Exhibit 10.22


 


Confidential Materials omitted and filed separately with the


Securities and Exchange Commission. 
Asterisks denote omissions.


 


MARCH 28,
2007


 


 


INO
THERAPEUTICS LLC


 


 


AGA
AB


 


 


IKARIA HOLDINGS, INC.


 






 


COMMERCIAL AGREEMENT


 






 


 




	
   

  	
  

  	
  FRESHFIELDS BRUCKHAUS DERINGER

  	
   

  






 

















 


CONTENTS


 


	
   

  	
   

  



 


	
  SECTION

  	
   

  	
   

  	
  PAGE

  
	
   

  	
   

  	
   

  	
   

  
	
  1.

  	
  Definitions and Interpretation

  	
  1

  
	
   

  	
  1.1

  	
  Definitions

  	
  1

  
	
   

  	
  1.2

  	
  Interpretation:

  	
  7

  
	
   

  	
   

  	
   

  	
   

  
	
  2.

  	
  Term

  	
  7

  
	
   

  	
   

  	
   

  	
   

  
	
  3.

  	
  Supply of Supply Products for Linde Territories

  	
  8

  
	
   

  	
   

  	
   

  	
   

  
	
  4.

  	
  New Indications for Linde Territories

  	
  8

  
	
   

  	
  4.1

  	
  Development Activities

  	
  8

  
	
   

  	
  4.2

  	
  Health Registration Applications

  	
  8

  
	
   

  	
  4.3

  	
  Sales Related Payment

  	
  9

  
	
   

  	
   

  	
   

  	
   

  
	
  5.

  	
  Right of First Refusal for New ROW Territories

  	
  9

  
	
   

  	
   

  	
   

  	
   

  
	
  6.

  	
  New Delivery Devices

  	
  11

  
	
   

  	
  6.1

  	
  Notice of New Delivery Devices

  	
  11

  
	
   

  	
  6.2

  	
  Regulatory Requirements for New Delivery Devices

  	
  11

  
	
   

  	
   

  	
   

  	
   

  
	
  7.

  	
  Covox

  	
  11

  
	
   

  	
  7.1

  	
  Health Registrations in Linde Territories

  	
  11

  
	
   

  	
  7.2

  	
  Marketing, Sales and Logistics in the Linde Territories

  	
  12

  
	
   

  	
  7.3

  	
  Royalties for sales in the Linde Territories

  	
  12

  
	
   

  	
  7.4

  	
  ROFR as Distributor in ROW

  	
  12

  
	
   

  	
  7.5

  	
  Milestones

  	
  12

  
	
   

  	
   

  	
   

  	
   

  
	
  8.

  	
  New Products and NO Dissolved in Liquid

  	
  13

  
	
   

  	
  8.1

  	
  New Products

  	
  13

  
	
   

  	
  8.2

  	
  NO Dissolved in Liquid

  	
  13

  
	
   

  	
   

  	
   

  	
   

  
	
  9.

  	
  Compliance Audits; Government Inspection

  	
  13

  
	
   

  	
  9.1

  	
  Compliance Audits

  	
  13

  
	
   

  	
  9.2

  	
  Regulatory Inspection

  	
  14

  
	
   

  	
   

  	
   

  	
   

  
	
  10.

  	
  Supply Of Supply Products

  	
  14

  
	
   

  	
  10.1

  	
  Supply

  	
  14

  
	
   

  	
  10.2

  	
  Forecasts

  	
  15

  
	
   

  	
  10.3

  	
  Orders

  	
  15

  
	
   

  	
  10.4

  	
  Manufacturing

  	
  16

  
	
   

  	
  10.5

  	
  Shipments

  	
  16

  
	
   

  	
   

  	
   

  	
   

  
	
  11.

  	
  Financial Terms

  	
  16

  
	
   

  	
  11.1

  	
  Supply of Supply Products by INO-T to the Recipients

  	
  16

  
	
   

  	
  11.2

  	
  Fixed price invoicing

  	
  16

  
	
   

  	
  11.3

  	
  Payment period and disputed payments

  	
  17

  
	
   

  	
  11.4

  	
  United Stated Dollars

  	
  17

  
	
   

  	
  11.5

  	
  Return of Cylinders

  	
  18

  
	
   

  	
   

  	
   

  	
   

  
	
  12.

  	
  Ownership of Health Registrations, Linde Group Know-How or
  Manufacturing Data

  	
  18

  



 

















 


	
  13.

  	
  Pharmacovigilence and Assistance

  	
  18

  
	
   

  	
  13.1

  	
  Regulatory Assistance

  	
  18

  
	
   

  	
  13.2

  	
  Clinical trials

  	
  18

  
	
   

  	
  13.3

  	
  Access to INO-T Database

  	
  19

  
	
   

  	
  13.4

  	
  Back-up facilities

  	
  19

  
	
   

  	
   

  	
   

  	
   

  
	
  14.

  	
  Joint Committee

  	
  19

  
	
   

  	
  14.1

  	
  Constitution

  	
  19

  
	
   

  	
  14.2

  	
  Functions

  	
  20

  
	
   

  	
  14.3

  	
  Meetings

  	
  20

  
	
   

  	
  14.4

  	
  Decisions

  	
  20

  
	
   

  	
   

  	
   

  	
   

  
	
  15.

  	
  Product Recall

  	
  20

  
	
   

  	
  15.1

  	
  Mandatory Recall

  	
  20

  
	
   

  	
  15.2

  	
  Voluntary recall

  	
  21

  
	
   

  	
   

  	
   

  	
   

  
	
  16.

  	
  Adverse Event Reporting

  	
  21

  
	
   

  	
   

  	
   

  	
   

  
	
  17.

  	
  Confidentiality and Announcements

  	
  21

  
	
   

  	
  17.1

  	
  Confidentiality

  	
  21

  
	
   

  	
  17.2

  	
  Announcements

  	
  22

  
	
   

  	
   

  	
   

  	
   

  
	
  18.

  	
  Termination

  	
  22

  
	
   

  	
  18.1

  	
  Termination by AGA

  	
  22

  
	
   

  	
  18.2

  	
  Termination by INO-T

  	
  23

  
	
   

  	
  18.3

  	
  Material Breach

  	
  23

  
	
   

  	
  18.4

  	
  Return of Materials

  	
  23

  
	
   

  	
  18.5

  	
  Effect of Termination

  	
  23

  
	
   

  	
  18.6

  	
  Dispute Resolution Procedure

  	
  24

  
	
   

  	
   

  	
   

  	
   

  
	
  19.

  	
  Indemnification; Limitation of Liability; Insurance

  	
  25

  
	
   

  	
  19.1

  	
  Indemnification

  	
  25

  
	
   

  	
  19.2

  	
  Limitation of Liability

  	
  26

  
	
   

  	
  19.3

  	
  Insurance

  	
  26

  
	
   

  	
   

  	
   

  	
   

  
	
  20.

  	
  Taxes

  	
  26

  
	
   

  	
   

  	
   

  	
   

  
	
  21.

  	
  Warranties, Representations and Covenants

  	
  27

  
	
   

  	
  21.1

  	
  Capacity and Compliance

  	
  27

  
	
   

  	
  21.2

  	
  Changes in Manufacturing Process

  	
  27

  
	
   

  	
   

  	
   

  	
   

  
	
  22.

  	
  Right of First Offer to Purchase Linde’s European NO and
  Covox Businesses

  	
  28

  
	
   

  	
   

  	
   

  	
   

  
	
  23.

  	
  Miscellaneous

  	
  29

  
	
   

  	
  23.1

  	
  INO Business Sale and Purchase Agreement

  	
  29

  
	
   

  	
  23.2

  	
  Independent Relationship

  	
  30

  
	
   

  	
  23.3

  	
  Amendments and Waivers

  	
  30

  
	
   

  	
  23.4

  	
  Assignment

  	
  30

  
	
   

  	
  23.5

  	
  Third-Party Beneficiaries

  	
  30

  
	
   

  	
  23.6

  	
  Notices

  	
  31

  
	
   

  	
  23.7

  	
  Counterpart Execution and Facsimile Delivery

  	
  32

  
	
   

  	
  23.8

  	
  Severability

  	
  32

  
	
   

  	
  23.9

  	
  Export Control

  	
  32

  
	
   

  	
  23.10

  	
  Force Majeure

  	
  33

  
	
   

  	
  23.11

  	
  Specific Performance

  	
  33

  



 

















 


	
   

  	
  23.12

  	
  Governing Law

  	
  33

  
	
   

  	
  23.13

  	
  Waiver of Jury Trial

  	
  33

  
	
   

  	
   

  	
   

  	
   

  
	
  SCHEDULE 1 PRODUCTS

  	
  35

  
	
   

  	
   

  	
   

  	
   

  
	
  SCHEDULE 2 JOINT COMMITTEE FUNCTIONS

  	
  36

  
	
   

  	
  1.

  	
  This Agreement

  	
  36

  
	
   

  	
   

  	
   

  	
   

  
	
  SCHEDULE 3 CHANGE CONTROL PROCEDURE

  	
  37

  
	
   

  	
  1.

  	
  Principles

  	
  37

  
	
   

  	
  2.

  	
  Procedure

  	
  37

  
	
   

  	
  3.

  	
  Costs

  	
  38

  



 

















 


EXECUTION
COPY


 


COMMERCIAL
AGREEMENT


 


This COMMERCIAL
AGREEMENT (this Agreement),
dated as of March 28, 2007, by and among INO
THERAPEUTICS LLC, a Delaware limited liability company, having its
principal place of business at 6 Route 173, Clinton, New Jersey, 08809, U.S.A.
(INO-T), IKARIA HOLDINGS, INC., a Delaware corporation
(Holdco),
and AGA AB, a Swedish aktiebloag,
having its principal place of business at SE-181 81 Lidingö, Sweden (AGA).


 


W I T N E S S E T H


 


WHEREAS, AGA is a
subsidiary of Linde AG.


 


WHEREAS, members of
the Linde Group have entered into supply and/or distribution agreements with
INO-T relating to the End Products in the Existing ROW Territories.


 


WHEREAS, pursuant to
the SPA, Holdco has agreed that its wholly owned subsidiary will purchase all
of the issued and outstanding limited liability company membership interests of
INO-T.


 


WHEREAS, the following
agreements were entered into in connection with the SPA:


 


(A)          the Global IP Assignment, the MGH
Partial Assignment Agreement (or the MGH Assignment Agreement) and the AGA
Contracts Assignment Agreements, under which AGA has agreed to assign to INO-T
certain trademarks, patents and patent applications, and its rights and
obligations under certain licenses and other agreements relating to the
manufacture and distribution of NO, and the development of Covox, so that INO-T
is able to continue its existing business in the INO-T Territories and ROW;


 


(B)           the Patent and Know-How License, the
Trademark Co-existence Agreement and, if the MGH Assignment Agreement was
entered into, the MGH Sub-License Agreement so that AGA is able to continue its
existing NO business in the Linde Territories; and


 


(C)           the Existing ROW Amendment Agreement
so that, among other things, the supply and/or distribution agreements between
members of the Linde Group and INO-T relating to the End Products in the
Existing ROW Territories as at the date of this Agreement are extended so that
they have a remaining term of at least 5 Years from the Effective Date.


 


WHEREAS, this
Agreement is the Commercial Agreement referred to in the SPA.  Under this Agreement, INO-T agrees to supply
the Supply Products to the Recipients on the terms of this Agreement.  INO-T also wishes to grant AGA rights of
first refusal to market and sell the End Products in the New ROW
Territories.  In addition, INO-T wishes
to grant AGA the right to apply for Health Registrations for New Indications
and Covox in the Linde Territories. 
Further, INO-T wishes to grant AGA rights of first refusal to market and
sell Covox in ROW.


 


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


 


1.                                      DEFINITIONS AND INTERPRETATION


 


1.1                               Definitions


 


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


 


Adverse Event means any:


 


(a)                                  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:


 

















 


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


 


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


 


(iii)                               associated with, or observed
in conjunction with product abuse; and/or


 


(iv)                              associated with, or observed
in conjunction with product withdrawal; and/or


 


(b)                                 significant failure of
expected pharmacological or biologic therapeutical action (except in clinical trials).


 


Adverse Manufacturing
Changes is defined in Section 21.2(a).


 


Affiliate means, with
respect to any Person, any other Person that controls, is controlled by or is
under common control with such first Person (and for this purpose, the term
control means the power to direct the management and policies of such Person
(directly or indirectly), whether through ownership of voting securities, by
Contract or otherwise (and the terms controlling and controlled have meanings
correlative to the foregoing)).


 


AGA is defined in
the Preamble.


 


AGA Contracts Assignment
Agreements means Contract assignment agreements, dated as of
the date hereof, by and between AGA and INO-T.


 


Ancillary Agreements has the
meaning given in the SPA.


 


Applicable Business is defined in Section 22(a).


 


Applicable Law means any
applicable U.S. or foreign federal, state or local statute, law, ordinance,
regulation, rule, code, order (whether executive, legislative, judicial or
otherwise), judgment, injunction, notice, decree or other requirement or rule of
law or legal process (including common law), or any other order of, or
agreement issued, promulgated or entered into by, any Governmental Entity.


 


Arbitration is defined in Section 18.6(f)(i).


 


Assumed Obligations is defined in Section 23.1(a)(i).


 


Australian Agreement has the
meaning given in the Existing ROW Amendment Agreement.


 


Business Day means any day
on which banks are not required or authorized by Applicable Law to close in the
State of New York or Sweden.


 


cGMPs means the
current Good Manufacturing Practices as promulgated by the FDA and other
Governmental Entities.


 


Change is defined in
Schedule 3.


 


Change Control Note is defined in
Schedule 3.


 


Chief Executives means, in
respect of INO-T, the chief executive of INO-T, and, in respect of AGA, the
head of Linde Gas Therapeutics, from time to time.


 


Confidential Information is defined in Section 17.1(b).


 


Contract means any
written contract, agreement, instrument, lease, license, indenture or
promissory note.


 


2

















 


Cost means the
amount of manufacturing costs (including direct and indirect overhead and
warehousing costs attributable to the manufacturing process) incurred by INO-T
in relation to the relevant Product.


 


Covox means any product
based on the medical use of carbon monoxide that is developed by, or on behalf
of, the INO-T Group (including delivery devices, measurement and calibration
devices and accessories, service and repair parts relating to such devices) in
relation to the rights licensed under the:


 


(a)                                  exclusive license agreement
dated 1 September 2003 between The Beth Israel Deaconess Medical Center, Inc.,
Yale University, Johns Hopkins University and University of Pittsburgh-of the
Commonwealth System of Higher Education and AGA, which was assigned by AGA to
INO-T under the relevant AGA Contracts Assignment Agreement; and/or


 


(b)                                 license agreement between
The Trustees of Columbia University in the City of New York and AGA dated December 18,
2002, which was assigned by AGA to INO-T under the relevant AGA Contracts
Assignment Agreement.


 


Covox Business is defined in Section 22(a)(ii).


 


Dispute means any
dispute, controversy or claim arising out of or in connection with this
Agreement, including any question regarding its existence, validity or
termination.


 


DLNO Gas Product means a gas
mixture containing NO to be used as a diagnostic agent in lung function
testing.


 


Effective Date means the
Closing Date as defined in the SPA.


 


End Date is defined in Section 22(c).


 


End Products means the
Products other than Bulk NO Gas.


 


Exclusivity Period is defined in Section 5(b)(ii).


 


Existing ROW Agreements has the
meaning given in the Existing ROW Amendment Agreement.


 


Existing ROW Amendment
Agreement means an amendment agreement, dated as of the date
hereof, by and between INO-T and 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 Territories means any
country in respect of which a supply and/or distribution agreement for all or
any of the End Products is in force, from time to time, between a member of the
INO-T Group and a member of the Linde Group. 
As of the Effective Date, the Existing ROW Territories are Argentina,
Australia, Chile, Colombia and Uruguay.


 


ICC is defined in Section 18.6(f)(i).


 


FDA means the
United States Food and Drug Administration and any successor entity.


 


FDA Approval means approval
by the FDA for the manufacture, distribution, use or sale of a pharmaceutical
product in the United States of America.


 


First Measuring Year is defined in Section 4.3(a).


 


Force Majeure is defined in Section 23.10.


 


Forecast is defined in Section 10.2(a).


 


3

















 


Global IP Assignment means an
assignment agreement, dated as of the date hereof, by and between AGA and
INO-T.


 


Governmental Entity means any U.S.
or foreign supra-national, federal, state, county, local, municipal or other
governmental, regulatory or administrative authority, agency, commission or
other instrumentality, any court, tribunal or arbitral body with competent
jurisdiction, including the European Commission.


 


Gross Margin means net
sales revenue less manufacturing costs (including direct and indirect overhead
and warehousing costs attributable to the manufacturing process) and transport
costs (neither of which shall include internal administrative costs and selling
costs) and royalties.


 


Gross Sales means the
revenues received by the Linde Group in a Quarter Year from the provision to
third parties of the End Products and related services in the Linde
Territories.


 


Group means, in
relation to INO-T, the INO-T Group and, in relation to AGA, the Linde Group.


 


Health Registrations means the
technical, medical and scientific licenses, registrations, authorizations
and/or approvals of a pharmaceutical producer (including the prerequisite
manufacturing approvals or authorizations, and marketing authorization based
upon those approvals and labeling approvals related to them) that are required
by any national, supra-national, regional, state, provincial or local
Regulatory Authority for the manufacture, distribution, use or sale of a
pharmaceutical product, as amended or supplemented from time to time, including
(in the United States of America) FDA Approval.


 


Holdco is defined in
the Preamble.


 


Ikaria means Ikaria, Inc.,
a Delaware corporation.


 


Initial Term is defined in Section 2.


 


INO Business Sale and
Purchase Agreement means the sale and purchase agreement (INO
Business) by and among INO Holdings LLC, Linde Gas LLC (formerly AGA Gas, Inc.)
and Inoco Inc. and, for limited purposes, AGA, Becton Dickinson and Company and
Instrumentarium Corporation, dated as of July 20, 1998.


 


INO-T is defined in
the Preamble.


 


INO-T Election Date is defined in Section 22(a).


 


INO-T  Election Notice is defined in Section 22(a).


 


INO-T Group means INO-T
and/or all or any of its Affiliates, other than AGA and its Affiliates, from
time to time (it being agreed that an Affiliate of AGA that is also an
Affiliate of INO-T shall not be considered part of the INO-T Group hereunder if
such Person is an Affiliate of INO-T solely as a result of (a) the
ownership of equity securities, or having the right to nominate and elect
members of the board of directors, of Ikaria Holdings, Inc.; (b) having
rights under any Ancillary Agreement; or (c) any combination thereof).


 


INO-T Pharmacovigilance
Database means the database maintained by, or on behalf of,
the INO-T Group relating to pharmacovigilance, as amended and updated from time
to time.


 


INO-T Territories means the
United States of America, Canada and Mexico.


 


JC Members is defined in Section 14.1(a).


 


Joint Committee is defined in Section 14.1(a).


 


Linde AG means
Linde AG, a German Aktiengesellschaft.


 


4

















 


Linde Group means AGA
and/or all or any of its Affiliates, other than INO-T and its Affiliates (it
being agreed that an Affiliate of AGA that is also an Affiliate of INO-T shall
be considered part of the Linde Group hereunder if such Person is an Affiliate
of INO-T solely as a result of (a) the ownership of equity securities, or
having the right to nominate and elect members of the board of directors, of
Ikaria Holdings, Inc.; (b) having rights under any Ancillary
Agreement; or (c) any combination thereof).


 


Linde Territories means Albania,
Andorra, Armenia, Austria, Azerbaijan, Azores, Belarus, Belgium,
Bosnia-Herzegovina, Bulgaria, Canary Islands, Channel Islands, Croatia, Cyprus,
Czech Republic, Denmark, Estonia, Faeroe Islands, Finland, France, Georgia,
Germany, Gibraltar, Greece, Greenland, Hungary, Iceland, Ireland, Isle of Man,
Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Macedonia, Madeira, Malta,
Moldova, Monaco, Netherlands, Norway, Poland, Portugal, Republic of Montenegro,
Romania, Russian Federation, Serbia, Slovak Republic, Slovenia, Spain, Sweden,
Switzerland, Turkey, Ukraine and United Kingdom.


 


Loss means direct
loss, liability, claim, damage or expense, including reasonable and documented
legal fees and expenses incurred in connection therewith.


 


Marketing Authorization means a Health
Registration for:


 


(a)                                  the whole of the European
Union (as it may be constituted from time to time);


 


(b)                                 France;


 


(c)                                  Germany;


 


(d)                                 Sweden; or


 


(e)                                  the United Kingdom.


 


MGH Assignment Agreement means the
assignment agreement to be entered into in the circumstances set out in the SPA
by and between AGA and INO-T.


 


MGH Partial Assignment Agreement means the
partial assignment agreement to be entered into in the circumstances set out in
the SPA by and between AGA and INO-T.


 


MGH Sub-License Agreement means the
sub-license agreement, relating to the MGH Assignment Agreement, to be entered
into in the circumstances set out in the SPA by and between AGA and INO-T.


 


New Delivery Devices is defined in Section 6.1(a).


 


New Indication means any
medical use of NO for inhalation other than that for which INOmax is the
subject of a Health Registration as at the Effective Date.


 


New Products means new
medical products (other than the Products and Covox) that are being developed
by the Linde Group and/or the INO-T Group that are about to enter, or have
entered, phase three clinical studies.


 


New ROW Territories means any
country in ROW, except for Existing ROW Territories, from time to time.


 


NO means nitric
oxide.


 


NO Business is defined in Section 22(a)(i).


 


Notice Date is defined in Section 22(a).


 


Outside Closing Date is defined in Section 22(b)(ii)(B).


 


5

















 


Participants means INO-T,
AGA and Holdco and Participant means INO-T, AGA
or Holdco (as the case may be).


 


Parties means INO-T
and AGA, and Party means INO-T or AGA (as
the case may be).


 


Patent and Know-How
License means the patent and know-how license agreement,
dated as of the date hereof, by and between INO-T and AGA.


 


Person means any
individual or any corporation, limited liability company, partnership, trust,
association or other entity of any kind.


 


Preamble means the
preamble to this Agreement.


 


Products are defined in
Schedule 1.


 


Quarter Year means a Year
ending on March 31, June 30, September 30, or December 31.


 


Recipient means AGA and
any other member of the Linde Group nominated by AGA.


 


Referral Notice is defined in Section 18.6(a).


 


Referring Party is defined in Section 18.6(a).


 


Regulatory Authority means the
applicable Governmental Entity regulatory authority involved in granting Health
Registrations for all and any of the Products.


 


Renewed Term is defined in Section 2.


 


Representatives means the
chief executive of INO-T in respect of INO-T, and the Head of Linde Gas
Therapeutics in respect of AGA.


 


ROFR is defined in Section 5(b).


 


ROW means a
country that is not in the INO-T Territories or in the Linde Territories.


 


Rules is defined in Section 18.6(f)(i).


 


Sales Related Payment is defined in Section 4.3(a).


 


Scott Medical Supply
Agreement means the supply agreement by and between Scott
Medical Products, Inc. and AGA in relation to calibration gases, dated November 22,
2004, as amended and assigned to INO-T.


 


SPA means the sale
and purchase agreement dated as of February 22, 2007 by and among Linde
Gas, Inc., Linde AG, Holdco, Ikaria Acquisition Inc. and Ikaria.


 


Specifications means, in relation
to each Product, the specification for that Product as at the Effective Date,
as notified by AGA to INO-T.


 


Standards means, in
relation to each Product, the standard for that Product as at the Effective
Date, as notified by AGA to INO-T.


 


Supply Products means the
Products other than INOmax.


 


Target Territory is defined in Section 5(b)(i).


 


Term means the Term
of this Agreement pursuant to Section 2.


 


6














 


Territory means, in
relation to the INO-T Group, the INO-T Territories and, in relation to the
Linde Group, the Linde Territories.


 


Trademark Co-existence
Agreement means the trademark co-existence agreement, dated
as of the date hereof, by and between INO-T and AGA.


 


Transferred Rights is defined in Section 23.1(a)(ii).


 


Ventek Agreement means the
joint development agreement between INO-T and Controlink, LLC, dated June 1,
2001.


 


Viasys Settlement
Agreement means the agreement, dated May 13, 2004,
between AGA, INO-T, The General Hospital Corporation doing business as
Massachusetts General Hospital, Pulmonox Medical, Inc. and SensorMedics
Corporation as amended by a side letter of May 24, 2005, and as further
amended by a Binding Term Sheet for DLNO Collaboration of December 23,
2005, the terms of which replaced Section 9 of the May 13, 2004
agreement.


 


Year means a period
of twelve months commencing at any time during a calendar year.


 


1.2                               Interpretation:


 


In This Agreement:


 


(a)                                  the definitions of terms in
this Agreement shall apply equally to the singular and plural forms of the
terms defined;


 


(b)                                 any pronoun shall include
the corresponding masculine, feminine and neuter forms;


 


(c)                                  the words “include”, “includes”
and “including” shall be deemed to be followed by the phrase “without
limitation”;


 


(d)                                 the word “will” shall be
construed to have the same meaning and effect as the word “shall”;


 


(e)                                  any definition of or
reference to any Contract or other record in this Agreement shall be construed
as referring to such Contract or other record as from time to time amended,
supplemented, restated or otherwise modified (subject to any applicable
restrictions on such amendments, supplements or modifications);


 


(f)                                    any reference in this
Agreement to any Person shall be construed to include such Person’s successors
and permitted assigns;


 


(g)                                 the words “herein”, “hereof”
and “hereunder”, and words of similar import, shall be construed to refer to
this Agreement in its entirety and not to any particular provision hereof;


 


(h)                                 all references in this
Agreement to Sections, Exhibits and Schedules shall be construed to refer to
Sections of, and Exhibits and Schedules to, this Agreement; and


 


(i)                                     the headings, captions and
defined terms used in this Agreement are for convenience of reference only and
are not to affect the construction of or to be taken into consideration in
interpreting this Agreement.


 


2.                                      TERM


 


This Agreement shall
commence on the Effective Date and continue up to and including the date that
is twenty (20) Years from the Effective Date (the Initial
Term), unless terminated earlier in accordance with Section 18.  At the end of the Initial Term, or any
subsequent term following a renewal under this Section 2 (a Renewed Term), this Agreement shall
be renewed automatically for a period of one Year unless either Party serves
written notice on the 


 


7

















 


other Party to that effect
no later than eighteen (18) months before the expiry of the Initial Term or the
Renewed Term, as the case may be.


 


3.                                      SUPPLY OF SUPPLY PRODUCTS FOR LINDE TERRITORIES


 


With effect from the
Effective Date, INO-T shall sell, and the Recipients shall purchase, such
quantities of the Supply Products as may be ordered by the Recipients from time
to time under Section 10.


 


4.                                      NEW INDICATIONS FOR LINDE TERRITORIES


 


4.1                               Development
Activities


 


(a)                                  INO-T shall keep AGA
informed of the progress of INO-T Group’s development activities relating to
New Indications.


 


(b)                                 INO-T shall not unreasonably
refuse to adapt INO-T Group’s plans for those development activities if AGA
notifies INO-T that any adaptation would, in AGA’s reasonable opinion, improve
the chances of obtaining Health Registrations for the New Indication in one or
more of the Linde Territories, without adversely affecting the chances of
obtaining such Health Registrations in the INO-T Territories.  If requested by AGA, INO-T shall meet with
AGA to discuss proposed adaptations.  AGA
shall pay INO-T’s reasonable costs associated with any such adaptation
implemented by INO-T.


 


4.2                               Health
Registration Applications


 


(a)                                  INO-T shall not, and shall
cause the INO-T Group not to, object to the Linde Group applying for Health
Registrations for New Indications in the Linde Territories.


 


(b)                                 In respect of any New
Indications for which the INO-T Group is in possession of, or has access to,
data reasonably sufficient for obtaining, and intends to apply for, a Health
Registration outside the Linde Territories, INO-T shall, except following a
transfer pursuant to Section 4.2(c)(ii):


 


(i)                                     give the Linde Group access
to all data and documentation relating to the New Indication that are in the
possession of, or otherwise accessible by, the INO-T Group;


 


(ii)                                  ensure that all data and
documentation that the INO-T Group possesses or has access to, that may be
requested by any Regulatory Authority in the Linde Territories, are maintained
in such a way that the Linde Group can promptly respond to such requests in an
appropriate manner; and


 


(iii)                               if requested by AGA, at AGA’s
cost, provide reasonable support and carry out such further studies in relation
to those New Indications as are required for submissions to Regulatory
Authorities in the Linde Territories.


 


(c)                                  In the event that the INO-T
Group decides that it no longer wishes to maintain data or documentation in
relation to a New Indication, INO-T shall, no later than:


 


(i)                                     [**] months prior to the
cessation of that maintenance, notify AGA that it so wishes; and


 


(ii)                                  [**] months prior to the
cessation of that maintenance transfer to AGA, or a member of the Linde Group
nominated by AGA, a copy of all data and originals of all documentation
(together with the right for the Linde Group to use that data and documentation
in any way whatsoever) that the INO-T Group possesses or has access to in
relation to that New Indication, in a format reasonably requested by AGA.


 


8

















 


4.3                               Sales Related
Payment


 


(a)                                  Subject to Section 4.3(b) and
the remainder of this Section 4.3(a), if the Linde Group obtains a
Marketing Authorization for a New Indication and commences the sale of End
Products for that New Indication, AGA shall pay INO-T an amount equal to [**]
percent ([**]%) of the amount by which Gross Sales for the Quarter Year in
question exceeded [**] euros (€[**]) (with the first Quarter Year in which the
Linde Group sells End Products for that New Indication and Gross Sales exceed
[**] euros (€[**]) being referred to as the First
Measuring Year).  Such
amount shall:


 


(i)                                     be due and payable on or
before the earliest of March 31, June 30, September 30, or December 31
of the Year following the Quarter Year in question, with the first such payment
due on March 31, June 30, September 30, or December 31 of
the Year following the First Measuring Year (and, for the avoidance of doubt,
relating to the First Measuring Year);


 


(ii)                                  only be required to be paid
in respect of the five consecutive Quarter Years commencing with the First
Measuring Year (with the last payment due, if at all, on the earliest of March 31,
June 30, September 30, or December 31 of the Year following such
fifth consecutive Quarter Year); provided that if the Linde Group
obtains a Marketing Authorization for any further New Indication during those
five consecutive Quarter Years commencing with the First Measuring Year, then
such amount shall be payable through the later of five consecutive Quarter
Years commencing with the:


 


(A)                              First Measuring Year; and


 


(B)                                Quarter Year in which the
Marketing Authorization for the further New Indication was obtained by the
Linde Group; and


 


(iii)                               be paid in euros by wire
transfer of immediately available funds to an account designated in writing by
INO-T.


 


The payment contemplated by
this Section 4.3(a) is referred to herein as the Sales
Related Payment.


 


(b)                                 The Sales Related Payment
shall be reduced to the extent, that (if applicable) royalties are payable by
all and any members of the Linde Group under Section 8 of the Viasys
Settlement Agreement in relation to Gross Sales; provided
that, such reduction shall not exceed [**] of the Sales Related
Payment that would be due in relation to such Gross Sales absent any such
royalties payable under Section 8 of the Viasys Settlement Agreement.


 


(c)                                  From the date on which the
first Sales Related Payment is due and payable under Section 4.3(a), the
Parties acknowledge that all amounts payable by the Linde Group to the INO-T
Group pursuant to the Existing ROW Agreements other than the Australian
Agreement shall be reduced by [**] in accordance with the Existing ROW
Amendment Agreement.


 


5.                                      RIGHT OF FIRST REFUSAL FOR NEW ROW TERRITORIES


 


(a)                                  INO-T shall not, and shall
cause the INO-T Group not to, sell the End Products (whether for a use that is
the subject of a Health Registration existing as at the Effective Date in any
territory, or for a New Indication) to a third party distributor that is not a
member of the INO-T Group or the Linde Group in any of the New ROW Territories
unless the provisions of this Section 5 have been complied with.


 


(b)                                 INO-T grants AGA, or a
member of the Linde Group nominated by AGA, a right of first refusal (ROFR) to be appointed as the
exclusive distributor of the End Products (for uses that are the subject of
Health Registrations existing as at the date of this Agreement in any territory,
and for New Indications) in the New ROW Territories on the following basis:


 


9

















 


(i)                                     INO-T shall provide written
notice to AGA of its intention to appoint a third party distributor (that is
not a member of the INO-T Group or the Linde Group) of the End Products in a
country or countries (the Target Territory);


 


(ii)                                  immediately following
receipt of that notice by AGA, INO-T shall grant AGA, and/or the nominated
member of the Linde Group, a [**] days’ period of exclusivity for negotiation
of an exclusive distribution agreement for End Products in the Target Territory
(the Exclusivity Period);


 


(iii)                               during the Exclusivity
Period, AGA, and/or the nominated member of the Linde Group, and INO-T shall
endeavor to enter into an exclusive distribution agreement for End Products in
the Target Territory;


 


(iv)                              INO-T shall provide AGA with
a written copy of the full principal terms on which INO-T wishes to enter into
an exclusive distribution agreement, including regarding the term and
termination of the agreement, its territorial scope, the exclusive rights
granted, noncompetition obligations, payments (including royalties, costs of
Products and profit sharing) and any minimum purchase obligations:


 


(A)                              within [**] days of the
start of the Exclusivity Period; and


 


(B)                                on the [**] day (or, if that
is not a Business Day, the next Business Day) following the start of the
Exclusivity Period,


 


unless, by each respective
date (I) INO-T and AGA, and/or the nominated member of the Linde Group,
have entered into an exclusive distribution agreement for the End Products in
the Target Territory; or (II) AGA has, by written notice to INO-T, waived
the ROFR contemplated by this Section 5 in respect of the Target
Territory;


 


(v)                                 if:


 


(A)                              INO-T and AGA, and/or the
nominated member of the Linde Group, have not entered into such an exclusive
distribution agreement by the end of the Exclusivity Period; or


 


(B)                                AGA, by written notice to
INO-T, waives the ROFR contemplated by this Section 5 in respect of the
Target Territory,


 


then the ROFR contemplated
by this Section 5 shall cease to apply in respect of the Target Territory
and, for a period of [**] days from the date on which the Exclusivity Period
expires or, if earlier, the date of any such waiver notice by AGA to INO-T,
INO-T shall be free to enter into a distribution agreement for End Products for
the Target Territory with another Person, in a form no less favorable to INO-T
than the principal terms proposed by INO-T in accordance with Section 5(b)(iv)(B) and
rejected or (by expiration of the Exclusivity Period) deemed rejected by AGA.


 


(vi)                              if such a distribution
agreement with any other Person is:


 


(A)                              not entered into within such
[**] days’ period; or


 


(B)                                entered into within such
[**] days’ period and that agreement expires or is terminated,


 


any subsequent proposed sale
to, or appointment of, a third party distributor of End Products in the Target
Territory shall again be subject to the ROFR in favor of AGA in this Section 5.


 


(c)                                  For the avoidance of doubt,
if AGA elects not to exercise its ROFR to be appointed as the exclusive
distributor of the End Products in a Target Territory pursuant to Section 5(b),
and INO-T enters into an 


 


10

















 


agreement with a third party in accordance with Section 5(b), AGA
shall not be entitled to any ROFR for New Indications in that Target Territory.


 


6.                                      NEW DELIVERY DEVICES


 


6.1                               Notice of New
Delivery Devices


 


(a)                                  INO-T shall from time to
time provide AGA with details of its development program for new or successor
delivery devices that are intended to replace INOvent (New
Delivery Devices).


 


(b)                                 No later than the date on
which the INO-T Group commences the sale of the New Delivery Devices in an
INO-T Territory, INO-T shall offer the Recipients the right to purchase the New
Delivery Devices on a cost plus [**] percent ([**]%) basis under, subject to Section 6.1(c),
the terms and conditions of this Agreement applicable to INOvents; for the
avoidance of doubt, after such date, Recipients (in their absolute discretion)
may choose to purchase INOvents (subject to the limitations set forth in Section 10.1(c)(ii))
and/or New Delivery Devices (subject to Section 6.1(c)).


 


(c)                                  INO-T shall:


 


(i)                                     consult with AGA (including
via the Joint Committee), from time to time (as appropriate) and when requested
by AGA, in relation to its program for the roll-out of New Delivery Devices;


 


(ii)                                  take into account the
requirements (including regarding quantity and delivery time) of the Recipients
for New Delivery Devices;


 


(iii)                               use commercially reasonable
efforts to enter into one or more Contracts pursuant to which one or more third
parties shall supply to INO-T sufficient New Delivery Devices to enable INO-T
to meet the requirements (including regarding quantity and delivery time) of
the Recipients; and


 


(iv)                              in the event that it has
complied with its obligations set out in Sections 6.1(c)(i) to 6.1(c)(iii) and
is nevertheless unable to supply the Recipients with their requirements for New
Delivery Devices, use commercially reasonable efforts to meet their
requirements itself and, if requested by AGA, use commercially reasonable
efforts to find an alternative supplier of New Delivery Devices in order that
their requirements (including regarding quantity and delivery time) for New
Delivery Devices can be met,


 


provided that, if despite
INO-T’s compliance with Sections 6.1(c)(i)-(iv) above, the available
supply of New Delivery Devices is inadequate to satisfy the requirements of both
INO-T and the Recipients, the supply requirements of INO-T shall be given
priority, and further provided that INO-T shall
satisfy the Recipients’ requirements for New Delivery Devices as soon as such
shortage in supply is ameliorated.


 


6.2                               Regulatory Requirements
for New Delivery Devices


 


AGA shall bear the costs of
implementing the requirements (including CE marking) of Regulatory Authorities
to the extent that they relate exclusively to putting New Delivery Devices on
the market in the Linde Territories.


 


7.                                      COVOX


 


7.1                               Health
Registrations in Linde Territories


 


(a)                                  INO-T shall not, and shall
cause the INO-T Group not to, object to the Linde Group applying for, Health
Registrations for Covox in the Linde Territories.


 


11

















 


(b)                                 If the INO-T Group is in
possession of, or has access to, data reasonably sufficient for obtaining, and
intends to apply for, a Health Registration for Covox outside the Linde
Territories, INO-T shall, except following a transfer pursuant to Section 7.1(d)(ii):


 


(i)                                     give the Linde Group access
to all data and documentation relating to Covox that are in the possession of,
or otherwise accessible by, the INO-T Group;


 


(ii)                                  ensure that all data and
documentation that the INO-T Group possesses or has access to, that may be
requested by any Regulatory Authority in the Linde Territories, are maintained
in such a way that the Linde Group can promptly respond to such requests in an
appropriate manner; and


 


(iii)                               if requested by AGA, at AGA’s
cost, provide reasonable support and carry out such further studies in relation
to Covox as are required for submissions to Regulatory Authorities in the Linde
Territories.


 


(c)                                  INO-T shall make Covox
available for purchase by the Recipients from the INO-T Group for the Linde
Territories on, subject to Section 7.3, substantially the same terms and
conditions as the Supply Products are supplied to the Recipients under this
Agreement.


 


(d)                                 In the event that the INO-T
Group decides that it no longer wishes to maintain data or documentation in
relation to Covox, INO-T shall, no later than:


 


(i)                                     [**] months prior to the
cessation of that maintenance, notify AGA that it so wishes; and


 


(ii)                                  [**] months prior to the
cessation of that maintenance transfer to AGA, or a member of the Linde Group
nominated by AGA, a copy of all data and originals of all documentation
(together with the right for the Linde Group to use that data and documentation
in any way whatsoever) that the INO-T Group possesses or has access to in relation
to Covox, in a format reasonably requested by AGA.


 


7.2                               Marketing,
Sales and Logistics in the Linde Territories


 


If the Linde Group obtains
Health Registrations for Covox in the Linde Territories, AGA shall, and shall
cause each applicable member of the Linde Group to, for as long as commercially
practicable, maintain a marketing, sales and logistics operation in the
relevant Linde Territories of a size and capacity that allows it to
commercialize Covox in those Linde Territories.


 


7.3                               Royalties for
sales in the Linde Territories


 


The Parties shall agree on a
royalty structure that results [**] the INO-T Group and the Linde Group of the
Gross Margin generated by the sale by the Linde Group of Covox in the Linde
Territories.  For the avoidance of doubt,
Section 4.3 shall not apply to the rights and obligations of the Parties
in relation to Covox.


 


7.4                               ROFR as
Distributor in ROW


 


All of the provisions of Section 5
shall apply to the appointment of a third party distributor by the INO-T Group
for Covox in ROW, mutatis mutandis,
and as if that Section referred to ROW instead of the New ROW
Territories.  If a member of the Linde
Group becomes a distributor for INO-T of Covox in a Target Territory, the
Parties shall agree a royalty structure that results [**] the INO-T Group and
the Linde Group of the Gross Margin generated by the sale by the Linde Group of
Covox in such Target Territory.


 


7.5                               Milestones


 


AGA shall pay INO-T [**]
dollars ($[**]) upon receipt by the Linde Group of the first Marketing
Authorization for Covox.


 


12

















 


8.                                      NEW PRODUCTS AND NO DISSOLVED IN LIQUID


 


8.1                               New Products


 


(a)                                  INO-T shall notify AGA of
New Products that the INO-T Group is developing, and keep AGA informed
regarding the progress of clinical trials and the status of applications and
proposed applications for Health Registrations for those New Products, for the
purpose of discussing whether the Parties wish to pursue a commercial
relationship for such New Products, provided that that notification shall be
subject to the restrictions set out in Section 17.1.


 


(b)                                 AGA shall notify INO-T of
New Products that the Linde Group is developing, and keep INO-T informed
regarding the progress of clinical trials and the status of applications and proposed
applications for Health Registrations for those New Products, for the purpose
of discussing whether the Parties wish to pursue a commercial relationship for
such New Products, provided that that notification shall be subject to the
restrictions set out in Section 17.1.


 


8.2                               NO Dissolved in
Liquid


 


(a)                                  Until the date that is [**]
months from the Effective Date, AGA shall not, and shall cause the Linde Group
not to, negotiate or enter into, or attempt to negotiate or enter into, any
Contract with Lars Gustafson of Sweden relating to a patent application made
before the Effective Date concerning the medical use of NO dissolved in
liquid.  If INO-T does not enter into
such a Contract with Mr. Gustafson within [**] months from the Effective
Date:


 


(i)                                     INO-T shall promptly provide
AGA with an update concerning negotiations undertaken with Mr. Gustafson
and AGA and INO-T will discuss in good faith the most effective way to conduct
any further negotiations with Mr. Gustafson; and


 


(ii)                                  in the event that INO-T has
initiated Contract negotiations with Mr. Gustafson and reasonably believes
that it will enter into such a Contract with Mr. Gustafson within a
further [**] months, and so notifies AGA, AGA shall not, and shall cause the
Linde Group not to, negotiate or enter into, or attempt to negotiate or enter
into, any Contract with Mr. Gustafson during those further [**] months.


 


(b)                                 For the avoidance of doubt,
nothing in this Agreement shall prevent the Linde Group from negotiating and/or
entering into such a Contract after the period specified in Section 8.2(a) and
AGA shall not be subject to any obligations under Section 17.1 in relation
to the subject-matter of that Contract.


 


(c)                                  If the INO-T Group and/or
the Linde Group enter into such a Contract with Mr. Gustafson, AGA and
INO-T contemplate that they will enter into a further Contract with each other
to provide for the mutual commercial benefit (including negotiating in good
faith appropriate intellectual property licenses) of the Linde Group and the
INO-T Group, pursuant to which the Linde Group would commercialize the
subject-matter of Mr. Gustafson’s patent technology in the Linde
Territories, and the INO-T Group would commercialize the subject-matter of Mr. Gustafson’s
patent technology in the INO-T Territories.


 


9.                                      COMPLIANCE AUDITS; GOVERNMENT INSPECTION


 


9.1                               Compliance
Audits


 


(a)                                  Each Party (or its nominated
representatives) shall have the right, during normal business hours and with
reasonable prior notice, to visit any of the other Party’s (or the relevant
members of that Party’s Group’s, or suppliers’) facilities utilized or to be
utilized in the manufacture, storage, distribution and/or handling of the
Supply Products (in respect of INO-T) or End Products (in respect of AGA), with
or without cause, to inspect for compliance with requirements of Regulatory
Authorities and Applicable Laws, including cGMPs, the Specifications and the
Standards.


 


13

















 


(b)                                 The Parties’ respective
quality assurance departments shall cooperate with each other, as necessary and
useful, in any inspection conducted pursuant to this Agreement.


 


(c)                                  INO-T shall permit AGA’s
representatives to access systems, documents and records associated with the
manufacture of the Supply Products, and allow them to make such copies (or
provide them with electronic copies) as are reasonably necessary for the
purpose of assessing compliance with requirements of Regulatory Authorities and
Applicable Laws, including cGMPs, the Specifications and the Standards.


 


9.2                               Regulatory
Inspection


 


Each Party shall notify the
other as soon as reasonably practicable following any threatened inspection by
a Regulatory Authority in relation to the Products.


 


10.                               SUPPLY OF SUPPLY PRODUCTS


 


10.1                        Supply


 


(a)                                  INO-T may manufacture Bulk
NO Gas for the Recipients at any FDA-approved facility, provided that INO-T
shall provide AGA with at least [**] months’ written notice before commencing
to supply Bulk NO Gas from any facility other than its Port Allen manufacturing
plant located at Baton Rouge as at the date of this Agreement.


 


(b)                                 The Linde Group shall not be
obligated to purchase any minimum quantity of the Supply Products from INO-T.


 


(c)                                  INO-T shall manufacture and
supply those quantities of the Supply Products that the Recipients require for
the Linde Territories, provided that INO-T shall not be required to supply:


 


(i)                                     Bulk NO Gas to the
Recipients in the event that INO-T:


 


(A)                              gives AGA at least [**]
months’ written notice that it will cease to supply Bulk NO Gas in the INO-T
Territories and so ceases; and


 


(B)                                uses commercially reasonable
efforts to assist (in AGA’s absolute discretion):


 


(I)                                    the Recipients to find, and
transition to, an alternative supplier of Bulk NO Gas in order that their
requirements (including regarding quantity and delivery time) for Bulk NO Gas
can be met; and/or


 


(II)                                if AGA so requests, the
Linde Group to develop operational facilities for the manufacture of Bulk NO
Gas prior to the expiry of the [**] months’ period referred to in Section 10.1(c)(i)(A),
including by promptly providing, and causing the INO-T Group promptly to
provide, to the Linde Group all relevant training, know-how, data,
documentation, and other assistance; and/or


 


(ii)                                  any Supply Product other
than Bulk NO Gas to the Recipients in the event that INO-T:


 


(A)                              gives AGA at least [**]
written notice that it will cease to supply that Supply Product in the INO-T
Territories and so ceases; and


 


(B)                                uses commercially reasonable
efforts to assist the Recipients to find, and transition to, an alternative
supplier of that Supply Product in order that their requirements (including
regarding quantity and delivery time) for that Supply Product can be met.


 


(d)                                 Without prejudice to Section 3
and the other provisions of Section 10 if because:


 


14

















 


(i)                                     of Force Majeure;


 


(ii)                                  a Regulatory Authority takes
any action the result of which is to prohibit the manufacture, sale or use or
any similar action of any of the Products, or any materials contained in them,
in the United States of America and/or the Linde Territories; or


 


(iii)                               of reasons (including a
shortage of Supply Products) otherwise outside its control,


 


a Party is unable to comply,
in whole or in part, with its obligations pursuant to Section 3 and the
other provisions of Section 10, the Parties shall (I) (subject to Section 23.10)
use their respective reasonable commercial efforts to eliminate, cure and
overcome any such causes and to allow the resumption of performance of that
Party’s obligations with all possible speed; and (II) confer in good faith
to reach a commercially reasonable resolution under which the supply needs of
the Recipients and INO-T are most fairly satisfied.


 


(e)                                  AGA shall, and shall cause
the Recipients to, purchase Supply Products from INO-T solely for medical
use.  In the event that any Recipient
wishes to purchase Supply Products or other NO-related products from INO-T for
non-medical uses, the Parties will discuss the possibility of INO-T supplying
such Supply Products or other NO-related products to Recipients for non-medical
uses.  For the avoidance of doubt,
nothing in this Agreement shall restrict the purchase by the Linde Group of
Supply Products from a Person other than INO-T (including for non-medical use(s)).


 


10.2                        Forecasts


 


(a)                                  AGA shall provide to INO-T
on or before the first day of each calendar quarter during the Term with a
rolling [**] month forecast of the Recipients’ anticipated requirements for the
Supply Products (the Forecast).  Any forecast provided before the Effective
Date shall be deemed not to be a binding commitment.


 


(b)                                 The requirements specified
for the first [**] months of each Forecast shall represent a binding commitment
by AGA (or the relevant Recipient) to purchase and pay for the Supply Products
specified in it.  The last [**] months of
the Forecast shall represent estimates and shall be non-binding.


 


10.3                        Orders


 


(a)                                  In respect of the
requirements specified for the first [**] months of each Forecast, AGA (or the
relevant Recipient) shall place binding purchase orders that shall set out the
required quantity of the Supply Products, proposed delivery dates and shipping
instructions for each shipment of the Supply Products.  Binding purchase orders for the Supply
Products shall be placed by AGA (or the relevant Recipient) in writing by the
[**] day of each calendar month (or the next applicable business day) and
supplemental binding purchase orders may be placed thereafter.


 


(b)                                 INO-T shall provide AGA (or
the relevant Recipient) with written confirmation of all purchase orders within
[**] days of receipt.  Confirmations
shall set out the quantities ordered by AGA (or the relevant Recipient) and
specify delivery dates for all quantities which shall be no later than [**]
days from the date of the relevant purchase order.


 


(c)                                  Subject to Section 10.1,
INO-T shall supply to the Recipients quantities of the Supply Products for a
given calendar quarter that are up to [**]% of AGA’s (or the relevant Recipient’s)
most recent Forecast for that calendar quarter. 
INO-T shall use commercially reasonable efforts to supply excess
quantities to the extent practicable.


 


15

















 


10.4                        Manufacturing


 


(a)                                  INO-T shall ensure that all
Supply Products provided to the Recipients by the INO-T Group shall meet the
Specifications, the Standards and all Supply Product specifications set out in
the Health Registrations and be manufactured in compliance with all Applicable
Laws, including cGMPs.


 


(b)                                 INO-T Shall ensure that the
Bulk NO Gas supplied by it shall have a minimum remaining shelf-life of at
least [**] months from the date of delivery.


 


10.5                        Shipments


 


All shipments of Supply
Products to AGA (or the relevant Recipient) shall be shipped in accordance with
international transport regulations and guidelines, CPT (Incoterms 2000) the
relevant port in the Linde Territories specified by AGA or the relevant
Recipient.  Title to the Supply Products
will pass when delivered to the relevant carrier and, for the avoidance of doubt,
before entry to the country of destination. 
The Recipient will be the importer of record.


 


11.                               FINANCIAL TERMS


 


11.1                        Supply of
Supply Products by INO-T to the Recipients


 


INO-T shall supply the
following Supply Products at the following prices to the Recipients in
accordance with the terms of this Section 11:


 


(a)                                  Bulk NO Gas: [**];


 


(b)                                 INOvent: [**];


 


(c)                                  INOvent Accessories: [**];


 


(d)                                 INOcal Gas:


 


(i)                                     for INOcal Gas purchased by
INO-T pursuant to the Scott Medical Supply Agreement, [**] for that INOcal Gas
pursuant to that agreement; or


 


(ii)                                  for INOcal Gas purchased by
the INO-T Group other than as described in Section 11.1(d)(i), [**] for
that INOcal Gas pursuant to the relevant agreement; or


 


(iii)                               for INOcal Gas manufactured
by INO-T, [**]; and


 


(e)                                  INOmeters:


 


(i)                                     for INOmeters purchased by
INO-T pursuant to the Ventek Agreement, [**] for INOmeters pursuant to that
agreement; or


 


(ii)                                  for INOmeters purchased by
the INO-T Group other than as described in Section 11.1(e)(i), [**] for
those INOmeters pursuant to the relevant agreement; or


 


(iii)                               for INOmeters manufactured
by INO-T, [**].


 


11.2                        Fixed price
invoicing


 


(a)                                  No later than [**] of each
calendar year the Parties shall agree on the:


 


16














 


(i)                                     price for Bulk NO Gas, and
any other Supply Product manufactured by INO-T, for the upcoming calendar year
that will be invoiced by INO-T; and


 


(ii)                                  amount by which the
Recipients have overpaid or underpaid for those Supply Products supplied by
INO-T during the previous calendar year (by comparing the invoiced price with
the actual price calculated in accordance with Section 11.1), and payment
shall be made by the relevant Party of such overpayment or underpayment within
[**] days thereafter.


 


(b)                                 INO-T shall:


 


(i)                                     at AGA’s request, provide
AGA with evidence reasonably sufficient to document any increase or decrease in
Cost; and


 


(ii)                                  promptly notify AGA,
providing full particulars, if it becomes aware that the amount by which the
Recipients will, or are likely to, overpay or underpay for Supply Products
pursuant to Section 11.2(a) exceeds [**] dollars ($[**]) in any
calendar year.


 


11.3                        Payment period
and disputed payments


 


(a)                                  Without prejudice to AGA’s
liability to pay any amounts pursuant to the Patent and Know-How License, the
purchase price for the Products shall be paid in full by AGA (or the relevant
Recipient) within [**] days of receipt of an undisputed invoice from INO-T.


 


(b)                                 If AGA (or the relevant
Recipient) receives an invoice from INO-T which it reasonably believes includes
a sum which is not valid and properly due:


 


(i)                                     AGA (or the relevant
Recipient) shall notify INO-T in writing as soon as reasonably practicable;


 


(ii)                                  promptly following receipt
of AGA’s (or the relevant Recipient’s) notice under Section 11.3(b)(i),
INO-T shall notify AGA (or the relevant Recipient) whether or not it believes
that that invoiced sum is valid and properly due and:


 


(A)                              if it so believes, the
matter shall be referred for resolution in accordance with Section 18.6;
or


 


(B)                                if it does not so believe,
INO-T shall revise and reissue that invoice accordingly;


 


(iii)                               AGA’s (or the relevant
Recipient’s) failure to pay any amount in dispute shall not be deemed to be a
breach of this Agreement;


 


(iv)                              AGA (or the relevant
Recipient) shall pay the balance of the invoice which is not in dispute by the
date specified in Section 11.3(a); and


 


(v)                                 once any such dispute has
been resolved, where either Party is required to make a balancing payment, it
shall do so within [**] days.


 


11.4                        United Stated
Dollars


 


All references to dollars in
this Agreement refer to United States currency. 
Unless otherwise stated in this Agreement (including in Sections 4.3(a) to
4.3(b), pursuant to which payments (if payable) shall be made in euros), AGA or
the relevant member of the Linde Group 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.


 


17

















 


11.5                        Return of
Cylinders


 


Each Bulk NO Gas cylinder
shall be returned by AGA (or the relevant member of the Linde Group) to INO-T
within [**] months of the completion of the cylinder’s use by AGA (or the
relevant member of the Linde Group).


 


12.                               OWNERSHIP OF HEALTH REGISTRATIONS, LINDE GROUP KNOW-HOW OR
MANUFACTURING DATA


 


(a)                                  Nothing in this Agreement or
otherwise transfers any rights to the INO-T Group in any of the following to
the extent that they are, as at the date of this Agreement, owned by the Linde
Group (all of which are, and remain, proprietary to the Linde Group):


 


(i)                                     Health Registrations in the
Linde Territories;


 


(ii)                                  marketing data relating to
the Linde Territories; and


 


(iii)                               other related know-how or
materials including pre-clinical, clinical, manufacturing, reporting and recall
data relating to the Linde Territories,


 


provided that, to the extent
any of the data identified above relates also to the INO-T Territories or ROW,
Linde shall, at INO-T’s request, provide INO-T with a copy of such data, which
data shall be co-owned by AGA and INO-T (subject to the INO-T Group and the
Linde Group being entitled to use (and sub-license the use of) that data for
any purpose, and subject to the provisions of Section 17.1).


 


(b)                                 The Linde Group shall be
entitled to apply for, hold and maintain Health Registrations (including in
relation to the Products and Covox) in its own name in the Linde Territories.


 


13.                               PHARMACOVIGILENCE AND ASSISTANCE


 


13.1                        Regulatory
Assistance


 


(a)                                  Each Party shall provide the
other Party with access to all data (including source data and technical data)
and materials that its Group possesses or has access to that may be required by
that Party to maintain Health Registrations for the End Products, to prepare
and update any submissions to Regulatory Authorities, or otherwise to comply
with requirements from Regulatory Authorities and Applicable Laws, and shall
make commercially reasonable efforts to ensure that all such data and
documentation that may be requested by any Regulatory Authority are maintained
in such a way that the other party can promptly respond to such requests in an
appropriate manner.


 


(b)                                 Each Party shall promptly
forward to the other Party copies of any written communications received from
Regulatory Authorities at any time regarding the Products, including the Health
Registrations.  If communications from
Regulatory Authorities are not in writing, the substance of the oral
communication shall be communicated. 
INO-T and AGA shall assist each other in such a way that each can report
pharmacovigilance data to Regulatory Authorities based on the activities of
both Parties.


 


(c)                                  Without prejudice to
Sections 15 and 16 and the other parts of this Section 13, promptly after
having become so aware, each Party shall notify the other Party (including, if
relevant, through the Joint Committee) of any event or fact that it believes is
likely to have an adverse effect on any Health Registrations for the Products
and/or Covox and the Parties shall cooperate to minimize any such adverse
effect.


 


13.2                        Clinical trials


 


(a)                                  Except pursuant to Section 13.2(b),
AGA shall not undertake or sponsor any Covox- or inhaled NO-related clinical
trials without the written approval of INO-T.


 


18

















 


(b)                                 AGA shall be entitled to
support Covox- or inhaled NO-related non-commercial clinical trials, including
academic research and research performed by clinical physicians for their own
purposes.


 


(c)                                  AGA shall:


 


(i)                                     promptly notify INO-T
(through the Joint Committee) of any request made to AGA for AGA to support a
non-commercial clinical trial of the type described in Section 13.2(b);
and


 


(ii)                                  to the extent that it is
aware, keep INO-T informed (through the Joint Committee) of the progress of
such clinical trials supported by AGA and consult with INO-T regarding
recommendations for the manner in which those clinical trials ought to be
conducted so as to minimize any risk to the Health Registrations for the
Products and/or Covox.


 


13.3                        Access to INO-T
Database


 


(a)                                  INO-T shall ensure that the
Linde Group is able to access and use the INO-T Pharmacovigilance Database in
the manner in which the Linde Group accesses and uses it as at the Effective
Date, and enable the Linde Group to use it for all its drug products, including
by ensuring that the:


 


(i)                                     Linde Group shall at all
times be able remotely to access all Linde Group data on the INO-T
Pharmacovigilance Database;


 


(ii)                                  INO-T Pharmacovigilance
Database is maintained at least to the standards (including regarding
availability, integrity, security, accessibility and functionality) to which it
operates as at the Effective Date; and


 


(iii)                               INO-T Group and third
parties are unable to access Linde Group data on the INO-T Pharmacovigilance
Database, except on a need-to-know basis for the purpose of carrying out
information technology-related tasks.


 


(b)                                 AGA shall reimburse INO-T in
respect of any reasonable costs incurred by INO-T Group exclusively in
connection with the maintenance of the INO-T Pharmacovigilance Database for the
Linde Group’s access to, and use of, it.


 


13.4                        Back-up
facilities


 


The Parties shall, through
the Joint Committee, evaluate the feasibility of allowing the Parties to rely
on each other’s manufacturing facilities for INOmax as back-up facilities.


 


14.                               JOINT COMMITTEE


 


14.1                        Constitution


 


(a)                                  The Participants shall
establish a joint committee (Joint Committee)
which shall consist of an equal number of representatives of, on the one hand,
AGA and, on the other hand, INO-T and Holdco (JC
Members), initially designated at [**] JC Members appointed by
each Party, provided that one JC Member appointed by INO-T shall be a
representative of Holdco.


 


(b)                                 Each JC Member shall be:


 


(i)                                     a board member of, senior
employee of, or senior consultant to, the Participant that he or she
represents; and


 


(ii)                                  responsible for function(s) relevant
to this Agreement (including research, clinical development, regulatory, legal,
manufacturing or commercialization).


 


19

















 


(c)                                  Each Party may replace their
JC Members from time to time with persons of equivalent seniority on [**] days’
notice to the other Party.


 


(d)                                 Each Party is entitled, on
reasonable notice to the other Party and with that other Party’s approval, to
invite to Joint Committee meetings employees or consultants other than its JC
Members to address specific issues discussed at those meetings.


 


(e)                                  The chairperson of the Joint
Committee shall be the INO-T Chief Executive.


 


14.2                        Functions


 


The Joint Committee shall
act as a consultative, information-sharing and decision-making body for the
purpose of the mutual development and promotion of NO for medical use, the
Products, Covox and (to the extent provided in Section 8.1) New
Products.  In particular, the Joint
Committee shall perform the functions set out in Schedule 2.


 


14.3                        Meetings


 


(a)                                  The Participants shall cause
the Joint Committee to meet not less than [**] per Year (or less often if
agreed by the Participants), and whenever requested by a Participant on
reasonable prior notice, to discuss matters relevant to the functions referred
to in Section 14.2.


 


(b)                                 Meetings of the Joint
Committee may be attended in person or by telephone or video conference.  If in person, the location of the meeting
shall alternate at a place decided by INO-T and AGA, sequentially.


 


(c)                                  The chairperson of the Joint
Committee shall, in consultation with the JC Members, be responsible for
providing an agenda for each meeting at least [**] days in advance of that
meeting.


 


(d)                                 Responsibility for the
preparation of minutes setting out discussions held at each Joint Committee
meeting shall alternate between the Parties as directed by the chairperson,
provided that such minutes shall not become official until agreed upon by the
JC Members of the Participants.  The
minutes of Joint Committee meetings shall be reasonably detailed and
distributed in draft to all JC Members for comment and review within [**] days
after the relevant meeting.  The JC
Members shall have [**] days to provide comments.  The Party preparing the minutes shall
incorporate timely received comments and distribute finalized minutes to all JC
Members within [**] days of the relevant meeting.


 


14.4                        Decisions


 


Decisions of the Joint
Committee shall be taken unanimously by the Participants.  In the event of a disagreement, the matter
shall be referred to senior executives of the Participants for resolution.


 


15.                               PRODUCT RECALL


 


15.1                        Mandatory
Recall


 


(a)                                  In the event of any
mandatory recall of a Product in the Linde Territories, INO-T shall, if
requested by AGA, assist AGA or the relevant member of the Linde Group, to
identify the cause of the recall and take any measures required to avoid
repetition of the cause of the recall. 
In the event that AGA can reasonably establish that the mandatory recall
was caused, in whole or in part, by a breach by INO-T of this Agreement, INO-T
shall indemnify AGA for the Loss incurred or suffered by the Linde Group in
relation to the recall to the extent that it was caused by that breach by
INO-T.


 


(b)                                 AGA shall inform INO-T
immediately of any mandatory recall of a Product in any of the Linde
Territories.


 


(c)                                  INO-T shall inform AGA
immediately of any mandatory recall of a Product outside the Linde Territories.


 


20

















 


15.2                        Voluntary
recall


 


(a)                                  If a Party believes that a
voluntary withdrawal or recall of a Product is necessary, both Parties shall
promptly use their respective commercially reasonable efforts to agree whether
it is necessary.  If the Parties agree
that it is necessary, in respect of the Linde Territories, AGA shall carry out
that withdrawal or recall and, in respect of countries outside the Linde
Territories and the Existing ROW Territories, INO-T shall carry out that
withdrawal and recall.  If the Parties
cannot agree, in respect of a proposed voluntary withdrawal or recall:


 


(i)                                     in the Linde Territories,
AGA shall (if it believes that there is sufficient time) refer the matter to an
independent third party qualified to assess the need for a recall and shall
follow the recommendation of that third party. 
If AGA does not so believe, it may (in its absolute discretion)
implement the voluntary withdrawal or recall provided that, in doing so, it
shall take into account INO-T’s reasonable representations to AGA; and


 


(ii)                                  outside the Linde
Territories and the Existing ROW Territories, INO-T shall (if it believes that
there is sufficient time) refer the matter to an independent third party
qualified to assess the need for a recall and shall follow the recommendation
of that third party.  If INO-T does not
so believe, it may (in its absolute discretion) implement the voluntary
withdrawal or recall, provided that, in doing so, it shall take into account
AGA’s reasonable representations to INO-T.


 


(b)                                 Any and all costs related to
the voluntary withdrawal or recall shall be paid by the Party which is
responsible for that recall.


 


16.                               ADVERSE EVENT REPORTING


 


(a)                                  The Parties shall, within
[**] days of the Effective Date, mutually agree in writing to procedures that
ensure that the INO-T Group and the Linde Group will be able to meet their
obligations to report Adverse Events.


 


(b)                                 AGA acknowledges that INO-T
is obligated under Applicable Laws to report Adverse Events to certain
Regulatory Authorities, and AGA agrees to comply with INO-T’s requirements so
as to assure that INO-T is in compliance with such laws.


 


(c)                                  INO-T acknowledges that the
Linde Group is obligated under Applicable Laws to report Adverse Events to
certain Regulatory Authorities, and INO-T agrees to comply with the Linde Group’s
requirements so as to assure that the Linde Group is in compliance with such
laws.


 


17.                               CONFIDENTIALITY AND ANNOUNCEMENTS


 


17.1                        Confidentiality


 


(a)                                  During the Term of this
Agreement and for the longer of:


 


(i)                                     [**] Years thereafter; and


 


(ii)                                  for so long as any
information in question shall have value as a trade secret,


 


no Participant shall,
without the specific written consent of the other Participants, disclose to any
third party or use for its own purposes or for the benefit of any third party
(except as contemplated in this Agreement and then with disclosure only on a
need to know basis) any of the Confidential Information disclosed by another
Participant.


 


21

















 


(b)                                 The term Confidential Information shall mean
technical and business information, whether written, oral or in any other form,
that one Participant shall provide to another Participant pursuant to this
Agreement, with the exception only of the following:


 


(i)                                     information which was known
to or in the possession of the receiving Participant prior to the time of
receipt from the disclosing Participant, except for information that was shared
by a Party with a member of the Group of the other Party prior to the Effective
Date where such information is of a type that a reasonable Person would deem to
be confidential or proprietary, or the circumstances or nature of the
information should reasonably put the other Party on notice that such
information should be treated as confidential or proprietary, provided that
nothing in this Agreement shall restrict or prevent the use by the Linde Group
in relation to goods and services other than those concerning NO and carbon
monoxide of information disclosed by INO-T to the Linde Group prior to the
Effective Date and the Linde Group continues to handle such information in
those circumstances with at least the same standard of care as it has applied
to such information in those circumstances prior to the Effective Date;


 


(ii)                                  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 Participant;


 


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


 


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


 


(v)                                 information which is
necessary or advisable to be disclosed by the receiving Participant to comply
with Applicable Law, applicable rules or regulations of any securities
exchange, or the request of any Governmental Entity, provided that the
receiving Participant gives the disclosing Participant reasonable prior written
notice to permit it to seek a protective order or other remedy to prevent or
limit such disclosure, and thereafter discloses only the minimum information
required to be disclosed in order to comply;


 


(vi)                              information which is
necessary or advisable to be disclosed by the receiving Participant in
connection with any suit, claim, investigation, arbitration, action or
proceeding, provided that the receiving Participant gives the disclosing
Participant reasonable prior written notice to permit it to seek a protective
order or other remedy to prevent or limit such disclosure; and


 


(vii)                           information which is specifically
permitted to be disclosed pursuant to the terms of this Agreement and/or any
other Contract by and among the Parties and/or the Participants.


 


17.2                        Announcements


 


No Participant shall
disclose to any third party, or originate any publicity, news release or public
announcement, written or oral, whether to the public or the press or otherwise,
referring to the terms of this Agreement except where mutually agreed upon in
writing.


 


18.                               TERMINATION


 


18.1                        Termination by
AGA


 


In the event that:


 


22

















 


(a)                                  AGA decides to discontinue
commercial activities relating to all of the Products and Covox in the Linde
Territories (which decision shall, for the avoidance of doubt, be in the sole
discretion of AGA (including for commercial, scientific or medical reasons)),
it shall notify INO-T in writing at least six (6) months prior to that
discontinuance; and


 


(b)                                 AGA notifies INO-T of its
decision in accordance with Section 18.1(a), the six (6) months’
notice period specified in Section 18.1(a) expires, and AGA
discontinues commercial activities relating to all of the Products and Covox in
the Linde Territories, this Agreement shall terminate immediately.


 


18.2                        Termination by
INO-T


 


(a)                                  In the event that, other
than following one or more Persons acquiring, or deciding to acquire, directly
or indirectly, all or substantially all of the assets of the INO-T Group
relating to the Products and Covox:


 


(i)                                     every member of the INO-T
Group decides to discontinue commercial activities relating to all of the
Products and Covox (which decision shall, for the avoidance of doubt, be in the
sole discretion of the INO-T Group (including for commercial, scientific or
medical reasons)), INO-T shall notify AGA in writing at least eighteen (18)
months prior to that discontinuance; and


 


(ii)                                  INO-T notifies AGA of the
decision of the INO-T Group in accordance with Section 18.2(a)(i), the
eighteen (18) months’ notice period specified in Section 18.2(a)(i) expires,
and every member of the INO-T Group discontinues commercial activities relating
to all of the Products and Covox, this Agreement shall terminate
immediately.  For the avoidance of doubt,
this Agreement shall not terminate by reason of an acquisition as described in Section 23.4(b).


 


(b)                                 INO-T may terminate this
Agreement by giving AGA not less than six (6) months’ notice if AGA sells
any Product or Covox:


 


(i)                                     in an INO-T Territory; or


 


(ii)                                  to a third party that AGA
knows is intending to sell that Product or Covox in an INO-T Territory,


 


unless AGA is required by
Applicable Law to make such sale.


 


18.3                        Material Breach


 


In addition to any other
rights or remedies available at law or in equity, a Party may, by written
notice, immediately terminate this Agreement following the occurrence of a
material breach by the other Party in the event that the Participants have not
been able amicably to resolve that breach in accordance with the dispute
resolution procedure set out in Section 18.6 and that breach is not
otherwise cured during the implementation of that procedure.


 


18.4                        Return of
Materials


 


Upon the expiration of the
Term or upon any termination of this Agreement, in addition to any other
obligations set out in this Agreement, each Participant shall, at its own cost
and expense, within [**] days of such termination, return to the other all
property, including cylinders, printed matters, and Confidential Information of
the others.


 


18.5                        Effect of
Termination


 


(a)                                  In the event that this
Agreement is terminated other than pursuant to Section 18.1, or expires,
INO-T shall use commercially reasonable efforts to assist:


 


(i)                                     in AGA’s absolute
discretion:


 


23

















 


(A)                              the Recipients to find, and
transition to, an alternative supplier of Bulk NO Gas in order that their
requirements (including regarding quantity and delivery time) for Bulk NO Gas
can be met; and/or


 


(B)                                if AGA so requests, the
Linde Group to develop operational facilities for the manufacture of Bulk NO
Gas, including by promptly providing, and causing the INO-T Group promptly to
provide, to the Linde Group all relevant training, know-how, data,
documentation, and other assistance in order that their requirements (including
regarding quantity and delivery time) for Bulk NO Gas can be met; and/or


 


(ii)                                  the Recipients to find, and
transition to, an alternative supplier of any Supply Product (other than Bulk
NO Gas) in order that their requirements (including regarding quantity and
delivery time) for that Supply Product can be met.


 


(b)                                 Expiration or termination of
this Agreement shall not relieve the Participants of any liability or
obligation accruing prior to such expiration or termination, and the provisions
of Sections 1, 8.2, 17, 18.4, 18.5, 18.6, 19.1 and 23 shall survive the
expiration or termination of this Agreement.


 


18.6                        Dispute
Resolution Procedure


 


The Participants adopt the
principle that all Disputes should be regarded as business problems to be
resolved promptly through business-oriented negotiations described below in
this Section 18.6 before resorting to arbitration pursuant to Section 18.6(f).  No Participant shall be entitled to make any
claim in respect of any Dispute, and/or terminate this Agreement other than
pursuant to Sections 18.1 and 18.2(a), without first implementing the following
procedure:


 


(a)                                  Any Dispute shall in the
first instance be referred by notice in writing (the Referral
Notice) by a Participant to the Representatives.  The Participant delivering the Referral
Notice (the Referring Party) shall
identify in the Referral Notice:


 


(i)                                     the matter(s) in
dispute;


 


(ii)                                  the relief and/or remedy
sought; and


 


(iii)                               brief reasons for claiming
the relief and/or remedy sought, including identification of the relevant
provisions in this Agreement.


 


(b)                                 The Representatives shall
consider the Dispute and use the respective commercially reasonable efforts to
try to reach agreement to resolve the Dispute. 
Any agreement of the Representatives to resolve the Dispute shall be
final and binding on the Participants and shall be in writing.


 


(c)                                  If the Representatives are
unable to, or fail to, resolve the Dispute within [**] days of receiving the
Referral Notice, then any Participant may within [**] days of the expiration of
this time period refer the Dispute to the Joint Committee.


 


(d)                                 If a Dispute is referred to
the Joint Committee in accordance with Section 18.6(c), the Joint
Committee shall consider the Dispute and use their respective commercially
reasonable efforts to try to resolve the Dispute.  Any unanimous agreement of the Joint
Committee shall be final and binding on the Participants and shall be in
writing.


 


(e)                                  If the Joint Committee fails
to resolve the Dispute within [**] days of receiving a copy of the Referral
Notice, then any Participant may within [**] days of the expiration of this
time period refer the Dispute to the Chief Executives.


 


(f)                                    Any Dispute not finally
resolved by the Chief Executives shall be finally settled by Arbitration as
follows:


 


24














 


(i)                                     In the event that any
Dispute cannot be resolved pursuant to this Section 18.6, such Dispute
shall be finally settled by binding arbitration (Arbitration)
under the Rules of Arbitration (the Rules) of
the International Chamber of Commerce (ICC) in force
at the time of such Arbitration and the United States Federal Arbitration Act
of 1925, as amended, by one or three arbitrators appointed in accordance with
the Rules.  The seat of the arbitration
shall be New York, New York.  The
language of the arbitration shall be English.


 


(ii)                                  In any Arbitration relating
to any Dispute, the arbitrator or arbitrators shall be required to select one
of the proposals submitted by or on behalf of AGA or INO-T and shall not be
permitted to determine an alternative or compromise remedy.


 


(iii)                               The arbitral award shall be
in writing, shall detail the disputed matters and reasons on which the arbitral
award is based, and shall (except as provided in this Section 18.6 with
respect to actions or applications for interim relief), be the sole and
exclusive remedy among the Participants regarding any Dispute.  The arbitral award shall be final and binding
upon the Participants and shall not be subject to appeal of any court or other
authority.  Notwithstanding the
foregoing, any party may file an application in the United States federal
courts sitting in the Borough of Manhattan seeking pre-arbitral attachment,
injunctive or other forms of interim relief to compel, aid or facilitate the
arbitration or to maintain the status quo pending
completion of the arbitration.  Judgment
upon the award or order may be entered in the Supreme Court of the State of New
York sitting in the Borough of Manhattan, the United States District Court for
the Southern District of New York or any other court of competent jurisdiction,
and application may be made to any such court for enforcement thereof.  Each Participant agrees not to oppose the
registration or enforcement of any such judgment in any other jurisdiction and
to consent to jurisdiction and venue in any applicable court for purposes of
registration or enforcement of any such judgment.  Each Participant accepts and submits to the
jurisdiction of the seat of arbitration referenced above and to the New York State
and United States federal courts sitting in the Borough of Manhattan (and to
any court in which appeals from those courts may be heard) with regard to
enforcement of the arbitral award or application for injunctive or other
interim relief, as provided in this Section 18.6.  Each Participant waives any defense or
objection that it could have in relation to diplomatic immunity, lack of
jurisdiction, improper venue, inconvenient forum or competence.  Process in any such action or proceeding may
be served on any Participant anywhere in the world.  Each Participant irrevocably consents to the
service of any and all process in any action or proceeding by the mailing or
delivery of copies of such process to it at its address for notices specified
in Section 23.6.


 


(iv)                              This Agreement and the
rights and obligations of the Participants shall remain in full force and
effect pending the award in any Arbitration proceeding hereunder.


 


19.                               INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE


 


19.1                        Indemnification


 


(a)                                  INO-T shall be liable for,
and shall indemnify and hold harmless the Linde Group from all Losses suffered
or incurred by the Linde Group to the extent arising out of, or relating to:


 


(i)                                     any breach of the
obligations of INO-T and/or Holdco under this Agreement; and/or


 


(ii)                                  subject to Section 19.1(c),
any claim, action or proceeding by a third party that is caused by the INO-T
Group’s manufacture, handling, storage, promotion and/or delivery to Recipients
of any of the Products, provided that each Party shall be solely liable for any
claim, action or proceeding by a third party regarding the safety or efficacy
of NO for therapeutic uses with respect to NO sold by a member of that Party’s
Group in its respective Territory.


 


(b)                                 AGA shall be liable for, and
shall indemnify and hold harmless the INO-T Group from all Losses suffered or
incurred by the INO-T Group to the extent arising out of, or relating to:


 


25

















 


(i)                                     any breach of the
obligations of AGA under this Agreement; and/or


 


(ii)                                  subject to Section 19.1(c),
any claim, action or proceeding by a third party that is caused by the Linde
Group’s manufacture, handling, storage, promotion, distribution and/or sale of
any of the Products, provided that each Party shall be solely liable for any
claim, action or proceeding by a third party regarding the safety or efficacy
of NO for therapeutic uses with respect to NO sold by a member of that Party’s
Group in its respective Territory.


 


(c)                                  Subject to Section 19.1(d),
INO-T shall not, pursuant to Section 19.1(a)(ii), and AGA shall not,
pursuant to Section 19.1(b)(ii), have any liability or be required to
indemnify the Group of the other Party to the extent that the Group of that
other Party’s Losses, in aggregate, exceed five million euros (€5,000,000).


 


(d)                                 The provisions of Section 19.1(c) shall
not apply to any claim or cause of action arising from or relating to any
fraud, intentional misrepresentation or willful covenant breach by the Party
that is liable and/or obliged to indemnify and hold harmless the Group of the
other Party in accordance with this Section 19.1.


 


19.2                        Limitation of
Liability


 


With respect to any claim by
one Participant against another arising out of the performance or failure of
performance of the other Participant under this Agreement, the Participants
expressly agree that the liability of such Participant to the other Participant
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 Participant be liable
(nor shall any other Participant be entitled to recover): (i) for
incidental, consequential, exemplary, punitive or any other special damages, or
any loss of profits or earnings or diminution in value or (ii) more than
once for the same Loss, notwithstanding the fact that the Loss related to a
breach of more than one provision of this Agreement.


 


19.3                        Insurance


 


In addition to the
obligations to obtain and maintain insurance set forth in the SPA,


 


(a)                                  INO-T shall obtain and
maintain, at its own expense, at all times during the Term and for six (6) Years
following expiration or termination, Products/Completed Operations Insurance in
an amount not less than two million dollars ($2,000,000) each occurrence and
twenty million dollars ($20,000,000) annual aggregate for bodily injury and
property damage combined single limit. 
Such insurance shall be from an insurer with a rating of “A” or higher
by Moody’s Investors Services (or any successor rating agency) or Standard &
Poors Corporation (or any successor rating agency)), naming AGA as an
additional insured beneficiary thereof, and shall not be terminated, amended or
modified without AGA’s prior written consent.


 


(b)                                 In addition, INO-T shall
obtain and maintain, at its own expense, all-risk property insurance covering
the replacement cost value of the Supply Products while they are in its care,
custody and control with a minimum limit of one million dollars ($1,000,000).


 


20.                               TAXES


 


(a)                                  AGA shall, and shall cause
the other members of the Linde Group to, be responsible for all sales, use,
excise, goods, services, value added and like taxes relating to its and their
import, distribution, handling and sale of the Products and New Indications in
the Linde Territories.


 


(b)                                 INO-T shall, and shall cause
the other members of the INO-T Group to, be responsible for all sales, use,
excise, goods, services, value added and like taxes relating to its and their
sale to the Recipients of the Products and New Indications.  INO-T shall, and shall cause the other members
of the INO-T Group to, be responsible for all taxes of any kind relating to
payments made by AGA, and the other members of the Linde Group, to INO-T under
this Agreement and AGA, and the other members of the Linde Group, shall 


 


26

















 


have no obligation to gross-up any payment to INO-T for tax required to
be withheld under Applicable Laws from any payment made to INO-T under this
Agreement.


 


(c)                                  The Parties agree to
cooperate in order to minimize, in the manner permitted under applicable tax
and customs Applicable Laws, the taxes (including value-added taxes) and duties
associated with the importation and/or exportation and sale of the Products and
New Indications, as the case may be.


 


21.                               WARRANTIES, REPRESENTATIONS AND COVENANTS


 


21.1                        Capacity and
Compliance


 


(a)                                  Each Party represents and
warrants to the other Party that:


 


(i)                                     it is a corporation duly
organized and validly existing under the laws of the jurisdiction of its
incorporation;


 


(ii)                                  it has full limited
liability company or corporate (as the case may be) power and 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; and


 


(iv)                              it has and shall maintain
all licenses, permits, governmental approvals, Health Registrations and other
authorizations necessary to perform its obligations hereunder.


 


(b)                                 INO-T covenants and agrees
that:


 


(i)                                     the Products shall meet the
Specifications and the Standards;


 


(ii)                                  INO-T shall manufacture the
Supply Products in conformity with the Specifications, and in a manner that
fully complies with cGMP guidelines and practices.


 


(c)                                  Each of INO-T and AGA
covenants and agrees that it will market, sell and distribute the Supply
Products and End Products, respectively, in compliance with Applicable Laws.


 


21.2                        Changes in
Manufacturing Process


 


(a)                                  INO-T shall not change the
manufacturing process, the Specifications, the raw materials or sources of
third party products, used or the analytical testing method it applies in
relation to the Supply Products in a way that has, or may have, an adverse
effect on the Linde Group (Adverse Manufacturing
Changes), unless, subject to Section 21.2(b), INO-T
indemnifies AGA in respect of any Loss suffered by the Linde Group as a direct
or indirect result of that Adverse Manufacturing Change.  Any proposed Adverse Manufacturing Change
shall be notified by INO-T to AGA before a final decision to change has been
taken by INO-T.


 


(b)                                 INO-T may make Adverse
Manufacturing Changes required to comply with Applicable Laws or requirements
of any Regulatory Authority without any obligation to indemnify AGA in respect
of any Loss suffered by the Linde Group as a direct or indirect result of those
Adverse Manufacturing Changes.


 


(c)                                  INO-T shall provide AGA with
a detailed written report of all changes to the manufacturing process, the
Specifications, the raw materials and third party products, or the analytical
method that:


 


(i)                                     require approval from a
Regulatory Authority before implementing them; and


 


(ii)                                  do not require approval from
a Regulatory Authority, unless agreed to by AGA in writing.


 


27

















 


(d)                                 If AGA is required by a
Regulatory Authority to change the manufacturing process or the Specifications,
INO-T shall accommodate the requested change unless doing so would adversely
impact an INO-T Health Registration in the United States of America.  AGA shall reimburse INO-T all costs incurred
by INO-T in making the change, provided that,
for the avoidance of doubt, if as a result of making such requested change
INO-T is required to make more than one version of any Product, such
reimbursement shall include reimbursement for all incremental costs associated
with providing more than one version of such Product.


 


(e)                                  If AGA requests a change in
the manufacturing process or the Specifications in relation to the Products
that is not a result of a requirement of a Regulatory Authority, INO-T shall
use commercially reasonable efforts to accommodate the request.  AGA shall reimburse INO-T all costs incurred
by INO-T in making the change.


 


22.                               RIGHT OF FIRST OFFER TO PURCHASE LINDE’S EUROPEAN NO AND
COVOX BUSINESSES


 


(a)                                  If, at any time, AGA desires
to sell to a third party that is not a member of the Linde Group:


 


(i)                                     all or substantially all of
its inhaled NO business (the NO Business);


 


(ii)                                  all or substantially all of
its Covox business (the Covox Business);
or


 


(iii)                               both the NO Business and the
Covox Business,


 


(each of (i), (ii), and
(iii), an Applicable Business), AGA
shall first provide written notice to INO-T of its intention to sell the
Applicable Business (with the date of such notice being referred to herein as
the Notice Date), and INO-T shall have
the right, but not the obligation, to purchase the Applicable Business, by
delivering written notice to AGA of INO-T’s election to do so (the INO-T Election Notice) within [**]
days after the Notice Date (the date such election is made, the INO-T Election Date).


 


(b)                                 Following the INO-T Election
Date, AGA and INO-T shall endeavor to enter into a definitive purchase
agreement in respect of the sale to INO-T of the Applicable Business, and the
closing of the sale thereunder shall take place within the later of:


 


(i)                                     [**] days after the
execution of such definitive purchase agreement; and


 


(ii)                                  the earlier of:


 


(A)                              [**] Business Days after
receipt of all regulatory approvals without which the purchase may not be
legally consummated; and


 


(B)                                [**] days from the date of
the signing of the definitive purchase agreement (such [**] day, the Outside Closing Date).


 


AGA may at any time prior to
executing such a definitive purchase agreement determine not to proceed with
the sale of the Applicable Business, in which event the transaction shall be
abandoned and no Applicable Business may be sold without first complying with
the provisions of this Section 22.


 


(c)                                  If, other than because AGA
determines not to proceed with the sale of the Applicable Business, AGA and
INO-T fail to enter into such a definitive purchase agreement within [**] days
after the INO-T Election Date (the End Date),
then the right to purchase the Applicable Business contemplated by this Section 22
shall be deemed to have been waived by INO-T and, for a period of [**] months
from the End Date, AGA shall be free to enter into a definitive purchase
agreement with any other Person, in a form no less favorable to AGA than the
form last proposed by AGA to INO-T and rejected or (by expiration of such
[**]-day period) deemed rejected by INO-T, and to consummate the purchase
thereunder (it being agreed that any portion of the purchase price which is not
in the form of cash or securities of a class which is publicly traded shall be
valued by an independent valuation or appraisal firm selected by AGA, and any
portion of 


 


28

















 


the purchase price which is in the form of securities of a class which
is publicly traded shall be valued at the [**]).  If such a definitive purchase agreement with
any other Person is not entered into within such [**]-month period, any
subsequent proposed sale of an Applicable Business shall again be subject to
the right of first offer in favor of INO-T in this Section 22.


 


(d)                                 If AGA and INO-T enter into
the definitive purchase agreement contemplated by Section 22(b), but the
closing thereunder does not occur:


 


(i)                                     by the Outside Closing Date
for reasons other than the breach of such definitive purchase agreement by AGA;
or


 


(ii)                                  because INO-T breaches its
obligation to close or breaches any other provision of such definitive purchase
agreement as a result of which AGA is permitted to terminate such definitive
purchase agreement,


 


then INO-T shall, as of the
Outside Closing Date or date of breach by INO-T, as applicable, be deemed to
have forfeited all its rights under this Section 22, and the provisions of
this Section 22 shall no longer apply to any proposed sale of any
Applicable Business.


 


(e)                                  If INO-T:


 


(i)                                     fails to deliver an INO-T
Election Notice within [**] days after the Notice Date; or


 


(ii)                                  notifies AGA that it is
declining to purchase the Applicable Business,


 


then AGA shall be free, for
a period of [**] months from the earlier of the date of such decline and the
date that is [**] days after the Notice Date, to enter into a definitive
purchase agreement with any other Person and to consummate the purchase
thereunder.  If such a definitive
purchase agreement is not entered into within such [**]-month period, any
subsequent proposed sale of an Applicable Business shall again be subject to
the right of first offer in favor of INO-T in this Section 22.


 


(f)                                    The provisions of this Section 22
shall not apply to a transaction in which either:


 


(i)                                     any other business of AGA or
Linde AG or of members of either of their Groups are being sold and any
Applicable Business is included, and such Applicable Business constitutes less
than [**] percent ([**]%) of the aggregate total revenue of the businesses
being sold; or


 


(ii)                                  any Applicable Business is
distributed in a spin-off, spin-out or other similar transaction in which the
stockholders of Linde AG receive equity interests in such Applicable Business.


 


23.                               MISCELLANEOUS


 


23.1                        INO Business
Sale and Purchase Agreement


 


(a)                                  The Parties acknowledge that
it is their intention that, pursuant to Section 7.6(c) of the SPA,
each of Linde Gas Inc., Holdco, Ikaria Acquisition Inc., and Ikaria shall, and
Linde Gas Inc. (prior to the Effective Date) and Holdco and Ikaria Acquisition
Inc. (following the Effective Date) shall cause INO-T to, use its respective
reasonable best efforts (at its own expense) to obtain, and to cooperate in
obtaining, all required or advisable consents, approvals, waivers, licenses,
permits, authorizations, registrations, qualifications or other permission
from, or action by, and giving all necessary notices to, INO Holdings LLC,
Linde Gas LLC (formerly AGA Gas, Inc.) and Inoco, Inc. to transfer to
INO-T the:


 


(i)                                     accrued and future
obligations of Linde Gas LLC (formerly AGA Gas, Inc.), AGA and any other
members of the Linde Group pursuant to sections 2.3(b)(ii)-(iv) of Exhibit 2.3(b) of
the INO Business Sale and Purchase Agreement (provided that any reference in
those sections to a member 


 


29

















 


of the Linde Group shall be treated as a reference to the relevant
member of the INO-T Group) to the extent that they relate to the business of
INO-T outside the Linde Territories (the Assumed Obligations);
and


 


(ii)                                  accrued and future rights of
Linde Gas LLC (formerly AGA Gas, Inc.), AGA and any other members of the
Linde Group pursuant to the INO Business Sale and Purchase Agreement to the
extent that they relate to the Assumed Obligations, which are the only existing
or future rights that relate to the business of INO-T outside the Linde
Territories (the Transferred Rights).


 


(b)                                 In the event that the
Parties are unable to transfer the Assumed Obligations and Transferred Rights
in accordance with Section 23.1(a) and the SPA by the Effective Date,
effective on and as of the Effective Date, as between the Parties:


 


(i)                                     INO-T shall assume, satisfy
and perform the Assumed Obligations for the benefit of AGA as if AGA were INO
Holdings LLC; and


 


(ii)                                  AGA shall, and shall cause
the Linde Group to:


 


(A)                              comply with its obligations
under sections 2.3(b)(ii)-(iv) of Exhibit 2.3(b) of the INO
Business Sale and Purchase Agreement to the extent that they relate to the
Assumed Obligations; and


 


(B)                                at INO-T’s request and
expense, enforce the Transferred Rights on behalf of INO-T.


 


23.2                        Independent
Relationship


 


Nothing in this Agreement
contained shall be deemed to create an employment, agency, joint venture or
partnership relationship between the Participants hereto or any of their agents
or employees, or any other legal arrangement that would impose liability upon
one Participant for the act or failure to act of another Participant.  No Participant shall have any power to enter
into any contracts or commitments or to incur any liabilities in the name of,
or on behalf of, another Participant, or to bind the another Participant in any
respect whatsoever.


 


23.3                        Amendments and
Waivers


 


Except pursuant to the
procedure set out in Schedule 3, this Agreement may not be amended or modified
except by an instrument in writing signed on behalf of the Participants.  By an instrument in writing, two Participants
may waive compliance by the other Participant with any term or provision of
this Agreement that such other Participant was or is obligated to comply with
or perform.


 


23.4                        Assignment


 


(a)                                  This Agreement and the
rights and obligations hereunder shall not be assignable or transferable by any
Participant without the prior written consent of the other Participants hereto
except that a Participant may assign this Agreement and the rights and
obligations hereunder, to an Affiliate or an acquirer of all or substantially
all of the assets of such Participant. 
Any attempted assignment in violation of this Section 23.4(a) shall
be null and void and of no effect.


 


(b)                                 In the event that, directly
or indirectly, one or more Persons acquire all or substantially all of the
assets of the INO-T Group relating to the Products and Covox, INO-T shall, and
Holdco shall cause INO-T to, assign this Agreement and the rights and
obligations hereunder, to those Persons.


 


23.5                        Third-Party
Beneficiaries


 


This Agreement is for the
sole and exclusive benefit of the Participants and their successors and
permitted assigns, and nothing in this Agreement expressed or implied shall
give, or be construed to give, to any Person, other than the 


 


30

















 


Participants and such
successors and permitted assigns, any legal or equitable right, remedies or
claims under or with respect to this Agreement or any provisions hereof.  Notwithstanding the foregoing, in the event
that any member of the Linde Group other than AGA suffers any Loss, such Loss
shall, for purposes of this Agreement be automatically deemed a Loss of AGA, as
to which AGA shall be entitled to seek any remedy (at law, equity or otherwise)
it would otherwise be entitled to seek as if it had suffered such Loss
directly.


 


23.6                        Notices


 


All notices, consents,
waivers, and other communications required or permitted under this Agreement
must be in writing and will be deemed to have been duly given when (a) delivered
by hand to the Participant to be notified, (b) when sent by facsimile if
sent during the normal business hours of the Participant to be notified, if
not, then on the next Business Day or (c) when received by the Participant
to be notified, if sent by an internationally recognized overnight delivery
service, specifying the soonest possible time and date of delivery, in each
case to the appropriate addresses and facsimile numbers set out below (or to
such other addresses and facsimile numbers as a Participant may designate by
notice to the other Participants from time to time).  All such notices and other communications
shall be sent:


 


(i)                                     if to INO-T, to:


 


INO Therapeutics LLC

6 Route 173

Clinton, New Jersey 08809 

Attention:  Dennis Smith, President and
Chief Executive Officer 

Facsimile: (908) 238-6699


 


INO Therapeutics LLC

6 Route 173

Clinton, New Jersey 08809 

Attention:  Elizabeth Holmberg Larkin,
Vice President, Global Finance 

Facsimile: (908) 238-6699


 


with a copy (which shall not
constitute notice) to:


 


Fried, Frank, Harris,
Shriver & Jacobson LLP

One New York Plaza


New York, NY 10004 

Attention:     Aviva Diamant, Esq.


Henry Lebowitz, Esq.


Facsimile: +1 212-859-4000;


 


(ii)                                  if to AGA to:


 


AGA AB

SE-181 81 Lidingö

Sweden

Attention:  Lars Källsäter, Head of Linde
Gas Therapeutics 

Facsimile: +46-8-731-91-55


 


with a copy (which shall not
constitute notice) to each of:


 


Freshfields Bruckhaus Deringer, LLP 

520 Madison Avenue, 34th Floor

New York, NY 10022

United States of America 


 


31

















 


Attention: 
Matthew F. Herman, Esq. 

Facsimile: +1 212-277-4001


 


Freshfields Bruckhaus Deringer

65 Fleet Street 

London 

EC4Y 1HS

Attention:  Richard G. R. Lister, Esq.

Facsimile: +44 207-832-7001;


 


and


 


(iii)                               if to Holdco, to:


 


Ikaria Holdings, Inc. 

c/o New Mountain Capital, LLC

787 Seventh Avenue 

New York, NY 10019 

Attention:  Alok Singh 

Facsimile: +1 212-582-2277


 


with a copy (which shall not
constitute notice) to:


 


Fried, Frank, Harris,
Shriver & Jacobson LLP 

One New York Plaza 

New York, NY 10004 

Attention:     Aviva Diamant, Esq.


Henry Lebowitz, Esq.


Facsimile: +1 212-859-4000.


 


23.7                        Counterpart
Execution and Facsimile Delivery


 


This Agreement may be
executed in any number of counterparts, all of which shall be considered one
and the same agreement, and shall become effective when one or more such
counterparts have been signed by each of the Participants and delivered to the
other Participants.  Any such counterpart
may be delivered by a Participant by facsimile, and any Participant who signs
this Agreement and transmits such signature to the other Participant by
facsimile or e-mail shall be deemed to have duly executed this Agreement.


 


23.8                        Severability


 


If any provision of this
Agreement (or any portion thereof) or the application of any such provision (or
any portion thereof) to any Person or circumstance shall be held invalid,
illegal or unenforceable in any respect by a court of competent jurisdiction,
such invalidity, illegality or unenforceability shall not affect any other
provision hereof (or the remaining portion thereof) or the application of such
provision to any other Persons or circumstances.  The Participants 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 Participants in drafting
this Agreement.


 


23.9                        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 any of the Participants from time to time by the government of the
United States of America.  Furthermore,
each Participant agrees that it will not export, directly or indirectly, any
technical information acquired from another Participant 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 


 


32

















 


written consent to do so
from the United States Department of Commerce or other agency of the United
States government when required by Applicable Law.


 


23.10                 Force Majeure


 


Subject to Section 10.1(d),
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 of the following:
acts of God, fire, terrorism, explosion, flood, drought, war, riot, sabotage,
embargo, a national health emergency or compliance with any order or regulation
of any Governmental Entity acting with color of right (Force Majeure).  The Party affected shall promptly notify the
other Party of the condition constituting Force Majeure and shall use its
reasonable commercial efforts to eliminate, cure and overcome any such causes
and to resume performance of its obligations with all possible speed.


 


23.11                 Specific Performance


 


Each Participant
acknowledges and agrees that, in addition to any other remedies that may be
available to it, INO-T and AGA shall be entitled to enforce the terms of this
Agreement by a decree of specific performance (in accordance with Section 18.6(f)),
to the extent available under Applicable Law, provided that each Participant hereby
waives, and agrees that it will not raise, any defense to such an action for
specific performance of the terms of this letter agreement based on any
obligation of the other Participants to mitigate damages or based upon another
Participant having an adequate remedy at law or a breach of this Agreement not
giving rise to irreparable harm.


 


23.12                 Governing Law


 


This Agreement shall be
construed in accordance with, and this Agreement and all matters arising out of
or relating in any way whatsoever (whether in contract, tort or otherwise) to
this Agreement shall be governed by, the law of the State of New York.


 


23.13                 Waiver of Jury Trial


 


Each Participant hereby
waives to the fullest extent permitted by Applicable Law, any right it may have
to a trial by jury in respect to any litigation directly or indirectly arising
out of, under or in connection with this Agreement and any transaction
contemplated hereby.  Each Participant:


 


(a)                                  certifies that no
representative, agent or attorney of any other Participant has represented,
expressly or otherwise, that such other Participant would not, in the event of
litigation, seek to enforce the foregoing waiver; and


 


(b)                                 acknowledges that it and the
other Participants have been induced to enter into this Agreement by, among
other things, the mutual waivers and certifications in this Section 23.13.


 


[SIGNATURE PAGE FOLLOWS]


 


33














 


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


 


 


	
   

  	
   

  	
  INO
  THERAPEUTICS LLC

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By:

  
	
   

  	
   

  	
  /s/ Dennis L. Smith

  
	
   

  	
   

  	
  Name:

  
	
   

  	
   

  	
  Dennis L. Smith

  
	
   

  	
   

  	
  Title:

  
	
   

  	
   

  	
  President & CEO

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  AGA AB

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By:

  
	
   

  	
   

  	
  /s/ Lars Källsäter

  
	
   

  	
   

  	
  Name:

  
	
   

  	
   

  	
  Lars Källsäter

  
	
   

  	
   

  	
  Title:

  
	
   

  	
   

  	
  Vice President

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  IKARIA
  HOLDINGS, INC.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By:

  
	
   

  	
   

  	
  /s/ Alok Singh

  
	
   

  	
   

  	
  Name:

  
	
   

  	
   

  	
  Alok Singh

  
	
   

  	
   

  	
  Title:

  
	
   

  	
   

  	
  President

  



 


34

















 


SCHEDULE
1


 


PRODUCTS


 


Products means the following products which are defined as
follows:


 


(a)                                  Bulk NO Gas means
cylinders of concentrated NO inhalation gas;


 


(b)                                 INOcal Gas means
cylinders of NO gas for use in calibration;


 


(c)                                  INOmax means a
finished drug product for inhalation which comprises NO diluted with nitrogen
that is, at the date of this Agreement, distributed under the “INOmax” brand;


 


(d)                                 INOmeter means a device
that records the amount of time that a NO cylinder valve is in the open
position;


 


(e)                                  INOvent means an
apparatus designed for administration of INOmax to patients; and


 


(f)                                    INOvent
Accessory  means any
accessory, service parts and/or repair parts for INOvent.


 


35

















 


SCHEDULE
2


 


JOINT
COMMITTEE FUNCTIONS


 


1.                                      THIS AGREEMENT


 


1.1           Monitor the
performance of this Agreement by both Parties.


 


[**].


 


36

















 


SCHEDULE
3


 


CHANGE
CONTROL PROCEDURE


 


1.                                      PRINCIPLES


 


1.1           Except as
provided in this Schedule 3, or as otherwise expressly stated in this
Agreement, any change to this Agreement (Change)
shall be dealt with in accordance with the procedure set out in paragraph 2 of
this Schedule 3.


 


1.2           Until a Change
is made in accordance with this Schedule 3, the Participants shall, unless
otherwise agreed in writing, continue to perform this Agreement in compliance
with its terms prior to that Change.


 


1.3           Any discussions
which may take place among the Participants in connection with a request for a
Change shall be without prejudice to the rights of any Participant.


 


2.                                      PROCEDURE


 


2.1           If a
Participant wishes to make a Change, it shall give written notice to the other
Participants of that proposed Change, setting out the following particulars of
the proposed Change:


 


(a)                                  the originator
and date of the request;


 


(b)           the reason for
it;


 


(c)           full details,
including any specifications;


 


(d)           the payment and
price implications, if any;


 


(e)           a timetable for
implementation;


 


(f)            details of the
likely impact, if any, of the Change on other aspects of this Agreement
including:


 


(i)                                     the timetable
for the provision of the Change;


 


(ii)                                  the personnel
to be provided;


 


(iii)                               the
documentation to be provided;


 


(iv)                              the training to
be provided;


 


(v)                                 working
arrangements; and


 


(vi)                              other contractual
amendments; and


 


(g)                                 provision for
signature by the Participants (Change Control Note).


 


2.2           The
Participants shall call cause the Joint Committee to meet to discuss the
proposed Change in good faith within [**] days of notification of the Change
Control Note to the Participants pursuant to paragraph 2.1.


 


2.3           In relation to
a Change proposed by a Participant, the other Participants shall be entitled to
ask for, and the proposing Participant shall provide, reasonable clarification.


 


2.4           The Participants
may agree, though the Joint Committee or otherwise, to revise the Change
Control Note.


 


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2.5           The
Participants shall be entitled to agree to, or reject, a Change Control Note in
their absolute discretion.  In the event
that all the Participants wish to implement a proposed Change, they shall all
sign the relevant Change Control Note, which shall constitute an amendment to
this Agreement.


 


3.                                      COSTS


 


Each Participant shall be
responsible for any costs that it incurs in connection with the preparation,
and evaluation, of a Change Control Note.


 


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