Document:

EXHIBIT 10.1 

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 (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 royalty 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.

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	     	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 Royalty” 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
  [****].

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	     	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 Royalty 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 Royalty 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 LCA which shall remain in full
      force and effect, including without limitation under such Section
      4.3.

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		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 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
      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 Royalty, as defined in and in accordance with
      Schedule 2, Section I.A.

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	     	11.	     	Bayer Royalty 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 Royalty
      rates 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 Royalty rates pursuant to this Section 11. If
      the Parties do not reach written agreement on adjustments to the Japan
      Royalty rates 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
      Royalty rates, 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 Royalty rates, 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. [****].
		 
		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.

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		(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 Royalty 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.
		 
		(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.

6

	     	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. The form of
      press release agreed to by the Parties announcing the execution of the
      Santen Co-Promotion Agreement and this Amendment Agreement is attached as
      Schedule 3 to 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 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 Royalty with any Bayer COGS, Shared Promotion Expenses or
      Japan Shared Promotion Expenses, as defined in Schedule 2, Section
      I.B.(i).

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	     	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:		
	 	 	 
	Name:		
	 	 	 
	Title:		
	 	 	 
	Date:		
		 	
		 	 
		 	
	REGENERON
      PHARMACEUTICALS, INC.	
		 	
		 	
	By:		
	 	 	 
	Name:		
	 	 	 
	Title:		
	 	 	 
	Date:		

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. 

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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 Royalty, 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.

11 

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 

12 

A. JAPAN ROYALTY 

The Japan Royalty 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
Royalty” 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 Royalty shall
equal [****] of Bayer Market Net Sales.

From and after a Santen Change of
Control, and in any event after [****], the Japan Royalty 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: 

		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	[****]	[****]	[****]

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	2016	[****]	[****]	[****]
	2017	[****]	[****]	[****]
	2018	[****]	[****]	[****]
	2019	[****]	[****]	[****]
	2020	[****]	[****]	[****]
	2021	[****]	[****]	[****]

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

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A series of examples of the
calculation of the Japan Royalty is set forth below:

[****]

15 

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 Royalty 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 Royalty 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

16 

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
Royalty 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
	[****]

17 

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.

18 

SCHEDULE 2A 

Assumed [****] by Year in Yen

19 

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

thereafter	[****]

20 

SCHEDULE 3 

Press Release 

21 

 
 

	For Immediate Release
	 
	Press Release

Regeneron
and Bayer Announce Co-Promotion Agreement With Santen For EYLEA® (aflibercept)
Injection in Japan

Collaboration agreement between Regeneron and Bayer amended to a royalty arrangement in Japan

Tarrytown, NY, USA (May 8, 2012) -- Regeneron
Pharmaceuticals, Inc. (Nasdaq: REGN) and Bayer HealthCare today announced that
Bayer’s Japanese subsidiary, Bayer Yakuhin, Ltd. (“Bayer Yakuhin”), and Santen
Pharmaceutical Co., Ltd. (“Santen”) entered into a co-promotion agreement for
EYLEA® (aflibercept) Injection in Japan. As previously announced,
Bayer Yakuhin has submitted an application for marketing authorization to the
Ministry of Health, Labor and Welfare (MHLW) for EYLEA for the treatment of
neovascular age-related macular degeneration (wet
AMD).

“With this agreement and upon marketing authorization, a
newly formed Bayer Yakuhin ophthalmology field force and Santen, the leading
ophthalmology company in Japan, will promote EYLEA,” said Sebastian Guth,
President & CEO of Bayer Yakuhin, Ltd. “We expect that the combined
resources of the two companies will allow EYLEA to achieve a broader and faster
reach into the Japanese ophthalmology community and potentially benefit a
greater number of patients.”

Bayer and Regeneron have also amended their existing
global license and collaboration agreement for EYLEA to convert the 50/50 profit
share for Japan into a royalty arrangement that approximates the economics of
the profit split. In certain specified circumstances, the royalty may revert to
a profit share arrangement.

EYLEA is approved for sale in the United States for the
treatment of wet AMD and marketing approval has also been granted in Australia.
Bayer HealthCare has submitted applications in Europe and other countries and
has initiated a Phase 3 clinical study for wet AMD in China. Beyond the wet AMD
indication, EYLEA is in Phase 3 clinical studies for the treatment of diabetic
macular edema (DME), myopic choroidal neovascularization (mCNV), and branch
retinal vein occlusion (BRVO). Regeneron has filed an sBLA for EYLEA in central
retinal vein occlusion (CRVO) in the United States, and has been granted a
Prescription Drug User Fee Act (PDUFA) date of September 23,
2012.

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of EYLEA®. EYLEA was approved in the United States for the treatment of wet AMD in November 2011. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare owns the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales of EYLEA, except for Japan where Regeneron will receive a royalty on net sales.

About EYLEA®
(aflibercept) Injection For Intravitreal Injection
Vascular Endothelial Growth Factor (VEGF) is a naturally
occurring protein in the body. Its normal role in a healthy organism is to
trigger formation of new blood vessels (angiogenesis) supporting the growth of
the body's tissues and organs. However, in certain diseases, such as wet
age-related macular degeneration, it is also associated with the growth of
abnormal new blood vessels in the eye, which exhibit abnormal increased
permeability that leads to edema. Scarring and loss of fine-resolution central
vision often results.

EYLEA (aflibercept) Injection, known in
the scientific literature as VEGF Trap-Eye, is a recombinant fusion protein,
consisting of portions of human VEGF receptors 1 and 2 extracellular domains
fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution
for intravitreal administration. EYLEA acts as a soluble decoy receptor that
binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the
binding and activation of these cognate VEGF receptors. 

IMPORTANT PRESCRIBING INFORMATION

In the United States, EYLEA is indicated
for the treatment of patients with neovascular age-related macular degeneration
(wet AMD).

The recommended dose for EYLEA is 2 mg
administered by intravitreal injection every four weeks (monthly) for the first
12 weeks (3 months), followed by 2 mg once every eight weeks (2 months).
Although EYLEA may be dosed as frequently as 2 mg every four weeks (monthly),
additional efficacy was not demonstrated when EYLEA was dosed every four weeks
compared to every eight weeks. 

IMPORTANT SAFETY INFORMATION

EYLEA is contraindicated in patients with
ocular or periocular infections, active intraocular inflammation, or known
hypersensitivity to aflibercept or to any of the excipients in EYLEA.

Intravitreal injections, including
those with EYLEA, have been associated with endophthalmitis and retinal
detachments. Proper aseptic injection technique must always be used when
administering EYLEA. Patients should be instructed to report any symptoms
suggestive of endophthalmitis or retinal detachment without delay and should be
managed appropriately. 

Acute increases in intraocular pressure
have been seen within 60 minutes of intravitreal injection, including with
EYLEA. Sustained increases in intraocular pressure have also been reported after
repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the
perfusion of the optic nerve head should be monitored and managed appropriately.

There is a potential risk of arterial
thromboembolic events (ATEs) following use of intravitreal VEGF inhibitors,
including EYLEA, defined as nonfatal stroke, nonfatal myocardial infarction, or
vascular death (including deaths of unknown cause). The incidence of ATEs with
EYLEA® in clinical trials was 1.8% during the first year. 

The most common adverse reactions
(greater than or equal to 5%) reported in patients receiving EYLEA (aflibercept)
Injection were conjunctival hemorrhage, eye pain, cataract, vitreous detachment,
vitreous floaters, and increased intraocular pressure. 

Serious adverse reactions related to
the injection procedure have occurred in less than 0.1% of intravitreal
injections with EYLEA including endophthalmitis, traumatic cataract, and
increased intraocular pressure. 

Please see the full Prescribing
Information for EYLEA, available online at www.regeneron.com/EYLEA-fpi.pdf.

About Wet AMD 
Age-related Macular Degeneration (AMD) is a leading cause of
acquired blindness. Macular degeneration is diagnosed as either dry
(non-exudative) or wet (exudative). In wet AMD, new blood vessels grow beneath
the retina and leak blood and fluid. This leakage causes disruption and
dysfunction of the retina creating blind spots in central vision, and it can
account for blindness in wet AMD patients. Wet AMD is the leading cause of
blindness for people over the age of 65 in the U.S. and Europe. 

About Regeneron Pharmaceuticals

Regeneron is a fully integrated
biopharmaceutical company that discovers, invents, develops, manufactures, and
commercializes medicines for the treatment of serious medical conditions.
Regeneron markets two products in the United States, ARCALYST®
(rilonacept) Injection For Subcutaneous Use and EYLEA®
(aflibercept) Injection, and has filed regulatory applications with the U.S.
Food and Drug Administration (FDA) for second indications for each of these
products. A regulatory application has also been submitted to the FDA for the
product candidate ZALTRAP® (aflibercept) Concentrate for Intravenous
Infusion. Phase 3 studies are in progress with EYLEA® in a third
indication, and with product candidate sarilumab. Earlier-stage clinical
programs are underway with nine additional monoclonal antibodies. Regeneron has
active research and development programs in many disease areas, including
ophthalmology, inflammation, cancer, and hypercholesterolemia. Additional
information and recent news releases are available on the Regeneron web site at
www.regeneron.com.

About Santen 
Founded in 1890, Santen is a global company headquartered in
Osaka, Japan. Santen researches, develops and markets ophthalmic products for
physicians worldwide. Among prescription ophthalmic pharmaceuticals, Santen
holds the top share within the Japanese market and is one of the leading
ophthalmic companies worldwide. For more information, visit www.santen.com.

About Bayer Yakuhin, Ltd.

Bayer Yakuhin Ltd., headquartered in
Osaka, is a healthcare company which combines business activities of
Pharmaceuticals, Radiology & Interventional and Animal Health (companion and
food animal products). Pharmaceuticals business is focused on the following
areas: Cardiovascular & Neurology, Oncology & Hematology, Women's Health
& Dermatology and Ophthalmology. Bayer Yakuhin aims to be one of leading
pharmaceutical companies, which responds to Japanese patients’ unmet medical
needs, with the spirit of Bayer’s corporate slogan “Science For A Better Life”.

Bayer Yakuhin homepage: http://www.bayer.co.jp/byl

About Bayer
HealthCare
The Bayer Group is a global
enterprise with core competencies in the fields of health care, nutrition and
high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales
of EUR 17.2 billion (2011), is one of the world’s leading, innovative companies
in the healthcare and medical products industry and is based in Leverkusen,
Germany. The company combines the global activities of the Animal Health,
Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s
aim is to discover, develop, manufacture and market products that will improve
human and animal health worldwide. Bayer HealthCare has a global workforce of
55,700 employees (Dec 31, 2011) and is represented in more than 100 countries.
Find more information at www.bayerhealthcare.com. 

To learn more about age-related macular
degeneration (AMD), please visit: www.bayerpharma.de/en/AMD

Regeneron Forward-Looking
Statements 
This news release includes forward-looking statements that
involve risks and uncertainties relating to future events and the future
performance of Regeneron, and actual events or results may differ materially
from these forward-looking statements. These statements concern, and these risks
and uncertainties include, among others, the nature, timing, and possible
success and therapeutic applications of EYLEA in Japan and other countries and
Regeneron's product candidates, potential new indications for EYLEA, and
research and clinical programs now underway or planned, the likelihood and
timing of possible regulatory approval and commercial launch of EYLEA in Japan,
Regeneron's late-stage product candidates and new indications for marketed
products, determinations by regulatory and administrative governmental
authorities which may delay or restrict Regeneron's ability to continue to
develop or commercialize EYLEA and other product and drug candidates and
possible new indications for marketed products, competing drugs that may be
superior to EYLEA and Regeneron's product and drug candidates and possible new
indications for marketed products, uncertainty of market acceptance of EYLEA and
Regeneron's product and drug candidates and possible new indications for
marketed products, unforeseen safety issues resulting from the administration of
products and product candidates in patients, the potential for any license or
collaboration agreement, including Regeneron’s agreements with Sanofi or Bayer
HealthCare, to be cancelled or terminated, and risks associated with third party
intellectual property and pending or future litigation relating thereto. A more
complete description of these and other material risks can be found in
Regeneron's filings with the United States Securities and Exchange Commission,
including its Form 10-K for the year ended December 31, 2011 and Form 10-Q for
the quarter ended March 31, 2012. Regeneron does not undertake any obligation to
update publicly any forward-looking statement, whether as a result of new
information, future events, or otherwise, unless required by law.

### 

	Contacts Information:	
	 
	Michael Aberman, M.D.	Peter Dworkin
	Investor Relations	Corporate Communications
	914.847.7799	914.847.7640
	michael.aberman@regeneron.com	peter.dworkin@regeneron.com

		

May 8, 2012 

News Release 

Bayer Yakuhin, Ltd.
Santen
Pharmaceutical Co., Ltd. 

Announcement of the conclusion of the
agreement on co-promotion of
VEGF Trap-Eye
(aflibercept intravitreal injection)

Bayer Yakuhin, Ltd. (Head
office : Osaka,
hereafter referred to as “Bayer Yakuhin”) and Santen Pharmaceutical Co., Ltd.
(Head office : Osaka, hereafter referred to as “Santen”) concluded on May 7 an agreement
of co-promotion of VEGF Trap-Eye (aflibercept intravitreal injection) in the
market of Japan. Bayer Yakuhin has submitted an authorization application to the
Ministry of Health, Labour and Welfare (MHLW) for marketing this product for the
treatment of wet age-related macular degeneration (wet AMD).

With this agreement, medical
representatives (MRs) of both companies will start promotional activities of
VEGF Trap-Eye after Bayer Yakuhin obtains a marketing authorization from the
MHLW. Bayer Yakuhin will hold the marketing authorization for the product, and
Santen will distribute it in Japan. 

With VEGF Trap-Eye, Bayer Yakuhin will
enter the product market for the back-of-the-eye area which mainly includes
retinal diseases. By partnering with Santen, the leading ophthalmic
pharmaceutical company in Japan, Bayer Yakuhin will be able to offer the latest
information relating to VEGF Trap-Eye to a broader range of ophthalmologists and
contribute to AMD therapy.

- 1/5 -

Santen offers a full lineup of
pharmaceutical ocular products that deal with problems in the front-of-the-eye
region. By adding an outstanding product, i.e., VEGF Trap-Eye, in the product
market for the back-of-the-eye area that covers wet AMD, for which Santen offers
less treatment options at present, Santen expects to meet the treatment needs of
patients and further contribute to the improvement in patients’ quality of life
(QOL). 

About VEGF Trap-Eye 
VEGF Trap-Eye is a
recombinant fusion protein consisting of portions of human VEGF receptors 1 and
2 extracellular domains fused to the Fc portion of human IgG1 and formulated as
an iso-osmotic solution for intravitreal administration. VEGF Trap-Eye acts as a
soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) with
higher affinity than their natural receptors, and thereby can inhibit the
binding and activation of these cognate VEGF receptors. VEGF Trap-Eye is
specially purified and contains iso-osmotic buffer concentrations, allowing for
injection into the eye. 

Vascular Endothelial Growth Factor (VEGF)
is a naturally occurring protein in the body. Its normal role in a healthy
organism is to trigger formation of new blood vessels (angiogenesis) supporting
the growth of the body's tissues and organs. However, in certain diseases, such
as wet age-related macular degeneration, it is also associated with the growth
of abnormal new blood vessels in the eye, which exhibit abnormal increased
permeability that leads to edema. Scarring and loss of fine-resolution central
vision often results. 

Bayer HealthCare and Regeneron
Pharmaceuticals are collaborating on the global development of VEGF Trap-Eye for
the treatment of wet AMD, central retinal vein occlusion (CRVO),
myopic choroidal
neovascularisation (CNV), diabetic macular edema (DME), and other eye diseases
and disorders. VEGF Trap-Eye was approved for the indication of wet AMD in the
US in November 2011 and in Australia in March 2012. 

About wet AMD 
Age-related Macular Degeneration (AMD) is a leading cause of
acquired blindness. Macular degeneration is diagnosed as either dry
(non-exudative) or wet (exudative). In wet AMD, new blood vessels grow beneath
the retina and leak blood and fluid. This leakage causes disruption and
dysfunction of the retina creating blind spots in central vision, and it can
account for blindness in wet AMD patients. 

- 2/5 -

Wet AMD is the leading cause of blindness
for people over the age of 65 in the U.S. and Europe. In Japan, age-related
macular degeneration (AMD) is the 4th most common cause of acquired blindness
and the number of patients is increasing. The research conducted in 2007
targeting residents in Hisayama, Fukuoka, shows that 1.2% of residents over the
age of 50 had wet AMD in at least one eye. Extrapolating from this study, the
number of patients in Japan estimated to have wet AMD eligible for treatment
with anti-VEGF therapy is approximately 700,000. 

Reference :

1 Ophthalmic Epidemiology, 17(I), 50-57,
2010: “Prevalence of Visual Impairment in the Adult Japanese Population by Cause
and Severity and Future Projections” Masakazu Yamada, Yoshimune Hiratsuka, Chris
B. Roberts, M. Lynne Pezzullo, Katie Yates, Shigeru Takano, Kensaku Miyake, and
Hugh R. Taylor 

	2  		 26(1) 25~30,2009:  	

 

Contact : 

Santen Pharmaceutical Co.,
Ltd
Corporate Communication Group
E-mail: ir@santen.co.jp 

About Santen 
Founded in 1890, Santen is a global company headquartered in
Osaka, Japan. Santen researches, develops and markets ophthalmic products for
physicians worldwide. Among prescription ophthalmic pharmaceuticals, Santen
holds the top share within the Japanese market and is one of the leading
ophthalmic companies worldwide. For more information, visit www.santen.com. 

About Bayer Yakuhin, Ltd.

Bayer Yakuhin Ltd., headquartered in
Osaka, is a healthcare company which combines business activities of
Pharmaceuticals, Radiology & Interventional and Animal Health (companion and
food animal products). Pharmaceuticals business is focused on the following
areas: Cardiovascular & Neurology, Oncology & Hematology, Women's Health
& Dermatology and Ophthalmology. Bayer Yakuhin aims to be one of leading
pharmaceutical companies, which responds to Japanese patients’ unmet medical
needs, with the spirit of Bayer’s corporate slogan “Science For A Better Life”.

- 3/5 -

Bayer Yakuhin homepage: http://www.bayer.co.jp/byl

About Bayer HealthCare

The Bayer Group is a global enterprise
with core competencies in the fields of health care, nutrition and high-tech
materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR
17.2 billion (2011), is one of the world’s leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Consumer Care,
Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to
discover, develop, manufacture and market products that will improve human and
animal health worldwide. Bayer HealthCare has a global workforce of 55,700
employees (Dec 31, 2011) and is represented in more than 100 countries. Find
more information at www.bayerhealthcare.com.

To learn more about age-related macular
degeneration (AMD), please visit: www.bayerpharma.de/en/AMD

About Regeneron
Regeneron is a fully integrated biopharmaceutical company that
discovers, invents, develops, manufactures, and commercializes medicines for the
treatment of serious medical conditions. Regeneron markets two products in the
United States, one for the treatment of neovascular (wet) age-related macular
degeneration and another for the treatment of a rare inflammatory condition.
Additionally, Regeneron has three regulatory applications pending before the
U.S. Food and Drug Administration (FDA) and 10 drug candidates in clinical
development. More information and recent news releases are available on the
Regeneron web site at www.regeneron.com

Bayer Forward-Looking
Statement
This release may contain
forward-looking statements based on current assumptions and forecasts made by
Bayer Group or subgroup management. Various known and unknown risks,
uncertainties and other factors could lead to material differences between the
actual future results, financial situation, development or performance of the
company and the estimates given here. These factors include those discussed in
Bayer’s public reports which are available on the Bayer website at
www.bayer.com. The company assumes no liability whatsoever to update these
forward-looking statements or to conform them to future events or
developments.

- 4/5 -

Santen Forward-looking
Statements
Information provided in this
press release contains so-called “Forward-looking Statements”. The realizations
of these forecasts are subject to risk and uncertainty from various sources.
Therefore, please note that the actual results may differ significantly from the
forecasts. Business performance and financial condition are subject to the
effects of change in regulations made by the governments of in Japan and other
nations concerning medical insurance, drug pricing and other systems, and to
fluctuations in market variables such as interest rates and foreign exchange
rates. 

- 5/5 -f8k040312ex4i_trig.htm

Exhibit 4.1

 

 

FORM OF SECURED NOTE

 

THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE “ACT”) AND ARE “RESTRICTED SECURITIES” AS THAT TERM IS DEFINED IN RULE 144 UNDER THE ACT.  THE SECURITIES MAY NOT BE OFFERED FOR SALE, SOLD OR OTHERWISE TRANSFERRED EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT OR PURSUANT TO AN EXEMPTION FROM REGISTRATION UNDER THE ACT, THE AVAILABILITY OF WHICH IS TO BE ESTABLISHED TO THE REASONABLE SATISFACTION OF THE ISSUER.

 

SECURED NOTE

Due April 8, 2013

TRIG Acquisition 1, Inc.

 

	Original Issue Date: May __, 2012	
$__________

 

FOR VALUE RECEIVED, TRIG Acquisition 1, Inc., a publicly held Nevada corporation (“TRIG” or the “Company”), hereby promises to pay to ____________________ (“Buyer”), or its registered assigns (the “Holder”), the principal sum of _________________________ ($_________), together with interest thereon at the rate of 12% per annum, on the terms set forth below.  This Secured Note (this “Note”) was issued pursuant to that certain Note Purchase Agreement dated the Original Issue Date set forth above by and between the Company and the Buyer (the “Note Purchase Agreement”).  This Note is one of a series of secured notes (the “Notes”) of like tenor in the aggregate principal amount of up to $300,000.  Notwithstanding the above, management of the Company, may in its sole discretion accept Notes in an aggregate principal amount of up to $600,000. Unless otherwise defined herein, capitalized terms used in this Note shall have the meanings ascribed to them in the Note Purchase Agreement.

 

1.             Payments

 

1.1         Interest.  Interest shall accrue and be payable on the last day of every fiscal quarter commencing June 30, 2012 and on the Maturity Date.

 

1.2         Principal.  Principal shall be due and payable on April 8, 2013 (the “Maturity Date”).

 

  

  

  

 

1.3         Place and Form of Payment.  Except as provided in Section 3, the Company shall pay principal and interest in United States Dollars to the Holder at the Holder’s address for notices or such other address at the Holder may designate in writing.

 

1.4         Prepayment.  The Company shall not have the right to prepay this Note.

 

2.             Definitions

 

For purposes of this Note, the following capitalized terms shall have the meanings set forth below:

 

“Acceleration Notice” shall have the meaning specified in Section 5.2.

 

“Common Stock Price” shall mean, with respect to the PIPE: (i) if the securities sold in the PIPE consist solely of Common Stock, the per share price of the Common Stock; (ii) if the securities sold in the PIPE consist solely Common Stock and securities exercisable for (e.g. warrants) or convertible into (e.g. convertible preferred stock or convertible debt) Common Stock, the lowest of the per share price of the Common Stock and the exercise or conversion price of the other securities; and (iii) if the securities sold in the PIPE consist solely of securities exercisable for or convertible into Common Stock, the lowest of the exercise price or conversion price of such securities.  For this purpose, the exercise or conversion price of any security shall be the exercise or conversion price on as of the date sold in the PIPE, not as the same may be adjusted thereafter pursuant to the terms thereof.

 

“Event of Default” shall have the meaning specified in Section 5.1.

 

“Holders” shall mean the Holder and all other holders of the Notes.

 

“Majority Holders” at any date shall mean the Holders of more than 50% of the principal amount of the Notes outstanding at such date.

 

“Payment Date” shall mean the date on which occurs the later of the closing of the PIPE and the closing of the Target Acquisition.

 

“Payment Price” shall mean an amount equal to 33.3% of the Common Stock Price with respect to the PIPE.

 

“Payment Shares” shall mean that portion of the Shares that the Company delivers to Holder to pay this Note pursuant to Section 3.

 

“Person” shall mean individual, partnership, corporation, trust, association or other entity.

 

“PIPE” shall mean the issuance and sale by TRIG of equity securities at or around the time of the closing of the Grilled Cheese Truck, Inc. Alternative Public Offering private placement.

 

“Pubco” shall mean TRIG Acquisition 1, Inc. a Nevada SEC reporting OTC Bulletin Board company.

 

  

2

  

 

3.             Payment with Payment Shares Prior to the Maturity Date

 

3.1         Payment of Note with Payment Shares.  If the Payment Date occurs prior to the Maturity Date, the Company shall pay this Note by delivering the Payment Shares to the Holder as provided in this Section 3.

 

3.2         Payment Date.  As promptly as practicable following the Payment Date, the Company shall give to the Holder written notice (the “Payment Notice”) setting forth: (a) the Payment Date; (b) the number of Payment Shares and the calculation of the number of Payment Shares; and (c) a copy of the investment letter or other information required by Pubco to permit the transfer of the Payment Shares from the Company to the Holder.  Interest shall cease to accrue on this Note as of the Payment Date.

 

3.3         Payment Shares.  The number of Payment Shares shall be an amount equal to the principal amount of this Note plus accrued and unpaid interest on this Note through the Payment Date, divided by the Purchase Price, rounded up to the nearest whole share.

 

3.4         Delivery of Payment Shares.  As promptly as possible after delivery of the Payment Notice, the Company shall transfer the Payment Shares to the Holder against delivery to the Company of: (a) this Note, which shall be marked “Cancelled”; (b) the investment letter required by TRIG; and (c) a signed UCC-1 Termination Statement.

 

3.5         Legend on Certificates.  Each certificate evidencing the Payment Shares will contain the legend required by Pubco relating to the fact that the Payment Shares will by “restricted securities” under the Securities Act.

 

4.             Grant of Security Interest

 

1.1         Grant of Security Interest.  Effective upon its acquisition of the Shares, the Company hereby grants to the Holders a first priority security interest in the Shares to secure timely payment and performance of its obligations under this Note.

 

1.2         Filing UCC.  Within 10 days of the closing, the Company shall file a Form UCC-1 to perfect the Holders’ security interest in the Shares.

 

1.3         Voting; Dividends.  The Company shall retain all voting and dividend rights with respect to the Shares unless and until an Event of Default occurs and for so long as such Event of Default is continuing.

 

1.4         Termination of Security Interest.  Upon the Payment Date, the security interest in the Shares shall terminate, and the Company may file a UCC-1 termination statement.  The Holder acknowledges that the Payment Shares delivered to the Holders shall be free and clear of Holder’s security interest in the Shares.  Holder agrees to execute such documents as may be requested by the Company to evidence the termination of the Holder’s security interest in the Shares, including a UCC-1 Termination Statement.

 

5.             Events of Default and Remedies

 

5.1         Events of Default.  Each of the following shall constitute an “Event of Default”:

 

  

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5.1.1         The failure of the Company to pay interest within 30 days following the delivery to the Company of written notice of default signed by the Majority based on the failure of the Company to pay interest when due;

 

5.1.2         Unless the Payment Date shall have occurred, the failure of the Company to pay the principal amount and accrued and unpaid interest on the Maturity Date;

 

5.1.3         The Company payment of any distribution by the Company to its members;

 

5.1.4         The material default by the Company under any of its material covenants or representations under the Note Purchase Agreement, which default is not cured within 30 days after receipt of written notice of such default delivered to the Company by the Majority Holders;

 

5.1.5         A decree, judgment, or order by a court of competent jurisdiction shall have been entered adjudging the Company as bankrupt or insolvent, or approving as properly filed a petition seeking reorganization of the Company under any bankruptcy or similar law, and such decree of order shall have continued undischarged and unstayed for a period of 90 days; or a decree or order of a court of competent jurisdiction ordering the appointment of a receiver, liquidator, trustee, or assignee in bankruptcy or insolvency of the Company, or for the winding up or liquidation of the affairs of the Company, shall have been entered, and such decree, judgment, or order shall have remained in force undischarged and unstayed for a period of 60 days;

 

5.1.6         The Company shall institute proceedings to be adjudicated a voluntary bankrupt, or shall consent to the filing of a bankruptcy proceeding against it, or shall file a petition or answer or consent seeking reorganization under any bankruptcy or similar law or similar statute, or shall consent to the filing of any such petition, or shall consent to the appointment of a custodian, receiver, liquidator, trustee, or assignee in bankruptcy or insolvency of it or any of its assets or property, or shall make a general assignment for the benefit of creditors, or shall admit in writing its inability to pay its debts generally as they become due.

 

5.2         Acceleration of Maturity Date.  If an Event of Default (other than an Event of Default specified in Section 5.1.5 or Section 5.1.6) occurs and is continuing, then, and in every such case, unless the principal of this Note shall have already become due and payable, the Majority Holders by written notice to the Company (an “Acceleration Notice”), may declare all of the principal of the Note, together with accrued interest thereon, to be due and payable immediately.  If an Event of Default specified in Section 5.1.5 or Section 5.1.6 occurs, all principal of and accrued interest on this Note ipso facto shall become and be immediately due and payable without any declaration or other act on the part of the Holder.

 

5.3         Foreclosure on Share.  If an Event of Default occurs and is continuing, the Holders may, by Majority Vote, assert all rights and remedies of a secured party under the Nevada Uniform Commercial Code or other applicable law, including, without limitation, the right to take possession of, hold, collect, sell, lease, deliver, grant options to purchase or otherwise retain, liquidate or dispose of all or any portion of the Shares.  If notice prior to disposition of the Shares or any portion thereof is necessary under applicable law, written notice mailed to the Company at least ten days prior to the date of such disposition shall constitute reasonable notice, but notice given in any other reasonable manner shall be sufficient.  So long as the sale of the Shares is made in a commercially reasonable manner and in compliance with applicable securities laws, the Holders may sell such Shares on such terms and to such purchaser(s) as the Secured Party in its absolute discretion may choose, without assuming any credit risk and without any obligation to advertise or give notice of any kind other than that necessary under applicable law.  The proceeds of any sale of the Shares shall be distributed among the Holders as set forth in the Nevada Uniform Commercial Code.  Without precluding any other methods of sale, the sale of the Collateral or any portion thereof shall have been made in a commercially reasonable manner if conducted in conformity with reasonable commercial practices of creditors disposing of similar property.  The Company hereby waives and releases to the fullest extent permitted by law any right or equity of redemption with respect to the Shares, whether before or after sale hereunder, and all rights, if any, of marshalling the Shares and any other security for the secured obligations or otherwise.  At any such sale, unless prohibited by applicable law, any Holder may bid for and purchase all or any part of the Shares so sold free from any such right or equity of redemption.  The Holders shall not be liable for failure to collect or realize upon any or all of the Collateral or for any delay in so doing, nor shall it be under any obligation to take any action whatsoever with regard thereto.

 

  

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5.4         Waiver.  No delay or omission by the Holders to exercise any right or remedy arising upon any Event of Default shall impair the exercise of any such right or remedy or constitute a waiver of any such Event of Default.  Every right and remedy given by this Section 5 or by law to the Holder may be exercised from time to time, and as often as may be deemed expedient, by the Holder.  No provision of this Note may be waived unless in writing signed by Holder, and waiver of any one provision of this Agreement shall not be deemed to be a waiver of any other provision.

 

6.             Transfer and Exchange.

 

When this Note is presented to the Company with a request to register the transfer of this Note or to exchange such Note for an equal principal amount of Notes of other authorized denominations (and assuming such transfer is in compliance with the Note Purchase Agreement), the Company shall register the transfer or make the exchange as requested if its reasonable requirements for such transaction are met; provided, however, that this Note surrendered for transfer or exchange shall be duly endorsed or accompanied by a written instrument of transfer in form reasonably satisfactory to the Company, duly executed by the Holder thereof or his attorney duly authorized in writing.  No service charge shall be made for any registration of transfer or exchange, but the Company may require payment of a sum sufficient to cover any transfer tax, assessments, or similar governmental charge payable in connection therewith.

 

7.             Replacement Note.

 

If a mutilated Note is surrendered to the Company or if the Holder claims and submits an affidavit or other evidence, satisfactory to the Company, to the Company to the effect that this Note has been lost, destroyed or wrongfully taken, the Company shall issue a replacement Note if the Company’s reasonable requirements are met, including, if required by the Company, provision by the Holder of an indemnity bond or other indemnity, sufficient in the judgment of the Company, to protect the Company from any loss which any of them may suffer if the Note is replaced.

 

8.             Miscellaneous

 

8.1         Successors.  The terms and conditions of this Note shall be binding upon and inure to the benefit of the parties to this Note and their respective successors, heirs and personal representatives.

 

  

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8.2         Governing Law.  This Note shall be construed in accordance with the laws of the State of Nevada without giving effect to the principles of conflicts of law thereof.

 

8.3         Captions.  The various captions of this Note are for reference only and shall not be considered or referred to in resolving questions of interpretation of this Note.

 

8.4         Notices.  All notices, requests, demands and other communications (collectively, “Notices”) given pursuant to this Agreement shall be in writing, and shall be delivered by personal service, courier, facsimile transmission, email transmission of a pdf format data file or by United States first class, registered or certified mail, postage prepaid, addressed to the Company at its principal executive offices or the Holder at its address as set forth on the books and records of the Company.  Any Notice, other than a Notice sent by registered or certified mail, shall be effective when received; a Notice sent by registered or certified mail, postage prepaid return receipt requested, shall be effective on the earlier of when received or the third day following deposit in the United States mails.  Any party may from time to time change its address for further Notices hereunder by giving notice to the other party in the manner prescribed in this Section.

 

8.5         Amendment.  The Notes may be amended with the consent of the Company and the consent or approval of the Majority Holders, provided that no such amendment shall reduce the interest rate or extend the Maturity Date without the consent or approval of the Holder.  In the event of such an amendment, at the request of the Company, the Holder shall tender back to the Company its Note and the Company shall substitute a replacement Note reflecting such amendment(s).

 

8.6         Severability.  Whenever possible each provision of this Note shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Note shall be or become prohibited or invalid under applicable law, such provision shall be ineffective to the extent of such prohibition or invalidity without invalidating the remainder of such provision or the remaining provisions of this Note.

 

8.7         Attorneys’ Fees.  If any action or proceeding is brought to enforce or interpret any provision of this Agreement, the prevailing party shall be entitled to recover reasonable attorneys’ fees to be fixed by the court.

 

8.8         Solely Obligations of Company.  The Holder acknowledges and agrees that the obligations of the Company under this Note are obligations solely of the Company, and are not obligations of any member, manager or officer of the Company.

 

IN WITNESS WHEREOF, the Company has caused this Note to be dated, executed and issued on its behalf by its officers thereto duly authorized.

 

	 	
TRIG Acquisition 1, Inc.

	 
	 	 	 
	 	By:	 	 
	 	A. J. Cervantes, Chief Executive Officer	 

 

 

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