Document:

Exhibit 10.1

 

 

Execution Date: May 31,
2006

 

 

 

 

 

 

 

 

 

AMENDED AND RESTATED

SUPPLY AND DISTRIBUTION AGREEMENT

 

 

 

 

 

between

 

 

SUPERGEN, INC.

(SUPPLIER)

 

 

and

 

 

WYETH

(DISTRIBUTOR)

 

 

Made Effective: 1 June
2006

 

 

 

 

 

 

 

CONFIDENTIAL

 

 

 

INDEX

	
  CLAUSE 1

  	
   

  	
  DEFINITIONS

  	
   

  	
  3

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CLAUSE 2

  	
   

  	
  APPOINTMENT OF DISTRIBUTOR

  	
   

  	
  7

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CLAUSE 3

  	
   

  	
  TRANSITION OF SERVICES

  	
   

  	
  10

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CLAUSE 4

  	
   

  	
  PURCHASE OF UNLABELED BULK
  VIALS OF PRODUCT

  	
   

  	
  14

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CLAUSE 5

  	
   

  	
  PACKAGING, TESTING AND
  DISTRIBUTION OF PRODUCT

  	
   

  	
  16

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CLAUSE 6

  	
   

  	
  ADVERSE EVENT REPORTING AND
  PRODUCT RECALL

  	
   

  	
  17

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CLAUSE 7

  	
   

  	
  CONFIDENTIALITY

  	
   

  	
  18

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CLAUSE 8

  	
   

  	
  WARRANTIES AND INDEMNITIES

  	
   

  	
  19

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CLAUSE 9

  	
   

  	
  INTELLECTUAL PROPERTY

  	
   

  	
  21

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CLAUSE 10

  	
   

  	
  TERM AND TERMINATION

  	
   

  	
  21

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CLAUSE 11

  	
   

  	
  CONSEQUENCES OF TERMINATION

  	
   

  	
  21

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CLAUSE 12

  	
   

  	
  OTHER PROVISIONS

  	
   

  	
  22

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SCHEDULE 1

  	
   

  	
  MARKETING AUTHORIZATIONS AND
  TERRITORY

  	
   

  	
  27

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SCHEDULE 2

  	
   

  	
  SAFETY DATA EXCHANGE PROCEDURE

  	
   

  	
  28

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SCHEDULE 3

  	
   

  	
  PROJECT LEADERS AND JTT MEMBERS

  	
   

  	
  36

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SCHEDULE 4

  	
   

  	
  TIME TABLE FOR REMITTING PROFIT

  	
   

  	
  37

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SCHEDULE 5

  	
   

  	
  THIRD PARTY OBLIGATIONS

  	
   

  	
  38

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

Exhibit A - Original Distribution Agreement as amended

 

Exhibit B - Technical Agreement

 

 2

 

 

THIS AMENDMENT AND RESTATEMENT (“Agreement”) is
made the 31st day of May 2006

BY AND
BETWEEN:

(1)            WYETH, a corporation organized in the State of Delaware,
USA, with offices at Five Giralda Farms, Madison, New Jersey 07940 (“Distributor”);
and

(2)            SUPERGEN, INC., a corporation organized in the State of Delaware,
USA, with offices at 4140 Dublin Boulevard, Suite 200, Dublin, California
94568 (“Supplier”).

Background

WHEREAS, Distributor and Supplier are the successors
in interest to that certain distribution agreement between American Cyanamid
Company and Warner-Lambert Company, respectively, dated June 1, 1992 as amended
on February 6, 1996 (the “Distribution Agreement”; attached hereto
as Exhibit A), pursuant to which Distributor agreed, through one or more
of its Affiliates, to distribute the Pentostatin-containing products under the trademark NIPENT;

WHEREAS, Supplier has requested the termination of the
Distribution Agreement and the return of the rights to the Product granted
thereunder;

WHEREAS, the Parties now desire to amend and restate
the Distribution Agreement as set forth herein in accordance with Section 6.5
thereof in order to formalize their understandings respecting the termination
of the Distribution Agreement and to effectuate the transition of services from
Distributor to Supplier.

NOW, THEREFORE, in consideration of the mutual
covenants contained herein and intending to be legally bound hereby, the
Parties hereto agree as follows:

CLAUSE 1   DEFINITIONS

1.1.         Specific
Definitions.   As used in this Agreement, the following terms shall
have the following meanings:

(a)            “Affiliate” means a legal entity directly or indirectly
controlling, controlled by or under common control with the Party in question. “Control”
means owning at least forty percent (40%) of the voting shares of equity or
having the right to appoint directors holding forty percent (40%) of the vote
or having the right to manage, in fact, the day-to-day operations of the entity
in question.

(b)           “Applicable Laws” means all laws, statutes, regulations of
any Competent Authority having jurisdiction over the Products in the Territory,
as may be in effect from time to time during the Term.

(c)            “Business Day” means 9:30 am to 5:30 pm on any day
excluding Saturdays, Sundays and public holidays.

 3
 

 

 

(d)           “cGMP” means current good manufacturing practice (as
provided for in EU Directive 2003/94/EC, as amended), together with any locally
imposed requirements.

(e)            “Catania Cost” means the sum of Distributor’s Purchase Price
for Unfinished Product, plus freight, insurance and all other direct costs
incurred by Distributor to deliver Unfinished Product to Distributor’s Plant
plus Distributor Packaging and Testing Cost.

(f)              “Competent Authority” means any governmental or regulatory
bodies including the European Commission, The Court of First Instance and the
European Court of Justice, local or national agencies, minister, ministry
officials, departments or entities, whether or not located in the Territory, which
regulate, direct or control commercial, medical and other related activities in
or with the Territory or which have jurisdiction over the activities of the
Agreement or any of the Parties under this Agreement.

(g)           “Compound” means (R)-3-(2-deoxy-beta-D-erythropentofuranosyl)-3,6,7,8-tetrahydroimidazo
[4,5-d] [1,3]diazapin-8-o1 (identified by Supplier as Pentostatin), which
formula has been approved by the United States Food and Drug Administration.

(h)           “Confidential Information” means any information and data
disclosed by one Party or its Affiliates to the other Party or its Affiliates
pursuant to or in connection with this Agreement or the supply or distribution
of Product hereunder (whether or not such information is expressly stated to be
confidential), including without limitation, information relating to
technology, processes, packaging specifications, inventions, designs, trade
secrets, know how and information of a commercially sensitive nature.

(i)               “Designee” means a person or legal entity designated by
Supplier to act on its behalf as set forth herein.

(j)               “Distributor’s Plant” means Distributor’s product
manufacturing and packaging facility located at XV Strada, Zone Industriale,
95030 Catania, Sicily.

(k)            “EEA” means the European Economic Area as constituted from
time to time.

(l)               “Force Majeure” means, in relation to either Party, any
circumstances beyond the reasonable control of that Party (including, without
limitation, any strike, lockout or other form of industrial action).

(m)         “Intellectual Property” means a patent, copyright,
registered design, the Trademark or any other trademark, Confidential
Information or other industrial or intellectual property right subsisting in
the Territory in respect of the Product, and applications for any of the
foregoing.

(n)           “Losses” means any and all Third Party losses, claims,
damages, liabilities, reasonable costs and expenses, including reasonable legal
fees (but excluding lost profit, loss of custom, consequential, incidental,
unforeseen or punitive 

 4
 

 

damages) arising from or
related to, any claim, action or proceeding made or brought by a Third Party.

(o)           “Marketing Authorization” means the product authorization to
market and sell the Product in the Territory as listed in Schedule 1.

(p)           “Net Sales” means the actual gross sales proceeds received
by a Party from Third Parties for the Product less each and all of the
following: trade, quantity and cash discounts, if any, actually allowed or paid
with respect to the Product; returns, allowances, rebates and adjustments
actually granted to customers; ; outbound freight or transportation charges and
all taxes including value added taxes and excise taxes (except income taxes),
tariffs, duties and all other existing or future governmental charges paid by a
Party.

(q)           “Packaging and Testing Cost” means Distributor’s standard
cost for packaging and testing Unfinished Product, calculated in accordance
with Distributor’s standard accounting practices, which shall, for 2006 be €14.50
(fourteen Euros and 50 cents) per 10mg vial.

(r)              “Packaging and Testing Instructions” means the instructions,
in strict accordance with the approved Marketing Authorization, provided by
Supplier to Distributor to package and test the Product; said Packaging and
Testing Instructions are held on file at Supplier’s offices and in the quality
department at Distributor’s Plant.

(s)            “Packaging Materials” means packaging and testing materials
and packaging inserts for the packaging and testing of the Products, in each
case to the extent such material do not include any Distributor trademarks;
provided, however, packaging materials for labelling product in Greece which
contain Distributor’s Lederle logo shall constitute Packaging Material. For the
avoidance of doubt, the Parties acknowledge and agree that packaging and
testing materials and packaging inserts which merely mention Distributor or its
Affiliate as a distributor of Product shall be considered Packaging Materials.

(t)              “Party” means Supplier or Distributor, as the case may be;
and both Supplier and Distributor when used in the plural.

(u)           “Person” means any individual, corporation, general or
limited partnership, limited liability company, joint venture, estate, trust,
association, organization, labor union, or other entity or Competent Authority.

(v)           “Product” means the finished pharmaceutical preparation of
the Compound (for human use).

(w)         “Project Leader” means each of the two individuals (one
representative from Supplier and one representative from Distributor) who shall
co-chair the Joint Transition Team and act in the capacity of a project manager
for the respective Party during the Transition Period.

 5
 

 

 

(x)             “QP” means Supplier’s representative appointed as qualified
person under GMP.

(y)           “RHA” means any relevant government health authority (or
successor agency thereof) in any country of the Territory whose approval is
necessary to market the Product in the relevant country of the Territory.

(z)             “Specification” means the specifications for the Product as
set forth in the relevant Marketing Authorization, which Supplier or its
relevant Affiliate shall amend pursuant to changes required by any RHA and
provide notification to Distributor in accordance with Clause 12.4.

(aa)      “Technical Agreement” means the Technical and Quality
Agreement executed by Supplier’s Affiliate and Distributor’s Affiliate
effective as of February 1, 2006, a copy of which is attached hereto as Exhibit
B, setting forth the quality provisions applicable to the manufacture of
the Product pursuant to this Agreement.

(bb)    “Territory” means all countries in the world where the
Product is or has been approved for sale except for the United States of
America and its territories and possessions (including the Commonwealth of
Puerto Rico), Mexico, Canada and Japan.

(cc)      “Third Party” or “Third Parties”
means any Person other than Supplier, Distributor or their respective
Affiliates.

(dd)    “Trademark” means the trademarks, NIPENT, ONCOPENT, or such
other trademarks, trade names and designs associated with the Product, whether
registered or unregistered.

(ee)      “Unfinished Product” means the bulk unlabelled vials of
Product which are manufactured by Supplier to Specification and purchased by
Distributor for labeling and packaging into finished Product at Distributor’s
Plant.

1.2.         Index
of Other Definitions:

In addition, the following definitions have the
meanings in the Clauses corresponding thereto, as set forth below:

	
  Definition

  	
   

  	
  Clause

  
	
  Acceptable
  Product

  	
   

  	
  5.8.2

  
	
  Acceptable
  Unfinished Product

  	
   

  	
  4.8.3

  
	
  Additional
  Distribution Fee

  	
   

  	
  2.2

  
	
  CoA

  	
   

  	
  4.8.1

  
	
  Claim

  	
   

  	
  8.7

  
	
  Closing Date

  	
   

  	
  3.2

  
	
  Country Handover
  Date

  	
   

  	
  3.5.1

  
	
  Distribution Fee

  	
   

  	
  2.2

  

 

 6
 

 

 

	
  Distributor’s Purchase Price

  	
   

  	
  4.2

  
	
  Effective Date

  	
   

  	
  10.1

  
	
  JTT

  	
   

  	
  3.7

  
	
  Transfer Cost

  	
   

  	
  2.3.3

  
	
  Release and Waiver

  	
   

  	
  3.6

  

 

CLAUSE 2  APPOINTMENT OF DISTRIBUTOR

2.1.         Appointment:

2.1.1                             Supplier
hereby appoints Distributor and authorizes Distributor to designate itself or
its Affiliates, as the exclusive distributor of the Product for Supplier in all
the countries in the Territory during the Term, except in Italy where Supplier
shall have the right to appoint, in addition to Distributor, its Affiliate or a
Third Party such that its Affiliate or a Third Party and Distributor shall be
the semi-exclusive distributors of the Product during the Term of this
Agreement as it relates to Italy.

2.1.2                             Pursuant
to Clause 3.5.1 below, upon a Country Handover Date, Distributor’s appointment
shall be deemed terminated as to that specific country in the Territory.

2.1.3                             Pursuant
to Clause 3.2 below, upon the Closing Date, Distributor’s appointment shall be
deemed terminated as to all countries in the Territory.

2.2.         Acceptance
and Compensation.   Distributor hereby accepts the appointment set
forth in Clause 2.1.1. The compensation to Distributor for sales of Product in
the Territory during the initial six-month period following the Effective Date
shall be five percent (5%) of Net Sales (“Distribution Fee”). If Distributor
has any sales of Product in accordance with this Agreement in any country of
the Territory following the initial six (6) months after the Effective Date
hereof, Distributor shall be compensated at a rate of twenty percent (20%) of
Net Sales for such sales occurring after such initial six-month period until
Closing (“Additional Distribution Fee”).

2.3.         Remittance
of Profit to Supplier.   In accordance with the time frames as outlined
in Schedule 4, Distributor shall remit to Supplier Product Net Sales invoiced
by Distributor for the month, if any, minus:

2.3.1                             Distributor’s
Distribution Fee (or any Additional Distribution Fee, if applicable);

2.3.2                             Catania
Cost;

2.3.3                             “Transfer
Cost”, which shall mean a mark-up amount equal to five percent (5%) of the
Catania Cost, plus actual freight, insurance and any other direct delivery costs
incurred by Distributor from Distributor’s Plant to/from its relevant Affiliate’s
(or Supplier’s Designee’s) premises for subsequent sale of the Product to
customers, provided however that the mark-up amount shall be twenty
percent (20%) of the Catania Cost where sale to an Affiliate 

 7
 

 

 

or Supplier
Designee occurs between the period beginning six (6) months after the Effective
Date until Closing;

2.3.4                             any
customer receivable arising during the relevant month which remains overdue to
Distributor by sixty (60) days or more; provided however, that Supplier
shall have the opportunity to review and approve standard terms (including
payment terms) for established customers based on local practices.

2.4.         Advertising
and Promotion.

2.4.1                             Beginning
upon the Effective Date, Supplier shall, at its expense and control, be
responsible for developing and submitting, as appropriate, promotional
materials to any RHA having jurisdiction over the use of such materials in the
Territory. Supplier shall inform Distributor of any submission to any RHA and,
upon reasonable request by Distributor, provide to Distributor a copy of such
submissions. Supplier shall be solely responsible for obtaining any necessary
approval by any RHA of the promotional materials for the Product and Supplier
shall be solely responsible for conducting or implementing any advertising or
promotional activities relating to the Product.

2.4.2                             All
advertising and promotional expenses incurred by Supplier relating to Supplier’s
distribution or Distributor’s distribution of Product in the Territory shall be
borne by Supplier.

2.4.3                             Supplier
shall comply with all Applicable Laws regarding the marketing and promotion of
Product in the Territory.

2.5.         Reports,
Forecasts and Audits.  From time to
time during the Term of this Agreement:

2.5.1                             Distributor
shall furnish to Supplier, such periodic forecasts and recommendations for each
country of the Territory as Distributor may reasonably develop for the proper
and reasonably timely exit from the business by Distributor and transition of
packaging, testing, distributing and related services regarding the Product to
Supplier or its Designee.

2.5.2                             Distributor
shall submit to Supplier sales and inventory reports in such form and such
frequency as agreed by the Joint Transition Team for the purpose of updating
the Parties on the progress of the transition during the Transition Period.

2.5.3                             The
Parties hereto shall keep or cause to be kept accurate records in sufficient
detail to enable all payments hereunder to be determined.

2.5.4                             Distributor
shall keep accurate records and books of account for the purpose of showing all
amounts to be calculated under this Agreement. Such records and books of
account shall be kept for five (5) years following the end of the calendar year
to which they relate and certified extracts of such records and books of
account shall be open to inspection by Supplier or its 

 8
 

 

 

representatives at
any time with notice of at least (5) Business Days during ordinary business
hours for the purpose of verifying any matter relevant to this Agreement.

Upon
the request of Supplier, Distributor shall permit (i) an independent
public accountant selected by Supplier and reasonably approved by Distributor
to have access, during ordinary business hours, to such records and books of
accounts relevant to this Agreement; and (ii) Supplier reasonable
inspection of that relevant portion of Distributor’s Plant relating to
Distributor’s activities pursuant to this Agreement. The cost of such audit or
inspection shall be the responsibility of Supplier, except if such audit
discloses an error benefiting Distributor by more than five percent (5%) in
respect of monies due to Supplier, then Distributor shall promptly reimburse
Supplier for its costs incurred for such audit.

2.5.5                             Not
later than five (5) Business Days after the beginning of each calendar month,
Distributor’s Plant shall provide the Joint Transition Team a rolling month by
month forecast (the “Rolling Forecast”) of the expected orders of Product
during the Term. In accordance with Clause 4.6 below, such Rolling Forecast may
take into account quantities requested by Supplier and agreed by Distributor
for special order purposes. Within ten (10) days of the first day of each
calendar month if Supplier (by way of the Joint Transition Team) does not
accept the Rolling Forecast for the first month of such forecast, the Parties
will negotiate and agree to a new forecast. The requirements indicated for the first
two (2) calendar months in such agreed upon Rolling Forecast shall be
considered firm for the purposes of production planning in Distributor’s Plant
and cannot thereafter be amended except by mutual agreement in writing or upon
unanimous approval by the Joint Transition Team. Under no circumstances shall
any order quantity designated for the purpose of Supplier’s stock build be
binding upon Distributor. No monthly amount set forth in any Rolling Forecast
may increase from the immediately preceding Rolling Forecast for such month by
more than twenty percent (20%), without the prior written consent of the
Parties.

2.5.5.1                    Information
regarding the Rolling Forecast or special orders (as provided in Clause 4.6
below) shall be communicated as follows:

	
  

  	
  To Distributor:

  	
   

  	
  Attention: Stefania Barbettani

  
	
   

  	
   

  	
  Telephone: 39 095 59 84 54

  
	
   

  	
   

  	
  E-mail: barbets@Wyeth.com

  
	
   

  	
   

  	
  Address: Wyeth lederle SpA, XV Strada, Zone

  
	
   

  	
   

  	
  Industriale, 95030 Catania, Sicily

  
	
   

  	
   

  	
   

  
	
   

  	
  To Supplier:

  	
   

  	
  Attention: Chris Ninomoto

  
	
   

  	
   

  	
  Title: Director, Commercial Operations

  
	
   

  	
   

  	
  Telephone: +925 560-0100 x. 386

  
	
   

  	
   

  	
  E-mail: cninomoto@supergen.com

  
	
   

  	
   

  	
  Address: 4140 Dublin Blvd, Suite 200, Dublin,

  
	
   

  	
   

  	
  CA 94568, USA

  

 

 9
 

 

 

2.6.         Expired
Product.   Distributor shall not distribute or sell any Product which
is expired or outdated and shall follow Supplier’s instructions regarding
expired Product and its destruction or return to Supplier.

2.7.         Goodwill.

2.7.1                             Each
Party shall use its best reasonable efforts to preserve the goodwill of the
Product.

2.7.2                             Distributor
shall continue to have the right to use the Trademark applied to the Product to
fulfil its obligations in accordance with this Agreement. Distributor shall
equally be entitled to trade upon and use the name or goodwill of Distributor
in connection with its activities hereunder. Upon the Closing Date, neither
Party shall thereafter use the other’s name in the promotion of its business or
offer for sale any goods which by their packaging, labeling or construction
would reasonably create a claim by the other Party that such goods are
imitative of any goods, products or packages or trade dress of the other Party.

CLAUSE 3  TRANSITION OF SERVICES

3.1.         On
the Effective Date hereof, Supplier agrees to pay Distributor, by wire transfer
in immediately available funds to a bank account designed by Distributor, the
sum of two million one hundred thousand US dollars ($2,100,000.00).

3.2.         Subject
to Clause 3.4 below, the effective date of expiration of this Agreement and
termination of the distribution relationship between the Parties, including all
packaging, testing, and distribution obligations hereunder, as to all countries
within the Territory shall be at the close of business on the date six (6) months
after the Effective Date (i.e. close of business on December 1, 2006) (“Closing
Date” or “Closing”) provided that, upon reasonable request from
Distributor, Supplier provides such reasonable assurances regarding Supplier’s
capability (itself or through one or more Third Parties) to test, package and
distribute Product in the Territory at the levels supported by Distributor as
of the Effective Date. The termination upon Closing shall be deemed to
constitute a termination by mutual agreement and shall not be deemed a
termination for default, and neither Party shall have any responsibility or
liability as a result of such termination except as otherwise expressly
provided herein. The Parties hereby waive all rights to notice of termination
or compensation relating to termination as may be otherwise provided under
Applicable Laws.

3.3.         Supplier
acknowledges that as prerequisites to Closing, Supplier shall: (1) obtain
all necessary variations to Marketing Authorizations for its or its Designee’s
packaging and testing contractor and in-country sales order and distribution
arrangements for the Product, together with obtaining any approvals for
associated changes to artwork and labeling as may be required by any relevant
Competent Authority; and (2) satisfy any other conditions for regulatory
approvals to effectuate the transition of the services provided hereunder from
Distributor to Supplier.

 10
 

 

 

3.4.         Subject
to Clause 3.2 above, in the circumstance where: (1) as a prerequisite
to Supplier assuming all distribution, packaging, testing, marketing and sale
of Product in a country of the Territory, Supplier has made the necessary
submissions for approval to the relevant Competent Authorities and such
submission(s) have not yet been approved; or (2) Supplier is unable to provide
reasonable assurances to Distributor pursuant to Clause 3.2 above and as
evidenced by gaps or incomplete processes in Supplier’s (or its Designee’s)
infrastructure for supporting testing, packaging and distribution operations,
then Distributor, in Distributor’s sole discretion, may extend the Closing Date
hereof to the date of the last anticipated approval or to the anticipated date
when Supplier can provide such reasonable assurances. If Distributor decides to
so extend the Closing, Distributor shall notify Supplier in writing. Under no
circumstances shall the Closing Date be extended beyond March 25, 2007.

3.5.         The
“Transition Period” is that period of time from the Effective Date hereof to
the Closing Date. Distributor and Supplier agree to work diligently, act in
good faith, use commercially reasonable efforts, cooperate and provide such
reasonable assistance to each other during the Transition Period to effectuate
the orderly and reasonably timely transfer of packaging, testing and
distribution services from Distributor to Supplier.

3.5.1                             During
the Transition Period and prior to Closing, the respective Project Leaders may
agree, in writing, to Supplier assuming all distribution responsibilities for
the Product in a specific country on a specified date (“Country Handover Date”).
Said writing shall include whether the associated packaging and testing
responsibilities also transfer to Supplier for that particular country and if
not, the date of transfer of the packaging and testing responsibilities shall
be specified, which date shall not be after the Closing Date. The Country
Handover Date (which may vary country-by-country) for each country shall be a
date on or prior to the Closing Date.

3.5.1.1                    On the Country
Handover Date for a particular country, Distributor (or its Affiliate) shall
discontinue all distribution activities regarding the Product in that specific
country. In accordance with this Clause 3.5.1, Distributor shall also
discontinue packaging and testing activities regarding the Product for that
specific country as agreed upon in writing by the Project Leaders.

3.6.         Supplier
agrees to forever release Distributor from any claims which may arise from
Supplier’s activities regarding the Product in a specific country after the
Country Handover Date for that country and as to all countries in the Territory
after Closing (“Release and Waiver”). Supplier shall execute a Release and
Waiver in a form mutually agreed by the Parties upon each Country Handover Date
and upon Closing.

3.7.         Joint
Transition Team.   Within five (5) Business Days following the
Effective Date hereof, the Parties shall establish a Joint Transition Team (the
“JTT”) to manage the transition of the packaging, testing and distribution
services from Distributor to Supplier. The JTT shall be comprised of an equal
number of representatives from each Party, with each Party having one Project
Leader participate as a member of the JTT. The JTT shall:

 

 11

 

 

3.7.1                             be
comprised of at least a Project Manager, regulatory representative, technical/quality
operations representative, and logistics specialist designated by each Party;

3.7.2                             meet
a minimum of twice per month (either face-to-face or by teleconference); each
Party shall be responsible for its own costs in respect of travel and accommodation
expenses in attending meetings; at such meetings, Supplier shall report on the
ongoing progress of the transition of packaging, testing and distribution
responsibilities from Distributor to Supplier;

3.7.3                             be
co-chaired by the Project Leaders;

3.7.4                             JTT
shall make decisions or provide approvals as may be required from time to time
pursuant to Clauses 2.5.2, 2.5.5, 4.1, 5.3, 6.6 or other relevant
provision of this Agreement.

3.8.         Reasonable
Support.   During the Transition Period, Distributor will continue to purchase
unlabeled vials of Unfinished Product pursuant to Clause 4 below, and package,
test and distribute Product pursuant to Clause 5 below. Distributor agrees
to also provide pharmacovigilance, medical and regulatory support (including
providing reasonable assistance to Supplier in handling any medical or
regulatory inquiries from Persons or Competent Authorities) as reasonably
requested by Supplier to facilitate the transition of rights to Supplier.

3.8.1                             Product Complaints.
In accordance with the Technical Agreement, Supplier shall be responsible for
interacting with the public or Third Parties with respect to complaints
regarding Product for any country in the Territory in which Distributor or its
AffIliates sold, packaged, distributed or provided Product on a named patient
basis.

3.9.         Inventory.   Supplier
shall purchase from Distributor all quantities of Product Packaging Material
and all quantities of stock of Product and Unfinished Product with at least
twelve (12) months of remaining shelf life (collectively the “Inventory”) in
the possession or under the control of Distributor on the Closing Date.

3.9.1                             Upon
Closing, Supplier is obligated to repurchase each unit of Unfinished Product
within the Inventory remaining in Distributor’s possession or under Distributor’s
control at a price equal to Distributor’s Purchase Price plus freight,
insurance and all other direct costs incurred by Distributor to deliver
Unfinished Product to Distributor’s Plant. On the Closing Date, Distributor
shall submit an invoice for such Unfinished Product and Supplier shall pay such
invoice within forty five (45) days after receipt thereof.

3.9.2                             On
the Country Handover Date for a specific country (or upon Closing, whichever
occurs first), Supplier is obligated to repurchase each unit of Product within
the Inventory remaining in Distributor’s possession or under Distributor’s
control for that particular country at a price equal to the Catania Cost plus
Transfer Cost. On the applicable Country Handover Date or Closing, as the case
may be, Distributor shall submit an invoice for such 

 12
 

 

 

Product and
Supplier shall pay such invoice within forty five (45) days after receipt
thereof.

3.9.3                             Upon
Closing, Supplier is obligated to repurchase all Packaging Materials remaining
in Distributor’s possession or under Distributor’s control at a price equal to
Distributor’s net book value; provided that Supplier shall have no such
obligation with respect to any Packaging Materials (i) that are not within
specification or (ii) in quantities in excess of four (4) months of normal
usage, based on past experience. On the Closing Date, Distributor shall submit
an invoice for such Packaging Materials and Supplier shall pay such invoice
within forty five (45) days after receipt thereof. Supplier may repurchase
country-specific Packaging Material upon a Country Handover Date; however, in
any event, any such remaining material must be repurchased by Supplier upon
Closing.

3.9.4                             Distributor
shall make the Inventory available at Distributor’s premises for pick-up on the
Closing Date or Country Handover Date, as the case may be.

3.9.5                             If
Supplier so desires, Supplier may, but is not obligated to, repurchase
Inventory prior to the dates as described herein. For the avoidance of doubt,
Supplier is obligated to repurchase all remaining Inventory upon Closing, with
payment for same due as described in this Clause 3.9 above.

3.10.                Release of
Claims.   Supplier, for itself, its successors and assigns, hereby
releases any claims or demands which Supplier has, had, may have or may have
had against Distributor, in each case arising out of any actual or alleged
failure on by or on behalf of Distributor to fulfill any of its obligations under
Sections 2.2 or 2.3 of the original Distribution Agreement including
relating to any of Distributor’s acts or omissions concerning the testing,
marketing, advertising, promotion or pursuit of clinical trial development work
pertaining to the Product.

3.11.                Upon Closing or
the Country Handover Date (whichever occurs first) for a particular country in
the Territory, Supplier shall assume all material obligations to Third Parties
which Distributor incurred prior to the Effective Date pursuant to the
Distribution Agreement or after the Effective Date subject to Supplier’s
reasonable approval. Subject to Clause 2.3.4, such material obligations to
Third Parties incurred by Distributor include solely those purchase orders and
named patient supplies filled in the ordinary course of business in accordance
with Distributor’s past practice and other obligations (contracts, agreements,
and commitments relating to the Product) as set forth in Schedule 5, attached
hereto.

3.12.                Supplier represents
and warrants to Distributor that at the end of the Transition Period, Supplier
shall (itself or through one or more Designees) have the capability and
infrastructure necessary to, in each case consistent with Distributor’s
practice during the term:

3.12.1          Comply with all relevant
applicable directives, laws and regulations relating to the manufacture,
storage, marketing, packaging, testing, distribution and sale of the Product in
the Territory; and

 13
 

 

 

3.12.2                       Employ or
otherwise engage sufficient trained and qualified personnel and maintain
adequate facilities for the manufacture, promotion, distribution and sale of
the Product throughout the Territory; and

3.12.3                       Maintain
sufficient stocks of Product to meet all reasonably foreseeable demand for the
Product in the Territory.

CLAUSE 4   PURCHASE
OF UNLABELED BULK VIALS OF PRODUCT

4.1.         Purchase.
During the Term of this Agreement, Distributor shall purchase Unfinished
Product, for packaging, testing and sale during the Transition Period, only
from Supplier or its Designee. Supplier or its Designee shall manufacture the
Unfinished Product in accordance with the Product Specifications and the
Technical Agreement (attached hereto as Exhibit B). Supplier or its
Designee shall deliver such Unfinished Product to Distributor’s Plant. It is
understood that the Unfinished Product shall be labelled and packaged by
Distributor in accordance with Supplier’s Packaging Instructions. Upon the
Closing Date and in accordance with Clause 3.2, Distributor shall have no
further obligation whatsoever hereunder with respect to Unfinished Product
except as provided in Clause 3.9.

Unless otherwise agreed in writing by the JTT, each
order of Unfinished Product shall consist of a minimum of: (1) one
thousand nine hundred (1,900) (10mg) unlabeled vials of Unfinished Product;
plus (2) free of charge, one hundred (100) (10mg) unlabeled vials of
Unfinished Product; plus (3) free of charge, a sufficient number of (10mg)
vials of Unfinished Product to meet cGMP and testing requirements.

4.2.         Purchase
Price. Supplier shall sell Unfinished Product to Distributor, excluding
those vials supplied free of charge pursuant to Clause 4.1 above, at a
price per (10mg) vial equal to two hundred and sixty five United States dollars
($US265) CIF (Incoterms 2000) Catania Airport (“Distributor’s Purchase Price”).

4.3.         Payment.
Supplier will issue an invoice for each shipment of bulk unlabeled vials of
Unfinished Product and Distributor agrees to pay for such Unfinished Product
United States dollars to an account specified by Supplier within forty five
(45) days of the date of such invoice.

4.4.         Title
and Risk of Loss. Title to the Unfinished Product sold to Distributor
hereunder and risk of loss thereof shall pass to Distributor when the
Unfinished Product is presented for customs clearance in the country of
destination in the Territory. Distributor shall be responsible for affecting
such customs clearance and for paying away all expenses related thereto on
behalf of Supplier.

4.5.         Orders.
Distributor understands that Supplier requires a lead time of eight (8) months
in order to manufacture bulk unlabeled vials of Unfinished Product for
packaging and testing under this Agreement. In order to ensure continuity of
supply of Product to the Territory during the Transition Period or until the
Country Handover Date for a particular country, Distributor will, from time to
time, place firm orders of Unfinished Product with Supplier in order amounts as
set forth or otherwise agreed by the Parties pursuant to Clause 2.5.5 and
Clause 4.1 above. 

 14
 

 

 

Promptly after receipt of
a firm order for bulk unlabeled vials of the Unfinished Product, Supplier shall
notify Distributor of Supplier’s firm commitment to deliver such Unfinished
Product to the location specified in Distributor’s order.

4.6.         Special
Orders.   During the Transition Period and upon reasonable approval by
Distributor, Supplier may request Distributor order quantities of Unfinished
Product from Supplier solely for packaging and testing (but not distribution)
by Distributor in order to assist Supplier in stock build of Product or for
eventual distribution by Supplier (or Supplier’s nominated Third Party).
Supplier shall be obligated to purchase such Product so packaged and tested by
Distributor at Catania Cost plus Transfer Cost.

4.7.         Technical
Agreement.   Supplier’s Affiliate and Distributor’s Affiliate have
executed the Technical Agreement, a copy of which is attached hereto as Exhibit B.

4.8.         CoA
and Testing of Unfinished Product.

4.8.1                             For
each batch of each delivery of Unfinished Product, Supplier shall provide to
Distributor a certificate of analysis (“CoA”) and batch documentation
certifying manufacture in accordance with cGMP, the Specifications and in
accordance with the provisions of the Technical Agreement.

4.8.2                             Unfinished
Product supplied by Supplier shall also be free from any liens or encumbrances.

4.8.3                             Distributor
may analyze the Unfinished Product in accordance with the Technical Agreement
for purposes of determining whether such Unfinished Product was manufactured by
Supplier in accordance with GMP and the Specifications (“Acceptable Unfinished
Product”).

4.8.4                             Distributor
shall notify Supplier in writing within thirty (30) days of receipt of any of
the Unfinished Product or portion thereof, which Distributor or its Affiliate
is rejecting because it is not Acceptable Unfinished Product.

4.8.5                             If
Supplier disputes any finding by Distributor or its Affiliate that Unfinished
Product is not Acceptable Unfinished Product, representative samples of such Unfinished
Product shall be forwarded to a Third Party jointly selected by Distributor and
Supplier, in their reasonable discretion, for analysis, which analysis shall be
performed in compliance with applicable regulations for re-testing of
pharmaceutical products. The findings of such analysis shall be binding upon
the Parties and the cost of such analysis shall be borne by the Party whose
findings differed from those generated by such Third Party.

4.8.6                             Supplier
shall, as soon as reasonably practicable, replace any Order, or portion
thereof, which is not Acceptable Unfinished Product (unless such
non-conformance is due to any negligent or wrongful act or omission by
Distributor or its agents, employees or sub-contractors), at Supplier’s cost
and expense. The foregoing shall be Distributor’s sole remedy in the event any
Unfinished Product is not Acceptable Unfinished Product.

 15
 

 

 

4.8.7                             Distributor
shall instruct Distributor’s Affiliates as to the disposition of any Order or
portion thereof determined not to be Acceptable Unfinished Product. At the sole
option of Supplier and at its expense, said Unfinished Product may be returned
to Supplier or destroyed in an environmentally acceptable manner in accordance
with Applicable Law.

CLAUSE 5   PACKAGING,
TESTING AND DISTRIBUTION OF PRODUCT

5.1.         Until
the occurrence of the Country Handover Date for a particular country or the
Closing Date (whichever occurs first), Distributor or its Affiliate shall
continue to act as distributor for Supplier within said country of the
Territory.

5.2.         Distributor
acknowledges that the Unfinished Product supplied hereunder shall be packaged
and tested by Distributor in accordance with Supplier’s Packaging and Testing
Instructions and shall not be subject to any variation in packaging, except as
otherwise provided in the Technical Agreement. It is understood that during the
Transition Period, Supplier shall obtain regulatory approval for Supplier or
its Designee to take over packaging and testing responsibilities from
Distributor.

5.3.         Supplier
shall work in collaboration with the Joint Transition Team regarding the
transition of packaging, testing and distribution activities from Distributor
to Supplier (or Supplier’s Designee). Supplier shall be responsible for
obtaining any and all necessary regulatory approvals or other approvals from
relevant Competent Authorities in connection therewith.

5.4.         Supplier
solely shall be responsible for ensuring the Packaging and Testing Instructions
are maintained in line with the relevant RHA’s requirements.

5.5.         Supplier
shall immediately notify Distributor of changes to Supplier’s Packaging and
Testing Instructions. Any cost or expenses (including any costs of
implementation) incurred by Distributor in effectuating such changes
(including, without limitation, changes to the Packaging Materials, artwork,
labeling or Packaging Specifications) whether required by a Competent Authority
or otherwise requested by Supplier shall be borne by Supplier.

5.6.         Except
as otherwise permitted hereunder, Supplier shall use no trademark or trade
dress that is identical or confusingly similar to any trademark or trade dress
owned by Distributor or its Affiliates. At no time following the Closing Date
shall Supplier use any trademark or trade dress of Distributor or its
Affiliates nor shall it permit, procure or facilitate the use of such
Distributor (or Distributor’s Affiliate) trademark or trade dress by any Third
Party; provided, however, to the extent any Greek packaging repurchased by
Supplier bearing Distributor’s or its Affiliate’s trademark or trade dress
exists upon Closing, Supplier shall be permitted to exhaust such inventory
during the four (4) months immediately following Closing.

5.7.         In
the case of stock build quantities, Distributor shall deliver Product ex works
(Incoterms 2000) at Distributor’s Plant to Supplier or Supplier’s Desginee
within twelve (12) weeks of Distributor’s date of receipt of special order
quantities. In accordance with Clause 4.6 above, the price at which Supplier
shall purchase such Product shall be equal to Catania Cost plus Transfer Cost.

 

 16

 

 

5.8.         Quality
Control for Packaged Product.

5.8.1                             Distributor
shall perform quality control tests on the Product and provide documentation to
Supplier in accordance with the Technical Agreement.

5.8.2                             Supplier
may analyze the Product in accordance with the Technical Agreement for purposes
of determining whether such Product was packaged and labelled by Distributor in
accordance with Supplier’s Packaging Instructions (“Acceptable Product”).

5.8.3                             In
the case of stock build quantities delivered to Supplier (or Supplier’s
Designee), Supplier shall notify Distributor in writing within thirty (30) days
of receipt of any of the Product or portion thereof, which Supplier or its
Designee is rejecting because Supplier’s belief that such Product was not
packaged in accordance with Supplier’s Packaging and Testing Instructions.

5.8.4                             Distributor
shall, as soon as reasonably practicable, re-package or take such other action
as deemed appropriate and in accordance with quality control procedure and
standards with respect to any special order, or portion thereof, which is not
Acceptable Product (unless such non-conformance is due to any negligent or
wrongful act or omission by Distributor or its agents, employees or
sub-contractors), at Supplier’s cost and expense. The foregoing shall be
Supplier’s sole remedy in the event any Product is not Acceptable Product.

5.8.5                             Supplier
shall instruct its Designee as to the disposition of any order or portion
thereof determined not to be Acceptable Product.

CLAUSE 6   ADVERSE
EVENT REPORTING AND PRODUCT RECALL

6.1.         The
Parties shall comply with all Applicable Laws regarding the reporting of
adverse experiences to the relevant authorities and hereby agree to the
procedures attached hereto as Schedule 2 regarding such reporting
and the exchange of adverse experience information.

6.2.         In
the event of an actual or threatened recall of the Product is required or
recommended by a Competent Authority within the Territory or if recall of the
Product is (i) reasonably deemed advisable by Distributor, Distributor’s
Affiliates, or by Supplier, or (ii) jointly deemed advisable by
Distributor and Supplier, such recall shall be promptly implemented, directed
and administered by Supplier in a manner which is appropriate and reasonable under
the circumstances and in conformity with accepted trade practices and the
Technical Agreement.

6.3.         The
costs of the recall of the Product, including the cost of replacement
quantities of Product, if any are needed or desired by Distributor, shall be
borne by Supplier; provided that if the recall is due to Distributor’s
negligent acts or omissions in handling, storing or packaging the Product or
Distributor’s failure to comply with Applicable Laws, then the costs of the
recall shall be borne by Distributor. Without limiting the generality of the
foregoing, Distributor will have no obligation to pay costs of recalls of
Product to the extent such recalls are (i) due to the withdrawal or
cancellation of any approval for the Product by a Competent Authority, (ii)
caused 

 17
 

 

by actions of Third
Parties occurring after such Product is sold by Distributor, (iii) due to
packaging or labeling defects for which Supplier has responsibility or (iv) due
to any breach by Supplier of its duties under this Agreement or Applicable
Laws.

6.4.         If
Supplier is responsible for bearing the costs of a recall, Supplier will
reimburse Distributor for all its reasonable costs and expenses of such recall.

6.5.         If
Distributor is responsible for bearing the costs of a recall, Distributor will
reimburse Supplier for all its reasonable costs and expenses of such recall and
Distributor shall be entitled but not obliged to take over and perform the
recall of the Product and Supplier shall provide Distributor, at Distributor’s
expense, with all such reasonable assistance as may be required by Distributor.

6.6.         Each
Party shall keep the other and the Joint Transition Team fully and promptly
informed of any notification, event or other information, whether received
directly or indirectly, which might result in a recall of Product.

6.7.         Distributor
shall have no obligations pursuant to this Agreement to re-supply the Product
subject to such recall in the Territory in which such recall takes place.

CLAUSE 7   CONFIDENTIALITY

7.1.         The
Parties shall continue to hold in the strictest confidence all Confidential
Information previously provided by the other Party to support such Party’s
obligations hereunder.

7.2.         Each
of the Parties undertakes and agrees:

7.2.1                             only
to use the Confidential Information received from the other Party for the
purposes set forth in this Agreement and not to use the same for any other
purpose whatsoever;

7.2.2                             to
ensure that only those of its officers and employees who are directly concerned
with the carrying out of this Agreement have access to the Confidential
Information received from the other Party on a reasonably applied “need to know”
basis and are informed of the secret and confidential nature of it; and

7.2.3                             to
keep the Confidential Information of/received from the other Party secret and
confidential and not directly or indirectly to disclose or permit to be
disclosed, make available or permit to be made available the same to any Third
Party for any reason without the prior written consent of the disclosing Party;

unless such
Confidential Information (i) is or becomes generally available to the
public without breach of the commitment provided for in this Clause 7;
(ii) at the time of disclosure is already in the receiving Party’s possession
other than, directly or indirectly, from the disclosing Party or any of its
Affiliates, which the receiving Party can show, through written records, was
created prior to the disclosure of the Confidential Information hereunder; or
(iii) is required to be disclosed by law, order or regulation of a
relevant Competent Authority; provided, however, in the case of 

 18
 

 

 

clause
(iii), the receiving Party shall notify the other Party as early as
practicable prior to disclosure to allow the other Party to take appropriate
measures to preserve the confidentiality of such information, and shall in any
event seek and secure confidential treatment for any such Confidential
Information it shall determine in its reasonable business judgment must be and
is disclosed to such Competent Authority, to the fullest extent permitted under
Applicable Law.

7.3.         This
continuing covenant of confidentiality set forth in this Clause 7 shall survive
the termination or expiration of this Agreement.

7.4.         All
Confidential Information disclosed hereunder shall remain the property of the
disclosing Party, and/or its Affiliate(s), as the case may be. The Parties
understand and agree that remedies in damages may be inadequate to protect
against any breach of any of the provisions of this Clause 7 by either
Party or their employees, officers or any other Person acting in concert with
it or on its behalf. Accordingly, each Party may be entitled to seek the
granting of interim and final injunctive relief by a court of competent
jurisdiction in the discretion of that court against any action that
constitutes any breach of this Clause 7.

7.5.         Except
as contained within the records and books of accounts maintained pursuant
Clause 2.5.4 or as otherwise required by Applicable Laws, each Party shall
deliver all of the Confidential Information (including all reproductions
thereof) belonging to the other Party to such other Party within ninety (90)
days after the Closing Date.

CLAUSE 8   WARRANTIES
AND INDEMNITIES

8.1.         Distributor
warrants that at the time Product leaves Distributor’s Plant, all Unfinished
Product packaged into Product by Distributor under this Agreement shall in all
material respects conform to the packaging and testing Specifications and shall
be packaged and tested in accordance with the Technical Agreement and the
Packaging and Testing Instructions. The foregoing warranty is exclusive, and so
far as is permissible in law is given in lieu of all other warranties (whether
written, oral or implied) including a warranty of merchantability on other
respects than expressly set forth in the preceding sentence and a warranty of
fitness for a particular purpose.

8.2.         Supplier
warrants and agrees that (a) it shall comply in all material respects with any
Applicable Laws regarding the marketing, sale, packaging, storage, shipment or
handling of Products, and (b) it has or will obtain prior to the expiration of
the Transition Period, and will maintain, all permits and licenses required to
perform manufacturing, packaging, testing, distribution, advertising and
promotion of Product under this Agreement.

8.3.         Distributor
warrants and agrees that until the Country Handover Date for a particular
country or Closing Date (whichever occurs first) it shall comply in all
material respects with any Applicable Laws pertaining to the packaging,
storage, shipment, or distribution of Products in the Territory.

8.4.         Distributor
shall be liable for and hereby undertakes to indemnify and hold harmless
Supplier against any Losses arising from (i) material breach by
Distributor or its Affiliates of the terms of this Agreement, of any
representations or warranties made 

 19
 

 

 

to Supplier, or
(ii) Distributor’s (or it’s Affiliate’s) negligence or willful misconduct,
except to the extent that such Losses arise as a consequence of any act,
default or negligence of Supplier, its Afftliates or Designees.

8.5.         Supplier
shall be liable for and hereby undertakes to indemnify and hold harmless
Distributor and its Affiliates against any Losses (including death) arising
from or in connection with (i) the manufacture of Product, arising from or
in connection with a deviation from the Product Specifications or cGMP, or
otherwise involving product liability; or (ii) Supplier’s (its Affiliate’s
or its Designee’s) distribution, marketing, promotion or sale of the Product;
or (iii) material breach by Supplier or by its Designee of the terms of
this Agreement, of any representations or warranties made to Distributor, or of
any Marketing Authorization held by Supplier or its Affiliate pursuant to which
Distributor packages and tests the Product for Supplier, or (iv) Supplier’s
(or it’s Affiliate’s or Designee’s) negligence or willful misconduct, except to
the extent that such Losses arise as a consequence of any act, default or
negligence of Distributor or its Afftliates.

8.6.         Each
Party shall take all reasonable steps to mitigate any Losses upon becoming
aware of any event which would reasonably be expected to give rise thereto and
shall be responsible for its own negligence or willful misconduct.

8.7.         Conditions
to Indemnification.   The obligations of the indemnifying Party under
this Agreement are conditioned upon the delivery of written notice to the
indemnifying Party of any claim (a “Claim”) as soon as reasonably
practical after it becomes aware of such Claim.

8.8.         Supplier
shall obtain and maintain in full force and effect the coverage for product
liability for the Product under its current insurance policies for up to € 1,000,000
per occurrence and per year, or else will obtain, prior to the lapse of any
such policy and upon written notice to Distributor, substantially similar
coverage with insurers that are reputable and financially sound or through
reasonably funded self insurance.

8.9.         The
liability of Distributor for any Claims arising out of or related to this
Agreement, regardless of the form of action and the Person or entity bringing
such action, shall not exceed, in the aggregate, the total aggregate amount of
Distributor’s Distribution Fees and Transfer Costs obtained hereunder during
the Term.

8.10.        The
Party seeking an indemnity shall:

8.10.1          fully and promptly
notify the other Party of any Claim or proceedings, or threatened Claim or
proceedings;

8.10.2          co-operate in the
investigation and defence of such Claim or proceedings; and

8.10.3          permit the indemnifying
Party to take full control of such Claim or proceedings, with counsel of the
indemnifying Party’s choice, provided that the indemnifying Party shall
reasonably and regularly consult with the indemnified Party in relation to the
progress and status of such claim or proceedings, provided, however, the
indemnifying Party shall not acknowledge the validity of, compromise, or
otherwise settle any Claim 

 20
 

 

 

without the prior
written consent of the other Party, which said consent shall not be
unreasonably held; in all circumstances, it shall be deemed reasonable for the
indemnified Party to withhold consent with respect to any settlement or
compromise which does not release the indemnified Party from all liability or
which involves an admission of liability of the part of the indemnified Party.

CLAUSE 9   INTELLECTUAL
PROPERTY

To the extent it becomes necessary that any
Intellectual Property owned by Supplier or its Affiliates or licensed to
Supplier or its Affiliates is required for Distributor to perform its
obligations under this Agreement, Supplier hereby grants, to the extent
necessary, to Distributor a royalty-free, non-exclusive license to use and
employ any such Intellectual Property related to the Product in the Territory
for the Term and for the purposes specified herein and Distributor in turn
agrees to comply (to the extent it is reasonably able to do so) with such terms
and conditions of any such license as are notified in writing to it by
Supplier.

CLAUSE 10   TERM
AND TERMINATION

10.1.                This Agreement shall
become effective as of June 1, 2006 (“Effective Date”) and shall continue
in full force until the Closing Date or, with respect to a particular country
within the Territory, the Country Handover Date therefor, as the case may be,
in accordance with Clauses 3.2 and 3.5 above, unless terminated sooner as
provided in Clause 10.2 below (the “Term”).

10.2.                Either Party may
terminate this Agreement upon written notice to the other Party in the event of
any of the following:

10.2.1          An assignment by the
other Party for the benefit of creditors; or

10.2.2          The admitted insolvency
of the other Party; or

10.2.3          The institution of
voluntary or involuntary proceedings by or against the other Party in
bankruptcy, insolvency, or moratorium or for a receivership, or for a
winding-up or for the dissolution or reorganization of the other Party.

CLAUSE 11   CONSEQUENCES
OF TERMINATION

11.1.                Upon termination
or expiration of this Agreement in its entirety, Distributor shall immediately
cease all packaging, testing, and distribution of the Product for all countries
in the Territory.

11.2.                Upon termination
or expiration of this Agreement as to any particular country in the Territory,
Distributor shall immediately cease all distribution of Product for that particular
country. Subject to Clause 4.6 above, and in Distributor’s sole
discretion, 

 21
 

 

 

Distributor may
package and test product in accordance with the terms herein in order to assist
Supplier in stock build of Product or for eventual distribution by Supplier (or
Supplier’s nominated Third Party). Upon Closing, Distributor shall have no
further obligation whatsoever hereunder, in any country of the Territory,
regarding packaging, testing, or distribution of Product.

11.3.                Termination upon
Closing shall be deemed to constitute a termination by mutual agreement and
shall not be deemed a termination for default. Neither Party shall be liable to
the other for damages, indemnity, or compensation solely on account of
termination or expiration of this Agreement, as provided herein, whether such
damages, indemnity or compensation might be claimed for loss through
commitments on obligations or leases, loss of investment, loss of present or
prospective profits, loss of goodwill, or any other loss caused by termination
or expiration of this Agreement as provided herein.

11.4.                Supplier shall
repurchase from Distributor all quantities of Product Packaging Material and
Inventory in accordance with Clause 3.9 above.

11.5.                Upon termination
or expiration of this Agreement as to any particular country in the Territory,
Distributor shall discontinue forthwith use of the Trademark in such country.

11.6.                Upon Closing,
Distributor shall provide Supplier such regulatory documents, data pertaining
to adverse events for the Product and other relevant documentation pertaining
to the Product in Distributor’s or its Affiliate’s possession or control.

11.7.                Survival.   In
addition to the right to receive payments and any clause which by its express
term survives termination or expiration, the respective rights and obligations
of the Parties under the provisions of Clause 1, Clause 2.5.4,
Clause 3.10, Clauses 6.2-6.7, Clause 7, Clauses 8.4-8.10,
and Clause 12 shall also survive any termination or expiration of this
Agreement.

CLAUSE 12   OTHER
PROVISIONS

12.1.                Governing Law;
Resolution of Disputes.   All incidents of this Agreement shall be
interpreted, construed and governed under and in accordance with the applicable
laws of the State of New York. Any dispute, controversy or claim arising out of
or relating to this Agreement or the breach thereof shall be submitted to the
exclusive jurisdiction of the state and Federal courts within New York City,
New York.

12.2.                Entire
Agreement.   The body of this Agreement together with the attached
Schedules and Exhibits contains the entire understanding between the Parties
and supersedes and cancels any and all agreements, understandings,
arrangements, promises, representations, warranties and contracts, whether
written or oral, previously made or entered into of any form or nature with
respect to the subject matter hereof, including the Distribution Agreement
(except those provisions therein that were expressly intended to survive the
termination thereof). No change, alteration or modification hereof may be made
except in writing signed by both Parties.

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12.3.                Force Majeure.

12.3.1          If either Party is
affected by Force Majeure it shall promptly notify the other Party of the
nature and extent of such Force Majeure.

12.3.2          Neither Party shall be
deemed to be in breach of this Agreement by reason of any delay in performance
or non-performance of any of its obligations under this Agreement to the extent
that such delay or non-performance is due to any Force Majeure notified to the
other Party, and the time for performance of that obligation shall be extended
accordingly.

12.3.3          If the Force Majeure in
question prevails for a continuous period in excess of three (3) months, the
Parties shall enter into discussions in good faith with a view to alleviating
its effects, or to agreeing upon such alternative arrangements as may be fair
and reasonable.

12.4.                Notices.   All
notices, requests, demands and other communications hereunder shall be in
writing and shall be deemed to have been duly given if (i) delivered
personally, on the date of such delivery, (ii) mailed by reputable
overnight courier, on the first Business Day following the date of such
mailing, (iii) mailed by certified mail (return receipt requested), on the
third Business Day after the date of such mailing, or (iv) sent by
telecopier (confirmed thereafter by such certified mail), on the date of such
delivery, each to the other Party at the following address (or at such other
address as shall be given in writing by either Party to the other in accordance
with these provisions):

(a)             If to Supplier, to:

SuperGen, Inc.

4140 Dublin Blvd.

Dublin, California 94568

USA

Attention: Legal Department

Fax: +925-551-6483

(b)            If to Distributor to:

Wyeth Lederle Spa

XV Strada,

Zone Industriale,

95030 Catania,

Sicily.

Attention: Wyeth Pharmaceuticals Production Director

Fax No.: +39-095-59-8254

With a required copy to:

Wyeth
Europa

Vanwall Road

Maidenhead

Berkshire SL6 4UB

UK

Attention: Chief Legal Counsel EMEA

Fax No.: +44-1628-692-522

 23
 

 

 

12.5.                No Agencv.   Each
Party shall be acting as an independent contractor and nothing in this
Agreement shall create or be deemed to create any relationship of agency,
employment, partnership or joint venture between the Parties. Neither Party
shall hold itself out as an agent or representative of the other Party and
shall not give warranties, enter into contracts or otherwise incur, assume or
create liabilities in the name of the other Party.

12.6.                Assignment.   This
Agreement shall be binding upon and inure to the benefit of the Parties hereto
and their respective successors and permitted assigns. Neither Party may assign
this Agreement without the prior written consent of the other Party, which
consent shall not be unreasonably withheld; provided, however, a Party shall
have the right to assign and otherwise transfer this Agreement as a whole
without consent to any success or that acquires all or substantially all of the
business or assets of such Party related to this Agreement by way of merger,
consolidation, other business reorganization, or the sale of stock or assets,
provided that the assigning Party notifies the other Party in writing of such
assignment and the successor agrees in writing to be bound by the terms and
conditions of this Agreement.

12.7.                No Third Party
Beneficiaries.   This Agreement shall be binding upon and inure solely
to the benefit of the Parties and their permitted assigns and nothing herein,
express or implied, is intended to or shall confer upon any other Person any
legal or equitable right, benefit or remedy of any nature whatsoever.

12.8.                English
Language.   The Parties acknowledge and agree that this Agreement has
been drafted in the English language which shall prevail over any translation
which may be made by either Party for any purpose whatsoever, including but not
limited to, the purpose of complying with local laws and regulations.

12.9.                Severability.   If
any term or other provision of this Agreement is invalid, illegal or incapable
of being enforced by any Applicable Law or public policy, all other terms and
provisions of this Agreement shall nevertheless remain in full force and effect
for so long as the economic or legal substance of the transactions contemplated
by this Agreement is not affected in any manner materially adverse to either
Party. Upon such determination that any term or other provision is invalid,
illegal or incapable of being enforced, the Parties shall negotiate in good
faith to modify this Agreement so as to effect the original intent of the
Parties as closely as possible in an acceptable manner in order that the
transactions contemplated by this Agreement are consummated as originally
contemplated to the greatest extent possible.

12.10.          Counterparts.   This
Agreement may be executed and delivered (including by facsimile transmission)
in one or more counterparts, and by each Party in separate counterparts, each
of which when executed shall be deemed to be an original, but all of which
taken together shall constitute one and the same agreement. Delivery of an
executed counterpart of a signature page to this Agreement by facsimile shall
be effective as delivery of a manually executed counterpart of this Agreement.

12.11.          Waiver.   The
failure of either Party to enforce at any time for any period the provisions of
or any rights deriving from this Agreement shall not be construed to be 

 24
 

 

 

a waiver of such
provisions or rights or the right of such Party thereafter to enforce such provisions.

12.12.          Headings.   The
descriptive headings contained in this Agreement are for convenience of
reference only and shall not affect in any way the meaning or interpretation of
the Agreement.

[The remainder of this
page left blank intentionally; signature page follows.]

 25
 

 

 

IN WITNESS WHEREOF this agreement has been signed on
behalf of the Parties hereto the day and year first above written.

	
  WYETH

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Paul J. Jones

  	
   

  
	
   

  	
  Name:  Paul J. Jones

  	
   

  
	
   

  	
  Title:    Vice President

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  SUPERGEN

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ James S. Manuso, Ph.D.

  	
   

  
	
   

  	
  Name:  James S. Manuso, Ph.D.

  	
   

  
	
   

  	
  Title:    President & Chief
  Executive Officer

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  WYETH
  HOLDINGS CORPORATION

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Jack M. O’Connor

  	
   

  
	
   

  	
  Name:  Jack M. O’Connor

  	
   

  
	
   

  	
  Title:    Vice President

  	
   

  

 

 26Exhibit 10.2

Portions
of this agreement, marked by asterisks (***), have been omitted pursuant to a
request for confidential treatment.  The
omitted information has been filed separately with the Securities and Exchange
Commission.

CLINICAL
STUDY AGREEMENT

LIPID SCIENCES PROTOCOL LS-081

This agreement is made
effective as of the 15th day of May, 2006 (“Effective Date”), between MedStar
Research Institute, with its principal offices located at 6495 New Hampshire
Avenue, Suite 201, Hyattsville, MD 20783, USA, Washington Hospital Center
located at 110 Irving St, NW, Washington, DC 20010 both affiliates of Medstar
Health hereinafter referred to as (“Medstar”) and Lipid Sciences, Inc. (“Sponsor”),
with its principal offices located at 7068 Koll Center Parkway, Suite 401,
Pleasanton, CA 94566.

Whereas,
Sponsor desires for Medstar to assist it in conducting clinical research
pursuant to the LS-011 Study designated below (“Study”); and

Whereas,
Medstar has the facilities and the personnel with the required skills, experience
and knowledge to undertake the Study;

Therefore,
in consideration of the foregoing and the covenants contained herein, the
receipt and adequacy of which is hereby acknowledged, the parties hereto agree
as follows:

1.             Scope
of Work and Principal Investigator,

1.1           The
Study shall be performed in accordance with the Protocol entitled “A
Randomized, Single-Blind, Placebo-Controlled Study to Evaluate the Safety of
the Lipid Sciences PDS-2 in Subjects with Prior Acute Coronary Syndrome
(LS-001)” (“Protocol”, Exhibit A) and this Clinical Study Agreement (“Agreement”),
copies of which have been provided to Medstar.. Any changes, amendments or
modifications to the Protocol or, the Agreement must be authorized in writing
by all parties. The Study will be conducted in full compliance with this
Agreement, and in accordance with the Protocol, any Agreement or Protocol
amendments, any conditions set forth by the reviewing Institutional Review
Board, Ethics Committee, or equivalent, and all applicable laws and regulations,
including but not limited to, the requirements of 21 C.F.R Part 312.

1.2           Medstar
agrees to appoint Ron Waksman, M.D., as Principal Investigator under this
Agreement. In the event the Principal Investigator shall be unable to complete
this clinical Study and Medstar and Sponsor shall be unable to mutually agree
to a substitute investigator within a period of fifteen (15) days, this
Agreement shall be immediately terminated at the discretion of Sponsor.

1.3           Medstar
certifies that neither Principal Investigator, nor any of Medstar’s officers,
employees or affiliated companies providing services to Sponsor under this
Agreement, have been debarred, nor have they been engaged in any acts which may
result in debarment as specified by the Genetic Drug Enforcement Act, codified
at 21 U.S.C. 306.

 

1.4           Medstar
shall contract with Kristen Alcorn, MD, Medical Director Transfusion Services,
Washington Hospital Center, to oversee the plasma pheresis portion of the
delipidation procedures as outlined in the Protocol.

2.             Consideration.  Sponsor will provide Study Device, support by
Sponsor’s personnel, materials and supplies required to carry out the Study to
Medstar at no charge to Medstar. Medstar shall provide access to Medstar’s
facilities to Sponsor’s personnel as required to carry out the Study at no
charge to Sponsor. Sponsor will compensate Medstar per Exhibit B and B I
attached. Medstar shall invoice Sponsor on a monthly basis for any billable
activity incurred in the previous month no later than twenty (20) days
following the end of each calendar month to the attention of Sandra Gardiner at
the address, or facsimile number, indicated in Section 13.1.

3.             Term
and Termination.

3.1           Term
of Agreement. The term of this Agreement shall commence on the Effective
Date and, unless terminated sooner pursuant to the provisions of Section 3.2,
will expire upon completion of the Study.

3.2           Termination
of Agreement. This Agreement may be terminated as follows:

3.2.1        Sponsor
may terminate this Agreement by providing at least thirty (30) days prior
written notice to Medstar thereof; or

3.2.2        If
one of the parties believes that another party has breached a material term of
this Agreement, that party may provide written notice to the breaching party,
with a copy to all other parties, describing the alleged Breach in reasonable
detail and containing a reference to this section. If the breaching party does
not cure the breach within thirty (30) days after receiving the notice of
breach, the party who gave the notice may immediately terminate this Agreement
for cause by providing written notice to the other parties.

3.3           Survival.  Any provision of this Agreement that imposes
or contemplates continuing obligations on a party will survive the expiration
or termination of this Agreement, including but not limited to sections 2, 4,
5, 6, 7, 8, 9 and 12.3.

4.             Independent
Contractor Status.  The relationships
of Medstar and Sponsor shall be solely that of independent contractors. Medstar
and Sponsor agree that neither Medstar nor Sponsor is an employee, employer,
agent, partner or joint venture of another party. Neither Medstar nor Sponsor
shall have or hold itself out as having the right or authority to assume or
create any obligations or responsibility, whether express or implied, an behalf
of or in the name of another party, except with the express written authority
of that party.

5.             Employees.  All employees of the Medstar or any other
person or organization appointed by Medstar in the performance of this
Agreement shall be considered employees of Medstar or such other person or
organization, as the case may be, and not employees of 

 

Sponsor.  Medstar shall be responsible for paying their
employees any and all wages and other compensation and for all employment taxes
and other employment related obligations arising in connection with those
employees.

6.             Usage,
and Ownership of Property.

6.1           Data
and Research Results Produced Under the Study.  The data and research results produced as a
result of the Study are the sole property of Sponsor.

6.2           Patents
and Inventions.  Sponsor shall own
all right, title and interest in and to any and all inventions, discoveries, or
innovations, whether or not patentable, arising directly or indirectly in the
performance of the Protocol (collectively “Inventions”). Medstar shall promptly
notify Sponsor in writing of any Inventions, and at Sponsor’s request and
expense, Medstar will cause to be assigned to Sponsor all right, title, and
interest in and to any Inventions and shall provide reasonable assistance to obtain
patents including causing the execution of any invention assignment or other
documents.

7.             Trademarks.
Logos, Etc.  Neither party shall,
without the prior written consent of the other party in each instance, use in
any manner whatsoever, including, without limitations, in any advertisement,
the name, trademarks, logos, symbols, or other images of the other party or of
any party affiliated therewith.

8.             Confidentiality.

8.1           Confidential
Information.  During the course of
the performance of this Agreement, it is anticipated that the parties will
exchange Confidential Information. “Confidential Information” means
confidential or proprietary information that is in tangible form and marked or
designated in writing to indicate its confidential or proprietary nature, or,
if disclosed orally, is confirmed as confidential in writing within thirty (30)
days of such disclosure. Each party receiving Confidential Information agrees
to limit disclosure of the furnishing party’s Confidential Information to
personnel having a need to know the information for the purposes of this
Agreement, and not to disclose any such Confidential Information to any third
party unless such third party is under a confidentiality agreement with the
receiving party or unless such disclosure is required by law. These obligations
will continue for five (5) years after the expiration or termination of this
Agreement. For the avoidance of doubt, as between the parties to this Agreement
all patient medical records are Medstar’s Confidential Information regardless
of whether or how they are marked.

8.2           Information
Not Deemed Confidential Information. 
Confidential Information received from the other party shall not be
deemed Confidential Information, and the receiving party will have no
obligation with respect to such Confidential Information if:

 

8.2.1        the
Confidential Information is part of the public domain as of the Effective Date,
or subsequently becomes part of the public domain through no fault of the
receiving party;

8.2.2        the
receiving party can show that the Confidential Information was rightfully in
its possession without obligation of confidentiality, as evidenced by written
records or by the proof of actual use at the time of executing this Agreement;

8.2.3        the
Confidential Information is subsequently disclosed to the receiving party
without obligation of confidentiality by a third party not in violation of any
right of, or obligation to, the other party to this Agreement;

8.2.4        the
Confidential Information is developed independently by any recipients without
reference to the Confidential Information; or

8.2.5        the
receiving party is obligated to produce the Confidential Information pursuant
to an order of a court of competent jurisdiction or a facially valid
administrative, Congressional or other subpoena, provided that the recipient is
subject to the order of the subpoena.

8.3           Patient
Confidentiality.  Patient
information, including identity, shall be treated confidentially by all parties
in accordance with all applicable federal, state, and local laws including, but
not limited to, the Standards for Individually Identifiable Health Information,
45 C.F.R. Parts 160 and 164 (the “HIPAA Privacy Regulation”).

9.             Publication
and Data.

9.1           Publication;
Presentation and Use of Material. 
Medstar has the right to publish and make public presentations regarding
the results of the research, and other information from the Study or otherwise
make results of the research available to the public in furtherance of its
charitable and educational purposes in accordance with this Agreement.
Publication will occur as promptly as reasonably possible and not less than
twenty-four (24) months after the conclusion of the Study. If Medstar desires
to present or publish materials relating to the Study, Medstar will provide
Sponsor with two (2) copies of any such publications or presentation materials
at least sixty (60) calendar days prior to the submission of manuscripts.
Sponsor will have sixty (60) calendar days from the receipt of such materials
to object in writing to publication or presentation of any materials that
Sponsor believes to contain Confidential Information. If Medstar receives no
response from Sponsor within such sixty (60) day period, Medstar will be free
to proceed with publication or presentation of the data, results, or
information from the Study. If the Sponsor raises an objection that the
materials disclose Confidential Information, Medstar shall refrain from the
disclosure of the Confidential Information identified by Sponsor in the
materials unless the parties agree on a mutually acceptable format for
publishing or presenting such Confidential 

 

Information.
Sponsor agrees that it may only object to such publication or dissemination by
Medstar on the basis of potential disclosure of Sponsor’s Confidential
Information.

9.2           Publishing
Rights.  Medstar retains all rights
to the publications and other copyrightable material that it produces pursuant
to Paragraph 9.1. Sponsor agrees that said copyrightable material is the sole
property of Medstar and hereby assigns and agrees to assign to Medstar, its
successors, and assigns any right, title and interest in and to said
copyrightable material Sponsor may have.

9.3           Continuing
Copyright Requirement.  This Article
shall survive termination or expiration of this Agreement.

10.           Indemnification

10.1         Indemnification
of Sponsor.  Medstar agrees to
indemnify, defend and hold harmless Sponsor, its directors, officers,
employees, representatives and agents from and against any and all third party
claims, suits, losses, damages, costs, fees and expenses (including reasonable
attorney’s fees), and other liabilities asserted by third parties arising out
of or related to this Agreement to the extent based upon: (i) any material
misrepresentation contained in or breach of any warranty made by Medstar under
this Agreement or (ii) any material breach, violations or nonperformance of any
covenant, condition or agreement in this Agreement by Medstar.

10.2         Indemnification
of Medstar.  Sponsor shall, at its
own expense, indemnify, defend and hold harmless Medstar and their
investigators, directors, officers, employees, representatives, agents and
affiliates, including without limitation any employee conducting the Study,
from and against any and all third party claims, suits, losses, damages, costs,
fines, fees and expenses (including reasonable attorneys’ fees) arising out of
or related to this Agreement (except to the extent covered by this Section
10.2) including without limitation, for injury to persons, damage to property,
or non-compliance with applicable laws and regulations whether litigated or
not, arising from the negligent or wrongful acts or omissions of Sponsor, its
agents or employees in the design, development, marketing, distribution, use or
sale of any product or services derived from or embodying the Study (including
the Protocol) or which is otherwise the subject of this Agreement. Sponsor
shall also, at its own expense, indemnify, defend and hold harmless Medstar and
their investigators, directors, officers, employees, representatives, agents
and affiliates including any employee conducting the Study from any and all
third party claims, suits, losses, damages, costs, fines, fees and expenses
(including reasonable attorney’s fees) arising out of the acts of the sponsor’s
employees participating in the Study at Medstar.

10.3         Sponsor
will be responsible for reasonable patient medical care costs that are a direct
result of a patient’s participation in this Study but are not covered by third
party payors and are not the result of negligence, failure to follow the
Protocol or 

 

IRB requirements
or applicable laws or regulations, or any reckless or willful malfeasance by
Medstar or its employees, agents, officers, or assignees.

10.4         Insurance
Requirements. Sponsor shall, at its own expense, carry and maintain
professional and general liability insurance from a carrier acceptable to
Medstar in amounts consistent with industry standards and adequate to protect
the Medstar, and the Sponsor from any and all claims of any nature for damage
to property or for personal injury, including death, which may arise from
performance of this Agreement and from claims which may arise pursuant to
Section 10.2 above. Sponsor shall provide evidence of insurance to Medstar
promptly upon execution of this Agreement.

11.           Inspections.

11.1         Inspections
by Sponsor.  Sponsor, its agents or
representatives, shall provide, during Medstar’s regular hours of business and
after reasonable prior notice to Medstar, reasonable scheduled access to
Medstar’s facility to perform quality assurance inspections at mutually
convenient times. Medstar shall cooperate with Sponsor’s inspectors and shall
provide Sponsor with copies of all documents reasonably required by Sponsor to
properly perform such inspections so long as Sponsor can assure patient
confidentiality.

11.2         Inspections
by Regulatory Authorities.  Medstar
shall notify Sponsor, as soon as reasonably practicable, of all inspections or
anticipated inspections of its facility conducted by any regulatory authority,
including, without limitation, the Food and Drug Administration, that in any
way directly relates to the Study. Medstar shall promptly provide copies of all
reports, emotions, violations, warnings, and notices of deficiency received by
Medstar with such inspections.

12.           Record
Keeping and Reporting

12.1         Medstar
shall report to Sponsor any Serious or Unexpected Adverse Event, as those terms
are defined at 21 C.F.R. 312.32(a), as required by the Protocol, by using the
appropriate Case Report Form within twenty-four (24) hours after Medstar or
Principal Investigator receives information about the event. All other Adverse
Events shall be timely reported to Sponsor as required by Protocol.

12.2         Medstar
shall maintain all records required to be maintained under federal, state or
local laws, including, but not limited to, case report forms, informed consent
forms, drug accountability records, source documents, data correction forms,
monitoring logs, correspondence, clinical supplies receipts, dispensing and final
disposition records, Medstar Review Board/Ethics Review Committee
correspondence and appropriate, and all other Study documents. Medstar shall
ensure that Principal Investigator signs a statement in each subject’s case
report form attesting to Principal Investigator’s review of the data, and
attesting that the data are an accurate accounting of the treatment, care, and
events surrounding the subject’s involvement in the Study.

 

 

Sections of this agreement marked by
asterisks (***) have been omitted pursuant to a request for confidential
treatment.  The omitted information has
been filed separately with the Securities and Exchange Commission.

12.3         Medstar
shall retain records for the Study produced pursuant to the Agreement for a
minimum of five (5) years following completion of the Study. To avoid any
possible errors, Medstar agrees to obtain the approval of Sponsor prior to the
destruction of any Study-related records. If Sponsor wishes to receive all
Study records in lieu of their destruction, Medstar shall, at the expense of
the Sponsor, ship all Study records to Sponsor within (30) days of Sponsor
request. In the event of accidental loss or destruction of any Study record, to
promptly notify Sponsor. This provision shall survive the expiration or
termination of this Agreement.

13.           Miscellaneous.

13.1         Notices.  All notices, requests, demands, and other
communications required or permitted to be given hereunder shall be in writing,
shall be deemed to have been duly given when delivered in person, or when sent
by telex, or telecopy, or other facsimile transmission (with the receipt
confirmed), or on the third business day after posting thereof by registered or
certified mail, return receipt requested, prepaid and addressed as follows (or
other such address site the parties may designate by written notice in the
manner aforesaid):

	
  In the case of Medstar:

  	
  In the case of Sponsor:

  
	
   

  	
   

  
	
  MedStar Research
  Institute

  6495 New Hampshire Avenue,

  Suite 201

  Hyattsville, MD 20783

  	
  Lipid Sciences, Inc.

  7068 Koll Center Parkway, Suite 401

  Pleasanton, CA 94566

  Attn: Lew Meyer

  
	
  Attn:

  	
  ***

  	
  Fax:  (925)
  249-4040

  
	
  Fax:

  	
  ***

  	
   

  
	
   

  	
   

  
	
  with a copy to:

  	
  with a copy to:

  
	
   

  	
   

  
	
  Cardiovascular Research
  Institute

  110 Irving Street, NW, Suite 4B1

  Washington, D.C. 20010

  Attn: Ron Waksman, M.D.

  	
  Lipid Sciences, Inc.

  7068 Koll Center Parkway, Suite 401

  Pleasanton, CA 94566

  Attn: Sandra Gardiner

  
	
  Fax:

  	
  ***

  	
  Fax:  (925)
  249-4080

  

13.2         Governing
Law. This Agreement shall be construed and enforced in all respects in
accordance with the laws of the District of Columbia, without regard to any
provision of District of Columbia law that would require or permit the
application of the substantive law of any other jurisdiction.

 

13.3         Non-Assignment.
This Agreement may not be assigned by either party without the prior written
consent of the other party, except in the case of an acquisition of at least
fifty one percent (51%) outstanding shares of either party (“Acquisition”). In
the case of an Acquisition, the party being acquired may assign this Agreement
without the prior written consent of the other party, provided the party being
acquired notifies the other party in writing.

13.4         Entire
Agreement.  This Agreement sets forth
the entire understanding of the parties with respect to the subject matter of
this Agreement. This Agreement supersedes all prior representations,
agreements, and understanding among the parties with respect to such subject
matter. In the event of any conflict between the Protocol and the other
provisions of this Agreement, the other provisions of this Agreement shall
govern.

The Exhibits referred to
in and attached to this Agreement are made a part of it as if fully included in
the text.

13.5         Amendment.  No changes or amendments or alterations shall
be effective unless in writing and signed by both parties.

13.6         Waiver.  No waiver of any default in the performance
of any of the duties or obligations arising out of this Agreement shall be
valid unless in writing and signed by the waiving party. Waiver of any one
default does not waive any successive or other default. No course of dealing
between the parties shall operate as a waiver or preclude the exercise of any
rights or remedies under this Agreement. Failure on the part of either party to
object to any act or failure to act by or on the part of the other party, or
declare the other party in default, regardless of the extent of such default,
shall not constitute a waiver by the party of its rights hereunder.

13.7         Severability.  The provisions of this Agreement will be
deemed severable, and the enforceability of any one or more provisions will not
affect the enforceability of any other provisions. In addition, if any
provision of this Agreement, for any reason, is declared to be unenforceable,
the parties will substitute an enforceable provision that, to the maximum
extent possible in accordance with applicable law, preserves the original
intentions and economic positions of the parties.

13.8         Construction.  This Agreement shall be interpreted without
any regard to any presumption or rule requiring construction against the party
causing this Agreement to be drafted.

13.9         Counterparts.  This Agreement may be executed in one or more
counterparts, including facsimile counterparts, each of which shall be deemed
an original and all of which together shall constitute one and the same
agreement.

13.10       Captions.  The captions contained in this Agreement are
inserted only as a matter of convenience and in no way define, limit, or extend
the scope or intent of this Agreement or any provision hereof.

 

THIS
SPACE INTENTIONALLY LEFT BLANK

 

IN WITNESS WHEREOF, the parties hereto have executed
this Agreement as of the date first written above.

	
  MedStar Research Institute

  	
  Lipid Sciences, Inc.

  
	
   

  	
   

  	
   

  
	
  By:

  	
  *** 

  	
  By:

  	
    /s/
  S. Lewis Meyer

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  *** 

  	
  Name:

  	
  S. Lewis Meyer

  
	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Sr. VP, Administration

  	
  Title:

  	
  President and CEO

  
	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
  May 24, 2006

  	
  Date:

  	
  May 16, 2006

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Read and Understood

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Ron Waksman, MD

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Name:

  	
  Ron Waksman, MD

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
  Principal Investigator

  	
   

  
	
   

  	
   

  	
   

  
	
  Date:

  	
  May 22, 2006

  	
   

  
						

 

EXHIBIT A

PROTOCOL

***  This
Exhibit has been omitted pursuant to a request for confidential treatment.  The omitted information has been filed
separately with the Securities and Exchange Commission.

 

Portions
of this agreement, marked by asterisks (***), have been omitted pursuant to a
request for confidential treatment.  The
omitted information has been filed separately with the Securities and Exchange
Commission.

EXHIBIT B

BUDGET

1.     The
anticipated budget worksheet is attached as Exhibit B1.

2.     Shipping:

Sponsor authorizes the use of Sponsor’s Federal
Express Number for returning to Sponsor and sites those materials, products,
documentation, etc. as commonly occurs during the conduct of a Study of this
nature.

3.     Payment
Information:

All payments shall be made by Sponsor in US Dollars to
the following fund:

	
  Fund Name:

  	
  MedStar Research Institute

  
	
  Tax ID#:

  	
  ***

  
	
  Mailing Address:

  	
  P.O. Box 632010

  
	
   

  	
  Baltimore, MD 21263

  
	
  Attention:

  	
  CFO

  

4.     Upon
written agreement by both parties, additional items may be added to the budget.

5.     MedStar
shall invoice Sponsor on a monthly basis for any billable patient related
charges incurred in the previous month no later than twenty (20) days following
the end of each calendar month to the attention to Sandra Gardiner at the
address, or facsimile number, indicated in Section 13.1.  Reimbursement for data management and project
management shall be invoiced as follows: 
50% at completion of first patient enrolled and 50% at completion of
last patient enrolled.

6.     ***

 

EXHIBIT B1

BUDGET WORKHEET

***  This Exhibit has been omitted pursuant to a
request for confidential treatment.  The
omitted information has been filed separately with the Securities and Exchange
Commission.

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