Supply Agreement - Steritech Inc.
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 products.
The first requisition shall be for a minimum of [*] 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 payments
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 [*] for the first requisitioned material
and future costs shall be commensurate allowing for mutually agreed upon changes
in process parameters.
3. In connection with 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, limits and test methods specified by Steritech. Such test methods
may include spectral and/or chromatographic characterization and
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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.
b. Occupational Safety and Health Administration (OSHA): [*] shall
comply with OSHA regulations.
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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 auditor 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 [*] 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
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3.
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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
property 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, 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 effect 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 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.
STERITECH, INC. [*]
By [SIG] /s/STEPHEN T. ISAACS By /s/[*]
--------------------------- ------------------------------
Name (Print): Stephen T. Isaacs Name (Print): [*]
-------------------------- -----------------------------
Title (Print): President/CEO Title (Print): President
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Date 7/22/94 Date 7/21/94
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STERITECH, INC. LETTERHEAD
EXHIBIT A
Page No. P.O.No. Order Date Vend No.
1 1695 7/15/94
PURCHASE ORDER
VENDOR SHIP TO
[*] [*]
[*] [*]
[*] [*]
[*]
[*]
[*]
[*]
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. DESCRIPTION REG. DATE QUANTITY QUANTITY QTY UNIT PRICE EXTENSION
MFG NO. LOCATION ORDERED BACK ORD. REC
[*] [*] [*] [*]
[*]
[*]
To be delivered to Steritech by Sept. 16, 1994.
Shipping requirements: Send [*] to Steritech plus [*] 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 [*]
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 cancelling 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.
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Exhibit B
SPECIFICATIONS FOR [*]
([*])
I. Identify
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 Anaylysis Analysis shall be [*]
NMR Analysis shall be [*]
HPLC Analysis shall be [*]
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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
[*] [*]
8 Feb 94 Vendor: [*] (cat. no. [*]) or equilvalent
[*] [*]
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.
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