-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Fqbdtb+vdXT3qkHySgrMVPXIt8DRv7PATzFN0LL824F8DdckHbo/jgGTeYHUM0L/ x1p9WZyt9sbeUBXzw/AidQ== 0000950133-01-502210.txt : 20010814 0000950133-01-502210.hdr.sgml : 20010814 ACCESSION NUMBER: 0000950133-01-502210 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20010630 FILED AS OF DATE: 20010813 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVAVAX INC CENTRAL INDEX KEY: 0001000694 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 222816046 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-26770 FILM NUMBER: 1706669 BUSINESS ADDRESS: STREET 1: 8320 GUILFORD RD STREET 2: STE C CITY: COLUMBIA STATE: MD ZIP: 21046 BUSINESS PHONE: 3078543900 MAIL ADDRESS: STREET 1: 8320 GUILFORD ROAD SUITE C STREET 2: 12111 PARKLAWN DR CITY: COLUMBIA STATE: MD ZIP: 21046 10-Q 1 w52015e10-q.htm FORM 10-Q e10-q

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q

QUARTERLY REPORT UNDER SECTION 13 or 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

     
For Quarter Ended
June 30, 2001
Commission File No.
0-26770

NOVAVAX, INC.

(Exact name of registrant as specified in its charter)
     
Delaware 22-2816046


(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
     
8320 Guilford Road, Columbia, MD
21046


(Address of principal executive offices) (Zip code)

(301) 854-3900


Registrant’s telephone number, including area code

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes     X      No

The number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:

Common Shares Outstanding at August 10, 2001: 22,850,870


NOVAVAX, INC.

Form 10-Q
For the Quarter Ended June 30, 2001

Table of Contents

             
Part I. Financial Information Page No.
Item 1 Financial Statements
Consolidated Balance Sheets as of June 30, 2001 and December 31, 2000 3
Consolidated Statements of Operations for the three month and six month periods ended June 30, 2001 and 2000 4
Consolidated Statements of Cash Flows for the six months ended June 30, 2001 and 2000 5
Notes to Consolidated Financial Statements 6
Item 2 Management’s Discussion and Analysis of Financial Condition and Results of Operations 10
Item 3 Quantitative and Qualitative Disclosure about Market Risk *
Part II. Other Information
Item 1 Legal Proceedings *
Item 2 Changes in Securities and Use of Proceeds *
Item 3 Defaults upon Senior Securities *
Item 4 Submission of Matters to a Vote of Security Holders 15
Item 5 Other Information *
Item 6 Exhibits and Reports on Form 8-K 16
Signature 17

*   No information provided due to inapplicability of item.

2


Part I. Financial Information
Item 1. Financial Statements

NOVAVAX, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share data)

                       
June 30, December 31,
2001 2000


ASSETS (unaudited)
Current assets:
Cash and cash equivalents $ 11,437 $ 14,864
Accounts receivable 2,495 954
Inventory 825 461
Prepaid expenses and other current assets 837 757


Total current assets 15,594 17,036
Property and equipment, net 2,457 1,927
Goodwill and other intangible assets, net 39,330 37,566


Total assets $ 57,381 $ 56,529


LIABILITIES and STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 1,521 $ 1,401
Accrued expenses 3,582 3,200
Deferred revenue — current 250 104


Total current liabilities 5,353 4,705


Convertible note 20,000 20,000
Deferred revenue 2,750
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $.01 par value, 2,000,000 shares authorized; no shares issued and outstanding
Common stock, $.01 par value, 50,000,000 shares authorized; 23,038,442 issued and 22,461,281 outstanding at June 30, 2001 and 22,586,304 issued and 22,104,087 outstanding at December 31, 2000 230 226
Additional paid-in capital 93,863 91,611
Accumulated deficit (59,125 ) (55,085 )
Treasury stock, 577,161 and 482,217 shares, cost basis, at June 30, 2001 and December 31, 2000, respectively (5,690 ) (4,928 )


Total stockholders’ equity 29,278 31,824


Total liabilities and stockholders’ equity $ 57,381 $ 56,529


The accompanying notes are an integral part of the consolidated financial statements.

3


NOVAVAX, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share data)
(unaudited)

                                       
Three months ended Six months ended
June 30, June 30,
2001 2000 2001 2000




Revenues
   Product sales
$ 4,278 $ $ 8,533 $
Contract research & development 1,167 588 1,878 1,298
Other 2,500 2,500




Total revenues 7,945 588 12,911 1,298
Operating costs and expense:
Cost of products sold 1,061 2,104
Research and development 3,837 2,113 6,429 3,637
Selling, general and administrative 4,729 1,302 8,213 1,943




Total operating costs and expenses 9,627 3,415 16,746 5,580




Loss from operations (1,682 ) (2,827 ) (3,835 ) (4,282 )




Interest (expense) income, net (126 ) 186 (205 ) 291




Net loss $ (1,808 ) $ (2,641 ) $ (4,040 ) $ (3,991 )




Basic and diluted net loss per share $ (.08 ) $ (.14 ) $ (.18 ) $ (.22 )




Weighted average shares used in computing net loss per share 22,339,517 19,385,903 22,252,580 18,349,819




The accompanying notes are an integral part of the consolidated financial statements.

4


NOVAVAX, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(amounts in thousands)
(unaudited)

                         
Six months ended
June 30,
2001 2000


Operating Activities:
Net loss $ (4,040 ) $ (3,991 )
Adjustments to reconcile net loss to net cash used by operating activities:
Non-cash compensation expense 2
Depreciation and amortization 1,719 206
Changes in operating assets and liabilities:
Accounts receivable (1,541 ) (327 )
Inventory (364 )
Prepaid expenses and other assets (80 ) 27
Accounts payable and accrued expenses 502 665
Deferred revenue 2,896 (500 )


Net cash used by operating activities (908 ) (3,918 )


Investing Activities:
Acquisition of product line (3,332 )
Capital expenditures (681 ) (485 )
Deferred patent costs (43 )


Net cash used in investing activities (4,013 ) (528 )


Financing Activities:
Payment of debt obligations (74 )
Issuance of common stock 11,255
Offering costs of common stock (757 )
Proceeds from the exercise of stock options and warrants 1,494 5,575


Net cash provided by financing activities 1,494 15,999


Net change in cash and cash equivalents (3,427 ) 11,553
Cash and cash equivalents at beginning of period 14,864 732


Cash and cash equivalents at end of period $ 11,437 $ 12,285


The accompanying notes are an integral part of the consolidated financial statements.

5


NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

1. BASIS OF PRESENTATION

Novavax, Inc., a Delaware corporation, (“Novavax” or the “Company”), is a specialty biopharmaceutical company engaged in the research, development and commercialization of proprietary products focused on women’s health and infectious diseases. The Company currently sells, markets and distributes a line of ethical pharmaceuticals and pre-natal vitamins. The Company’s principal technology platform involves the use of proprietary, microscopic, organized, non-phospholipid structures as vehicles for the delivery of a wide variety of drugs and therapeutic products.

The consolidated financial statements of Novavax for the six months ended June 30, 2001 and 2000 are unaudited. These financial statements reflect all adjustments, which, in the opinion of management, are necessary for a fair presentation of the results for the interim periods presented. All such adjustments are of a normal recurring nature. These interim results are not necessarily indicative of the results to be expected for the year ending December 31, 2001.

Certain information in footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles has been condensed or omitted pursuant to SEC rules and regulations, although the Company believes the disclosures are adequate to make the information presented not misleading. It is suggested that these consolidated financial statements be read in conjunction with the consolidated financial statements and the notes thereto in the Company’s Annual Report on Form 10-K for the year ended December 31, 2000.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

      The accompanying consolidated financial statements include the accounts of Novavax and its wholly owned subsidiaries Fielding Pharmaceutical Company, Micro-Pak, Inc., Micro Vesicular Systems, Inc. and Lipovax, Inc. All significant intercompany accounts and transactions have been eliminated in consolidation.

Use of Estimates

      The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

6


NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

Inventories

      Inventories consist of raw materials and are priced at the lower of cost or market, using the first-in-first-out method (FIFO).

Revenue Recognition

      Revenues from product sales are recognized upon shipment, net of allowances for returns, rebates and chargebacks. The Company is obligated to accept from customers the return of pharmaceuticals which have reached their expiration date.

      Revenues from the sale of scientific prototype vaccines and adjuvants are recorded as the products are produced and shipped. Revenues earned under research contracts are recognized when the related contract services are performed.

      Revenues from milestone payments are recorded as the earning process has been completed and services have been rendered.

Net Loss per Share

      Basic earnings per share are computed by dividing the net loss available to common shareholders by the weighted average number of common shares outstanding during the period. Diluted loss per share is computed by dividing net loss available to common shareholders by the weighted average number of common shares outstanding after giving effect to all dilutive potential common shares that were outstanding during the period.

      Potential common shares are not included in the computation of dilutive earnings per share if they are antidilutive. Net loss per share as reported was not adjusted for potential common shares, as they are antidilutive.

Comprehensive Loss

      Under Financial Accounting Standards No. 130 (“SFAS 130”), “Reporting Comprehensive Income,” the Company is required to display comprehensive loss and its components as part of the consolidated financial statements. Comprehensive loss is comprised of the net loss and other comprehensive income (loss), which includes certain changes in equity that are excluded from the net loss. Comprehensive loss for the Company was the same as net loss for the period ended June 30, 2001 and 2000.

7


NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

Business Combinations, Goodwill and Other Intangible Assets

      In June 2001, the Financial Accounting Standards Board issued Statements of Financial Accounting Standards No. 141, Business Combinations, and No. 142, Goodwill and Other Intangible Assets, effective for fiscal years beginning after December 15, 2001. Under the new rules, goodwill and intangible assets deemed to have indefinite lives will no longer be amortized but will be subject to annual impairment tests in accordance with the Statements. Other intangible assets will continue to be amortized over their useful lives.

      The Company will apply the new rules on accounting for goodwill and other intangible assets beginning in the first quarter of 2002. The Company will perform the first of the required impairment tests of goodwill and indefinite lived intangible assets as of January 1, 2002 and has not yet determined what the effect of these tests will be on the earnings and financial position of the Company. Amortization of intangible assets for the quarter and six months ended June 30, 2001 amounted to approximately $700,000 and $1.4 million.

3. PRODUCT LICENSING AND CO-PROMOTION AGREEMENTS

In June 2001, the Company expanded its January 2001 licensing agreement with King Pharmaceuticals, Inc. (“King”) for ESTRASORB, Novavax’s proprietary topical estrogen replacement therapy. The amended agreements grant King exclusive rights to promote, market and distribute ESTRASORB in Canada, and five additional countries in Europe – Switzerland, Greece, Italy, Spain and the Netherlands and adds ANDROSORB, a topical testosterone replacement therapy for testosterone deficient women to the license agreements. Under the terms of the expanded agreement Novavax received $3.0 million from King in up-front licensing fees, which was recorded as deferred revenue and will be recognized over the life of the agreement, and the Company will also receive additional milestone payments of $1.0 million upon ESTRASORB’s approval in Canada and $2.0 million upon the first approval of ESTRASORB in one of the five countries included in the expanded agreement. The Company will also receive royalties on future sales.

On June 29, 2001 the Company submitted an NDA with the FDA, for our ESTRASORB product. Under the terms of the Company’s co-promotion agreement with King, for ESTRASORB, Novavax received a $2.5 million milestone payment from King for this submission and is entitled to an additional $2.5 million upon the FDA’s formal acceptance of the filing, which is expected to occur by the end of August 2001. Also, upon the formal acceptance of the filing, Novavax will receive an additional $5.0 million from King representing the remaining portion of the $25.0 million convertible note which the company entered into in December 2000.

8


NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

4. PRO FORMA FINANCIALS

In December 2000, Novavax acquired privately owned Fielding Pharmaceutical Company (“Fielding”), based in St. Louis, Missouri, which sells, markets and distributes a proprietary line of pharmaceutical products focused on women’s health. The puchase method of accounting was used to account for the transaction.

The operating results of Fielding and the AVC Product Line have been included in the consolidated statement of operations for the quarter. The following summary represents pro forma results of operations as if the acquisition had occurred at the beginning of 2000. These pro forma results have been prepared for comparative purposes only and do not purport to be indicative of the results of operations that would have actually resulted had the combination been in effect and are not intended to be indicative of future results.

         
6 Months ended June 30, 2000

(amounts in thousands except per share information)
Revenue $ 6,545
Net loss (5,177 )
Loss per share applicable to common stockholders $ (0.25 )

9


Item 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATION

The following discussion may contain statements that are not purely historical. Certain statements contained herein or as may otherwise be incorporated by reference herein constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include but are not limited to statements regarding product sales, future product development and related clinical trials and statements regarding future research and development. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

Such factors include, among other things, the following: general economic and business conditions; competition; unexpected changes in technologies and technological advances; ability to obtain rights to technology; ability to obtain and enforce patents; ability to commercialize and manufacture products; statements regarding establishment of commercial-scale manufacturing capabilities; statements regarding future collaboration with industry partners; results of clinical studies; research and development activities; business abilities and judgment of personnel; availability of qualified personnel; changes in, or failure to comply with, governmental regulations; ability to obtain adequate financing in the future; and other factors referenced herein.

All forward-looking statements contained in this document are based on information available to the Company on the date hereof, and the Company assumes no obligation to update any such forward-looking statements. Accordingly, past results and trends should not be used to anticipate future results or trends.

Overview

Novavax, Inc. (“Novavax”, “we”, “our”, or the “Company”) is a specialty biopharmaceutical company engaged in the research, development and commercialization of proprietary products focused on women’s health and infectious diseases. We were incorporated in Delaware in 1987. Our principal executive offices are located at 8320 Guilford Road, Columbia, Maryland 21046.

The Company has incurred net losses since its inception from the development of its technologies for human pharmaceuticals, vaccines and vaccine adjuvants. As of June 30, 2001 our accumulated deficit was approximately $59.1 million. We expect the losses to continue in the near-term, as we conduct additional human clinical trials, seek regulatory approval for our product candidates and expand our commercialization activities.

In December 2000, we acquired the privately owned Fielding Pharmaceutical Company (“Fielding”), based in St. Louis, Missouri, which sells, markets and distributes a proprietary line of pharmaceutical products focused on women’s health. Under the terms of the acquisition agreement, we acquired 100% of the outstanding shares of Fielding for approximately $36.5

10


MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATION

million. Fielding was established in 1959 and markets women’s healthcare products nationally to obstetricians and gynecologists through its sales force of over 60 personnel. Fielding fills packages and warehouses all of its own products, which are purchased from contract manufacturers. Fielding’s products included Nestabs®, a complete line of pre-natal vitamins; Gynodiol®, an oral form of estrogen replacement therapy, as well as several other over-the-counter women’s healthcare products. We will use Fielding to sell, market and distribute additional future products.

During the first quarter of 2001, we completed a multi-center Phase III study of ESTRASORB™ in symptomatic menopausal women. ESTRASORB is our topical transdermal estrogen replacement therapy. The study was designed to measure ESTRASORB’s ability to deliver 17b estradiol through the skin, when applied as a topical lotion. The study results indicate that there is a statistically significant difference between ESTRASORB and placebo treatment with respect to the trial’s primary clinical endpoint, a reduction in the number of hot flushes. In June 2001 we submitted a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for ESTRASORB.

In December 2000 we entered into a Note Purchase Agreement with King Pharmaceuticals, Inc. (“King”) whereby we agreed to issue to King a 4% senior convertible promissory note in the aggregate amount of $25.0 million. On that same date, we issued a 4% senior convertible promissory note with King for $20.0 million in principal due December 19, 2007 with interest payable in semi-annual installments on June 30 and December 31 commencing on June 30, 2001 (the “Note”). A second promissory note of $5.0 million is due to be executed upon the FDA’s formal acceptance of the NDA filing for our ESTRASORB product, which is expected to occur by the end of August 2001 (“the Formal Acceptance”). In addition, under a co-promotion agreement with King, we received a milestone payment from King of $2.5 million upon our submission of the ESTRASORB NDA, and we will receive an additional milestone of $2.5 million upon the Formal Acceptance.

In June 2001, the Company also expanded its January 2001 licensing agreement with King for ESTRASORB. The amended agreements grant King exclusive rights to promote, market and distribute ESTRASORB in Canada, and five additional countries in Europe, and adds ANDROSORB, a topical testosterone replacement therapy for testosterone deficient women to the license agreements. Under the terms of the expanded agreement we received $3.0 million from King in up-front licensing fees, and we will also receive additional milestone payments of $1.0 million upon ESTRASORB’s approval in Canada and $2.0 million upon the first approval of ESTRASORB in Europe. The Company will also receive royalties on future sales.

11


MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATION

Results of Operations

The following is a discussion of the historical consolidated financial condition and results of operations of Novavax, Inc. and its subsidiaries and should be read in conjunction with the consolidated financial statements and notes thereto set forth in this Form 10-Q. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements is contained from time to time in the Company’s SEC filings, including, but not limited to, the Company’s Annual Report on Form 10-K for the year ended December 31, 2000.

Three months ended June 2001 (“2001”) compared to the three months ended June 2000 (“2000”)

Net loss for 2001 was $1.8 million or $(0.08) per share, compared to $2.6 million or $(0.14) per share for 2000, a decrease of $800,000 or $0.06 per share. Total revenues for 2001 were $7.9 million, an increase of $7.3 million compared to 2000 revenues of $600,000. Revenues for 2001 included $4.3 million of product sales from our acquisition of Fielding, in addition to revenue from research and development contracts with the National Institutes of Health (“NIH”) and other government agencies of $1.2 million, and a $2.5 million milestone payment from King for the timely submission of our ESTRASORB NDA in June 2001. Revenues for 2000 included $250,000 from a license agreement and $338,000 from research and development contracts with the NIH. In connection with the product sales in 2001, we incurred $1.1 million for costs of products sold.

Selling, general and administrative expenses were $4.7 million for 2001, compared to $1.3 million incurred for the same period in 2000, an increase of $3.4 million. This increase was due to a number of factors, including the sales and marketing costs to support product sales, the increases in personnel from the Fielding acquisition, the full effect of increases in administrative and executive employees in 2000 and 2001 to support our growth and the initiation of commercialization activities for ESTRASORB. In addition, we also expensed approximately $700,000 for goodwill amortization related to the Fielding acquisition and the acquisition of the AVC™ Product Line from King in January 2001 for $3.3 million. Research and development expenses were $3.8 million in 2001 compared to $2.1 million in 2000. This $1.7 million increase in research and development expenses is primarily due to NDA preparation and filing costs related to ESTRASORB and additional expenses to support the growth in research and development contracts.

Net interest expense for 2001 was $126,000 compared to net interest income in 2000 of $186,000. The net change in interest of $312,000 is primarily due to the interest expense accrued on the Note with King.

12


MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATION

Six months ended June 2001 (“2001”) compared to the six months ended June 2000 (“2000”)

Net loss for 2001 was $4.0 million or $(0.18) per share, compared to $4.0 million or $(0.22) per share for 2000, a decrease of $0.04 per share. Total revenues for 2001 were $12.9 million, an increase of $11.6 million compared to 2000 revenues of $1.3 million. Revenues for 2001 included $8.5 million of product sales from our acquisition of Fielding, revenue from research and development contracts with the NIH and other government agencies of $1.9 million, and a $2.5 milestone payment from King for the timely submission of our ESTRASORB NDA in June 2001. Revenues for 2000 included $500,000 from a license agreement and $798,000 from research and development contracts with the NIH. In connection with the product sales in 2001, we incurred $2.1 million for costs of products sold.

Selling, general and administrative expenses were $8.2 million for 2001, compared to $1.9 million incurred for the same period in 2000, an increase of $6.3 million. This increase was due to a number of factors, including the sales and marketing costs to support product sales, the increases in personnel from the Fielding acquisition, the full effect of increases in administrative and executive employees in 2000 and 2001 to support our growth, and, the initiation of commercialization activities for ESTRASORB. In addition, we also expensed approximately $1.4 million for goodwill amortization related to the Fielding acquisition and the acquisition of the AVC™ Product Line from King in January 2001 for $3.3 million. Research and development expenses were $6.4 million in 2001 compared to $3.6 million in 2000. This $2.8 million increase in research and development expenses is primarily due to NDA preparation and filing costs related to ESTRASORB and additional expenses to support the growth in research and development contracts.

Net interest expense for 2001 was $205,000 compared to net interest income in 2000 of $291,000. The net change in interest of $496,000 is primarily due to the interest expense on the Note with King and higher cash balances in 2000 due to an equity financing the first quarter of that year.

Liquidity and Capital Resources

Our capital requirements depend on numerous factors, including but not limited to the progress of our research and development programs, the progress of pre-clinical and clinical testing, the time and costs involved in obtaining regulatory approvals, the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights, competing technological and market developments, product sales and changes in our development and commercialization activities and arrangements. We plan to have multiple products in clinical trials. Future activities including clinical development, the establishment of commercial-scale manufacturing capabilities and developing sales and marketing programs is subject to our ability to raise funds through equity financing or collaborative arrangements with industry partners.

13


MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATION

In addition to the AVC Product Line acquisition of $3.3 million we also have used $3.8 million during the six month period ended June 30, 2001 to fund the activities of our research and development programs, particularly, costs associated with obtaining regulatory approvals, manufacturing process validation and NDA filing costs. Cash balances of the Company funded these expenditures. Working capital was $10.2 million at June 30, 2001 as compared to $12.3 million at December 31, 2000. The $2.1 million decrease in working capital is primarily due to the uses of cash discussed above, offset by working capital provided by product sales, licensing fees and milestone payments. Cash and cash equivalents totaled $11.4 million at June 30, 2001 compared to $14.9 million at December 31, 2000.

We estimate that based on projected levels of spending and revenues, and giving effect to future financings and milestone payments of $7.5 million with King related to the Formal Acceptance of the ESTRASORB NDA, existing cash resources will be sufficient to finance our operations for approximately 12 to 18 months. Past spending levels are not necessarily indicative of future spending. Future expenditures for product development, including these related to outside testing and human clinical trials, are discretionary and, accordingly, can be adjusted for available cash. As we continue to progress in our clinical development activities and commercial scale-up of product manufacturing, we anticipate future increases in spending associated with these activities. Moreover, we will continue to seek to establish one or more collaborations with industry partners, to defray the costs of clinical trials, product development, product line expansion and other related activities. We will also consider sources of additional funds through public or private equity or debt financing, collaborative arrangements with pharmaceutical companies and government agency contracts. There can be no assurance that additional funding or bank financing will be available at all or on acceptable terms to permit successful commercialization of our technologies and products. If adequate funds are not available, We may be required to significantly delay, reduce the scope of or eliminate one or more of our research or development programs, or seek alternative measures including arrangements with collaborative partners or others that may require us to relinquish rights to certain of our technologies, product candidates or products.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

      Not applicable.

14


Part II. Other Information

NOVAVAX, INC. AND SUBSIDIARIES

Item 1 – Legal Proceedings

      The Company is not a party to any material pending legal proceedings.

Item 2 – Changes in Securities

      None.

Item 3 – Defaults upon Senior Securities

      None.

Item 4 – Submission of Matters to a Vote of Security Holders

      At the Company’s Annual Meeting of Stockholders held on May 9, 2001, the following proposals were adopted by the vote specified below:

  1.   To elect the following nominees as Class III Directors to serve on the Board of Directors for a three year term expiring at the Annual Meeting of Stockholders in 2004.

                 
FOR WITHHELD


Mitchell J. Kelly 16,703,534 1,129,759
Michael A. McManus, Jr. 17,717,882 115,411
John A. Spears 17,717,682 115,611

  2.   To ratify the appointment of Ernst & Young LLP as independent auditors for the    company for the current fiscal year ending December 31, 2001.

                 
FOR AGAINST ABSTAIN



17,646,996 140,242 46,055

Item 5 – Other Information

      None.

15


Item 6 – Exhibits and Reports on Form 8-K

      (a) Exhibits:

  3.1   Amended and Restated Certificate of Incorporation of the Company (Incorporated herein by reference to Exhibit 3.1 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 1996).
 
  3.2   Certificate of Designations of Series A Custom Convertible Preferred Stock of the Company, dated January 28, 1998. (Incorporated herein by reference to Exhibit 4.2 to the Company’s Registration Statement on Form S-3, filed February 17, 1998).
 
  3.3   Certificate of Amendment to Amended and Restated Certificate of Incorporation of the Company, dated December 18, 2000. (Incorporated herein by reference to Exhibit 3.4 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2000).
 
  3.4   Certificate of Elimination of the Company, dated April 25, 2001.
 
  3.5   Amended and Restated By-Laws of the Company.
 
  10.1   1 First Amendment to Copromotion Agreement, dated as of June 29, 2001, between the Company and King Pharmaceuticals, Inc.
 
  10.2   Second Amendment to Copromotion Agreement, dated as of June 29, 2001, between the Company and King Pharmaceuticals, Inc.
 
  10.3   First Amendment to Exclusive License and Distribution Agreement, dated as of June 29, 2001, between the Company and King Pharmaceuticals, Inc.
 
  10.4   Second Amendment to Exclusive License and Distribution Agreement, dated as of June 29, 2001, between the Company and King Pharmaceuticals, Inc.

      (b) Reports on Form 8-K:

      None

16


NOVAVAX, INC. AND SUBSIDIARIES
SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned duly authorized.

             
NOVAVAX, INC.
(Registrant)
 
Date: August 13, 2001 By: /s/ Dennis W. Genge

Dennis W. Genge
  Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)

17 EX-3.4 3 w52015ex3-4.htm CERTIFICATE OF ELIMINATION ex3-4

Exhibit 3.4

CERTIFICATE OF ELIMINATION

of

NOVAVAX, INC.

Pursuant to Section 151
of the General Corporation Law of the State of Delaware

      Novavax, Inc. (the “Corporation”), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware, does hereby certify as follows:

      1. That the Certificate of Designation filed on January 28, 1998 pursuant to Article FOURTH of the Corporation’s Amended and Restated Certificate of Incorporation, as amended, is hereby eliminated in its entirety, in accordance with the resolution of the Board of Directors of the Corporation, set forth below:

  “No shares of Series A Custom Convertible Preferred Stock of the Corporation will be issued pursuant to the Certificate of Designation filed January 28, 1998 pursuant to Article FOURTH of the Corporation’s Amended and Restated Certificate of Incorporation, as amended. As there is no outstanding preferred stock of the Corporation, including shares of Series A Custom Convertible Preferred Stock described in said Certificate of Designation, said Certificate of Designation and all rights and obligations stated in such Certificate of Designation shall be eliminated in their entirety, in accordance with Section 151 of the General Corporation Law of the State of Delaware.”

      The undersigned President of the Corporation hereby makes this certificate, declaring and certifying that the facts stated herein are true, and accordingly has hereunto set his hand this 25th day of April, 2001.

         
NOVAVAX, INC.
 
ATTEST: By: /s/ John A. Spears

John A. Spears, President
/s/ David A. White

David A. White, Secretary

EX-3.5 4 w52015ex3-5.htm AMENDED AND RESTATED ex3-5

Exhibit 3.5

AMENDED AND RESTATED
BY-LAWS

OF

NOVAVAX, INC.

Amended 3/16/01


AMENDED AND RESTATED BY-LAWS
TABLE OF CONTENTS

           
ARTICLE 1 – Stockholders 1
Section 1.1    Place of Meetings 1
Section 1.2    Annual Meeting 1
Section 1.3    Special Meetings 1
Section 1.4    Notice of Meetings 1
Section 1.5    Voting List 1
Section 1.6    Quorum 2
Section 1.7    Adjournments 2
Section 1.8    Voting and Proxies 2
Section 1.9    Action at Meeting 2
Section 1.10  Nomination of Directors 3
Section 1.11  Notice of Business at Annual Meetings 3
Section 1.12  Action without Meeting 4
Section 1.13  Organization 4
ARTICLE 2 – Directors 5
Section 2.1    General Powers 5
Section 2.2    Number; Election and Qualification 5
Section 2.3    Classes of Directors 5
Section 2.4    Terms of Office 5
Section 2.5    Allocation of Directors Among Classes
                      in the Event of Increases or
                      Decreases in the Number of Directors
6
Section 2.6    Vacancies 6
Section 2.7    Resignation 6
Section 2.8    Regular Meetings 6
Section 2.9    Special Meetings 6
Section 2.10  Notice of Special Meetings 6
Section 2.11  Meetings by Telephone Conference Calls 7
Section 2.12  Quorum 7
Section 2.13  Action at Meeting 7
Section 2.14  Action by Consent 7
Section 2.15  Removal 7
Section 2.16  Committees 8
Section 2.17  Compensation of Directors 8
ARTICLE 3 – Officers 8
Section 3.1    Enumeration 8
Section 3.2    Election 8
Section 3.3    Qualification 8
Section 3.4    Tenure 9

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Section 3.5    Resignation and Removal 9
Section 3.6    Vacancies 9
Section 3.7    Chairman of the Board and Vice Chairman of the Board 9
Section 3.8    President 9
Section 3.9    Vice Presidents 10
Section 3.10  Secretary and Assistant Secretaries 10
Section 3.11  Treasurer and Assistant Treasurers 10
Section 3.12  Salaries 11
ARTICLE 4 – Capital Stock 11
Section 4.1    Issuance of Stock 11
Section 4.2    Certificates of Stock 11
Section 4.3    Transfers 11
Section 4.4    Lost, Stolen or Destroyed Certificates 12
Section 4.5    Record Date 12
ARTICLE 5 – General Provisions 12
Section 5.1    Fiscal Year 12
Section 5.2    Corporate Seal 13
Section 5.3    Waiver of Notice 13
Section 5.4    Voting of Securities 13
Section 5.5    Evidence of Authority 13
Section 5.6    Certificate of Incorporation 13
Section 5.7    Transaction with Interested Parties 13
Section 5.8    Severability 14
Section 5.9    Pronouns 14
ARTICLE 6 – Amendments 14
Section 6.1    By the Board of Directors 14
Section 6.2    By the Stockholders 14
Section 6.3    Certain Provisions 14

ii


AMENDED AND RESTATED BY-LAWS

OF

NOVAVAX, INC.

ARTICLE 1 – Stockholders

      1.1    Place of Meetings. All meetings of stockholders shall be held at such place within or without the State of Delaware as may be designated from time to time by the Board Directors or the President or, if not so designated, at the registered office of the corporation.

      1.2    Annual Meeting. The annual meeting of stockholders for the election of directors and for the transaction of such other business as may properly be brought before the meeting shall be held within six months after the end of each fiscal year of the corporation on a date to be fixed by the Board of Directors or the President (which date shall not be a legal holiday in the place where the meeting is to be held) at the time and place to be fixed by the Board of Directors or the President and stated in the notice of the meeting. If no annual meeting is held in accordance with the foregoing provisions, the Board of Directors shall cause the meeting to be held as soon thereafter as convenient. If no annual meeting is held in accordance with the foregoing provisions, a special meeting may be held in lieu of the annual meeting, and any action taken at that special meeting shall have the same effect as if it had been taken at the annual meeting, and in such case all references in these By-Laws to the annual meeting of the stockholders shall be deemed to refer to such special meeting.

      1.3    Special Meetings. Special meetings of stockholders may be called at any time by the Chief Executive Officer (or, if there is no Chief Executive Officer, the President) or by the Board of Directors. Business transacted at any special meeting of stockholders shall be limited to matters relating to the purpose or purposes stated in the notice of meeting.

      1.4    Notice of Meetings. Except as otherwise provided by law, written notice of each meeting of stockholders, whether annual or special, shall be given not less than 10 nor more than 60 days before the date of the meeting to each stockholder entitled to vote at such meeting. The notices of all meetings shall state the place, date and hour of the meeting. The notice of a special meeting shall state, in addition, the purpose or purposes for which the meeting is called. If mailed, notice is given when deposited in the United States mail, postage prepaid, directed to the stockholder at his address as it appears on the records of the corporation.

      1.5    Voting List. The officer who has charge of the stock ledger of the corporation shall prepare, at least 10 days before every meeting of stockholders, a complete list of the stockholders entitled to vote at the meeting, arranged in alphabetical order, and showing the address of each stockholder and the number of shares registered in the name of each stockholder. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting, during ordinary business hours, for a period of at least 10 days prior to the meeting, at a place within the city where the meeting is to be held. The list shall also be produced and kept at the time and place of the meeting during the whole time of the meeting, and may be inspected by any stockholder who is present.

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      1.6    Quorum. Except as otherwise provided by law, the Certificate of Incorporation or these By-Laws, the holders of a majority of the shares of the capital stock of the corporation issued and outstanding and entitled to vote at a meeting, present in person or represented by proxy, shall constitute a quorum for the transaction of business. For any meeting of the holders of common stock, the holders of a majority of the shares of the common stock of the corporation issued and outstanding and entitled to vote at the meeting, present in person or represented by proxy, shall constitute a quorum at such meeting for the transaction of business.

      1.7    Adjournments. Any meeting of stockholders may be adjourned to any other time and to any other place at which a meeting of stockholders may be held under these By-Laws by the stockholders present or represented at the meeting and entitled to vote, although less than a quorum, or, if no stockholder is present, by any officer entitled to preside at or to act as Secretary of such meeting. It shall not be necessary to notify any stockholder of any adjournment of less than 30 days if the time and place of the adjourned meeting are announced at the meeting at which adjournment is taken, unless after the adjournment a new record date is fixed for the adjourned meeting. At the adjourned meeting, the corporation may transact any business which might have been transacted at the original meeting.

      1.8    Voting and Proxies. Each stockholder shall have one vote for each share of stock entitled to vote held of record by such stockholder and a proportionate vote for each fractional share so held, unless otherwise provided by the General Corporation Law of the State of Delaware, the Certificate of Incorporation or these By-Laws. Each stockholder of record entitled to vote at a meeting of stockholders, or to express consent or dissent to corporate action in writing without a meeting, may vote or express such consent or dissent in person or may authorize another person or persons to vote or act for him by written proxy executed by the stockholder or his authorized agent and delivered to the Secretary of the corporation. No such proxy shall be voted or acted upon after three years from the date of its execution, unless the proxy expressly provides for a longer period.

      1.9    Action at Meeting. When a quorum is present at any meeting, the holders of a majority of the stock present or represented and voting on a matter (or if there are two or more classes of stock entitled to vote as separate classes, then in the case of each such class, the holders of a majority of the stock of that class present or represented and voting on a matter) shall decide any matter to be voted upon by the stockholders at such meeting, except when a different vote is required by express provision of law, the Certificate of Incorporation or these By-Laws. Any election by stockholders shall be determined by a plurality of the votes cast by the stockholders entitled to vote at the election.

      1.10    Nomination of Directors. Only persons who are nominated in accordance with the following procedures shall be eligible for election as directors. Nomination for election to the Board of Directors of the corporation at a meeting of stockholders may be made by the Board of Directors or by any stockholder of the corporation entitled to vote for the election of directors at such meeting who complies with the notice procedures set forth in this Section 1.10. Such nominations, other than those made by or on behalf of the Board of Directors, shall be made by notice in writing delivered or mailed by first class United States mail, postage prepaid, to the Secretary, and received not less than 60 days nor more than 90 days prior to such meeting; provided, however, that if less than 70 days’ notice or prior public disclosure of the date of the

2


meeting is given to stockholders, such nomination shall have been mailed or delivered to the Secretary not later than the close of business on the 10th day following the date on which the notice of the meeting was mailed or such public disclosure was made, whichever occurs first. Such notice shall set forth (a) as to each proposed nominee (i) the name, age, business address and, if known, residence address of each such nominee, (ii) the principal occupation or employment of each such nominee, (iii) the number of shares of stock of the corporation which are beneficially owned by each such nominee, and (iv) any other information concerning the nominee that must be disclosed as to nominees in proxy solicitations pursuant to Regulation 14A under the Securities Exchange Act of 1934, as amended (including such person’s written consent to be named as a nominee and to serve as a director if elected); and (b) as to the stockholder giving the notice (i) the name and address, as they appear on the corporation’s books, of such stockholder and (ii) the class and number of shares of the corporation which are beneficially owned by such stockholder. The corporation may require any proposed nominee to furnish such other information as may reasonably be required by the corporation to determine the eligibility of such proposed nominee to serve as a director of the corporation.

      The chairman of the meeting may, if the facts warrant, determine and declare to the meeting that a nomination was not made in accordance with the foregoing procedure, and if he should so determine, he shall so declare to the meeting and the defective nomination shall be disregarded.

      1.11    Notice of Business at Annual Meetings. At an annual meeting of the stockholders, only such business shall be conducted as shall have been properly brought before the meeting. To be properly brought before an annual meeting, business must be (a) specified in the notice of meeting (or any supplement thereto) given by or at the direction of the Board of Directors, (b) otherwise properly brought before the meeting by or at the direction of the Board of Directors, or (c) otherwise properly brought before an annual meeting by a stockholder. For business to be properly brought before an annual meeting by a stockholder, if such business relates to the election of directors of the corporation, the procedures in Section 1.10 must be complied with. If such business relates to any other matter, the stockholder must have given timely notice thereof in writing to the Secretary. To be timely, a stockholder’s notice must be delivered to or mailed and received at the principal executive offices of the corporation not less than 60 days nor more than 90 days prior to the meeting; provided, however, that in the event that less than 70 days’ notice or prior public disclosure of the date of the meeting is given or made to stockholders, notice by the stockholder to be timely must be so received not later than the close of business on the 10th day following the date on which such notice of the date of the meeting was mailed or such public disclosure was made, whichever occurs first. A stockholder’s notice to the Secretary shall set forth as to each matter the stockholder proposes to bring before the annual meeting (a) a brief description of the business desired to be brought before the annual meeting and the reasons for conducting such business at the annual meeting, (b) the name and address, as they appear on the corporation’s books, of the stockholder proposing such business, (c) the class and number of shares of the corporation which are beneficially owned by the stockholder, and (d) any material interest of the stockholder in such business. Notwithstanding anything in these By-Laws to the contrary, no business shall be conducted at any annual meeting except in accordance with the procedures set forth in this Section 1.11 and except that any stockholder proposal which complies with Rule 14a-8 of the proxy rules (or any successor provision) promulgated under the Securities Exchange Act of 1934, as amended, and is to be

3


included in the corporation’s proxy statement for an annual meeting of stockholders shall be deemed to comply with the requirements of this Section 1.11.

      The chairman of the meeting shall, if the facts warrant, determine and declare to the meeting that business was not properly brought before the meeting in accordance with the provisions of this Section 1.11, and if he should so determine, the chairman shall so declare to the meeting that any such business not properly brought before the meeting shall not be transacted.

      1.12    Action without Meeting. Stockholders may not take any action by written consent in lieu of a meeting.

      1.13    Organization. The Chairman of the Board, or in his absence the Vice Chairman of the Board designated by the Chairman of the Board, or the President, in the order named, shall call meetings of the stockholders to order, and shall act as chairman of such meeting; provided, however, that the Board of Directors may appoint any stockholder to act as chairman of any meeting in the absence of the Chairman of the Board. The Secretary of the corporation shall act as secretary at all meetings of the stockholders; but in the absence of the Secretary at any meeting of the stockholders, the presiding officer may appoint any person to act as secretary of the meeting.

ARTICLE 2 – Directors

      2.1    General Powers. The business and affairs of the corporation shall be managed by or under the direction of a Board of Directors, who may exercise all of the powers of the corporation except as otherwise provided by law, the Certificate of Incorporation or these By-Laws. In the event of a vacancy in the Board of Directors, the remaining directors, except as otherwise provided by law, may exercise the powers of the full Board until the vacancy is filled.

      2.2    Number; Election and Qualification. The number of directors which shall constitute the whole Board of Directors shall be determined by resolution of the Board of Directors, but in no event shall be less than three. The number of directors may be decreased at any time and from time to time by a majority of the directors then in office, but only to eliminate vacancies existing by reason of the death, resignation, removal or expiration of the term of one or more directors. The directors shall be elected at the annual meeting of stockholders by such stockholders as have the right to vote on such election. Directors need not be stockholders of the corporation.

      2.3    Classes of Directors. The Board of Directors shall be and is divided into three classes: Class I, Class II and Class III. No one class shall have more than one director more than any other class. If a fraction is contained in the quotient arrived at by dividing the designated number of directors by three, then, if such fraction is one-third, the extra director shall be a member of Class I, and if such fraction is two-thirds, one of the extra directors shall be a member of Class I and one of the extra directors shall be a member of Class II, unless otherwise provided from time to time by resolution adopted by the Board of Directors.

4


      2.4    Terms of Office. Each director shall serve for a term ending on the date of the third annual meeting following the annual meeting at which such director was elected; provided, that each initial director in Class I shall serve for a term ending on the date of the annual meeting of stockholders in 1996; each initial director in Class II shall serve for a term ending on the date of the annual meeting of stockholders in 1997; and each initial director in Class III shall serve for a term ending on the date of the annual meeting of stockholders in 1998; and provided further, that the term of each director shall be subject to the election and qualification of his successor and to his earlier death, resignation or removal.

      2.5    Allocation of Directors Among Classes in the Event of Increases or Decreases in the Number of Directors. In the event of any increase or decrease in the authorized number of directors, (i) each director then serving as such shall nevertheless continue as a director of the class of which he is a member and (ii) the newly created or eliminated directorships resulting from such increase or decrease shall be apportioned by the Board of Directors among the three classes of directors so as to ensure that no one class has more than one director more than any other class. To the extent possible, consistent with the foregoing rule, any newly created directorships shall be added to those classes whose terms of office are to expire at the latest dates following such allocation, and any newly eliminated directorships shall be subtracted from those classes whose terms of offices are to expire at the earliest dates following such allocation, unless otherwise provided from time to time by resolution adopted by the Board of Directors.

      2.6    Vacancies. Any vacancy in the Board of Directors, however occurring, including a vacancy resulting from an enlargement of the Board, shall be filled only by vote of a majority of the directors then in office, although less than a quorum, or by a sole remaining director. A director elected to fill a vacancy shall be elected for the unexpired term of his predecessor in office, and a director chosen to fill a position resulting from an increase in the number of directors shall hold office until the next election of the class for which such director shall have been chosen, subject to the election and qualification of his successor and to his earlier death, resignation or removal.

      2.7    Resignation. Any director may resign by delivering his written resignation to the corporation at its principal office or to the President or Secretary. Such resignation shall be effective upon receipt unless it is specified to be effective at some other time or upon the happening of some other event.

      2.8    Regular Meetings. Regular meetings of the Board of Directors may be held without notice at such time and place, either within or without the State of Delaware, as shall be determined from time to time by the Board of Directors; provided that any director who is absent when such a determination is made shall be given notice of the determination. A regular meeting of the Board of Directors may be held without notice immediately after and at the same place as the annual meeting of stockholders.

      2.9    Special Meetings. Special meetings of the Board of Directors may be held at any time and place, within or without the State of Delaware, designated in a call by the Chairman of the Board, President, two or more directors, or by one director in the event that there is only a single director in office.

5


      2.10    Notice of Special Meetings. Notice of any special meeting of directors shall be given to each director by the Secretary or by the officer or one of the directors calling the meeting. Notice shall be duly given to each director (i) by giving notice to such director in person or by telephone at least 24 hours in advance of the meeting, (ii) by sending a telegram, telecopy, or telex, or delivering written notice by hand, to his last known business or home address at least 24 hours in advance of the meeting, or (iii) by mailing written notice to his last known business or home address at least 72 hours in advance of the meeting. A notice or waiver of notice of a meeting of the Board of Directors need not specify the purposes of the meeting.

      2.11    Meetings by Telephone Conference Calls. Directors or any members of any committee designated by the directors may participate in a meeting of the Board of Directors or such committee by means of conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other, and participation by such means shall constitute presence in person at such meeting.

      2.12    Quorum. A majority of the total number of the whole Board of Directors shall constitute a quorum at all meetings of the Board of Directors. In the event one or more of the directors shall be disqualified to vote at any meeting, then the required quorum shall be reduced by one for each such director so disqualified; provided, however, that in no case shall less than one-third (1/3) of the number so fixed constitute a quorum. In the absence of a quorum at any such meeting, a majority of the directors present may adjourn the meeting from time to time without further notice other than announcement at the meeting, until a quorum shall be present.

      2.13    Action at Meeting. At any meeting of the Board of Directors at which a quorum is present, the vote of a majority of those present shall be sufficient to take any action, unless a different vote is specified by law, the Certificate of Incorporation or these By-Laws. Notwithstanding the foregoing, at any time during which the directors of the corporation who are affiliated with IGI, Inc. shall constitute at least half of the membership of the Board of Directors, any matter requiring approval of the Board of Directors shall be subject to the approval of not less than two-thirds of the directors.

      2.14    Action by Consent. Any action required or permitted to be taken at any meeting of the Board of Directors or of any committee of the Board of Directors may be taken without a meeting, if all members of the Board or committee, as the case may be, consent to the action in writing, and the written consents are filed with the minutes of proceedings of the Board or committee.

      2.15    Removal. Directors of the corporation may be removed only for cause by the affirmative vote of the holders of two-thirds of the shares of the capital stock of the corporation issued and outstanding and entitled to vote.

      2.16    Committees. The Board of Directors may, by resolution passed by a majority of the whole Board, designate one or more committees, each committee to consist of one or more of the directors of the corporation. The Board may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee. In the absence or disqualification of a member of a committee, the member or members of the committee present at any meeting and not disqualified from voting, whether or

6


not he or they constitute a quorum, may unanimously appoint another member of the Board of Directors to act at the meeting in the place of any such absent or disqualified member. Any such committee, to the extent provided in the resolution of the Board of Directors and subject to the provisions of the General Corporation Law of the State of Delaware, shall have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the corporation and may authorize the seal of the corporation to be affixed to all papers which may require it. Each such committee shall keep minutes and make such reports as the Board of Directors may from time to time request. Except as the Board of Directors may otherwise determine, any committee may make rules for the conduct of its business, but unless otherwise provided by the directors or in such rules, its business shall be conducted as nearly as possible in the same manner as is provided in these By-Laws for the Board of Directors.

      2.17    Compensation of Directors. Directors may be paid such compensation for their services and such reimbursement for expenses of attendance at meetings as the Board of Directors may from time to time determine. No such payment shall preclude any director from serving the corporation or any of its parent or subsidiary corporation in any other capacity and receiving compensation for such service.

ARTICLE 3 – Officers

      3.1    Enumeration. The officers of the corporation shall consist of a President, a Secretary, a Treasurer and such other officers with such other titles as the Board of Directors shall determine, including a Chairman of the Board, a Vice Chairman of the Board, and one or more Vice Presidents, Assistant Treasurers, and Assistant Secretaries. The Board of Directors may appoint such other officers as it may deem appropriate.

      3.2    Election. The President, Treasurer and Secretary shall be elected annually by the Board of Directors at its first meeting following the annual meeting of stockholders. Other officers may be appointed by the Board of Directors at such meeting or at any other meeting.

      3.3    Qualification. No officer need be a stockholder. Any two or more offices may be held by the same person.

      3.4    Tenure. Except as otherwise provided by law, by the Certificate of Incorporation or by these By-Laws, each officer shall hold office until his successor is elected and qualified, unless a different term is specified in the vote choosing or appointing him, or until his earlier death, resignation or removal.

      3.5    Resignation and Removal. Any officer may resign by delivering his written resignation to the corporation at its principal office or the President or Secretary. Such resignation shall be effective upon receipt unless it is specified to be effective at some other time or upon the happening of some other event.

      Any officer may be removed at any time, with or without cause, by vote of a majority of the entire number of directors then in office.

7


      Except as the Board of Directors may otherwise determine, no officer who resigns or is removed shall have any right to any compensation as an officer for any period following his resignation or removal, or any right to damages on account of such removal, whether his compensation be by the month or by the year or otherwise, unless such compensation is expressly provided in a duly authorized written agreement with the corporation.

      3.6    Vacancies. The Board of Directors may fill any vacancy occurring in any office for any reason and may, in its discretion, leave unfilled for such period as it may determine any offices other than those of President, Treasurer and Secretary. Each such successor shall hold office for the unexpired term of his predecessor and until his successor is elected and qualified, or until his earlier death, resignation or removal.

      3.7    Chairman of the Board and Vice Chairman of the Board. The Board of Directors may appoint a Chairman of the Board and may designate the Chairman of the Board as Chief Executive Officer. If the Board of Directors appoints a Chairman of the Board, he shall perform such duties and possess such powers as are assigned to him by the Board of Directors. If the Board of Directors appoints a Vice Chairman of the Board, he shall, in the absence or disability of the Chairman of the Board, perform the duties and exercise the powers of the Chairman of the Board and shall perform such other duties and possess such other powers as may from time to time be vested in him by the Board of Directors.

      3.8    President. The President shall, subject to the direction of the Board of Directors, have general charge and supervision of the business of the corporation. Unless otherwise provided by the Board of Directors, he shall preside at all meetings of the stockholders, and if he is a director, at all meetings of the Board of Directors. Unless the Board of Directors has designated the Chairman of the Board or another officer as Chief Executive Officer, the President shall be the Chief Executive Officer of the corporation. The President shall perform such other duties and shall have such other powers as the Board of Directors may from time to time prescribe.

      3.9    Vice Presidents. Any Vice President shall perform such duties and possess such powers as the Board of Directors or the President may from time to time prescribe. In the event of the absence, inability or refusal to act of the President, the Vice President (or if there shall be more than one, the Vice Presidents in the order determined by the Board of Directors) shall perform the duties of the President and when so performing shall have all the powers of and be subject to all the restrictions upon the President. The Board of Directors may assign to any Vice President the title of Executive Vice President, Senior Vice President or any other title selected by the Board of Directors.

      3.10    Secretary and Assistant Secretaries. The Secretary shall perform such duties and shall have such powers as the Board of Directors or the President may from time to time prescribe. In addition, the Secretary shall perform such duties and have such powers as are incident to the office of the secretary, including without limitation the duty and power to give notices of all meetings of stockholders and special meetings of the Board of Directors, to attend all meetings of stockholders and the Board of Directors and keep a record of the proceedings, to maintain a stock ledger and prepare lists of stockholders and their addresses as required, to be

8


custodian of corporate records and the corporate seal and to affix and attest to the same on documents.

      Any Assistant Secretary shall perform such duties and possess such powers as the Board of Directors, the President or the Secretary may from time to time prescribe. In the event of the absence, inability or refusal to act of the Secretary, the Assistant Secretary (or if there shall be more than one, the Assistant Secretaries in the order determined by the Board of Directors) shall perform the duties and exercise the powers of the Secretary.

      In the absence of the Secretary or any Assistant Secretary at any meeting of stockholders or directors, the person presiding at the meeting shall designate a temporary secretary to keep a record of the meeting.

      3.11    Treasurer and Assistant Treasurers. The Treasurer shall perform such duties and shall have such powers as may from time to time be assigned to him by the Board of Directors or the President. In addition, the Treasurer shall perform such duties and have such powers as are incident to the office of treasurer, including without limitation the duty and power to keep and be responsible for all funds and securities of the corporation, to deposit funds of the corporation in depositories selected in accordance with these By-Laws, to disburse such funds as ordered by the Board of Directors, to make proper accounts of such funds, and to render as required by the Board of Directors statements of all such transactions and of the financial condition of the corporation.

      The Assistant Treasurers shall perform such duties and possess such powers as the Board of Directors, the President or the Treasurer may from time to time prescribe. In the event of the absence, inability or refusal to act of the Treasurer, the Assistant Treasurer (or if there shall be more than one, the Assistant Treasurers in the order determined by the Board of Directors) shall perform the duties and exercise the powers of the Treasurer.

      3.12    Salaries. Officers of the corporation shall be entitled to such salaries, compensation or reimbursement as shall be fixed or allowed from time to time by the Board of Directors.

ARTICLE 4 – Capital Stock

      4.1    Issuance of Stock. Unless otherwise voted by the stockholders and subject to the provisions of the Certificate of Incorporation, the whole or any part of any unissued balance of the authorized capital stock of the corporation or the whole or any part of any unissued balance of the authorized capital stock of the corporation held in its treasury may be issued, sold, transferred or otherwise disposed of by vote of the Board of Directors in such manner, for such consideration and on such terms as the Board of Directors may determine.

      4.2    Certificates of Stock. Every holder of stock of the corporation shall be entitled to have a certificate, in such form as may be prescribed by law and by the Board of Directors, certifying the number and class of shares owned by him in the corporation. Each such certificate shall be signed by, or in the name of the corporation by, the Chairman or Vice Chairman, if any, of the Board of Directors, or the President or a Vice President, and the Treasurer or an Assistant

9


Treasurer, or the Secretary or an Assistant Secretary of the corporation. Any or all of the signatures on the certificate may be a facsimile.

      Each certificate for shares of stock which are subject to any restriction on transfer pursuant to the Certificate of Incorporation, the By-Laws, applicable securities laws or any agreement among any number of stockholders or among such holders and the corporation shall have conspicuously noted on the face or back of the certificate either the full text of the restriction or a statement of the existence of such restriction.

      4.3    Transfers. Except as otherwise established by rules and regulations adopted by the Board of Directors, and subject to applicable law, shares of stock may be transferred on the books of the corporation by the surrender to the corporation or its transfer agent of the certificate representing such shares properly endorsed or accompanied by a written assignment or power of attorney properly executed, and with such proof of authority or the authenticity of signature as the corporation or its transfer agent may reasonably require. Except as may be otherwise required by law, by the Certificate of Incorporation or by these By-Laws, the corporation shall be entitled to treat the record holder of stock as shown on its books as the owner of such stock for all purposes, including the payment of dividends and the right to vote with respect to such stock, regardless of any transfer, pledge or other disposition of such stock until the shares have been transferred on the books of the corporation in accordance with the requirements of these By-Laws.

      4.4    Lost, Stolen or Destroyed Certificates. The corporation may issue a new certificate of stock in place of any previously issued certificate alleged to have been lost, stolen, or destroyed, upon such terms and conditions as the Board of Directors may prescribe, including the presentation of reasonable evidence of such loss, theft or destruction and the giving of such indemnity as the Board of Directors may require for the protection of the corporation or any transfer agent or registrar.

      4.5    Record Date. The Board of Directors may fix in advance a date as a record date for the determination of the stockholders entitled to notice of or to vote at any meeting of stockholders, or entitled to receive payment of any dividend or other distribution or allotment of any rights in respect of any change, conversion or exchange of stock, or for the purpose of any other lawful action. Such record date shall not be more than 60 nor less than 10 days before the date of such meeting, nor more than 60 days prior to any other action to which such record date relates.

      If no record date is fixed, the record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders shall be at the close of business on the day before the day on which notice is given, or, if notice is waived, at the close of business on the day before the day on which the meeting is held. The record date for determining stockholders for any other purpose shall be at the close of business on the day on which the Board of Directors adopts the resolution relating to such purpose.

      A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting; provided, however, that the Board of Directors may fix a new record date for the adjourned meeting.

10


ARTICLE 5 – General Provisions

      5.1    Fiscal Year. Except as from time to time otherwise designated by the Board of Directors, the fiscal year of the corporation shall begin on the first day of January in each year and end on the last day of December in each year.

      5.2    Corporate Seal. The corporate seal shall be in such form as shall be approved by the Board of Directors.

      5.3    Waiver of Notice. Whenever any notice whatsoever is required to be given by law, by the Certificate of Incorporation or by these By-Laws, a waiver of such notice either in writing signed by the person entitled to such notice or such person’s duly authorized attorney, or by telegraph, cable or any other available method, whether before, at or after the time stated in such waiver, or the appearance of such person or persons at such meeting in person or by proxy, shall be deemed equivalent to such notice.

      5.4    Voting of Securities. Except as the directors may otherwise designate, the President or Treasurer may waive notice of, and act as, or appoint any person or persons to act as, proxy or attorney-in-fact for this corporation (with or without power of substitution) at, any meeting of stockholders or shareholders of any other corporation or organization, the securities of which may be held by this corporation.

      5.5    Evidence of Authority. A certificate by the Secretary, or an Assistant Secretary, or a temporary Secretary, as to any action taken by the stockholders, directors, a committee or any officer or representative of the corporation shall as to all persons who rely on the certificate in good faith be conclusive evidence of such action.

      5.6    Certificate of Incorporation. All references in these By-Laws to the Certificate of Incorporation shall be deemed to refer to the Certificate of Incorporation of the corporation, as amended and in effect from time to time.

      5.7    Transactions with Interested Parties. No contract or transaction between the corporation and one or more of the directors or officers, or between the corporation and any other corporation, partnership, association, or other organization in which one or more of the directors or officers are directors or officers, or have a financial interest, shall be void or voidable solely for this reason, or solely because the director or officer is present at or participates in the meeting of the Board of Directors or a committee of the Board of Directors which authorizes the contract or transaction or solely because his or their votes are counted for such purpose, if:

  (1)   The material facts as to his relationship or interest and as to the contract or transaction are disclosed or are known to the Board of Directors or the committee, and the Board or committee in good faith authorizes the contract or transaction by the affirmative votes of a majority of the disinterested directors, even though the disinterested directors be less than a quorum;

11


  (2)   The material facts as to his relationship or interest and as to the contract or transaction are disclosed or are known to the stockholders entitled to vote thereon, and the contract or transaction is specifically approved in good faith by vote of the stockholders; or
 
  (3)   The contract or transaction is fair as to the corporation as of the time it is authorized, approved or ratified, by the Board of Directors, a committee of the Board of Directors, or the stockholders.

      Common or interested directors may be counted in determining the presence or a quorum at a meeting of the Board of Directors or of a committee which authorizes the contract or transaction.

      5.8    Severability. Any determination that any provision of these By-Laws is for any reason inapplicable, illegal or ineffective shall not affect or invalidate any other provision of these By-Laws.

      5.9    Pronouns. All pronouns used in these By-Laws shall be deemed to refer to the masculine, feminine or neuter, singular or plural, as the identity of the person or persons may require.

ARTICLE 6 – Amendments

      6.1    By the Board of Directors. These By-Laws may be altered, amended or repealed or new by-laws may be adopted by the affirmative vote of a majority of the directors present at any regular or special meeting of the Board of Directors at which a quorum is present.

      6.2    By the Stockholders. Except as otherwise provided in Section 6.3, these By-Laws may be altered, amended or repealed or new by-laws may be adopted by the affirmative vote of the holders of a majority of the shares of the capital stock of the corporation issued and outstanding and entitled to vote at any regular or special meeting of stockholders, provided notice of such alteration, amendment, repeal or adoption of new by-laws shall have been stated in the notice of such regular or special meeting.

      6.3    Certain Provisions. Notwithstanding any other provision of law, the Certificate of Incorporation or these By-Laws, and notwithstanding the fact that a lesser percentage may be specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the shares of the capital stock of the corporation issued and outstanding and entitled to vote shall be required to amend or repeal, or to adopt any provision inconsistent with Section 1.3, Section 1.10, Section 1.11, Section 1.12, Section 1.13, Article 2 or Article 6 or these By-Laws.

12 EX-10.1 5 w52015ex10-1.htm FIRST AMENDMENT ex10-1

Exhibit 10.1

FIRST AMENDMENT TO THE COPROMOTION AGREEMENT

         This FIRST AMENDMENT TO THE COPROMOTION AGREEMENT (hereinafter, the “First Amendment”) is entered into and is effective as of this 29th day of June, 2001 (the “Effective Date”), by and between KING PHARMACEUTICALS, INC., a Tennessee corporation (hereinafter, “KING”), and NOVAVAX, INC., a Delaware corporation (hereinafter, “NOVAVAX”).

W I T N E S S E T H:

         WHEREAS, KING and NOVAVAX entered into the Copromotion Agreement dated as of January 8, 2001 (the “Copromotion Agreement”);

         WHEREAS, the parties desire to modify certain provisions of the Copromotion Agreement, as more specifically set forth below;

         WHEREAS, KING and NOVAVAX desire to clarify that the term NOVAVAX Product, as used and defined in the Copromotion Agreement, covers and includes ANDROSORB™ and any other NOVAVAX products that contain or use testosterone or other anabolic or androgenic substances in connection with hormone replacement therapy in the field of women’s health, and to further clarify that the term NOVAVAX Trademark, as used and defined in the Copromotion Agreement, covers and includes ANDROSORB™ as a NOVAVAX TRADEMARK (hereinafter, “Joint Construction and Understanding”);

         WHEREAS, for purposes of clarification, KING and NOVAVAX each desire to amend and revise the Copromotion Agreement to specifically recite this Joint Construction and Understanding (hereinafter, “Clarification”); and

         WHEREAS, to accomplish this Clarification, KING and NOVAVAX each desire to amend and revise ANNEX I, entitled DEFINITIONS, and EXHIBIT 2.3(d) and EXHIBIT 9.1 attached to the Copromotion Agreement.

         NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and intending to be legally bound hereby, the parties hereto agree as follows:

      1.01 KING and NOVAVAX agree that capitalized terms used herein but not otherwise defined shall have the same meanings set forth in the Copromotion Agreement.

      1.02 To accomplish the Clarification, KING and NOVAVAX agree that the term “NOVAVAX Product”, as set forth in ANNEX I, entitled

 


DEFINITIONS, attached to the Copromotion Agreement is hereby deleted and replaced in its entirety with the following definition:

        “NOVAVAX Product” shall mean ESTRASORB™, ANDROSORB™ and, subject to Section 8.6 hereof, any hormone replacement therapy pharmaceutical product marketed in the field of women’s health, including, but not limited to, those products that (1) include or use technology or Know How derived from ESTRASORB™ or from ANDROSORB™, (2) include or use testosterone or any other anabolic or androgenic substance, or (3) contain a combination of a NOVAVAX Product and another pharmaceutical product. NOVAVAX Product shall specifically exclude any pharmaceutical or related products owned by NOVAVAX as a direct result of the consummation of the Fielding Acquisition Agreement (as defined in the Note Purchase Agreement) so long as any such pharmaceutical product or related product does not include or use ESTRASORB™ or ANDROSORB™ technology or Know How.

      1.03 To further accomplish the Clarification, KING and NOVAVAX agree that the term “NOVAVAX Trademark “, as set forth in ANNEX I, entitled DEFINITIONS, attached to the Copromotion Agreement, is hereby deleted and replaced it in its entirety with the following definition:

        “NOVAVAX Trademark” shall mean, whether or not registered, the mark ESTRASORB™ including any other related trademark or servicemark containing the word “ESTRASORB”, the mark ANDROSORB™ including any other related trademark or servicemark containing the word “ANDROSORB”, and any other trademark or service mark (whether or not registered) that NOVAVAX decides to use on or with the NOVAVAX Products or in any promotional material related to any of the NOVAVAX Products.

      1.04 Consistent with the Joint Construction and Understanding and the Clarification, KING and NOVAVAX agree that Exhibit 2.3(d), as attached to the Copromotion Agreement, is hereby deleted and replaced it in its entirety with the following new Exhibit 2.3(d):

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EXHIBIT 2.3(d)

PRIMARY BRAND TRADEMARKS

ESTRASORB™

NORDETTE®

ANDROSORB™

      1.05 Consistent with the Joint Construction and Understanding and the Clarification, King and Novavax agree that the first and second paragraphs under Part I of Exhibit 9.1, as attached to the Copromotion Agreement, are hereby deleted and replaced in their entirety with the following:

        NP Consideration Fee to be paid to King as follows:

        (50% of the Net Sales of the applicable Novavax Product in the Territory) MINUS (50% on the Net Costs of such Novavax Product in the Territory)*

        *Novavax is solely responsible for Net Costs in excess of 17% of Net Sales.

      1.06 Except as otherwise expressly provided in this First Amendment, KING and NOVAVAX agree that all provisions of the Copromotion Agreement are hereby ratified and agreed to be in full force and effect, and are incorporated herein by reference.

      1.07 The Copromotion Agreement, as amended by this First Amendment, and the Confidentiality Agreements contain the entire agreement among the parties with respect to the transactions contemplated herein and supersede any prior agreements, understandings or arrangements between them, whether oral or in writing. This First Amendment may not be amended, modified, altered or supplemented except by means of a written agreement or other instrument executed by both of the parties hereto. No course of conduct or dealing between the parties shall act as a modification or waiver of any provisions of this First Amendment.

      1.08 This First Amendment may be executed in separate counterparts, none of which need contain the signatures of all parties, each of which shall be deemed to be an original, and all of which taken together constitute one and the same

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instrument. It shall not be necessary in making proof of this First Amendment to produce or account for more than the number of counterparts containing the respective signatures of, or on behalf of, all of the parties hereto. Original signatures transmitted by facsimile shall be acceptable to purposes of executing this First Amendment. If original signatures are transmitted by facsimile, the parties shall endeavor in good faith to deliver to each other executed counterpart originals as soon as practicable after the date of this First Amendment.

[Signature page follows]

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         IN WITNESS WHEREOF, each of the parties hereto has executed this First Amendment, or has caused this First Amendment to be duly executed and delivered in its name on its behalf, all as of the Effective Date first above written.

                 
KING PHARMACEUTICALS, INC. NOVAVAX, INC.
By: By:


Name: Name:


Title: Title:


-5- EX-10.2 6 w52015ex10-2.htm SECOND AMENDMENT ex10-2

Exhibit 10.2

SECOND AMENDMENT TO THE COPROMOTION AGREEMENT

         This SECOND AMENDMENT TO THE COPROMOTION AGREEMENT (hereinafter, the “Second Amendment”) is entered into and is effective as of this 29th day of June, 2001 (hereinafter, the “Effective Date”), by and between KING PHARMACEUTICALS, INC., a Tennessee corporation (hereinafter, “KING”), and NOVAVAX, INC., a Delaware corporation (hereinafter, “NOVAVAX”).

W I T N E S S E T H:

         WHEREAS, KING and NOVAVAX entered into the Copromotion Agreement dated as of January 8, 2001 (hereinafter, “the Copromotion Agreement”), as amended by the First Amendment to the Copromotion Agreement dated as of the date hereof (hereinafter, the “First Amendment”);

         WHEREAS, the parties now desire to modify certain provisions of the Copromotion Agreement, as more specifically set forth below;

         WHEREAS, KING and NOVAVAX each desire to reduce the baseline sales figures for the KING Products, as set forth in Exhibit 9.1(b) to the Copromotion Agreement;

         WHEREAS, NOVAVAX desires for KING and KING desires to equally share with NOVAVAX in the Direct Costs for the development of ANDROSORB™, and NOVAVAX further desires for KING and KING further desires to receive fifty percent (50%) of any revenues that NOVAVAX actually receives from the sales of ANDROSORB™; and KING and NOVAVAX each desire to revise and amend Section 8.6 of the Copromotion Agreement, accordingly;

         WHEREAS, KING and NOVAVAX each desire to revise and amend the milestone payments, as set forth in Section 9.2, entitled Milestone Payments, of the Copromotion Agreement;

         WHEREAS, KING desires for NOVAVAX and NOVAVAX desires to spend at least Five Million U.S. Dollars ($5,000,000.00) in Pre-Launch Marketing Expenses for ESTRASORB™ during the Pre-Launch Period; and

         WHEREAS, KING and NOVAVAX each desire to add Filed, Pre-Launch Marketing Expenses, Pre-Launch Period and Submitted as four newly defined terms to ANNEX I, entitled “DEFINITIONS”, attached to the Copromotion Agreement.

         NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and intending to be legally bound hereby, the parties hereto agree as follows:

 


      1.01 KING and NOVAVAX agree that capitalized terms used herein but not otherwise defined shall have the same meanings set forth in the Copromotion Agreement, as amended by the First Amendment.

      1.02 KING and NOVAVAX agree that ANNEX I, entitled “DEFINITIONS”, attached to the Copromotion Agreement, is hereby amended by adding “Filed”, “Pre-Launch Marketing Expenses”, “Pre-Launch Period” and “Submitted” as four newly defined terms thereto, as follows:

      “Filed” shall mean that (1) the ESTRASORB™ NDA has been Submitted in its entirety by NOVAVAX on or before June 29, 2001, and (2) the FDA shall have issued written notification to NOVAVAX on or before September 1, 2001, which (i) accepts for filing the ESTRASORB™ NDA, which was Submitted by NOVAVAX on or before June 29, 2001, and (ii) assigns the ESTRASORB™ NDA, which was Submitted on or before June 29, 2001, a reference number and filing date.

      “Pre-Launch Marketing Expenses” shall mean the costs and expenses incurred by NOVAVAX which directly and solely relate to the marketing and promotion of the applicable NOVAVAX Product during the Pre-Launch Period in the Territory and shall include, without limitation, costs and expenses incurred in connection with (i) general advertising, including without limitation journal advertising, direct mail advertising and point of prescription advertising; (ii) continuing medical education programs, (iii) publications related to such NOVAVAX Product; (iv) trade shows and conventions; and (v) Marketing Materials.

      “Pre-Launch Period” shall mean that period of time that extends from the Effective Date up to, but excluding the NOVAVAX Product Initiation Date.

      “Submitted” shall mean that NOVAVAX shall have delivered the ESTRASORB™ NDA to the FDA, in accordance with the applicable laws, regulations and rules that govern the FDA.

      1.03 KING and NOVAVAX agree that KING shall equally share with NOVAVAX in the Direct Costs and Pre-Launch Marketing Expenses for the development of ANDROSORB™ in the Territory and receive fifty percent (50%) of any revenues that NOVAVAX actually receives from the sales of ANDROSORB™ in the Territory. KING and NOVAVAX therefore agree that Section 8.6 of the Copromotion Agreement is hereby amended by adding a new Section 8.6(c) thereto, as follows:

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        (c) KING and NOVAVAX agree that KING shall equally share with NOVAVAX in the Direct Costs and Pre-Launch Marketing Expenses for the development of ANDROSORB™ in the Territory and receive fifty percent (50%) of any revenues that NOVAVAX actually receives from the sales of ANDROSORB™ in the Territory. NOVAVAX’s allocation and spending of such Direct Costs and Pre-Launch Marketing Expenses shall be subject to review and approval of the PMC.

      1.04 KING and NOVAVAX agree to reduce the baseline sales figures for KING Products from Thirty Million U.S. Dollars ($30,000,000.00) per calendar year, as set forth in EXHIBIT 9.1(b) in the Copromotion Agreement, to Twenty-Five Million U.S. Dollars ($25,000,000.00) per calendar year. KING and NOVAVAX therefore agree that the original EXHIBIT 9.1(b) to the Copromotion Agreement is hereby deleted and replaced in its entirety with the following new EXHIBIT 9.1(b):

EXHIBIT 9.1(b)

BASELINES FOR CALCULATING INCREMENTAL SALES

         
NORDETTE®


QUARTER BASELINE


1Q (January 1—March 31) $5,330,000


2Q (April 1—June 30) $6,250,000


3Q (July 1—September 30) $6,670,000


4Q (October 1—December 31) $6,750,000


      1.05 KING and NOVAVAX further desire to modify the milestone obligations as set forth in Section 9.2 of the Copromotion Agreement. KING and NOVAVAX therefore agree that original Section 9.2, entitled Milestone Payments, of the Copromotion Agreement is hereby deleted and replaced it in its entirety with the following new Section 9.2, entitled Milestone Payments:

      9.2 Milestone Payments

         KING shall pay NOVAVAX the following milestone payments if the conditions to such payments shall have been satisfied by NOVAVAX on or prior to the dates specified below:

         (a) KING shall pay NOVAVAX on June 29, 2001 Two Million Five Hundred Thousand U.S. Dollars ($2,500,000) if on or prior to June 29, 2001, the following shall have occurred: (i) the New Drug Application for ESTRASORB™ (the

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“ESTRASORB™ NDA”) shall have been Submitted, and (ii) NOVAVAX shall have provided to KING the Consultant Opinion Letters required to be delivered pursuant to Section 5(a) of that certain Note Purchase Agreement dated as of December 19, 2000, by and between KING and NOVAVAX (the “Note Purchase Agreement”); and

      (b) KING shall pay NOVAVAX an additional Two Million Five Hundred Thousand U.S. Dollars ($2,500,000) if on or prior to September 1, 2001, the ESTRASORB™ NDA shall have been Filed by the FDA.

      1.06 NOVAVAX agrees to allocate and spend at least Five Million U.S. Dollars ($5,000,000) in Pre-Launch Marketing Expenses to promote ESTRASORB™ during the Pre-Launch Period in the Territory. KING and NOVAVAX therefore agree that original Section 9.6, entitled Other Miscellaneous Costs and Expenses, of the Copromotion Agreement is hereby deleted and replaced it in its entirety with the following new Section 9.6, entitled Other Miscellaneous Costs and Expenses:

      9.6 Other Miscellaneous Costs and Expenses.

        (a) Except as otherwise expressly provided in this Agreement, KING and NOVAVAX shall each pay one-half (1/2) of all costs and expenses, which are specifically approved by the PMC; provided, however that this Section 9.6 shall not be construed to require KING or any of its Affiliates to manufacture the NOVAVAX Products or samples of the NOVAVAX Products, nor shall it be construed to require NOVAVAX or any of its Affiliates to manufacture the KING Products or samples of the KING Products.

        (b) Notwithstanding anything to the contrary in this Agreement, NOVAVAX agrees to allocate and spend during the Pre-Launch Period at least Five Million U.S. Dollars ($5,000,000) in Pre-Launch Marketing Expenses to promote ESTRASORB™ (taking into account the duration of the Pre-Launch Period), and all such Pre-Launch Marketing Expenses shall be borne solely by NOVAVAX. It is understood and agreed to by NOVAVAX that such Pre-Launch Marketing Expenses to promote ESTRASORB™ during the Pre-Launch Period shall be in addition to those expenses required to be incurred by NOVAVAX to promote ESTRASORB™ pursuant to Section 5(c) of the Note Purchase Agreement. NOVAVAX’s allocation and spending of such Pre-Launch Marketing Expenses shall be subject to review and approval of the PMC.

      1.07 Except as otherwise expressly provided in this Second Amendment, KING and NOVAVAX agree that all provisions of the Copromotion Agreement, as

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amended by the First Amendment, are hereby ratified and agreed to be in full force and effect, and are incorporated herein by reference.

      1.08 The Copromotion Agreement, as amended by the First Amendment and this Second Amendment, and the Confidentiality Agreements contain the entire agreement among the parties with respect to the transactions contemplated herein and supersede any prior agreements, understandings or arrangements between them, whether oral or in writing. This Second Amendment may not be amended, modified, altered or supplemented except by means of a written agreement or other instrument executed by both of the parties hereto. No course of conduct or dealing between the parties shall act as a modification or waiver of any provisions of this Second Amendment.

      1.09 This Second Amendment may be executed in separate counterparts, none of which need contain the signatures of all parties, each of which shall be deemed to be an original, and all of which taken together constitute one and the same instrument. It shall not be necessary in making proof of this Second Amendment to produce or account for more than the number of counterparts containing the respective signatures of, or on behalf of, all of the parties hereto. Original signatures transmitted by facsimile shall be acceptable to purposes of executing this Second Amendment. If original signatures are transmitted by facsimile, the parties shall endeavor in good faith to deliver to each other executed counterpart originals as soon as practicable after the date of this Second Amendment.

[Signature page follows]

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      IN WITNESS WHEREOF, each of the parties hereto has executed this Second Amendment, or has caused this Second Amendment to be duly executed and delivered in its name on its behalf, all as of the Effective Date first above written.

         
KING PHARMACEUTICALS, INC NOVAVAX, INC.
By: By:


Name: Name:


Title: Title:


  EX-10.3 7 w52015ex10-3.htm FIRST AMENDMENT TO THE EXCLUSIVE LICENSE ex10-3

Exhibit 10.3

FIRST AMENDMENT TO THE EXCLUSIVE LICENSE
AND DISTRIBUTION AGREEMENT

            This FIRST AMENDMENT TO THE EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT (hereinafter, the “First Amendment”) is entered into and is effective as of this 29th day of June, 2001 (the “Effective Date”), by and between KING PHARMACEUTICALS, INC., a Tennessee corporation (hereinafter, “KING”), and NOVAVAX, INC., a Delaware corporation (hereinafter, “NOVAVAX”).

W I T N E S S E T H:

            WHEREAS, KING and NOVAVAX entered into the Exclusive License and Distribution Agreement dated as of January 8, 2001 (the “Exclusive License and Distribution Agreement”);

            WHEREAS, the parties now desire to modify certain provisions of the Exclusive License and Distribution Agreement, as more specifically set forth below;

            WHEREAS, KING and NOVAVAX desire to clarify that the term Product, as used and defined in the Exclusive License and Distribution Agreement, covers and includes ANDROSORB™ and any other products that contain or use testosterone or other anabolic or androgenic substances in connection with hormone replacement therapy in the field of women’s health, and to further clarify that the term NOVAVAX Trademark, as used and defined in the Exclusive License and Distribution Agreement, covers and includes ANDROSORB™ as a NOVAVAX Trademark (hereinafter, “Joint Construction and Understanding”);

            WHEREAS, for purposes of clarification, KING and NOVAVAX each desire to amend and revise the Exclusive License and Distribution Agreement to specifically recite this Joint Construction and Understanding (hereinafter, “Clarification”); and

            WHEREAS, to accomplish this Clarification, KING and NOVAVAX each desire to amend and revise ANNEX I, entitled DEFINITIONS, and EXHIBIT 2.3(c)(ii) attached to the Exclusive License and Distribution Agreement.

            NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and intending to be legally bound hereby, the parties hereto agree as follows:

      1.01      KING and NOVAVAX agree that capitalized terms used herein but not otherwise defined shall have the same meanings set forth in the Exclusive License and Distribution Agreement.


      1.02      To accomplish the Clarification, KING and NOVAVAX agree that the term Product, as set forth in ANNEX I, entitled DEFINITIONS, which is attached to the Exclusive License and Distribution Agreement, is hereby deleted and replaced in its entirety with the following definition:

        “Product” shall mean ESTRASORB™, ANDROSORB™ and any hormone replacement therapy pharmaceutical product marketed in the field of women’s health, including, but not limited to, those products that (1) include or use technology or Know How derived from ESTRASORB™ or from ANDROSORB™, (2) include or use testosterone or any other anabolic or androgenic substance, or (3) contain a combination of a Product and another pharmaceutical product. Product shall specifically exclude any pharmaceutical or related products owned by NOVAVAX as a direct result of the consummation of the Fielding Acquisition Agreement so long as any such pharmaceutical product or related product does not include or use ESTRASORB™ or ANDROSORB™ technology or Know How.

      1.03      To further accomplish the Clarification, KING and NOVAVAX agree that the term “NOVAVAX Trademark”, as set forth in ANNEX I, entitled DEFINITIONS, attached to the Exclusive License and Distribution Agreement, is hereby deleted and replaced in its entirety with the following definition:

        “NOVAVAX Trademark” shall mean, whether or not registered, the mark ESTRASORB™ including any other related trademark or servicemark containing the word “ESTRASORB”, the mark ANDROSORB™ including any other related trademark or servicemark containing the word “ANDROSORB”, and any other trademark or service mark (whether or not registered) that NOVAVAX decides to use on or with a Product or in any promotional material related to or concerning a Product.

      1.04      Consistent with the Joint Construction and Understanding and the Clarification, KING and NOVAVAX agree that Exhibit 2.3(c)(ii), as attached to the Exclusive License and Distribution Agreement, is hereby deleted and replaced in its entirety with the following new Exhibit 2.3(c)(ii):

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EXHIBIT 2.3(c)(ii)

PRIMARY BRAND TRADEMARKS

ESTRASORB™

ANDROSORB™

      1.05      Except as otherwise expressly provided in this First Amendment, KING and NOVAVAX agree that all provisions of the Exclusive License and Distribution Agreement are hereby ratified and agreed to be in full force and effect, and are incorporated herein by reference.

      1.06      The Exclusive License and Distribution Agreement, as amended by this First Amendment, and the Confidentiality Agreements contain the entire agreement among the parties with respect to the transactions contemplated herein and supersede any prior agreements, understandings or arrangements between them, whether oral or in writing. This First Amendment may not be amended, modified, altered or supplemented except by means of a written agreement or other instrument executed by both of the parties hereto. No course of conduct or dealing between the parties shall act as a modification or waiver of any provisions of this First Amendment.

      1.07      This First Amendment may be executed in separate counterparts, none of which need contain the signatures of all parties, each of which shall be deemed to be an original, and all of which taken together constitute one and the same instrument. It shall not be necessary in making proof of this First Amendment to produce or account for more than the number of counterparts containing the respective signatures of, or on behalf of, all of the parties hereto. Original signatures transmitted by facsimile shall be acceptable to purposes of executing this First Amendment. If original signatures are transmitted by facsimile, the parties shall endeavor in good faith to deliver to each other executed counterpart originals as soon as practicable after the date of this First Amendment.

[Signature page follows]

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      IN WITNESS WHEREOF, each of the parties hereto has executed this First Amendment, or has caused this First Amendment to be duly executed and delivered in its name on its behalf, all as of the Effective Date first above written.

         
KING PHARMACEUTICALS, INC. NOVAVAX, INC.
By: By:


Name: Name:


Title: Title:


EX-10.4 8 w52015ex10-4.htm SECOND AMENDMENT TO THE EXCLUSIVE LICENSE ex10-4

Exhibit 10.4

SECOND AMENDMENT TO THE EXCLUSIVE LICENSE
AND DISTRIBUTION AGREEMENT

            This SECOND AMENDMENT TO THE EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT (hereinafter, the “Second Amendment”) is entered into and is effective as of this 29th day of June, 2001 (the “Effective Date”), by and between KING PHARMACEUTICALS, INC., a Tennessee corporation (hereinafter, “KING”), and NOVAVAX, INC., a Delaware corporation (hereinafter, “NOVAVAX”).

W I T N E S S E T H:

            WHEREAS, KING and NOVAVAX entered into the Exclusive License and Distribution Agreement dated as of January 8, 2001 (hereinafter, “the Exclusive License and Distribution Agreement”), as amended by the First Amendment to the Exclusive License and Distribution Agreement dated as of the date hereof (hereinafter, the “First Amendment”);

            WHEREAS, the parties now desire to modify certain provisions of the Exclusive License and Distribution Agreement, as more specifically set forth below;

            WHEREAS, KING and NOVAVAX each desire to expand the original Territory in the Exclusive License and Distribution Agreement to now include Canada, Italy, the Netherlands, Greece, Switzerland and Spain;

            WHEREAS, King desires to pay NOVAVAX and NOVAVAX desires to receive from KING additional monies for expanding the original Territory in the Exclusive License and Distribution Agreement to include Canada, Italy, the Netherlands, Greece, Switzerland and Spain;

            WHEREAS, KING and NOVAVAX each desire to amend the definition of the term Territory in ANNEX I, entitled “DEFINITIONS”, attached to the Exclusive License and Distribution Agreement and as amended in the First Amendment, to include Canada, Italy, the Netherlands, Greece, Switzerland and Spain;

            WHEREAS, KING and NOVAVAX each desire to amend the definition of the term Purchase Price in ANNEX I, entitled “DEFINITIONS”, attached to the Exclusive License and Distribution Agreement and as amended in the First Amendment; and

            WHEREAS, KING and NOVAVAX each desire to add Canadian Territory, European Territory, and Original Territory, as newly defined terms to


ANNEX I, entitled “DEFINITIONS”, attached to the Exclusive License and Distribution Agreement and as amended in the First Amendment.

            NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and intending to be legally bound hereby, the parties hereto agree as follows:

      1.01      KING and NOVAVAX agree that capitalized terms used herein but not otherwise defined shall have the same meanings set forth in the Exclusive License and Distribution Agreement, as amended by the First Amendment.

      1.02      KING and NOVAVAX agree that ANNEX I, entitled “DEFINITIONS”, attached to the Exclusive License and Distribution Agreement, is hereby amended by adding Original Territory, Canadian Territory, European Territory, Original Territory Purchase Price, Canadian Purchase Price, and European Purchase Price and Regulatory Assets as newly defined terms thereto, as follows:

      “Canadian Purchase Price” shall have the meaning set forth in Section 5.1(a)(2).

      “Canadian Territory” shall mean Canada, its territories and possessions.

      “European Purchase Price” shall have the meaning set forth in Section 5.1(a)(3).

      “European Territory” shall mean, collectively, Italy; the Netherlands; Greece; Switzerland; and Spain, including their territories and possessions.

      “Original Territory” shall mean anywhere in the world except the United States, its territories and possessions, the District of Columbia, the Commonwealth of Puerto Rico, the Canadian Territory, and the European Territory.

      “Original Territory Purchase Price” shall have the meaning set forth in Section 5.1(a)(1).

      “Regulatory Assets” shall mean all registrations, regulatory files, applications, approvals, licenses, franchises, certificates of compliance and permits relating to the Products from any governmental authority which regulates the manufacturing, marketing and/or the sale of drugs or medical products in the Territory, including, without limitation, any and all NDAs, whether issued, pending, or in draft form, and all records, reports, data and other information concerning any of the Products required to be kept under applicable laws in the

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Territory and all correspondence to or from all governmental authorities in the Territory which relates to the Products.

      1.03       KING and NOVAVAX agree that the terms “Cost of Products”, “Purchase Price” and “Territory”, and, as set forth in ANNEX I, entitled DEFINITIONS, attached to the Exclusive License and Distribution Agreement, are hereby deleted and replaced in their entirety with the following definitions:

      “Cost of Products” shall mean (i) the amount equal to the fully allocated costs of the Products incurred by NOVAVAX in connection with manufacturing the Products, and NOVAVAX’s performance of this Agreement, in accordance with GAAP or (ii) in the event the Products are being manufactured by a third party for NOVAVAX, then the “Cost of Products” shall mean the invoice amounts actually paid by NOVAVAX to such third party to purchase the Products.

      “Purchase Price” shall mean either the Original Territory Purchase Price, Canadian Purchase Price and/or European Purchase Price, as applicable.

      “Territory” shall mean anywhere in the world except the United States, its territories and possessions, the District of Columbia, and the Commonwealth of Puerto Rico.

      1.04       KING and NOVAVAX agree that the following Section 2.5 shall be added to the Exclusive License and Distribution Agreement:

            2.5       Additional Trademark Filings.

            NOVAVAX shall file and register the NOVAVAX Trademarks in such additional countries in the Territory as KING shall reasonably request, and each such filing and registration shall be included in the trademarks licensed to KING under this Agreement.

      1.05       KING and NOVAVAX agree that the following sentence shall be added to the end of Section 4.2 of the Exclusive License and Distribution Agreement:

            Notwithstanding anything to the contrary contained in this Agreement, KING shall own all right, title and interest in and to the Regulatory Assets.

      1.06       KING and NOVAVAX agree that original Section 5, entitled FEES and EXPENSES, of the Exclusive License and Distribution Agreement is hereby deleted

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and replaced in its entirety with the following new Section 5, entitled FEES and EXPENSES:

      5.       FEES and EXPENSES

            5.1       Purchase Price.

                  (a)       KING and NOVAVAX agree that the Purchase Price for Product shall be as follows:

                        (1)       For those Products sold by KING in the Original Territory, KING shall purchase from NOVAVAX, and NOVAVAX shall sell to KING, the Products at the price equal to the Cost of Products plus ten percent (10%) (the “Original Territory Purchase Price”). NOVAVAX may, from time to time, upon thirty (30) calendar days written notice to KING, increase the Original Territory Purchase Price for one or more Products sold by King in the Original Territory by an amount equal to the increase in NOVAVAX’s costs for labor and materials used in connection with the manufacture, storage and/or delivery to KING of such Products; provided, however, that during the twelve (12) month period following the Effective Date, NOVAVAX shall not increase the Original Territory Purchase Price for any Product because of any increased labor cost experienced by NOVAVAX. Notwithstanding anything to the contrary in the above Section 5.1(a)(1), in no event shall the total percentage increase in the Original Territory Purchase Price in any calendar year during the Term exceed the percentage increase in the Pharmaceutical Producer Price Index, Pharmaceutical Preparations, Ethical (Prescription) series code PCU-2834 #1, published by the United States Department of Labor, Bureau of Labor Statistics (the “PPPI”) for such calendar year.

                        (2)       For those Products sold by KING in the Canadian Territory, KING shall purchase from NOVAVAX, and NOVAVAX shall sell to KING, the Products at the price equal to the Cost of Products plus twelve percent (12%) (the “Canadian Purchase Price”). NOVAVAX may, from time to time, upon thirty (30) calendar days written notice to KING, increase the Canadian Purchase Price for one or more Products sold by King in the Canadian Territory by an amount equal to the increase in NOVAVAX’s costs for labor and materials used in connection with the manufacture, storage and/or delivery to KING of such Products; provided, however, that during the twelve (12) month period following the Effective Date of this Second Amendment, NOVAVAX shall not increase the Canadian Purchase Price for any Product because of any increased labor cost experienced by NOVAVAX. Notwithstanding anything to the contrary in the above Section 5.1(a)(2), in no event shall the total percentage increase in the Canadian Purchase Price in any calendar year during the Term exceed the percentage increase in the PPPI for such calendar year.

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                        (3)       For those Products sold by KING in the European Territory, KING shall purchase from NOVAVAX, and NOVAVAX shall sell to KING, the Products at the price equal to the Cost of Products plus twenty percent (20%) (the “European Purchase Price”). NOVAVAX may, from time to time, upon thirty (30) calendar days written notice to KING, increase the European Purchase Price for one or more Products sold by KING in the European Territory by an amount equal to the increase in NOVAVAX’s costs for labor and materials used in connection with the manufacture, storage and/or delivery to KING of such European Products; provided, however, that during the twelve (12) month period following the Effective Date of this Second Amendment, NOVAVAX shall not increase the European Purchase Price for any Product because of any increased labor cost experienced by NOVAVAX. Notwithstanding anything to the contrary in the above Section 5.1(a)(3), in no event shall the total percentage increase in the European Purchase Price in any calendar year during the Term exceed the percentage increase in the PPPI for such calendar year.

                  (b)       In addition to the Purchase Price, KING shall pay all actual freight, insurance and government sales, use, excise, property, import, export or similar taxes or excises imposed on purchases for resale, and duties and other fees (except tax on income to NOVAVAX) incurred in connection with the sale and shipment of the Products to KING.

                  (c)       NOVAVAX shall keep adequate and complete records, in accordance with GAAP, of all Costs of Products. Such records shall include all information necessary to verify the total amount and computation of the Purchase Price due hereunder and NOVAVAX’s compliance with the terms and conditions of this Agreement, and shall be available once per year to inspection by or on behalf of KING during normal business hours, upon reasonable notice, to verify such costs and whether an increase in such costs has occurred and to verify NOVAVAX’s compliance with this Agreement. NOVAVAX shall retain such records for not fewer than twenty-four (24) months after the close of any calendar year to which they relate or such period as required by the FDA. NOVAVAX agrees to make prompt adjustment, if necessary, to compensate for any errors or omissions disclosed by such inspection. Should such inspection reveal a shortfall of more than three percent (3%) between the costs actually incurred and the Costs of Products reported to KING, the cost of such inspection shall be paid by NOVAVAX.

                  (d)       Payments to NOVAVAX for the Purchase Price of delivered Products shall be made by KING within thirty (30) days after the later of (i) the date of delivery thereof to the destination specified by KING, or (ii) the date of invoice from NOVAVAX.

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                5.2       Royalty Payment.

                        (a)       In addition to the amounts paid under Section 5.1:

                              (1)       With respect to Products sold in the Original Territory, KING agrees to pay royalties only on the Net Sales of such Products at a rate of seven and one-half percent (7.5%) of Net Sales of such Products. Such royalties are payable forty-five (45) days after the end of each Calendar Quarter in which such Products are sold in the Original Territory during the Term of this Agreement;

                              (2)       With respect to Products sold in the Canadian Territory, KING agrees to pay royalties only on the Net Sales of such Products at a rate of nine percent (9.0%) of Net Sales of such Products. Such royalties are payable forty-five (45) days after the end of each Calendar Quarter in which such Products are sold in the Canadian Territory during the Term of this Agreement; and

                              (3)       With respect to Products sold in the European Territory, KING agrees to pay royalties only on the Net Sales of such Products at a rate of eight percent (8.0%) of Net Sales of such Products. Such royalties are payable forty-five (45) days after the end of each Calendar Quarter in which such Products are sold in the European Territory during the Term of this Agreement.

                        (b)       KING shall keep adequate and complete records, in accordance with GAAP, showing all Net Sales of Products with respect to which royalties are due under this Agreement. Such records shall include all information necessary to verify the total amount and computation of royalties due hereunder and KING’s compliance with the terms and conditions of this Agreement, and shall be available once per year to inspection by or on behalf of NOVAVAX during normal business hours, upon reasonable notice, to verify the amounts thereof or to ascertain such amounts in the event of a failure of KING to report and to verify KING’s compliance with this Agreement. KING shall retain such records for not fewer than twenty-four (24) months after the close of any calendar year to which they relate or such period as required by the FDA. KING agrees to make prompt adjustment, if necessary, to compensate for any errors or omissions disclosed by such inspection. Should such inspection reveal a shortfall of more than three percent (3%) between the royalties reported and those actually owed by KING, the cost of such inspection shall be paid by KING.

                5.3       Distribution, Warehousing, Billing, Pricing.

                        KING (and/or its Affiliates) shall have the sole responsibility for the distribution, warehousing, billing and order confirmation of the Products to be sold in the Territory after receipt at the designated destination and for the

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collection of receivables resulting from sales of the Products in the Territory. KING shall have the sole authority to determine the price of the Products in the Territory during the Term, including resale price increases and decreases and the timing thereof.

            5.4       Milestones Payments.

                  Subject to the satisfaction of the conditions set forth below, KING shall pay NOVAVAX a total of Six Million Dollars ($6,000,000) in milestone payments for acquiring the exclusive right hereunder to promote, market, distribute and sell Product in the Canadian Territory and the European Territory, as follows:

                        (a)       KING shall pay NOVAVAX a one time fee in the amount of Three Million Dollars ($3,000,000) upon execution of this Second Amendment;

                        (b)       KING shall pay NOVAVAX a one time fee in the amount of One Million Dollars ($1,000,000) upon receipt of written notice issued by an appropriate regulatory authority in the Canadian Territory which grants final approval to market ESTRASORB™ in the Canadian Territory; and

                        (c)       KING shall pay NOVAVAX a one time fee in the amount of Two Million Dollars ($2,000,000) upon receipt of written notice issued by an appropriate regulatory authority in any one of the countries in the European Territory which grants final approval to market ESTRASORB™ in at least one of the countries in the European Territory. Other than the one time payment of Two Million Dollars ($2,000,000) described in the previous sentence, no additional fees or consideration shall be payable to NOVAVAX in connection with any subsequent notices issued by any authorities in the European Territory.

      1.07       Except as otherwise expressly provided in this Second Amendment, KING and NOVAVAX agree that all provisions of the Exclusive License and Distribution Agreement, as amended by the First Amendment, are hereby ratified and agreed to be in full force and effect, and are incorporated herein by reference.

      1.08       The Exclusive License and Distribution Agreement, as amended by the First Amendment and this Second Amendment, and the Confidentiality Agreements contain the entire agreement among the parties with respect to the transactions contemplated herein and supersede any prior agreements, understandings or arrangements between them, whether oral or in writing. This Second Amendment may not be amended, modified, altered or supplemented except by means of a written agreement or other instrument executed by both of the parties hereto. No course of

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conduct or dealing between the parties shall act as a modification or waiver of any provisions of this Second Amendment.

      1.09       This Second Amendment may be executed in separate counterparts, none of which need contain the signatures of all parties, each of which shall be deemed to be an original, and all of which taken together constitute one and the same instrument. It shall not be necessary in making proof of this Second Amendment to produce or account for more than the number of counterparts containing the respective signatures of, or on behalf of, all of the parties hereto. Original signatures transmitted by facsimile shall be acceptable to purposes of executing this Second Amendment. If original signatures are transmitted by facsimile, the parties shall endeavor in good faith to deliver to each other executed counterpart originals as soon as practicable after the date of this Second Amendment.

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      IN WITNESS WHEREOF, each of the parties hereto has executed this Second Amendment, or has caused this Second Amendment to be duly executed and delivered in its name on its behalf, all as of the Effective Date first above written.

         
KING PHARMACEUTICALS, INC. NOVAVAX, INC.
By: By:


Name: Name:


Title: Title:


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