Exhibit 10.5
ACTIQ SUPPLEMENTAL LICENSE AND
SUPPLY AGREEMENT
This ACTIQ Supplemental License and
Supply Agreement (this “ Agreement ”) is entered
into as of this 1 st 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 controls and has
the right to grant rights under certain patent rights relating to
Cephalon’s proprietary pharmaceutical product known as
ACTIQ®, a drug indicated for the treatment of breakthrough
cancer pain, and is the assignee or exclusive licensee of certain
rights in, and has the right to grant sublicenses under certain
patent rights relating to ACTIQ®;
WHEREAS, Cephalon is developing a
substantially sugar-free formulation of ACTIQ® (“
ACTIQ SF ”) and controls and has the right to grant
rights under certain patent rights relating to ACTIQ SF;
and
WHEREAS, in order to resolve certain
antitrust concerns raised by the Federal Trade Commission (the
“ Commission ”) in connection with
Cephalon’s acquisition of CIMA LABS INC. (“ CIMA
”), and as a condition of Commission approval of such
acquisition, Cephalon entered into an Agreement Containing Consent
Order (“ Consent Agreement ”), which required
Cephalon to enter into a license and supply agreement with Barr to
develop, manufacture and market generic versions of ACTIQ® and
ACTIQ SF, including contingent supply of both products;
WHEREAS, on July 7, 2004, Cephalon
and Barr entered into that certain License and Supply Agreement
(the “ Existing License and Supply Agreement ”)
pursuant to which Cephalon granted to Barr certain rights and
licenses and assumed certain supply and other obligations, as
required under the Consent Agreement;
WHEREAS, in connection with
Barr’s submission of ANDA No. 77-312 to the Food and Drug
Administration (the “ FDA ”) under Section
505(j) of the U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C.
§ 355(j)), Cephalon filed suit against Barr in an action
captioned Cephalon, Inc., et al . v. Barr Laboratories,
Inc., Civil Action No. 05-29 (JJF), in the United States
District Court for the District of Delaware, and Barr answered the
complaint by denying infringement, by asserting affirmative
defenses of noninfringement and invalidity, and by filing
counterclaims for declaratory judgment of noninfringement and
invalidity;
WHEREAS, simultaneously with the
execution of this Agreement, Cephalon and Barr have entered into
that certain Actiq Settlement Agreement pursuant to which the
Parties have resolved and settled the claims described above;
and
**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, in connection with such
settlement, and without amending or modifying any terms and
conditions of the Existing License and Supply Agreement, Cephalon
wishes to grant to Barr, and Barr wishes to receive, the additional
rights and licenses set forth in this Agreement, subject to the
terms and conditions hereof.
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
All capitalized terms not defined
herein shall have the respective meanings ascribed to such terms in
the Existing License and Supply Agreement. The following terms
shall have the following respective meanings:
1.1
“ ACTIQ
Licensed Product ” means both “ACTIQ Licensed
Product” and “ACTIQ SF Licensed Product” as each
of those terms are defined in the Existing License and Supply
Agreement.
1.2
“
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.
1.3
“
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
“
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, successors, and assigns; its
subsidiaries, divisions, groups, and the respective directors,
officers, employees, agents and representatives, successors, and
assigns of each.
1.5
“
Exclusivity Period ” means the period from December 6,
2006 through the Existing License Effective Date.
**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.
2
1.6
“
Existing License Effective Date ” means the date on
which the license granted under Section 2.1(a) (i), (ii) and (iv)
of the Existing License and Supply Agreement becomes effective
under Section 2.1(b) of the Existing License and Supply
Agreement.
1.7
“
Generic Subject OTFC Product ” means any Subject OTFC
Product that is not marketed under the ACTIQ®
mark.
1.8
“
Licensed Patents ” means the (a) ACTIQ Patent Rights,
including those patents owned by Cephalon and identified in
Exhibits C and E to the Existing License and Supply Agreement, (b)
ACTIQ Patent Rights licensed to Cephalon, including those
identified in Exhibit D to the Existing License and Supply
Agreement, and (c) ACTIQ SF Patent Rights, including those patents
owned by Cephalon and identified in Exhibit F to the Existing
License and Supply Agreement.
1.9
“ Net
Profits ” shall mean the gross receipts derived in
arms-length transactions from the sale of ACTIQ Licensed 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 ACTIQ Licensed Product by Barr and/or
its Affiliates;
(b)
Credit for returns, refunds, rebates
and allowances, or trades to customers for returned or recalled
ACTIQ Licensed 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 ACTIQ Licensed Product pursuant to Section 6.1(d) of the
Existing License and Supply Agreement, as incorporated herein by
Section 4.1(c) of this Agreement, or Barr’s direct and
reasonable costs of making ACTIQ Licensed Product, as applicable,
which shall in no event be greater than Barr’s costs of
purchasing ACTIQ Licensed Product from Cephalon pursuant to Section
6.1(d) of the Existing License and Supply Agreement as so
incorporated.
Gross and Net Profits shall be
calculated according to US GAAP. Sales or transfers between or
among a Party 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) ACTIQ Licensed Product is
sold as one of a number of items without a separate price; or (ii)
the consideration for the ACTIQ Licensed Product shall include any
non-cash element; or (iii) the ACTIQ Licensed Product shall be
transferred in any manner other than
**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
an invoiced sale, the gross sales applicable to
any such transaction shall be deemed to be the selling
party’s average gross sales in the United States for the
applicable quantity of ACTIQ Licensed Product during the calendar
quarter. If there are no independent gross sales of ACTIQ Licensed
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.
1.10
“
Party ” or “ Parties ” means a
party, or the parties, to this Agreement.
1.11
“
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)).
1.12
“ Shelf
Stock Adjustment ” means the customary practice of
providing a purchaser of ACTIQ Licensed Product an adjustment to
the net purchase price for on-hand inventory in response to an
offer from a supplier of a competing Generic Subject OTFC
Product,.
1.13
“
Subject OTFC Product ” means [**].
2.
GRANT OF RIGHTS
2.1
Exclusivity;
License . If, and only if, the
Existing License Effective Date has not occurred on or prior to
December 6, 2006, then the following terms and conditions shall
apply:
(a)
Exclusive
Authorized Generic . During the Exclusivity
Period, Cephalon shall not market or sell, nor shall it license or
authorize any entity other than Barr to market or sell, Generic
Subject OTFC Products in the United States.
(b)
Grant of
Licenses . Cephalon grants to Barr an
irrevocable, non-transferable, exclusive (even as to Cephalon)
license, without the right to sublicense, to develop, use, sell,
offer for sale, distribute or have distributed, promote or
advertise, import or have imported ACTIQ Licensed Product solely in
the United States and solely during the Exclusivity Period, in each
case, under:
(i)
the Licensed
Patents; and
(ii)
(A) the U.S.
Trademark Registration No. 2,622,734 as needed for a single dose
entity of an ACTIQ Licensed Product (B) any trademark or trade
dress covering the size, shape and color of a single dose entity of
ACTIQ Licensed Product, to the extent Barr desires; and (C) the
appearance, structure, textual or graphical content and/or color
scheme of any labeling, dosing information, product inserts,
Skeeper or other materials, and any Risk Management Program, as may
be necessary for the marketing and sale of ACTIQ Licensed
Product.
The Parties acknowledge Barr’s rights to
certain manufacturing know-ho
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