Exhibit 10.25


 


Confidential Materials omitted and filed separately with the


Securities and Exchange Commission. Asterisks denote omissions.


 


DISTRIBUTION AGREEMENT


 


THIS DISTRIBUTION AGREEMENT (this “Agreement”),
effective as of the          day of
                    
20     (the “Effective Date”), is made by and between INO
THERAPEUTICS LLC, a Delaware limited liability corporation having its principal
place of business at 6 Route 173, Clinton, New Jersey, 08809, U.S.A.
(hereinafter called “INO-T”), and                                         ,
a                     
corporation having its offices at
                                                    
(hereafter called “AGA”).  INO-T and AGA
are sometimes referred to herein individually as a “Party” and collectively as
the “Parties”.


 


WHEREAS INO-T desires to
appoint AGA to market the Product (as hereinafter defined) in the Territory (as
hereinafter defined) during the Term (as hereinafter defined), in accordance
with the terms of this Agreement; and


 


WHEREAS AGA possesses the
facilities and ability to support and perform as official distributor and
market holder for INO-T and the Product in the Territory, and wishes to accept
the appointment in accordance with the terms of this Agreement.


 


NOW, THEREFORE, in
consideration of the mutual agreements, covenants and conditions herein
contained, the Parties have agreed as follows:


 


I.  DEFINITIONS


 


In addition to any other
definitions appearing in this Agreement, the following terms shall have the
following meanings and any term referred to in the singular shall be deemed to
include the plural and vice versa as the context requires:


 


1.1                                 The term “Affiliate”
shall mean any individual or entity directly or indirectly controlling,
controlled by or under common control with a Party to this Agreement.  For purposes of this Agreement, the direct or
indirect ownership of fifty percent (50%) or more of the outstanding voting
securities of an entity or the right to receive fifty percent (50%) or more of
the profits or earnings of an entity shall be deemed to constitute
control.  Such other relationship as in
fact results in actual control over the management, business and affairs of an
entity shall be deemed to constitute control.


 


1.2                                 The term “Adverse
Event” shall have the meaning set forth on Exhibit I.


 


1.3                                 The term “Confidential
Information” shall have the meaning set forth in Article XII.


 


1.4                                 The term “Current
Good Manufacturing Practice” or “cGMP” shall mean current good manufacturing
practices for the methods to be used in, and the facilities and controls to be
used for, the manufacturing, processing, packing and holding of drugs, all as
set forth from time to time by the relevant Regulatory Authorities in the
Territory.  With respect to the United
States, cGMPs shall include those regulations set forth in 21 CFR 210-21,
including all amendments and supplements, or successor regulations, throughout
the Term of this Agreement.


 

















 


1.5                                 The term “Distribution
Approvals” shall mean the licenses, authorizations and/or approvals that are
required of a distributor of pharmaceutical products, including any that are
specific to the Product, in the Territory by any national, supra-national
(e.g., the European Commission or the Council of the European Union), regional,
state, provincial or local Regulatory Authority in the Territory for the
import, handling, storage, distribution, or sale, as amended or supplemented
from time to time.


 


1.6                                 The term “Effective
Date” shall mean the date first above written.


 


1.7                                 The term “FDA”
shall mean the United States Food and Drug Administration and any analogous
Regulatory Authority in the Territory or any successor entity thereto.


 


1.8                                 The term “FDCA”
shall mean the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§301-397, as
amended.


 


1.9                                 The term “Gross
Sales Price” shall mean for any bona fide sale of Product by AGA to a bona fide
customer by AGA, the actual invoice price of the Product to AGA’s customers
without any deductions.


 


1.10                           The term “Health
Registrations” shall mean the technical, medical and scientific licenses,
registrations, authorizations and/or approvals of a pharmaceutical product
(including the prerequisite manufacturing approvals or authorizations, and
marketing authorization based upon such approvals and labeling approvals
related thereto) that are required by any national, supra-national (e.g., the
European Commission or the Council of the European Union), regional, state,
provincial or local Regulatory Authority in the Territory, for the manufacture,
distribution, use or sale of a pharmaceutical product in the Territory, as
amended or supplemented from time to time.  
For the avoidance of doubt, Health Registrations includes Pricing
Approvals.


 


1.11                           The term “INO-T
Regulatory Department” shall mean INO-T’s Vice President, Global Regulatory
Affairs, located at the address set forth in the first paragraph of this
Agreement, or his or her designee.


 


1.12                           The term “INO-T
Trademarks” shall mean trademarks set forth on Schedule
1.12, including, without limitation, all trade dress or logos
associated with or included in such trademarks.


 


1.13                           The term “Launch
Date” shall mean the date Health Registrations are granted by Regulatory
Authorities for the Product in the Territory.


 


1.14                           The term “Laws”
shall mean all applicable federal, state, provincial, local or foreign statute
or law and shall be deemed also to refer to all rules and regulations
promulgated by any Regulatory Authorities in the Territory, unless context
requires otherwise.  Any reference to a
particular law or regulation will be interpreted to include any revision of or
successor to such statute, law, rule or regulation regardless of how it is
numbered or classified.


 


1.15                           The term “Net
Sales Price” shall mean:


 

















 


(a)                                  for any bona
fide sale to a bona fide customer by AGA, the actual invoice price of the
Product to AGA’s customers less the following amounts actually paid or
credited:


 


(i)                                     Customary or
usual trade or quantity discounts or other charge-backs actually taken by the
customer,


 


(ii)                                  Sales, use,
value-added or other excise taxes, imposed and paid directly with respect to
the sale, and included in the invoice price, and listed separately on the
invoice,


 


(iii)                               Customary
administration fees paid to group purchasing organizations or other entities
that represent hospital or health facility groups in the Territory; provided,
however, that all such fees are in compliance with all Laws in the Territory;


 


(iv)                              Customer
returns, recalls, credits or allowances, if any, actually given or made.


 


(b)                                 In the event
that AGA sells any Product in a bona fide sale as a component of a combination
of active functional agents, in accordance with the terms of this Agreement,
including Section 8.3, the Net Sales Price of the combination shall be
determined by multiplying the full net sales price of the combination, adjusted
to a one-to-one dosage relation of active agents and not including diluents,
propellants, stabilizers of other such substances, by the fraction A over A+B,
in which “A” is the standard fully-absorbed cost of the Product portion of such
combination, and “B” is the sum of the standard fully-absorbed costs of the
other active functional agent component(s), such costs being arrived at using
the standard accounting procedures of AGA which will be in accord with
generally accepted accounting practices, provided that in no event shall the
resulting fraction be less than one half (1/2).


 


(c)                                  If AGA
commercially uses or disposes of any Product other than in a bona fide sale to
a bona fide customer, the Net Sales Price shall be the price which would be
then payable in an arm’s length transaction, except in the case of (i) use
in product testing or control, (ii) promotional distribution to
physicians, or (iii) use for obtaining regulatory approvals.


 


(d)                                 Transfer of
Product to an Affiliate for sale by the transferee shall not be considered a
sale, commercial use of disposition for the purpose of the foregoing
paragraphs; in the case of such transfer, the Net Sales Price shall be based on
sale price of the Product by the transferee.


 


1.16                           The term “Pricing
Approvals” shall mean the pricing and third party reimbursement approvals that
are required by any national, supra-national (e.g., the European Commission or
the Council of the European Union), regional, state, provincial or local Regulatory
Authority in the Territory, for the distribution, use or sale of a
pharmaceutical product in the Territory, as amended or supplemented from time
to time.


 


1.17                           The term “Product”
shall mean, an 88-liter or a D cylinder filled with nitric oxide (NO) 800 ppm
mol/mol, inhalation gas filled at 155 bar which may contain an “INOmeter”, a 


 

















 


time-meter fitted on to the valve of each
cylinder, marketed in the United States as INOmaxTM, and to be marketed by AGA
utilizing the INO-T Trademark(s) set forth on Schedule 1.12.


 


1.18                           The term “Product
Quality Complaints” shall have the meaning set forth in Exhibit II.


 


1.19                           The term “Regulatory
Authority” shall mean the applicable government regulatory authority in the
Territory involved in granting the Health Registrations for the Product.


 


1.20                           The term “Term”
shall have the meaning set forth in Article II.


 


1.21                           The term “Territory”
shall mean the
                ,
including its territories, possessions and commonwealths.


 


II.  TERM


 


2.1                                 Term.  Subject to the provisions of Article XIII,
the term of this Agreement shall commence on the Effective Date and end on that
date that is five (5) years following the Launch Date (the “Term”).


 


III.  DISTRIBUTORSHIP AND OTHER
RIGHTS


 


3.1                                 Product
Distributorship Rights.


 


(a)                                  AGA shall promptly,
following its execution of this Agreement, use commercially reasonable efforts
to apply for and obtain Distribution Approvals and Pricing Approvals for the
Product in the Territory.


 


(b)                                 Subject to the provisions of
Article XIII, INO-T hereby grants to AGA an exclusive right during the
Term to market, promote, sell and distribute the Product in the Territory.


 


(c)                                  During the Term, AGA shall
use commercially reasonable efforts to market, promote, sell and distribute the
Product in accordance and compliance with all terms of this Agreement.


 


(d)                                 AGA acknowledges and
respects the exclusive rights of INO-T to sell the Product outside of the
Territory, and AGA shall not take orders for Product from customers outside of
the Territory.


 


(e)                                  AGA shall without delay
forward all inquiries and orders for Products from customers outside the
Territory to INO-T. AGA is not entitled to commission or any other compensation
for any orders resulting directly or indirectly from such inquiries.


 


(f)                                    INO-T hereby grants to AGA a
non-exclusive right in the Territory during the Term to utilize the INO-T
Trademarks, without any modification, 


 

















 


solely to promote the Product in the Territory. AGA and/or its
Affiliates shall neither use nor seek to register in connection with the
Product (i) any trademarks which are identical or confusingly similar to
any INO-T Trademarks, trade names, trade dress or logos used or (ii) any
trademarks other than the INO-T Trademarks. 
In the event that either AGA becomes aware of any infringement within
the Territory of any issued patent or trademark rights owned in whole or in
part by INO-T, it will notify INO-T in writing to that effect.  Any such notice shall include the specific
details known to AGA regarding the infringement.


 


IV.  CERTAIN ADDITIONAL INO-T
OBLIGATIONS


 


4.1                                 Training.  INO-T shall, at no cost to AGA, provide AGA
with initial training and materials relating to the Product, including
marketing and sales, customer training, customer service, as well as
pharmacovigilance, which information shall be updated, as required by Law, and
otherwise, at the discretion of INO-T, within a commercially reasonable time
following the update of such information and training that is provided by INO-T
to its United States personnel.  INO-T
will provide AGA with technical assistance, and other assistance as reasonably
requested by AGA.


 


4.2                                 Patent and
Trademark Infringement. 
INO-T shall be responsible for filing, prosecuting and maintaining any
patent or trademark rights owned in whole or in part by INO-T.  AGA shall, at no charge to INO-T, provide
INO-T with all documents and assistance reasonably requested by INO-T with
respect to the prosecution or defense of any such action.


 


V.  HEALTH REGISTRATION PROCESS;
COMMUNICATIONS WITH 

REGULATORY AUTHORITIES


 


5.1                                 (a)                                  Health
Registrations Holder and Ownership.  AGA shall make all applications to Regulatory
Authorities for the Health Registrations, as well as any amendment, supplement,
annual reports or necessary withdrawal of the Health Registrations, in a form
prepared and provided by AGA, and approved in writing by INO-T. AGA shall make
no changes to the Health Registrations without the written instruction or
consent of INO-T. The Health Registrations will include, among other things, INO-T’s
proprietary data. No ownership, license or other rights to any materials
contained in the application, amendment, supplement, annual reports or
necessary withdrawal, including, without limitation, the INO-T data, is
conveyed or transferred to AGA, and AGA shall have a right to use the
materials, including the INO-T data, solely for the purpose of making
application for and maintaining the Health Registrations.  AGA shall promptly file the materials
necessary for the Health Registrations, including, without limitation, changes
in labeling, with the appropriate Regulatory Authority, and provide INO-T with
prompt written notification regarding the status and approval of such
filings.  AGA shall cooperate with INO-T
in taking all necessary actions, executing all required documents to be filed
with Regulatory Authorities, and providing such other reasonable assistance as
INO-T may reasonably request, to obtain and maintain Health Registrations for
the Product in the Territory.


 

















 


(b)                                 Communications
with Regulatory Authorities.  Any communications received from Regulatory
Authorities at any time regarding the Product, including without limitation,
the Health Registrations, shall be promptly provided to INO-T Regulatory
Department.  If such communications from
Regulatory Authorities are not in writing, AGA shall communicate the substance
of the oral communication to the INO-T Regulatory Department.  Unless otherwise required by Law, AGA shall
not provide any information or materials to Regulatory Authorities without the
advice and written approval of the INO-T Regulatory Department.  In the event of any required disclosure by
AGA, AGA shall promptly notify the INO-T Regulatory Department.  Any decisions regarding communications
received from Regulatory Authorities shall be made by the INO-T Regulatory
Department.


 


(c)                                  Ownership and
Transfer of Health Registrations.  AGA shall apply for, hold and maintain the
Health Registrations in its own name, subject to the terms of this Agreement,
and shall not transfer, assign, pledge, or otherwise encumber or transfer the
Health Registrations, in part or in full, in any manner, except as specifically
instructed in writing by the INO-T Regulatory Department.  Upon any notice to AGA from the INO-T
Regulatory Department to transfer the Health Registrations, AGA shall promptly
take all actions necessary to transfer the Health Registrations, and all other
rights in the Territory relating to the Product, to INO-T or the third party
designated by the INO-T Regulatory Department.


 


5.2                                 Regulatory
Approvals.  INO-T shall
be responsible, at its expense, for using reasonable commercial efforts to
provide the technical data and other materials necessary to obtain and maintain
Health Registrations for the Product in the Territory, and shall provide
reasonable assistance to AGA if requested by AGA; provided that nothing in this
Agreement shall be construed as a guarantee by INO-T that its efforts will
result in an approved Health Registrations for the Product.


 


5.3                                 Cost of Health
Registrations.  During the
Term, INO-T shall be responsible for the costs relating to the application for
Health Registrations, excluding Pricing Approvals. AGA shall be responsible, at
its expense, for all costs relating to Health Registrations for the Product in
the Territory necessary to (a) maintain, amend, supplement, or withdraw
Health Registrations, as well as annual or other required reports; (b) obtain
and maintain Pricing Approvals and (c) translate any application,
amendment, supplement, annual reports or necessary withdrawal of Health
Registrations.  Adverse Events. During
the Term and thereafter, AGA shall furnish INO-T in a timely manner with any
adverse reaction reports, in accordance with Article X, and all other
information as may be necessary to include in any periodic reports to
Regulatory Authorities.


 


5.4                                 Labeling.  INO-T shall be responsible for the content
and accuracy of all labels and labeling for the Product, and their compliance
with the requirements of the Product’s Health Registrations.


 


5.5                                 Compliance
Audits.  INO-T shall have the right,
during normal business hours and with reasonable advance notice, to visit any
of AGA’s facilities utilized or to be utilized in the distribution of the
Product in the Territory, with or without cause, to inspect for compliance 


 

















 


with requirements of Regulatory Authorities
and Laws including, without limitation, cGMP’s and storage of the Product.  AGA, including without limitation, AGA’s
quality assurance department shall cooperate with INO-T, as necessary and
useful, in any inspection conducted pursuant to this Agreement.


 


VI.  SUPPLY OF PRODUCTS


 


6.1                                 Supply.  AGA shall not be obligated to purchase any
minimum quantity of Product from INO-T and INO-T shall not be obligated to
manufacture or sell any minimum quantity of Product to AGA.


 


6.2                                 Forecasts.  AGA shall furnish INO-T on or before the
first day of each month during the Term with a rolling [**] month forecast of
AGA’s anticipated requirements for Product. 
The first [**] months of each such forecast shall represent a binding
commitment by AGA to purchase and pay for the Product specified therein.  The last [**] months of such forecasts
represent estimates and shall be non-binding. 
For the avoidance of doubt, each monthly forecast shall incorporate,
without modification, the binding commitments of prior forecasts.


 


6.3                                 Orders.  For the [**] month binding forecast period
provided in Section 6.2, AGA shall place binding purchase orders that
shall set forth the quantity of Product, proposed delivery dates and shipping
instructions for each shipment of Product. 
INO-T shall provide AGA with written confirmation of all purchase orders
within [**] days of receipt, which confirmation shall set forth the quantities
ordered by AGA and specify delivery dates for all such quantities.  AGA’s purchase orders shall provide for at
least [**] days lead time for delivery for Product.  INO-T shall not be obligated to supply
quantities of Product for a given [**] that exceed [**] percent ([**]%) of AGA’s
most recent forecast for such [**], provided, however, that INO-T shall use
reasonable efforts to supply such excess quantities to the extent practicable.


 


6.4                                 Manufacturing.  INO-T will use reasonable commercial efforts
to manufacture, test, label, package and release the Product in such quantities
as are necessary to fulfill orders placed by AGA in accordance to Sections 6.2
and 6.3 of this Agreement.  All Product
provided to AGA shall meet all Product specifications set forth in the Health
Registrations and be manufactured in compliance with all Laws, including,
without limitation, cGMPs.


 


6.5                                 Shipments.  All shipments to AGA shall be shipped CPT
(Incoterms 2000) Cartagena if by ship, and CPT (Incoterms 2000) Bogota if by
air, as designated by AGA at least [**] days prior to shipment.  In the event that AGA fails to designate any
shipment, the shipment shall be shipped CPT (Incoterms 2000) Cartagena.


 


VII.  FINANCIAL TERMS


 


7.1                                 Product Price.  Product shall be manufactured and supplied to
AGA by INO-T at a price of [**] per 88-liter cylinder of Product, and [**] per
D cylinder, which price may be increased by INO-T by no more than [**] percent
([**]%) once each calendar year by INO-T providing AGA with [**] day’s written
notice.  The purchase price shall be paid
in full within [**] days of date of invoice.


 

















 


7.2                                 Additional
Profit Split.  The Gross
Sales Price of Product, to the extent that the Gross Sales Price exceeds an
average invoice price of [**] per 88-liter cylinder or [**] per D cylinder,
respectively, shall be [**], unless otherwise agreed by the parties in
writing.  AGA shall pay such additional
monies to INO-T on or before the [**] day of each calendar month, on a monthly
basis.  There shall be no deduction,
credit or other adjustment to this profit split payment for any reason.


 


7.3                                 Royalty Payment.  In addition to the cost per cylinder
referenced in Section 7.1 above, and any profit split calculated as set
forth in Section 7.2, AGA shall, on or before the twentieth day of each
calendar month, on a monthly basis, pay to INO-T [**] percent ([**]%) of total
Net Sales of Product for the prior calendar month.


 


7.4                                 Sales and
Royalty Report.  On or
before the [**] day of each calendar month, on a monthly basis, AGA shall
provide to INO-T a report setting forth the following information:


 


(i)                                     Quantity of
Product sold by AGA and its Affiliates in the Territory;


 


(ii)                                  Total billings
for Product by AGA in the Territory;


 


(iii)                               Quantities of
Product used by AGA and its Affiliates in the Territory;


 


(iv)                              Total royalties
payable to INO Therapeutics;


 


(v)                                 Gross Sales
Price of Product, broken down by customer name and address, the number of
Product cylinders delivered to each customer, the number of Product cylinders
picked up at each customer, the number of Product cylinders remaining at each
customer, the therapeutic use of the Product for each patient to whom Product
was administered (without providing any information that identifies the name of
the patient) and such other information requested by INO-T from time to time;
and


 


(vi)                              Additional
information requested by INO Therapeutics from time to time, including, without
limitation, additional information required for INO-T to comply with its
obligations under its license agreements relating to the Product, such as,
without limitation, use of the Product with other pharmaceuticals and devices
utilized to deliver the Product.


 


7.5                                 Product Orders.  All orders for Product shall be submitted in
accordance with the forecasting procedures set forth in Section 6.2 in a
form reasonably acceptable to INO-T.  In
the event of any conflict or inconsistency between the terms of any such
purchase order and the terms of this Agreement, the terms of this Agreement
shall govern and control the rights and obligations of the Parties.


 


7.6                                 United Stated
Dollars.  All references to dollars
within this Agreement refer to United States currency.  AGA shall make all payments under this
Agreement to INO-T in United States Dollars by wire transfer, in accordance
with the instructions of INO-T.


 

















 


7.7                                 Confidentiality
of Financial Terms.  AGA shall
not disclose the information provided to INO-T under this Article VII, or
any financial terms of this Agreement under this Article VII, such
information being deemed Confidential Information of INO-T pursuant to Article XII,
without the express written consent of INO-T, unless required by Law, in which
event AGA shall comply with the requirements of Article XII.


 


7.8                                 Late Fees.  Any late payments shall bear interest at the
Prime of Citibank, New York Rate plus [**] percent ([**]%).


 


VIII.  DISTRIBUTION AND PROMOTION
OF PRODUCT; NON-COMPETE


 


8.1                                 Distribution.  AGA shall comply with all applicable Laws in
connection with its handling, storage, distribution, promotion and sale of the
Product, including, without limitation, the requirements set forth in the
Health Registrations.


 


8.2                                 Inventory.  AGA shall maintain an inventory of the
Product at its facility(ies), in accordance with all applicable Laws, including
without limitation, cGMP’s, and the requirements of the Health Registrations,
which is adequate to support the population of patients to be agreed upon, and
assure that inventory of Product is placed at the facility(ies) of its
customers to assure access to the Product by the patients of each respective
customer.


 


8.3                                 Promotion.  All promotion will be consistent with the
sales materials and training provided by INO-T pursuant to Section 4.1,
and AGA shall provide, and obtain INO-T’s written approval before using any
sales and training materials relating to the Product that were not provided by
INO-T.  Without limiting the foregoing,
AGA shall comply with INO-T’s policies regarding promotion of Products for
off-label use, which will be provided by INO-T to AGA, as modified from time to
time in writing upon notice by INO-T to AGA. In the event that AGA, in good
faith, believes any materials relating to the Product that are provided by
INO-T may violate Laws in the Territory, AGA shall promptly advise INO-T in
writing, including a written description of any concerns.  Without limiting the foregoing, AGA shall not
sell the Product as a component of a combination of active functional agents,
without the prior written consent of INO-T.


 


8.4                                 Non-Compete.  During the Term, and for three years
thereafter, AGA shall not, and shall assure that its Affiliates shall not, sell
any product in the Territory that competes with the Product.


 


8.5                                 Minimum Service
Requirements.  AGA
represents and covenants that it shall comply with, at minimum, the minimum
service standards required by INO-T, as amended from time to time by INO-T
providing [**] days written notice to AGA.


 


8.6                                 Nitric Oxide
Delivery.  AGA shall
not provide the Product to any hospital or other customer that does not have
the ability to provide safe administration of Nitric Oxide in accordance with
the labeling approved by Regulatory Authorities in the Territory, including,
without distribution limitation, delivery devices that comply with the
requirements set forth in the Health Registrations and labeling, or otherwise
required by Regulatory Authorities.


 














 


8.7           Return of Cylinders.  (a)  Each individual cylinder shall be
returned by AGA to INO-T within [**] months of the cylinders receipt by AGA. In
the event that AGA fails to return an individual cylinder within such time
frame, and INO-T incurs additional costs relating to the export and return of
the cylinders, and INO-T shall invoice, or deduct from any credit due AGA for
the return of cylinders, all such costs.


 


(b)                                 AGA shall, during the Term,
return all used and/or expired cylinders to INO-T on a monthly basis, in
coordination with the designated representative of INO-T. Without limiting the
foregoing, AGA shall advise INO-T on or before the [**] day of the calendar
month of the number of used and/or expired cylinders, and arrange for delivery
of the cylinders to Port Allen, Louisiana, U.S.A. on the date coordinated with
INO-T’s designated representative. AGA shall be responsible for all costs to
ship, insure and export the cylinders to Port Allen, Louisiana, U.S.A., and
INO-T shall be responsible for any costs relating to importing the cylinders
into the United States, except as set forth in Section 8.7(a) above.


 


(c)                                  INO-T shall bill AGA for the
cost of any repair or replacement of damaged cylinder returned to INO-T, and
any cylinder not returned within [**]_months. For the avoidance of doubt,
damaged cylinders means damage that would make the cylinder or other packaging
components unusable for reuse and/or transport, and cosmetic damage incurred in
the normal transport of the package shall not result in any deduction.


 


IX.  PRODUCT RECALL


 


9.1           Mandatory Recall. 
In the event of any mandatory recall of a Product triggered by a
Regulatory Authorities, INO-T will assist AGA, to the extent necessary, in
implementing the recall.  Any and all
costs related to the recall should be paid by the Party which is responsible
for the recall.


 


9.2           Voluntary Recall. 
If a Party believes that a voluntary withdrawal or recall of a Product
is necessary both Parties will mutually agree to the need for a recall.  If the Parties cannot agree, they will use an
independent third party qualified to assess the need for a recall and will
follow the recommendation of the third party. 
INO-T will assist AGA, to the extent necessary in implementing the
withdrawal or recall.  Any and all costs
related to the recall should be paid by the Party which is responsible for the
recall.


 


X.  ADVERSE EVENT REPORTING


 


10.1         The Parties shall, within [**] days of the Effective Date,
mutually agree in writing to procedures that assure that INO-T will be able to
meet its obligations to report Adverse Events, as such term is defined in Exhibit I, including all of the
requirements, outside of the Territory. 
AGA acknowledges that INO-T is obligated under applicable laws outside
of the Territory to report Adverse Events to certain regulatory authorities
outside of the Territory, and AGA agrees to comply with INO-T’s requirements so
as to assure that INO-T is in compliance with such laws.  INO-T acknowledges that AGA has or may have
obligations to report Adverse Events to Regulatory Authorities in the
Territory; however, AGA agrees that in all such 


 

















 


communications with Regulatory Authorities,
it shall comply with the requirements of Section 5.1(b).


 


10.2         With respect to any product complaint that does not require
Adverse Event reporting (hereinafter “Product Quality Complaints”), the Parties
agree to utilize the procedure set forth on Exhibit II.


 


XI.  RETENTION OF RECORDS/AUDIT


 


AGA shall maintain complete
and accurate records to verify the performance of its obligations under the
Agreement, and any other record that it is required by Law to maintain in order
to perform its obligations under this Agreement.  All such records shall be subject to review
and audit by INO-T on reasonable notice, and at reasonable times during normal
business hours, including as those set forth under Article V.  AGA shall provide access to all requested
records and cooperate fully in the conduct of any such review or audit.


 


All records to be maintained
under this provision shall be retained for a period of not less than [**]
years, or such longer period as required by Law.


 


XII.  CONFIDENTIALITY


 


During the Term of this
Agreement and for [**] years thereafter neither Party shall, without the
specific written consent of the other Party, disclose to any third party or use
for its own purposes or for the benefit of any third party (except as
contemplated herein and then with disclosure only on a need to know basis) any
of the Confidential Information (as defined below) disclosed by the other
Party.


 


The term “Confidential
Information” shall mean technical and business information, whether written,
oral or in any other form, that one Party shall provide to the other Party
pursuant to this Agreement or otherwise during the term of this Agreement, with
the exception only of the following:


 


(a)                                  information which was known
to or in the possession of the receiving Party prior to the time of receipt
from the disclosing Party;


 


(b)                                 information which as of the
time of receipt is generally available to the public or subsequently becomes
generally available to the public through no breach of this Agreement by the
receiving Party;


 


(c)                                  information which at any
time is furnished to the receiving Party by a third party that was lawfully in
possession of the same and had the lawful right to disclose the same;


 


(d)                                 information which at any
time corresponds to information independently developed by the receiving Party
without the aid, use or application of any information which constitutes
Confidential Information;


 

















 


(e)                                  information which is
required by Law, or order of any governmental authority or agency or any
national stock exchange or national market system to be disclosed by the
receiving Party; provided, however that the receiving Party gives the
disclosing Party sufficient advance written notice to permit it to seek a
protective or similar order and thereafter discloses only the minimum
information required to be disclosed in order to comply; and


 


(f)                                    information which is
specifically permitted to be disclosed pursuant to the terms of this Agreement.


 


XIII.  TERMINATION


 


13.1         Termination by INO-T. 
INO-T shall have the right to terminate this Agreement by giving AGA not
less than thirty (30) days notice in writing if (a) AGA disposes of a
substantial part of its assets; (b) AGA changes the direction of its
activities; or (c) INO-T, in its sole discretion, for commercial,
scientific or medical reasons decides to discontinue or suspend commercial
activities relating to the Product in the Territory.


 


13.2         Material Breach. 
In addition to any other rights or remedies available at law or in
equity, a Party may terminate this Agreement, upon written notice, upon the
occurrence of a material breach by the other Party which is not cured within
sixty (60) days of written notice thereof.


 


13.3         Bankruptcy. 
Either Party may terminate this Agreement upon written notice to the
other (i) upon the filing or institution of bankruptcy, reorganization,
liquidation or receivership proceedings by the other Party; (ii) upon an
assignment of a substantial portion of the other Party’s assets for the benefit
of creditors; or (iii) if a substantial portion of the other Party’s
business is subject to attachment or similar process; provided, however, that
in the case of any involuntary bankruptcy such right to terminate will become
effective only if the other Party consents to the involuntary bankruptcy or
such proceeding is not dismissed within sixty (60) days after its filing.


 


13.4         No Release of Obligations.  Any expiration or termination of this
Agreement shall not release the Parties from liabilities or obligations accrued
as of the date thereof.


 


13.5         Return of INO-T Materials.  Upon the expiration of the term or upon any
termination of this Agreement, in addition to any other obligations set forth
in this Agreement, AGA shall, at its own cost and expense, within [**] days of
such termination, return to INO-T all INO-T property, including, without
limitation, cylinders, printed matters, including without limitation records of
correspondence with Regulatory Authorities and all sales promotion materials in
its possession relating to the Products, and furnish to INO-T a copy of AGA’s
then current customer register.


 


13.6         Use of Product Information by INO-T Upon Termination.  Notwithstanding any provisions of this
Agreement to the contrary, including, without limitation, Article XII of
this Agreement, upon any termination of this Agreement, INO-T may utilize
information relating to the Product and its sale in the Territory that was
provided by or on behalf of AGA, and, in its 


 

















 


discretion, provide access to such
information to any business entity, if any, with which INO-T contemplates a
business relationship involving the Product


 


13.7         Effect of Termination.  Expiration or termination of the Agreement
shall not relieve the Parties of any obligation accruing prior to such
expiration or termination, and the provisions of Articles I, V, VII, IX, X, XI,
XII, XIV, XV, and XVII, and Sections 3.1(d), 3.1(e), 3.2(b), 4.2, 8.4, 8.7, 13.4,
13.5, 13.6 and 13.7 shall survive the expiration of the Agreement.


 


XIV.  INDEMNIFICATION; LIMITATION
OF LIABILITY; INSURANCE


 


14.1         Indemnifications. 
(a) INO-T shall indemnify and hold AGA harmless from claims based
on infringement of any patents, trademarks, copyrights or other intellectual
property rights relating to any of the Product, from any claim, suit or penalty
arising from or imposed by any federal, state or municipal regulatory agencies
pertaining to INO-T or its manufacture of any of the Product, from any product
liability claims relating to any of the Product, except to the extent that a
claim is based on AGA’s negligent handling, storage or distribution of Product
or on any other negligent act or omission of AGA in violation of its obligations
under this Agreement.


 


(b)           AGA shall indemnify and hold INO-T harmless from claims
based in connection with its storage, promotion, distribution or sale of the
Product, from any labor or employment claims arising from AGA’s employees,
agents, consultants, and the like, from any claim, suit or penalty arising from
or imposed by any federal, state or municipal regulatory agencies pertaining to
AGA or its distribution or sale of any of the Product, and from any product
liability claims relating to any of the Product to the extent that a claim is
based on AGA’s negligent handling, promotion, storage or distribution of
Product or on any other negligent act or omission of AGA in violation of its
obligations under this Agreement.


 


14.2         Limitation of Liability.  With respect to any claim by one Party
against the other arising out of the performance or failure of performance of
the other Party under this Agreement, the Parties expressly agree that the
liability of such Party to the other Party for such breach shall be limited
under this Agreement or otherwise at law or equity to direct damages only and
in no event shall a Party be liable for, punitive, exemplary or consequential
damages.


 


14.3         Insurance.  AGA
acknowledges and agrees that during the Term of this Agreement it shall
maintain, at its own expense, Products/Completed Operations Insurance in an
amount not less than $1,000,000 each occurrence and $1,000,000 annual aggregate
for bodily injury and property damage combined single limit, with an
internationally recognized reliable and financially sound insurance company.


 


If this coverage is written
on a Claims-Made Basis, then an Extended Reporting Period of sixty (60) months
must be provided under the policy. No provision of this Agreement, including
without limitation, Section 14.2 above, shall be interpreted to release,
or decrease the obligations of, any insurance carrier under the policies
referenced in this Section.


 

















 


XV.  TAXES


 


15.1         Taxes.  AGA
shall be responsible for all sales, use, excise, use, goods, services, value
added and like taxes relating to its import, distribution, handling and sale of
Product in the Territory.  The Parties
agree to cooperate in order to minimize, in the manner permitted under applicable
tax and customs Laws, the taxes (including value-added taxes) and duties
associated with the importation and/or exportation of the Product, as the case
may be.


 


XVI.  WARRANTIES AND
REPRESENTATIONS


 


16.1         Mutual Representations, Warranties and Covenants.  Each Party represents and warrants that: (i) it
is a corporation duly organized and validly existing under the laws of the
jurisdiction of its incorporation; (ii) it has full power and corporate
authority to enter into and perform under this Agreement; (iii) all
corporate actions necessary to authorize execution and delivery of this
Agreement and to carry out its obligations hereunder have been duly taken; (iv) it
has and shall maintain all licenses, permits, governmental approvals, and other
authorizations necessary to perform its obligations hereunder; and (v) it
is not a Party to any other agreements or arrangements that are inconsistent
with the performance of its obligations hereunder.  Each Party represents and warrants that it
will market, sell and distribute the Product in compliance with applicable
legal requirements in the Territory.


 


XVII.  GENERAL PROVISIONS


 


17.1         Assignment. 
Neither Party shall assign or delegate any right or obligation hereunder
without the prior written consent of the other Party, which consent shall not
be unreasonably withheld, except that INO-T may assign its rights hereunder to
any Affiliate.  Any attempted assignment
in violation hereof shall be void.  For
the avoidance of doubt, AGA may not appoint sub-distributors, agents or other
intermediaries, without a written consent of INO-T.


 


17.2         Entire Agreement and Amendments.  This Agreement sets forth the entire
understanding between the Parties and shall supersede any prior agreements
which relate to the matters covered herein. 
No amendment to this Agreement shall be binding unless reduced to
writing and  signed by both Parties.  Without limiting the foregoing, no
understanding, agreement, representation or promise, not explicitly set forth
herein, has been relied on by either Party in deciding to execute this Agreement.


 


17.3         Waiver of Default. 
No waiver of any default hereunder by either Party or any failure to
enforce any rights hereunder shall be deemed to constitute a waiver of any
subsequent default with respect to the same or any other provision hereof.  No waiver shall be effective unless made in
writing with specific reference to the relevant provision(s) of this
Agreement and signed by a duly authorized representative of the Party granting
the waiver.


 


17.4         Independent Relationship.  Nothing herein contained shall be deemed to
create an employment, agency, joint venture or partnership relationship between
the Parties hereto or any of their agents or employees, or any other legal
arrangement that would impose liability upon one Party for the act or failure
to act of the other Party.  Neither Party
shall have any power to enter into any contracts or commitments or to incur any
liabilities in the name of, or on behalf of, the other Party, or to bind the
other Party in any respect whatsoever.


 

















 


17.5         Arbitration. 
The laws of the State of New Jersey, U.S.A. shall govern the terms of
this Agreement.  Except for disputes
brought in courts of equity to enforce non-monetary rights, including, without
limitation, restraining orders, any unresolved dispute between the Parties or
any claim of one Party against the other arising under or in connection with
this Agreement will be resolved through binding arbitration pursuant to the rules of
the American Arbitration Association. 
All proceedings shall take place in English in New York City, New York,
U.SA.


 


17.6         Force Majeure. 
Failure of either Party to perform its obligations under this Agreement
(except the obligation to make payments when properly due) shall not subject
such Party to any liability or place them in breach of any term or condition of
this Agreement to the other Party if such failure is due to any cause beyond
the reasonable control of such non-performing Party (“force majeure”).  Causes of non-performance constituting force
majeure shall include, without limitation, acts of God, fire, terrorism,
explosion, flood, drought, war, riot, sabotage, embargo, strikes or other labor
trouble, failure in whole or in part of suppliers to deliver on schedule
materials, equipment or machinery, interruption of or delay in transportation,
a national health emergency or compliance with any order or regulation of any
government entity acting with color of right. 
The Party affected shall promptly notify the other Party of the condition
constituting force majeure as defined herein and shall exert reasonable efforts
to eliminate, cure and overcome any such causes and to resume performance of
its obligations with all possible speed. 
If a condition constituting force majeure as defined herein exists for
more than ninety (90) consecutive days, INO-T shall have the right, but not the
obligation, to terminate this Agreement, as set forth in Section 13.1, if
the Parties have not negotiated a mutually satisfactory resolution to the
problem, if practicable.


 


17.7         Notices.  Each
notice required or provided under this Agreement shall be in writing and shall
be given by mail prepaid or facsimile transmission and properly addressed to
the addresses or fax numbers of the Party to be served as shown below.  Notice shall be effective upon receipt to the
Parties at the addresses and facsimile numbers indicated below:


 


	
  If
  to INO-T (excluding communications with Regulatory Authorities):

  	
   

  	
  If
  to INO-T (with respect to communications with Regulatory Authorities):

  
	
   

  	
   

  	
   

  
	
  Vice
  President, Global Commercial Operations

  	
   

  	
  Vice
  President, Global Regulatory Affairs

  
	
  INO
  Therapeutics LLC

  	
   

  	
  INO
  Therapeutics LLC

  
	
  6
  Route 173

  	
   

  	
  6
  Route 173

  
	
  Clinton,
  New Jersey, 08809 U.S.A.

  	
   

  	
  Clinton,
  New Jersey, 08809 U.S.A.

  
	
  Fax
  No.: (908) 238-6403

  	
   

  	
  Fax
  No.: (908) 238-6402

  
	
  With
  a copy to:

  	
   

  	
  With
  a copy to:

  
	
   

  	
   

  	
   

  
	
  Vice
  President and General Counsel

  	
   

  	
  Vice
  President, Global Commercial Operations

  
	
  INO
  Therapeutics LLC

  	
   

  	
  INO
  Therapeutics LLC

  
	
  6
  Route 173

  	
   

  	
  6
  Route 173

  
	
  Clinton,
  New Jersey, 08809 U.S.A.

  	
   

  	
  Clinton,
  New Jersey, 08809 U.S.A.

  
	
  Fax.
  No. (908) 238-6699

  	
   

  	
  Fax
  No.: (908) 238-6403

  
	
  If to AGA:

  	
   

  	
   

  



 

















 


Either Party may change its address or its facsimile
number by giving the other Party written notice, delivered in accordance with
this provision.


 


17.8         Effect of Invalidity. 
If any term or provision of this Agreement shall be held invalid or
unenforceable by a competent authority in the Territory, such determination of
invalidity shall not affect the validity or enforceability of any other
provisions of this Agreement which shall remain in full force and effect.  The Parties hereto shall meet and mutually
agree to amend this Agreement to incorporate new terms which shall, to the
greatest extent possible, restore the intent of the Parties in drafting this
Agreement.


 


17.9         Headings. 
Headings are inserted for convenience and shall not by themselves
determine the interpretation of this Agreement.


 


17.10       Export Control. 
This Agreement is made subject to any restrictions concerning the export
of products or technical information from the United States of America which
may be imposed upon or related to AGA or INO-T from time to time by the
government of the United States of America. 
Furthermore, each Party agrees that it will not export, directly or
indirectly, any technical information acquired from the other Party under this
Agreement or any products using such technical information to any country for
which the United States government or any agency thereof at the time of export
requires an export license or other governmental approval, without first
obtaining the written consent to do so from the Department of Commerce or other
agency of the United States government when required by an applicable statute
or regulation.


 


IN WITNESS WHEREOF, INO-T
and AGA have caused this Agreement to be executed by their duly authorized
officers.


 


INO
THERAPEUTICS LLC


 


 


	
  By:

  	
   

  	
   

  	
  By:

  	
   

  
	
   

  	
  Name and Title

  	
   

  	
   

  	
  Name and Title

  
	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
   

  	
   

  	
  Date:

  	
   

  
							



 





















 


EXHIBIT I


 


ADVERSE REPORTING PROCEDURES


 


The Parties understand and
agree that these procedures are intended to comply with, requirements for
global adverse event reporting. These procedures may be amended by the 


 

















 


Parties
at any time, at the request of either Party, to ensure that they fully and
accurately reflect the procedures in place for surveillance, receipt,
evaluation and reporting of adverse drug experiences by the pharmacovigilance
department of INO-T and the Regulatory Affairs department of AGA and comply
with applicable laws and regulations in the countries in which the Product is
marketed and/or is under investigation. In that regard, upon the written
request of either Party, the Parties shall meet to renegotiate in good faith,
all or some of these procedures. These procedures are meant to summarize or
abstract the most relevant aspects of INO-T’s pharmacovigilance Standard
Operating Procedures (SOPs), but are not intended to supercede those SOPs. As
set forth in Section 10.1, the parties shall agree to detailed written
procedures within [**] days of the Effective Date.


 


1.                                       Definitions:


 


(a)                                  An Adverse
Event (“AE”) is defined as:


 


(i)                                     Any experience
which is adverse, including what are commonly described as adverse or
undesirable experiences, adverse events, adverse reactions, side effects, or
death due to any cause associated with, or observed in conjunction with the use
of a drug, biological product, or device in humans, whether or not considered
related to the use of that product:


 


(1)                                  occurring in
the course of the use of a drug, biological product or device;


 


(2)                                  associated
with, or observed in conjunction with product overdose, whether accidental or
intentional;


 


(3)                                  associated
with, or observed in conjunction with product abuse;


 


(4)                                  associated
with, or observed in conjunction with product withdrawal.


 


(ii)                                  Any significant
failure of expected pharmacological or biologic therapeutical action (with the
exception of in clinical trials).


 


(b)                                 Associated with
or related to the use of the drug is defined as:  A reasonable possibility exists that the AE
was caused by the drug.


 


(c)                                  Expected or
unexpected are defined as:


 


(i)                                     Expected or “labeled”
AE - An AE which is included in the Investigators’ Brochure for clinical
trials, included in local labeling (e.g., Summary of distribution product
characteristics) for Marketed Drugs, or in countries with no local labeling, in
the Company Core Data Sheet (CCDS).


 


(ii)                                  Unexpected or “unlabeled”
AE - An AE that does not meet the criteria for an expected AE or an AE which is
listed but differs from that event in terms of severity or specificity.


 

















 


(d)                                 IND Holder is
defined as:  A “Sponsor” (as defined in
21 CFR Part 312.2(b)) of an investigational new drug in any regulatory
jurisdiction, including a holder of a foreign equivalent thereto.


 


(e)                                  Life-threatening
is defined as:  any adverse drug
experience that places the patient, in the view of the initial reporter, at
immediate risk of death from the adverse drug experience as it occurred, i.e.,
it does not include an AE that, had it occurred in more severe form, might have
caused death.


 


(f)                                    NDA Holder is
defined as:  An “Applicant” as defined in
21 CFR Part 314.3(b), for regulatory approval of a product in any
regulatory jurisdiction, including a holder of a foreign equivalent thereto.


 


(g)                                 Serious or
Non-Serious are defined as:


 


(i)                                     Any adverse
drug experience occurring at any dose that results in any of the following
outcomes:  Death, a life-threatening
adverse drug experience, inpatient hospitalization or prolongation of existing
hospitalization, a persistent or significant disability/incapacity, or a
congenital anomaly/birth defect. Important medical events that may not result
in death, be life-threatening, or require hospitalization may be considered
serious when, based upon appropriate medical judgment, they may jeopardize the
patient or subject and may require medical or surgical intervention to prevent
one of the outcomes listed in this definition. 
Examples of such medical events include allergic bronchospasm requiring
intensive treatment in an emergency room or at home, blood dyscrasias or convulsions
that do not result in inpatient hospitalization, or the development of drug
dependency or drug abuse.


 


(ii)                                  A Non-serious
AE is any AE, which does not meet the criteria for a serious AE.


 


(h)                                 Not associated
or unrelated to the use of the drug means it does not meet the definition of “associated.”


 


2.                                       Capitalized
terms not defined in this Exhibit shall have the meaning assigned thereto
in the Agreement.


 


3.                                       With respect to
all Product:


 


All initial reports (oral or
written) for any and all serious AEs as defined above which become known to AGA
must be communicated by, telefax or electronically directly to INO-T or their
designee for the Territory within [**] of receipt of the information.  Follow-up Serious AE information received by
AGA should also be communicated in writing within [**] of obtaining such
information. In all cases, AGA will provide sufficient contact details such
that INO-T or their designee may seek further medical details.  Case reports will be assessed medically by
INO-T for their expectedness and relatedness as per INO-T’s SOP for
pharmacovigilance processing.


 














 


Medwatch and/or CIOMS forms
for expedited reporting to health authorities will be provided by INO-T or
their designee.  Other health authority
reports such as Periodic Safety Update Reports will be provided by INO-T within
[**] working days of submission due date to the regulatory agency of the
Territory.


 


All initial reports and
follow-up information received for all non-serious AEs for marketed
Product which become known to AGA must be communicated in writing, by telefax
or electronically to INO-T or their designee within [**] calendar days of
becoming aware of the non-serious AE utilizing INO-T provided forms.  INO-T or their designee will provide AGA with
a written report regarding all Serious AEs; in such time to allow AGA to
meet reporting deadlines according to applicable law or regulations regarding
the reporting of adverse events in the Territory.


 


4.                                       The Parties
further agree that:


 


(a)                                  a written
report for AEs for animal studies which suggest a potential significant risk
for humans shall be managed according to the process for SAE reporting above;


 


(b)                                 INO-T or their
designee will give AGA any necessary information required for AGA to meet
reporting requirements in the Territory relating to the Product within the
preceding 365 days/calendar year, within [**] days of receipt of a request from
AGA;


 


(c)                                  disclosure
according to these procedures of information hereunder by a Party to the other
Party shall continue as long as either Party continues to clinically test or
market products containing the Product or holds an open IND, United States NDA
or foreign equivalent thereto;


 


5.                                       Each Party
shall diligently undertake the following further obligations where both Parties
are or will be commercializing products hereunder and/or performing clinical
trials with respect to the Product:


 


(a)                                  to immediately
advise the other Party of any product safety communication received from a
health authority and consult with the other Party with respect to any proposed
change to product warnings, labeling or an Investigator’s Brochure involving
safety issues, including, but not limited to, safety issues agreed to by the
Parties;


 


(b)                                 to provide
INO-T reasonable annual audit rights of AGA’s AE reporting system and
documentation, upon prior notice, during normal business hours, at the expense
of the auditing Party and under customary confidentiality obligations;


 


(c)                                  to meet in a
timely fashion from time to time as may be reasonably required to implement the
adverse event reporting and consultation procedures described in this Exhibit,
including identification of those individuals in each Party’s pharmacovigilance
group who will be responsible for reporting to and receiving AE information
from the other Party, and the development by AGA of a written 


 

















 


standard operating procedure with respect to
adverse event reporting responsibilities, including reporting responsibilities
to investigators in the Territory, should they exist under protocols managed by
AGA;


 


(d)                                 where possible,
to transmit all data electronically;


 


(e)                                  to report to
each other any addenda, revisions or changes to the Agreement (e.g., change in
territories, local regulations, addition of new licensors/licensees to the
agreement, etc.) which might alter the adverse event reporting responsibilities
hereunder;


 


(f)                                    to utilize
English as the language of communication and data exchange between the Parties;


 


(g)                                 to develop a
system of exchange of documents and information in the event that the Agreement
involves more than two Holders.


 

















 


EXHIBIT II.


 


INO-T’S PROCEDURES FOR REPORTING PRODUCT QUALITY
COMPLAINT


INFORMATION


 


A.                                   The Parties
agree to transmit to each others’ complaint coordinators, as soon as reasonably
practicable, but not more than [**] working days after receipt, any complaints
received by the Parties relating to the Product(s) in accordance with the
following:


 


1.                                       The Parties
shall transmit:


 


(a)                                  Information that causes the
drug Product(s) or its labeling to be mistaken for, or applied to, another
article;


(b)                                 information concerning any
bacteriological contamination, or any chemical, physical, or other change or
deterioration in the distributed drug Product(s), or any failure of one or more
distributed batches to meet its specifications; and


(c)                                  any other product quality
complaint that is related to the Product(s’) identity, strength, quality or
purity or that alleges a product defect.


 


2.                                       The transmittal
to the other party’s complaint coordinators shall be via telephone or, if
transmittal via telephone is not feasible, via fax:


 


	
  For
  AGA

  	
  For
  INO-T

  
	
  Tel:

  	
  1-800-526-4099

  	
  Tel:

  	
  US:
  225-376-4350

  
	
   

  	
   

  	
   

  	
  Fax;
  225-3765-4450

  
	
  Fax:

  	
  1-973-921-7228

  	
  Fax:

  	
  33
  134 77 83 61

  



 


3.                                       The Parties
shall provide the following information:


(a)                                  complainant name;


(b)                                 complainant address;


(c)                                  complainant telephone
number;


(d)                                 Product involved;


(e)                                  lot number/expiration date;


(f)                                    description of complaint.


 


B.                                     The Parties
agree that changes can be made on a mutual basis to these procedures in writing
as may be necessary or appropriate to comply with changes in applicable law or
regulations relating to reporting of product quality information, and that the
Parties shall amend their policies and procedures to enable each other to
comply with applicable laws and regulations for reporting such information.


 

















 


Schedule 1.12


 


Trademarks


 


INOflo


INOtherapy


INOmeter


 

















 


EXISTING ROW AMENDMENT AGREEMENT


 


This
EXISTING ROW AMENDMENT AGREEMENT (this Agreement), dated as of
                                        ,
2007, is entered into by and among INO
THERAPEUTICS LLC, a
Delaware limited liability company (INO-T);
AGA S.A., an Argentinean corporation; BOC LIMITED, an Australian corporation; AGA
S.A., a Chilean corporation; AGA FANO,  FABRICA
NACIONAL DE OXÍGENO S.A., a
Colombian corporation; and AGA S.A., a Uruguayan corporation.


 


W I T N E S S E T H


 


WHEREAS  INO-T and the
AGA Entities wish to amend the Existing ROW Agreements on the terms and
conditions set out in this Agreement with effect from the date hereof.


 


NOW, THEREFORE, in consideration of the
mutual terms, conditions and other agreements set forth in this Agreement, the
Parties hereby agree as follows:


 


1.                                      DEFINITIONS
AND INTERPRETATION


 


1.1                               Definitions


 


(a)                                  As used in this Agreement,
the following terms have the following meanings:


 


AGA Entities  means AGA S.A., an
Argentinean corporation, BOC Limited, an Australian corporation; AGA S.A., a Chilean
corporation, AGA FANO, Fabrica Nacional De
Oxígeno S.A., a
Colombian corporation and AGA S.A., a Uruguayan corporation.


 


Existing ROW Agreements  means the distribution
agreements between INO-T and the following:


 


(i)                       AGA S.A. (an Argentinean
corporation) dated April 26, 2005 in respect of Argentina (the Argentinean Agreement);


 


(ii)                    BOC Limited (an Australian
corporation) dated May 9, 2006 in respect of Australia (the Australian Agreement);


 


(iii)                 AGA S.A. (a Chilean corporation) dated March 30,
2005 in respect of Chile;


 


(iv)                AGA FANO, Fabrica Nacional De Oxígeno S.A. (a Colombian corporation)
in respect of Colombia; and


 


(v)                   AGA S.A. (a Uruguayan corporation) dated April 15,
2005 in respect of Uruguay.


 


Commercial Agreement  means the agreement by and
among INO-T, Ikaria Holdings, Inc. and AGA AB, a Swedish aktiebloag,
entered into as of the date hereof.


 


(b)                                 All other defined terms in
the Existing ROW Agreements shall have the meanings specified in those agreements.


 

















 


2.                                      EXTENSION
OF TERMS OF EXISTING ROW AGREEMENTS


 


(a)                                  Section 2 of each of
the Existing ROW Agreements other than the Australian Agreement shall be
amended so that the words “Launch Date” shall be replaced with the words “later
of the Launch Date and the Closing Date”;


 


(b)                                 Section 2 of the
Australian Agreement shall be amended so that the words “31 December 2011”
shall be replaced with the words “date that is five (5) years following
the Closing Date”; and


 


(c)                                  a new Section 1.22
shall be inserted into each of the Existing ROW Agreements as follows:


 


“1.22  The term “Closing Date” shall have the
meaning given to “Effective Date” in the Commercial Agreement, and the term “Commercial
Agreement” shall mean the commercial agreement by and among INO-T, Ikaria
Holdings, Inc. and AGA AB, a Swedish aktiebloag, dated
                                          ,
2007.”.


 


3.                                      ROYALTY
RATES


 


In
accordance with Section 4.3(c) of the Commercial Agreement:


 


(a)                                  a new Section 1.23
shall be inserted into each of the Existing ROW Agreements other than the
Australian Agreement as follows:


 


“1.23  The term “Sales Related Payment” shall have
the meaning given in the Commercial Agreement.”;


 


(b)                                 a  new  Section 7.3A  shall  be  inserted  into  each  of  the  Existing  ROW  Agreements  other  than  the  Australian  Agreement  as  follows:


 


“7.3A  Reduction.  Notwithstanding the provisions of Section 7.2,
from the date on which the Sales Related Payment is first payable pursuant to Section 4.3
of the Commercial Agreement all amounts payable by AGA to INO-T pursuant to
this Section VII (FINANCIAL TERMS) shall be reduced by [**] percent
([**]%).”.


 


4.                                      CONTINUANCE
IN FORCE


 


Except
as modified by the terms of this Agreement, all other terms in the Existing ROW
Agreements shall continue in full force and effect.


 


5.                                      GENERAL


 


The
following provisions of the Existing ROW Agreements other than the Australian
Agreement:  Sections 17.2 (Entire
Agreement and Amendments), 17.4 (Independent Relationship), 17.5 (Arbitration),
17.8 (Effect of Invalidity) and 17.9 (Headings) shall apply to this Agreement mutatis mutandis.


 

















 


[SIGNATURE PAGE FOLLOWS]


 

















 


IN WITNESS WHEREOF, each of the
Parties has duly executed this Agreement as of the date first written above.


 


	
   

  	
  INO-T
  THERAPUTICS LLC

  
	
   

  	
   

  
	
   

  	
  By:

  
	
   

  	
   

  
	
   

  	
  Name:

  
	
   

  	
   

  
	
   

  	
  Title:

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  AGA S.A., an Argentinean
  corporation

  
	
   

  	
   

  
	
   

  	
  By:

  
	
   

  	
   

  
	
   

  	
  Name:

  
	
   

  	
   

  
	
   

  	
  Title:

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  BOC LIMITED,
  an Australian corporation

  
	
   

  	
   

  
	
   

  	
  By:

  
	
   

  	
   

  
	
   

  	
  Name:

  
	
   

  	
   

  
	
   

  	
  Title:

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  AGA S.A. a Chilean corporation

  
	
   

  	
   

  
	
   

  	
  By:

  
	
   

  	
   

  
	
   

  	
  Name:

  
	
   

  	
   

  
	
   

  	
  Title:

  
	
   

  	
   

  



 

















 


	
   

  	
  AGA FANO, FABRICA NACIONAL DE
  OXIGENO S.A., a Colombian
  corporation

  
	
   

  	
   

  
	
   

  	
  By:

  
	
   

  	
   

  
	
   

  	
  Name:

  
	
   

  	
   

  
	
   

  	
  Title:

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  AGA
  S.A. a Uruguayan corporation

  
	
   

  	
   

  
	
   

  	
  By:

  
	
   

  	
   

  
	
   

  	
  Name:

  
	
   

  	
   

  
	
   

  	
  Title: