EXHIBIT 10.11
ANALGESIC LICENSE AGREEMENT
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This Analgesic License Agreement (the "Agreement") dated the 27th day
of October, 1997 (the "Effective Date"), is entered into by and among The DuPont
Merck Pharmaceutical Company ("DuPont Merck"), a Delaware general partnership,
and Endo Laboratories, L.L.C. ("Endo"), a subsidiary of DuPont Merck (Endo and
DuPont Merck together are referred to herein as "Licensor"), and Endo
Pharmaceuticals Inc., a Delaware corporation ("Licensee").
W I T N E S S E T H
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WHEREAS, Licensor and Licensee are parties to that certain Asset
Purchase Agreement dated June 27, 1997, by and among DuPont Merck, DuPont Merck
Pharma, Endo and Licensee (the "Asset Purchase Agreement"); and
WHEREAS, in connection with the transactions contemplated by the Asset
Purchase Agreement, Licensor desires to grant to Licensee an exclusive,
worldwide license with respect to the Patent Rights (as defined below) and Know-
How (as defined below), and Licensee desires to receive such license;
NOW THEREFORE, in consideration of the foregoing and of the covenants
herein contained, intending to be legally bound, Licensor and Licensee hereby
covenant and agree as follows:
1. Definitions
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1.1 "Confidential Information" means certain secret and proprietary
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information and documents relating to the Patents and Know-How licensed
hereunder or relating to or held by any of the parties hereto, and
includes, without limitation, compounds, intermediates, designs, formulas
and formulations, methods, processes, know-how, and all other confidential
scientific, clinical, regulatory, marketing, financial and commercial
information or data, marketing strategies, product plans, plans for
research, development and experimental research, test and safety data,
supplier lists and all information relating to any Licensed Product,
whether communicated in writing or orally (to be confirmed in writing
within ten (10) days) or by other means, which is
provided or supplied by one party to the other party in connection with
this Agreement.
1.2 "Know-How" means information, materials, methods and practices,
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including but not limited to, preclinical, clinical, toxicological,
regulatory, manufacturing, safety and pharmacological information which on
the Effective Date of this Agreement are in Licensor's possession or
control, are not generally known to the public and are necessary or useful
for Licensee in the development, manufacture, use or sale of any Licensed
Product. Know-How shall not include any such data or information which is
available to Licensor under a license pursuant to which Licensor does not
have the right to grant sublicenses.
1.3 "Licensed Compounds" means individually and collectively the
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following:
(i) the selective kappa agonist compound referred to within DuPont
Merck as DuP 747, published as: X. Xxxxxxxxxxx, X.X Xxxxxxxx, X.
Xxxxxx, X.X. Xxxxxxx, X.X. Xxx, X.X. Xxxxxxxxx, and X. Xxxx, "DuP 747:
A New, Potent, Kappa Opioid Analgesic. Synthesis and Pharmacology",
Bioorganic & Medicinal Chemistry Letters, Vol. 2, No. 7, pp. 715-720
(1992);
(ii) the nalbuphine prodrug referred to with in DuPont Merck as DuP
769, published as: X.X. Xxxxxxx, X.X. Xxxxxx, G.A. Xxxxxxx, Jr., X.X.
Xxxxxx, M.E. Xxxxxxxxxx, X.X. Xxxxxxxx, X.X. Xxxxxxxxx, A. Sunshine,
and X. Xxxx, "Nalbuphine N-Oxide Prodrug: Analgesia and Nalbuphine
Serum Levels Following Administration of DuP 769 in Rats and Dogs",
Monograph No. 132: Problems of Drug Dependence, 1992: Proceedings of
the 54th Annual Scientific Meeting, The College on Problems of Drug
Dependence, Inc., pp. 147;
(iii) the compound referred to within DuPont Merck as DuP 631,
published as Y.N. Xxxx, X.X. Xxxxxxx, X.X. Xxxxx, and X.X. Xxxx,
"Metabolism and Disposition of Exp 631-A Novel Antidepressant
Analgesic", Biopharmaceutics and Drug Disposition, Vol. 14, pp. 519-
531 (1993); and
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any active metabolite, prodrug, stereoisomeric, crystalline and/or
salt forms thereof, provided however, that Licensed Analgesic
Compounds shall not include nalbuphine.
1.4 "Licensed Product" means a formulation for human pharmaceutical use in
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dosage form containing one or more Licensed Compounds.
1.5 "Patent Rights" means the patents and patent applications listed on
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Schedule A hereto and any and all patents and patent applications owned by
or licensed to Licensor as of the Effective Date, which contain one or more
claims covering any Licensed Product and/or Licensed Compound, or any
method for synthesis or use thereof, and any and all divisions,
continuations, and continuations-in-part thereof, and any reissues,
renewals, reexaminations, extensions or the like of any such patents and
patent applications and all foreign equivalents of any of the foregoing.
Patent Rights shall not include any patents or patent rights available to
Licensor under a license pursuant to which Licensor does not have the right
to grant sublicenses.
2. Grant. Licensor hereby grants to Licensee an exclusive, worldwide, fully
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paid-up, irrevocable license (collectively being the "Licensed Rights"), under
the Patent Rights and Know-How to attempt to make, make, have made, import, use,
offer for sale and sell Licensed Compounds and Licensed Products. The foregoing
grant shall include the right to xxx for past infringement, and also the right
to grant exclusive and/or non-exclusive sublicenses to third parties, at
Licensee's sole discretion. The foregoing grant shall be exclusive as to
everyone, including Licensor. It shall be understood, however, that Licensor
retains all rights under the Patent Rights to all compounds and inventions
claimed therein except with respect to Licensed Compounds and Licensed Products.
3. Delivery. Licensor shall disclose and make available to Licensee, as soon
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as possible but in no event later than thirty (30) days after the Effective
Date, copies of all Know-How embodied in tangible form, in any media, whether
electronic, written or otherwise. Such disclosure shall, as far as reasonably
practicable, be made in writing by furnishing copies of relevant materials.
Licensor shall also, as soon as possible but in no event later than thirty (30)
days after the Effective Date, deliver to the recipient designated by Licensee
any and all quantities of Licensed Compounds and Licensed Products which on the
Effective Date are in Licensor's possession or control.
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4. Term. The license to the Patent Rights hereunder shall commence upon the
----
Effective Date and continue on a country-by-country basis until the expiration
of the last to expire of the Patent Rights in such country. The license to the
Know-How hereunder shall be perpetual. Notwithstanding the foregoing, the
licenses granted in Section 2 hereof will terminate if Licensee shall cease to
carry on business or shall go into liquidation or a receiver shall be appointed
to Licensee's assets, except in the case where Licensee has assigned this
Agreement in accordance with Section 8.3 below.
5. Patent Maintenance and Patent Infringement
------------------------------------------
5.1 Patent Maintenance. Licensor shall be responsible for prosecuting and
------------------
maintaining the Patent Rights. In meeting such responsibility, Licensor
shall rely on its staff attorneys or outside counsel to the same extent it
usually does in prosecuting similar patents and patent applications owned
by Licensor. Licensor acknowledges its obligation to pay all maintenance
fees and annuities as they become due and payable to the U.S. Patent and
Trademark Office and other patent offices throughout the world, in order to
avoid premature expiration of any of the Patent Rights. In the event that
Licensor does not wish to continue to prosecute and/or maintain any of the
Patent Rights, Licensor shall inform Licensee of such decision in writing
as soon as practicable and Licensee shall have the right, but not the
obligation, to take such steps itself at its own expense.
5.2 Notice of Infringement. Each party shall immediately give notice to
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the other of (i) any potential infringement or actual infringement by a
third party of any Patent Rights or any misappropriation of Know-How of
which it becomes aware, or (ii) any certification of which it becomes aware
filed under the United States "Drug Price Competition and Patent Term
Restoration Act of 1984" claiming (x) that Patent Rights covering any
Licensed Product are invalid or unenforceable or (y) that infringement will
not arise from the manufacture, use or sale of Licensed Product by a third
party.
5.3 Licensee's Right to Bring Suit. With respect to any infringement of
------------------------------
the Licensed Rights with respect to any Licensed Compound and/or Licensed
Product, Licensee shall have the exclusive right, in its discretion, to
settle with the infringer or to bring suit or other proceeding at its
expense against the infringer. Licensee shall keep Licensor advised at all
times of such suit or proceedings brought by Licensee. Licensor agrees to
cooperate with Licensee
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in its efforts to protect the Patent Rights, including joining as a party
where necessary. Licensee agrees to prosecute diligently any litigation it
initiates under this Section 5.3. Licensee shall retain the full amount of
any recovery hereunder, after reimbursing Licensor for its out-of-pocket
expenses in connection with its participation in such suit or proceeding.
5.4 Licensee Accused of Infringement. In the event that Licensor or
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Licensee receives notice that a suit or other proceeding has been
instituted against Licensee, claiming that by exercising the Patent Rights
with respect to any Licensed Compound and/or Licensed Product Licensee is
infringing or has infringed the intellectual property of a third party,
each party shall notify the other of the same.
5.5 Patent Term Extension. The parties hereto shall cooperate with each
---------------------
other in obtaining patent term extension or supplemental protection
certificates or their equivalents in any country applicable to the Patent
Rights, as follows: The parties will notify each other within five (5)
business days of receiving approval for any Licensed Product from the U.S.
Food & Drug Administration or its equivalent in any country. The parties
will promptly negotiate in good faith extension strategies that would
permit both parties to take maximum advantage of extensions for all Patent
Rights hereunder.
6. Indemnification and Warranties
------------------------------
6.1 Indemnification. Licensee hereby indemnifies and holds Licensor
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harmless from any and all claims of personal injury or property damage
which may result from the manufacture, use or sale of any Licensed Products
or Licensed Compounds.
6.2 Warranties. Licensor represents and warrants that it has sole and
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exclusive right, title and interest in and to the Patent Rights; that it
has not entered into any other agreement that would conflict with this
Agreement; that it has the full legal right to grant the licenses provided
hereunder; that it has not granted rights in or to the Patent Rights or the
Know-How with respect to the Licensed Compounds to any person other than
Licensee; that no patent search has been conducted to ascertain whether the
exercise of the Licensed Rights will infringe any patent rights owned by
third parties; and to the best of its knowledge, the exercise of the
Licensed Rights will not infringe any third-party patent rights and neither
the Patent Rights nor the
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Know-How have been limited due to Licensor's not having the right to grant
sublicenses. Licensor hereby indemnifies and holds harmless Licensee from
all damages (including attorneys' fees) arising from any breach of the
foregoing representations and warranties.
6.3 No Other Warranties. LICENSOR MAKES NO OTHER WARRANTIES, EXPRESS OR
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IMPLIED, AS TO ANY MATTER WHATSOEVER, INCLUDING, WITHOUT LIMITATION, THE
CONDITION, MERCHANTABILITY OR FITNESS FOR PURPOSE OF ANY PRODUCTS OR
PROCESSES COVERED BY THE PATENT RIGHTS.
7. Confidentiality
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7.1 Nondisclosure Obligation. All Confidential Information hereunder
------------------------
disclosed by one party to another, whether in the past or in the future,
shall be governed by the terms and conditions of this Section 7. The
parties hereto agree that all Confidential Information shall be maintained
in confidence by the recipient and shall not be disclosed by the recipient
to any other natural person, or any corporation, firm, partnership or other
business entity, or any government or any agency thereof, without the prior
written consent of the other party, except to the extent that such
Confidential Information:
(i) is known by recipient at the time of its receipt as documented
by business records;
(ii) is properly in the public domain through no fault of the
receiving party;
(iii) is subsequently disclosed to the receiving party by a third
party who may lawfully do so and is not under an obligation of
confidentiality to the disclosing party;
(iv) is developed by the receiving party independently of
Confidential Information or other information received from the other
party;
(v) is disclosed to governmental or other regulatory agencies in
order to obtain patents or to gain approval to conduct clinical trials
or
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to market Licensed Products, but such disclosure may be only to the
extent reasonably necessary to obtain patents or authorizations;
(vi) is necessary or useful to be disclosed to prospective investors,
sublicensees, agents, consultants and/or other third parties for the
research and development, manufacturing, marketing and or sale of
Licensed Products (or for such parties to determine their interest in
performing such activities) in accordance with this Agreement on the
condition that such third parties agree to be bound by the
confidentiality obligations contained in this Agreement, provided that
the term of confidentiality for such third parties shall be no less
than five (5) years from the date of disclosure; or
(vii) is required to be disclosed by law or court order, provided that
notice is promptly delivered to the other party in order to provide an
opportunity to challenge or limit the disclosure obligations.
The receiving party shall use the same level of care, but no less than a
reasonable level of care, to prevent the use or disclosure of Confidential
Information received under this Agreement, as it exercises in protecting
its own secret and proprietary information of similar nature. The receiving
party shall only communicate Confidential Information to its employees,
legal and financial advisors who need to know such Confidential
Information, who have been previously made aware of the terms of this
Agreement pertaining to Confidential Information and who have agreements
with the receiving party obligating them to keep confidential such
Confidential Information.
7.2 Use of Confidential Information. Both parties agree that the
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Confidential Information shall only be used in connection with the exercise
of the parties' respective rights and the fulfillment of their obligations
under this Agreement.
8. Miscellaneous
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8.1 This Agreement shall be construed in accordance with the laws of the
United States and the laws of the State of Delaware, without regard for
principles of conflicts of law thereof.
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8.2 This Agreement contains the entire and only agreement between the
parties, and supersedes all preexisting oral or written agreements between
them regarding the subject matter hereof. Any changes or modifications
hereto shall be effective only if made in writing and signed by both
parties.
8.3 The rights of Licensee under this Agreement shall not be transferred
or assigned without the consent of Licensor, which consent shall not be
unreasonably withheld, except such that such rights may be assigned or
transferred to a successor to Licensee's business through the sale of all
or substantially all of Licensee's assets and/or shares, or merger or
reorganization, without the consent of Licensor.
8.4 In the event that any provision of this Agreement is held invalid or
unenforceable in any circumstance by a court of competent jurisdiction, the
remainder of this Agreement, and application of such provision in any other
circumstances, shall not be affected thereby.
8.5 The headings of this Agreement are for convenience of reference only
and shall not affect the meaning or interpretation of this Agreement in any
way.
8.6 Each party hereto is an independent contractor and neither the making
of this Agreement nor the performance of any of the provisions hereof shall
be construed to make one party an agent, employee or legal representative
of another party for any purpose, nor shall this Agreement be deemed to
establish a joint venture or partnership.
8.7 The failure of either party to assert a right hereunder or to insist
upon compliance with any term or condition of this Agreement shall not
constitute a waiver of that right or excuse a similar subsequent failure to
perform any such term or condition by the other party.
8.8 This Agreement may be executed in two or more counterparts, and when
each party has signed and delivered at least one counterpart, each
counterpart shall be deemed an original, and, when taken together with
other signed counterparts, shall constitute one Agreement, which shall be
binding upon and effective as to all parties.
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IN WITNESS WHEREOF, the parties have duly executed this Agreement as
of the date first above written.
THE DUPONT MERCK PHARMACEUTICAL COMPANY
/s/ XXXX X. XXXXX
By: _____________________________________
Name: Xxxx X. Xxxxx
Title: President, CEO
ENDO LABORATORIES, L.L.C.
/s/ XXXX X. XXXXX
By: _____________________________________
Name: Xxxx X. Xxxxx
Title: President, CEO
ENDO PHARMACEUTICALS INC.
/s/ XXXXX XXXXX
By: _____________________________________
Name: Xxxxx Xxxxx
Title: President, CEO
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DuPont Legal Patent Division
License Agreement: NorthStar & Endo Pharmaceuticals DuP 631 Exhibit A
27 October 1997
Page 1
Docket Number Country Name Appl. Date Applic. Number Patent Number Sub Sta Abandon Date Grant Date
BP6333 PHILIPPINES 21 Mar 1989 38357 XXX
XX0000 XXXXXXX 22 Mar 1989 89/001456 XXX
XX0000 XXXXX SOUTH 28 Mar 1989 89/003866 XXX
XX0000 XXXXX 28 Mar 1989 89/074129 EPP
BP6333 U.S.A. 28 Mar 1988 07/174356 ABN 01 Dec 1989
BP6333 NORWAY 22 Mar 1989 89/001260 ABN 22 Oct 1994
BP6333 TAIWAN 24 Mar 1989 78102254 052941 ISS 01 Apr 1992
BP6333 EUR PATENT 22 Mar 1989 89105083.3 0337167 ISS 03 Aug 1994
BP6333 BELGIUM 22 Mar 1989 UNKN 0337167 ISS 03 Aug 1994
BP6333 FRANCE 22 Mar 1989 UNKN 0337167 ISS 03 Aug 1994
BP6333 GREAT BRITAIN 22 Mar 1989 UNKN 0337167 ISS 03 Aug 1994
BP6333 ITALY 22 Mar 1989 UNKN 0337167 ISS 03 Aug 1994
BP6333 LUXEMBOURG 22 Mar 1989 UNKN 0337167 ISS 03 Aug 1994
BP6333 NETHERLANDS 22 Mar 1989 UNKN 0337167 ISS 03 Aug 1994
BP6333 SPAIN 22 Mar 1989 UNKN 0337167 ISS 03 Aug 1994
BP6333 SWEDEN 22 Mar 1989 UNKN 0337167 ISS 03 Aug 1994
BP6333 SWITZERLAND 22 Mar 1989 UNKN 0337167 ISS 03 Aug 1994
BP6333 GREECE 22 Mar 1989 940402613 3013326 ISS 03 Aug 1994
BP6333 GERMANY 22 Mar 1989 P68917185.4-08 68917185 ISS 03 Aug 1994
BP6333 AUSTRIA 22 Mar 1989 UNKN E0109465 ISS 03 Aug 1994
BP6333 HUNGARY 28 Mar 1989 89/001532 213671 ISS 05 Aug 1997
BP6333 FINLAND 28 Mar 1989 89/001473 94240 ISS 10 Aug 1995
BP6333 PORTUGAL 28 Mar 1989 90127 90127 ISS 13 Dec 1993
BP6333 AUSTRALIA 28 Mar 1989 89/031717 623637 ISS 15 Sep 1992
BP6333 ISRAEL 27 Mar 1989 89746 89746 ISS 16 Jun 1993
10
Docket Number Country Name Appl. Date Applic. Number Patent Number Sub Sta Abandon Date Grant Date
BP6333 RUSSIAN FED 27 Mar 1989 4613736/04 1836346 ISS 24 Jan 1992
BP6333 CANADA 22 Feb 1989 591753 1337418 ISS 24 Oct 1995
XX0000 XXXXX XXXXXX 22 Mar 1989 89/002171 89/002171 ISS 28 Nov 1990
BP6333 NEW ZEALAND 23 Mar 1989 228479 228479 ISS 29 Apr 1992
BP6333 MEXICO 28 Mar 1989 015430 183916 XXX 00 Xxx 0000
XX0000 XXXXXXXX 27 Mar 1989 PI8900381 MY103990A ISS 30 Oct 1993
BP6333 IRELAND 23 Mar 1989 89/000913 65811 ISS 31 Oct 1995
BP6333A U.S.A. 28 Aug 1989 07/398999 5019650 ISS 28 May 1991
BP6333B U.S.A. 28 Aug 1989 07/398996 5086063 ISS 04 Feb 1992
11
DuPont Legal Patent Division
License Agreement: NorthStar & Endo Pharmaceuticals DuP 747 Exhibit A
27 October 1997
Page 1
Docket Number Country Name Appl. Date Applic. Number Patent Number Sub Sta Abandon Date Grant Date
BP6322 U.S.A. 10 Sep 1986 905543 ABN 01 Jan 1989
BP6322A PHILIPPINES 10 Sep 1987 35798 XXX
XX0000X XXXXXX 08 Sep 1987 546354 XXX
XX0000X XXXXXXXXX 10 Sep 1987 87/078224 607935 ISS 01 Aug 1991
BP6322A ISRAEL 09 Sep 1987 83842 83842 ISS 02 Oct 1991
BP6322A MALAYSIA 10 Sep 1987 XX0000000 MY101368A ISS 05 Sep 1991
BP6322A DENMARK 09 Sep 1987 87/004700 169071 ISS 08 Aug 1994
BP6322A IRELAND 09 Sep 1987 87/002406 60423 ISS 08 Jul 1994
BP6322A KOREA SOUTH 10 Sep 1987 87/010028 107765 ISS 15 Nov 1996
BP6322A HUNGARY 09 Sep 1987 87/004018 198016 ISS 19 Apr 1989
BP6322A PORTUGAL 09 Sep 1987 85668 85668 XXX 00 Xxx 0000
XX0000X XXXXX 09 Sep 1987 87/224204 2110963 ISS 21 Nov 1996
BP6322A EUR PATENT 05 Sep 1987 87113010.0 0260555 ISS 22 Apr 1992
BP6322A BELGIUM 05 Sep 1987 UNKN 0260555 ISS 22 Apr 1992
BP6322A FRANCE 05 Sep 1987 UNKN 0260555 ISS 22 Apr 1992
BP6322A GREAT BRITAIN 05 Sep 1987 UNKN 0260555 ISS 22 Apr 1992
BP6322A ITALY 05 Sep 1987 UNKN 0260555 ISS 22 Apr 1992
BP6322A LUXEMBOURG 05 Sep 1987 UNKN 0260555 ISS 22 Apr 1992
BP6322A NETHERLANDS 05 Sep 1987 UNKN 0260555 ISS 22 Apr 1992
BP6322A SPAIN 05 Sep 1987 UNKN 0260555 ISS 22 Apr 1992
BP6322A SWEDEN 05 Sep 1987 UNKN 0260555 ISS 22 Apr 1992
BP6322A SWITZERLAND 05 Sep 1987 UNKN 0260555 ISS 22 Apr 1992
BP6322A GREECE 05 Sep 1987 UNKN 3004962 ISS 22 Apr 1992
BP6322A GERMANY 05 Sep 1987 P3778463.3-08 3778463 ISS 22 Apr 1992
BP6322A AUSTRIA 05 Sep 1987 UNKN E0075223 ISS 22 Apr 1992
12
Docket Number Country Name Appl. Date Applic. Number Patent Number Sub Sta Abandon Date Grant Date
BP6322A RUSSIAN FED 09 Sep 1987 4203411/04 1582984 ISS 23 Dec 1988
BP6322A U.S.A. 16 Jul 1987 07/071028 4876269 ISS 24 Oct 1989
BP6322A FINLAND 09 Sep 1987 87/003896 88298 ISS 26 Apr 1993
BP6322A MEXICO 10 Sep 1987 008173 170515 ISS 27 Aug 1993
BP6322A NEW ZEALAND 08 Sep 1987 221726 221726 ISS 28 Aug 1990
BP6322A NORWAY 09 Sep 1987 87/003762 172934 ISS 29 Sep 1993
XX0000X XXXXX XXXXXX 10 Sep 1987 87/006778 87/006778 ISS 30 May 1989
BP6322A TAIWAN 09 Sep 1987 76105341 031661 ISS 31 Jul 1989
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DuPont Legal Patent Division
License Agreement: NorthStar & Endo Pharmaceuticals DuP 769 Exhibit A
27 October 1997
Page 1
Docket Number Country Name Appl. Date Applic. Number Patent Number Sub Sta Abandon Date Grant Date
BP6295 U.S.A. 02 Dec 1985 803222 4722928 ABN 02 Aug 1995 02 Feb 1988
BP6295 JAPAN 01 Dec 1986 86/284459 1966196 ISS 25 Aug 1995
BP6295 1 JAPAN 24 May 1993 93/121382 2017591 ISS 19 Feb 1996
BP6295A U.S.A. 01 Oct 1987 07/103213 ABN 01 Aug 1989
BP6295B U.S.A. 27 Jul 1989 07/391406 4990617 ISS 05 Feb 1991
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