Exhibit 10.2
Portions of this Exhibit Have Been Omitted and
Separately
Filed with the Securities and Exchange Commission with a
Request for Confidential Treatment
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TRAP -2 TERMINATION AGREEMENT
By and Between
NOVARTIS PHARMA AG
NOVARTIS PHARMACEUTICALS CORPORATION
AND
REGENERON PHARMACEUTICALS, INC.
Dated as of June 8, 2009
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Table of Contents
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SECTION 1.
DEFINITIONS
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2
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SECTION 2.
WAIVER AND TERMINATION
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7
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2.1
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Waiver
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7
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2.2
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Purpose and
Effect of this Agreement; Termination of the CLO Agreement
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7
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SECTION 3.
COVENANT NOT TO SUE
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8
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3.1
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Covenant Not to
Sue
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8
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3.2
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Rights in
Bankruptcy
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8
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3.3
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Covered
Products
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8
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SECTION 4.
CONSIDERATION
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9
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4.1
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Royalty
Payments
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9
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4.2
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[*************]
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10
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4.3
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No
Projections
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10
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SECTION 5.
REPORTS AND PAYMENT TERMS
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10
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5.1
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Payment
Terms
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10
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5.2
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Currency
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11
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5.3
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Taxes
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11
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5.4
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Accounting
Standards
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11
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5.5
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Records and
Audit Rights
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11
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SECTION 6.
CONFIDENTIALITY
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12
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6.1
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Confidential
Regeneron Company Information
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12
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6.2
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Injunctive
Relief
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13
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SECTION 7.
REPRESENTATIONS AND WARRANTIES
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13
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7.1
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Due
Organization, Valid Existence and Due Authorization
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13
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7.2
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Disclaimers
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14
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SECTION 8.
INDEMNIFICATION
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14
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8.1
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Indemnity and
Insurance
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14
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8.2
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Indemnity
Procedure
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14
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SECTION 9.
MISCELLANEOUS
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15
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9.1
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Dispute
Resolution
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15
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9.2
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Governing
Law
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17
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9.3
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Waiver
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17
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9.4
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Force
Majeure
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17
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9.5
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Notices
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17
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9.6
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Entire
Agreement
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17
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9.7
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Amendments
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17
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9.8
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Headings
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17
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9.9
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Severability
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17
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9.10
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Registration
and Filing of the Agreement
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18
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9.11
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Assignment
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18
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9.12
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Successors and
Assigns
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18
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9.13
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Counterparts
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18
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9.14
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Third-Party
Beneficiaries
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18
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9.15
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Relationship of
the Parties
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18
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9.16
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Limitation of
Damages
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19
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EXHIBIT A – SAMPLE
INVOICE
EXHIBIT B –
NOTICES
i
TRAP -2 TERMINATION AGREEMENT
THIS TRAP-2 TERMINATION AGREEMENT
(“ Agreement ”), made as of June 8, 2009 (the
“ Effective Date ”), is by and between NOVARTIS
PHARMA AG, a corporation organized under the laws of Switzerland
and having a principal place of business at Lichtstrasse 35, 4056
Basel, Switzerland (“ Novartis ”), NOVARTIS
PHARMACEUTICALS CORPORATION of One Health Plaza, East Hanover, New
Jersey (“ NPC ”) and REGENERON PHARMACEUTICALS,
INC., a corporation organized under the laws of New York and having
a principal place of business at 777 Old Saw Mill River Road,
Tarrytown, New York 10591 (“ Regeneron ”) (with
each of Novartis and Regeneron referred to herein individually as a
“ Party ” and collectively as the “
Parties ”, and with NPC being a “ Party
” to this Agreement for purposes of Section 2
only).
WHEREAS, on March 28, 2003 the
Parties and NPC (for limited provisions only) entered in to the
Collaboration, License and Option Agreement (“ CLO
Agreement ”) whereby (i) Novartis and Regeneron agreed to
collaborate with respect to the development, manufacture and
commercialization of the Trap-1 Product (as defined in the CLO
Agreement); (ii) Novartis granted Regeneron the right to elect to
share in the development and commercialization of the IL-1 Antibody
Product (as defined in the CLO Agreement); and (iii) Regeneron
granted Novartis the right to elect to share in the development and
commercialization of the Trap-2 Product (as defined in the CLO
Agreement);
WHEREAS, by letter dated February
27, 2004, Novartis terminated the CLO Agreement with respect to the
Trap-1 Product under Section 19.4(a) of the CLO Agreement (“
Termination Letter ”);
WHEREAS, the Parties wish to enter
into this Agreement for the purpose of defining certain rights and
obligations of the Parties with respect to the Trap-2 Product and
other Covered Products (as defined herein) on the terms and
conditions set forth in this Agreement following the termination of
the CLO Agreement pursuant to the IL-1 Antibody Termination
Agreement (as defined herein);
WHEREAS, concurrent with their
execution of this Agreement, the Parties will also enter into an
agreement terminating the CLO Agreement and relating to certain
rights and obligations of the Parties with respect to
Novartis’ development and commercialization of the IL-1
Antibody Product (as defined in the CLO Agreement) and other
products targeting interleukin-1 (the “ IL-1 Antibody
Termination Agreement ”); and
WHEREAS, the Parties intend this
Agreement, together with the IL-1 Antibody Termination Agreement,
to supersede and replace the CLO Agreement in its
entirety.
NOW, THEREFORE, in consideration of
the following mutual promises and obligations, and for other good
and valuable consideration the adequacy and sufficiency of which
are hereby acknowledged, the Parties agree as follows:
SECTION 1.
DEFINITIONS
The following capitalized terms,
whether used in the singular or plural, shall have the meanings set
forth below:
“ Affiliate ”
shall mean, with respect to any Person, any other Person which
controls, is controlled by or is under common control with such
Person. A Person shall be deemed to control another Person if such
Person possesses, directly or indirectly, the power to direct or
cause the direction of the management and policies of such Person,
whether through the ownership of voting securities, by contract or
otherwise. For purposes of this Agreement, in no event shall
Novartis or any of its Affiliates be deemed Affiliates of Regeneron
or any of its Affiliates nor shall Regeneron or any of its
Affiliates be deemed Affiliates of Novartis or any of its
Affiliates.
“ Approval ”
shall mean, with respect to each Covered Product, any approval
(excluding Pricing Approvals), registration, license or
authorization from any Regulatory Authority required for the
manufacture, development, commercialization, sale, storage or
transport of such product in any country, and shall include,
without limitation, an approval, registration, license or
authorization granted in connection with any Registration
Filing.
“ Bioequivalent Product
” shall mean, with respect to any Covered Product, a product
which has the same (or substantially similar) amino acid sequence
as such Covered Product and is authorized on the basis of a
reference to a Covered Product under either (1) Article 10.1 or (2)
Article 10.4 and Part II.4 of Annex I of Parliament and Council
Directive 2001/83/EC as amended by Directive 2004/27/EC, in each
case as amended from time to time, or successor legislation in each
case, and equivalent provisions of applicable law in other
jurisdictions for biosimilar, follow-on, or generic biologic
products.
“ Calendar Quarter
” shall mean the respective periods of three (3) consecutive
calendar months ending on March 31, June 30, September 30 and
December 31.
“ Calendar Year ”
shall mean a period of twelve (12) consecutive calendar months
ending on December 31.
“ CLO Agreement ”
has the meaning set forth in the recitals.
“ Covered Product
” shall mean [********************************].
“ Derivative ”
means: (a) any functional protein which primarily and specifically
binds to interleukin-1 and has [*****************************] or
(b) any functional fragment of a protein which specifically binds
to interleukin-1 and has [*********************].
“ EMEA ” shall
mean the European Medicines Agency or any successor agency
thereto.
2
“ Executive Officers
” shall mean the Chief Executive Officer of Regeneron and the
Chief Executive Officer of Novartis, or their respective
designees.
“ FDA ” shall
mean the United States Food and Drug Administration and any
successor agency thereto.
“ First Commercial Sale
” shall mean, with respect to a Covered Product in a country,
the first sale of such product by Regeneron or one of its
Affiliates or a Product Licensee/Assignee to a Third Party (other
than a Product Licensee/Assignee) following Approval of such
product in accordance with the applicable Laws of such country on
arm’s length commercial terms. Sales for clinical trial
purposes shall not constitute a First Commercial Sale.
“ Governmental
Authority ” shall mean any court, agency, authority,
department, regulatory body or other instrumentality of any
government or country or of any national, federal, state,
provincial, regional, county, city or other political subdivision
of any such government or any supranational organization of which
any such country is a member.
“ IL-1 Antibody Termination
Agreement ” has the meaning set forth in the
recitals.
“ Law ” or
“ Laws ” shall mean all laws, statutes, rules,
regulations, orders, judgments, injunctions and/or ordinances of
any Governmental Authority in the applicable country.
“ Major Market Country
” shall mean [*************************].
“ Net Sales ”
shall mean, with respect to each Covered Product, the gross
invoiced sales price of such Covered Product billed by or on behalf
of Regeneron or its Affiliates or any Product Licensee/Assignee for
that product to Third Parties (other than Product
Licensees/Assignees) in bona fide, arms-length transactions, less
the following deductions (to the extent included in the gross
invoiced sales price), determined in accordance with
Regeneron’s (or its Affiliate’s or Product
Licensee’s/Assignee’s, as the case may be) standard
accounting methods, which are in accordance with generally accepted
accounting principles as applicable in the United States (that is,
US GAAP) or International Financial Reporting Standards (IFRS), as
applicable, as consistently applied at Regeneron, its Affiliates or
Product Licensees/Assignees, as the case may be:
(a) normal and customary trade and quantity
discounts actually allowed and properly taken directly with respect
to sales of such Covered Product;
(b) free goods;
(c) amounts repaid or credited by reason of defects,
rejections, recalls, returns, rebates and allowances;
(d) chargebacks and other amounts paid on sale or
dispensing of such Covered Product;
3
(e) Third Party cash rebates and
chargebacks related to sales of the finished Covered Product, to
the extent allowed;
(f) Medicaid rebates;
(g) retroactive price reductions
that are actually allowed or granted;
(h) tariffs, duties, excise,
sales, value-added or other taxes (other than taxes based on
income);
(i) cash discounts for timely
payment;
(j) delayed ship order
credits;
(k) discounts pursuant to
indigent patient programs and patient discount programs, including,
without limitation, “Together Rx, ” and coupon
discounts;
(l) insurance expenses included
as a separately billed item in the invoice amount;
(m)
[******************************************]; and
(n) any other specifically
identifiable costs or charges included in the gross invoiced sales
price of such Covered Product falling within categories
substantially equivalent to those listed above.
Sales from Regeneron to its
Affiliates or Product Licensees/Assignees shall be disregarded for
purposes of calculating Net Sales. Any of the items set forth above
that would otherwise be deducted from the invoice price in the
calculation of Net Sales but which are separately charged to Third
Parties shall not be deducted from the invoice price in the
calculation of Net Sales.
Further:
(i) In the case of any sale or other
disposal of Covered Product between or among Regeneron and its
Affiliates and Product Licensees/Assignees, for resale, Net Sales
shall be calculated as above only on the value charged or invoiced
on the first arm’s-length sale thereafter to a Third
Party;
(ii) In the case of any sale which
is not invoiced or is delivered before invoice, Net Sales shall be
calculated at the time all revenue recognition criteria under GAAP
or IFRS, as the case may be, are met;
(iii) In the case of any sale or
other disposal for value, such as barter or counter-trade, of any
product, or part thereof, other than in an arm’s length
transaction exclusively for money, Net Sales shall be calculated as
above on the value of the non-cash consideration received or the
fair market price (if higher) of the product in the country of sale
or disposal;
4
(iv) In the event the Covered
Product is sold in a finished dosage form in combination with one
or more other active ingredients (a “Combination
Product”), the Net Sales of the product, for the purposes of
determining royalty payments, shall be determined by multiplying
the Net Sales (as defined above in this Section) of the Combination
Product by the fraction, A/(A+B) where A is the weighted (by sales
volume) average sale price in a particular country of the Covered
Product when sold separately in finished form and B is the weighted
average sale price in that country of the other product(s) sold
separately in finished form. In the event that such average sale
price cannot be determined for both the Covered Product and the
other product(s) in combination, Net Sales for purposes of
determining royalty payments shall be agreed by the Parties based
on the relative value contributed by each component, such agreement
shall not be unreasonably withheld; and
(v) In the case of deductions for
bad debt, any amounts subsequently paid to Regeneron, its
Affiliates or Product Licensees/Assignees for sales previously
treated as “bad debt” shall be captured as Net Sales in
the ensuing quarterly royalty calculation pursuant to Section
5.
“ Novartis Patents
” shall mean those Patent Rights which are owned by or
licensed (with the right of sublicense) to Novartis or any of its
Affiliates, as at the Effective Date or at any time during the
Royalty Term, which include at least one claim which would be
infringed by the manufacture, use, sale, offer for sale or import
of the Trap-1, Trap-1 Product, Trap-2 or the Trap-2 Product as it
exists and is manufactured, used, sold, offered for sale, or
imported from time to time. Patent Rights covering general
recombinant protein expression technology, cell culture and
fermentation, protein purification and formulation technologies
shall be excluded from this definition.
“ Patent Application
” shall mean any application for a Patent.
“ Patent Rights ”
shall mean unexpired Patents and Patent Applications.
“ Patents ” shall
mean patents and all substitutions, divisions, continuations,
continuations-in-part, reissues, reexaminations and extensions
thereof and supplemental protection certificates relating thereto,
and all counterparts thereof in any country.
“ Person ” shall
mean and include an individual, partnership, joint venture, limited
liability company, a corporation, a firm, a trust, an
unincorporated organization and a government or other department or
agency thereof.
“ Pricing Approval
” shall mean such approval, agreement, determination or
governmental decision establishing prices for a Covered Product
that can be charged to consumers and will be reimbursed by
Governmental Authorities in countries where governmental
authorities or Regulatory Authorities of such country approve or
determine pricing for pharmaceutical products for reimbursement or
otherwise.
“Product
Licensee/Assignee” shall mean any Third Party that licenses, or,
under Section 9.11, is assigned, rights to any particular Covered
Product (or any particular indication for any particular Covered
Product) in a particular country by Regeneron or any of its
Affiliates where the licensed or assigned rights include the right
to book sales of such Covered Product in such country. For the
avoidance or doubt, “Product Licensee/Assignee” shall
not include any Third Party engaged by Regeneron or its applicable
Affiliate to provide particular services related to the
development, manufacture or commercialization of a Covered Product,
including, without limitation, research, development, contract
manufacturing, supply, distribution, commercialization, or
co-commercialization services, unless such Third Party also books
sales of the applicable Covered Product in the applicable
country.
5
“ Regeneron Company
Information ” shall mean information or materials
provided by Regeneron in the Sales & Royalty Reports (and all
information contained therein) and any audits thereof pursuant to
Section 5.5.
“ Regulatory Authority
” shall mean any federal, national, multinational, state,
provincial or local regulatory agency, department, bureau or other
governmental entity with authority over the marketing, pricing
and/or sale of any Covered Product in any country, including,
without limitation, FDA in the United States and EMEA in
Europe.
“ Royalty Term ”
shall have the meaning set forth in Section 4.1(b).
“ Sales & Royalty
Report ” means a written report or reports showing each
of: (a) the Net Sales of each Covered Product during the reporting
period by Regeneron, its Affiliates, and Product
Licensees/Assignees, which information shall be provided on a
country-by-country basis in United States Dollars; and (b) the
royalties payable, in United States Dollars, which shall have
accrued hereunder with respect to such Net Sales.
[*************************************].
“ Seventh Anniversary
Date ” shall mean the seventh anniversary of the
Effective Date.
“Termination
Letter ” has
the meaning set forth in the recitals.
“ Third Party ”
shall mean any Person other than Novartis or Regeneron or any
Affiliate of either Party.
“ Trap-1 ” shall
have the meaning set forth in the CLO Agreement.
“Trap-1
Product” shall
have the meaning set forth in the CLO Agreement.
“ Trap-2 ” shall
have the meaning set forth in the CLO Agreement.
“ Trap-2 Product
” shall mean one or more pharmaceutical products for human
and/or animal use which include the Trap-2 (whether as a protein, a
nucleic acid encoding a protein, or a cell line expressing a
protein) or any Derivative thereof, including fusions comprising
any such antibody or Derivative and any composition, formulation or
device that incorporates or includes any such antibody or
Derivative as an active ingredient, alone or in combination with
one or more other active ingredients, for all
indications.
“ US GAAP ” shall
mean generally accepted accounting principles in the United
States.
6
SECTION 2.
WAIVER AND TERMINATION
2.1 Waiver . Novartis hereby waives any and all rights it
may have with respect to the Trap-2, and any Trap-2 Product,
pursuant to the CLO Agreement or any other agreement (other than
this Agreement) between any of the Parties existing as of the
Effective Date relating to the Trap-2 or any Trap-2
Product.
2.2 Purpose and Effect of this Agreement;
Termination of the CLO Agreement . With effect from the Effective Date, this
Agreement, together with the Trap-2 Agreement, is intended to
supersede and replace the CLO Agreement and to represent the whole
of the Parties’ agreement with respect to each of the
products described in the definition of IL-1 Products in the CLO
Agreement. Accordingly, the Parties confirm that, pursuant to the
IL-1 Antibody Termination Agreement, the Parties agree that, with
effect from the Effective Date, the CLO Agreement is terminated and
of no further force or effect (other than as set forth in the IL-1
Antibody Termination Agreement and other than with respect to
definitions of terms defined in the CLO Agreement which are
expressly referenced in this Agreement).
7
SECTION 3.
COVENANT NOT TO SUE
3.1 Covenant Not to Sue . Novartis unconditionally agrees, promises,
and covenants that neither it nor any of its Affiliates will
enforce (or attempt to enforce) any Novartis Patent against
Regeneron, any Regeneron Affiliate, any Product Licensee/Assignee
or any of their respective agents or service providers, for having
made, making, using, offering for sale, selling, or importing any
Covered Product or Trap-1 Product or any component thereof. This
covenant does not constitute an admission: (a) by Regeneron that
the claims of any Novartis Patent are valid, enforceable or
infringed by Regeneron, any Regeneron Affiliate, or any Product
Licensee/Assignee, for having made, making, using, offering for
sale, selling, or importing any Covered Product, Trap-1 Product or
any component thereof; or (b) by Novartis that the claims of any
Novartis Patent are invalid, unenforceable or not infringed by
Regeneron, any Regeneron Affiliate or any Product Licensee/Assignee
of any Covered Product or Trap-1 Product, for having made, making,
using, offering for sale, selling, or importing any Covered
Product, Trap-1 Product or any component thereof. For purposes of
this Section 3.1, the term “Covered Product” shall
exclude any product first sold by Novartis or any of its Affiliates
(or any of their respective licensees or assignees of such product)
anywhere in the world, or any biosimilar, follow-on or generic
biologic product thereof that is authorized on the basis of a
reference to such product under either (1) Article 10.1 or (2)
Article 10.4 and Part II.4 of Annex I of Parliament and Council
Directive 2001/83/EC as amended by Directive 2004/27/EC, in each
case as amended from time to time, or successor legislation in each
case, and equivalent provisions of applicable law in other
jurisdictions. For the avoidance of doubt, this covenant shall be
binding upon and shall inure to the benefit of the parties and
their respective successors-in-interest.
3.2 Rights in Bankruptcy . The covenants in Section 3.1 are, and will
otherwise be deemed to be, for purposes of Section 365(n) of the US
Bankruptcy Code (the “ Code ”) and any similar
laws in any other country, licenses of rights to
“intellectual property” as defined under Section 101 of
the Code. The Par