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EXHIBIT 10.5
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EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
SUBLICENSE AGREEMENT
This Sublicense Agreement (the "Agreement") dated the 31st day of July,
2001 is by and among Becton, Xxxxxxxxx and Company, a corporation organized and
existing under the laws of New Jersey and having a place of business at 0 Xxxxxx
Xxxxx, Xxxxxxxx Xxxxx, Xxx Xxxxxx 00000 ("BD"), TriPath Imaging, Inc., a
corporation organized and existing under the laws of Delaware and having its
principal office at 000 Xxxxxxxxxx Xxxxx, Xxxxxxxxxx, Xxxxx Xxxxxxxx 00000
("TriPath"), and TriPath Oncology, Inc., a corporation organized and existing
under the laws of Delaware and a wholly-owned subsidiary of TriPath, having its
principal office at 000 Xxxxxxxxxx Xxxxx, Xxxxxxxxxx, Xxxxx Xxxxxxxx 00000
("Newco").
INTRODUCTION
1. BD holds licenses under certain intellectual property rights
owned and/or controlled by Millennium Pharmaceuticals, Inc. ("MPI") through a
certain Collaboration and License Agreement by and between BD and MPI dated
February 21, 1999 (as amended by a First Amendment of Collaboration and License
Agreement dated November 17, 2000, a Second Amendment of Collaboration and
License Agreement dated December 20, 2000 and a Third Amendment of Collaboration
and License Agreement (hereinafter the "Third Amendment") of even date herewith)
(hereinafter the "BD/MPI Collaboration Agreement"); and
2. Pursuant to certain of BD's licenses through the BD/MPI
Collaboration Agreement, BD has the right to grant sublicenses to certain
entities that have been approved as Approved Sublicensees (as defined in the
BD/MPI Collaboration Agreement) in accordance with procedures set forth in the
BD/MPI Collaboration Agreement; and
3. Newco and TriPath desire to receive from BD, and BD desires to
grant to Newco and TriPath, certain sublicenses under such licenses held by BD.
NOW, THEREFORE, BD, TriPath and Newco agree as follows:
Article I
Definitions
Capitalized terms used herein which are not otherwise defined shall
have the same meanings as are assigned to them in the BD/MPI Collaboration
Agreement. When used in this Agreement, each of the following terms shall have
the meanings set forth in this Article I:
Section 1.1 "Agreement" means this agreement and any exhibits,
attachments or addenda hereto, and any renewals or extensions of this agreement.
Section 1.2 "BD/Newco Development Agreement" means that certain
development and license agreement by and among BD, Newco and TriPath of even
date herewith.
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Section 1.3 "Effective Date" means the date on which the last of
the conditions set forth in Article XI of the BD/Newco Development Agreement
shall have been fulfilled or waived.
Section 1.4 "Exempt Third Party" means a company which, together
with its Affiliates, had worldwide annual revenues [*****] during its most
recently completed fiscal year.
Section 1.5 "Newco Inventions" means all inventions made solely
by Newco's and/or TriPath's employees, agents and consultants (or jointly with
BD's employees, agents and consultants during the term of the Transitional
Services Agreement and/or the term of the BD/Newco Development Agreement) in the
course of the Research Program and the Development Program.
Section 1.6 "Newco Program Intellectual Property" means Newco
Program Know-How and Newco Program Patent Rights, collectively.
Section 1.7 "Newco Program Know-How" means any Know-How that
(a) is developed using MPMx Program Intellectual Property or Becton Xxxxxxxxx
Intellectual Property (as defined in the BD/Newco Development Agreement), (b)
either (i) Newco or TriPath develops or acquires in the course of the Research
Program and/or the Development Program, or (ii) Newco or TriPath develops or
acquires during the term of, but not in the course of, the Research Program
and/or the Development Program, and (c) is owned or controlled by, or licensed
to, Newco or TriPath and to which Newco or TriPath has the right to grant
licenses or sublicenses without violating the terms of any agreement with a
third party; provided that Newco Program Know-How shall not include Newco/MPI
Joint Program Know-How.
Section 1.8 "Newco Program Patent Rights" means a Patent Right
(a) that covers Newco Program Know-How, (b) that is owned or controlled by, or
is licensed to, Newco or TriPath, and (c) to which Newco or TriPath has the
right to grant a license or sublicense without violating the terms of any
agreement with a third party.
Section 1.9 "Newco/MPI Joint Inventions" means inventions made
jointly by employees, agents and consultants of Newco and/or TriPath (and/or BD,
Newco and TriPath during the term of the Transitional Services Agreement and/or
the term of the BD/Newco Development Agreement), on the one hand, and employees,
agents and consultants of MPI, on the other, in the course of the Research
Program and/or the Development Program, such Newco/MPI Joint Inventions to be
owned jointly on the basis of Newco and MPI each having an undivided interest in
the whole.
Section 1.10 "Newco/MPI Joint Program Intellectual Property" means
Newco/MPI Joint Program Know-How and Newco/MPI Joint Program Patent Rights,
collectively.
Section 1.11 "Newco/MPI Joint Program Know-How" means any
Know-How that is developed or acquired jointly by Newco and/or TriPath (and/or
BD, Newco and TriPath during the term of the Transition Services Agreement
and/or the term of the BD/Newco Development Agreement), on the one hand, and
MPI, on the other, in the course of the Research Program and/or the Development
Program, including Newco/MPI Joint Inventions.
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Section 1.12 "Newco/MPI Joint Program Patent Rights" means a
Patent Right that covers Newco/MPI Joint Program Know-How.
Section 1.12 "Party" means Newco, TriPath or BD as appropriate;
"Parties" means any combination of two or more of Newco, TriPath, and BD, as the
context indicates. As used in this Agreement, references to "third parties" do
not include a Party or its Affiliates.
Section 1.13 "Non-Exempt Change of Control" means any sale of
securities, any sale or transfer of assets, or any merger, consolidation,
reorganization, spinoff or similar transaction that, directly or indirectly, (i)
transfers over fifty percent (50%) of the assets of TriPath and/or Newco that
relate to the subject matter of this Agreement to other than an Exempt Third
Party or (ii) results in other than an Exempt Third Party becoming the
beneficial owner, directly or indirectly, of at least fifty percent (50%) of
those securities of TriPath and/or Newco entitled to vote for the election of
directors of TriPath and/or Newco.
Section 1.14 "Reference Laboratory Services" means any service
that utilizes a Program Product to obtain information that is reported to a
third party for which the provider of the service receives financial
consideration.
Section 1.15 "Transitional Services Agreement" means that certain
transitional services agreement by and among BD, Newco and TriPath of even date
herewith.
Article II
Grant of Rights
Section 2.1 BD Grants.
(a) Research Sublicenses. Subject to the terms and
conditions of the BD/MPI Collaboration Agreement, BD hereby grants to Newco, a
[*****] right and sublicense in the Territory, [*****], under BD's rights under
(x) the MPMx Program Intellectual Property and (y) MPI's rights in the Joint
Program Intellectual Property, to (i) make and use Program Candidate Markers and
Program Validated Markers in the course of the Research Program [*****] for
Newco to undertake BD's responsibilities as set forth in the Research Plan and
(ii) make and use Program Validated Markers in the course of the Development
Program [*****] for Newco to undertake BD's responsibilities as set forth in the
Development Program.
(b) Product Commercialization Sublicenses.
(i) Subject to the terms and conditions of the
BD/MPI Collaboration Agreement, BD hereby grants to Newco [*****] and sublicense
in the Territory, [*****], under BD's rights under (x) the MPMx Program
Intellectual Property and (y) MPI's rights in the Joint Program Intellectual
Property, to make and use (A) any Program Diagnostic Product that has not
received FDA
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Approval for the purpose of Newco providing Reference Laboratory
Services inside any Exclusive Non-Colon Product Area, and (B) any Program
Diagnostic Product that has not received FDA Approval and that contains a
Program Validated Marker controlled by a Party that was developed for an
Exclusive Non-Colon Product Area for the purpose of Newco providing Reference
Laboratory Services inside the Disease Area that includes such Exclusive
Non-Colon Product Area.
(ii) Subject to the terms and conditions of the
BD/MPI Collaboration Agreement, BD hereby grants to Newco [*****] right and
sublicense in the Territory, [*****], in and to BD's co-exclusive rights under
(x) the MPMx Program Intellectual Property and (y) MPI's rights in the Joint
Program Intellectual Property, to make and use any Program Pharmacogenomic
Product that has not received FDA Approval for the purpose of Newco providing
Reference Laboratory Services to address any Co-Exclusive Non-Colon
Pharmacogenomic Product Opportunity.
(iii) Subject to the terms and conditions of the
BD/MPI Collaboration Agreement, BD hereby grants to Newco [*****] right and
sublicense in the Territory, [*****], under BD's rights under (x) the MPMx
Program Intellectual Property and (y) MPI's rights in the Joint Program
Intellectual Property, to make and use (A) any Program Diagnostic Product that
has received FDA Approval for the purpose of Newco providing Reference
Laboratory Services inside any Exclusive Non-Colon Product Area, and (B) any
Program Diagnostic Product that has received FDA Approval and that contains a
Program Validated Marker controlled by a Party that was developed for an
Exclusive Non-Colon Product Area for the purpose of Newco providing Reference
Laboratory Services inside the Disease Area that includes such Exclusive
Non-Colon Product Area.
(iv) Subject to the terms and conditions of the
BD/MPI Collaboration Agreement, BD hereby grants to Newco [*****] right and
sublicense in the Territory, [*****], under BD's rights under (x) the MPMx
Program Intellectual Property and (y) MPI's rights in the Joint Program
Intellectual Property, to make and use any Program Pharmacogenomic Product that
has received FDA Approval for the purpose of Newco providing Reference
Laboratory Services to address any Co-Exclusive Non-Colon Pharmacogenomic
Product Opportunity.
(v) Subject to the terms and conditions of the
BD/MPI Collaboration Agreement, BD hereby grants to each of Newco and TriPath a
[*****], royalty-bearing right and sublicense in the Territory, [*****], under
BD's rights under (x) the MPMx Program Intellectual Property and (y) MPI's
rights in the Joint Program Intellectual Property, to make, use, import, offer
to sell and sell (A) any Program Diagnostic Product that is a Staging Product
that has received FDA Approval inside any Exclusive Non-Colon Product Area and
(B) any Program Diagnostic Product that is a Staging Product that has received
FDA Approval and that contains a Program Validated Marker controlled by a Party
that was developed for a Screening Product in an Exclusive Non-Colon Product
Area inside the Disease Area that includes such Exclusive Non-Colon Product
Area.
(vi) Subject to the terms and conditions of the
BD/MPI Collaboration Agreement, BD hereby grants to each of Newco and TriPath a
[*****] right and sublicense in the Territory, [*****], under BD's rights under
(x) the MPMx Program Intellectual Property and (y) MPI's rights in the Joint
Program Intellectual Property, to make, use, import, offer to
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sell and sell any Program Pharmacogenomic Product that has received FDA Approval
to address any Co-Exclusive Non-Colon Pharmacogenomic Product Opportunity.
(vii) Subject to the terms and conditions of the
BD/MPI Collaboration Agreement, BD hereby grants to each of Newco and TriPath a
[*****] right and sublicense in the Territory, without the right to grant
sublicenses, under BD's rights under (x) the MPMx Program Intellectual Property
and (y) MPI's rights in the Joint Program Intellectual Property, to make, use,
import, offer to sell and sell (A) any Program Diagnostic Product that is a
Screening Product and that has received FDA Approval inside any Exclusive
Non-Colon Product Area within the Disease Area [*****] and (B) any Program
Diagnostic Product that is a Screening Product for the Disease Area [*****] that
has received FDA Approval and that contains a Program Validated Marker
controlled by a Party that was developed for a Staging Product in an Exclusive
Non-Colon Product Area inside the Disease Area [*****].
(viii) Subject to the terms and conditions of the
BD/MPI Collaboration Agreement, BD hereby grants to each of Newco and TriPath a
[*****] and sublicense in the Territory, [*****], under BD's rights under (x)
the MPMx Program Intellectual Property and (y) MPI's rights in the Joint Program
Intellectual Property, to make, use, import, offer to sell and sell:
(A) any Program Diagnostic Product that is a
Staging Product [*****] and as an Analyte Specific Reagent ("ASR") product
inside any Exclusive Non-Colon Product Area, (B) any Program Diagnostic Product
that is a Staging Product [*****] and that contains a Program Validated Marker
controlled by a Party that was developed for an Exclusive Non-Colon Product Area
as a [*****] and as an ASR product inside the Disease Area that includes such
Exclusive Non-Colon Product Area, (C) any Program Diagnostic Product that is a
Screening Product [*****] and as an ASR product inside any Exclusive Non-Colon
Product Area within the Disease Area [*****], and (D) any Program Diagnostic
Product that is a Screening Product [*****] and that contains a Program
Validated Marker controlled by a Party that was developed for a Staging Product
as a [*****] and as an ASR product inside any Exclusive Non-Colon Product Area
within the Disease Area [*****].
(ix) Subject to the terms and conditions of the
BD/MPI Collaboration Agreement, BD hereby grants to each of Newco and TriPath a
co-exclusive [*****] right and sublicense in the Territory, [*****], under BD's
rights under (x) the MPMx Program Intellectual Property and (y) MPI's rights in
the Joint Program Intellectual Property, to make, use, import, offer to sell and
sell any Program Pharmacogenomic Product that has not received FDA Approval as a
RUO product and as an ASR product to address any Co-Exclusive Non-Colon
Pharmacogenomic Product Opportunity.
(c) Third Party Pharmacogenomic Products. To the extent
that BD obtains rights that it can sublicense in accordance with the BD/MPI
Collaboration Agreement and that it can sublicense in a manner commensurate in
scope with the grant of Section 2.1(b)(vi), BD shall grant to each of Newco and
TriPath sublicense rights for Third Party Pharmacogenomic Products that are
commensurate in scope, to the extent possible in view of BD's license rights
from MPI, with the sublicense rights granted in Section 2.1(b)(vi).
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(d) Further License Grants. In the event that it is
determined that Newco and/or TriPath shall have development rights,
commercialization rights and/or responsibilities with respect to any Program
Diagnostic Product which is a Screening Product under the BD/Newco Development
Agreement and Newco and/or TriPath require(s) additional sublicense rights under
BD's rights under (x) the MPMx Program Intellectual Property and/or (y) MPI's
rights in the Joint Program Intellectual Property with respect thereto, BD
hereby agrees to grant to Newco and/or TriPath [*****] right and sublicense in
the Territory, without the right to grant sublicenses, under BD's rights under
(x) the MPMx Program Intellectual Property and/or (y) MPI's rights in the Joint
Program Intellectual Property necessary to exercise such commercialization
rights and perform such responsibilities.
Section 2.2 Newco Grants; Third Party License Fees.
(a) Rights Subject to BD Collaboration Agreement
Obligations. TriPath and Newco each hereby grants to BD [*****] and license in
the Territory, [*****], under TriPath's and Newco's rights in Program
Intellectual Property, Becton Xxxxxxxxx Platform Intellectual Property and
improvements thereto, if any, for the purpose of enabling BD to grant to MPI all
rights and licenses granted to MPI under Section 3.2 of the BD/MPI Collaboration
Agreement.
(b) Third Party License Fees. In the event that TriPath
or Newco owes a royalty to a third party on the sale by BD or its sublicensees
of products covered by Patent Rights licensed to BD pursuant to subsection (a)
above, TriPath or Newco shall notify BD of such royalty obligation as soon as
practicable (and, in any event, no later than [*****] after the execution of the
agreement with such third party giving rise to such royalty obligation),
including in such notice the pertinent details of the royalty obligation. Within
[*****] after receipt of such notice, BD shall [*****].
(c) License to Exploit BD Retained Rights. Subject to the
terms and conditions of this Agreement, each of Newco and TriPath hereby grants
to BD [*****] rights and licenses in the Territory, [*****], under its rights in
the Newco Program Intellectual Property and the Newco/MPI Joint Program
Intellectual Property, [*****] to exploit BD's retained rights, as set forth in
Section 2.3 below, and TriPath hereby grants to BD [*****] rights and licenses
in the Territory, [*****], under the TriPath Program Intellectual Property (as
defined in the BD/Newco Development Agreement), to the extent necessary to
exploit BD's retained rights, as set forth in Section 2.3 below. In the event
that Newco or TriPath owes a royalty to a third party on the sale by BD or its
sublicensees of products covered by Newco Program Patent Rights or TriPath
Program Patent Rights, Newco or TriPath, as applicable shall notify BD of such
royalty obligation as soon as practicable (and, in any event, no later than
[*****] after the execution of the agreement with such third party giving rise
to such royalty obligation), including in such notice the pertinent details of
the royalty obligation. Within [*****] after receipt of such notice, BD shall
[*****].
Section 2.3 BD Retained Rights. Except as specifically provided
for, BD retains all other rights and licenses to exploit MPMx Program
Intellectual Property granted to BD under the BD/MPI Collaboration Agreement,
including but not limited to BD's rights to research, develop, make, use,
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import, sell and offer for sale, and sublicense others to research, develop,
make, use, import, sell and offer for sale, Program Diagnostic Products that are
Screening Products in Disease Areas in addition to [*****]. Notwithstanding the
foregoing, [*****] (as defined in the BD/Newco Development Agreement) [*****] or
any dispute with respect thereto being resolved in accordance with the terms of
the BD/Newco Development Agreement.
Section 2.4 Section 365(n) of the Bankruptcy Code. All rights
and licenses granted under or pursuant to any section of this Agreement are, and
shall otherwise be deemed to be, for purposes of Section 365(n) of the
Bankruptcy Code, licenses of rights to "intellectual property" as defined under
Section 101(35A) of the Bankruptcy Code. The Parties and MPI shall retain and
may fully exercise all of their respective rights and elections under the
Bankruptcy Code. Upon the bankruptcy of any Party, the non-bankrupt Party or MPI
shall further be entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property, and such, if not already in its
possession, shall be promptly delivered to the non-bankrupt Party or MPI.
Section 2.5 Failure to Meet Diligence.
(a) BD/MPI Collaboration Agreement.
(i) Subject to the provisions of Section 2.12(d)
of the BD/MPI Collaboration Agreement, if any diligence benchmark as set forth
in Section 2.12(a) of the BD/MPI Collaboration Agreement is not met, and
pursuant to the BD/MPI Collaboration Agreement MPI elects to convert the
Exclusive Product Area for a Program Diagnostic Product to a Non-Exclusive
Product Area, or the Co-Exclusive Pharmacogenomic Product Opportunity for a
Program Pharmacogenomic Product to a Non-Exclusive Pharmacogenomic Product
Opportunity, as the case may be, then the sublicenses granted in Section 2.1
herein shall, at the election of BD, become non-exclusive or be terminated, but
only with respect to any Program Products relating to such Exclusive Product
Area or Co-Exclusive Pharmacogenomic Product Opportunity. In addition to the
foregoing, Newco and TriPath shall (A) deliver to MPI copies of any and all
[*****] the Program Validated Markers included in such Program Product (but
excluding information relating to the related Viable Platform, Assay formats and
manufacturing processes) that Newco and TriPath own or otherwise control and as
to which Newco or TriPath has the right to grant licenses or sublicenses without
violating the terms of any agreement (the[*****]), and (B) [*****]Program
Product for such Non-Exclusive Product Area or such Non-Exclusive
Pharmacogenomic Product Opportunity, as the case may be, and (C) deliver to BD
copies of any and all [*****] the Program Validated Markers included in such
Program Product including, without limitation, [*****] that Newco owns or
otherwise controls and as to which Newco has the right to grant licenses or
sublicenses without violating the terms of any agreement (the [*****]), and (D)
[*****] Program Product for such Non-Exclusive Product Area or such
Non-Exclusive Pharmacogenomic Product Opportunity, as the case may be.
(ii) Subject to the provisions of Section 2.12(d)
of the BD/MPI Collaboration Agreement, in the event any diligence obligations
with respect to a Major Market Country, as set forth in Section 2.12(b) of the
BD/MPI Collaboration Agreement are not met, and pursuant to the BD/MPI
Collaboration Agreement MPI elects to convert BD's rights with respect to the
development and commercialization of a Program Product for an Exclusive Product
Area or a Co-Exclusive
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Pharmacogenomic Product Opportunity, as the case may be, to non-exclusive with
respect to such Product Area or product opportunity for such Major Market
Country (an "Abandoned Market") and such Product Area or such product
opportunity is deemed a Non-Exclusive Product Area or a Non-Exclusive
Pharmacogenomic Product Opportunity, as the case may be, but for the Abandoned
Market only, then the sublicenses granted in Section 2.1 herein shall at the
election of BD, become non-exclusive or be terminated, but only with respect to
any Program Products relating to such Exclusive Product Area, or Co-Exclusive
Pharmacogenomic Product Opportunity and only with respect to such Major Market.
In addition, Newco and TriPath shall (A) [*****] Program Product in the
Abandoned Market for such Non-Exclusive Product Area or such Non-Exclusive
Pharmacogenomic Product Opportunity, as the case may be, and (C) [*****] (D)
[*****] Program Product for such Non-Exclusive Product Area or such
Non-Exclusive Pharmacogenomic Product Opportunity, as the case may be.
(iii) BD shall promptly, but in any event within
seventy-two (72) hours, notify TriPath and Newco of receipt of notice from MPI
with respect to any failure by BD to meet any obligations in the BD/MPI
Collaboration Agreement, including, without limitation, notice to BD pursuant to
Section 2.12(d) thereof regarding any failure to meet diligence obligations.
(iv) If this Agreement shall be terminated
pursuant to Section 8.3 and Newco or TriPath is the Breaching Party, then Newco
and TriPath shall (A) deliver to BD[*****], and [*****].
(b) BD/Newco Development Agreement.
(i) If [*****] granted by BD pursuant to the
BD/Newco Development Agreement with respect to any Program Products relating to
an Exclusive Product Area or Co-Exclusive Non-Colon Pharmacogenomic Product
Opportunity, either for all purposes or only with respect to a Major Market
Country, pursuant to Section 2.7 of the BD/Newco Development Agreement, then the
sublicenses granted in Section 2.1 herein [*****], but only with respect to such
Program Products relating to such Exclusive Product Area or Co-Exclusive
Non-Colon Pharmacogenomic Product Opportunity. In such event, Newco and TriPath
shall deliver, and xxxxx XX a license, to [*****] on the same terms as is set
forth in Sections 2.5(a)(i) and (ii), as applicable.
(ii) If any license granted by BD pursuant to the
BD/Newco Development Agreement terminates or is terminated with respect to any
Program Products relating to an Exclusive Product Area or Co-Exclusive
Pharmacogenomic Product Opportunity, either for all purposes or only with
respect to a Major Market Country, then the sublicenses granted in Section 2.1
herein also shall terminate to the same extent, but only with respect to such
Program Products relating to such Exclusive Product Area or Co-Exclusive
Pharmacogenomic Product Opportunity. In such event, Newco and TriPath shall
[*****] .
Article III
Financial Provisions
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Section 3.1 Royalty Payments to BD. Newco or TriPath shall pay
to BD royalties as follows:
(a) Program Products. With respect to each sale of any
Program Product by Newco or TriPath, Newco or TriPath, as the case may be, shall
pay to BD a royalty [*****].
(b) Third Party Pharmacogenomic Products. With respect
to each sale of each Third Party Pharmacogenomic Product by Newco or TriPath,
Newco or TriPath, as the case may be, shall pay to BD a royalty [*****].
(c) Reference Laboratory Services. With respect to
each use of a Program Product to provide Reference Laboratory Services by Newco
to a third party, Newco shall pay to BD a royalty [*****].
(d) Generic Competition Adjustment.
(i) [*****]. If Newco or TriPath believes that
BD is entitled to a royalty adjustment under Section 4.7(d) of the BD/MPI
Collaboration Agreement, then Newco and/or TriPath shall provide written notice
to BD providing evidence supporting such belief. Thereafter, BD shall either (A)
indicate to Newco and/or TriPath within thirty (30) days after receipt of such
notice that [*****].
(ii) Royalty Adjustment. If [*****] of the
BD/MPI Collaboration Agreement pursuant to subsection (d)(i)(B), then Newco's or
TriPath's royalty obligations to BD under this Section 3.1 [*****] on account of
sales or uses by TriPath or Newco [*****].
Section 3.2 Length of Royalty Payments. The royalties payable
under this Article III shall be paid [*****] on each such Program Product or
Third Party Pharmacogenomic Product until the later of (a) the expiration of all
Program Patent Rights which cover such Program Product or Third Party
Pharmacogenomic Product [*****] (b) [*****]after the First Commercial Sale of
such Program Product or Third Party Pharmacogenomic Product [*****].
Section 3.3 Royalties Payable Only Once. Newco's and TriPath's
obligation to pay royalties under Section 3.1 is imposed only once with respect
to the same unit of Program Product or Third Party Pharmacogenomic Product.
Except as specifically provided in this Agreement, there shall be no deductions
from the royalties payable hereunder.
Article IV
Royalty Reports and Accounting
Section 4.1 Royalty Reports; Royalty Payments. Newco and TriPath
shall each deliver to MPI and BD, within sixty (60) days after the end of each
calendar quarter, reasonably detailed written accountings of Gross Profits on
Program Products and/or Third Party Pharmacogenomic Products that are subject to
royalty payments due to BD for such calendar quarter. Such quarterly reports
shall indicate (a) gross sales and Net Sales on a product-by-product basis,
(b) the determination of Direct Cost of Goods Sold and Cost of Goods Sold, and
(c) the calculation of royalties from such gross sales,
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Gross Profits and Net Sales. When Newco and TriPath deliver such accounting to
BD, Newco shall also deliver all royalty payments due under Section 4.1 to BD
for the calendar quarter.
Section 4.2 Audits. Newco and TriPath shall each keep complete
and accurate records of the latest [*****] relating to Net Sales, [*****], and
Sections 4.3, 4.4 and 4.5. For the sole purpose of verifying royalties payable
to BD (and in turn, payable to MPI by BD), MPI and BD shall have the right
annually at their expense to retain an independent, certified public accountant
selected by them and reasonably acceptable to Newco and TriPath, to review such
records in the location(s) where such records are maintained by Newco and
TriPath upon reasonable notice and during regular business hours and under
obligations of strict confidence. Results of such review shall be made available
to the Parties. If the review reflects an underpayment of royalties to BD, such
underpayment shall be promptly remitted to BD, together with interest calculated
in the manner provided in Section 4.3 below, for payment to MPI. If the
underpayment is equal to or greater than [*****] of the royalty amount that was
otherwise due, MPI or BD, as applicable, shall be entitled to have Newco and
TriPath pay all of the costs of such review.
Section 4.3 Currency and Method of Payments; Late Payments. All
payments under this Agreement shall be made in United States dollars by transfer
to such bank account as BD may designate from time to time within no more than
thirty (30) days of invoice or when such payment is due in accordance with the
provisions of this Agreement. Any royalty payments due hereunder with respect to
sales outside of the United States shall be payable in U.S. Dollars; provided,
however, that if any payment on account of Net Sales is received by Newco or
TriPath in a foreign currency, such amount shall be converted monthly to United
States funds at the rate published by Reuters on the last Wednesday of the month
in which Net Sales occurred (or such other publicly available source as BD may
subsequently utilize generally in its currency accounting procedures, in which
case BD shall provide notice to Newco and TriPath promptly of any such change).
Newco and TriPath shall pay interest to BD on the aggregate amount of any
payments that are not paid on or before the date such payments are due under
this Agreement at a rate per annum equal to the lesser of the [*****] for the
applicable period, or the highest rate permitted by applicable law, calculated
on the number of days such payment is delinquent. In the event any invoice
issued by BD contains any terms which conflict with the terms of this Agreement,
the terms of this Agreement shall prevail.
Section 4.4 Tax Withholding. Newco and TriPath shall use all
reasonable and legal efforts to reduce tax withholding on payments made to BD
hereunder. Notwithstanding such efforts, if Newco or TriPath concludes that tax
withholdings under the laws of any country are required with respect to payments
to BD, Newco or TriPath, as applicable, shall withhold the required amount and
pay it to the appropriate governmental authority. In such a case, Newco or
TriPath, as applicable, shall promptly provide BD with original receipts or
other evidence reasonably required and sufficient to allow BD to document such
tax withholdings adequately for purposes of claiming foreign tax credits and
similar benefits.
Section 4.5 Blocked Payments. In the event that, by reason of
applicable laws or regulations in any country, it becomes impossible or illegal
for Newco or TriPath to transfer, or have transferred on its behalf, royalties
or other payments to BD, such royalties or other payments shall be deposited in
local currency in the relevant country to the credit of BD in a recognized
banking institution designated
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CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
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by BD or, if none is designated by BD within a period of thirty (30) days, in a
recognized banking institution selected by Newco or TriPath and identified in a
notice in writing given to BD.
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Article V
Intellectual Property and Related Matters
Section 5.1 Acknowledgement of BD/MPI Collaboration Agreement
Intellectual Property Provisions.
(a) Program Know-How. BD, Newco and TriPath each
acknowledge that all (i) Newco Program Know-How falls under the definition of
Becton Xxxxxxxxx Program Know-How, and as such is subject to the rights and
obligations of the BD/MPI Collaboration Agreement, and (ii) Newco/MPI Joint
Program Know-How falls under the definition of Joint Program Know-How, and as
such is subject to the rights and obligations of the BD/MPI Collaboration
Agreement. All rights and obligations that BD may have with regard to such Newco
Program Know-How and Newco/MPI Joint Program Know-How under the BD/MPI
Collaboration Agreement, including without limitation, any rights and
obligations relating to Section 15 of the Third Amendment, shall be undertaken
by BD in accordance with written instructions from Newco consistent with MPI's
rights under the BD/MPI Collaboration Agreement.
(b) Program Patent Rights. BD, Newco and TriPath each
acknowledge that (i) all Newco Program Patent Rights fall under the definition
of Becton Xxxxxxxxx Program Patent Rights, and as such are subject to the rights
and obligations of the BD/MPI Collaboration Agreement, and (ii) all Newco/MPI
Joint Patent Rights fall under the definition of Joint Program Patent Rights,
and as such are subject to the rights and obligations of the BD/MPI
Collaboration Agreement. All rights and obligations that BD may have with regard
to such Newco Program Patent Rights and Newco/MPI Joint Program Patent Rights
under the BD/MPI Collaboration Agreement, including without limitation, any
rights and obligations relating to Section 15 of the Third Amendment, shall be
undertaken by BD in accordance with written instructions from Newco consistent
with MPI's rights under the BD/MPI Collaboration Agreement.
(c) Newco Inventions. Newco and TriPath each hereby agree
that, if neither BD nor Newco elects to prosecute and maintain patent rights for
a Newco Invention, then, for the purpose of prosecution and maintenance of
patent rights for such Newco Invention, such Newco Invention shall be treated as
a Becton Xxxxxxxxx Invention under Section 5.2 of the BD/MPI Collaboration
Agreement, except for name and ownership, which shall be in Newco. All rights
and obligations that BD may have with regard to such Newco Inventions under the
BD/MPI Collaboration Agreement, including without limitation, any rights and
obligations relating to Section 15 of the Third Amendment, shall be undertaken
by BD in accordance with written instructions from Newco consistent with MPI's
rights under the BD/MPI Collaboration Agreement.
(d) Newco/MPI Joint Inventions. BD, Newco and TriPath
each hereby agree that, for the purpose of prosecution and maintenance of patent
rights for Newco/MPI Joint Inventions, Newco/MPI Joint Inventions shall be
treated as Joint Inventions under Section 5.2 of the BD/MPI Collaboration
Agreement, except for name and ownership, which shall be jointly in Newco and
MPI. All rights and obligations that BD may have with regard to such Newco/MPI
Joint Inventions under the BD/MPI Collaboration Agreement, including without
limitation, any rights and obligations relating to Section 15 of the Third
Amendment, shall be undertaken by BD in accordance with written instructions
from Newco consistent with MPI's rights under the BD/MPI Collaboration
Agreement.
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(e) TriPath Program Intellectual Property. BD and TriPath
each hereby agree that, for the purposes set forth in Section 3.2(a), and as
applicable thereto, Section 2.7(e) of the BD/MPI Collaboration Agreement,
TriPath Program Intellectual Property (as defined in the BD/Newco Development
Agreement) shall be treated as Becton Xxxxxxxxx Platform Intellectual Property,
and as such is subject to the rights and obligations of such Sections of the
BD/MPI Collaboration Agreement. All rights and obligations that BD may have with
regard to such TriPath Program Intellectual Property under the BD/MPI
Collaboration Agreement, including without limitation, any rights and
obligations relating to Section 15 of the Third Amendment, shall be undertaken
by BD in accordance with written instructions from Newco consistent with MPI's
rights under the BD/MPI Collaboration Agreement.
(f) Blocking, Enabling and Enhancing Third Party
Intellectual Property. BD, Newco and TriPath each acknowledge that Newco Program
Know-How, Newco Program Patent Rights, Newco's and TriPath's rights in Newco/MPI
Joint Program Know-How, Newco's and TriPath's rights in Newco/MPI Joint Program
Patent Rights and Newco's and TriPath's rights in Newco/MPI Joint Inventions are
not Blocking Third Party Intellectual Property, Enabling Third Party
Intellectual Property or Enhancing Third Party Intellectual Property under the
BD/MPI Collaboration Agreement.
(g) BD Obligations Under BD/MPI Collaboration Agreement.
Newco and TriPath each hereby agree to take all actions and execute all
assignments and other documents, and to provide all cooperation, reasonably
necessary to enable BD to fulfill its obligations with respect to Program
Intellectual Property, including without limitation with respect to Becton
Xxxxxxxxx Program Know-How, Becton Xxxxxxxxx Program Patent Rights, Joint
Program Know-How, Joint Program Patent Rights and Joint Inventions, under
Article V of the BD/MPI Collaboration Agreement. Newco's and TriPath's
obligations under this subsection (g) include, but are not limited to, taking
actions, executing assignments and other documents and providing cooperation
reasonably necessary to enable BD to fulfill its obligations under Section
5.2(e) of the BD/MPI Collaboration Agreement.
Section 5.2 Patent Marking. Each of Newco and TriPath agrees to
comply with the patent marking statutes in each country in which Program
Products are sold by such Party.
Section 5.3 Patent Invalidity Claim. If a third party at any time
asserts a claim that any MPMx Program Patent Right or Joint Program Patent Right
is invalid or otherwise unenforceable (an "Invalidity Claim") in an action
brought against Newco and/or TriPath, then Newco and/or TriPath shall cooperate
with MPI in preparing and formulating a response to such Invalidity Claim.
Neither Newco nor TriPath shall settle or compromise any Invalidity Claim
without the consent of MPI.
Article VI
Confidentiality
Section 6.1 Confidential Information. All Confidential
Information disclosed by a Party to another Party, and/or by MPI to TriPath
and/or Newco, during the term of this Agreement shall not be used by the
receiving Party except in connection with the activities contemplated by this
Agreement, shall be maintained in confidence by the receiving Party (except to
the extent reasonably necessary for FDA Approval of products developed by Newco,
BD or MPI or any of their respective Affiliates or Approved Sublicensees or for
the filing, prosecution and maintenance of Patent Rights), and shall not
otherwise be disclosed by the receiving Party to any other person, firm, or
agency, governmental or private, without the prior written consent of the
disclosing Party (or, in the case of Confidential
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Information disclosed by MPI to TriPath and/or Newco, of MPI), except to the
extent that the Confidential Information (as determined by competent
documentation):
(a) was known or used by the receiving Party prior to its
date of disclosure to the receiving Party; or
(b) either before or after the date of the disclosure to
the receiving Party is lawfully disclosed to the receiving Party by sources
other than the disclosing Party (or, in the case of Confidential Information
disclosed by MPI to TriPath and/or Newco, MPI) rightfully in possession of the
Confidential Information and not bound by confidentiality obligations to the
disclosing Party (or, in the case of Confidential Information disclosed by MPI
to TriPath and/or Newco, MPI); or
(c) either before or after the date of the disclosure to
the receiving Party is or becomes published or generally known to the public
(including information known to the public through the sale of products in the
ordinary course of business) through no breach hereof on the part of the
receiving Party or its sublicensees; or
(d) is independently developed by or for the receiving
Party without reference to or reliance upon the Confidential Information; or
(e) is required to be disclosed by the receiving Party to
comply with applicable laws, to defend or prosecute litigation or to comply with
governmental regulations, provided that the receiving Party provides prior
written notice of such disclosure to the disclosing Party (or, in the case of
Confidential Information disclosed by MPI to TriPath and/or Newco, MPI) and
takes reasonable and lawful actions to avoid and/or minimize the degree of such
disclosure.
Section 6.2 Disclosure of Provisions of Agreement.
(a) Each Party agrees to hold as confidential the terms
of this Agreement except that each Party shall have the right to disclose such
terms to potential investors and other third parties in connection with
financing activities, provided that any such third party has entered into a
written obligation with the disclosing Party to treat such information and
materials as confidential. At the request of the other Party, the disclosing
Party shall use commercially reasonable efforts to enforce such obligations
against such third parties.
(b) In the event that this Agreement shall be included in
any report, statement or other document filed by any Party or an Affiliate of
any Party with the SEC, such Party shall use, or shall cause its Affiliate, as
the case may be, to use, reasonable efforts to obtain confidential treatment
from the SEC of any financial information or other information of a competitive
or confidential nature, and shall include in such confidentiality request such
provisions of this Agreement as may be reasonably requested by the other Party.
Section 6.3 Employee and Advisor Obligations. The Parties each
agree that they shall provide Confidential Information received from another
Party only to their respective employees, consultants and advisors, and to the
employees, consultants and advisors of such Party's Affiliates, who have a need
to know, provided that such employees, consultants and advisors agree to treat
such information and materials as confidential.
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Section 6.4 Term. All obligations of confidentiality imposed
under this Article VI shall expire five (5) years following termination or
expiration of the BD/MPI Collaboration Agreement.
Section 6.5 Publications. The Parties acknowledge that scientific
lead time is a key element of the value of the Research Program and further
agree that scientific publications must be strictly monitored to prevent any
adverse effect of the premature publication of results of the Research Program
and the Development Program. The Parties shall establish a procedure for
publication review and approval and each Party shall first submit to the other
Parties an early draft of all such publications, whether they are to be
presented orally or in written form, at least [*****] prior to presentation or
submission for publication. Each Party shall review each such proposed
publication in order to avoid the unauthorized disclosure of a Party's
Confidential Information and to preserve the patentability of inventions arising
from the Research Program and the Development Program. If, as soon as reasonably
possible but no longer than [*****] following receipt of an advance copy of a
Party's proposed publication, the other Party informs such Party that its
proposed publication contains Confidential Information of the other Party, then
such Party shall delete such Confidential Information from its proposed
publication. If, as soon as reasonably possible but no longer than [*****]
following receipt of an advance copy of a Party's proposed publication, the
other Party informs such Party that its proposed publication could be expected
to have a material adverse effect on any Patent Rights or Know-How of such other
Party, then such Party shall delay such proposed publication, for up to [*****]
from the date the other Party informed such Party of its objection to the
proposed publication, to permit the timely preparation and first filing of
patent application(s) on the information involved. The Parties agree that all
publications of results of the Research Program shall acknowledge the
contribution of the other Parties and third party collaborators to such results.
Article VII
Representations and Warranties
Section 7.1 Representations of Authority. Newco, TriPath and
BD each represents and warrants to the others that as of the Effective Date it
has full right, power and authority to enter into this Agreement and to perform
its respective obligations under this Agreement. BD represents and warrants to
Newco that BD has the right to grant to Newco the sublicenses granted pursuant
to this Agreement. Newco, TriPath and BD each represents and warrants that (a)
the execution, delivery and performance by it of this Agreement, and the
consummation by it of the transactions contemplated hereby, have been duly
authorized by all necessary corporate action, and (b) this Agreement has been
duly executed and delivered by it and constitutes a valid and binding obligation
of it, enforceable in accordance with its terms.
Section 7.2 Consents. Newco, TriPath and BD each represents and
warrants that all necessary consents, approvals and authorizations of all
government authorities and other persons required to be obtained by such Party
in connection with the execution, delivery and performance of this Agreement
have been obtained.
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CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
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Section 7.3 No Conflict. Newco, TriPath and BD each represents
and warrants that the execution and delivery of this Agreement and the
performance of such Party's obligations hereunder (a) do not conflict with or
violate any requirement of applicable laws or regulations and (b) do not and
shall not conflict with, violate or breach or constitute a default (with or
without the giving of notice or lapse of time, or both) or require any consent
under, any contractual obligations of such Party or order, judgement or decree
to which such Party or any of its assets are bound, except such consents as
shall have been obtained prior to the Effective Date.
Section 7.4 Third Party Rights.
(a) To the knowledge of BD, as of the Effective Date, the
practice by Newco and TriPath of the rights granted under the sublicenses by BD
herein does not and shall not infringe or conflict with the rights of any third
party in respect of Know-How or issued patents or published patent applications
owned by such third party. As of the Effective Date, there is no claim or demand
of any person pertaining to, or any proceeding which is pending or, to the
knowledge of BD, threatened, that challenges the rights of BD in respect of
Know-How or Patent Rights owned, controlled or used by BD.
(b) To the knowledge of Newco and TriPath, as of the
Effective Date, the conduct by Newco and TriPath of the Research Program and the
Development Program does not and shall not knowingly infringe or conflict with
the rights of any third party in respect of Know-How or issued patents or
published patent applications owned by such third party.
(c) Newco, TriPath and BD each represents and warrants
that (i) it has taken reasonable precautions (A) to protect its rights in its
Know-How and Patent Rights to which it has granted a license or sublicense
herein ("Licensed Intellectual Property") and (B) to maintain the
confidentiality of its confidential Licensed Intellectual Property, and (ii) to
its knowledge, there have been no acts or omissions (other than those made based
on reasonable, good faith business decisions) by its officers, directors,
shareholders and employees, the result of which would be to materially
compromise its rights to apply for or enforce appropriate legal protection of
its Licensed Intellectual Property.
Section 7.5 BD represents, warrants, and covenants that:
(a) As of the effective date of this Agreement, the
BD/MPI Collaboration Agreement is in full force and effect and that to the best
of its knowledge, neither BD nor MPI is in material breach thereof.
(b) It will use its best efforts not to breach any of its
obligations under the BD/MPI Collaboration Agreement.
Section 7.6 No Warranties. EXCEPT AS OTHERWISE EXPRESSLY SET
FORTH HEREIN, THE PARTIES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF
ANY KIND, EITHER EXPRESS OR IMPLIED, AND PARTICULARLY THAT PROGRAM PRODUCTS OR
THIRD PARTY PHARMACOGENOMIC PRODUCTS WILL BE SUCCESSFULLY DEVELOPED HEREUNDER,
AND IF DEVELOPED, WILL HAVE
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COMMERCIAL UTILITY OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
Article VIII
Term and Termination
Section 8.1 Term. This Agreement shall become effective as of the
Effective Date, may be terminated as set forth in this Article VIII, and
otherwise remains in effect until the expiration of all of the obligations to
pay royalties set forth in Article III.
Section 8.2 Survival of Sublicenses. Subject to the terms and
conditions of the BD/MPI Collaboration Agreement, upon the expiration of Newco's
and TriPath's obligations to pay royalties to BD under Section 3.2 with respect
to each Program Product or Third Party Pharmacogenomic Product in any country,
the sublicenses under BD's rights under (x) MPMx Program Intellectual Property
and (y) MPI's rights in the Joint Program Intellectual Property set forth in
Sections 2.1(b)(i), (ii), (iii), (iv), (v) and (vi) shall be deemed to be
perpetual, fully paid up, non-exclusive sublicenses with respect to such Program
Product or Third Party Pharmacogenomic Product.
Section 8.3 (a) Termination For Material Breach. Upon any
material breach of a material provision of this Agreement by a Party (in such
capacity, the "Breaching Party"), any other Party or Parties affected by such
breach (in such capacity, the "Non-Breaching Parties") may terminate this
Agreement by providing [*****] written notice to the Breaching Party, specifying
the material breach. The termination shall become effective at the end of the
[*****] period unless (a) the Breaching Party cures such breach during such
[*****], or (b) if such breach is not susceptible to cure within [*****] of the
receipt of written notice of the breach, the Breaching Party is diligently
pursuing a cure. Notwithstanding the foregoing, if such breach, by its nature,
is incurable this Agreement may be terminated immediately. The Parties shall use
reasonable efforts to work together to cure any breach. In the event of a
dispute concerning whether a material breach has occurred, the [*****] cure
period specified above shall be suspended during the period (not to exceed
[*****] commencing upon the submission of such dispute for resolution to the
executive officers of the Parties and continuing until the earlier of the
resolution of such dispute and the end of such [*****].
(b) Termination for Bankruptcy, Etc. This Agreement
may be terminated by BD, Newco or TriPath if any other Party (the "Insolvent
Party") (i)(A) institutes any proceeding or files a petition commencing a
voluntary case for the relief of debtors, or seeking liquidation, dissolution,
winding up, reorganization, arrangement, adjustment, protection, relief or
composition of it or its debts under any law relating to bankruptcy, insolvency,
reorganization or relief of debtors, or seeking the entry of an order for relief
or the appointment of a receiver, trustee, custodian or other similar official
for any party hereto or for any substantial part of its property, (B) shall
admit in writing its inability to pay its debts generally, (C) shall make a
general assignment for the benefit of creditors, or (D) shall take any action to
authorize or effect any of the actions set forth above in this subsection; or
(ii) becomes the subject of any proceeding seeking to adjudicate it a bankrupt
or insolvent, or seeking dissolution, liquidation, winding up, reorganization,
arrangement, adjustment, protection, relief or debtors, or seeking the entry of
an order for relief or the appointment of a receiver, trustee, custodian or
other similar official for the parties hereto or any substantial part of its
property, and either such
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CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
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proceeding shall remain undismissed or unstayed for a period for a period of
sixty (60) days or any of the actions sought in such proceeding (including,
without limitation, the entry of an order for relief against it or the
appointment of a receiver, trustee, custodian or other similar official for it
or for any substantial part of its property) shall occur.
(c) Termination for BD Breach of BD/MPI
Collaboration Agreement. In accordance with Section 8.5(b)(ii) of the BD/MPI
Collaboration Agreement, this Agreement shall terminate upon the termination of
the BD/MPI Collaboration Agreement pursuant to Section 8.3 thereof wherein BD is
the Breaching Party thereof.
Section 8.4 Effect of Termination.
(a) General. In the event this Agreement is terminated by
any Party, all rights and obligations of the Parties, including Newco's right to
commercialize and develop Program Products, shall cease, except as follows:
(i) except as set forth in subsections (b)(i)
and (b)(ii) below, all sublicenses set forth in Section 2.1 and all licenses set
forth in Section 2.2 then in effect shall survive such termination, subject to
continued compliance with obligations related to such sublicenses or licenses as
applicable, such as the royalty payments, reports, accounting and auditing
provisions of Articles III and IV;
(ii) all financial obligations under Article III
owed as of the effective date of such termination shall remain effective and
shall be timely paid;
(iii) Newco's and TriPath's obligations under
Section 5.1 shall survive such termination;
(iv) obligations regarding confidentiality set
forth in Article VI shall survive such termination;
(v) obligations of defense and indemnity set
forth in Section 10.1, which obligations shall continue in full force and effect
for an unlimited period;
(vi) any cause of action or claim of BD, TriPath,
Newco or MPI accrued or to accrue because of any breach or default by another
party hereunder shall survive such termination;
(vii) the right to complete the manufacture and
sale of Program Products which qualify as "work in progress" under generally
accepted cost accounting standards or which are in stock at the date of
termination, and the obligation to pay royalties on Gross Profits of such
Program Products; and
(viii) all other terms, provisions,
representations, rights and obligations contained in this Agreement which by
their sense and context are intended to survive termination of this Agreement.
(b) Termination of Sublicenses.
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(i) If this Agreement is terminated under
Section 8.3(a) and BD is the Breaching Party and Newco is a Non-Breaching Party,
or under Section 8.3(b) and BD is the Insolvent Party, the licenses granted by
Newco to BD under Section 2.2(c) shall terminate as of the effective date of
such termination, and all sublicenses granted under such licenses to third
parties by BD shall also terminate as of such date.
(ii) If this Agreement is terminated under
Section 8.3(a) and Newco or TriPath is the Breaching Party and BD is the
Non-Breaching Party, or under Section 8.3(b) and Newco or TriPath is the
Insolvent Party, the sublicenses granted by BD to Newco and TriPath under
Section 2.1 shall terminate.
Article IX
Dispute Resolution
Section 9.1 Alternative Dispute Resolution. Any controversy,
claim or dispute between the Parties relating to this Agreement shall be subject
to the same dispute resolution procedures set forth in Article II and Article X
of the BD/Newco Development Agreement.
Section 9.2 No Limitation. Notwithstanding the forgoing, nothing
in this Agreement shall be construed as limiting in any way the right of a
Party, or, pursuant to Section 10.13, MPI, to bring suit with respect to any
matter relating to this Agreement or to seek injunctive or other equitable
relief from a court of competent jurisdiction with respect to any actual or
threatened breach of this Agreement.
Article X
Miscellaneous Provisions
Section 10.1 Indemnification.
(a) TriPath and Newco. TriPath and Newco agree, jointly
and severally, to defend BD, MPI and their respective Affiliates at TriPath's
and Newco's cost and expense, and shall jointly and severally indemnify and hold
BD, MPI and their respective Affiliates and their respective directors,
officers, employees and agents (the "Licensing Indemnified Parties") harmless
from and against any losses, costs, damages, fees or expenses arising out of any
claim relating to (i) any breach by Newco or TriPath of any of their
representations, warranties, covenants, or obligations pursuant to this
Agreement, or (ii) personal injury from the development, manufacture, use, sale
or other disposition of any Program Product offered by TriPath, Newco and/or
their respective Affiliates. In the event of any such claim against the
Licensing Indemnified Parties by any third party, BD or MPI, as applicable,
shall promptly notify TriPath and Newco in writing of the claim and TriPath and
Newco shall manage and control, at their sole expense, the defense of the claim
and its settlement. The Licensing Indemnified Parties shall cooperate with
TriPath and Newco and may, at their option and expense, be represented in any
such action or proceeding. TriPath and Newco shall not be liable for any
litigation costs or expenses incurred by the Licensing Indemnified Parties. In
addition, TriPath and Newco shall not be responsible for the indemnification of
any Licensing Indemnified Party arising from any negligent or wrongful acts by
such party, or as the result of any settlement or compromise by the Licensing
Indemnified Parties without TriPath's prior written consent.
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(b) BD. BD agrees to defend Newco and its Affiliates at
its cost and expense, and shall indemnify and hold Newco and its Affiliates and
their respective directors, officers, employees and agents (the "Newco
Indemnified Parties") harmless from and against any losses, costs, damages, fees
or expenses arising out of any claim relating to any breach by BD of any of its
representations, warranties, covenants, or obligations pursuant to this
Agreement. In the event of any claim against the Newco Indemnified Parties by
any third party, Newco shall promptly notify BD in writing of the claim and BD
shall manage and control, at its sole expense, the defense of the claim and its
settlement. The Newco Indemnified Parties shall cooperate with BD and may, at
their option and expense, be represented in any such action or proceeding. BD
shall not be liable for any litigation costs or expenses incurred by the Newco
Indemnified Parties. In addition, BD shall not be responsible for the
indemnification of any Newco Indemnified Party arising from any negligent or
wrongful acts by such party, or as the result of any settlement or compromise by
the Newco Indemnified Parties without BD's prior written consent.
Section 10.2 Governing Law. This Agreement shall be construed and
the respective rights of the Parties determined (including in any arbitration
proceeding under Article IX) according to the substantive laws of the State of
Delaware notwithstanding the provisions governing conflict of laws under such
Delaware law to the contrary and without giving effect to the United Nations
Convention on Contracts for the International Sale of Goods, the 1974 Convention
on the Limitation Period in the International Sale of Goods (the "1974
Convention") and the Protocol amending the 1974 Convention, done at Vienna April
11, 1980, except matters of intellectual property law which shall be determined
in accordance with the national intellectual property laws relevant to the
intellectual property in question.
Section 10.3 Assignment. This Agreement is assignable to the same
extent as, and in accordance with the provisions of, the BD/Newco Development
Agreement. TriPath and/or Newco will provide BD and MPI with written notice
concerning any such assignment within ten (10) days after the occurrence
thereof.
Section 10.4 Amendments. This Agreement constitutes the entire
agreement among the Parties with respect to the subject matter hereof, and
supersedes all previous arrangements with respect to the subject matter hereof,
whether written or oral. Any amendment or modification to this Agreement shall
be made in writing signed by all Parties.
Section 10.5 Notices.
Notices to BD shall be addressed to:
Becton, Xxxxxxxxx and Company
0 Xxxxxx Xxxxx
Xxxxxxxx Xxxxx, XX 00000
Attn: Xxxxxxx X. Xxxxxxxx
Becton, Xxxxxxxxx and Company
0 Xxxxxx Xxxxx
Xxxxxxxx Xxxxx, Xxx Xxxxxx 00000
Attn: Vice President and Chief Intellectual Property Counsel
Notices to TriPath shall be addressed to:
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TriPath Imaging, Inc.
000 Xxxxxxxxxx Xxxxx
Xxxxxxxxxx, Xxxxx Xxxxxxxx 00000
Attn: President
with a copy to:
Xxxxxx & Dodge LLP
Xxx Xxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Xxxxxx X. Xxxxxx, Esq.
Telecopy No.: 1-617-227-4420
Notices to Newco shall be addressed to:
TriPath Oncology, Inc.
000 Xxxxxxxxxx Xxxxx
Xxxxxxxxxx, Xxxxx Xxxxxxxx 00000
Attn: President
with a copy to:
Xxxxxx & Dodge LLP
Xxx Xxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Xxxxxx X. Xxxxxx, Esq.
Telecopy No.: 1-617-227-4420
Any Party may change its address by giving notice to the other Parties
in the manner herein provided. Any notice required or provided for by the terms
of this Agreement shall be in writing and shall be (a) sent by registered or
certified mail, return receipt requested, postage prepaid, (b) sent via a
reputable overnight courier service, or (c) sent by facsimile transmission with
an original to be followed the same day via a reputable overnight courier
service, in each case properly addressed in accordance with the paragraph above.
The effective date of notice shall be the actual date of receipt by the Party
receiving the same.
Section 10.6 Force Majeure. No failure or omission by the Parties
in the performance of any obligation of this Agreement shall be deemed a breach
of this Agreement or create any liability if the same shall arise from any cause
or causes beyond the control of the Parties, including, but not limited to, the
following: acts of God; acts or omissions of any government; any rules,
regulations or orders issued after the Effective Date by any governmental
authority or by any officer, department, agency or instrumentality thereof;
fire; storm; flood; earthquake; accident; war; rebellion; insurrection; riot;
and invasion and provided that such failure or omission resulting from one of
the above causes is cured as soon as is practicable after the occurrence of one
or more of the above-mentioned causes.
Section 10.7 Public Announcements. Any announcements or similar
publicity with respect to the execution of this Agreement shall be agreed upon
among the Parties in advance of such
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announcement as set forth herein. Any Party may make such public announcements
with respect hereto. The Parties agree that any such announcement shall not
contain Confidential Information and, if disclosure of Confidential Information
is required by law or regulation, shall make reasonable efforts to minimize such
disclosure and obtain confidential treatment for any such information which is
disclosed to a governmental agency or group. Each Party agrees to provide to the
other Parties with a copy of any public announcement as soon as reasonably
practicable under the circumstances prior to its scheduled release. Except under
extraordinary circumstances, each Party shall provide the others with an advance
copy of any public announcement at least [*****] prior to the scheduled
disclosure. Each Party shall have the right to expeditiously review and
recommend changes to any announcement regarding this Agreement or the subject
matter of this Agreement, provided that such right of review and recommendation
shall only apply for the first time that specific information is to be
disclosed, and shall not apply to the subsequent disclosure of substantially
similar information that has previously been disclosed. Except as otherwise
required by law, the Party whose public announcement has been reviewed shall
remove or revise any information the reviewing Parties reasonably deem to be
inappropriate for disclosure.
Section 10.8 Independent Contractors. It is understood and agreed
that the relationship between the Parties hereunder is that of independent
contractors and that nothing in this Agreement shall be construed as
authorization for either BD, TriPath or Newco to act as agent for the other(s).
Section 10.9 No Strict Construction. This Agreement has been
prepared jointly and shall not be strictly construed against any Party.
Section 10.10 Headings. The captions or headings of the sections
or other subdivisions hereof are inserted only as a matter of convenience or for
reference and shall have no effect on the meaning of the provisions hereof.
Section 10.11 No Implied Waivers; Rights Cumulative. No failure
on the part of MPI, BD, TriPath or Newco to exercise, and no delay in
exercising, any right, power, remedy or privilege under this Agreement, or
provided by statute or at law or in equity or otherwise, shall impair, prejudice
or constitute a waiver of any such right, power, remedy or privilege or be
construed as a waiver of any breach of this Agreement or as an acquiescence
therein, nor shall any single or partial exercise of any such right, power,
remedy or privilege preclude any other or further exercise thereof or the
exercise of any other right, power, remedy or privilege.
Section 10.12 Severability. If any provision hereof should be held
invalid, illegal or unenforceable in any respect in any jurisdiction, then, to
the fullest extent permitted by law, (a) all other provisions hereof shall
remain in full force and effect in such jurisdiction and shall be liberally
construed in order to carry out the intentions of the Parties as nearly as may
be possible and (b) such invalidity, illegality or unenforceability shall not
affect the validity, legality or enforceability of such provision in any other
jurisdiction.
Section 10.13 Third Party Beneficiaries. MPI and its Affiliates
are intended by the Parties to be third party beneficiaries of Sections 2.2,
2.4, 2.5, 4.1, 4.2, 8.4, 9.2, 10.1, 10.3, 10.14, 10.16, 10.17
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and 10.18 and Articles I, V, VI and VII of this Agreement and shall be entitled
to enforce such provisions directly against the Parties.
Section 10.14 Certain Acknowledgements and Agreements; Further
Assurances. TriPath and Newco each acknowledge that BD and MPI regard them as
Approved Sublicensees under the BD/MPI Collaboration Agreement and, accordingly,
each agrees that the terms and conditions of this Agreement are intended to be
limited by the terms and conditions in the BD/MPI Collaboration Agreement
relating to Approved Sublicensees. TriPath and Newco each further acknowledge
that the BD/MPI Collaboration Agreement contains certain obligations on the part
of BD with respect to Approved Sublicensees and, accordingly, each agrees to
take all actions and execute all assignments and other documents, and to provide
all cooperation, reasonably necessary to enable BD to fulfill its obligations
with respect to TriPath and Newco under the BD/MPI Collaboration Agreement.
TriPath and Newco each further acknowledge that Paragraph 19 of the Third
Amendment of the BD/MPI Collaboration Agreement contains certain obligations on
the part of BD with respect to [*****] and, accordingly, each agrees to take all
actions and execute all waivers and other documents, and to provide all
cooperation, reasonably necessary to enable BD to fulfill such obligations with
respect to[*****]. The Parties further agree that in the event of any conflict
between the terms of this Agreement and the terms of the BD/Newco Development
Agreement or any other agreement among them, the terms of this Agreement shall
prevail.
Section 10.15 Execution in Counterparts. This Agreement may be
executed in counterparts, each of which counterparts, when so executed and
delivered, shall be deemed to be an original, and all of which counterparts,
taken together, shall constitute one and the same instrument.
Section 10.16 Exclusivity. Subject to the following paragraph,
TriPath and Newco each agree that [*****] it shall [*****] (i) [*****].
Notwithstanding the foregoing, nothing in this Section 10.16 shall be
construed as preventing TriPath or Newco from:
(i) commencing any research program directed to the discovery or
validation of Candidate Markers having utility outside any Exclusive Non-Colon
Product Area, Reserved Non-Colon Product Area, or Co-Exclusive Pharmacogenomic
Product Opportunity;
(ii) acquiring or being acquired by a Third Party (by merger or
otherwise), which Third Party, prior to such acquisition or merger, was already
engaged in any activity that, if undertaken directly by TriPath or Newco, would
violate the provisions of this Section 10.16; provided that (A) TriPath and/or
Newco do not expand the scope of, or financial commitment to, such activity, and
(B) this exception shall not apply if substantially all of such Third Party's
activities would, if undertaken directly by TriPath or Newco, violate the
provisions of this Section 10.16;
(iii) commencing any research program directed to expanding the
applicability of TriPath's imaging platform, including, without limitation,
enabling the platform to perform tests on third party Validated Markers; or
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(iv) commencing any research program directed to enhancing
TriPath's cervical cancer business, including, without limitation, validating
third party Validated Markers for cervical cancer.
Section 10.17 Non-Exempt Change of Control. TriPath and/or Newco
shall provide written notice to BD and MPI upon the occurrence of a Non-Exempt
Change of Control, such notice to be provided within [*****] after such
occurrence. Such notice shall include the name of the acquiror (the "Non-Exempt
Acquiror"). Except as otherwise agreed upon by MPI, from and after the
occurrence of the Non-Exempt Change of Control, (a) [*****].
Section 10.18 Use of Program Know How. TriPath and Newco agree
that all Program Know How provided to them by BD or MPI shall be used in
material compliance with all applicable federal, state or local laws,
regulations and guidelines and consistent with the scope of licenses to such
Program Know How that are (a) granted by MPI to BD under the Agreement, and (b)
granted by BD to TriPath and Newco under the Sublicense Agreement.
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first set forth above.
BECTON, XXXXXXXXX AND COMPANY
By: /s/ Xxxxxxx X. Xxxxxxxx
---------------------------------------------
Name: Xxxxxxx X. Xxxxxxxx
----------------------------------------------
Title: Sr. Vice President - Technology, Strategy
--------------------------------------------
and Development
---------------------------------------------
TRIPATH IMAGING, INC.
By: /s/ Xxxx X. Xxxxxx, M.D.
---------------------------------------------
Name: Xxxx X. Xxxxxx, M.D.
---------------------------------------------
Title: President and Chief Executive Officer
---------------------------------------------
TRIPATH ONCOLOGY, INC.
By: /s/ Xxxx X. Xxxxxx, M.D.
---------------------------------------------
Name: Xxxx X. Xxxxxx, M.D.
----------------------------------------------
Title: President
----------------------------------------------
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