Exhibit 10.10.1

RESTATED AMENDMENT AGREEMENT
This Amendment Agreement (this “Amendment Agreement”) dated as of May 7, 2012,
is by and between Regeneron Pharmaceuticals, Inc., a corporation organized and
existing under the laws of the State of New York and having its principal office
at 777 Old Saw Mill River Road, Tarrytown, New York 10591 (“Regeneron”), and
Bayer Healthcare LLC, a limited liability company having a principal place of
business at 511 Benedict Avenue, Tarrytown, NY 10591 (“Company”).

INTRODUCTION

WHEREAS, Regeneron and BHC are Parties to a License and Collaboration Agreement,
having an effective date of October 18, 2006, as amended on May 7, 2012 (the
“LCA”); and

WHEREAS, Regeneron and BHC have mutually determined that, during the term of the
Co-Promotion and Distribution Agreement, by and between Bayer Yakuhin, Ltd.
(“BYL”), an Affiliate of BHC, and Santen Pharmaceutical Co., Ltd. (“Santen”),
dated of even date herewith (the “Santen Co-Promotion Agreement”) which is being
executed and delivered concurrently with the execution and delivery of this
Amendment, Licensed Products will be Commercialized in Japan pursuant to the
Santen Co-Promotion Agreement.

WHEREAS, in connection with, and as a condition to Regeneron consenting to the
Commercialization of Licensed Products in Japan pursuant to, the Santen
Co-Promotion Agreement, this Amendment Agreement is being entered into to amend
and supplement the LCA to (a) convert the financial arrangements with respect to
the Commercialization of Licensed Products in Japan from a profit split as
provided in the LCA to a purchase price adjustment payable by Bayer to Regeneron
(subject to reversion to a profit split under certain circumstances), and
(b) reflect the agreements among Company, BYL and Regeneron regarding the
Commercialization of Licensed Products in Japan , including, in particular, the
financial, governance and reporting provisions of the LCA with respect to Japan.

NOW, THEREFORE, in consideration of the foregoing, and the mutual promises and
obligations set forth herein, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties, intending
to be legally bound, hereby agree as follows:
   
1.
Existing Definitions. Capitalized terms used in this Amendment Agreement which
are not defined herein and are defined in the LCA shall have the meanings
ascribed to them in the LCA. Capitalized terms used in this Amendment Agreement
which are not defined herein and are not defined in the LCA shall have the
meanings ascribed to them in the Santen Co-Promotion Agreement and such
definitions are hereby deemed incorporated by reference into Article I of the
LCA.

1

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

2.
New Definitions. Article 1 of the LCA is hereby amended to add the following
definitions:

(a)
“[****]” shall mean [****].

(b)
“Amendment Agreement” shall mean this Amendment Agreement, as it may be amended
from time to time.

(c)
“Bayer Market Net Sales” shall mean Net Sales in Japan calculated in accordance
with the definition of Net Sales set forth in Article I of the LCA.

(d)
“Bayer Sales” shall mean the number of units of Licensed Product sold by Bayer
to Santen during the respective Quarter multiplied by [****] and multiplied by
[****].

(e)
“BYL” shall mean Bayer Yakuhin Ltd., an Affiliate of Company.

(f)
“Japan Profit Share” shall have the meaning, and shall be calculated as, set
forth in Schedule 2, Section I.B.

(g)
“Japan Purchase Price Adjustment” shall have the meaning, and shall be
calculated as, set forth in Schedule 2, Section I.A.

(h)
“Japan Shared Promotion Expenses” shall have the meaning set forth in Schedule
2, Section I.B.(i).

(i)
“Santen” shall mean Santen Pharmaceutical Co., Ltd., a Japanese corporation
having its principal place of business at 3-9-19, Shimoshinjo,
Higashiyodogawa-ku, Osaka 533-8651, Japan.

(j)
“Santen Change of Control” shall mean any of the following events: (a) Company
or any of its Affiliates, alone or together, acquire(s) shares of capital stock
of Santen representing a majority of the total voting power represented by all
classes of capital stock then outstanding of Santen normally entitled to vote in
the election of members of the board of directors (or analogous governing body)
of Santen; (b) Santen consolidates with or merges with or into Company or any of
its Affiliates; or (c) Santen conveys, transfers or leases all or substantially
all of its assets to Company or any of its Affiliates.

(k)
“Santen Co-Promotion Agreement” shall mean the Co-Promotion and Distribution
Agreement dated of even date herewith by and between BYL and Santen, as amended
from time to time in accordance with the terms thereof and with the consent of
Regeneron if required pursuant to the Amendment Agreement.

(l)
“Santen Market Net Sales” shall mean the number of units of Licensed Product
sold by Santen to wholesalers or other Third Parties during the respective
Quarter multiplied by [****] and multiplied by[****].

2

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

   
3.
Amended Definitions. The following definitions in Article I of or elsewhere in
the LCA are hereby amended as follows:

(a)
References in the LCA to “Agreement” shall mean the LCA, as amended by this
Amendment Agreement.

(b)
“Consolidated Payment Report”. The definition of “Consolidated Payment Report”
set forth in Article I of the LCA is amended by adding the following sentence at
the end thereof: "In addition, the Consolidated Payment Report shall also
include for such Quarter (i) if the Santen Co-Promotion Agreement is in effect
and the Japan Purchase Price Adjustment is applicable for such Quarter and, in
accordance with Schedule 2, is calculated based on Santen Market Net
Sales, (A) Santen Market Net Sales, (B) the applicable NHI Price and (C) unit
sales of the Licensed Product in Japan, (ii) if the Japan Purchase Price
Adjustment is applicable for such Quarter and is calculated based on Bayer
Market Net Sales in accordance with Schedule 2, Bayer Market Net Sales, and
(iii) if the Santen Co-Promotion Agreement is in effect and the Japan Profit
Share is applicable for such Quarter, (A) Bayer Sales, (B) COGS applicable to
Bayer Sales and (C) Japan Shared Promotion Expenses incurred by BYL (following
reconciliation with Santen) and by Regeneron, if any."

(c)
“Net Sales”. The definition of “Net Sales” set forth in Article I of the LCA is
amended by adding the following sentence at the end thereof: “So long as the
Santen Co-Promotion Agreement remains in effect, Net Sales excludes sales of
Licensed Products in the Field in Japan.”

(d)
“Shared Promotion Expenses”. The definition of “Shared Promotion Expenses” in
Article I of the LCA is amended by adding the following sentence at the end
thereof: “So long as the Santen Co-Promotion Agreement is in effect, Shared
Promotion Expenses excludes any of the items listed in this definition to the
extent related to the Commercialization of Licensed Products in Japan.”

4.
Schedule 2. Schedule 2 of the LCA is deleted in its entirety and replaced with
the Amended and Restated Schedule 2 attached to this Amendment Agreement, and
all references to Schedule 2 in this Amendment Agreement, or in the LCA from and
after the date of this Amendment Agreement, refer to such Amended and Restated
Schedule 2.

5.
Regeneron Consent to Sublicense Grant. Regeneron hereby expressly agrees and
consents for the Initial Term to a sublicense by BHC to BYL of BHC’s rights
under the Regeneron Intellectual Property granted by Regeneron to BHC pursuant
to the LCA, provided such sublicense is in compliance with Section 4.3 of the
LCA unless agreed in writing by Regeneron with BHC, and to BYL’s further
sublicense of such rights to Santen, to the extent that they comprise Licensed
Intellectual Property, pursuant to the terms of the Santen Co-Promotion
Agreement, provided that such agreement and consent shall not alter or affect in
any manner BHC’s obligations or Regeneron’s rights under the

3

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

LCA which shall remain in full force and effect, including without limitation
under such Section 4.3.
6.
Commercialization Governance. For so long as the Santen Co-Promotion Agreement
remains in effect, all management and governance of the Commercialization
efforts for the Licensed Product in Japan shall be determined under the LCA as
if such efforts were conducted by Company alone (it being understood that for so
long as the Santen Co-Promotion Agreement remains in effect, Company may fulfill
its obligations under the first two sentences of Section 6.6 and Section 6.7 of
the LCA through Santen), except that Regeneron shall not participate in the
Joint Steering Committee (as defined in the Santen Co-Promotion Agreement) for
Japan. For the avoidance of doubt, Company must still prepare and present to the
JCC the Country Commercialization Plan for Japan in accordance with Section 6.3
of the LCA. If the Santen Co-Promotion Agreement is no longer in effect, this
Section 6 of this Amendment shall have no further force or effect and the
management and governance of the Commercialization efforts for the Licensed
Product in Japan shall again be governed by and subject to the LCA in all
respects. Company shall provide to Regeneron, within ten (10) Business Days of
receipt, all reports and information provided to BYL or Company under Section
3.3 of the Santen Co-Promotion Agreement. Notwithstanding anything to the
contrary in this Section 6, Company shall provide, or shall cause BYL to
provide, to Regeneron such other reports and information required to be provided
under the LCA in the form required by the LCA.

7.
Section 9.3(f). Section 9.3(f) of the LCA is amended by adding the following at
the end thereof: “provided, that if the Santen Co-Promotion Agreement is in
effect and the Japan Profit Share is applicable, within forty-five (45) days
following the end of each Quarter commencing after the First Commercial Sale in
Japan (or such earlier agreed upon calendar Quarter, if appropriate), each Party
that has (or whose Affiliate has) incurred Japan Shared Promotion Expenses in
that Quarter shall deliver electronically to the other Party a written report
setting forth in reasonable detail the Japan Shared Promotion Expenses incurred
by that Party or its Affiliates in such Quarter”.

8.
Section 9.3(g). Section 9.3(g) of the LCA is amended by adding immediately after
the words “for such Quarter” the following: “and, if the Santen Co-Promotion
Agreement is in effect and the Japan Profit Share is applicable, Company shall
deliver electronically to Regeneron a written report setting forth (i) COGS
applicable to Bayer Sales and (ii) COGS incurred by Company or its Affiliates
applicable to Net Sales in the Territory excluding Japan”.

9.
Section 11.6. Section 11.6 of the LCA is amended by adding the following at the
end of the first sentence of such Section (after the word “materials” and before
the period): “;and provided further that if including Regeneron’s name with
equal prominence on materials exclusively related to each Licensed Product in
the Field as provided above is prohibited under applicable Laws, Company will
use Commercially Reasonable Efforts to include, to the extent permitted by
applicable Laws, a reference to Regeneron and its

4

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

contribution to such Licensed Product (e.g., ‘EYLEA was jointly developed by
Regeneron and Bayer HealthCare’).
10.
Calculation of the Japan Profit Split. Unless the Japan Profit Share is
applicable as provided in Section 11 or Section 12 of this Amendment Agreement,
the Japan Profit Split (as defined in Schedule 2, Section I.) shall be
calculated as the Japan Purchase Price Adjustment, as defined in and in
accordance with Schedule 2, Section I.A.

11.
Bayer Renegotiation Option. If the actual [****] in a given calendar year is
less than [****] of the Assumed [****] for such calendar year as set forth in
the table in Schedule 2A attached to this Amendment Agreement, either Party may
request in writing that the Japan Purchase Price Adjustment set forth in
Schedule 2, Section I.A., be renegotiated to reflect the changed circumstances
and to restore the economic basis of such financial arrangements. The Parties
agree to renegotiate in good faith for thirty (30) days following the written
request by a Party for renegotiation of such Japan Purchase Price Adjustment
pursuant to this Section 11. If the Parties do not reach written agreement on
adjustments to the Japan Purchase Price Adjustment within such thirty (30)- day
period, the Japan Profit Split (as defined in Schedule 2, Section I.) shall
thereafter be the Japan Profit Share, as defined in and calculated in accordance
with Schedule 2, Section I.B., beginning in the next calendar Quarter commencing
on or after the expiration of the thirty (30)-day period referenced above in
this Section 11.

12.
Launch Delay Option. In the event that the First Commercial Sale of a Licensed
Product in Japan occurs after [****], either Party may request in writing that
the schedule of annual Baseline A Santen Market Net Sales forth in Schedule 2,
Section I.A., and, if the delay materially adversely affects the economic basis
of the financial arrangements regarding the Commercialization of Licensed
Products in Japan provided for in this Amendment Agreement (including Schedule
2), the Japan Purchase Price Adjustment, be renegotiated to reflect the delayed
launch date and to restore the economic basis of such financial arrangements.
The Parties agree to renegotiate in good faith for thirty (30) days following
such a written request. If the Parties do not reach written agreement on a
revised schedule of Baseline A Santen Market Net Sales and, if applicable,
revised Japan Purchase Price Adjustment, within such thirty (30)-day period, the
Japan Profit Split (as defined in Schedule 2, Section I.) shall thereafter be
the Japan Profit Share, as defined in and calculated in accordance with Schedule
2, Section I.B., beginning in the next calendar Quarter commencing on or after
the expiration of the thirty (30)-day period referenced above in this Section
12. If the schedule of Baseline A Santen Market Net Sales is adjusted, the
schedule of Baseline B and Baseline C Santen Market Net Sales will also be
adjusted proportionately.

13.
[****].

Beginning with the first commercial sale in Japan of [****], Company shall pay
to Regeneron a royalty of [****] of Net Sales [****] in Japan (calculated
consistent with Section 1.65 of the LCA) until the earlier of: (i) the
expiration or termination of the Santen Co-Promotion Agreement, or (ii) a Santen
Change of Control. [****].

5

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

14.
Calculation of Sales Milestones Payments. For so long as the Santen Co-Promotion
Agreement is in effect, Santen Market Net Sales shall be added to Net Sales in
calculating aggregate Net Sales for purposes of determining the achievement of
the sales milestone events described on Schedule 3 to the LCA. If the Santen
Co-Promotion Agreement is no longer in effect, Bayer Market Net Sales shall be
utilized in calculating aggregate Net Sales for such purposes.

15.
Restrictions on BYL Actions under Santen Co-Promotion Agreement.

(a)
Company will not, and will ensure that BYL does not, without Regeneron's prior
written consent (such consent regarding subparagraphs (ii) and (iv) below not to
be unreasonably withheld, delayed or conditioned):

(i)
Agree to any amendment or modification of, waive or fail to enforce any material
rights or grant any consent or approval under (including without limitation to
permit Santen to conduct any Non-Approval Trial related to the Licensed Product
in Japan), extend the Initial Term of, or terminate in part, the Santen
Co-Promotion Agreement;

(ii)
Agree to or permit any Public Relations Activity related to the Licensed Product
in Japan;

(iii)
Agree to or permit any reduction in the Minimum Audited Detail, or any downward
revision in the Market Share Target percentage;

(iv)
Enter into or thereafter amend any of the agreements referred to in Section 6.2
or 7.13 of the Santen Co-Promotion Agreement;

(v)
Accept Santen's rejection of any delivery of Licensed Product if such rejection
is based on actions or omissions of Regeneron in connection with the Manufacture
of such Licensed Product, unless Regeneron has confirmed in writing the basis
for such rejection in its reasonable judgment prior to such acceptance. For the
avoidance of doubt, neither Santen nor BYL shall be required to introduce to the
market or keep on the market any Licensed Product that they have tendered for
rejection;

(vi)
Resolve or agree to resolve any dispute under the Santen Co-Promotion Agreement
if such resolution would diminish the economic benefit reasonably expected to
accrue to Regeneron pursuant to the Japan Purchase Price Adjustment or Japan
Profit Split, as applicable, or would adversely affect the Collaboration in the
Territory outside Japan; or

(vii)
Agree, pursuant to Section 7.11 of the Santen Co-Promotion Agreement, on an
extension of the Minimum Remaining Shelf-Life of the Licensed Product to be
delivered to Santen.

6

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

(b)
If BYL is entitled to terminate the Santen Co-Promotion Agreement, Company and
BYL will consult with Regeneron regarding the advisability of such termination,
but BYL will have the ultimate decision on whether to terminate. Upon such
termination, the Existing LCA, as amended by this Amendment Agreement, will
govern Commercialization of the Licensed Product in Japan.

(c)
For so long as the Santen Co-Promotion Agreement is in effect, Company will not
and will ensure that BYL does not make any sales of Licensed Products in Japan.
The foregoing does not apply to sales of Licensed Product by Company or BYL to
Santen as contemplated by the Santen Co-Promotion Agreement, or any other
Commercialization activities expressly provided in the Santen Co-Promotion
Agreement to be performed by Company or BYL.

16.
Supply Chain. Notwithstanding the obligations set forth in the Santen
Co-Promotion Agreement, Company and BYL will maintain a minimum inventory of
[****] of work-in-process inventory of Licensed Product allocated for Japan for
the first [****] following the First Commercial Sale in Japan, and thereafter, a
minimum inventory of [****] of work-in-process inventory of Licensed Product
allocated for Japan. The foregoing requirements shall be reviewed by the parties
in good faith if [****]. For purposes of this paragraph 16, “work in progress
inventory” shall mean Licensed Product in vials or syringes prior to labeling or
blistering, filled vials or syringes of Licensed Product that are labeled or
blistered prior to sterilization, or sterilized and filled vials or blisters of
Licensed Product that are labeled or blistered prior to packaging.

17.
Public Announcement. The Company and Regeneron will mutually agree upon the
contents of any press release regarding the Santen Co-Promotion Agreement and
this Amendment Agreement. Any other press release or public announcement
concerning the Santen Co-Promotion Agreement or this Amendment Agreement shall
be governed by Section 16.4 of the LCA. To the extent that a Party concludes in
good faith that it is or may be required to file or register this Amendment
Agreement or a notification thereof with any Governmental Authority in
accordance with applicable Laws, such Party may do so subject to the provisions
of Sections 16.4 and 20.8 of the LCA.

18.
Continuing Effect. Except as specifically modified by this Amendment Agreement,
all of the provisions of the LCA are hereby ratified and confirmed to be in full
force and effect, and shall remain in full force and effect.

19.
Company Representation; Performance by BYL. Company hereby represents and
warrants to Regeneron that neither Company, BYL nor any of their Affiliates
doing business principally in Japan has any current or planned agreement,
arrangement or understanding with Santen or any of its Affiliates, other than
the Santen Co-Promotion Agreement. Company shall cause BYL to perform all its
obligations under the Santen Co-Promotion Agreement and will notify Regeneron if
it or any of its Affiliates enters into any such agreement, arrangement or
understanding with Santen or any of its Affiliates, other than the Santen
Co-Promotion Agreement. For the avoidance of doubt, the foregoing representation
and warranty, and the requirement to notify Regeneron, does

7

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

not apply to agreements, such as routine Confidentiality Agreements, Material
Transfer Agreements or the like, that do not relate to new business
opportunities that have not been disclosed to Regeneron.
20.
No Offset. For the avoidance of doubt, Bayer will have no right to offset the
Japan Purchase Price Adjustment with any Bayer COGS, Shared Promotion Expenses
or Japan Shared Promotion Expenses, as defined in Schedule 2, Section I.B.(i).

21.
Entire Agreement; Successors and Assigns. The LCA, this Amendment Agreement, and
any written agreements executed by both Parties pertaining to the subject matter
therein or herein, contain the complete understanding and entire agreement of
the Parties hereto with respect to subject matter hereof and thereof and said
documents supersede all prior understandings and agreements, whether written or
oral, relating to the subject matter hereof and thereof. This Amendment
Agreement shall be binding upon and inure to the benefit of the Parties and
their respective successors and permitted assigns.

22.
Headings. Headings in this Amendment Agreement are for convenience of reference
only and shall not be considered in construing this Amendment Agreement.

23.
Counterparts. This Amendment Agreement may be executed in counterparts and by
facsimile signatures, each of which shall be deemed an original, and shall
become a binding agreement when one or more counterparts have been signed by
each Party and delivered to the other Party.

24.
Miscellaneous. The provisions of Section 20.1 of the LCA shall apply, mutatis
mutandis, to this Amendment Agreement. If there is a direct conflict between the
provisions of the LCA and this Amendment Agreement, this Amendment Agreement
shall govern. This Amendment Agreement may be amended only by a writing executed
by an authorized representative of each of the Parties.

[Signatures appear on following page]

8

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

IN WITNESS WHEREOF, each of the Parties has caused this Amendment to be executed
as of the date hereof by a duly authorized corporate officer.

BAYER HEALTHCARE LLC

By:     /s/ R. Scott Meece                
Name:     R. Scott Meece
Title:     General Counsel, Senior Vice President and     Secretary

Date:    December 30, 2014

REGENERON PHARMACEUTICALS, INC.

By:    /s/ Murray A. Goldberg            
Name:    Murray A. Goldberg
Title:    Senior Vice President

Date:    December 30, 2014

9

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

AMENDED AND RESTATED SCHEDULE 2

Quarterly True-Up

At the end of each Quarter, the Parties will calculate the net payment one Party
shall be required to make to the other Party (the “Quarterly True-Up”) equal to
(a) the Territory Profit Split for such Quarter (as set forth in Part I), plus
(b) the Regeneron Reimbursement Amount for such Quarter (as set forth in Part
II), plus or minus (c) the Global True-Up (as set forth in Part III), minus (d)
the Global Development Balance Payment (commencing in the Quarter of the First
Commercial Sale in a Major Market Country) (as set forth in Part IV). In the
event that the Quarterly True-Up is an amount greater than zero, such amount
shall be payable by Company to Regeneron in accordance with the terms set forth
in Article 9. In the event that the Quarterly True-Up is an amount less than
zero, the absolute value of such amount shall be payable by Regeneron to Company
in accordance with the terms set forth in Article 9. An example of the Quarterly
True-Up is shown in Part V.

I. TERRITORY PROFIT SPLIT
The “Territory Profit Split” shall mean the sum of fifty percent (50%) of
Territory Profits in the Quarter plus the Japan Profit Split in the Quarter.
“Territory Profits” shall mean aggregate Net Sales in the Territory, excluding
Japan, in the Quarter less the sum of aggregate COGS and aggregate Shared
Promotion Expenses incurred by both Parties in the Territory, excluding Japan,
in the Quarter.

The “Japan Profit Split” shall equal the US Dollar equivalent (calculated in
accordance with Section 9.6) of (a) either (i) the Japan Purchase Price
Adjustment, as defined below, or (ii) the Japan Profit Share, as defined below,
as applicable for such Quarter, plus (b) the Regeneron Detail Default Payment,
if any. The “Regeneron Detail Default Payment” shall equal [****] of the Detail
Default Payment paid by Santen to the BYL in a Quarter, if any.

10

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

An example of a calculation of the Territory Profit Split in a Quarter would be:

 
Aggregate
Company

Regeneron

 
 
 
 
 
 
Net Sales in the Territory*
1000
1000
 
 
 
 
 
 
 
COGS*

(50)
(50)
0
 
 
 
 
 
 
Shared Promotion Expenses*
(350)
(300)
(50)
 
 
 
 
 
 
Territory Profits
600
 
 
 

50% of Territory Profits

300
 
 
 
Japan Profit Split
100
 
 
 
Territory Profit Split
400
 
 
 

* Excluding Japan

A.
JAPAN PURCHASE PRICE ADJUSTMENT

The Japan Purchase Price Adjustment mechanism shall always apply unless the
Parties cannot reach agreement for adjustments pursuant to paragraphs 9 and 10,
in which case the Japan Profit Share will apply.
For each calendar year through December 31, 2021 that the Santen Co-Promotion
Agreement is in effect, the “Japan Purchase Price Adjustment” shall equal the
sum of (i) 33.5% of Santen Market Net Sales up to Baseline A Santen Market Net
Sales for such year, (ii) [****] of Santen Market Net Sales in excess of
Baseline A Santen Market Net Sales up to Baseline B Santen Market Net Sales for
such year, (iii) [****] of Santen Market Net Sales in excess of Baseline B
Santen Market Net Sales up to Baseline C Santen Market Net Sales for such year,
and (iv) 40.0% of Santen Market Net Sales in excess of Baseline C Santen Market
Net Sales.
For each calendar year through [****] that the Santen Co-Promotion Agreement is
not in effect, the Japan Purchase Price Adjustment shall equal [****] of Bayer
Market Net Sales.
From and after a Santen Change of Control, and in any event after [****], the
Japan Purchase Price Adjustment shall equal [****] of Bayer Market Net Sales.
Baseline A Santen Market Net Sales, Baseline B Santen Market Net Sales, and
Baseline C Santen Market Net Sales are set forth below:

11

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

 
Santen Market Net Sales
(in millions of Yen)
 
Year
Baseline A
Baseline B 
(=[****] of Baseline A) 
Baseline C  
(=[****] of Baseline A)
 
2012
[****]
[****]
[****]
 
2013
[****]
[****]
[****]
 
2014
[****]
[****]
[****]
 
2015
[****]
[****]
[****]
 
2016
[****]
[****]
[****]
 
2017
[****]
[****]
[****]
 
2018
[****]
[****]
[****]
 
2019
[****]
[****]
[****]
 
2020
[****]
[****]
[****]
 
2021
[****]
[****]
[****]
 

When the Santen Co-Promotion Agreement is in effect, the Japan Purchase Price
Adjustment for a Quarter shall be calculated based on Santen Market Net Sales in
such Quarter using a rate(s) based on aggregate year-to-date Santen Market Net
Sales in accordance with the formula set forth above.

12

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

A series of examples of the calculation of the Japan Purchase Price Adjustment
is set forth below:
[****]

13

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

B. JAPAN PROFIT SHARE
The Japan Profit Share applies only if the Parties cannot reach agreement for
adjustments pursuant to paragraphs 11 and 12, otherwise the Japan Purchase Price
Adjustment mechanism will apply.
Japan Profit Share – Santen Co-Promotion Agreement in Effect

If the Santen Co-Promotion Agreement is in effect, the “Japan Profit Share”
shall equal fifty percent (50%) of Japan Profits in the Quarter. “Japan Profits”
for this Paragraph (i) shall mean Bayer Sales in the Quarter less the sum of
COGS applicable to Bayer Sales and Japan Shared Promotion Expenses incurred by
BYL (following reconciliation with Santen) (and Regeneron, if any) in Japan in
the Quarter. “Japan Shared Promotion Expenses” shall mean the sum of (a)
Promotional Expenses (as defined in the Santen Co-Promotion Agreement) and (b)
[****] of the Promotion Fee (as defined in the Santen Co-Promotion Agreement).
The other [****] of the Promotion Fee will be borne by the Company and will not
be included as a part of the calculation of Japan Profits.

Japan Profit Share – Santen Co-Promotion Agreement Not in Effect and no Japan
Purchase Price Adjustment payable

If the Santen Co-Promotion Agreement is not in effect, the “Japan Profit Share”
shall equal fifty percent (50%) of Japan Profits in the Quarter. “Japan Profits”
for this Paragraph (ii) shall mean Bayer Market Net Sales in the Quarter less
the sum of COGS applicable to Bayer Market Net Sales and Shared Promotion
Expenses incurred by BYL (and Regeneron, if any) in Japan in the Quarter.

II. REGENERON REIMBURSEMENT AMOUNT
The “Regeneron Reimbursement Amount” for a Quarter shall mean (a) Shared
Promotion Expenses incurred by Regeneron in the Quarter (if any), plus (b)
Commercial Supply Costs incurred by Regeneron in the Quarter (if any), plus (c)
Development Costs incurred by Regeneron under the Territory Development Plan in
the Quarter (if any).

An example of a calculation of the Regeneron Reimbursement Amount in a Quarter
would be:

Regeneron Shared Promotion Expenses    50

Regeneron Commercial Supply Costs    10

Regeneron Development Costs under Territory Development Plan    5

Regeneron Reimbursement Amount    65

14

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

III. GLOBAL TRUE-UP

The “Global True-Up” for a Quarter shall mean (a) fifty percent (50%) of the sum
of (i) aggregate Development Costs incurred by both Parties under the Global
Development Plan in the Quarter and (ii) aggregate Other Shared Expenses
incurred by both Parties in the Quarter, minus (b) one hundred percent (100%) of
the sum of (i) Development Costs incurred by Company under the Global
Development Plan in the Quarter and (ii) Other Shared Expenses incurred by
Company during the Quarter. If the Global True-Up is a positive number, it shall
be added in the calculation of the Quarterly True-Up and, if it is a negative
number, the absolute value of such amount shall be subtracted in the calculation
of the Quarterly True-Up.

An example of a calculation of the Global True-Up in a Quarter would be:
 
 
Aggregate
 
Company
 
Regeneron
Global True-Up
Development Costs under Global Development Plan
 
80

 
30

 
50

 
Other Shared Expenses
 
40

 
35

 
5

 
Total
 
120

 
65

 
55

(5
)

IV. GLOBAL DEVELOPMENT BALANCE PAYMENT

The “Global Development Balance” for a Quarter shall mean (a) twenty-five
percent (25%) of the aggregate amount of Development Costs incurred by both
Parties under the Global Development Plan from January 1, 2007 through the close
of such Quarter ([****]), plus (b) fifty percent (50%) of the aggregate amount
of Development Costs incurred by both Parties under the Territory Development
Plan from the Effective Date through the close of such Quarter ([****]), less
(c) the aggregate amount of Global Development Balance Payments included in the
calculation of the Quarterly True-Up in all prior Quarters. On the date of the
First Commercial Sale in Japan, if the Japan Purchase Price Adjustment mechanism
is applicable, the Global Development Balance shall never include Pre-Launch
Marketing Expenses relating to Japan.

The “Global Development Balance Payment” shall mean, [****]

An example of a calculation of the Global Development Balance Payment in a
Quarter would be:
Territory Profit Split
 
400

Global Development Balance
 
200

[****]
 
[****]

Global Development Balance Payment
 
[****]

15

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

V. EXAMPLE OF QUARTERLY TRUE-UP

An example of a calculation of the Quarterly True-up in a Quarter would be:
Territory Profit Split
 
400

Regeneron Reimbursement Amount
 
65

Global True-Up
 
(5
)
[****]
 
[****]

Quarterly True-up
 
[****]

In this example, Company would pay Regeneron [****] in accordance with the terms
set forth in Article 9.

 

16

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

SCHEDULE 2A

Assumed [****] by Year in Yen

Year
Assumed [****]
2012
[****]
2013
[****]
2014
[****]
2015
[****]
2016
[****]
2017
[****]
2018
[****]
2019
[****]
2020
[****]
2021
[****]
2022
[****]
2023
[****]
2024
[****]
2025
[****]
2026 and thereafter
[****]

17