EXHIBIT 10.24
Portions of this exhibit were
omitted and filed separately with the Secretary of the Commission
pursuant to an application for confidential treatment filed with
the Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934. Such portions are marked by a series of
asterisks.
LICENSE, JOINT DEVELOPMENT,
AND MANUFACTURING ASSISTANCE AGREEMENT
Recitals
.
Parties . This Agreement is entered into as of
October 29, 2004 between Debiotech S.A., a Swiss company
having a place of business at 28 Avenue de Sevelin, CH-1004
Lausanne, Switzerland, and Animas Corporation, a Delaware
corporation having a place of business at 200 Lawrence Drive, West
Chester, PA 19380, USA.
Development Funding and License
. Debiotech is prepared to undertake
the development of an externally worn micro-pump for the delivery
of insulin based upon Debiotech’s Micro Electro-Mechanical
Systems technology and related know-how. Animas desires to have
exclusive rights to make, use sell and/or import such a pump and to
obtain exclusive license rights to all of Debiotech Intellectual
Property useful for such purpose for all uses relating to the
administration of insulin.
Confidentiality Agreement.
Debiotech and Animas entered into a
confidential disclosure agreement dated July 6, 2004. Upon
execution of this Agreement, the Confidentiality Agreement shall be
terminated and replaced with the terms of this
Agreement.
Term Sheet. Debiotech and Animas signed on August 31,
2004 a Term Sheet containing most of the material terms upon which
they intended to agree and providing a basis for this Agreement.
Upon execution of this Agreement, the Term Sheet shall be
terminated and replaced with the terms of this
Agreement.
Parallel Agreement. Simultaneously with the execution of this
Agreement, Debiotech and Animas shall enter into a parallel
License, Joint Development and Manufacturing Assistance Agreement
in connection with a micro-needle product of Debiotech.
Due-Diligence Prior to Agreement
Signed . Prior to
signature of this Agreement, Animas has conducted a due diligence
review of Debiotech’s relevant technology and related
manufacturing, Debiotech having provided all information requested
by Animas, as well as a further due diligence review relating to
such relevant technology, including intellectual
property.
Consideration . In consideration of the mutual promises and
obligations contained herein, the parties agree as set forth in
this Agreement.
1.
Definitions
The
following capitalized terms are used in this Agreement with the
meanings indicated or referred to below.
1.1 Affiliate: any corporation, partnership, limited liability
company or other enterprise or organization that directly or
indirectly through one or more intermediaries controls, is
controlled by, or is under common control with a party, where
“control” means beneficial ownership of at least fifty
percent (50%) of the then outstanding voting shares or equity
interests in the party in question or the power to direct or
otherwise cause the direction of the management and policy of the
party in question (for the avoidance of doubt, Existing
Shareholders listed under Exhibit D shall not be considered
Affiliates given their current ownership of Animas).
1.2 Agreement: this LICENSE, JOINT DEVELOPMENT, AND
MANUFACTURING ASSITANCE AGREEMENT and all attached exhibits,
together with any future amendments entered into in accordance with
Section 16.13 of this Agreement.
1.3 Agreement Date: the date on which this Agreement is entered into
by the Parties.
1.4 Animas: Animas Corporation, a Delaware corporation
having a place of business at 200 Lawrence Drive, West Chester, PA
19380, USA.
1.5 Animas Group: Animas and its Affiliates.
1.6 Annual Royalties Statement:
a statement prepared by Animas at
the end of each Year in accordance with Section 4.6 of this
Agreement, setting forth the Net Revenue relating to Pump Products
subject to a royalty in that Year. The Annual Royalty Statement
shall set forth (i) the number of Pump Products placed or sold
to end-users, by product and by country, and the Net Revenue, by
product and by country, associated with such Pump Products;
(ii) the number of Pump Products placed or sold to
distributors, by product and by country, and the Net Revenue, by
product and by country, associated with such Pump Products;
(iii) the number of Pump Products placed or sold by
Sub-licensees, by product and by country, and Net Payments received
by Animas from Sub-licensees associated with such Pump Products;
and (iv) the royalties payable by Animas with respect to such
Net Revenue for that Year and the Sublicense Fees payable by Animas
with respect to such Net Payments from Sub-licensees for that Year,
if any, and the royalties and Sublicense Fees previously shown due
in the Quarterly Royalties Statements for that Year.
1.7 Change of Control: a change of control of Animas Group shall be
deemed to have occurred at such time as any third party, other than
an Existing Shareholder listed
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under
Exhibit D, acquires more than 50% of the voting stock of
Animas or Animas merges with a third party except where Animas is
the surviving entity. A Change of Control will be deemed to have
occurred if this Agreement is assigned directly or indirectly to a
third party, excluding an Animas Affiliate, including without
limitation the sale of substantially all of the assets of Animas in
accordance with Section 16.6 of this Agreement.
1.8 Commercial Launch: the date at which the first Pump Product is sold
to an end-user in any country, directly or indirectly, by a
Licensee.
1.9 Debiotech: Debiotech S.A., a Swiss company having a place
of business at 28 Avenue de Sevelin, CH-1004 Lausanne, Switzerland
(together with successors and assigns, and those Affiliates who
(i) own Debiotech Intellectual Property or (ii) have
license rights therein in the Field, or (iii) employ any
personnel having been involved as an employee of Debiotech
(including successors and assigns) or an Affiliate in the
development of an externally worn micro-pump utilizing MEMS
technology).
1.10 Debiotech Intellectual
Property: all patents,
copyrights, trade secrets, know-how and other intellectual property
related to or useful to an externally-worn micro-pump utilizing
MEMS technology owned by, developed by or licensed to Debiotech,
now or until such time as the license granted pursuant to this
Agreement is terminated in accordance with Section 15 of this
Agreement or becomes a fully paid-up license in accordance with
Section 2.2 of this Agreement (including, without limitation,
the intellectual property described more specifically in
Exhibit A). Debiotech Intellectual Property includes, without
limitation, all ideas, methods, concepts, design features,
diagrams, schematics, flowcharts, specifications, code (source and
object) and any other intellectual property necessary or useful for
Animas to fully exercise its rights and perform its obligations
under this Agreement or otherwise commercialize Pump Products in
the Field. Notwithstanding the foregoing, Debiotech Intellectual
Property shall include intellectual property developed jointly by
Debiotech and a third party unless Debiotech is prohibited by
contractual agreement with such third party to license such
intellectual property to another party.
1.11 Debiotech Pump: an externally worn micro-pump system for the
delivery of insulin incorporating a MEMS Chip and based upon
Debiotech Intellectual Property. In its initial configuration, a
Debiotech Pump will comprise both a MEMS Pump and a Pump Controller
according to the Specifications.
1.12 Debiotech Pump System:
a system incorporating Debiotech
Pump including Pump Accessories.
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1.13 Development Program:
the development program described
more fully in Article 5 of this Agreement pursuant to which
Debiotech is to use commercially reasonable efforts to develop
fully functional prototypes of the Debiotech Pump which meet the
Specifications.
1.14 Distributors: Third parties (outside Animas Group) that
distribute Pump Products sold to them by a Licensee.
1.15 FDA Approval: 510(k) clearance by the Food and Drug
Administration (FDA) for sale in the United States of the
Debiotech Pump.
1.16 FDA Submission: filing for FDA Approval.
1.17 Field: all uses of an externally worn micro-pumps
relating to the administration of insulin which insulin may be
administered through a single pump, alone or in combination with
other medications (such as glucagon and insulin).
1.18 Filling System: all the components necessary to fill and refill
the Debiotech Pump with insulin, such as insulin vial adaptor(s),
syringes to apply pressure or vacuum, external cartridge (if any),
needles, caps, cleaning and sterilizing supplies and the
like.
1.19 Infusion Accessories:
all components used together with
the Debiotech Pump System, such as Infusion Sets, prolongation
sets, automatic placement tool for Infusion Sets, carrying case, PC
software and interface, printer, and the like.
1.20 Infusion Sets: all sterile infusion sets to be used in
conjunction with the Debiotech Pump.
1.21 Knowledge: “to the best knowledge of Debiotech”
shall mean to the actual or implied knowledge, as of the Agreement
Date, of the officers, directors, owners and management of
Debiotech; provided that, “implied knowledge” shall
mean only the knowledge readily obtainable from all information
available in the books, records and files of Debiotech.
1.22 License: the exclusive license granted to Animas pursuant
to Section 2.1 of this Agreement (including further extensions
to future rights, in particular in accordance with
Section 13.1 of this Agreement and Section 13.2 of this
Agreement).
1.23 Licensed Patents: all patents, patent applications and patent
rights included in Debiotech Intellectual Property as well as
patents, patent applications and patent rights resulting from joint
inventions under Section 13.1 of this Agreement. A
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comprehensive list of such Licensed Patents, as
of the Agreement Date, is described in Exhibit A.
1.24 Licensees: Animas, Affiliates of Animas and
Sub-licensees.
1.25 License Shares: 400’000 shares of restricted Animas Common
Stock to be delivered by Animas to Debiotech in accordance with
Section 3.2 of this Agreement.
1.26 Major Countries: France, Germany, United Kingdom and United
States.
1.27 Manufacturing Program:
The manufacturing program as defined
in Section 7.3 of this Agreement.
1.28 MEMS: Micro Electromechanical Systems using
fabrication techniques similar to those utilized in the
micro-electronics industry.
1.29 MEMS Chip: the silicon/Pyrex micro-chip pump utilizing
Debiotech Intellectual Property.
1.30 MEMS Pump: replaceable/disposable housing containing MEMS
Chip, piezo actuator, insulin reservoir (if any) and related
internal components.
1.31 MEMS Pump Business:
the business of Debiotech relating
specifically to the design, development and production of
externally worn micro-pumps utilizing MEMS technology and all
licensing, consulting and investment activities and operations
relating thereto, whether in the Field or outside the
Field.
1.32 Micro-Needle Agreement:
a parallel agreement entered into
between Debiotech and Animas in connection with a micro-needle
product of Debiotech, entitled Micro-Needle License, Joint
Development and Manufacturing Assistance Agreement and all attached
exhibits, together with any future amendments entered into in
accordance with such parallel agreement.
1.33 Net Revenue: gross revenue of Animas Group on a consolidated
basis (excluding all revenue from Sublicensees) from the sale of
Pump Products to distributors and end-users minus contractual
allowances and discounts, as calculated in accordance with US
Generally Accepted Accounting Principles, as such principles are in
effect at that time, and as recognized in accordance with
Animas’ standard accounting practices in effect for the
relevant period, consistently applied
(“GAAP”).
1.34 Patient Installed Base:
Installed base of patients under
Debiotech Pump System estimated as of July 1 of any Year
considered.
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1.35 Pump Accessories: Filling Systems, Infusion Sets and all other
Infusion Accessories.
1.36 Pump Controller: long-term use (about ******) module, containing
all the hardware and firmware necessary to control and monitor the
MEMS Pump and also providing user interface means, as well as any
other device related therewith (e.g. remote programming system,
including as the case may be a strip blood glucose monitoring
device, and the like).
1.37 Pump Products: products constituting Debiotech Pump System,
i.e. MEMS Pump, Pump Controller and Pump Accessories collectively
or separately, including components therein and assemblies into
such products.
1.38 Quarterly Royalties Statement:
a statement prepared by Animas for
a calendar quarter in accordance with Section 4.5 of this
Agreement, setting forth the Net Revenue of products subject to a
royalty in that quarter (with relevant figures of units placed to
end-users and to distributors and Net Revenues, product by product
and country by country), the Net Payments received by Animas from
Sub-licensees in that quarter and the royalties and Sub-license
Fees due by Animas with respect to such Net Revenues and such Net
Payments from Sub-licensees.
1.39 Royalties Term: the period during which at least one Licensed
Patent is Valid in at least one Major Country.
1.40 ******-License : the non-exclusive license from ****** in favor
of Debiotech with regard to certain patents, including the right to
sub-license.
1.41 Specifications: the specifications set forth in Exhibit B,
as such specifications may be amended, pursuant to this
Agreement.
1.42 Steering Group: a six person committee composed of three senior
employees of each party, but not their CEO’s, which shall
review in accordance with Section 5.5 of this Agreement all
the developmental, logistical and technical aspects of the
Development Program.
1.43 Sub-licensees: third party (outside Animas Group) sub-licensees
appointed by Animas in accordance with Section 2.3 of this
Agreement and distributing Pump Products which have not been sold
to them by Animas Group or a Sub-licensee (so that such Pump
Products have not yet been taken into account for determining
royalties due to Debiotech). Sub-licensees do not include
(i) parties that manufacture Pump Products, or components
therein, on behalf of Animas, but do not distribute such Pump
Products or components therein, or (ii) Distributors. However,
the parties acknowledge that, the same person might be a
Distributor in connection with certain Pump Products (bought from
Animas Group or a Sub-licensee, e.g. Debiotech
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Pumps)
and a Sub-licensee in connection with certain other Pump Products
(not bought from Animas Group or a Sub-licensee, e.g. Infusion
Sets).
1.44 Valid: qualifier for a patent in a determined country,
meaning that such patent in such country is valid, not expired and
has not been declared unenforceable by a competent body of such
country (such as a United States Federal District Court) for any
defect related to the patent (such as a failure from patentee to
make relevant disclosures) and affecting its validity lato
sensu , but not making the patent technically invalid. Whether
the validity of the patent is challenged and infringers can
effectively be prevented is irrelevant to determine whether any
patent is Valid.
1.45 Year: a calendar year, from January 1 to
December 31.
2. License to
Animas.
2.1 Exclusive License . Debiotech hereby grants to Animas an
exclusive, even as to Debiotech, worldwide license, with the right
to sublicense in accordance with Section 2.3 of this Agreement,
under all Debiotech Intellectual Property, excluding intellectual
property jointly developed by Debiotech and a third party, and a
non-exclusive sub-license under (i) the ******-License and
(ii) Debiotech Intellectual Property jointly developed by
Debiotech and a third party, to make, have made, use, sell, offer
for sale, or import Debiotech Pump System in the Field. During the
term of this Agreement, Debiotech shall not enter into any
agreement with any other party to develop an externally-worn
micro-pump utilizing MEMS technology for use in the
Field.
2.2 Duration . The License shall be perpetual (subject to
Article 15 of this Agreement). After the Royalties Term, the
License shall become a fully paid-up, royalty free, irrevocable,
non-exclusive worldwide license.
2.3 Sublicense . The License shall include the right for Animas
to sublicense the licensed rights; provided that Animas obtains
Debiotech’s written consent which consent shall not be
unreasonably withheld or delayed. Animas’ sub-licensees shall
conform to the applicable material terms of this Agreement and
Animas shall remain directly liable to Debiotech with regard to any
breach of the terms of this Agreement by Animas’
sub-licensees remaining uncured after a 90 day period
following a default notice; provided that, Animas shall no longer
be considered in breach of this Section 2.3 in the event
Animas terminates the sublicense agreement within a reasonable
period after the breach.
2.4 Limitation to the Field
. Licensees shall not make, use,
sell, offer for sale, or import Pump Products outside the
Field.
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2.5 Further Documents . Debiotech hereby agrees to execute, or cause
its employees, partners, licensors, agents, or consultants to
execute all documents and shall take all actions necessary or
desirable to effect, confirm and perfect the rights granted to
Animas pursuant to the License, including without limitation,
assignment to Debiotech of inventions past, present and future from
its employees and consultants.
2.6 Promotion . Animas shall use reasonable commercial efforts
to commercialize the Debiotech Pump, independent of the economic
attractiveness of other competing Animas products.
2.7 Sales, Marketing and
Distribution . All
sales, marketing, and distribution activities for Pump Products
shall be the responsibility of Animas. Animas shall give Debiotech
periodic updates on the progress of Animas marketing
activities.
3. License
Fees.
3.1 Initial License Fee: Part in
Cash. Animas shall pay to
Debiotech a non-refundable license fee of Twelve Million Dollars
($12,000,000), payable within 10 days following Agreement
Date.
3.2 Initial License Fee: Part in
Shares . Animas shall
deliver to Debiotech the License Shares, deliverable within
10 days following Agreement Date. In the event Debiotech sells
any of the License Shares while termination by Animas under Section
15.1(c) of this Agreement would still be permissible, Debiotech
shall provide to Animas a bank guarantee, letter of credit, escrow
arrangement or such other form of security acceptable to Animas to
secure the termination payment payable to Animas pursuant to
Section 15.1(c) of this Agreement.
3.3 Restriction for sale of shares
. The License Shares shall be
issued pursuant to the Subscription Agreement attached hereto as
Exhibit E.
3.4 Additional License Fee
. Animas shall pay Debiotech a
one-time additional license fee (“Additional License
Fee”), subject to the provisions of this Section 3.4, at
such time as Debiotech provides Animas all deliverables reasonably
necessary for Animas to complete the FDA Submission (“FDA
Deliverables”). A list of such FDA Deliverables is included
in Exhibit I and may be amended by Animas as reasonably
necessary, up to the date which is nine (9) months prior to
the due date for delivery of FDA Deliverables as set forth in the
Development Program. To the extent, at any time, Animas
substantially modifies the FDA Deliverables (e.g. based on new
requirements by the FDA, changes in the market conditions, or the
need to perform clinical studies prior to FDA Submission), the
dates below shall be extended to the extent reasonably necessary
for Debiotech to deliver additional FDA Deliverables.
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The
Additional License Fee shall be Two Million Dollars ($2,000,000) if
FDA Deliverables have been received by Animas prior to
January 1, 2007 if there has been no Change of Control, or
prior to July 1, 2007 if there has been a Change of Control.
The Additional License Fee shall be One Million Dollars
($1,000,000) if FDA Deliverables have been received by Animas after
January 1, 2007 but prior to July 1, 2007 if there has
been no Change of Control, or after July 1, 2007 but prior to
January 1, 2008 if there has been a Change of Control. If
Animas paid a One Million Dollars Additional License Fee, but a Two
Million Dollars Additional License Fee would be due following a
Change of Control, the unpaid part of the Additional License Fee
shall be due within 30 days following Change of Control. This
license fee is payable only one-time even if multiple submissions
are made to FDA. The Additional License Fee, to the extent paid by
Animas pursuant to this Section 3.4, shall be payable within
30 days after Debiotech provides Animas with FDA Deliverables.
Except as set forth in the following two sentences, no Additional
License Fee shall be payable if FDA Deliverables are received by
Animas after January 1, 2008. The dates of January 1,
2007, July 1, 2007 and January 1, 2008 shall each be
extended (i) for such number of days as the Steering Group
agrees to extend the Development Program in accordance with
Section 5.5, and/or (ii) to the extent delays of the
development of the Pump Controllers and/or Infusion Accessories
impacts the delivery by Debiotech of the FDA Deliverables, for each
day that the development of the Pump Controllers and/or Infusion
Accessories in accordance with the Development Program is delayed
by Animas. If Animas decides to perform clinical trials prior to
FDA Submission, the Additional License Fee shall be Two Million
Dollars ($2,000,000) and shall be paid within 30 days after
Debiotech provides Animas with FDA Deliverables, irrespective of
the deadlines above.
3.5 Advance on Royalties.
In the event of a Change of Control,
Animas (or its successor) shall pay Debiotech, a non-refundable
advance on future royalties of Five Million Dollars ($5,000,000),
which payment shall be made within 180 days following a Change
of Control. No advance payment shall be due if, within
180 days following a Change of Control, this Agreement is
terminated in accordance with Section 15.1 or 15.2(c) of this
Agreement.
Such
advance payment shall be credited against 50% of actual royalty
payments made pursuant to Section 4.1 of this Agreement until
such credit has been fully utilized.
3.6 Sublicense Fees . Except to the extent a Sub-licensee Royalty
Rate is applicable, Animas shall pay to Debiotech ****** of any Net
Payments Animas receives from Sub-licensees and Distributors
(“Base Sub-licensee Rate”) . Net Payments equal the
gross cash (including royalties) received by Animas Group from
Sub-licensees pursuant to any sub-license agreement between Animas
Group and such Sub-licensee relating to Debiotech Intellectual
Property and the gross cash received by Animas
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Group
from Distributors pursuant to any agreement between Animas Group
and such Distributor relating to Debiotech Intellectual Property
but excluding any cash received by Animas Group from sales of Pump
Products to such Distributors (provided that, to the extent
Debiotech can demonstrate that a substantial portion of the sales
price of Pump Products sold by Animas Group to Distributors
includes what should be characterized as a sublicense fee or
royalties due to Animas Group, Debiotech may require that such part
of the sales price be included in the Net Payments instead of in
the Net Revenue), minus applicable import, export and excise duties
and sales tax (including VAT), and minus any taxes withheld from
the gross cash (excluding any taxes that were withheld after the
gross cash payable to Animas Group was increased to provide that
after the withholding of the taxes Animas Group was to receive the
same amount of payment it would have received but for the
withholding) to the extent not recoverable by Animas Group within
two years of the receipt of the gross cash. In the event either
(i) the total aggregate number of Debiotech Pumps sold by all
Sub-licensees and sold by Animas Group to Distributors for resale
outside the USA in a Year exceeds ****** of all Debiotech Pumps
sold by Animas Group (including those to Distributors) and its
Sub-licensees in such Year, or (ii) the total aggregate number
of Infusion Sets sold by all Sub-licensees and sold by Animas Group
to Distributors for resale outside the USA in a Year exceeds ******
of all Infusion Sets sold by Animas Group (including those to
Distributors) and its Sub-licensees in such Year, Animas shall pay
to Debiotech a Sub-licensee License Fee equal to the greater of
(i) a royalty equal to ****** of net revenues of Pump Products
sold by all Sub-licensees (“Sub-licensee Royalty
Rate”), or (ii) Base Sub-licensee Rate.
3.7 Currency . All payments under this Agreement shall be
made in US Dollars, and all references in this Agreement to
“Dollars” shall mean “US Dollars”. Payments
to be made to Debiotech shall be made by SWIFT bank transfer to
Debiotech’s bank account.
4.
Royalties.
4.1 Base royalties . Animas agrees to pay Debiotech a royalty equal
to a percentage of Net Revenue of Pump Products sold or placed by
Animas Group. The royalty rate shall vary (based on Patient
Installed Base) and shall be fixed each Year as set forth on
Exhibit H, except for certain adjustments as provided in
Sections 4.3 and 4.4, in this Agreement, when
applicable.
4.2 Allocation of Net Revenues.
In the event the Pump Products are
sold in combination with a product(s) that is not a Pump Product,
such as insulin, a continuous glucose monitoring device and related
accessories (“Non-Pump Products”), the applicable
royalty on Pump Products shall be based on the Net Revenue of Pump
Products as if
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they
were sold on a stand-alone basis (excluding additional net revenue
for Non-Pump Products).
In
such case, Animas will give written notice to Debiotech of a
proposed allocation of the Net Revenue attributable to Pump
Products sold with Non-Pump Products. Following such notice, to the
extent Debiotech does not agree with Animas’ proposed
allocation, the parties shall negotiate in good faith for a period
of ninety (90) days. If the parties are unable to agree on an
allocation, either party may require that the matter be determined
by binding baseball arbitration pursuant to Section 16.2 of this
Agreement.
4.3 Net Revenue Adjustment.
In the event that less than ******
of Debiotech Pumps placed to end-users or sold by Animas Group in
any given Year are placed to end-users or sold through its direct
sales force, the parties shall negotiate in good faith an
appropriate correction factor of the Net Revenue for that Year,
which correction factor shall increase royalty payments payable to
Debiotech to compensate, in part, for the reduced average selling
prices of Debiotech Pumps, and hence royalties to Debiotech, as a
result of the lower percentage of direct sales. The parties in such
negotiations shall consider a correction factor to provide for what
the average selling price of Pump Products would have been had
Animas Group sold at least ****** of Debiotech Pumps through its
direct sales force; provided that the gross margin percentage of
Pump Products, in aggregate, sold by Animas Group after the
increased royalties does not fall below customary gross margin
percentages for manufacturers in the med-tech industry that provide
similar levels of customer service, have similar mix of direct
versus indirect sales, and perform similar levels of R&D
activities. Following any Change of Control, the correction factor
shall apply without regard to its impact on gross margin. If the
parties are unable to agree on a correction, either party may
require that the matter be determined by binding baseball
arbitration pursuant to Section 16.2 of this
Agreement.
4.4 Royalties reduction . During the Royalties Term, if none of the
Licensed Patents covering any Pump Product is Valid in any Major
Country, the royalty rate as set forth in Exhibit H shall be
reduced to ****** of such rate in those countries in which Pump
Products are sold, but Licensed Patents are not Valid; provided
that such reduction in royalty rates shall only occur if
(i) there is another competing pump product utilizing MEMS
pump technology being sold in such country and, (ii) the Pump
Products sold in such country are not manufactured in a country
where a Licensed Patent covering any Pump Product is
Valid.
4.5 Quarterly Calculation and Payment of
Royalties . Royalties
shall be due and payable with respect to the Net Revenue made in
each calendar quarter within 45 days following the end of such
calendar quarter ( a “ Payment Date ”), except
for after the fourth quarter in which case, Section 4.6
applies. On or before each Payment
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Date
on which royalties are due, Animas shall prepare and deliver to
Debiotech a Quarterly Royalties Statement. The royalty rate for the
second through fourth quarters of a Year shall be determined by the
applicable Patient Installed Base. The royalty rate for the first
quarter of a Year shall be provisionally calculated based on the
sum of the estimated patient installed base as of December 31
of the prior Year plus two times the increase in patient installed
base during the first quarter of the current Year. In the event the
royalty rate so determined initially for the first quarter is
different (whether higher or lower) than the royalty rate after the
second quarter of that Year, the correction shall be made to the
previously issued Quarterly Royalties Statement from the first
quarter and the difference added to or deducted from the second
Quarterly Royalties Statement prepared by Animas. Information
provided to Debiotech in the Quarterly Royalties Statement shall
remain confidential and not disclosed by Debiotech to other
parties.
4.6 Annual Calculation and Payment of
Royalties . Within
45 days following the end of the Year, Animas shall prepare
and deliver to Debiotech an Annual Royalties Statement, applying
the royalty rate applicable pursuant to the Patient Installed Base
of that Year, subject to modifications as set forth in
Sections 4.2-4.4. Information provided to Debiotech in the
Annual Royalties Statement shall remain confidential and not
disclosed by Debiotech to other parties.
4.7 Records and Audits . Licensees shall maintain detailed books and
records containing information sufficient to verify the
completeness and accuracy of the information presented in each
Royalty Statement for a period of at least five years after the
period to which such Royalty Statement relates.
Debiotech shall have the right, not more than
once each Year, on reasonable advance notice to Animas, during
usual business hours, to cause the examination of relevant records
of Licensees for the period since the last period covered by any
previous examination (including records which are more than five
years old, if then available) and ending with the calendar quarter
covered by the most recent Payment Date for the sole purpose of
verifying the completeness and accuracy of the Quarterly Royalty
Statements and Annual Royalty Statements, including any specific
calculation relevant under this Agreement (such as with regard to
Sections 3.6, 4.3 and 15.1(c)(ii)of this Agreement). At
Debiotech’s election, any such examination shall be conducted
by Animas’s auditors, if allowed by law and agreeable to such
auditors, or by independent public accountants selected by
Debiotech and reasonably acceptable to Animas.
As a
condition to such examination, Animas may require such independent
public accountants to execute a confidentiality agreement in form
and substance reasonably satisfactory to Animas pursuant to which
such independent public accountants will agree to retain in
confidence all information learned by them in the course of
such
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examination, except that any discrepancy in any
information included in a Quarterly Royalty Statement or an Annual
Royalty Statement, or being a relevant information under this
Agreement, may be disclosed to Debiotech.
Debiotech shall pay the costs of conducting such
audit unless the final results of an audit reveal an underpayment
by Animas of five percent (5%) or more during the audited period,
in which case Animas shall pay the costs of conducting such
audit.
4.8 Duration . Royalties are to be paid on the sale of all
Pump Products sold by Licensees throughout the world during the
Royalties Term. Following the Royalties Term, the provisions of
Section 2.2 of this Agreement shall apply.
5. The Development Program
and Debiotech Pump System.
5.1 Responsibilities of Debiotech
. Debiotech shall use reasonable
commercial efforts to complete the Development Program (including
without limitation the MEMS Pump and the Filling System) and
provide to Animas, in accordance with the milestones set forth in
Exhibit B, fully functional prototypes of (a) the MEMS
Pump, including MEMS Chip, and (b) Pump Accessories (except
for the Infusion Accessories). Such prototypes shall (i) meet
the Specifications, (ii) be sufficient for FDA Submission, and
(iii) be in a form which permits redesign for manufacturing
and scaling up for large scale industrial manufacturing. Debiotech
shall furnish to Animas and any manufacturer designated by Animas
all documentation necessary for the redesign for manufacturing of
the Pump Products. Debiotech shall cooperate with such designated
manufacturer to assist in any redesign necessary for manufacturing
Pump Products.
To the
extent that such prototypes of the MEMS Pump fail to meet the
requirements set forth above (and on Exhibit B), Debiotech
shall, at its sole expense, use reasonable commercial efforts to
continue development work to satisfy such requirements; provided
that Debiotech shall not be required to continue development if
Animas has commenced marketing of the Debiotech Pump.
Without limiting Debiotech’s ability to
demonstrate how it uses reasonable commercial efforts, Debiotech
shall in any event be deemed to use reasonable commercial efforts
to fulfill its responsibilities under this Section 5.1 to the
extent Debiotech’s efforts represent at least ****** in
average each Year during 3 Years following Agreement Date in global
development costs, including investments costs, consulting and
external development costs and internal engineering costs
calculated based upon rates provided in Exhibit C.
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5.2 Responsibilities of Animas
. Animas shall use reasonable
commercial efforts to complete the Development Program (including
without limitation the Pump Controller and the Infusion
Accessories) and provide, in accordance with the milestones set
forth in Exhibit B, fully functional examples of the Pump
Controller and Infusion Accessories. The Pump Controller and
Infusion Accessories shall (i) meet the Specifications,
(ii) be sufficient for FDA Submission, and (iii) be in a
form which permits redesign for manufacturing and scaling up for
large scale industrial manufacturing.
Animas
shall be responsible for establishing the large scale manufacturing
and Debiotech shall propose appropriate materials to be used to
manufacture the MEMS Pump and Filling System and shall assist by
supplying engineering support necessary to facilitate production of
the Debiotech Pump System in large scale by Animas or suppliers
designated by Animas.
5.3 Development Expenses
. Each party shall be responsible
for bearing its own costs of the Development Program. Debiotech
shall be solely responsible for all expenditures of any nature
required to complete the development of (a) the MEMS Pump,
including MEMS Chip, and (b) Pump Accessories (except for the
Infusion Accessories) in a form which in fact permits scaling up
for large scale industrial manufacturing and which satisfies the
requirements set forth in 5.1 above. Animas shall be solely
responsible for all expenditures of any nature required to complete
the development of the Pump Controller and Infusion Accessories in
a form which in fact permits scaling up for large scale industrial
manufacturing and which satisfies the requirements set forth in 5.2
above. Animas shall be responsible for the costs of any tooling and
equipment for manufacturing of the Debiotech Pump System as well as
for the cost of all required redesign for manufacturing.
Animas
agrees to spend not less than ****** to develop Debiotech Pump
System prior to January 2007 unless both parties agree, in
good faith, that the Debiotech Pump System is not feasible as a
commercial product.
5.4 Reports. Debiotech shall keep Animas fully informed with
regard to the progress of the development of the Debiotech Pump
System.
Not
later than fifteen (15) days prior to the meetings with CEOs
contemplated by Section 5.5, Debiotech shall submit to Animas
a written report including all information regarding progress on
the Development Program, disclosing any inventions or other
improvements in technology, whether or not patentable, discovered
or created in the course of the Development Program. The reports
will also include a confirmation from Debiotech that Debiotech
believes that the
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Development Program can be completed consistent
with the schedule contemplated by Exhibit B, or Debiotech
shall submit to Animas a revised schedule setting forth the revised
estimated time to complete the Development Program.
If
reasonably necessary in addition to the above, and to the extent it
would not be unreasonably burdensome on Debiotech, upon request
from Animas, Debiotech shall allow Animas’ representatives
and, where Animas shows a reasonable business purpose, third party
guests (subject to appropriate confidentiality agreements with
Debiotech), to visit the development facilities where the
Development Program is conducted, to attend presentations by
Debiotech representatives of the current state of the Development
Program and to receive additional written reports addressing
specific issues.
5.5 Program Management . Each party shall appoint three senior
employees, but not their CEOs, to form the Steering Group, which
shall review all the developmental, logistical and technical
aspects of the Development Program. In addition, major financial
issues shall be discussed when they arise.
At
least two members of the Steering Group from each side shall meet
in person at least once every two months. Each party may invite
additional participants from its own party to attend. Minutes of
the meetings shall be prepared by Debiotech, indicating, in
particular, the steps believed to be satisfactorily performed by
the parties and the next steps to be performed. Minutes shall be
reviewed and approved or rejected and amended at the next meeting
of the Steering Group. Minutes of the Steering Group shall not
constitute amendments of this Agreement or the Specifications even
if signed by representatives of the parties or the CEOs of each
Party.
The
Steering Group shall be charged with managing the Development
Program with a view to completing development of the Debiotech Pump
System as rapidly as possible. In addition, the Steering Group
shall insure that such development be completed in accordance with
the Specifications and that the manufacturing cost of the Debiotech
Pump System be consistent with the levels set forth in the
Specifications. The Steering Group shall make recommendations to
either Party regarding design and engineering issues and shall make
recommendations to Animas regarding the most appropriate
supplier(s) to manufacture the Debiotech Pump System or any part
thereof. Debiotech employees shall be primarily responsible for
issues relating to design, engineering and intellectual property
with regard to the MEMS Pump and Pump Accessories (excluding
Infusion Accessories). Animas employees shall be primarily
responsible for issues relating to design, engineering and
intellectual property with regard to the Pump Controller and
Infusion Accessories as well as manufacturing and selection of
suppliers. Animas shall also be responsible
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for
facilitating any incorporation of Animas’ technology, if any,
in the Debiotech Pump System.
Either
Party’s members on the Steering Group may recommend
modifications to the Specifications and the Development Program by
submitting a written request to the other Party’s members on
the Steering Group detailing the nature of the modification, the
reason for the modification and the anticipated costs associated
with implementing the modification. Any modification must be
approved in writing by each Party’s CEO. Each Party agrees
not to unreasonably withhold their approval to a modification
suggested by the other Party so long as the consenting Party cannot
demonstrate with written documentation that the modification
(i) materially adversely affect the marketability and
desirability of the Debiotech Pump System, (ii) materially
affects the cost of the development effort, or
(iii) materially affects the timing of the availability on the
market of the Debiotech Pump System.
Each
Party’s members on the Steering Group shall keep their
respective CEOs informed as necessary. The Steering Group shall
meet in person with the CEOs as a group of eight at least once
every 4 months. The Steering Group shall attempt to resolve
issues without the involvement of the CEOs; provided that, in the
event the parties cannot agree, the issue shall be put before the
CEOs who shall use commercially reasonable efforts to resolve the
issue.
Meetings of the Steering Group (other than those
to attended by the CEOs) shall be held at the location where the
most active development work is being conducted, which the parties
anticipate will be in Lausanne Switzerland through the early and
middle stages of the Development Program, and may be the site of
anticipated manufacturing facilities later in the Development
Program. Meetings of the Steering Group attended by the CEOs shall
alternate between locations designated by the CEO of Animas and the
CEO of Debiotech.
5.6 Obligations to develop Product
. Debiotech agrees that it will
devote the resources as reasonably necessary to ensure development
of the MEMS Chip and Pump Accessories (excluding the Infusion
Accessories) by June 30, 2007. In the event Debiotech is not
successful in developing the MEMS Chip and Pump Accessories
(excluding the Infusion Accessories) by June 30, 2007, Animas
may terminate this Agreement in accordance with
Section 15.1(c) of this Agreement or, Animas may, in its sole
discretion, extend the Development Program by up to an additional
eighteen (18) months; provided, however, the June 30,
2007 date shall be extended (i) for such number of days as the
Steering Group agrees to extend the Development Program in
accordance with Section 5.5, and/or (ii) for each day
that the development of the Pump Controllers and/or Infusion
Accessories in accordance with the Development Program is delayed
by Animas.
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Animas
agrees that it will devote the resources as reasonably necessary to
ensure development of the Pump Controller and Infusion Accessories
in time for Debiotech to complete the Development Program by
June 30, 2007.
5.7 Failure to complete Development
Program. Because of the
uncertainties associated with the development work, neither party
warrants that it will successfully complete the Development
Program.
5.8 Choice of Suppliers under Development
Program . Debiotech and
Animas must jointly agree on choice of suppliers for any part or
process of the Development Program if Non-recurring Engineering
Expense (NRE) or tooling charge exceeds $20,000.
6. Regulatory
Responsibility.
6.1 Regulatory Filings . Animas shall use commercially reasonable
efforts to file regulatory approvals, including to the FDA, pending
completion of test results and other documentation required for
such submission.
6.2 Documentation for regulatory
submission . In
connection with preparation by Animas of the FDA Submission and
during the review by FDA of the FDA Submission, Debiotech shall: a)
furnish all test results and documentation on MEMS Pump and Pump
Accessories (except for Infusion Accessories) required by FDA and,
b) remain available for responding to questions by FDA relating to
such FDA Submission.
6.3 Clinical Studies . Animas shall be responsible for oversight of
clinical studies, if any, necessary to obtain FDA Approval, and
shall be responsible for the cost of any such studies. Protocol of
clinical studies must be approved by Debiotech in
advance.
6.4 Material for Clinical Studies
. Notwithstanding the provisions of
Section 7.1 of this Agreement, Debiotech shall furnish MEMS
Pumps and related Pump Accessories (except Infusion Accessories
which shall be supplied by Animas), in accordance with
Specifications, needed for clinical studies as required in
Section 6.3 of this Agreement, provided that ****** MEMS Pumps
and related Pump Accessories shall be delivered. The cost of all
such deliverables shall be borne solely by Debiotech, provided
that, Animas shall be responsible for any investments necessary for
manufacturing and redesign for manufacturing, to the extent
required.
6.5 Regulatory Obligations
. Animas and Debiotech shall
cooperate in the preparation of, and shall execute, as part of the
Development Program, a Quality Agreement in order
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to
meet the requirements of ISO13485, European MDD and FDA QSR (21 CFR
820) requirements for medical devices, to the extent
applicable.
7. Manufacturing Program of
MEMS Chip.
7.1 Manufacturing Responsibility
. Animas shall be responsible for
all aspects of manufacturing of Pump Products, and shall bear all
corresponding costs, except to the extent specifically stated
otherwise.
7.2 Choice of Initial Manufacturer
. Debiotech shall recommend not
less than three candidates of initial manufacturer for the MEMS
Chip. Animas may choose between one of three candidates to be the
initial manufacturer. If for whatever reason, Animas finds the
three candidates unacceptable, Animas may recommend other
candidates, whose endorsement by Debiotech may not be unreasonably
withheld.
7.3 Debiotech Assistance.
Debiotech, at its own cost, shall
provide (i) all documentation of all processes, materials,
testing, and assembly instructions necessary for the initial
manufacturer to manufacture the MEMS Chip in small-scale
manufacturing and further enter into a redesign for manufacturing
for large-scale production, (ii) any training required of personnel
of the initial manufacturer to manufacture the MEMS Chip,
(iii) any additional technical support including for
re-design/ revalidation of processes necessary for large-scale
manufacturing ((i) to (iii) constituting the Manufacturing
Program), and (iv) continued technical support including for
re-design/revalidation of processes, until the initial manufacturer
has delivered to Animas ****** MEMS Chips to be placed on the
market.
7.4 Cost. The cost of all required manufacturing tools and
equipments as well as for the redesign for manufacturing shall be
borne by Animas.
7.5 Support after Manufacturing
Program. Debiotech shall
provide employees as reasonably requested by Animas from time to
time to support manufacturing and technical issues, as they may
arise of MEMS Pump after completion of Manufacturing Program.
Animas shall reimburse Debiotech at rates as provided for in
Exhibit C, plus out-of-pocket expenses.
7.6 Access to MEMS Chip and MEMS Pump
Manufacturer. Subject to
the terms and conditions of this Section 7.6 and
Section 12.1 of this Agreement, Debiotech shall have the right
to buy directly from the manufacturer (the “MEMS
Manufacturer”) the MEMS Chips and/or MEMS Pump used in the
Debiotech Pump for use outside the Field.
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To the
extent Debiotech requires MEMS Manufacturer to use substantially
the same tooling and equipment which is either (a) used by and
has been specifically paid for by Animas, or (b) is owned by
Animas (the “Tooling”), then (i) Debiotech must
reimburse Animas for its pro rata share of any non-recurring
engineering costs (excluding Animas personnel) and tooling costs
incurred by Animas for the manufacture of such MEMS Chips and/or
MEMS Pump, irrespective of when such costs were incurred (provided
such reimbursement shall not apply to prototypes and ****** in an
amount less than ****** requested by Debiotech for development,
clinical evaluation and registration purposes so long as the
manufacture of such prototypes and small series do not cause delays
to Animas deliveries); (ii) Animas shall have priority in the
supply of MEMS Chips over Debiotech in the event that the MEMS
Manufacturer is unable to provide all quantities of MEMS Chips
requested by both Debiotech and Animas unless Animas has failed to
provide MEMS Manufacturer an adequate forecast of such requirements
as set forth in the agreement between the MEMS Manufacturer and
Animas; (iii) any request for a change by Debiotech in the
design or manufacturing of Tooling must be approved by Animas prior
to any discussion with MEMS Manufacturer, and further any such
discussions between MEMS Manufacturer and Debiotech, after such
approval by Animas for such discussions, may only be done in the
presence of Animas personnel; and (iv) in no case, may any
change in the design or manufacturing of such Tooling be made
without the explicit approval in writing by Animas, and further
Animas is under no obligation to approve a change in the design or
manufacture of such Tooling, even if Debiotech believes that Animas
is unreasonably withholding its approval.
All
rights and obligations of Debiotech in this Section 7.6 shall
inure to Debiotech’s licensees outside the Field, provided
that, such licensees agree to indemnify Animas from any third party
claims in connection with their use of the Tooling as per this
Section 7.6, and further provided, that the prior written
approval by Animas is obtained, which approval shall not be
unreasonably withheld. Debiotech shall indemnify and hold harmless
Animas, its successors and assigns, Affiliates, and their
respective agents, officers, employees, representatives and
directors from any third party claims in connection with Debiotech
using the Tooling as per this Section 7.6. In the event
Debiotech or its licensees sell product in the Field in a manner
which is under the reasonable control of Debiotech or its licensee,
in addition to any remedies that may exist under this Agreement,
all rights of Debiotech under this Section 7.6 may be
terminated, provided (i) sales were made willfully in the
Field, or (ii) sales were made negligently in the Field and
are materially harmful to Animas. Such termination rights shall not
apply to the extent Debiotech or its licensee, following notice
from Animas, fails to cure the breach within ******.
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8. Representations,
Warranties and Covenants.
8.1 Authorization. Each party represents that it is duly organized,
validly existing and in good standing under the laws of the state
of its organization, that it has full power to execute, deliver and
perform this Agreement, that this Agreement has been duly
authorized, executed and delivered by such party and is the legal,
valid and binding obligation of such party, enforceable against
such party in accordance with its terms, subject as to enforcement,
to applicable bankruptcy, insolvency, moratorium, reorganization or
similar laws affecting creditors’ rights generally and
general principles of equity.
8.2 No Conflict . Each party represents that the execution,
delivery and performance of this Agreement do not require any
approval, license, qualification, consent or filing or exemption
therefrom, or other action by any court, governmental authority or
other person, and do not contravene or constitute a default under
any legal requirement binding on such party, any agreement binding
on such party or any of its assets, or any judgment, injunction or
order or decree binding on such party or any of its properties. In
particular, Debiotech represents that its agreement with Inverness
Medical Technology and its successor has been terminated as of
January 18, 2004 and Inverness does not retain any rights to
any Debiotech Intellectual Property under such
agreement.
8.3 No Litigation . Each Party represents that there is no actual,
pending or, to the best knowledge of such Party, threatened action,
suit, proceeding or investigation against or affecting it or any of
its assets (including, with respect to Debiotech, Debiotech
Intellectual Property and, with respect to Animas, the License
Shares) before or by any court or arbiter or any governmental
authority which would prohibit or interfere with such Party
performance of its duties under this Agreement.
8.4 No Intellectual Property of Third
Parties . Debiotech
represents that, to the best knowledge of Debiotech, there is no
Valid intellectual property owned by any third party which would
restrict Animas from making, using and selling Debiotech Pump
System (as defined in the Specifications) in the Field throughout
the world under the License in accordance with the terms of this
Agreement without payment to third parties. Debiotech further
warrants that it has not received any communication from third
parties (i) notifying it that the Debiotech Pump System might
infringe intellectual property rights of any third party, or
(ii) questioning the ability of Debiotech Intellectual
Property to adequately prevent third parties from duplicating the
Debiotech Pump System without infringing.
8.5 Ownership of Intellectual
Property . Debiotech
represents that it owns (whether by ownership directly or through
licensed rights) the Licensed Patents described in Exhibit A,
free and clear of any claims of any third party. Debiotech
represents that,
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to the
best knowledge of Debiotech, it owns (whether by ownership directly
or through licensed rights) all of the intellectual property
necessary or useful for the development of the Debiotech Pump
System under the Development Program, including without limitation,
the Debiotech Intellectual Property, free and clear of any claims
of any third party. Debiotech represents (i) that, to the best
knowledge of Debiotech, none of such intellectual property
infringes or misappropriates any intellectual property rights or
other property rights of any third party other than third parties
identified in (v) below that have licensed relevant technology
to Debiotech; (ii) that no intentional misrepresentations were
made in any applications for patents included within Debiotech
Intellectual Property; (iii) that all such patent applications
have been made in good faith; (iv) that Debiotech does not
have any knowledge of any factors which would compromise the
validity of any of the Licensed Patents; and (v) that, to the
best knowledge of Debiotech, with exception of the license dated
August 1992 from ****** to Debiotech (the “ ******
License ”) and the ****** License, Debiotech does not
possess, nor does it currently require, any other third party
license(s) to make, sell, use and/or import the Debiotech
Pump.
8.6 Authorization to License
. Debiotech represents that
Debiotech is legally authorized to license, on a worldwide basis,
all Licensed Patents, including those identified as “******
patents” and covenants to protect Animas from any recourse
made by ****** (the patents assignee) as evidenced by the estoppel
letter described in Section 8.7 of this Agreement. Debiotech
also represents that it is legally authorized to sub-license, on a
worldwide non-exclusive basis, the ****** License.
8.7 ****** Intellectual Property.
Debiotech, at its sole expense,
shall arrange for Animas to receive an estoppel letter, in form and
substance reasonably satisfactory to Animas, from the owner of the
intellectual property licensed to Debiotech under the ******
License, confirming, among other things, that Animas may use the
License without obligation to pay any royalties to ****** or any
third party and that such owners will look solely to Debiotech for
payment of any royalties owing to them as a result of Animas’
exploitation of the License.
8.8 License under Future Patents
. Debiotech represents and covenants
that Animas shall be granted exclusive worldwide license rights,
under any future patents of Debiotech (in furtherance of
Sections 13.1 and 13.2 of this Agreement) or of ****** to the
extent such future patents are included within Debiotech
Intellectual Property for use in the Field.
8.9 Feasibility of Development
Program . Debiotech
represents that it reasonably believes that the Development Program
can be successfully completed within the timeframes set forth in
this Agreement and the manufacturing costs set forth in Exhibit
B.
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8.10 Data . Debiotech represents that all test data
presented to Animas during the due diligence are correct, accurate
and true.
8.11 Indemnification . Debiotech shall indemnify, defend and hold
harmless Licensees, their respective successors and assigns, and
their respective agents, officers, employees, representatives and
directors from and against claims made against them by third
parties, including any and all actions, suits, damages, claims,
loss or liabilities (including, without limitation, reasonable
attorneys’ fees and costs of collection) arising out of or
caused by a breach by Debiotech of any of its representations made
in this Article 8. Notwithstanding the foregoing,
Debiotech’s indemnification obligations set forth in this
Section shall not apply with respect to any claims by Licensees
that Debiotech Intellectual Property infringes the intellectual
property of such Licensee.
Licensee shall promptly notify Debiotech of such
claim. Debiotech shall have the right to assume and control the
defense, direct the investigation, and control the settlement of
each such claim, provided that, Debiotech shall not settle the
claim or otherwise consent to a judgment relating to such claim
without the prior written consent of the Licensee (such consent not
to be unreasonably withheld or delayed). Licensee shall be
permitted to participate to any proceedings at its own
expense.
Debiotech and Licensee shall fully cooperate
with each other in connection with the defense of such claim,
including by furnishing all available documentary or other evidence
as is reasonably requested by the other.
If
Debiotech elects not to settle or defend such claim, the Licensee
shall (at the expense of Debiotech) have the right to assume the
defense of such claim and shall have the right to settle (with the
prior written consent of Debiotech, such consent not to be
unreasonably withheld or delayed).
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9. Limitations of
Liability
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9.1
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EXCEPT AS EXPRESSLY SET FORTH IN
THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR
WARRANTIES, ORAL OR WRITTEN, EXPRESS OR IMPLIED, ARISING FROM
COURSE OF DEALING, COUSE OF PERFORMANCE, USAGE OF TRADE, OR
OTHERWISE, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE OR TITLE.
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9.2
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EACH PARTY’S TOTAL AGGREGATE
LIABILITY FOR DAMAGES UNDER THIS AGREEMENT SHALL UNDER NO
CIRCUMSTANCES EXCEED $ 5 MILLION, EXCEPT AS PROVIDED BELOW
(PROVIDED THAT DEBIOTECH’S LIABILITY FOR DAMAGES SHALL
BE
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