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%