Form 8-K MOMENTA PHARMACEUTICALS For: Jun 17

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of report (Date of earliest event reported):  June 17, 2015

 

Momenta Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

(617) 491-9700

(Registrant’s telephone number,
including area code)

 

Not applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

Item 1.01                   Entry into a Material Definitive Agreement.

 

On June 17, 2015, Momenta Pharmaceuticals, Inc. (“Momenta”) and Sandoz AG and Sandoz Inc. (together “Sandoz”) entered into a letter agreement (the “Amendment”) amending the Collaboration and License Agreement, dated November 1, 2003, by and between Momenta and Sandoz (the “Agreement”) relating to, among other things, the development and commercialization of Enoxaparin Sodium Injection, a generic version of Lovenox®.  As amended, Sandoz’s obligation under the Agreement to pay Momenta a royalty on net sales of Enoxaparin Sodium Injection is replaced, effective as of April 1, 2015, with an obligation to pay 50% of contractually-defined profits on sales of Enoxaparin Sodium Injection.

 

The foregoing description of the Amendment does not purport to be a complete statement of the parties’ rights under the amended Agreement and is qualified in its entirety by reference to the full text of the Amendment, a copy of which is filed as an exhibit to this report and incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.		Description
10.1		Amendment, dated as of June 17, 2015, to the Collaboration and License Agreement dated November 1, 2003 by and among Sandoz AG, Sandoz Inc. and Momenta Pharmaceuticals, Inc.

 

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SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

	MOMENTA PHARMACEUTICALS, INC.
Date: June 19, 2015	By:	/s/ Richard P. Shea
		Richard P. Shea Chief Financial Officer (Principal Financial Officer)

 

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EXHIBIT INDEX

 

Exhibit No.		Description
10.1		Amendment, dated as of June 17, 2015, to the Collaboration and License Agreement dated November 1, 2003 by and among Sandoz AG, Sandoz Inc. and Momenta Pharmaceuticals, Inc.

 

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Exhibit 10.1

 

Amendment to the Collaboration Agreement

 

This Amendment (the “Amendment”) to the Collaboration Agreement (defined below) is entered into as of the Effective Date (defined below) by and between Sandoz  AG,  a company organized under the laws of Switzerland, with an  office  at  Lichtstraβe  35,  CH 4056, Basel, Switzerland, Sandoz Inc., a Colorado corporation with an office at 100 College Road West, Princeton, NJ 08540 (Sandoz AG and  Sandoz Inc.,  collectively the  “Sandoz Parties”) and Momenta Pharmaceuticals, Inc., a Delaware corporation with an office  at  675  West  Kendall Street, Cambridge, MA 02142 (“Momenta,” collectively with the Sandoz Parties, the “Parties”).

 

WHEREAS, the Sandoz Parties and Momenta are parties to that certain Collaboration and License Agreement, dated November 1, 2003, as amended and supplemented (the “Collaboration  Agreement”);

 

WHEREAS, the Parties desire to amend the Collaboration Agreement;

 

NOW THEREFORE, in consideration of the promises of each of the Parties to the other herein contained, it is mutually agreed as follows:

 

1.                                      Definitions. All capitalized terms used herein that are not otherwise defined in this Amendment shall have the meanings ascribed to them in the Collaboration Agreement.

 

2.                                      Effective Date. This Amendment shall be effective as of April 1, 2015 (the  “Effective Date”). For the avoidance of doubt, nothing herein shall affect the calculation of Profit Interest or royalties owed, or any adjustment to Profit Interest under Schedule 4.3, under the Collaboration Agreement for Post-Launch Quarters prior to the Effective Date of this Amendment.

 

3.                                      Delete Selling Expenses. Section 1.91 of the Collaboration Agreement is hereby deleted in its entirety.

 

4.                                      Profits. Section 1.79 of the Collaboration Agreement is hereby deleted in its entirety and replaced with the following:

 

“1.79.  “Profits.”  Profits  means  Net  Sales  less  Manufacturing  Costs  for  the Product sold (regardless of whether the Product is rejected, returned or recalled).”

 

5.                                      U.S. Profit Interest. Section 4.5 of the Collaboration Agreement is hereby deleted in its entirety and replaced with the following:

 

“4.5.                     U.S. Profit Interest.  For each Post-Launch Quarter during which Sandoz, its Affiliates or distributors is selling the Product in the U.S. Territory, Sandoz shall pay Momenta an amount computed by multiplying fifty percent (50%) times the Profits in the U.S. Territory during such Post-Launch Quarter (the “Profit Interest”), which shall be adjusted pursuant to Schedule 4.3.”

 

For avoidance of doubt, in calculating the Actual Momenta Economic Interest under Schedule 4.3 on or after the Effective Date of this Agreement,  Profits and royalties payable prior to April 1, 2015 shall be determined based on actual amounts paid or payable for the pre-April 1,2015 Post-Launch Quarter, without taking into account the effect of this Amendment, and Profits payable on or after April 1, 2015,

 

 

shall be determined after taking into account the effect of this Amendment.

 

6.                                      Section C(1)(a) of Schedule 4.3 to the Collaboration Agreement shall be deleted in its entirety and replaced with the following: “(a) fifty percent (50%) times.”

 

7.                                      Deletion of Obsolete Sections.

 

7.1.                            In Section 11.3(e) of the Collaboration Agreement, the following phrase shall be deleted in its entirety: “during the Post-NTPC Period, the Non-NTPC Period or the Aventis TPC Period.”

 

7.2.                            Sections 1.7, 4.6, 4.7, 4.8 and 4.9 of the Collaboration Agreement shall be deleted in their entirety.

 

7.3.                            The last two sentences of Section B(1) of Schedule 4.3 to the Collaboration Agreement (beginning “For example . . .”) shall be deleted in their entirety.

 

7.4.                            Section F of Schedule 4.3 to the Collaboration Agreement, and Figures 4.3(a) and 4.3(b) to the Collaboration Agreement shall be deleted in their entirety.

 

8.                                      Ratification of Terms. All other terms and conditions of the Collaboration Agreement not amended by this Amendment shall remain in full force and effect.

 

9.                                      Counterparts; Facsimile/PDF Signature.  This Amendment may be exexuted in any number of counterparts, each of which shall be an original, but all of which together shall constitute one instrument.  This Amendment may also be executed via facsimile or  PDF, which shall be deemed an original.  Such counterparts may be exchanged by facsimile or PDF (provided that each executed counterpart is transmitted in one complete transmission or electronic mail message). Where there is an exchange of executed counterparts by facsimile or PDF, each Party shall be bound by the Amendment notwithstanding that original copies of the Amendment may not be exchanged immediately. The Parties shall cooperate after execution of the Amendment and exchange by facsimile or PDF to ensure that each Party obtains an original executed copy of this Amendment with reasonable  promptness.

 

[signature page follows]

 

 

IN WITNESS WHEREOF, this Amendment is effective as of the Effective Date.

 

 

SANDOZ AG
By:	/s/ Andreas Eggmann		Date: June 12, 2015
	Name: Andreas Eggmann
	Title: Head Sandoz AG
By:	/s/ Claudio Zamuner		Date: June 12, 2015
	Name: Claudio Zamuner
	Title: Head Funds Flow Operations & IT Sandoz AG
SANDOZ INC.
By:	/s/ Peter Goldschmidt		Date: June 11, 2015
	Name: Peter Goldschmidt
	Title: President Head of North America
MOMENTA PHARMACEUTICALS, INC.
By:	/s/ Richard P. Shea		Date: June 17, 2015
	Name: Richard P. Shea
	Title: Chief Financial Officer