License Agreement - Sepracor Inc. and Hoechst Marion Roussel Inc.
LICENSE AGREEMENT
by and between
SEPRACOR INC.
and
HOECHST MARION ROUSSEL, INC.
August 31, 1999
This document is the confidential information of both parties hereto.
It should be distributed on a need-to-know basis and kept in secure area.
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ARTICLE 1 - DEFINITIONS................................................2
ARTICLE 2 - ASSIGNMENT AND LICENSE GRANT...............................6
ARTICLE 3 - ROYALTIES AND OTHER CONSIDERATION..........................7
ARTICLE 4 - ROYALTY PAYMENTS, REPORTS AND RECORDS......................7
ARTICLE 5 - RIGHTS IN TECHNOLOGY, INVENTIONS AND PATENTS..............10
ARTICLE 6 - INFRINGEMENT INVOLVING PRODUCT............................10
ARTICLE 7 - CONFIDENTIALITY...........................................12
ARTICLE 8 - TERM......................................................13
ARTICLE 9 - BREACH AND TERMINATION....................................13
ARTICLE 10 - RIGHTS AND OBLIGATIONS UPON TERMINATION..................14
ARTICLE 11 - REPRESENTATIONS AND WARRANTIES...........................14
ARTICLE 12 - INDEMNIFICATION..........................................16
ARTICLE 13 - CHOICE OF LAW............................................16
ARTICLE 14 - FORCE MAJEURE............................................17
ARTICLE 15 - NOTICES..................................................17
ARTICLE 16 - WAIVER...................................................18
ARTICLE 17 - ENTIRE AGREEMENT.........................................18
ARTICLE 18 - ASSIGNMENT...............................................18
ARTICLE 19 - TITLES...................................................19
ARTICLE 20 - PUBLICITY................................................19
ARTICLE 21 - UNENFORCEABLE PROVISIONS.................................21
ARTICLE 22 - CONSTRUCTION.............................................21
ARTICLE 23 - HMR OWNERSHIP............................................21
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ARTICLE 24 - EXECUTION................................................22
ARTICLE 25 - CLOSING..................................................22
SCHEDULE 1.21 SEPRACOR PATENTS
SCHEDULE 2.1 FORM OF ASSIGNMENT
SCHEDULE 20.1 JOINT PRESS RELEASE
SCHEDULE 20.2.2 LISTING OF ALLEGRA(R)
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
This License Agreement is made as of this 31st day of August, 1999 by and
between Sepracor Inc. ("Sepracor"), a Delaware corporation having a place of
business at 111 Locke Drive, Marlborough, Massachusetts 01752, and Hoechst
Marion Roussel, Inc. ("HMR"), a Delaware corporation having a place of business
at Route 202-206, P.O. Box 6800, Bridgewater, New Jersey 08867.
BACKGROUND
WHEREAS, Sepracor is the assignee of U.S. Patent No. 5,375,693, entitled
"Methods and Compositions for Treating Allergic Disorders and Other Disorders
using Metabolic Derivatives of Terfenadine" (the "693 Patent") and U.S. Patent
Application Serial No. 08/191,149, entitled "Methods and Compositions for
Treating Allergic Disorders and Other Disorders using Optically Pure Isomers of
Metabolic Derivatives of Terfenadine" (the "149 Application");
WHEREAS, Sepracor also owns a portfolio of patents and patent applications
generally directed to Terfenadine Carboxylate Technology and certain know-how
relating to the use of Terfenadine Carboxylate Technology;
WHEREAS, the parties entered into a license agreement on June 1, 1993 (the "1993
License Agreement"), whereby Sepracor granted HMR an exclusive license under
U.S. Patent Application Serial No. 07/924,156 entitled "Methods and Compositions
for Treating Allergic Disorders and Other Disorder using Metabolic Derivatives
of Terfenadine" (the "156 Application") and any patents issuing therefrom, and
the 693 Patent subsequently issued from a continuation of the 156 Application;
WHEREAS, HMR made two milestone payments to Sepracor under the 1993 License
Agreement, such payments were made under protest and totaled [**];
WHEREAS, an interference was declared by the U.S. Patent and Trademark Office
("PTO") relating to the 693 Patent, the 149 Application, and HMR's U.S. Patent
Application Serial No. 08/397,542, entitled "A Method of Providing an
Antihistaminic Effect in a Hepatically Impaired Patient" (the "542
Application");
WHEREAS, on the terms and conditions set forth herein, Sepracor is willing to
assign the Assigned Patents (as defined below) to HMR and license to HMR the
exclusive right to use additional Sepracor Patents and Sepracor Know-How to
develop and sell Products; and
WHEREAS, HMR wishes to accept such assignment and license.
NOW, THEREFORE, in consideration of the mutual promises, covenants and
agreements hereinafter set forth, the sufficiency of which is hereby
acknowledged, the parties to this
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
Agreement mutually agree as follows:
ARTICLE 1 - DEFINITIONS
For purposes of this Agreement, the following initially capitalized terms in
this Agreement, whether used in the singular or plural, shall have the following
meanings, unless the context clearly requires otherwise:
1.1 Affiliate. "Affiliate" shall mean, with respect to either party hereto,
any corporation, company, partnership, joint venture or any other entity
which directly or indirectly controls, is controlled by, or is under
common control with such party. For purposes of this definition, "control"
shall mean direct or indirect ownership of at least fifty percent (50%) of
the outstanding voting securities of the entity.
1.2 Agreement. "Agreement" shall mean this License Agreement, including all
Schedules hereto.
1.3 Assigned Patents. "Assigned Patents" shall mean U.S. Patent No. 5,375,693,
U.S. Patent Application Serial No. 08/191,149, and any and all related
United States patent applications, including any additions, divisions,
continuations, continuations-in-part, reissues, reexaminations,
substitutions, extensions, patent term extensions and renewals thereof,
and patents issued therefrom.
1.4 Business Day. "Business Day" shall mean a day on which banks are open for
business in both Marlborough, Massachusetts and Bridgewater, New Jersey.
1.5 Closing Date. "Closing Date" shall mean the latest of (a) the date on
which Sepracor executes this Agreement; (b) the date on which HMR executes
this Agreement; and (c) if applicable, not later than the fifth Business
Day following the expiration or earlier termination of any notice and
waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of
1976, as amended ("HSR Act").
1.6 Combination Patent. "Combination Patent" shall mean United States Patent
Application Serial No. [**], and any and all related United States patent
applications, including any additions, divisions, continuations,
continuations-in-part, reissues, reexaminations, substitutions,
extensions, patent term extensions and renewals thereof, and patents
issued therefrom.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
1.7 Combination Product. "Combination Product" shall mean a Product which is
comprised in part of Compound, and in part of one or more other active
ingredients; provided, however, that Combination Product shall not include
any Product encompassed by a Live Claim of an issued Combination Patent.
Notwithstanding the foregoing, Products containing Compound and
pseudoephedrine as the only active ingredients, including but not limited
to the Product currently identified by the trademark Allegra-D(R), shall
not be considered a Combination Product for the purposes of this
Agreement.
1.8 Compound. "Compound" shall mean the terfenadine metabolite known as
terfenadine carboxylate and fexofenadine, also identified by the chemical
name 4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-
(alpha),(alpha)-dimethyl benzeneacetic acid, and any stereoisomer,
solvate, clathrate, salt, or non-covalent derivative thereof.
1.9 Confidential Information. "Confidential Information" shall mean all
Sepracor Know-How, and all technical and scientific know-how and
information, pre-clinical and clinical trial results, computer programs,
knowledge, technology, means, methods, processes, practices, formulas,
techniques, procedures, designs, drawings, apparatus, written and oral
representations of data, specifications, and all other scientific,
clinical, regulatory, marketing, financial and commercial information or
data, whether communicated in writing, verbally or electronically, which
is provided by one party to the other party in connection with this
Agreement. When Confidential Information is disclosed in a manner other
than in writing, it shall be reduced to written form, marked
"Confidential" and transmitted to the receiving party within [**] Business
Days of disclosure to the receiving party.
1.10 Control or Controlled. "Control" or "Controlled", when used in connection
with intellectual property rights, shall mean the legal authority or right
of a party hereto to grant a license or sublicense of intellectual
property rights to another party hereto, or to otherwise disclose
proprietary or trade secret information to such other party, without
breaching the terms of any agreement with a Third Party, or
misappropriating the proprietary or trade secret information of a Third
Party. Information that is generally known or available to the public as
of the Closing Date, or which becomes known or available to the public
through no fault of the party, shall not be deemed Controlled by a party
hereto.
1.11 Dollar. "Dollar" shall mean lawful money of the United States of America.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
1.12 Generic Equivalent. "Generic Equivalent" shall mean any pharmaceutical
product that is sold by a Third Party without the consent or approval of
HMR or any Affiliate or Licensee thereof, and which includes the same
Compound as an active ingredient as that used in a particular Product for
the same indication and by the same route of administration as the
particular Product. For the purposes of this Section 1.12, an Optically
Pure stereoisomer of a Compound shall be considered a separate and
distinct Compound, and solvates, clathrates, salts or noncovalent
derivatives of a Compound shall be considered one and the same Compound.
1.13 Improvement. "Improvement" shall mean any enhancement of or improvement to
Terfenadine Carboxylate Technology developed, invented or acquired by, or
coming under the Control of, Sepracor during the term of this Agreement.
1.14 Licensee. "Licensee" shall mean any person, corporation, unincorporated
body, or other entity that is not an Affiliate of HMR and to whom HMR
grants a license or sublicense of the rights assigned or granted to HMR
pursuant to this Agreement.
1.15 Live Claim. "Live Claim" shall mean a claim of any issued, unexpired
patent which has not been withdrawn, canceled or surrendered, or held
invalid or unenforceable by a court of competent jurisdiction in a final,
unappealable decision.
1.16 Net Sales. "Net Sales" shall mean the gross amount invoiced by HMR and its
Affiliates and Licensees on account of sales of Product to Third Parties
in the Territory, less the total of (a) [**] and/or [**] and other [**] to
the extent [**] in the [**] and other [**] to the extent [**] in the [**]
by reason of [**] or the equivalents thereof.
Actual Net Sales for any Combination Product (except Product encompassed
by a Live Claim of an issued Combination Patent) shall be multiplied by
the Combination Allocation Portion (as defined below) attributable to such
Combination Product. The "Combination Allocation Portion", as used herein,
shall mean [**] only the [**] of the [**] only the [**] and the [**] of
the [**] that are [**] in Section 1.16(a)-(f) above. [**] for the [**] in
the [**] that are [**] on the [**]
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1.17 Optically Pure. "Optically Pure" shall mean Compound comprising at least
ninety percent (90%) by weight of one stereoisomer and ten percent (10%)
by weight or less of the other stereoisomer.
1.18 Payment Period. "Payment Period" shall mean a calendar quarter ending on
March 31st, June 30th, September 30th, or December 31st .
1.19 Product. "Product" shall mean any composition which contains Compound as
an active ingredient. Product shall include any Product encompassed by a
Live Claim of an issued Combination Patent. Product containing an
Optically Pure stereoisomer of a Compound shall be considered a separate
and distinct Product. Product containing solvates, clathrates, salts or
noncovalent derivatives of a Compound shall be considered one and the same
Product. If encompassed by a Live Claim of a Combination Patent, Product
containing one or more leukotriene inhibitors and fexofenadine shall be
considered a separate and distinct Product, and not a Combination Product.
Line extensions of a Product shall be considered one and the same Product;
for example, the composition currently identified by the trademark
Allegra-D(R) shall be considered the same Product as the composition
currently identified by the trademark Allegra(R).
1.20 Sepracor Know-How. "Sepracor Know-How" shall mean all proprietary,
non-public Terfenadine Carboxylate Technology, including, without
limitation, processes, techniques, formulas, data, methods, equipment
designs, know-how, show-how and trade secrets, discoveries, practices,
inventions, technology, manufacturing procedures, test procedures,
purification and isolation techniques, instructions, test data and other
intellectual property, patentable or otherwise, tangible or intangible,
that are owned or Controlled by Sepracor as of the Closing Date or which
were developed by or at the request of Sepracor prior to or during the
term of this Agreement and which are not generally known; provided,
however, that "Sepracor Know-How" shall not include any HMR information or
materials.
1.21 Sepracor Patents. "Sepracor Patents" shall mean all United States patents
and patent applications owned or Controlled by Sepracor and relating to
Terfenadine Carboxylate Technology, including those set forth in Schedule
1.21 hereto as it may be updated from time to time, and all additions,
divisions, continuations, continuations-in-part, substitutions,
extensions, patent term extensions and renewals thereof, and patents
issued thereon. The term "Sepracor Patents" includes Combination Patents,
but does not include the Assigned Patents.
1.22 Sepracor Technology. "Sepracor Technology" shall mean the Sepracor
Patents, Sepracor Know-How and Improvements.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
1.23 Terfenadine Carboxylate Technology. "Terfenadine Carboxylate Technology"
shall mean technology related to Compound, including, but not limited to,
methods of use, processes, compositions, or formulations thereof.
1.24 Territory. "Territory" shall mean the United States of America and its
territories and possessions as of the Closing Date.
1.25 Third Party. "Third Party" shall mean any person, corporation,
unincorporated body, or other entity other than Sepracor and HMR and their
respective Affiliates and HMR's Licensees.
ARTICLE 2 - ASSIGNMENT AND LICENSE GRANT
2.1 On the Closing Date, Sepracor shall assign all right, title and interest
to the Assigned Patents to HMR pursuant to an assignment substantially in
the form attached hereto as Schedule 2.1. HMR may, at its sole discretion,
attend to filing and recordation thereof with the U.S. Patent and
Trademark Office (PTO).
2.2 Sepracor grants to HMR an exclusive license (exclusive even as to
Sepracor) to develop, have developed, make, have made, use, market, sell,
have sold and distribute Product in the Territory under the Sepracor
Technology, subject to the terms and conditions set forth in this
Agreement.
2.3 The rights and licenses granted hereunder to the Sepracor Patents shall be
sublicensable by HMR subject to the terms and conditions set forth in this
Agreement, provided that HMR remains responsible to Sepracor under this
Agreement and each Licensee confirms in writing to HMR that it agrees to
be bound by all of the terms and conditions contained in this Agreement.
2.4 To the extent necessary, each of Sepracor and HMR shall file within
fifteen (15) days after the date of this Agreement with the Federal Trade
Commission and the Antitrust Division of the U.S. Department of Justice,
any notification and report form required of it in the reasonable opinion
of both Parties under the HSR Act with respect to the transactions
contemplated hereby. The parties shall cooperate with one another to the
extent necessary in the preparation of any notification and report form
required to be filed under the HSR Act. Each Party shall be responsible
for its own costs, expenses, and filing fees associated with any filing
under the HSR Act.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
ARTICLE 3 - ROYALTIES AND OTHER CONSIDERATION
3.1 In consideration of the assignment of the Assigned Patents and the rights
and licenses granted under the Sepracor Technology:
3.1.1 HMR shall pay to Sepracor a royalty of [**] on the Net Sales of
Product in the Territory ("Royalties");
3.1.2 Royalties shall be payable on Net Sales of Product in the Territory
for sales made on or after February 17, 2001, and shall continue on
a Product by Product basis until the first to occur of the following
events: (1) with respect to a particular Product line, the
introduction in the Territory of a Generic Equivalent of a Product
in such Product line by a Third Party without approval or consent of
HMR or any Affiliate or Licensee thereof; or (2)(a) with respect to
all Products (except as provided in clause (2)(b) below), the
anniversary of the Closing Date in the year 2012, or (b) with
respect to a Product encompassed by a Live Claim of an issued
Combination Patent, the expiration date of such Combination Patent.
Royalties payable for the month of February 2001 shall be calculated
on a pro rata basis, i.e., twelve twenty-eighths (12/28) of the
total Net Sales for February 2001 will be used to calculate the
Royalties due for February 2001. In addition, Royalties payable for
the month during which Royalties on a Product cease to be payable
shall also be calculated on a pro rata basis ; and
3.1.3 Sepracor shall retain the payment of [**] made by HMR to Sepracor on
April 30, 1997, and the payment of [**] made by HMR to Sepracor on
May 4, 1998, both payments having been made by HMR to Sepracor in
connection with Section 4.1 of the 1993 License Agreement and under
protest, and such payments shall be non-refundable and
non-creditable.
ARTICLE 4 - ROYALTY PAYMENTS, REPORTS AND RECORDS
4.1 HMR shall deliver to Sepracor within [**] days following the end of each
Payment Period, beginning with the first Payment Period, a written report
(the "Royalty Statement") describing, for the applicable Payment Period:
(a) the gross sales during the Payment Period for all Products;
(b) the Net Sales during the Payment Period for all Products; and
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
(c) the calculation used to determine the total Royalties due for the
Payment Period.
4.2 Each Royalty Statement for a Payment Period required by Section 4.1 above
shall be accompanied by full payment to Sepracor, made in accordance with
Section 4.3, of Royalties and any interest that may have accrued in
accordance with Articles 3 and 4.
4.3 With regard to any payments due to Sepracor, the following shall apply:
(a) All payments to Sepracor pursuant to this Agreement shall be made by
wire transfer, to Fleet Bank of Massachusetts, 75 State Street,
Boston, Massachusetts 02109 (ABA #011000138) to Account No. [**] or
such other bank or account as Sepracor may from time to time
designate in writing. All such payments shall be made in Dollars.
(b) Whenever any payment hereunder shall be stated to be due on a day
which is not a Business Day, such payment shall be made on the
immediately succeeding Business Day.
(c) Payments hereunder shall be considered to be made as of the day on
which they are received in Sepracor's designated bank account.
(d) All payments due to Sepracor hereunder but not paid by HMR on the
due date thereof shall bear interest at the rate which is the lesser
of: (i) LIBOR plus two percent (2%) per annum; and (ii) the maximum
lawful interest rate permitted under applicable law. Such interest
shall accrue on the balance of unpaid amounts from time to time
outstanding from the date on which portions of such amounts become
due and owing until payment thereof in full.
4.4 Any income or other taxes which HMR is required by law to pay or withhold
on behalf of Sepracor with respect to Royalties, and any interest thereon,
payable to Sepracor under this Agreement, shall be deducted from the
amount of such Royalties and interest due, and paid or withheld, as
appropriate, by HMR on behalf of Sepracor. Any such tax required to be
paid or withheld shall be an expense of, and borne solely by, Sepracor.
The previous two sentences notwithstanding, the parties hereto will
reasonably cooperate in completing and filing documents required under the
provisions of any applicable tax laws or under any other applicable law,
in order to enable HMR to make such payments to Sepracor without any
deduction or withholding.
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4.5 HMR shall keep and maintain, and shall cause its Affiliates and its
Licensees to keep and maintain, complete and accurate records and books of
account in sufficient detail and form so as to enable Royalties and any
interest payable to be determined, including, but not limited to, true and
accurate records of sales of Products and calculations of Net Sales and
Royalties. Sepracor shall have the right to audit the records of HMR at
its own expense (except as otherwise provided in Section 4.6) using HMR's
independent certified accountants unless good cause can be shown as to why
such accountants should not be used, in which case Sepracor may elect to
use any nationally recognized firm of independent certified accountants to
whom HMR has shown no good cause objection. Such accountants will have
access on reasonable notice to HMR and its Affiliates' and Licensees'
records during reasonable business hours for the purpose of verifying the
Royalties and any interest payable as provided in this Agreement for the
two preceding years. Notwithstanding the foregoing, this right may not be
exercised more than once in any calendar year, and once a calendar year is
audited it may not be reaudited, and said accountant shall disclose to
Sepracor only information relating solely to the accuracy of the Royalty
Statements provided to Sepracor and the payments made to Sepracor under
this Agreement.
4.6 Any adjustment required as a result of an audit conducted under this
Article shall be made within twenty-five (25) days after the date on
which the accountant conducting the audit issues a written report to
Sepracor and HMR containing the results of the audit. If any
underpayment by HMR is greater than ten percent (10%) of the amount
previously paid to Sepracor for the relevant Payment Period, the costs
and expenses of the audit shall be paid for by HMR. In the case of
overpayment, HMR may elect, at its option, to either offset any
Royalties and any interest payable to Sepracor by the amount of the
overpayment or request reimbursement and HMR shall, within [**] Business
Days of issuance of the auditor's written report, provide written
notice to Sepracor of its election regarding any overpayment. If HMR
elects reimbursement of an overpayment, Sepracor shall have the longer
of a) ten (10) Business Days from its receipt of HMR's written notice, or
b) ten (10) days after the date on which the accountant conducting the
audit issues a written report to Sepracor and HMR containing the results
of the audit, to send HMR the requested overpayment reimbursement.
4.7 No part of any amount payable to Sepracor under this Agreement may be
reduced due to any counterclaim, set-off, adjustment or other right which
HMR might have against Sepracor, any other party or otherwise, except as
expressly stated to the contrary in this Agreement.
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ARTICLE 5 - RIGHTS IN TECHNOLOGY, INVENTIONS AND PATENTS
5.1 Sepracor agrees to use reasonable efforts to continue, at its sole cost
and expense, the prosecution of the Sepracor Patents and maintenance of
the Sepracor Patents and Sepracor Know-How. Prosecution of pending patent
applications shall mean through final patent office appeal and any
interference proceedings or the like, including, but not limited to,
re-issue applications and re-examination proceedings.
5.2 After the Closing Date, Sepracor and HMR shall consult with each other in
connection with the prosecution and maintenance of the Sepracor Patents.
Sepracor agrees to provide HMR with a reasonable opportunity to comment on
all material written correspondence with the PTO in connection with
Sepracor Patents, and Sepracor shall notify HMR of the allowance, grant or
acceptance of any Sepracor Patent. Should Sepracor decide not to pursue or
maintain any of the Sepracor Patents, it shall first offer to assign such
Sepracor Patents to HMR before letting such Sepracor Patents lapse.
5.3 Sepracor shall consult and cooperate with HMR in good faith with respect
to the filing and prosecution of any patent applications for Improvements
and the maintenance of patents issued thereon including, without
limitation, by executing and obtaining from employees and other persons
all assignments and other documents reasonably required in connection
therewith.
5.4 The parties agree to cooperate in order to avoid loss of any rights which
may otherwise be available to the parties under the U.S. Drug Price
Competition and Patent Term Restoration Act of 1984 and other similar
measures. Without limiting the foregoing, each of HMR and Sepracor agrees
to provide the other with reasonable information and assistance in order
to permit the timely filing of an application for patent term extension
within the sixty (60) day period following NDA approval to market Product
in the United States.
ARTICLE 6 - INFRINGEMENT INVOLVING PRODUCT
6.1 In the event that either HMR or Sepracor becomes aware of Third Party
infringement of any issued Sepracor Patent in the Territory, which
infringement involves Product, it will notify the other party in writing
to that effect. Any such notice shall include evidence to support an
allegation of infringement by such Third Party.
6.1.1 Except as provided in Section 6.1.3, HMR shall have the right, but
not the obligation, to enforce (with Sepracor's cooperation and at
HMR's expense) any Sepracor Patents licensed hereunder against
infringement by Third Parties. Any recovery or damages derived from
enforcement of any Sepracor Patent shall be used to first reimburse
HMR for its documented out-of-pocket legal expenses and costs
relating to such enforcement, then
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to reimburse Sepracor for its documented out of pocket legal
expenses and costs relating to such enforcement. Any remaining
compensatory damages, such as lost profit damages and reasonable
royalty damages, shall be treated as Net Sales hereunder for which
Sepracor shall be entitled to receive a royalty as provided in
Articles 3 and 4 of this Agreement. Any punitive damages, exemplary
damages, or other enhanced damages shall be shared equally by the
parties.
6.1.2 Except as provided in Section 6.1.3, in the event of infringement of
Sepracor Patents, if HMR does not file suit or enter into
negotiations with the Third Party infringer of such Sepracor Patents
within three (3) months of receiving evidence of such infringement
that provides a reasonable basis for jurisdiction of a court, then
Sepracor shall have the right, but not the obligation, to enforce
the Sepracor Patents against such infringement (on its own behalf
and at its own expense). Any recovery or damages derived from
enforcement of any Sepracor Patent shall first be used to reimburse
Sepracor for its documented out of pocket legal expenses and costs
relating to such enforcement, then to reimburse HMR for its
documented out of pocket legal expenses and costs relating to such
enforcement. Any remaining damages shall be divided by allocating
three quarters of such damages to Sepracor and one quarter of such
damages to HMR.
6.1.3 Notwithstanding any other provisions herein, if HMR, or its
Affiliates or Licensees is not selling any Product recited in a Live
Claim of an issued Combination Patent in the Territory, and
infringement by a Third Party involves Product recited in a Live
Claim of an issued Combination Patent, Sepracor shall have the
right, but not the obligation, to enforce the Combination Patents
against such infringement (on its own behalf and at its own
expense), and Sepracor shall retain all recoveries from such
enforcement.
6.2 In any suit or dispute involving infringement of Sepracor Patents or
Assigned Patents by a Third Party, the parties shall cooperate fully. Upon
the request and at the expense of the party bringing suit, the other party
shall make available to the party bringing suit (at reasonable times and
under appropriate conditions) all relevant assistance. In particular, the
parties agree to furnish technical and other necessary assistance to each
other in conducting any litigation necessary to enforce or defend the
Sepracor Patents and Assigned Patents against Third Parties.
ARTICLE 7 - CONFIDENTIALITY
7.1 During the term of this Agreement, and for a period of five (5) years
thereafter, each party hereto will maintain in confidence all Confidential
Information disclosed by the other party hereto. Neither party shall use,
disclose or grant use of such
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Confidential Information except as required under this Agreement. To the
extent that disclosure is authorized by this Agreement, the disclosing
party shall obtain prior agreement from its employees, agents,
consultants, Affiliates, Licensees or clinical investigators to whom
disclosure is to be made to hold in confidence and not make use of such
information for any purpose other than those permitted by this Agreement.
Each party shall use at least the same standard of care as it uses to
protect its own Confidential Information to ensure that such employees,
agents, consultants, Affiliates, Licensees, and clinical investigators do
not disclose or make any unauthorized use of such Confidential
Information. Each party shall promptly notify the other upon discovery of
any unauthorized use or disclosure of Confidential Information.
Confidential Information shall not include any information which:
7.1.1 was already known to the receiving party, other than under an
obligation of confidentiality, at the time of disclosure by the
other party;
7.1.2 was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the other party;
7.1.3 becomes generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act or
omission of the receiving party in breach of this Agreement;
7.1.4 was disclosed to the receiving party, other than under an obligation
of confidentiality, by a Third Party who had no obligation to the
other party not to disclose such information; or
7.1.5 was independently developed by the receiving party without reference
to the disclosure by the other party.
7.2 The parties agree that the material financial terms of the Agreement shall
be considered the Confidential Information of both parties.
7.3 Each party may disclose the Confidential Information to the extent such
disclosure is reasonably necessary in filing or prosecuting patent
applications, prosecuting or defending litigation, or complying with any
applicable statute or governmental regulation. In addition, either party
may disclose Confidential Information to its Affiliates, and HMR may
disclose Confidential Information to Licensees; provided, however, in
connection with any such disclosure the disclosing party shall use
diligent efforts to secure confidential treatment of such information.
7.4 The parties shall undertake to ensure that all their employees who have
access to Confidential Information of the other party are under
obligations of confidentiality fully consistent with those provided in
this Article 7.
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7.5 To the extent legally required, the parties agree to comply with the
requirements of 35 U.S.C.ss.135(c) relating to submission of agreements
between the parties to the U.S. Patent and Trademark Office.
ARTICLE 8 - TERM
8.1 This Agreement will commence as of the Closing Date and, unless sooner
terminated as provided hereunder, shall continue in full force and effect
until the expiration of the last to expire of the Combination Patents,
after which time HMR will have a fully paid-up, royalty-free and
irrevocable non-exclusive license under the Sepracor Technology in the
Territory.
ARTICLE 9 - BREACH AND TERMINATION
9.1 In the event HMR or Sepracor are in material breach of any of the
respective obligations and conditions contained in this Agreement, the
other party shall be entitled to give the breaching party written notice
requiring it to cure such material breach. If such material breach is not
cured within ninety (90) days after receipt of such written notice, the
notifying party may seek a determination of damages for the uncured breach
from the breaching party. If the uncured breach is an uncured material
breach under Section 20.6 of this Agreement, Sepracor agrees that such
uncured breach may result in irreparable harm to HMR and HMR may seek
temporary or permanent injunctive relief or other equitable relief.
9.2 If HMR fails to pay Sepracor Royalties, or any interest thereon, due and
payable in accordance with the terms of this Agreement, and such Royalties
or interest are not paid to Sepracor within ninety (90) days after receipt
of written notice as set forth in Section 9.1 above, Sepracor shall have
the right to terminate this Agreement by giving written notice thereof to
HMR, which notice shall take effect immediately upon issuance. In
addition, immediately upon receipt of such termination notice, HMR shall
assign to Sepracor the entire right, title, and interest in and to the
Assigned Patents.
9.3 In the event that one of the parties hereto becomes bankrupt or insolvent,
a receiver or a trustee is appointed for the property or estate of such
party and said receiver or trustee is not removed within sixty (60) days,
or the party makes an assignment for the benefit of its creditors, and
whether any of the aforesaid events be the outcome of the voluntary act of
that party, or otherwise, the other party shall be entitled to terminate
this Agreement forthwith by giving a written notice to the first party.
9.4 Nothing herein shall prevent either party hereto from exercising such
party's right to obtain temporary or permanent injunctive relief or other
equitable relief.
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ARTICLE 10 - RIGHTS AND OBLIGATIONS UPON TERMINATION
10.1 Termination of this Agreement by either party shall not prejudice the
rights of such party under this Agreement, at law or in equity or
otherwise, to seek damages or injunctive relief for any breach of this
Agreement by the other party hereto.
10.2 The termination of this Agreement for any reason shall be without
prejudice to (i) Sepracor's right to receive all payments accrued and
unpaid as of the effective date of such termination, (ii) the provisions
of Sections 4.5 and 4.6 hereof as to Payment Periods, or any portion
thereof, prior to the effective date of such termination, and (iii) the
remedy of either party hereto in respect of any previous breach of any of
the covenants herein contained.
10.3 Articles 7, 10, 12, 20 and 23 shall survive termination of this Agreement.
ARTICLE 11 - REPRESENTATIONS AND WARRANTIES
11.1 Sepracor represents and warrants to HMR that:
11.1.1 The execution, delivery and performance of this Agreement by
Sepracor does not conflict with any agreement, instrument or
understanding, oral or written, to which it is a party or by which
it may be bound, and, to the best of its knowledge, does not
violate any material law or regulation of any court, governmental
body or administrative or other agency having authority over it;
11.1.2 Sepracor is not currently a party to, and during the term of this
Agreement will not enter into, any agreements, oral or written,
that are inconsistent with its obligations under this Agreement;
11.1.3 Sepracor is duly organized and validly existing under the laws of
the state of its incorporation and has full legal power and
authority to enter into this Agreement;
11.1.4 Sepracor is not subject to any order, decree or injunction by a
court of competent jurisdiction which prevents or materially delays
the consummation of the transactions contemplated by this
Agreement;
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11.1.5 Sepracor is the sole and exclusive owner or licensee of the
Assigned Patents, Sepracor Patents and the Sepracor Know-How, all
of which, to the best of Sepracor's knowledge, are free and clear
of any liens, charges and encumbrances, and, except for Sepracor's
Affiliates, no other person, corporate or other private entity, or
governmental entity or subdivision thereof has, or shall have, any
claim of control with respect to the Assigned Patents, Sepracor
Patents and the Sepracor Know-How as they relate to Terfenadine
Carboxylate Technology or Product; and
11.1.6 In the Territory, there are no Third Party claims, judgments or
settlements against or owed by Sepracor pending or, to the
knowledge of Sepracor, threatened, with respect to the Assigned
Patents, the Sepracor Patents and the Sepracor Know-How as they
relate to Terfenadine Carboxylate Technology or Product.
11.2 HMR represents and warrants to Sepracor that:
11.2.1 The execution, delivery and performance of this Agreement by HMR
does not conflict with any agreement, instrument or understanding,
oral or written, to which it is a party or by which it may be
bound, and, to the best of its knowledge, does not violate any
material law or regulation of any court, governmental body or
administrative or other agency having authority over it;
11.2.2 HMR is not currently a party to, and during the term of this
Agreement will not enter into, any agreements, oral or written,
that are inconsistent with its obligations under this Agreement;
11.2.3 HMR is duly organized and validly existing under the laws of the
state of its incorporation and has full legal power and authority
to enter into this Agreement; and
11.2.4 HMR is not subject to any order, decree or injunction by a court of
competent jurisdiction which prevents or materially delays the
consummation of the transactions contemplated by this Agreement.
11.3 THE LIMITED WARRANTIES CONTAINED IN THIS ARTICLE ARE THE SOLE WARRANTIES
GIVEN BY THE PARTIES AND ARE MADE EXPRESSLY IN LIEU OF AND EXCLUDE ANY
IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
TITLE, INFRINGEMENT OR OTHERWISE, AND ALL OTHER EXPRESS OR IMPLIED
REPRESENTATIONS AND WARRANTIES PROVIDED BY COMMON LAW, STATUTE OR
OTHERWISE ARE HEREBY DISCLAIMED BY BOTH PARTIES.
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ARTICLE 12 - INDEMNIFICATION
12.1 HMR agrees to defend, indemnify and hold harmless, Sepracor, its
successors and assigns, and its officers, directors, employees, agents,
Affiliates and any person who controls any of such persons (an
"Indemnified Sepracor Party") from and against any and all liabilities,
claims, demands, judgments, losses, costs, damages, fees or expenses
(including reasonable attorneys', consultants' and other professional fees
and disbursements of every kind, nature and description incurred by such
Indemnified Sepracor Party in connection therewith) (collectively,
"Damages") that such Indemnified Sepracor Party may sustain, suffer or
incur (a) arising out of or in connection with any product liability
action brought by a Third Party purchaser or user (or any heir or assign
thereof) of a Product, including, but not limited to, any actual or
alleged injury, damage, death or other consequence occurring to any person
as a result, directly or indirectly, of the possession, use or consumption
of any Product, whether claimed by reason of breach of warranty,
negligence, product defect or otherwise, or (b) arising out of or in
connection with acts or omissions by or on behalf of HMR or any Affiliate
or Licensee thereof with respect to the manufacture, commercialization,
marketing, sale or use of any Product.
12.2 Sepracor shall defend, indemnify and hold harmless HMR, its successors and
assigns, and its officers, directors, employees, agents, Affiliates and
any person who controls any of such persons (an "Indemnified HMR Party")
from and against any liabilities, claims, demands, judgments, losses,
costs, damages or expenses whatsoever (including reasonable attorneys',
consultants' and other professional fees and disbursements of every kind,
nature and description incurred by such Indemnified HMR Party in
connection therewith) (collectively, "Damages") that such Indemnified HMR
Party may incur to the extent that such Damages are attributed to any
breach of any representation, warranty, covenant or agreement of Sepracor
contained in this Agreement.
ARTICLE 13 - CHOICE OF LAW
13.1 The construction, validity and performance of this Agreement shall be
governed in all respects by the laws of the State of Delaware without
giving effect to principles of conflict of laws.
ARTICLE 14 - FORCE MAJEURE
14.1 No failure or omission by the parties hereto in the performance of any
obligation of this Agreement shall be deemed a breach of this Agreement
nor 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 which, for the purposes of this
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Agreement, shall be regarded as beyond the control of the party in
question: act of God; acts or omissions of any government or any rules,
regulations or orders of any governmental authority or any officer,
department, agency or instrument thereof; fire; storm; flood; earthquake;
accident; acts of the public enemy; war; rebellion; insurrection; riot;
invasion; or strikes or lockouts.
ARTICLE 15 - NOTICES
15.1 Any notice required or permitted to be given under this Agreement shall be
mailed by registered or certified air mail, postage prepaid, addressed to
the party to be notified at its address stated below, or at such other
address as may hereafter be furnished in writing to the notifying party,
or by telefax to the numbers set forth below, or to such changed telefax
numbers as may thereafter be furnished.
If to SEPRACOR: Sepracor Inc.
111 Locke Drive
Marlborough, MA 01752
Attn: Chief Executive Officer
Telefax: 508-357-7495
If to HMR:
Hoechst Marion Roussel, Inc.
Route 202-206
P.O. Box 6800
Bridgewater, New Jersey 08807-0800
U.S.A.
Attention: Vice President, Licensing and Alliances
Telefax: 908-231-2257
With a copy to:
Morgan, Lewis & Bockius LLP
214 Carnegie Center
Princeton, New Jersey 08540
Attn: Randall B. Sunberg, Esq.
Telefax: 609-520-6639
Any notice sent under this Article shall be deemed to have been received
on the date actually received, or (i) five (5) Business Days after being
mailed in the case of a notice mailed by registered or certified mail,
postage prepaid; and (ii) one (1) Business Day after being transmitted in
the case of a notice transmitted via telefax.
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ARTICLE 16 - WAIVER
16.1 Any term or provision of this Agreement may be waived at any time by the
party entitled to the benefit thereof by a written instrument duly
executed by such party. The failure of any party at any time or times to
require performance of any provision hereof shall in no manner affect the
right of such party at a later time to enforce the same or any other
provision of this Agreement. No waiver of any condition or of the breach
of any provision of this Agreement in one or more instances shall operate
or be construed as a waiver of any other condition or subsequent breach.
ARTICLE 17 - ENTIRE AGREEMENT
17.1 This Agreement constitutes the entire agreement between the parties hereto
concerning the subject matter hereof and any representation, promise or
condition in connection therewith not incorporated herein shall not be
binding upon either party. This Agreement, including, without limitation,
the Schedules attached hereto, are intended to define the full extent of
the legally enforceable undertakings of the parties hereto, and no promise
or representation, written or oral, which is not set forth explicitly
herein is intended by either party to be legally binding.
17.2 This Agreement shall expressly supersede the 1993 License Agreement
entered by and between Sepracor and HMR (formerly known as Marion Merrell
Dow Inc.) on June 1, 1993. As of the Closing Date, the 1993 License
Agreement shall be of no further force or effect.
ARTICLE 18 - ASSIGNMENT
18.1 Except as otherwise provided herein, this Agreement is not assignable
either in whole or in part without the prior written consent of the other
party; provided, however, that either party may assign this Agreement to
any of its Affiliates or to any successor by merger or sale of
substantially all of the business unit to which the Agreement relates.
18.2 This Agreement will be binding upon successors and permitted assigns of
the parties and the name of a party appearing herein will be deemed to
include the name of such party's successors and permitted assigns to the
extent necessary to carry out the intent of this section.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
ARTICLE 19 - TITLES
19.1 It is agreed that the marginal headings appearing at the beginning of the
numbered Articles hereof have been inserted for convenience only and do
not constitute any part of this Agreement.
ARTICLE 20 - PUBLICITY
20.1 On or shortly after the date hereof, the parties will issue the joint
press release regarding this Agreement attached hereto as Schedule 20.1
(the "Joint Press Release").
20.2 After the date hereof, [**] whether to the [**] stating that [**] or had
[**] insofar as otherwise provided in this Agreement, [**]
20.2.1 Notwithstanding any other provision in this Agreement, [**] after
the date hereof, [**] concerning the subject matter of this
Agreement, [**].
20.2.2 Notwithstanding anything to the contrary in the foregoing, [**] the
Agreement, [**] in any [**] including the [**] to this language in
connection with [**]; provided, however, [**] For the avoidance of
doubt, the parties agree that, [**] in connection with [**] the
statements [**]
20.2.3 Within [**] days of the date hereof, Sepracor shall provide to HMR
the redacted version of this Agreement that Sepracor proposes to
submit to the Securities and Exchange Commission (the "SEC"), and
HMR shall have the right to provide comments thereon. Sepracor
shall consider HMR's comments in good faith and, to the extent
permitted by law, will not unreasonably withhold its acceptance of
such comments. Sepracor shall notify promptly HMR of any comments
of the SEC with respect to such submission.
20.3 HMR may use the Joint Press Release and any Sepracor announcement
concerning the subject matter of this Agreement, and any statements made
in any of the foregoing, without prior notice or approval.
20.3.1 Notwithstanding anything to the contrary in the foregoing, but
subject always to Sections 20.4 and 20.5 below, HMR may use
whatever publicity, news release or public announcements, written
or oral, whether
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to the public or press, stockholders, investors, customers,
suppliers or otherwise which it deems, in it sole discretion, to be
appropriate for the purpose of commercializing the Product in the
Territory.
20.3.2 Notwithstanding anything to the contrary in the foregoing, but
subject always to section 20.5 below, HMR may make reference to the
ownership and origin of the technology underlying the Agreement,
including, but not limited to, the outcome of HMR's determination
of priority of invention between the Assigned Patents and the 542
application and the basis of such determination, including but not
limited to the interference arbitrator's decision or opinion.
20.4 Except to the extent set forth in the Joint Press Release, neither party
shall disclose the material business terms of this Agreement except to the
extent required by law or regulation.
20.5 The parties acknowledge that the interference proceeding and arbitration
between them are dissolved and settled by this Agreement, and neither
party shall refer to the interference arbitrator's decision or opinion as
a legally binding decision in or determination of the interference or
arbitration thereof.
20.6 Any publicity, news release or public announcement made out of compliance
with this Article will be considered a material breach of this Agreement
subject only to the provisions of Section 9.1.
ARTICLE 21 - UNENFORCEABLE PROVISIONS
21.1 The provisions of this Agreement shall be deemed severable and the
invalidity or unenforceability of any provision shall not affect the
validity or enforceability of the other provisions hereof. If any
provision of this Agreement, or the application thereof to any person or
entity or any circumstance, is invalid or unenforceable, (i) a suitable
and equitable provision shall be substituted therefore in order to carry
out, so far as may be valid and enforceable, the intent and purpose of
such invalid and unenforceable provision and (ii) the remainder of this
Agreement and the application of such provision to other persons, entities
or circumstances shall not be affected by such invalidity or
unenforceability, nor shall such invalidity or unenforceability affect
such provision, or the application thereof, in any other jurisdiction.
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ARTICLE 22 - CONSTRUCTION
22.1 As used in this Agreement, singular includes the plural and plural
includes the singular, wherever so required by fact or context.
ARTICLE 23 - HMR OWNERSHIP
23.1 Nothing in this Agreement shall be construed as conveying or transferring
patent or technology rights of any kind owned by HMR to Sepracor.
23.2 All business decisions, including, but not limited to, decisions
concerning pricing, reimbursement, package design, sales and promotional
activities for Product, and the decision to launch or continue to market
Product in the Territory, shall be within the sole discretion of HMR.
23.3 No right, express or implied, is granted by this Agreement to use in any
manner any trade name or trademark of HMR. When making reference to any
HMR trademark relating to Compound, Sepracor shall include an
acknowledgement that such trademark is the property of HMR. Such
acknowledgement shall be included in an appropriate manner on, for
example, any literature, promotional material or advertising. Sepracor
will not use any of HMR's trademarks or trade names relating to Compound
in a manner which a Third Party could reasonably consider to compromise
the quality and goodwill associated therewith.
ARTICLE 24 - EXECUTION
24.1 This Agreement may be executed in counterparts, each of which shall for
all purposes be deemed an original.
ARTICLE 25 - CLOSING
25.1 The respective obligations of each party to effect the transactions
contemplated under this Agreement shall be subject to the satisfaction, at
or prior to the Closing Date of the following conditions (the performance
of any of which by the other party may be waived in writing by Sepracor or
HMR).
25.1.1 Neither Sepracor nor HMR shall be subject to any order, decree or
injunction by a court of competent jurisdiction which prevents or
materially delays the consummation of the transactions contemplated
hereby.
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25.1.2 No statute, rule or regulation shall have been enacted by the
government, or any governmental agency of the United States or any
state, municipality or other political subdivision thereof, that
makes the consummation of the transactions contemplated hereby
illegal.
25.1.3 The representations and warranties of the other party shall be
accurate in all material respects as of the time of the Closing
Date.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their respective duly authorized officers or representatives as of
the day and year first above written.
SEPRACOR INC.
By: /s/ Timothy J. Barberich
------------------------------
Name: Timothy J. Barberich
Title: President & CEO
HOECHST MARION ROUSSEL, INC.
By: /s/ Peter W. Ladell
------------------------------
Name: Peter W. Ladell
Title: Chief Operating Officer
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SCHEDULE 2.1: FORM OF ASSIGNMENT
ASSIGNMENT
WHEREAS, Sepracor Inc. ("Sepracor"), a Delaware corporation having a place of
business at 111 Locke Drive, Marlborough, Massachusetts 01752, is the sole owner
of U.S. Patent No. 5,375,693, entitled "Methods and Compositions for Treating
Allergic Disorders and Other Disorders using Metabolic Derivatives of
Terfenadine" (the "693 Patent") and U.S. Patent Application Serial No.
08/191,149, entitled "Methods and Compositions for Treating Allergic Disorders
and Other Disorders using Optically Pure Isomers of Metabolic Derivatives of
Terfenadine" (the "149 Application"), and United States patent applications
related thereto; and
WHEREAS, Hoechst Marion Roussel, Inc. ("HMR"), a Delaware corporation having a
place of business at Route 202-206, P.O. Box 6800, Bridgewater, New Jersey
08807, is desirous of obtaining Sepracor's entire right, title, and interest in,
to, and under the 693 Patent, the 149 Application, and United States patent
applications related thereto.
NOW, THEREFORE, in consideration of the premises, one dollar, and other good and
valuable consideration to Sepracor, the receipt and sufficiency of which is
hereby acknowledged, Sepracor hereby assigns to HMR its entire right, title and
interest in, to, and under the 693 Patent and the 149 Application (hereby
incorporated by reference as if fully set forth herein) together with any and
all related United States patent applications, including, but not limited to,
any additions, divisions, continuations, continuations-in-part, reissues,
re-examinations, substitutions, extensions, patent term extensions and renewals
thereof, and patents issuing therefrom, in each case, as fully and entirely as
the same would have been held and enjoyed by Sepracor if this assignment had not
been made.
Sepracor also authorizes and requests that the Commissioner of Patents and
Trademarks of the United States, whose duty it is to issue patents or other
evidence or forms of industrial property protection on applications as
aforesaid, to issue the same to HMR in accordance with the terms of this
instrument.
IN WITNESS WHEREOF, the undersigned duly authorized representative of
Sepracor has affixed his signature.
SEPRACOR INC.
By: _____________________________ Date: ______________________
Timothy J. Barberich
President & CEO
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Commonwealth of Massachusetts )
) SS.:
County of Middlesex )
On this _____ day of _________, 1999, before me, a Notary Public in and
for the Commonwealth and County aforesaid, personally appeared Timothy J.
Barberich, to me known and known to me to be the person of that name, who signed
and sealed the foregoing instrument, and he acknowledged the same to be his free
act and deed.
_________________________,
Notary Public.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
SCHEDULE 1.21:
SEPRACOR PATENTS
[**]