THIS EXHIBIT HAS BEEN REDACTED
AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
MASTER SERVICES
AGREEMENT
This Master
Services Agreement, dated as of March 31, 2009 (the
“Effective Date”), is between Cadila Pharmaceuticals
Limited, a company incorporated under the laws of India having its
registered office at “Cadila Corporate Campus, Sarkhej
— Dholka Road, Bhat, Ahmedabad-382210, Gujarat, India
(“Cadila”), and Novavax, Inc., a Delaware corporation
having its principal place of business at 9920 Belward Campus
Drive, Rockville, Maryland, 20850, United States
(“Novavax”).
1.
Description of Services.
1.1 General
. This Master Services Agreement contemplates that Novavax may
request various services from Cadila from time to time in the areas
of biologics research, preclinical development, clinical
development, process development and manufacturing scale up and
general manufacturing related services in India, and that the
provision of such periodic services by Cadila shall be governed by
this Agreement.
Novavax shall
request services from Cadila by means of one or more written
Services Requests, which shall set forth a description of the
desired services, timeline for completion, and any other
information that Novavax believes is relevant to the requested
services. Novavax and Cadila will confer as necessary for Cadila to
understand the details of the requested services. Cadila shall
promptly respond to Novavax with a Project Estimate that sets forth
an estimated cost and timeline for the requested services. In
March 2009 Novavax visited the Cadila Campus in Ahmedabad to
conduct due diligence of Cadila personnel and facilities, and
understand Cadila’s capabilities of performing the desired
services at the required level of performance and Novavax was
generally satisfied with Cadila’s capabilities to perform the
desired services. Novavax may request minor changes in procedures,
equipment or similar to enhance the performance capabilities of a
project by Cadila from time to time. Novavax may also consider
other service providers for the desired services. Novavax will
remit the initial Services Request within sixty (60) days of
execution of this Agreement. The Project Plans as may be approved
by the parties will be attached hereto as Exhibit A (Project
Plans) forming part of this Agreement within sixty (60) days
of Cadila’s receipt of the initial Service
Request.
Novavax shall
issue Services Requests to Cadila and Cadila shall then promptly
prepare a detailed draft Project Plan that describes the services,
cost and payment schedule based on fully loaded actual costs
(including escalated costs, if any) plus [* * *], timelines,
primary contacts, scheduled teleconferences and meetings, and
deliverables. Novavax and Cadila will then work together to
finalize the Project Plan for approval and final agreement by both
the parties. In addition, if the services require the use of
tangible research materials (e.g., biological or chemical
materials) provided by Novavax, the Project Plan shall contain a
description of such materials, delivery arrangements, timelines,
and special treatment instructions (if any). Each Project Plan
shall become effective after execution by both parties. The
services described in each executed
THIS EXHIBIT HAS BEEN REDACTED
AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
Project Plan
shall be defined as “Services” under this Agreement.
Each Project Plan shall constitute an addendum to this Agreement,
and shall therefore be governed by and incorporated into the terms
of this Agreement.
Cadila will
assign a qualified Project Manager to each Project Plan who shall
be named in the Project Plan. The Project Manager will coordinate
performance of the Project Plan and all communication between
Cadila and Novavax regarding the Project Plan.
2.
Performance by Cadila .
Cadila shall
diligently perform the Services according to the applicable Project
Plan using commercially reasonable efforts. Novavax shall timely
provide Cadila with any materials specified in the applicable
Project Plan and shall timely furnish Cadila with any information
or additional materials as reasonably requested by Cadila for the
performance of the Services. Cadila shall not be responsible for
any delays caused by Novavax. If Novavax delays a Project Plan or
desires to reschedule a Project Plan, Cadila will use good faith
efforts to accommodate the needs of Novavax, but makes no
commitment to commence or complete the Services under the Project
Plan on the original schedule. Cadila shall conduct the Services in
a professional manner consistent with applicable industry standards
and consistent with all applicable Indian laws and regulations and
United States federal Food and Drug Administration regulations,
including Good Laboratory Practices (GLP), Good Manufacturing
Practices (GMP) and Good Clinical Practices (GCP).
Cadila shall
prepare and maintain complete and accurate records containing all
results generated by Cadila in the performance of the Services (the
“Project Results”). Cadila shall meet with Novavax by
teleconference and furnish Novavax with interim reports of the
Project Results periodically as provided in the applicable Project
Plan, or as otherwise agreed by the parties. After the Services are
completed under a Project Plan, Cadila shall provide Novavax with a
final report on the Project Results in accordance with the
requirements of the applicable Project Plan.
4. Payment
by Novavax; Guaranty of Services .
Novavax shall
pay to Cadila the costs of the Services in accordance with the fees
on the schedule set forth in the applicable Project Plan. All
amounts shall be due and payable within thirty (30) days after
invoice by Cadila. All payments shall be made in US dollars unless
otherwise agreed by the parties. If the actual costs of the
Services under a Project Plan exceed the estimated costs as
included in the Project Plan, then Novavax shall pay the actual
costs; provided, however, that Cadila shall not incur nor invoice
any costs in excess of [* * *] of the estimated cost in the Project
Plan without the prior written consent of Novavax. If any amount
payable under this Agreement is not paid when due and payable,
Cadila reserves the right, without prejudice to its other rights
and remedies, to charge interest on such amount at the rate of [* *
*] per annum. In
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THIS EXHIBIT HAS BEEN REDACTED
AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
addition,
Cadila may suspend its performance of the Services under all
Project Plans if any amounts due and payable by Novavax have not
been timely paid.
It is the
intent of the parties that, during the first three years of the
term of this Agreement (the “Services Period”), Novavax
will have engaged Cadila to perform Services hereunder that will in
the aggregate equal $7.5 million in fees paid to Cadila. If,
at the end of the Services Period, the Services Amount (defined
below) does not equal or exceed $7.5 million, then Novavax
shall pay Cadila an amount (the “Final Amount”) equal
to the sum of (a) the portion of the Shortfall Amount that is
less than or equal to $2.0 million, plus (b) the product
of fifty percent (50%) times the portion, if any, of the Shortfall
Amount that exceeds $2.0 million. For purposes of this
Section 4 and Section 9.2, “ Services Amount
” equals the sum of (A) the amounts paid under all
Project Plans, and (B) amounts to be paid under executed
Project Plans if the Services under such Project Plans are
completed as provided therein, and (C) any amounts that would
have been paid for services under a reasonable Service Request
provided to Cadila under this Agreement, which Service Request
(i) concerns legitimate products or projects within
Novavax’s scope of its own business and (ii) involves
services that Cadila is reasonably able to provide within its scope
of resources and expertise, but for the fact that Cadila exercised
its right not to prepare a Project Estimate or agree to a Project
Plan reasonably offered to Cadila by Novavax containing terms
substantially consistent with those contained in Cadila’s
Project Estimate therefor (which amounts shall be reasonably
determined based on amounts that would be reasonably charged for
such services had Cadila actually provided a Project Estimate and
the parties had entered into a Project Plan therefor); and “
Shortfall Amount ” equals the difference between
$7.5 million and the Services Amount.
5. Ownership
of Work Product .
5.1
Disclosures . Cadila will promptly notify Novavax of any
invention, discovery, improvement, formula, know-how, design,
process or technique, whether patentable or not, which is conceived
or reduced to practice by Cadila in the course of Cadila’s
performance of Services.
5.2 Novavax
Ownership . Except as set forth in Section 5.3, Novavax
shall have sole ownership of all right, title, and interest in and
to all (a) Project Results, and (b) inventions,
discoveries, improvements, formulas, know-how, designs, processes
and techniques, whether or not patentable, patent rights,
copyrights, and any other intellectual property rights (all the
foregoing, collectively, “IP Rights”) directed or
specific to Novavax’s VLP vaccines, Novavax’s VLP
platform or the particular products or programs of Novavax
described in the Project Plan (“Novavax Technology”)
conceived or reduced to practice by Cadila in the course of
performance of the Services, and (c) IP Rights directed or
specific to Novavax Technology conceived or reduced to practice
jointly by Cadila and Novavax in the course of performance of the
Services (collectively, the “Novavax IP Rights”).
Cadila hereby assigns, transfers, and conveys to Novavax all right,
title, and interest in the Novavax IP Rights (subject, as
applicable, to the license granted by Novavax to the joint venture
to be formed under the Joint Venture Agreement between Novavax and
Cadila). Cadila further agrees to execute any documents
and
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THIS EXHIBIT HAS BEEN REDACTED
AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
to provide
Novavax with any other assistance that is reasonably necessary for
Novavax to perfect and enjoy its rights under this
Section.
5.3 Cadila
Ownership; Non-Exclusive License . Novavax acknowledges that,
in the course of providing Services, Cadila (solely or jointly with
Novavax) may conceive of, or reduce to practice, IP Rights in the
course of performance of the Services that are not directed to or
specific to the Novavax Technology, including, without limitation,
any improvements to Cadila’s existing technologies or
capabilities (collectively, “Cadila IP Rights”).
Therefore, notwithstanding the provisions of Section 5.2,
Cadila shall have sole ownership of all Cadila IP Rights. Novavax
hereby assigns, transfers, and conveys to Cadila all right, title,
and interest in Cadila IP Rights. Novavax further agrees to execute
any documents and to provide Cadila with any other assistance that
is reasonably necessary for Cadila to perfect and enjoy its rights
under this Section. Cadila hereby grants to Novavax a fully paid,
nonexclusive right and license to use any Cadila IP Rights in
connection with the research, development, manufacture and sale of
Novavax vaccine products anywhere in the world. Except as expressly
provided herein, Cadila retains all of its rights, title and
interest in, to and under its intellectual property, technology and
other assets, and no transfer of ownership or license is provided
hereunder with respect thereto (by implication or otherwise),
except as expressly provided for herein.
6.
Confidential Information .
6.1 “
Confidential Information ” means any confidential or
proprietary information furnished by one party (the
“Disclosing Party”) to the other party (the
“Receiving Party”) in connection with any Services
Request or Project Plan or otherwise in connection with the
performance of Services hereunder, any information within the
Project Results and any Novavax IP Rights and any Cadila
Improvements and Cadila IP Rights. All information within the
Project Results, other than Cadila Improvements and Cadila IP
Rights, shall be the Confidential Information of Novavax and
Novavax shall be deemed the Disclosing Party with respect to such
information. All information relating to Cadila Improvements and
Cadila IP Rights shall be the Confidential Information of Cadila
and Cadila shall be deemed the Disclosing Party with respect to
such information. Such Confidential Information may include,
without limitation, trade secrets, know-how, inventions, product or
technical data or specifications, testing methods, and research and
development activities and results.
6.2
Restrictions . During the term of this Agreement and
thereafter for a period of ten (10) years, the Receiving Party
shall (i) maintain all Confidential Information in strict
confidence, except that the Receiving Party may disclose or permit
the disclosure of any Confidential Information to its directors,
officers, employees, consultants, and advisors who are obligated to
maintain the confidential nature of such Confidential Information
and who need to know such Confidential Information for the purposes
of this Agreement; (ii) use all Confidential Information
solely for the purposes of this Agreement (or any other agreements
entered into by the parties); and (iii) allow its directors,
officers, employees, consultants, and advisors to reproduce the
Confidential Information only to the extent necessary to fulfill
the purposes of this Agreement, with all such reproductions being
considered Confidential Information.
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