EXHIBIT 10.10
SOLE AND EXCLUSIVE LICENSE AGREEMENT
Between
HIND HEALTH CARE, INC.
And
ENDO PHARMACEUTICALS INC.
THIS AGREEMENT is effective as of the 20th day of November 1998, between Hind
Healthcare, Inc., a California corporation, having its principal office at Suite
101, ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇ ("HIND") and Endo
Pharmaceuticals Inc., a Delaware corporation, having its principal office at ▇▇▇
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇ ("ENDO").
WITNESSETH THAT:
WHEREAS, HIND represents that it is the owner of certain patents, know-how and
trademarks for the topical treatment of post-herpetic neuralgia, other forms of
neuralgia and neuropathy and has the right to grant licenses to said patents,
know-how, and trademarks;
WHEREAS, ENDO is a pharmaceutical company engaged in research, development, and
marketing of various products, including pain management products;
WHEREAS, ENDO wishes to secure a license to said Hind patents, know-how, and
trademarks to develop, import, use, market, promote, and sell a pharmaceutical
product for the topical treatment of post-herpetic neuralgia, other forms of
neuralgia and neuropathy in the United States;
WHEREAS, HIND is willing to grant and Endo is willing to accept a license to
said Hind patents, know-how, and trademarks upon the terms and conditions
hereinafter set forth;
NOW, THEREFORE, in consideration of the covenants and obligations hereinafter
set forth and intending to be legally bound, the parties hereby agree as
follows:
I. DEFINITIONS
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The following capitalized terms shall have the meanings set forth below for
purposes of this Agreement:
(a) "Affiliate" means any entity controlling, controlled by or under common
control of either ENDO or HIND. For purposes hereof, "control" shall mean
ownership, directly or indirectly, of more than fifty percent (50%) of the
securities having the right to vote for the election of directors, in the
case of a corporation, and more than fifty percent (50%) of the beneficial
interest in the capital, in the case of a business entity other than a
corporation.
(b) "Approvable Letter" means a written communication from the FDA, in
accordance with Section 21 CFR 314.110, which states that the NDA for the
Product substantially meets all FDA requirements for approval to market,
promote, and sell the Product in the Territory contingent upon the NDA
applicant satisfactorily addressing any minor issues raised by the FDA.
The confidential portions of this exhibit have been filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request
in accordance with Rule 406 of the Securities Act of 1933.
REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN ***.
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HIND-ENDO
SOLE AND EXCLUSIVE LICENSE AGREEMENT
(c) "Approval Letter" means a written communication from the FDA, in accordance
with Section 21 CFR 314.105, which states that the NDA for the Product meets
all FDA requirements for the Product and the Product may be marketed,
promoted, and sold in the Territory.
(d) "Commercial Sale" means the sale for value of Product by ENDO to an
unaffiliated third party. Commercial Sale does not include transfer or sale
of Product by ENDO to Affiliates or sublicensees nor any donation or
transfer of Product free of charge by ENDO to unaffiliated third parties.
(e) "FDA" means the United States Food and Drug Administration.
(f) "FDA Communication" means any action, request, order, instruction,
communication, complaint, notice, public announcement or inquiry by the FDA
or any submission, filing, letter or other communication by HIND to the FDA,
regarding the Product which is sent by or is received by HIND or which comes
to Hind's or its agent's attention, including, but not limited to field
actions, investigations or recalls of the Product in the Territory.
(g) "Intellectual Property Rights" means the Licensed Patents, Know-How, and
Trademarks listed in Exhibit A which are necessary or useful for the
development, manufacture, use, marketing, promotion, and sale of the Product
and all improvements and enhancements thereto by HIND, TEIKOKU and/or any
related party.
(h) "Know-how" means all information and data, regardless of form, which is
necessary or useful for the development, use, marketing, promotion, and
sale of the Product.
(i) "Licensed Patent" means the United States patents listed in Exhibit A owned
in whole or in part or licensed or assigned to HIND and all reissues,
extensions, substitutions, confirmations, registrations, revalidations,
additions, continuations, continuations-in-part, and divisions thereof.
(j) "License Year" means a twelve (12) month period beginning on the date of the
Product Launch and thereafter on the anniversary date thereof.
(k) "NDA" means the new drug application covering the Product on file with the
FDA, as amended from time to time.
(l) "Net Sales" means the gross invoice price of Products sold by ENDO to any
third party, excluding Affiliates and sublicensees, less (i) cash, trade,
promotional, or quantity discounts and/or rebates, (ii) retroactive price
reductions, (iii) sales, use, or other excise taxes, (iv) returns and
allowances, (v) expired Products and (vi) transportation and/or shipping
charges.
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SOLE AND EXCLUSIVE LICENSE AGREEMENT
(m) "Product" means any topical formulation of lidocaine in a bandage and/or
transdermal (Patch) formulation, whether sold over-the counter or by
prescription, for human use which falls within the claims of the Licensed
Patents.
(n) "Product Launch" means the first Commercial Sale of the Product by ENDO for
resale or use to an unaffiliated third party in the Territory.
(o) "Reasonable Commercial Efforts" means those efforts which would be made by a
reasonably prudent business person acting in good faith, in the exercise of
reasonable commercial judgment and in a manner consistent with those efforts
a party devotes to a pharmaceutical product resulting from its own research
efforts and having a similar market potential.
(p) "Related Agreement" means the Supply and Manufacturing Agreement entered
into by Teikoku Seiyaku Co. Ltd., and Teikoku Pharma USA, Inc (collectively
hereinafter referred to as "TEIKOKU"), the manufacturer of the transdermal
delivery system for the Product and ENDO of even date herewith and attached
hereto as Exhibits B made a part hereof.
q) "Royalty Period" means the period commencing with the second (2nd)
anniversary of the date of receipt by ENDO of HIND's receipt of notice of
the Approval Letter by ENDO in the Territory until the shorter of (i) the
life of the last issued Licensed Patent or (ii) thirteen (13) years from the
effective date of this Agreement.
(r) "Submission Package" means all pre-clinical, laboratory, clinical,
biocompatibility and other testing data, labeling, processing, material and
packaging specifications, and supplements or amendments to the foregoing;
and all other information in the possession of and used by HIND for
submitting, obtaining, and maintaining approval of an NDA in accordance with
the requirements of the Food Drug & Cosmetic Act, as amended, from time to
time.
(s) "Supply and Manufacturing Agreement" means the Supply Agreement between
TEIKOKU and ENDO of even date herewith and attached hereto as Exhibit B and
made a part hereof.
(t) "Territory" means the United States, its territories, commonwealths, and
possessions.
(u) "Trademark" shall mean the HIND trademarks "LIDODERM" or TAKON that may be
used to market the Product in the Territory
II. LICENSE GRANT
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HIND hereby grants to ENDO and ENDO hereby accepts a sole and exclusive license,
including the right to sublicense, to all of the Intellectual Property Rights
including the rights to develop, use, market, promote, and sell the Product in
the Territory.
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SOLE AND EXCLUSIVE LICENSE AGREEMENT
III. LICENSE FEES
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3.1 As consideration for entering into the binding Term Sheet between the
parties hereto, dated as of October 8, 1998, ENDO paid to HIND a fee of Fifty
Thousand Dollars ($50,000). Such fee shall be credited against the license fee
set forth in Paragraph 3.2 below and such license fee shall be reduced
accordingly.
3.2 ENDO shall pay HIND Two Million Dollars ($2,000,000), as part consideration
for the license granted by HIND to ENDO in Article 2 above, within fifteen (15)
business days of HIND's delivery to ENDO of the original Approvable Letter from
the FDA for the Product, provided, however, that the terms of such Approvable
Letter are reasonably acceptable to ENDO, at ENDO's discretion. In the event
that HIND is able to obtain an Approval Letter from the FDA with regard to the
Product, without having to first obtain an Approvable Letter as provided for
under this Paragraph, ENDO will still pay HIND the amount set forth in this
Paragraph in addition to the amount set forth in Paragraph 3.3 below, provided
that the Approval Letter contain terms that are reasonably acceptable to ENDO,
at ENDO's discretion.
3.3 ENDO shall pay HIND Six Million Dollars ($6,000,000), as part consideration
for the license granted by HIND to ENDO in Article 2 above, within fifteen (15)
business days of HIND's delivery to ENDO of the original Approval Letter from
the FDA for the Product.
3.4 ENDO shall pay HIND Two Million Dollars ($2,000,000), as part consideration
for the license granted by HIND to ENDO in Article 2 above, within fifteen (15)
business days of ENDO's Product Launch.
3.5 The payments set forth in Paragraphs 3.2, 3.3, and 3.4 above shall only be
paid upon the occurrence of the designated event.
IV. ROYALTIES
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4.1 As part consideration for the license granted by HIND to ENDO in Article 2
above, ENDO shall pay HIND royalty payments as follows:
(a) Commencing with the second (2nd) annual anniversary of the date of
ENDO's receipt of the original Approval Letter for the Territory and
for twelve (12) months thereafter, ENDO shall pay HIND an annual
royalty of *** percent (***%) of Net Sales of the Product in the
Territory.
(b) Commencing with the third (3rd) annual anniversary of the date of
ENDO's receipt of the original Approval Letter for the Territory and
until the shorter of the life of the last to expire Licensed Patent or
thirteen (13) years from the effective date of this Agreement, ENDO
shall pay HIND an annual royalty of *** (***%) percent of Net Sales of
the Product in the Territory.
(c) Commencing with the second (2nd) annual anniversary of the date of
ENDO's receipt of the original Approval Letter for the Territory and
until the shorter of the life of the last to expire
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SOLE AND EXCLUSIVE LICENSE AGREEMENT
Licensed Patent or thirteen (13) years from the effective date of this
Agreement, ENDO shall pay to HIND annual royalties under this
Agreement of at least *** for each twelve month (12) period
thereafter. None of the minimum royalty payments are refundable once
due and paid.
(d) Notwithstanding the provisions in Paragraphs 4.1 (a) through (c),
ENDO's obligation to pay royalties, including minimum royalties, to
HIND shall cease if the applicable claims in a Licensed Patent in the
Territory are held invalid by an unappealed or unappealable decision
of a court of competent jurisdiction in the Territory. In the event
that ENDO's obligation to pay royalties terminates in accordance with
this Paragraph, ENDO shall have the option to use the Trademarks upon
payment of a *** percent (***%) royalty to HIND based on the royalty
calculations set forth in this Agreement.
4.2 Royalty Reports. ENDO will provide to HIND, within sixty (60) days after
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the end of each calender quarter in a relevant twelve (12) month Royalty Period,
a written report setting forth the total Net Sales for the Product in the
Territory for that period and will accompany such report with an appropriate
payment of royalty or minimum royalty due for such period. Any Royalty
payments, which are not paid on time, shall bear interest at the compounded rate
of *** percent (***%) per month.
4.3 Nothing contained herein shall obligate ENDO to pay HIND more than one
royalty on any unit of Product sold in the Territory, provided however, that
Endo shall be responsible for payment of all Royalties and delivery of all
Royalty Reports due hereunder, either from ENDO or its sublicenses.
V. OBLIGATIONS OF THE PARTIES
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5.1 REGULATORY
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(a) FDA Communications. Upon being contacted by the FDA for any regulatory
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purpose related to the Product or the NDA for the Product, HIND shall
immediately notify ENDO. ENDO shall be responsible for providing all
responses directly to the FDA regarding inquiries related to the marketing,
promotion, and/or sale of the Product, including any amendments or
supplements to the NDA for the Product with regard to such issues.
(b) Ownership of the NDA.
----------------------
(i) The NDA for the Product shall be owned by TEIKOKU USA in accordance
with a separately negotiated agreement between HIND and TEIKOKU USA.
(ii) TEIKOKU shall be responsible for maintaining the good standing of the
NDA for the Product in the Territory, in accordance with the
applicable regulations and laws of the Territory. TEIKOKU obligations
in this regard shall include, but shall not be limited to, the
preparation and filing of any Submission Package for the Product to
maintain ENDO's right to continue to market, promote, and sell the
Product in the Territory and
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HIND-ENDO
SOLE AND EXCLUSIVE LICENSE AGREEMENT
the various statutory obligations of NDA owners as set forth on
Exhibit C attached hereto and made a part hereof as amended from time
to time by the FDA and other relevant authorities.
(iii) Each party hereto shall provide the other parties copies of all new
information, with regard to the Product. TEIKOKU and/or HIND will
provide ENDO with copies of all information, with regard to the
Product that they may file with regulatory authorities outside the
Territory.
(iv) ENDO shall be solely responsible for the initiation and conduct of
any clinical or other trial for additional indications for the
Product, other than its current indication for post-herpetic
neuralgia. Neither HIND nor TEIKOKU shall provide Product to any
party for any use within the Territory, whether compassionate or
otherwise, provided that ENDO will continue to fulfill the
commitments and obligations made by HIND under its compassionate use
program prior to the execution of the binding Term Sheet.
(c) Adverse Drug Reactions
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(i) Adverse Reaction or Complaint: Each party hereto hereby agrees to
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notify the other party by facsimile with a follow up hard copy,
within twenty-four hours (24) of receipt of any adverse reaction or
complaint reported to it or its agent resulting from the use of the
Product.
(ii) FDA Reporting.
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(a) Adverse Reactions and Field Alerts: HIND/TEIKOKU will be
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responsible for completion and submission to the FDA of any Form
FDA 3500a with respect to an adverse reaction involving the
Product or any complaint that would require a field alert, as and
when appropriate, unless such request is made directly to ENDO
and ENDO is under any statutory or regulatory obligation to make
such or similar report or filing to the FDA. Each party will
forward to the other a copy of each completed Form FDA3500a or
similar report or filing with respect to the Product at least
forty-eight (48) hours prior to filing such a report with the
FDA.
(b) Periodic Adverse Experiences Reports and Annual Reports:
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HIND/TEIKOKU will be responsible for completion of the periodic
ADE (Adverse Drug Experiences) reports and annual reports
required by the FDA with respect to the Product. HIND/TEIKOKU
will forward to ENDO a copy of each such report dealing with the
Product at least forty eight (48) hours before filing such with
the FDA.
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HIND-ENDO
SOLE AND EXCLUSIVE LICENSE AGREEMENT
5.2 MARKETING
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Reasonable Commercial Efforts. ENDO shall use reasonable commercial efforts to
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commercialize the Product and introduce the Product into the commercial market
in the Territory as soon as practical.
VI. OPTION FOR ADDITIONAL TERRITORIES - CANADA and MEXICO
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HIND hereby grants ENDO an option to extend this Agreement to cover a sole and
exclusive, license, on royalty terms that are substantially similar to those set
forth in this Agreement, with the right to sublicense, (subject to HIND's
approval which shall not be unreasonably withheld) to the Intellectual Property
Rights including the right to develop, use, market, promote, and sell Product in
Canada and Mexico. ENDO must exercise this Option for each of these respective
territories within six (6) months of the regulatory registration of the Product
in each territory.
VII. OPTION FOR DEVELOPMENT PRODUCT
------------------------------
7.1 HIND hereby grants ENDO an option for a sole and exclusive license, with
the right to sublicense, to the Intellectual Property Rights including the right
to develop, use, market, promote, and sell a topical formulation of lidocaine in
a gel formulation ("Development Product"), whether sold over-the-counter or by
prescription, for human use which falls within the claims of the Licensed
Patents. HIND expects the clinical development for the Development Product to be
completed and its NDA subsequently filed by the end of calendar year 1999.
Within six (6) months of the Product Launch, ENDO shall complete its due
diligence on the Development Product. Within one (1) month of the completion of
ENDO's due diligence on the Development Product, ENDO may exercise the option
granted by HIND under this Paragraph. In the event ENDO exercises its option
under this Paragraph, ENDO shall bear all reasonable costs for the completion of
the NDA, including any applicable filing fees, provided that all such activities
are under ENDO's general supervision and such reasonable costs do not exceed
HIND's anticipated development and NDA filing budget of One Million Dollars
($1,000,000). Any reasonable expense over and beyond the budget approved by ENDO
for the Development Product, must receive prior written approval from ENDO. In
the event that ENDO fails to exercise its option under this Paragraph in the
time provided herein, all of HIND's rights to the Development Product shall
remain with HIND to do as it may decide.
7.2 ***.
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HIND-ENDO
SOLE AND EXCLUSIVE LICENSE AGREEMENT
VIII. WARRANTIES AND REPRESENTATIONS
------------------------------
8.1 Legal Authority. Each party represents and warrants to the other that it
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has the legal power, authority and right to enter into this Agreement and to
perform its respective obligations set forth herein.
8.2 No Conflicts. Each party represents and warrants that as of the date of
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this Agreement it is not a party to any agreement or arrangement with any third
party or under any obligation or restrictions, which in any way limits or
conflicts with its ability to fulfill any of its obligations under this
Agreement.
8.3 Third Party Claims. HIND warrants to ENDO that there are no third party
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claims that would challenge or impair the license of the rights granted to ENDO
herein, including without limitation, any claims based upon patents, copyrights,
trademarks, or trade secret laws of the Territory. In the event, that a ▇▇▇▇
fide third party claim manifests itself with regard to the Intellectual Property
and ENDO is able to negotiate an appropriate royalty bearing license from such
third party, HIND shall pay fifty percent (50%) of such third party royalty,
provided that in no event shall HIND be required to pay more than fifty percent
(50%) of the royalties paid by ENDO to HIND hereunder. To the extent that the
royalty due to the third party exceeds 12% per annum, ENDO shall have the option
to terminate this Agreement.
8.4 Submission Package. HIND hereby warrants and represents to ENDO that the
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Submission Package for the Product and all information contained therein, as of
the effective date of this Agreement, are true and correct and that HIND is
unaware of any fact that would render such information inaccurate or untrue .
8.4 Survival. The foregoing representations and warranties shall survive the
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execution, delivery, and performance of this Agreement, notwithstanding any due
diligence investigation by or on behalf of either party.
IX. TRADEMARKS
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9.1. Trademark License Grant. HIND hereby grants ENDO an exclusive, royalty-
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free right and license, subject to Paragraph 4.3 above, to use the Trademark in
connection with the marketing, promotion, advertising, and sale or other
distribution of the Product in the Territory. ENDO may sublicense such right and
license to use such Trademark to any permitted sublicensees if such sublicensee
agrees in writing to be bound by the terms and conditions of this Paragraph.
9.2 ENDO may request HIND's reasonable assistance, at the expense of ENDO, in
applying for or maintaining any registration of the Trademark in the Territory.
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SOLE AND EXCLUSIVE LICENSE AGREEMENT
9.3 HIND shall notify ENDO at least sixty (60) days prior to abandoning the
registration for the Trademark to allow ENDO to maintain such registration if it
so chooses.
X. INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS BY THIRD PARTIES
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10.1 In the event that any infringement of any aspect of the Intellectual
Property Rights shall come to the attention of HIND or ENDO, HIND or ENDO shall
duly inform each other, and ENDO shall, in its sole discretion, determine
whether or not HIND should prosecute an infringement action in connection with
such Rights, provided that if ENDO so elects that HIND should initiate legal
proceedings against the alleged infringer, such proceedings shall be at ENDO's
expense, subject to the provisions of this Agreement. HIND hereby agrees to
work with ENDO in the initiation and prosecution of any such Intellectual
Property Rights infringement proceedings.
10.2 ENDO may deduct the expenses of any such proceedings against up to fifty
percent (50%) of the Royalty, if any due to HIND from ENDO, including minimum
royalties, under this Agreement. Out of any damages or awards recovered by HIND
in such action, HIND will first recover all royalties up to the 50% of Royalty
payable by ENDO to HIND and withheld by ENDO to defray costs of such
proceedings. ENDO will then recover its expenses for conducting said litigation
beyond the costs defrayed by the withheld royalties. HIND will also recover any
expenses, which it incurred on behalf of the litigation. Any amount remaining
thereafter belongs to ENDO. Sales made by the infringer shall be treated as a
sale made by ENDO for Royalty purposes under this Agreement.
XI. CONFIDENTIAL INFORMATION
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11.1 All information disclosed by one party to the other under this Agreement
shall be deemed to be confidential information ("Confidential Information").
The parties hereby agree to hold in strictest confidence any and all
Confidential Information disclosed by one party to the other under this
Agreement or obtained by either party as a result of performing its obligations
under this Agreement. The parties hereby agree that the following shall not be
considered Confidential Information subject to this Agreement:
(a) information which at the time of disclosure by one party to the other is in
the public domain;
(b) information which, after disclosure by one party to the other becomes part
of the public domain by publication or otherwise, provided that such
publication is not in violation of this Agreement or any other
confidentiality agreement;
(c) information, which the receiving party can establish in writing, was
already known to it or was in its possession at the time of disclosure by
the other party and was not acquired, directly or indirectly, from the
disclosing party.
(d) information, which the receiving party lawfully receives from a third
party, provided, however, that such third party was not obligated to hold
such information in confidence.
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(e) information which the receiving party is compelled to disclose by a court
or other tribunal of competent jurisdiction, or the FDA, provided however,
that in each such case the receiving party shall immediately give notice to
the disclosing party to enable the disclosing party to exercise its legal
rights to prevent and/or limit such disclosure. In any event, the receiving
party shall disclose only that portion of the Confidential Information
that, in the opinion of the disclosing party's legal counsel, is legally
required to be disclosed and will exercise reasonable efforts to ensure
that any such information so disclosed will be accorded confidential
treatment by said court or tribunal.
11.2 The receiving party shall not use Confidential Information for any
purpose other than for the purposes set forth in this Agreement.
11.3. The receiving party will not disclose Confidential Information to any
person other than to its employees, officers, agents, and consultants that have
a need to know such information to effectuate the purpose of this Agreement and
that only if employees, officers, agents, and consultants shall be informed of
this Confidentiality Agreement and shall, in writing, be bound by its terms.
All Confidential Information will contain a statement indicating that the
information is confidential and should not be disclosed to unauthorized
individuals.
11.4 Upon written request from the disclosing party or termination of this
Agreement, whichever comes sooner, the receiving party shall either promptly
return to the disclosing party all Confidential Information provided to the
receiving party pursuant to this Agreement, including any copies thereof and
notes or extracts based thereon or certify to the disclosing party that all such
Confidential Information have been duly destroyed; except the receiving party
may keep one (1) copy for archival purposes and until this Agreement is
terminated or becomes inoperative, shall keep confidential and not use in any
way detrimental to the disclosing party any analyses, compilation, studies or
other documents which reflect any of the Confidential Information.
XII. RECORDS
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ENDO shall keep accurate books and accounts of records in connection with the
sale of the Product in the Territory in sufficient detail to permit accurate
determination of the amount of royalties to be paid by ENDO to HIND. Such
records shall be maintained for a period of two (2) years from the end of the
License Year in which sales occurred. HIND, at its expense, through an
independent certified public accountant, shall have the right to access such
books and records for the sole purpose of verifying the royalty calculations;
such access shall be conducted after reasonable prior notice by HIND to ENDO
during ENDO's ordinary business hours and shall not be more frequent than once
per License Year. Said accountant shall not disclose to HIND or any other party
any information except that which should properly be contained in a royalty
report required under this Agreement. Any underpaid or overpaid royalties shall
be credited to the appropriate party within thirty (30) days after notice of and
agreement regarding such under or over payment. Any under payment will be
subject to compounded interest at the rate of one percent (1%) per month and any
over payment shall bear an interest rate equal to the prime rate for the period
in which such overpayment relates to.
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XIII. TERM
-----
This Agreement and the license granted to the Intellectual Property Rights
hereunder, shall expire upon the shorter of thirteen (13) years from the
Approval Letter or the expiration of the last to expire Licensed Patent.
Thereafter, ENDO shall have a fully paid up license to use all Intellectual
Property Rights to develop, use, market, promote, and sell the Product in the
Territory
XIV. TERMINATION
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This Agreement may be terminated by either HIND or ENDO for the following
reasons:
(a) Material Breach. Either party may terminate this Agreement in the case of
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a material breach by the other party which is not cured within forty-five
(45) days after written notice of the breach by the terminating party
(b) Bankruptcy. Either party may terminate this Agreement immediately in its
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entirety if the other party is declared insolvent by a court of competent
jurisdiction, files a petition of bankruptcy, is adjudged bankrupt, takes
advantage of any insolvency act, is in receivership, or executes a ▇▇▇▇ of
sale, deed of trust, or assignment for the benefit of creditors.
(c) ENDO may terminate this Agreement immediately upon termination of the
Related Agreement.
XV. EFFECT OF TERMINATION
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Upon termination of this Agreement pursuant to Article 14, all rights in the
development, importation, use, marketing, promotion, or sale of Product shall
revert to HIND, apart from any intellectual property that belongs exclusively to
ENDO.
XVI. EFFECT OF TERMINATION ON OTHER OBLIGATIONS
------------------------------------------
Termination of this Agreement shall have no effect on, or relieve any party from
the obligation to make any payment or perform any actions arising prior to the
effective date of termination.
XVII. ARBITRATION
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17.1 All disputes over the meaning and interpretation of this Agreement shall
be resolved by conciliation and non-binding mediation and if such mediation is
unsuccessful then such disputes shall be finally settled by a single Arbitrator
selected by HIND and ENDO. If HIND and ENDO cannot agree on a single
Arbitrator, then disputes shall be resolved by an Arbitration Panel comprising
one arbitrator appointed by HIND and one arbitrator appointed by ENDO, and a
Chairman of the Arbitration Panel appointed by the first two arbitrators. Any
such arbitration proceeding shall be conducted in accordance with AAA rules;
shall be held in the Commonwealth of Pennsylvania, unless otherwise agreed by
the parties; and judgment upon the arbitration award may be entered in any court
having jurisdiction.
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17.2 In order to initiate procedures for dispute resolution by conciliation,
mediation and arbitration either party may give written notice to the other of
intention to resolve a dispute, and absent satisfactory resolution, then to
arbitrate. Such notice shall contain a statement setting forth the nature of
the dispute and the resolution sought. If, within thirty (30) days of such
notice a resolution by conciliation between the parties themselves or by
mediation has not been achieved to the satisfaction of both parties, and if
within forty-five (45) days from said written notice an Arbitrator or
Arbitration Panel has not been appointed with an arbitration schedule
satisfactory to both parties, then either party may proceed with judicial
remedies.
17.3 Notwithstanding the above, HIND reserves the right and power to proceed
with direct judicial remedies against ENDO without conciliation, mediation or
arbitration for material breach of the royalty payment and sales reporting
provisions of this Agreement after giving written notice of such breach to ENDO
followed by an opportunity period of forty-five (45) days in which to cure such
breach. In collecting overdue royalty payments and securing compliance with
reporting obligations, HIND may use all judicial remedies available.
XVIII. OTHER
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ENDO agrees that it will not use the indicia or name HIND or any of HIND's
personnel in advertising, promotion, or labeling of Products without prior
written approval of HIND.
XIX. INDEMNIFICATION
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(a) ENDO hereby defends, indemnifies and holds HIND harmless from and against
all liability, demands, damages, expenses or losses for death, personal
injury, illness or property damage (including reasonable attorneys' fees)
arising out of the marketing, promotion, and/or sale of the Product in
the Territory. As used in this clause, HIND includes its Affiliates,
officers, agents and employees, and "ENDO" includes its Affiliates,
officers, agents, and employees.
(b) HIND hereby defends, indemnifies and holds ENDO harmless from and against
all liability, demands, damages, expenses or losses for death, personal
injury, illness or property damage (including reasonable attorneys' fees)
arising out of the breach of any of HIND's representations and warranties
under this Agreement. As used in this clause, ENDO includes its
Affiliates, officers, agents, and employees.
XX. ASSIGNMENT
----------
Neither party may assign its rights and obligations under this Agreement without
the prior written consent of the other party, which will not be unreasonably
withheld, provided, however, that ENDO may assign its rights and obligations
hereunder to its successor in business and/or any subsidiary or parent entity,
provided that ENDO shall remain liable.
12
HIND-ENDO
SOLE AND EXCLUSIVE LICENSE AGREEMENT
XXI. FORCE MAJEURE
-------------
No party shall be liable for a delay in performance or failure to perform an
obligation under this Agreement if such delay or failure is due to an act of God
or any other occurrence beyond the control of the party, including but not
limited to fire, explosion, disease, war, invasion, government acts, weather or
civic unrest, or strikes, provided, however, that the party who is unable to
perform its obligations under this Agreement due to such occurrence resumes its
performance as soon as possible following the end of the occurrence causing
delay or failure. In the event that a party claims non-performance of its
obligations under this Agreement as a result of this Paragraph, the other party
shall have the right to terminate this Agreement if the force majeure that is
claimed results in non performance by the claiming party that last more than
ninety (90) days.
XXII. NOTICE
------
All notices and other communications required or permitted hereunder shall be in
writing and shall be deemed to have been given when hand delivered or sent via a
facsimile machine or within five (5) business days of being mailed by registered
or certified United States mail or sent by courier to the following addresses:
▇▇▇▇▇ ▇. ▇▇▇▇
President
Hind Health Care, Inc.
Suite 101, ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
with a copy to:
▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Consulting Research Director
Hind Health Care, Inc.
Suite 101, ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
and to ENDO:
▇▇▇▇▇ ▇. ▇▇▇▇▇
President & CEO
Endo Pharmaceuticals Inc.
▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Tel: (▇▇▇) ▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
With a copy to:
▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
Senior Vice President, Business Development
13
HIND-ENDO
SOLE AND EXCLUSIVE LICENSE AGREEMENT
Endo Pharmaceuticals Inc.
▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Tel: (▇▇▇) ▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
XXIII. GOVERNING LAW
-------------
This Agreement shall be interpreted under the laws of the Commonwealth of
Pennsylvania, not taking into consideration its conflicts of laws.
XXIV. ENTIRE AGREEMENT
----------------
This Agreement, together with its attached Exhibits, constitute the entire
agreement between HIND and ENDO with respect to the subject matter hereof and
supersedes all prior and/or contemporaneous agreements and understandings,
whether oral, written or in any other medium, that might exist between the
parties with relation to the subject matter hereof. No modification to any
provision of this Agreement shall be binding unless in writing and signed by
both HIND and ENDO. No waiver of any rights under this Agreement, will be
effective unless in writing signed by the party to be charged. All of the terms
and provisions of this Agreement shall be binding upon and inure to the benefit
of and be enforceable by the respective successors and permitted assigns of the
parties hereto.
XXV. PUBLICITY:
---------
HIND shall not originate any publicity, news release, or other public
announcement or comment, written or oral, relating to the Product and/or this
Agreement, without the prior written consent of ENDO, except for such
announcement which is required by law. In the event HIND needs to make any
announcement which is required by law, it will provide ENDO a reasonable
opportunity to review the form and content of such announcement and comment upon
it before it is made public.
IN WITNESS WHEREOF, the parties hereto have caused this instrument to be
executed in duplicate as of the day and year first above written by their duly
authorized officers as set forth below.
HIND HEALTH CARE, INC. ENDO PHARMACEUTICALS INC.
/s/ ▇▇▇▇▇ ▇. ▇▇▇▇ /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇
By: __________________________ By: _________________________
▇▇▇▇▇ ▇. ▇▇▇▇ ▇▇▇▇▇ ▇. ▇▇▇▇▇
President President & CEO
14
HIND-ENDO
SOLE AND EXCLUSIVE LICENSE AGREEMENT
EXHIBIT A
PATENTS
-------
U.S. Patent Number Title Issue Date
-------------------- ----- ----------
5,709,869 "Method for Treating Nerve Injury 1/20/98
Pain Associated with Shingles"
5,411,738 "Method for Treating Nerve Injury 5/2/95
Pain Associated with Shingles
Herpes-Zoster and Post-Herpetic
Neuralgia) by Topical Application
Of Lidocaine"
5,601,838 "Method for Treating Pain Associated with 2/11/97
Herpes Zoster and Post-Herpetic Neuralgia"
5,589,180 "Method for Treating Nerve Injury 12/31/96
Pain Associated with Shingles (Herpes-Zoster
and Post Herpetic Neuralgia) by Topical
Application of Lidocaine"
TRADEMARKS
----------
U.S. Trademark Registration number Trademark Registration Date
------------------------------------ --------- -----------------
1597110 LIDODERM(R) July 8, 1996
1821958 TAKON(R) February 15, 1994
15
HIND-ENDO
SOLE AND EXCLUSIVE LICENSE AGREEMENT
EXHIBIT B
SUPPLY AND MANUFACTURING AGREEMENT BETWEEN TEIKOKU SEIYKAKU CO.,
TEIKOKU PHARMA USA, INC. AND ENDO
16
HIND-ENDO
SOLE AND EXCLUSIVE LICENSE AGREEMENT
EXHIBIT C
NDA OWNERS' STATUTORY OBLIGATIONS
--------------------------------------------------------------------------------
21 CFR 314. CONTENT SUMMARY
--------------------------------------------------------------------------------
70 . Changes to the drug substance (i.e., synthesis, source, relax
specification limits)
. Changes to the drug product (i.e., add an ingredient, change
manufacturing site, container/closure change)
. Changes to the product labeling
--------------------------------------------------------------------------------
72 Change in ownership/sponsorship of the NDA
--------------------------------------------------------------------------------
80 . 15-day "Alert reports"
. Periodic adverse drug experience reports (quarterly intervals for
the first 3 years and annual thereafter)
--------------------------------------------------------------------------------
81 . NDA - Field alert report (quality concerns)
. Annual Report
. Advertisements and promotional labeling
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
PDUFA User Fee for approved NDAs (Product Fee)*
--------------------------------------------------------------------------------
*
-------------------------------------------------------
1998 1999 2000 2001
-------------------------------------------------------
$*** $*** $*** $***
-------------------------------------------------------
17
