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.
TECHNICAL SERVICES
AGREEMENT
This Technical Services Agreement
(the “Agreement”) is made as of March 31, 2009
(the “Execution Date”), by and between Novavax, Inc. , a Delaware
corporation having an address at 9920 Belward Campus Drive,
Rockville, Maryland 20850, United States of America
(“Novavax”) and CPL Biologicals Limited, a limited
company incorporated under the laws of India having an address at
“Cadila Corporate Campus”, Sarkhej-Dholka Road, Bhat,
Ahmedabad — 382210, Gujarat, India (“Company”). Novavax
and Company are sometimes referred to herein each individually as a
“Party” and collectively as the
“Parties.”
Whereas , the
Company, a joint venture formed pursuant to a Joint Venture
Agreement dated as of the date hereof (the “Joint Venture
Agreement”) between Novavax and Cadila Pharmaceuticals
Limited, organized under the laws of India (“Cadila”),
was formed for developing, manufacturing, marketing and selling
certain pharmaceutical and medicinal products to cater the needs of
the market in India;
Whereas ,
Novavax and Cadila intend that Company will establish U.S. and
India cGMP acceptable manufacturing facilities (the
“Manufacturing Facilities”) in India and the structure
for developing, producing, marketing and selling pharmaceutical
products either directly or through partners / contractors as
further described in the Joint Venture Agreement;
Whereas ,
Novavax has granted the Company a license to certain of
Novavax’s Patents and Know-How for the Company to develop and
commercialize Novavax Products under the Novavax Licenses (as each
such term is defined in the Joint Venture Agreement);
and
Whereas
, Novavax has
significant subject matter expertise in biologics, preclinical
development, clinical development, process development and
manufacturing scale up and general manufacturing related
services.
Now, Therefore
, in consideration of
the foregoing premises and the mutual covenants set forth below,
and for other good and valuable consideration, the receipt of which
is hereby acknowledged, Novavax and Company hereby agree as
follows:
Section 1.1.
References in the body of this Agreement to “Sections”
will refer to the sections of this Agreement. In addition, as used
herein, the following initially capitalized terms will have the
following meanings:
(a) “Affiliate”
means any corporation or other business entity controlled by,
controlling, or under common control with a Party, with
“control” (for purposes of this Section 1.1)
meaning (a) direct or indirect beneficial ownership of fifty
percent (50%) or
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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
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EXCHANGE COMMISSION.
more of the
voting stock (or, in the case of a non-corporate entity, of the
equity interests with the power to direct the management and
policies) of such corporation or other business entity, or
(b) possession, directly or indirectly, of the power to
direct, or cause the direction of, the management and policies of
such corporation or other business entity, whether through the
ownership of voting securities, by contract, or otherwise; provided
that for purposes of this Agreement, Novavax and Cadila shall not
be deemed to be an Affiliate of Company.
(b) “Bankruptcy
Event” means, with respect to a specified Person,
(i) the filing by such Person in any court or agency, pursuant
to any statute or regulation of any state or country, a petition in
bankruptcy or insolvency or for reorganization or for an the
appointment of a receiver or trustee of such other Party or of its
assets, (ii) the filing against such Person of an involuntary
petition for any bankruptcy or insolvency proceeding which petition
is not dismissed within sixty (60) days after filing,
(iii) the making by such Person of an assignment for the
benefit of its creditors, (iv) the taking of possession of a
substantial part of the assets of such Person by a lien holder or
other encumbrancer, or (v) the levy or enforcement of any
distress, execution or other process upon or against a substantial
part of the assets of such Person.
(c) “Business
Day” means any day other than a Saturday, Sunday or other day
on which the principal commercial banks located in Mumbai, India
are not open for business during normal business hours.
(d) “Company
Indemnitee” has the meaning set forth in
Section 6.2.
(e) “Consulting
Services” shall mean the services set forth in
Section 2.3.
(f) “Development
and Regulatory Services” shall mean the services set forth in
Section 2.2.
(g) “Effective
Date” means the date on which the condition precedent set
forth in Article 7 is first satisfied.
(h) “Governmental
Authority” means any court, agency, department or other
instrumentality of any foreign, federal, state, county, city or
other political subdivision.
(i) “Improvements”
means any enhancements or modifications in the production process
concerning Novavax Products.
(j) “Indeminitee”
means a Company Indemnitee or Novavax Indemnitee, as
applicable.
(k) “Indemnitor”
means the Company or Novavax, as applicable.
(l) “Joint
Venture Agreement” has the meaning set forth in the
Recitals.
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AND
EXCHANGE COMMISSION.
(m) “Know-How”
means any tangible and intangible (a) techniques, technology,
practices, trade secrets, inventions (whether patentable or not),
methods, protocols, processes, formulas, knowledge, know-how,
skill, experience, records, documents, data and results (including
pharmacological, toxicological, non-clinical and clinical test data
and results), analytical and quality control data, results or
descriptions, software and algorithms and (b) compositions of
matter, cells, cell lines, assays, animal models and physical,
biological or chemical material.
(n) “Laws”
means applicable laws, statutes, rules, regulations, ordinances and
other pronouncements having the effect of law of the United States
and India.
(o) “Losses”
has the meaning set forth in Section 6.1.
(p) “Manufacturing
Facilities” has the meaning set forth in the
Recitals.
(q) “Manufacturing
Services” shall mean the services set forth in
Section 2.1.
(r) “Novavax
Indemnitee” has the meaning set forth in
Section 6.1.
(s) “Novavax
Licenses” has the meaning set forth in the
Recitals.
(t) “Novavax
Product” has the meaning set forth in the Joint Venture
Agreement.
(u) “Patents”
mean any and all (a) issued patents and inventors’
certificates in the Territory and re-examinations, reissues,
renewals, extensions, registrations, substitutions, supplementary
protection certificates and term restorations with respect to any
of the foregoing, and (b) pending applications for patents and
inventors’ certificates in the Territory and patents that
issue therefrom, including, without limitation, provisional
applications, continuations, continuations-in-part, divisional and
substitute applications with respect to any of the
foregoing.
(v) “Regulatory
Approval” means any and all approvals (including supplements,
amendments, pre- and post-approvals, pricing and reimbursement
approvals), licenses, registrations or authorizations of any
national, supra-national, regional, state or local regulatory
agency, department, bureau, commission, council or other
governmental entity, that are necessary for the manufacture,
distribution, use or sale of a Novavax Product in a regulatory
jurisdiction in the Territory.
(w) “Services”
means Consulting Services, Development and Regulatory Services and
Technology Transfer Services.
(x) “Technology
Transfer Services” means the Manufacturing Services and other
technology transfer services described in
Section 2.1:
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AND
EXCHANGE COMMISSION.
(y) “Territory”
means India.
(z) “Third
Party” means a person or entity other than (a) Novavax,
(b) Company, (c) an Affiliate of Novavax or (d) an
Affiliate of Company.
Section 2.1.
Technology Transfer Services .
(a) Promptly
after the Effective Date (but in any event within sixty
(60) days thereof), Novavax shall disclose and provide to the
Company the Know-How set forth on Exhibit 1 (the
“Manufacturing Know-How”) and any other relevant
manufacturing-related Know How licensed to the Company by Novavax
to allow the Company to establish a Manufacturing Facility for
Novavax Products. As reasonably requested by the Company, Novavax
shall disclose and provide to the Company any Improvements to the
Manufacturing Know-How made by Novavax.
(b) To
effectuate the transfer and implementation of the Manufacturing
Know-How and the establishment of the Manufacturing Facility for
Novavax Products, Novavax shall provide the Manufacturing Services
set forth on Exhibit 2 . As soon as practicable after
the date of this Agreement, the Representative and the Company
shall develop a reasonable schedule pursuant to which the
Manufacturing Services will be provided.
(c) Promptly
after the Effective Date (but in any event within sixty
(60) days thereof), and thereafter as reasonably requested by
the Company, Novavax shall disclose and provide to the Company any
Know-How licensed to the Company by Novavax under the Novavax
Licenses (which is not addressed in Section 2.1(a) above), and
shall provide reasonable assistance and cooperation to the Company
for the purpose of effectively transferring such Know-How and
enabling the Company to use such Know-How within the scope of the
Novavax Licenses.
Section 2.2.
Development and Regulatory Services .
(a) To
assist the Company in developing and obtaining Regulatory Approval
for Novavax Products in the Territory, Novavax shall provide the
Development and Regulatory Services set forth on
Exhibit 3 .
(b) The
Company and the Representative shall coordinate the execution and
delivery of the Development and Regulatory Services. The
Development and Regulatory Services shall be provided at reasonable
times as shall be mutually agreed to by the Company and the
Representative.
Section 2.3.
Consulting Services .
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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.
(a) At
the Company’s request, Novavax may provide consulting
services to Company in the areas of biologics, preclinical
development, clinical development, process development,
manufacturing scale up and general manufacturing related services
and any other areas in which Novavax has subject matter
expertise.
(b) Upon
the Company’s request for and upon Novavax’s agreement
to provide such Consulting Services, the Company and the
Representative shall develop a description of the desired
Consulting Services and a plan for completing the requested
Consulting Services, including an outline of the level of staffing
required and an estimated timeline for completion.
Section 2.4.
Novavax Representative . Novavax designates James Robinson
(the “Representative”) as the Company’s primary
contact for all Services provided under this Agreement and Novavax
shall make such Representative reasonably available to the Company.
The Company shall direct all high-level communications regarding
the Services and this Agreement to the Representative. Novavax may
substitute the Representative at any time upon notice to the
Company.
Section 2.5.
Impracticability . Novavax shall not be obligated to provide
any Service to the extent the performance of such Service becomes
commercially impracticable as a result of events or circumstances
outside of the control of Novavax, including, to the extent the
performance of such Services would require Novavax to breach any
applicable Law or could reasonably be expected to result in the
breach of any applicable contract, license, or other agreement;
provided however, that Novavax represents and warrants to Company
that, as of the date of this Agreement, Novavax has no knowledge of
any event or circumstance that would cause the performance of
Services to violate any applicable Law or could reasonably be
expected to result in the breach of any applicable contract,
license or other agreement. Novavax shall provide Company with
reasonable notice of the occurrence of any event which would cause
Novavax to curtail or cease any Service pursuant to this
Section 2.5.
Section 2.6.
Rights to Know-
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