Exhibit 10.31
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
LICENSE AGREEMENT
by and between
SEPRACOR INC.
and
HOECHST XXXXXX XXXXXXX, INC.
[EX-US LICENSE]
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.
TABLE OF CONTENTS
Page
ARTICLE 1 - DEFINITIONS................................................1
ARTICLE 2 - LICENSE GRANT..............................................5
ARTICLE 3 - PENDING PROCEEDINGS AND ACTIONS............................6
ARTICLE 4 - ROYALTIES..................................................6
ARTICLE 5 - ROYALTY PAYMENTS, REPORTS AND RECORDS......................7
ARTICLE 6 - RIGHTS IN TECHNOLOGY, INVENTIONS AND PATENTS...............9
ARTICLE 7 - INFRINGEMENT INVOLVING PRODUCT............................10
ARTICLE 8 - CONFIDENTIALITY...........................................11
ARTICLE 9 - TERM......................................................12
ARTICLE 10 - BREACH AND TERMINATION...................................12
ARTICLE 11 - RIGHTS AND OBLIGATIONS UPON TERMINATION..................13
ARTICLE 12 - REPRESENTATIONS AND WARRANTIES...........................14
ARTICLE 13 - INDEMNIFICATION..........................................15
ARTICLE 14 - FORCE MAJEURE............................................16
ARTICLE 15 - NOTICES..................................................16
ARTICLE 16 - WAIVER...................................................17
ARTICLE 17 - ENTIRE AGREEMENT.........................................17
ARTICLE 18 - ASSIGNMENT...............................................18
ARTICLE 19 - TITLES...................................................18
ARTICLE 20 - PUBLICITY................................................18
ARTICLE 21 - UNENFORCEABLE PROVISIONS.................................20
ARTICLE 22 - CONSTRUCTION.............................................20
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ARTICLE 23 - CHOICE OF LAW............................................20
ARTICLE 24 - HMR OWNERSHIP............................................20
ARTICLE 25 - EXECUTION................................................21
ARTICLE 26 - DISPUTE RESOLUTIONS......................................21
ARTICLE 27 - CLOSING..................................................22
SCHEDULE 1.17 CLAIMS ENCOMPASSING PRODUCT
SCHEDULE 1.19 SEPRACOR PATENTS
SCHEDULE 3.1 RELEASE
SCHEDULE 20.1 JOINT PRESS RELEASE
SCHEDULE 20.2.2 LISTING OF ALLEGRA(R)
SCHEDULE 26 ARBITRATION PROVISIONS
ii
This License Agreement is made as of this 31st day of August, 1999 (the
"Effective Date") by and between Sepracor Inc. ("Sepracor"), a Delaware
corporation having a place of business at 000 Xxxxx Xxxxx, Xxxxxxxxxxx,
Xxxxxxxxxxxxx 00000, and Hoechst Xxxxxx Xxxxxxx, Inc. ("HMR"), a Delaware
corporation having a place of business at Xxxxx 000-000, X.X. Xxx 0000,
Xxxxxxxxxxx, Xxx Xxxxxx 00000.
BACKGROUND
WHEREAS, Sepracor owns a portfolio of patents and patent applications generally
directed to Terfenadine Carboxylate Technology and certain know-how relating to
Terfenadine Carboxylate Technology;
WHEREAS, HMR and Sepracor are parties to a number of ongoing actions and
proceedings in various forums and countries, including proceedings in the
Australian, United Kingdom, and European Patent Offices, and actions in Belgium
and England;
WHEREAS, Sepracor is willing to license HMR the exclusive right to use the
Sepracor Technology to develop and sell Product in the Territory; and
WHEREAS, HMR wishes to accept such 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 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 Business Day. "Business Day" shall mean a day on which banks are open for
business in both Marlborough, Massachusetts and Bridgewater, New Jersey.
1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
1.4 Combination Patent. "Combination Patent" shall mean any and all foreign
equivalents of United States Patent Application Serial No. [**] in the
Territory, and any and all related patent applications in the Territory,
including any additions, divisions, continuations, continuations-in-part,
reissues, reexaminations, substitutions, extensions, patent term
extensions and renewals, and patents issued therefrom.
1.5 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 all active ingredients of which are recited in a Live Claim of
one or more issued Sepracor Patents. 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.
1.6 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.
1.7 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.
1.8 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
2
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
Effective 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.
1.9 Dollar. "Dollar" shall mean lawful money of the United States of America.
1.10 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 1.10, 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.
1.11 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 course or term of this
Agreement.
1.12 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 sublicense of the rights granted to HMR pursuant to this
Agreement.
1.13 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.
1.14 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 [**] and/or [**] and other [**] to the
extent [**] in the [**] and other [**] to the extent [**] in the [**]
pursuant to [**] or the equivalent thereof.
Actual Net Sales for any Combination Product (except Product encompassed
by a Live Claim of an issued Sepracor 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 [**] as its [**] only the [**] of the [**] containing as its
active ingredient [**] and the [**] that are [**] by a [**] to a [**]
Section 1.14(a)-
3
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
(f) above. [**] for the other [**] in the [**] that are [**] on the [**]
for such [**]
1.15 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.
1.16 Payment Period. "Payment Period" shall mean a calendar quarter ending on
March 31st, June 30th, September 30th, or December 31st; provided,
however, that the first Payment Period under this Agreement shall include
the calender quarter ending September 30, 1999, and the period from March
1, 1999, to June 30, 1999.
1.17 Product. "Product" shall mean any composition which contains Compound as
an active ingredient, and that is encompassed by a Live Claim of a
Sepracor Patent. 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). For the purposes of this
Agreement, claims identical or substantially equivalent to those set forth
in Schedule 1.17 are deemed to be claims that encompass Product as
specified in Schedule 1.17.
1.18 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 Effective 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.
4
1.19 Sepracor Patents. "Sepracor Patents" shall mean all patents and patent
applications in the Territory owned or Controlled by Sepracor at any time
during the term of this Agreement and relating to Terfenadine Carboxylate
Technology, including those set forth in Schedule 1.19 hereto as it may be
updated from time to time, and all additions, divisions, continuations,
continuations-in-part, reissues, re-examinations, substitutions,
extensions, supplementary protection certificates, and renewals thereof
(or foreign equivalents in the Territory of any of the foregoing), and
patents issued therefrom. The term "Sepracor Patents" includes Combination
Patents.
1.20 Sepracor Technology. "Sepracor Technology" shall mean the Sepracor
Patents, Sepracor Know-How and Improvements.
1.21 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.
1.22 Territory. "Territory" shall mean countries of the entire world aside from
the United States and its territories and possessions as of the Effective
Date.
1.23 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 - LICENSE GRANT
2.1 Sepracor grants to HMR an exclusive (exclusive even as to Sepracor)
license 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.
2.2 The rights and licenses granted hereunder 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.
ARTICLE 3 - PENDING PROCEEDINGS AND ACTIONS
3.1 The parties will execute a mutual release in substantially the same form
attached as Schedule 3.1, dismissing, withdrawing, releasing or
terminating any and all proceedings or actions currently pending against
the other party before any court,
5
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
administrative agency, patent authority or other government agency or the
equivalent thereof in the Territory and pertaining to the subject matter
of this Agreement. The provisions of Articles 15, 19, 22, 23 and 25 of
this Agreement shall apply with equal force and effect to the mutual
release set forth in Schedule 3.1.
3.2 HMR shall not be obligated to deliver to Sepracor any amount payable
pursuant to Section 4.1.2 prior to Sepracor's or its agent's or
representative's execution of notifications or other correspondence
substantially in the forms set forth in Exhibits 1-4, 6 and 7 of Schedule
3.1.
ARTICLE 4 - ROYALTIES
4.1 In consideration of the rights and licenses granted under the Sepracor
Technology:
4.1.1 HMR shall pay to Sepracor a royalty of [**] on the Net Sales of
Product in the Territory ("Royalties").
4.1.2 Royalties shall be payable on Net Sales of Product in the Territory,
on a country by country basis, beginning upon the later of March 1,
1999, and the date of issuance of a Sepracor Patent in such country
in the Territory, and continuing on a Product by Product basis until
the first of the following to occur: (1) with respect to a
particular Product line, the introduction in such country 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) with respect to all Products, the
expiration of the last of the Sepracor Patents in such country in
the Territory. The period during which Royalties shall be payable is
hereinafter referred to as the "Royalty Period." In those countries
where Royalties on a Product are payable as of the date of issuance
of a Sepracor Patent in such country, Royalties payable for the
month in which the Sepracor Patent issues shall be calculated on a
pro rata basis, for example, if a Sepracor Patent issues on April
14th, sixteen thirtieths (16/30) of the total April Net Sales for
that Product in the country will be used to calculate the Royalties
due for April of the year of issuance. In addition, on a country by
country basis, Royalties payable for the month during which
Royalties on a Product cease to be payable in a country shall also
be calculated on a pro rata basis.
6
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
4.1.3 With respect to that product which is not encompassed by a Live
Claim of a granted or issued Sepracor Patent, no royalty will be due
under this Agreement.
ARTICLE 5 - ROYALTY PAYMENTS, REPORTS AND RECORDS
5.1 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, on a country-by-country basis, 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 the
exchange rate used to convert any currency other than Dollars into
Dollars; and
(c) the calculation used to determine the total Royalties due for the
Payment Period.
5.2 Each Royalty Statement for a Payment Period required by Section 5.1 above
shall be accompanied by full payment to Sepracor, made in accordance with
Section 5.3, of Royalties and any interest which may have accrued in
accordance with Articles 4 and 5.
5.3 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, 00 Xxxxx Xxxxxx,
Xxxxxx, Xxxxxxxxxxxxx 00000 (ABA #000000000) 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) If Net Sales of any Product for a Payment Period is stated in a
currency other than Dollars, then, for the purpose of determining
the amount of Royalties payable to Sepracor such Net Sales shall be
converted into Dollars using an average exchange rate between those
two currencies during the Payment Period for which such Royalties
become due, wherein such calculated average exchange rate is
calculated as the average of the exchange rates most recently quoted
in the Wall Street Journal in New York on or before each of the last
days for (i) each month in the Payment Period, and (ii) the last
month in the immediately preceding Payment Period. If no such
exchange rates have been quoted in the Wall Street Journal in New
York at any time during the twelve (12) month period
7
preceding the date on which such Royalties become due, then such Net
Sales shall be converted to Dollars at the average exchange rate
used by BankBoston during the Payment Period.
(c) 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.
(d) Payments hereunder shall be considered to be made as of the day on
which they are received in Sepracor's designated bank account.
(e) 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.
5.4 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 any 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.
5.5 HMR shall keep and maintain, and shall cause its Affiliates, Licensees and
assigns 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 5.6) 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
8
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.
5.6 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(s), 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
Royalties and any interest payable to Sepracor by the amount of the
overpayment or request reimbursement and HMR shall, within ten (10)
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) 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, to send HMR the requested
overpayment reimbursement.
5.7 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.
ARTICLE 6 - RIGHTS IN TECHNOLOGY, INVENTIONS AND PATENTS
6.1 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
opposition proceedings or the like, including but not limited to, re-issue
applications and re-examination proceedings or the equivalent thereof.
6.2 After the Effective Date, Sepracor and HMR shall consult with each other
in connection with prosecution and maintenance of, and annuities for, the
Sepracor Patents. Sepracor agrees to provide HMR with a reasonable
opportunity to comment on all material written correspondence issued by
the relevant patent office 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.
9
6.3 Sepracor shall consult and cooperate with HMR in good faith with respect
to the filing 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.
ARTICLE 7 - INFRINGEMENT INVOLVING PRODUCT
7.1 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.
7.1.1 Except as provided in Section 7.1.3, 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 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 received a
royalty as provided in Articles 4 and 5 of this Agreement. Any
punitive damages, exemplary damages, or other enhanced damages shall
be shared equally by the parties.
7.1.2 Except as provided in Section 7.1.3, 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.
10
7.1.3 Notwithstanding any other provisions herein, if HMR, or its
Affiliates or Licensees is not selling any Product encompassed by a
Live Claim of an issued Combination Patent in the Territory, and
infringement by a Third Party involves Product encompassed by such 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.
7.2 In any suit or dispute involving infringement of Sepracor 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 involving Product necessary to enforce or defend
the Sepracor Patents against Third Parties.
ARTICLE 8 - CONFIDENTIALITY
8.1 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 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:
8.1.1 was already known to the receiving party, other than under an
obligation of confidentiality, at the time of disclosure by the
other party;
8.1.2 was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the other party;
8.1.3 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;
11
8.1.4 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
8.1.5 was independently developed by the receiving party without reference
to the disclosure by the other party.
8.2 The parties agree that the material financial terms of the Agreement shall
be considered the Confidential Information of both parties.
8.3 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 such Confidential Information to its Licensees; provided,
however, in connection with any such disclosure the disclosing party shall
use diligent efforts to secure confidential treatment of such information.
8.4 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 8.
ARTICLE 9 - TERM
9.1 This Agreement will commence as of the Effective Date and, unless sooner
terminated as provided hereunder, shall continue in full force and effect
on a country-by-country basis in the Territory until the expiration of the
last to expire of Sepracor Patents in a country, at which point HMR will
have a fully paid-up, royalty-free and irrevocable non-exclusive license
under the Sepracor Technology in such country.
ARTICLE 10 - BREACH AND TERMINATION
10.1 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.
12
10.2 HMR may terminate this Agreement for any reason by giving Sepracor sixty
(60) days written notice. In the event of such a termination, HMR shall
relinquish all rights and licenses granted by Sepracor to HMR under the
Agreement and return all Sepracor Know-How, except for one copy of any
documents, which shall be retained for solely for the purpose of
determining any continuing obligations under Articles 8 and 13 of this
Agreement.
10.3 Sepracor shall have the right to terminate this Agreement, effective
immediately, if HMR (i) does not comply with the provisions of Article 3
and Section 27.1.4, or (ii) except as provided in Articles 6 and 7,
without the consent of the other party, at any time after the Effective
Date of this Agreement initiates or participates in (a) any proceeding or
action against Sepracor or its Affiliates involving Compound or Product,
or (b) any proceeding or action involving Sepracor Technology, in each
case before any court, administrative or other government agency, or
patent authority.
10.4 HMR shall have the right to terminate this Agreement, effective
immediately, if Sepracor (i) does not comply with the provisions of
Article 3 and Section 27.1.4, or (ii) except as provided in Articles 6 and
7, without the consent of the other party, at any time after the Effective
Date of this Agreement initiates or participates in (a) any proceeding or
action against HMR or its Affiliates involving Compound or Product, or (b)
any proceeding or action involving HMR's technology relating to Compound,
in each case before any court, administrative or other government agency,
or patent authority.
10.5 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.
10.6 Nothing herein shall prevent either party hereto from exercising such
party's right to obtain temporary or permanent injunctive relief or other
equitable relief.
ARTICLE 11 - RIGHTS AND OBLIGATIONS UPON TERMINATION
11.1 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.
11.2 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
13
date of such termination, (ii) the provisions of Section 5.5 and 5.6
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.
11.3 Articles 8, 11, 13, 20 and 24 shall survive termination of this Agreement.
ARTICLE 12 - REPRESENTATIONS AND WARRANTIES
12.1 Sepracor represents and warrants to HMR that:
12.1.1 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;
12.1.2 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;
12.1.3 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;
12.1.4 Sepracor is not currently 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;
12.1.5 Sepracor is the sole and exclusive owner or licensee of the
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 Sepracor Patents and the Sepracor
Know-How as they relate to Terfenadine Carboxylate Technology or
Product; and
12.1.6 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 Sepracor
Patents and the Sepracor Know-How as they relate to Terfenadine
Carboxylate Technology or Product.
14
12.2 HMR represents and warrants to Sepracor that:
12.2.1 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;
12.2.2 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;
12.2.3 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
12.2.4 HMR is not currently 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.
12.3 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.
ARTICLE 13 - INDEMNIFICATION
13.1 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
15
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
themanufacture, commercialization, marketing, sale or use of any Product.
13.2 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 sustain 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 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 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.
000 Xxxxx Xxxxx
Xxxxxxxxxxx, XX 00000
Attn: Chief Executive Officer
Telefax: 000-000-0000
If to HMR:
00
Xxxxxxx Xxxxxx Xxxxxxx, Inc.
Route 202-206
X.X. Xxx 0000
Xxxxxxxxxxx, Xxx Xxxxxx 00000-0000
X.X.X.
Attention: Vice President, Licensing and Alliances
Telefax: 000-000-0000
With a copy to:
Xxxxxx, Xxxxx & Xxxxxxx LLP
000 Xxxxxxxx Xxxxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
Attn: Xxxxxxx X. Xxxxxxx, Esq.
Telefax: 000-000-0000
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.
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
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
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.
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
18
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 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 10.1.
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
19
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.
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 - CHOICE OF LAW
23.1 The construction, validity and performance of this Agreement shall be
governed in all respects by the laws of the United Kingdom, without giving
effect to principles of conflict of laws and any suit brought pursuant to
this Agreement shall be filed in the appropriate forum in London, England.
ARTICLE 24 - HMR OWNERSHIP
24.1 Nothing in this Agreement shall be construed as conveying or transferring
patent or technology rights of any kind owned by HMR to Sepracor.
24.2 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.
24.3 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 25 - EXECUTION
25.1 This Agreement may be executed in counterparts, each of which shall for
all purposes be deemed an original.
20
ARTICLE 26 - DISPUTE RESOLUTIONS
26.1 In the event any dispute, difference or question arises between the
parties pertaining to or in connection with whether a Product is
encompassed by a Live Claim of a Sepracor Patent in a country in the
Territory, then such dispute shall be resolved in the step-wise process
set forth in Sections 26.1(a) to (d) below.
(a) Promptly upon receiving notice of the expected issuance or grant of
a Sepracor Patent in a particular country, HMR shall make a good
faith, reasonable determination as to whether the Product is
encompassed by a Live Claim of a Sepracor Patent in that country.
(b) If in good faith HMR reasonably determines that such Product is not
encompassed by a Live Claim of a Sepracor Patent in the country, HMR
shall provide Sepracor with written notification of its
determination, and the parties shall meet and discuss the reasons
for HMR's determination.
(c) If the parties' discussions do not resolve the dispute as to whether
a Product is encompassed by a Live Claim of a Sepracor Patent in the
country, the parties shall jointly retain a mutually acceptable
attorney with expertise in the field of patents and/or intellectual
property rights in the relevant country to render an independent
expert opinion on the issue. If both parties agree in writing with
the independent expert's opinion, it will be binding upon the
parties.
(d) If either party does not agree in writing with the independent
expert's opinion, within thirty (30) days of the receipt of the
opinion, the disagreeing party may submit the disputed matter to
binding arbitration in accordance with Schedule 26. If the disputed
matter is not submitted to binding arbitration within the thirty
(30) day period, the expert opinion will be final and binding on the
parties for the purpose of determining whether the Product at issue
is encompassed by a Live Claim of a Sepracor Patent in the country
at issue.
ARTICLE 27 - CLOSING
27.1 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 Effective Date of the following conditions (the
performance of any of which by the other party may be waived in writing by
Sepracor or HMR).
27.1.1 Neither Sepracor nor HMR shall be subject to any order, decree or
injunction by a court of competent jurisdiction which prevents or
21
materially delays the consummation of the transactions contemplated
hereby.
27.1.2 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.
27.1.3 The representations and warranties of the other party shall be
accurate in all material respects as of the time of the Effective
Date and such other party shall have delivered a certificate of an
officer certifying the same.
27.1.4 The parties shall have executed a mutual release in substantially
the form attached as Schedule 3.1, dismissing, withdrawing,
releasing or terminating without prejudice any and all actions or
proceedings currently pending against the other party before any
court, administrative agency, patent authority or other government
agency or the equivalent thereof in the Territory and pertaining to
the subject matter of this Agreement.
22
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/ Xxxxxxx X. Xxxxxxxxx
------------------------------
Name: Xxxxxxx X. Xxxxxxxxx
Title: President & CEO
HOECHST XXXXXX XXXXXXX, INC.
By: /s/ Xxxxx X. Xxxxxx
------------------------------
Name: Xxxxx X. Xxxxxx
Title: Chief Operating Officer
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
SCHEDULE 1.19:
SEPRACOR PATENTS
[**]
