LICENSE AGREEMENT between OUTLOOK PHARMACEUTICALS, INC. and AURIGA LABORATORIES, INC.
between
OUTLOOK
PHARMACEUTICALS, INC.
and
Confidential
THIS
LICENSE AGREEMENT (this “Agreement”),
effective as of November 28, 2007 (the “Effective Date”), is
entered into between Outlook
Pharmaceuticals, Inc., an Ohio corporation (“Outlook”), and Auriga Laboratories,
Inc., a Delaware
corporation (“Auriga”).
Recitals
WHEREAS, Outlook is the owner
of the rights relating to the product immediate release Dextroamphetamine
Sulfate Oral Solution, 5mg/5ml, a pharmaceutical product;
WHEREAS, Outlook has filed and
is the sponsor of abbreviated new drug application 40-776.
WHEREAS, Auriga desires to
obtain an exclusive license to Exploit, defined below, the Product in the
Territory, defined below, and;
WHEREAS, Outlook is willing to
grant to Auriga said license, subject to the terms and limitations set forth
herein.
Based on
the foregoing Recitals, and the mutual covenants set forth below, the parties
agree as follows:
1 DEFINITIONS
“Affiliate” shall
mean, with respect to any person or entity, any other person or entity that
controls, is controlled by or is under common control with such person or
entity. For purposes of this Agreement, a person or entity shall be
in “control” of an entity if it owns or controls at least fifty percent (50%) of
the equity securities of the subject entity entitled to vote in the election of
directors (or, in the case of an entity that is not a corporation, for the
election of the corresponding managing authority), or otherwise has the power to
control the management and policies of such other entity.
"ANDA" the abbreviated
new drug application * * *.
“Agreement” shall have
the meaning set forth in the preamble to this Agreement.
"Act" shall mean the
United States Federal Food, Drug & Cosmetic Act (21 U.S. 301) and the
regulations promulgated thereunder.
“Auriga” shall have
the meaning set forth in the preamble to this Agreement.
"Auriga Common Stock"
shall mean the Common Stock of Auriga, $.001 par value per share.
“Bankruptcy Code”
shall have the meaning set forth in Section 11.3.1 of the
License Agreement.
"Business Days" shall
mean any day that banking institutions are open for regular business in
Cincinnati, Ohio.
“Commercially Reasonable
Efforts” shall have the meaning set forth in Section 4.1.2 of this
Agreement.
“Confidential
Information” shall mean, with respect to a party, all information (and
all tangible and intangible embodiments thereof), that is owned or controlled by
such party, is disclosed by or on behalf of such party to the other party
pursuant to this Agreement, and (if disclosed in writing or other tangible
medium) is marked or identified as confidential at the time of disclosure to the
receiving party or (if otherwise disclosed) is identified as confidential at the
time of disclosure to the receiving party and described as such in writing
within thirty (30) days after such disclosure. Notwithstanding the
foregoing, Confidential Information of a party shall not include information
which, and only to the extent, the receiving party can establish by written
documentation (a) has been generally known prior to disclosure of such
information by the disclosing party to the receiving party; (b) has become
generally known, without the fault of the receiving party, subsequent to
disclosure of such information by the disclosing party to the receiving party;
(c) has been received by the receiving party at any time from a source,
other than the disclosing party, rightfully having possession of and the right
to disclose such information free of confidentiality obligations; (d) has
been otherwise known by the receiving party free of confidentiality obligations
prior to disclosure of such information by the disclosing party to the receiving
party; or (e) has been independently developed by employees or others on
behalf of the receiving party without use of such information disclosed by the
disclosing party to the receiving party (each, a “Confidentiality
Exception”).
“Confidentiality
Exception” shall have the meaning set forth in the preceding
definition.
"Controlling
Stockholders" shall have the meaning set forth in Section
5.1.4(b).
“Effective Date” shall
have the meaning set forth in the preamble to this Agreement.
“Encumbrance” shall
mean any lien, mortgage, deed of trust, pledge, security interest, charge,
condition, equitable interest, right of first refusal, community property
interest, covenant, option, title defect, claim, restriction, variance,
exception, license, or other adverse claim or interest or encumbrance of any
kind or nature whatsoever, whether or not perfected, including any restriction
on use, voting, transfer, receipt of income or exercise of any other attribute
of ownership
“Exploit,” “Exploiting” or “Exploitation” shall
mean to make, have made, distribute, commercialize, market, offer for sale and
sell the Product in the Territory.
“FDA” shall mean the
Food and Drug Administration of the United States, or the successor
thereto.
"FDA Approval" shall
mean written communication from the FDA that the FDA has approved the
Product.
“First Commercial
Sale” shall mean the first sale for use or consumption by the general
public of the Product; conclusive indicia of a First Commercial Sale shall
include, but is not limited to, the shipment of Product to
wholesalers.
"First Product
Delivery" shall mean the first delivery of a commercial supply of the
Product by Mikart, Inc., or any other manufacturer or supplier, to Auriga or its
designee.
“Indemnitee” shall
have the meaning set forth in Section 10.3 of this
Agreement.
“Law” shall mean any
federal, state or local law, statute or ordinance, or any rule, regulation, or
published guidelines promulgated by any governmental authority, including the
United States Food, Drug and Cosmetic Act and applicable regulations promulgated
thereunder.
“License Agreement”
shall mean this Agreement pursuant to which Outlook grants certain exclusive
license rights for Auriga to Exploit the Products in the Territory.
"Minimum Annual Performance
Payments" shall have the meaning set forth in Section 5.2.3
below.
“Net Sales” shall mean
the amounts * * *.
"Outlook" shall mean
Outlook Pharmaceuticals, Inc., an Ohio corporation.
“Outlook Know-How
Rights” shall mean, collectively, all trade secret and other know-how
rights relating to the Product which Outlook has an ownership or licensable
interest as of the Effective Date.
“Outlook Technology”
shall mean, collectively, (a) the ANDA; (b) Outlook Know-How Rights; and
(c) Trademark.
"Performance Payments"
shall have the meaning set forth in Section 5.2.2
below.
“Product” or “Products” shall mean
immediate release * * * Solution, 5 mg/5ml.
"Term" shall have the
meaning set forth in Section
11.1.
“Territory” shall be
the United States, its territories and possessions and the District of
Columbia.
"Trademark" shall mean
the trademark Liquadd™, serial
number 77252236 filed in the United States Patent and Trademark Office on August
10, 2007 by Outlook.
2 REPRESENTATIONS
AND WARRANTIES
2.1 Both
Parties. Each party represents and warrants to the other party
as follows:
2.1.1 Organization. Such
party is duly organized, validly existing and in good standing under the laws of
the jurisdiction in which it is organized.
2.1.2 Authorization and
Enforcement of Obligations. Such party (a) has the
requisite power and authority and the legal right to enter into this Agreement
and to perform its obligations hereunder; and (b) has taken all requisite
action on its part to authorize the execution and delivery of this Agreement and
the performance of its obligations hereunder. This Agreement has been
duly executed and delivered on behalf of such party, and constitutes a legal,
valid, binding obligation, enforceable against such party in accordance with its
terms.
2.1.3 Consents. All
necessary consents, approvals and authorizations of all governmental authorities
and other persons or entities required to be obtained by such party in
connection with this Agreement have been obtained.
2.1.4 No
Conflict. The execution and delivery of this Agreement and the
performance of such party’s obligations hereunder (a) do not conflict with
or violate any requirement of applicable Laws, regulations or orders of
governmental bodies; and (b) do not conflict with, or constitute a default
under, any contractual obligation of such party.
2.2 Outlook Additional
Representations and Warranties. Outlook hereby represents and
warrants to Auriga that:
2.2.1 Intellectual Property
Matters.
(a) Other
than pursuant to this Agreement, Outlook has not assigned, licensed,
sublicensed, granted any interest in or options to, nor has Outlook otherwise
entered into any existing agreement with respect to, the ANDA for use in the
Territory and shall not do so prior to the expiration or termination of this
Agreement.
(b) As of the
Effective Date, to Outlook's knowledge, the use of the ANDA in accordance with
the terms of this Agreement does not infringe the intellectual property rights
of any third party and does not constitute a misappropriation of the trade
secrets or other intellectual property rights of any third party in the
Territory.
(c) As of the
Effective Date, to Outlook's knowledge, no third party has interfered with,
infringed upon or misappropriated the ANDA.
(d) As of the
Effective Date, Outlook has not been served with notice of any interference
action, opposition, or litigation with respect to the ANDA nor has Outlook
received any written communication which expressly threatens any interference
action, opposition, litigation, requests that Outlook obtain a license from any
third party or otherwise threatens or contemplates litigation with respect to
the ANDA, whether before any patent and trademark office, court, or any other
governmental authority. To Outlook's knowledge, as of the
Effective Date: (i) no such action or litigation has been threatened,
and (ii) no event has occurred or circumstance exists that may give rise to or
serve as a basis for the commencement of any such action or
litigation.
2.2.2 Regulatory
Matters.
(a) Outlook
has not received any warning letters or written correspondence from the FDA
and/or any other governmental authority requiring the termination, suspension or
modification of any clinical or pre-clinical studies or tests with respect to
the Product.
(b) As of the
Effective Date, there are no actual or, to the knowledge of Outlook, threatened
enforcement actions relating to the Product by the FDA or any other governmental
authority which has jurisdiction over Outlook's or any applicable third-party
manufacturer’s operations or products, including, without limitation, any fines,
injunctions, civil or criminal penalties, investigations, debarments or
suspensions.
2.2.3 Compliance with
Laws. To Outlook's knowledge, as of the Effective Date,
Outlook is in compliance in all material respects with all Laws that are
applicable to the ownership, operation or use of any of the Product or Outlook
Technology. To the knowledge of Outlook, there are no events,
conditions, circumstances, activities, practices, incidents or actions of
Outlook relating to the Outlook Technology that would interfere with or
prevent compliance with or give rise to any liabilities or investigative,
corrective or remedial obligations with respect to the Outlook Technology under
applicable Laws.
2.3 Disclaimer of
Warranties. EXCEPT AS EXPRESSLY SET FORTH IN THIS SECTION 2, OUTLOOK
MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE
OUTLOOK TECHNOLOGY, INCLUDING WITHOUT LIMITATION, ANY REPRESENTATION OR WARRANTY
REGARDING VALIDITY, ENFORCEABILITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE OR NONINFRINGEMENT. EXCEPT AS EXPRESSLY SET FORTH IN THIS
SECTION 2, ALL
RIGHTS IN THE OUTLOOK TECHNOLOGY PROVIDED TO AURIGA HEREUNDER ARE PROVIDED “AS
IS.”
3 LICENSE
GRANT AND SUBLICENSING
3.1 Outlook
Technology. Outlook hereby grants to Auriga an exclusive (even
as against Outlook), sublicensable (as set forth in Section 3.2), license
under the Outlook Technology to Exploit the Products in the Territory (the
"License").
3.2 Sublicenses. Subject
to obtaining the prior written consent from Outlook Auriga shall have the right
to grant sublicenses under any portion or all of the license set forth in Section 3.1 to one or
more Affiliates and/or third parties. A copy of each sublicense shall
be delivered to Outlook within thirty (30) days after signing the
sublicense. Each sublicense shall be subject to the applicable terms
and conditions of this Agreement. No such sublicense shall grant any
right to grant further sublicenses.
4 DILIGENCE
EFFORTS.
4.1 Order, Launch Date and
Efforts.
4.1.1 Order and Launch
Date. Within five (5) Business Days after the Product receives
FDA Approval, Auriga shall place a purchase order on Mikart, Inc. for a
commercial supply of the Product and shall promptly provide Outlook with a copy
of such purchase order. Auriga shall make the First Commercial Sale
of the Product no later than thirty (30) days after the delivery of the Product
to Auriga, or its designee, pursuant to such purchase order.
4.1.2 Diligence
Efforts. Auriga shall use Commercially Reasonable Efforts
(defined below) to maximize sales of the Products in the
Territory. The term “Commercially Reasonable
Efforts” shall mean that level of effort and resources as Auriga applies
to its other first priority products.
4.1.3 Abandonment. If
at any time Auriga abandons or suspends its manufacture, marketing or intent to
market the Products for a period exceeding forty-five (45) days, Auriga shall
immediately notify Outlook, giving reasons therefore and a statement of its
actions.
4.2 Safety Monitoring and
Notice, Promotion, Sales Reports.
4.2.1 Safety Monitoring and
Notice.
(a) Auriga
shall comply with all Laws applicable to the testing, manufacture,
transportation, packaging, labeling, promotion, distribution, sales and use of
the Products. Without limiting the foregoing, Auriga shall be solely
responsible for assuring compliance with the Act and regulations applicable to
this Agreement and Auriga's activities hereunder, including but not limited to
safety monitoring and adverse event reporting.
(b) Auriga
shall promptly notify Outlook of its knowledge of any fact, circumstance,
condition or knowledge that bears on (i) the safety or efficacy of the Products,
or (ii) any report of an adverse event associated with the
Product. Auriga and Outlook may use and disclose such information to
the extent necessary to comply with the Law. Auriga shall have sole
responsibility in taking all actions which may be required or commercially
reasonable in connection with any such fact, circumstance, condition or
knowledge.
4.2.2 Promotion. Auriga
shall develop, review and in all other respects be responsible for all
promotional materials related to the Product. Auriga represents and
agrees only to promote the Product within and in accordance with the FDA
approved labeling and this Agreement.
4.2.3 Sales
Reports. Within sixty (60) days following the end of each
calendar quarter during the Term, Auriga shall prepare and deliver to Outlook a
written report which shall (a) describe, in reasonable detail,
Auriga’s efforts to promote and sell Products during such quarter, and (b)
disclose the results thereof achieved during such quarter. The report
and contents of any such report shall be owned exclusively by Auriga and Outlook
shall treat the report and its contents as Confidential Information of Auriga
consistent with Section 9 of this
Agreement.
5 PAYMENTS
5.1 Auriga Common Stock or
Cash.
5.1.1 Delivery. *
* *.
5.1.2 Payment Amount and
Time.
* * *
*
5.1.3 Value. * *
*
5.1.4 Anti-Dilution and Tag Along
Rights.
* *
*
5.2 Performance
Payments.
* *
*
5.3 Performance Payments
Reports.
5.3.1 * *
*.
5.3.2 * *
*.
5.3.3 * *
*.
5.3.4 * *
*.
5.3.5 * *
*.
5.4 Audits.
5.4.1 Upon the
written request of Outlook and not more than once in each calendar year, Auriga
shall permit an independent certified public accounting firm of nationally
recognized standing, selected by Outlook and reasonably acceptable to Auriga, at
Outlook’s expense, to have access during normal business hours to such of the
records of Auriga as may be reasonably necessary to verify the accuracy of the
Performance Payment reports hereunder for any year ending not more than
thirty-six (36) months prior to the date of such request. The
accounting firm shall be required to sign a confidentiality agreement for the
benefit of, and in a form reasonably acceptable to, Auriga, and shall disclose
to Outlook and Auriga only whether the reports are correct or not and the
specific details concerning any discrepancies. No other information
shall be shared.
5.4.2 If such
accounting firm concludes that additional Performance Payments were owed during
the audited period, Auriga shall pay such additional Performance Payments within
thirty (30) days of the date Outlook delivers to Auriga such accounting firm’s
written report so concluding. If such accounting firm concludes that
Auriga has overpaid Performance Payments during the audited period, Auriga shall
have the right to credit the amount of the overpayment against each subsequent
quarterly payment due to Outlook until the overpayment has been fully applied
against future Performance Payments. If the overpayment is not fully
applied prior to the final quarterly payment of Performance Payments due
hereunder, Outlook shall promptly refund to Auriga an amount equal to any such
remaining overpayment. The fees charged by such accounting firm shall
be paid by Outlook; provided, however, if the audit
discloses that the Performance Payments payable by Auriga for such period are
more than one hundred ten percent (110%) of the Performance Payments actually
paid for such period, then Auriga shall pay the reasonable fees and expenses
charged by such accounting firm.
5.4.3 * *
*.
5.5 Payment
Method. All cash payments by Auriga to Outlook hereunder shall
be in United States Dollars in immediately available funds and shall be made by
wire transfer from a United States bank located in the United States to such
bank account as designated from time to time by Outlook to
Auriga.
6 TRANSFER
OF SPONSORSHIP AND MANAGEMENT OF ANDA
6.1 Transfer of
Sponsorship. Outlook shall within eight (8) business days
after the date of FDA Approval send written notice to the FDA transferring the
sponsorship of the ANDA to Auriga and Auriga shall at the same time send written
notice to the FDA assuming all obligations thereunder, and such notices shall
have an effective date that is approximately thirty (30) days after the date of
FDA Approval. The parties shall coordinate with one another and shall
send such notices simultaneously, and each party shall deliver a copy of its FDA
notice to the other party.
6.2 FDA Communications and
Management of ANDA. Prior to FDA Approval, Outlook shall
communicate with the FDA and undertake all actions that it deems necessary, in
its sole discretion, with respect to the ANDA. Outlook shall send
copies of all correspondence it receives from the FDA, prior to the transfer of
sponsorship described in Section 6.1 above, to
Auriga.
7 TRADEMARKS
7.1 Auriga
agrees to use the Trademark only in connection with the Product in compliance
with the standards, specifications, directions, information and know-how
supplied and approved by Outlook.
7.2 Auriga
agrees to comply with any requirements established by Outlook concerning the
style, design, display and use of the Trademark; to correctly use the
appropriate trademark symbol with every use of the xxxx; and to submit in
advance to Outlook for approval a copy of its use on all advertising, labels,
stickers or packaging, which shall not be unreasonably withheld.
7.3 Auriga
agrees to submit to Outlook from time to time and to permit Outlook or its duly
authorized representative the right to inspect the Products. When
requested, Auriga agrees to send samples of advertising and promotional
materials, as well as goods and promotional and advertising materials bearing or
sold under the Trademark and any other documents which may permit Outlook to
determine whether the goods and services and trademark uses meet the standards,
specifications and directions approved by Outlook.
7.4 Auriga
agrees that ownership of the Trademark and the goodwill relating thereto shall
remain vested in Outlook both during the period of this Agreement and
thereafter. Auriga agrees to inform Outlook of the use of any marks
similar to the Trademark and any potential infringements of the Trademark which
come to its attention.
8 AUTHORIZED
GENERIC
8.1 * *
*.
9 CONFIDENTIALITY
9.1 Confidentiality. During
the Term and for a period of seven (7) years following the expiration or earlier
termination hereof, each party shall maintain in confidence the Confidential
Information of the other party, shall not use or grant the use of the
Confidential Information of the other party except as expressly permitted
hereby, and shall not disclose the Confidential Information of the other party
except on a need-to-know basis to such party’s directors, officers, employees,
consultants, Affiliates and permitted sublicensees hereunder, to the extent such
disclosure is reasonably necessary in connection with such party’s activities as
expressly authorized by this Agreement. To the extent that disclosure
to any person is authorized by this Agreement, prior to disclosure, a party
shall obtain written agreement of such person to hold in confidence and not
disclose, use or grant the use of the Confidential Information of the other
party except as expressly permitted under this Agreement. Each party
shall notify the other party promptly upon discovery of any unauthorized use or
disclosure of the other party’s Confidential Information.
9.2 Terms of
Agreement. Neither party shall disclose any terms or
conditions of this Agreement to any third party without the prior consent of the
other party; provided, however, that a party
may disclose the terms or conditions of this Agreement, (a) on a
need-to-know basis to its legal and financial advisors to the extent such
disclosure is reasonably necessary, and (b) to a third party in connection
with (i) an equity investment in, or lending arrangement with, such party,
(ii) a sublicense, collaboration, co-promotion, strategic partnership,
merger, consolidation or similar transaction by such party, or (iii) the
sale of all or substantially all of the assets of such
party.
9.3 Permitted
Disclosures. The confidentiality obligations under this Section 9 shall not
apply to the extent that a party is required to disclose information by Law;
provided, however, that such
disclosing party shall provide written notice thereof to the other party,
consult with the other party with respect to such disclosure, provide the other
party sufficient opportunity to object to any such disclosure or to request
confidential treatment thereof, and to the extent of any objection, make only
the minimum disclosure of information required by Law.
9.4 Publicity. If
either party wishes to make a public disclosure concerning this Agreement or the
relationship established hereunder, such party shall provide the other party in
advance with a copy of such proposed disclosure and the other party shall have
three (3) business days within which to approve or disapprove the content of the
proposed disclosure. Neither party shall unreasonably withhold
approval of such disclosure. Failure to respond within such three (3)
business day period shall constitute approval.
10 INDEMNIFICATION
10.1 Indemnification by
Auriga. Except to the extent that Outlook is obligated to
indemnify Auriga under Section 10.2
below, Auriga shall indemnify and hold harmless Outlook, and its directors,
officers, employees and agents, from and against all losses, liabilities,
damages and expenses, including reasonable attorneys’ fees and costs, arising
from any claims, demands, actions or other proceedings by any third party
arising from (a) the breach of any representation, warranty or covenant by
Auriga under this Agreement; (b) the use of the
Outlook Technology by or on behalf Auriga; or (c) the
Exploitation, handling or storage of Products by Auriga, its sublicensees or
their respective Affiliates (excluding Outlook), customers or end-users provided, however, that such
indemnification right shall not apply to any losses, liabilities, damages or
expenses to the extent directly attributable to the negligence, reckless
misconduct, or intentional misconduct of a party seeking indemnification under
this Section 10.1.
10.2 Indemnification by
Outlook. Outlook
shall indemnify and hold harmless Auriga, and its directors, officers, employees
and agents, from and against all losses, liabilities, damages and expenses,
including reasonable attorneys’ fees and costs, arising from any claims,
demands, actions or other proceedings by any third party arising from the breach
of any representation, warranty or covenant by Outlook under this
Agreement;
provided, however, that such
indemnification right shall not apply to any losses, liabilities, damages or
expenses to the extent directly attributable to the negligence, reckless
misconduct, or intentional misconduct of a party seeking indemnification under
this Section 10.2.
10.3 Procedure. A
party that intends to claim indemnification under this Section 10.3
(the “Indemnitee”) shall
promptly notify the other party (the “Indemnitor”) in
writing of any claim, demand, action or other proceeding for which the
Indemnitee intends to claim indemnification; provided, however, that the
failure to provide written notice of such claim within a reasonable period of
time will not relieve the Indemnitor of any of its obligation hereunder, except
to the extent that the Indemnitor is prejudiced by such failure to provide
prompt notice. The Indemnitor shall have the right to participate in,
and to the extent the Indemnitor so desires to assume the defense thereof with
counsel selected by the Indemnitor; provided, however, that the
Indemnitee, shall have the right to retain its own counsel, with the fees and
expenses to be paid by the Indemnitee, if representation of the Indemnitee by
the counsel retained by the Indemnitor would be inappropriate due to actual or
potential differing interests between the Indemnitee and any other party
represented by such counsel in such proceedings. The Indemnitor may
not settle or otherwise consent to an adverse judgment in any such claim,
demand, action or other proceeding, that diminishes the rights or interests of
the Indemnitee without the prior express written consent of the Indemnitee,
which consent shall not be unreasonably withheld or delayed, unless (a) there is
no finding or admission of any violation of Law or any violation of the rights
of any person and no effect on any other claims that may be made against the
Indemnitee and (b) the sole relief provided is monetary damages that are paid in
full by the Indemnitor.
10.4 Insurance. Auriga
shall maintain insurance with respect to its activities under this Agreement as
is normal and customary in the pharmaceutical industry generally for parties
similarly situated. Auriga shall, upon request of Outlook, provide
the requesting party with a copy of the foregoing policies of insurance, along
with any amendments and revisions thereto. Outlook shall be named as
an additional insured on any such policies maintained hereunder by
Auriga. If there is any additional costs for adding Outlook as an
additional insured, Auriga shall pay such additional costs.
11 TERM;
TERMINATION
11.1 Term. This
Agreement shall commence on the Effective Date and be perpetual unless
terminated pursuant to this Section 11; provided,
however, the license to the Trademark shall terminate and all rights to the
Trademark shall revert to Outlook if Auriga ceases to use the Trademark in any
material manner in connection with the Product or fails to use the Trademark in
the marketing associated with the First Commercial Sale of the Product
("Term").
11.2 Termination for
Breach.
11.2.1 If Auriga
has breached any of its obligations to pay any of the payments to which Outlook
is entitled under this Agreement, and such breach continues for thirty (30) days
after written notice of such breach was provided to Auriga by Outlook, Outlook
shall have the right at its option to terminate this Agreement effective at the
end of such thirty (30) day period.
11.2.2 If a
party has materially breached any of its obligations hereunder, and such
material breach continues for sixty (60) days after written notice of such
breach was provided to the breaching party by the nonbreaching party, the
nonbreaching party shall have the right at its option to terminate this
Agreement effective at the end of such sixty (60) day period.
11.3 Termination
for Bankruptcy.
11.3.1 Either
party may terminate this Agreement upon the occurrence of one or more of the
following:
(a) immediately
upon written notice to the other party in the event such other party becomes
insolvent or initiates a voluntary proceeding under the U.S. Bankruptcy Code
(beginning at 11 U.S.C. 101, as amended) (the “Bankruptcy Code”);
or
(b) immediately
upon written notice to the other party in the event such other party becomes the
subject of an involuntary proceeding under the U.S. Bankruptcy Code and such
proceeding is not dismissed or stayed within ninety (90) days of its
commencement.
11.4 Termination by
Auriga. * * *.
11.5 Termination by
Outlook. * * *.
11.6 Effect of Expiration or
Termination.
11.6.1 Expiration
or termination of this Agreement shall be without prejudice to any rights which
shall have accrued to the benefit of a party prior to such expiration or
termination. Without limiting the foregoing, Articles 1, 9, 10, 11
and 12 and Sections 2.3, 4.2.3, 5.1.4, 5.2, 5.3 and 5.4 of this Agreement shall
survive any expiration or termination of this Agreement.
11.6.2 Promptly
upon the expiration or earlier termination of this Agreement: (a) Auriga
shall destroy or return (at Outlook's expense) to Outlook (as Outlook shall
direct) all Outlook Technology and any data or information related to the
Product; (b) Auriga shall grant Outlook a perpetual exclusive royalty free
license in the Territory to use all tradenames and trademarks under which the
Product is being marketed or has been marketed and (c) Auriga shall promptly
send written notice to the FDA transferring the sponsorship of the ANDA to
Outlook and Outlook shall at the same time send written notice to the FDA
assuming all obligations thereunder, and such notices shall have an effective
date that is approximately thirty (30) days after the date of expiration or
termination of this Agreement. The parties shall coordinate with one
another and shall send such notices simultaneously, and each party shall deliver
a copy of its FDA notice to the other party.
12 GENERAL
PROVISIONS
12.1 Governing
Law. This Agreement shall be governed by, interpreted and
construed in accordance with the laws of the State of Ohio, without regard to
the conflicts of law principles thereof.
12.2 Arbitration. Any
dispute, controversy or claim initiated by either party arising out of,
resulting from or relating to this Agreement, or the performance by either party
of any obligation under this Agreement, whether before or after termination of
this Agreement, shall be finally resolved by binding
arbitration. Whenever a party shall decide to institute
arbitration proceedings, it shall give written notice to that effect to the
other party. Any such arbitration shall be conducted under the
Commercial Arbitration Rules of the American Arbitration Association by a panel
of three arbitrators appointed in accordance with such rules. Any
such arbitration shall be held in Chicago, Illinois. The method and
manner of discovery in any such arbitration proceeding shall be governed by the
Commercial Arbitration Rules of the American Arbitration
Association. Each party shall choose one (1) arbitrator within thirty
(30) days after receipt of notice of the intent to
arbitrate. Such arbitrators shall thereafter choose a third
arbitrator within thirty (30) days of their appointment. If one
or both of the parties fails to make a timely appointment of its arbitrator,
then such missing arbitrator(s) will be appointed by the American Arbitration
Association. The arbitrators shall have the authority to grant
specific performance and to allocate between the parties the costs of
arbitration in such equitable manner as they determine. The
arbitrators shall make their award and decision by majority approval, which
shall be made in accordance with the terms of this Agreement and applicable
law. Judgment upon the award so rendered may be entered in any court
having jurisdiction or application may be made to such court for judicial
acceptance of any award and an order of enforcement, as the case may
be. In no event shall a demand for arbitration be made after the date
when institution of a legal or equitable proceeding based upon such claim,
dispute or other matter in question would be barred by the applicable statute of
limitations. Notwithstanding the foregoing, either party shall have
the right, without waiving any right or remedy available to such party under
this Agreement or otherwise, to seek and obtain from any court of competent
jurisdiction any interim or provisional relief that is necessary or desirable to
protect the rights or property of such party, pending the selection of the
arbitrators hereunder or pending the arbitrators’ determination of any dispute,
controversy or claim hereunder. Each of the parties agrees that if
certain material obligations under this Agreement are not performed in
accordance with their specific terms or are otherwise breached, (a) severe and
irreparable damage would occur, (b) no adequate remedy at law would exist and
(c) damages would be difficult to determine. Each of the parties
agrees that, in such case, the injured party or parties shall be authorized and
entitled to obtain from any court of competent jurisdiction injunctive relief,
whether preliminary or permanent, as well as any other relief permitted by
applicable law, and the breaching party shall waive any requirement that such
party or parties post bond as a condition for obtaining any such
relief.
12.3 Waiver. No
waiver by a party hereto of any breach or default of any of the covenants or
agreements herein set forth shall be deemed a waiver as to any subsequent and/or
similar breach or default. The failure by either party to take any
action or assert any right hereunder shall in no way be construed to be a waiver
of such right, nor in any way be deemed to affect the validity of this Agreement
or any part hereof, or the right of a party to thereafter enforce each and every
provision of this Agreement
12.4 Rights Under U.S. Bankruptcy
Code. All rights and licenses granted under or pursuant to
this Agreement by Outlook are, and shall otherwise be deemed to be, for purposes
of Section 365(n) of the Bankruptcy Code, licenses to intellectual property as
defined under Section 101 of the Bankruptcy Code. Outlook agrees that
Auriga shall retain and may fully exercise its rights and elections under the
Bankruptcy Code.
12.5 Assignment. Neither
this Agreement nor any right or obligation hereunder may be assigned or
delegated, in whole or part, by either party without the prior express written
consent of the other. Any permitted assignee shall assume all
obligations of its assignor under this Agreement. Any purported
assignment in violation of this Section 12.5
shall be void.
12.6 Further
Actions. Each party agrees to execute, acknowledge and deliver
such further documents and instruments and to perform all such other acts as may
be necessary or appropriate in order to carry out the purposes and intent of
this Agreement.
12.7 Notices. All
requests and notices required or permitted to be given to the parties hereto
shall be given in writing, shall expressly reference the section(s) of this
Agreement to which they pertain, and shall be delivered to the other party,
effective on receipt, at the appropriate address as set forth below or to such
other addresses as may be designated in writing by the parties from time to time
during the term of this Agreement.
If to
Outlook:
Outlook
Pharmaceuticals, Inc.
Attn:
Xxxxxx Xxxxxxxxx
000
Xxxxxxxx Xxx.
Xxxxxxxxxx,
Xxxx 00000
with a
copy to:
Xxxxxxxx
& Shohl LLP
Attn: Xxxx
X. Xxxxxxxxx, Esq.
000 Xxxx
Xxxxx Xxxxxx, Xxxxx 0000
Xxxxxxxxxx,
Xxxx 00000
If to
Auriga:
Attn: Xxxxxx
X. Xxxxx
00000
Xxxxx Xxxxxx Xxxx., Xxxxx 000
Xxx
Xxxxxxx, Xxxxxxxxxx 00000
12.8 No Implied
Licenses. Only licenses and rights granted expressly herein
shall be of legal force and effect. No license or other right shall
be created hereunder by implication, estoppel or otherwise.
12.9 Force
Majeure. Nonperformance of a party (other than for the payment
of money) shall be excused to the extent that performance is rendered impossible
by strike, fire, earthquake, flood, governmental acts or orders or restrictions,
failure of suppliers, or any other reason where failure to perform is beyond the
reasonable control and not caused by the negligence, intentional conduct or
misconduct of the nonperforming party; provided, however, that the
nonperforming party shall use commercially reasonable efforts to resume
performance as soon as reasonably practicable.
12.10 No Consequential
Damages. IN NO EVENT SHALL A PARTY BE LIABLE FOR SPECIAL,
INCIDENTAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES ARISING OUT OF THIS AGREEMENT OR
THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING WITHOUT LIMITATION LOST PROFITS
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY
NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 12.10 IS
INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF
EITHER PARTY UNDER SECTION 10
ABOVE.
12.11 Complete
Agreement. This Agreement constitutes the entire agreement
between the parties regarding the subject matter hereof, and all prior
representations, understandings and agreements regarding the subject matter
hereof, either written or oral, expressed or implied, are superseded and shall
be and of no effect.
12.12 Counterparts. This
Agreement may be executed in counterparts, each of which shall be deemed to be
an original and together shall be deemed to be one and the same
agreement.
12.13 Headings. The
captions to the several sections hereof are not a part of this Agreement, but
are included merely for convenience of reference only and shall not affect its
meaning or interpretation.
IN
WITNESS WHEREOF, the parties have caused this Agreement to be executed by their
respective duly authorized officers as of the day and year first above
written.
OUTLOOK
PHARMACEUTICALS, INC.
By:
Its:
Print
Title:
By:
Its:
Print
Title:
For the
purposes of Section 5.1.4(b) only:
CONTROLLING
STOCKHOLDERS:
___________________________________________
Xxxxxx X.
Xxxxx
EXHIBIT
A
CONTROLLING
STOCKHOLDERS
Xxxxxx X.
Xxxxx
