Back to top

TECHNICAL SERVICES AGREEMENT

Consulting Services Agreement

TECHNICAL SERVICES AGREEMENT | Document Parties: NOVAVAX INC | CPL Biologicals Limited You are currently viewing:
This Consulting Services Agreement involves

NOVAVAX INC | CPL Biologicals Limited

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: TECHNICAL SERVICES AGREEMENT
Date: 5/11/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

TECHNICAL SERVICES AGREEMENT, Parties: novavax inc , cpl biologicals limited
50 of the Top 250 law firms use our Products every day

Exhibit 10.6

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.”

RECITALS

           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:

ARTICLE 1
DEFINITIONS

     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

1


 

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.

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.

2


 

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.

               (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:

3


 

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.

               (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.

ARTICLE 2
SERVICES

     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 .

4


 

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-


 
SITE SEARCH

AGREEMENTS / CONTRACTS

Document Title:

Entire Document: (optional)

Governing Law:(optional)


Try our advanced search >>
 

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates
Email:
This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more