EXHIBIT 10.27
DEVELOPMENT AGREEMENT
This Development Agreement ("Agreement") is entered into as of March
30, 1998, by and between XXXXXX PHARMACEUTICALS, INC. ("Xxxxxx") and ACUTE
THERAPEUTICS INC. ("ACUTE"), with respect to the following:
RECITALS
A. WHEREAS, ACUTE desires to retain the services of Xxxxxx to
manufacture Product as defined herein for use by ACUTE in performing clinical
trials preliminary to the submission by ACUTE to the Federal (U.S.) Food and
Drug Administration ("FDA") of a new drug application ("NDA") and
B. WHEREAS, Xxxxxx desires to manufacture Product as defined herein for
use by ACUTE in performing clinical trials preliminary to the submission by
ACUTE to the Federal (U.S.) Food and Drug Administration ("FDA") of a new drug
application ("NDA").
NOW THEREFORE, in consideration of the mutual covenants set forth
herein, and other good and valuable consideration, the receipt and legal
sufficiency of which is hereby acknowledged, the parties hereto agree as
follows:
ARTICLE 1
DEFINITIONS
1.1 "Product Transfer Program" or "PTP" shall mean, in the aggregate, all
work conducted by Xxxxxx for ACUTE hereunder, towards the transfer and
validation of the injectable formulation for the Product. In connection with the
PTP, it shall be the responsibility of ACUTE to provide all new material and
components for the Development of the Product except as outlined in the Project
Outline.
1.2 "Product" shall mean XX0 Xxxxxxxxxx.
1.3 "Project Outline" shall mean the written description, as described in
Exhibit "A", all the terms and conditions incorporated herein by reference, of
all activities, data, validation and other documents to be conducted or prepared
by Xxxxxx in connection with the Product Transfer Program.
1.4 "Clinical Trial Supplies" shall mean the material manufactured by
Xxxxxx as described in Exhibit "A", according to the specifications provided by
Acute Therapeutics.
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ARTICLE 2
PRODUCT TRANSFER
2.1 Scope. Xxxxxx shall undertake a Product Transfer Program, as
follows:
(a) In connection with providing ACUTE with its required Clinical
Trial Supplies, Xxxxxx will undertake the following pursuant to the Project
Outline:
(i) Special Equipment Needs & Facility Modifications
(ii) Testing Methods Transfer
(iii) Production Process Developmental Batch Manufacturing
(iv) Production Process Validations
(v) Clinical Supply Manufacturing
(vi) Production Process Validations
(vii) Regulatory Support (if required)
2.2 Facilities/Personnel. All facilities, general equipment and
personnel necessary to permit Xxxxxx to perform its obligations hereunder will
be provided by Xxxxxx at its expense, and under their responsibility.
2.3 Cooperation. ACUTE agrees to cooperate with Xxxxxx and in
connection with Xxxxxx'x performance hereunder and further agrees to provide
Xxxxxx with all information, know-how methodology, and other technical
information regarding the Product. ACUTE will have a representative in the plant
to observe and participate in each phase of the project.
ARTICLE 3
REMUNERATION
3.1 Payment: Amount and Timing. ACUTE agrees to pay Xxxxxx in
accordance with' the payment and terms as outlined on page two of the attached
Exhibit "A", all the terms and conditions incorporated herein by reference.
ARTICLE 4
MANUFACTURING FOR CLINICAL TRIALS
4.1 Manufacturing. Xxxxxx agrees to manufacture the Product
according to current good Manufacturing Practices (cGMPs), pursuant to the
Project Outline and the specifications set forth therein, which such
specifications have been provided by ACUTE. ALL OTHER EXPRESS OR IMPLIED
WARRANTIES, INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED.
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4.2 Manufacturing Compliance. Xxxxxx shall advise ACUTE immediately
if an authorized agent of any regulatory body visits Xxxxxx'x manufacturing
facility and makes any inquiry regarding Xxxxxx'x method of manufacture of the
Product for ACUTE.
4.3 Shipping. Product provided by Xxxxxx to ACUTE hereunder shall
be FOB Xxxxxx'x Facility in Decatur, Illinois.
ARTICLE 5
PRESERVATION OF TRADE SECRETS AND REGULATORY
SUBMISSION INFORMATION
5.1 Confidentiality. The Parties hereto acknowledge and agree that
some information disclosed to and/or received from each other pursuant to this
Agreement may be confidential and may contain trade secrets and other
information proprietary to the disclosing party. It is therefore agreed that any
information received by either party from the other pursuant to or in
furtherance of the performance or this Agreement, clearly designated in writing
as CONFIDENTIAL (hereinafter referred to as "Information") shall not be
disclosed by the receiving party to any third party and shall not be used by the
receiving party for the purposes other than those contemplated by this Agreement
for a period ending seven (7) years after the date of termination of this
Agreement or for so long as the Information remains a trade secret, whichever is
longer.
5.2 Exceptions. The obligations of confidentiality set forth in
this Agreement shall not apply to the extent that (a) either party is required
to disclose information by order or regulation of a governmental agency or a
court of competent jurisdiction, or (b) the recipient can demonstrate that (i)
the disclosed information is in the public domain other than as a result of the
actions of the recipient, its employees, consultants, agents or subcontractors
in violation of this Agreement, (ii) the disclosed information was already
rightfully known to the recipient (as shown by its written records) prior to the
date of disclosure to the recipient in connection with the negotiation or
performance of this Agreement, or (iii) the disclosed information was received
by the recipient on an unrestricted basis from a source unrelated to any party
of this Agreement and not under a duty of confidentiality to the other party, or
(c) disclosure is made to the FDA as part of the FDA's product approval process
(or to an equivalent agency of a foreign country as part of such country's
product approval process), or (d) is independently developed by the Recipient
without reference to the Proprietary Information of the Disclosing Party.
ARTICLE 6
MISCELLANEOUS
6.1 Binding. This Agreement shall inure to the benefit of, and
shall be binding upon, the Parties hereto, their heirs, personal
representatives, successors, or assigns.
6.2 Governing Law. This Agreement shall be governed in all
respects, whether as to validity, construction, capacity, performance or
otherwise, by the
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laws of the State of Illinois. Additionally, Jurisdiction and Venue over any
controversy, claim or remedy, arising out of, or relating to, this Agreement or
any breach hereof, shall be the Circuit Court located in Macon County, Illinois.
6.3 Notice. All notices under this Agreement must be in writing and
must be given (a) by depositing such notice in the United States Mail, postage
prepaid, certified or registered, return receipt requested, (b) by prepaid
telegram, or (c) by delivering Such notice in person or by commercial messenger.
For purposes of notice, the addresses of the Parties shall be as set forth below
each Party's signatures below. Notices made in accordance with the foregoing
shall be effective when received. Any Party may designate to all other Parties
hereto, pursuant to the notice provisions hereof, a different address to which
notices shall thereafter be directed by written notice.
6.4 Severability. If any provision herein is declared invalid, it
shall be considered deleted from this Agreement and shall not invalidate the
remaining provisions hereof; unless such would materially alter the underlying
intent of the Parties hereto in which case the entire Agreement shall be deemed
null and void.
6.5 Entire Subject Matter/No Prior Agreements. This document and
those other documents expressly referenced herein and made a part hereto as
Exhibits, constitute the entire agreement of the Parties, and supersede any and
all prior agreements whether in writing or verbal, and neither of the Parties is
relying upon any warranties, representations, or inducements not expressly set
forth herein.
6.6 Amendments. The provisions of this Agreement may be waived,
altered, amended or repealed, in whole or in part, only by an instrument in
writing signed by both Parties.
6.7 No Third-Party Rights. Nothing in this Agreement, whether
express or implied, is intended to or does confer any rights or remedies on any
persons other than the parties, hereto.
6.8 Counsel. Notwithstanding that Xxxxxxx & Xxxxx, LLP, counsel to
Xxxxxx Pharmaceuticals, Inc., drafted this Agreement, the terms and provisions
hereof have been negotiated between the Parties and the parties agree that this
Agreement shall not be construed against the party whose counsel drafted this
Agreement.
6.9 Relationship of Parties. Xxxxxx is an Independent Contractor
for ACUTE and the Parties are not partners or joint venturers.
6.10 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, and all of which
together constitute one and the same instrument.
6.11 Assignment. This Agreement shall not be assignable or
delegated by either party without the written consent of the other.
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6.12 Mutual Exclusivity. Xxxxxx agrees to manufacture the Product
exclusively for ACUTE. ACUTE agrees to use Xxxxxx as its exclusive manufacturer
for the Product as long as capacity requirements can be met by Xxxxxx, as
mutually agreed by the Parties and any changes to the cost structure as outlined
in Exhibit "A", all the terms and conditions incorporated herein by reference,
are mutually agreed to by the Parties in writing.
6.13 Term. The obligation of the parties hereunder shall
effectively commence on the execution of the Agreement by each of the parties
and continue for four (4) Annual Periods; provided the Agreement will
automatically be extended for one (1) Annual Period unless either party notifies
the other party in writing twelve (12) months prior to the end of the term of
its desire not to extend the Agreement. Thereafter, the Agreement will be
automatically extended for consecutive one (1) year terms unless either party
notifies the other party in writing twelve (12) months in advance of its desire
not to extend the Agreement.
The Parties hereto have caused this Agreement to be executed on the
dates set forth opposite the signature of each of the Parties below.
Dated: April 7, 1998
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ACUTE, INC.
By: /s/ Xxxxxx X. Xxxxxxxx
---------------------------
(Print Name)
-------------------------------
Title: President/CEO
Acute Therapeutics, Inc.
Xxxxxxxxxx, Xx 00000
Dated: April 16, 1998
------------------------
XXXXXX PHARMACEUTICALS,
an Illinois corporation
By: /s/ Xxxxx Xxxxxxxx
---------------------------
XXXXX XXXXXXXX
President
000 X. Xxxxxxx Xxxx
Xxxxxxx, Xxxxxxxx 00000
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EXHIBIT A
DEVELOPMENT PROJECT FOR KL4 - SURFACTANT
PROPOSAL NO.: 1020-ATI-03 (03/31/98)
The following sections define the individual components to be carried out under
the proposed in support of the clinical supply of KL4 - Surfactant. This
proposal covers Xxxxxx Pharmaceuticals' understanding of the requested Scope of
Work. This proposal incorporates the following work:
TIMING (See Attached)
RAW MATERIALS, COMPONENTS AND FILTERS
* Cost of these goods incorporated into the per batch price
SPECIAL EQUIPMENT NEEDS [***]
FACILITY MODIFICATIONS/POST-MODIFY VALIDATIONS [***]
PHASE I:
Methods and Process Transfer and Validation
A. Testing Methods Transfer [***]
1. Analyical
2. Microbiology
B. Production Process Validations
1. Vessel/TFE Validations [***]
2. Autoclave Cycle Development/Validations for KL4 Support Equipment [***]
3. Media Fills (x3) [***]
4. Mixing Validation [***]
5. Container/Closure Integrity [***]
C. Production Process Development Batch Manufacturing
1. Master Batch Record Development (for Development Batch) [***]
2. Production Process Development Batch Manufacture and Testing
o Option 1 [***] [***]
o Option 2 [***] [***]
PHASE II:
Provide ATI with its required Clinical Trial Supplies
A. Clinical Supply Manufacturing
1. Master Batch Record Development (for Clinical Batch) [***]
2. Clinical Batch Manufacturing and Testing
o Option 1 [***] [***]
o Option 2 [***] [***]
3. Shipping: F.O.B. Decatur [***]
-----------------
[***]Confidential Treatment Requested. Omitted portions have been filed
separately with the Commission.
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B. Production Process Validations for Full Scale Batches
1. Scaled Up Batch Mixing Validation [***] [***]
2. Semi-Automated Inspection Validation [***] [***]
C. Regulatory Support for the CMC Section
1. Special Equipment Purchases [***] 50% Due Upon Project Agreement
and Facility Modification/Validation 50 Due Upon Install/Valid Complete
2. Phase I
a. Option 1 [***] [***] 50% Will be Invoiced upon project
agreement. Half of the invoiced amount
will be due upon receipt of invoice,
the balance of the invoice will be due
60 days thereafter.
b. Option 2 [***] [***] 25% Due Upon Media Fill Complete
25% Due Upon Batch Complete
3. Phase II.A.
a. Option 1 [***] [***] 25% Due Upon Fill Scheduling
b. Option 2 [***] [***] 50% Due Upon Fill Complete
25% Due Upon Batch Release
4. Phase II.B. & C. [***] [***]
[***]
[***]
[***]
[***]
[***] Due Upon Regulatory
Submission
5. Additional Clinical Batches
a. Option 1 [***] [***] 25% Due Upon Fill Scheduling
b. Option 2 [***] [***] 50% Due Upon Fill Complete
25% Due Upon Batch Release
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[***]Confidential Treatment Requested. Omitted portions have been filed
separately with the Commission.
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RAW MATERIALS, COMPONENTS AND FILTERS:
A. Proposed Raw Materials: Source: Concentration: Provided
By:
[***] [***] [***] [***]
B. Components:
[***]
C. Filters (Quantity per batch):
[***]
-----------
[***]Confidential Treatment Requested. Omitted portions have been filed
separately with the Commission.
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SPECIAL EQUIPMENT NEEDS/FACILITY MODIFICATIONS:
A. Equipment Requirements:
[***]
B. TP Facility Modifications (Expense Incurred by ATI):
[***]
PHASE I:
Methods and Process Transfer and Validation:
A. Methods Transfer:
[***]
B. Production Process Validations:
[***]
2. Autoclave Cycle Development/Validation for KL4 specific support equipment:
[***]
3. Media Fills:
[***]
4. Mixing Validation [***]
5. Container/Closure Integrity Testing [***]
C. Production Process Development Batch:
[***]
--------
[***]Confidential Treatment Requested. Omitted portions have been filed
separately with the Commission.
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PHASE II:
Provide ATI with its required Clinical Trial Supplies:
A. Phase I Clinical Supply Manufacturing:
1. Master batch records will be developed by TP and approved by TP and ATI
based on the development batch manufacturing processes performed at TP
for the KL4- Surfactant products.
[***]
2. Clinical Batch Manufacturing and Testing:
a. [***]
b. In-Process Testing will be performed as follows:
[***]
c. The product will be filled and stoppered [***]
d. Finished product testing will be performed as follows:
[***]
e. Inspection: [***]
f. Labeling: The vials will be individually labeled using computer
generated labels. Provided by TP based on label text provided by ATI
g. Packaging: Bulk Packaged with labels computer generated by TP
3. Shipping: Finished product will be shipped to ATI under a controlled
and regulated refrigerated temperature. Shipping charges to be
reimbursed to TP by ATI.
B. Scaled Up Product Validations:
1. Mixing Validation [***]. The validation will consist of:
[***]
2. Inspection Validation to Semi-Automated Process: [***]
------------
[***]Confidential Treatment Requested. Omitted portions have been filed
separately with the Commission.
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C. Regulatory support in assembling the CMC Section for the IND
submissions.
TP will copy and provide documentation to ATI for support of their IND
submissions.
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