Exhibit 10.3
MODAFINIL LICENSE AND SUPPLY
AGREEMENT
This Modafinil License and Supply
Agreement (this “ Agreement ”) is entered into
as of this 1st day of February 2006 (the “ Effective
Date ”) by and between Cephalon, Inc., a Delaware
corporation, having its principal place of business located at 41
Moores Road, P.O. Box 4011, Frazer, Pennsylvania 19355, and
Barr Laboratories, Inc., a Delaware corporation, having its
principal place of business located at 400 Chestnut Ridge Road,
Woodcliff Lake, New Jersey 07677.
WHEREAS, Cephalon is the owner by
assignment of all right and title in U.S. Reissue Patent
No. RE37,516 (the “ RE ‘516 Patent
”), issued by the United States Patent and Trademark Office
on January 15, 2002 and expiring on October 6,
2014.
WHEREAS, PROVIGIL® modafinil,
which is covered by claims of the RE ‘516 Patent, is the
commercial formulation of modafinil developed, manufactured and
sold by Cephalon pursuant to FDA approval of Cephalon’s NDA
20-717.
WHEREAS, by letter dated
February 20, 2003, Barr notified Cephalon that Barr had
submitted ANDA No. 76-597 to the FDA under Section 505(j)
of the U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C.
§ 355(j)), seeking approval to engage in the commercial
manufacture, use, and sale of tablets containing 100 mg and 200 mg
of modafinil, a generic version of PROVIGIL® modafinil
tablets, before the expiration date of the RE ‘516 Patent,
and certifying that the RE ‘516 Patent is invalid,
unenforceable, or not infringed by Barr’s generic
product.
WHEREAS, Cephalon timely filed suit
against Barr and three other companies that had also filed
Paragraph IV ANDAs concerning PROVIGIL® modafinil in an action
captioned Cephalon, Inc. v. Mylan Pharmaceuticals Inc., et
al ., Civil Action No. 03-CV-1394 (JCL), in the United
States District Court for the District of New Jersey, seeking,
among other things, a declaration that Barr’s making, using,
offering to sell, selling, or importing tablets as described in
Barr’s ANDA No. 76-597 would infringe the RE ‘516
Patent, an order providing that the effective date of any approval
of Barr’s ANDA No. 76-597 shall be a date which is not
earlier than the date of the expiration of the RE ‘516
Patent, and an order permanently enjoining Barr from making, using,
offering to sell, selling, or importing tablets as described in
Barr’s ANDA No. 76-597 until after the date of the
expiration of the RE ‘516 Patent.
WHEREAS, Barr answered
Cephalon’s complaint by denying infringement, by asserting an
affirmative defense that incorporated by reference Barr’s
co-defendants’ allegations that the RE ‘516 patent is
invalid and unenforceable, and by filing a counterclaim seeking
declaratory judgment of noninfringement.
WHEREAS, Cephalon and Barr have
taken discovery, but no partial or final judgment has been entered
as to any issue in dispute.
**Portions of the Exhibit have been omitted
and have been filed separately pursuant to an application for
confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
WHEREAS, to avoid the time and
expense of further litigation, and in compromise of the disputed
claims set forth above, the Parties now desire to resolve their
disputes by settlement in accordance with that certain Provigil
Settlement Agreement dated February 1, 2006 between the
Parties (the “ Provigil Settlement Agreement
”).
WHEREAS, in connection with such
settlement, Cephalon wishes to grant to Barr, and Barr wishes to
receive, certain rights and licenses, subject to the terms and
conditions of this Agreement.
NOW, THEREFORE, in consideration of
the foregoing and for good and valuable consideration, the receipt
and adequacy of which is hereby affirmed, and intending to be
legally bound hereby, the Parties hereby agree as
follows.
1.
DEFINITIONS
1.1
“
Affiliate ” means any corporation, partnership, joint
venture or firm which controls, is controlled by or under common
control with a specified person or entity. For purposes of this
definition, “control” shall be presumed to exist if one
of the following conditions is met: (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 policy decisions of such non-corporate
entities.
1.2
“
ANDA ” means an Abbreviated New Drug Application, as
defined under 21 U.S.C. § 355 (j) et seq
.
1.3
“
Barr ” means Barr Laboratories, Inc., a
corporation organized and existing under the laws of the State of
Delaware, with its principal place of business at 400 Chestnut
Ridge Road, Woodcliff Lake, New Jersey 07677, and its directors,
officers, employees, agents and representatives, predecessors,
successors, and assigns; its subsidiaries, divisions, groups, and
the respective directors, officers, employees, agents and
representatives, successors, and assigns of each.
1.4
“ Barr
ANDA Modafinil Product ” means [**].
1.5
“ Barr
Generic Modafinil Product ” means a Barr ANDA Modafinil
Product or a Cephalon Supplied Modafinil Product.
1.6
“ Barr
Indemnitees ” has the meaning assigned in
Section 8.1.
1.7
“ Barr
Modafinil ANDA ” means ANDA No. 76-597.
1.8
“
Cephalon ” means Cephalon, Inc., a corporation
organized and existing under the laws of the State of Delaware,
with its principal place of business at 41 Moores Road, Frazer,
Pennsylvania, and its directors, officers, employees, agents and
representatives, predecessors,
**Portions of the Exhibit have been omitted
and have been filed separately pursuant to an application for
confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
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successors, and assigns; its subsidiaries,
divisions, groups, and the respective directors, officers,
employees, agents and representatives, successors, and assigns of
each.
1.9
“
Cephalon Indemnitees ” has the meaning assigned in
Section 8.2.
1.10
“
Cephalon Supplied Modafinil Product ” means Subject
Modafinil Product sold by Cephalon to Barr for ultimate resale in
the United States pursuant to the terms and conditions of a
separate supply agreement between the Parties as described in
Article 4.
1.11
“
Commercially Reasonable Efforts ” means efforts and
resources that would normally be expected to be used by a
pharmaceutical company to develop, seek required FDA approvals for,
manufacture, control and assure quality of, introduce into markets
and otherwise commercialize a drug product owned by it or to which
it has rights, which is of similar market potential at a similar
stage of development or product life, taking into account issues of
safety and efficacy, competitiveness in the marketplace, the
proprietary position of the drug product, the regulatory
structure(s) involved, the profitability of the drug product, and
other material and relevant factors.
1.12
“
Confidential Information ” has the meaning assigned in
Section 7.1.
1.13
“ Date
Certain ” means the later of:
(a) October 6, 2011 (which is three years prior to the
expiration of the RE ‘516 Patent); or (b) in the event
that Cephalon obtains a pediatric extension of the RE ‘516
Patent, April 6, 2012 (which is three years prior to the
expiration of Pediatric Exclusivity, if obtained).
1.14
“
FDA ” means the United States Food and Drug
Administration.
1.15
“
Independent Auditor ” has the meaning assigned in
Section 3.7.
1.16
“ Listed
Patents ” means [**].
1.17
“
Modafinil License Effective Date ” has the meaning
assigned in Section 2.2.
1.18
“
Modafinil Litigation ” means (a)
Cephalon, Inc. v. Mylan Pharmaceuticals Inc., et al .,
Civil Action No. 03-CV-1394 (JCL), pending in the United
States District Court for the District of New Jersey; (b)
Cephalon, Inc. v. Carlsbad Tech., Inc. , Civil
Action No. 05-CV-1089 (JCL), pending in the United States
District Court for the District of New Jersey; and (c) any
action filed under Title 35, United States Code, 35 U.S.C.
§§ 271 and 281 against any Modafinil Paragraph IV
ANDA Filing Entity.
1.19
“
Modafinil Paragraph IV ANDA Filing Entity ” shall mean
any entity that has notified or subsequently notifies Cephalon that
it has filed an ANDA with a Paragraph IV certification concerning a
product containing modafinil as an active ingredient for which
Provigil is the reference listed drug.
**Portions of the Exhibit have been omitted
and have been filed separately pursuant to an application for
confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
3
1.20
“
NDA ” means New Drug Application, as defined under 21
U.S.C. § 355(b) et seq .
1.21
“ Net
Profits ” means the gross receipts derived in
arm’s-length transactions from the sale of Barr Generic
Modafinil Product in the United States by Barr (or by its
Affiliates), to independent third parties in the United States,
less the sum of the following items:
(a)
Import, export, excise and sales
taxes and custom duties paid or allowed by the selling party and
any other governmental charges imposed upon the production,
importation, use or sale of Barr Generic Modafinil Product by Barr
and/or its Affiliates;
(b)
Credits for returns, refunds,
rebates and allowances, or trades to customers for returned or
recalled Barr Generic Modafinil Product;
(c)
Trade, quantity and cash discounts
actually allowed;
(d)
Transportation, freight and
insurance allowances;
(e)
Rebates to wholesalers,
administrative fees in lieu of rebates paid to managed care and
other similar institutions, chargebacks and retroactive price
adjustments, including Shelf Stock Adjustments, and any other
similar allowances which effectively reduce the net selling price;
and
(f)
The purchase price paid to Cephalon
for such Barr Generic Modafinil Product that is Cephalon Supplied
Modafinil Product or Barr’s direct and reasonable costs of
making such Barr Generic Modafinil Product that is Barr ANDA
Modafinil Product, as applicable.
Gross and Net Profits shall be
calculated according to US GAAP. Sales or transfers between or
among Barr and its Affiliates shall be excluded from the
computation of Net Profits except where such Affiliates are end
users, but Net Profits shall include the subsequent final sales to
third parties by such Affiliates.
Where (i) Barr Generic
Modafinil Product is sold as one of a number of items without a
separate price; or (ii) the consideration for the Barr Generic
Modafinil Product shall include any non-cash element; or
(iii) the Barr Generic Modafinil Product shall be transferred
in any manner other than an invoiced sale, the gross sales
applicable to any such transaction shall be deemed to be the
selling party’s average gross sales for the applicable
quantity of Barr Generic Modafinil Product during the calendar
quarter. If there are no independent gross sales of Barr Generic
Modafinil Product in the United States at that time, then Barr and
Cephalon shall mutually agree on a surrogate measure to be used in
lieu thereof.
1.22
“ Other
Modafinil Paragraph IV ANDA Filing Entity ” means any
Modafinil Paragraph IV ANDA Filing Entity besides Barr or Cephalon
or its and their Affiliates.
1.23
“
Party ” or “ Parties ” means a
party, or the parties, to this Agreement.
**Portions of the Exhibit have been omitted
and have been filed separately pursuant to an application for
confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
4
1.24
“
Pediatric Exclusivity ” means exclusivity obtained in
accordance with the requirements of Section 505(a) of the
U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C.
§ 355(a)).
1.25
“
Providing Party ” has the meaning assigned in
Section 7.1.
1.26
“
Provigil ” means the commercial formulation of
modafinil developed, manufactured and, as of the Effective Date,
sold by Cephalon pursuant to FDA approval of Cephalon’s NDA
20-717.
1.27
“
Receiving Party ” has the meaning assigned in
Section 7.1 of this Agreement.
1.28
“ Shelf
Stock Adjustment ” means the customary practice of
providing a purchaser of Barr Generic Modafinil Product an
adjustment to the net purchase price for on-hand inventory in
response to an offer from a supplier of a competing Subject
Modafinil Product.
1.29
“
Subject Modafinil Product ” shall mean
[**].
2.
GRANT OF RIGHTS
2.1
Grant of
License . Subject to Sections 2.2 and
2.3 below, Cephalon grants to Barr a royalty-bearing, non-exclusive
license, without a right to sublicense, under the Listed Patents
and any regulatory exclusivities, including Pediatric Exclusivity,
to use, offer for sale, sell, distribute and have distributed,
promote, market and advertise, import and have imported, the Barr
Generic Modafinil Product, and to make and have made the Barr ANDA
Modafinil Product, in the United States.
2.2
Modafinil
License Effective Date . The license granted by
Cephalon to Barr pursuant to Section 2.1 shall become
effective upon the earliest of:
(a)
the Date
Certain;
(b)
the sale of a
Subject Modafinil Product in the United States pursuant to a
license or authorization granted by Cephalon to a third party
(other than a license or authorization granted to a third party,
whether by settlement or otherwise, under circumstances similar to
those that would trigger Barr’s license under
Section 2.2(c) below, and that is subject to suspension
provisions similar to those set forth in
Section 2.3);
(c)
the sale of a
Subject Modafinil Product by any Other Modafinil Paragraph IV ANDA
Filing Entity in the United States that is not pursuant to a
license or authorization granted by Cephalon (in which case, Barr
would receive a license to enter the market which is subject to
suspension as set forth in Section 2.3); and
(d)
the entry of a
final, non-appealable judgment in the Modafinil Litigation
declaring that one or more Other Modafinil Paragraph IV ANDA Filing
Entities may sell or offer
**Portions of the Exhibit have been omitted
and have been filed separately pursuant to an application for
confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.
5
to sell Subject Modafinil Products in the United
States without infringing any valid, enforceable claim of any
Listed Patent on which Cephalon has brought suit in such
litigation.
The earliest to occur of the dates in
subsections (a) through (d) of this Section 2.2
shall constitute the “ Modafinil License Effective
Date ”.
2.3
Suspension of
License . If, at any time after the
Modafinil License Effective Date (where such Modafinil License
Effective Date is triggered as a result of an event set forth in
Section 2.2(c)), (a) Cephalon obtains a temporary
restraining order or other relief sufficient to stop further offers
to sell or sales in the United States of Subject Modafinil Products
by all Other Modafinil Paragraph IV ANDA Filing Entities, or
(b) Cephalon prevails against all Other Modafinil Paragraph IV
ANDA Filing Entities in any Modafinil Litigation, such that offers
to sell or sales in the United States of Subject Modafinil Products
by Other Modafinil Paragraph IV ANDA Filing Entities are admitted
by such Other Modafinil Paragraph IV ANDA Filing Entities or held
by the court to infringe one or more valid and enforceable claims
of the Listed Patents, then (i) Barr’s license under
Section 2.1 shall be suspended until the Date Certain, or, if
applicable, the earlier occurrence of an event described in
Section 2.2(b), (ii) Barr and/or its Affiliates shall
immediately cease offering to sell and/or selling any Barr Generic
Modafinil Product as of the earliest date on which such injunctive
or other relief may be enforced, or otherwise when Cephalon
prevails in the action described in subsection (b) above,
and (iii) [**]. For purposes of clarity, nothing in this
Agreement or in the Provigil Settlement Agreement shall obligate
Cephalon to seek injunctive or other relief to stop any Other
Modafinil Paragraph IV ANDA Filing Entity from offering to sell or
selling Subject Modafinil Products in the United
States.
2.4
Notification
to FDA of License . Subject to
Section 2.3, immediately upon the Modafinil License Effective
Date, Cephalon shall reasonably cooperate with Barr in notifying
the FDA that Cephalon has granted Barr the license set forth in
Section 2.1, including, but not limited to, by filing with the
FDA such documentation as is necessary to affirm such
license.
2.5
Infringement
.
(a)
Notice
Regarding and Authority to Take Action Against
Infringers . Barr shall promptly notify
Cephalon of any known infringement by third parties of the rights
licensed to Barr under this Agreement. If any of the Listed Patents
are infringed, Cephalon shall have the sole and exclusive right,
but not the obligation, to commence appropriate legal action to
enjoin such infr
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