<PAGE>
Exhibit 10.1
DEVELOPMENT AND LICENSE AGREEMENT
BETWEEN
THERASENSE, INC.
AND
INSULET CORPORATION
DATED AS OF JANUARY 23, 2002
*** Confidential treatment has been requested for portions of this
exhibit. The
copy filed herewith omits the information subject to the
confidentiality
request. Omissions are designated as [***]. A complete version of
this exhibit
has been filed separately with the Securities and Exchange
Commission.
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TABLE OF CONTENTS
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RECITALS.................................................................
1
ARTICLE
I................................................................
2
DEFINITIONS...........................................................
2
1.1
"AFFILIATE"...................................................
2
1.2
"CLAIMS"......................................................
2
1.3
"COMPETITOR"..................................................
2
1.4
"CONFIDENTIAL
INFORMATION".................................... 2
1.5
"DEVELOPMENT
COMMITTEE"....................................... 2
1.6
"DEVELOPMENT
PROGRAM"......................................... 2
1.7
"DEVELOPMENT PROGRAM
TECHNOLOGY".............................. 2
1.8
"EFFECTIVE
DATE".............................................. 2
1.9
"FDA".........................................................
2
1.10
"FREESTYLE METER".............................................
2
1.11
"IMPROVEMENT".................................................
2
1.12
"INITIAL TERM"................................................
2
1.13
"INSULET".....................................................
2
1.14
"INSULET LIABILITY"...........................................
2
1.15
"INSULET MARKS"...............................................
3
1.16
"INSULET TECHNOLOGY"..........................................
3
1.17
"PARTY".......................................................
3
1.18
"PRODUCT".....................................................
3
1.19
"PRODUCT TECHNOLOGY"..........................................
3
1.20
"PUMP"........................................................
3
1.21
"REMOTE CONTROLLER"...........................................
3
1.22
"RIGHT".......................................................
3
1.23
"SPECIFICATIONS"..............................................
3
1.24
"TECHNICAL INFORMATION........................................
3
1.25
"TERRITORY"...................................................
3
1.26 "TEST
STRIPS".................................................
3
1.27
"THERASENSE"..................................................
3
1.28
"THERASENSE LIABILITY"........................................
3
1.29
"THERASENSE MARKS"............................................
3
1.30
"THERASENSE PATENTS"..........................................
3
1.31
"THERASENSE TECHNOLOGY".......................................
3
ARTICLE
II...............................................................
3
THE DEVELOPMENT
PROGRAM............................................... 4
2.1
GENERAL.......................................................
4
2.2
OVERSIGHT AND
SPECIFICATIONS.................................. 4
2.3
TECHNICAL
INFORMATION......................................... 4
2.4
WORK, COSTS AND
FACILITIES.................................... 4
2.5
PATENT AND
CONFIDENTIAL INFORMATION AGREEMENTS................ 4
2.6
COMPLIANCE WITH
SPECIFICATIONS................................ 4
2.7
GOVERNMENTAL
APPROVALS........................................ 5
2.8
MANUFACTURING
RIGHTS.......................................... 5
2.9
TECHNICAL
ASSISTANCE.......................................... 5
2.10
THERASENSE COMPONENTS.........................................
5
2.11
MODIFICATIONS.................................................
5
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ARTICLE
III..............................................................
6
CONFIDENTIAL
INFORMATION..............................................
6
3.1
TREATMENT OF
CONFIDENTIAL INFORMATION......................... 6
3.2
RELEASE FROM
RESTRICTIONS..................................... 6
ARTICLE
IV...............................................................
7
INTELLECTUAL PROPERTY
RIGHTS.......................................... 7
4.1
THERASENSE
TECHNOLOGY......................................... 7
4.2
INSULET
TECHNOLOGY............................................ 7
4.3
DEVELOPMENT PROGRAM
TECHNOLOGY................................ 7
4.4
RESPONSIBILITY FOR
PROTECTION OF TECHNOLOGY................... 7
4.5
RIGHT OF OTHER PARTY
TO PROSECUTE APPLICATIONS................ 8
4.6
ASSISTANCE....................................................
9
4.7
CLAIMED
INFRINGEMENT.......................................... 9
4.8
WARRANTY......................................................
11
ARTICLE
V................................................................
12
LICENSES..............................................................
12
5.1
PATENT
LICENSE................................................
12
5.2
TECHNICAL INFORMATION
LICENSE................................. 12
5.3
DEVELOPMENT PROGRAM
TECHNOLOGY LICENSE........................ 12
5.4
TRADEMARK
LICENSES............................................ 13
ARTICLE
VI...............................................................
14
MARKETING, SALES
PROMOTION AND CUSTOMER SUPPORT....................... 14
2.8
COMMERCIALIZATION.............................................
14
6.2
MARKETING AND CUSTOMER
SUPPORT ASSISTANCE..................... 14
6.3
LABELING......................................................
14
6.4
REPORTING AND
NOTICE.......................................... 15
6.5
COMPLAINTS AND
RECALLS........................................ 16
6.6
PUBLICITY.....................................................
16
ARTICLE
VII..............................................................
17
TERMINATION...........................................................
17
7.1
TERM..........................................................
17
7.2
TERMINATION FOR
CAUSE......................................... 17
7.3
TERMINATION FOR LACK
OF PROGRESS.............................. 17
7.4
DISPOSITION OF
LICENSED PRODUCTS.............................. 18
7.5
SURVIVAL OF
OBLIGATIONS; RETURN OF CONFIDENTIAL INFORMATION... 18
7.6
ACCRUED
OBLIGATIONS........................................... 18
ARTICLE
VIII.............................................................
19
MISCELLANEOUS.........................................................
19
8.1
COMPETING
SYSTEMS............................................. 19
8.2
LIMITATION OF
LIABILITY; INSURANCE............................ 19
8.3
ASSIGNMENT....................................................
19
8.4
GOVERNING
LAW................................................. 20
8.5
FORCE
MAJEURE.................................................
20
8.6
WAIVER........................................................
20
8.7
NOTICES.......................................................
20
8.8
NON-SOLICITATION..............................................
21
8.9
NO
AGENCY.....................................................
21
8.10
ENTIRE AGREEMENT..............................................
21
8.11
HEADINGS......................................................
21
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8.12
SEVERABILITY..................................................
21
8.13
SUCCESSORS AND ASSIGNS........................................
21
8.14
COUNTERPARTS..................................................
22
8.15
DISPUTE RESOLUTION............................................
22
8.16
INSULET LIABILITY; THERASENSE LIABILITY.......................
23
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<PAGE>
DEVELOPMENT AND LICENSE AGREEMENT
AGREEMENT dated as of January 23, 2002, between TheraSense, Inc.,
a
Delaware corporation, having its principal place of business at
1360 South Loop
Road, Alameda, CA 94502 (hereinafter referred to as "TheraSense")
and Insulet
Corporation, a Delaware corporation having its principal place of
business at
100 Cummings Center, Suite 231G, Beverly, MA 01915 (hereinafter
referred to as
"Insulet").
RECITALS
WHEREAS, TheraSense has developed electronic hardware and software
capable
of coulometrically measuring glucose in a human blood sample that
is currently
marketed by TheraSense as its "FreeStyle" meter (the "FreeStyle
Meter");
WHEREAS, TheraSense has developed and currently markets glucose
test strips
for use in conjunction with the FreeStyle Meter (the "Test
Strips");
WHEREAS, Insulet desires to design, develop, manufacture and market
a
patient drug delivery system (the "Product") consisting of an
insulin infusion
pump (the "Pump") and a hand held electronic device for controlling
the Pump
(the "Remote Controller"), which includes a wireless transceiver
for
communicating with the Pump, diabetes management software and a
meter capable of
coulometrically measuring glucose in a human blood sample;
WHEREAS, Insulet desires to adapt the FreeStyle Meter for use with
the
Remote Controller;
WHEREAS, TheraSense is willing, for the consideration and upon the
terms
set forth herein, to facilitate the adaptation of the FreeStyle
Meter for use
with the Remote Controller; and
WHEREAS, the Parties desire to coordinate on Insulet's marketing of
the
Product and TheraSense's marketing of the Test Strips for use with
the Product;
NOW,
THEREFORE, in consideration of the mutual covenants and
promises
contained in this Agreement and other good and valuable
consideration,
TheraSense and Insulet agree as follows:
<PAGE>
ARTICLE I
DEFINITIONS
As
used in this Agreement, the following terms, whether used in
the
singular or plural, shall have the following meanings:
1.1
"AFFILIATE" means any corporation, company, partnership, joint
venture
and/or firm which controls, is controlled by or is under common
control with a
Party. For purposes of this Section 1.1, "control" shall mean (a)
in the case of
corporate entities, direct or indirect ownership of at least fifty
percent (50%)
of the stock or shares entitled to vote for the election of
directors; and (b)
in the case of non-corporate entities, direct or indirect ownership
of at least
fifty percent (50%) of the equity interest with the power to direct
the
management and policies of such non-corporate entities. Unless
agreed to in
writing by the Parties, in no event shall a Competitor be an
Affiliate.
1.2
"CLAIMS" is defined in Section 8.16(a).
1.3
"COMPETITOR" means, (i) regarding Insulet, ***.
1.4
"CONFIDENTIAL INFORMATION" means the Technical Information and
any
other information designated in writing by the disclosing Party as
confidential
or proprietary, whether or not related to the subject matter
hereof.
1.5
"DEVELOPMENT COMMITTEE" is defined in Section 2.2.
1.6
"DEVELOPMENT PROGRAM" means the collaborative effort conceived,
planned, organized, controlled and performed by the Parties to
enable Insulet to
produce, manufacture and market a Product that includes the
FreeStyle Meter, as
adapted for this purpose.
1.7
"DEVELOPMENT PROGRAM TECHNOLOGY" is defined in Section 4.3.
1.8
"EFFECTIVE DATE" means January 23, 2002.
1.9
"FDA" means the United States Food and Drug Administration.
1.10
"FREESTYLE METER" is defined in the Recitals.
1.11
"IMPROVEMENT" is defined in Section 2.11.
1.12
"INITIAL TERM" is defined in Section 7.1.
1.13
"INSULET" means Insulet Corporation, a Delaware corporation.
1.14
"INSULET LIABILITY" is defined in Section 8.16(a).
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1.15
"INSULET MARKS" means the trademarks owned and used by Insulet
in
connection with the promotion, marketing and sale of the Product in
the
Territory and such other trademarks as the Parties may stipulate in
writing.
1.16
"INSULET TECHNOLOGY" is defined in Section 4.2.
1.17
"PARTY" means TheraSense or Insulet; "PARTIES" means TheraSense
and
Insulet.
1.18
"PRODUCT" is defined in the Recitals.
1.19
"PRODUCT TECHNOLOGY" is defined in Section 4.4.
1.20
"PUMP" is defined in the Recitals.
1.21
"REMOTE CONTROLLER" is defined in the Recitals.
1.22
"RIGHT" is defined in Section 4.7(a).
1.23
"SPECIFICATIONS" is defined in Section 2.2.
1.24
"TECHNICAL INFORMATION means electrical and mechanical designs,
manufacturing processes, component lists, software, algorithms,
technical
advice, know-how, and other technical information utilized in the
design and
manufacture of the FreeStyle Meter (as unaltered and unmodified,
and
specifically excluding all works derived therefrom).
1.25
"TERRITORY" means the United States of America.
1.26
"TEST STRIPS" is defined in the Recitals.
1.27
"THERASENSE" means TheraSense, Inc., a Delaware corporation.
1.28
"THERASENSE LIABILITY" is defined in Section 8.16(b).
1.29
"THERASENSE MARKS" means the "TheraSense" mark, the "FreeStyle"
trademark and such other TheraSense trademarks as the Parties may
stipulate in
writing.
1.30
"THERASENSE PATENTS" means the patents and patent applications
set
forth on Schedule A hereto, all continuations and divisions of
such
applications, all patents issuing from such applications, divisions
and
continuations, and any reissues, reexaminations and extensions of
any such
patents.
1.31 "THERASENSE
TECHNOLOGY" is defined in Section 4.1.
ARTICLE II
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THE DEVELOPMENT PROGRAM
2.1
GENERAL. Subject to the terms and conditions contained in this
Agreement, the Parties agree to undertake the Development Program
and shall use
all commercially reasonable efforts to ensure that the Development
Program is
completed in a timely fashion.
2.2
OVERSIGHT AND SPECIFICATIONS.
(a) The Parties shall establish a committee (the "Development
Committee"), comprised of one designee of TheraSense and one
designee of
Insulet, to oversee the Development Program. All actions of the
Development
Committee shall require the concurrence of both designees. If
both
designees do not concur, then the matter shall be referred to the
Vice
President of Business Development of TheraSense and the Chief
Executive
Officer of Insulet for resolution.
(b) The Development Committee shall undertake commercially
reasonable
efforts to produce complete performance specifications (the
"Specifications") of the Remote Controller, including the FreeStyle
Meter
as
adapted for use with the Remote Controller, within sixty (60) days
of
the
Effective Date. The Specifications shall include both accuracy
and
precision specifications, which shall meet or exceed such
specifications as
applicable to the FreeStyle Meter as then used independent of the
Remote
Controller.
2.3
TECHNICAL INFORMATION. TheraSense shall provide the Technical
Information to Insulet and the Development Committee. If the
Development
Committee determines that the Development Program could be
facilitated by use of
existing TheraSense hardware and/or software (other than software
provided as
part of Technical Information), then the Parties shall enter into
good-faith
negotiations regarding mutually acceptable terms under which such
hardware or
software may be utilized by Insulet.
2.4
WORK, COSTS AND FACILITIES. Insulet shall undertake all
engineering,
development, prototyping and manufacturing work and bear all costs
incurred in
the Development Program and the production of the Product, other
than costs
incurred by TheraSense in providing Technical Information and as
otherwise set
forth herein or as the Parties may otherwise agree. Insulet shall
provide the
facilities and staff to be utilized for the Development Program,
except as
otherwise set forth herein or as the Parties may otherwise
agree.
2.5
PATENT AND CONFIDENTIAL INFORMATION AGREEMENTS. Each Party
shall
require its designee to the Development Committee and all
engineers, assistants,
technicians and technical personnel, including consultants,
assigned to the
Development Program to execute an agreement for the assignment of
inventions in
accordance with Sections 4.2 and 4.3 and for the protection of
Confidential
Information in such reasonable form as may from time to time be
used by the
Party for such purpose.
2.6
COMPLIANCE WITH SPECIFICATIONS.
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(a) The Development Committee shall ensure that the Product
complies
with
the Specifications before commercial sales of the Product commence.
If
the
Development Committee is unable to verify such compliance, or
its
members are not in agreement and the matter is not resolved
following the
referral procedures set forth in Section 2.2, then Insulet shall
refer the
Product to an independent testing facility selected by Insulet,
but
reasonably acceptable to TheraSense, which shall evaluate such
compliance.
The
costs of such evaluation shall be borne equally by the Parties.
The
Parties agree that Insulet shall not commence commercial sales of
the
Product until TheraSense concurs that the Product complies with
the
Specifications, provided that such concurrence shall not be
unreasonably
withheld or delayed.
(b) TheraSense shall undertake commercially reasonable efforts
to
ensure that the Test Strips will permit the Product to function
within the
Specifications.
2.7
GOVERNMENTAL APPROVALS.
(a) TheraSense acknowledges that the Product has not been reviewed
or
approved for sale or use for any purpose by governmental or
regulatory
bodies in the Territory. Insulet shall be solely responsible for
satisfying
all
regulatory requirements necessary for the sale by it of the Product
in
the
Territory, including the conduct of all necessary clinical
trials;
provided, however, that TheraSense shall provide to Insulet or
appropriate
regulatory authority, at TheraSense's expense, all information,
data,
materials and product samples in its possession reasonably
necessary to
obtain such approvals.
(b) TheraSense shall be solely responsible for satisfying all
regulatory requirements necessary for all of the Test Strips in
the
Territory, including the conduct of all necessary clinical
trials.
2.8
MANUFACTURING RIGHTS. Insulet shall have sole rights and options
with
respect to the manufacture of the Product. TheraSense shall have
sole rights and
options with respect to the manufacture of the Test Strips.
2.9
TECHNICAL ASSISTANCE. During the Development Program and throughout
the
term of this Agreement, TheraSense shall make available to Insulet
members of
TheraSense's technical staff and consultants to advise Insulet on
the scale-up
of operations; the obtaining of government approvals necessary to
produce,
manufacture, distribute and market the Product in the Territory;
the start-up of
Insulet's commercial production of the Product; and manufacturing
of the
Product, including training of Insulet personnel, as all such
advice relates to
the FreeStyle Meter and the Test Strips. ***.
2.10
THERASENSE COMPONENTS. If the Development Program could be
facilitated
by using existing TheraSense components, then the Parties shall
negotiate
mutually acceptable terms under which such components may be used
by Insulet.
2.11
MODIFICATIONS.
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(a) If TheraSense makes any modification, enhancement, bug-fix
or
upgrade to the FreeStyle Meter that (i) enhances the blood
glucose
measurement accuracy of the FreeStyle Meter, (ii) increases the
blood
glucose measurement speed of the FreeStyle Meter or (iii) reduces
the size
of
the blood sample required for the FreeStyle Meter to measure
blood
glucose levels (individually hereinafter referred to as an
"Improvement"),
then, if TheraSense has the right to do so, TheraSense shall make
such
Improvement available to Insulet, and such Improvement shall be
deemed to
be
part of the Technical Information for all purposes of this
Agreement.
TheraSense shall undertake commercially reasonable efforts to
secure the
rights necessary to make Improvements available to Insulet.
(b) Insulet shall not, without prior consultation with
TheraSense,
modify the Product if such modification would result in a failure
to
conform with the Specifications.
ARTICLE III
CONFIDENTIAL INFORMATION
3.1
TREATMENT OF CONFIDENTIAL INFORMATION. Each Party shall maintain
the
Confidential Information of the other Party in confidence, and
shall not
disclose, divulge or otherwise communicate such Confidential
Information to
others, or use it for any purpose, except pursuant to, and in order
to carry
out, the terms and objectives of this Agreement, and hereby agrees
to exercise
the same standard of care it employs to protect its own
Confidential Information
(and in no event less than a reasonable standard of care) to
prevent and
restrain the unauthorized disclosure of such Confidential
Information by any of
its directors, officers, employees, consultants, subcontractors,
sublicensees,
agents or Affiliates. Without limiting the foregoing, each Party
agrees not to
make any disclosure of the other party's Confidential Information
that will
impair the other Party's ability to obtain U.S. or foreign patents
on any
patentable invention or discovery described in such Confidential
Information.
The Confidential Information of each Party includes information
about third
parties disclosed by one Party to the other Party.
3.2
RELEASE FROM RESTRICTIONS. The provisions of Section 3.1 shall
not
apply to any Confidential Information disclosed hereunder
which:
(a) was known or used by the receiving Party prior to its date
of
disclosure to the receiving Party, as evidenced by the prior
written
records of the receiving Party; or
(b) either before or after the date of this disclosure to the
receiving Party, is lawfully disclosed to the receiving Party by
an
independent, unaffiliated third party rightfully in possession of
the
Confidential Information; or
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(c) either before or after the date of the disclosure to the
receiving
Party, becomes published or generally known to the public through
no fault
or
omission on the part of the receiving Party or its Affiliates and
under
no
obligation of confidentiality; or
(d) was developed by employees or agents of the receiving Party,
as
evidenced by the written records of the receiving party, such
employees
having had no access to any Confidential Information communicated
to the
receiving Party.
The receiving Party shall not be in violation of this Article III
if
Confidential Information of the disclosing Party is required to be
disclosed by
the receiving Party in response to a valid order by a court or
other
governmental body, provided that the receiving Party provides the
disclosing
Party with prior written notice of such disclosure in order to
permit the
disclosing Party to seek confidential treatment of such
information.
ARTICLE IV
INTELLECTUAL PROPERTY RIGHTS
4.1
THERASENSE TECHNOLOGY. TheraSense shall own the entire right, title
and
interest in and to all TheraSense Patents, Technical Information
and to all
patents, patent applications, know-how and other intellectual
property rights to
any product, method or apparatus conceived, reduced to practice or
developed
solely by employees or consultants of TheraSense at any time which
relates to
the FreeStyle Meter and the Test Strips or their use or
manufacture, including
those developed for and in the course of the Development Program
(referred to,
collectively hereunder, as the "TheraSense Technology"), subject,
however, to
the limited licenses granted hereunder to Insulet.
4.2
INSULET TECHNOLOGY. Insulet shall own the entire right, title
and
interest in and to all patents, patent applications, know-how and
other
intellectual property rights to any product, method or apparatus
conceived,
reduced to practice or developed solely by employees or consultants
of Insulet
at any time which relates to the Product or its use or manufacture,
including
those developed for and in the course of the Development Program
(the "Insulet
Technology").
4.3
DEVELOPMENT PROGRAM TECHNOLOGY. *** in and to all patents,
patent
applications, know-how and other intellectual property rights in
any product,
method or apparatus conceived, reduced to practice or developed
jointly by
TheraSense and Insulet in the course of the Development Program
(hereinafter,
the "Development Program Technology"), subject to the limited
license thereto
granted to TheraSense under this Agreement.
4.4
RESPONSIBILITY FOR PROTECTION OF TECHNOLOGY.
(a) Except as otherwise provided in this Agreement, Insulet shall
have
the
right and responsibility, at Insulet's expense and in its sole,
commercially reasonable judgement, to:
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(i) decide whether or not to seek or continue patent protection
in any country on any Insulet Technology and Development
Program
Technology (referred to collectively hereinafter as the
"Product
Technology");
(ii) file for, procure and maintain patents in any country on
any
Product Technology; and
(iii) protect and enforce any patents issued on any Product
Technology, subject to Section 4.5.
(b) TheraSense hereby authorizes and empowers Insulet and
hereby
grants to Insulet its permission and consent for Insulet and its
authorized
attorneys, agents or representatives to assume the responsibilities
set
forth in Section 4.4(a). Insulet agrees to assume responsibilities
and to
pay
all costs and expenses incurred in carrying out such
responsibilities.
(c) Except as otherwise provided in this Agreement, TheraSense
shall
have
the right and responsibility, at TheraSense's expense and in its
sole,
commercially reasonable judgement, to:
(i) decide whether or not to seek or continue patent protection
in any
country on any TheraSense Technology and the Test Strips;
(ii) file for, procure and maintain patents in any country on
any
TheraSense Technology and the Test Strips; and
(iii) protect and enforce any patents issued on any TheraSense
Technology and the Test Strips, subject to Section 4.5.
(d) Insulet hereby authorizes and empowers TheraSense and
hereby
grants to TheraSense its permission and consent for TheraSense and
its
authorized attorneys, agents or representatives to assume the
foregoing
responsibilities. TheraSense agrees to assume all responsibilities
and to
pay
all costs and expenses incurred in carrying out such
responsibilities.
4.5
RIGHT OF OTHER PARTY TO PROSECUTE APPLICATIONS. If Insulet elects
not
to file a patent application or application for a certificate of
invention, not
to maintain a patent or certificate of invention, or to abandon a
pending patent
application or application for a certificate of invention in the
Territory
regarding any Development Program Technology, Insulet shall advise
TheraSense of
such election in a timely manner, and TheraSense shall have the
right, at the
expense of TheraSense, of filing such application, maintaining such
patent or
certificate of invention or continuing to attempt to obtain
protection on the
subject matter disclosed in such pending application. In such case,
TheraSense
will grant to Insulet a fully paid up, worldwide, nonexclusive
license to any
such issued patent for the purpose of manufacturing, having
manufactured, using,
having used, importing, having imported, selling and having sold
any
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<PAGE>
Insulet product or service without the right to sublicense such
issued patent,
except as set forth below. If TheraSense elects to file and
prosecute such
application, it shall provide Insulet with written notice and
Insulet shall have
*** from receipt of such notice to deliver to TheraSense Insulet's
agreement
to pay ***. Upon Insulet's payment of the Shared Expenses,
Insulet's license to
the issued patent described above in this Section 4.5 shall include
the right to
sublicense without restriction.
4.6
ASSISTANCE. TheraSense shall make available to Insulet or its
authorized attorneys, agents or representatives, such of
TheraSense's employees
as reasonably necessary to
