EXHIBIT 10.6
CONFIDENTIAL TREATMENT
ASSIGNMENT AND LICENSE AGREEMENT
This Agreement is made this 6th day
of October, 2000 (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:
RECITALS
WHEREAS, CUBIST and ELI LILLY have
entered into a License Agreement for Daptomycin on November 7,
1997 granting CUBIST limited rights under Lilly patents to make,
use and sell only Daptomycin for use in the Field of infectious
disease excluding induced colitis;
WHEREAS, CUBIST and ELI LILLY now
desire to terminate such November 7, 1997, License Agreement
in order that they may enter into this Assignment and License
Agreement whereby CUBIST will obtain expanded rights under the ELI
LILLY patents;
WHEREBY, CUBIST will obtain an
exclusive license under ELI LILLY Know-How and Patents) to make,
use and sell Daptomycin for use in the Field of infectious disease
no longer excluding induced colitis; and
WHEREBY, CUBIST will obtain an
assignment to other ELI LILLY Assigned Patents giving CUBIST
complete ownership, control and all rights to the subject matter
claimed therein for all compounds and all uses;
NOW, THEREFORE, in consideration of
the premises and the mutual covenants hereinafter set forth, the
parties intending to be bound, agree as follows:
*Confidential treatment requested: Material has
been omitted and filed with the Commission
ARTICLE 1
DEFINITIONS
As used throughout this Agreement,
the following terms shall have the meanings indicated in this
Article.
1.00 “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 fifty percent (50%) 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 fifty percent (50%) 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.
1.01 “Assigned Patents”
shall mean those patents and patent applications listed in
Exhibit 3 which have been assigned to CUBIST by ELI
LILLY.
1.02 “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.
1.03 “Compound” means [
]* or a pharmaceutically acceptable salt thereof or a
pharmaceutically acceptable formulation thereof which is in
Lilly’s possession on November 7, 1997.
1.04 “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: (i) is
or becomes part of the public domain other than by unauthorized
acts of the party obligated not to disclose such Confidential
Information; (u) 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.
1.05 “ELI LILLY Program”
shall mean a research, development and/or marketing project that
ELT 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.
*Confidential treatment requested: Material has
been omitted and filed with the Commission
1.06 “Field” shall mean
the treatment of infectious diseases.
1.07 “Know-How” means
all information and data reasonably useful for the development,
process development, regulatory approval, manufacture, use,
formulation or sale of Compound in the Field which (i) is in
the possession of ELI LILLY as of the November 7, 1997 or is
created by ELI LILLY after the November 7, 1997, (u) ELI
LILLY can provide using reasonable 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.
1.08 “Major Market
Country” shall mean the United States, Canada, Japan, the
United Kingdom, Germany, France, Italy, Spain, Switzerland,
Netherlands and Belgium.
1.09 “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) trade, cash and quantity
discounts, including, without limitation, chargebacks and
rebates;
(b) taxes, duties and other
governmental charges set forth separately in the amount
invoiced;
(c) freight, insurance and
other transportation expenses to the extent added to the sales
prices and set forth separately as such in the total amount
invoiced; and
(d) credits or allowances on
account of refunds, returns, rejections, or price
adjustments.
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 (u) 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.
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 A over A+B, in which “A” is
the gross selling price of the Compound portion of the combination
when sold separately during the accounting period in which the sale
was made, and “B” is the gross selling price of the
non-Compound portion of the combination sold separately during the
accounting period. In the event no separate sale of either such
above-designated Compound or such above-designated non-Compound
portion of the combination is
*Confidential treatment requested: Material has
been omitted and filed with the Commission
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
C over C+D, in which “C” is the standard fully
allocated cost of the Compound portion of such combination, and
“D” is the standard fully allocated cost of the other
component(s). For purposes of the foregoing sentence, “fully
allocated cost” shall mean all direct and indirect labor and
overhead, materials and supplies, fringe benefits, taxes and
charges and direct and indirect general and administration charges
incurred by CUBIST or its sublicensees, and accounted for according
to CUBIST’s or its sublicensees’ standard accounting
practices consistent with generally accepted accounting
principles.
1.10 “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 2 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 sub-licenses.
1.11 “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.
1.12 “Phase BI Clinical
Trial” shall mean large scale clinical studies in patients
conducted in accordance with GCPs primarily to establish safety and
efficacy of Compound.
1.13 “Valid Claim” shall
mean a claim of an issued and unexpired Assigned Patent and/or
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
ARTICLE 2
LICENSE GRANT
2.00 As of the Effective Date, ELI
LILLY shall assign, transfer, convey and deliver to CUBIST all
rights to Assigned Patents in a separate assignments) for each of
such Assigned Patents. ELI LILLY shall further file copies of such
assignments) in the United States Patent and Trademark Office. Such
assignments shall be treated by both parties as sales for United
States federal income tax purposes.
2.01 ELI LILLY grants to CUBIST the
following worldwide, exclusive
*Confidential treatment requested: Material has
been omitted and filed with the Commission
licenses subject to the conditions set forth
herein below in Section 2.02:
(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.
2.02 (i) Subject to
Section 2.02(u) below, CUBIST shall have the right to
grant sublicenses 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 [ ]* days (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 [
]* days 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 if the parties negotiate in
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, provided that such
sub-license is granted on no better terms to the sub-licensee,
taken as a whole, than the terms for such rights, if any, which ELI
LILLY last offered to CUBIST during the Negotiation
Period.
2.03 CUBIST shall notify ELI LILLY
within [ ]* days 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.
2.04 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 2.01 and which ELI LILLY can
provide to CUBIST using reasonable efforts.
2.05 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
*Confidential treatment requested: Material has
been omitted and filed with the Commission
which are reasonably able to provide CUBIST with
ELI LILLY Know-How relating to the scaleup, 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.
2.06 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 as of November 7,
1997, which contained 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. CUBIST will provide ELI LILLY with bi-annual status
reports regarding the development progress of the Compound;
however, any material events or changes in the Compound development
plan will be reported to ELI LILLY as soon as reasonably possible
after such event occurs.
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 ELI LILLY hereby grants CUBIST
the right of reference to the Investigational New Drug Application
filed with the United States Food and Drug Administration
(“FDA”) relating to the Compound, and ELI LILLY agrees
to provide to CUBIST copies of all related contact reports, minutes
and other regulatory correspondence filed with or communicated to
the FDA. ELI LILLY shall transfer all reasonably 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 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.
*Confidential treatment requested: Material has
been omitted and filed with the Commission
ARTICLE 4
PAYMENTS
4.00
CUBIST will 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 (u) 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.
4.01 During the first [ ]* months
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 [ ]* on aggregate annual Net Sales in
excess of [ ]* 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 [ ]* percent or more in any twelve month
period.
4.02 After the expiration of the
first [ ]* months 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 13.5% on aggregate
annual Net Sales between [ ]* and [ ]* in 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 [ ]* percent or more in any twelve month
period.
4.03 For a period often [ ]* years
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.
*Confidential treatment requested: Material has
been omitted and filed with the Commission
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 4.01, 4.02 and 4.03 shall be due within [ ]* days after
December 31 or June 30, whichever such date occurs first
after the first commercial sale or transfer of Compound.
Thereafter, payments under Articles 4.01, 4.02 or 4.03 shall be
made within [ ]* days of each of December 31 and June 30
of each year. Payments shall be 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 [
]* 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 [ ]* day
period described above, in a recognized banking institution
selected by CUBIST 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,