Exhibit 10.19

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

SUPPLY AGREEMENT FOR STERITECH COMPOUND [ * ]

Agreement, effective as of July 18, 1994, by and between [ * ] , and STERITECH,
INC., a California corporation with offices at 2525 Stanwell Drive, Concord,
California 94520 (“Steritech”).

WITNESSETH:

WHEREAS, Steritech is the owner of certain intellectual property rights
respecting, and engages in certain research regarding the uses of, the compound
designated [ * ] (the “Compound”); and

WHEREAS, [ * ] is able to synthesize and supply the Compound, manufactured in
accordance with current U.S. Good Manufacturing Practices (“GMP”) standards and
meeting Food and Drug Administration (“FDA”) quality standards;

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

1. Promptly upon mutual agreement regarding amount of Compound to be
manufactured as set forth in a requisition (sample shown in Exhibit A), [ * ]
shall commence, and thereafter, as expeditiously as possible, shall proceed with
the synthesis of Compound and shall deliver the completed Compound, meeting the
analytical specifications defined in Exhibit B, to Steritech within a maximum
time of ninety (90) days from date of requisition. [ * ] also agrees to deliver
to Steritech all batch records and analytical data confirming conformance to
specifications for each raw material, isolated intermediate and final product.
The first requisition shall be for a minimum of ten (10) kilograms of Compound
and future requisitioned amounts shall be within the limits of [ * ] present
manufacturing capacity.

2. In consideration of the supply by [ * ] of the Compound as provided in this
Agreement, Steritech agrees that it shall pay to [ * ] the amount agreed upon in
writing at the time of the request to manufacture. Such payment shall be made by
Steritech upon final delivery by [ * ] of the Compound conforming to agreed upon
specifications and all test and batch records relating to its preparation.
Steritech agrees to pay [ * ] sixty thousand dollars ($60,000) for the first
requisitioned material and future costs shall be commensurate allowing for
mutually agreed upon changes in process parameters.

3. In connection with the performance of this Agreement, [ * ] shall:

a. Purchase, test and release raw materials and intermediates as defined in
specifications agreed upon by both parties. Raw materials shall conform to
American Chemical Society (ACS), United States Pharmacopoeia / National
Formulary (USP/NF) or European Pharmacopoeia (EP) specifications. Any exceptions
to these specifications are shown in Exhibit C of this contract. All isolated
intermediates as well as the Compound shall be analyzed at each step by [ * ] to
adequately identify, characterize and assess purity of materials per attributes,

 

1

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limits and test methods specified by Steritech. Such test methods may include
spectral and/or chromatographic characterization and elemental analysis in
conformance with stringent elemental analyses established by the Journal of
Medicinal Chemistry or equivalent when requested by Steritech.

b. Prepare data sheets, spectral/chromatographic sheets, and description of
preparative methods for all materials. [ * ] shall utilize a data sheet format
that conforms to the requirements for a Batch Production Record as described in
Part 211 of Title 21 of the Code of Federal Regulations. Further, Steritech
reserves the right to review and approve all such records prior to their use in
the production of intermediates or bulk drug substances. The preparative methods
shall be sufficiently detailed for filing with the FDA as bulk manufacturing
processes. This includes details of sources, purities and lot numbers of all raw
materials and solvents used, their quantities, and detailed methodology of
isolation and/or purification procedures.

c. Retain samples of Compound for one year after manufacture. Samples of this
material will be made available to Steritech upon request.

d. Analyze Compound by test methods agreed upon by both parties that conform to
USP or EP methods. Upon Steritech’s request and approval, samples of Compound
shall be made available to a third party for analytical testing.

e. Provide Steritech with a copy of each data sheet or Batch Production Record
and all pertinent analytical data for its review and approval prior to delivery
of each batch of Compound.

f. Provide evidence of the use of validated cleaning methods for equipment as
per present manufacturing standards.

4. [ * ] shall also provide Steritech with samples of specified intermediates
defined in the requisition (Exhibit A) for monitoring purposes only. Results
obtained by such studies will have no effect on the acceptance and approval by
Steritech of the final Compound.

5. [ * ] shall comply with all Government health and safety regulations:

a. FDA: [ * ] shall be registered with the FDA as a manufacturer of bulk drug
substances. [ * ] shall inform Steritech of any facilities inspection or any
other FDA action relative to the continued approval of its facilities by FDA for
the manufacture of bulk drug substances and shall supply a copy of any FDA Form
483 or any other regulatory compliance letter or notice issued by the FDA to [ *
] during the term of this contract. Facilities shall meet FDA standards in
accordance with the current Good Manufacturing Practices (cGMP). If during the
course of the contract FDA inspections cite deficiencies which, in the opinion
of Steritech, are judged to compromise the purity and/or quality of materials to
be delivered, Steritech will have the right, by written notice to [ * ] and
without incurring liability, to terminate the contract, without limitation of
any other rights or remedies. An FDA facilities Drug Master File is available
and on file with the FDA and is updated annually as required by FDA regulations.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

 

2.

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b. Occupational Safety and Health Administration (OSHA): [ * ] shall comply with
OSHA regulations.

c. Environmental Protection Agency (EPA): [ * ] shall comply with EPA
regulations regarding the discharge of water and air pollutants and for assuring
that disposal of all chemicals residues meet current EPA regulations.

d. Good laboratory safety controls and procedures shall be followed by [ * ] in
carrying out the activities for this project.

6. In connection with the performance of the Agreement, Steritech shall:

a. Furnish reference samples needed for the required analyses.

b. Retain samples of the Compound for internal use and to support a Compound
Drug Master File and Steritech’s Investigational New Drug (IND) application.

c. Approve all specifications and production records prior to manufacture of the
Compound.

7. Upon approval by Steritech, materials prepared shall be shipped as directed
by Steritech. Containers shall be previously approved by Steritech. Batch
records and required test samples must be received and approved prior to
acceptance of the bulk shipment. Compound that does not meet the agreed upon
specifications shall not be accepted under this agreement.

8. Steritech reserves the right to inspect [ * ] facilities, equipment, and
controls for the manufacture of Steritech’s compounds at dates and times that
are mutually acceptable. Steritech also reserves the right to delegate such
inspections to qualified third party auditors of its choosing as long as such
auditors are bound by the same confidentiality agreement currently in effect
between the two parties.

9. [ * ] further consents to the review by Steritech of [ * ] Master File for
the Compound and the facility’s Drug Master File. If requested by Steritech, [ *
] will provide such additional form of consent or authorization as the FDA may
require in connection with such review. Steritech may include this Agreement
and/or such additional form in Steritech’s IND application.

10. This agreement shall apply to all requisitions of the Compound within three
(3) years of the signing of this agreement unless superseded by a mutually
agreed upon in subsequent agreement. This agreement does not obligate Steritech
to request or pay for a specified number of batches or quantity of the Compound.
Recognizing that a timely supply of Compound is critical to the ability of
Steritech to proceed in its business, [ * ] shall give ninety (90) days notice
in writing if it does not intend to accept one or several future requests for
Compound under the terms of this agreement.

11. The Nondisclosure Agreement dated April 13, 1993 between the parties shall
be deemed incorporated herein by reference and apply to all information
disclosed by Steritech to [ * ]

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

 

3.

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and all information generated hereunder. The chemicals prepared or handled under
this contract shall be regarded as proprietary in nature. Under no circumstances
shall chemicals or any information associated with these chemicals be released
or divulged without prior approval of Steritech.

12. [ * ] will make prompt written disclosure to Steritech, will hold in trust
for the sole right and benefit of Steritech, and hereby assigns to Steritech all
right, title and interest in and to any inventions, developments, improvements
or trade secrets, including without limitation optimized procedures, which [ * ]
its employees or agents may solely or jointly conceive or reduce to practice, in
the course of or as a result of the work hereunder concerning the Compound
(including without limitation processes associated with its manufacture). [ * ]
will assist Steritech in every proper way to obtain and enforce United States
and foreign proprietary rights relating to any and all inventions, development,
improvements or trade secrets of Steritech in any and all countries. To that end
[ * ] will execute, verify and deliver such documents and perform such other
acts (including appearing as a witness) Steritech may reasonably request for use
in applying for, obtaining, perfecting, evidencing, sustaining and enforcing
such proprietary rights and the assignment thereof. In addition, [ * ] will
execute, verify and deliver assignments of such proprietary rights to Steritech
or its designee. Steritech shall compensate [ * ] at a reasonable rate for the
time actually spent by [ * ] at Steritech’s request on such assistance. In the
event Steritech is unable for any reason, after reasonable effort, to secure [ *
] signature on any document needed in connection with the actions specified in
the preceding paragraph, [ * ] hereby irrevocably designates and appoints
Steritech and its duly authorized officers and agents as its agent and
attorney-in-fact, to act for and in its behalf to execute, verify and file any
such documents and to do all other lawfully permitted acts to further the
purposes of the preceding paragraph with the same legal force and effect as if
executed by [ * ]

13. If any provision or clause of this Agreement, or portion thereof, shall for
any reason be held to be invalid, illegal or unenforceable, such invalidity,
illegality, or unenforceability shall not affect any other provision of this
Agreement, but this Agreement shall be construed as if such provision or clause,
or portion thereof, had never been contained in this Agreement, and there shall
be deemed substituted therefor such other provision or clause, or portion
thereof, as will most nearly accomplish the intent of the parties as expressed
in this Agreement to the fullest extent permitted by law.

14. This Agreement shall be governed by and construed and enforced under the
internal laws of the State of California (and not its principles of conflicts of
law). The parties consent and submit to the jurisdiction of the courts of the
State of California and of the United States for a judicial district within the
territorial limits of the State of California for all purposes with respect to
any action or proceeding in connection with this Agreement.

IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed
and delivered by their respective authorized representatives as of the effective
date first above written.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

 

4.

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STERITECH, INC.

   

[ * ]

By:

 

/s/ Stephen Isaacs

   

By:

 

[ * ]

Name (Print):

 

Stephen Isaacs

   

Name (Print):

 

[ * ]

Title (Print):

 

President/CEO

   

Title (Print):

 

President

Date:

 

July 22, 1994

   

Date:

 

July 21, 1994

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

 

5.

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EXHIBIT A

 

STERITECH, INC.

2525 Stanwell Dr., Suite 300

Concord, CA 94520

510-603-9071 FAX 510-603-9099

   PAGE
NO.    P.O. No.    ORDER DATE    VEND.    1    1695    7/15/94                  
PURCHASE ORDER

 

V

E

N

D

O

R

   [ * ]    S
H
I
P    [ * ]                T
O   

ORDER DATE    CANCELLATION DATE    SHIP VIA    F.O.B.       TERMS 7/15/94      
to be determined          Net 30 days RESALE NO.    RESPONSIBILITY       BRANCH
     

ITEM NO.

MFG. NO.

   DESCRIPTION   

REG. DATE

LOCATION

  

QUANTITY

ORDERED

  

QUANTITY

BACK ORD.

   QTY REC.    UNIT PRICE    EXTENSION [ * ]   

[ * ] *

[ * ]

      10 Kg          $60,000   

 

To be delivered to Steritech by Sept. 16, 1994.

 

Shipping requirements: Send 10g to Steritech plus one gram (1g) from each
additional container. Upon approval, send rest of order to [ * ] unless
specified otherwise.

 

Intermediates requested: Send to Steritech samples 1g of [ * ] [ * ] [ * ] and
[ * ] prepared and used for the manufacture of this lot of [ * ]

 

* As per agreement signed July 18, 1994. “Supply Agreement for Steritech
Compound [ * ]

 

      SUBTOTAL    $60,000       PURCHASE ORDER NO.    1695          TOTAL ORDER
VALUE   

 

    AUTHORIZED SIGNATURE

ORDER TERMS AND CONDITIONS

 

1. INVOICES must bear exact same prices and terms or authorization for changes
must be received from our company in writing prior to shipping.

 

2. Goods not in accordance with specifications will be rejected and held at
vendor’s risk awaiting disposal. Vendor must pay freight on all rejected
material.

 

3. The right is reserved, to cancel all or part of this order if not delivered
within the time specified.

 

4. Packing slips must accompany all shipments.

 

5. By acceptance of this order, vendor warrants that all merchandise shipped
under this order does comply with all laws and regulations of Federal and State
governments.

 

6. Back orders must be prepaid when less than a minimum freight shipment.

 

7. In the event of interruption of our business in whole or in part by reason of
fire, flood, windstorm, earthquake, war, strike, embargo, acts of God,
governmental action, or any causes beyond our control, we shall have the option
of canceling undelivered orders in whole or part.

 

8. Acceptance of the purchase order, or shipment of any part of it will
constitute an agreement to all of its specifications as to terms, delivery and
prices.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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EXHIBIT B

Specifications for [ * ]

[ * ] [ * ]

 

I.    Identity          A.    IR spectrum    spectrum compares with reference   
B.    NMR    spectrum compares with reference          [ * ] II.    Purity      
   A.    HPLC    [ * ] of reference standard by peak area          [ * ]    B.
   Loss on Drying    [ * ] by weight

For documentation purposes only, the following other analyses of purity shall
also be completed:

 

Elemental Analysis    Analysis shall be [ * ] NMR    Analysis shall be [ * ]
HPLC    Analysis shall be [ * ]

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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EXHIBIT C

Raw materials to be used in the manufacture of Steritech’s [ * ] [ * ] [ * ]
that do not conform to ACS, USP/NF or EP specifications for these reagents, or
such specifications are not available:

 

[ * ]

Part Number and
Effective date

  

Description and Vendor Information

[ * ]

22 Feb 93

  

[ * ]

Vendor: [ * ]

[ * ]

28 Mar 94

  

[ * ]

Vendor: [ * ] (cat. no. [ * ] )

[ * ]

8 Feb 94

  

[ * ]

Vendor: [ * ] (cat. no. [ * ] or equivalent)

[ * ]

8 Feb 94

  

[ * ]

Vendor: [ * ] (cat. no. [ * ] or equivalent)

[ * ]

18 Feb 94

  

[ * ]

Vendor: [ * ] (cat. no. [ * ] or equivalent)

[ * ]

7 Mar 94

  

[ * ]

Vendor: [ * ] (cat. no. N/A), [ * ] (cat. no. [ * ] or equivalent)

[ * ]

8 Feb 94

  

[ * ]

Vendor: [ * ] (cat. no. N/A)

All other raw materials used in this manufacturing process are of ACS, USP/NF or
EP Grade.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.