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EXHIBIT 10.1




AMENDMENT NO. 2 TO DEVELOPMENT AND LICENSE AGREEMENT




     This Amendment No. 2 (the “Amendment”) dated June 30, 2010 (“Amendment No. 2 Effective
Date”) is entered into by and between Abbott Diabetes Care Inc., formerly known as TheraSense,
Inc., (“ADC”) and Insulet Corporation (“Insulet”) to amend the Development and
License Agreement entered into between TheraSense, Inc. (“Therasense”) and Insulet,
effective as of January 23, 2002 and as amended on March 3, 2008 (together with this Amendment No.
2 hereinafter referred to collectively as the “Agreement”). Capitalized terms used herein
but not otherwise defined shall have the meanings ascribed to them in the Agreement.



     WHEREAS, pursuant to that Amendment No.1 to Development and License Agreement dated March 3,
2008, ADC and Insulet amended their original Development and License Agreement to provide for an
exclusive relationship in the United States and Israel pursuant to which Insulet would not market,
promote, offer for sale, sell or distribute a Product with any DBGM other than an ADC DBGM; and



     WHEREAS, in connection with that same Amendment No. 1 the parties agreed on certain commercial
terms and conditions pursuant to which ADC would compensate Insulet for certain services performed
by Insulet for New Customers and Upgrade Customers in the United States and Israel; and



     WHEREAS, ADC and Insulet now desire to further amend the Agreement to enable Insulet to,
directly or indirectly, market and sell, on a non-exclusive basis in the Expansion Territory, the
Product (which as of the Amendment No. 2 Effective Date is marketed and sold by Insulet as the
OmniPod Insulin Management System) with a Remote Controller that includes an ADC DBGM (which as of
the Amendment No.2 Effective Date is (i) made up of the FreeStyle Glucose Engine and the FreeStyle
Test Strip Port, and (ii) uses the FreeStyle Test Strip or the FreeStyle Lite Test Strip to measure
blood glucose values); and



     WHEREAS, ADC and Insulet have also decided that they wish for Insulet to provide certain
services for New Customers in the Expansion Territory, on such commercial terms and conditions as
the parties deem appropriate in the Expansion Territory in consideration of the nature of the
services and the markets and conditions in which they will be provided; and



     WHEREAS, ADC and Insulet desire to incorporate into the Agreement certain of the terms of that
letter agreement dated May 27, 2010, and agreed and acknowledged on June 8, 2010 (“Letter
Agreement”) regarding the provision by ADC to Insulet of certain no-charge meters for Insulet
to provide to its end-user customers in the United States; and



     WHEREAS, ADC and Insulet desire to update certain other provisions of the Agreement including
the requirements and commitments with respect to labeling and branding of the Product;



     NOW, THEREFORE, in consideration of the premises and mutual covenants contained in this
Amendment and in the Agreement, and expressly incorporating the foregoing recitals, ADC and Insulet
hereby agree as follows:



 









 






	 	1.	 	The definition of “FreeStyle Meter” in the Recitals of the Agreement is amended as
follows:
	 
	 	 	 	“FreeStyle Meter” means that certain discrete blood glucose monitoring device owned
and developed by ADC which (i) is made up of certain circuitry to measure glucose based on
coulometric glucose measurement technology (the “FreeStyle Glucose Engine”) and the
FreeStyle Test Strip Port, (ii) uses a FreeStyle Test Strip or FreeStyle Lite Test Strip to
measure blood glucose values and (iii) is commercialized by ADC under the tradename
“FreeStyle Blood Glucose Monitor” and/or such other tradename as ADC may determine. For
avoidance of doubt, the definition of a FreeStyle Meter does not include the FreeStyle Lite
Blood Glucose Monitor.
	 
	 	2.	 	The definition of “Test Strips” in the Recitals of the Agreement is amended as follows:
	 
	 	 	 	“Test Strips” means those certain blood glucose test strips commercialized by ADC as
the FreeStyle Test Strip and/or the FreeStyle Lite Test Strip.
	 
	 	3.	 	The definition of “New Customer” at Section 1.35 is amended and restated as follows:
	 
	 	 	 	“New Customer” is an end-user customer (i) who has not previously purchased or
received a Remote Controller with an ADC DBGM, or (ii) who purchases or receives a Remote
Controller that includes an ADC DBGM having connectivity to an ADC continuous glucose
monitoring system.
	 
	 	4.	 	The definition of Territory at Section 1.25 is amended and restated as follows:
	 
	 	 	 	“Territory” means the United States of America, Canada and Israel.
	 
	 	5.	 	The following new definition is hereby added at Section 1.37:
	 
	 	 	 	“Expansion Territory” means Germany, France, UK, Netherlands, Switzerland, Belgium,
Finland, Norway, and Sweden. Except as otherwise set forth herein, the Expansion Territory
shall be considered a part of the Territory.
	 
	 	6.	 	The following new definition is hereby added at Section 1.38:
	 
	 	 	 	“Expansion Territory Customer Service Event” means the services performed by or on
behalf of Insulet for a New Customer in the Expansion Territory in support of sale or
placement of a Remote Controller that includes an ADC DBGM with such New Customer, as such
services are further outlined on Schedule B attached hereto and made a part hereof. The
sale or placement of a Remote Controller is any transfer of a Remote Controller to an
end-user customer for which Insulet receives compensation. The sale or




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	 	 	 	placement of a Remote Controller does not include any transfer of a Remote Controller to
satisfy a product warranty claim or FDA recall requirement.
	 
	 	7.	 	Section 2.7(a) is amended and restated in its entirety as follows:
	 
	 	 	 	(a) Insulet represents and warrants that is has all regulatory approvals necessary for, or
has submitted for regulatory approval for, the sale by it of the Product with ADC DBGM in
the United States, Israel and Germany. Insulet shall be solely responsible for satisfying
all regulatory requirements (including without limitation the obtaining and maintaining of
all regulatory approvals) necessary for the sale by it of the Product with ADC DBGM in the
Territory, including the conduct of all necessary clinical trials; provided that, upon
request by Insulet, ADC shall provide to Insulet or the appropriate regulatory authorities,
at ADC’s expense, and pursuant to such commercially reasonable timelines as agreed to by
both Parties, such information, data, materials and product samples in its possession as
reasonably necessary to obtain such approvals; and, provided further, that (i) in the event
ADC determines in its reasonable discretion that any information or documentation to be
provided pursuant to this Section 2.7(a) contains information of a sensitive nature, ADC
shall have the right to provide any such information or documentation in confidence directly
to the applicable Regulatory Authorities provided it notifies Insulet of such submission,
and (ii) ADC shall have no obligation to provide any information or documentation beyond
that which has already been provided by ADC to the applicable regulatory authorities.
Insulet shall keep ADC reasonably informed with respect to any regulatory filings and
clinical trials that Insulet has conducted or is conducting regarding the Product and at a
minimum shall provide ADC with written notice of all filings for regulatory approvals
commensurate with Insulet’s submission of such filings.
	 
	 	8.	 	Section 2.11(a) is amended and restated in its entirety as follows:
	 
	 	 	 	(a) If ADC introduces to the market in the Territory a FreeStyle Meter that incorporates any
modification, enhancement or improvement to the FreeStyle Glucose Engine or FreeStyle Test
Strip Port in the FreeStyle Meter (hereinafter referred to as an “Improvement”),
then, if ADC has the right to do so, ADC 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. ADC shall undertake commercially reasonable efforts to secure
the right to make Improvements available to Insulet. For the avoidance of doubt, an
Improvement does not include any new features or new functionality which ADC may bring to
market for the FreeStyle Meter.
	 
	 	9.	 	Section 2.11(b) is amended and restated in its entirety as follows:
	 
	 	 	 	(b) Insulet shall not, without prior consultation with ADC, modify the Product with ADC
DBGM.




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	 	10.	 	Section 6.3(a) is amended and restated as follows:
	 
	 	 	 	(a) Insulet will ensure that:
	 
	 	 	 	(i) by [***] the Product with ADC DBGM marketed and sold in the United States, Canada and
Israel will contain the ADC “FreeStyle” trademark on the front bezel of the Remote
Controller in a size and configuration as agreed in writing between ADC and Insulet, such
size and configuration at a minimum requiring that the mark be clearly legible, prominent
and visible, and in no event [***]; and
	 
	 	 	 	(ii) prior to any commercialization in the Expansion Territory, the Product with ADC DBGM
marketed and sold in the Expansion Territory will contain the ADC “FreeStyle” trademark on
the Remote Controller in such appearance and placement as finally determined by Insulet;
provided that (1) the size of the mark shall be such that it is clearly legible and in no
event [***], and (2) to the extent possible, [***].
	 
	 	11.	 	Section 6.4(f) of Agreement is deleted in its entirety.
	 
	 	12.	 	New Section 6.7 is added as follows:
	 
	 	 	 	6.7 Notice of Commercialization in Expansion Territories. Insulet will notify ADC in
writing of its intent to begin marketing and selling the Product with ADC DBGM in each
country in the Expansion Territory at least [***] prior to any such planned launch; provided
that Insulet may launch in France and the UK on [***] prior written notice and in Germany
upon execution of this Amendment.
	 
	 	13.	 	New Section 6.8 is added as follows:
	 
	 	 	 	6.8 [***] Meters for New Customers
	 
	 	 	 	(a) At Insulet’s request, and solely for inclusion as a sample with Insulet’s OmniPod
Insulin Management System system starter kit for the Product with ADC DBGM for New
Customers, ADC will supply Insulet [***], up to the amount of the Kit Forecast (defined
below), with kits containing an ADC meter system and a vial of up to [***] test strips (the
“Kits”); provided, that Insulet shall provide ADC with a [***] rolling forecast of
its Kit requirements for New Customers, on a country by country basis, at least [***] in
advance of any month in which such Kits are required (the “Kit Forecast”), which Kit
Forecast shall be subject to ADC’s approval and acceptance in its sole discretion. ADC may
terminate its obligation to provide Kits at any time upon [***] prior written notice to
Insulet. ADC and Insulet agree that the Letter Agreement, and for the avoidance of doubt the
letters dated March 3, 2005 and September 19, 2005 referenced therein, are hereby terminated
and of no further force and effect.




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	 	 	 	(b) Insulet represents, warrants and covenants as follows:






     i. Insulet will not provide any Kits other than to a New Customer (or to a third
party only for distribution to a New Customer) as part of an OmniPod Insulin Management
System starter kit for the Product with ADC DBGM; and




     ii. Insulet will provide Kits at no charge and will not bill any third party for
such Kits.




	 	 	 	(c) Insulet and ADC each agree to comply with laws applicable to their respective operations
and the transactions contemplated hereby, including but not limited to the Federal Social
Security Act and applicable regulations thereunder related to the Federal Medicare and
Medicaid Programs.
	 
	 	 	 	(d) EXCEPT FOR THE LIMITED WARRANTIES PROVIDED IN KIT LABELING OR INSERTS, ADC GRANTS NO
OTHER WARRANTIES OR CONDITIONS, EXPRESS OR IMPLIED, BY STATUTE, IN ANY COMMUNICATION WITH
INSULET OR ITS CUSTOMRS OR END-USERS, OR OTHERWISE, REGARDING THE KITS. ADC SPECIFICALLY
DISCLAIMS ANY IMPLIED WARRANTIES OF FITNESS FOR PARTICULAR PURPOSE, MERCHANTABILITY, AND
NONINFRINGEMENT, ADC DOES NOT WARRANT THAT OPERATION OF THE KITS WILL BE INTERRUPTED OR
ERROR-FREE. ADC NEITHER ASSUMES NOR AUTHORIZES ANY OTHER PERSON TO ASSUME ANY OTHER
LIABILITIES ARISING OUT OF OR IN CONNECTION WITH THE SALE OR USE OF ANY KIT. ANY OTHER
REPRESNTATIONS OR WARRANTIES MADE BY ANY PERSON OR ENTITY, INCLUDING EMPLOYEES OR
REPRESENTATIVES OF ADC, THAT ARE INCONSISTENT HEREWITH WILL BE DISREGARDED AND WILL NOT BE
BINDING UPON ADC. ADC WILL HAVE NO LIABILITY FOR INDIRECT, INCIDENTAL, SPECIAL OR
CONSEQUENTIAL DAMAGES RELATING TO THE SALE OR USE OF ANY OF THE KITS AND ADC’S LIABILITY
THEREFOR WILL BE LIMITED TO [***].
	 
	 	14.	 	For the avoidance of doubt, discontinuance of the FreeStyle Test Strips, or notice of
discontinuance of the FreeStyle Test Strips pursuant to Section 6.4(e)(iii), does not
entitle either Party to terminate the Agreement;
	 
	 	15.	 	For the avoidance of doubt, Section 8.1 of the Agreement shall not apply to sales of
the Product in the Expansion Territory and Insulet may offer versions of the Product with a
DBGM other than ADC DBGM, or no DBGM, in the Expansion Territory.
	 
	 	16.	 	For the avoidance of doubt, Section 9.3 of the Agreement shall apply [***] and it is
hereby agreed between ADC and Insulet that [***].
	 
	 	17.	 	New Section 9.4 is added as follows:




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	 	 	 	9.4 Customer Service Event Payments — Expansion Territory. For each Expansion Territory
Customer Service Event during the term, ADC will pay Insulet on a calendar quarterly basis:
(i) an initial fee equal to [***] payable within [***] of ADC receiving a written report
from Insulet identifying the number of New Customers added in each country of the Expansion
Territory in the preceding calendar quarter and specifying the Expansion Territory Customer
Service Events to be provided for such end-user customers, and (ii) an annual fee of [***]
for each of the [***] years following the addition of any such New Customer (provided that
at least some portion of each such year occurs during the term, and, in the event the
Agreement terminates during any such year, Insulet continues to provide the contemplated
services to such end-user customer for the duration of that year), which annual fee will be
payable within [***] of ADC receiving a written report from Insulet confirming and/or
specifying, as applicable:






     (a) that each such end-user customer has purchased “OmniPod Pods” within six
months of such report,




     (b) that each such end-user customer has not received a Remote Controller with
a DBGM other than an ADC DBGM, or a Remote Controller with no DBGM, and




     (c) the Expansion Territory Customer Service Events to be provided for such
end-user customer.




	 	 	 	For avoidance of doubt, Insulet will assign to each New Customer a unique patient
identification number (“PIN”) that will be used to identify such customer in all
reports submitted by Insulet. Insulet will (A) not change the PIN for any such New Customer
during the term of this Agreement, and (B) ensure that in the event of an audit as provided
in Section 10.2, such PIN will enable ADC or its designated auditors to verify the
information provided by Insulet to ADC on the reports submitted pursuant to this Section
9.4. Subject to the audit provisions at Section 10.2, payments under this Section 9.4 are
non-refundable, provided that ADC will receive a credit in the amount of the most recently
paid annual fee or initial fee, as applicable, in the event that Insulet accepts return of
any Remote Controller in the Expansion Territory that includes an ADC DBGM and refunds the
end-user customer’s (or its insurer’s) payment for such Remote Controller. For the
avoidance of doubt, in the event an end-user customer receives a Remote Controller with a
DBGM other than an ADC DBGM, or a Remote Controller with no DBGM, ADC will have no further
obligations for Expansion Territory Customer Service Event payments for such end-user
customer.




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	 	18.	 	New Section 9.5 is added as follows:
	 
	 	 	 	9.5 Customer Service Event Payments (United States, Canada and Israel) Upon Expiration of
Initial Term. Commencing on the first day following expiration of the Initial Term and
continuing through the expiration of the term, for each Customer Service Event in the United
States, Canada and Israel (except for Upgrade Customers), ADC will pay Insulet on a calendar
quarterly basis: (i) an initial fee equal to [***] payable within [***] of ADC receiving a
written report from Insulet identifying the number of New Customers added in each of the
United States, Canada and Israel in the preceding calendar quarter and specifying the
Customer Service Events to be provided for such end-user customers, and (ii) an annual fee
of [***] for each of the [***] years following the addition of any such New Customer
(provided that at least some portion of each such year occurs during the term, and, in the
event the Agreement terminates during any such year, Insulet continues to provide the
contemplated services to such end-user customer for the duration of that year), which annual
fee will be payable within [***] of ADC receiving a written report from Insulet confirming
and/or specifying, as applicable:






     (a) that each such end-user customer has purchased “OmniPod Pods” within six
months of such report,




     (b) that each such end-user customer has not received a Remote Controller with
a DBGM other than an ADC DBGM, or a Remote Controller with no DBGM, and




     (c) the Customer Service Events to be provided for such end-user customer.




	 	 	 	For avoidance of doubt, Insulet will assign to each New Customer a PIN that will be used to
identify such customer in all reports submitted by Insulet. Insulet will (A) not change the
PIN for any such New Customer during the term of this Agreement, and (B) ensure that in the
event of an audit as provided in Section 10.3, such PIN will enable ADC or its designated
auditors to verify the information provided by Insulet to ADC on the reports submitted
pursuant to this Section 9.5. Subject to the audit provisions at Section 10.3, payments
under this Section 9.5 are non-refundable, provided that ADC will receive a credit in the
amount of the most recently paid annual fee or initial fee, as applicable, in the event that
Insulet accepts return of any Remote Controller in the United States, Canada and Israel that
includes an ADC DBGM and refunds the end-user customer’s (or its insurer’s) payment for such
Remote Controller. For the avoidance of doubt, in the event an end-user customer receives a
Remote Controller with a DBGM other than an ADC DBGM, or a Remote Controller with no DBGM,
ADC will have no further obligations for Customer Service Event payments for such end-user
customer.






	 	19.	 	For the avoidance of doubt, Section 10.1 shall apply only to audits of [***].
	 
	 	20.	 	New Section 10.2 is added as follows:
	 
	 	 	 	10.2 Audit of Expansion Territory Customer Service Events. Insulet will maintain a record
system through which ADC can determine [the Expansion Territory Customer





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	 	 	 	Service Events and verify the data set forth in the reports provided pursuant to Section
9.4; provided, however, that Insulet shall only be required to maintain such
records for a period of [***] following such Expansion Territory Customer Service Events
and/or the date of the applicable report. Insulet will make such information available for
inspection by ADC’s designated independent auditors [***] during the term, and for [***]
thereafter, on such dates as reasonably agreed between the Parties but no later than [***]
following ADC’s request. Such information shall be made available during regular business
hours. Except as set forth below, ADC shall be solely responsible for the costs of any such
audit. If ADC’s designated independent auditors discover that Insulet has reported
Expansion Territory Customer Service Events in excess of those calculated by the audit,
Insulet will refund to ADC the excess amounts paid by ADC within [***] of issuance of the
audit report. If ADC’s designated independent auditors discover that any end-user customer
data submitted by Insulet pursuant to Section 9.4 was inaccurate, Insulet will refund to ADC
all amounts paid by ADC for any such end-user customer for which inaccurate data was
provided within [***] of issuance of the audit report. If ADC’s designated independent
auditors discover that Insulet has reported Expansion Territory Customer Service Events in
excess of [***] of those calculated by the audit, and/or that inaccurate data was provided
for more than [***] of end-user customers during the period for which reports were audited,
Insulet will, in addition to refunding to ADC the amounts set forth above, reimburse ADC for
the reasonable and documented costs of the audit yielding such results within [***] of
issuance of the audit report.
	 
	 	21.	 	New Section 10.3 is added as follows:
	 
	 	 	 	10.3 Audit of Customer Service Events (United States, Canada and Israel) After Initial Term.
Insulet will maintain a record system through which ADC can determine [***] and verify the
data set forth in the reports provided pursuant to Section 9.5; provided,
however, that Insulet shall only be required to maintain such records for a period
of [***] following such Customer Service Events and/or the date of the applicable report.
Insulet will make such information available for inspection by ADC’s designated independent
auditors [***] during the term, and for [***] thereafter, on such dates as reasonably agreed
between the Parties but no later than [***] following ADC’s request. Such information shall
be made available during regular business hours. Except as set forth below, ADC shall be
solely responsible for the costs of any such audit. If ADC’s designated independent
auditors discover that Insulet has reported Customer Service Events in excess of those
calculated by the audit, Insulet will refund to ADC the excess amounts paid by ADC, within
[***] of issuance of the audit report. If ADC’s designated independent auditors discover
that any end-user customer data submitted by Insulet pursuant to Section 9.5 was inaccurate,
Insulet will refund to ADC all amounts paid by ADC for any such end-user customer for which
inaccurate data was provided within [***] of issuance of the audit report. If ADC’s
designated independent auditors discover that Insulet has reported Customer Service Events
in excess of [***] of those calculated by the audit, and/or that inaccurate data was
provided for more than [***] of end-user customers during the period for which reports were
audited, Insulet will, in addition to refunding to ADC the amounts set forth above,
reimburse ADC for the reasonable and





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	 	 	 	documented costs of the audit yielding such results within [***] of issuance of the audit
report.
	 
	 	22.	 	Except as specifically modified or amended hereby, the Agreement shall remain in full
force and effect, and as so modified or amended, is hereby approved. No provision of this
Amendment may be modified or amended except expressly in a writing signed by both parties.





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IN WITNESS WHEREOF, the parties have caused this Amendment to be signed by a duly authorized
representative effective as of the date set forth above.




	 	 	 	 	 	 	 

	Insulet Corporation	 	Abbott Diabetes Care Inc.
	 
	By: 	 /s/ Duane DeSisto	 	By: 	      /s/   Robert Ford
	 
	 	 	 
	 	Name: 	 Duane DeSisto	 	 	Name: 	              Robert Ford
	 	Title:	 CEO	 	 	Title:	             Vice President







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