of such Events of Force
Majeure and within thirty (30) days shall furnish the other party with a
recovery plan of action. Without limiting the foregoing, a party suffering
an Event of Force Majeure shall use its reasonable best efforts to limit the
impact of the Event of Force Majeure on such party's performance of this
Agreement.
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* Confidential Treatment requested: material has been omitted and
filed separately with the Commission.
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Article 12
Notices
12.00 Any notice required or permitted to be given under this Agreement
shall be in writing and shall be deemed to have been sufficiently given for
all purposes five (5) days after having been mailed by first class certified
or registered mail, postage prepaid or by fax which is confirmed by certified
mail. Unless otherwise specified in writing, the mailing addresses of the
parties shall be as described below.
For ELI LILLY
ELI LILLY & COMPANY
Attn: Legal Division
Lilly Corporate Center
Indianapolis, Indiana 46285
For CUBIST:
Mark Carthy
Chief Business Officer
Cubist Pharmaceuticals Incorporated
24 Emily Street
Cambridge, MA 02139
with a copy to:
CUBIST's Legal Counsel:
Michael Lytton
Palmer & Dodge
One Beacon Street
Boston, MA 02108
Article 13
Governing Law
13.00 This Agreement shall be governed by and interpreted in accordance with
the laws of the State of Indiana, United States of America, without reference
to conflict of laws principles.
In the event of any action, controversy or claim arising out of or relating
to any provision of this Agreement or the breach, termination or
enforceability thereof, ELI LILLY and CUBIST shall make all efforts to settle
those conflicts amicably between themselves. Should they fail to
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agree, the parties may assert any remedy available at law or in equity to
enforce its rights under this Agreement.
Article 14
Partial Validity
14.00 If any provision of this Agreement shall be found or be held to be
invalid or unenforceable by a court of competent jurisdiction in which this
Agreement is being performed, then the meaning of said provision shall be
construed, to the extent feasible, so as to render the provision enforceable,
and if no feasible interpretation would save such provision, it shall be
severed from the remainder of this Agreement, which shall remain in full
force and effect. In such event, the parties shall negotiate, in good faith,
a substitute, valid and enforceable provision which most nearly effects the
parties' intent in entering into this Agreement.
Article 15
Confidentiality
15.00 Except as otherwise provided in this Article 15, during the term of
this Agreement and for a period of [ ]* the parties shall maintain
the Confidential Information in confidence and use it only for purposes
specifically authorized under this Agreement. To the extent it is reasonably
necessary or appropriate to fulfill its obligations or exercise its rights
under this Agreement: (i) a party may disclose Confidential Information it is
otherwise obligated under this Article 15 not to disclose to third parties,
on a need-to- know basis and on condition that such entities or persons agree
to keep the Confidential Information confidential for the same time periods
and to the same extent as such party is required to keep the Confidential
Information confidential hereunder; and (ii) a party may disclose such
Confidential Information to government or other regulatory authorities as
required by law or statute. The parties hereto understand and agree that
remedies at law may be inadequate to protect against any breach of any of the
provisions of this Article 15 by either party or their employees, agents,
officers or directors or any other person acting in concert with it or on its
behalf Accordingly, each party shall be entitled to, but not limited to, the
granting of injunctive relief by a court of competent Jurisdiction against
any action that constitutes any such breach of this Article 15.
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* Confidential Treatment requested: material has been omitted and
filed separately with the Commission.
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15.01 Notwithstanding the provisions of Section 15.00 above, CUBIST shall be
free to make disclosures to third parties of Confidential Information of ELI
LILLY consisting of data regarding the Compound in the Field under
circumstances where, in CUBIST's reasonable business judgment, such
disclosures will (i) further the development and commercialization of the
Compound and (ii) not adversely affect any patent rights of ELI LILLY of
which it is aware, provided, however, that in the case of (a) technical
papers disclosing such Confidential Information, or (b) other disclosures
where LILLY's name is used or would reasonably be implied from the context,
CUBIST will provide a copy of the proposed paper or disclosure to ELI LILLY
at least [ ]* in advance of publication and will not proceed with
such publication or disclosure without the consent of ELI LILLY, which
consent will not be unreasonably withheld; and further, provided, that in the
case of all other written disclosures of Confidential Information, CUBIST
will provide to ELI LILLY a copy of the material incorporating such
disclosure as promptly as is practicable, and in no event later than one (1)
week after the disclosure takes place.
15.02 ELI LILLY will make no public pronouncements referencing this
Agreement or CUBIST without CUBIST's express written approval. No license or
rights are granted to either party to use the name of the other without
express written approval. CUBIST's first public announcement of this
Agreement, attached hereto as Exhibit 4, may be released by CUBIST upon full
execution of this Agreement. Except as provided by Exhibit 4, CUBIST shall
not release any information regarding the existence or terms of this
Agreement that is not required by law.
Article 16
Entire Agreement
16.00 The terms and conditions herein contained, including the Exhibits
hereto, constitute the entire agreement and understanding of the parties
relating to the subject matter of this Agreement and supersedes all previous
communications, proposals, representations, and agreements, whether oral or
written, relating to the subject matter of this Agreement.
---------------
* Confidential Treatment requested: material has been omitted and
filed separately with the Commission.
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No agreement or understanding varying or extending the same shall be binding
upon either party hereto unless in a written document which expressly refers
to this Agreement and which is signed by both parties to be bound thereby.
Article 17
Miscellaneous
17.00 It is understood and agreed that each party shall have the status of
an independent contractor under this Agreement and that nothing in this
Agreement shall be construed as authorization for either ELI LILLY or CUBIST
to act as agent for the other. Nothing contained herein or done in pursuance
of this Agreement shall constitute either party the agent of the other party
for any purpose or in any sense whatsoever, or constitute the parties as
partners or joint venturers.
17.01 The failure of either party to enforce at any time any of the
provisions of this Agreement, or the failure to require at any time
performance by the other party of any of the provisions of this Agreement,
shall in no way be construed to be a present or future waiver of such
provisions, nor in any way affect the validity of either party to enforce
each and every such provision thereafter.
17.02 The headings set forth at the beginning of the various Articles of
this Agreement are for reference and convenience and shall not affect the
meanings of the provisions of this Agreement.
17.03 During the term of this Agreement, ELI LILLY shall not, directly or
indirectly through or in connection with any third party, conduct research,
develop, make or market Compound for use in the Field.
17.04 This Agreement may not be amended, supplemented, or otherwise modified
except by an instrument in writing signed by both parties.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
signed in duplicate by duly authorized officers or representatives as of the
date first above written.
ELI LILLY & COMPANY CUBIST PHARMACEUTICALS
INCORPORATED
By:/s/ William R. Ringo By:/s/ Mark Carthy
-------------------------- ---------------------------
William R. Ringo
President, Infectious Diseases Print name: Mark Carthy
--------------------
Business Unit Title: Vice President and Chief
---------------------------
Business Officer
---------------------------
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