Document:

EXHIBIT 10.1

Exhibit 10.1

*Confidential Treatment Requested Under

17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

AMENDMENT TO

EXCLUSIVE DISTRIBUTION AGREEMENT

BETWEEN

AKORN. INC., AND

MASSACHUSETTS BIOLOGICAL LABORATORIES

     This Amendment (the “Amendment”) is entered into as of July 3, 2008 (the “Effective Date”), by
and between Massachusetts Biologic Laboratories of the University of Massachusetts Medical School
(“MBL”) and Akorn, Inc. (“Akorn”) (each a “Party” and together the “Parties”).

Recitals

     WHEREAS, MBL as manufacturer and Akorn as distributor entered into an Exclusive Distribution
Agreement for Tetanus-Diphtheria vaccine (“Td vaccine’) on March 22, 2007 (the “Exclusive
Distribution Agreement” or the “Agreement”);

     WHEREAS, Akorn to date has not picked up shipments to fulfill Akorn’s purchase obligations
through June 30, 2008;

     WHEREAS, Akorn has requested that its obligations to take delivery of Td vaccine under the
Agreement be modified and reduced for the remainder of the Agreement’s term;

     WHEREAS, a dispute arose between the Parties whereby, among other claims, (a) MBL claimed that
Akorn is or would be in breach of the Exclusive Distribution Agreement, and (b) Akorn claimed that
it was mislead concerning the market for Td vaccine (collectively, the “Disputes”);

     WHEREAS, the Parties mediated their Disputes on June 26, 2008 with the Hon. Charles B.
Swartwood III of JAMS;

     WHEREAS, the Parties have resolved all material aspects of their Disputes, and have
memorialized this resolution in the agreement entitled “MBL-Akorn Binding Term Sheet — July 3,
2008” (the “Term Sheet’); and

     WHEREAS, as provided in sections 8 and 10 of the Term Sheet, the Parties wish to embody the
rights and obligations set out in the Term Sheet (a) in a more formal amendment to the Exclusive
Distribution Agreement, and (b) in a more formal mutual release, executed simultaneously with this
Amendment (the “Mutual Release”);

 

			
	*	 	CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with the Securities and Exchange Commission.

1

 

*Confidential Treatment Requested Under

17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

     NOW, THEREFORE, the Parties agree to amend the Exclusive Distribution Agreement as follows:

Amendment

	1.	 	Consideration. The Parties agree that the consideration for this Amendment consists of (i)
the rights and obligations obtained and assumed in this Amendment, and (ii) the releases
obtained under the Mutual Release.
	 
	2.	 	Amendment to Section 1. The following section 1(d) is added to Section 1 of the Exclusive
Distribution Agreement:

	 	 	 	Additional Definitions.
	 
	 	 	 	“Full Year 1 Doses” shall mean the total of (i) the doses Akorn had picked-up and
paid for as of June 30, 2008; (ii) the Replacement Doses; and (iii) the Additional
Year 1 Doses.
	 
	 	 	 	“Year 1” means the period September 1, 2007 through June 30, 2008.
	 
	 	 	 	“Year 2” means the period July 1, 2008 through June 30, 2009.
	 
	 	 	 	“Year 3” means the period July 1, 2009 through June 30, 2010.

	3.	 	Amendment to Section 2(a). Section 2(a) of the Exclusive Distribution Agreement is deleted
in its entirety, and replaced with the following:

	 	 	 	 	 
	 

	 	2(a)(i)
	 	Exchange of Single Dose for Multi-Dose Vials. MBL will provide an exchange of
single dose Td vaccine for multi-dose Td vaccine as follows:

	 	 	 	 	 
	 

	 	2(a)(1)(1)
	 	Destruction of Multi-Dose Vials to MBL. MBL will accept from Akorn for
return [***...***] doses in multi-dose vials for destruction, which Akorn
currently holds in inventory (the “Original Doses”). Rather than physically
return the Original Doses, Akorn at its cost shall arrange for the destruction
of the Original Doses, on or before July 31, 2008. Akorn shall (i) pay the
destruction costs billed by the contractor responsible for the destruction of
the Original Doses (the “Contractor”); and (ii) provide MBL with the
Contractor’s destruction certificate for the Doses, as well as all required
documentation to allow proper processing for Excise Tax purposes.

 

			
	*	 	CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with the Securities and Exchange Commission.

2

 

*Confidential Treatment Requested Under

17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

	 	 	 	 	 
	 

	 	2(a)(1)(2)
	 	Delivery of Single Dose Vials to Akorn. MBL will make available to Akorn
for pickup [***...***] doses in single dose vials (the “Replacement Doses”) in
consideration of Akorn’s timely payment of the first installment of the Year 1
Resolution Amount (as such term is defined in Section 2(a)(3) (Akorn Resolution
Payment) below). Of the Replacement Doses, Akorn will pick up [***...***] doses
on or before August 15, 2008, and the remainder of the Replacement Doses on or
before September 30, 2008. Dating for Replacement Doses will be no less
favorable than the dating for single dose vials distributed in Year 1 under
Section 2(c) of the Exclusive Distribution Agreement, i.e. no less than 12
months. Specifically, not more than [***...***] of the [***...***] Replacement
Doses to be delivered on August 15, 2008 will have an expiration date of April
15, 2010 and all remaining Replacement Doses will have at least 20 months of
dating.
	 
	 	 	 	 
	 

	 	2(a)(1)(3)
	 	Excise Tax. As the quantities of Original Doses being destroyed equal
the Replacement Doses, the Parties expect the credit issued for the destruction
of the Original Doses will offset the Federal Excise Tax due on the Replacement
Doses. This will require Akorn to provide proper documentation per section
2(a)(1)(1). To be clear, MBL will process the Federal Excise Tax and apply the
credit to its quarterly Federal Excise Tax filing and thus no new charge of
excise tax will be made for Replacement Doses to Akorn.

	 	 	 	 	 
	 

	 	2(a)(2)
	 	Additional Year 1 Single Dose Vials. In consideration of Akorn’s timely payments
under Section (a)(3) (Akorn Resolution Payment), MBL shall make available to Akorn for
pickup [***...***] doses in single dose vials (the
“Additional Year 1 Doses”). Akorn
shall take delivery of these doses on or before July 17, 2008. Upon Akorn’s pick-up
and payment for the Full Year 1 Doses, Akorn’s obligations to pick-up and pay for Year
1 doses shall be satisfied.
	 
	 	 	 	 
	 

	 	2(a)(3)
	 	Akorn Resolution Payment. In consideration of Section 2(a)(2) (Additional Year 1
Single Dose Vials), Akorn shall pay MBL the amount of [***...***] inclusive of federal
excise tax (the “Year 1 Resolution Amount”) in the following two installments: (i)
Akorn shall pay [***...***] to MBL on July 11, 2008; and (ii) Akorn shall pay [***...***]
to MBL on July 31, 2008.

2(a)(4) Year 2.

	 	 	 	 	 
	 

	 	2(a)(4)(1)
	 	Year 2 Dose and Payment Amounts. In Year 2, Akorn shall pick-up and pay
for, and MBL shall manufacture, [***...***] single dose

 

			
	*	 	CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with the Securities and Exchange Commission.

3

 

*Confidential Treatment Requested Under

17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

	 	 	 	 	 
	 

	 	 	 	vials in the contract price amount of [***...***] per dose inclusive of
federal excise tax for a total of [***...***] inclusive of federal
excise tax (the “Year 2 Doses”).
	 
	 	 	 	 
	 

	 	2(a)(4)(2)
	 	Year 2 Schedule of Pick-Ups. Akorn shall pick-up the Year 2 Doses in
nine (9) shipments, on the second Wednesday of each month, commencing on
October 8, 2008. The quantities of those nine (9) shipments will be as
follows:

	 	 	 	 	 
	Pick-Up Date: Month	 	Number of Doses
	October 2008
	 	 	[***...***]	 
	November 2008
	 	 	[***...***]	 
	December 2008
	 	 	[***...***]	 
	January 2009
	 	 	[***...***]	 
	February 2009
	 	 	[***...***]	 
	March 2009
	 	 	[***...***]	 
	April 2009
	 	 	[***...***]	 
	May 2009
	 	 	[***...***]	 
	June 2009
	 	 	[***...***]	 

2(a)(5) Year 3.

	 	 	 	 	 
	 

	 	2(a)(5)(1)
	 	Year 3 Dose and Payment Amounts. In Year 3, Akorn shall pick-up and pay
for, and MBL shall manufacture, [***...***] single dose vials in the contract
price amount of [***...***] inclusive of federal excise tax (the “Year 3
Doses”). This dosage commitment is based upon a price of [***...***] including
Federal Excise Tax.
	 
	 

	 	2(a)(5)(2)
	 	Year 3 Schedule of Pick-Ups. Akorn shall pick-up the Year 3 Doses in
twelve (12) equal shipments, on the second Wednesday of each month, commencing
on July 8, 2009.

	4.	 	Amendment to Section 2(b). Section 2(b) and Exhibit A of the Exclusive Distribution
Agreement are deleted in their entirety.
	 
	5.	 	Amendment to Section 2(d). Section 2(d) of the Exclusive Distribution Agreement is deleted
in its entirety, and replaced by the following provision:

 

			
	*	 	CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with the Securities and Exchange Commission.

4

 

*Confidential Treatment Requested Under

17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

	 	 	 	Payment terms for the remaining Full Year 1 Doses shall be as set
out in Section 2(a)(3) (Akorn Resolution Payment). Payment terms
for the Year 2 Doses and Year 3 Doses shall be net forty-five (45)
days from the scheduled Akorn pick-up dates set out in Section
2(a)(4)(2) (Year 2 Schedule of Pick-Ups) for the Year 2 Doses and in
Section 2(a)(5)(2) (Year 3 Schedule of Pick-Ups) for the Year 3
Doses. All payments except the July 11, 2008 payment shall be by
wire transfer, to such bank account as MBL designates in writing.

	6.	 	Additional Provision. The following shall be added as section 13 to the Exclusive
Distributor Agreement:

	 	13.	 	Payment Delays. MBL is not obligated to release Product for
pick-up if Akorn is delinquent in payments.

	7.	 	Distribution to Massachusetts Users. The Massachusetts Department of Public Health,
responsible for distribution of MBL Td vaccine in Massachusetts, shall be entitled to retain
Mckesson under a Centers for Disease Control contract to distribute such Td vaccine, provided
each of the following conditions is met: (i) such distribution is at no cost to customers of
the Td vaccine, and (ii) such customers are located in Massachusetts.

	8.	 	Confidentiality. The Parties understand and agree that the terms and conditions of this
Amendment are and shall at all times remain confidential. Neither Party shall disclose the
terms or conditions of this Amendment, except for required disclosures to: (a) tax advisors;
(b) attorneys; (c) accountants; or (d) if required to do so by law, regulatory authorities, or
legal process.

	9.	 	Effect of Term Sheet. The parties agree that this Amendment and the Mutual Release will
supersede the Term Sheet and agree that the Term Sheet has no further force and effect, and
that the Parties’ rights and obligations with respect to the Term Sheet are governed entirely
by this Amendment and the Mutual Release.

	10.	 	Effect of Amendment. Nothing in this Amendment is intended to modify, alter, reduce or
change the rights or obligations of Akorn and MBL in the Exclusive Distribution Agreement,
except as expressly stated in this Amendment. In the event there is any conflict between the
terms of this Amendment and the terms of the Agreement, the terms of this Amendment shall
control.

	11.	 	Continued Effectiveness. Unless specifically modified or amended by the terms of this
Amendment, all the terms, conditions, liabilities and obligations of the Exclusive
Distribution Agreement shall be and remain applicable, in effect, valid, and enforceable

 

			
	*	 	CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with the Securities and Exchange Commission.

5

 

*Confidential Treatment Requested Under

17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

	 	 	between the parties and applicable to this Amendment; all in accordance with the terms of
the Exclusive Distribution Agreement.

	12.	 	Additional Defined Terms. Capitalized terms used herein and not otherwise defined shall have
the meaning ascribed to such terms in the Exclusive Distribution Agreement.

	13.	 	Execution in Counterparts. This Amendment may be executed in one or more counterparts, each
of which when so executed will be deemed to be an original, and all such counterparts together
will constitute but one and the same instrument.

       In Witness Whereof, the Parties have caused this Amendment to be executed by their duly
authorized representatives.

	 	 	 	 	 	 	 	 	 
	Akorn, Inc.	 	Massachusetts Biologic	 	 
	 	 	 	 	Laboratories of the University of	 	 
	 	 	 	 	Massachusetts Medical School	 	 
	 
	 	 	 	 	 	 	 	 
	By:

	 	/s/ Arthur Przybyl
 

	 	By:
	 	/s/ Donna M. Ambrosino
 

	 	 
	 

	 	Arthur Przybyl
	 	 	 	Donna M. Ambrosinno, M.D.	 	 
	 

	 	President and CEO
	 	 	 	Director	 	 

 

			
	*	 	CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with the Securities and Exchange Commission.

6EXHIBIT 10.2

Exhibit 10.2

Mutual Release

     This Mutual Release (the “Mutual Release”) is entered into as of July 3, 2008 (the “Effective
Date”), by and between Massachusetts Biologic Laboratories of the University of Massachusetts
Medical School (“MBL”) and Akorn, Inc. (“Akorn”) (each a “Party” and together the “Parties”).

Recitals

     WHEREAS, MBL as manufacturer and Akorn as distributor entered into an Exclusive Distribution
Agreement for Tetanus-Diphtheria vaccine (“Td vaccine”) on March 22, 2007 (the “Exclusive
Distribution Agreement”);

     WHEREAS, Akorn to date has not picked up shipments to fulfill Akorn’s purchase obligations
through June 30, 2008;

     WHEREAS, Akorn has requested that its obligations to take delivery of Td vaccine under the
Agreement be modified and reduced for the remainder of the Agreement’s term;

     WHEREAS, a dispute arose between the Parties whereby, among other claims, (a) MBL claimed that
Akorn is or would be in breach of the Exclusive Distribution Agreement, and (b) Akorn claimed that
it was mislead concerning the market for Td vaccine (collectively, the “Disputes”);

     WHEREAS, the Parties mediated their Disputes and related issues on June 26, 2008 with the Hon.
Charles B. Swartwood III of JAMS;

     WHEREAS, the Parties have resolved all material aspects of their Disputes and related issues,
and have memorialized this resolution in the agreement entitled “MBL-Akorn Binding Term Sheet —
July 3, 2008” (the “Term Sheet”); and

     WHEREAS, as provided in sections 8 and 10 of the Term Sheet, the Parties wish to embody the
rights and obligations set out in the Term Sheet (a) in a more formal mutual release, as set out
below, and (b) in a more formal amendment to the Exclusive Distribution Agreement, which is being
executed simultaneously with this Mutual Release (the “Amendment”);

     NOW, THEREFORE, the Parties agree as follows:

Release

	1.	 	Definitions.

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	 	1.1	 	“Akorn Releasees” means Akorn and all of its present and former officers,
directors, members, managers, shareholders, trustees, partners, subsidiaries,
affiliates, parent companies, agents, representatives, insurers, employees, and
attorneys and all of their respective predecessors, successors, heirs, executors,
administrators, and assigns.
	 
	 	1.2	 	“Akorn Releasors” means Akorn and all of its present and former officers,
directors, members, managers, shareholders, trustees, partners, subsidiaries,
affiliates, parent companies, agents, insurers, representatives, employees, and
attorneys and all of their respective predecessors, successors, heirs, executors,
administrators, and assigns.
	 
	 	1.3	 	“MBL Releasees” means MBL and all of its present and former officers,
directors, members, managers, shareholders, trustees, partners, subsidiaries,
affiliates, parent companies, agents, representatives, insurers, employees, and
attorneys and all of their respective predecessors, successors, heirs, executors,
administrators, and assigns.
	 
	 	1.4	 	“MBL Releasors” means MBL and all of its present and former officers,
directors, members, managers, shareholders, trustees, partners, subsidiaries,
affiliates, parent companies, agents, insurers, representatives, employees, and
attorneys and all of their respective predecessors, successors, heirs, executors,
administrators, and assigns.
	 
	 	1.5	 	“Performance Obligation” means an obligation to perform under a contract. By
way of example and not by way of limitation, the term “Performance Obligation”
excludes non-contractual duties, such as duties in tort.

	2.	 	MBL Specific Release. In consideration of Akorn’s release under Section 3 (Akorn Specific
Release), the MBL Releasors hereby fully and forever release, remise, and forever discharge
the Akorn Releasees of and from all claims, demands, disputes, or objections based in
contract, tort, and other theories (contingent, accrued, mature, direct, derivative,
subrogated, personal, assigned, discovered, undiscovered, inchoate, or otherwise), arising (i)
out of the Disputes; (ii) out of the formation, negotiation, pre-Effective Date performance,
or other pre-Effective Date activities or omissions concerning the Exclusive Distribution
Agreement; and (iii) out of the Parties’ relationship with respect to Td vaccine through the
Effective Date (collectively, the “MBL Release”); provided, however, that (by way of example
and not by way of limitation) the MBL Release shall not apply (a) to Performance Obligations
under the Amendment or (b) to Performance Obligations under the Exclusive Distribution
Agreement that meet the following two criteria: the Performance Obligation (i) is not amended
or altered by the Amendment; and (ii) is due on or after the Effective Date.

2

 

	3.	 	Akorn Specific Release. In consideration of MBL’s release under Section 2 (MBL Specific
Release), the Akorn Releasors hereby fully and forever release, remise, and forever discharge
the MBL Releasees of and from all claims, demands, disputes, or objections based in contract,
tort, and other theories (contingent, accrued, mature, direct, derivative, subrogated,
personal, assigned, discovered, undiscovered, inchoate, or otherwise), arising (i) out of the
Disputes; (ii) out of the formation, negotiation, pre-Effective Date performance, or other
pre-Effective Date activities or omissions concerning the Exclusive Distribution Agreement;
and (iii) out of the Parties’ relationship with respect to Td vaccine through the Effective
Date (collectively, the “Akorn Release”); provided, however, that (by way of example and not
by way of limitation) the Akorn Release shall not apply (a) to Performance Obligations under
the Amendment or (b) to Performance Obligations under the Exclusive Distribution Agreement
that meet the following two criteria: the Performance Obligation (i) is not amended or altered
by the Amendment; and (ii) is due on or after the Effective Date.
	 
	4.	 	No Admission of Liability. This Mutual Release shall neither constitute nor be deemed or
construed as an admission by Akorn of any breach of any obligation of any kind or nature owed
to MBL. This Mutual Release shall neither constitute nor be deemed or construed as an
admission by MBL of any breach of any obligation of any kind or nature owed to Akorn. This
Mutual Release shall be construed solely for the purpose of settlement and compromise of
disputed claims.
	 
	5.	 	Independent Judgment. The Parties agree and pledge that in making this Mutual Release, they
rely on their own respective judgment, belief and knowledge, and not on any representations or
statements made by any other Party, or any other Party’s officers, agents, representatives, or
counsel. The Parties acknowledge that they have had the opportunity to consult with counsel
of their choosing concerning the terms and conditions of this Mutual Release, and that the
execution hereof is the free act and deed of each Party.
	 
	6.	 	Waiver of Breach. Waiver by any Party of any term and/or breach of this Mutual Release shall
not be deemed or construed as a waiver of any other term and/or breach, whether prior,
subsequent, or contemporaneous with this Mutual Release.
	 
	7.	 	Entirety of Mutual Release; Modification. The foregoing constitutes the entire agreement of
the Parties with respect to the subject matter of this Mutual Release, and supersedes all
prior and contemporaneous oral or written discussions, agreements, promises, or
representations. This Mutual Release shall not be modified or amended except in a writing
signed by all Parties.
	 
	8.	 	Construction of Mutual Release. The language of all parts of this Mutual Release shall in
all cases be construed as a whole, according to its fair meaning, and not strictly for or
against either Party. Neither Party shall be deemed to be the drafting

3

 

	 	 	party of this Mutual Release for the purposes of construction and interpretation. Each
Party acknowledges that no other Party, or any agent or attorney of any Party, has made any
promise, representation, or warranty whatsoever, express or implied, not contained herein,
concerning the subject matter hereof, to induce it to enter into or execute this Mutual
Release, and each Party acknowledges that it has not entered into this Mutual Release in
reliance on any such promise, representation, or warranty not contained herein. As used in
this Mutual Release, the singular or plural number shall be deemed to include the other
whenever the context so indicates or requires.

	9.	 	Choice of Law; Forum Selection. This Mutual Release shall be construed as and governed by
the laws of the Commonwealth of Massachusetts. Any action for breach of or to enforce this
Mutual Release shall be brought exclusively in Suffolk County Superior Court, Massachusetts.
	 
	10.	 	Severability. If any provision of this Mutual Release is declared or determined by any court
to be illegal or invalid, the validity of the remaining parts, terms, or provisions shall not
be affected and any illegal or invalid part, term or provision shall be deemed not to be a
part of this Mutual Release.
	 
	11.	 	Execution in Counterparts. This Mutual Release may be executed in one or more counterparts,
each of which when so executed will be deemed to be an original, and all such counterparts
together will constitute but one and the same instrument.
	 
	12.	 	Representation of Authority. Each Party agrees that the individual signing this Mutual
Release on its behalf is duly authorized to do so, and that the signature of such individual
hereon binds that entity for which the individual executes this Mutual Release.
	 
	13.	 	Confidentiality. The Parties understand and agree that the terms and conditions of this
Mutual Release are and shall at all times remain confidential. Neither Party shall disclose
the terms or conditions of this Mutual Release, except for required disclosures to: (a) tax
advisors; (b) attorneys; (c) accountants; or (d) if required to do so by law, regulatory
authorities, or legal process.

          In Witness Whereof, the Parties have caused this Mutual Release to be executed by their duly
authorized representatives.

4

 

	 	 	 	 	 	 	 	 	 	 	 
	Akorn, Inc.	 	 	 	Massachusetts Biologic

Laboratories of the University of

Massachusetts Medical School	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Arthur Przybyl
	 	 	 	By:
	 	/s/ Donna M. Ambrosinno	 	 
	 

	 	 
	 	 	 	 	 	 	 	 
	 

	 	Arthur Przybyl
	 	 	 	 	 	Donna M. Ambrosinno, M.D.	 	 
	 

	 	President and CEO
	 	 	 	 	 	Director	 	 

5

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