Supply Agreement, dated July 18, 1994



 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 








 
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. 








 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. 








 
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. 









									
	 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. 








 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. 










 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. 










 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.