Exhibit 10.28.3

CONFIDENTIAL

 

SECOND AMENDMENT TO THE LICENSE AGREEMENT

THIS SECOND AMENDMENT (the “Second Amendment”) to the License Agreement, dated
as of April 2, 2012 (the “Original License Agreement”), as amended on January
30, 2015, (the “Agreement”), by and between Elobix AB (“Elobix”) and EA Pharma
Co., Ltd. (formerly known as Ajinomoto Pharmaceuticals Co., Ltd., “EA”) is
entered into on April 6, 2016.  Elobix and EA may each be referred to herein
individually as a “Party” and collectively as the “Parties.”

WITNESSETH:

WHEREAS, Albireo AB, an affiliate of Elobix, and EA previously entered into the
Original License Agreement and that certain First Amendment to the Original
License Agreement on January 30, 2015 (the “First Amendment”);

WHEREAS, Albireo AB has previously transferred all of its rights and obligations
under the Agreement to Elobix;

WHEREAS, Section 12.6 of the Agreement states that any amendment or modification
of the Agreement must be in writing and signed by authorized representatives of
both Parties; and

WHEREAS, Elobix and EA desire to amend the Agreement as provided herein.  

NOW THEREFORE, in consideration of the mutual promises and covenants set forth
herein and in the Agreement, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties agree as
follows:

 

1.

Definitions; Confirmation.  

 

 

1.1.

Capitalized terms used in this Second Amendment and not defined herein shall
have the meanings assigned thereto in the Agreement.

 

 

1.2

Although the First Amendment was executed after the transfer of rights and
obligations under the Agreement from Albireo AB to Elobix and the party thereto
(other than EA) was not Elobix but instead Albireo AB, the Parties hereby
confirm that the First Amendment was intended to be executed between Elobix and
EA and deem that the First Amendment is and was effective, ab initio, between
Elobix and EA.      

 

2.

Amendments.  

 

 

2.1.

The following definitions shall be added to Section 1 of the Agreement.

 

“1.11(A).  “Albireo Liver Disease” means each (i) Potential Albireo Liver
Disease for which there has been [***], if any, or (ii) Liver Disease for which
an Albireo Liver Disease Approval is granted, if any.”

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL

 

 

“1.11(B). “Albireo Liver Disease Approval” means the written approval by Albireo
for Ajinomoto or its Affiliate to conduct an [***].”

 

“1.11(C). “Albireo Liver Disease Milestone” has the meaning set forth in Section
5.2.4.”

 

“1.11(D). “Albireo Liver Disease Patent Rights” means any Patent Right that
Albireo or its Affiliates Control as of the Second Amendment Date or that comes
into the Control of Albireo or its Affiliates thereafter during the Term,
including, without limitation, any Patent Right that is conceived, developed and
Invented solely by employees of Albireo or its Affiliates, or Third Parties
acting on behalf of Albireo or its Affiliates, thereafter during the Term in the
course of Albireo’s performance under this Agreement to the extent such rights
are necessary or useful to Manufacture, Develop or Commercialize the Albireo
Compound or Products for the treatment of an Albireo Liver Disease.  For the
avoidance of doubt, (A) Joint Patent Rights and Patent Rights which are
Ajinomoto Patent Rights licensed to Albireo pursuant to this Agreement are not
included in the definition of Albireo Liver Disease Patent Rights and (B)
Albireo Liver Disease Patent Rights are not Albireo Patent Rights, unless and
except to the extent that a particular Albireo Liver Disease Patent Right would
be an Albireo Patent Right if the definition of “Field” in this Agreement did
not include clause (iii) thereof (referring to any Albireo Liver Disease).  For
the sake of clarity, (1) if a Valid Claim is included within an Albireo Liver
Disease Patent Right, such Valid Claim shall only provide Innovator Protection
if such Valid Claim satisfies the requirements of Section 1.66, and (2) the word
“treatment” in this Section 1.11(D) and Section 1.12 below shall be deemed to
include, in the alternative, prevention.”

 

“1.73(A).  “[***]” means a clinical trial of the Albireo Compound and/or a
Product relating to the treatment or prevention of [***].”

 

“1.94(A).  “Potential Albireo Liver Disease” means each [***], if any, for which
Albireo, its Affiliate or a Licensee conducts an [***] as part of a development
plan for the Albireo Compound and/or such Product to seek Regulatory Approval to
treat or prevent such [***].  Albireo shall provide Ajinomoto with written
notice within [***] days after (i) Albireo or its Affiliate determines by its
official internal procedure, or Albireo or its Affiliate receives notice that a
Licensee has determined by its official internal procedure, to conduct an [***],
or (ii) the first subject is dosed in such [***], if any, identifying the [***];
provided that Albireo shall not be required to provide such notice more than
once for such [***].”

 

“1.107(A). “Second Amendment Date” means April 6, 2016.”

 

“1.109(A). “[***]” means, with respect to each Potential Albireo Liver Disease,
that [***] to (i) conduct a subsequent [***] for the treatment or prevention of
such Potential Albireo Liver Disease or (ii) [***]with respect to a [***] such
Potential Albireo Liver

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL

 

Disease in any country or regulatory jurisdiction outside the Territory. Albireo
shall provide Ajinomoto with written notice within [***] days after each [***],
if any.

 

 

2.2.

Section 1.44 (the definition of “Field”) is hereby amended and restated in its
entirety as follows:

 

“1.44          “Field” means all prophylactic and therapeutic uses of a
pharmaceutical product in any formulation or dosage form: (i) for
Gastrointestinal Diseases, symptoms of constipation of all causes, or
postoperative ileus; (ii) in colonoscopy cleansing procedures or (iii) from and
after the Second Amendment Date, for any Albireo Liver Disease.”

 

 

2.3.

Section 1.86 of the Agreement is hereby amended by adding the following to the
end thereof:

 

“Notwithstanding the foregoing, Net Sales in Japan of Ajinomoto’s Sublicensee
Mochida Pharmaceutical Co., Ltd. or its Affiliates for any particular period
shall instead be calculated on a Product-by-Product basis in accordance with X
times Y, where:

 

X = [***]; and

 

Y = [***] of the Drug Price for such Product [***]

 

(for the avoidance of doubt, in the case that Mochida or any of its Affiliates
sells to Third Parties (other than Mochida and its Affiliates) Product purchased
from Ajinomoto, (1) Net Sales in respect of such Product shall be calculated as
Mochida Net Sales and (2) such sales of Product from Ajinomoto to Mochida shall
not be included in Net Sales).

 

In addition, in the event that a Product is sold as a [***] by Mochida in Japan,
in determining Mochida Net Sales, (i) the reference to “average gross invoice
price” as applied to ‘A’ (in respect of the fraction A/(A+B)) above in this
Section 1.86 shall be deemed instead a reference to “Drug Price” and (ii) the
reference to “average gross invoice price” as applied to ‘B’ (in respect of the
fraction A/(A+B)) above in this Section 1.86 shall be deemed instead a reference
to “Japan’s National Health Insurance drug price, per dosage unit, assigned to
the product containing the other prophylactically and/or therapeutically active
pharmaceutical ingredient(s) included in the [***]”

 

 

2.4.

Section 2.1 of the Agreement is hereby amended and restated in its entirety as
follows:

 

“2.1License to Ajinomoto.  Subject to the terms and conditions of this
Agreement, Albireo hereby grants to Ajinomoto, a royalty-bearing, exclusive
license (even as to Albireo), with the right to sublicense as set forth in
Section 2.5, (x) effective on the Effective Date, under the Albireo Technology
and Albireo’s interest in the Joint Technology, and (y) effective upon the
occurrence of the first Albireo Liver Disease, if any, under the Albireo Liver
Disease Patent Rights, to (i) Develop, Manufacture and Commercialize the Albireo
Compound and Products in the Field in the Territory; and (ii)

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL

 

conduct pre-clinical Development and Manufacture of the Albireo Compound and
Products in any country in the world for Commercialization in the Field in the
Territory; provided, however, that Ajinomoto shall not be permitted to conduct
any clinical trials for any Albireo Liver Disease [***] or [***] unless Albireo
has first requested and thereafter received prior written consent for Albireo or
its Affiliates to [***], as the case may be, pursuant to Section 2.3.  For the
sake of clarity, neither Ajinomoto nor any of its Sublicensees or Affiliates
shall conduct clinical Development activities related to the Albireo Compound or
Products outside of the Territory.”

 

 

2.5.

Section 2.2 of the Agreement is hereby amended and restated in its entirety as
follows:

 

“2.2License to Albireo.  Subject to the terms and conditions of this Agreement,
Ajinomoto hereby grants to Albireo (i) a royalty-free, non-exclusive license,
with the right to sublicense as set forth in Section 2.5, under the Ajinomoto
Technology and Ajinomoto’s interest in the Joint Technology to the extent
necessary for Albireo to exercise its rights and perform its obligations under
this Agreement; (ii) a royalty-free, non-exclusive license, with the right to
sublicense as set forth in Section 2.5, under the Ajinomoto Technology to
conduct development and manufacture of the Albireo Compound and Products in any
field in any country in the world (except to conduct clinical development of the
Albireo Compound and Products in the Territory during the Term) and to
commercialize the Albireo Compound and Products in any field outside of the
Territory; and (iii) a royalty-free, exclusive license, with the right to
sublicense as set forth in Section 2.5, under Ajinomoto’s interest in the Joint
Technology to conduct development and manufacture of the Albireo Compound and
Products in any field in any country in the world (except to conduct clinical
development of the Albireo Compound and Products in the Territory during the
Term) and to commercialize the Albireo Compound and Products in any field
outside of the Territory, provided that Ajinomoto reserves the right under its
interest in the Joint Technology to, and to have Third Parties acting on
Ajinomoto’s behalf, conduct pre-clinical Development and Manufacture of the
Albireo Compound and Products in any country in the world for Commercialization
in the Field in the Territory.  Neither Albireo nor its Affiliates shall
directly or indirectly (through Licensees or otherwise) commercialize a Product
outside the Field in the Territory during the Term. Ajinomoto acknowledges and
confirms that Albireo or its Affiliates may commercialize one or more products
other than the Product outside the Field in the Territory during the Term, and
that such commercialization is not prohibited by the immediately preceding
sentence or otherwise by this Agreement.”

 

 

2.6.

Section 2.3 of the Agreement is hereby amended and restated in its entirety as
follows:

 

“2.3.  Restrictions.  Except as permitted by this Agreement, Albireo will not
exercise or otherwise exploit the Ajinomoto Technology for any purpose other
than to commercialize the Albireo Compound and Products in the Field outside the
Territory.  Except as permitted by this Agreement, Ajinomoto will not exercise
or otherwise exploit the Albireo Technology to commercialize the Albireo
Compound and Products (i) in the Field outside of the Territory; or (ii) outside
the Field.  Without the prior written consent of Ajinomoto, neither Albireo nor
its Affiliates shall, directly or indirectly, through

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL

 

Licensees or otherwise, (A) commercialize the Albireo Compound and/or a Product
as a pharmaceutical product to treat or prevent Liver Diseases in the Territory
or (B) conduct any clinical trial of the Albireo Compound and/or a Product to
treat or prevent any Liver Disease in or outside the Territory, where [***] such
clinical trial (1) [***] or (2) [***]; provided that, for clarity [***], Albireo
and its Affiliates shall be expressly permitted, directly or indirectly, through
Licensees or otherwise, to research, develop, manufacture or commercialize the
Albireo Compound and/or a Product to treat or prevent any or all Liver Diseases
outside the Territory. Neither Albireo nor its Affiliates shall directly sell or
distribute for sale any Product through channels that are intended to permit
importation of a Product into the Territory, other than pursuant to the rights
granted to Ajinomoto under this Agreement, and Albireo shall ensure that each
License contains a provision prohibiting the relevant Licensee from undertaking
any such sales or distribution.  Likewise, neither Ajinomoto nor its Affiliates
shall directly sell or distribute for sale any Product through channels that are
intended to permit importation of a Product outside the Territory, other than
pursuant to the rights granted to Albireo under this Agreement, and Ajinomoto
shall ensure that each Sublicense to which it is a party contains a provision
prohibiting the relevant Sublicensee from undertaking any such sales or
distribution.”

 

2.7.

Section 3.1.2(l) of the Agreement is hereby amended and restated in its entirety
as follows:

 

“(l) receiving and discussing all material data, information, material or
results relating to development of Products by Albireo or Licensees for
commercialization outside of the Territory, including for clarity for use to
treat or prevent any Albireo Liver Disease or Potential Albireo Liver
Disease.  For clarity, neither the JDC nor JCC shall have any decision making
authority with respect to Albireo’s development or commercialization of Products
outside the Territory; provided that Albireo shall reasonably consider the
comments of Ajinomoto’s representative at the JDC or JCC regarding matters
relating to the development of Products outside the Territory for use to treat
or prevent any Albireo Liver Disease or Potential Albireo Liver Disease.”  

 

 

2.8.

Section 3.2.2(g) of the Agreement is hereby amended and restated in its entirety
as follows:

 

“(g)receiving and discussing material data and information regarding
commercialization of Products by Albireo or Licensees outside the Territory,
including for clarity for use to treat or prevent any Albireo Liver Disease or
Potential Albireo Liver Disease.”

 

 

2.9.

Section 4.3.2 of the Agreement is hereby amended and restated in its entirety as
follows:

 

“4.3.2Regulatory Cooperation.  The Parties shall, each at its own expense,
provide the other Party with reasonable access to and copies of any documents or
other materials Controlled by such Party that are useful for regulatory filings
and correspondence and maintenance of Regulatory Approvals for Products in the
Field in

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL

 

such other Party’s territory and will otherwise cooperate with the other Party’s
efforts to obtain and maintain Regulatory Approvals for Products in the
applicable field and territory; provided, however, that in no event shall either
Party be required to provide access to and copies of any documents or other
materials relating to any compound other than the Albireo Compound or any
product other than Products.  Albireo shall keep Ajinomoto reasonably (but at
least on a quarterly basis) informed regarding the status and progress of all
regulatory matters relating to Products outside of the Territory by providing
Ajinomoto with a copy and English abstract of any regulatory submission made to
a Regulatory Authority and all written correspondence and abstracts of all
material oral correspondence involved in such regulatory submission, in each
case to the extent Controlled by Albireo.  Albireo shall provide Ajinomoto with
any data Controlled by Albireo necessary to comply with requirements from
Regulatory Authorities in the Territory, with respect to the Product in the
Field, such as annual reports, PSUR and CCDS required by Regulatory
Authorities.”

 

 

2.10.

The Agreement shall be amended by adding a new Section 4.7 to read as follows:

 

“4.7Ajinomoto Request for Albireo Liver Disease Approval.  In the event
Ajinomoto requests that Albireo or its Affiliate grant an Albireo Liver Disease
Approval for a particular Liver Disease, Albireo or its Affiliate shall consider
and discuss such request with Ajinomoto in good faith.”

 

 

2.11.

The table in Section 5.2.1 of the Agreement is hereby amended as follows:

 

 

(i)

The fourth row of the table (covering the “EVENT” of [***]) is hereby deleted in
its entirety;

 

 

(ii)

After the third row of the table (covering the “EVENT” of [***]), the following
two (2) rows are inserted; and

 

“The Second Amendment Date

Eight million U.S. Dollars ($8,000,000)

[***]

[***]”; and

 

 

(iii)

The [***] in the sixth row of the table (after giving effect to the amendments
above) (covering the “EVENT” of [***] is replaced with [***].”

 

 

2.12.

The Agreement shall be amended by adding a new Section 5.2.4 to read as follows:

 

“5.2.4. Milestone Payment to Ajinomoto.  Albireo will pay to Ajinomoto a
non-creditable, non-refundable amount of [***] within [***] days after the first
occurrence of NDA Approval granted to Albireo, its Affiliates or Licensees
outside the Territory for the use of a Product for the treatment or prevention
of any Liver Disease (the “Albireo Liver Disease Milestone”).  For the avoidance
of doubt, in the event that this Agreement is terminated in its entirety by
Albireo pursuant to Section 10.2.1 or by Ajinomoto pursuant to Section 10.2.2
prior to the occurrence of the Albireo Liver Disease

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL

 

Milestone, Albireo shall remain obligated to make the Albireo Liver Disease
Milestone payment if the Albireo Liver Disease Milestone occurs prior to the
effectiveness of such termination. For the avoidance of doubt, the Albireo Liver
Disease Milestone shall be owed not more than once.  If Albireo makes or become
obligated for the Albireo Liver Disease Milestone payment, Albireo will not be
obligated to make any payment with respect to any subsequent occurrence of NDA
Approval granted to Albireo, its Affiliates or Licensees outside the Territory
for the use of a Product for the treatment or prevention of any Liver Disease.”

 

 

2.13.

Section 5.3.1 of the Agreement is hereby amended and restated in its entirety as
follows:

 

“5.3.1. Royalty Rates. Subject to Section 5.3.2, Ajinomoto shall pay to Albireo,
with respect to sales of each Product sold by Ajinomoto, its Affiliates or its
Sublicensees in the Field in the Territory during the Royalty Period for each
Product, an amount equal to:

 

[***] of aggregate Net Sales of all Products in a Year in the Territory for the
portion thereof [***]; plus

 

[***] of aggregate Net Sales of all Products in a Year in the Territory for the
portion thereof [***]; plus

 

[***] of aggregate Net Sales of all Products in a Year in the Territory for the
portion thereof [***]; plus

 

[***] of aggregate Net Sales of all Products in a Year in the Territory for the
portion thereof [***].

 

For the purpose of clarification, if there are [***] of aggregate Net Sales of
all Products in each Calendar Quarter in a given Year, then Ajinomoto will pay a
royalty of [***] in the first Calendar Quarter, a royalty of [***] in the second
Calendar Quarter, a royalty of [***] in the third Calendar Quarter, and a
royalty of [***] in the fourth Calendar Quarter.

 

For the purpose of further clarification, if the [***] of a [***] is [***] or
does not [***] in a [***], the [***] of such [***] in such [***] shall not be
[***] under this Agreement and, thereby, in no way will such sales be counted in
determining whether a [***] has been [***] under Section 5.2.2 or determining
the applicable [***] pursuant to this Section 5.3.”

 

 

2.14.

Section 5.5.3 of the Agreement is hereby amended and restated in its entirety as
follows:

 

“5.5.3      Currency.  Other than the amounts specifically indicated for payment
in US Dollars in this Agreement, all amounts payable hereunder shall be in
Euros.  

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL

 

Currency translation into Euros shall be made by using the simple arithmetic
average of the telegraphic transfer selling (TTS) rates on the last business day
of each calendar month of the relevant Calendar Quarter quoted by Bank of
Tokyo-Mitsubishi UFJ.  If, due to restrictions or prohibitions imposed by a
national or international authority, payments cannot be made as provided in this
Section 5, the Parties shall consult with a view to finding a prompt and
acceptable solution, and the paying Party shall deal with such payments as the
other Party may lawfully direct at no additional out-of-pocket expense to the
paying Party.”

 

 

2.15.

The Agreement shall be amended by adding a new subsection (c) to Section 6.3.1
to read as follows:

 

 

“(c)

Solely for purposes of this Section 6.3.1, neither [***] nor any of its [***]
shall be considered to be [***].”

 

 

2.16.

The Agreement is hereby amended by adding the following new Section 6.5 to read
as follows:

 

“6.5Albireo Third Party Licenses.  Albireo agrees that, prior to granting any
new License to a Licensee after the Second Amendment Date, Albireo shall use
commercially reasonable efforts to secure the right to grant to Ajinomoto, its
Affiliates and Sublicensees access, a license or a sublicense, in each case on a
non-exclusive basis, to Know-How that (i) [***] and (ii) [***]; provided that
(A) [***], and (B) [***] agrees that, if (1) [***] will (1) [***] and (2)
[***].”

 

3.

Current Payment.As the result of the insertion of the row covering the “EVENT”
of “The Second Amendment Date” into the table in Section 5.2.1 of the Agreement
via this Second Amendment, and notwithstanding the period for payment provided
in Section 5.2.1, it is hereby confirmed that the amount of Eight Million U.S.
Dollars ($8,000,000) will be paid to Elobix by EA on or before April 15, 2016 by
wire transfer to the bank account which has been previously designated by Elobix
pursuant to Section 5.5.4 of the Agreement.

 

4.

Elobix.  EA and Elobix hereby agree that each reference in the Agreement to
Albireo (to the extent referring to Albireo AB and not speaking expressly as of
the Effective Date (for clarity, of the Original License Agreement)) is deemed
to be a reference to Elobix.

 

5.

Effect.  The amendments to the Agreement set forth in Section 2 of this Second
Amendment shall take effect on and as of the date of this Second Amendment.  

 

6.

No Other Amendments.  This Second Amendment shall be deemed to be part of and
incorporated into the Agreement.  Except as expressly set forth in this Second
Amendment, all of the terms and conditions of the Agreement shall remain
unchanged, are ratified and confirmed in all respects, and remain in full force
and effect.

 

7.

Counterparts.  This Second Amendment may be executed in counterparts, each of
which shall constitute an original and all of which, when taken together, shall
constitute one and the

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL

 

same agreement. An executed signature page to this Second Amendment delivered by
facsimile transmission shall be as effective as an original executed signature
page.

 

[THE REMAINDER OF THE PAGE INTENTIONALLY LEFT BLANK]

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

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IN WITNESS WHEREOF, each of the parties has caused this Second Amendment to be
executed on its behalf by their respective officers thereunto duly authorized
all as of the date first written above.

 

ELOBIX AB

 

By:  

/s/ Jan Mattsson

 

Name:   Jan Mattsson, Ph.D.

 

Title:    Chief Operating Officer

 

EA PHARMA CO., LTD.

 

By:  

/s/ H. Shimizu

 

Name: Hajime Shimizu

 

Title:  Representative Director, President & CEO

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.