Exhibit 10.36


 






*** Indicates confidential material that has been omitted pursuant to a
Confidential Treatment Request filed with the Securities and Exchange
Commission.  A complete copy of this
agreement has been separately filed with the Securities and Exchange
Commission.


 


EXECUTION COPY


 


COMMERCIAL SUPPLY AGREEMENT


 


This Commercial Supply Agreement (this “Agreement”)
is entered into by and between Baxter Oncology GmbH, with an address at
Kantstrasse 2, 33790 Halle / Westphalia, Germany (“BAXTER”) and Poniard
Pharmaceuticals, Inc., a Washington corporation, having offices at 7000
Shoreline Court, Suite 270, South San Francisco, CA 94080 (“PONIARD”).


 


RECITALS


 


	
  1.

  	
  PONIARD is engaged in the development, bulk
  production, formulation, sale and distribution of pharmaceutical products;

  
	
   

  	
   

  
	
  2.

  	
  BAXTER is among other pharmaceutical
  activities engaged in the formulation, filling, inspection, labeling and
  packaging of pharmaceutical products for various pharmaceutical companies
  including competitors of PONIARD and BAXTER;

  
	
   

  	
   

  
	
  3.

  	
  PONIARD and BAXTER desire to have BAXTER
  formulate, fill, inspect, package, label, test, and store pharmaceutical
  products for PONIARD for commercial supply.

  
	
   

  	
   

  
	
  4.

  	
  PONIARD is relying on the experience and
  reputation of BAXTER in being PONIARD’s source for such commercial supply,
  which is of utmost importance to PONIARD and its commercialization of
  products.

  



 


NOW, THEREFORE, in consideration of the mutual covenants and
agreements contained herein, the parties agree as follows:


 


	
  Article 1.

  	
  DEFINITIONS

  



 


As used in
this Agreement, the following words and phrases shall have the following
meanings:


 


	
  1.1

  	
  “Acceleration Fee” shall mean *** (***) Euro per Batch.

  
	
   

  	
   

  
	
  1.2

  	
  “Active
  Pharmaceutical Ingredient”,  “Active” or “API” shall mean Picoplatin, also known
  as NX473.

  
	
   

  	
   

  
	
  1.3

  	
  “Affiliate” with respect to a person shall mean any other
  person that directly, or indirectly through one or more intermediaries,
  controls, is controlled by or is under common control with such person. For
  the purposes of this definition only, “control” and, with correlative
  meanings, the terms “controlled by” and “under common control with”, shall
  mean (a) the possession, directly or indirectly, of the power to direct
  the management or policies of a person, whether through the ownership of
  voting securities, by contract or otherwise, or (b) the ownership,
  directly or indirectly, of at least fifty percent (50%) of the voting
  securities or other ownership interest of a person.

  



 


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  1.4

  	
  “Batch” shall mean a
  specific quantity of a Product comprising a number of Units mutually agreed
  upon between PONIARD and BAXTER, and that (a) is intended to have
  uniform character and quality within specified limits, and (b) is
  Produced according to a single manufacturing order during the same cycle of
  Production.

  
	
   

  	
   

  
	
  1.5

  	
  “BAXTER SOPs” shall mean BAXTER’s Standard Operating
  Procedures, which PONIARD shall have the right to access and inspect during
  annual audits; provided, however, specific BAXTER SOPs can be requested and
  reviewed by PONIARD on an individual basis at any time.

  
	
   

  	
   

  
	
  1.6

  	
  “Competent Authorities” shall mean the United States Food and Drug
  Administration, Health Canada Therapeutic Products Directorate, and the EMEA
  or any successor entity thereto.

  
	
   

  	
   

  
	
  1.7

  	
  “Components” shall mean all components used by BAXTER in
  the Production of Product under this Agreement. Components are listed in the
  Product Master Plan and include Packaging Materials and Raw Materials.

  
	
   

  	
   

  
	
  1.8

  	
  “Component
  Specifications”
  shall mean the specifications and testing to be performed for the Components,
  as set forth in the Product Master Plan.

  
	
   

  	
   

  
	
  1.9

  	
  “Confidential Information” The Confidential Information of each
  respective party is as follows: PONIARD Confidential Information: NX 473
  platinum compound technology, including the following information related to
  NX 473: manufacturing methods and processes, the composition, testing,
  storage and stability of the drug substance and drug product, trade secrets
  and know-how, which includes information, data and strategies relating to
  research and development, preclinical and clinical programs, manufacturing,
  product and business development, financial information, and third-party
  relationships. BAXTER Confidential Information: BAXTER’s contract
  manufacturing operations, technologies, capabilities, systems, equipment,
  procedures, and bid proposals relating to its contract manufacturing, and its
  financial records and other related information. Confidential Information
  does not include information

  
	
   

  	
   

  
	
   

  	
  (a)    that was
  available to the public through no fault of Recipient, or

  
	
   

  	
   

  
	
   

  	
  (b)    Recipient
  already possessed prior to receipt from Discloser, or

  
	
   

  	
   

  
	
   

  	
  (c)    Recipient
  acquired from a third party without obligation of confidence, or

  
	
   

  	
   

  
	
   

  	
  (d)    was
  independently developed by or for Recipient.

  
	
   

  	
   

  
	
  1.10

  	
  “Current Good Manufacturing Practices” or “cGMP” shall
  mean the good manufacturing practices required by the Competent Authorities
  and set forth in the applicable law, policies or guidelines, in effect at any
  time during the term of this Agreement, for the Production and testing of
  pharmaceutical materials as applied solely to Product.

  
	
   

  	
   

  
	
  1.11

  	
  “Data” shall mean analytical validation reports and
  methods, development reports, master batch records, executed master batch
  records, raw material specifications, Active specifications and results of
  any type arising from the

  



 


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  services under this Agreement. For the
  avoidance of doubt, Data does not include BAXTER’s Proprietary Information.

  
	
   

  	
   

  
	
  1.12

  	
  “Delivery Date” shall mean the date that Product is to be
  made available for pick up at BAXTER’s facility by a common carrier
  designated by PONIARD.

  
	
   

  	
   

  
	
  1.13

  	
  “Effective Date” shall mean the date on which the second of
  both parties has duly signed this Agreement.

  
	
   

  	
   

  
	
  1.14

  	
  “FD&C Act” shall mean the
  United States Federal Food and Cosmetic Act, as amended, or any corresponding
  Act in each jurisdiction.

  
	
   

  	
   

  
	
  1.15

  	
  “Intellectual
  Property”
  shall mean ideas, concepts, discoveries, inventions, developments, know-how,
  trade secrets, techniques, methodologies, modifications, innovations,
  improvements, writings, documentation, data, rights or the like, whether or
  not written or otherwise fixed in any form or medium, regardless of the media
  on which contained, and whether or not patentable, copyrightable or otherwise
  protectable under state, federal or foreign patent, trademark, copyright or
  similar laws, and all patents, copyrights and trademarks related thereto.
  BAXTER agrees that PONIARD will retain sole and exclusive rights of ownership
  in and to any PONIARD Confidential Information.

  
	
   

  	
   

  
	
  1.16

  	
  “Master Batch Record” shall mean, with respect to the Presentation
  of Product to be Produced hereunder, a formal set of instructions for the
  Production of the Presentation of such Product.

  
	
   

  	
   

  
	
  1.17

  	
  “NDA” shall mean the FDA-required New Drug
  Application.

  
	
   

  	
   

  
	
  1.18

  	
  “Packaging Materials” as used in this Agreement shall mean any
  material employed in the packaging of the Product, excluding any outer
  packaging used for transportation or shipment. Packaging Materials are
  referred to as primary or secondary according to whether or not they are
  intended to be in direct contact with the Product. All Packaging Materials
  are listed in the Product Master Plan.

  
	
   

  	
   

  
	
  1.19

  	
  “PONIARD Trademarks” shall mean the proprietary mark(s) for
  Product owned by PONIARD as stated in the Product Master Plan.

  
	
   

  	
   

  
	
  1.20

  	
  “Presentation” shall mean the specific formula and
  Components for the Product.

  
	
   

  	
   

  
	
  1.21

  	
  “Process
  Intellectual Property” shall mean any Intellectual Property that constitutes new
  manufacturing technologies, methods, processes or techniques, or improvements
  to existing manufacturing technologies, methods, processes or techniques, and
  that is broadly applicable to pharmaceutical products in general. Process
  Intellectual Property shall not include such Intellectual Property that
  (i) is only applicable to Product or the Active or (ii) requires
  the use of Product or the Active Pharmaceutical Ingredient.

  
	
   

  	
   

  
	
  1.22

  	
  “Produce” or “Production” shall
  mean the formulation, filling, packaging, inspecting, labeling and testing of
  Product by BAXTER.

  
	
   

  	
   

  
	
  1.23

  	
  “Product” shall mean product as specified in the
  Product Master Plan that is to be Produced under this Agreement.

  



 


3

















 


	
  1.24

  	
  “Product Intellectual Property” shall mean any
  Intellectual Property relating to a Product, the Active or their manufacture,
  or arising out of performance of this Agreement or any use of PONIARD’s
  Intellectual Property, the Product or the Active. Product Intellectual
  Property does not include Process Intellectual Property.

  
	
   

  	
   

  
	
  1.25

  	
  “Product Master Plan” shall mean an addendum to this Agreement for
  the Product Produced hereunder, which may include, without limitation, the
  Product, Product Specifications, Components, Component Specifications, Raw
  Materials, Regulatory Authorities, the countries where such Product will be
  sold, Presentations, and pricing for such Product Produced under this
  Agreement as set forth in Section 2.1.

  
	
   

  	
   

  
	
  1.26

  	
  “Product Requirements” shall mean the Product Specifications, and
  cGMPs of those countries as set forth in the Product Master Plan.

  
	
   

  	
   

  
	
  1.27

  	
  “Product Specifications” shall mean, with respect to Product, the
  specifications and testing to be performed for the Raw Materials, the
  Product, and/or the stability program that are set forth in BAXTER’s SOP’s
  and the Master Batch Records. The Product Specifications include all tests
  that BAXTER is required to conduct or cause to be conducted as specified in
  the Product Master Plan. The Product Specifications may be modified from time
  to time only by a written agreement of both PONIARD and BAXTER.

  
	
   

  	
   

  
	
  1.28

  	
  “Purchase Order” shall mean written orders from PONIARD to
  BAXTER which shall specify (a) the quantity of Product ordered,
  (b) shipping instructions (e.g. choice of container, temperature
  requirements), and (c) delivery dates.

  
	
   

  	
   

  
	
  1.29

  	
  “Quality Agreement”
  shall mean an
  addendum to this Agreement under which the Parties allocate and coordinate
  the responsibilities with respect to quality system elements functions as set
  forth in Section 2.2.

  
	
   

  	
   

  
	
  1.30

  	
  “Raw Material” shall mean all
  materials used by BAXTER in the
  Production of Product under this Agreement with the exception of Packaging
  Materials. All Raw Materials are listed in the Product Master Plan.

  
	
   

  	
   

  
	
  1.31

  	
  “Regulatory Approval” shall mean all authorizations by the
  appropriate Regulatory Authority necessary for commercial sale in a
  jurisdiction, including without limitation, approval of labeling and
  Production.

  
	
   

  	
   

  
	
  1.32

  	
  “Regulatory Authority” shall mean those agencies or authorities
  responsible for regulation of the Product in the respective country of
  distribution. BAXTER shall have no obligation to Produce Product in
  compliance with the explicit requirements of a Regulatory Authority not
  specified in the applicable Product Master Plan.

  
	
   

  	
   

  
	
  1.33

  	
  “Released Executed Batch Record” shall mean the completed batch record and
  associated deviation reports, investigation reports, and Certificates of
  Analysis created for each Batch of Product as specified in the Product Master
  Plan.

  



 


4

















 


	
  1.34

  	
  “Reservation Fees” shall be the fees
  payable by PONIARD for modification or cancellation of a Firm Purchase Order
  as set forth in the Product Master Plan.

  
	
   

  	
   

  
	
  1.35

  	
  “Rolling Forecast” shall be defined in Section 4.1.

  
	
   

  	
   

  
	
  1.36

  	
  “Unit” shall mean an individually packaged dose of
  a Product, including by way of example only, vial, as specified in the
  Product Master Plan.

  



 


	
  Article 2.

  	
  PRODUCT MASTER PLAN, QUALITY AGREEMENT

  



 


	
  2.1

  	
  Product Master Plan. For the Product to be Produced by BAXTER
  hereunder, the parties shall agree in writing upon a Product Master Plan. In
  no event shall BAXTER be required to schedule the Production of any Product
  until a Product Master Plan for such Product has been approved in writing by
  both BAXTER and PONIARD.

  
	
   

  	
   

  
	
  2.2

  	
  Quality Agreement. For the Production by BAXTER hereunder, the
  parties shall conclude a Quality Agreement to allocate and coordinate the responsibilities
  of the pharmaceutical quality functions and systems that control and assure
  the Product is Produced in compliance with Regulatory Authority requirements
  and meets the Product Requirements. In no event shall BAXTER be required to
  schedule the Production of any Product until a Quality Agreement has been
  duly signed by both BAXTER and PONIARD.

  
	
   

  	
   

  
	
  2.3

  	
  Amendment of Plans. The Product Master Plan may be amended from
  time to time, as the parties’ experience with the development, Production,
  testing and use of the Product warrants, only upon mutual written agreement
  of PONIARD and BAXTER.

  
	
   

  	
   

  
	
  2.4

  	
  Governing Document. Upon execution of any Quality Agreement or
  Product Master Plan, such Plan / Agreement shall be deemed to be incorporated
  herein and by reference and made an integral part of this Agreement. In case
  of any inconsistencies between this Agreement and the Quality Agreement, the
  Quality Agreement will prevail for matters of quality and Regulatory
  Authority compliance and this Agreement shall prevail for all business,
  legal, or financial issues, unless otherwise explicitly agreed to in writing
  by the Parties.

  
	
   

  	
   

  
	
  2.5

  	
  Effect of Failure to Execute Plans or
  Addendum.
  Neither party shall be obligated under this Agreement with respect to a
  Product if the parties have failed to execute a Quality Agreement and Product
  Master Plan with respect to the Product; provided, however, that PONIARD
  shall reimburse BAXTER for all non-cancelable costs incurred by BAXTER for
  work performed and Components ordered with respect to such Product.

  



 


	
  Article 3.

  	
  PURCHASE AND SUPPLY OF PRODUCT

  



 


	
  3.1

  	
  Agreement to Purchase and Supply. Pursuant to the terms and conditions of this
  Agreement, PONIARD shall purchase from BAXTER the Binding

  



 


5

















 


	
   

  	
  Forecast of Product, and BAXTER shall
  Produce and deliver to PONIARD the Binding Forecast of Product, in accordance
  with and subject to Section 4.2.

  
	
   

  	
   

  
	
  3.2

  	
  Reproduction, Rework or Reprocessing. If during the Production of any Batch of
  Product, any reprocessing, rework, or reproduction is required in order to
  meet the Product Specifications, BAXTER shall conduct such reprocessing,
  rework, or reproduction in compliance with cGMP’s. Any reprocessing, rework,
  reproduction, concerning compounding, aseptic filling, or capping must be
  approved in writing by PONIARD prior to implementation. If such reprocessing,
  rework, or reproduction is requested by PONIARD and not due to the failure of
  BAXTER to Produce according to Product Requirements, PONIARD shall be
  responsible for, and promptly reimburse BAXTER for all costs and expenses
  incurred in connection with such reprocessing, rework, reproduction, or
  change.

  
	
   

  	
   

  
	
  3.3

  	
  Purchase of
  Packaging Materials. BAXTER will purchase the Packaging Materials itemized in the  Product Master Plan and marked “BAXTER”, primary
  container Components and secondary packaging materials, required to Produce
  the Product in sufficient quantity to fulfill PONIARD’s Purchase Order for
  Product.

  
	
   

  	
   

  
	
  3.4

  	
  Components. BAXTER will purchase the Components itemized
  in the Product Master Plan and marked with “BAXTER” in quantities sufficient
  to meet PONIARD’s Purchase Orders for Product consistent with Article 4.
  PONIARD shall supply BAXTER *** with the Components itemized in the Product
  Master Plan and marked with “PONIARD” in quantities sufficient to meet
  PONIARD’s Purchase Orders for Product consistent with Article 4. PONIARD
  is responsible for the timely delivery of all Components including all
  required documents itemized in the Product Master Plan and marked with
  “PONIARD”. The responsibility for vendor / supplier qualification is set
  forth in the Product Master Plan.

  
	
   

  	
   

  
	
  3.5

  	
  Importer of Record. In the event any material or equipment to be
  supplied by PONIARD is imported into Germany for delivery to BAXTER
  (“Imported Goods”), such Imported Goods shall be imported DDP Halle/Künsebeck
  (Incoterms 2000). PONIARD shall be the “Importer of Record” of such Imported
  Goods. As the Importer of Record, PONIARD shall be responsible for all
  aspects of the Imported Goods including, without limitation (a) customs
  and other regulatory clearance of Imported Goods, (b) payment of all
  tariffs, duties, customs, fees, expenses and charges payable in connection
  with the importation and delivery of the Imported Goods, and (c) keeping
  all records, documents, correspondence and tracking information required by
  applicable laws, rules and regulations arising out of or in connection
  with the importation or delivery of the Imported Goods.

  
	
   

  	
   

  
	
  3.6

  	
  Storage

  
	
   

  	
   

  
	
   

  	
  3.6.1

  	
  Product Storage. In no event shall BAXTER be required to
  store Product for more than *** (***) days after the Product release without
  BAXTER’s prior written consent and PONIARD’s agreement to reimburse BAXTER
  for *** costs incurred in connection with such storage as set fort in the
  Product Master Plan.

  



 


6

















 


	
   

  	
  3.6.2

  	
  Third Party
  Storage.
  BAXTER shall be permitted to store Product and Components in third party
  storage facilities, provided that BAXTER provides PONIARD with *** (***) days
  prior notice if such facilities are used; the decision to use such facilities
  shall be at the discretion of BAXTER.

  



 


	
  Article 4.

  	
  FORECASTS, ORDERS, and CAPACITY

  



 


	
  4.1

  	
  Forecasts.  Commencing on the Effective Date of
  this Agreement and prior to *** of each year during the Term, PONIARD will
  provide to BAXTER in writing *** forecast of PONIARD’s estimated *** Product
  requirements for the next *** (***) calendar years (the “Long Range
  Forecast”).  The parties specifically agree that such Long Range
  Forecasts will be for general planning purposes only, and shall not be
  binding on PONIARD or BAXTER.  Commencing on the Effective Date of this
  Agreement and prior to the ***calendar day of each *** thereafter, PONIARD
  will provide BAXTER in writing a *** (***) *** rolling forecast of the
  requested Product amounts to be delivered (the “Rolling Forecast”).  The
  first *** of the Rolling Forecast shall specify quantities required by ***.
  The first *** (***) *** of the Rolling Forecast shall be binding upon both
  parties (the “Binding Forecast”).

  
	
   

  	
   

  
	
  4.2

  	
  Product Orders. During ***, BAXTER shall supply PONIARD with
  the quantity of Product ordered by PONIARD, unless the quantity for ***
  exceeds the greater of either *** or *** (***%) of the total forecasted quantity
  for the *** set forth in the most recent Long Range Forecast (the “Maximum
  Quantity”); in which event BAXTER shall use good faith efforts to supply
  quantities in excess of the Maximum Quantity.  During ***, PONIARD shall
  request product for delivery of not less than either the smaller of *** less
  than or *** (***%) of the total forecasted quantity for the *** set forth in
  the most recent Long Range Forecast (the “Minimum Quantity”).  However,
  in the event that PONIARD requests for delivery are less than the Minimum
  Quantity for the ***, then PONIARD shall pay to BAXTER the difference between
  the Purchase Price of Product actually requested for delivery and the
  Purchase Price of the Minimum Quantity.

  
	
   

  	
   

  
	
  4.3

  	
  Purchase Orders.  PONIARD shall submit Purchase Orders
  to BAXTER for the purchase of Product pursuant to this Agreement. 
  PONIARD shall not, without the written consent of BAXTER, request a delivery
  date in a Purchase Order earlier than *** (***) months from the date PONIARD
  submits the Purchase Order.

  
	
   

  	
   

  
	
   

  	
  BAXTER shall
  provide a confirmation of receipt of each Purchase Order setting forth the
  Delivery Date that BAXTER will meet and setting forth BAXTER’s filling date
  for such order within *** days of receiving the PONIARD Purchase Order. 
  Upon sending of the confirmation, such Purchase Order shall become a “Firm
  Purchase Order.”

  
	
   

  	
   

  
	
   

  	
  If BAXTER is unable to meet the delivery
  date specified by PONIARD, BAXTER shall so notify PONIARD within *** (***)
  days of receiving PONIARD’s Purchase Order and establish an alternative
  Delivery Date, which

  



 


7

















 


	
   

  	
  shall not be more than *** (***) calendar
  days later than the initial delivery date designated by PONIARD in its
  Purchase Order.

  
	
   

  	
   

  
	
   

  	
  In the event that PONIARD modifies or
  cancels a Firm Purchase Order without BAXTER’s written consent, PONIARD shall
  pay the Reservation Fees as set forth in the Product Master Plan.  To
  the extent of any conflict between Purchase Orders submitted by PONIARD and
  this Agreement, this Agreement shall control.

  
	
   

  	
   

  
	
   

  	
  PONIARD shall order full Batches of Product
  on a single Purchase Order.

  
	
   

  	
   

  
	
  4.4

  	
  Component Delivery Delays. BAXTER shall have no responsibility for
  delays in delivery of Product caused by delays in receipt of Components
  supplied by Poniard; provided BAXTER has complied with the vendor purchasing
  requirements and lead times. Timely delivery shall mean that the respective
  Component and the required documents reach BAXTER at least *** (***) working
  days prior to the scheduled manufacturing date of such Product determined by
  the Firm Purchase Order. BAXTER shall notify PONIARD if any BAXTER supplied
  components have not been received at least *** (***) working days prior to
  the scheduled manufacturing date and which will also compromise the scheduled
  manufacturing date. Baxter shall use good faith efforts to reschedule the
  Production of Product as soon as possible. Notwithstanding anything in this
  Agreement to the contrary, in the event that BAXTER receives the API and
  associated GMP documents for the Production of Product from PONIARD less than
  *** (***) working days prior to the scheduled manufacturing date of such
  Product, but greater than *** (***) working days prior to the scheduled
  manufacturing date and within sufficient time to Produce such Product by such
  scheduled date as determined by BAXTER in its sole discretion, BAXTER may
  charge PONIARD an Acceleration Fee as set forth in the Product Master Plan.

  



 


	
  Article 5.

  	
  PRICE

  



 


	
  5.1

  	
  Product Purchase Price. The price to be
  paid by PONIARD for the Product (“Purchase Price”) shall be set forth in the
  Product Master Plan.

  
	
   

  	
   

  
	
  5.2

  	
  Purchase
  Price Adjustment. Upon the *** of the date of this Agreement and on each ***
  thereafter, the Purchase Price of such Product may be adjusted by BAXTER upon
  written notice to PONIARD at least *** (***) days prior to such anniversary by the increase
  in the
  Index of Producer Prices of Industrial Products as published by the Statistischen Bundesamt
  (German Federal Authority for Statistics) for the previous *** plus ***.

  



 


	
  Article 6.

  	
  SHIPMENT AND INVOICING

  



 


	
  6.1

  	
  Delivery Terms. Product shall be delivered to PONIARD, or
  to a location designated by PONIARD in the Purchase Order, EXW (Incoterms,
  2000) BAXTER’s facility in Halle/Künsebeck, Westphalia, Germany freight collect,
  by a common carrier designated by PONIARD, at PONIARD’s expense.

  



 


8

















 


	
   

  	
  PONIARD shall procure, at its cost,
  insurance covering damage or loss to the Product during shipping.

  
	
   

  	
   

  
	
  6.2

  	
  Exporter of Record. PONIARD shall be the exporter of record for
  any Product shipped out of Germany, as PONIARD remains the owner of the
  Product. PONIARD shall export Product from Germany in compliance with all
  applicable German export laws and regulations and all applicable import laws
  and regulations into the country of importation.

  
	
   

  	
   

  
	
   

  	
  PONIARD shall be responsible for obtaining
  and paying for any licenses or other governmental
  authorization(s) necessary for the exportation from Germany. PONIARD
  shall select and pay the freight forwarder who shall solely be PONIARD’s
  agent. PONIARD and its freight forwarder shall be solely responsible for
  preparing and filing the Shipper’s Export Declaration and any other
  documentation required for the export.

  
	
   

  	
   

  
	
  6.3

  	
  Subsequent Export. PONIARD agrees and represents that PONIARD
  is the owner of the API that is delivered to BAXTER for contract
  manufacturing services. At no time does BAXTER assume ownership or title to
  the API. Where the Product is destined for subsequent export or re-export, PONIARD,
  as owner of the Product, shall be responsible for any subsequent export or
  re-export and will comply with all applicable U.S. laws and regulations
  relating to the export or re-export, including the prohibition against
  unlawful transhipments. PONIARD further agrees to defend BAXTER against any
  action, civil or criminal, private or public, in connection with the
  subsequent export or re-export by PONIARD of the Product. This Agreement
  represents PONIARD’s express agreement of assumption of responsibility for
  export and re-export and that Baxter is not a Foreign Principal Party in
  Interest under this Agreement.

  
	
   

  	
   

  
	
  6.4

  	
  Foreign Corrupt
  Practices Act.
  Each party agrees and acknowledges it is not the agent of the other party and
  represents and warrants that it has not, and covenants that it will not pay
  anything of value to any government employee in connection with the
  Production or sale hereunder of the Product.

  
	
   

  	
   

  
	
  6.5

  	
  Payment Terms. The following invoicing and payment terms
  apply:

  



 


	
  Status

  	
   

  	
  Invoice Date

  	
   

  	
  Payment Due

  	
   

  
	
  Commercial Batches

  	
   

  	
  Date Product available for pickup as
  notified by BAXTER (Shipment date documents under Section 9.3)

  	
   

  	
  Invoice Date + *** days

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Regulatory Services

  	
   

  	
  ***

  	
   

  	
  Receipt of Invoice

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Termination

  	
   

  	
  Termination date

  	
   

  	
  Invoice date + *** days

  	
   

  



 


Payments shall be made by wire
transfer to a bank account specified by BAXTER. Each invoice shall be payable
by PONIARD in accordance with the 


 


9

















 


	
   

  	
  terms noted above. All prices quoted by
  BAXTER will be quoted in EURO and are ex value added taxes. Any payment due
  under this Agreement not received within the times noted above shall bear
  interest of *** on the outstanding balance compounded *** unless the subject
  of a good faith dispute. PONIARD shall have the right to dispute, in good
  faith, payments due under this Agreement by providing written notice of such
  dispute along with an explanation of such dispute to BAXTER within *** (***)
  days of receipt of such invoice. The Parties agree to work together in good
  faith to resolve such dispute within *** (***) days of written notice of
  dispute.

  
	
   

  	
   

  
	
   

  	
  All payments will be invoiced and paid in
  EURO.

  
	
   

  	
   

  
	
  6.6

  	
  Default in Payment
  Obligations.
  In addition to all other remedies available to BAXTER in the event of a
  PONIARD default, if PONIARD fails to make payments as required hereunder,
  BAXTER may refuse all further Purchase Orders, refuse to Produce any Product
  until PONIARD’s account is paid in full, modify the foregoing terms of
  payment, place the account on a letter of credit basis, require full or
  partial payment in advance, or suspend deliveries of Product until PONIARD
  provides assurance of performance reasonably satisfactory to BAXTER, brings
  current all required payments, and/or takes other reasonable means as BAXTER
  may determine.

  



 


	
  Article 7.

  	
  ACCEPTANCE OF PRODUCT

  



 


	
  7.1

  	
  Product Conformity.

  



 


	
   

  	
  7.1.1

  	
  Within *** (***) working days after PONIARD
  receives the Released Executed Batch Record or CoA and CoC from BAXTER as set
  forth in the Quality Agreement, PONIARD shall determine whether Product and
  related documents conform to the Product Requirements; provided, however,
  that PONIARD shall have the right to revoke acceptance if, within ***
  (***) days of receipt of the Batch, PONIARD discovers a defect or
  adulteration not reasonably discoverable at time of delivery. If (a) any
  shipment of Product conforms to the Product Requirements, or (b) PONIARD
  fails to notify BAXTER in writing within the applicable time periods set
  forth in Section 7.1 above that any shipment of Product does not conform
  to the Product Requirements, then PONIARD shall be deemed to have accepted
  the Product and waived its right to revoke acceptance.

  
	
   

  	
   

  	
   

  
	
   

  	
  7.1.2

  	
  If PONIARD believes any shipment of Product
  does not conform to the Product Requirements, it shall notify BAXTER by
  e-mail confirmed by fax or letter including a detailed explanation of the
  non-conformity. Upon receipt of such notice, BAXTER will investigate such
  alleged non-conformity, and (i) if BAXTER agrees such Product is
  non-conforming, BAXTER and PONIARD will mutually determine a corrective
  action plan within *** (***) calendar days after receipt of PONIARD’s
  written notice of non-conformity, or such additional time as is reasonably
  required if such investigation or plan requires data from sources other than
  PONIARD or BAXTER, or (ii) if BAXTER disagrees with PONIARD’s
  determination that the shipment of Product

  



 


10














 


	
   

  	
   

  	
  is non-conforming, BAXTER shall so notify PONIARD by
  telephone within *** (***) working days and confirm such notice in writing by
  overnight delivery.

  
	
   

  	
   

  	
   

  
	
   

  	
  7.1.3

  	
  If the parties dispute whether a shipment of Product
  is conforming or non-conforming, the shipment of Product will be submitted to
  a mutually acceptable laboratory or consultant for resolution, whose
  determination of conformity or non-conformity, and the cause thereof of
  non-conformity, shall be binding upon the parties.  The costs of such laboratory or consultant
  are to be borne by the party whose determination of conformity or
  non-conformity was incorrect.

  
	
   

  	
   

  	
   

  
	
  7.2

  	
  Remedies for Non Conforming Product

  
	
   

  	
   

  	
   

  
	
   

  	
  7.2.1

  	
  BAXTER shall replace such non-conforming Product
  within *** (***) calendar days from the date of determination by the third
  party of non-conformity or agreement by BAXTER of such non-conformity
  assuming sufficient Active will be provided by PONIARD ***, except as set
  forth below, in due time to carry out the manufacturing. The non-conforming
  Product shall be returned to BAXTER for disposal. In the event of any
  destruction of the non-conforming Product, the party directing the
  destruction shall deliver to the other an appropriate certificate of
  destruction.  If the non-conformity was
  due solely to BAXTER’s negligence or willful misconduct or solely to BAXTER’s
  breach of its representations or warranties under this Agreement, as may be
  agreed to by BAXTER or determined by the laboratory or consultant named in
  Section 7.1.3, BAXTER shall be responsible for the costs of disposal of
  the non-conforming Product, BAXTER’s costs associated with Product
  replacement, and BAXTER shall reimburse PONIARD for the API for the
  non-conforming Batch, which API reimbursement shall amount to *** (***) Euros
  per *** of API but in no event shall such API reimbursement amount exceed the
  value of the Firm Purchase Order.

  
	
   

  	
   

  	
   

  
	
   

  	
  7.2.2

  	
  However, BAXTER is not responsible for defects that
  are caused by Components supplied by PONIARD or upon specific manufacturing
  instructions of PONIARD as set forth in the Product Master Plan.

  
	
   

  	
   

  	
   

  
	
   

  	
  7.2.3

  	
  Deviations which occur during the Production of
  Product and testing and that cause the Production to be non-compliant with
  cGMPs or registration requirements as agreed upon by BAXTER and PONIARD shall
  be deemed to cause such Product to be non-conforming.  Likewise, deviations which occur during
  Production and testing of Product, which do not cause the Product to be
  non-compliant with cGMPs or registration requirements, shall not be deemed to
  cause such Product to be non-conforming.

  



 


	
  Article 8.

  	
  TERM AND TERMINATION

  



 


	
  8.1

  	
  Initial Term.  This Agreement shall be effective on the Effective Date and shall
  continue for *** (***) months thereafter (the “Initial Term”), unless 

  



 


11

















 


	
   

  	
  earlier terminated in accordance with
  Sections 8.2, 8.3 or 8.5. This Agreement will be renewed automatically for
  one *** commencing at the expiration of the Initial Term and one ***
  commencing at the end of the first renewal term unless either PONIARD or
  BAXTER terminates this Agreement by giving the other party written notice of
  intent to terminate at least *** (***) months prior to the expiration of the
  Initial Term or the first renewal term. The Initial Term as it may be
  extended is referred to herein as the “Term.”

  
	
   

  	
   

  
	
  8.2

  	
  Termination for Breach. Either party may terminate this Agreement
  upon the material breach of any provision of this Agreement by the other
  party if such breach is not cured by the breaching party within thirty
  (30) calendar days for monetary defaults, and forty-five
  (45) calendar days for non-monetary defaults, after receipt by the
  breaching party of written notice of such default. At the option of the
  non-breaching party, such termination may be with respect to the entire
  Agreement, or only with respect to the Product, which is subject to the
  breach.

  
	
   

  	
   

  
	
  8.3

  	
  Termination for Financial Matters. This Agreement may be terminated
  immediately by either party by giving the other party written notice thereof
  in the event such other party makes a general assignment for the benefit of
  its creditors, or proceedings of a case are commenced in any court of
  competent jurisdiction by or against such party seeking (a) such party’s
  reorganization, liquidation, dissolution, arrangement or winding up, or the
  composition or readjustment of its debts, (b) the appointment of a
  receiver or trustee for or over such party’s property, or (c) similar
  relief in respect of such party under any law relating to bankruptcy, insolvency,
  reorganization, winding up or composition or adjustment of debt, and such
  proceedings shall continue undismissed, or an order with respect to the
  foregoing shall be entered and continue unstayed, for a period of more than
  sixty (60) days.

  
	
   

  	
   

  
	
  8.4

  	
  Additional Rights and Remedies. Subject to Section 13.1, termination
  under this Article 8 shall be in addition to the other rights and
  remedies of the terminating party. Termination of this Agreement for any
  reason shall not relieve any party of any obligations accruing prior to such
  termination.

  
	
   

  	
   

  
	
  8.5

  	
  Non-cancelable Costs and Expenses. In the event of the termination or
  cancellation of this Agreement, except by PONIARD as a result of a breach by
  BAXTER pursuant to Section 8.2, PONIARD shall (a) reimburse BAXTER
  for all Components ordered prior to the termination notice (or after notice
  with PONIARD’s approval) and not cancelable at no cost to BAXTER, provided
  BAXTER delivers the Components to PONIARD and, upon the request of PONIARD,
  cancels or returns orders requested by PONIARD, with stop order or restocking
  charges reimbursed by PONIARD, and (b) pay BAXTER the Reservation Fees
  as set forth in the Product Master Plan. In addition, in the event of
  termination or cancellation for any reason, PONIARD shall pay prices
  described in Article 5 for (i) all work-in-process commenced by
  BAXTER and (ii) all finished Product of BAXTER; provided, that such
  items are for delivery under Firm Purchase Orders, are delivered to PONIARD
  in accordance with the terms of this Agreement and, at PONIARD’s election
  with respect to such work-in-process items, are turned in to finished Product
  in accordance with this Agreement or are not completed (for which PONIARD
  pays BAXTER its costs to date for such work-in-process items). BAXTER shall
  deliver such

  



 


12

















 


	
   

  	
  materials to PONIARD pursuant to
  Section 6.1. PONIARD shall make payment for all expenses described in
  this Section 8.5 thirty (30) days from the invoice date, which shall not
  be earlier than the date of delivery of such materials to PONIARD.

  
	
   

  	
   

  
	
  8.6

  	
  Procedure in case
  of Expiry of this Agreement. In case this Agreement expires pursuant to Section 8.1, PONIARD
  is obliged to buy from BAXTER at cost all Components at hand unless BAXTER can
  use these materials otherwise. Moreover, PONIARD assumes the responsibility
  to purchase from BAXTER all semi-finished and finished Products in stock.

  
	
   

  	
   

  
	
  8.7

  	
  Survival. Termination or expiration of this Agreement
  through any means or for any reason, except as set forth in
  Section 13.1, shall be without prejudice to the rights and remedies of
  either party with respect to any antecedent breach of any of the provisions
  of this Agreement. The provisions of Sections 8.4, 8.8, 12, 13, 14, 15,
  16, 17 and 18 hereof shall survive expiration or termination of this
  Agreement.

  
	
   

  	
   

  
	
  8.8

  	
  Transfer of
  Technology

  



 


	
   

  	
  8.8.1

  	
  On termination or expiration of this
  Agreement through any means and for any reason, the right of BAXTER to make
  or use Product hereunder shall terminate and, except for termination as a
  result of a breach by PONIARD under Section 8.2 and not BAXTER’s breach,
  BAXTER shall cooperate with PONIARD by providing to PONIARD, copies or drafts
  of the following items, to the extent they exist, within thirty (30) days of
  termination:

  
	
   

  	
   

  	
   

  
	
   

  	
  8.8.2

  	
  BAXTER’s CMC documentation in support of
  PONIARD’s filing of its NDA (or its foreign equivalent) for Product;

  
	
   

  	
   

  	
   

  
	
   

  	
  8.8.3

  	
  Development, Manufacturing and Validation
  Reports relating to the Product;

  
	
   

  	
   

  	
   

  
	
   

  	
  8.8.4

  	
  BAXTER’s Manufacturing Batch Records for the
  Product;

  
	
   

  	
   

  	
   

  
	
   

  	
  8.8.5

  	
  pertinent analytical reports and
  manufacturing instructions related to the Product; and

  
	
   

  	
   

  	
   

  
	
   

  	
  8.8.6

  	
  Any and all Active in storage at BAXTER;

  
	
   

  	
   

  	
   

  
	
   

  	
  8.8.7

  	
  All technology, know how, or other
  Intellectual Property, including Process Intellectual Property, relating to
  the Production of the Product, all in a form and with content reasonably
  satisfactory to PONIARD as required to enable PONIARD’s reasonably competent
  staff to transfer the process of manufacturing the Product (to the extent
  such process exists at the time of termination) to a third party. BAXTER
  shall also conduct a technical review meeting with PONIARD to address issues
  raised by PONIARD regarding the information so provided. PONIARD shall have a
  fully paid-up, royalty-free, worldwide license under such Intellectual
  Property to use, manufacture, have manufactured, sell and import Picoplatin,
  including any product containing API, with right to sublicense.

  



 


13

















 


	
   

  	
  8.8.8

  	
  PONIARD will reimburse BAXTER at a rate of
  ***(***) Euros per hour for personnel costs beyond those considered
  reasonable to assist in the transfer of the information provided in
  Sections 8.8.1-8.8.7 with PONIARD’s support.

  



 


	
  Article 9.

  	
  PRODUCTION OF PRODUCT

  



 


	
  9.1

  	
  Production. BAXTER shall Produce Product in conformance
  with the Product Requirements. During the normal course of managing the
  collaboration between PONIARD and BAXTER or in the event of any changes to
  the manufacturing equipment or manufacturing process, PONIARD shall
  reserve the right of having not more than *** PONIARD employees to be on-site
  and observe manufacturing of Picoplatin drug product. These visits will be
  limited to not more than *** per ***. Additional visits will be allowed for
  changes in manufacturing scale, and process validation.

  
	
   

  	
   

  
	
  9.2

  	
  Audits. PONIARD shall have the right to audit
  BAXTER’s facilities to determine compliance with (i) cGMP and
  (ii) applicable laws and regulations, and to audit records, e.g., cGMP related
  documents, relating to the services being provided under this Agreement, but
  excluding financial records, other than records pertaining to costs of
  Components or other costs to be reimbursed or paid by PONIARD hereunder. Such
  audits shall be scheduled at mutually agreeable times upon reasonable advance
  written notice to BAXTER. *** audits through the *** years following Product
  approval, and *** audits thereafter, as well as audits required by BAXTER’s
  compliance status with regard to Production of Product (“For Cause Audits”)
  shall be ***. Additional audits under this Agreement shall be at PONIARD’s
  expense as detailed in Product Master Plan. Such fees shall be paid promptly
  upon completion of such audits. If PONIARD requests For Cause Audits BAXTER shall
  use its best efforts to expedite the scheduling of such audits. In connection
  with performing such audits, PONIARD shall comply with all reasonable
  rules and regulations promulgated by BAXTER. All information disclosed
  or reviewed in such audits relative to BAXTER facilities, equipment, etc.
  shall be deemed to be the property of BAXTER and BAXTER Confidential
  Information unless it applies, of course, to PONIARD API, Product, or PONIARD
  Confidential Information or Intellectual Property.

  
	
   

  	
   

  
	
  9.3

  	
  Testing and Disposition. BAXTER shall test, or cause to be tested by
  third party testing facilities audited by BAXTER, in accordance with the
  Product Specifications, each Batch of Product Produced pursuant to this
  Agreement before delivery to PONIARD. A certificate of analysis (“CoA”) for each Batch of Product delivered to PONIARD
  shall set forth the items tested by BAXTER specifications and test results.
  BAXTER shall send, or cause to be sent, such certificates along with a
  certificate of conformance (“CoC”) to PONIARD
  prior to or at the same time of shipment of Product to PONIARD and within ***
  (***) weeks from the date of fill if such Batch requires no investigations
  and/or additional testing.

  
	
   

  	
   

  
	
   

  	
  BAXTER will also send to PONIARD the additional documentation as set
  forth in the Quality Agreement.

  



 


14

















 


	
   

  	
  PONIARD shall assume full responsibility for final quality assurance
  release of each Batch of the Product as set forth in the Quality Agreement.

  
	
   

  	
   

  
	
  9.4

  	
  Stability Testing. At PONIARD’s cost and expense, BAXTER shall
  perform all stability testing required to be performed on commercial,
  development, conformance and / or production batches of Product. Such testing
  shall be performed in accordance with the procedures set out in the product
  specific BAXTER SOPs for the stability protocol and Product Master Plan.

  
	
   

  	
   

  
	
  9.5

  	
  Permits and
  Licenses
  PONIARD shall have sole responsibility at its expense for obtaining all
  permits and licenses necessary and required for the use of Product Produced
  by BAXTER hereunder. BAXTER shall be responsible at its expense to obtain and
  maintain all generally required licenses required for it to carry out its
  regulatory and production obligations hereunder.

  
	
   

  	
   

  
	
  9.6

  	
  Regulatory Requirements. Each party promptly shall notify the other
  of new regulatory requirements of which it becomes aware which are relevant
  to the Production of a Product under this Agreement and which are required by
  an applicable Regulatory Authority or other applicable laws or governmental
  regulations, and shall confer with each other with respect to the best means
  to comply with such requirements.

  
	
   

  	
   

  
	
  9.7

  	
  Equipment Expenses. If BAXTER needs to obtain specialized
  equipment in order to Produce Product for PONIARD, a description and estimated
  cost of the equipment shall be set forth in the Product Master Plan. The
  costs of such equipment shall be paid by PONIARD, i.e., the actual purchase
  price paid by BAXTER including shipping and insurance  costs
  plus a service fee of *** on the actual purchase price plus VAT. This fee
  shall include BAXTER’s execution of installation and operational
  qualification of purchased equipment, excluding performance qualification.
  BAXTER shall advise PONIARD of the specialized equipment required and the
  estimated costs associated with the purchase and installation of such
  equipment. PONIARD shall be invoiced for all approved costs regarding
  equipment by BAXTER, and PONIARD shall make payments promptly thereafter. In
  case expenses for specialized equipment exceeds *** Euros, the parties
  will agree separately on the conditions for these expenses.

  
	
   

  	
   

  
	
  9.8

  	
  Ownership of Equipment. Upon termination or expiration of this
  Agreement, BAXTER can, upon agreement by PONIARD, purchase such specialized
  equipment by paying PONIARD the then current book value of such equipment.
  Depreciation of such equipment shall be calculated in accordance with
  applicable generally accepted accounting principles. If BAXTER does not wish
  to purchase the equipment or PONIARD does not agree to the purchase, BAXTER
  shall then transfer ownership of the specialized equipment paid for by
  PONIARD to PONIARD.

  
	
   

  	
   

  
	
  9.9

  	
  Records. BAXTER will, in accordance with applicable
  laws and as reasonably requested by PONIARD, maintain complete cGMP
  production records and reports relating to its activities performed in
  providing the services under this Agreement (including, without limitation,
  keeping accurate records of the manufacture, testing and packaging of the
  Product). BAXTER will

  



 


15

















 


	
   

  	
  provide PONIARD with access to all such
  records at any time during the term of this Agreement, provided, however,
  that such access will be required only during normal business hours and with
  reasonable advance written notice. The Parties agree that this excludes
  financial records.

  



 


	
  Article 10.

  	
  REGULATORY

  



 


	
  10.1

  	
  Regulatory Approvals. PONIARD will diligently pursue Regulatory
  Approval of marketing licenses for Product Produced by BAXTER hereunder.
  PONIARD will advise BAXTER of document requirements in support of filings and
  similar applications required of foreign governments and agencies including
  amendments, license applications, supplements and maintenance of such. BAXTER
  will provide documents and assist PONIARD in preparation of submissions to
  Regulatory Authorities designated by PONIARD in support of PONIARD’s
  applications required of governments and licenses. All regulatory submission
  preparation and maintenance performed by BAXTER for PONIARD shall be
  specified in the BAXTER-supplied quotations in the Product Master Plan. Prior
  to submission to the Regulatory Authority, PONIARD will provide BAXTER with a
  copy of the CMC Section for review and comment. A final copy of the CMC
  Section will be provided by PONIARD to BAXTER upon submission to the
  Regulatory Authority, with comments from BAXTER to be received within ***
  (***) business days. Upon Regulatory Approval, PONIARD will notify BAXTER
  within *** (***) business days of such approval and the anticipated date of
  Product launch to the market.

  
	
   

  	
   

  
	
  10.2

  	
  Regulatory Authority Inspections. At PONIARD’s request, BAXTER will authorize
  Regulatory Authorities to review related applications on PONIARD’s behalf.
  BAXTER will notify PONIARD immediately by email with confirmation by fax /
  mail of all contacts with Regulatory Authorities (both written and verbal)
  related to the Product. BAXTER shall inform PONIARD of the result of any
  regulatory inspection which directly affects the Production of Product,
  including any notice of inspection, notice of violation or other similar
  notice received by BAXTER affecting Production, facility, testing, storage or
  handling of a Product. In the event of an FDA inspection that directly
  involves the Product, PONIARD shall be immediately informed of the issuance of
  the Notice of Inspection. In the event that there are Inspectional
  Observations, PONIARD shall be informed immediately and shall have the
  opportunity to review and provide BAXTER with comments to BAXTER’s response.
  PONIARD shall provide its comments to the response of these observations
  within ***(***) calendar days. BAXTER and PONIARD shall mutually determine
  the contents of BAXTER’s response, where such comments strictly involve the
  manufacture of Product and do not impact other products produced by BAXTER,
  or BAXTER’s regulatory status with Regulatory Authorities. For all other
  situations, to the extent possible BAXTER will take PONIARD’s comments into
  account in this response. PONIARD shall bear the costs of Regulatory
  Authority Inspection as set forth in the Product Master Plan.

  



 


16

















 


	
  Article 11.

  	
  TRADEMARKS

  



 


	
  11.1

  	
  PONIARD grants to BAXTER a non-exclusive,
  royalty free license to use PONIARD Trademarks for the sole purpose of
  allowing BAXTER to fulfill its responsibilities under this Agreement. Such
  license shall not be transferable in whole or in part.

  
	
   

  	
   

  
	
  11.2

  	
  PONIARD shall be solely responsible for
  selecting, registering and enforcing PONIARD Trademarks used to identify the
  Product and, except as set forth in Section 11.1, shall have sole and
  exclusive rights in such PONIARD Trademarks.

  
	
   

  	
   

  
	
  11.3

  	
  BAXTER, on behalf of its employees,
  agents, subcontractors and Affiliates, agrees not to use the name of PONIARD
  or any of its employees, agents or affiliates, or reference any of their
  products, in any publicity, advertising or other publication without
  PONIARD’s prior written approval.  Results and services provided by
  BAXTER do not constitute an endorsement of the Product or PONIARD’s
  scientific conclusions.

  



 


	
  Article 12.

  	
  REPRESENTATIONS AND WARRANTIES

  



 


	
  12.1

  	
  Mutual Representations. Each party hereby represents and warrants
  to the other party that (a) the person executing this Agreement is
  legally authorized to execute this Agreement; (b) this Agreement is
  legal and valid and the obligations binding upon such party are enforceable
  by their terms; and (c) the execution, delivery and performance of this
  Agreement does not conflict with any agreement, instrument or understanding,
  oral or written, to which such party may be bound, nor violate any law or
  regulation of any court, governmental body or administrative or other agency
  having jurisdiction over it.

  
	
   

  	
   

  
	
  12.2

  	
  BAXTER Warranty. BAXTER represents and warrants that Product
  shall be Produced in accordance with Product Requirements and the applicable
  rules and regulations regarding Environmental, Health and Safety
  practices within Germany. BAXTER represents and warrants that it has obtained
  (or will obtain prior to Producing Product), and will maintain, update and
  remain in compliance with, during the term of this Agreement, all permits,
  licenses and other authorizations (the “Permits”) which are required under
  laws and regulations applicable to the Production only of Product as
  specified in the Product Master Plan; provided, however, BAXTER shall have no
  obligation to obtain Permits relating to the sale, marketing, distribution or
  use of Product or with respect to the labeling of Product. BAXTER makes no
  representation or warranty with respect to the sale, marketing, distribution
  or use of printed materials specified by PONIARD or its consignee.

  
	
   

  	
   

  
	
  12.3

  	
  Disclaimer of Warranties. Except for those warranties set forth in
  Sections 12.1 and 12.2 of this Agreement, BAXTER makes no warranties,
  written, oral, express or implied, with respect to Product or the Production
  of Product. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
  LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
  PARTICULAR PURPOSE AND NONINFRINGEMENT HEREBY ARE DISCLAIMED BY BAXTER. NO

  



 


17

















 


	
   

  	
  WARRANTIES OF BAXTER MAY BE CHANGED BY
  ANY REPRESENTATIVES OF BAXTER. PONIARD accepts Product subject to the terms
  hereof.

  
	
   

  	
   

  
	
  12.4

  	
  PONIARD Warranties. PONIARD warrants that (a) it has the
  right to give BAXTER any information provided by PONIARD hereunder, and that
  BAXTER has the right to use such information for the Production of Product;
  (b) PONIARD has no knowledge, as of the date of this Agreement, of any
  (i) patents or other intellectual property rights that would be
  infringed by BAXTER’s Production of Product under this Agreement, or
  (ii) proprietary rights of third parties which would be violated by
  BAXTER’s performance hereunder; and (c) has obtained (or will obtain
  prior to producing the Product), and will maintain, update and remain in
  compliance with, all permits, licenses and other authorizations during the
  term of this Agreement, which are required under federal, state and local
  law, rules and regulations applicable to the Production, use and sale of
  the Product, except those Permits required of BAXTER. PONIARD warrants that
  the API provided to BAXTER hereunder will (1) conform to the API
  specifications and (2) not be adulterated or misbranded within the
  meaning of the FD&C Act. PONIARD’s use and promotion of the Product
  will be in accordance with its regulatory filings and approvals.

  
	
   

  	
   

  
	
  12.5

  	
  BAXTER represents as of the date of this
  Agreement and continuously during the term of this Agreement that it is not
  debarred pursuant to Section 335(a) or 335(b) of the Federal
  Food, Drug, and Cosmetic Act (the “Act”). BAXTER represents that it has not
  been debarred under the Act in the past five (5) years. BAXTER will not
  employ or use the services of any person or entity to perform the Production
  of Product who is debarred under the Act or to BAXTER’s knowledge has engaged
  in activities that could lead to being debarred under the Act. Baxter
  shall notify PONIARD in writing if it is debarred, or if BAXTER learns that
  any other person or entity performing the Services is debarred.

  



 


	
  Article 13.

  	
  LIABILITY

  



 


	
  13.1

  	
  Limitation of Liability. PONIARD’s sole and exclusive remedies for
  breach of this Agreement are limited to those remedies set forth in Articles
  7, 8, 14 and 16 and to replace the non-conforming Product. Notwithstanding the
  foregoing, in the event BAXTER fails to supply PONIARD with Product as
  required hereunder due to BAXTER’s intentional breach of this Agreement,
  PONIARD’s remedies shall not be limited by the foregoing. However, under no circumstances shall BAXTER be
  liable for loss of use or profits or other collateral, special, consequential
  or other damages, losses, or expenses, including but not limited to the cost
  of cover or the cost of a recall, except as specifically set forth in Article 16,
  in connection with or by reason of the Production and delivery of Product
  under this Agreement whether such claims are founded in tort or contract. The
  foregoing constitutes the sole and exclusive remedies of PONIARD and the sole
  and exclusive liability of BAXTER. All claims by PONIARD for breach or
  default under this Agreement shall be brought within one (1) year after
  the cause of action accrued or shall be deemed waived. As permitted by the
  applicable laws, the

  



 


18

















 


	
   

  	
  liability of BAXTER is limited to the value
  of the respective Firm Purchase Order. BAXTER shall not be liable for any
  costs incurred through the loss of Active Pharmaceutical Ingredient except as
  set forth in Section 7.2.1.  Under
  no circumstances shall PONIARD be liable to BAXTER under this Agreement for
  loss of use or profits or other collateral, special, punitive or
  consequential damages.

  



 


	
  Article 14.

  	
  INDEMNIFICATION

  



 


	
  14.1

  	
  PONIARD
  Indemnification.  PONIARD
  shall indemnify, defend and hold harmless BAXTER and its Affiliates and any
  of their respective directors, officers, employees, subcontractors and agents
  (collectively “BAXTER Indemnified Parties”) from and against any and all
  liabilities, obligations, penalties, claims, judgments, demands, actions,
  disbursements of any kind and nature, suits, losses, damages, costs and
  expenses (including, without limitation, reasonable attorney’s fees) arising
  out of or in connection with property damage or personal injury (including
  without limitation death) of third parties (collectively “Claims”) in
  connection with (a) PONIARD’s transport, storage, promotion, labeling,
  marketing, distribution, use or sale of Product, (b) PONIARD’s
  negligence or willful misconduct, (c) PONIARD’s breach of this Agreement,
  or (d) any claim that the use, sale, Production, marketing or
  distribution of Product by BAXTER or PONIARD violates the patent, trademark,
  copyright or other proprietary rights of any third party, except if any of
  the foregoing (a) or (d) is caused solely by the negligence or
  willful misconduct of the BAXTER Indemnified Parties or solely by the breach
  by BAXTER of its obligations under this Agreement.

  
	
   

  	
   

  
	
  14.2

  	
  BAXTER
  Indemnification. BAXTER shall
  indemnify, defend and hold harmless PONIARD and its Affiliates and any of
  their respective directors, officers, employees, subcontractors and agents
  (collectively “PONIARD Indemnified Parties”) from and against any and all
  liabilities, obligations, penalties, claims, judgments, demands, actions,
  disbursements of any kind and nature, suits, losses, damages, costs and
  expenses (including, without limitation, reasonable attorney’s fees) arising
  out of or in connection with property damage or personal injury (including
  without limitation death) of third parties (collectively “Claims”) resulting
  solely from BAXTER’s negligence, willful misconduct or solely by the breach
  of its obligations under this Agreement.

  
	
   

  	
   

  
	
  14.3

  	
  Indemnitee Obligations. A party (the “Indemnitee”) which intends to
  claim indemnification under this Article 14 shall promptly notify the
  other party (the “Indemnitor”) in writing of any action, claim or other
  matter in respect of which the Indemnitee or any of its Affiliates, or any of
  their respective directors, officers, employees, subcontractors, or agents,
  intend to claim such indemnification; provided, however, that failure to
  provide such notice within a reasonable period of time shall not relieve the
  Indemnitor of any of its obligations hereunder except to the extent the
  Indemnitor is prejudiced by such failure. The Indemnitee shall permit, and
  shall cause its Affiliates, and their respective directors, officers,
  employees, subcontractors and agents to permit, the Indemnitor, at its
  discretion, to settle any such action, claim or other matter, and the
  Indemnitee agrees to the complete control of such defense or

  



 


19

















 


	
   

  	
  settlement by the Indemnitor.
  Notwithstanding the foregoing, the Indemnitor shall not enter into any
  settlement that would adversely affect the Indemnitee’s rights hereunder, or
  impose any obligations on the Indemnitee in addition to those set forth
  herein, in order for it to exercise such rights, without Indemnitee’s prior
  written consent, which shall not be unreasonably withheld or delayed. No such
  action, claim or other matter shall be settled without the prior written
  consent of the Indemnitor, which shall not be unreasonably withheld or
  delayed. The Indemnitee, its Affiliates, and their respective directors,
  officers, employees, subcontractors and agents shall fully cooperate with the
  Indemnitor and its legal representatives in the investigation and defense of
  any action, claim or other matter covered by the indemnification obligations
  of this Article 14. The Indemnitee shall have the right, but not the
  obligation, to be represented in such defense by counsel of its own selection
  and at its own expense.

  
	
   

  	
   

  
	
  14.4

  	
  Injunction. In the event that
  the Production of Product in BAXTER’s facility is enjoined due to alleged
  infringement by either party of the proprietary rights of a third party,
  BAXTER shall not be required to Produce Product and such non-Production shall
  not be deemed a breach of this Agreement

  



 


	
  Article 15.

  	
  INSURANCE

  



 


	
  15.1

  	
  PONIARD Insurance. PONIARD shall procure and maintain, during the Term of this Agreement
  and for a period *** (***) *** beyond the expiration date of Product,
  Commercial General Liability Insurance and Product Liability Insurance, which
  shall include Contractual Liability coverage (the “PONIARD Insurance”).
  PONIARD Insurance shall cover amounts not less than *** (***) combined per claim and in annual aggregate and shall be with a commercially acceptable insurance carrier. BAXTER
  shall be named as an additional insured with respect to this commercial
  supply, and PONIARD promptly shall deliver a certificate of PONIARD Insurance
  and endorsement of additional insured to BAXTER evidencing such coverage. If
  PONIARD fails to furnish such certificates or endorsements, or if at any time
  during the Term of this Agreement BAXTER is notified of the cancellation or
  lapse of PONIARD Insurance, and PONIARD fails to rectify the same within ten
  (10) calendar days after notice from BAXTER, in addition to all other
  remedies available to BAXTER hereunder, BAXTER, at its option, may obtain the
  PONIARD Insurance and PONIARD promptly shall reimburse BAXTER for the cost of
  the same. Any deductible and/or self insurance retention shall be the sole
  responsibility of PONIARD.

  
	
   

  	
   

  
	
  15.2

  	
  BAXTER Insurance. BAXTER is, and shall during the Term of
  this Agreement remain, self-insured for the type of liability that could
  arise under Section 14.2 of this Agreement. “BAXTER shall provide a
  written statement of the existence of such insurance to PONIARD upon written
  request.

  



 


	
  Article 16.

  	
  COMPLAINTS, RECALL OF PRODUCT

  



 


	
  16.1

  	
  In case PONIARD or BAXTER receives
  complaints regarding Products which require any investigations or tests on
  the side of BAXTER, PONIARD is

  



 


20














 


	
   

  	
  obliged to reimburse BAXTER for any costs
  accrued in connection with this complaint provided that the Product has been
  accepted by PONIARD as conforming to Product Requirements, unless such
  complaint is determined to be caused solely by the negligence or willful
  misconduct of BAXTER or solely by BAXTER’s breach of its warranties under
  this Agreement.

  
	
   

  	
   

  
	
  16.2

  	
  In the event PONIARD shall be required to
  recall any Product because such Product may violate local, state or federal
  laws or regulations, the laws or regulations of any applicable foreign
  government or agency or the Product Requirements, or in the event that
  PONIARD elects to institute a voluntary recall, PONIARD shall be responsible
  for coordinating such recall. PONIARD promptly shall notify BAXTER if any
  Product is the subject of a recall and provide BAXTER with a copy of all
  documents relating to such recall. BAXTER shall cooperate with PONIARD in
  connection with any recall, at PONIARD’s expense. Unless such recall is
  caused solely by the negligence or willful misconduct of BAXTER or solely by
  BAXTER’s breach of its warranties under this Agreement, PONIARD shall be
  responsible for all of the costs and expenses of such recall. In the event a
  recall, Product withdrawal or field correction is necessary because both
  (i) BAXTER has delivered a non-conforming Product to PONIARD, and
  (ii) such non-conformity is solely due to the negligence of BAXTER,
  BAXTER will bear all reasonable costs associated with such recall, Product
  withdrawal or field correction (including but not limited to costs associated
  with receiving and administering the recalled Product and notification of the
  recall to those persons whom PONIARD deems appropriate). In no event shall
  BAXTER’s liability for costs associated with such recall, Product withdrawal
  or field correction exceed the Purchase Price for the Product which is the
  subject of such recall, Product withdrawal or field correction. As permitted by the applicable laws the
  liability of BAXTER is limited to the value of the respective Firm Purchase
  Order.

  



 


	
  Article 17.

  	
  INTELLECTUAL PROPERTY

  



 


	
  17.1

  	
  Existing Intellectual Property. Except as the parties may otherwise
  expressly agree in writing, each party shall continue to own its existing
  Intellectual Property, without conferring any interests therein on the other
  party. Without limiting the generality of the preceding sentence, BAXTER
  agrees that PONIARD shall retain all right, title and interest arising under
  the applicable laws, rules and regulations in and to all API, Products
  and their manufacture, all Intellectual Property relating thereto, and all
  labeling and trademarks associated therewith (collectively, “PONIARD’s
  Intellectual Property”). Neither BAXTER nor any third party shall acquire any
  right, title or interest in PONIARD’s Intellectual Property by virtue of this
  Agreement or otherwise, except to the extent expressly provided herein.

  
	
   

  	
   

  
	
  17.2

  	
  New Intellectual Property. Except as the parties may otherwise agree in
  writing and except as set forth in Sections 17.3 and 17.4, all
  Intellectual Property which is conceived, reduced to practice, or created by
  a party in the course of performing its obligations under this Agreement
  shall be owned and subject to use and exploitation by the party and, in the
  case of patentable inventions, shall be owned by the party whose employees,
  consultants or agents are the “inventors” thereof under the U.S. patent laws.
  In the event the

  



 


21

















 


	
   

  	
  parties jointly own a patentable invention,
  each party may use and exploit the joint invention without a duty to account
  to the other party for its use or exploitation of the joint invention.

  
	
   

  	
   

  
	
  17.3

  	
  Product Intellectual Property. PONIARD and BAXTER each acknowledge and agree that
  all rights, title and interest in and to any Product Intellectual Property
  shall be owned by PONIARD, and BAXTER hereby assigns to PONIARD any Product
  Intellectual Property conceived, discovered or made (jointly or solely) by
  BAXTER or its Affiliates. BAXTER shall disclose to PONIARD all information
  pertaining to the Product Intellectual Property conceived, discovered or made
  by BAXTER or its Affiliates as it becomes available.

  
	
   

  	
   

  
	
  17.4

  	
  Process
  Intellectual Property. For Process Intellectual Property conceived, discovered or made solely
  by BAXTER or its Affiliates, the parties agree that such Process Intellectual
  Property shall be owned by BAXTER; however, BAXTER hereby grants to PONIARD a
  paid-up, royalty-free, irrevocable worldwide license, with right for PONIARD
  or any sub-licensees to sublicense, to such Process Intellectual Property for
  the manufacturing of any Products that are subject to this Agreement or other
  products containing Picoplatin API.
  All Process Intellectual Property conceived, discovered or made by PONIARD
  shall be owned by PONIARD.

  
	
   

  	
   

  
	
  17.5

  	
  Disclaimer. Except as otherwise expressly provided above
  or herein, nothing contained in this Agreement shall be construed or
  interpreted, either expressly or by implication, or otherwise, as: (i) a
  grant, transfer or other conveyance by either party to the other of any
  right, title, license or other interest of any kind in any of its
  Intellectual Property, (ii) creating an obligation on the part of either
  party to make any such grant, transfer or other conveyance or (iii) requiring
  either party to participate with the other party in any cooperative
  development program or project of any kind or to continue with any such
  program or project.

  
	
   

  	
   

  
	
  17.6

  	
  Patents. The party owning any Intellectual Property
  shall have the worldwide right to control the drafting, filing, prosecution
  and maintenance of patents covering the Intellectual Property, including
  decisions about the countries in which to file patent applications. Patent
  costs associated with the patent activities described in this section shall
  be borne by the owner. Each party will cooperate with the other party in the
  filing and prosecution of patent applications. Such cooperation will include,
  but not be limited to, furnishing supporting data and affidavits for the
  prosecution of patent applications and completing and signing forms needed
  for the prosecution, assignment and maintenance of patent applications. In
  the event the parties jointly own a patentable invention, they shall mutually
  agree upon the drafting, filing, prosecution and maintenance of patent
  applications and patents thereon.

  
	
   

  	
   

  
	
  17.7

  	
  Confidentiality of Intellectual Property. Intellectual Property shall be deemed to be
  the Confidential Information of the party owning such Intellectual Property
  to the extent it has not become publicly available. The protection of each
  party’s Confidential Information is described in Article 18. Any
  disclosure of information by one party to the other under the provisions of

  



 


22

















 


	
   

  	
  Article 18 shall be treated as the
  disclosing party’s Confidential Information under this Agreement. It shall be
  the responsibility of the party preparing a patent application to obtain the
  written permission of the other party to use or disclose the other party’s
  Confidential Information in the patent application before the application is
  filed and for other disclosures made during the prosecution of the patent
  application.

  



 


	
  Article 18.

  	
  CONFIDENTIAL INFORMATION, NONDISCLOSURE AND
  PUBLICITY

  



 


	
  18.1

  	
  Confidentiality. It is contemplated that in the course of
  the performance of this Agreement each party may, from time to time, disclose
  Confidential Information to the other. Each party agrees to take all
  reasonable steps to prevent disclosure of Confidential Information to third
  parties. No provision of this Agreement shall be construed so as to preclude
  disclosure of Confidential Information as may be reasonably necessary to
  secure from any governmental agency necessary approvals or licenses or to
  obtain patents with respect to the Product. Each party shall not disclose or
  use, except as permitted by this Agreement subject to Section 18.2, the
  other party’s Confidential Information.

  
	
   

  	
   

  
	
  18.2

  	
  Prior Confidentiality Agreement. This Agreement, by reference, incorporates
  the Confidentiality Agreement signed by PONIARD and BAXTER on
  January 13, 2005, and is made a part hereof as though fully set forth
  herein and all terms and conditions set forth in the Confidentiality
  Agreement shall continue to govern any disclosure made under the
  Confidentiality Agreement and shall govern any disclosure made as of the
  Effective Date of this Agreement.

  
	
   

  	
   

  
	
  18.3

  	
  Third Party Disclosure. BAXTER shall be permitted to disclose
  Product information to third party developmental and analytical services providers
  in connection with performance of its obligations hereunder provided such
  providers shall be subject to confidentiality agreements no less restrictive
  than the confidentiality provisions contained herein. Either party may
  disclose Confidential Information of the disclosing party to those
  Affiliates, agents and consultants who need to know such information to
  accomplish the purposes of this Agreement (collectively, “Permitted
  Recipients”); provided that such Permitted Recipients are bound to maintain
  such Confidential Information in confidence and are subject to
  confidentiality agreements no less restrictive than this Agreement.

  
	
   

  	
   

  
	
  18.4

  	
  Litigation and Governmental Disclosure. Each party may disclose Confidential
  Information hereunder to the extent such disclosure is reasonably necessary
  for prosecuting or defending litigation, or complying with applicable
  governmental regulations provided that if a party is required by law or
  regulation to make any such disclosure of the other party’s Confidential Information
  it will, except where impractical for necessary disclosures, for example in
  the event of a medical emergency, give reasonable advance notice to the other
  party of such disclosure requirement and will use good faith efforts to
  assist such other party to secure a protective order or confidential
  treatment of such Confidential Information required to be disclosed.

  



 


23

















 


	
  18.5

  	
  Limitation of Disclosure. The parties agree that, except as otherwise
  may be required by applicable laws, regulations, rules or orders,
  including without limitation the rules and regulations, and except as
  may be authorized in Section 18.4 and unless otherwise agreed in this
  Agreement, no information concerning this Agreement and the transactions
  contemplated herein shall be made public by either party without the prior
  written consent of the other, except as may be required by law.

  
	
   

  	
   

  
	
  18.6

  	
  Publicity and SEC Filings. The parties agree that the public
  announcement of the execution of this Agreement shall only be by one or more
  press releases mutually agreed to by the parties, except where earlier
  disclosure or SEC filings are required by law or other regulations. The
  failure of a party to return a draft of a press release with its proposed
  amendments or modifications to such press release to the other party within
  three (3) business days of such party’s receipt of such press release
  shall be deemed as such party’s approval of such press release as received by
  such party. Each party agrees that it shall cooperate fully and in a timely
  manner with the other with respect to all disclosures to the Securities and
  Exchange Commission or any other governmental or regulatory agencies,
  including requests for confidential treatment of Confidential Information of
  either party included in any such disclosure.

  
	
   

  	
   

  
	
  18.7

  	
  Duration of Confidentiality. All obligations of confidentiality and
  non-use imposed upon the parties under this Agreement shall expire *** (***)
  years after the expiration or earlier termination of this Agreement.

  
	
   

  	
   

  
	
  18.8

  	
  Production of
  similar / Identical products for other Customers. It is understood that BAXTER may have present
  or future initiatives, including initiatives with third parties, involving
  products or processes that compete or are similar / identical with the
  Product Produced under this Agreement. Accordingly, PONIARD acknowledges that
  nothing in this Agreement shall be construed as a representation or inference
  by either party that it will not develop for itself, or produce for others
  products or implement processes that compete with the Product or are similar
  / identical, provided that Confidential Information is not used in breach of
  this Agreement.

  



 


	
  Article 19.

  	
  FORCE MAJEURE

  



 


	
  19.1

  	
  Any delay in the performance of any of the
  duties or obligations of either party hereto (except the payment of money)
  caused by an event outside the affected party’s reasonable control shall not
  be considered a breach of this Agreement, and unless provided to the contrary
  herein, the time required for performance shall be extended for a period
  equal to the period of such delay. Such events shall include without
  limitation, acts of God; acts of public enemies; insurrections; riots;
  terrorist actions; injunctions; embargoes; labor disputes, including strikes,
  lockouts, job actions, or boycotts; fires; explosions; floods; shortages of
  material or energy; delays in the delivery of raw materials; acts or orders
  of any government or agency thereof or of Competent Authority or other
  unforeseeable causes beyond the reasonable control and without the fault or
  negligence of the party so affected. The party so affected shall give prompt
  notice to the other party of such cause and a good faith estimate of the

  



 


24

















 


	
   

  	
  continuing effect of the force majeure
  condition and duration of the affected party’s nonperformance, and shall take
  whatever reasonable steps are appropriate to relieve the effect of such
  causes as rapidly as possible. If the period of nonperformance by BAXTER
  because of BAXTER force majeure conditions exceeds 90 (ninety) calendar days,
  PONIARD may terminate this Agreement by written notice to BAXTER. If the
  period of nonperformance by PONIARD because of PONIARD force majeure
  conditions exceeds 90 (ninety) calendar days, BAXTER may terminate this
  Agreement by written notice to PONIARD.

  



 


	
  Article 20.

  	
  NOTICES

  



 


	
  20.1

  	
  All notices hereunder shall be delivered by
  facsimile and confirmed by registered mail, to the following address of the
  respective parties:

  



 


	
  If to BAXTER:

  	
  Baxter Oncology GmbH

  	
   

  
	
   

  	
  Kantstr. 2

  	
   

  
	
   

  	
  33790 Halle / Westfalen

  	
   

  
	
   

  	
  Germany

  	
   

  
	
   

  	
  Attn: Associate Director for Contract
  Manufacturing and Business Development

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Fax No.

  	
  +49 5201 711 1880

  	
   

  
	
   

  	
  Telephone No.

  	
  +49 5201 711 1896

  	
   

  
	
   

  	
   

  	
   

  
	
  With a copy to:

  	
  Baxter Germany

  	
   

  
	
   

  	
  Edisonstr. 4

  	
   

  
	
   

  	
  85719 Unterschleißheim

  	
   

  
	
   

  	
  Germany

  	
   

  
	
   

  	
  Attn: Legal Counsel

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Fax No.

  	
  +49 89 31701 547

  	
   

  
	
   

  	
  Telephone No.

  	
  +49 89 31701 285

  	
   

  
	
   

  	
   

  	
   

  
	
  If to PONIARD:

  	
  Director of Manufacturing

  	
   

  
	
   

  	
  Poniard Pharmaceuticals, Inc.

  	
   

  
	
   

  	
  300 Elliott Avenue West #500

  	
   

  
	
   

  	
  Seattle, Washington 98119

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Fax No.

  	
  206-284-7112

  	
   

  
	
   

  	
  Telephone No.

  	
  206-281-7001, ext 103

  	
   

  
	
   

  	
   

  	
   

  
	
  With a copy to:

  	
  Vice-President, Legal

  	
   

  
	
   

  	
  Poniard Pharmaceuticals, Inc.

  	
   

  
	
   

  	
  300 Elliott Avenue West #500

  	
   

  
	
   

  	
  Seattle, Washington 98119

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Fax No.

  	
  206-286-2537

  	
   

  
	
   

  	
  Telephone No.

  	
  206-281-7001, ext 526

  	
   

  



 


	
   

  	
  Notices shall be effective on the day
  following the date of transmission if sent by facsimile, and on the second
  business day following the date of delivery to

  



 


25

















 


	
   

  	
  the overnight delivery service if sent by
  overnight delivery. A party may change its address listed above by notice to
  the other party given in accordance with this section.

  



 


	
  Article 21.

  	
  APPLICABLE LAW

  



 


	
  21.1

  	
  This Agreement shall be construed,
  interpreted and governed by the substantive laws of Switzerland, without
  regard to conflict of law principles to the contrary. The courts of
  Switzerland shall have personal jurisdiction over the parties hereto in all
  matters arising hereunder, and venue for such suit will be in any competent
  court of Zurich.

  



 


	
  Article 22.

  	
  ASSIGNMENT

  



 


	
  22.1

  	
  Neither party shall assign this Agreement
  or any part hereof or any interest herein to any third party (or use any
  subcontractor) without the prior written approval of the other party. The
  parties shall be entitled to assign this Agreement to one of its Affiliates
  (so long as it remains an Affiliate) without the other party’s prior
  approval. No consent shall be required in the case of a transfer or partnership
  of a PONIARD program, or in the case of a transfer or partnership to a
  wholly-owned subsidiary, or transaction involving the merger, consolidation,
  sale or partnership of all or substantially all of the assets of the party
  seeking such assignment or transfer and such transaction relates to the
  business covered by this Agreement and the resulting entity assumes all of
  the obligations under this Agreement.  No
  assignment shall be valid unless the permitted assignee(s) assumes all
  obligations of its assignor under this Agreement.  No assignment shall
  relieve any party of responsibility for the performance of its obligations
  hereunder. PONIARD shall inform BAXTER in writing prior to concluding a
  partnership or transferring rights to the Product. If the Product partnership
  or transfer involves a direct competitor of BAXTER in the area of cytotoxic
  contract manufacturing, BAXTER shall be entitled, within sixty (60) days
  of receiving notice of such partnership or transfer, to terminate this
  Agreement by giving twenty-four (24) months’ prior written notice.
  During this termination period PONIARD will remain BAXTER’s contact partner
  with respect to all questions arising under this Agreement. PONIARD will
  strictly adhere to its confidentiality obligations towards its partner and /
  or successor, especially but not limited to BAXTER’s manufacturing.

  



 


26

















 


	
  Article 23.

  	
  SUCCESSORS AND ASSIGNS

  



 


	
  23.1

  	
  This Agreement shall be binding upon and
  shall inure to the benefit of the parties hereto, their successors and
  permitted assigns.

  



 


	
  Article 24.

  	
  ENTIRE AGREEMENT

  



 


	
  24.1

  	
  This Agreement, including the agreements
  identified in Articles 2 and 18.2, constitute the entire agreement between
  the parties concerning the subject matter hereof and supersedes all written
  or oral prior agreements or understandings with respect thereto.

  



 


	
  Article 25.

  	
  SEVERABILITY

  



 


	
  25.1

  	
  If any term or provision of this Agreement
  shall for any reason be held invalid, illegal or unenforceable in any
  respect, such invalidity, illegality or unenforceability shall not affect any
  other term or provision hereof, and this Agreement shall be interpreted and
  construed as if such term or provision, to the extent the same shall have
  been held to be invalid, illegal or unenforceable, had never been contained
  herein.

  



 


	
  Article 26.

  	
  WAIVER AND MODIFICATION OF AGREEMENT

  



 


	
  26.1

  	
  No waiver or modification of any of the
  terms of this Agreement shall be valid unless in writing and signed by both
  parties hereto. Failure by either party to enforce any rights under this
  Agreement shall not be construed as a waiver of such rights nor shall a
  waiver by either party in one or more instances be construed as constituting
  a continuing waiver or as a waiver in other instances.

  



 


	
  Article 27.

  	
  INDEPENDENT CONTRACTOR

  



 


	
  27.1

  	
  Both parties shall act as an independent
  contractor for the other party in providing the services required hereunder
  and shall not be considered an agent of, or joint venturer with, the other
  party.

  



 


	
  Article 28.

  	
  NO SUBCONTRACTORS

  



 


	
   

  	
  BAXTER shall obtain written approval from
  PONIARD prior to subcontracting any work or services involved in the
  fulfillment of this Agreement, its extensions, or any purchase orders
  referencing this Agreement.  Exempt
  from said obligations are subcontracts for warehousing, cleaning, and
  technical and maintenance services.  In
  the event PONIARD authorizes any such subcontracting, BAXTER agrees to remain
  fully responsible to PONIARD for any portion of the services performed to the
  same extent as if such portion of the services was performed directly by
  BAXTER.

  



 


27

















 


IN WITNESS WHEREOF, the parties have caused this Commercial Supply
Agreement to be signed by their duly authorized representatives.


 


	
  “BAXTER”

  	
  “PONIARD”

  
	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
  11/20/08

  	
  Date:

  	
  11/22/08

  
	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
  /s/
  Brik V. Eyre

  	
   

  	
  By:

  	
   

  	
  /s/
  Ronald A. Martell

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
       Brik
  V. Eyre

  	
   

  	
  Name:

  	
  Ronald
  A. Martell

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   General
  Manager, BPS

  	
   

  	
  Title:

  	
   

  	
  President

  
									



 


28














 






*** Indicates confidential material that has
been omitted pursuant to a Confidential Treatment Request filed with the
Securities and Exchange Commission.  A
complete copy of this agreement has been separately filed with the Securities
and Exchange Commission.


 


PRODUCT
MASTER PLAN


 


FOR
Picoplatin Injection


 


This Product Master Plan to the
CLINICAL and COMMERCIAL SUPPLY AGREEMENTS is between Poniard Pharmaceuticals
Inc. having an office at 300 Elliott Ave. West, Suite 500, Seattle, WA
98119-4114, USA, as such term is defined herein (“PONIARD”) and Baxter Oncology GmbH, with its principal place
of business at Kantstr. 2, 33790 Halle / Westfalen, Germany, as such term is
defined herein (“BAXTER”).


 


RECITALS


 


PONIARD and BAXTER have concluded CLINICAL and COMMERCIAL SUPPLY AGREEMENT and a QUALITY AGREEMENT regarding the Production of the Products set
forth in this Product Master Plan.


 


This Product Master Plan is concluded as an integral part of the
CLINICAL and COMMERCIAL SUPPLY AGREEMENTS and the
CLINICAL and COMMERCIAL QUALITY AGREEMENTS to define details for the
production of Presentations of Picoplatin Injection.


 


This document is a living document. Any changes will be made in writing
after discussion between the parties and mutual agreement of the changes. Any
amendments have to be signed by the representatives of the technical team from
both parties.  Revisions to the pricing
for *** scale Development, Clinical, Validation and
Commercial batches shall be subject to the appropriate sections of the COMMERCIAL
SUPPLY AGREEMENT.


 


Version:  No. 4


 


	
  Change Index:

  	
  · Update
  of the chapter ‘Recitals’

  
	
   

  	
   

  
	
   

  	
  · New
  responsibilities for signature at Poniard

  
	
   

  	
   

  
	
   

  	
  · Update
  of the chapter ‘Presentations’: ***, adding several new countries

  
	
   

  	
   

  
	
   

  	
  · Update
  of the chapter ‘Product manufacturing’: Adding of new documents, ***

  
	
   

  	
   

  
	
   

  	
  · Update
  of the chapter ‘Specifications’: ***

  
	
   

  	
   

  
	
   

  	
  · Update of the chapter ‘Quality
  Control’: ***

  
	
   

  	
   

  
	
   

  	
  ·
  Update of the chapter ‘Validation in Production’:

  
	
   

  	
   

  
	
   

  	
  ·
  Joining of the updated chapter ‘Documentation’ and the updated chapter ‘Pricing and Production Schedule

  
	
   

  	
   

  
	
   

  	
  · Update
  of the table ‘Contacts and Responsible Persons’

  



 


CONFIDENTIAL


 


1

















 


In witness whereof, the parties have caused this Product Master Plan to
be signed by their duly authorized representatives.


 


 


	
  “BAXTER”

  	
   

  	
  “BAXTER”

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Sven
  Remmerbach

  	
   

  	
  By:

  	
  /s/ Uwe Wolk

  
	
  Name:

  	
  Sven
  Remmerbach, Ph.D.

  	
   

  	
  Name:

  	
  Uwe Wölk,
  Ph.D:

  
	
  Title:

  	
  Associate
  Director Business Development / Contract Manufacturing

  	
   

  	
  Title:

  	
  Manager
  Contract Manufacturing / Process 

  Transfer

  
	
  Date:

  	
  October 10,
  2008

  	
   

  	
  Date:

  	
  October 9,
  2008

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  “PONIARD”

  	
   

  	
  “PONIARD”

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Alstair
  Leigh,

  	
   

  	
  By:

  	
  /s/ Kevin
  Hovda

  
	
  Name:

  	
  Alistair
  Leigh, Ph.D.

  	
   

  	
  Name:

  	
  Keith Hovda

  
	
  Title:

  	
  Sr. Director, Product
  Development

  	
   

  	
  Title:

  	
  Director, Manufacturing

  
	
  Date:

  	
  October 17,
  2008

  	
   

  	
  Date:

  	
  October 20,
  2008

  



 


 


REMAINDER OF PAGE
INTENTIONALLY LEFT BLANK


 


CONFIDENTIAL


 


2

















 


Table of
contents


 


	
  1

  	
  Presentations

  	
  4

  
	
   

  	
   

  	
   

  
	
  2

  	
  Product Manufacturing

  	
  5

  
	
   

  	
   

  	
   

  
	
  2.1

  	
  Composition of compounding
  solution

  	
  5

  
	
   

  	
   

  	
   

  
	
  2.2

  	
  Manufacturing Instructions /
  Master Batch Record

  	
  5

  
	
   

  	
   

  	
   

  
	
  2.3

  	
  Packaging
  Master / Aufmachungsvorschrift

  	
  5

  
	
   

  	
   

  	
   

  
	
  2.4

  	
  Storing / Shipping
  Conditions

  	
  5

  
	
   

  	
   

  	
   

  
	
  3

  	
  Specifications

  	
  6

  
	
   

  	
   

  	
   

  
	
  3.1

  	
  API, supplied by PONIARD

  	
  6

  
	
   

  	
   

  	
   

  
	
  3.2

  	
  Excipient(s), supplied by
  BAXTER

  	
  6

  
	
   

  	
   

  	
   

  
	
  3.3

  	
  Packaging Material(s),
  supplied by BAXTER

  	
  6

  
	
   

  	
   

  	
   

  
	
  3.4

  	
  Clinical labels, supplied by
  PONIARD

  	
  7

  
	
   

  	
   

  	
   

  
	
  3.5

  	
  Finished Drug Product
  Release Specification

  	
  7

  
	
   

  	
   

  	
   

  
	
  4

  	
  Quality Control

  	
  8

  
	
   

  	
   

  	
   

  
	
  4.1

  	
  In Process Control

  	
  8

  
	
   

  	
   

  	
   

  
	
  4.2

  	
  Analytical Methods (API)

  	
  8

  
	
   

  	
   

  	
   

  
	
  4.3

  	
  Analytical Methods
  (Excipients)

  	
  8

  
	
   

  	
   

  	
   

  
	
  4.4

  	
  Analytical
  Methods (Water for Injection)

  	
  8

  
	
   

  	
   

  	
   

  
	
  4.5

  	
  Analytical Methods (Drug
  Product)

  	
  9

  
	
   

  	
   

  	
   

  
	
  4.6

  	
  Microbiological Methods
  (Validation Protocols, Validation Reports and Testing Methods)

  	
  9

  
	
   

  	
   

  	
   

  
	
  4.7

  	
  Stability Storage and Drug
  Product Development Studies

  	
  10

  
	
   

  	
   

  	
   

  
	
  4.8

  	
  Retention Samples

  	
  10

  
	
   

  	
   

  	
   

  
	
  5

  	
  Validation in Production

  	
  11

  
	
   

  	
   

  	
   

  
	
  5.1

  	
  Cleaning validation

  	
  11

  
	
   

  	
   

  	
   

  
	
  5.2

  	
  Process validation

  	
  11

  
	
   

  	
   

  	
   

  
	
  6

  	
  Batch Documentation, Pricing
  and Production Schedule

  	
  12

  
	
   

  	
   

  	
   

  
	
  6.1

  	
  Batch Documentation

  	
  12

  
	
   

  	
   

  	
   

  
	
  6.2

  	
  Purchase Price

  	
  12

  
	
   

  	
   

  	
   

  
	
  6.3

  	
  Value of the API

  	
  13

  
	
   

  	
   

  	
   

  
	
  6.4

  	
  Production Schedule

  	
  13

  
	
   

  	
   

  	
   

  
	
  6.5

  	
  Quality Assurance Audits

  	
  13

  
	
   

  	
   

  	
   

  
	
  6.6

  	
  Regulatory Authority
  Inspection Audits

  	
  13

  
	
   

  	
   

  	
   

  
	
  6.7

  	
  Batch Records Review

  	
  13

  
	
   

  	
   

  	
   

  
	
  6.8

  	
  Reservation Fees

  	
  13

  
	
   

  	
   

  	
   

  
	
  6.9

  	
  Acceleration Fees

  	
  13

  
	
   

  	
   

  	
   

  
	
  6.10

  	
  Extended Storage of Picoplatin
  Drug Product

  	
  13

  
	
   

  	
   

  	
   

  
	
  7

  	
  Shipping Responsibilities

  	
  14

  
	
   

  	
   

  	
   

  
	
  8

  	
  Contacts and Responsible
  Persons

  	
  15

  



 


CONFIDENTIAL


 


3

















 


1                 Presentations


***


 


BAXTER
shall Produce Picoplatin Injection in accordance with cGMP for utilization in
clinical trials conducted in the EU, Russia, Ukraine, Bosnia, Belarus, Croatia, Serbia, Montenegro, India,
Argentina, Chile, Uruguay, US
and Canada.


 


BAXTER
shall Produce Picoplatin Injection in accordance with cGMP for commercial sale
in the following countries:  Argentina, Armenia, Aruba, Aserbaidschan, Australia, Austria, Bahrain,
Bangladesh, Belgium, Belarus, Benin, Bolivia, Bosnia, Brazil, Canada, Chile,
China, Czech Rep., Costa Rica, Croatia, Cyprus, Denmark, Dominican Republic,
Ecuador, Egypt, Estonia, Finland, France, Georgia, Greece, Germany, Guatemala,
Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Iceland, Italy, Japan,
Kamerun, Kazakhstan, Kirgistan, Kroatia, Kuwait, Latvia, Lithuania, Luxembourg,
Malaysia, Malta, Mexico, Moldavia, Montenegro, Myanmar, New Zealand, Nicaragua,
Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines,
Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, South Korea, Sweden,
Switzerland, Singapor, Slowakia, Slovenia, Spain, Sri Lanka, South Africa,
Taiwan, Thailand, Trinidad, Turkey, Tunisia, Turkmenistan, Ukraine, Uzbekistan,
Venezuela, United Arabian Emirates, UK, US,Uruguay Vietnam, Yemen


 


No
Trademark has currently been registered, therefore the name “Picoplatin
Injection” is to be used for the product until such time as a registered mark
is available.


 


The product
Picoplatin Injection shall be filled into ***.


 


CONFIDENTIAL


 


4

















 


2                 Product
Manufacturing


 


2.1       Composition of compounding solution


***


 


2.2       Manufacturing Instructions / Master Batch Record


***


 


2.3       Packaging Master / Aufmachungsvorschrift


***


 


2.4       Storing / Shipping Conditions


***


 


CONFIDENTIAL


 


5

















 


3                 Specifications


 


3.1       API, supplied by PONIARD


***


 


3.2       Excipient(s), supplied by BAXTER


***


 


3.3       Packaging Material(s), supplied by BAXTER


***


 


CONFIDENTIAL


 


6

















 


3.4       Clinical labels, supplied by PONIARD.


***


 


3.5       Drug Product Release Specification


***


 


CONFIDENTIAL


 


7














 


4                 Quality
Control


 


4.1            In Process Control


***


 


4.2            Analytical Methods (API)


***


 


4.3            Analytical Methods (Excipients)


***


 


4.4            Analytical Methods (Water for Injection)


***


 


CONFIDENTIAL


 


8

















 


4.5            Analytical Methods (Drug Product)


***


 


4.6            Microbiological Methods (Validation Protocols, Validation Reports
and Testing Methods)


***


 


CONFIDENTIAL


 


9

















 


4.7            Stability Storage and Drug Product Development Studies


***


 


4.8            Retention Samples


 


Retention samples of the drug or finished product will
be handled as described in the Master Batch Record or Sampling Plan and the
retention samples of the excipients will be handled as described in the QUALITY AGREEMENT.


 


If changes are necessary, this will be mentioned in an
amendment to this Product Master Plan.


 


CONFIDENTIAL


 


10

















 


5                 Validation
in Production


 


5.1            Cleaning validation


 


Cleaning validation is required if a multi purpose vessel will be used
and if the product should be a new worst-case product. If the product is not a
worst-case product, it will be implemented into the existing grouping. Based on
the information Poniard has provided so far, a cleaning verification (***) has been
performed for the compounding in the ***. The assessment of these results led
to the conclusion that ***.


 


A cleaning validation for the compounding in the *** is necessary.


 


***


 


5.2            Process validation


***


 


CONFIDENTIAL


 


11

















 


6                 Batch
Documentation, Pricing and Production Schedule


 


6.1            Batch Documentation


 


·                  Photocopy of the
Released Executed Batch Record(s) to be available to
PONIARD upon request within *** business days ***.  Prior to this ***, BAXTER will provide a
photocopy of the Released Executed Batch
Record(s) for each produced batch.


·                  Certificate of Analysis, to be provided by BAXTER to PONIARD for each produced batch.


·                  Certificate of Compliance, to be provided by BAXTER to PONIARD for each produced batch.


 


BAXTER shall maintain all of
the production and testing records (raw data with respect to analytical
measurements including microbiological analysis) for *** years. Details are
regulated in the QUALITY AGREEMENT.


 


6.2            Purchase Price


***


 


Price Adjustment for Batches
is described in the Commercial Supply Agreement


***


 


CONFIDENTIAL


 


12

















 


6.3            Value of the API


 


The value of the API is *** Euro per ***.


 


6.4            Production Schedule


 


PONIARD will provide BAXTER with purchase orders as set forth in the
CLINICAL and COMMERCIAL SUPPLY AGREEMENTS.


 


6.5            Quality Assurance Audits


 


A charge of *** Euro (in words: *** Euro) for *** days will be paid to
BAXTER by PONIARD for quality assurance audits in excess of the number defined
in the COMMERICAL SUPPLY AGREEMENT, except in the case of “For Cause Audits”.


 


6.6            Regulatory Authority Inspection Audits


 


A charge of *** Euro (in words: ***) per day will be paid to BAXTER by
PONIARD for Picoplatin Injection related regulatory authority inspections
(FDA-PAI).  In the event that the
inspection is for more than one product, these fees will be pro-rated.


 


A charge *** Euro (in words ***) per hour will be paid to BAXTER for
PONIARD requested regulatory support (per signed regulatory plan).


 


6.7            Batch Records Review


 


A charge of *** Euro (in words: ***) per hour will be paid to BAXTER
for PONIARD requested revisions to Master Batch Records in excess of *** per
year.


 


6.8            Reservation Fees


 


In case of a change to or cancellation of a Firm
Purchase Order, either upon PONIARD`s request or due to delayed Component
deliveries caused by PONIARD, BAXTER shall use its best efforts to find a
replacement for the unused capacity. If Baxter is unable to find a replacement
for the unused capacity, PONIARD will be charged *** to compensate BAXTER for any unused
direct labor and unused other resources due to the change or cancellation.


 


6.9            Acceleration Fees


 


A charge of *** Euro (***) will be paid to BAXTER for
delivery dates of material supplied by Poniard (e.g. API) that are less than
the required *** days before a reserved Picoplatin manufacturing date.


 


6.10     Extended Storage of Picoplatin Drug Product


 


A charge of *** Euro (***) per *** per *** will be paid to BAXTER for
PONIARD requested storage of the Picoplatin Drug Product in the warehouse of
BAXTER for more than *** (***) days after PONIARD’s Quality Assurance release
of Product.


 


The duration of the storage time that is free
of charge is defined in the COMMERCIAL SUPPLY AGREEMENT.


 


CONFIDENTIAL


 


13

















 


7                 Shipping
Responsibilities


 


All
shipping activities will be done under EX WORKS conditions according to the
INCOTERMS 2000.


 


PONIARD
will be responsible to assign the shipments with an international forwarding
company and to organize the transportation from Baxter to the country and the
company specified by PONIARD, which conducts or arranges the final packaging
and labeling activities.


 


BAXTER
will support these activities with information to the forwarding company and
preparation of the products for transportation.


 


All
shipping activities from Poniard or its designees to Baxter shall be done under
DDP conditions according to the INCOTERMS 2000.


 


CONFIDENTIAL


 


14

















 


8                 Contacts
and Responsible Persons


 


BAXTER


 


	
  Contacts

  	
   

  	
  Name

  	
   

  	
  Phone (Fax), email

  
	
  Technical
  pharmaceutical questions

  	
   

  	
  Uwe Woelk, Ph.D.

  	
   

  	
  [telephone number and e-mail address]

  
	
  Technical
  pharmaceutical questions

  	
   

  	
  Eckhard Fliegner

  	
   

  	
  [telephone
  number and e-mail address]

  
	
  Quality Control

  	
   

  	
  Michael Rattay, Ph.D.

  	
   

  	
  [telephone number and e-mail address]

  
	
  Quality Assurance

  	
   

  	
  Dietmar Hofmann, Ph.D.

  	
   

  	
  [telephone number and e-mail
  address]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Responsible
  persons

  	
   

  	
  Name

  	
   

  	
  Phone/Fax

  
	
  Responsible for
  manufacturing

  	
   

  	
  Olaf Reer, Ph.D.

  	
   

  	
  [telephone
  number and e-mail address]

  
	
  Responsible for Quality Control (= qualified
  person as referred to in Art. 48 ff. of EU Directive 2001/83)

  	
   

  	
  Dietmar Hofmann, Ph.D.

  	
   

  	
  [telephone number and e-mail
  address]

  
	
  Head of Quality Assurance

  	
   

  	
   

  



 


PONIARD


 


	
  Contacts

  	
   

  	
  Name

  	
   

  	
  Phone/Fax

  
	
  Technical pharmaceutical questions/Manufacturing

  	
   

  	
  Keith Hovda

  	
   

  	
  [telephone number and e-mail address]

  
	
  Quality Assurance

  	
   

  	
  Dana Wolf

  	
   

  	
  [telephone
  number and e-mail address]

  
	
  Quality Control

  	
   

  	
  Bruce Girton

  	
   

  	
  [telephone number and e-mail address]

  



 


CONFIDENTIAL


 


15