Exhibit 10.3
Confidential Treatment has been
requested for portions of this exhibit. The copy filed herewith
omits the information subject to the confidentiality request.
Omissions are designated as “***”. A complete version
of this exhibit has been filed separately with the Securities and
Exchange Commission.
KBI BioPharma, Inc. Services
Agreement
This Services Agreement
(“Agreement”) dated 5 September, 2008 between
Senesco Technologies, Inc , a Delaware company
(“Client”) having its principal place of business at
303 George Street, Suite 420, New Brunswick, NJ 0890 1
and KBI BioPharma, Inc., a Delaware company (“KBI
BioPharma”) having its principal place of business at 1101
Hamlin Road, Durham, North Carolina 27704 (each a
“Party”, collectively the
“Parties”).
Whereas:
Client desires KBI BioPharma to
perform services in accordance with the terms of this Agreement and
KBI BioPharma desires to perform such services.
In consideration of the above
statements, which form part of this Agreement, and other good and
valuable consideration, the sufficiency and receipt of which are
hereby acknowledged, the Parties hereto agree as
follows:
1.
Performance
KBI BioPharma will perform the
services (the “Services”) detailed in the proposal
and/or scope-of-work set forth in Attachment One (the
“Proposal”) on behalf of Client in accordance with this
Agreement herein incorporating the Proposal and incorporating the
Quality Agreement ( applicable only for projects with cGMP
activities ) attached hereto as Attachment Two. In the
event of any conflict between this Agreement and the Proposal, this
Agreement shall control. In the event of any conflict between
the Proposal and any applicable Quality Agreement, the Quality
Agreement shall control.
Client shall support and cooperate
with the execution of the services and shall not engage in any act
or omission, which may reasonably be expected to prevent or delay
the successful execution of the Services. Such support and
cooperation shall include, but not be limited to, informing KBI
BioPharma of global regulatory strategy for development and
approval of the product(s) to the extent relevant to the
Proposal, prompt review and approval of documents requiring
Client’s signature, timely delivery of methods and materials
and prompt response to other similar issues.
2.
Compliance with Applicable Government Regulations
KBI BioPharma will undertake the
Services in compliance in all material respects with applicable
laws, rules, regulations and guidelines; provided that the U.S.
Food and Drug Administration (FDA) current Good Manufacturing
Practices (cGMP) shall apply if and only to the extent cGMP
activities are specified in the Proposal.
3.
Client Obligations
Unless otherwise agreed to by the
Parties in writing, Client is solely responsible, in each case in
accordance with the Proposal, for: (a) provision of complete
and accurate scientific data regarding the Proposal;
(b) provision of all information necessary to effect the
reliable transfer of methods to KBI BioPharma; (c) provision
of specific reagents, reference standards or other
materials
1
necessary for execution of the
Proposal; (d) if applicable, review and approve in-process and
finished product test results to ensure conformity of such results
with product specifications, regardless of which party is
responsible for finished product release; (e) preparation of
all submissions to regulatory authorities; and (f) performance
of other obligations of Client set forth in the
Proposal.
4.
Hazardous Materials
Client warrants to KBI BioPharma
that no specific safe handling instructions are applicable to any
substance or material provided by Client to KBI BioPharma, except
as disclosed to KBI BioPharma in sufficient time for review and
training by KBI BioPharma prior to delivery. Where
appropriate or required by law Client shall provide a Material
Safety Data Sheet and instructions for proper storage for all
Client-provided materials, finished product and reference
standards.
5.
Facility Visits and Audits
Client’s representatives may
visit KBI BioPharma’s facilities during normal business hours
and with prior written notice to observe the progress of the
Proposal, provided that such access does not compromise cGMP
compliance or safety. KBI BioPharma will assist Client in
scheduling such visits, which will be conducted in a manner
reasonably required to protect confidentiality of other
clients.Client may conduct one quality assurance audit per calendar
year at no cost in accordance with the provisions of the Quality
Agreement (if applicable). Additional audits will be invoiced
separately on a time and materials basis at the then current rate
for such services.
6.
Regulatory Inspections
KBI BioPharma will promptly notify
Client of any regulatory inspections directly relating to the
Proposal in accordance with the terms of the Quality Agreement (if
applicable) incorporated herein. Client accepts reasonable
and documented costs charged by a regulatory authority for
inspections directly related to the Proposal.
7.
Compensation
KBI BioPharma will invoice Client as
set forth in the Proposal. Payments are due thirty (30) days
from date of invoice. Late payments are subject to an
interest charge of one and one half percent (1½%) per month
or, if less, the maximum legal interest rate per month.
Failure to bill for interest due shall not be a waiver of KBI
BioPharma’s right to charge interest.
KBI BioPharma requires payment of an
initial fee, specified in the proposal, prior to commencement of
Services, to account for facilities preparation costs and resource
allocation commitments with respect to Client’s
project(s). Unless otherwise provided in the applicable
Proposal, initial fees are nonrefundable (absent an uncured breach
by KBI BioPharma) and are due and payable at signing, or in any
event within five (5) days, without issuance of an invoice by
KBI BioPharma.
8.
Taxes
Client will pay (or reimburse in
full to KBI BioPharma) any sales, use, gross receipts, compensating
or other taxes, licenses or fees (excluding KBI BioPharma’s
net income and franchise taxes) to be paid by KBI BioPharma to any
tax jurisdiction arising from the Proposal.
9.
Change Orders
KBI BioPharma may revise the price
for the Services as set forth in the Proposal if (a) Client
revises KBI BioPharma’s responsibilities, the specifications,
the Proposal instructions, procedures, assumptions, processes, test
protocols, test methods, analytical requirements or otherwise
requests a modification to the Proposal, (b) Client’s
requirements or any Client-provided
2
information is inaccurate or
incomplete and such inaccuracy or incompleteness results in
increased costs to KBI BioPharma, (c) necessitated by changes
to applicable laws, rules or regulations (d) if
necessitated by an event outside the control of KBI BioPharma,
including , without limitation, the events described in section 16
(Force Majeure) or (e) for other such reasons set out in the
Proposal. Client will be notified of such revision via
issuance of a Change Order detailing the reasons for the price
revision and subject to Client’s written consent.
10.
Shipment
Unless otherwise agreed in writing
by the parties, all products, raw materials, samples components or
other materials shipped by KBI BioPharma are delivered F.O.B. KBI
BioPharma’s facilities. KBI BioPharma shall package for
shipment such product, raw materials, samples, components or other
materials at Client’s expense (including insurance) and in
accordance with Client’s full written and reasonable
instructions.
11.
Limitations of Liability
Notwithstanding any other provision
in this Agreement, KBI BioPharma’s liability for losses to
Active Pharmaceutical Ingredient, bulk drug product, intermediates,
samples, reagents or other materials provided by Client, whether or
not incorporated into finished product, shall in no event exceed
the undisputed fair market value thereof.
Notwithstanding anything herein to
the contrary, UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE
ENTITLED TO INCIDENTAL, INDIRECT, CONSEQUENTIAL, EXEMPLARY OR
SPECIAL DAMAGES, WHETHER OR NOT FORESEEABLE, ARISING IN CONNECTION
WITH THE DEFAULT OR BREACH OF ANY OBLIGATION OF THE OTHER PARTY
UNDER THIS AGREEMENT, THE PROPOSAL, THE QUALITY AGREEMENT OR ANY
APPENDICES OR DOCUMENTS RELATED THERETO, SUBJECT TO SECTION 15
HEREOF.
12.
Warranties
KBI BioPharma warrants to Client
that (i) it will render the Services in a manner that meets
professional and industry standards for work of a similar nature
and (ii) it will use commercially reasonable efforts to
perform the Services and, to the extent applicable for cGMP
services, the Quality Agreement. EXCEPT AS EXPRESSLY STATED IN
THIS SECTION 12, KBI BIOPHARMA DISCLAIMS ALL WARRANTIES,
EXPRESS OR IMPLIED WITH RESPECT TO THE SERVICES AND ANY MATERIALS
PROVIDED HEREUNDER, AND CLIENT HEREBY WAIVES ALL SUCH WARRANTIES,
EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED
WARRANTIES OF MERCHANTABILITY, NONINFRINGEMENT OR FITNESS FOR A
PARTICULAR PURPOSE. Except as otherwise provided in
this Agreement, Client’s sole remedy and KBI
BioPharma’s exclusive obligation under the foregoing warranty
in this Section 12 is for KBI BioPharma, at its option, to
either re-perform or correct such services (without cost or expense
to Client, including shipping conforming KBI BioPharma deliverables
to Client) or to refund to Client the amount paid therefore,
including the cost of shipping. For avoidance of doubt,
Client understands and agrees that the Services are experimental in
nature, that biopharmaceutical process development is subject to
certain inherent risks, and as such nothing in this Agreement shall
be construed as a guarantee or warranty by KBI BioPharma that the
Services, or the materials, data, information of other results
produced in connection therewith, will meet or otherwise satisfy
any of the objectives, goals or targets stated in the
Proposal.
13.
Confidentiality
All information disclosed by a party
in connection with the Proposal shall be considered confidential
information. For the duration of the Proposal and for a
period of five (5) years thereafter, neither
