Document:

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
ANDROSORBTM 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 ANDROSORBTM 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 ESTRASORBTM,
ANDROSORBTM 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 ESTRASORBTM
or from ANDROSORBTM, (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 ESTRASORBTM or ANDROSORBTM 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
ESTRASORBTM including any other related trademark or servicemark
containing the word “ESTRASORB”, the mark ANDROSORBTM 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):

-2-

EXHIBIT 2.3(d)

PRIMARY BRAND TRADEMARKS

ESTRASORBTM

NORDETTE®

ANDROSORBTM

      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

-3-

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]

-4-

         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-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 ANDROSORBTM, 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
ANDROSORBTM; 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
ESTRASORBTM 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 ESTRASORBTM 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 ESTRASORBTM
NDA, which was Submitted by NOVAVAX on or before June 29, 2001, and (ii)
assigns the ESTRASORBTM 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
ESTRASORBTM 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
ANDROSORBTM in the Territory and receive fifty percent (50%) of any
revenues that NOVAVAX actually receives from the sales of ANDROSORBTM
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:

-2-

		
	 	      (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
ANDROSORBTM in the Territory and receive fifty
percent (50%) of any revenues that NOVAVAX actually receives
from the sales of ANDROSORBTM 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
ESTRASORBTM
(the

-3-

“ESTRASORBTM 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 ESTRASORBTM
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
ESTRASORBTM 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 ESTRASORBTM (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
ESTRASORBTM during the Pre-Launch Period shall be in addition to those
expenses required to be incurred by NOVAVAX to promote
ESTRASORBTM
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

-4-

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]

-5-

      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:

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00028-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00028-of-00352.parquet"}]]