Exhibit 10.1

 

CONFIDENTIAL TREATMENT REQUESTED

 

INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND
NOTED WITH “****”. AN UNREDACTED VERSION OF THIS DOCUMENT HAS ALSO BEEN PROVIDED
TO THE SECURITIES AND EXCHANGE COMMISSION.

 

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October 14, 2011

 

Mallinckrodt LLC

675 McDonnell Blvd

Hazelwood, MO 63042

Attn: CFO and Interim President

 

Re: Amendment No. 2 to Manufacturing and Supply Agreement

 

Ladies and Gentlemen:

 

Reference is made to a Manufacturing and Supply Agreement dated as of April 6,
2009 (the “Agreement”) between Mallinckrodt Inc. and Lantheus Medical
Imaging, Inc and Amended as of August 2, 2010 (“Amendment No. 1”). Terms defined
in the Agreement and not otherwise defined herein are used herein with the
meanings so defined.

 

Effective June 23, 2011, Mallinckrodt Inc. converted from a Delaware corporation
to a Delaware limited liability company named Mallinckrodt LLC.  The conversion
was made in accordance with Section 18-244 of the Delaware Limited Liability Act
and Section 266 of the Delaware General Corporation Law, which provide that the
converted entity retains all of the assets and rights of, and is subject to all
the debts and other liabilities of, the pre-conversion entity.  As a result of
the foregoing, references herein and in the Agreement and Amendment No. 1 to
Mallinckrodt (or any defined term herein or therein having such meaning) shall
be understood to refer to Mallinckrodt LLC.

 

The Parties recognize and agree that the demand for Product is different from
that initially contemplated by the Parties when the Agreement was first
negotiated and consummated and when Amendment No. 1 was executed.  Nevertheless,
COV shall be under no obligation to agree to any future reduction(s) in LMI’s
obligation to purchase Drug Substance, Product or Inventory under the Agreement,
as previously and hereby amended, regardless of whether demand for Product is
consistent with or different from that which is currently contemplated by LMI.

 

IN CONSIDERATION of the mutual promises and covenants hereinafter set forth, and
for other good and valuable consideration, the sufficiency of which is hereby
acknowledged, the Parties hereby agree to enter into this Amendment No. 2 to the
Agreement  (the “Amendment No. 2”) as follows:

 

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1.     Amendments.

 

1.1.    Section 2.2, the preamble to Section 2.4, Sections 2.4(a), (b), (c),
(d)(i), (e), and (f), and Exhibit 2.4 of the Agreement, as amended by Amendment
No. 1, are hereby amended by deleting them in their entirety.

 

1.2.    (a)          The preamble to Section 2.4 is hereby amended to be
restated as follows: “COV will manufacture and supply Drug Substance, Product
and certain Inventory (as hereinafter defined) to LMI, and LMI will purchase
Drug Substance, Product and certain Inventory, in accordance with Sections 1.4,
1.5, 1.6 and 1.8 of this Amendment No. 2.”

 

(b)           Section 2.4(a) is hereby amended to be restated as follows:

 

“(a)         Orders.  Concurrent with the execution of this Amendment No. 2 with
respect to the Revised Shipments (as such term is defined below) scheduled for
purchase by LMI on ****, and (ii) not later than **** (****) days before any
other Revised Shipments provided for in this Second Amendment, LMI will furnish
COV with purchase orders for the volume of Drug Substance, Product or Inventory
specified in this Second Amendment.”

 

1.3.    Notwithstanding anything to the contrary in the Agreement, Sections
2.5(a) and 2.6(a) of the Agreement shall not be applicable to and shall be
considered deleted with respect to, the purchases and shipments described and
set forth in Sections 1.4, 1.5 and 1.6 of this Amendment No. 2 (such shipments,
the “Revised Shipments”). With respect to the Revised Shipments, COV agrees to
cause the Revised Shipments to be made on the applicable date specified in
Sections 1.4, 1.5 and 1.6 of this Amendment No. 2, and LMI hereby agrees to
remit payment for the Revised Shipments within **** (****) days after the date
of receipt of such Drug Substance, Product or Inventory, as the case may be,
comprising such Revised Shipment. In no event shall LMI be responsible for any
payments related to Drug Substance, Product and Inventory, as applicable, for
which COV was unable to satisfy its obligations under the Agreement, whether by
Force Majeure Event or otherwise.  In the event LMI notifies COV that it is
refusing or delaying shipment of any Revised Shipment, COV may invoice LMI for
the full purchase price of the refused or delayed shipment and payment by LMI
shall be due in full within **** (****) days after receipt of the invoice (but
not earlier than **** (****) days after the originally scheduled shipment date).
Payments by LMI shall be made in U.S. dollars by wire transfer to COV’s
designated account.

 

1.4.    COV agrees to manufacture and supply, and LMI agrees to purchase, ****
(****) shipments of Drug Substance as follows: (i) **** Kilograms (**** kg) for
the amount of **** Dollars ($****) on ****; and (ii) **** Kilograms (**** kg)
for the amount of **** ($****) on ****.  For purposes of clarity, all

 

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references in this Second Amendment to kilograms of Drug Substance are to
volumes of Drug Substance that have been corrected for assay and water content.

 

1.5.    COV agrees to process Drug Substance and Ligand Excipient provided by
LMI, and LMI agrees to purchase **** shipments of Product as follows:

 

1.5.1.       approximately **** Kilograms (**** kg) of Drug Substance and the
required corresponding amount of Ligand Excipient processed into approximately
**** (****) **** ml vials (+/- ****%) by ****, for the amount of **** Dollars
($****) ;

 

1.5.2.       approximately **** Kilograms (**** kg) of Drug Substance and the
required corresponding amount of Ligand Excipient processed into approximately
**** (****) **** ml vials (+/- ****%) by ****, for the amount of **** Dollars
($****); and

 

1.5.3.       approximately **** Kilograms (**** kg) of Drug Substance and the
required corresponding amount of Ligand Excipient processed into approximately
**** (****) **** ml vials (+/- ****%) by ****, for the amount of **** Dollars
($****).

 

LMI shall bear responsibility for assuring that all Drug Substance and Ligand
Excipient provided to COV pursuant to this Section 1.5 meet all applicable
Specifications as of the scheduled processing date.

 

1.6.    LMI hereby agrees to purchase Inventory by **** in accordance with the
schedule attached hereto as Exhibit A-1, and to purchase additional Inventory by
**** (the “**** Inventory Purchase”) in accordance with the schedule attached
hereto as Exhibit A-2.  As used herein, “Inventory” shall mean raw materials,
intermediates, finished goods and the like relating to ABLAVAR®.

 

1.7.    In reference to Section 2.7 of the Agreement, the Parties agree to
commence the Technology transfer referred to in such Section 2.7 on **** and to
complete the Technology transfer as soon as reasonably practicable, but in no
event later than ****. COV hereby acknowledges that this Section 1.7 of
Amendment No. 2 constitutes the Technology Transfer Notice referred to in
Section 2.7 of the Agreement.  COV will use commercially reasonable efforts to
(A) provide the deliverables for such Technology transfer as set forth on the
schedule attached hereto as Exhibit B and (B) use commercially reasonable
efforts to complete such Technology transfer as provided hereby and in
accordance with Section 2.7 of the Agreement by no later than ****.

 

1.8.    COV hereby agrees to make commercially reasonable efforts to process and
supply Product to LMI in addition to those purchases set forth under Section 1.5
of this Amendment No. 2 on an as-needed basis through **** upon **** (****)

 

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months prior written notice from LMI. The parties shall negotiate the terms of
any such processing and supply of Product by COV in good faith with such terms
to include, without limitation, pricing, minimum volumes, and ongoing charges
for the required stability program.  LMI shall provide Drug Substance and Ligand
Excipient for processing and supply of the Product.  LMI shall bear
responsibility for assuring that all Drug Substance and Ligand Excipient
provided to COV pursuant to this Section 1.8 meets all applicable
Specifications.  LMI will also bear responsibility and cost for acquiring and
validating any new analytical columns required in connection with any Product
processed and supplied by COV under this Section 1.8

 

1.9.    Section 3.1 of the Agreement is hereby amended to delete the term
“September 30, 2012” in the third line and replace it with “September 30, 2014.”

 

1.10.          For purposes of Section 3.3(d) of the Agreement, as hereby
amended, the term Minimum Volume shall mean the purchase obligations of LMI
associated with the Revised Shipments.

 

2.     Effective Date. The effective date of this Amendment No. 2 is October 14,
2011.

 

3.     Waiver and Release. Each party hereby waives and forever releases the
other party for any and all claims relating to any past non-compliance with the
terms and provisions of the Agreement (including Amendment No. 1) as in effect
immediately prior to the amendments contemplated by this Amendment No. 2.  
Nothing herein shall be considered a waiver by either party of any claims
relating to any non-compliance by the other party with the terms and provisions
of this Second Amendment.

 

4.     General. Except as specifically amended hereby, the Agreement remains in
full force and effect and otherwise unamended hereby, and, as used in the
Agreement, the terms “Agreement,” “herein,” “hereunder,” “hereto,” “hereof,” and
words of similar impact shall, unless the context otherwise requires, refer to
the Agreement as modified and amended by this Amendment No. 2. This Amendment
No. 2 constitutes a final written expression of the terms hereof and is a
complete and exclusive statement of those terms. This Amendment No. 2 shall be
exclusively interpreted in accordance with and governed by the laws of the State
of New York, without regards with the conflicts of laws rules thereof.

 

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If the foregoing is in accordance with your understanding of our agreement,
please sign this Amendment No. 2 in the place indicated below.

 

Thank you.

 

 

Sincerely,

 

LANTHEUS MEDICAL IMAGING, INC.

 

 

By:

/s/ Michael P. Duffy

 

 

Name and Title:

Michael P. Duffy

 

 

 

Vice President and Secretary

 

 

 

Acknowledged and agreed:

 

MALLINCKRODT LLC

 

 

 

 

 

By:

/s/ Matthew K. Harbaugh

 

 

Name and Title:

 

 

Matthew K. Harbaugh,

 

 

CFO and Interim President

 

 

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Exhibit A-1

Inventory Payment Schedule

 

No later than ****, LMI shall purchase from COV for total consideration of $****
the following inventory:

 

 

·

****:

*

***kgs (does not include “bag house” material)

 

·

****

****kgs

 

·

****

****kgs

 

·

****

****kgs

 

All quantities shall be +/- **** percent (****%) of the volume listed (which
will not affect the total consideration).  Such inventory shall be delivered to
LMI in accordance with Section 2.5(b) of the Agreement, subject to the
warranties, covenants and exclusions contained in Section 5 of the Agreement,
except that Section 5.6 shall not be applicable in connection therewith.

 

LMI will notify COV concurrent with the execution of this Second Amendment if it
would prefer that COV dispose of, instead of ship, any of the inventory
reflected on this Exhibit A-1.  In such event, COV will dispose of the inventory
at LMI’s cost.  LMI will remain obligated to pay COV the applicable purchase
price for any such inventory.

 

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Exhibit A-2

Inventory Payment Schedule

 

No later than ****, LMI shall purchase from COV for total consideration of
$****, the following inventory:

 

 

·

****

****kgs

 

·

****

****kgs

 

All quantities shall be +/- **** percent (****%) of the volume listed (which
will not affect the total consideration).  Such inventory shall be delivered to
LMI in accordance with Section 2.5(b) of the Agreement, subject to the
warranties, covenants and exclusions contained in Section 5 of the Agreement,
except that Section 5.6 shall not be applicable in connection therewith.

 

LMI will notify COV prior to **** if it would prefer that COV dispose of,
instead of ship, any of the inventory reflected on this Exhibit A-2.  In such
event, COV will dispose of the inventory at LMI’s cost.  LMI will remain
obligated to pay COV the applicable purchase price for any such inventory.

 

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Exhibit B

Technology Transfer Deliverables

 

1.     API and DP

 

****

 

2.     Analytical / Quality: Covidien will provide the following materials to
the extent reasonably available:

 

****

 

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