Document:

alks-ex1011_41.htm

Exhibit 10.11

 

A complete version of this Exhibit has been filed separately with the Securities and Exchange Commission pursuant to an application requesting confidential treatment pursuant to Rule 24b-2 promulgated under the Securities Act of 1934, as amended. Certain confidential portions of this Exhibit were omitted and replaced with double asterisks ([**]).

 

SIXTH AMENDMENT TO THE MANUFACTURING AND SUPPLY AGREEMENT

 

This Sixth Amendment (the “Amendment”) is effective as of July 1, 2018 to the Manufacturing and Supply Agreement entered into as of August 6, 1997, as amended, by and between Janssen Phamaceutica International, a division of Cilag GmbH International, having a place of business in Gubelstrasse 34, 6300 Zug, Switzerland (“JPI”) and Janssen Pharmaceuticals, Inc. (formerly known as Janssen Pharmaceutica Inc.), a New Jersey corporation, having a place of business at 1125 Trenton-Harbourton Road, Titusville, NJ 08560 (“JANSSEN US”) (JPI and JANSSEN US collectively referred to herein as “JANSSEN”) on the one hand, and Alkermes, Inc. (as successor in interest to Alkermes Controlled Therapeutics Inc. II), a Pennsylvania corporation, having a place of business at 852 Winter St., Waltham, MA 02451 (“ACT II”) on the other hand (the “Agreement”).

 

All capitalized terms used herein shall have the meaning set forth in the Agreement, as applicable, unless clearly indicated otherwise. 

 

RECITALS:

 

WHEREAS, ACT II and JANSSEN have entered into the Agreement; and

 

WHEREAS, ACT II and JANSSEN now wish to amend the Agreement to extend the term of the Agreement.

 

NOW, THEREFORE, in consideration of the mutual promises contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledges, the parties, intending to be legally bound hereby, agree as follows:

 

	
1. 
	
Article 2.11 shall be deleted in its entirety and replaced with new Article 2.11 as follows: 

 

	
“2.11
	
The parties hereto agree that during the term of this Agreement, JANSSEN will order and purchase a minimum number of Product during any given calendar year starting on the first commercial launch of the Final Product (the year of first commercial launch to be calculated on a pro rata basis).  Such minimum numbers are expressed in kilograms of bulk Product (excluding for this purpose the vials) and are set forth in Exhibit C attached hereto. In the event that JANSSEN does not achieve the applicable minimum quantity of the Product to be Manufactured during a given calendar year, the parties hereto will in good faith renegotiate an adjusted Manufacturing Fee, duly considering the effect of the shortfall. In the event that the parties agree to an adjusted Manufacturing Fee, the parties will amend Exhibit D to reflect the new fee schedule and amend this Article 2.11 to delete the paragraph immediately below. In the event the parties cannot agree an adjusted Manufacturing Fee, ACT II will be entitled to terminate this Agreement upon giving a one year prior notice. ACT II shall provide such commercially reasonable assistance and other information in order for JANSSEN to manufacture or have manufactured the Product after such one year notice period. 

 

In the event that (i) JANSSEN does not achieve the applicable minimum quantity of the Product during any given calendar year in accordance with the paragraph immediately above, (ii) the parties cannot agree to an adjusted Manufacturing Fee, and (iii) this Agreement has not been terminated by ACT II pursuant to this Article 2.11, then ACT II shall continue to supply, and JANSSEN shall continue to purchase, Product in accordance with the terms of this Agreement until the first to occur of (a) the parties agree on an adjusted Manufacturing Fee in accordance with the paragraph immediately above, (b) either party terminates this Agreement in accordance with such party’s rights hereunder, or (c) expiry of this Agreement under Article 10.1. For clarity, nothing in this last paragraph of this Article 2.11 shall limit ACT II’s right to terminate this Agreement in accordance with the first paragraph of this Article 2.11.”  

 

 

 

	
2. 
	
Article 10.1 shall be deleted in its entirety and replaced with new Article 10.1 as follows:

 

	
“10.1
	
The term of this Agreement shall continue until [**], unless sooner terminated as provided hereafter.”

 

	
3. 
	
Article 12.10 shall be deleted in its entirety and replaced with new Article 12.10 as follows:

 

“12.10Any notice required or permitted to be given under this Agreement shall be mailed by registered or certified air mail, postage prepaid, addressed to the party to be notified at its address stated below, or at such other address as may hereafter be furnished in writing to the notifying party or by telefax to the numbers set forth below or to such changes telefax numbers as may thereafter be furnished.

 

If to ACT II:

 

		
	
Alkermes, Inc.
	
 

	
852 Winter Street
	
 

	
Waltham, MA 02451
	
 

	
U.S.A.
	
 

	
Telefax: 781-609-5856
	
 

	
Attention: Chief Legal Officer
	
 

 

If to JANSSEN:

 

		
	
JPI PHARMACEUTICA INTERNATIONAL, a division of Cilag GmbH International
	
 

	
Gubelstrasse 34, 6300 
	
 

	
Zug, Switzerland
	
 

	
Telefax: +41 58 231 50 51
	
 

	
Attention: General Manager
	
 

	
 
	
 

	
and
	
 

	
 
	
 

	
JANSSEN PHARMACEUTICALS, INC.
	
 

	
One Johnson & Johnson Plaza
	
 

	
New Brunswick, NJ 08901
	
 

	
U.S.A.
	
 

	
Telefax: 732-524-6377
	
 

	
Attention: Vice President, Business Development, Neuroscience
	
 

	
 
	
 

	
With a copy to:
	
 

	
 
	
 

	
Johnson & Johnson
	
 

	
One Johnson & Johnson Plaza
	
 

	
New Brunswick, NJ 08901
	
 

	
U.S.A.
	
 

	
Telefax: 732-524-2138
	
 

	
Attn:  Chief Intellectual Property Counsel
	
 

 

Any such notice shall be deemed to have been received when it has been delivered in the ordinary course of post or received by telefax.”

 

2

 

 

	
4. 
	
Exhibit D to the Agreement shall be deleted in its entirety and replaced with new Exhibit D attached hereto.

 

	
5. 
	
Governing Law. This Amendment will be governed by and construed in accordance with the laws of the State of New York without regard to its conflict of law provisions.

 

	
6. 
	
Integration. Except as expressly provided in this Amendment, all other terms, conditions and provisions of the Agreement will continue in full force and effect as provided therein. This Amendment and the Agreement constitute the entire agreement between the parties hereto relating to the subject matter hereof and thereof and supersede all prior and contemporaneous negotiations, agreements, representations, understandings and commitments with respect thereto. In the event of a conflict between the terms and conditions of the Agreement and the terms and conditions of this Amendment, the terms and conditions of this Amendment shall control.

 

[Signature page follows]

 

 

3

 

 

IN WITNESS WHEREOF, JPI, Janssen US and ACT II have executed and delivered this Amendment effective as of the date of the last signature below.

 

					
	
JPI PHARMACEUTICA INTERNATIONAL 

a division of 

CILAG GmbH INTERNATIONAL
	
 
	
ALKERMES, INC.

	
 
	
 
	
 

	
By:
	
/s/ Andrea Ostinelli
	
 
	
By:
	
/s/ James M. Frates

	
 
	
 
	
 
	
 
	
 

	
Name:
	
Andrea Ostinelli
	
 
	
Name:
	
James M. Frates

	
 
	
 
	
 
	
 
	
 

	
Title:
	
Senior Finance Director
	
 
	
Title:
	
CFO

	
 
	
 
	
 
	
 
	
 

	
Date:
	
27 June 2018
	
 
	
Date:
	
9/24/18

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
By:
	
/s/ Martin Hochstrasser   
	
 
	
By:
	
/s/ Michael Landine

	
 
	
 
	
 
	
 
	
 

	
Name:
	
Martin Hochstrasser, Ph D.   
	
 
	
Name:
	
Michael Landine

	
 
	
 
	
 
	
 
	
 

	
Title:
	
Senior Director, Strategic Business
	
 
	
Title:
	
Senior Vice President

	
 
	
Support, Cilag GmbH International 
	
 
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
Date:
	
27 June 2018
	
 
	
 
	
 

 

 

				
	
JANSSEN PHARMACEUTICALS INC.
	
 
	
 

	
 
	
 
	
 

	
By:
	
/s/ Courtney Billington
	
 
	
 

	
 
	
 
	
 
	
 

	
Name:
	
Courtney Billington
	
 
	
 

	
 
	
 
	
 
	
 

	
Title:
	
President Neuroscience 
	
 
	
 

	
 
	
 
	
 
	
 

	
Date:
	
6/24/2018
	
 
	
 

 

 

 

 

Exhibit D

 

Manufacturing Fee

 

	
Amount purchased

(vials)
	
 
	
% of

Licensed

Net Selling Price
	
 
	
Amount purchased

(vials)
	
 
	
% of Licensed

Net Selling

Price

	
From
	
    
	
To
	
    
	
 
	
 
	
From
	
    
	
To
	
    
	
 

	
0
	
 
	
399,999
	
 
	
24.5%
	
 
	
2,100,000
	
 
	
2,199,999
	
 
	
8.8%

	
400,000
	
 
	
499,999
	
 
	
19.5%
	
 
	
2,200,000
	
 
	
2,299,999
	
 
	
8.6%

	
500,000
	
 
	
599,999
	
 
	
16.5%
	
 
	
2,300,000
	
 
	
2,399,999
	
 
	
8.5%

	
600,000
	
 
	
699,999
	
 
	
14.0%
	
 
	
2,400,000
	
 
	
2,499,999
	
 
	
8.3%

	
700,000
	
 
	
799,999
	
 
	
12.3%
	
 
	
2,500,000
	
 
	
2,599,999
	
 
	
8.2%

	
800,000
	
 
	
899,999
	
 
	
12.0%
	
 
	
2,600,000
	
 
	
2,699,999
	
 
	
8.1%

	
900,000
	
 
	
999,999
	
 
	
11.7%
	
 
	
2,700,000
	
 
	
2,799,999
	
 
	
8.0%

	
1,000,000
	
 
	
1,099,999
	
 
	
11.4%
	
 
	
2,800,000
	
 
	
2,899,999
	
 
	
7.9%

	
1,100,000
	
 
	
1,199,999
	
 
	
11.0%
	
 
	
2,900,000
	
 
	
2,999,999
	
 
	
7.8%

	
1,200,000
	
 
	
1,299,999
	
 
	
10.7%
	
 
	
3,000,000
	
 
	
3,099,999
	
 
	
7.8%

	
1,300,000
	
 
	
1,399,999
	
 
	
10.4%
	
 
	
3,100,000
	
 
	
3,199,999
	
 
	
7.7%

	
1,400,000
	
 
	
1,499,999
	
 
	
10.1%
	
 
	
3,200,000
	
 
	
3,299,999
	
 
	
7.7%

	
1,500,000
	
 
	
1,599,999
	
 
	
9.8%
	
 
	
3,300,000
	
 
	
3,399,999
	
 
	
7.6%

	
1,600,000
	
 
	
1,699,999
	
 
	
9.7%
	
 
	
3,400,000
	
 
	
3,499,999
	
 
	
7.6%

	
1,700,000
	
 
	
1,799,999
	
 
	
9.5%
	
 
	
3,500,000
	
 
	
3,599,999
	
 
	
7.5%

	
1,800,000
	
 
	
1,899,999
	
 
	
9.3%
	
 
	
3,600,000
	
 
	
3,699,999
	
 
	
7.5%

	
1,900,000
	
 
	
1,999,999
	
 
	
9.2%
	
 
	
3,700,000
	
 
	
3,799,999
	
 
	
7.5%

	
2,000,000
	
 
	
2,099,999
	
 
	
9.0%
	
 
	
3,800,000
	
 
	
3,899,999
	
 
	
7.5%

	
 
	
 
	
 
	
 
	
 
	
 
	
3,900,000
	
 
	
4,000,000
	
 
	
7.5%alks-ex1012_100.htm

Exhibit 10.12

 

A complete version of this Exhibit has been filed separately with the Securities and Exchange Commission pursuant to an application requesting confidential treatment pursuant to Rule 24b-2 promulgated under the Securities Act of 1934, as amended. Certain confidential portions of this Exhibit were omitted and replaced with double asterisks ([**]).

 

FIRST AMENDMENT TO THE LICENSE AND COLLABORATION AGREEMENT BETWEEN ALKERMES PHARMA IRELAND LIMITED AND BIOGEN SWISS MANUFACTURING GMBH

 

WHEREAS, the parties desire to amend the License and Collaboration Agreement dated November 27, 2017 between Alkermes Pharma Ireland Limited and Biogen Swiss Manufacturing GMBH (the “Agreement”) such that GI Inferiority for Part B of the GI Tolerability Clinical Trial shall be revised in consideration for a commitment from Alkermes around the expenditure of efforts to make available topline data from said Trial as soon as reasonably practicable.

 

Now, therefore, the Parties agree to amend the Agreement, effective October 3, 2018 (the “Effective Date”), as follows:

 

	
 
	
1) 
	
Sections 1.1.47 and 1.1.48 of the Agreement shall be stricken in their entirety and replaced with the following (with that text that is new to the definitions underlined):

 

1.1.47. “GI Inferiority” will be deemed to exist if (i) the [**] of patients not previously enrolled in the GI Tolerability Clinical Trial or otherwise exposed to a fumarate that discontinue participation in the Long-Term Safety Clinical Trial due to a GI Event is greater than [**]; or if both of the following in (ii) and (iii) occur: (ii) the percentage of patients who discontinue participation in the ALKS 8700 arm of Part B of the GI Tolerability Clinical Trial due to a GI Event is greater than the percentage of patients who discontinue participation in the Tecfidera® arm of Part B of the GI Tolerability Clinical Trial due to a GI Event, in all cases as set forth in the Complete GI Tolerability Data Package, provided that, if the rate of discontinuations due to a GI Event in Part A of the GI Tolerability Clinical Trial is lower in the Tecfidera® arm of such trial and the Parties jointly agree in writing not to conduct Part B of the GI Tolerability Clinical Trial, then GI Inferiority will be deemed to exist; and (iii) Part B of the GI Tolerability Clinical Trial demonstrates the Tecfidera® arm as [**] to the ALKS 8700 arm [**] on the primary endpoint, which is defined as [**]. For clarity, unless subsections (ii) and (iii) above are both met, GI Inferiority will not be deemed to exist.  If the Parties jointly agree in writing not to conduct Part B of the GI Tolerability Clinical Trial for reasons other than because the rate of discontinuations due to a GI Event in Part A of the GI Tolerability Clinical Trial is lower in the Tecfidera® arm of such trial, then, unless the Parties agree otherwise in writing, GI Inferiority will not be deemed to exist.

 

1.1.48. “GI Tolerability Clinical Trial” means the Clinical Study Protocol ALK8700-A302 Amendment 2.0, as such may be further amended from time to time.

 

	
 
	
2) 
	
Section 3.2, Development Responsibilities and Rights, is amended by adding the following paragraph at the end of Section 3.2.1:

 

In addition, Alkermes agrees that it shall use best efforts to make available to Biogen an abstract and the supporting Topline Data report (consisting of the tables and graphs for the data supporting the abstract)  based upon the Topline Data (as defined below) from Part B of the GI Tolerability Clinical Trial no later than [**] with said abstract to be of the caliber that meets industry standard.  For purposes of this Section 3.2.1, “Topline Data” shall mean the results of the primary and pre-specified secondary analyses and all key safety information available as of the date of such primary and pre-specified secondary analyses (consisting, at a minimum, of baseline demographics, subject disposition, adverse events, serious adverse events, and discontinuations) for Part B of the GI Tolerability Clinical Trial. 

 

 

 

	
 
	
3) 
	
Section 3.8.1, Development Costs Incurred by Alkermes, is amended by adding the following at the end of Section 3.8.1:

 

[**]

 

	
 
	
4) 
	
Pursuant to, and in satisfaction of, the authority delegated to the Parties’ respective JSC members under Section 2.1.2 of the Agreement, Alkermes and Biogen hereby approve an increase in the Initial Development Plan budget of [**] U.S. Dollars (US$[**]).

 

	
 
	
5) 
	
Reference in this Amendment to terms written in upper case in shall have the meaning as set out in the Agreement.

 

	
 
	
6) 
	
In all other respects, the Agreement shall remain in full force and effect.

[Signature page follows]

2

 

Whereas, each of the Parties has caused this First Amendment to be executed and delivered by its duly authorized representatives to be effective as of the Effective Date.

 

					
	
ALKERMES PHARMA IRELAND LIMITED
	
 
	
BIOGEN SWISS MANUFACTURING GMBH

	
 
	
 
	
 

	
By:
	
/s/ Shane Cooke
	
 
	
By:
	
/s/ Frederick Lawson

	
 
	
 
	
 
	
 
	
 

	
Name:
	
Shane Cooke
	
 
	
Name:
	
Frederick Lawson

	
 
	
 
	
 
	
 
	
 

	
Title:
	
Director
	
 
	
Title:
	
Senior Director

	
 
	
 
	
 
	
 
	
 

	
Date:
	
3 October 2018
	
 
	
Date:
	
4-10-2018

 

3

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