Exhibit 10.32

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

FIRST AMENDMENT TO DEVELOPMENT AND SUPPLY AGREEMENT

 

THIS FIRST AMENDMENT TO DEVELOPMENT AND SUPPLY AGREEMENT (this “First
Amendment”“) is entered into as of the 28th day of March, 2014 by and between
K-V Pharmaceutical Company (“KV”) and Hospira Worldwide, Inc. (“Hospira”) to
amend the terms of that certain Development and Supply Agreement between Hospira
and Hologic, Inc. dated September 17, 2009 which was subsequently assigned to KV
by Hologic (the “Agreement”‘).

 

Whereas, KV and Cytyc Prenatal Products Corp., a wholly owned subsidiary of
Hologic entered into an Asset Purchase Agreement dated January 16, 2008, and as
subsequently amended, (collectively, the “APA”) pursuant to which KV agreed to
purchase the worldwide rights to the product Gestiva (now known as Makena)
(hydroxyprogesterone caproate injection) and its related assets; and

 

Whereas, In connection with the APA, KV agreed to assume the Agreement; and

 

Whereas, Hologic notified Hospira of such assignment in accordance with
Section 12.5 of the Agreement by letter dated February 10, 2011 from Mr. Robb
Hesley, Vice President, Business Development, Hologic to Mr. Cacich, VP & GM
Contract Manufacturing Services, Hospira; and

 

Whereas, Hospira and KV have continued to perform their respective obligations
under the Agreement since such assignment; and

 

Whereas, KV assumed the Agreement in connection with its bankruptcy proceedings
jointly administered under Case No. 12-13346 in the United States Bankruptcy
Court for the Southern District of New York; and

 

Whereas, Hospira has confirmed its intention to continue to perform under the
Agreement by letter dated September 11, 2013 from Mr. Kevin Orfan, Vice
President, One 2 One (Hospira) to Mr. Daniel Thompson, Chief Compliance Officer
and Vice President Business Development, KV; and

 

Whereas, Hospira and KV mutually desire to amend the terms of the Agreement to
reflect, among other items, the development of a [***] Product (as hereinafter
defined), the pricing for the [***] Product and the minimum purchase
requirements with respect to the Product and the [***] Product.

 

Now, therefore in consideration of the mutual promises and agreements contained
herein, the parties agree to amend the Agreement as follows:

 

1.                            Incorporation of the Agreement.  All capitalized
terms which are not defined herein shall have the same meanings as set forth in
the Agreement, and the Agreement is incorporated herein by this reference as
though the same was set forth in its entirety.  Except as specifically set forth
herein, the Agreement shall remain in full force and effect and its provisions
shall be binding on the parties hereto.

 

2.                            Transfer of Agreement to KV.  The parties hereby
recognize the transfer of the Agreement from Hologic to KV.  All references to
Hologic shall now refer to KV.

 

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

3.                            Definitions.

 

3.1                     The definition of “Product” is revised as follows:

 

·                  “Product” shall mean the Drug in final dosage form, filled in
a [***] vial, including labeling and secondary packaging meeting the Product
Specifications.

 

3.2                     The following definitions are added to the Agreement:

 

a.              “[***] Product” shall mean the Drug in final dosage form, filled
in a [***] vial, including labeling, and secondary packaging meeting the [***]
Product Specifications.

 

b.              “[***] Product Specifications” shall mean the Product
Specifications for the [***] Product.

 

c.               “Submission Batches” shall mean the manufacture of [***]
registration batches of the [***] Product manufactured under GMP conditions that
meet the [***] Product Specifications as demonstrated by internal testing and as
set forth in Exhibits 3 and 4 to this First Amendment.

 

d.              “Target Date” is August 28, 2014, the date by which Hospira must
complete the Submission Batches.  The Parties shall revise the Target Date to
reflect any additional time needed to address (i) any change in the assumptions
set forth on Exhibit 3; (ii) any delay resulting from the action, inaction or
negligence of KV; and/or or (iii) any delay due in no fault to either party. 
Notwithstanding the foregoing, the Target Date shall not be revised if such
delay is caused by the actions, inaction or negligence of Hospira.

 

4.                            Addition of [***] Product to the Agreement. 
Except as otherwise set forth herein, the Agreement shall be amended to include
the [***] Product when the term “Product” is referenced, including by way of
example and not of exclusion:

 

·                  Article 4 shall apply to the [***] Product and [***] Project;

·                  Article 5 shall apply to the [***] Product and [***] Project
except as amended below;

·                  Article 6 shall apply to the [***] Product and [***] Project
except as amended below;

·                  Article 7 shall apply to the [***] Product and [***] Project;

·                  Article 8 shall apply to the [***] Product and [***] Project;

·                  Article 9 shall apply to the [***] Product and [***] Project;

·                  Article 10 shall apply to the [***] Product and [***] Project
except as amended below; and

·                  Article 11 shall apply to the [***] Product and [***]
Project;

·                  Article 12 shall apply to the [***] Product and [***]
Project.

 

For purposes of the [***] Project, Articles 2 and 3 of the Agreement shall be
deleted in their entirety and replaced as set forth in Sections 5 and 6 below.

 

5.                            Article 2, Development Program.

 

·                  [***] Project.  The activities set forth in Article 2 of the
Agreement regarding the Project have been completed.  The parties agree promptly
after the Effective Date of this First Amendment (as set forth in Section 11) to
undertake a product development project to develop the [***] Product consisting
of the development activities set forth in Exhibits 3 and 4 attached hereto (the
“[***] Project”).  As set forth in the [***] Project, Hospira shall assist KV in
the development of the [***] Product and in obtaining an approved FDA filing for
the

 

2

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

[***] Product.  Subject to the approval of the applicable Regulatory
Authorities, Hospira shall manufacture and deliver [***] Product to KV for sale
by KV as a human pharmaceutical.  The current scope of the [***] Project is a
flip top vial presentation.  Each party shall use its commercially reasonable
efforts to successfully complete the [***] Project.  However, the parties agree
and understand that neither party hereto guarantees that the [***] Project will
be successful, nor warrants or guarantees that a marketable [***] Product will
result from the [***] Project.

 

·                  [***] Project.  KV and Hospira agree that Hospira will not
develop a [***] presentation of the Product.

 

6.                            Article 3, Payment for Hospira’s Development
Efforts.  To reimburse Hospira for its efforts in the [***] Project, KV shall
pay to Hospira a nonrefundable development fee of [***] (the “[***] Development
Fee”); provided such amount shall adjust as set forth in the Agreement (as
amended hereby) in the event of early termination in accordance with the terms
and conditions of the Agreement (as amended hereby).  The [***] Development Fee
shall be paid to Hospira in accordance with the payment schedule set forth in
Exhibit 4.  KV has already paid [***] of the [***] Development Fee which is
noted in Exhibit 4.  In addition to the [***] Development Fee, KV shall pay to
Hospira a development incentive fee as set forth in the schedule in Exhibit 4
(the [***] Development Incentive Fee”) in the event that Hospira completes the
Submission Batches prior to the Target Date.  If earned by Hospira, KV shall pay
the [***] Development Incentive Fee to Hospira in accordance with the payment
schedule in Exhibit 4.  For the avoidance of doubt, Sections 3.2, 3.3 and 3.4 of
the Agreement shall also apply to the [***] Project.

 

7.                            Article 5, Manufacture and Supply of Product. 
Article 5 shall apply to the Product and the [***] Product subject to the
following revisions:

 

·                  Section 5.1 Purchase and Sale of Product is hereby deleted in
its entirety and replaced with the following:

 

5.1 Purchase and Sale of Product.  Pursuant to the terms and conditions of this
Agreement and for the duration of this Agreement, Hospira shall manufacture,
sell and deliver Product and [***] Product to KV for sale in the United States.

 

·                  Section 5.8(a) Price is hereby deleted in its entirety and
replaced with the following:

 

Hospira shall invoice KV for Product and [***] Product delivered by Hospira at
the prices set forth below.  These prices are for United States vial Product and
[***] Product presentations only.  Prices are firm through December 31, 2014. 
Beginning on January 1, 2015, and on each succeeding January 1 during the term
hereof, Hospira may increase the prices of the Product and the [***] Product by
giving KV no less than [***] days’ written notice of such price change.  Price
increases shall be effective for orders for Product and [***] Product filled
after January 1 of each calendar year.  Such increases shall not exceed the
[***].  For the sake of clarity, the Product Price includes bulk packaging (i.e.
case and pallet) of the Product.

 

3

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Table 1

 

Year

 

[***] Vial

 

[***] Vial

[***]

 

[***]

 

[***]

 

·                  Section 5.8(b) Payment is hereby deleted in its entirety and
replaced with the following:

 

Hospira shall invoice KV upon shipment of Product and [***] Product.  KV shall
make payment net [***] days from the date of Hospira’s invoice.

 

8.                            Section 6.3. Minimum Purchase Requirement. 
Section 6.3 is deleted in its entirety and replaced with the following:

 

6.3                               Minimum Purchase Requirements.

 

(a)                                 Provided the following conditions have been
met: a) KV obtains an approved FDA filing covering the [***] Product that allows
its commercial sale by KV; b) FDA has approved Hospira as a manufacturer of the
[***] Product; and c) Hospira is able to manufacture and release the [***]
Product for commercial sale by KV (collectively, the “[***] Product Approval”),
the following minimum purchase requirements shall apply:

 

i.                  During the calendar year in which the [***] Product Approval
takes place (the “Partial Time Period”), KV agrees to purchase at least the pro
rata amount of a minimum purchase requirement of [***] of Product and/or [***]
Product (“Pro Rata Amount”) (as way of example only, if the [***] Product
Approval occurs on July 1, 2015, the Pro Rata Amount that KV must make for the
Partial Time Period will be [***].  If KV has not purchased the Pro-Rata Amount
during such Partial Time Period, then within [***] days after the end of the
Partial Time Period, Hospira shall invoice KV the difference between the Pro
Rata Amount and the amount of Product and [***] Product purchased for such time
period (the “Pro-Rata Minimum Payment”), noting that KV’s purchases may be
purchases of (i) all Product, (ii) all [***] Product; or (iii) a combination of
both.  Such invoice shall be payable within [***] days after issuance.

 

ii.               Provided the [***] Product Approval occurs before the end of
calendar year 2015, KV agrees to purchase at least [***] of Product and/or [***]
Product combined (“Annual Amount”) in calendar year 2016.  If the [***] Product
Approval does not occur until calendar year 2016 then the Annual Amount shall be
prorated as set forth in Section 6.3(a)(i) above.  If KV has not purchased the
Annual Amount during the 2016 Calendar Year, then within [***] days following
the end of the 2016 Calendar Year, Hospira shall invoice KV the difference
between the Annual Amount and the amount of Product and [***] Product purchased
for such time period (the “Annual Minimum Payment”); noting that KV’s purchases
may be purchases of (i) all Product, (ii) all [***] Product; or (iii) a
combination of both.  Each such invoice shall be payable within [***] days after
issuance.

 

iii.            The Pro-Rata Minimum Payment and the Annual Minimum Payment
described above shall be determined for such time period by the amount of
Product and [***] Product purchased by KV (meaning such Product and/or [***]
Product has been paid for by KV to Hospira during the applicable time

 

4

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

period).  Provided however, in the event KV’s purchases are less than the
Pro-Rata Minimum Payment or the Annual Minimum Payment as a result of a
manufacturing yield causing the orders to be fulfilled at less than the amount
ordered, the Pro-Rata Minimum Amount and the Annual Minimum Amount shall be
reduced accordingly.

 

(b)                                 KV will only be obligated to the minimum
purchase requirements under Section 6(a) above as long as: (a) the FDA has not
suspended or revoked the NDA and/or orphan designation for the Product and/or
[***] Product; (b) there has been no material change in the safety or efficacy
for the Product and/or [***] Product; (c) there has been no material change in
KV’s ability to commercialize the Product or [***] Product as a result of an FDA
action; (d) the Product and [***] Product conform in all respects to their
respective specifications and are not otherwise adulterated; and (e) Hospira has
not exercised its right to terminate the manufacture of the Product or [***]
Product in accordance with the terms specified in Section 10.2 of the Agreement
(as amended hereby).

 

9.                            Product Take or Pay for Calendar Year [***].  For
calendar year [***], Hospira shall manufacture the Product for KV only if KV
submits a forecast and a purchase order to Hospira on or before [***] for [***]
of the Product for delivery during calendar year [***].

 

10.                     Section 10.1, Term.  Section 10.1 is hereby deleted in
its entirety and replaced with the following:

 

10.1 Term.  This Agreement shall commence on the Effective Date and, unless
earlier terminated as provided below, shall expire (i) with respect to the
manufacture of [***] Product on December 31, [***] (specifically, Hospira will
not fill any [***] Product after December 31, [***], although labeling or other
secondary packaging of vials filled near the end of [***] may extend into
[***]); (ii) if KV has not submitted a forecast and purchase order for [***] of
Product on or before September 30, [***] in accordance with Section 9 above,
then on December 31, [***]; and (iii) if KV has exercised its option to purchase
[***] of Product during calendar year [***] in accordance with Section 9 above,
then on December 31, [***].

 

11.                     Section 10.2, Termination of Product Development
Project.  Section 10.2 is hereby deleted in its entirety and replaced with the
following:

 

10.2 Termination of [***] Project.  Hospira may terminate the [***] Project upon
[***] days prior written notice to KV if Hospira determines in good faith that
the development of the [***] Product is not technically feasible.  KV may
terminate the [***] Project upon [***] days prior written notice to Hospira if
KV determines in good faith that the development of the [***] Product is not
commercially feasible.  If the [***] Project is terminated by either party,
Hospira shall advise KV of Hospira’s actual development costs on the [***]
Project incurred prior to such termination.  KV shall pay Hospira for all
reasonable and documented development costs incurred to the date the termination
notice is received.

 

12.                     Orphan Drug Status.  KV represents, and Hospira
recognizes, that (i) FDA approved the Product on February 3, 2011 for an orphan
indication; and (ii) at the time of such approval, KV received seven years of
exclusivity under the Orphan Drug Act for the Product.

 

5

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

13.                     Recitals.  The third recital shall be deleted in its
entirety to reflect the semi-exclusive relationship contemplated herein between
the Parties for Hospira to manufacture and supply and for KV to purchase and
distribute the Product and [***] Product.

 

14.                     Effective Date.  The amendment to the Agreement
contemplated by this First Amendment shall be deemed effective as of the date
first written above upon the full execution of this First Amendment and without
any further action required by the parties hereto.  There are no conditions
precedent or subsequent to the effectiveness of this First Amendment.

 

15.                     Counterparts.  This First Amendment may be executed in
two or more counterparts, each of which shall be deemed to be an original, but
all of which together shall constitute one and the same instrument.  One or more
counterparts of this First Amendment may be delivered by facsimile or by e-mail
of a “.pdf” format data file, with the intention that delivery by such means
shall have the same effect as delivery of an original counterpart thereof.

 

[Signature page follows]

 

6

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

IN WITNESS WHEREOF, the parties hereto have duly executed this First Amendment
as of the date first above written.

 

 

HOSPIRA WORLDWIDE, INC

 

KV PHARMACEUTICAL CO.

 

 

 

 

 

 

By

/s/ Kevin Orfan

 

 

By

 /s/ Thomas McHugh

 

 

 

 

 

 

Name

Kevin Orfan

 

 

Name

Thomas McHugh

 

(type or print)

 

 

 

(type or print)

 

 

 

 

 

 

Title

Vice President, One 2 One

 

 

Title

CFO

 

--------------------------------------------------------------------------------

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Exhibit 3

 

[***] Project Development Activities

 

Assumptions.  In the event of any changes to any of the assumptions set forth
below, the Target Date shall be revised according to the terms of the First
Amendment.

 

·                  Container/Closure.  The container/closure for the [***]
Product will be a [***]-[***] treated vial with a [***] finish.  The stopper for
the [***] Product will be made of the same material as is used with the Product.

 

·                  [***] Line.  Hospira will fill the [***] Product on Line
[***] at [***]

 

·                  Batch Runs.  Hospira shall run the following batches:

 

Item

 

Description

 

Batch Size

1

 

[***] - Engineering Batches

 

[***]L per batch - only fill

~ [***] units

Bulk Package

2

 

[***] - Submission Batches

 

[***]L per batch - only fill

~ [***] units

Bulk Package

3

 

[***] - Process Validation Batches

 

[***]L per batch - only fill

~ [***] units

Bulk Package

4

 

[***] - Engineering Package Run

 

Approximately [***] units

 

·                  Stability Testing.  Hospira shall conduct [***] month
stability testing on the [***] Submission Batches at [***] month time points
([***] orientation) and [***] month time points ([***] orientation) Hospira
shall conduct the stability testing on the [***] Submission Batches
concurrently.  KV shall submit its regulatory submission based on [***] month
stability data.

 

·                  Commercial Packaging.  Commercial packaging shall consist of
[***] unit cartons per [***] shelf carton to be priced separately.

 

Schedule - Project milestones, costs, durations, start dates and invoice
amounts/dates are set forth on Exhibit 4.

 

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Exhibit 4

 

Development Costs payable to Hospira
Project milestones, costs, durations, start dates and invoice schedule and
amounts

 

Description

 

Cost

 

Target / Completion
Date

 

Invoicing Schedule

 

Invoice
Amount

Project Initiation

 

$ [***]

 

[***]

 

$[***] will be paid specifically for the Kickoff meeting on 15Jan14 per the
9Jan14 Letter Agreement.

 

$[***]*

 

 

Upon execution of this Amendment

 

The remainder ($[***]) will be invoiced upon execution of this Amendment

 

$[***]

 

 

 

 

 

 

 

 

 

Analytical / Microbial Development

 

$[***]

 

Upon execution of this Amendment

 

50% upon execution of this Amendment

 

$[***]

 

 

[***]

 

50% upon both parties’ approval of the control monograph

 

$[***]

 

 

 

 

 

 

 

 

 

Engineering Batch ([***])

 

$[***], $[***] has been paid for initial purchase of Seals/Stoppers/ vials

 

[***]

 

100% upon fill

 

$[***]

 

 

 

 

 

 

 

 

 

Submission Batches ([***])**

 

$[***]
($[***]
completion of each Submission Batch)

 

Target Date (subject to revision as set forth in the Agreement, as amended
hereby)

 

100% upon batch acceptance or completion of t=0 stability test

 

$[***]

Process Validation

 

$[***]

 

[***]

 

50% upon both parties’ approval of protocols (VPP)

 

$[***]

 

 

 

 

[***]

 

50% upon both parties’ approval of reports (VPPR)

 

$[***]

 

 

 

 

 

 

 

 

 

Regulatory Filing

 

$[***]

 

[***]

 

100% upon submission by KV Pharma to the Regulatory Authority

 

$[***]

 

 

 

 

 

 

 

 

 

Packaging Engineering Run

 

$ [***]

 

[***]

 

100% upon completion

 

$[***]

 

 

 

 

 

 

 

 

 

Commercialization***

 

$ [***]

 

[***]

 

100% upon both parties’ approval of First Lot to Stock and Commercialization
achieved.

 

$[***]

 

 

 

 

 

 

 

 

 

Development Stability Testing ([***] batches tested concurrently)

 

$[***] For the avoidance of doubt, this payment is for the stability testing of
all [***] batches collectively, and not per batch

 

[***]

 

Payment due upon each time point during the stability testing period: [***]
months ([***] orientation) and [***] month time points ([***] orientation)

 

$[***] (x[***]) + final payment of $[***] upon completion of [***] months
stability

 

 

 

 

 

 

 

 

 

Total

 

$[***]

 

 

 

 

 

$[***]

 

--------------------------------------------------------------------------------

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

--------------------------------------------------------------------------------

* Amount already paid per Letter Agreement dated January 9, 2014

 

**[***].

 

*** “Commercialization” shall be deemed achieved once KV has received [***]
Product Approval (as that term is defined in the First Amendment) to sell the
[***] Product in the United States.

 

Development Incentive

 

Description

 

Incentive

 

Completion Date

 

Invoicing Schedule

 

Invoice amount

Submission Batches
([***])

 

$[***]

 

[***]

 

50% upon the [***] batch acceptance; 50% upon Commercialization as defined above

 

$[***]; $[***]

Submission Batches
([***])

 

$[***]

 

[***]

 

50% upon the [***] batch acceptance; 50% upon Commercialization as defined above

 

$[***];

$[***]

Submission Batches
([***])

 

$[***]

 

[***]

 

50% upon the [***] batch acceptance; 50% upon Commercialization as defined above

 

$[***];

$[***]

Submission Batches
([***])

 

$[***]

 

[***]

 

50% upon the [***] batch acceptance; 50% upon Commercialization as defined above

 

$[***];

$[***]

 

10

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