1
EXHIBIT 10.1
Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
COLLABORATION AND LICENSE AGREEMENT
BY AND BETWEEN
BECTON, XXXXXXXXX AND COMPANY
AND
MILLENNIUM PREDICTIVE MEDICINE, INC.
2
TABLE OF CONTENTS
Page
Article I
Definitions.................................................................. 1
Section 1.1 "Affiliate"............................................... 1
Section 1.2 "Amortizable License Payments"............................ 2
Section 1.3 "Approved Sublicensees"................................... 2
Section 1.4 "Assays".................................................. 3
Section 1.5 "Bayer Agreement"......................................... 3
Section 1.6 "Becton Xxxxxxxxx Platform Intellectual Property"......... 3
Section 1.7 "Becton Xxxxxxxxx Platform Know-How"...................... 3
Section 1.8 "Becton Xxxxxxxxx Platform Patent Rights"................. 3
Section 1.9 "Becton Xxxxxxxxx Program Intellectual Property".......... 3
Section 1.10 "Becton Xxxxxxxxx Program Know-How"....................... 4
Section 1.11 "Becton Xxxxxxxxx Program Patent Rights".................. 4
Section 1.12 "Blocking Third Party Intellectual Property".............. 4
Section 1.13 "Candidate Marker"........................................ 4
Section 1.14 "Change of Control"....................................... 4
Section 1.15 "Co-Exclusive Pharmacogenomic Product Opportunity"........ 5
Section 1.16 "Colon Product Area"...................................... 5
Section 1.17 "Confidential Information"................................ 5
Section 1.18 "Contract Quarter"........................................ 5
Section 1.19 "Contract Year"........................................... 5
Section 1.20 "Cost of Goods Sold"...................................... 5
Section 1.21 "Development Program"..................................... 6
Section 1.22 "Diagnostic Product"...................................... 6
Section 1.23 "Direct Cost of Goods Sold"............................... 6
Section 1.24 "DOJ"..................................................... 7
Section 1.25 "Effective Date".......................................... 7
Section 1.26 "Enabling Third Party Intellectual Property".............. 7
Section 1.27 "Enhancing Third Party Intellectual Property"............. 7
Section 1.28 "Equity Closing Date"..................................... 8
Section 1.29 "Exclusive Non-Colon Product Area"........................ 8
Section 1.30 "Exclusive Product Area".................................. 8
Section 1.31 "Executive Officers"...................................... 8
Section 1.32 "FDA"..................................................... 8
Section 1.33 "Field"................................................... 8
Section 1.34 "First Commercial Sale"................................... 8
Section 1.35 "FTC"..................................................... 8
Section 1.36 "FTE"..................................................... 8
Section 1.37 "Gross Profit"............................................ 9
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Section 1.38 "Home Brew Product"....................................... 9
Section 1.39 "HSR Act"................................................. 9
Section 1.40 "HSR Clearance Date"...................................... 9
Section 1.41 "HSR Filing".............................................. 9
Section 1.42 "Joint Program Intellectual Property"..................... 9
Section 1.43 "Joint Program Know-How".................................. 9
Section 1.44 "Joint Program Patent Rights"............................. 9
Section 1.45 "Kit"..................................................... 9
Section 1.46 "Know-How"................................................ 9
Section 1.47 "Lilly Research and License Agreement".................... 10
Section 1.48 "Major Market Country".................................... 10
Section 1.49 "Marker Validation Project"............................... 10
Section 1.50 "MBio".................................................... 10
Section 1.51 "MPI"..................................................... 10
Section 1.52 "MPMx Program Intellectual Property"...................... 10
Section 1.53 "MPMx Program Know-How"................................... 10
Section 1.54 "MPMx Program Patent Rights".............................. 11
Section 1.55 "Net Sales"............................................... 11
Section 1.56 "Non-Colon Product Area".................................. 12
Section 1.57 "Non-Exclusive Non-Colon Product Area".................... 12
Section 1.58 "Non-Exclusive Pharmacogenomic Product Opportunity"....... 12
Section 1.59 "Non-Exclusive Product Area".............................. 12
Section 1.60 "Party"................................................... 12
Section 1.61 "Patent Rights"........................................... 12
Section 1.62 "PGX Project Proposal".................................... 12
Section 1.63 "Pharmacogenomic Product"................................. 12
Section 1.64 "Pharmacogenomic Service"................................. 13
Section 1.65 "Product"................................................. 13
Section 1.66 "Product Area"............................................ 13
Section 1.67 "Program Candidate Marker"................................ 13
Section 1.68 "Program Diagnostic Product".............................. 13
Section 1.69 "Program Director"........................................ 13
Section 1.70 "Program Home Brew Product"............................... 13
Section 1.71 "Program Intellectual Property"........................... 13
Section 1.72 "Program Know-How"........................................ 13
Section 1.73 "Program Patent Rights"................................... 14
Section 1.74 "Program Pharmacogenomic Product"......................... 14
Section 1.75 "Program Pharmacogenomic Service"......................... 14
Section 1.76 "Program Product"......................................... 14
Section 1.77 "Program Term"............................................ 14
Section 1.78 "Program Validated Marker"................................ 14
Section 1.79 "Research Plan"........................................... 14
Section 1.80 "Research Program"........................................ 14
Section 1.81 "Reserved Non-Colon Product Area"......................... 15
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
Section 1.82 "Reserved Product Area"................................... 15
Section 1.83 "ROFN Products"........................................... 15
Section 1.84 "Stock Purchase Agreement"................................ 15
Section 1.85 "Territory"............................................... 15
Section 1.86 "Third Party Pharmacogenomic Product"..................... 15
Section 1.87 "U.S. GAAP"............................................... 15
Section 1.88 "Validated Marker"........................................ 15
Section 1.89 "Viable Platform"......................................... 15
Section 1.90 Additional Definitions.................................... 15
Article II
Research Program............................................................. 18
Section 2.1 Exclusivity............................................... 18
Section 2.2 Joint Steering Committee.................................. 19
Section 2.3 Management of Research Program............................ 22
Section 2.4 Non-Colon Cancer Programs................................. 22
Section 2.5 Colon Cancer Programs..................................... 25
Section 2.6 Right of MPMx to Develop Third Party
Pharmacogenomic Products.................................. 28
Section 2.7 Research Program Responsibilities......................... 29
Section 2.8 Revision or Early Termination of Research
Program Relating to Year [**] Milestone................... 31
Section 2.9 Revision or Early Termination of Research
Program for Change of Control............................. 32
Section 2.10 Development Program....................................... 33
Section 2.11 Commercialization......................................... 33
Section 2.12 Becton Xxxxxxxxx Development and
Commercialization Diligence Obligations................... 34
Section 2.13 Progress Reports.......................................... 38
Article III
Grant of Rights.............................................................. 38
Section 3.1 MPMx Grants............................................... 38
Section 3.2 Becton Xxxxxxxxx Grants................................... 40
Section 3.3 MPMx Retained Rights...................................... 41
Section 3.4 Becton Dickinson's [**]................................... 41
Section 3.5 Section 365(n) of the Bankruptcy Code..................... 42
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Article IV
Financial Provisions........................................................ 42
Section 4.1 License Payment.......................................... 42
Section 4.2 Additional Payment....................................... 42
Section 4.3 Equity Investment........................................ 42
Section 4.4 Convertible Note......................................... 43
Section 4.5 Research Funding......................................... 44
Section 4.6 Milestone Payments....................................... 45
Section 4.7 Royalty Payments to MPMx................................. 50
Section 4.8 Royalty Payments to Becton Xxxxxxxxx..................... 52
Section 4.9 Length of Royalty Payments............................... 52
Section 4.10 Royalties Payable Only Once.............................. 52
Section 4.11 Royalty Reports and Accounting........................... 53
Section 4.12 Currency and Method of Payments; Late Payments........... 53
Section 4.13 Tax Withholding.......................................... 54
Section 4.14 Blocked Payments......................................... 54
Article V
Intellectual Property Ownership, Protection and Related Matters............. 54
Section 5.1 Ownership of Inventions.................................. 54
Section 5.2 Prosecution and Maintenance of Patent Rights............. 55
Section 5.3 Exploitation of Joint Program Intellectual
Property................................................. 56
Section 5.4 Blocking, Enabling and Enhancing Third Party
Intellectual Property.................................... 56
Section 5.5 Third Party Infringement................................. 58
Section 5.6 Claimed Infringement; Claimed Invalidity................. 59
Section 5.7 Patent Term Extensions................................... 60
Section 5.8 Patent Marking........................................... 61
Article VI
Confidentiality............................................................. 61
Section 6.1 Confidential Information................................. 61
Section 6.2 Disclosure of Provisions of Agreements................... 62
Section 6.3 Employee and Advisor Obligations......................... 62
Section 6.4 Term..................................................... 62
Section 6.5 Publications............................................. 62
Article VII
Representations and Warranties.............................................. 63
Section 7.1 Representations of Authority............................. 63
Section 7.2 Consents................................................. 63
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
Section 7.3 No Conflict.............................................. 63
Section 7.4 Employee Obligations..................................... 64
Section 7.5 Third Party Rights....................................... 64
Section 7.6 Agreements with MPI...................................... 65
Section 7.7 Year 2000 Compliance..................................... 66
Section 7.8 No Warranties............................................ 66
Article VIII
Term and Termination........................................................ 66
Section 8.1 Term..................................................... 66
Section 8.2 Survival of Licenses..................................... 66
Section 8.3 Termination For Material Breach.......................... 66
Section 8.4 No Effectiveness Upon HSR Denial or Termination
of Stock Purchase Agreement.............................. 67
Section 8.5 Effect of Termination.................................... 67
Article IX
Dispute Resolution.......................................................... 68
Section 9.1 Alternative Dispute Resolution........................... 68
Section 9.2 No Limitation............................................ 68
Article X
Miscellaneous Provisions.................................................... 69
Section 10.1 Product Liability Indemnification........................ 69
Section 10.2 Governing Law............................................ 70
Section 10.3 Assignment............................................... 70
Section 10.4 Amendments............................................... 70
Section 10.5 Notices.................................................. 70
Section 10.6 Force Majeure............................................ 71
Section 10.7 Public Announcements..................................... 71
Section 10.8 Independent Contractors.................................. 72
Section 10.9 No Strict Construction................................... 72
Section 10.10 Headings................................................. 72
Section 10.11 No Implied Waivers; Rights Cumulative.................... 72
Section 10.12 Severability............................................. 72
Section 10.13 Execution in Counterparts................................ 72
Section 10.14 HSR Filing............................................... 72
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Exhibits
Exhibit A -- Non-Colon Product Areas
Exhibit B -- Research Plan
Exhibit C -- Year [**] Milestone
Exhibit D -- Form of Convertible Note
Exhibit E -- Research Funding Payments for First Contract Year
Exhibit F -- Alternative Dispute Resolution Process
Exhibit G -- Guaranty
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COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement (the "Agreement"), dated the
21st day of February, 1999 (the "Execution Date"), is by and between Becton,
Xxxxxxxxx and Company, a corporation organized and existing under the laws of
New Jersey and having its principal office at Xxx Xxxxxx Xxxxx, Xxxxxxxx Xxxxx,
Xxx Xxxxxx 00000 ("Becton Xxxxxxxxx") and Millennium Predictive Medicine, Inc.,
a corporation organized and existing under the laws of the State of Delaware and
having its principal office at 000 Xxxxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx
00000 ("MPMx").
INTRODUCTION
1. MPMx is engaged in the business of using genetics, genomics
and proteomics technologies to discover and develop diagnostic and
pharmacogenomic products and to provide pharmacogenomic services.
2. Becton Xxxxxxxxx is engaged in the business of discovering,
developing and marketing diagnostic products.
3. Becton Xxxxxxxxx and MPMx are interested in collaborating in
certain areas of cancer to discover and commercialize novel diagnostic and
pharmacogenomic products.
NOW, THEREFORE, Becton Xxxxxxxxx and MPMx agree as follows:
ARTICLE I
DEFINITIONS
When used in this Agreement, each of the following terms shall have the
meanings set forth in this Article I:
SECTION 1.1 "AFFILIATE" means any corporation, company, partnership,
joint venture or other entity which controls, is controlled by, or is under
common control with a Party or, solely with respect to Section 2.1(c), MPI. For
purposes of this Section 1.1, "control" shall mean (a) in the case of corporate
entities, direct or indirect ownership of at least fifty percent (50%) of the
stock or shares having the right to vote for the election of directors, and (b)
in the case of non-corporate entities, direct or indirect ownership of at least
fifty percent (50%) of the equity interest with the power to direct the
management and policies of such non-corporate entities.
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
SECTION 1.2 "AMORTIZABLE LICENSE PAYMENTS" means amounts determined as
follows: In the event that Becton Xxxxxxxxx shall pay to a third party (or MPMx
shall pay to a third party and be reimbursed by Becton Xxxxxxxxx pursuant to
Section 5.4) any license, access or similar fee in respect of licenses obtained
to Blocking Third Party Intellectual Property, Enabling Third Party Intellectual
Property or Enhancing Third Party Intellectual Property, [**] in the case of
both Blocking Third Party Intellectual Property and Enabling Third Party
Intellectual Property, and (b) [**], in the case of Enhancing Third Party
Intellectual Property, shall be deemed to be Amortizable License Payments and
shall be amortized in quarterly amounts, and each such quarterly amount shall be
added to Cost of Goods Sold as follows: Becton Xxxxxxxxx shall include in Costs
of Goods Sold an amount equal to [**] for the applicable Program Product (the
"Per Product License Amortization Amount") until the total amount of the Per
Product License Amortization Amounts included in Cost of Goods Sold is
equivalent to the Adjusted Amortizable License Payment. For purposes of this
Section 1.2, "Adjusted Amortizable License Payment" shall mean the total amount
of the Amortizable License Payment for the applicable Program Product plus
interest compounded quarterly on the unamortized balance of such amount at the
[**] in effect at the time the obligation to make the Amortizable License
Payment was incurred (i.e. the date the applicable license was obtained). For
example, assuming that (i) Becton Xxxxxxxxx paid [**] in license fees to a
third-party on [**], with respect to Blocking Third Party Intellectual Property
that covers Program Product X, (ii) the [**] on [**] (iii) no Net Sales of
Program Product X occur in [**], and Net Sales of Program Product X during the
calendar quarter ending on [**], respectively, then (A) the amount included in
Cost of Goods Sold for Program Product X for the quarter ended [**] will be [**]
and (B) the amount included in Cost of Good Sold for Program Product X for the
quarter ended [**] will be [**] but cumulatively capped in the aggregate by the
Adjusted Amortizable License Payment of [**] per annum compounded quarterly x
[**] years = [**] per annum compounded quarterly x [**] years = [**]).
SECTION 1.3 "APPROVED SUBLICENSEES" means (a) a third party with which
Becton Xxxxxxxxx is, as of the Execution Date, negotiating to enter into a
collaborative alliance, the purpose of which is to develop a nucleic acid-based
platform for in vitro diagnostic and pharmacogenomic tests; (b) academic
institutions which are engaged for conducting clinical trials on behalf of
Becton Xxxxxxxxx relating to the Development Program, PROVIDED THAT (i) any
sublicense to such an academic institution shall be limited to the conduct of
such clinical trials for non-commercial purposes only and (ii) Becton Xxxxxxxxx
shall review with the Joint Steering Committee the choice of such academic
institutions; (c) any direct or indirect wholly-owned subsidiary of Becton
Xxxxxxxxx; and (d) such other persons or entities as may be designated in
accordance with the following procedures: (i) if Becton Xxxxxxxxx, in its sole
discretion, determines that it would be advantageous to grant a sublicense to
secure access to technological or commercialization resources or expertise
useful
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
for the development or commercialization of a Program Product, it shall notify
the Joint Steering Committee, including in such notice the scope of the proposed
sublicense and the names of any proposed sublicensees; and (ii) the Joint
Steering Committee shall be responsible for determining the scope of any such
sublicense and for selecting and approving any such sublicensee, whether one of
the potential sublicensees suggested by Becton Xxxxxxxxx or such other person or
entity as the Joint Steering Committee shall determine to be appropriate.
SECTION 1.4 "ASSAYS" means formatted reagents for conducting a
diagnostic or pharmacogenomic test using (i) an instrument(s) owned by Becton
Xxxxxxxxx, or to which Becton Xxxxxxxxx otherwise has access, and/or (ii) any
other platform(s) designated by the Joint Steering Committee.
SECTION 1.5 "BAYER AGREEMENT" means the Agreement dated September 22,
1998 by and between MPI and Xxxxx XX ("Xxxxx").
SECTION 1.6 "BECTON XXXXXXXXX PLATFORM INTELLECTUAL PROPERTY" means
Becton Xxxxxxxxx Platform Know-How and Becton Xxxxxxxxx Platform Patent Rights,
collectively.
SECTION 1.7 "BECTON XXXXXXXXX PLATFORM KNOW-HOW" means equipment
existing as of the Effective Date and new versions of such equipment, and Know-
How relating to such equipment and new versions of such equipment, including
without limitation Becton Dickinson's [**] and all Know-How and equipment
relating to sample [**] (a) that is reasonably necessary to make [**] (b) that
is owned or controlled by, or licensed to, Becton Xxxxxxxxx, and (c) to which
Becton Xxxxxxxxx has the right to grant licenses or sublicenses without
violating the terms of any agreement with a third party.
SECTION 1.8 "BECTON XXXXXXXXX PLATFORM PATENT RIGHTS" means a Patent
Right (a) that covers Becton Xxxxxxxxx Platform Know-How, (b) that is owned or
controlled by, or licensed to, Becton Xxxxxxxxx, and (c) to which Becton
Xxxxxxxxx has the right to grant licenses or sublicenses without violating the
terms of any agreement with a third party.
SECTION 1.9 "BECTON XXXXXXXXX PROGRAM INTELLECTUAL PROPERTY" means
Becton Xxxxxxxxx Program Know-How and Becton Xxxxxxxxx Program Patent Rights,
collectively.
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SECTION 1.10 "BECTON XXXXXXXXX PROGRAM KNOW-HOW" means any Know-How
that (a) is developed using MPMx Program Intellectual Property, (b) either (i)
Becton Xxxxxxxxx or an Approved Sublicensee develops or acquires in the course
of the Research Program and/or the Development Program, or (ii) Becton Xxxxxxxxx
or an Approved Sublicensee 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, Becton Xxxxxxxxx or such Approved
Sublicensee and to which Becton Xxxxxxxxx or such Approved Sublicensee has the
right to grant licenses or sublicenses without violating the terms of any
agreement with a third party; PROVIDED THAT Becton Xxxxxxxxx Program Know-How
shall not include Becton Xxxxxxxxx Platform Know-How and Joint Program Know-How.
SECTION 1.11 "BECTON XXXXXXXXX PROGRAM PATENT RIGHTS" means a Patent
Right (a) that covers Becton Xxxxxxxxx Program Know-How, (b) that is owned or
controlled by, or licensed to, Becton Xxxxxxxxx or an Approved Sublicensee, and
(c) to which Becton Xxxxxxxxx or an Approved Sublicensee has the right to grant
a license or sublicense without violating the terms of any agreement with a
third party.
SECTION 1.12 "BLOCKING THIRD PARTY INTELLECTUAL PROPERTY" means, with
respect to any country in the Territory, on a country-by-country basis, Patent
Rights in such country owned or controlled by a third party that cover either
(a) the composition of matter of a Program Validated Marker, or (b) a method of
using a Program Validated Marker that is independent of platform, but only if
the manufacture, use, offer for sale, sale, or import of a Program Product for
use in the Field in such country would, in the absence of a license granted by
such third party, infringe such Patent Rights, as determined pursuant to Section
5.4, PROVIDED, HOWEVER, that Blocking Third Party Intellectual Property shall
only include those Patent Rights to which a license is necessary to enable
Becton Xxxxxxxxx to develop and commercialize a Program Product that contains
such Program Validated Marker and to enable MPMx to research and develop such
Program Validated Marker for use in a Program Product.
SECTION 1.13 "CANDIDATE MARKER" means any reagent, including without
limitation DNA, RNA, protein or antibody, which is suggested by scientific data
to be of potential use as a Product or component thereof.
SECTION 1.14 "CHANGE OF CONTROL" means (a) a merger, consolidation or
other transaction or series of related transactions as a result of which persons
who were shareholders of MPMx immediately prior thereto would not immediately
thereafter beneficially own (as defined in Rule 13d-3 promulgated under the
Exchange Act) at least [**] of the combined voting power of MPMx or the
surviving entity immediately after such transaction; or (b) any one person or
"group", as such terms are used in Section 13(d) and 14(d) of the Securities
Exchange Act of 1934, as amended (the "Exchange Act") (other than any trustee or
other fiduciary holding securities under an
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
employee benefit plan of MPMx), together with any of such person's "affiliates"
or "associates", as such terms are used in the Exchange Act, becoming the
beneficial owner (as defined in Rule 13d-3 promulgated under the Exchange Act)
of [**] or more of the combined voting power of the outstanding securities of
MPMx.
SECTION 1.15 "CO-EXCLUSIVE PHARMACOGENOMIC PRODUCT OPPORTUNITY" means a
Co-Exclusive Colon Pharmacogenomic Product Opportunity and/or a Co-Exclusive
Non-Colon Pharmacogenomic Product Opportunity.
SECTION 1.16 "COLON PRODUCT AREA" means a Staging or Screening Product
application in colon cancer.
SECTION 1.17 "CONFIDENTIAL INFORMATION" means all Know-How or other
information, including, without limitation, proprietary information and
materials (whether or not patentable) regarding a Party's technology, products,
business information or objectives, which is designated as confidential in
writing by the disclosing Party, whether by letter or by the use of an
appropriate stamp or legend, prior to or at the time any such Know-How or other
information is disclosed by the disclosing Party to the other Party.
Notwithstanding the foregoing, (a) all Program Know-How, Program Patent Rights
and Becton Xxxxxxxxx Platform Intellectual Property shall constitute
Confidential Information and (b) Know-How or other information which is orally,
electronically or visually disclosed by a Party, or is disclosed in writing
without an appropriate letter, stamp or legend, shall constitute Confidential
Information of a Party (i) if the disclosing Party, within thirty (30) days
after such disclosure, delivers to the other Party a written document or
documents describing the Know-How or other information and referencing the place
and date of such oral, visual, electronic or written disclosure and the names of
the persons to whom such disclosure was made, or (ii) such Know-How or other
information is of the type that is customarily considered to be confidential
information by persons engaged in activities that are substantially similar to
the activities being engaged in by the Parties pursuant to this Agreement.
SECTION 1.18 "CONTRACT QUARTER" means the period beginning on the first
day of the First Contract Year and ending on March 31, 1999, and each succeeding
quarter thereafter during the Program Term.
SECTION 1.19 "CONTRACT YEAR" means (a) the period beginning on February
1, 1999 and ending on September 30, 1999 (the "First Contract Year"), (b) each
of the four (4) succeeding twelve (12) month periods thereafter during the
Program Term (referred to as the "Second Contract Year", "Third Contract Year",
etc.), and (c) the period beginning on October 1, 2003 and ending January 31,
2004 (the "Sixth Contract Year").
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
SECTION 1.20 "COST OF GOODS SOLD" means, with respect to each Program
Product for each calendar quarter, Direct Cost of Goods Sold for such Program
Product for such calendar quarter plus (a) [**] of the royalties accrued in such
calendar quarter by Becton Xxxxxxxxx (or paid by MPMx and reimbursed by Becton
Xxxxxxxxx pursuant to Section 5.4 below) to third parties based on the sale of
such Program Product pursuant to licenses obtained by a Party from such third
parties with respect to Blocking Third Party Intellectual Property relating to
such Program Product; (b) [**] of the royalties accrued in such calendar quarter
by Becton Xxxxxxxxx (or paid by MPMx and reimbursed by Becton Xxxxxxxxx pursuant
to Section 5.4 below) to third parties based on the sale of such Program Product
pursuant to licenses obtained by a Party from such third parties with respect to
Enabling Third Party Intellectual Property incorporated in such Program Product;
(c) [**] of the royalties accrued in such calendar quarter by Becton Xxxxxxxxx
(or paid by MPMx and reimbursed by Becton Xxxxxxxxx pursuant to Section 5.4
below) to third parties pursuant to licenses obtained by a Party from such third
parties based on the sale of such Program Product with respect to Enhancing
Third Party Intellectual Property incorporated in such Program Product; and (d)
the portion of any Amortizable License Payment allocable to such Program Product
for such calendar quarter. Notwithstanding the foregoing, royalty and/or
license, access or similar fees paid to third parties pursuant to licenses
obtained to Blocking Third Party Intellectual Property, Enabling Third Party
Intellectual Property or Enhancing Third Party Intellectual Property shall only
be included in the definition of "Cost of Goods Sold" if the Party obtaining
such licenses has complied with the terms of Section 5.4.
SECTION 1.21 "DEVELOPMENT PROGRAM" means the product development
program to be performed by Becton Xxxxxxxxx and Approved Sublicensees, if any,
during and after the term of the Research Program, to develop Program Products
for use in the Field, the term of which shall continue until [**] after the
termination of the Research Program.
SECTION 1.22 "DIAGNOSTIC PRODUCT" means any Kit that (a) contains one
or more Validated Markers, and (b) identifies patients having a particular
disease, or having a predisposition to a particular disease (a "Screening
Product"), and/or monitors the aggressivity or prognosis of any disease in
patients (a "Staging Product"). The term Diagnostic Product includes both Home
Brew Products and products that have received regulatory review and/or approval.
SECTION 1.23 "DIRECT COST OF GOODS SOLD" means, with respect to each
Program Product for each calendar quarter, the sum of (a) Becton Dickinson's
cost of [**]
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14
Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
quarter (as calculated on an annual basis in accordance with and consistent with
the methods used by Becton Xxxxxxxxx to calculate direct costs for its other
product lines), and (b) the amortizable cost of any Special Purpose Equipment.
As used herein, the term "Special Purpose Equipment" means manufacturing
equipment that is (x) [**] and (y) [**] all as determined by the Joint Steering
Committee. Special Purpose Equipment shall be amortized monthly on a straight
line basis for a number of months not to exceed the period set forth in Becton
Dickinson's Finance Policy Guide in effect as of the time such Special Purpose
Equipment was purchased by Becton Xxxxxxxxx; provided that under no
circumstances shall the Special Purpose Equipment be amortized over a period of
less than sixty (60) months. The monthly amortization of Special Purpose
Equipment shall be included in Direct Cost of Goods Sold beginning with the
first month in which Program Products manufactured with the Special Purposes
Equipment are sold and shall be included each month thereafter until the full
amortizable cost of the Special Purpose Equipment has been included in Direct
Cost of Goods Sold.
SECTION 1.24 "DOJ" means the United States Department of Justice.
SECTION 1.25 "EFFECTIVE DATE" means the later of the HSR Clearance Date
and the Equity Closing Date.
SECTION 1.26 "ENABLING THIRD PARTY INTELLECTUAL PROPERTY" means, with
respect to any country in the Territory, on a country-by-country basis, Patent
Rights in such country owned or controlled by a third party that cover either
(a) the composition of matter of a Validated Marker that is not a Program
Validated Marker, or (b) a method that is independent of platform of using a
Validated Marker which is not a Program Validated Marker, but only if (x) such
Validated Marker is included in a Program Product because such Program Product
would have no medical value in the Field without the inclusion of such Validated
Marker, and (y) the manufacture, use, offer for sale, sale, or import of such
Program Product for use in the Field in such country would, in the absence of a
license granted by such third party, infringe such Patent Rights, all as
determined pursuant to Section 5.4, PROVIDED, HOWEVER, that Enabling Third Party
Intellectual Property shall only include those Patent Rights to which a license
is necessary to enable Becton Xxxxxxxxx to develop and commercialize a Program
Product that contains such Validated Marker and to enable MPMx to research and
develop such Validated Marker for use in a Program Product.
SECTION 1.27 "ENHANCING THIRD PARTY INTELLECTUAL PROPERTY" means, with
respect to any country in the Territory, Patent Rights in such country owned or
controlled by a third party that cover either (a) the composition of matter of a
Validated Marker
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that is not a Program Validated Marker, or (b) a method of using a Validated
Marker which is not a Program Validated Marker that is independent of platform,
but only if (x) such Validated Marker is included in a Program Product because
such Validated Marker materially enhances the commercial value of such Program
Product for use in the Field, and (y) the manufacture, use, offer for sale,
sale, or import of such Program Product for use in the Field in such country
would, in the absence of a license granted by such third party, infringe such
Patent Rights, all as determined pursuant to Section 5.4, PROVIDED, HOWEVER,
that Enabling Third Party Intellectual Property shall only include those Patent
Rights to which a license is necessary to enable Becton Xxxxxxxxx to develop and
commercialize a Program Product that contains such Validated Marker and to
enable MPMx to research and develop such Validated Marker for use in a Program
Product.
SECTION 1.28 "EQUITY CLOSING DATE" means the Closing Date (as defined
in the Stock Purchase Agreement).
SECTION 1.29 "EXCLUSIVE NON-COLON PRODUCT AREA" means a Non-Colon
Product Area that (a) is selected by Becton Xxxxxxxxx for inclusion in the
Research Program; and (b) is (i) an active area of research by MPMx and Becton
Xxxxxxxxx within the Research Program with a committed staffing and funding
level and appropriate scientific rationale that is approved by the Joint
Steering Committee and/or (ii) a Product Area for which a Program Diagnostic
Product that was developed within the Research Program is being further
developed in the Development Program or is being commercialized by Becton
Xxxxxxxxx or an Approved Sublicensee.
SECTION 1.30 "EXCLUSIVE PRODUCT AREA" means an Exclusive Colon Product
Area and/or an Exclusive Non-Colon Product Area.
SECTION 1.31 "EXECUTIVE OFFICERS" means the Chief Executive Officer of
Becton Xxxxxxxxx (or a senior executive officer of Becton Xxxxxxxxx designated
by Becton Xxxxxxxxx) and the President of MPMx (or a senior executive officer of
MPMx designated by MPMx).
SECTION 1.32 "FDA" means the United States Food and Drug
Administration.
SECTION 1.33 "FIELD" means, collectively, the following human diseases:
melanoma, breast cancer, uterine cancer, ovarian cancer, cervical cancer,
prostate cancer and colon cancer. Each of the foregoing human diseases is
referred to as a "Disease Area".
SECTION 1.34 "FIRST COMMERCIAL SALE" means, for each Program Product,
the first commercial sale in a country by Becton Xxxxxxxxx, its Affiliates
and/or Approved Sublicensees as part of a nationwide product introduction. Sales
for test
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marketing, clinical trial purposes or compassionate or similar use shall not be
considered to constitute a First Commercial Sale.
SECTION 1.35 "FTC" means the United States Federal Trade Commission.
SECTION 1.36 "FTE" means a full time equivalent person year (consisting
of a total of one thousand eight hundred eighty (1,880) hours per year) of
scientific, technical or managerial work on or directly related to the Research
Program and/or the Development Program.
SECTION 1.37 "GROSS PROFIT" means, with respect to a Program Product
for each calendar quarter, Net Sales for such Program Product for such calendar
quarter less Cost of Goods Sold for such Program Product for such calendar
quarter.
SECTION 1.38 "HOME BREW PRODUCT" means a Product that (a) is sold or
licensed solely to reference laboratories, and (b) has not been approved by
applicable regulatory authorities.
SECTION 1.39 "HSR ACT" means the Xxxx-Xxxxx-Xxxxxx Antitrust
Improvements Act of 1976, as amended (15 U.S.C. Sec. 18a), and the rules and
regulations promulgated thereunder.
SECTION 1.40 "HSR CLEARANCE DATE" means the earlier of (a) the date on
which the FTC shall notify Becton Xxxxxxxxx and MPMx of early termination of the
applicable waiting period under the HSR Act, or (b) the day after the date on
which the applicable waiting period under the HSR Act expires.
SECTION 1.41 "HSR FILING" means filings by Becton Xxxxxxxxx and MPMx
with the FTC and the Antitrust Division of the DOJ of a Notification and Report
Form for Certain Mergers and Acquisitions (as that term is defined in the HSR
Act) with respect to the matters set forth in this Agreement and the Stock
Purchase Agreement, together with all required documentary attachments thereto.
SECTION 1.42 "JOINT PROGRAM INTELLECTUAL PROPERTY" means Joint Program
Know- How and Joint Program Patent Rights, collectively. For purposes of this
Agreement, Blocking Third Party Intellectual Property, Enabling Third Party
Intellectual Property and Enhancing Third Party Intellectual Property that is
licensed-in pursuant to Section 5.4 shall be considered to be Joint Program
Know-How and/or Joint Program Patent Rights, as applicable.
SECTION 1.43 "JOINT PROGRAM KNOW-HOW" means any Know-How that is
developed or acquired jointly by the Parties in the course of the Research
Program and/or the Development Program, including Joint Inventions, as that term
is defined in Section 5.1(c).
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SECTION 1.44 "JOINT PROGRAM PATENT RIGHTS" means a Patent Right that
covers Joint Program Know-How.
SECTION 1.45 "KIT" means the Validated Markers and set of reagents and
other materials that are consumed, that constitute a Product.
SECTION 1.46 "KNOW-HOW" means any information, inventions, copyrights,
trade secrets, data or materials, including without limitation biological
materials (such as cell lines, RNA, RNA fragments, DNA, DNA fragments,
organisms, proteins, polypeptides, plasmids, vectors, fragments of such
proteins, polypeptides, plasmids and vectors, and unmodified derivatives,
progeny and variants of all of the foregoing), and software.
SECTION 1.47 "LILLY RESEARCH AND LICENSE AGREEMENT" means the Amended
and Restated Research and License Agreement dated December 22, 1998 by and
between MPI and Xxx Xxxxx and Company ("Lilly").
SECTION 1.48 "MAJOR MARKET COUNTRY" means the United States, the United
Kingdom, Germany, France, Italy or Japan.
SECTION 1.49 "MARKER VALIDATION PROJECT" means a project undertaken by
MPMx in the course of the Research Program pursuant to Section 2.8(b), Section
2.9(b), or Section 4.5(c), with the goal of validating a Program Candidate
Marker or a set of Program Candidate Markers, delivered by MPMx to Becton
Xxxxxxxxx pursuant to the Research Plan, to the extent necessary to qualify any
such marker(s) as a Program Validated Marker(s).
SECTION 1.50 "MBIO" means Millennium BioTherapeutics, Inc., (a) a
corporation organized and existing under the laws of the State of Delaware and
having its principal office at 000 Xxxxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx
00000, and (b) an Affiliate of MPMx, as of the Execution Date.
SECTION 1.51 "MPI" means Millennium Pharmaceuticals, Inc., (a) a
corporation organized and existing under the laws of the State of Delaware and
having its principal office at 000 Xxxxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx
00000, and (b) an Affiliate of MPMx, as of the Execution Date.
SECTION 1.52 "MPMX PROGRAM INTELLECTUAL PROPERTY" means MPMx Program
Know-How and MPMx Program Patent Rights, collectively.
SECTION 1.53 "MPMX PROGRAM KNOW-HOW" means any Know-How that (a) MPMx
reasonably determines to be useful to discover and develop Validated Markers
relevant to the Field and to develop, make, use, sell or seek approval to
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
market Products for use in the Field, (b) either (i) is in MPMx's possession on
the Effective Date and is used in the course of the Research Program, or (ii)
MPMx develops or acquires in the course of the Research Program, or (iii) MPMx
acquires during the term, but not in the course, of the Research Program, and
(c) is owned or controlled by, or licensed to, MPMx and to which MPMx has the
right to grant licenses or sublicenses without violating the terms of any
agreement with a third party; PROVIDED THAT MPMx Program Know-How shall not
include (A) methods or technology, including without limitation software, for
conducting genomic, proteomic, pharmacogenomic and diagnostic research and
development, (B) Joint Program Know-How and (C) Know-How developed or acquired
by MPMx in the course of the research and development of products in
Non-Exclusive Product Areas or Non-Exclusive Pharmacogenomic Product
Opportunities.
SECTION 1.54 "MPMX PROGRAM PATENT RIGHTS" means a Patent Right (a) that
covers MPMx Program Know-How, (b) that is owned or controlled by, or is licensed
to MPMx, and (c) to which MPMx has the right to grant a license or sublicense
without violating the terms of any agreement with a third party.
SECTION 1.55 "NET SALES" means the gross amount invoiced by Becton
Xxxxxxxxx, its Affiliates and/or Approved Sublicensees on sales or other
dispositions of a Program Product to unrelated third parties, less the following
items:
a. [**] with respect to such sales; and
b. [**]
It is understood by the Parties that a Program Product may be sold
under a reagent rental agreement, or analogous agreement, where a purchaser is
provided an instrument for use in conjunction with a Program Product and the
costs associated with the placement and use of the instrument are not separately
billed, but instead represent some portion of the purchase price of the Program
Product, such that the transaction does not enable determination of the Net
Sales solely with respect to a Program Product. In such event, the Net Sales for
those units of such a particular Program Product which are sold on a reagent
rental or analogous basis shall be calculated by multiplying for each Program
Product on a country-by-country basis, (i) the average Net Sales price per unit
when the said Program Product is sold during the royalty-paying period in
question to end users on other than a reagent rental or analogous basis, by (ii)
the number of such units of said Program Product sold on a reagent rental or
analogous basis during the period for which Net Sales is being calculated.
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
If no Program Products are sold other than under a reagent rental
agreement or analogous basis during the period for which Net Sales is being
calculated, then the Net Sales for purposes of determining royalty payments
shall be the Net Sales reduced by the amount of allocated instrument price (to
include instrument interest and service, if applicable), that amount being
calculated by multiplying the number of cumulative installed instruments
amortized for that period, that amortization being established in accordance
with U.S. GAAP.
In the event Program Products are sold together with other products at
a single price, or a Program Product is configured as a combination package
containing other products which do not interact with the Program Validated
Marker to yield a diagnostic or pharmacogenomic result (e.g. sample collection,
stabilization or purification products), such single price shall be allocated
among Program Products and the other products based on the market price for such
products when sold separately, PROVIDED THAT if either of such products is not
also then being sold alone, Becton Xxxxxxxxx and MPMx shall agree upon the
market price that could reasonably be expected for that product or a comparable
product.
c. All such amounts as described in this Section 1.47
shall be determined from the books and records of Becton Xxxxxxxxx, its
Affiliates and/or Approved Sublicensees, maintained in accordance with U.S.
GAAP.
SECTION 1.56 "NON-COLON PRODUCT AREA" means [**] that is not colon
cancer, as shown in EXHIBIT A.
SECTION 1.57 "NON-EXCLUSIVE NON-COLON PRODUCT AREA" means a Non-Colon
Product Area that is neither an Exclusive Non-Colon Product Area nor a Reserved
Non-Colon Product Area.
SECTION 1.58 "NON-EXCLUSIVE PHARMACOGENOMIC PRODUCT OPPORTUNITY" means
a Non-Exclusive Colon Pharmacogenomic Product Opportunity and/or a Non-
Exclusive Non-Colon Pharmacogenomic Product Opportunity.
SECTION 1.59 "NON-EXCLUSIVE PRODUCT AREA" means a Non-Exclusive Colon
Product Area and/or a Non-Exclusive Non-Colon Product Area.
SECTION 1.60 "PARTY" means Becton Xxxxxxxxx or MPMx; "PARTIES" means
Becton Xxxxxxxxx and MPMx. As used in this Agreement, references to "third
parties" do not include a Party or its Affiliates.
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
SECTION 1.61 "PATENT RIGHTS" means a U.S. and/or foreign patent or
patent application and all divisions, continuations, continuations-in-part,
reissues, reexaminations and extensions thereof, in whole or in part.
SECTION 1.62 "PGX PROJECT PROPOSAL" means a Colon PGX Project Proposal
and/or a Non-Colon PGX Project Proposal.
SECTION 1.63 "PHARMACOGENOMIC PRODUCT" means any Kit that contains one
or more Validated Markers, and (a) is used to [**]. The term "Pharmacogenomic
Product" includes both Home Brew Products and products that have received
regulatory review and/or approval.
SECTION 1.64 "PHARMACOGENOMIC SERVICE" means a service in which any Kit
incorporating a Validated Marker is used for the selection of patients for
participation in a clinical trial organized by a third party to evaluate at
least one therapeutic drug candidate or prophylactic drug candidate that has not
previously failed in development.
SECTION 1.65 "PRODUCT" means a Diagnostic Product and/or a
Pharmacogenomic Product, as the case may be.
SECTION 1.66 "PRODUCT AREA" means a Colon Product Area and/or a
Non-Colon Product Area.
SECTION 1.67 "PROGRAM CANDIDATE MARKER" means a Candidate Marker that
(a) incorporates, is derived from, is developed using or is covered by Program
Intellectual Property and (b) has been shown in a study of clinically annotated
human tissue samples to be of potential use in the development of a Program
Product or a component thereof. The determination that a Candidate Marker has
achieved the status of a Program Candidate Marker shall be made in good faith by
the Joint Steering Committee.
SECTION 1.68 "PROGRAM DIAGNOSTIC PRODUCT" means a Diagnostic Product
that (a) contains one or more Program Validated Markers, and (b) is developed
for use in one or more of the Disease Areas.
SECTION 1.69 "PROGRAM DIRECTOR" means the research executive appointed
by a Party to serve as such Party's principal coordinator and liaison for the
Research Program. The Program Director appointed by Becton Xxxxxxxxx is referred
to as the "Becton Xxxxxxxxx Program Director," and the Program Director
appointed by MPMx is referred to as the "MPMx Program Director."
SECTION 1.70 "PROGRAM HOME BREW PRODUCT" means a Home Brew Product that
contains one or more Program Validated Markers.
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
SECTION 1.71 "PROGRAM INTELLECTUAL PROPERTY" means Program Know-How and
Program Patent Rights, collectively.
SECTION 1.72 "PROGRAM KNOW-HOW" means MPMx Program Know-How, Becton
Xxxxxxxxx Program Know-How and Joint Program Know-How, collectively.
SECTION 1.73 "PROGRAM PATENT RIGHTS" means MPMx Program Patent Rights,
Becton Xxxxxxxxx Program Patent Rights and Joint Program Patent Rights,
collectively.
SECTION 1.74 "PROGRAM PHARMACOGENOMIC PRODUCT" means a Pharmacogenomic
Product that (a) contains one or more Program Validated Markers, and (b) is
developed for use with any drug or class of drugs with an approved indication in
one or more of the Disease Areas.
SECTION 1.75 "PROGRAM PHARMACOGENOMIC SERVICE" means a Pharmacogenomic
Service that (a) is provided using one or more Program Validated Markers, and
(b) relates to a therapeutic and/or prophylactic agent which is intended to
treat and/or prevent an indication in one or more of the Disease Areas.
SECTION 1.76 "PROGRAM PRODUCT" means a Program Diagnostic Product
and/or Program Pharmacogenomic Product, as the case may be.
SECTION 1.77 "PROGRAM TERM" means the period commencing on the
Effective Date and ending on the earlier of (a) the last day of the Sixth
Contract Year, (b) the termination of the Research Program pursuant to Section
2.8 or 2.9 or (c) the date of the termination of this Agreement.
SECTION 1.78 "PROGRAM VALIDATED MARKER" means a Program Candidate
Marker or set of Program Candidate Markers that has been validated by MPMx in a
clinically relevant population mirroring the intended use of the Product to
demonstrate clinical significance and [**]. The determination that a Program
Candidate Marker has achieved the status of a Program Validated Marker shall be
approved in good faith by the Joint Steering Committee.
SECTION 1.79 "RESEARCH PLAN" means (a) the generic research and
development plan to be undertaken in the Research Program and Development
Program, which is attached as EXHIBIT B to this Agreement, as such plan may be
updated or amended pursuant to Section 2.3(c), and (b) a more specific research
and development plan for each Exclusive Product Area, Co-Exclusive Colon Product
Area, Exclusive Colon
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
Pharmacogenomic Product Opportunity and Co-Exclusive Pharmacogenomic Product
Opportunity, as reviewed and approved by the Joint Steering Committee.
SECTION 1.80 "RESEARCH PROGRAM" means the research program to be
undertaken by the Parties to develop Products for use in the Field, including
Screening Products, Staging Products and Pharmacogenomic Products, as more fully
set forth in the Research Plan. The Research Program does not encompass
activities undertaken by either Party with respect to Non-Exclusive Product
Areas or NonExclusive Pharmacogenomic Product Opportunities.
SECTION 1.81 "RESERVED NON-COLON PRODUCT AREA" means a Non-Colon
Product Area that (a) is selected by Becton Xxxxxxxxx; (b) is not an Exclusive
Non-Colon Product Area; and (c) can become EITHER an Exclusive Non-Colon Product
Area upon selection by Becton Xxxxxxxxx OR a Non-Exclusive Non-Colon Product
Area.
SECTION 1.82 "RESERVED PRODUCT AREA" means a Reserved Colon Product
Area and/or a Reserved Non-Colon Product Area.
SECTION 1.83 [**] means [**].
SECTION 1.84 "STOCK PURCHASE AGREEMENT" means the Stock Purchase
Agreement between Becton Xxxxxxxxx and MPMx dated as of the Execution Date.
SECTION 1.85 "TERRITORY" means all countries of the world.
SECTION 1.86 "THIRD PARTY PHARMACOGENOMIC PRODUCT" means a
Pharmacogenomic Product for use in the Field developed in the course of the
provision by MPMx of Pharmacogenomic Services to a third party.
SECTION 1.87 "U.S. GAAP" means United States generally accepted
accounting principles, consistently applied.
SECTION 1.88 "VALIDATED MARKER" means a Candidate Marker that has been
shown by statistically significant data in a study of human materials to be of
use as a Product or a component thereof.
SECTION 1.89 "VIABLE PLATFORM" means a semi or fully automated
instrument used to detect and/or measure clinically relevant analyte(s) of test
specimens, which instrument is [**].
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
SECTION 1.90 ADDITIONAL DEFINITIONS. Each of the following definitions
is set forth in the section of this Agreement indicated below:
DEFINITION SECTION
---------- -------
"1974 Convention" 10.3
"501(k)" 2.12(a)(i)
"[**]" 2.12(d)(i)
"Adjusted Amortizable License Payment" 1.2
"ADR" 9.1
"Affected Program Product" 4.7(d)(i)(a)
"Agreement" Preamble
"Annual Adjustment" 4.5(a)
"Bayer" 1.5
"Becton Xxxxxxxxx" Preamble
"Becton Xxxxxxxxx Indemnified Parties" 10.1(b)
"Becton Xxxxxxxxx Inventions" 5.1(a)
"Becton Xxxxxxxxx Program Director" 1.62
"Breaching Party" 8.3
"Co-Exclusive Colon Pharmacogenomic Product Opportunity" 2.5(b)(ii)(e)
"Co-Exclusive Colon Product Area" 2.5(a)(iii)
"Co-Exclusive Non-Colon Pharmacogenomic Product Opportunity" 2.4(b)(iii)
"Colon Diagnostic Project" 2.5(a)(i)
"Colon Diagnostic Project Proposal" 2.5(a)(iii)
"Colon PGX Project" 2.5(b)(i)
"Colon PGX Project Proposal" 2.5(b)(ii)(b)
"Commercial Requirement" Exhibit C
"Competing Generic Product" 4.7(d)(i)(a)
"Convertible Note" 4.4(c)
"CPR" 10.2
"Disease Area" 1.30
"Exchange Act" 1.13
"Exclusive Colon Pharmacogenomic Product Opportunity" 2.5(b)(ii)(e)
"Exclusive Colon Product Area" 2.5(a)(iii)
"Execution Date" Preamble
"FDA Approval" 2.12(a)(ii)
"FDC Act" 2.12(a)(ii)
"First Diligence Benchmark" 2.12(a)(i)
"Funding Amount" 4.5(a)
"Independent Party" Exhibit C
"Initial Public Offering" 4.4(a)
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
"Intellectual Property Requirement" Exhibit C
"Invalidity Claim" 5.6(d)
"Joint Inventions" 5.1(c)
"Joint Steering Committee" 2.2(a)
"Licensed Intellectual Property" 7.5(e)
"Lilly" 1.47
"Loan Option" 4.4(a)
"Loan Option Conditions" 4.4(a)
"Marker Validation Project Proposal" 2.8(b)
"Market Analysis" Exhibit C
"MBio/MPI Rights Exchange Agreement" 2.1(c)
"Migrated Product" 4.6(b)(ii)
"Milestone Achievement Date" 4.6
"Milestoned Program Diagnostic Product 4.6(b)(i)
"Milestoned Program Pharmacogenomic Product 4.6(b)(i)
"MPMx" Preamble
"MPMx Indemnified Parties" 10.1(a)
"MPMx Inventions" 5.1(b)
"MPMx/MPI Rights Exchange Agreement" 7.6(a)
"MPMx Program Director" 1.62
"MPMx Royalty-Bearing Product" 4.8
"New PGX Product 4.6(b)
"Non-Breaching Party" 8.3
"Non-Colon PGX Project" 2.4(b)(iv)
"Non-Colon PGX Project Proposal" 2.4(b)(ii)
"Non-Exclusive Colon Pharmacogenomic Product Opportunity" 2.5(b)(ii)(f)
"Non-Exclusive Colon Product Area" 2.5(a)(ii), (iv)
"Non-Exclusive Non-Colon Pharmacogenomic Product Opportunity" 2.4(b)(iv)
"Per Product License Amortization Amount" 1.2
"Performance Specifications" 2.2(b)
"PGX Approval Period" 2.5(b)
"PMA" 2.12(a)(i)
"Product Related Information" 2.12(e)(i)
"Reserved Colon Product Area" 2.5(a)(ii)
"Responsible Party" 5.5(c)
"Response Period" 3.4
"Requirements" Exhibit C
"[**]" 3.4
"Scientific/Clinical Requirement" Exhibit C
"Screening Product" 1.19
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
"SEC" 6.3
"Second Anniversary Year" 2.4(a)(ii)
"Second Diligence Benchmark" 2.12(a)(i)
"Securities Act" 4.4(a)
"[**]" 4.7(d)
"Special Purpose Equipment" 1.20
"Staging Product" 1.19
"Successful Projects" Exhibit C
"Third Anniversary Year" 2.4(a)(iii)
"Third Diligence Benchmark" 2.12(a)(i)
"Third Party Claim" 5.6
"Third Party Damages" 5.6(b)
"Third Party Settlement Payments" 5.6(c)
"Transfer Documents" 7.6(a)
"Unmet Benchmark" 2.12(a)(i)
"Unspent Funding Amount" 4.5(c)
"Waived Non-Colon PGX Project" 2.4(b)(iv)
"Year [**] Milestone" 2.8(a)
ARTICLE II
RESEARCH PROGRAM
SECTION 2.1 EXCLUSIVITY.
a. MPMX OBLIGATION. During the Program Term, MPMx agrees
that [**], (i) [**] pursuant to this Agreement), as part of a [**], in any such
case [**] for the development of Diagnostic Products for use in any [**] or (ii)
[**], in either case [**].
x. XXXXXX XXXXXXXXX OBLIGATION. During the Program Term,
Becton Xxxxxxxxx agrees that [**], in any such case [**] development of
Diagnostic Products for use in any [**] or (ii) [**], in either case [**].
c. MPI OBLIGATIONS. For the period that begins on the
Execution Date and ends on the earlier to occur of (i) the termination of the
Program Term and (ii) the termination of the MPMx/MPI Rights Exchange Agreement,
MPI agrees that [**] and covenants that its Affiliates (other than MPMx and
MBio) [**] (A) [**] (B) [**] (including to either Lilly or Bayer pursuant to an
amendment to the Lilly Research and License Agreement or the Bayer Agreement,
respectively) [**] granted to Lilly
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
pursuant to the Lilly Research and License Agreement. For the period that begins
on the Execution Date and ends [**] as those agreed to by MPI pursuant to the
preceding sentence.
SECTION 2.2 JOINT STEERING COMMITTEE.
a. COMPOSITION; RESPONSIBILITIES. The Parties shall
establish a joint steering committee (the "Joint Steering Committee"), comprised
of (i) three (3) representatives of Becton Xxxxxxxxx and three (3) senior
executives of MPMx, and (ii) the Program Directors. Each Party shall make its
designation of its representatives not later than thirty (30) days after the
Effective Date. Each Party shall use reasonable efforts to designate as its
representatives individuals that shall have the requisite experience and
knowledge to oversee the Research Program and the Development Program. The Joint
Steering Committee shall meet within forty-five (45) days after the Effective
Date and, thereafter, at least quarterly during the course of the Research
Program and at least once every six (6) months during the course of the
Development Program or until termination of this Agreement, if earlier, to (i)
review the efforts of the Parties in the conduct of the Research Program and the
Development Program, (ii) review and approve amendments to the Research Plan,
(iii) review the annual development plan to be prepared by Becton Xxxxxxxxx for
the Development Program, (iv) review and approve the committed staffing and
funding levels and scientific rationale for each Product Area that is proposed
by a Party as an Exclusive Product Area and for each Pharmacogenomic Product
Opportunity that is proposed by a Party as an Exclusive Colon Pharmacogenomic
Product Opportunity or a Co-Exclusive Pharmacogenomic Product Opportunity, (v)
establish Performance Specifications in accordance with subsection (b) below,
(vi) determine whether the Year [**] Milestone (as defined in Section 2.8) has
been accomplished, (vii) approve the determination of the Program Directors as
to which, if any, Program Candidate Markers have been validated as Program
Validated Markers, (viii) determine the allocation of the Funding Amount for
each Contract Year after the First Contract Year, (ix) consider and act upon
such other matters as are specified in this Agreement and (x) attempt to resolve
any disputes relating to this Agreement that may arise between the Parties. The
location of such meetings of the Joint Steering Committee shall alternate
between Massachusetts and Maryland, or as otherwise agreed by the Parties. The
Joint Steering Committee may also meet by means of a telephone conference call.
Each Party may change any one or more of its representatives to the Joint
Steering Committee at any time upon notice to the other Party. Each Party shall
use reasonable efforts to cause its representatives to attend the meetings of
the Joint Steering Committee. If a representative of a Party is unable to attend
a meeting, such Party may designate an alternate to attend such meeting in place
of the absent
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representative. In addition, each Party may, at its discretion, invite
non-voting employees, and, with the consent of the other Party, consultants or
scientific advisors (provided they are engaged under obligations of
confidentiality) to attend the meetings of the Joint Steering Committee to,
among other things, review and discuss the Research Program and/or the
Development Program, as the case may be, and its results.
b. ESTABLISHING PRODUCT PERFORMANCE SPECIFICATIONS.
Within [**] after the initiation of work under the Research Program for each
Exclusive Product Area, Co-Exclusive Colon Product Area, Exclusive Colon
Pharmacogenomic Product Opportunity or Co-Exclusive Pharmacogenomic Product
Opportunity (other than for a Third Party Pharmacogenomic Product), the Joint
Steering Committee shall, in consultation with marketing and other specialists,
agree upon performance specifications ("Performance Specifications") including
without limitation, quantitative levels of sensitivity and/or specificity and
positive and/or negative predictive value for each Program Product for such
Exclusive Product Area, Co-Exclusive Colon Product Area, Exclusive Colon
Pharmacogenomic Product Opportunity or Co-Exclusive Pharmacogenomic Product
Opportunity. In defining Performance Specifications, the Joint Steering
Committee shall consider commercially available products, if any, which are
"market leaders" either in terms of market share and/or technical performance.
Such commercial product or products shall serve as a reference for establishing,
as applicable, sensitivity and/or specificity and positive and/or negative
predictive value guidelines for each Program Product. Performance Specifications
may be modified from time to time by the Joint Steering Committee during the
Program Term and the term of the Development Program.
c. DECISION MAKING.
i. In general, matters to be agreed upon or
approved by the Parties shall be referred to the Joint Steering Committee. Upon
five business days written notice, either Party may convene a special meeting of
the Joint Steering Committee for the purpose of resolving disputes. All
decisions of the Joint Steering Committee (including, without limitation,
resolution of disputes) shall be made by majority vote of all of the members of
the Joint Steering Committee (i.e., the affirmative vote of not less than five
(5) members), and the goal of all decision making shall be to achieve consensus.
If the Joint Steering Committee is unable to reach agreement on any matter
referred to it for resolution by the Parties within one month after the matter
is referred to it, such matter shall be referred to the Executive Officers. Any
resolution of the Executive Officers shall be final and binding on the Parties.
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ii. Each Executive Officer shall have the right
to engage the services of any number of independent experts in the field in
question (each individual so engaged by each Executive Officer to be engaged
under obligations of confidentiality and with consideration of competitive
issues for the other Party) to assist the Executive Officers in making a joint
determination in the best interests of the collaboration, and each Executive
Officer shall be obligated to consider in good faith the analyses and opinions
of any such independent experts engaged by either of them in making a
determination.
iii. If the Executive Officers are unable to
resolve a matter referred to them under this Section within one month after the
matter is referred to them, the provisions of Article IX shall apply; PROVIDED
THAT (A) if the Executive Officers are unable to resolve a disagreement of the
Joint Steering Committee with respect to the selection of a specific Approved
Sublicensee then the Parties agree that [**]; (B) if the Executive Officers are
unable to resolve a disagreement of the Joint Steering Committee with respect to
Blocking Third Party Intellectual Property, Enabling Third Party Intellectual
Property and/or Enhancing Third Party Intellectual Property, the provisions of
Section 5.4 shall govern the resolution of such disagreement; (C) any dispute
with respect to patent validity or inventorship shall be determined by mutually
acceptable independent patent counsel not regularly engaged by either Party; (D)
if the Executive Officers are unable to resolve a disagreement with respect to
adjustments to the Funding Amount pursuant to Section 4.5(a)(i), then no such
adjustment shall be made; (E) if the Executive Officers are unable to resolve a
disagreement relating to Special Purpose Equipment, the relevant Special Purpose
Equipment shall not become a component of the Direct Cost of Goods Sold and (F)
if the Executive Officers are unable to resolve a disagreement of the Joint
Steering Committee with respect to changes or modifications to the Year [**]
Milestone pursuant to Section 2.8, the Year [**] Milestone shall not be changed
or modified.
SECTION 2.3 MANAGEMENT OF RESEARCH PROGRAM.
a. PROGRAM DIRECTORS. Becton Xxxxxxxxx and MPMx shall
each appoint a Program Director prior to the Effective Date. Each Party shall
have the right, after consultation with the other Party, to designate a
different Program Director. The Program Directors shall jointly oversee the
conduct of the Research Program and shall be responsible for, among other
things, (i) determining which Program Candidate Markers, if any, have been
validated as Program Validated
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Markers and (ii) recommending to the Joint Steering Committee any changes to the
Research Plan.
b. PROJECT TEAMS. The Program Directors shall appoint
one or more appropriate project teams, in each case consisting of
representatives from Becton Xxxxxxxxx and MPMx, to facilitate the conduct of
elements of the Research Program and the collaboration of the Parties in (i) the
areas set forth in the Research Plan; and (ii) such other areas as may be agreed
upon by the Joint Steering Committee.
c. RESEARCH PLAN. The Parties shall undertake the
Research Program during the Program Term in accordance with the Research Plan.
The Research Plan shall set forth the research goals for the Research Program
during each Contract Year. The Program Directors shall review the Research Plan
on at least an annual basis and submit any proposed modifications or updates to
the Joint Steering Committee for its review, as well as proposed revised
research goals for the following Contract Year. Any such modifications, updates
or research goals shall not become effective until approved by the Joint
Steering Committee. The Joint Steering Committee shall review and consider any
such proposed modifications, updates or research goals on an expeditious basis.
d. Notwithstanding anything in this Section 2.3 to the
contrary, Becton Xxxxxxxxx shall have the right, in its discretion, to modify
the Research Program in order to pursue other Research Plans, provided the Joint
Steering Committee or Executive Officers agree as to whether any adjustment to
the Year [**] Milestone should be made pursuant to Section 2.8 as a result
thereof. In modifying Research Plans, Becton Xxxxxxxxx shall consider the impact
of such actions on commitments (financial or otherwise) made by MPMx and/or the
Parties to third parties (e.g. academic institutions) pursuant to the Research
Program.
SECTION 2.4 NON-COLON CANCER PROGRAMS.
a. EXCLUSIVE, RESERVED AND NON-EXCLUSIVE NON-COLON
PRODUCT AREAS.
i. EXCLUSIVE AND RESERVED NON-COLON PRODUCT
AREAS AS OF THE EXECUTION DATE. The Parties have agreed to [**] Exclusive
Non-Colon Product Areas as of the Execution Date that are identified in the
Research Plan. The [**] remaining Non-Colon Product Areas shall be Reserved
Non-Colon Product Areas.
ii. EXCLUSIVE, RESERVED AND NON-EXCLUSIVE
NON-COLON PRODUCT AREAS AS OF THE [**. At the end of the [**] period immediately
following the Effective Date (the "[**]"), the Research Program shall include
Exclusive Non-Colon Product Areas that are selected by Becton Xxxxxxxxx and
approved by the Joint Steering
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Committee, which approval shall be based on a determination by the Joint
Steering Committee that, with respect to each such Exclusive Non-Colon Product
Area, there is an appropriate scientific rationale and a commitment by Becton
Xxxxxxxxx of appropriate funding. The number of Reserved Non-Colon Product Areas
on the Second Anniversary Date shall be [**]; these Reserved Non-Colon Product
Areas shall be selected by Becton Xxxxxxxxx from the Non-Colon Product Areas
which have not been selected by Becton Xxxxxxxxx as Exclusive Non-Colon Product
Areas. Following the [**], the Non-Colon Product Areas that are neither
Exclusive nor Reserved Non-Colon Product Areas shall be Non-Exclusive Non-Colon
Product Areas.
iii. EXCLUSIVE AND NON-EXCLUSIVE NON-COLON
PRODUCT AREAS AS OF THE [**]. At the end of the [**] period immediately
following the Effective Date ("Third Anniversary Date"), the Research Program
shall include Exclusive Non-Colon Product Areas that are selected by Becton
Xxxxxxxxx and approved by the Joint Steering Committee, which approval shall be
based on a determination by the Joint Steering Committee that, with respect to
each such Exclusive Non-Colon Product Area, there is an appropriate scientific
rationale and a commitment by Becton Xxxxxxxxx of appropriate funding. The
number of Reserved Non-Colon Product Areas on the [**] shall be [**] the
category of Reserved Non-Colon Product Areas. Following the [**], the Non-Colon
Product Areas that are not Exclusive Non-Colon Product Areas shall be
Non-Exclusive Non-Colon Product Areas.
b. NON-COLON PHARMACOGENOMIC PROJECTS.
i. OVERVIEW. The Parties contemplate that, from
time to time during the Program Term, either Party may become aware of projects
relating to the research and development of a Pharmacogenomic Product in the
Field outside of the Disease Area of colon cancer (each, a "Non-Colon PGX
Project"). The Parties hereby agree [**] with the provisions of this Section
2.4(b).
ii. NON-COLON PGX PROJECT PROPOSAL. In the event
that either Party wishes to either include a Non-Colon PGX Project in the
Research Program or undertake a Non-Colon PGX Project during the Program Term in
collaboration with a third party, such Party shall first submit to the Joint
Steering Committee a proposal with respect to such Non-Colon PGX Project (a
"Non-Colon PGX Project Proposal"). A Non-Colon PGX Project Proposal may relate
to a therapeutic or prophylactic drug or class of therapeutic or prophylactic
drugs or class of compounds containing a therapeutic or prophylactic drug. A
Non-Colon PGX Project Proposal shall include (A) a scientific rationale
reasonably designed to lead to the discovery of Program Validated Markers of
sufficient importance that Program Pharmacogenomic Products incorporating such
Program Validated Markers would be likely to provide a meaningful clinical
advance; (B) a project plan describing the required research headcount for such
project and timelines to the identification of Program Validated
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Markers; (C) a description of the resources, if any, required from third
parties, including without limitation academic and/or clinical organizations,
and the plan to access such resources; (D) a definition of the scope of the
project with respect to the approved drug(s) and/or class of compounds
containing such approved drug; and (E) an analysis of intellectual property
relating to the proposed Program Pharmacogenomic Product and Validated Markers
contemplated for use in such Program Pharmacogenomic Product. The Joint Steering
Committee shall have a period of [**] days after receipt of a Non-Colon PGX
Project Proposal in which to approve the Non-Colon PGX Project described therein
for inclusion in the Research Program (the "PGX Approval Period"). Such approval
shall be based on a determination by the Joint Steering Committee that, with
respect to such Non-Colon PGX Project, there is an appropriate scientific
rationale and a commitment by Becton Xxxxxxxxx of appropriate funding. The
Parties hereby agree that a commitment by Becton Xxxxxxxxx of appropriate
funding may include a situation in which either:
(a) Becton Xxxxxxxxx indicates in
writing that it will provide the requisite funding on a specified date that is
[**] after the expiration of the applicable PGX Approval Period, or
(b) Becton Xxxxxxxxx indicates in
writing that it will provide the requisite funding on a specified date following
such determination by the Joint Steering Committee (which date shall [**] after
the expiration of the applicable PGX Approval Period), but only if (x) [**]
during the time period between the initiation of such Non-Colon PGX Project and
the provision of funding by Becton Xxxxxxxxx, (y) [**] Becton Xxxxxxxxx [**] of
such project, and (z) the Parties reach agreement prior to the expiration of the
applicable PGX Approval Period with respect to financial arrangements intended
to [**] which arrangements may include incremental royalty payments, milestone
payments or other financial considerations.
iii. APPROVED NON-COLON PGX PROJECTS. In the
event that the Joint Steering Committee approves a Non-Colon PGX Project, the
Parties shall expeditiously amend the Research Plan in order to accommodate and
reflect the inclusion of such Non-Colon PGX Project. Each Non-Colon PGX Project
that is included in the Research Program shall define a Pharmacogenomic Product
opportunity, the scope of which shall be determined by the scope of the
Non-Colon PGX Project and as to which Becton Xxxxxxxxx shall have co-exclusive
rights as set forth in Section 3.1(b)(ii), subject to Becton Dickinson's
obligation to meet development and commercialization obligations set forth in
Section 2.12 (a "Co-Exclusive Non-Colon Pharmacogenomic Product Opportunity").
iv. WAIVED PGX NON-COLON PROJECTS. In the event
that the Joint Steering Committee does not approve a Non-Colon PGX Project, then
such Non-Colon PGX Project shall not be included in the Research Program (a
"Waived
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Non-Colon PGX Project"). Each Waived Non-Colon PGX Project shall define a
Pharmacogenomic Product opportunity, the scope of which shall be determined by
the scope of the Waived Non-Colon PGX Project and as to which Becton Xxxxxxxxx
shall have non-exclusive rights as set forth in Section 3.1(b)(iv) (a
"Non-Exclusive Non-Colon Pharmacogenomic Product Opportunity"). Each Party shall
have the right to undertake such Waived Non-Colon PGX Project, either alone or
in collaboration with a third party, and shall have no further obligation to the
other Party with respect to such Waived Non-Colon PGX Project and any
Pharmacogenomic Product resulting therefrom (except that to the extent that any
such Pharmacogenomic Product is a Program Product, in which case the provisions
of this Agreement shall generally apply); PROVIDED THAT if neither Party begins
such Waived Non-Colon PGX Project either alone or in collaboration with a
commercial third party within one (1) year after the Joint Steering Committee
failed to approve such project, then neither Party shall subsequently undertake
such Waived Non-Colon PGX Project in collaboration with a commercial third party
without first re-submitting such project to the Joint Steering Committee for
inclusion in the Research Program, in accordance with the procedures set forth
in this Section 2.4.
SECTION 2.5 COLON CANCER PROGRAMS.
x. XXXXX DIAGNOSTIC PROJECTS.
i. The Parties contemplate that, from time to
time during the Program Term, either Party may desire to undertake a project
relating to the research and development of a Diagnostic Product for a Colon
Product Area (a "Colon Diagnostic Project"). The Parties hereby agree [**],
unless it complies with the provisions of this Section 2.5(a).
ii. The Parties have agreed that during the [**]
period immediately following the Effective Date, [**] Colon Product Areas shall
be deemed to be a "Reserved Colon Product Area", unless [**] such Colon Product
Areas is made an Exclusive Colon Product Area or a Co-Exclusive Colon Product
Area, as further provided in Section 2.5(a)(iii) below. In the event that [**]
Reserved Colon Product Areas is made an Exclusive Colon Product Area or a
Co-Exclusive Colon Product Area during the [**] period immediately following the
Effective Date, then (A) [**] Colon Product Area shall remain a Reserved Colon
Product Area until [**] of the Effective Date, unless such Colon Product Area is
made an Exclusive Colon Product Area or a Co-Exclusive Colon Product Area
pursuant to Section 2.5(a)(iii) below, or a Non-Exclusive Colon Product Area
pursuant to Section 2.5(a)(iv) below, and (B) if [**] Colon Product Area has
remained a Reserved Colon Product Area as of [**] of the Effective Date, then
such Colon Product Area shall be deemed to be a "Non-Exclusive Colon Product
Area" on such [**] date. In the event that [**] Reserved Colon Product Areas is
made an Exclusive Colon Product Area or a Co-Exclusive Colon Product
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Area on or prior to [**] of the Effective Date, [**] of the Effective Date. With
respect to a Reserved Colon Product Area, MPMx shall retain the right to (1)
obtain a license to third party intellectual property relevant to such Reserved
Colon Product Area, and/or (2) undertake, in the absence of a commercial third
party collaborator, a Colon Diagnostic Project that addresses such Reserved
Colon Product Area, and/or (3) enter into a co-exclusive agreement with a
commercial third party collaborator to undertake a Colon Diagnostic Project that
addresses such Reserved Colon Product Area, PROVIDED, HOWEVER, that MPMx shall
promptly, upon the initiation of any such project or the execution of any such
license or agreement, submit to the Joint Steering Committee a proposal with
respect to such Reserved Colon Product Area, in accordance with the provisions
of Section 2.5(a)(iii) below.
iii. In the event that either Party wishes to
include in the Research Program a Colon Diagnostic Project that addresses a
Reserved Colon Product Area (or, in the case of MPMx pursuant to the provisions
of Section 2.5(a)(ii) above, MPMx is obligated to offer a Colon Diagnostic
Project that addresses a Reserved Colon Product Area to the Joint Steering
Committee for inclusion in the Research Program), then such Party shall submit
to the Joint Steering Committee a proposal with respect to such Colon Diagnostic
Project (a "Colon Diagnostic Project Proposal") which shall include the
information set forth in Section 2.4(b)(ii)(A), (B), (C), and (E) with respect
to such Colon Diagnostic Product. A Colon Diagnostic Project shall be included
in the Research Program, and the Colon Product Area addressed by such Colon
Diagnostic Project shall be deemed to be a "Co-Exclusive Colon Product Area", in
the event that the Joint Steering Committee approves the Colon Diagnostic
Project Proposal that describes such Colon Diagnostic Project, which approval
shall be based on a determination by the Joint Steering Committee that, with
respect to such project, there is an appropriate scientific rationale and a
commitment by both Parties of appropriate funding. Appropriate funding shall
include (A) a commitment by each Party [**] required to identify the set of
Program Candidate Markers to be provided to Becton Xxxxxxxxx for Assay
formatting in the course of the Colon Diagnostic Project, and (B) a commitment
by Becton Xxxxxxxxx [**] with respect to such Colon Diagnostic Project,
PROVIDED, HOWEVER, that MPMx shall [**] with respect to the [**] by an [**]
third party intellectual property relevant to such Colon Diagnostic Project that
MPMx elects to contribute to such project, such value to be determined in good
faith by the Joint Steering Committee. In the event that (1) MPMx [**] that in
the opinion of the Joint Steering Committee has an appropriate scientific
rationale and (2) MPMx [**] with respect to such Colon Diagnostic Project, then
Becton Xxxxxxxxx shall [**] with respect to such Colon Diagnostic Project and
such Colon Diagnostic Project shall be included in the Research Program and the
Colon Product Area addressed by such Colon Diagnostic Project shall be deemed to
be an "Exclusive Colon Product Area".
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iv. In the event that a Colon Diagnostic Project
that is the subject of a Colon Diagnostic Project Proposal submitted to the
Joint Steering Committee during the [**] period immediately following the
Effective Date is not approved, then such project shall not be included in the
Research Program and the Colon Product Area addressed by such Colon Diagnostic
Project shall remain a Reserved Colon Product Area until such Product Area is
deemed to be an Exclusive, Co-Exclusive or Non-Exclusive Colon Product Area
[**]. In the event that a Colon Diagnostic Project that is the subject of a
Colon Diagnostic Project Proposal submitted to the Joint Steering Committee
following [**] of the Effective Date is not approved, then such project shall
not be included in the Research Program and the Colon Product Area addressed by
such Colon Diagnostic Project shall be deemed to be a "Non-Exclusive Colon
Product Area" at the time that the Joint Steering Committee makes its
determination not to approve such project.
x. XXXXX PHARMACOGENOMIC PROJECTS.
i. The Parties contemplate that, from time to
time during the Program Term, either Party may wish to undertake a project
relating to the research and development of a Pharmacogenomic Product in colon
cancer (a "Colon PGX Project"). The Parties hereby agree [**] unless it complies
with the provisions of this Section 2.5(b).
ii. The process under which a Colon PGX Project
shall be considered for inclusion in the Research Program shall be as follows:
(a) With respect to any Colon PGX
Project, [**] (1) obtain a license to third party intellectual property relevant
to such Colon PGX Project, and/or (2) undertake such Colon PGX Project in the
absence of a commercial third party collaborator, and/or (3) enter into a
co-exclusive agreement with a commercial third party collaborator to undertake
such Colon PGX Project, PROVIDED, HOWEVER, that (A) [**] upon the initiation of
any such project or the execution of any such license or agreement, [**] with
respect to such Colon PGX Project, in accordance with the provisions of this
Section 2.5(b), and (B) under no circumstance (except as provided in Section
2.6), during [**] immediately following the Effective Date, shall [**] enter
into an exclusive agreement with a commercial third party collaborator to
undertake a Colon PGX Project.
(b) In the event that either Party
wishes to include in the Research Program a Colon PGX Project (or, [**] pursuant
to the provisions of subsection (a) above, [**] a Colon PGX Project to [**] in
the Research Program), then such Party shall submit to the Joint Steering
Committee a proposal with respect to such Colon PGX Project (a "Colon PGX
Project Proposal") which shall include the information set forth in Sections
2.4(b)(ii)(A), (B), (C), (D) and (E) with respect to such
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Colon PGX Project, and shall define the scope of the Pharmacogenomic Product
opportunity addressed by such Colon PGX Project; PROVIDED, HOWEVER, that the
Parties shall only present a Colon PGX Project to the Joint Steering Committee
in the situation in which [**] into the Research Program during [**] period
immediately following the Effective Date and a Colon Product Area has been made
into an Exclusive Colon Product Area or a Co-Exclusive Colon Product Area.
(c) The process by which a Colon PGX
Project shall be considered for inclusion in the Research Program shall be the
same as that observed for inclusion of a Colon Diagnostic Project, as set forth
in Section 2.5(a)(iii) above.
(d) If the Joint Steering Committee
approves a Colon PGX Project for inclusion in the Research Program, then the
Pharmacogenomic Product opportunity addressed by such Colon PGX Project shall be
deemed to be an "Exclusive Colon Pharmacogenomic Product Opportunity" or a
"Co-Exclusive Colon Pharmacogenomic Product Opportunity", as the case may be,
[**] as described in Section 2.5(a)(iii) above for Colon Diagnostic Projects.
(e) If the Joint Steering Committee
determines that a Colon PGX Project shall not be included in the Research
Program [**] of the Effective Date, then the Colon Pharmacogenomic Product
Opportunity addressed by such Colon PGX Project shall be deemed to be a
"Non-Exclusive Colon Pharmacogenomic Product Opportunity".
(f) [**] of the Effective Date, [**].
SECTION 2.6 RIGHT OF MPMX TO DEVELOP THIRD PARTY PHARMACOGENOMIC
PRODUCTS. Notwithstanding the provisions of Sections 2.4(b) and 2.5(b), if in
the course of [**] to participate in the development and commercialization of
such Third Party Pharmacogenomic Product under the Research Program and the
Development Program. However, [**] to such Third Party Pharmacogenomic Product,
then (i) such [**] in collaboration with MPMx), [**], and (ii) MPMx shall have
[**] with respect to, or to undertake with [**] for use in conjunction with a
therapeutic and/or prophylactic drug that is in the same class of compounds as
the therapeutic and/or prophylactic [**] with MPMx), [**]. In the event that
[**] in researching and developing Program Pharmacogenomic Products for use in
conjunction with a class of therapeutic or prophylactic drugs as a result of a
Pharmacogenomic Services arrangement [**] in which [**] then the [**] shall be
[**]. In the event that [**] in researching and developing Program
Pharmacogenomic Products for use in conjunction with a second class of
therapeutic or prophylactic drugs as a result of the same or another
Pharmacogenomic Services arrangement [**].
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SECTION 2.7 RESEARCH PROGRAM RESPONSIBILITIES.
a. GENERAL. Each Party agrees to use commercially
reasonable efforts to (i) undertake the responsibilities assigned to such Party
in the Research Plan, including, but not limited to, the dedication of
laboratory facilities, equipment and personnel appropriate to such efforts, (ii)
perform its obligations hereunder in good faith in a scientific/commercially
reasonable and workpersonlike manner; (iii) as appropriate, make available to
the other Party those resources set forth in the Research Plan; and (iv) carry
out all work done in the course of the Research Program in material compliance
with all applicable federal, state or local laws, regulations and guidelines
governing the conduct of such work, including, without limitation, all
applicable export and import control laws.
b. MPMX RESPONSIBILITIES., MPMx shall undertake those
activities set forth in the Research Plan which are to be undertaken by MPMx in
connection with the Research Program, including, but not limited to: (i)
obtaining access to appropriate biological resources; (ii) discovery and
development of Program Candidate Markers and Program Validated Markers; (iii)
preparation, filing, prosecution and maintenance of patent applications and
patents relating to MPMx Program Intellectual Property and Joint Program
Intellectual Property developed during the Research Program, as further provided
in Section 5.2; (iv) provision to Becton Xxxxxxxxx on an annual basis of a
written description of MPMx Program Patent Rights originating outside the course
of the Research Program including a title, U.S. patent number or application
serial number and list of other countries in which a corresponding patent
application has been filed, (v) disclosure to Becton Xxxxxxxxx of issued patents
and pending foreign patent applications known to MPMx that are owned by third
parties and required to commercialize Program Validated Markers as Program
Products for use in the Field and (vi) sharing expertise and providing such
support as is reasonably required by Becton Xxxxxxxxx in order for Becton
Xxxxxxxxx to perform its responsibilities under Section 2.7 (c) below.
x. XXXXXX XXXXXXXXX RESPONSIBILITIES. Becton Xxxxxxxxx
shall undertake those activities set forth in the Research Plan which are to be
undertaken by Becton Xxxxxxxxx in connection with the Research Program,
including but not limited to (i) sharing expertise and providing such support as
is reasonably required by MPMx in order for MPMx to perform its responsibilities
under Section 2.7(b) above and (ii) undertaking all activities with respect to
the development of reagents, prototype Assays and Assays, including but not
limited to, the identification of a Viable Platform on which such Assays will be
analyzed;
d. PROGRAM KNOW-HOW TRANSFER.
i. For the purposes of facilitating the conduct
of the Research Program and/or the Development Program, each Party shall provide
to the other Party such Program Know-How as the other Party shall reasonably
require to conduct the Research Program and/or the Development Program, based on
the reasonable determination of the Party providing such Program Know-How,
including
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without limitation (A) the transfer by MPMx to Becton Xxxxxxxxx of Program
Validated Markers and (B) the transfer by Becton Xxxxxxxxx to MPMx of Assays, in
each case as specified from time to time in the Research Plan. Each Party agrees
to provide all such Program Know-How to the other Party in accordance with the
Research Plan.
ii. For the purposes of enabling MPMx to exploit
its retained rights set forth in Section 3.3, Becton Xxxxxxxxx shall provide to
MPMx such Becton Xxxxxxxxx Program Know-How and Joint Program Know-How as MPMx
shall reasonably require.
iii. The Parties agree that: (A) all Program
Know-How provided by one Party to the other shall be used in material compliance
with all applicable federal, state or local laws, regulations and guidelines and
consistent with the scope of the licenses to such Program Know-How which are set
forth in this Agreement; (B) all such Program Know-How is provided without any
warranties, express or implied; and (C) the Party providing such Program
Know-How shall obtain (or cause its third party collaborators to obtain or
certify that they have obtained) all required consents from the source of such
Program Know-How.
x. XXXXXX XXXXXXXXX PLATFORM KNOW-HOW TRANSFER. Becton
Xxxxxxxxx shall provide to MPMx the Becton Xxxxxxxxx Platform Know-How specified
in the Research Plan and such other Becton Xxxxxxxxx Platform Know-How as MPMx
may reasonably request from time to time in conjunction with the rights granted
to MPMx by Becton Xxxxxxxxx under Section 3.2(b)(ii). The Parties agree that:
(i) all Becton Xxxxxxxxx Platform Know-How provided by Becton Xxxxxxxxx to MPMx
shall be used in material compliance with all applicable federal, state or local
laws, regulations and guidelines and consistent with the scope of the licenses
to such Becton Xxxxxxxxx Platform Know-How which are set forth in this
Agreement; and (ii) all such Becton Xxxxxxxxx Platform Know-How is provided
without any warranties, express or implied other than customary warranties
provided by Becton Xxxxxxxxx to its customers in the ordinary course of business
with respect to its products and equipment.
SECTION 2.8 REVISION OR EARLY TERMINATION OF RESEARCH PROGRAM RELATING
TO YEAR [**] MILESTONE.
a. YEAR [**] MILESTONE. Becton Xxxxxxxxx shall have the
right to revise or terminate the Research Program if the milestone for the
Research Program set forth on EXHIBIT C to this Agreement relating to the [**]
period immediately following February 1, 1999 (the "Year [**] Milestone") is not
achieved, such right to be exercised within [**] after the Joint Steering
Committee (or the Executive Officers in the event of disagreement, as provided
in Section 2.2(b)) has determined that such
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Year [**] Milestone has not been achieved. It is the expectation of the Parties
that the Year [**] Milestone shall be adjusted, to the extent appropriate, by
the Joint Steering Committee to reflect any changes or modifications to the
Research Plans approved by the Joint Steering Committee following the Execution
Date.
b. REVISION OF RESEARCH PROGRAM. In the event that
Becton Xxxxxxxxx elects to revise the Research Program pursuant to Section
2.8(a), Becton Xxxxxxxxx shall have a period of [**] after the determination is
made that the Year [**] Milestone has not been achieved in which to submit a
proposal to the Joint Steering Committee with respect to the Marker Validation
Project(s) that Becton Xxxxxxxxx has selected for MPMx to undertake (a "Marker
Validation Project Proposal"). The Joint Steering Committee shall have a period
of [**] after receipt of the Marker Validation Project Proposal in which to
approve the Marker Validation Project(s) described therein. Such approval shall
be based on a determination by the Joint Steering Committee that, with respect
to such Marker Validation Project(s), there is an appropriate scientific
rationale and a commitment by Becton Xxxxxxxxx of appropriate funding.
c. TERMINATION OF RESEARCH PROGRAM. In the event that
(i) Becton Xxxxxxxxx elects to terminate the Research Program pursuant to
Section 2.8(a) or (ii) the Joint Steering Committee fails to approve a Marker
Validation Project Proposal, if any, provided by Becton Xxxxxxxxx pursuant to
Section 2.8(b), then the Research Program shall terminate. This Agreement,
including all terms, provisions, representations, rights and obligations set
forth herein that do not relate to the Research Program, shall survive any
termination of the Research Program pursuant to this Section 2.8.
d. RESOLUTION OF DISPUTES. If the Joint Steering
Committee is unable to reach a determination with respect to whether or not the
Year [**] Milestone has been achieved and the Executive Officers are also unable
to reach such determination, the following provisions shall govern the
resolution of such matter:
i. with respect to a disagreement that relates
to the Scientific/Clinical Requirement, the matter shall be resolved by the
determination of a mutually acceptable independent scientific expert not
regularly engaged by either Party;
ii. with respect to a disagreement that relates
to the Intellectual Property Requirement, the matter shall be resolved by the
determination of a mutually acceptable independent patent counsel not regularly
engaged by either Party; and
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iii. with respect to the Commercial Requirement,
the determination by the Independent Party selected by the Parties to undertake
the Market Analysis shall be binding on the Joint Steering Committee.
In the event of any dispute with respect to the Year [**] Milestone, each of the
Parties is relieved of its obligations with respect to the Research Program
during the term of such dispute.
SECTION 2.9 REVISION OR EARLY TERMINATION OF RESEARCH PROGRAM FOR
CHANGE OF CONTROL.
a. CHANGE OF CONTROL. If a Change of Control occurs
during the Research Program, MPMx shall give prompt written notice to Becton
Xxxxxxxxx of such Change of Control. Becton Xxxxxxxxx shall have the right, in
its sole discretion, to revise or terminate the Research Program by giving MPMx
written notice within [**] after such Change of Control.
b. REVISION OF RESEARCH PROGRAM. In the event that
Becton Xxxxxxxxx elects to revise the Research Program pursuant to Section
2.9(a), Becton Xxxxxxxxx shall submit a Marker Validation Project Proposal to
the Joint Steering Committee with respect to the Marker Validation Project(s)
that Becton Xxxxxxxxx has selected for MPMx to undertake. The Joint Steering
Committee shall have a period of [**] after receipt of the Marker Validation
Project Proposal in which to approve the Marker Validation Project(s) described
therein. Such approval shall be based on a determination by the Joint Steering
Committee that, with respect to such Marker Validation Project(s), there is an
appropriate scientific rationale and a commitment by Becton Xxxxxxxxx of
appropriate funding.
c. TERMINATION OF RESEARCH PROGRAM. In the event that
(i) Becton Xxxxxxxxx elects to terminate the Research Program pursuant to
Section 2.9(a) or (ii) the Joint Steering Committee fails to approve a Marker
Validation Project Proposal, if any, provided by Becton Xxxxxxxxx pursuant to
Section 2.9(b), then the Research Program shall terminate. This Agreement,
including all terms, provisions, representations, rights and obligations set
forth herein that do not relate to the Research Program, shall survive any
termination of the Research Program pursuant to this Section 2.9.
SECTION 2.10 DEVELOPMENT PROGRAM. Becton Xxxxxxxxx shall have
responsibility for undertaking the conduct of the Development Program, which
activities shall include but not be limited to:
a. identifying one or more appropriate clinical
laboratories to provide fee-for-services using Program Home Brew Products;
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with the Securities and Exchange Commission. Asterisks denote omissions.
b. conducting all clinical trials which are required for
Becton Xxxxxxxxx to obtain regulatory approval to manufacture, market and sell
Program Products in the Territory;
c. determining the nature and content of any submissions
to the FDA or any foreign regulatory agencies which are necessary for Becton
Xxxxxxxxx to obtain approval to manufacture, market and sell Program Products in
the Territory and the preparation and filing of any such submissions; PROVIDED
THAT MPMx shall have an opportunity (not to exceed [**]) to review in advance
all regulatory submissions to be made by Becton Xxxxxxxxx in Major Market
Countries and, at the option of Becton Xxxxxxxxx, shall be permitted to attend
all preparatory and regulatory meetings with the FDA or any foreign regulatory
agencies in Major Market Countries concerning such submissions;
d. obtaining all regulatory and other approvals
necessary for Becton Xxxxxxxxx to manufacture, market and sell Program Products
in the Territory.
SECTION 2.11 COMMERCIALIZATION.
a. RESPONSIBILITIES. Becton Xxxxxxxxx shall have the
responsibility of undertaking the commercialization of Program Products, which
shall include the manufacture, marketing, promotion, sale and distribution of
Program Products in the Territory after such time as all required regulatory and
other approvals have been obtained; PROVIDED THAT Becton Xxxxxxxxx and MPMx
shall discuss issues concerning marketing, including without limitation product
labeling, advertising strategies and patient and physician education strategies;
and FURTHER PROVIDED THAT, Becton Xxxxxxxxx and MPMx shall jointly develop and
implement marketing activities with respect to Program Products which relate to
melanoma.
b. PRODUCT LABELING. All Program Products shall carry
the Becton Xxxxxxxxx name and logo and, unless otherwise requested by MPMx, the
MPMx name and logo (or any successor name and logo) on the product label to the
extent MPMx has rights to use and license such name and logo, PROVIDED THAT,
Becton Xxxxxxxxx may omit the MPMx name, but not the MPMx logo, on the product
label if, and only if, a space constraint precludes the use of the MPMx name.
Becton Xxxxxxxxx shall in its reasonable discretion determine how the MPMx logo
and/or name shall be incorporated on the label. All written materials associated
with each Program Product shall indicate that the Program Product was developed
with the use of MPMx technology. If the MPMx name and/or logo appears on the
product label for any Program Products, either MPMx or an Affiliate designated
by MPMx shall have the right to monitor the quality of such Program Products in
accordance with reasonable procedures to be agreed upon by the Parties.
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
SECTION 2.12 BECTON XXXXXXXXX DEVELOPMENT AND COMMERCIALIZATION
DILIGENCE OBLIGATIONS.
a. TABLE I DILIGENCE OBLIGATIONS. Table I below sets
forth Becton Dickinson's specific diligence obligations with respect to the
development and commercialization of Program Products for each Exclusive Product
Area, Exclusive Colon Pharmacogenomic Product Opportunity and Co-Exclusive
Pharmacogenomic Product Opportunity. Becton Xxxxxxxxx shall meet, for at least
one Program Product for each Exclusive Product Area, Co-Exclusive Colon Product
Area, Exclusive Colon Pharmacogenomic Product Opportunity or Co-Exclusive
Pharmacogenomic Product Opportunity, the First Diligence Benchmark, Second
Diligence Benchmark and Third Diligence Benchmark (as those terms are defined
below) within the time periods specified in Table I. With respect to each such
Program Product, Becton Dickinson's development and commercialization diligence
obligations shall commence upon the selection and transfer to Becton Xxxxxxxxx
of Program Candidate Markers for use in formatting an Assay.
i. FIRST DILIGENCE BENCHMARK. To meet the
"First Diligence Benchmark" with respect to a Program Product, Becton Xxxxxxxxx
must:
(a) [**];
(b) [**]; and,
(c) as determined necessary by the
Joint Steering Committee, [**].
ii. SECOND DILIGENCE BENCHMARK. To meet the
"Second Diligence Benchmark" with respect to a Program Product, Becton Xxxxxxxxx
must:
(a) [**]; and
(b) [**].
iii. THIRD DILIGENCE BENCHMARK. To meet the
"Third Diligence Benchmark" with respect to a Program Product, Becton Xxxxxxxxx
must [**].
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with the Securities and Exchange Commission. Asterisks denote omissions.
Table I
Number of Months
-----------------------------------------
Program
Screening Staging Pharmacogenomic
Event Product Product Product
----- --------- ------- ---------------
MPMx, in consultation with [**] [**] [**]
Becton Xxxxxxxxx, selects and
transfers Program Candidate
Markers for Becton Dickinson's
use in Assay formatting
--------------------------------------------------------------------------------
First Diligence Benchmark [**] [**] [**]
--------------------------------------------------------------------------------
Second Diligence Benchmark [**] [**] [**]
--------------------------------------------------------------------------------
Third Diligence Benchmark [**]
Notwithstanding anything to the contrary in this Section 2.12(a), in the event
Becton Xxxxxxxxx fails to meet any diligence benchmark described in this Section
2.12(a) with respect to a Program Product (an "Unmet Benchmark"), [**] under
this Section 2.12(a) with respect to such Program Product if:
1. Becton Xxxxxxxxx can demonstrate
that it has [**] such Program Product [**].
2. the Joint Steering Committee [**]
in which event [**] as shall be agreed upon by the Joint Steering Committee)
[**]; and
3. [**].
b. GENERAL DILIGENCE OBLIGATIONS. In addition to the
specific diligence obligations set forth in Section 2.12(a) above, Becton
Xxxxxxxxx shall [**] for each Exclusive Product Area, Co-Exclusive Colon Product
Area, Exclusive Colon Pharmacogenomic Product Opportunity and Co-Exclusive
Pharmacogenomic Product Opportunity in each Major Market Country. Such efforts
and commitment shall not be less than the efforts and commitment expended by
Becton Xxxxxxxxx in connection with its other development and commercialization
projects that are at a comparable stage of its development and commercialization
process and that are of comparable scientific and commercial potential.
Specifically, for each Program Product in clinical development for each
Exclusive Product Area, Co-Exclusive Colon Product Area,
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with the Securities and Exchange Commission. Asterisks denote omissions.
Exclusive Colon Pharmacogenomic Product Opportunity and Co-Exclusive
Pharmacogenomic Product Opportunity, Becton Xxxxxxxxx agrees [**] for such
Program Product in each Major Market Country. Upon receipt of regulatory
approval, Becton Xxxxxxxxx agrees to use commercially reasonable efforts to
market and sell each such Program Product in each Major Market Country.
c. PROGRESS REPORTS. Becton Xxxxxxxxx shall provide MPMx
with a quarterly written report describing Becton Dickinson's progress
consistent with Exhibit B in developing and commercializing all Program Products
upon commencement of the diligence obligations set forth in Section 2.12(a)
above. Such reports shall be provided within [**] after the conclusion of the
first Contract Year in which such diligence obligations commenced and quarterly
thereafter for each Program Product until the First Commercial Sale of each such
Program Product in each Major Market Country.
d. PROCESS FOR DETERMINATION OF DILIGENCE. In the event
that MPMx does not believe that Becton Xxxxxxxxx has satisfied its diligence
obligations under this Section 2.12, MPMx shall notify Becton Xxxxxxxxx in
writing specifying the diligence obligation believed not to be satisfied. Any
such notice prior to the First Commercial Sale of a Program Product in each
Major Market Country shall be delivered to Becton Xxxxxxxxx within [**] of MPMx'
receipt of a progress report pursuant to Section 2.12(c). If Becton Xxxxxxxxx
believes that it has satisfied such obligations, it shall so notify MPMx within
[**] after receipt of MPMx's notice. Such notice by Becton Xxxxxxxxx shall
indicate the reasons that Becton Xxxxxxxxx believes it has satisfied its
obligations under Sections 2.12(a) and (b), as applicable, and provide
supporting information for such position. If MPMx disagrees with Becton
Dickinson's response, the Parties shall attempt in good faith to resolve the
disagreement, referring the matters to the Executive Officers for resolution
pursuant to Section 2.2(b), if necessary.
e. FAILURE TO MEET DILIGENCE.
i. Subject to the provisions of Section
2.12(d), if Becton Xxxxxxxxx fails to meet any diligence benchmark as set forth
in Section 2.12(a) above, then, [**] as the case may be. In addition to the
foregoing, Becton Xxxxxxxxx shall (A) deliver to MPMx copies of any and all
regulatory and clinical information related to the Program Validated Market
included in such Program Product (but excluding information relating to the
related Viable Platform, Assay formats and manufacturing processes) that Becton
Xxxxxxxxx owns or otherwise controls and as to which Becton Xxxxxxxxx has the
right to grant licenses or sublicenses without violating the terms of any
agreement (the "Product Related Information"), and (B) grant to MPMx a fully
paid-up, non-royalty bearing license, with the right to grant sublicenses, to
use, copy, display, modify and create derivative works of such Product Related
Information to
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develop and commercialize such 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), in the event Becton Xxxxxxxxx fails to meet its diligence obligations
with respect to a Major Market Country, as set forth in Section 2.12(b) above,
then, [**], as the case may be, [**] for such Major Market Country (an [**]) and
such Product Area or such product opportunity shall be deemed to be a
Non-Exclusive Product Area or a Non-Exclusive Pharmacogenomic Product
Opportunity, as the case may be, [**]. In addition, Becton Xxxxxxxxx shall (A)
deliver to MPMx any and all Product Related Information for such Program Product
[**] and (B) grant to MPMx a fully paid-up non-royalty bearing license with the
right to grant sublicenses, to use, copy, display, modify and create derivative
works of such Product Related Information to develop and commercialize such
Program Product in the Abandoned Market for such NonExclusive Product Area or
such Non-Exclusive Pharmacogenomic Product Opportunity, as the case may be.
iii. The rights of MPMx under Sections 2.12(e)(i)
and (ii) shall be MPMx' sole and exclusive remedies for Becton Dickinson's
failure to meet any of its diligence obligations under Sections 2.12(a) and/or
(b).
SECTION 2.13 PROGRESS REPORTS. Within [**] after the end of each
calendar quarter, each Party shall provide to the Joint Steering Committee a
written report summarizing the activities undertaken by such Party during the
preceding calendar quarter in connection with the Research Program and the
Development Program.
ARTICLE III
GRANT OF RIGHTS
SECTION 3.1 MPMX GRANTS.
a. RESEARCH LICENSES. Subject to the terms and
conditions of this Agreement, MPMx hereby grants to Becton Xxxxxxxxx, a
non-exclusive, non-royalty- bearing right and license in the Territory, without
the right to grant sublicenses except as provided in Section 3.1(c) below, under
the MPMx Program Intellectual Property, to (i) make and use Program Candidate
Markers and Program Validated Markers in the course of the Research Program to
the extent necessary for Becton Xxxxxxxxx to undertake its responsibilities as
set forth in the Research Plan and (ii) make and use Program Validated Markers
in the course of the Development Program to research and develop Program
Products for use in the Field.
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b. PRODUCT COMMERCIALIZATION LICENSES.
i. Subject to the terms and conditions of this
Agreement, MPMx hereby grants to Becton Xxxxxxxxx an exclusive, royalty-bearing
right and license in the Territory, without the right to grant sublicenses
except as provided in Section 3.1(c) below, under the MPMx Program Intellectual
Property and MPMx' rights in the Joint Program Intellectual Property, to make,
use, import, offer to sell and sell (A) any Program Product inside any Exclusive
Product Area or to address any Exclusive Colon Pharmacogenomic Product
Opportunity, and (B) any Program Diagnostic Product that contains a Program
Validated Marker that was developed for an Exclusive Non-Colon Product Area
inside the Disease Area that includes such Exclusive Non-Colon Product Area.
ii. Subject to the terms and conditions of this
Agreement, MPMx hereby grants to Becton Xxxxxxxxx a co-exclusive (with MPMx and
its Affiliates), royalty-bearing right and license in the Territory, without the
right to grant sublicenses except as provided in Section 3.1(c) below, under the
MPMx Program Intellectual Property and MPMx' rights in the Joint Program
Intellectual Property, to make, use, import, offer to sell and sell any Program
Product to address any Co-Exclusive Non-Colon Pharmacogenomic Product
Opportunity.
iii. Subject to the terms and conditions of this
Agreement, MPMx hereby grants to Becton Xxxxxxxxx a co-exclusive (with MPMx, its
Affiliates and no more than one sublicensee in the case of each of the
Co-Exclusive Colon Product Areas and each of the Co-Exclusive Colon
Pharmacogenomic Product Opportunities), royalty-bearing right and license in the
Territory, without the right to grant sublicenses, under the MPMx Program
Intellectual Property and MPMx' rights in the Joint Program Intellectual
Property, to make, use, import, offer to sell and sell any Program Product
inside any Co-Exclusive Colon Product Area or to address any Co-Exclusive Colon
Pharmacogenomic Product Opportunity.
iv. Subject to the terms and conditions of this
Agreement and except as specifically provided for in Section 3.1(b)(i)(B), MPMx
hereby grants to Becton Xxxxxxxxx a non-exclusive, royalty-bearing right and
license in the Territory, under the MPMx Program Intellectual Property and MPMx'
rights in the Joint Program Intellectual Property, to make and have made, use
and have used, import, offer to sell and sell any Program Product inside any
Non-Exclusive Product Area and to address any Non-Exclusive Pharmacogenomic
Product Opportunity.
x. XXXXXX XXXXXXXXX SUBLICENSE RIGHTS. Becton Xxxxxxxxx
shall have the right to grant sublicenses under the licenses from MPMx set forth
in Sections 3.1(a) and (b)(i) and (ii) above to Approved Sublicensees; PROVIDED,
HOWEVER, that Approved Sublicensees shall have no right to grant further
sublicenses without the prior written consent of MPMx. Becton Xxxxxxxxx shall
have responsibility for all obligations of Approved Sublicensees and guarantees
to MPMx the performance of all such obligations. The payment of royalties by
Becton Xxxxxxxxx under Section 4.7
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with the Securities and Exchange Commission. Asterisks denote omissions.
below shall be the obligation of Becton Xxxxxxxxx regardless of whether sales
are made by Becton Xxxxxxxxx or an Approved Sublicensee.
d. LICENSE TO PROVIDE PROGRAM PHARMACOGENOMIC SERVICES.
Subject to the terms and conditions of this Agreement, MPMx hereby grants to
Becton Xxxxxxxxx a non-exclusive, royalty-bearing right and license in the
Territory, without the right to grant sublicenses, under the MPMx Program
Intellectual Property and MPMx' rights in the Joint Program Intellectual
Property, to make, import and use Program Validated Markers in order to provide
Program Pharmacogenomic Services in the Field.
e. THIRD PARTY LICENSES. MPMx represents and warrants
that, in the event that MPMx seeks to grant to a third party a license or
sublicense with respect to Program Products as permitted under Sections
3.1(b)(ii), 3.1(b)(iii), 3.1(b)(iv) and 3.1(d), it is the intention of MPMx to
seek royalty and financial provisions that are at least as favorable to MPMx as
the applicable provisions of Article IV of this Agreement, provided that the
Parties recognize that the foregoing is an expression of MPMx' intention and
shall not preclude MPMx from consummating a transaction on terms less favorable
to MPMx than the applicable terms of this Agreement.
SECTION 3.2 BECTON XXXXXXXXX GRANTS.
a. RESEARCH LICENSE. Subject to the terms and conditions
of this Agreement, Becton Xxxxxxxxx hereby grants to MPMx and its Affiliates a
non-exclusive, non-royalty-bearing right and license in the Territory, with the
right to grant sublicenses as contemplated by the Research Plan or as otherwise
approved by the Joint Steering Committee, under the Becton Xxxxxxxxx Program
Intellectual Property and the Becton Xxxxxxxxx Platform Intellectual Property,
to make and use Program Candidate Markers and Program Validated Markers in the
course of the Research Program to the extent necessary for MPMx to research and
develop Program Products for use in the Field.
b. LICENSES TO EXPLOIT MPMX RETAINED RIGHTS.
i. Subject to the terms and conditions of this
Agreement, Becton Xxxxxxxxx hereby grants to MPMx a non-exclusive,
non-royalty-bearing (except as provided below) right and license in the
Territory, with the right to grant sublicenses as provided in Section 3.2(c),
under the Becton Xxxxxxxxx Program Intellectual Property and Becton Dickinson's
rights in the Joint Program Intellectual Property, to the extent necessary to
exploit MPMx's retained rights, as set forth in Section 3.3 below. In the event
that Becton Xxxxxxxxx owes a royalty to a third party on the sale by MPMx or its
sublicensees of products covered by Becton Xxxxxxxxx Program Patent Rights,
Becton Xxxxxxxxx shall notify MPMx of such royalty
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
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, MPMx shall provide Becton
Xxxxxxxxx written notice of its election to either (A) pay Becton Xxxxxxxxx an
amount equal to the royalty payable to the third party on account of such sales
by MPMx or its sublicensees, or (B) relinquish its rights under this Section
3.2(b)(i) under such Becton Xxxxxxxxx Program Patent Rights.
ii. Subject to the terms and conditions of this
Agreement (including without limitation the right of first negotiation with
respect to ROFN Products set forth in Section 3.4 below), Becton Xxxxxxxxx
hereby grants to MPMx (A) a non-royalty-bearing, non-exclusive right and license
in the Territory, without the right to grant sublicenses except as provided in
Section 3.2 (c) below, under the Becton Xxxxxxxxx Platform Intellectual
Property, to research and develop Products for use outside the Field, and (B) to
the extent Becton Xxxxxxxxx may do so, without violating the terms of any
agreement with a third party executed prior to MPMx' notice to Becton Xxxxxxxxx
under Section 4.8 with respect to each MPMx Royalty- Bearing Product, a
non-exclusive, royalty-bearing right and license in the Territory, without the
right to grant sublicenses except as provided in Section 3.2 (c) below, under
Becton Xxxxxxxxx Platform Intellectual Property, to make, use, import, offer to
sell and sell Products for use outside the Field.
c. MPMX SUBLICENSE RIGHTS. MPMx shall have the right to
grant sublicenses under the licenses from Becton Xxxxxxxxx set forth in Section
3.2(b)(i) and (ii), PROVIDED THAT, with respect to sublicense grants under
Section 3.2(b)(ii), MPMx shall only grant sublicenses to parties collaborating
with MPMx in the research, development and commercialization of Products for use
outside the Field, which sublicenses Becton Xxxxxxxxx has approved, which
approval shall not be unreasonably withheld, after MPMx has (i) provided prior
written notice to Becton Xxxxxxxxx of any such proposed sublicense, and (ii)
provided Becton Xxxxxxxxx with information concerning the name of such proposed
sublicensee and the scope of the sublicense.
SECTION 3.3 MPMX RETAINED RIGHTS. Except as specifically provided for
herein (including without limitation the right of first negotiation with respect
to ROFN Products set forth in Section 3.4 below), MPMx retains all rights and
licenses to exploit MPMx Program Intellectual Property, including but not
limited to MPMx's rights to research, develop, make, use, import, sell and offer
for sale, and to sublicense others to research, develop, make, use, import, sell
and offer for sale, with respect to:
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with the Securities and Exchange Commission. Asterisks denote omissions.
a. therapeutic and/or prophylactic products for any
indications inside and outside the Field,
b. Diagnostic Products for use inside the Field, other
than a Diagnostic Product inside any Exclusive Product Area or Reserved Product
Area and except as specifically provided for in Section 3.1(b)(i)(B),
c. Diagnostic Products for use outside the Field;
d. Pharmacogenomic Products for use inside and outside
the Field, other than a Pharmacogenomic Product to address any Exclusive Colon
Pharmacogenomic Product Opportunity;
e. Pharmacogenomic Services inside and outside the
Field.
Nothing contained in this Agreement shall be construed to restrict or
limit the right of MPMx to exploit any of such retained rights through or with
any of its Affiliates, including the right to assign any of such retained rights
to one or more Affiliates.
SECTION 3.4 BECTON DICKINSON'S [**]. If, prior to the expiration of the
Program Term, MPMx seeks to commercialize [**] in collaboration with a third
party, MPMx shall [**]. Becton Xxxxxxxxx shall [**] Becton Xxxxxxxxx indicates
that [**], the Parties shall [**] as may be mutually agreeable. [**] reach
mutual agreement.
SECTION 3.5 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 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 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, unless the bankrupt Party elects
to continue, and continues, to perform all of its obligations under this
Agreement.
ARTICLE IV
FINANCIAL PROVISIONS
SECTION 4.1 LICENSE PAYMENT. On the Effective Date, and in
consideration of the grant by MPMx to Becton Xxxxxxxxx of the rights granted
under Article III,
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with the Securities and Exchange Commission. Asterisks denote omissions.
Becton Xxxxxxxxx shall make an initial non-refundable license payment to MPMx of
[**].
SECTION 4.2 ADDITIONAL PAYMENT. On each anniversary of the Effective
Date during the Program Term, and in consideration for the rights granted by
MPMx to Becton Xxxxxxxxx under MPMx Program Patent Rights originating subsequent
to the Effective Date during each Contract Quarter of the Program Term, but
outside the course of the Research Program, Becton Xxxxxxxxx shall make a
payment to MPMx of [**].
SECTION 4.3 EQUITY INVESTMENT. On the Execution Date, MPMx and Becton
Xxxxxxxxx shall execute the Stock Purchase Agreement pursuant to which Becton
Xxxxxxxxx shall purchase, and MPMx shall sell, as of the Effective Date,
1,200,000 shares of MPMx Series C Convertible Preferred Stock at a purchase
price of $12.50 per share.
SECTION 4.4 CONVERTIBLE NOTE.
a. MPMX OPTION. Subject to the provisions of Section
2.6, MPMx shall have the option to require that Becton Xxxxxxxxx make a loan or
loans in an aggregate amount up to [**] in accordance with this Section 4.4 (the
"Loan Option") in the event that the following conditions (the "Loan Option
Conditions") have been met: (i) at the time MPMx exercises such option, MPMx has
neither (A) completed an initial public offering of any class of its equity
securities (an "Initial Public Offering") pursuant to a registration statement
declared effective under the Securities Act of 1933, as amended (the "Securities
Act"), nor (B) filed a registration statement meeting the requirements of the
Securities Act for the purpose of completing an Initial Public Offering, which
has not been withdrawn by MPMx or otherwise terminated prior to effectiveness;
(ii) either (A) the [**] has been achieved, or (B) if the [**] has not been
achieved, Becton Xxxxxxxxx has not elected to terminate the Research Program
pursuant to Section 2.8; (iii) at the time MPMx exercises such option, MPMx is
not in breach of this Agreement; (iv) there shall not have occurred and be
continuing an Event of Default (as defined in the Convertible Note); (v) the
Guaranty Agreement, in substantially the form attached hereto as EXHIBIT G,
shall be in full force and effect, (vi) MPMx shall have certified to Becton
Xxxxxxxxx that the representations and warranties of MPMx set forth in the
Convertible Note are true and correct as of the closing date specified pursuant
to subsection (b), (vii) there shall not have occurred a Change of Control, and
(viii) MPMx shall have not exercised its conversion rights under Section 1 of
the Convertible Note.
b. EXERCISE OF MPMX OPTION. Subject to the provisions of
Section 2.6, MPMx may exercise the Loan Option at any time or times after the
Third Anniversary Date and prior to the end of the Sixth Contract Year so long
as, with
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
respect to each exercise thereof, each of the Loan Option Conditions have been
met at the time of such exercise. MPMx shall exercise the Loan Option by
providing written notice to Becton Xxxxxxxxx specifying (i) the desired amount
of the loan (not to exceed an aggregate of [**] for all such loans), and (ii)
the desired closing date for the loan (which shall be at least thirty (30) days
following the date of such notice). Each exercise of the Loan Option shall be
for a loan of not less than [**].
c. FORM OF LOAN; CLOSING. Any loan or loans made to MPMx
by Becton Xxxxxxxxx pursuant to this Section 4.4 shall be evidenced by an
interest-bearing convertible note in substantially the form of EXHIBIT D to this
Agreement (the "Convertible Note"). It shall be a condition to the making of any
loan by Becton Xxxxxxxxx pursuant to this Section 4.4 that MPMx shall have
executed and delivered the Convertible Note to Becton Xxxxxxxxx. On the closing
date specified pursuant to subsection (b), Becton Xxxxxxxxx shall transmit funds
to MPMx in the form of a wire transfer equal to the principal amount specified
pursuant to subsection (b). Becton Xxxxxxxxx shall note on the Schedule to the
Convertible Note the amount of all loans made pursuant to this Section 4.4 and
payments of principal (including amounts set off against Becton Dickinson's
royalty obligations hereunder) and interest made in connection therewith. The
failure of Becton Xxxxxxxxx to make such notation upon the making of any loan or
the payment (or set-off) of any principal or interest, however, shall not alter
or impair the rights and remedies of Becton Xxxxxxxxx if a loan has actually
been made, or the rights and remedies of MPMx if payment (or set-off) of
principal or interest has been made, in accordance with the terms of this
Agreement and the Convertible Note.
SECTION 4.5 RESEARCH FUNDING.
a. FUNDING AMOUNT. In support of the Research Program
and MPMx's contribution to the Development Program, if any, Becton Xxxxxxxxx
shall pay to MPMx a total of [**] during the six (6) Contract Years of the
Program Term (the "Funding Amount"), such amount to be (i) subject to adjustment
upwards or downwards by the Joint Steering Committee, (ii) subject to the Annual
Adjustment (as defined below) and (iii) allocated by the Joint Steering
Committee among the Contract Years pursuant to subsection (b), PROVIDED THAT in
no event shall the Funding Amount for any of the Second Contract Year, Third
Contract Year and Fourth Contract Year be [**] per Contract Year. The Funding
Amount shall be subject, beginning with the Third Contract Year, to an annual
adjustment equal to the percentage increase or decrease in the United States
Consumer Price Index for the preceding twelve (12) month period (the "Annual
Adjustment"). The Funding Amount provided by Becton Xxxxxxxxx to MPMx shall
consist of (i) amounts allocated for support of MPMx personnel (at a rate of
[**] per FTE annually, subject to the Annual Adjustment), (ii) amounts for the
funding of external relationships with third parties (e.g., costs associated
with collaborations and the in-licensing of
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with the Securities and Exchange Commission. Asterisks denote omissions.
technology (including tissues and samples) other than Blocking Third Party
Intellectual Property, Enabling Third Party Intellectual Property and Enhancing
Third Party Intellectual Property from academic and clinical institutions)
undertaken from time to time as part of the Research Program.
b. PAYMENTS. Within [**] after the Effective Date,
Becton Xxxxxxxxx shall pay to MPMx the Funding Amount for the first Contract
Quarter, as specified in EXHIBIT E. On or prior to the first day of each
subsequent calendar month after the end of the first Contract Quarter during the
First Contract Year, Becton Xxxxxxxxx shall pay to MPMx the Funding Amount for
such calendar month, as specified in EXHIBIT E. At least [**] prior to the
commencement of each subsequent Contract Year, the Joint Steering Committee
shall agree upon the allocation of the Funding Amount for each Contract Quarter
of such Contract Year. On or prior to the first day of each calendar month
during each such Contract Quarter, Becton Xxxxxxxxx shall pay to MPMx [**] of
the Funding Amount for such Contract Quarter.
c. ADJUSTMENTS. Within [**] after the completion of each
Contract Quarter during the Program Term, MPMx shall provide Becton Xxxxxxxxx
with a written statement setting forth the number of FTEs working on the
Research Program and a description of the work completed, and external
collaboration funding and the purpose of such funding during the preceding
Contract Quarter. Except as provided below, MPMx shall provide to Becton
Xxxxxxxxx a credit for any amounts overpaid by Becton Xxxxxxxxx (except that
with respect to the last Contract Quarter of the last Contract Year, MPMx shall
reimburse Becton Xxxxxxxxx for any amounts overpaid by Becton Xxxxxxxxx) or
invoice Becton Xxxxxxxxx for any amounts underpaid during such Contract Quarter
(except that Becton Xxxxxxxxx shall not be obligated to pay to MPMx an amount
that exceeds (i) the funding levels set forth in EXHIBIT E, with respect to the
First Contract Year, or (ii) the funding levels established by the Joint
Steering Committee, with respect to subsequent Contract Years). Notwithstanding
the foregoing, if any of the Funding Amount remains unspent at the end of the
Sixth Contract Year (the "Unspent Funding Amount") then Becton Xxxxxxxxx may
allocate (a) all or some portion of the Unspent Funding Amount to one or more
Marker Validation Projects and (b) if any remains, up to [**] of the Unspent
Funding Amount to the completion of one or more aspects of the Development
Program or Becton Dickinson's activities relating to the commercialization of
Program Products.
d. RECORDS AND AUDITS. MPMx shall keep, and shall
require its Affiliates to keep, complete and accurate records relating to
funding of the Research Program by Becton Xxxxxxxxx and MPMx' expenses for MPMx
Program Patent Rights, all in accordance with U.S. GAAP. Becton Xxxxxxxxx shall
have the right once each Contract Year at Becton Dickinson's expense to retain
an independent, certified public accountant, selected by Becton Xxxxxxxxx and
reasonably acceptable to MPMx, to review such records in the location(s) where
such records are maintained by
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with the Securities and Exchange Commission. Asterisks denote omissions.
MPMx upon reasonable notice and during regular business hours and under
obligations of strict confidence for the sole purposes of verifying the number
of FTEs working on the Research Program and the work performed and external
collaborations undertaken as part of the Research Program for which MPMx has
provided funding pursuant to the Research Program. Results of such review shall
be made available to both Parties. If the review reflects an overpayment of
funding to MPMx, such overpayment shall be promptly remitted to Becton
Xxxxxxxxx, together with interest calculated in accordance with Section 4.12. If
the overpayment is equal to or greater than [**] of the actual annual funding
amount that was otherwise due, Becton Xxxxxxxxx shall be entitled to have MPMx
pay all of the costs of such review.
SECTION 4.6 MILESTONE PAYMENTS.
a. PAYMENT SCHEDULE. Becton Xxxxxxxxx shall make the
following milestone payments to MPMx in connection with Program Products
licensed to Becton Xxxxxxxxx under this Agreement upon achievement by Becton
Xxxxxxxxx or any Approved Sublicensee of the applicable milestones:
Payment Due
Upon Achievement
Milestone of Milestone
--------- ------------
1. Upon [**] of the following Disease Areas:
a. [**] [**]
b. [**] [**]
c. [**] [**]
d. [**] [**]
e. [**] [**]
f. [**] [**]
2. Upon [**] [**]
3. Upon [**] [**]
4. Upon [**] [**]
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Payment Due
Upon Achievement
Milestone of Milestone
--------- ------------
5. Upon the earlier of [**] in each of the
following Disease Areas:
a. [**] [**]
b. [**] [**]
c. [**] [**]
d. [**] [**]
e. [**] [**]
6. Upon the [**] except as provided in [**]
subsection (b) below
7. Upon the [**], except as provided in [**]
subsection (b) below
8. Upon the [**] except as provided in [**]
subsection (b) below
9. Upon the [**] except as provided in [**]
subsection (b) below
10. Upon the [**] [**]
11. Upon the [**] [**]
12. Upon [**] [**]
13. Upon [**] [**]
14. Upon [**]
(a) [**] then the following milestone payments shall be made:
i. Upon the [**] [**]
ii. Upon the [**] [**]
iii. Upon the [**] [**]
iv. Upon the [**] [**]
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with the Securities and Exchange Commission. Asterisks denote omissions.
(b) Alternatively, [**] then the following milestone payments shall
be made:
i. Upon the [**] [**]
ii. Upon the [**] [**]
iii. Upon the [**] [**]
iv. Upon the [**] [**]
b. MIGRATION ADJUSTMENT. Notwithstanding the milestone
payments set forth in Items 6, 7, 8 and 9 of subsection (a) above, in the event
that:
x. Xxxxxx Xxxxxxxxx has made a milestone
payment to MPMx with respect to a Program Diagnostic Product under Item 5 of
subsection (a) above (a "Milestoned Program Diagnostic Product") or has made or
is obligated to make milestone payments to MPMx with respect to a Program
Pharmacogenomic Product under Items 6 and 7 or 8 and 9 of subsection (a) above
(a "Milestoned Program Pharmacogenomic Product"); AND
ii. either (A) the Milestoned Program Diagnostic
Product receives FDA Approval as a Program Pharmacogenomic Product (a "Migrated
Product"), or (B) the Milestoned Program Pharmacogenomic Product receives FDA
Approval for a different drug and/or Disease Area than the drug and/or Disease
Area for which the milestone referred to in subsection (i) was paid (a "New PGX
Product"),
then, [**].
c. TIMING OF PAYMENTS. Each milestone payment shall be
made by Becton Xxxxxxxxx to MPMx within [**] after the achievement of the
applicable milestone.
SECTION 4.7 ROYALTY PAYMENTS TO MPMX. Becton Xxxxxxxxx shall pay to
MPMx royalties as follows:
a. PROGRAM PRODUCTS. With respect to each sale of any
Program Product by Becton Xxxxxxxxx, its Affiliates or Approved Sublicensees,
Becton Xxxxxxxxx shall pay to MPMx a royalty equal to [**] on such Program
Product.
b. THIRD PARTY PHARMACOGENOMIC PRODUCTS. With respect to
each sale of each Third Party Pharmacogenomic Product by Becton Xxxxxxxxx, its
Affiliates or Approved Sublicensees, Becton Xxxxxxxxx shall pay to MPMx a
royalty of (i) [**]
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on such Third Party Pharmacogenomic Product if MPMx has retained, and has
licensed to Becton Xxxxxxxxx, exclusive rights to commercialize such Third Party
Pharmacogenomic Product, or (ii) [**] on such Third Party Pharmacogenomic
Product if MPMx has retained, and has licensed to Becton Xxxxxxxxx,
non-exclusive rights to commercialize such Third Party Pharmacogenomic Product.
c. PROGRAM PHARMACOGENOMIC SERVICES. Becton Xxxxxxxxx
shall pay to MPMx a royalty in connection with the use of any product which
contains a Program Validated Marker in Program Pharmacogenomic Services provided
by Becton Xxxxxxxxx. [**] for such service shall be considered to be the [**].
d. [**]
i. [**]. The royalty rates set forth in
subsections (a), (b) and (c) above shall [**] (as described below). As used in
this subsection, [**] as follows:
(a) If, in any country, any third party
shall sell or otherwise distribute [**]; and
(b) The regulatory requirements (if
any) [**]; and
(c) The [**]; and
(d) The dollar sales of the [**], as
measured by publicly available industry data (such as IMS data);
then [**] shall be deemed to exist [**] of the Affected Program Product. If
Becton Xxxxxxxxx [**] in any country with respect to an Affected Program
Product, it shall provide written notice to MPMx providing supporting evidence
thereof. MPMx shall indicate to Becton Xxxxxxxxx within [**] after receipt of
such notice whether it [**]. If MPMx [**], the provisions of subsection (ii)
shall apply; if MPMx [**], and the Parties are unable in good faith to reach
agreement, then [**] shall be submitted to the Executive Officers.
ii. ROYALTY ADJUSTMENT. During the period in
which [**], the royalty rates set forth in subsections (a), (b) and (c) shall be
[**] during the applicable calendar quarter and whose [**] in the affected
country during the applicable calendar quarter, PROVIDED THAT in no event shall
such royalty rates [**]. For example, [**] royalty rate under subsection (a)
shall be [**].
SECTION 4.8 ROYALTY PAYMENTS TO BECTON XXXXXXXXX. In the event that
MPMx intends to commercialize a Product that is covered by the license to Becton
Xxxxxxxxx Platform Intellectual Property granted pursuant to Section
3.2(b)(ii)(B) above but is
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not commercialized in collaboration with Becton Xxxxxxxxx pursuant to Section
3.4 (an "MPMx Royalty-Bearing Product"), MPMx shall notify Becton Xxxxxxxxx in
writing of such intent. Such notice shall be provided [**] to the anticipated
date of the commercial introduction of such MPMx Royalty-Bearing Product.
Promptly following such notice, the Parties shall negotiate in good faith the
royalty rates (which shall be [**] of Net Sales) and royalty-related and other
terms applicable to such MPMx Royalty-Bearing Product. If the Parties have not
agreed upon such royalty rates and royalty-related terms within [**] after such
notice, the matter shall be submitted to the Executive Officers, and, failing
resolution by them, to ADR proceedings pursuant to Section 9.1, PROVIDED that
with respect to any such ADR proceeding, (a) the Parties agree to select a
neutral party to preside in the resolution of such disagreement who has
appropriate industry experience as to make a determination of what a reasonable
royalty rate should be, and (b) such neutral party shall select a royalty rate
[**].
SECTION 4.9 LENGTH OF ROYALTY PAYMENTS. The royalties payable under
Section 4.7 shall be paid on a country-by-country basis on each such Program
Product, Third Party Pharmacogenomic Product or Program Pharmacogenomic Service
until the later of (a) the expiration of all Program Patent Rights which cover
such Program Product, Third Party Pharmacogenomic Product or Program
Pharmacogenomic Service in such country or (b) [**] after the First Commercial
Sale of such Program Product, Third Party Pharmacogenomic Product or Program
Pharmacogenomic Service in such country.
SECTION 4.10 ROYALTIES PAYABLE ONLY ONCE. Becton Dickinson's obligation
to pay royalties under Section 4.7 is imposed only once with respect to the same
unit of Program Product, Third Party Pharmacogenomic Product and/or Program
Pharmacogenomic Service. Except as specifically provided in this Agreement,
there shall be no deductions from the royalties payable hereunder.
SECTION 4.11 ROYALTY REPORTS AND ACCOUNTING.
a. ROYALTY REPORTS; ROYALTY PAYMENTS. Becton Xxxxxxxxx
shall deliver to MPMx, within [**] after the end of each calendar quarter,
reasonably detailed written accountings of Gross Profits on Program Products,
Third Party Pharmacogenomic Products and/or Pharmacogenomic Services that are
subject to royalty payments due to MPMx for such calendar quarter. Such
quarterly reports shall indicate (i) gross sales and Net Sales on a
product-by-product basis, (ii) the determination of Direct Cost of Goods Sold
and Cost of Goods Sold, and (iii) the calculation of royalties from such gross
sales, Gross Profits and Net Sales. When Becton Xxxxxxxxx delivers such
accounting to MPMx, Becton Xxxxxxxxx shall also deliver all royalty payments due
under Section 4.7 to MPMx for the calendar quarter.
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b. AUDITS BY MPMX. Becton Xxxxxxxxx shall keep, and
shall require its Approved Sublicensees to keep, complete and accurate records
of the latest three (3) years relating to Net Sales, Direct Cost of Goods Sold,
Cost of Goods Sold, Gross Profits, and Sections 4.12, 4.13 and 4.14. For the
sole purpose of verifying royalties payable to MPMx, MPMx shall have the right
annually at MPMx's expense to retain an independent, certified public accountant
selected by MPMx and reasonably acceptable to Becton Xxxxxxxxx, to review such
records in the location(s) where such records are maintained by Becton
Xxxxxxxxx, its Affiliates or Approved Sublicensees upon reasonable notice and
during regular business hours and under obligations of strict confidence.
Results of such review shall be made available to both Parties. If the review
reflects an underpayment of royalties to MPMx, such underpayment shall be
promptly remitted to MPMx, together with interest calculated in the manner
provided in Section 4.12 below. If the underpayment is equal to or greater than
[**] of the royalty amount that was otherwise due, MPMx shall be entitled to
have Becton Xxxxxxxxx pay all of the costs of such review.
SECTION 4.12 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 MPMx may designate from time to time within no more than
[**] 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 Becton Xxxxxxxxx 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 Becton Xxxxxxxxx may
subsequently utilize generally in its currency accounting procedures, in which
case Becton Xxxxxxxxx shall provide notice to MPMx promptly of any such change).
Becton Xxxxxxxxx shall pay interest to MPMx 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 U.S. prime rate
reported by THE WALL STREET JOURNAL 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 MPMx contains any terms which
conflict with the terms of this Agreement, the terms of this Agreement shall
prevail.
SECTION 4.13 TAX WITHHOLDING. The Parties shall use all reasonable and
legal efforts to reduce tax withholding on payments made to MPMx hereunder.
Notwithstanding such efforts, if Becton Xxxxxxxxx concludes that tax
withholdings under the laws of any country are required with respect to payments
to MPMx, Becton Xxxxxxxxx shall withhold the required amount and pay it to the
appropriate governmental authority. In such a case, Becton Xxxxxxxxx shall
promptly provide MPMx with original receipts or other evidence reasonably
required and sufficient to allow MPMx to document such tax withholdings
adequately for purposes of claiming foreign tax credits and similar benefits.
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SECTION 4.14 BLOCKED PAYMENTS. In the event that, by reason of
applicable laws or regulations in any country, it becomes impossible or illegal
for Becton Xxxxxxxxx or its Affiliates or Approved Sublicensees, to transfer, or
have transferred on its behalf, royalties or other payments to MPMx, such
royalties or other payments shall be deposited in local currency in the relevant
country to the credit of MPMx in a recognized banking institution designated by
MPMx or, if none is designated by MPMx within a period of thirty (30) days, in a
recognized banking institution selected by Becton Xxxxxxxxx or its Affiliates or
Approved Sublicensees, as the case may be, and identified in a notice in writing
given to MPMx.
ARTICLE V
INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS
SECTION 5.1 OWNERSHIP OF INVENTIONS.
x. XXXXXX XXXXXXXXX INVENTIONS. Becton Xxxxxxxxx shall
exclusively own all inventions made solely by its employees, agents and
consultants in the course of the Research Program and the Development Program
("Becton Xxxxxxxxx Inventions").
b. MPMX INVENTIONS. MPMx shall exclusively own all
inventions made solely by its employees, agents and consultants in the course of
the Research Program and the Development Program ("MPMx Inventions").
c. JOINT INVENTIONS. All inventions made jointly by
employees, agents and consultants of Becton Xxxxxxxxx and employees, agents and
consultants of MPMx in the course of the Research Program and/or the Development
Program ("Joint Inventions") shall be owned jointly on the basis of each Party
having an undivided interest in the whole.
d. INVENTORSHIP. The determination of inventorship shall
be made in accordance with relevant patent laws. In the event of a dispute
regarding inventorship, if the Parties are unable to resolve the dispute,
mutually acceptable independent patent counsel not regularly employed by either
Party shall resolve such dispute.
SECTION 5.2 PROSECUTION AND MAINTENANCE OF PATENT RIGHTS.
x. XXXXXX XXXXXXXXX INVENTIONS. Becton Xxxxxxxxx shall
have the exclusive right and option to file and prosecute any patent
applications and to maintain any patents covering Becton Xxxxxxxxx Inventions;
PROVIDED THAT in the event that Becton Xxxxxxxxx declines the option to file and
prosecute any such patent applications or maintain any such patents covering any
Becton Xxxxxxxxx Invention, it shall give MPMx reasonable notice to this effect
and thereafter MPMx may, upon written notice to Becton Xxxxxxxxx, file and
prosecute such patent applications and maintain such patents in Becton
Dickinson's name, all at MPMx's expense, and all
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such Becton Xxxxxxxxx Inventions shall remain owned exclusively by Becton
Xxxxxxxxx.
b. MPMX INVENTIONS. MPMx shall have the exclusive right
and option to file and prosecute any patent applications and maintain any
patents covering MPMx Inventions; PROVIDED THAT in the event that MPMx declines
the option to file and prosecute any such patent applications or maintain any
such patents covering any MPMx Invention, it shall give Becton Xxxxxxxxx
reasonable notice to this effect and thereafter Becton Xxxxxxxxx may, upon
written notice to MPMx, file and prosecute such patent applications and maintain
such patents in MPMx's name, all at Becton Dickinson's expense, and all such
MPMx Inventions shall remain owned exclusively by MPMx.
c. JOINT INVENTIONS. MPMx shall have the exclusive right
and option to file and prosecute any patent applications and to maintain any
patents covering Joint Inventions made in the course of the Research Program;
PROVIDED THAT in the event that MPMx declines the option to file and prosecute
any such patent applications or maintain any such patents covering any such
Joint Inventions, it shall give Becton Xxxxxxxxx reasonable notice to this
effect and thereafter Becton Xxxxxxxxx may, upon written notice to MPMx, file
and prosecute such patent applications and maintain such patents jointly in both
Parties' names. Becton Xxxxxxxxx shall have the exclusive right and option to
file and prosecute any patent applications and to maintain any patents covering
Joint Inventions made in the course of the Development Program; PROVIDED THAT in
the event that Becton Xxxxxxxxx declines the option to file and prosecute any
such patent applications or maintain any such patents covering any such Joint
Inventions, it shall give MPMx reasonable notice to this effect and thereafter
MPMx may, upon written notice to Becton Xxxxxxxxx, file and prosecute such
patent application and maintain such patents jointly in both Parties' names.
d. COSTS AND EXPENSES. Each Party shall bear its own
costs and expenses in preparing, filing, prosecuting, maintaining and extending
Program Patent Rights, except that Becton Xxxxxxxxx shall reimburse MPMx for
[**] of the internal and external costs and expenses incurred by MPMx on and
after the Effective Date under Section 5.2(b) and (c) for preparing, filing,
prosecuting, maintaining and extending Program Patent Rights, PROVIDED, HOWEVER,
that (i) reimbursed internal MPMx costs shall be limited to costs incurred by
MPMx attorneys, patent agents, technical specialists and administrative
assistants for work on or directly related to preparing, filing, prosecuting,
maintaining and extending Program Patent Rights, and (ii) such reimbursement to
MPMx shall be reduced by any reimbursed amounts received by MPMx from third
parties relating to the same Patent Rights.
e. COOPERATION. Each Party agrees to cooperate with the
other with respect to the filing, prosecution, maintenance and extension of
patents and patent
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applications pursuant to this Section 5.2, including, without limitation, the
execution of all such documents and instruments and the performance of such acts
as may be reasonably necessary in order to permit the other Party to continue
any filing, prosecution, maintenance or extension of patents and patent
applications that such Party has elected not to pursue, as provided for in
Sections 5.2(a), (b) and (c).
SECTION 5.3 EXPLOITATION OF JOINT PROGRAM INTELLECTUAL PROPERTY.
Subject to all provisions of this Agreement, including without limitation (a)
the grant of licenses to Becton Xxxxxxxxx and MPMx, respectively, under Article
III; and (b) Becton Dickinson's royalty obligations pursuant to Article IV, each
Party shall be free to exploit Joint Program Intellectual Property worldwide
without restriction and without payment of any additional compensation to the
other Party.
SECTION 5.4 BLOCKING, ENABLING AND ENHANCING THIRD PARTY INTELLECTUAL
PROPERTY.
a. GENERAL. If either Party believes that there exists
third party intellectual property which constitutes Blocking Third Party
Intellectual Property, Enabling Third Party Intellectual Property or Enhancing
Third Party Intellectual Property, it shall notify the Joint Steering Committee.
The Joint Steering Committee shall then determine (i) whether or not such third
party Patent Rights constitute Blocking Third Party Intellectual Property,
Enabling Third Party Intellectual Property or Enhancing Third Party Intellectual
Property, as the case may be, and, if so, whether the Program Validated Marker
or Validated Marker, as applicable, should be included in the Program Product;
and (ii) if the determination of the Joint Steering Committee is affirmative,
then whether, on what terms (economic or otherwise), and by which Party such
Blocking Third Party Intellectual Property, Enabling Third Party Intellectual
Property or Enhancing Third Party Intellectual Property, as the case may be,
shall be licensed for the purposes of this Agreement.
b. RESOLUTION OF DISPUTES. If the Joint Steering
Committee is unable to reach a determination with respect to any third party
Patent Rights under subsection (a)(i) or (a)(ii) above and the Executive
Officers are also unable to reach such a determination, the following provisions
shall govern the resolution of such matter:
i. with respect to Blocking Third Party
Intellectual Property, (A) Becton Xxxxxxxxx shall make the determination as to
whether a Program Validated Marker should be included in a Program Product, and
(B) the determination of whether third party Patent Rights cover such Program
Validated Marker (i.e. that such Patent Rights constitute Blocking Third Party
Intellectual Property) shall be made by mutually acceptable independent patent
counsel not regularly engaged by either Party;
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ii. with respect to Enabling Third Party
Intellectual Property, (A) the determination of whether a Program Product would
have no medical value in the Field without the inclusion of a Validated Marker
shall be made by a mutually acceptable technical expert not regularly employed
by either Party; and (B) the determination of whether third party Patent Rights
cover such Validated Marker shall be made by mutually acceptable independent
patent counsel not regularly engaged by either Party;
iii. with respect to Enhancing Third Party
Intellectual Property, if the Joint Steering Committee is unable to make a
determination as to whether a Validated Marker materially enhances the
commercial value of a Program Product, or whether third party Patent Rights
cover such Validated Marker or the terms of the license for such third party
Patent Rights, then such third party Patent Rights shall not constitute
Enhancing Third Party Intellectual Property; and
iv. with respect to the terms under which
Blocking or Enabling Third Party Intellectual Property shall be licensed, Becton
Xxxxxxxxx shall make the determination.
c. REIMBURSEMENT. If the Joint Steering Committee
determines that it shall be the responsibility of MPMx to license any Blocking
Third Party Intellectual Property, Enabling Third Party Intellectual Property or
Enhancing Third Party Intellectual Property, as the case may be, then Becton
Xxxxxxxxx shall reimburse MPMx for [**] of any royalties and/or license fees
paid by MPMx to a third party for such Blocking Third Party Intellectual
Property, Enabling Third Party Intellectual Property or Enhancing Third Party
Intellectual Property, as the case may be, subject to Becton Dickinson's right
to treat such reimbursed costs as if it had made the payments directly for
purposes of determining Cost of Goods Sold.
SECTION 5.5 THIRD PARTY INFRINGEMENT.
a. REASONABLE ACTION. MPMx and Becton Xxxxxxxxx each
agrees to take reasonable actions to protect the Program Patent Rights from
infringement in the Field and to protect the Program Know-How from unauthorized
use in the Field, when, from its own knowledge or upon notice from the other
Party, the Party with knowledge or receiving notice becomes aware of the
reasonable probability that such infringement or unauthorized use exists in the
Field.
b. INFRINGEMENT ACTION. Within [**] of becoming aware of
the infringement of the Program Patent Rights in the Field or unauthorized use
of the Program Know-How in the Field, the Responsible Party (as defined below)
shall decide whether to institute an infringement suit or take other appropriate
action that it believes is reasonably required to protect the Program Patent
Rights and Program Know-How in the Field. If the Responsible Party fails to
institute such suit or take
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such action within such ninety (90) day period, then the other Party shall have
the right at its sole discretion to institute such suit or other appropriate
action in the name of either or both Parties. In such event, the Responsible
Party shall cooperate with the other Party to the extent reasonably possible,
including the joining of suit if necessary or desirable.
c. RESPONSIBLE PARTY. As used herein, the term
"Responsible Party" means (i) Becton Xxxxxxxxx with respect to Becton Xxxxxxxxx
Program Patent Rights and/or Becton Xxxxxxxxx Program Know-How, (ii) MPMx with
respect to MPMx Program Patent Rights and/or MPMx Program Know-How, and (iii)
MPMx with respect to Joint Program Patent Rights and/or Joint Program Know-How.
d. COSTS. Each Party shall assume and pay all of its own
out-of-pocket costs incurred in connection with any litigation or proceedings
described in this Section 5.5, including, without limitation, the fees and
expenses of that Party's counsel.
e. RECOVERIES. Any recovery obtained by any Party as a
result of any proceeding described in this Section 5.5 or from any counterclaim
or similar claim asserted in a proceeding described in Section 5.6, by
settlement or otherwise, shall be applied in the following order of priority:
i. first, to reimburse each Party for all
litigation costs in connection with such proceeding paid by that Party and not
otherwise recovered (on a pro rata basis based on each Party's respective
litigation costs, to the extent the recovery was less than all such litigation
costs); and
ii. second, the remainder of the recovery shall
be paid [**] to the Responsible Party and [**] to the other Party, PROVIDED,
HOWEVER, that if the Responsible Party does not institute suit or take action as
set forth in Section 5.5(b) or elects not to respond to an invalidity claim
pursuant to Section 5.6, then the recovery shall be paid fifty percent (50%) to
each Party.
SECTION 5.6 CLAIMED INFRINGEMENT; CLAIMED INVALIDITY.
a. DEFENSE OF THIRD PARTY INFRINGEMENT CLAIMS. If the
activities of either Party in connection with the Research Program, or if the
making, importing, using, offering to sell or selling of a Program Product in
the Field or providing of Program Pharmacogenomic Services in the Field result
in a claim of patent infringement or other violation of the intellectual
property rights of any third party (a "Third Party Claim"), the Party which is
accused of such infringement shall defend itself at its sole cost. The other
Party shall cooperate with the accused Party in such defense and shall have the
right to be represented by counsel of its own choice.
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b. TREATMENT OF DAMAGE AWARDS. In the event that in any
judicial proceeding referred to in subsection (a) above involving a Third Party
Claim that Blocking Third Party Intellectual Property exists with respect to the
sale of a Program Product, judgment is rendered against Becton Xxxxxxxxx and
damages are awarded to a third party relating to such claim of Blocking Third
Party Intellectual Property, such damages shall be paid by Becton Xxxxxxxxx and
such damages (other than any enhanced damages which, in such judgment, are
attributed to willful infringement by Becton Xxxxxxxxx) ("Third Party Damages")
shall, for purposes of this Agreement, be treated as follows:
i. If Becton Xxxxxxxxx is not enjoined from
selling such Program Product, then:
(a) [**] for the applicable Program
Product; and
(b) [**] for the applicable Program
Product.
ii. If Becton Xxxxxxxxx is enjoined from selling
such Program Product, then:
(a) [**] for other Program Products;
and
(b) [**] and shall be [**] of Becton
Xxxxxxxxx.
c. TREATMENT OF SETTLEMENT PAYMENTS. In the event that
in any judicial proceeding referred to in subsection (a) above involving a Third
Party Claim that Blocking Third Party Intellectual Property exists with respect
to the sale of a Program Product, Becton Xxxxxxxxx xxxxxxx such judicial
proceeding and agrees to make payments to a third party relating to such claim
of Blocking Third Party Intellectual Property ("Third Party Settlement
Payments") such payments shall be made by Becton Xxxxxxxxx and shall, for
purposes of this Agreement, be treated as follows:
i. [**] shall be deemed [**] for the applicable
Program Product; and
ii. [**] shall be deemed [**] for the applicable
Program Product.
d. PATENT INVALIDITY CLAIM. If a third party at any time
asserts a claim that any Program Patent Right is invalid or otherwise
unenforceable (an "Invalidity Claim"), whether as a defense in an infringement
action brought by Becton Xxxxxxxxx or MPMx pursuant to Section 5.5 or in an
action brought against Becton Xxxxxxxxx or MPMx under Section 5.6(a), the
Parties shall cooperate with each other
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in preparing and formulating a response to such Invalidity Claim. The Party
responsible for responding to such claim, at its sole expense, shall be
initially the Responsible Party, subject to the other Party's right, at its sole
expense, to assume responsibility if the Responsible Party elects not to do so.
Neither Party shall settle or compromise any Invalidity Claim without the
consent of the other Party, which consent shall not be unreasonably withheld.
SECTION 5.7 PATENT TERM EXTENSIONS. The Parties shall cooperate, if
necessary and appropriate, with each other in gaining patent term extension
wherever applicable to Program Patent Rights covering Program Products. The
Parties shall, if necessary and appropriate, use reasonable efforts to agree
upon a joint strategy relating to patent term extensions, but, in the absence of
mutual agreement with respect to any extension issue, a patent shall be extended
if either Party elects to extend such patent. All filings for such extension
shall be made by the Party to whom the patent is assigned, PROVIDED, HOWEVER,
that in the event that the Party to whom the patent is assigned elects not to
file for an extension, such Party shall (i) inform the other Party of its
intention not to file and (ii) grant the other Party the right to file for such
extension.
SECTION 5.8 PATENT MARKING. Becton Xxxxxxxxx agrees to comply with the
patent marking statutes in each country in which Program Products are sold by
Becton Xxxxxxxxx or Approved Sublicensees.
ARTICLE VI
CONFIDENTIALITY
SECTION 6.1 CONFIDENTIAL INFORMATION. All Confidential Information
disclosed by a Party to the other Party 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 regulatory
approval of products developed by Becton Xxxxxxxxx or MPMx 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, 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 rightfully in possession of the Confidential
Information and not bound by confidentiality obligations to the disclosing
party; or
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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 and takes reasonable
and lawful actions to avoid and/or minimize the degree of such disclosure.
SECTION 6.2 DISCLOSURE OF PROVISIONS OF AGREEMENTS.
a. Each Party agrees to hold as confidential the terms
of this Agreement and the Stock Purchase 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 or the Stock
Purchase Agreement shall be included in any report, statement or other document
filed by either Party or an Affiliate of either 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. Becton Xxxxxxxxx and MPMx
each agree that they shall provide Confidential Information received from the
other 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.
SECTION 6.4 TERM. All obligations of confidentiality imposed under this
Article VI shall expire five (5) years following termination or expiration of
this Agreement.
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
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 Party an
early draft of all such publications, whether they are to be presented orally or
in written form, at least two (2) months 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 Party and third party
collaborators to such results.
ARTICLE VII
REPRESENTATIONS AND WARRANTIES
SECTION 7.1 REPRESENTATIONS OF AUTHORITY. Becton Xxxxxxxxx and MPMx
each represents and warrants to the other that as of the Execution Date it has,
and as of the Effective Date it will have, full right, power and authority to
enter into this Agreement and to perform its respective obligations under this
Agreement. Becton Xxxxxxxxx and MPMx each represents and warrants to the other
that it has the right to grant to the other the licenses and sublicenses granted
pursuant to this Agreement, and that, to the best of its knowledge, it has, as
of the Effective Date, access to and the right to use its Know-How necessary to
perform its obligations hereunder. Becton Xxxxxxxxx and MPMx 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.
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SECTION 7.2 CONSENTS. Becton Xxxxxxxxx and MPMx 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, except with respect to approvals required under the HSR Act.
SECTION 7.3 NO CONFLICT. Becton Xxxxxxxxx and MPMx each represents and
warrants that the execution and delivery of this Agreement, the performance of
such Party's obligations hereunder and the conduct of the Research Program and
the Development Program by it (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 EMPLOYEE OBLIGATIONS. Becton Xxxxxxxxx and MPMx each
represents and warrants that all of its employees, officers, consultants and
advisors who are or will be involved in the Research Program and in the
Development Program have executed or will have executed agreements or have
existing obligations under law requiring assignment to such Party of all
intellectual property made during the course of and as the result of their
association with such Party, and obligating the individual to maintain as
confidential such Party's Confidential Information, to the extent required to
support such Party's obligations under this Agreement. Becton Xxxxxxxxx and MPMx
each represents and warrants that to its knowledge, none of its employees who
are or will be involved in the Research Program are, as a result of the nature
of such Research Program to be conducted by the Parties, in violation of any
covenant in any contract with a third party relating to non-disclosure of
proprietary information, non-competition or non-solicitation.
SECTION 7.5 THIRD PARTY RIGHTS.
a. To the knowledge of MPMx, as of the Execution Date
and the Effective Date, the conduct by MPMx of the Research Program and the
practice by Becton Xxxxxxxxx under the rights and licenses granted by MPMx
herein 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. To the knowledge of MPMx, as of the
Execution Date, none of the Know-How or Patent Rights owned, controlled or used
by MPMx that is expected to be utilized by MPMx in the Research Program is being
infringed by any third party. As of the Execution Date, there is no claim or
demand of any person pertaining to, or any proceeding which is pending or, to
the knowledge of MPMx, threatened, that challenges the rights of MPMx in respect
of Know-How or Patent Rights owned, controlled or used by MPMx.
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b. To the knowledge of Becton Xxxxxxxxx, as of the
Execution Date and the Effective Date, the conduct by Becton Xxxxxxxxx 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. To
the knowledge of Becton Xxxxxxxxx, as of the Execution Date, none of the Becton
Xxxxxxxxx Platform Know- How or Becton Xxxxxxxxx Platform Patent Rights owned,
controlled or used by Becton Xxxxxxxxx that is expected to be utilized by Becton
Xxxxxxxxx in the Research Program and the Development Plan is being infringed by
any third party. As of the Execution Date, there is no claim or demand of any
person pertaining to, or any proceeding which is pending or, to the knowledge of
Becton Xxxxxxxxx, threatened, that challenges the rights of Becton Xxxxxxxxx in
respect of Becton Xxxxxxxxx Platform Know-How or Becton Xxxxxxxxx Platform
Patent Rights.
c. MPMx represents and warrants that it, as of the
Execution Date and the Effective Date, owns, free and clear of all encumbrances,
or to the knowledge of MPMx, has the valid right to use, all Know-How and Patent
Rights owned, controlled or used by MPMx that are expected to be utilized by
MPMx in the Research Program. To the knowledge of MPMx, as of the Execution Date
and the Effective Date, no person or entity (other than Lilly under the Lilly
Research and License Agreement, Bayer under the Bayer Agreement, MBio under the
MBio/MPI Rights Exchange Agreement and third parties granted non-exclusive
licenses in the ordinary course of MPMx' business) has any rights to any of the
Know-How or Patent Rights owned, controlled or used by MPMx and expected to be
utilized by MPMx in the Research Program that would limit MPMx in the conduct of
the Research Program or Becton Xxxxxxxxx in the practice of its rights and
licenses granted by MPMx herein.
x. Xxxxxx Xxxxxxxxx represents and warrants that, as of
the Execution Date and the Effective Date, it owns, free and clear of all
encumbrances, or to the knowledge of Becton Xxxxxxxxx, has the valid right to
use, all Becton Xxxxxxxxx Platform Know-How and Becton Xxxxxxxxx Platform Patent
Rights owned, controlled or used by Becton Xxxxxxxxx that are expected to be
utilized by Becton Xxxxxxxxx in the Research Program.
e. MPMx and Becton Xxxxxxxxx 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 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.
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SECTION 7.6 AGREEMENTS WITH MPI.
a. MPMx represents and warrants to Becton Xxxxxxxxx that
it has delivered to Becton Xxxxxxxxx true and correct copies of (i) the Rights
Exchange Agreement dated February 1, 1999 by and between MPMx and MPI (the
"MPMx/MPI Rights Exchange Agreement"), (ii) the Technology Transfer and License
Agreement, (iii) the Trademark License Agreement, (iv) the Administrative
Services Agreement and (v) the Research Services Agreement, each dated as of
February 1, 1999 and by and between MPMx and MPI. The foregoing agreements are
herein referred to as the "Transfer Documents". MPMx hereby further represents
and warrants to Becton Xxxxxxxxx that each of the Transfer Documents is in full
force and effect and has not been amended or modified.
b. MPMx covenants and agrees with Becton Xxxxxxxxx that
MPMx shall perform all of its obligations arising under the Transfer Documents
and that MPMx shall not, without the prior written consent of Becton Xxxxxxxxx,
terminate any of the Transfer Documents, or modify or amend any of the Transfer
Documents to the extent that any such amendment or modification would adversely
affect the ability of MPMx to fulfill its obligations hereunder.
SECTION 7.7 YEAR 2000 COMPLIANCE. To the knowledge of MPMx, the
statements to be set forth in MPI's Annual Report on Form 10-K for the year
ending December 31, 1998 under the heading "Management's Discussion and Analysis
of Financial Condition and Results of Operations - - Impact on Year 2000," a
draft of which has been furnished to Becton Xxxxxxxxx, are true and correct in
all material respects.
SECTION 7.8 NO WARRANTIES. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH
HEREIN OR IN THE STOCK PURCHASE AGREEMENT, 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 COMMERCIAL
UTILITY OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
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 IV.
SECTION 8.2 SURVIVAL OF LICENSES.
a. LICENSE TO BECTON XXXXXXXXX. Upon the expiration of
Becton Dickinson's obligations to pay royalties to MPMx under Section 4.7 with
respect to each Program Product, Third Party Pharmacogenomic Product or
Pharmacogenomic Service in any country, the licenses under MPMx Program
Intellectual Property and MPMx' rights in the Joint Program Intellectual
Property set forth in Section 3.1(b) and Section 3.1(d) shall be deemed to be
perpetual, fully paid up, non-exclusive licenses with respect to such Program
Product, Third Party Pharmacogenomic Product or Pharmacogenomic Service in such
country.
b. LICENSES TO MPMX. Upon the expiration of MPMx'
obligation to pay royalties to Becton Xxxxxxxxx under Section 4.8 with respect
to each MPMx Royalty Bearing Product in any country, the licenses under Becton
Xxxxxxxxx Platform Know- How and Becton Xxxxxxxxx Platform Patent Rights set
forth in Section 3.2(b)(ii) shall be deemed to be perpetual, fully paid-up,
non-exclusive licenses with respect to such MPMx Royalty Bearing Product in such
country.
SECTION 8.3 TERMINATION FOR MATERIAL BREACH. Upon any material breach
of a material provision of this Agreement by a Party (in such capacity, the
"Breaching Party"), the other Party (in such capacity, the "Non-Breaching
Party") 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 [**] period, 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 the 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 and continuing until the earlier of the resolution of
such dispute and the end of such [**] period.
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SECTION 8.4 NO EFFECTIVENESS UPON HSR DENIAL OR TERMINATION OF STOCK
PURCHASE AGREEMENT. The Agreement shall not become effective (and accordingly
shall immediately terminate) in the event that (a) the FTC and/or the DOJ shall
seek a preliminary injunction against MPMx and Becton Xxxxxxxxx to enjoin the
transactions contemplated by this Agreement and/or the Stock Purchase Agreement;
or (b) the HSR Clearance Date shall not have occurred on or prior to June 30,
1999.
SECTION 8.5 EFFECT OF TERMINATION.
a. GENERAL. In the event this Agreement is terminated by
either Party, all rights and obligations of the Parties, including performance
of work under the Research Program and the Development Program and Becton
Dickinson's right to commercialize and develop Program Products, shall cease,
except as follows:
i. except as set forth in subsection b(i) or
b(ii) below, all licenses set forth in Sections 3.1 and 3.2 shall survive such
termination, subject to continued compliance with obligations related to such
licenses, such as the milestone and royalty payments, reports, accounting and
auditing provisions of Article IV;
ii. all financial obligations under Article IV
or Article V owed as of the effective date of such termination shall remain
effective and shall be timely paid;
iii. the right to complete the manufacture and
sale of Program Products which qualify as "work in process" 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;
iv. obligations set forth in Section 2.12;
v. obligations set forth in Sections 5.5 and\
5.6;
vi. obligations regarding confidentiality set
forth in Article VI;
vii. obligations of defense and indemnity set
forth in Section 10.1, which obligations shall continue in full force and effect
for an unlimited period;
viii. any cause of action or claim of MPMx or
Becton Xxxxxxxxx accrued or to accrue because of any breach or default by the
other party hereunder; and
ix. 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.
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
b. TERMINATION OF LICENSES.
i. If this Agreement is terminated under
Section 8.3 and MPMx is the Breaching Party, the licenses granted by Becton
Xxxxxxxxx to MPMx under Section 3.2(a) and 3.2(b) shall terminate as of the
effective date of such termination, and all sublicenses granted to third parties
by MPMx pursuant to Section 3.2 shall also terminate as of such date.
ii. If this Agreement is terminated under
Section 8.3 and Becton Xxxxxxxxx is the Breaching Party, the licenses granted by
MPMx to Becton Xxxxxxxxx under Section 3.1(a), (b) and (d) shall terminate, and
all sublicenses granted to third parties by Becton Xxxxxxxxx pursuant to Section
3.1(c) shall also terminate as of such date.
ARTICLE IX
DISPUTE RESOLUTION
SECTION 9.1 ALTERNATIVE DISPUTE RESOLUTION. If any controversy, claim
or dispute arising out of or relating to [**] with respect to a dispute relating
to the issue of [**] of this Agreement has not been resolved by the Executive
Officers within thirty (30) days of referral in accordance with Section 2.2 or
any other applicable provisions of this Agreement, or if the Executive Officers
fail to meet within such thirty (30) days, then either Party may initiate an
Alternative Dispute Resolution ("ADR") proceeding as provided in EXHIBIT F
hereto; PROVIDED THAT with respect to any such controversy, claim or dispute
relating to Section 4.8, the neutral party shall have the qualifications
referenced in Section 4.8. The Parties shall have the right to be represented by
counsel in such a proceeding.
SECTION 9.2 NO LIMITATION. Notwithstanding the foregoing, nothing in
this Article IX shall be construed as limiting in any way the right of a Party
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 PRODUCT LIABILITY INDEMNIFICATION.
x. XXXXXX XXXXXXXXX. Xxxxxx Xxxxxxxxx agrees to defend
MPMx and its Affiliates at its cost and expense, and shall indemnify and hold
MPMx and its
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Affiliates and their respective directors, officers, employees and agents (the
"MPMx Indemnified Parties") harmless from and against any losses, costs,
damages, fees or expenses arising out of any claim relating to (i) any breach by
Becton Xxxxxxxxx of any of its representations, warranties or obligations
pursuant to this Agreement or (ii) personal injury from the development,
manufacture, use, sale or other disposition of any Program Products offered by
Becton Xxxxxxxxx, its Affiliates and/or Approved Sublicensees. In the event of
any such claim against the MPMx Indemnified Parties by any third party, MPMx
shall promptly notify Becton Xxxxxxxxx in writing of the claim and Becton
Xxxxxxxxx shall manage and control, at its sole expense, the defense of the
claim and its settlement. The MPMx Indemnified Parties shall cooperate with
Becton Xxxxxxxxx and may, at their option and expense, be represented in any
such action or proceeding. Becton Xxxxxxxxx shall not be liable for any
litigation costs or expenses incurred by the MPMx Indemnified Parties. In
addition, Becton Xxxxxxxxx shall not be responsible for the indemnification of
any MPMx Indemnified Party arising from any negligent or wrongful acts by such
party, or as the result of any settlement or compromise by the MPMx Indemnified
Parties without Becton Dickinson's prior written consent.
b. MPMX. MPMx agrees to defend Becton Xxxxxxxxx and its
Affiliates at its cost and expense, and shall indemnify and hold Becton
Xxxxxxxxx and its Affiliates and their respective directors, officers, employees
and agents (the "Becton Xxxxxxxxx Indemnified Parties") harmless from and
against any losses, costs, damages, fees or expenses arising out of any claim
relating to (i) any breach by MPMx of any of its representations, warranties or
obligations pursuant to this Agreement or (ii) personal injury from the
development, manufacture, use, sale or other disposition of any MPMx
Royalty-Bearing Products offered by MPMx, its Affiliates and/or its
sublicensees. In the event of any claim against the Becton Xxxxxxxxx Indemnified
Parties by any third party, Becton Xxxxxxxxx shall promptly notify MPMx in
writing of the claim and MPMx shall manage and control, at its sole expense, the
defense of the claim and its settlement. The Becton Xxxxxxxxx Indemnified
Parties shall cooperate with MPMx and may, at their option and expense, be
represented in any such action or proceeding. MPMx shall not be liable for any
litigation costs or expenses incurred by the Becton Xxxxxxxxx Indemnified
Parties. In addition, MPMx shall not be responsible for the indemnification of
any Becton Xxxxxxxxx Indemnified Party arising from any negligent or wrongful
acts by such party, or as the result of any settlement or compromise by the
Becton Xxxxxxxxx Indemnified Parties without MPMx'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
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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. Neither MPMx nor Becton Xxxxxxxxx may assign
this Agreement in whole or in part without the consent of the other Party, which
consent shall not be unreasonably withheld, PROVIDED, HOWEVER, that MPMx may
assign this Agreement without the consent of Becton Xxxxxxxxx if such assignment
is in connection with a Change of Control.
SECTION 10.4 AMENDMENTS. This Agreement constitutes the entire
agreement between 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 both Parties.
SECTION 10.5 NOTICES.
Notices to MPMx shall be addressed to:
Millennium Predictive Medicine, Inc.
000 Xxxxxxxx Xxxxx
Xxxxxxxxx, XX 00000
Attn: President
with a copy to:
Millennium Predictive Medicine, Inc.
000 Xxxxxxxx Xxxxx
Xxxxxxxxx, XX 00000
Attention: Legal Department
Notices to Becton Xxxxxxxxx shall be addressed to:
Xxxxxxxx Xxxxxx
Becton Xxxxxxxxx BioSciences
00 Xxxxxxx Xxxxxx
Xxxxxx, XX 00000
with copies to:
Becton, Xxxxxxxxx and Company
0 Xxxxxx Xxxxx
Xxxxxxxx Xxxxx, XX 00000
Attn: Vice President and Chief Intellectual Property Counsel
XxXxx Xxxxxx
Becton Xxxxxxxxx BioSciences
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00000 Xxxxxxxxxx Xxxx
Xxxxxxx, XX 00000
Any Party may change its address by giving notice to the other Party 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 Execution 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 or the Stock Purchase
Agreement shall be agreed upon among the Parties in advance of such announcement
as set forth herein. Either 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 Party 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 other with an advance
copy of any public announcement at least five (5) business days 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 Party reasonably deems 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
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that nothing in this Agreement shall be construed as authorization for either
MPMx or Becton Xxxxxxxxx to act as agent for the other. The Program Directors
and members of Project Teams shall remain employees of Becton Xxxxxxxxx or MPMx,
as the case may be.
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 MPMx or Becton Xxxxxxxxx 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 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 10.14 HSR FILING. As soon as practicable after the Execution
Date, each of Becton Xxxxxxxxx and MPMx shall promptly file any Notification and
Report Forms and related materials that either such Party may be required to
file with the FTC and the DOJ under the HSR Act, shall seek to obtain an early
termination of the applicable waiting period, and shall promptly make any
further filings or information submissions pursuant thereto, or responses to
requests to additional information thereunder, that may be necessary, proper or
advisable.
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first set forth above.
MILLENNIUM PREDICTIVE MEDICINE, INC.
By: /s/ Xxxxxxx X. Xxxxxxx
----------------------------------------
Name: Xxxxxxx X. Xxxxxxx
Title: President
By: /s/ Xxxxxxxx X. Xxxx
----------------------------------------
Name: X. Xxxx
Title: Senior Director, Research and
Development
BECTON, XXXXXXXXX AND COMPANY
By: /s/ Xxxxxxx Xxxxxxxx
----------------------------------------
Name: Xxxxxxx Xxxxxxxx
Title: Senior Vice President
By: /s/ Xxxxxxx X. Xxxx
----------------------------------------
Name: Xxxxxxx X. Xxxx
Title: President-BDB
Millennium Pharmaceuticals, Inc. hereby agrees to (a) fulfill its obligations
under Section 2.1(c), and (b) for so long as MPMx remains an Affiliate of MPI,
unconditionally guarantee the obligations and liabilities of MPMx under this
Agreement. MPI hereby acknowledges and agrees that (i) MPMx and Becton Xxxxxxxxx
may amend or modify this Agreement without the requirement of providing notice
of such amendment or modification to MPI or of obtaining MPI's consent thereto
and (ii) Becton Xxxxxxxxx shall be entitled to interact and deal with MPMx on
all matters relating to this Agreement (and any modifications or amendments
hereto) without regard to the guaranty made by MPI hereunder, and that in each
such case, the obligations and liabilities of MPI under this guaranty shall not
be released or otherwise affected or impaired as a result thereof.
MILLENNIUM PHARMACEUTICALS, INC.
By: /s/ Xxxx Xxxxx
-----------------------------------------
Name: Xxxx Xxxxx
Title: CEO
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
EXHIBIT A
NON-COLON PRODUCT AREAS
Disease Area Staging Product Screening Product
------------ --------------- -----------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**]
--------------------------------------------------------------------------------
[**]
--------------------------------------------------------------------------------
[**] [**]
--------------------------------------------------------------------------------
[**] [**]
--------------------------------------------------------------------------------
An "x" indicates an Exclusive Product Area as of the Execution Date.
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
EXHIBIT B
RESEARCH AND DEVELOPMENT PLAN
The goals of the program are to develop more effective cancer screening
tools, diagnostic staging assays, and diagnostic tools to direct the appropriate
regime of chemotherapy. The goal of screening assays is to identify disease in
the absence of clinical symptoms. The test will likely be an immunochemistry
test for the detection of circulating shedded antigens and the determination of
the tissue of origin. The goal of staging assays is to provide accurate staging
and assessment of aggressiveness to determine the course of therapy. The goal of
chemoprediction assays is to identify effective therapy of the diagnosed cancer.
The specific program milestones are to discover novel genetic markers,
validate the clinical utility of the markers, submit for regulatory approval and
commercialize as diagnostic and pharmacogenomic tests. MPMx will discover the
markers and validate the clinical efficacy. The development of the assay in a
homebrew format may be done by MPMx or Becton Xxxxxxxxx, dependent of the
particular product. Becton Xxxxxxxxx will develop the assay in a commercial
format, conduct clinical trials in support of regulatory approval and
commercialize the assay.
GENERAL PROGRAM TASKS AND MILESTONES
[**].
Milestones by Phase are:
PHASE 0:
- [**]
- [**]
- [**]
- [**]
- [**]
- [**]
- [**]
- [**]
- [**]
- [**]
PHASE 1:
- [**]
- [**]
- [**]
- [**]
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
- [**]
- [**]
- [**]
- [**]
- [**]
- [**]
PHASE 2:
- [**]
- [**]
- [**]
- [**]
- [**]
- [**]
- [**]
- [**]
- [**]
PHASE 3:
- [**]
- [**]
- [**]
- [**]
- [**]
- [**]
PHASE 4:
- [**]
- [**]
- [**]
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
EXHIBIT C
YEAR [**] MILESTONE
a. YEAR [**] MILESTONE COMPOSITION.
i. The Year [**] Milestone consists of [**] all more
fully described below. Successful achievement of the Year [**] Milestone by MPMx
shall occur once it has been determined that all the requirements for each
component ("Requirements") have been met by [**].
ii. Specific Components of the Year [**] Milestone.
(a) [**]
(i) The Requirements for fulfilling the
[**] shall consist of subsections(a)(ii) - (A), (B), (C), (a)(iii), (a)(iv),
(a)(v), and (a)(vi) below.
(ii) At least [**] of the overall total
projects in the Exclusive Product Area(s) [**] initiated during the [**] being
referred to herein, as "Successful Projects") shall have met the following
achievements:
(A) [**];
(B) [**] Product.
(C) [**] Product.
(iii) [**] PROVIDED, HOWEVER, that [**];
(iv) For projects in [**] of MPMx's
research milestones [**] set forth in the Research Plans [**];
(v) [**] the [**] by the Joint Steering
Committee for such Research Plans.
(vi) [**] agreed to by the Joint
Steering Committee for the Research Plans for such Products.
(b) [**]
(i) The Requirements for fulfilling the
[**] shall consist of subsections (b)(ii) and (b)(iii) below.
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
(ii) [**] under the Research Program
have been [**].
(iii) [**] under the Research Program
have [**].
(c) [**]
(i) The Requirements for fulfilling the
II shall consist of subsections (c)(ii) - (iii) below.
(ii) No later than [**], the Parties
shall by mutual agreement [**] of the [**]. Specifically, the [**] shall include
an [**] and for which Research Plans [**].
(iii) In the event that [**].
b. ADJUSTMENTS [**]
Notwithstanding anything to the contrary in this Exhibit C, as
a condition precedent to MPMx's timely performance of its obligations with
respect to the [**] as described in each Research Plan [**] for such
Requirements [**].
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EXHIBIT D
FORM OF CONVERTIBLE NOTE
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Confidential Materials omitted and filed separately
with the Securities and Exchange Commission. Asterisks denote omissions.
EXHIBIT E
RESEARCH FUNDING PAYMENTS
FOR FIRST CONTRACT YEAR
PAYMENT TO BE AMOUNT OF
PERIOD MADE ON OR BEFORE PAYMENT
---------------------- -------------------- ---------
FIRST CONTRACT QUARTER WITHIN 10 DAYS AFTER [**]
EFFECTIVE DATE
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
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EXHIBIT F
ALTERNATIVE DISPUTE RESOLUTION PROCEDURES
a. To begin an ADR proceeding, a Party shall provide written
notice to the other Party of the issues to be resolved by ADR. Within fourteen
(14) days after its receipt of such notice, the other Party may, by written
notice to the Party initiating the ADR, add additional issues subject to ADR
pursuant to Section 9.1 to be resolved within the same ADR.
b. Within twenty-one (21) days following receipt of the original
ADR notice, the Parties shall select a mutually acceptable neutral party to
preside in the resolution of any disputes in this ADR proceeding. If the Parties
are unable to agree on a mutually acceptable neutral party within such period, a
Party may request the President of the CPR Institute for Dispute Resolution
("CPR"), 000 Xxxxxxx Xxxxxx, 00xx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000, to select a
neutral party pursuant to the following procedures:
i. The CPR shall submit to the Parties a list of not
less than five (5) candidates within fourteen (14) days after receipt of the
request, along with a Curriculum Vitae for each candidate. No candidate shall be
an employee, director or shareholder of a Party or any of their Affiliates.
ii. Such list shall include a statement of disclosure by
each candidate of any circumstances likely to affect his or her impartiality.
iii. Each Party shall number the candidates in order of
preference (with the number one (1) signifying the greatest preference) and
shall deliver the list to the CPR within seven (7) days following receipt of the
list of candidates. If a Party believes a conflict of interest exists regarding
any of the candidates, that Party shall provide a written explanation of the
conflict to the CPR along with its list showing its order of preference for the
candidates. Any Party failing to return a list of preferences on time shall be
deemed to have no order of preference.
iv. If the Parties collectively have identified fewer
than three (3) candidates deemed to have conflicts, the CPR immediately shall
designate as the neutral party the candidate for whom Becton Xxxxxxxxx on the
one hand, and MPMx on the other hand, have indicated the greatest preference. If
a tie should result between two candidates, the CPR may designate either
candidate. If the Parties collectively have identified three (3) or more
candidates deemed to have conflicts, the CPR shall review the explanations
regarding conflicts and, in its sole discretion, may either (i) immediately
designate as the neutral party the candidate for whom the Parties collectively
have indicated the greatest preference, or (ii) issue a new list of not less
than five (5) candidates, in which case the procedures set forth in subsection
b(i)-(iv) shall be repeated.
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c. No earlier than twenty-eight (28) days or later than fifty-six
(56) days after selection, the neutral party shall hold a hearing to resolve
each of the issues identified by the Parties. The ADR proceeding shall take
place at a location agreed upon by the Parties. If the Parties cannot agree, the
neutral party shall designate a location other than the principal place of
business of either Party or any of their Affiliates.
d. At least seven (7) days prior to the hearing, each Party shall
submit the following to the other Party and the neutral party:
i. a copy of all exhibits on which such Party intends to
rely in any oral or written presentation to the neutral party;
ii. a list of any witnesses such Party intends to call at
the hearing, and a short summary of the anticipated testimony of each witness;
iii. a proposed ruling on each issue to be resolved,
together with a request for a specific damage award or other remedy for each
issue. The proposed rulings and remedies shall not contain any recitation of the
facts or any legal arguments and shall not exceed one (1) page per issue.
iv. a brief in support of such Party's proposed rulings
and remedies, provided that the brief shall not exceed twenty (20) pages. This
page limitation shall apply regardless of the number of issues raised in the ADR
proceeding.
Consistent with subsections d(i)-(iv), the neutral party shall
establish the rules for discovery, including depositions, interrogatories,
requests for admissions, or production of documents.
e. The hearing shall be conducted on two (2) consecutive days and
shall be governed by the following rules:
i. Each Party shall be entitled to five (5) hours of
hearing time to present its case. The neutral party shall determine whether each
Party has had the five (5) hours to which it is entitled.
ii. Each Party shall be entitled, but not required, to
make an opening statement, to present regular and rebuttal testimony, documents
or other evidence, to cross-examine witnesses, and to make a closing argument.
Cross- examination of witnesses shall occur immediately after their direct
testimony, and cross-examination time shall be charged against the party
conducting the cross- examination.
iii. The Party initiating the ADR shall begin the hearing
and, if it chooses to make an opening statement, shall address not only issues
it raised but
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