Exhibit 10.17


 


[ * ] =
Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.


 


DISTRIBUTION, MANUFACTURING AND SUPPLY AGREEMENT


 


This Distribution, Manufacturing and Supply Agreement (the “Agreement”)
is made and entered into as of September 30, 2003 (the “Effective Date”) by and between Aerogen, Inc., a Delaware corporation, with
offices at 2071 Stierlin Court, Mountain View, CA  94043 (“Aerogen”),
and Medical Industries America, Inc.,  an Iowa corporation, with offices at 2636
289th Place, Adel, IA  50003 (“MIA”). 
Aerogen and MIA may be referred to herein individually as a “Party” or collectively as the “Parties”.


 


Background


 


Whereas, Aerogen has designed and developed a proprietary, open-cup,
continuous-flow, general-purpose portable nebulizer and desires to have MIA
manufacture and distribute that product for use by customers solely in the home
or in alternate care facilities;


 


Whereas, MIA is engaged in the manufacture, distribution and sale of medical
products and desires to obtain such rights to manufacture and distribute
Aerogen’s nebulizer product; and


 


Whereas, the Parties also desire to provide terms under which Aerogen will
supply to MIA, or allow MIA to manufacture, a key component of the Aerogen
nebulizer product.


 


Now, Therefore, in consideration of the foregoing premises and the covenants
contained herein, the Parties hereby agree as follows:


 


Agreement


 


1.                                      Definitions.


 


In
addition to the terms defined in the other provisions of this Agreement, the
following capitalized terms shall have the meanings indicated for purposes of
this Agreement:


 


1.1                               “Aerogen
Patents” means all patents and patent applications that are
Controlled by Aerogen during the Term and that claim the Product.  The Aerogen Patents as of the Effective Date
are listed on Exhibit K.


 


1.2                               “Aerogen
Licensed Rights” means the claims within the Aerogen Patents that
specifically claim the Product and the Aerogen Technology.


 


1.3                               “Aerogen
Technology” means proprietary trade secrets, know-how, techniques,
methods, technical specifications, and test data that are Controlled by Aerogen
and are necessary or useful for the manufacture or marketing of the Product.


 


1

















 


1.4                               “Affiliate”  means, with respect to a Party, any
natural person, company or entity controlled by, controlling, or under common
control with such Party.  As used in
this Section 1.4, the term
“controlling” (with correlative meanings for the terms “controlled by” and
“under common control with”) means possession, directly or indirectly, of the
power to direct or cause the direction of the management and policies of the
controlled entity, whether by ownership of a majority of the voting securities
of such entity, by contract, or otherwise.


 


1.5                               “Approval
Date” means the first day of the first month after the date upon
which 510(k) marketing clearance is first obtained for the Product in the
United States.


 


1.6                               “Confidential
Information”  means any
information deemed by a Party to be its confidential or proprietary information
that it discloses to the other Party under this Agreement and marks as
“confidential” or the equivalent at the time of disclosure, which may include,
without limitation, engineering designs and drawings, know-how, trade secrets,
research data, processes, techniques, research projects, work in process,
future developments, and any scientific, manufacturing, marketing, business
plan, financial or personnel matters relating to a Party or its present or
future products, sales, suppliers, customers and patients, employees, investors
or business.  Any “Confidential
Information” as defined in the Letter Agreement dated February 25, 2003
between the Parties and exchanged pursuant thereto, shall be deemed to be
Confidential Information for purposes of this Agreement.


 


1.7                               “Controlled”
means, with respect to particular information or intellectual property, that
the applicable Party owns or has a license to such information or intellectual
property and has the right to grant to the other Party access and a license to
such information or intellectual property as provided in this Agreement without
violating any obligations to any third party.


 


1.8                               “Cost of
Goods” means MIA’s actual direct costs associated with the
manufacturing and assembling of the Product, to include:  materials and labor, and reasonable overhead
and administrative costs to the extent directly allocable to such manufacturing
activity of such Products (such as ordering process, collections, and account
maintenance for those Products), and shipping.


 


1.9                               “FDA”
means the United States Food and Drug Administration, and any successor thereto.


 


1.10                        “Financing
Event” means [*].


 


1.11                        “Gross
Selling Price” means, on a country-by-country basis, the actual,
bona fide gross selling price, before term discounts, at which MIA or its
Affiliate (or a Related Sub-Distributor, if applicable) sells or otherwise
markets Product, including Product components and Product accessories, to
sub-distributors and to end users in such country; provided, however, that the Gross Selling Price for
transfers from MIA to a Related Sub-Distributor shall be the greater of (i) the
actual, bona fide gross selling price, before discounts, by such Related
Sub-Distributor to an unaffiliated third party, or (ii) the fair market value,
based on arms-length sales, of Product, including components and Product
accessories.  If MIA sells the Product
at more than


 


2

















 


one
gross selling price in a given country within the Territory, the Gross Selling
Price in such country with respect to Product shall mean the total revenue at
such bona fide gross selling prices, in the relevant Sales Quarterly accounting
period, divided by the number of Products sold in that period in such
country.  No Gross Selling Price shall
be assessed on units of Product transferred free of charge by MIA to sub-distributors
solely for use for marketing purposes and not for resale.  The Gross Selling Price for Product sold in
combination or bundled with other products shall be determined on a
country-by-country basis as follows:


 


(a)           If
the Product and each of the other products in the combination or bundle are
sold separately in such county, the Gross Selling Price shall be calculated by
multiplying the gross selling price of the combination or bundle by the
fraction A/(A+B) where A is the average Gross Selling Price of Product when
sold separately, and B is the gross selling price of the other product(s) in
the combination or bundle.


 


(b)           If each of the other
products in the combination or bundle are not sold separately in such country,
but the Product is sold separately in such country, the Gross Selling Price
shall be calculated by multiplying the gross selling price of the combination
or bundle by the fraction A/C where A is the Gross Selling Price of the Product
when sold separately, and C is the gross selling price of the combination or
bundle.


 


(c)           If the Product is not
sold separately in such country, Gross Selling Price shall be calculated by
multiplying the gross selling price of the combination or bundle by the
fraction D/(D+E), where D is the fair market value of the Product and E is the
fair market value of the other product(s) in the combination or bundle, as such
fair market values are determined in good faith by the Parties.


 


1.12                        “Manufacturing
Improvements” has the meaning set forth in Section 3.4(a).


 


1.13                        “OnQ
Aerosol Generator” means Aerogen’s proprietary aerosol generator, as
described in Exhibit A.


 


1.14                        “OnQ
Aerosol Generator Manufacturing Facility” means the facility at
which manufacture and assembly of OnQ Aerosol Generators is conducted, which
shall either be the facility being used as of the Effective Date, or such other
location and facility as established by mutual agreement of the Parties
pursuant to Section 3.8.


 


1.15                        “OnQ
Manufacturing Period” means that period of time commencing on the
Effective Date and ending upon the exercise by Aerogen of its Repurchase
Option.


 


1.16                        “Product”
means Aerogen’s proprietary Aeroneb® Go open-cup, continuous-flow,
general-purpose portable nebulizer, and described on Exhibit B,
incorporating the OnQ Aerosol Generator, and including any Product Improvement
incorporated therein.


 


1.17                        “Product
Improvement” means, on a country-by-country basis, any modification
or line extension of the Product, or accessory that is designed for use with
the Product, that:


 


(a)           is developed by
Aerogen, or by MIA as permitted in Section
3.4(a); and (b) does not require any separate 510(k) marketing
clearance, Premarket approval (PMA) application, Biologics License Application
(BLA), or New Drug Application (NDA) regulatory filing or approval, or any
foreign equivalent thereto, to promote, market and sell a Product containing
such modification or line extension or accessory in the Territory.


 


3

















 


 


1.18                        “Related
Sub-Distributor” means any distributor (or similar entity) (a) to
which MIA (or its Affiliate) sells or otherwise transfers Products for resale
or redistribution, and (b) with which MIA or any Affiliate of MIA has any
direct or indirect financial relationship (which may include, without
limitation, equity ownership, credit facilities, rebates, profit or revenue
interest, etc.).


 


1.19                        “Regulatory
Agency” means any national, supranational, regional, state,
provincial or local regulatory agency or other governmental entity that has
authority, responsibility or jurisdiction with regard to the manufacture,
marketing and sale of the Product within the Territory.


 


1.20                        “Repurchase
Option” has the meaning set forth in Section 3.8(f).


 


1.21                        “Sales
Quarter” means a period of three (3) successive calendar months
commencing on the later of (a) the first day of the first full month following
delivery of [*] OnQ Aerosol Generators or (b) the
Approval Date, and each three (3) successive calendar month period thereafter
during the Term.


 


1.22                        “Sales Year”  means the period of twelve (12) successive
calendar months commencing on the later of of (a) the first day of the first
full month following delivery of [*] OnQ Aerosol Generators or (b) the
Approval Date, and each successive twelve (12) month period thereafter during
the Term.


 


1.23                        “Specifications”
means the technical and performance specifications for the OnQ Aerosol
Generators or the Product, as may be amended from time to time to incorporate
any improvements, modifications, changes or revisions thereto.  The Specifications for the OnQ Aerosol
Generator are attached as Exhibit
A, and the  Specifications
for the Product are attached as Exhibit B.


 


1.24                        “Supply
Quarter” means a period of three (3) successive calendar months
commencing on the later of (a) the first day of the first full month following
delivery of [*] OnQ Aerosol Generators or (b) the
Approval Date, and each three (3) successive calendar month period thereafter
during the Term.


 


1.25                        “Term”
means the term of this Agreement, more fully described in Section 13.1.


 


1.26                        “Territory”
means those countries identified on Exhibit C, as may be amended by the Parties
pursuant to Section 2.4.


 


1.27                        “Trademarks”  shall mean those trademarks and trade
names of Aerogen that Aerogen from time to time during the Term deems
appropriate for use in connection with the marketing and sale of the Product,
the current versions of which are listed on Exhibit D.  Jointly


 


4

















 


developed
or applied-for trademarks and/or trade names pursuant to Section 8.1 shall be considered
Trademarks.


 


2.                                      Distribution Rights.


 


2.1                               Distribution Rights. 
Subject to the terms of this Agreement, Aerogen hereby appoints MIA as
its distributor during the Term to market, promote, distribute and sell the
Product in the Territory:  (a) on an
exclusive basis solely for use in the home-based, open-cup, continuous-flow,
general-purpose nebulizer market (e.g., not for use in hospitals); and (b) on a
non-exclusive basis solely for use in alternate care facilities.  Subject to the terms of Section 2.2 and Section 5.2, MIA may appoint
sub-distributors in the Territory subject to approval by Aerogen, which
approval shall not be unreasonably withheld. 
Subject to the terms of the Agreement, Aerogen hereby grants to MIA
during the Term the royalty-bearing, non-transferable right and license under
the Aerogen Licensed Rights to import, export, offer for sale and sell the
Product in the Territory solely for use by end users in the home-based,
open-cup, continuous-flow, general purpose nebulizer market and in alternate
care facilities.


 


2.2                               Sub-Distributor Obligation.  In
order for MIA to retain distribution rights in each Expansion Country of the
Territory (as defined in Exhibit
C), MIA shall complete and present to Aerogen a definitive
business plan, including a distribution strategy with either intent to contract
or hire sales representatives, or a letter of intent and a draft definitive
agreement with a sub-distributor, in each such Expansion Country within [*]
following the Effective Date.  The
business terms of each such agreement shall be subject to approval by
Aerogen.  At any time during such [*]
period, MIA may elect to terminate the Agreement with respect to any Expansion
Country, which will result in a commensurate reduction of the minimum royalties
and Product System (as Systems are defined on Exhibit A) sales requirements
attributable to such country as reflected in Exhibit  I
and Exhibit J;
provided, however, that the aggregate minimum
Product System sales requirements for Europe in its entirety (as defined in Exhibit J) shall
remain unchanged and the minimums for the remaining individual European
countries adjusted as mutually agreed upon by the Parties.  If as to any particular Expansion Country,
MIA has not met the preceding requirements of this section by the end of
such [*] period, then Aerogen may thereafter terminate MIA’s rights
under this Agreement with respect to such country, by written notice, and on
such termination such country shall no longer be in the Territory and all
rights in such country shall revert exclusively to Aerogen.  MIA will provide Aerogen with written notice
regarding any direct or indirect financial affiliation that arises between MIA
(or any of its Affiliates) and any of its existing or proposed sub-distributors
during the Term, with such notice to be given promptly upon the commencement of
negotiations with a sub-distributor involving any financial interest
(including, but not limited to, equity ownership, credit facilities, rebates,
profit or revenue interest, etc.), with full details of the final relationship
to be provided to Aerogen upon final deal closure.  MIA shall require that any Related Sub-Distributors make complete
and accurate reports to MIA in writing on a quarterly basis of all Gross
Selling Prices for Products sold or otherwise transferred by such Related
Sub-Distributor, and Aerogen shall have the right to inspect and audit all such
reports pursuant to Section 5.7.


 


5

















 


2.3                               No Conflicts.


 


(a)                                  Notwithstanding any term or provision of this
Agreement, Aerogen retains the right to develop and/or commercialize products
for use in hospitals, alternate care facilities, and any other use, and
products for home-based use other than the Product; provided, however,
that during the Term, other than through MIA, Aerogen agrees not to introduce
in the Territory, nor grant to any third party the right to introduce in the
Territory, any open-cup, continuous-flow, general-purpose nebulizer for
home-based use incorporating the OnQ Aerosol Generator.


 


(b)                                  During the Term, MIA agrees that neither it
nor its Affiliates or sub-distributors will develop, market or distribute in
the Territory, either directly or through a third party, any products (other
than the Product) that contain an aerosol generator utilizing a vibrating
element that would directly compete with or otherwise reduce the sales of the
Product.


 


(c)                                  MIA covenants that it and its Affiliates and
sub-distributors shall not market, promote, distribute or sell the Product for
any use other than home-based use or use in an alternate care facility.


 


2.4                               Right of First Negotiation
to Expand the Territory.  During the Term, but no sooner than [*]
from the Effective Date, MIA shall have a right of first negotiation to obtain
rights to distribute the Product in a country that is not listed on Exhibit C.  MIA shall notify Aerogen of its intent in
writing, and, if the marketing rights for the Product in such country are
available for licensing to MIA, then the Parties shall negotiate in good faith
to reach an agreement regarding the expansion of the Territory to include such
country.  If the Parties reach agreement
on the expansion of the Territory, Exhibit C shall be amended to reflect the
additional country(ies) in which MIA may distribute the Product pursuant to
this Agreement.


 


3.                                      Product Manufacture.


 


3.1                               Product Manufacturing
License.  Subject to the terms of this Agreement,  Aerogen hereby grants to MIA during the
Term, the non-transferable license (without the right to grant sublicenses,
except to subcontractors and/or vendors that fabricate and/or supply components
of the Product on behalf of MIA as shall be mutually agreed to from time to
time) under the Aerogen Licensed Rights and the Manufacturing Improvements to
manufacture and assemble components of the Product (excluding the OnQ Aerosol
Generator) and to assemble final Product for distribution and sale in the
Territory as permitted under Section 2.1.


 


3.2                               Manufacture of Product.  MIA
shall be responsible for manufacturing all of its (and its sub-distributors’)
requirements for the Product (excluding the OnQ Aerosol Generator component,
which shall be supplied by Aerogen as provided in this Agreement), in order to
meet on a timely basis all market demand therefore.  With respect to such manufacturing, MIA shall:  (a) manufacture, assemble and distribute the
Product in accordance with the Quality System Regulations; (b) maintain
certification to current, applicable EN/ISO standards and any future
amendments; (c) maintain certification compliant with all European regulations
and directives applicable to the manufacture of medical devices; and (d) comply
with applicable requirements of any other Regulatory Agencies having jurisdiction
over the development, manufacture, testing


 


6

















 


or
use of the Product.  MIA shall, at its
own expense, obtain and maintain the necessary licenses and permits required to
manufacture and distribute the Product in accordance with this Agreement.


 


3.3                               Product Quality.  At
Aerogen’s request, MIA shall provide Aerogen samples of the Product being
manufactured and distributed by MIA (or its Affiliates or sub-distributors),
for inspection by Aerogen to assure that the quality of such Product meets with
Aerogen’s approval, not to be unreasonably withheld.  If Aerogen determines that any such Product sample is deficient
(e.g., because such Product or its packaging does not meet the applicable
Product Specifications or quality of manufacture), then Aerogen may give MIA
written notice of such deficiencies, and MIA shall promptly thereafter remedy
such deficiencies to Aerogen’s reasonable satisfaction.


 


3.4                               Product Modifications.


 


(a)                                  MIA may make manufacturing changes to the
Product for the purpose of reducing Product manufacture and assembly costs (“Manufacturing Improvements”), subject to
Aerogen’s written consent, which shall not be unreasonably withheld.  All such Manufacturing Improvements shall be
disclosed to Aerogen in writing.  MIA
will make no changes to the OnQ Aerosol Generator.  If MIA desires to make any other changes to the Product or any
components thereof, MIA shall first request the right to make such changes, and
such proposed changes shall be discussed with Aerogen and shall not be made
without Aerogen’s prior written consent. 
If any changes are agreed upon, they will be made, either (i) by MIA at
MIA’s expense or (ii) by Aerogen, with Aerogen’s activities to be reimbursed by
MIA.  For clarity, the only changes or
modifications that MIA may make that relate to the Product or its manufacture
are changes that would qualify as Product Improvements, Manufacturing
Improvements, or cost reductions, and any such changes or modifications require
Aerogen’s prior written consent as provided above.


 


(b)                                  Nothing in the Agreement, other than the
restrictions described in Section 2.3(b),
will prevent MIA from continuing to develop and commercialize products for the
home market in the respiratory field separate from the Product or from making
any Manufacturing Improvements to the Product as permitted by subclause (a)
above, (but no such development will negate or limit MIA’s obligation to make
minimum purchases as provided in Section 6.1);
provided, however, MIA will have
no right to use the OnQ Aerosol Generator or any Aerogen Licensed Rights in
connection with any such activities. 
Subject to the foregoing, MIA will be free to use any inventions MIA may
make outside the scope of the Agreement in such other products.


 


3.5                               [*] Arrangement. 
Aerogen agrees to work with MIA in good faith to devise a work plan for
the development and regulatory activities associated with a new product that
would include [*]. 
If a work plan is agreed upon, the Parties will negotiate in good faith
an agreement for the development and commercialization of that new
product.  If no agreement is reached by [*],
then neither Party will have any further obligation to negotiate with the other
concerning such a new product.


 


7

















 


3.6                               Quality Control Procedures.  MIA
shall maintain all documentation and quality control test results relating to
the quality control procedures for each Product for a period of [*]
after it delivers such Product to any sub-distributor or customer.  During the Term, Aerogen may periodically
review MIA’s quality control program documentation, and may work with MIA to
audit, survey, or verify the adherence of MIA to the quality control and to
assess its compliance with the quality control procedures, and to discuss any
related issues with MIA’s manufacturing and management personnel.


 


3.7                               OnQ Aerosol Generator
Manufacturing.  Other than as provided for during the OnQ
Manufacturing Period in Section 3.8
below, Aerogen will be solely responsible during the Term for the manufacture
and supply to MIA of its requirements of the OnQ Aerosol Generator for
incorporation into the Product, pursuant to the terms of Article 4.  Aerogen will use reasonable efforts to time its production of OnQ
Aerosol Generators so as to maintain in stock not less than the number of OnQ
Aerosol Generators firm-ordered by MIA (in accordance with appropriate
forecasts) for delivery within [*], as provided in Section 4.1.


 


3.8                               OnQ Manufacturing Period.


 


(a)                                  MIA Manufacturing. 
During the OnQ Manufacturing Period, MIA shall have the right, but not
the obligation, to manufacture, pursuant to the terms of this Section 3.8, all its requirements of
OnQ Aerosol Generators for use in assembling Product for sale and distribution
by MIA as permitted in Section 2.1.  MIA shall comply with all applicable Aerogen
Specifications and protocols for the OnQ Aerosol Generators it manufactures as
disclosed by Aerogen as part of the Aerogen Technology.


 


(b)                                  OnQ Aerosol Generator Manufacturing License.  Aerogen hereby grants to MIA a
non-exclusive, non-transferable license (without the right to grant
sublicenses) under the Aerogen Technology to manufacture and assemble the OnQ
Aerosol Generator at the OnQ Aerosol Generator Manufacturing Facility solely
during the OnQ Manufacturing Period, and solely for use in assembling the
Product that MIA is permitted to distribute and sell pursuant to Section 2.1, and for use by Aerogen
pursuant to Section 3.8(e).


 


(c)                                  Equipment Sale. 
Upon Aerogen’s receipt of the payments owed in Section 5.1, Aerogen sells and assigns
to MIA Aerogen’s entire right, title and interest in the equipment listed in Exhibit E (the “Equipment”).  During the OnQ Manufacturing Period, the Equipment will continue
to be housed at the OnQ Aerosol Generator Manufacturing Facility.  Upon the Effective Date, MIA shall have the
right to assume full authority over the manufacturing of the OnQ Aerosol
Generator at the OnQ Aerosol Generator Manufacturing Facility in the event of
Aerogen’s non-performance under Section 3.8(d)
that results in a failure to satisfy MIA’s requirements for
quantities of OnQ Aerosol Generators set forth in the forecasts and purchase
orders provided by MIA in accordance with Sections
4.1 and 4.2,  until expiration of the OnQ Manufacturing
Period, including the authority to direct Aerogen as to the operational
objectives to be achieved by the key manufacturing personnel to be provided by
Aerogen pursuant to Section 3.8(d),
but subject to Section 3.8(e).  During the OnQ Manufacturing Period, MIA
shall obtain and maintain all-risk insurance coverage with respect to the
Equipment insuring against, among other things:  casualty, including loss or damage due to fire and the risks


 


8

















 


normally
included in extended coverage, malicious mischief and vandalism, for not less
than the full replacement value of said Equipment.


 


(d)                                  Contract Manufacturing Services. 
During the OnQ Manufacturing Period, Aerogen shall provide to MIA and
MIA agrees to accept from Aerogen contract manufacturing services for the
manufacture of MIA’s requirements of OnQ Aerosol Generators (subject to the
forecasts in Exhibit F)
at the OnQ Aerosol Generator Manufacturing Facility using the Equipment (the “Services”).  In connection with the Services, Aerogen shall:  (i) provide and supervise appropriately
trained personnel resources necessary to manufacture MIA’s requirements of OnQ
Aerosol Generators (but not to exceed that number of manufacturing personnel employed
by Aerogen as of the Effective Date in conducting its manufacture of OnQ
Aerosol Generators at the OnQ Aerosol Generator Manufacturing Facility at its
location as of the Effective Date unless additional personnel are necessary to
satisfy MIA’s requirements for quantities of OnQ Aerosol Generators set forth
in the forecasts and purchase orders provided by MIA in accordance with Sections 4.1 and 4.2); and (ii) maintain the Equipment at the OnQ Aerosol
Generator Manufacturing Facility in good working condition; and (iii) if
applicable, transfer manufacturing activities, including moving all Equipment,
to the new location for the OnQ Aerosol Generator Manufacturing Facility, if
such location is agreed to and secured by the Parties pursuant to Section 3.9.  The methods, details and means of performing such services will
be determined by Aerogen in its reasonable discretion.  In connection with the Services, Aerogen
will be solely responsible for all monthly expenses associated with the current
OnQ Aerosol Generator Manufacturing Facility, including without limitation, all
rents, taxes, equipment maintenance, payroll and employee benefit and insurance
expenses, utilities, and phone charges. 
In the event of commencement of bankruptcy proceedings against Aerogen,
MIA’s right to access and use the Equipment, and to manufacture the OnQ Aerosol
Generator shall not be limited, prohibited, or encumbered by Aerogen.  The terms and conditions of Article 4 shall apply to the order,
purchase and delivery of OnQ Aerosol Generators manufactured by Aerogen
pursuant to the Services.  OnQ Aerosol
Generators manufactured by Aerogen in the course of providing the Services
shall meet the OnQ Aerosol Generator Specifications set forth in Exhibit A and shall
be subject to the warranty set forth in Section 9.4.


 


(e)                                  Manufacturing Capacity.  It
is understood and agreed that during the OnQ Manufacturing Period, production
of OnQ Aerosol Generators shall include making OnQ Aerosol Generators required
by MIA for use in MIA’s assembly of the Product and also for use by Aerogen in
making other Aerogen products and for Aerogen’s research purposes (which
estimated requirements are set forth in Exhibit F); provided
that MIA is appropriately reimbursed, to the extent that MIA bears associated
costs for such production.


 


(f)                                    Repurchase Option. 
Following the earliest of [*]
provided that Aerogen has met its obligations under the Agreement up to and
including that date, Aerogen shall have the right to repurchase the Equipment
from MIA, and to simultaneously revoke and terminate the rights granted to MIA
under Section 3.8(a), (the “Repurchase Option”).  Aerogen may exercise the Repurchase Option
upon thirty (30) days written notice to MIA and including with such notice,
delivery of evidence of [*], if applicable, and payment to MIA of [*]
as consideration for the repurchase of the Equipment and the termination and
revocation of rights.  Within such
thirty (30) day notice period, MIA shall sell and assign to Aerogen the entire
right, title and interest in


 


9

















 


the
Equipment, free and clear of any and all encumbrances, and shall take such
action as reasonably requested by Aerogen to document and perfect such sale and
assignment.  MIA covenants that it shall
not sell, lease, mortgage or otherwise encumber in any manner its interest in
the Equipment.


 


3.9                               Leasehold.  Following the Effective Date, and provided that Aerogen terminates its
obligations under the lease to the current OnQ Aerosol Generator Manufacturing
Facility, Aerogen and MIA shall mutually negotiate with appropriate third
parties in an effort to secure a new location for the OnQ Aerosol Generator
Manufacturing Facility.  The terms of
such lease shall be mutually agreeable to both MIA and Aerogen.  MIA shall sign as lessee of such leasehold,
and Aerogen will be solely responsible for all monthly expenses associated with
such new OnQ Aerosol Generator Manufacturing Facility, including without
limitation, all rents, taxes, equipment maintenance, payroll, utilities, and
phone charges.  Aerogen agrees to
sublease the facility from MIA on the same terms and conditions of said lease,
upon the end of the OnQ Manufacturing Period, and MIA agrees to grant such sublease
to Aerogen on such terms.  If Aerogen
does not terminate its obligations under the lease to the current OnQ Aerosol
Generator Manufacturing Facility, it will provide for access by MIA to the OnQ
Aerosol Generator Manufacturing Facility for a period of sixty (60) days, in
the event of Aerogen’s default under such lease.


 


3.10                        Back-Up Manufacturing Right. 
Following the end of the OnQ Manufacturing Period, if at any time during
the remainder of the Term, Aerogen (or its Affiliate or assignee, as
applicable) either:  (a) is not financially
able to maintain the OnQ Aerosol Generator Manufacturing Facility, and
therefore ceases operating such facility; or (b) fails to timely supply to MIA
a material quantity of the OnQ Aerosol Generators ordered by MIA in accordance
with the terms and conditions of Article 4,
then MIA may, by written notice to Aerogen, require that Aerogen meet
immediately with MIA to resolve the problem. 
In such case, the Parties shall discuss in good faith the issue and seek
to achieve a resolution as soon as possible. 
If such resolution is not reached within [*] of such
notice from MIA, and Aerogen has not by that date otherwise cured the problem
and supply deficiency, then Aerogen shall grant to MIA a non-exclusive,
non-transferable license (without the right to grant sublicenses) under the
Aerogen Technology to manufacture and assemble the OnQ Aerosol Generator solely
for MIA’s use in assembling the Product for sale and distribution as permitted
in Section 2.1, which license
shall automatically terminate on the earlier of [*], or
termination of the Agreement by MIA or by Aerogen pursuant to Article 13.


 


4.                                      OnQ Aerosol Generator
Forecasts, Orders and Delivery.


 


4.1                               Forecasts.  On
the first day of [*] during the Term, MIA shall provide to
Aerogen a rolling forecast of MIA’s anticipated OnQ Aerosol Generator purchases
for the following [*] period. 
MIA shall provide each forecast to Aerogen [*] in advance of
the beginning of the forecast period to which the forecast pertains.  The [*] of each such forecast shall constitute an
order to buy the amount of OnQ Aerosol Generators listed in the forecast for
such [*]; the remaining [*] of each forecast will constitute a
non-binding, good faith forecast.  An
initial forecast is shown on Exhibit F; the forecast shown in [*]
shall constitute a firm order by MIA for


 


10

















 


which MIA will promptly
submit a purchase order to Aerogen on the Effective Date for at least the
quantities indicated for such [*].


 


4.2                               Purchase Orders.  Each
forecast shall be accompanied by a binding purchase order for [*]
of the forecast period.  The quantity
requested in such purchase order may not deviate from the amount previously
forecasted for such [*] in the most recent prior forecast by more
than [*], unless Aerogen otherwise agrees.  The quantities
forecasted for [*] of each
forecast shall not deviate from the quantities forecasted for the same [*]
period in the prior forecast by more than [*], unless Aerogen otherwise agrees.  MIA shall place each purchase order for quantities
of the OnQ Aerosol Generator at least [*] prior to the delivery date specified
therein, and each such purchase order shall be binding on MIA upon receipt by
Aerogen.  MIA may use its standard
purchase order form to order OnQ Aerosol Generators; provided, however, that all purchase orders and confirmation
memoranda exchanged in connection with an order and delivery of the Product
shall be subject to the terms of this Agreement, and any conflicting or
additional terms are hereby expressly rejected.  Aerogen shall use reasonable efforts to deliver the OnQ Aerosol
Generators ordered by MIA under such binding purchase orders by the delivery
dates specified in such orders.


 


4.3                               Order Limits.  Aerogen shall not be obligated to supply in a calendar month a quantity
of OnQ Aerosol Generators that is more than [*] of the amount previously forecasted for
such [*] in the prior forecast submitted by MIA (each, an “Order Limit”).  However, if requested by MIA, Aerogen will use reasonable efforts
to supply any amounts of OnQ Aerosol Generators in excess of the Order Limit
for a particular [*]. 
Aerogen shall notify MIA in writing promptly after receiving a purchase
order from MIA whether it is able to supply the amount of such purchase order
that exceeds such Order Limit.  Any
excess amounts that Aerogen accepts (in whole or in part) pursuant to this Section 4.3 within [*]
after the date of such purchase order shall be binding upon MIA.  If Aerogen fails to respond within [*]
after the date of a purchase order that requests delivery of amounts in excess
of the Order Limit, then Aerogen shall be deemed to have accepted only the
amount of such purchase order that falls within the Order Limit.


 


4.4                               Delivery.  Each
shipment of OnQ Aerosol Generators will be delivered FCA (Incoterms 2000) the
OnQ Aerosol Generator Manufacturing Facility in accordance with the
instructions in MIA’s purchase orders. 
Upon MIA’s written instructions, and at MIA’s risk and expense, Aerogen
shall arrange for shipment of OnQ Aerosol Generators to MIA’s Product
manufacturing location(s).  MIA shall
maintain a direct-billed account with the common carrier(s) of its choice, and
shall inform Aerogen in a timely manner as to which such carrier(s) Aerogen
shall use for all OnQ Aerosol Generator shipments.


 


4.5                               Inspection; Defective OnQ
Aerosol Generators.


 


(a)                                  Inspection; Rejection;
Acceptance.  MIA will visually inspect all deliveries of
the OnQ Aerosol Generators on arrival. 
Within [*] of receipt of shipment of OnQ Aerosol
Generators, MIA shall promptly give notice to Aerogen of any complaint
regarding qualitative and/or quantitative defects of the delivered OnQ Aerosol
Generators that are or would have been discovered by a reasonable visual
inspection and of its rejection of such OnQ Aerosol


 


11

















 


Generators.  If MIA fails to notify Aerogen of any such
defects within such period, MIA shall be deemed to have accepted the OnQ
Aerosol Generators.  Rejected goods
shall be returned freight prepaid to Aerogen within [*] of rejection.


 


(b)                                  Sole Remedies.  With
respect to any such OnQ Aerosol Generators that Aerogen reasonably determines,
pursuant to its failure investigation process, in which MIA may participate at
its reasonable request, to have been defective at the time of delivery to MIA
pursuant to Section 4.5(a),
Aerogen shall, at its option, either repair or replace the defective OnQ
Aerosol Generators free of charge, or credit the MIA with the purchase price of
the defective OnQ Aerosol Generators. 
Any replacement goods shall be shipped by Aerogen to MIA freight
prepaid.  The remedies set forth in this
Section 4.5(b) are MIA’s sole
and exclusive remedies for claims based on defective OnQ Aerosol Generators
supplied by Aerogen prior to incorporation into assembled Product by MIA,
subject to the limited warranty set forth in Section 9.4
below and the applicable remedies set forth in Section 9.5.


 


4.6                               Inventory.  In order to prevent out-of-stock situations, at any time during the
Term upon Aerogen’s request, MIA shall keep an inventory of OnQ Aerosol
Generators for assembly into Product in amounts to cover at least MIA’s
forecasted requirements for the following [*]. 
Aerogen will time its production of OnQ Aerosol Generators so as to
maintain in stock not less than the number of OnQ Aerosol Generators
firm-ordered by MIA for delivery within [*].


 


5.                                      Payments.


 


5.1                               Up Front Payments.


 


(a)                                  In consideration of the Product distribution
rights granted by Aerogen to MIA pursuant to Section 2.1
and the exclusive Product manufacturing and assembly license granted by Aerogen
to MIA pursuant to Section 3.1,
MIA will pay to Aerogen one million five hundred thousand U.S. dollars
($1,500,000), payable [*].


 


(b)                                  In consideration of the sale by Aerogen to
MIA of the Equipment, MIA will pay to Aerogen within [*] of the
Effective Date one million U.S. dollars ($1,000,000).


 


5.2                               Sub-Distributor Agreement
Revenue.  MIA shall pay to Aerogen [*]
of any upfront fees, milestone payments and any other payments or consideration
obtained by MIA pursuant to the terms of any sub-distributor agreement entered
into by MIA as permitted by this Agreement, but
excluding amounts paid by such sub-distributor, as long as MIA has
no financial interest in such sub-distributor, as transfer price for purchase
of the Product from MIA, on which amounts Aerogen is paid royalties as
specified in Section 5.3.


 


12

















 


5.3                               Sales-Based Payments.  In
consideration of the rights granted by Aerogen to MIA under this Agreement, MIA
will make payments to Aerogen based on the Gross Selling Price of each unit of
Product, including Product components and Product accessories, sold by MIA (or
its Affiliate or Related Sub-Distributor, as applicable) to sub-distributors or
to end-user customers in the Territory. 
Such payments shall be as set forth in Exhibit G.  Commencing with the first commercial sale of the Product in the
Territory, sales based payments payable to Aerogen under this Section 5.3 shall be paid on a Sales
Quarterly basis during each Sales Year of the Term, within [*]
following the end of each such Sales Quarter.


 


5.4                               Transfer Pricing.


 


(a)                                  The transfer price for the first [*]
OnQ Aerosol Generators to be supplied by Aerogen to MIA pursuant to this
Agreement will be equal to [*] per unit.  The transfer price for the next [*] OnQ Aerosol Generators to be supplied by
Aerogen to MIA pursuant to this Agreement will be equal to [*]
per unit.  Aerogen will use reasonable
efforts to supply to MIA the first [*] OnQ Aerosol Generators no later than [*]
following the Effective Date, and [*] additional OnQ Aerosol Generators no
later than [*] following the Effective Date.


 


(b)                                  During the [*] immediately following the later of (i)
the delivery of [*] OnQ Aerosol Generators or (ii) the
Approval Date, up to [*] additional OnQ Aerosol Generators will be
provided to MIA at [*] for which Aerogen will invoice MIA, such
invoice to be paid within [*] of receipt.  Such quantity of [*] OnQ Aerosol Generators excludes any OnQ
Aerosol Generators used in Product provided to Aerogen pursuant to Section 5.4(e).


 


(c)                                  After the earlier of:  (i) the end of [*] (provided
that Aerogen has satisfied MIA’s requirements for quantities of OnQ Aerosol
Generators set forth in the forecasts and purchase orders submitted by MIA in
accordance with Sections 4.1 and 4.2); or (ii) the shipment by Aerogen to
MIA of a total of [*] OnQ Aerosol Generators, the transfer
price for OnQ Aerosol Generators from Aerogen to MIA will be equal to [*]
per unit, subject to subclause (d) below and the other provisions of the
Agreement, and exclusive of taxes, shipping and similar items.


 


(d)                                  Aerogen’s transfer price to MIA for the OnQ
Aerosol Generator may be increased by Aerogen, no more frequently than once in
any [*] period, in an amount not to exceed [*],
the first such increase to be effective on the earlier of:  (i) shipment by Aerogen of a total of [*]
OnQ Aerosol Generators; or (ii) the [*] of the Agreement.  Notwithstanding the foregoing, Aerogen may
adjust the transfer price of OnQ Aerosol Generators to reflect increases in the
costs (if any) of unique or scarce materials used in the manufacture of OnQ
Aerosol Generators or changes in regulatory requirements that create an
increase in OnQ Aerosol Generator manufacturing costs.  The Parties will negotiate in good faith the
transfer prices for any Product Improvements created during the Term as
provided in this Agreement.


 


(e)                                  Subject to the quantity limits set forth in
the forecast to be provided by Aerogen within [*] after the Effective Date and the minimum
order quantity of [*] per order, MIA will supply Product to
Aerogen at MIA’s Cost of Goods [*],
to be used by Aerogen to satisfy its Aeroneb® Portable Nebulizer System
warranty replacement obligations and distributor and pharmaceutical
partner/customer requirements.  MIA will
receive a credit under


 


13

















 


Section 5.4(c) for its cost of each OnQ Aerosol Generator
assembled into Product that is delivered by MIA to Aerogen under this Section 5.4(e).  If so requested by Aerogen, MIA also agrees
to negotiate in good faith a supply agreement on commercially reasonable terms
under which MIA would supply to Aerogen additional Product for use by Aerogen
in its business (i.e., outside of the rights granted to MIA under this
Agreement).


 


5.5                               Payment Terms; Reports.  For
the first [*] OnQ Aerosol Generators delivered by
Aerogen to MIA pursuant to this Agreement, MIA shall pay Aerogen the purchase
price for OnQ Aerosol Generators as stated on Aerogen’s invoice for each
shipment via wire transfer initiated within [*] of receipt of each shipment.  For the next [*] OnQ Aerosol
Generators delivered by Aerogen to MIA pursuant to this Agreement, MIA shall
pay Aerogen the purchase price for OnQ Aerosol Generators as stated on
Aerogen’s invoice for each shipment via wire transfer initiated within [*].  Thereafter, MIA shall pay Aerogen the
purchase price for OnQ Aerosol Generators as stated on Aerogen’s invoice for
each shipment within [*] from the date of the invoice.  In addition, commencing with the first
commercial sale of Product, within [*] of the end of each Sales Quarter, MIA
will provide Aerogen with written sales report listing all Product and
components sold, by part number, by country, by country and by sub-distributor
and channel of sale, and providing the gross selling price for each such
Product, and calculating the royalties owed pursuant to Section 5.3.  Any payments to Aerogen under this Agreement shall be made by
wire transfer to such bank or account as Aerogen shall specify from time to
time.


 


5.6                               Late Payments.  Any amounts not paid by MIA when due under this Agreement shall be
subject to interest from the date payment is due through the date upon which
Aerogen has collected immediately available funds in an account designated by
Aerogen at a rate equal to the sum of [*] or, if lower, the highest rate permitted
under applicable law.  In the event that
MIA fails to make payments for an invoice relating to any of the first [*]
OnQ Aerosol Generators when due as specified in Section 5.5, such failure shall constitute a material
breach of the Agreement, and MIA shall have [*] from the date of written notice by
Aerogen to cure such breach by payment via wire transfer to Aerogen of an amount
equal to the invoice amount due plus [*].


 


5.7                               Records and Audit.  MIA shall keep, and shall require all its Affiliates and Related
Sub-Distributors to keep, complete and accurate records pertaining to the
manufacture, sale or other disposition of the Product and components sold and
of the amounts payable under this Agreement in sufficient detail to allow the
determination of the payments due to Aerogen, or payments owed by Aerogen under
Section 5.4(e).  Aerogen shall have the right to cause an
independent, certified public accountant designated by Aerogen and reasonably
acceptable to MIA to audit such records to confirm the accuracy of MIA’s
payments due hereunder or amounts owed by Aerogen.  Such audit rights may be exercised no more often than once a year,
within three (3) years after the Sales Quarter to which such records relate,
upon reasonable notice to MIA and during normal business hours.  Aerogen will bear the full cost of such
audit unless such audit discloses an underpayment by MIA, or overpayment by
Aerogen, as applicable, of more than five percent (5%) from the amount of
payments due, in which case MIA shall bear the full cost of such audit.  Within thirty (30) days of the completion of
such audit, MIA shall pay to


 


14

















 


Aerogen
the amount of any such payment discrepancy disclosed in such audit, or Aerogen
shall pay to MIA the amount of any overpayment disclosed in such audit, as
applicable.  The terms of this Section 5.7 shall survive any termination
or expiration or termination of this Agreement for a period of three (3) years.


 


5.8                               Taxes and Duties.


 


(a)                                  MIA shall pay all import duties, any and all
sales, use, excise, value added, transfer, export or other taxes or
assessments, imposed by any governmental authority on any sale to MIA under
this Agreement or any of MIA’s or its sub-distributors activities, except for
any taxes which are imposed on Aerogen’s net income, gross receipts or other
similar direct taxable income of Aerogen.


 


(b)                                  If MIA is required to withhold any taxes on
amounts payable to Aerogen pursuant to the laws and regulations of a
jurisdiction within the Territory, MIA shall deduct withholding taxes from the
amounts otherwise payable by MIA hereunder for payment to the proper tax authorities
on behalf of Aerogen.  MIA agrees to
cooperate with Aerogen in the event Aerogen claims exemption from such
withholding or seeks deductions under any double taxation or other similar
treaty or agreement from time to time in force, such cooperation to consist of
providing receipts of payment of such withheld tax or other documents
reasonably available to Aerogen.


 


6.                                      Minimums.


 


6.1                               Minimum OnQ Aerosol
Generator Purchases.  Commencing on the Effective Date, MIA shall
purchase during the Term, on a [*] basis, those quantities of OnQ Aerosol
Generators set forth in Exhibit
H for assembly into Systems (as described on Exhibit B) of the
Product.  Such quantities are in
addition to the first [*] units to be provided pursuant to Section 5.4 above.  Failure by MIA to purchase the minimum
quantities [*] as set forth in Exhibit H shall be
deemed to be a material breach for which Aerogen may terminate the Agreement
pursuant to Section 13.5,
unless MIA has purchased, during the calendar year in which such [*]
occurs, more than the aggregate minimum quantities required under Exhibit H for such
calendar year through such [*], and subject further to MIA’s right to
cure in accordance with Section 6.2
below, unless such failure is due to supply shortages of the OnQ Aerosol
Generators (provided that MIA’s orders conform to the terms of Section 4.2).


 


6.2                               Minimum Purchase Shortfalls.  If
MIA has not met its minimum [*] purchase requirements (as described on Exhibit H and Exhibit F), and
Aerogen intends to terminate the Agreement pursuant to Section 13.5, Aerogen will provide [*]
prior written notice to MIA of its intent to terminate the Agreement for MIA’s
failure to meet minimum purchasing requirements.  Upon notice of intended termination, MIA shall have the right to cure
such shortfall in MIA’s minimum purchase requirement by purchasing during such [*]
notice period the amount of such OnQ Aerosol Generators equal to such shortfall
plus also purchasing at least MIA’s minimum purchase requirements for the [*]
in which the [*] cure period falls (linearly prorated for
the fraction of the [*].


 


15

















 


If
MIA purchases such quantities of OnQ Aerosol Generators to cure the minimum
purchase shortfall during the [*] notice period, and also purchases its
prorated minimum purchase requirements for the [*] in which said
cure period falls, Aerogen’s notice of termination shall not become effective
and the Agreement will continue in full force and effect.  Aerogen shall provide to MIA the [*]
notice of termination described in this Section 6.2,
no later than [*] after the end of the [*]
in which such minimum purchase shortfall failure occurs, after which Aerogen’s
option to terminate for said breach based upon MIA’s failure to meet its minimum
purchasing requirements for the applicable [*] will lapse.


 


6.3                               Minimum Royalties.  Commencing with the [*] Sales Quarter of the [*]
Sales Year, and on a Sales Quarterly basis thereafter, MIA shall pay to
Aerogen, on a country-by-country basis, minimum quarterly royalties which shall
be calculated as set forth on Exhibit I.  Minimum royalties due for each
Sales Quarter shall be payable within [*] following the end of such quarter and
shall be credited against sales-based royalty payments due and payable to
Aerogen pursuant to Section 5.3
above.  Such minimum royalties will be
due and payable with respect to any country that is part of the Territory for
any portion of a Sales Quarter, regardless of whether that country remains a
part of the Territory thereafter. 
Notwithstanding this Section 6.3,
if Aerogen fails, for a period of greater than [*], to supply
OnQ Aerosol Generators in fulfillment of MIA’s purchase orders submitted in
accordance with Section 4.2,  and such supply failure results in Product
System backorders for the United States, then during the Sales Quarter(s) in
which such OnQ Aerosol Generator supply shortage occurs, MIA shall only be
required to pay the actual sales-based royalty payments due and payable to
Aerogen pursuant to Section 5.3
above for Product sales in the United States in such Sales Quarter(s).  The minimum royalty requirement for the
United States shall be reinstated in the first full Sales Quarter following
resolution of the OnQ Aerosol Generator supply shortage.


 


6.4                               Minimum Product System Sales
Requirements.  Notwithstanding MIA’s satisfaction of its
OnQ Aerosol Generator purchase requirements as described in Sections 6.1 and 6.2 above, MIA shall also be required to sell Product Systems
(as Systems are defined on Exhibit
A) in the Sales Quarterly quantities specified for each country
on Exhibit J.  Failure by MIA to sell the minimum
quantities as set forth in Exhibit
J for a particular country in any particular Sales Quarter shall
be deemed to be a material breach for which Aerogen may terminate the Agreement
with respect to such country pursuant to Section 13.5,
or the Agreement in its entirety if such country is the United States, in each
case unless MIA has sold, during the Sales Year in which such Sales Quarter
occurs, more than the aggregate minimum required sales of Product Systems in
such country for such Sales Year through such Sales Quarter, as specified in Exhibit J, but
subject to MIA’s right to cure in accordance with Section 6.5(a) below, and unless such failure is due to
Aerogen’s failure to supply OnQ Aerosol Generators (ordered by MIA in
compliance with Section 4.2)
for a period exceeding [*] that results in Product System backorders
in such country immediately following such failure by Aerogen.  Aerogen may terminate the Agreement with
respect to all of Europe (as defined in Exhibit J) if MIA fails to sell the aggregate
minimum quantities, in any particular Sales Quarter, for all of Europe (as
determined by aggregating the minimum sales quantities in Exhibit J for each
country in Europe in such Sales Quarter), unless MIA has sold, during the Sales
Year in which such Sales Quarter


 


16

















 


occurs,
more than the aggregate minimum required sales of Product Systems in all of
Europe for such Sales Year through such Sales Quarter, as specified in Exhibit J and
determined as above, and subject to MIA’s right to cure in accordance with Section 6.5(b) below, and unless such
failure is due to Aerogen’s failure to supply OnQ Aerosol Generators (ordered
by MIA in compliance with Section 4.2)
for a period exceeding [*] that results in Product System backorders
in Europe immediately following such failure by Aerogen.


 


6.5                               Minimum Sales Shortfalls.


 


(a)                                  Individual Countries.  If
MIA has not met its minimum Sales Quarterly sales requirements for a particular
country (as described on Exhibit
J), and Aerogen intends to terminate the Agreement with respect
to such country, or, in the case of the United States, the Agreement in its
entirety, pursuant to Section 13.5,
Aerogen will provide ninety (90) days prior written notice to MIA of its intent
to terminate the Agreement with respect to such country for MIA’s failure to
meet minimum sales requirements.  Upon
notice of intended termination, MIA shall have the right to cure such shortfall
in MIA’s minimum sales requirement by selling during such ninety-day notice
period the amount of such Product Systems equal to such shortfall in the
particular country plus also selling at least MIA’s minimum sales requirements
in the particular country for the Sales Quarter(s) in which the ninety-day cure
period falls (linearly prorated for the fraction of the second Sales Quarter,
if any, in which a portion of the ninety-day-notice period may fall).  If MIA sells such quantities of Product
Systems in the particular country to cure the minimum sales shortfall during
the ninety-day notice period, and also sells its prorated minimum sales
requirements in the particular country for the Sales Quarter(s) in which said
cure period falls, Aerogen’s notice of termination shall not become effective
and the Agreement will continue in full force and effect with respect to the
country.


 


(b)                                  Europe. 
If MIA has not met its aggregate minimum Sales Quarterly sales
requirement for all of Europe (as indicated in Exhibit J)  by aggregating the minimum sales
quantities for each country in Europe in such Sales Quarter, and Aerogen
intends to terminate the Agreement with respect to Europe pursuant to Section 13.5, Aerogen will provide
ninety (90) days prior written notice to MIA of its intent to terminate the
Agreement with respect to Europe for MIA’s failure to meet the aggregate
minimum sales requirements.  Upon notice
of intended termination, MIA shall have the right to cure such shortfall in
MIA’s minimum sales requirement by selling during such ninety-day notice period
that quantity of Product Systems equal to such shortfall in Europe plus also
selling at least MIA’s minimum sales requirements in Europe for the Sales
Quarter(s) in which the ninety-day cure period falls (linearly prorated for the
fraction of the second Sales Quarter, if any, in which a portion of the
ninety-day-notice period may fall).  If
MIA sells such quantities of Product Systems in Europe to cure the minimum sales
shortfall during the ninety-day notice period, and also sells its prorated
minimum sales requirements in Europe for the Sales Quarter(s) in which said
cure period falls, Aerogen’s notice of termination shall not become effective
and the Agreement will continue in full force and effect with respect to the
country.  Such sales may occur in any
country then currently within MIA’s Europe territory (as indicated in Exhibit J, as may be
amended by the Parties from time to time); provided,
however, that individual countries within Europe may nevertheless be
lost if shortfalls in such countries are not cured as provided in Section 6.5(a) above.


 


17

















 


(c)                                  Notice Requirement. 
Aerogen shall provide to MIA the ninety (90) day notice of termination
described in this Section 6.5
with respect to a particular country, Europe or the Agreement in its entirety
(for a Sales Quarterly minimum sales short fall in the United States), as the
case may be, no later than [*] after MIA provides to Aerogen pursuant to
Section 5.5 all required
reports for the Sales Quarter in which said failure occurs in said area, after
which Aerogen’s option to terminate for said breach based upon MIA’s failure to
meet its minimum Sales Quarterly Product System sales in said area for the
applicable Sales Quarter will lapse.


 


6.6                               Adjustments to Minimum
Purchase, Minimum Royalties and Product System Sales Requirements.


 


(a)                                  Europe, Expansion Country Minimum Purchases.  If
Aerogen terminates the Agreement with respect to any country in Europe (as
described in Exhibit J)
due to MIA’s failure to cure its Sales Quarterly minimum Product System sales
shortfalls in such country, MIA’s future minimum Supply Quarterly OnQ Aerosol
Generator purchases (as described in Exhibit H) shall remain firm commitments; however, if termination occurs (either by
Aerogen as provided above or by MIA as provided in Section 13.3) with respect to any other country in the
Territory (other than the United States), or for Europe in its entirety, MIA’s
future minimum Supply Quarterly OnQ Aerosol Generator purchases will be
adjusted to reflect such termination.


 


(b)                                  Europe, Expansion Country Royalty, Sales
Reductions.  Any termination of the Agreement with
respect to a particular country or Europe in its entirely will result in a
commensurate reduction of the minimum royalties (Exhibit I) and Product System sales
requirements (Exhibit J)
attributable to such country or Europe, effective in the first Sales Quarter in
which such country or Europe is no longer part of the Territory.


 


(c)                                  U.S. Minimums Adjustments.  The
minimum Supply Quarterly OnQ Aerosol Generator purchase quantities and minimum
Sales Quarterly Product Systems sales requirements for the United States, as
described in Exhibit H
and Exhibit J,
respectively, for Sales Quarters [*] shall be discussed by the Parties in
Sales Quarter [*] of the Term, and, if mutually agreed
upon, adjusted to no less than [*] of the stated minimum for said quarters
as of the Effective Date.


 


7.                                      Regulatory and Customer
Support Matters.


 


7.1                               Regulatory Filings. 
Aerogen will be solely responsible for obtaining FDA 510(k) marketing
clearance for the Product and marketing clearance in the European Union, at no
expense to MIA.  For all other countries
in the Territory, MIA shall be responsible for preparing a reasonably detailed
plan and practical schedule for obtaining all necessary marketing
clearances for each such country within [*] following the Effective Date.  Aerogen, and/or its authorized agent(s), will
be responsible for obtaining marketing clearance from the appropriate
Regulatory Agency at MIA’s expense, provided that, for clarity, MIA shall have
no responsibility for any expenses associated with Aerogen’s ISO compliance.  MIA shall provide all regulatory and
technical information relating to its manufacture of the Product as reasonably
requested by Aerogen, and shall otherwise assist Aerogen in obtaining any
necessary or desirable regulatory


 


18

















 


approvals
in the Territory.  Aerogen will promptly
advise MIA each time that it obtains marketing clearance for the Product in a
country or jurisdiction in the Territory. 
Aerogen shall grant to MIA a right of reference to the marketing
clearances obtained by Aerogen in the Territory.


 


7.2                               Medical Device and Vigilance
Reporting.  MIA shall be responsible for receiving,
investigating, and documenting all complaints which may, or may not, be Medical
Device Reportable (“MDR”) events
and other adverse experiences relating to the use of the Product sold or
distributed by MIA or its Affiliates or sub-distributors.  MIA will be solely responsible for filing
all reports of such events, including, but not limited to, MDR Reports,
Vigilance Reports, Reports of Corrections and Removals, recalls and any other
reports required by Regulatory Agencies, or as required by applicable laws or
regulations.  In the event that MIA
receives a report of an adverse experience relating to the use of the Product
anywhere in the world, it shall notify Aerogen in writing within five (5)
business days, or if such event is serious and unexpected, within forty eight
(48) hours.


 


7.3                               Customer Support.  MIA
shall have sole responsibility for providing first-line Product support to
sub-distributors and customers, and for responding to questions and complaints
relating to Product from its sub-distributors and customers, all at MIA’s
expense.  Complaints received by MIA
from sub-distributors or customers, which MIA determines to be related to the
OnQ Aerosol Generator, shall be promptly referred to Aerogen.  MIA shall cooperate as reasonably required
to allow Aerogen to determine the cause of and resolve any complaints regarding
the OnQ Aerosol Generator.  Any such
complaints that are determined by Aerogen to relate solely to OnQ Aerosol
Generator performance shall be investigated and resolved at Aerogen’s
expense.  MIA will provide Aerogen with
monthly reports of complaints received, and actions taken.  MIA will be responsible for coordinating and
handling product returns and replacements relating to customer complaints, and
shall bear the costs thereof.  Aerogen
will provide administration/support for MIA’s customer support activities, if
requested by MIA, at an agreed upon rate of reimbursement to Aerogen.  MIA shall be responsible for complying with
all applicable regulations and laws as they relate to complaint handling and
closure.


 


7.4                               Recall.  If
either Party believes or is notified that a recall in the Territory of the
Product is desirable or required by law, it will promptly notify the other
Party.  The Parties will then discuss
reasonably and in good faith whether such recall is appropriate or required and
the manner in which any mutually agreed recall shall be handled.  In the event of a recall, the Parties shall
bear the expenses incurred in connection with such recall ratably and in
proportion to their, or their agents’ and/or Affiliates’, relative
responsibility for the cause of such recall.


 


7.5                               Inspections.  MIA shall notify Aerogen promptly of any inspection or regulatory
actions by representatives of any governmental agency within the Territory
concerning the Product and shall provide Aerogen with copies of all
correspondence relating to the inspection and/or action, including, but not limited
to, any Form 483s, Establishment Inspection Reports, FDA Warning Letters,
and/or Untitled Letters.  MIA shall also
provide Aerogen with a summary of the results of such inspection and such
actions, if any, taken to remedy conditions cited in such


 


19

















 


inspections.  Both Parties agree to cooperate fully with
each other in connection with any inquiry or inspection conducted by a
governmental agency concerning the Product.


 


8.                                      Product Branding; Marketing Materials;
Trademarks.


 


8.1                               Co-Branding.  MIA agrees that it will brand the Product distributed by it (and its
Affiliates and sub-distributors) in the Territory using both MIA and Aerogen
brands and trademarks (including the Trademarks) as jointly agreed by the
Parties, and in conformance with the agreed upon branding strategy for each
country in the Territory.


 


8.2                               Annual Business Plan and
Review.  During the Term,  Representatives from MIA and Aerogen shall meet annually, no
later than October 31 of each year, to present and discuss MIA’s detailed
marketing plans and budgets for the following calendar year in each of the
countries in the Territory.  To the
extent that MIA markets the Product entirely via sub-distributors in a country,
MIA shall present said sub-distributors plans in comparable detail to MIA’s own
plans.


 


8.3                               Product Marketing Materials. 
Aerogen will make available to MIA any marketing materials for the
Product that have been prepared by Aerogen as of the Effective Date, including
Aerogen’s Product branding and messaging, brand standards, retail packaging
design, and pre-launch marketing materials. 
During the Term, Aerogen shall provide such additional marketing support
as reasonably requested by MIA, at MIA’s expense.  MIA will provide to Aerogen copies of all promotional literature,
sales aids, technical information, and clinical publications intended to be
used by MIA in connection with promotion or distribution of the Product for
review and final approval by Aerogen. 
Each Party will provide the other with reports available to it of any
clinical studies and in vitro data for the Product that may be performed by or
on behalf of such Party, and Aerogen will provide reasonable technical support
and technical troubleshooting expertise as it relates to the OnQ Aerosol
Generator, and Product design.  In the
event that MIA requires Aerogen’s assistance with issues relating to Product
manufacture, such assistance will be provided by Aerogen on an as-available
basis, and at MIA’s expense.  MIA will be
obligated to provide to Aerogen no more than [*] Product Systems per year, [*],
for use in Aerogen’s marketing, research activities, and other purposes.


 


8.4                               Trademark License.  Subject to the terms of this Agreement, Aerogen hereby grants to MIA
during the Term a non-exclusive, nontransferable, royalty-free license (with no
right to sublicense) to use the Trademarks in each country of the Territory in
connection with the marketing, sale and distribution of Product in the
Territory as permitted under Sections 2.1 and 3.1.


 


8.5                               Trademark Use.  MIA
will display the Trademarks designated by Aerogen for the OnQ Aerosol Generator
on each Product component that bears a Trademark, and on all packaging and
labeling.  Any use of the Trademarks by
MIA shall be in conformity with Aerogen’s trademark usage guidelines and other
instructions.  MIA may use its own
trademarks and trade names on Product labeling and packaging for the purpose of
identifying MIA as manufacturer and distributor of the Product in the Territory
to the extent permitted by law; provided,
however, that in no event shall MIA’s trademarks or trade names
appear more


 


20

















 


prominent
than Aerogen’s Trademarks.  Aerogen
grants no rights other than those expressly granted hereunder, and MIA hereby
agrees to and recognizes Aerogen’s exclusive ownership of the Trademarks.  MIA agrees not to take any action
inconsistent with such ownership and further agrees to take any action, at
Aerogen’s expense, which Aerogen reasonably deems necessary to establish and
preserve Aerogen’s exclusive rights in and to the Trademarks including but not
limited to cooperating in the registration of the Trademarks on trademark
registries or other appropriate registration procedure in the Territory.  If MIA, in the course of distributing
Product, acquires any goodwill or reputation in the Trademarks, then at the
expiration or termination of this Agreement all such goodwill and reputation
automatically shall vest in Aerogen without any separate payment or
consideration of any kind to MIA, and MIA agrees to take all actions necessary
to effect such vesting.


 


8.6                               No Similar Marks.  MIA
shall not adopt, use, or register any acronym, trademark, trade names, service
mark or other marketing name that is confusingly similar to the Trademarks or
the Aerogen name, other than in connection with distribution of Product
pursuant to this Agreement, and shall not use the Trademarks or the Aerogen
name other than in connection with distribution of Product pursuant to this
Agreement.


 


9.                                      Representations and
Warranties; Limitation of Liability.


 


9.1                               Mutual Representations and
Warranties.  Each Party hereby represents and warrants
that:


 


(a)                                  it is duly organized and validly existing
under the laws of the state of its incorporation and has full corporate power
and authority to enter into this Agreement and to carry out the provisions
hereof;


 


(b)                                  it is duly authorized to execute and deliver
this Agreement and to perform its obligations hereunder;


 


(c)                                  the person executing this Agreement on its
behalf has been duly authorized to do so by all requisite corporate action;


 


(d)                                  this Agreement is a legal and valid
obligation binding upon it and enforceable in accordance with its terms,
subject to bankruptcy, insolvency or similar laws of general application
affecting the enforcement of rights of creditors, and subject to equitable
principles limiting rights to specific performance or other equitable remedies,
and subject to the effect of federal and state securities laws on the
enforceability of indemnification provisions relating to liabilities arising
under such laws;


 


(e)                                  the execution, delivery and performance of
this Agreement does not conflict with any agreement, instrument or
understanding, oral or written, to which it is a party or by which it may be
bound, nor violate any material law or regulation of any court, governmental
body, or administrative or other agency having jurisdiction over it;


 


21

















 


(f)                                    it has obtained all necessary consents that
are required with respect to the execution, delivery and performance of this
Agreement and the consummation of the transactions contemplated hereby; and


 


(g)                                 there is no broker, finder or other
intermediary that has been retained by or authorized to act for such Party who
would be entitled to any fee or commission upon entry into the Agreement.


 


9.2                               Additional Representations
and Warranties of Aerogen.  Except as otherwise provided in the
disclosure schedule attached as Schedule 9.2 (the “Disclosure Schedule”), Aerogen represents
and warrants that as of the Effective Date:


 


(a)                                  no insolvency proceeding of any kind, whether
voluntary or involuntary, is pending, or to Aerogen’s knowledge threatened,
against Aerogen, and Aerogen has not taken any action to initiate any
insolvency proceeding, whether voluntary or involuntary;


 


(b)                                  Aerogen believes that, based on its existing
agreements with its suppliers, it has sufficient access to raw materials of the
quality, quantity and condition needed to manufacture the OnQ Aerosol Generator
to be supplied under this Agreement;


 


(c)                                  no unsatisfied judgment is presently pending
against Aerogen that relates to the Product or the Equipment, and there are no
actions, suits or proceedings before any court, agency or other governmental
body pending or, to Aerogen’s knowledge, threatened against Aerogen relating to
the Product or the Equipment;


 


(d)                                  since the last public disclosure by Aerogen
(the 10-Q filed on August 14, 2003, which contains financial statements as
of June 30, 2003), Aerogen has conducted its operations in the normal
course consistent with past practices and there has been no material adverse
change in Aerogen’s business, assets, or liabilities relating to the Product or
Equipment;


 


(e)                                  Aerogen does not have any reason to believe
that any loss of an employee, or supplier will result because of the
consummation of the transactions contemplated under this Agreement;


 


(f)                                    Aerogen has not received notice of alleged
material violations of any law, statute, order, rule or regulation that relates
to the Product or the Equipment;


 


(g)                                 Aerogen, with respect to the Equipment, the
OnQ Aerosol Generator or the Product, as applicable, is not a party to or
subject to:  (i) any lease with respect
to any portion of the Equipment, whether as lessor or lessee; (ii) any contract
for the purchase of materials, supplies, goods, services, or equipment in
excess of the requirements of the manufacture of OnQ Aerosol Generators for
normal operating procedures; (iii) any agreement, contract, or commitment to
sell or supply OnQ Aerosol Generators in excess of [*]; and (iv) any
license agreement, franchise agreement or agreement in respect to similar
rights granted to or held by MIA with respect to the Product.


 


22

















 


(h)                                 (i) the Equipment constitutes all of the
equipment used or held for use by Aerogen primarily for manufacturing OnQ
Aerosol Generators; (ii) upon the completion of the transaction contemplated by
Section 3.8(c), MIA will have
acquired good and marketable title to the Equipment, free and clear of all
liens, claims, and encumbrances; (iii) Exhibit E contains a correct and complete
list of all the Equipment; and (iv) the Equipment is in good operating condition
and repair, subject to normal wear and maintenance, and is useable in the
ordinary course of manufacturing OnQ Aerosol Generators;


 


(i)                                    (i) to Aerogen’s knowledge, it Controls all
rights it purports to grant to MIA to the Aerogen Licensed Rights pursuant to
this Agreement; and (ii) it has not received any notice or claim that the
Aerogen Licensed Rights infringe upon the intellectual property rights of a
third party;


 


(j)                                    to Aerogen’s knowledge, it is in material
compliance with all laws, rules and regulations relating to the environment
with respect to the Equipment and the OnQ Aerosol Generator Manufacturing
Facility at its location as of the Effective Date;


 


(k)                                to Aerogen’s knowledge, no schedule,
certificate, document or written statement furnished to MIA by or on behalf of
Aerogen in connection with this Agreement contains any untrue statement of a
material fact or omits to state a material fact necessary to make such
statements not materially misleading; and


 


(l)                                    Aerogen has taken all reasonable actions
legally appropriate, including requiring the execution of confidentiality
agreements, to protect Aerogen’s Confidential Information and the confidential
portions of the Aerogen Technology from disclosure to unauthorized third
parties by any of its personnel, agents, subcontractors or vendors who have had
significant involvement with the design, engineering, manufacturing, sales, or
marketing of the Product; and


 


(m)                              Aerogen will perform the OnQ Aerosol
Generator manufacturing services to be provided pursuant to Section 3.8(d) during the OnQ
Manufacturing Period in accordance with generally accepted professional design,
engineering, and manufacturing standards in effect at the time of such
performance.


 


9.3                               Additional Representations
and Warranties of MIA.  MIA represents and warrants to Aerogen that:


 


(a)                                  it has, or will acquire, and will maintain
during the Term all government permits and licenses including, without
limitation, health, safety, and environmental permits, necessary for MIA’s
Product manufacturing, distribution and sales activities contemplated by this
Agreement;


 


(b)                                  a Product manufactured by MIA in the exercise
of its rights under this Agreement will be manufactured in accordance with the
Product Specifications; and


 


23

















 


(c)                                  as of the Effective Date, Neither MIA nor its
Affiliates have an existing or in-negotiation financial interest (including,
but not limited to, equity ownership, credit facilities, or other economic
rights) in any sub-distributor in the Territory; and (ii) no sub-distributor in
the Territory has an existing or in-negotiation financial interest in MIA.


 


9.4                               Limited Warranty. 
Aerogen warrants to MIA that each OnQ Aerosol Generator supplied under
this Agreement, shall at the time of shipment and for a period of [*]
thereafter, conform in all material respects to the OnQ Aerosol Generator
Specifications listed on Exhibit
A.


 


9.5                               Exclusive Remedies. 
Aerogen will, at its option, repair, replace or otherwise correct any
OnQ Aerosol Generator that does not conform to the warranty set forth in Section 9.4 above, provided that:


 


(a)                                  For OnQ Aerosol Generators that have not been
incorporated into Product that has been sold by MIA, MIA has notified Aerogen
of such nonconformity pursuant to Section 4.5(a),
with respect to apparent defects, within [*] after Aerogen’s delivery of a
nonconforming OnQ Aerosol Generator; and, with respect to hidden defects which
could not reasonably be discovered within such [*] visual
inspection period, before the expiration of [*] from Aerogen’s delivery of the
nonconforming OnQ Aerosol Generator;


 


(b)                                  For OnQ Aerosol Generators that have been
incorporated into Product that has been sold to an end-customer by MIA or MIA’s
sub-distributors, MIA has notified Aerogen of such nonconformity within [*]
from Aerogen’s delivery of the nonconforming OnQ Aerosol Generator;


 


(c)                                  MIA, at Aerogen’s request and MIA’s expense,
returns the nonconforming OnQ Aerosol Generator to Aerogen’s facility; and


 


(d)                                  such nonconformity is not the result of any
mishandling, abuse, damage, or use of the OnQ Aerosol Generator other than in
strict accordance with Aerogen’s instructions.


 


9.6                               Disclaimer. 
Except as set forth in Section 9.4
above, the OnQ Aerosol Generators are delivered to MIA “as is” and Aerogen
makes no warranties with respect to the OnQ Aerosol Generators, express or
implied, and specifically, without limitation, disclaims any implied warranty
or merchantability, warranty of fitness for a particular purpose or warranty of
non-infringement of third party intellectual property rights.  The warranties shall apply only if the final
analysis and report from Aerogen’s failure investigation process, in which MIA
may participate at its reasonable request, with a copy of such report to be
provided to MIA upon its reasonable request, discloses that alleged defects
actually exist and were not caused by misuse, unauthorized modifications,
neglect, improper use or storage, attempts to repair, or the like, or by
accident, fire, or other hazard.


 


9.7                               No Warranty
Pass-Through.  MIA shall not pass through to customers or
any other third party the warranties made by Aerogen under this Article 9, shall make no


 


24

















 


representations
to sub-distributors or customers other than that they must look solely to MIA
in connection with any problems, warranty, claim or other matters concerning
the Product.  No warranty,
representation or agreement herein shall be deemed to be made for the benefit
of any sub-distributor or customer of MIA or any other third party.


 


9.8                               Limitation of Liability.  In
no event shall Aerogen be liable for any indirect, incidental, special or
consequential damages, including loss of profits, revenue, or use, incurred by
MIA or any third party, whether in an action in contract or tort or based on a
warranty, even if Aerogen has been advised of the possibility of such
damages.  Excluding Aerogen’s
indemnification obligation set forth in Section 11.1
below, Aerogen’s liability for any damages under this Agreement shall in no
event exceed the amounts actually paid by MIA to Aerogen under this Agreement.


 


10.                               Intellectual Property.


 


10.1                        Ownership of Intellectual
Property Rights.  Aerogen shall retain all of its right, title
and interest in and to and ownership of the Product, the OnQ Aerosol Generator
and the Aerogen Licensed Rights, subject only to the manufacturing and
distribution rights granted to MIA pursuant to this Agreement.  Aerogen will own all Product Improvements,
Manufacturing Improvements and any other improvements, modifications or
enhancements to the Product or the OnQ Aerosol Generator made by either Party
(collectively, the “Developed IP”).  Except as otherwise expressly provided in
this Agreement, MIA has no right, title or interest in the Product, the Aerogen
Technology or any Aerogen Licensed Rights and shall not reproduce or otherwise
use or practice, in whole or in part, the Product, the Aerogen Technology or
the Aerogen Licensed Rights except as permitted by this Agreement.


 


10.2                        Cooperation and
Assistance.  At Aerogen’s request, MIA shall execute and
deliver to Aerogen all descriptions, applications, assignments and other
documents and instruments necessary or proper to perfect and assert ownership
of the Developed IP as contemplated by Section 10.1.  MIA shall cooperate with and assist Aerogen,
at Aerogen’s expense, in Aerogen’s efforts in obtaining, maintaining, defending
and enforcing its intellectual property rights in the United States and
elsewhere.


 


10.3                        Enforcement of Intellectual
Property Rights.  MIA agrees that only Aerogen has the right
to enjoin any infringement or registration by a third party of the Trademarks
or the Aerogen Licensed Rights relating to the Product.  In the event that any unlawful infringement
of Aerogen’s rights in the Product, or infringement or registration by a third
party of the Trademarks or other intellectual property rights of Aerogen in the
Territory comes to the attention of MIA, MIA shall immediately inform Aerogen
in writing, stating the full facts of the infringement or registration known to
it, including the identity of the suspected infringer or registrant, the place
of the asserted infringement or registration and evidence thereof.  MIA agrees to cooperate fully with Aerogen,
at Aerogen’s expense for MIA’s reasonable out-of-pocket costs, if Aerogen sues
to enjoin such infringements or to oppose or invalidate any such registration.


 


25

















 


10.4                        Infringement of Third Party
Intellectual Property Rights.  In the event that the manufacture, use or
sale of the Product infringes or misappropriates third party Intellectual
Property Rights, Aerogen may, in its sole discretion, (a) obtain for MIA the
right to continue to market, sell and distribute the Product in the Territory,
(b) replace or modify the Product so as to make the Product non-infringing, or
(c) terminate MIA’s rights to distribute the Product in the Territory by
written notice effective upon receipt pursuant to Section 14.9,  but
subject to Section 13.6(b).  Aerogen may, in its sole discretion, enter
into a settlement with the third party, including but not limited to, obtaining
the rights described in subsection (a) above.  If Aerogen terminates pursuant to subsection (c) above, MIA
will remove all Product from the market and will cease distributing the
Product.  Aerogen shall not be obligated
to indemnify MIA for third party claims arising out of the Product’s
infringement of any intellectual property right of a third party resulting from
MIA’s (x) modification of the Product by MIA other than Product Improvements or
Manufacturing Improvements made pursuant to Section 3.4(a),
(y) the combination of the Product with other technology or devices or (z) the
modification, misuse or mishandling of OnQ Aerosol Generators after delivery
thereof pursuant to Section 4.4.


 


11.                               Indemnity.


 


11.1                        Indemnification by Aerogen. 
Aerogen shall indemnify, defend and hold harmless MIA and its directors,
officers, employees and agents from and against any and all third party suits,
claims, actions, demands, liabilities, expenses, or losses (including legal
expenses and reasonable attorneys’ fees) (collectively, “Claims”) arising out of or resulting
from:  (a) a defect in the design or
manufacture of the OnQ Aerosol Generator; (b) any defect in the design of the
Product as of the Effective Date; (c) any negligent actions or willful
misconduct by Aerogen; or (d) any infringement of third party Intellectual
Property Rights directly resulting from the manufacture, use or sale of the
Product up to the date of receipt of notice given pursuant to Section 10.4.  Such indemnity shall not apply to the extent
that MIA has an indemnity obligation for such Claim pursuant to Section 11.2.  The foregoing indemnity does not apply to
any Claim to the extent such Claim is based on manufacturing defects in any
portion or component of the Product or Product Improvement not manufactured by
Aerogen, or the use, combination or inclusion of any such Product or Product
Improvement, component or portion thereof, with any other product.


 


11.2                        Indemnification by MIA.  MIA
shall indemnify, defend and hold harmless Aerogen and its directors, officers,
employees and agents from and against any and all Claims arising out of or
resulting from:  (a) MIA’s failure to
adhere to the terms of this Agreement; (b) any damage to the OnQ Aerosol
Generators occurring after shipment from Aerogen to MIA; (c) the sale or other
distribution of Product by MIA or its sub-distributors or use by any customer,
(d) any representation made or warranty given by MIA with respect to the
Product, (e) the manufacture, sale or use of any product that is not supplied
by Aerogen and that is sold or combined with the Product, (f) any negligent
actions or willful misconduct by MIA, or (g) any failure by MIA or its agents
to comply with all regulatory and/or legal requirements in the Territory,
including, but not limited to, promotion of off-label use.  Such indemnity shall not apply to the extent
that Aerogen has an indemnity obligation for such Claim pursuant to Section 11.1.


 


26

















 


11.3                        Conditions of
Indemnification.  If either Party is entitled to
indemnification under this Article 11
(the “Indemnified Party”), it
shall give prompt written notice to the Party providing indemnification (the “Indemnifying Party”) of any Claims that may
be subject to indemnification promptly after learning of such Claim.  The Indemnifying Party shall assume, manage
and control (by way of intervention or otherwise) the defense and/or settlement
of any such Claim.  The Indemnified
Party will cooperate in the defense or settlement negotiations as reasonably
required by the Indemnifying Party.  The
Indemnifying Party shall not agree to any settlement that may adversely affect
the Indemnified Party’s rights or interest without the Indemnified Party’s
prior written approval (which approval shall not be unreasonably
withheld).  


 


11.4                        Insurance.  During the Term, each Party shall obtain and maintain at its own cost
and expense, comprehensive general liability insurance, including products
liability insurance, through reputable and financially secure insurance
carriers, adequate to cover its obligations under this Agreement.  Such insurance, (a) shall be in an amount
which is customarily carried by companies introducing new medical devices, and
(b) shall cover claims incurred, discovered, manifested, or made during or
after expiration of this Agreement. 
Each Party agrees to furnish the other Party with a certificate of
insurance evidencing the same within thirty (30) days after the Effective Date,
and thereafter upon any material change in its coverage described above.


 


12.                               CONFIDENTIALITY.


 


12.1                        Disclosure of Confidential
Information.  During and in furtherance of this Agreement,
each Party may disclose certain of its Confidential Information to the other
Party.  During the term of this
Agreement, and for a period of [*] after its termination or expiration, each
Party agrees (a) to use the other Party’s Confidential Information solely as
necessary to perform its obligations or exercise its rights under this
Agreement, (b) to hold in strict confidence all Confidential Information of the
other Party, and (c) to not disclose the other Party’s Confidential Information
to any third party without the prior written consent of the other Party.  Notwithstanding the foregoing, each Party
may disclose the other Party’s Confidential Information to its directors,
officers, employees, contractors and agents as necessary for the purposes
contemplated under this Agreement; provided
that such directors, officers, employees, contractors and agents are bound by
obligations of confidentiality and non-use with respect to such Confidential
Information that are at least as restrictive as those set forth in this
Agreement.  


 


12.2                        Exceptions.  The
obligations of non-disclosure and non-use set forth in Section 12.1 shall not apply to any
Confidential Information or portion thereof to the extent that the Party
receiving such information can demonstrate, by competent proof, that such
information (a) was already known by the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure, (b) was generally
available to the public or otherwise part of the public domain at the time of
disclosure, (c) later became part of the public domain through no act or
omission of the receiving Party, (d) was disclosed to the receiving Party,
other than under an obligation of confidentiality, by a third party who had no obligation
to the disclosing Party not to disclose such information to others, or (e) was
independently developed by employees of either Party who were unaware of and
did not have access to the Confidential Information.


 


27

















 


12.3                        Authorized Disclosure.  Subject to any applicable legal requirements, each Party may disclose
Confidential Information belonging to the other Party to the extent such
disclosure is reasonably necessary in the following:  (a) filing or prosecuting patents relating to Product; (b)
regulatory filings; (c) prosecuting or defending litigation; (d) complying with
applicable governmental regulations; and (e) disclosure to Affiliates,
sub-distributors and potential future investors who agree to be bound by
similar terms of confidentiality. 
Notwithstanding the foregoing, in the event a Party is required to make
a disclosure of the other Party’s Confidential Information pursuant to this Section 12.3, it will, except where
impracticable, give reasonable advance notice to the other Party of such
disclosure and use best efforts to secure confidential treatment of such
information.  In any event, the Parties
agree to take all reasonable action to avoid disclosure of Confidential
Information hereunder.


 


13.                               TERM AND TERMINATION.


 


13.1                        Term.  The
term of this Agreement shall commence as of the Effective Date and continue for
a period of [*] from the Effective Date, unless
terminated earlier as provided in this Article 13
(the “Term”).  Unless the Agreement is earlier terminated,
the Term shall be extended on the [*] anniversary of the Effective Date for a
period of [*]; provided
that MIA is not then in material breach of the Agreement (subject to the cure
periods set forth in Section 13.5)
and MIA has met the Minimum Purchase Requirements, subject to agreement by the
Parties as to appropriate pricing and minimums for such additional time period.


 


13.2                        Termination for Failure to
Make Payments.  Aerogen shall have an immediate right of
termination if MIA fails to make any of the initial payments set forth in Section 5.1 on the dates specified in Section 5.1 or fails to honor the
initial purchase order provided to Aerogen pursuant to Section 4.1.  Such termination shall be immediately effective upon the receipt
by MIA of written notice of termination for any such failure.  On the effective date of such termination,
all of the rights and licenses granted by Aerogen to MIA pursuant to this
Agreement shall immediately terminate.


 


13.3                        Termination by MIA for
Convenience.  MIA may terminate this Agreement on a
country-by-country basis, except as otherwise provided below, or in its
entirety, at any time upon [*]
prior written notice to Aerogen. 
Notwithstanding the foregoing, any termination by MIA with respect to
one or more countries in Europe (as defined in Exhibit J) shall not change the
obligations of MIA under Section 6.3
and 6.4 with respect to minimum
royalties and sales for Europe, which minimums will remain the same regardless
of termination as to particularly countries in Europe as provided in Section 2.2, unless MIA terminates the
Agreement for all countries in Europe in its entirety.  Further, any termination by MIA with respect
to the United States will be deemed to be a termination of the Agreement in its
entirety.


 


13.4                        Termination by Aerogen.  Aerogen may terminate the Agreement [*].


 


28

















 


13.5                        Termination for Breach. 
Either Party may terminate this Agreement at any time by giving not less
than [*] prior written notice in
the event of a material breach of this Agreement by either Party and failure to
cure such material breach within [*]
from receipt of a written notice from the non-breaching Party specifying such
breach.  Notwithstanding the foregoing,
Aerogen shall only have the right to terminate the Agreement with respect to a
particular country or group of countries for breaches by MIA arising under Section 6.4.


 


13.6                        Effect of Termination.


 


(a)                                  Early Termination by MIA.  If
MIA terminates the entire Agreement for its convenience pursuant to Section 13.3 after the first (1st)
anniversary of the Effective Date, then MIA will pay Aerogen [*],
for the resulting interruption in market supply of the Product.  


 


(b)                                  Early Termination by Aerogen.  If
Aerogen terminates this Agreement pursuant to Section 13.4
or Section 10.4(c),
the following provisions of this subsection 13.6(b) shall apply:


 


(i)                                    The Parties shall meet promptly after such
termination to discuss in good faith and seek to find an appropriate resolution
to the problem that resulted in the termination, which may include discussing
how to modify the Product so that the problem is addressed.  If the Parties reach an agreement on how to
proceed to try to resolve the problem, they shall set forth such agreement in
an amendment to this Agreement, and effective upon entering into such amendment
the earlier termination shall be deemed void and the Agreement shall remain in
full force, as modified by such amendment.


 


(ii)                                If the Parties do not reach an agreement to
resolve the problem, as provided in subclause (i) above, within [*] of such termination by Aerogen, Aerogen
shall covenant that it shall not sell or distribute the Product in the
Territory for use in the home-based, open-cup, continuous-flow, general
nebulizer market or in alternate care facilities, for a period of [*]
after such termination.  In addition, if
such termination occurs prior to the date [*] after the Effective Date, then (unless
the Parties otherwise agree) Aerogen shall reimburse MIA for the payments made
to Aerogen by MIA under Sections 5.1(a) of
the Agreement on a pro-rata basis (determined by multiplying the sum of such
payments by a fraction having a numerator equal to the number of months from
the date of such termination until [*] of the Effective Date, and a denominator
equal to [*]), plus the sum of any amounts received by
Aerogen from MIA pursuant to Sections 5.1(b)
and 5.4(a) reduced by [*]
per OnQ Aerosol Generator unit supplied by Aerogen to MIA during the Term up to
a maximum of [*].  


 


(iii)                            If Aerogen elects after the [*]
period set forth in subclause (ii) above to re-introduce the Product for use in
the home-based, open-cup, continuous-flow, general nebulizer market or in
alternate care facilities, it shall so notify MIA, and MIA shall have a right
of first negotiation, exercisable by written notice to Aerogen within [*] of Aerogen’s


 


29

















 


notice, to obtain the rights
to distribute the Product upon terms to be mutually agreed upon by the
Parties.  If the Parties are unable to
reach a definitive agreement regarding such rights after [*] of good faith negotiations, or if MIA
fails to exercise its right of negotiation within the specified [*] period, Aerogen shall have no further obligation
to MIA with respect to distribution rights for the Product for use in the
home-based, open-cup, continuous-flow, general nebulizer market or in alternate
care facilities.  


 


(iv)                               If Aerogen elects after the [*]
period set forth in subclause (ii) above to re-introduce the Product for use in
the home-based, open-cup, continuous-flow, general nebulizer market or in
alternate care facilities, and MIA subsequently exercises its negotiation right
as provided in subclause (iii) above, provided that the termination by Aerogen
occurs after [*], then (1) MIA shall receive a pro-rata
credit of the payment made under Section 5.1(a)
towards the financial terms of the negotiated definitive agreement (i.e., the credit shall equal a percentage
amount (such amount, the “Pro-Rata Amount”)
of such payment where the percentage is equivalent to [*],
or (2) if the Parties do not enter into such negotiated definitive agreement,
and Aerogen subsequently either (A) signs an agreement with a third party for
distribution of the Product within the United States or (B) itself sells the
Product directly within the United States, then Aerogen shall pay to MIA an
amount equal to the Pro-Rata Amount within [*]
of the execution of such third party agreement, or if Aerogen sells the Product
directly, Aerogen will pay to MIA, on a quarterly basis, [*]
of Aerogen’s gross sales of Product until the Pro-Rata Amount is paid in full.


 


(c)                                  General.  Upon termination of the
Agreement for any reason, MIA’s obligation to pay Aerogen sales-based royalties
pursuant to Section 5.3 shall
also terminate upon the effective date of such termination; provided, however, that unpaid minimum
royalties for the Sales Quarter in which termination becomes effective and any
unpaid or accrued royalties, which shall be calculated on Product sales made
through the effective date of the termination, shall be due and payable to
Aerogen within thirty (30) days of such termination effective date.  In addition, should Product sales continue
after the effective date of termination pursuant to Section 13.7 or by mutual agreement, royalties on such
sales, calculated as provided in Section 5.3,  shall also be payable to Aerogen on a
monthly basis, in arrears.


 


13.7                        Transfer or Sell-Out of
Inventory.  On the effective date of expiration or
termination of this Agreement, Aerogen shall have the right to require that MIA
cease its manufacturing of the Product, provided that MIA may sell its
remaining inventory of Product for a period not to exceed ninety (90) days
after such date, for so long as such Product is saleable (unless termination is
under Section 13.4).  Any inventory remaining after such period
shall be, at Aerogen’s election, (a) sold by MIA or (b) transferred to Aerogen
against payment of a purchase price representing MIA’s Cost of Goods for the
Product and the costs incurred for the shipping of the Product to Aerogen.  Notwithstanding the foregoing, if Aerogen
terminates this Agreement under Section 13.4
Aerogen shall have the right to prohibit MIA from selling any remaining
inventory, and shall at Aerogen’s election, destroy or return to Aerogen all
remaining Product, in which case, Aerogen shall reimburse MIA for its cost of
OnQ Aerosol Generators assembled into such Product.


 


30

















 


13.8                        Cooperation and Return of
Materials.  Upon termination of the Agreement for any
reason, including the end of the Term, MIA will cooperate fully with Aerogen to
transfer all sales, marketing, manufacture and customer support activities in
an orderly fashion to Aerogen or to its designees.  Aerogen shall have the right, at its discretion, to obtain from
MIA at MIA’s documented cost, any tooling, designs for improvements, and other
manufacturing-related materials generated by MIA for the manufacture and
assembly of Product.  On the effective
date of termination or no later than ninety (90) days thereafter if MIA elects
under Section 13.7 to sell
out its remaining inventory, MIA shall return to Aerogen or its nominee all
price lists, catalogs, sales literature, operating and service manuals,
advertising literature and other materials relating to the Product.  Upon the termination or expiration of this
Agreement, each Party shall use diligent efforts (including, without
limitation, performing a diligent search of files and computer storage devices)
to return all Confidential Information received by it from the other Party
within sixty (60) days after the effective date of such termination. 


 


13.9                        Survival. 
Expiration or termination of this Agreement shall not release, or be
construed as releasing, any Party from any liability to the other arising out
of or in connection with a Party’s breach of, or failure to perform any
obligation contained in this Agreement. 
Neither Party shall be relieved from any obligations vested prior to the
date of termination of this Agreement. 
The following provisions shall survive any expiration or termination of
this Agreement:  Sections 3.6, 5.6, 5.7,
7.3, 7.4, 9.6, 9.8, 10.1, 13.6, 13.7, 13.8, and 13.9 and Articles 1, 11, 12 and
14.


 


14.                               MISCELLANEOUS.


 


14.1                        Export Law Compliance.  MIA
understands and recognizes that the Product and other materials made available
to it hereunder may be subject to the export administration regulations of the
United States Department of Commerce and other United States government
regulations related to the export of medical products.  MIA represents that it is familiar with and
agrees to comply with all such regulations, including any future modifications
thereof, in connection with the manufacture and distribution of the
Product.  MIA agrees that it will not
manufacture, sell or distribute the Product or clinical data relating to the
Product without complying with all applicable regulations.


 


14.2                        Non-Solicit.  Each Party agrees it will not knowingly hire or solicit any of the
other Party’s employees or sales representatives during the Term and for a
period of one (1) year following termination; provided
that (a) the employee or sales representative was employed or retained by the
other Party on the date of termination of the Agreement, and (b) each Party
provides the other with a list of employees and sales representatives as of the
effective date of termination of the Agreement.  This foregoing shall not apply to Aerogen employees directly
involved in the manufacture of OnQ Aerosol Generators if Aerogen files for
Chapter 7 bankruptcy during the OnQ Manufacturing Period.


 


14.3                        Force Majeure. 
Neither Party shall be liable to the other for any failure or delay in
performance hereunder where such failure or delay is due, in whole or in part,
to any cause beyond its reasonable control, including but not limited to acts
of God, fire, earthquake, flood, warfare, acts of terrorism, labor disputes,
government regulations or other similar events.  The


 


31

















 


Party affected by force
majeure shall inform the other Party promptly of the event, an estimate of the
period during which performance of its obligations is compromised, and shall
undertake all reasonable efforts to overcome the event and resume the
performance of its obligations as quickly as possible.


 


14.4                        Severability.  In
case one or more of the provisions contained in this Agreement shall be
invalid, illegal or unenforceable in any respect under any applicable statute
or rule of law, then such provision shall be considered inoperable to the
extent of such invalidity, illegality or non-enforceability and the remainder
of this Agreement shall continue in full force and effect. The Parties hereto agree
to replace any such illegal or unenforceable provision with a new provision
which has the most nearly similar permissible economic effect.


 


14.5                        Entire Agreement.  This
Agreement and any exhibits referred to herein state the complete and final
agreement of the Parties with respect to the subject matter hereof, and shall
supercede all previous communications, understandings and agreements between
the Parties with respect to the subject matter of this Agreement, including
without limitation, the Letter Agreement regarding confidentiality between the
Parties dated February 25, 2003.


 


14.6                        No Third Party
Beneficiaries.  Except as expressly provided to the contrary,
provisions of this Agreement are solely for the benefit of the Parties to this
Agreement, and not for the benefit of any other person or legal entity.


 


14.7                        Amendments.  No waiver, alteration, amendment, or modification of any of the
provisions of this Agreement shall be binding unless made in writing with
express reference to this Agreement, and signed by a duly authorized
representative of each Party.


 


14.8                        Assignment; Successors.  Neither Party may assign any of its rights and obligations
hereunder without the prior written consent of the other Party, and any such
assignment or purported assignment shall be void, except that Aerogen may
assign its rights and obligations pursuant to merger, acquisition or sale of
all or substantially all of the assets of Aerogen relating to the Product.  This Agreement shall be binding upon and
inure to the benefit of the successors and permitted assigns of the Parties.


 


14.9                        Notices. Any notice required or permitted to be given
under this Agreement shall be in writing, shall specifically refer to this
Agreement and shall be deemed to have been sufficiently given for all purposes
(a) five (5) days after mailing by registered first class mail, (b) two (2)
days after sending by international express delivery service, (c) the same day
if sent by facsimile transmission, with transmission confirmed or (d)
immediately if personally delivered. Unless otherwise specified in writing, the
mailing addresses and facsimile numbers of the Parties shall be as described
below.


 


	
  To MIA:

  	
  Medical Industries
  America, Inc.

  
	
   

  	
  2636 289th
  Place

  
	
   

  	
  Adel, IA  50003

  
	
   

  	
  Attn:  Chief Executive Officer

  
	
   

  	
  Fax:  (515) 993 4172

  



 


32

















 


	
  To Aerogen:

  	
  Aerogen, Inc.

  
	
   

  	
  2071 Stierlin Court,

  
	
   

  	
  Mountain View, CA  94043

  
	
   

  	
  Attn:  Chief Financial Officer

  
	
   

  	
  Fax:  (650) 864 7433

  



 


 


For
notices relating to Product complaints, and reportable events pursuant to Section 7.2, such notices shall be
directed to the Vice President of Regulatory Affairs and Quality at Aerogen.


 


14.10                 Construction.  The
section headings are inserted for convenience of reference only and are
not intended to be a part of or to affect the meaning or interpretation of this
Agreement.  As used in this Agreement,
the word “including” means “including but not limited to”.  All references to Aerogen mean Aerogen, Inc.
and its Affiliates.  In constructing the
terms of this Agreement, no presumption will operate in favor of or against any
Party as a result of its counsel’s role in drafting the terms and provisions
hereof.


 


14.11                 Independent Contractors.  In
making and performing this Agreement, Aerogen and MIA shall act at all times as
independent contractors and nothing contained in this Agreement shall be
construed as to create an agency, partnership or employer and employee
relationship between Aerogen and MIA.


 


14.12                 Waiver.  No
waiver of any right under this Agreement shall be deemed effective unless
contained in a writing signed by the Party charged with such waiver, and no
waiver of any right arising from any breach or failure to perform shall be
deemed to be a waiver of any future such right or of any other right arising
under this Agreement.


 


 


<< Signature Page Follows >>


 


33

















 


IN WITNESS WHEREOF, both Aerogen and MIA have executed this Agreement by their duly
authorized officers as of the Effective Date.


 


 


	
  AEROGEN,
  INC.

  	
  MEDICAL
  INDUSTRIES AMERICA, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
  /s/ Robert S. Breuil

  	
   

  	
  /s/ Russell Bird

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Name:  Robert Breuil

  	
  Name:  Russell Bird

  
	
  Title:  Chief Financial Officer

  	
  Title:  President

  



 


 












[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.


 


34

















 


EXHIBIT A


 


OnQ® AEROSOL GENERATOR 


 


DESCRIPTION AND SPECIFICATIONS 


 


The OnQ Aerosol Generator
consists of the following parts and components, with the Specifications for
each as listed below (all dimensions in inches unless specified):  


 


[*]


 


 












[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.


 

















 


EXHIBIT B


 


AERONEB® GO DESCRIPTION AND SPECIFICATIONS


 


 


The Aeroneb Go, a
proprietary product of Aerogen, is an open-cup nebulizer intended for use by
pediatric and adult patients, for continuous aerosolization of
physician-prescribed solutions for inhalation that are approved for use with a
general-purpose nebulizer. 


 


PRODUCT
COMPONENTS & ACCESSORIES


 


[*]


 


PRODUCT
SPECIFICATIONS


 


[*]


 


PRODUCT
PERFORMANCE


 


[*]


 


GENERAL-PURPOSE
NEBULIZER SOLUTIONS


 


The list of approved
general-purpose nebulizer solutions varies by country. As of the agreement
Effective date, the following chart summarizes those nebulizer solutions
approved for use with a general-purpose nebulizer in the United States:


 


	
  Nebulized
  Drug

  	
   

  	
  Label Restrictions for

  Nebulizer Use

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Albuterol

  	
   

  	
  None

  	
   

  
	
  Levalbuterol (Xopenex)

  	
   

  	
  None

  	
   

  
	
  Metproteronol sulfate

  	
   

  	
  None

  	
   

  
	
  Bitolterol (Tornalate)

  	
   

  	
  None

  	
   

  
	
  Ipratropium bromide

  	
   

  	
  None

  	
   

  
	
  Albuterol/Ipratropium bromide combination

  	
   

  	
  None

  	
   

  
	
  Cromolyn sodium

  	
   

  	
  None

  	
   

  
	
  N-acetylcysteine

  	
   

  	
  None

  	
   

  
	
  Tobramycin (TOBI®)

  	
   

  	
  PARI LC  Plus
  with PulmoAide  compressor

  	
   

  
	
  Pulmozyme

  	
   

  	
  Three
  specified jet nebulizers

  	
   

  
	
  Budesonide (PulmiCort  Respules)

  	
   

  	
  PARI LC  Plus
  Nebulizer

  	
   

  



 












[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.


 

















 


EXHIBIT C


 


TERRITORY


 


United States of America


Mexico**


Canada**


 


United Kingdom**


France**


Germany**


Spain**


Poland**


Greece**


Italy**


 


Japan**


 


Argentina**


Australia**


 












**Expansion Country


 


 


[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.


 

















 


EXHIBIT D


 


TRADEMARKS


 


 




Aerogen®


 


 





Aeroneb® Go


 


 







OnQTM Aerosol Generator


 


 












[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.


 

















 


EXHIBIT E


EQUIPMENT


 


	
  TOOL
  NAME

  	
   

  	
  LOCATION

  	
   

  	
  S/N or A/N

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  Core Manufacturing

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  AP Clean Room

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  QC Laboratory

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  QC Laboratory

  	
   

  	
  [*]

  	
   

  



 












[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.


 

















 


EXHIBIT F


 


INITIAL FORECAST OF OnQ AEROSOL GENERATOR PROCUREMENTS
by MIA*


 




	
  Contract Month

  (from Effective Date):

  	
   

  	
  MIA’s OnQ Procurement

  Requirements*

  	
   

  
	
  Month 1

  	
   

  	
  [*]

  	
   

  
	
  Month 2

  	
   

  	
  [*]

  	
   

  
	
  Month 3

  	
   

  	
  [*]

  	
   

  
	
  Month 4

  	
   

  	
  [*]

  	
   

  
	
  Month 5

  	
   

  	
  [*]

  	
   

  
	
  Month 6

  	
   

  	
  [*]

  	
   

  
	
  Month 7

  	
   

  	
  [*]

  	
   

  
	
  Month 8

  	
   

  	
  [*]

  	
   

  
	
  Month 9

  	
   

  	
  [*]

  	
   

  
	
  Month 10

  	
   

  	
  [*]

  	
   

  
	
  Month 11

  	
   

  	
  [*]

  	
   

  
	
  Month 12

  	
   

  	
  [*]

  	
   

  
	
  Total

  	
   

  	
  [*]

  	
   

  






 


Note:  Pursuant to the provisions of Section 5.4, MIA [*],
but MIA is obligated to take delivery of these minimum quantities, whether or
not [*].


 


 


AEROGEN’S ESTIMATED OnQ AEROSOL GENERATOR REQUIREMENTS


 




	
  Calendar Month

  (from Effective Date):

  	
   

  	
  Aerogen’s OnQ Procurement

  Requirements*

  	
   

  
	
  Month 1

  	
   

  	
  [*]

  	
   

  
	
  Month 2

  	
   

  	
  [*]

  	
   

  
	
  Month 3

  	
   

  	
  [*]

  	
   

  
	
  Month 4

  	
   

  	
  [*]

  	
   

  
	
  Month 5

  	
   

  	
  [*]

  	
   

  
	
  Month 6

  	
   

  	
  [*]

  	
   

  
	
  Month 7**

  	
   

  	
  [*]

  	
   

  
	
  Month 8**

  	
   

  	
  [*]

  	
   

  
	
  Month 9**

  	
   

  	
  [*]

  	
   

  
	
  Month 10**

  	
   

  	
  [*]

  	
   

  
	
  Month 11**

  	
   

  	
  [*]

  	
   

  
	
  Month 12**

  	
   

  	
  [*]

  	
   

  
	
  Total

  	
   

  	
  [*]

  	
   

  






 












*Note: Pursuant to the
provisions of Section 3.8(e). 


 


**Note: Could increase to [*]
per month in event of new product launch


[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.


 

















 


EXHIBIT G


 


ROYALTIES


 


 


[*] of Gross Selling Price


 


 












[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.


 

















 


EXHIBIT H


 


[*] ONQ AEROSOL GENERATOR MINIMUM
PURCHASES


 


The minimum quantity
commitments for any period beyond the [*] anniversary of the Effective Date will be
agreed upon in good faith by the Parties no later than three (3) months prior
to the end of the [*] year during the Term.


 


[*]


 












*[*] minimums, and
payment therefore, for [*] of the
Term are governed by Sections 4.1, 5.4 and
5.5.  The initial order and delivery schedule for the [*] specified in Exhibit F can be modified
only by mutual agreement of the parties, with subsequent modifications governed
by Sections 4.2 and 4.3. 


 


**OnQ Aerosol Generator minimum purchases for [*] shall
be subject to re-assessment as described in Section 6.6(c).


 


This Exhibit H is subject
to adjustment as set forth in Section 6.6(a).


 












[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.


 

















 


Exhibit I


 


INITIAL* MINIMUM QUARTERLY ROYALTIES


 




	
  Country

  	
   

  	
  Minimum

  Quarterly Royalty

  
	
  United States of America

  	
   

  	
  [*]

  
	
  Japan

  	
   

  	
  [*]

  
	
  Each of Mexico, Canada,
  United Kingdom, France, Germany, Spain, Poland, Greece
  and Italy

  	
   

  	
  [*] each

  
	
  Each of Argentina and Australia

  	
   

  	
  [*] each

  






 


Minimum royalties for a
given Sales Quarter are due within [*] following the end of such quarter.  


 


After [*]
quarterly payments, future minimum royalties will be determined on Sales
Quarterly basis, by country, by selecting the greater of (a) [*]
and (b) [*].


 


This Exhibit I is subject
to adjustment as set forth in Section 2.2
and Section 6.6(b).


 


 












[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.


 

















 


Exhibit J


 


MINIMUM QUARTERLY PRODUCT SYSTEM* SALES


 


[*]


 


*“System” as defined on Exhibit B


 


**Minimum Sales Quarterly
Product System Sales for [*] as stated in [*] shall be
subject to re-assessment as described in Section 6.6(c)


 


***As described in Sections 6.4 and 6.5(b)


 


This Exhibit J is subject
to adjustment as set forth in Section 2.2
and Section 6.6.


 


 












[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.


 

















 


EXHIBIT K


 


AEROGEN PATENTS


 


	
  U.S.
  Patent No. 5,164,740

  	
   

  	
   

  
	
  High frequency printing mechanism

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  April 24, 1991

  	
   

  	
  Issued:  November 17, 1992

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. 5,586,550

  	
   

  	
   

  
	
  Apparatus and methods for the delivery of therapeutic
  liquids to the respiratory system

  
	
   

  	
   

  	
   

  
	
  Filed:  August 31, 1995

  	
   

  	
  Issued:  December 24, 1996

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. 5,758,637

  	
   

  	
   

  
	
  Liquid dispensing apparatus and methods

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed: February 21,
  1996

  	
   

  	
  Issued:  June 2, 1998

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. 5,938,117

  	
   

  	
   

  
	
  Methods and apparatus for dispensing liquids as an
  atomized spray

  
	
   

  	
   

  	
   

  
	
  Filed:  April 5, 1995

  	
   

  	
  Issued:  August 17, 1999

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. 6,014,970

  	
   

  	
   

  
	
  Methods & Apparatus for Storing Chemical Compounds in
  Portable Inhaler

  
	
   

  
	
  Filed:  June 11, 1998

  	
   

  	
  Issued:  January 18, 2000

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. 6,085,740

  	
   

  	
   

  
	
  Liquid dispensing apparatus and methods

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  April 10, 1998

  	
   

  	
  Issued:  July 11, 2000

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. 6,205,999

  	
   

  	
   

  
	
  Methods & Apparatus for Storing Chemical Compounds in
  Portable Inhaler

  
	
   

  	
   

  	
   

  
	
  Filed:  September 8, 1998

  	
   

  	
  Issued:  March 27, 2001 

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. 6,235,177

  	
   

  	
   

  
	
  Method for the construction of an aperture plate for
  dispensing liquid droplets

  
	
   

  	
   

  	
   

  
	
  Filed:  September 9, 1999

  	
   

  	
  Issued:  May 22, 2001

  



 

















 


	
  A. U.S. Patents Issued

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. 6,427,682

  	
   

  	
   

  
	
  Improved methods and apparatus for aerosolizing a
  substance

  
	
   

  	
   

  	
   

  
	
  Filed:  January 14, 2000

  	
   

  	
  Issued:  August 6, 2002

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. 6,467,476

  	
   

  	
   

  
	
  Liquid Dispensing Apparatus and Methods

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  May 18, 2000

  	
   

  	
  Issued:  October 22, 2002

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. D469,866

  	
   

  	
   

  
	
  Inhaler For Dispensing Medications

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  January 7, 2002

  	
   

  	
  Issued:  February 4, 2003

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. D471,273

  	
   

  	
   

  
	
  Inhaler For Dispensing Medications

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  January 7, 2002

  	
   

  	
  Issued:  March 4, 2003

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. 6,540,153

  	
   

  	
   

  
	
  Methods & Apparatus for Dispensing Liquids as an
  Atomized Spray

  
	
   

  	
   

  	
   

  
	
  Filed:  May 27, 1999

  	
   

  	
  Issued:  April 1, 2003

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. 6,540,154

  	
   

  	
   

  
	
  Systems & Methods for Controlling Fluid Feed to an
  Aerosol Generator

  
	
   

  	
   

  	
   

  
	
  Filed:  October 2, 2000

  	
   

  	
  Issued:  April 1, 2003

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. 6,543,443

  	
   

  	
   

  
	
  Methods & Devices for Nebulizing Fluids

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  July 12, 2000

  	
   

  	
  Issued:  April 8, 2003

  



 

















 


	
  U.S. Patent No. 6,546,927

  	
   

  	
   

  
	
  Methods & Apparatus for Controlling Piezoelectric
  Vibrations

  
	
   

  	
   

  	
   

  
	
  Filed:  March 13, 2001

  	
   

  	
  Issued:  April 15, 2003

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. 6,550,472

  	
   

  	
   

  
	
  Devices & Methods for Nebulizing Fluids Using Flow
  Directors

  
	
   

  	
   

  	
   

  
	
  Filed:  March 16, 2001

  	
   

  	
  Issued:  April 22, 2003

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. 6,554,201

  	
   

  	
   

  
	
  Insert Molded Aerosol Generator and Methods

  
	
   

  	
   

  	
   

  
	
  Filed:  May 2, 2001

  	
   

  	
  Issued:  April 29, 2003

  
	
   

  	
   

  	
   

  
	
  U.S. Patent No. D474,536 S

  	
   

  	
   

  
	
  Inhaler For Dispensing Medications

  
	
   

  	
   

  	
   

  
	
  Filed:  January 7, 2002

  	
   

  	
  Issued:  May 13, 2003

  



 

















 


	
  B. Foreign Patents Issued

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Argentina Patent No.  547686

  	
   

  	
   

  
	
  High frequency printing mechanism

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  April 27, 1992

  	
   

  	
  Issued:  March 31, 1995

  
	
   

  	
   

  	
   

  
	
  Mexico Patent No, 179906

  	
   

  	
   

  
	
  High frequency printing mechanism

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  April 23, 1992

  	
   

  	
  Issued:  October 25, 1995

  
	
   

  	
   

  	
   

  
	
  France Patent No. FR 0510648

  	
   

  	
   

  
	
  High frequency printing mechanism

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  April 23, 1992

  	
   

  	
  Issued:  July 16, 1996

  
	
   

  	
   

  	
   

  
	
  Great Britain Patent No.  GB 0510648

  	
   

  	
   

  
	
  High frequency printing mechanism

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  April 23, 1992

  	
   

  	
  Issued:  July 16, 1996

  
	
   

  	
   

  	
   

  
	
  Denmark Patent No.  69212688

  	
   

  	
   

  
	
  High frequency printing mechanism

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  April 23, 1992

  	
   

  	
  Issued:  July 16, 1996

  
	
   

  	
   

  	
   

  
	
  European Patent No. 510648

  	
   

  	
   

  
	
  High frequency printing mechanism

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  April 23, 1992

  	
   

  	
  Issued:  8/14/96

  
	
   

  	
   

  	
   

  
	
  Canada Patent No.  2066838

  	
   

  	
   

  
	
  High frequency printing mechanism

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  April 22, 1992

  	
   

  	
  Issued:  February 4, 1997

  



 

















 


	
  Brazil Patent No.  PI 9201487-9

  	
   

  	
   

  
	
  High frequency printing mechanism

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  April 23, 1992

  	
   

  	
  Issued:  April 29, 1997

  
	
   

  	
   

  	
   

  
	
  Australia Patent No.  711059

  	
   

  	
   

  
	
  Liquid Dispensing Apparatus and Methods

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  August 22, 1996

  	
   

  	
  Issued:  January 20, 2000

  
	
   

  	
   

  	
   

  
	
  Denmark Patent No.  402 05 656.6

  	
   

  	
   

  
	
  Inhaler For Dispensing Medication

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  July 4, 2002

  	
   

  	
  Issued:  August 21, 2002

  
	
   

  	
   

  	
   

  
	
  Ireland Patent No.  20028

  	
   

  	
   

  
	
  Inhaler For Dispensing Medication

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  July 5, 2002

  	
   

  	
  Issued:  April 2, 2003

  
	
   

  	
   

  	
   

  
	
  Ireland Patent No.  20029

  	
   

  	
   

  
	
  Inhaler For Dispensing Medication

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Filed:  July 5, 2002

  	
   

  	
  Issued:  April 2, 2003

  



 


 












[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.


 

















 


SCHEDULE 9.2


 


DISCLOSURE SCHEDULE


 


[*]


 


 












[ * ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.