SUPPLY AGREEMENT
THIS AGREEMENT is made as of this 10th day of December, 1997, by and between
Acute Therapeutics, Inc. (a corporation organized and existing under the laws
Delaware, with its principal office at 0000 Xxxxxx Xxxx, Xxxxxxxxxx, XX 00000;
hereinafter "ATI"), and PolyPeptide Laboratories (a corporation organized and
existing under the laws of Delaware, with principal manufacturing facilities at
000 Xxxxx Xxxxxx, Xxxxxxxx, Xxxxxxxxxx 00000; hereinafter "PPL").
WITNESSETH
WHEREAS, ATI is active in the pharmaceutical business and is the owner of all
rights to certain proprietary technical information, patents and patent
applications relating to the KL(4)-peptide Substance (hereinafter "Substance");
and
WHEREAS, ATI desires to contract with PPL for the processing of the
KL(4)-peptide (hereinafter "Substance"); and
WHEREAS, PPL possesses the requisite expertise, personnel and facilities for the
manufacture and supply of the Substance to ATI;
NOW, THEREFORE, in consideration of the foregoing and of the mutual covenants
and conditions herein contained, ATI and PPL agree as follows:
1. DESCRIPTION OF WORK
PPL shall supply ATI's requirements for the conversion of insoluble
Substance to soluble Substance (using a procedure supplied by ATI and
attached as Exhibit A) for use in the production of clinical product for
human use. Such Substance shall meet the specifications in Exhibit B
(hereinafter "Specifications"). Subject to PPL's prior written consent,
such consent not to be unreasonably withheld, ATI may, as needed, change
the Specifications.
2. QUANTITIES
ATI will provide PPL with [***] of insoluble Substance, which PPL will
process to Soluble Substance in six (6) lots of approximately [***] each.
ATI and PPL shall cooperate in scheduling the production of these lots.
3. QUALITY
3.1. ATI or its agent shall have the right, but not the obligation, to
inspect PPL's quality control procedures and records and to obtain
specimens for analysis of the Substance from PPL's production to
confirm quality. ATI's employees may perform inspections of PPL's
manufacturing facilities. ATI employees who inspect PPL's facilities
shall comply with PPL regulations and rules.
[***] - Confidential treatment requested.
Supply Agreement 2
between Acute Therapeutics, Inc., and PolyPeptide
Laboratories, Inc.
December 10, 1997
3.2. ATI will approve initial testing documents, the master batch record,
and any revisions to these documents thereafter.
3.3. For each batch of the Substance produced by PPL, ATI shall undertake
testing for compliance with the Specifications. PPL will supply ATI
with a pre-shipment sample of each finished lot along with a
Certificate of Analysis from PPL, which will be shipped to ATI in
accord with instructions provided by ATI. Upon receipt of the
pre-shipment sample, ATI will engage a testing facility who will
perform the analysis according to ATI's instructions. Upon
completion of its testing, ATI shall submit to PPL a certificate of
analysis listing testing results and all agreed upon records for
each lot of the Substance produced.
3.4. ATI or it's agent shall have thirty (30) days upon receipt of the
pre-shipment sample to determine whether or not it conforms to the
Specifications. ATI shall promptly give PPL written notice of any
respect in which the Substance fails to conform to Specifications.
If ATI fails to notify PPL of any nonconformity within such 30-day
period, ATI shall be deemed to have accepted the Substance. At this
point PPL will arrange to ship all the Substance of the same batch
to ATI in accord with instructions provided by ATI. If ATI notifies
PPL of any nonconformity, payment of the invoice for the
nonconforming batch shall be held in abeyance until the dispute is
resolved.
3.5. Pursuant to Section 3.4, if ATI shall claim that any lot(s) of the
Substance fails to meet the Specifications, PPL reserves the right
to retest such lot(s) at its own expense at an outside facility
mutually agreed by both parties. In the event that the outside
party's test results indicates that the lot(s) meets the
Specifications, further action shall be negotiated.
3.6. In the event of a rejection of a batch of the Substance, PPL will
cease further production of the Substance until such time as the
results of an investigation have been communicated to ATI, and PPL
has concurred with the corrective action to be taken. Should ATI
desire to have additional lots of the Substance manufactured while
the investigation is in process, ATI will be responsible for the
fees for service performed by PPL whether the batch is accepted or
not.
3.7. ATI will provide a lot number and expiry period for each lot
manufactured by PPL.
3.8. ATI is responsible for release of the final Substance.
3.9. ATI is responsible for the Stability Testing Program.
3.10. ATI is responsible for maintaining Retention Samples.
Supply Agreement 3
between Acute Therapeutics, Inc., and PolyPeptide
Laboratories, Inc.
December 10, 1997
3.11. PPL will provide the name and phone number(s) of a contact person(s)
who may be called at any hour when PPL is manufacturing the
Substance or when the Substance is in transit outside of PPL.
4. PRICE
The prices to be paid by ATI for quantities of the Substance purchased
pursuant to Section 3 will be $[***] per batch of Substance as agreed in
writing and will be firm for the six (6) batches ($[***] for the entire
project).
5. TERM OF AGREEMENT
5.1 This Agreement shall become effective on the date first stated above
and, except as otherwise provided herein, shall be in effect until
the six (6) lots of soluble Substance have been produced.
5.2. Either party may terminate this Agreement for a material breach by
the other party by giving the breaching party written notice,
specifying the breach relied on, and giving the breaching party
thirty (30) days to cure such breach. If the default has not been
cured at the end of the thirty (30) day period, then, upon notice
thereof to the breaching party by the other, this Agreement shall
terminate. Termination for breach will have no effect on performance
obligations or amounts to be paid which have accrued up to the
effective date of such Termination.
5.3. In event of termination, transition will be conducted in such a
manner as to not cause inconvenience to either party.
6. PAYMENT TERMS
6.1. PPL will issue an invoice at such time as the PPL Quality Control
Department has completed its testing, found the Substance suitable
to be shipped and has shipped the test result documents to ATI. The
purchase price for the Substance will be paid to PPL no later than
thirty (30) days after the date of PPL's invoice to ATI.
6.2. All prices of the Substance shall be on the basis of F.O.B. on the
dock at PPL's plant in Torrance, California.
7. FACILITIES
7.1. PPL represents that it has obtained all approvals required by
Regulatory Authorities (hereinafter "RA") for its manufacturing
facilities and that its manufacturing facilities conform, and will
in the future conform, to current Good Manufacturing Practices
established by the RA from time to time. No material change in PPL's
manufacturing or testing procedures shall be made without prior
approval of ATI, for such testing procedures which are specific to
the Substance.
[***] - Confidential treatment requested.
Supply Agreement 4
between Acute Therapeutics, Inc., and PolyPeptide
Laboratories, Inc.
December 10, 1997
7.2. All documents and updates with regard to those activities covered by
this Agreement which are required by any RA shall be provided by
PPL, and PPL shall submit to all inquiries and inspections by such
RA. All documents provided by PPL to any RA shall be made available
to ATI, in advance if feasible, and in no case shall such documents
be made available for inspection by ATI later than two (2) working
days after such documents are provided to any RA. PPL shall promptly
notify ATI of all RA inspections concerning those activities covered
by this Agreement and in no case shall the written notification be
more than seven (7) days after the inspection has begun.
8. INDEMNIFICATION
8.1. ATI hereby holds harmless and indemnifies PPL against any and all
claims, losses, liabilities, lawsuits, proceedings, costs and
expenses, including, without limitation, reasonable attorneys' fees,
(hereinafter collectively referred as "Claim" or "Claims") resulting
from, arising out of or in connection with PPL's performance under
this Agreement except to the extent that such Claims are the result
of PPL's action, inaction or negligence in its performance under
this Agreement. If any Claim shall be made against PPL as to which
this indemnification applies, PPL shall immediately inform ATI of
such Claim which will be brought against PPL and/or ATI and in such
case PPL shall not take any step nor conduct any legal proceeding
before consulting and obtaining ATI's written approval. At PPL's
request, ATI and/or its insurers shall assume direction and control
of the defense against such Claim, including, without limitation,
the settlement thereof at the sole option of ATI or its insurer. PPL
may, at its option and expense, have its own counsel participate in
any proceeding which is under the direction and control of ATI. PPL
shall cooperate with ATI and its insurer in the disposition of any
such matters. In addition, PPL may at any time relieve ATI of its
responsibilities under Section 8.1 as to any other Claim.
8.2. PPL hereby holds harmless and indemnifies ATI against any and all
claims resulting from, arising out of or in connection with the
action, inaction or negligence of PPL in its performance under this
Agreement. If any Claims shall be made against ATI as to which this
indemnification applies, ATI shall immediately inform PPL of such
Claim which will be brought against ATI and/or PPL and in such case
ATI shall not take any step nor conduct any legal proceeding before
consulting and obtaining PPL's written approval. At ATI's request,
PPL and/or its insurers shall assume direction and control of the
defense against such Claim, including, without limitation, the
settlement thereof at the sole option of PPL or its insurer. ATI
may, at its option and expense, have its own counsel participate in
any proceeding which is under the direction and control of PPL. ATI
shall cooperate with PPL and its insurer in the disposition of any
such matters. In addition, ATI may at any time relieve PPL of its
responsibilities under Section 8.2 as to any other Claim.
Supply Agreement 5
between Acute Therapeutics, Inc., and PolyPeptide
Laboratories, Inc.
December 10, 1997
9. CONFIDENTIALITY
9.1. Except as hereinafter provided, information provided by one party to
the other party shall be treated as confidential (hereinafter
"Confidential Information") by the other party. Confidential
Information shall not include:
a) Information which was known to the receiving party, prior to
receipt from the delivering party;
b) Information which was in the public domain or generally known
to the trade at the time of receipt from the delivering party;
c) Information which, other than by breach of this Agreement,
enters the public domain or becomes generally known to the
trade;
d) Information which is disclosed to the receiving party by a
third party who is free to make such disclosure;
e) Information which is independently developed by the receiving
party without use of the delivering party's Confidential
Information; or
f) Information which is required to be disclosed by law,
regulatory, administrative or judicial order.
9.2. Each party's Confidential Information shall be kept confidential for
a period not less than seven (7) years by the other party and shall
not be disclosed by such other party other than to its officers,
employees and agents who are engaged in its operations relating to
the Substance and who have the need to know such Confidential
Information.
9.3. The provisions of Section 9 shall survive termination of this
Agreement for any reason.
10. FORCE MAJEURE
Neither party shall be liable for any failure or delay in performance when
any such failure or delay shall be caused (directly or indirectly) by
fires, flood, earthquakes, accidents, explosions, sabotage, strikes, or
other labor disturbances (regardless of the reasonableness of the demands
of labor), civil commotions, riots, invasions, wars, intervening
governmental regulations or orders, shortages of labor, fuel, power, or
raw material, inability to obtain equipment or supplies, inability to
obtain or delays in transportation, acts of God, or any cause (whether
similar or dissimilar to the foregoing) beyond the reasonable control of
ATI or PPL, as the case may be.
11. INDEPENDENT CONTRACTOR
Neither party shall have the right to control the activities of the other
in performance of this Agreement and each shall perform as an independent
contractor and nothing herein shall be construed to be inconsistent with
that relationship or status. Under no circumstances shall the employees or
agents of one party be considered employees or agents of the other. This
Agreement shall not constitute, create, or in any way be interpreted as a
joint venture, partnership, or formal business organization of any kind.
Supply Agreement 6
between Acute Therapeutics, Inc., and PolyPeptide
Laboratories, Inc.
December 10, 1997
12. NOTICES
Any and all notices or other communications required or permitted under
this Agreement must be in written form and be deemed to have been given
upon receipt of telefax to the notified party (followed by hard copy of
documents) addressed to the party to be notified as listed below or to
such other, address as either party shall have heretofore specified in a
notice to the other in the manner herein provided.
Contact Addresses:
ATI: Acute Therapeutics, Inc.
0000 Xxxxxx Xxxx
Xxxxxxxxxx, XX 00000
Attn: Xx. Xxxxx X. Xxxxxxxx
PPL: PolyPeptide Laboratories, Inc.
000 Xxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
Attn: Xx. Xxxx Xxxxx
13. ASSIGNMENT OF AGREEMENT
Neither this Agreement nor any rights or obligations hereunder may be
assigned by either party hereto without the prior written consent of the
other party, which shall not be unreasonably withheld. Any subsequent
assignee, purchaser, or transferee shall be bound by the terms of this
Agreement.
14. DEBARRED PERSONS STATEMENT
PPL shall not use in any capacity persons or the services of persons that
are debarred, on the Debarment List, or that have been convicted of
actions that could lead to debarment as described in Section 306(a) and
(b) of The Federal Food, Drug and Cosmetic Act or its amendments.
15. GOVERNING LAW
This Agreement shall be construed, interpreted and applied in accordance
with the laws of the State of Pennsylvania.
16. ARBITRATION
At the request of either party any controversy or claim arising out of, or
relating to, this Agreement shall be settled by arbitration either in Los
Angeles, CA, or in Philadelphia, PA, in accordance with the then current
arbitration rules of the American Arbitration Association. Judgment upon
the award rendered by the arbitrator(s) shall be binding on the parties
and may
Supply Agreement 7
between Acute Therapeutics, Inc., and PolyPeptide
Laboratories, Inc.
December 10, 1997
be entered by either party in the court or forum, state or federal, having
jurisdiction. Each party will bear half of the costs.
17. ENTIRE AGREEMENT
This Agreement constitutes the entire understanding between the parties
and is intended as a final expression of the agreement and as a complete
statement of terms and conditions thereof, and shall not be amended except
in writing signed by an authorized representative of each party and
specifically referring to this Agreement. If there is any inconsistency
between this document and any other writings which are referred to or are
incorporated herein, the terms and conditions of this document shall take
precedence. This Agreement supersedes any previous agreements or
arrangements between the parties and any customary practice of the parties
at variance with the terms hereof.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement by their
duly authorized representatives.
ACUTE THERAPEUTICS, INC. POLYPEPTIDE LABORATORIES, INC.
/s/ Xxxxxx Xxxxxxxx /s/ Xxxx Xxxxx
------------------------------------- --------------------------------------
Authorized signature Authorized signature
Xxxxxx Xxxxxxxx Xxxx Xxxxx
------------------------------------- --------------------------------------
Printed Name Printed Name
12/10/97 12/12/97
------------------------------------- --------------------------------------
Date Date
Supply Agreement 8
between Acute Therapeutics, Inc., and PolyPeptide
Laboratories, Inc.
December 10, 1997
Exhibit A
[***]
[***] - Confidential treatment requested.
Supply Agreement 9
between Acute Therapeutics, Inc., and PolyPeptide
Laboratories, Inc.
December 10, 1997
Exhibit B
Specifications for the Soluble KL(4) Peptide Substance
[***]
[***] - Confidential treatment requested.
