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SUPPLY AGREEMENT | Document Parties: NOVAVAX INC | CPL Biologicals Limited You are currently viewing:
This Supply Agreement involves

NOVAVAX INC | CPL Biologicals Limited

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Title: SUPPLY AGREEMENT
Date: 5/11/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

This Supply Contract Form is an actual legal document drafted by a top law firm for their client.
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Exhibit 10.5

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.

SUPPLY AGREEMENT

     This Supply Agreement (this “ Agreement ”) is made as of this 31 st day of March, 2009 (the “Execution Date”), by and among 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 , Company, a joint venture formed pursuant to a Joint Venture Agreement (the “ Joint Venture Agreement ”) dated as of the date hereof between Novavax and Cadila Pharmaceuticals Limited, organized under the laws of India, was formed for developing, manufacturing, marketing and selling the Products (as defined in the Joint Venture Agreement) in India to cater the needs of the market in India; and

                WHEREAS , Novavax has granted to Company a license to certain of Novavax’s patents, patent applications and know-how for the Company to develop and commercialize certain Novavax Products (as defined in the Joint Venture Agreement) (the “ License ”); and

                WHEREAS , in connection with the foregoing, Novavax is willing to supply certain pre-clinical and clinical supplies of the Novavax Seasonal Product to Company and Company wishes to buy Products from Novavax under the terms and conditions of this Agreement.

                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, and intending to be legally bound hereby, Novavax and Company hereby agree as follows:

1.

 

Definitions . 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

 

1.1

 

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

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.

 

 

 

any distress, execution or other process upon or against a substantial part of the assets of such person.

 

 

1.2

 

cGMP ” means then current Good Manufacturing Practices.

 

 

1.3

 

Company Indemnitee ” has the meaning set forth in Section 8.2 .

 

 

1.4

 

Defect ” or “ Defective ” means any non-conformance with the Specifications or the existence of any impurity, contaminant or any other defect that renders the Products unfit for human use.

 

 

1.5

 

Effective Date ” means the date on which the condition precedent set forth in Article 11 is first satisfied.

 

 

1.6

 

First Commercial Sale ” means the first sale for monetary value for use or consumption by the general public of the Novavax Products in India.

 

 

1.7

 

Fully-Loaded Cost ” means the direct costs and expenses for manufacturing the Products (including quality assurance/quality control charges and including escalation costs, if any), and indirect costs that are reasonably attributable and fairly allocable to the manufacture of Product reasonably determined by Novavax’s internal accounting in accordance with United States generally accepted accounting practices.

 

 

1.8

 

Indeminitee ” means a Company Indemnitee or Novavax Indemnitee, as applicable.

 

 

1.9

 

Indemnitor ” means Company or Novavax, as applicable.

 

 

1.10

 

Joint Venture Agreement ” has the meaning set forth in the Recitals.

 

 

1.11

 

Laws ” means all (a) applicable laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of the United States and India; and (b) any guideline or directive of the World Health Organization or other applicable non-governmental agency.

 

 

1.12

 

License ” has the meaning set forth in the Recitals.

 

 

1.13

 

Losses ” has the meaning set forth in Section 8.1 .

 

 

1.14

 

Manufacturin g Facility ” means the manufacturing facility or facilities of Novavax used to manufacture the Products.

 

 

1.15

 

Novavax Indemnitee ” has the meaning set forth in Section 8.1 .

 

 

1.16

 

Novavax Products ” has the meaning set forth in the Joint Venture Agreement.

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.

 

1.17

 

Novavax Seasonal Product ” means the Seasonal Influenza Licensed Product as defined in the License.

 

 

1.18

 

Order Requirements ” has the meaning set forth in Section 3.2 .

 

 

1.19

 

Products ” means Novavax’s pre-clinical and clinical supplies of the Novavax Seasonal Product which conform to the Specifications.

 

 

1.20

 

Purchase Order ” has the meaning set forth in Section 3.2 .

 

 

1.21

 

Specifications ” means Novavax’s standard specifications and manufacturing criteria for the Products (consistent with cGMP), a written copy of which shall be provided by Novavax to the Company within thirty (30) days after the Effective Date, as amended from time to time by mutual written agreement of the Parties.

 

 

1.22

 

Third Party ” means a person or entity other than (a) Novavax, (b) Company, (c) an Affiliate of Novavax or (d) an Affiliate of Company

 

 

1.23

 

Transfer Price ” has the meaning set forth in Section 4.1 .

2.

 

Manufacture and Supply .

 

 

2.1

 

General Obligations . Novavax shall sell to Company, and Company shall purchase from Novavax, the Products in accordance with the terms and conditions of this Agreement.

 

 

2.2

 

Manufacturing Standards . All Products supplied by Novavax to Company will be manufactured in accordance with any applicable Laws including, without limitation, cGMP and any requirements set forth herein.

3.

 

Product Supply, Orders and Delivery .

 

 

3.1

 

Purchase Orders . Purchase and delivery of the Products shall be made pursuant to written or electronic individual purchase orders issued by Company to Novavax (each a “ Purchase Order ”). Company shall submit such Purchase Orders to Novavax as far in advance as reasonably practicable, but in any event not less than twelve (12) weeks in advance of the delivery date(s) requested in such Purchase Order. A Purchase Order shall be deemed to be accepted by Novavax when Novavax returns a written or electronic order acknowledgement to Company. Novavax shall promptly return a written or electronic order acknowledgement to Company for each Purchase Order received unless Novavax will be unable to timely meet Company’s requirement for Product as set forth in the applicable Purchase Order. Purchase Orders shall specify quantities ordered, delivery dates, and delivery and shipping instructions. Inconsistencies between a Purchase Order and this Agreement shall be resolved in favor of this Agreement.

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.

 

 

 

Company acknowledges that Novavax may be prevented from meeting a delivery date and/or order quantity set forth in a Purchase Order (the “ Order Requirements ”) as a result of the Manufacturing Facility production schedule, and in such event Novavax will use commercially reasonable efforts to meet the Order Requirements at such time as the Manufacturing Facility production schedule reasonably permits. If Novavax anticipates that it will be unable to meet Order Requirements for a reason other than the Manufacturing Facility production schedule, Novavax will notify Company immediately of such inability, and the Parties will negotiate in good faith a new mutually acceptable delivery date and/or quantity.

 

 

3.2

 

Certificate of Analysis . Novavax shall deliver with each shipment a certificate of analysis consistent with cGMP executed by an authorized representative of Novavax, accompanied by a statement that the Products were manufactured according to the Specifications.

 

 

3.3

 

Delivery . The Products shall be packaged according to the Specifications and supplied FCA (Incoterms 2000) the Manufacturing Facility. Insurance on Products in transit shall be the responsibility of Company and Company shall be responsible for clearing the Products for import into India. Novavax shall provide any assistance reasonably requested by Company to clear the Products for import into India at Company’s expense. Company agrees to designate a carrier prior to or at the time of entry of each Purchase Order hereunder; however, if Company fails to designate a carrier prior to or on its purchase order, Novavax may select a carrier for the account and risk of Company.

4.

 

Price and Payment .

 

 

4.1

 

Price. The price at which the Products will be sold to Company by Novavax hereunder will be 110% of the Fully-Loaded Cost therefore (the “ Transfer Price ”). Novavax will include with each shipment of Product an invoice setting forth the Transfer Price for the Product in the shipment.

 

 

4.2

 

Payment. Payment shall be due to Novavax thirty (30) days after Company’s receipt of the Products.

 

 

4.3

 

Books and Records . Novavax will keep accurate books and accounts of record in connection with its manufacture of Products in sufficient detail to permit verification of the Fully-Loaded Cost and the Transfer Price for Product purchased by Company as set forth in this Article 4. Novavax will maintain its records for the sale of Products for a period of three (3) years from the end of each year in which such sales occurred.

 

 

4.4

 

Audits . Company, at its expense, through an internationally recognized, independent accountant reasonably acceptable to Novavax, will have the right to

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.

 

 

 

access Novavax’s relevant books and records upon reasonable advanced notice once per year for the sole purpose of verifying the Fully-Loaded Cost and the Transfer Price for Product purchased by Company; such access will be conducted during Novavax’s ordinary business hours, and the books and records for a given time period may only be audited once. Said accountant will execute a confidentiality agreement with Novavax in customary form and will only disclose to Company whether Novavax’s invoices were accurate and if they were not, any information necessary to explain the source of the inaccuracy. If such audit determines that Novavax charged Company more than the amount properly owed in respect of any quarter, then Novavax will reimburse Company any excess amount paid by Company within thirty (30) days of the completion of the audit, and if the amount paid exceeds ten percent (10%) of the amount actually owed over the audited period, Novavax will also reimburse Company for the reasonable costs of such audit (including the fees and expenses of the certified public accountant). In the event such audit determines that Novavax charged Company less than the amount properly owed in respect of any quarter, then Company will pa


 
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