EXHIBIT 10.15
HYDROCODONE API SUPPLY OPTION AGREEMENT
HYDROCODONE API SUPPLY OPTION AGREEMENT (this "Agreement")
dated as of February 6, 2004 between XXXXXX DRUG CO, INC., a New York
corporation ("HDC"), HOUBA, INC., an Indiana corporation ("Houba" and together
with HDC, collectively, "Xxxxxx") and XXXXXX PHARMACEUTICALS INC., a Nevada
corporation ("Xxxxxx", and together with Xxxxxx, the "Parties").
PRELIMINARY STATEMENT
Xxxxxx desires to provide Xxxxxx with an exclusive option to
enter into a supply agreement with Xxxxxx for hydrocodone bitartrate active
pharmaceutical ingredient on the terms and subject to the conditions set forth
herein.
NOW, THEREFORE, the parties hereto agree as follows:
1. DEFINED TERMS; RULES OF CONSTRUCTION; CALCULATIONS.
1.1 Rules of Construction. This Agreement shall be
subject to the Rules of Construction set forth herein.
1.2 Definitions. As used in this Agreement, capitalized
terms defined in the preamble and other Sections of this Agreement shall have
the meanings set forth therein, and terms defined in Exhibit A shall have the
meanings set forth therein and capitalized terms used herein but not otherwise
defined herein shall have the meanings set forth as follows:
"Action" means any claim, action, suit, arbitration, inquiry,
proceeding or investigation by or before any Governmental Authority.
"Business Day" means any day other than a Saturday, Sunday or
day which banks are generally closed in the State of California.
"Encumbrance" means any security interest, pledge,
hypothecation, mortgage, lien (including environmental and tax liens),
violation, charge, lease, license, encumbrance, servient easement,
adverse claim, reversion, reverter, preferential arrangement,
restrictive covenant, condition or restriction of any kind, including
any restriction on the use, voting, transfer, receipt of income or
other exercise of any attributes of ownership.
"Environmental Laws" means all Laws, now or hereafter in
effect and as amended, and any judicial or administrative
interpretation thereof, including any judicial or administrative order,
consent decree or judgment, relating to the environment, health,
safety, natural resources or Hazardous Materials, including CERCLA; the
Resource Conservation and Recovery Act, 42 U.S.C. Sections 6901 et
seq.; the Hazardous Materials
Transportation Act, 49 U.S.C. Sections 6901 et seq.; the Clean Water
Act, 33 U.S.C. Sections 1251 et seq.; the Toxic Substances Control Act,
15 U.S.C. Sections 2601 et seq.; the Clean Air Act, 42 U.S.C. Sections
7401 et seq.; the Safe Drinking Water Act, 42 U.S.C. Sections 300f et
seq.; the Atomic Energy Act, 42 U.S.C. Sections 2011 et seq.; the
Federal Insecticide, Fungicide and Rodenticide Act, 7 U.S.C. Sections
136 et seq.; and the Federal Food, Drug and Cosmetic Act, 21 U.S.C.
Sections 301 et seq.
"Governmental Authority" means any federal, national,
supranational, state, provincial, local, or similar government,
governmental, regulatory or administrative authority, agency or
commission or any court, tribunal, or judicial or arbitral body.
"Governmental Order" means any order, writ, judgment,
injunction, decree, stipulation, determination or award entered by or
with any Governmental Authority.
"Xxxxxx Indemnified Party" has the meaning given such term in
Section 7(b).
"Indemnified Party" means a Xxxxxx Indemnified Party or a
Xxxxxx Indemnified Party, as the case may be.
"Indemnifying Party" means Xxxxxx pursuant to Section 7(a) and
Xxxxxx pursuant to Section 7(b), as the case may be.
"Law" means any federal, national, supranational, state,
provincial, local or similar statute, law, ordinance, regulation, rule,
code, order, requirement or rule of law (including common law).
"Liabilities" means any and all debts, liabilities and
obligations, whether accrued or fixed, absolute or contingent, matured
or unmatured or determined or determinable, including those arising
under any Law (including any Environmental Law), Action or Governmental
Order and those arising under any contract, agreement, arrangement,
commitment or undertaking.
"Option Exercise Date" means the date that the Option Exercise
Notice shall have been given to Xxxxxx, as provided in Section 3(a) of
the Agreement.
"Option Period" means the period commencing on the date of
this Agreement and expiring on the 180th day following the date of this
Agreement.
"Third Party Claim" has the meaning given such term in Section
7(d)(ii).
"Xxxxxx Indemnified Party" has the meaning given such term in
Section 7(a).
2. GRANT OF OPTION. Subject to the conditions set forth
herein, Xxxxxx hereby grants to Xxxxxx or its designee a non-assignable
exclusive option (the "Option") to enter into a supply agreement with Xxxxxx
(the "Supply Agreement") pursuant to which Xxxxxx will
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supply, and Xxxxxx will purchase, on a non-exclusive, preferential basis,
hydrocodone bitartrate active pharmaceutical ingredient ("Hydrocodone API")
manufactured using Xxxxxx'x proprietary hydrocodone bitartrate API process (the
"Hydrocodone Process") which Option is exercisable at any time during the Option
Period by delivery of an Election Notice in accordance with Section 3.
3. EXERCISE OF OPTION.
(a) Exercise Notice. Xxxxxx may only exercise the Option
by giving a written notice (the "Election Notice") with respect to such exercise
during the Option Period. Such notice shall be given in accordance with Section
6 to Xxxxxx on a Business Day.
(b) Option Exercise Conditions. Xxxxxx may exercise the
Option if the following conditions shall have been satisfied or waived by Xxxxxx
in its sole discretion:
(i) the Option Exercise Date occurs during the
Option Period;
(ii) the Election Notice contains a commitment by
Xxxxxx to fund (A) fifty percent (50%), up
to an aggregate maximum of $3,500,000, of
the Development and Scale-Up Expenses (as
defined in Exhibit A) to develop the
Hydrocodone Process through commercial
scale-up and final regulatory approvals for
commercial distribution in the United
States. Such funding by Xxxxxx shall be paid
on a monthly basis within thirty (30) days
after the end of each month in which Xxxxxx
actually incurs such Development and
Scale-Up Expenses;
(iii) Xxxxxx commits to negotiate in good faith
with Xxxxxx the terms of the Supply
Agreement for a period of 75 days following
Xxxxxx'x receipt of the Election Notice,
which shall include, without limitation, the
terms specified in Exhibit A hereto.
(c) Promptly following Xxxxxx'x receipt of the Election
Notice, (i) Xxxxxx shall use commercially reasonable efforts to obtain financing
dedicated to its portion of the Development and Scale-Up Expenses, and (ii) the
Parties shall negotiate in good faith the terms of the Supply Agreement and
shall use reasonable best efforts to execute the Supply Agreement within sixty
(60) days following Xxxxxx'x receipt of the Election Notice; provided, however,
that if during the sixty (60) day period following Xxxxxx'x receipt of the
Election Notice Xxxxxx is unable, despite using commercially reasonable efforts,
to obtain financing dedicated to the cost of its portion of the Development and
Scale-Up Expenses, the Parties shall discuss and negotiate in good faith
alternatives relating to Xxxxxx'x development and scale-up of the Hydrocodone
Process.
4. EXPENSES. Except as otherwise specified in this
Agreement, all costs and expenses, including fees and disbursements of counsel,
financial advisors and accountants, incurred in connection with this Agreement
and the transactions contemplated by this Agreement shall be paid by the party
incurring such costs and expenses, whether or not the Closing shall have
occurred.
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5. REPRESENTATIONS AND WARRANTIES. (a) Xxxxxx hereby
represents and warrants as follows:
(i) Xxxxxx is a corporation duly organized, validly
existing and in good standing under the laws of the jurisdiction of its
incorporation and has all necessary power and authority to enter into
this Agreement and the related documents to which it is a party, to
carry out its obligations hereunder and thereunder and to consummate
the transactions contemplated hereby and thereby. Xxxxxx is duly
licensed or qualified to do business and is in good standing in each
jurisdiction which the properties owned or leased by it or the
operation of its business makes such licensing or qualification
necessary, except where the failure to be so qualified will not have a
material adverse effect on its operations or financial condition. The
execution and delivery of this Agreement and the related documents
(upon execution and delivery) by Xxxxxx, the performance by Xxxxxx of
its obligations hereunder and thereunder and the consummation by Xxxxxx
of the transactions contemplated hereby and thereby have been duly
authorized by all requisite action on the part of Xxxxxx and its
stockholders. This Agreement and the related documents, upon their
execution shall have been duly executed and delivered by Xxxxxx, and
(assuming due authorization, execution and delivery by the other
Parties thereto) this Agreement and the related documents to which it
is a party, upon their execution, shall constitute, legal, valid and
binding obligations of Xxxxxx, enforceable against Xxxxxx in accordance
with their respective terms, subject, as to enforceability, to
bankruptcy, insolvency, moratorium, reorganization and other laws of
general application relating to or affecting creditors' rights and to
general equitable principles.
(ii) The execution, delivery and performance of this
Agreement and the related documents (upon execution and delivery) to
which it is a party do not and will not (a) violate, conflict with or
result in the breach of any provision of the certificate of
incorporation or by-laws (or similar organizational documents) of
Xxxxxx, (b) conflict with or violate any Law or Governmental Order
applicable to Xxxxxx, or any of its assets, properties or businesses,
or (c) conflict with, result in any breach of, constitute a default (or
event which with the giving of notice or lapse of time, or both, would
become a default) under, require any consent under, or give to others
any rights of termination, amendment, acceleration, suspension,
revocation or cancellation of any note, bond, mortgage or indenture,
contract, agreement, lease, sublease, license, permit, franchise or
other instrument or arrangement to which Xxxxxx is a party or by which
the Hydrocodone Process, as the case may be, is bound or affected.
(iii) There are no pending or threatened actions, suits or
proceedings against or affecting Xxxxxx or any of its properties by or
before any court or administrative agency in respect of this Agreement,
the Hydrocodone Process, as the case may be, which are reasonably
likely to materially adversely affect the ability of Xxxxxx to perform
its obligations hereunder or call into question the validity of this
Agreement and the related documents (upon execution and delivery) or
the enforceability thereof in accordance with the respective terms
thereof.
(iv) Neither the execution and delivery by Xxxxxx of this
Agreement and the related documents (upon execution and delivery) to
which it is a party nor the
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consummation by Xxxxxx of any of the transactions contemplated hereby
or thereby nor the performance by Xxxxxx of any of its obligations
requires the consent or approval of, the giving of notice to, the
filing or registration with, or the taking of any other action in
respect of any Governmental Authority.
(v) Xxxxxx has not taken any action nor have any other
steps been taken or legal proceedings commenced or threatened against
Xxxxxx for its dissolution, winding-up, bankruptcy, examination,
administration, court protection, reorganization or appointment of a
receiver, examiner, trustee or similar official with respect to Xxxxxx
or any of its assets or property or for the granting of suspension of
payments to Xxxxxx.
(vi) There are no contracts or agreements to which Xxxxxx
is a party providing for any lease, sale, disposition of title or
beneficial ownership of Xxxxxx'x rights in or to the Hydrocodone
Process.
(b) Xxxxxx hereby represents and warrants as follows:
(i) The execution and delivery of this Agreement by
Xxxxxx, the performance by Xxxxxx of its obligations hereunder and the
consummation by Xxxxxx of the transactions contemplated hereby have
been duly authorized by all requisite action on the part of Xxxxxx.
This Agreement constitutes the legal, valid and binding obligation of
Xxxxxx and is enforceable against Xxxxxx in accordance with its terms,
except as the enforceability thereof may be limited by the effect of
any applicable bankruptcy, insolvency, reorganization, moratorium or
similar laws affecting creditors' rights generally and by general
principles of equity.
(ii) The execution, delivery and performance by Xxxxxx of
this Agreement does not contravene its constituent documents or any Law
or material contractual restriction binding on or affecting it.
6. NOTICES. All notices, requests, claims, demands and
other communications hereunder shall be in writing and shall be given or made
(and shall be deemed to have been duly given or made upon receipt) by delivery
in person, by an internationally recognized overnight courier service, by
facsimile or registered or certified mail (postage prepaid, return receipt
requested) to the respective parties hereto at the following addresses (or at
such other address for a party as shall be specified in a notice given in
accordance with this Section 7):
If to Xxxxxx, at:
Xxxxxx Drug Co., Inc.
000 Xx. Xxxxxxxxxx Xxxx
Xxxxxxxx, Xxxxxxxx 00000
Attention: Chief Executive Officer
Fax: (000) 000-0000
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If to Xxxxxx, at:
Xxxxxx Pharmaceuticals, Inc.,
000 Xxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxx 00000
Attention: Chief Financial Officer
Fax: (000) 000-0000
cc: General Counsel
7. INDEMNIFICATION. (a) Indemnification by Xxxxxx.
Xxxxxx and its Affiliates, officers, directors, employees, agents, successors
and assigns (each a "Xxxxxx Indemnified Party") shall be indemnified and held
harmless by Xxxxxx for and against any and all Liabilities, losses, diminution
in value, damages, claims, costs and expenses, interest, awards, judgments and
penalties (including attorneys' and consultants' fees and expenses) actually
suffered or incurred by them (including any Action brought or otherwise
initiated by any of them) (hereinafter a "Loss"), arising out of or resulting
from the breach of any representation, warranty or covenant made by Xxxxxx
contained in this Agreement.
To the extent that Xxxxxx'x undertakings set forth in this Section 7(a) may be
unenforceable, Xxxxxx shall contribute the maximum amount that it is permitted
to contribute under applicable Law to the payment and satisfaction of all Losses
incurred by Xxxxxx Indemnified Parties.
(b) Indemnification by Xxxxxx. Xxxxxx and its Affiliates,
officers, directors, employees, agents, successors and assigns (each a "Xxxxxx
Indemnified Party") shall be indemnified and held harmless by Xxxxxx for and
against any and all Losses, arising out of or resulting from the breach of any
representation or warranty made by the Xxxxxx contained in this Agreement. To
the extent that Xxxxxx'x undertakings set forth in this Section 7(b) may be
unenforceable, Xxxxxx shall contribute the maximum amount that it is permitted
to contribute under applicable Law to the payment and satisfaction of all Losses
incurred by the Xxxxxx Indemnified Parties.
(c) Notice of Loss; Third Party Claims. (i) An
Indemnified Party shall give the Indemnifying Party notice of any matter which a
Indemnified Party has determined has given or could give rise to a right of
indemnification under this Agreement, within 60 days of such determination,
stating the amount of the Loss, if known, and method of computation thereof, and
containing a reference to the provisions of this Agreement in respect of which
such right of indemnification is claimed or arises.
(ii) If an Indemnified Party shall receive notice of any
Action, audit, demand or assessment (each, a "Third Party Claim") against it or
which may give rise to a claim for the Loss under this Section 7, within 30 days
of the receipt of such notice, the Indemnified Party shall give the Indemnifying
Party notice of such Third Party Claim; provided, however, that the failure to
provide such notice shall not release the Indemnifying Party from any of its
obligations under this Section 7 except to the extent that the Indemnifying
Party is materially prejudiced by such failure and shall not relieve the
Indemnifying Party from any other obligation or Liability
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that it may have to any Indemnified Party otherwise than under this Section 7.
If the Indemnifying Party acknowledges in writing its obligation to indemnify
the Indemnified Party hereunder against any Losses that may result from such
Third Party Claim, then the Indemnifying Party shall be entitled to assume and
control the defense of such Third Party Claim at its expense and through counsel
of its choice if it gives notice of its intention to do so to the Indemnified
Party within ten days of the receipt of such notice from the Indemnified Party;
provided, however, that if there exists or is reasonably likely to exist a
conflict of interest that would make it inappropriate in the judgment of the
Indemnified Party in its sole and absolute discretion for the same counsel to
represent both the Indemnified Party and the Indemnifying Party, then the
Indemnified Party shall be entitled to retain its own counsel in each
jurisdiction for which the Indemnified Party determines counsel is required, at
the expense of the Indemnifying Party. In the event that the Indemnifying Party
exercises the right to undertake any such defense against any such Third Party
Claim as provided above, the Indemnified Party shall cooperate with the
Indemnifying Party in such defense and make available to the Indemnifying Party,
at the Indemnifying Party's expense, all witnesses, pertinent records, materials
and information in the Indemnified Party's possession or under the Indemnified
Party's control relating thereto as is reasonably required by the Indemnifying
Party. Similarly, in the event the Indemnified Party is, directly or indirectly,
conducting the defense against any such Third Party Claim, the Indemnifying
Party shall cooperate with the Indemnified Party in such defense and make
available to the Indemnified Party, at the Indemnifying Party's expense, all
such witnesses, records, materials and information in the Indemnifying Party's
possession or under the Indemnifying Party's control relating thereto as is
reasonably required by the Indemnified Party. No such Third Party Claim may be
settled by the Indemnifying Party without the prior written consent of the
Indemnified Party, which consent shall not be unreasonably withheld or delayed.
8. AMENDMENTS. No change or modification of this
Agreement shall be valid unless the same shall be in writing and signed by the
Parties.
9. ASSIGNMENTS. This Agreement shall not be assignable
by any of the Parties hereto.
10. GOVERNING LAW. This Agreement shall be governed by,
and construed in accordance with, the laws of the State of New York applicable
to contracts executed in and to be performed in that State. All Actions arising
out of or relating to this Agreement shall be heard and determined exclusively
in any New York federal court sitting in the Borough of Manhattan of The City of
New York, provided, however, that if such federal court does not have
jurisdiction over such Action, such Action shall be heard and determined
exclusively in any New York state court sitting in the Borough of Manhattan of
The City of New York. Consistent with the preceding sentence, the Parties hereto
hereby (a) submit to the exclusive jurisdiction of any federal or state court
sitting in the Borough of Manhattan of The City of New York for the purpose of
any Action arising out of or relating to this Agreement brought by any party
hereto and (b) irrevocably waive, and agree not to assert by way of motion,
defense, or otherwise, in any such Action, any claim that it is not subject
personally to the jurisdiction of the above-named courts, that its property is
exempt or immune from attachment or execution, that the Action is brought in an
inconvenient forum, that the venue of the Action is improper, or that this
Agreement or the transactions contemplated by this Agreement may not be enforced
in or by any of the above-named courts.
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11. BENEFIT AND BINDING EFFECT. This Agreement shall be
binding upon and shall inure to the benefit of the Parties and their respective
successors, heirs and assigns; provided that the Parties hereby consent to the
appointment by Xxxxxx of any of its affiliate as its designee for purposes of
exercising the Option.
12. SEVERABILITY OF PROVISIONS. Except as otherwise
provided in the succeeding sentence, every provision of this Agreement is
intended to be severable, and, if any term or provision of this Agreement is
illegal or invalid for any reason whatsoever, such illegality or invalidity
shall not affect the validity or legality of the remainder of this Agreement.
The preceding sentence of this Section shall be of no force or effect if the
consequence of enforcing the remainder of this Agreement without such illegal or
invalid term or provision would be to cause any Party to lose the benefit of its
economic bargain.
13. HEADINGS. Section headings in this Agreement are
included herein for the convenience of reference only and shall not constitute a
part of this Agreement for any other purpose.
14. COUNTERPARTS. This Agreement may be executed in any
number of counterparts and by the different Parties hereto in separate
counterparts, each of which when so executed shall be deemed to be an original
and all of which taken together shall constitute one and the same agreement.
15. WAIVER OF JURY TRIAL. Each of the Parties hereby
waives to the fullest extent permitted by applicable law any right it may have
to a trial by jury with respect to any litigation directly or indirectly arising
out of, under or in connection with this Agreement or the transactions
contemplated by this Agreement. Each of the Parties hereby (a) certifies that no
representative, agent or attorney of the other party has represented, expressly
or otherwise, that such other party would not, in the event of litigation, seek
to enforce the foregoing waiver and (b) acknowledges that it has been induced to
enter into this Agreement and the transactions contemplated by this Agreement,
as applicable, by, among other things, the mutual waivers and certifications in
this Section 15.
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IN WITNESS WHEREOF, the Parties hereto have signed this
Agreement as of the day and year first above written.
XXXXXX DRUG CO., INC.
By: _______________________________
Name: Xxxxxx X. Xxxxxxx
Title: President and Chief Executive
Officer
HOUBA, INC.
By: _______________________________
Name: Xxxxx X. Xxxxxxx
Title: Vice President
XXXXXX PHARMACEUTICALS INC.
By: _______________________________
Name:
Title:
EXHIBIT A
TERMS TO BE INCLUDED IN HYDROCODONE API SUPPLY AGREEMENT
X. Xxxxxx will fund fifty percent (50%), subject to an aggregate maximum
of $3,500,000, of the cost to develop and commercialize the Hydrocodone
Process, including, without limitation, the capital improvements
required at Xxxxxx'x Xxxxxx, Indiana facility, the purchase,
installation and validation of associated manufacturing equipment, the
preparation and filing of the Drug Master File for the Hydrocodone API
and the related direct labor expenses (the "Development and Scale Up
Expenses"). Such funding by Xxxxxx shall be paid on a monthly basis
within thirty (30) days after the end of each month in which Xxxxxx
actually incurs such Development and Scale-Up Expenses;
X. Xxxxxx will supply to Xxxxxx and Xxxxxx shall purchase on a
preferential basis up to a maximum annual quantity of 4,600 kg of
Hydrocodone API;
C. The transfer price to Xxxxxx for the Hydrocodone API shall be Xxxxxx'x
fully absorbed manufacturing cost as determined based on US GAAP plus
50% of the difference between such manufacturing cost and the lowest
price available to Xxxxxx from an alternative supplier for comparable
quantities of Hydrocodone API; provided, however, that the transfer
price shall not be less than Xxxxxx'x fully absorbed manufacturing
costs plus 35%.
D. The Supply Agreement shall have a term of five (5) years.
