Document:

exv10w1

 

EXHIBIT 10.1

First Amendment to 

Drug Product Production and Clinical Supply Agreement

     This First Amendment (the “Amendment”) is entered into and effective as of June
25, 2007 (the “Amendment Date”) for the purpose of amending that certain Drug Product Production
and Clinical Supply Agreement dated August 15, 2006 (the “Agreement”) by and between Altus
Pharmaceuticals Inc., a Delaware corporation (“Altus”), and Althea Technologies,
Inc., a Delaware corporation (“Althea”). Capitalized terms used but not otherwise defined
herein shall have the meanings provided in the Agreement.

     Whereas, the Parties had not reached agreement on a final Schedule 1 pursuant to
Section 3.2 of the Agreement,

     Whereas, the Parties desire to resolve any differences and mutually agree to a
modified Schedule 1, along with related pricing and payment structure changes to reflect changes to
the expectations of the Parties and to facilitate the efficient completion of the Project Plan; and

     Now, Therefore, in consideration of the mutual covenants contained herein and other
good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties agree as follows:

1. Amendment and Restatement of Schedule 1. Schedule 1 to the Agreement is hereby amended and
restated to read in its entirety as set forth in Exhibit A to this Amendment (the “Restated
Schedule”). All references in Schedule 1 in the Agreement, shall, as of the Amendment Date, be
deemed to be references to the Restated Schedule. The Parties acknowledge that the Restated
Schedule includes all activities to be performed under the Agreement through production of the
[***] Batch. The Parties agree that performances of the activities set forth on the Restated
Schedule, and substantial compliance with the timelines by the Parties in the Restated Schedule are
[***] of the Parties under the Agreement, as amended by this Amendment. The Parties expect that the
[***] Batches to be produced pursuant to Section 4.1 of the Agreement will be completed no later
than [***], and Altus acknowledges that a [***] in such [***] will require one or more change
orders as described in paragraph 4 of this Amendment.

2. Work Performed As of the Amendment Date. The Parties agree that, notwithstanding any provision
of the Agreement or any other correspondence or communication between the Parties to the contrary,
the total amount due by Altus for all work performed by Althea pursuant to the Agreement (other
than the facilities modification payment of [***] previously paid by Altus to Althea and excluding
work pursuant to the change orders referred to in Section 4 below) up to and including the
Amendment Date is [***]. Of such amount, Althea acknowledges that it has already

1.

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED

SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT
UNDER RULE 24B-2 OF THE EXCHANGE ACT.

 

received [***] (consisting of all payments due to Althea and paid by Altus within [***] days of the
Effective Date pursuant to Sections 5.2 ([***] and [***]), 5.3 ([***]), 5.4 ([***]), and 5.5
([***])). Altus further agrees to pay upon execution of this Amendment:

     (a) an additional [***] in consideration for services performed by Althea as of the Amendment
Date; and

     (b) [***] for the first validation run for syringes (media fill), which was conducted by
Althea on [***].

3. Work Performed on or After the Amendment Date. Subject to paragraph 4 of this Amendment, the
Parties agree that, beginning as of the Amendment Date, all additional work related to the specific
activities described in the Restated Schedule shall be paid as currently provided in the Agreement.
For avoidance of doubt, this includes the following activities more precisely described on the
Restated Schedule:

     (a) installation of the Equipment (including the skid), IQ, OQ and PQ validation and cleaning
validation under Section 3.3 of the Agreement;

     (b) Process technology transfer work under Section 3.4 of the Agreement, including all
necessary process documentation;

     (c) analytical methods technology transfer under Section 3.5 of the Agreement;

     (d) validation runs under Section 3.6, and all work necessary to enable Althea to perform the
services outlined in Article 4 of the Agreement, except for any work expressly required by the
Agreement to be performed at Althea’s cost; and

     (e) additional buffer runs at the prices set forth in Section 5.3 of the Agreement in addition
to the initial buffer run contemplated by Section 3.4 of the Agreement.

4. Change Orders. Notwithstanding the provisions of paragraph 3 of this Amendment:

     (a) the Parties acknowledge and agree that the work described in Contract Change Order Nos. 6,
11, 13, 17 and 18 attached as Exhibit B to this Amendment were not contemplated by the Agreement
and that the payment amounts set forth in the Agreement do not cover such work. Altus hereby
approves each such change order and all amounts payable to Althea as specified in each such change
order shall be due and payable within [***] days after receipt by Altus of an invoice from Althea
relating thereto; and

     (b) the Parties further acknowledge and agree that any additional change to the Project Plan,
or to Altus’ requirements with respect to Production of Drug Product pursuant to Articles 3, 4 and
5 of the Agreement (including, without limitation, [***] in addition to that specified by Althea as
of the Amendment Date), that Altus may propose

2.

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED

SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT
UNDER RULE 24B-2 OF THE EXCHANGE ACT.

 

will require a written change order signed by at least one of each Party’s representatives on
the Steering Committee (for change orders up to [***]) and a written change order executed by both
Parties (for change orders equal to or in excess of [***]). If Altus proposes any such change,
Althea shall submit a written price proposal to Altus, which will note any delays that Althea
anticipates will result from such change, and Althea shall not be required or authorized to
implement such change unless and until the Parties agree in writing on the price to be paid by
Altus for such work.

     5. [***] to Compensation Structure. Altus acknowledges that processing of additional change orders
may result in significant administrative time and expense on Althea’s part, and that project delays
and/or price increases are likely to result from additional change orders. Accordingly, if, at any time on or after [***] days from the Amendment Date, [***] of the Steering Committee determines in
good faith that the pricing structure as outlined in the Agreement and modified by paragraphs 3 and
4 of this Amendment (i.e., fixed fee plus additional charges for change orders) is no longer [***]
or [***] in light of (i) [***] in the [***] resulting from circumstances outside [***] and/or (ii)
the [***] and/or [***] of change(s) to the Project Plan or Drug Product requirements requested by
Altus, such Steering Committee [***] shall so notify the other Party’s representatives on the
Steering Committee, and the Parties shall promptly meet and consider in good faith an [***] of
[***] the [***] to Althea for its services under the Agreement.

6. Arrival and Functionality of Equipment; Delays.

     (a) In addition to the amounts specified above in this Amendment (or specified in the
Agreement and referenced in this Amendment), it is anticipated the production skid and tanks
required to manufacture the Drug Product arrived at Althea’s facilities fully functional and
operational, subject to customary and reasonable adjustments in the installation and start up
phase, in each case as reasonably necessary for installation of such equipment and for
manufacturing of the Drug Product (“Operational”). If at any time it is determined [***] (unless
such [***]), [***] shall pay to Althea [***], but not more than [***], for the period such [***]
(the [***]). In such event, [***]. The payment of such [***] shall not exceed the amount accrued
from the date it is determined that such [***] to the end of such [***] period. Altus shall be
responsible for the cost associated with the removal of such equipment from the Facility and the
subsequent return and replacement of such equipment to the Facility. [***] shall meet and [***]
shall reschedule the planned manufacturing activities pursuant to the notice provisions of Section
4.1 of the Agreement.

     (b) All amounts payable to Althea under this paragraph 6 shall be due and payable within [***]
days after receipt of an invoice from Althea.

7. Facility Usage and Reservation. In addition to the amounts specified above in this Amendment
(or specified in the Agreement and referenced in this Amendment), and in further consideration of
resolving the Parties’ performance obligations under the Restated Schedule, Altus shall pay to
Althea [***] as follows:

3.

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED

SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT
UNDER RULE 24B-2 OF THE EXCHANGE ACT.

 

     (a) [***] by [***];

     (b) [***] by [***];

     (c) [***] by [***]; and

     (d) [***] by [***];

In addition, in the event that Altus’ usage of the Facility extends beyond the timeline set forth
in the Restated Schedule (and such extension is due to Altus’ election or is otherwise directly and
primarily caused by Altus or a third party acting at Altus’ request or direction), such extension
would be implemented through one or more written change order(s) in accordance with Section 4(b)
above (it being understood that the daily and weekly rates for such extended usage would be [***]
set forth in the [***] and that such change order(s) would allow for a [***], an associated [***],
and related matters as set forth [***]). For the avoidance of confusion, the Parties acknowledge
that the production of the [***] and [***] Batches as contemplated by Section 4.1 of the Agreement
shall not be deemed to constitute usage of the Facility beyond the timeline set forth in the
Restated Schedule for purposes of this Section 7, provided that Altus has complied with the advance
notice requirements of Section 4.1 with respect to such Batches.

8. Success Bonus Payment. Altus confirms its obligation to pay the success bonus payment provided
for in, and in accordance with the terms of, Section 5.7 of the Agreement, and the Parties
acknowledge that they have mutually agreed to the timeline set forth in the Restated Schedule for
the purpose of Section 5.7; provided that if Production of the first Batch has not been completed
by [***] and [***] or is [***], the success bonus payment specified in Section 5.7 of the Agreement
shall become immediately due and payable.

9. Steering Committee. Each Party shall appoint 3 members to the Steering Committee. Altus
confirms that its Steering Committee members are: [***], [***] and [***]. Althea confirms that its
Steering Committee members are: [***], [***], and [***].

10. Effectiveness of Agreement. Except as specifically amended by this Amendment, the terms and
conditions of the Agreement shall remain in full force and effect.

11. Counterparts. This Amendment may be executed in counterparts, each of which shall be deemed an
original document, and all of which, together with this writing, shall be deemed one instrument.

[SIGNATURE PAGE FOLLOWS]

4.

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED

SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT
UNDER RULE 24B-2 OF THE EXCHANGE ACT.

 

     In Witness Whereof, the Parties hereto have duly executed this Amendment as of the
Amendment Date.

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Altus Pharmaceuticals Inc. 	 	 	 	Althea Technologies, Inc.
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Sheldon Berkle
	 	 	 	By:
	 	/s/ W. Alan Moore	 	 	 	 	 	 
	 

	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	

	 	Name:  Sheldon Berkle
	 	 	 	
	 	Name:  W. Alan Moore	 	 	 	 	 	 
	

	 	Title: President and Chief Executive Officer
	 	 	 	
	 	Title: Executive Vice President and

          Chief Business Officer	 	 	 	 	 	 

5.

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED

SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT
UNDER RULE 24B-2 OF THE EXCHANGE ACT.

 

Exhibit A

Amended and Restated Schedule 1

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED

SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT
UNDER RULE 24B-2 OF THE EXCHANGE ACT.

 

ALTU-238 Project Plan

[***]

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED

SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT
UNDER RULE 24B-2 OF THE EXCHANGE ACT.

 

Exhibit B

Change Orders Submitted as of the Amendment Date

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED

SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT
UNDER RULE 24B-2 OF THE EXCHANGE ACT.

 

 

Contract Change Order No. 6

Altus Pharmaceuticals, Inc. ALTU-238 Phase III Manufacturing

Page 1 of 1

	 	 	 	 	 	 
	 	To: [***]
	 	 	Change Order No:  6	 
	 	Manager, Contract Manufacturing
	 	 	Change Order Date:  05-02-07	 
	 	Altus Pharmaceuticals Inc.
	 	 	 	 
	 	125 Sidney Street
	 	 	 	 
	 	Cambridge, MA 02139-4807
	 	 	 	 
	 	 
	 	 	Althea Contact:  [***]	 
	 	Telephone No: [***]
	 	 	Office: [***]	 
	 	Fax No: (617) 299-2899
	 	 	Fax:     [***]	 
	 	Email: [***]@altus.com
	 	 	Email: [***]@altheatech.com	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Change Order Description	 	 	Qty	 	 	 	Unit Price	 	 	 	Total Price	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	[***]	 	 	 	 	[***]	 	 	 	 	[***]	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	TOTAL
	 	 	 	 	 	 	 	 	 	 	 	 	 	[***]	 	 
	 	 	 	 	 	 	 	 	 	 	 	 

Pursuant to the terms and conditions of the Drug Product Production and Clinical Supply Agreement
dated August 16, 2006 by and between Altus Pharmaceuticals, Inc. and Althea Technologies, Inc.
Signatures below acknowledge agreement with the quotation description of services.

	 	 	 	 	 	 	 
	ALTUS PHARMACEUTICALS, INC

	 	 
	 	ALTHEA TECHNOLOGIES, INC.
	 	 
	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	PRINT NAME

	 	 
	 	PRINT NAME	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	TITLE

	 	 	 	TITLE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	SIGNATURE

	 	 	 	SIGNATURE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	DATE

	 	 	 	DATE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	ALTUS PURCHASE ORDER NUMBER
	 	 	 	 	 	 

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED

SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT
UNDER RULE 24B-2 OF THE EXCHANGE ACT.

 

Contract Change Order No. 11

Altus Pharmaceuticals, Inc. ALTU-238 Phase III Manufacturing

Page 1 of 1

	 	 	 	 	 	 
	 	To: [***]
	 	 	Change Order No:  11	 
	 	Manager, Contract Manufacturing
	 	 	Change Order Date:  06-06-07	 
	 	Altus Pharmaceuticals Inc.
	 	 	 	 
	 	125 Sidney Street
	 	 	 	 
	 	Cambridge, MA 02139-4807
	 	 	 	 
	 	 
	 	 	Althea Contact:  [***]	 
	 	Telephone No: [***]
	 	 	Office: [***]	 
	 	Fax No: (617) 299-2899
	 	 	Fax:     [***]	 
	 	Email: [***]@altus.com
	 	 	Email: [***]@altheatech.com	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Change Order Description	 	 	Qty	 	 	 	Unit Price	 	 	 	Total Price	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	[***]	 	 	 	 	[***]	 	 	 	 	[***]	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	[***]	 	 	 	 	[***]	 	 	 	 	[***]	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	TOTAL
	 	 	 	 	 	 	 	 	 	 	 	 	 	[***]	 	 
	 	 	 	 	 	 	 	 	 	 	 	 

Pursuant to the terms and conditions of the Drug Product Production and Clinical Supply Agreement
dated August 16, 2006 by and between Altus Pharmaceuticals, Inc. and Althea Technologies, Inc.
Signatures below acknowledge agreement with the quotation description of services.

	 	 	 	 	 	 	 
	ALTUS PHARMACEUTICALS, INC

	 	 
	 	ALTHEA TECHNOLOGIES, INC.
	 	 
	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	PRINT NAME

	 	 
	 	PRINT NAME	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	TITLE

	 	 	 	TITLE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	SIGNATURE

	 	 	 	SIGNATURE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	DATE

	 	 	 	DATE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	ALTUS PURCHASE ORDER NUMBER
	 	 	 	 	 	 

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED

SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT
UNDER RULE 24B-2 OF THE EXCHANGE ACT.

 

Contract Change Order No. 13

Altus Pharmaceuticals, Inc. ALTU-238 Phase III Manufacturing

Page 1 of 1

	 	 	 	 	 	 
	 	To: [***]
	 	 	Change Order No:  13	 
	 	Manager, Contract Manufacturing
	 	 	Change Order Date:  06-06-07	 
	 	Altus Pharmaceuticals Inc.
	 	 	 	 
	 	125 Sidney Street
	 	 	 	 
	 	Cambridge, MA 02139-4807
	 	 	 	 
	 	 
	 	 	Althea Contact:  [***]	 
	 	Telephone No: [***]
	 	 	Office: [***]	 
	 	Fax No: (617) 299-2899
	 	 	Fax:     [***]	 
	 	Email: [***]@altus.com
	 	 	Email: [***]@altheatech.com	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Change Order Description	 	 	Qty	 	 	 	Unit Price	 	 	 	Total Price	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	[***]	 	 	 	 	[***]	 	 	 	 	[***]	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	TOTAL
	 	 	 	 	 	 	 	 	 	 	 	 	 	[***]	 	 
	 	 	 	 	 	 	 	 	 	 	 	 

Pursuant to the terms and conditions of the Drug Product Production and Clinical Supply Agreement
dated August 16, 2006 by and between Altus Pharmaceuticals, Inc. and Althea Technologies, Inc.
Signatures below acknowledge agreement with the quotation description of services.

	 	 	 	 	 	 	 
	ALTUS PHARMACEUTICALS, INC

	 	 
	 	ALTHEA TECHNOLOGIES, INC.
	 	 
	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	PRINT NAME

	 	 
	 	PRINT NAME	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	TITLE

	 	 	 	TITLE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	SIGNATURE

	 	 	 	SIGNATURE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	DATE

	 	 	 	DATE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	ALTUS PURCHASE ORDER NUMBER
	 	 	 	 	 	 

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED

SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT
UNDER RULE 24B-2 OF THE EXCHANGE ACT.

 

Contract Change Order No. 17

Altus Pharmaceuticals, Inc. ALTU-238 Phase III Manufacturing

Page 1 of 1

	 	 	 	 	 	 
	 	To: [***]
	 	 	Change Order No:  17	 
	 	Manager, Contract Manufacturing
	 	 	Change Order Date:  06-06-07	 
	 	Altus Pharmaceuticals Inc.
	 	 	 	 
	 	125 Sidney Street
	 	 	 	 
	 	Cambridge, MA 02139-4807
	 	 	 	 
	 	 
	 	 	Althea Contact:  [***]	 
	 	Telephone No: [***]
	 	 	Office: [***]	 
	 	Fax No: (617) 299-2899
	 	 	Fax:     [***]	 
	 	Email: [***]@altus.com
	 	 	Email: [***]@altheatech.com	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Change Order Description	 	 	Qty	 	 	 	Unit Price	 	 	 	Total Price	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	[***]	 	 	 	 	[***]	 	 	 	 	[***]	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	TOTAL
	 	 	 	 	 	 	 	 	 	 	 	 	 	[***]	 	 
	 	 	 	 	 	 	 	 	 	 	 	 

Pursuant to the terms and conditions of the Drug Product Production and Clinical Supply Agreement
dated August 16, 2006 by and between Altus Pharmaceuticals, Inc. and Althea Technologies, Inc.
Signatures below acknowledge agreement with the quotation description of services.

	 	 	 	 	 	 	 
	ALTUS PHARMACEUTICALS, INC

	 	 
	 	ALTHEA TECHNOLOGIES, INC.
	 	 
	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	PRINT NAME

	 	 
	 	PRINT NAME	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	TITLE

	 	 	 	TITLE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	SIGNATURE

	 	 	 	SIGNATURE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	DATE

	 	 	 	DATE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	ALTUS PURCHASE ORDER NUMBER
	 	 	 	 	 	 

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED

SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT
UNDER RULE 24B-2 OF THE EXCHANGE ACT.

 

Contract Change Order No. 18

Altus Pharmaceuticals, Inc. ALTU-238 Phase III Manufacturing

Page 1 of 1

	 	 	 	 	 	 
	 	To: [***]
	 	 	Change Order No:  18	 
	 	Manager, Contract Manufacturing
	 	 	Change Order Date:  06-06-07	 
	 	Altus Pharmaceuticals Inc.
	 	 	 	 
	 	125 Sidney Street
	 	 	 	 
	 	Cambridge, MA 02139-4807
	 	 	 	 
	 	 
	 	 	Althea Contact:  [***]	 
	 	Telephone No: [***]
	 	 	Office: [***]	 
	 	Fax No: (617) 299-2899
	 	 	Fax:     [***]	 
	 	Email: [***]@altus.com
	 	 	Email: [***]@altheatech.com	 
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Change Order Description	 	 	Qty	 	 	 	Unit Price	 	 	 	Total Price	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	[***]	 	 	 	 	[***]	 	 	 	 	[***]	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	TOTAL
	 	 	 	 	 	 	 	 	 	 	 	 	 	[***]	 	 
	 	 	 	 	 	 	 	 	 	 	 	 

Pursuant to the terms and conditions of the Drug Product Production and Clinical Supply Agreement
dated August 16, 2006 by and between Altus Pharmaceuticals, Inc. and Althea Technologies, Inc.
Signatures below acknowledge agreement with the quotation description of services.

	 	 	 	 	 	 	 
	ALTUS PHARMACEUTICALS, INC

	 	 
	 	ALTHEA TECHNOLOGIES, INC.
	 	 
	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	PRINT NAME

	 	 
	 	PRINT NAME	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	TITLE

	 	 	 	TITLE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	SIGNATURE

	 	 	 	SIGNATURE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	DATE

	 	 	 	DATE	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	ALTUS PURCHASE ORDER NUMBER
	 	 	 	 	 	 

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED

SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT
UNDER RULE 24B-2 OF THE EXCHANGE ACT.exv10w2

 

EXHIBIT 10.2

TERMINATION AGREEMENT

     This Termination Agreement (the “Termination Agreement”) dated as of June 6, 2007 (the
“Effective Date”) is an amendment to the Development, Commercialization and Marketing Agreement
(the “Agreement”) dated as of December 23, 2002 by and between Altus Pharmaceuticals Inc. (the
successor in interest to Altus Biologics Inc.), a Delaware corporation, with its principal office
at 125 Sidney Street, Cambridge, MA 02139 USA (“ALTUS”) and Dr. Falk Pharma GmbH, a German
corporation, with its principal office at Leinenweberstrasse 5, 79041 Freiberg Germany (“FALK”).

BACKGROUND

     The Parties have concluded that it is in their strategic interest to discontinue their
collaboration and terminate the Agreement. This Termination Agreement sets forth the terms and
conditions applicable to such termination as well and any rights and obligations that survive such
termination. All capitalized terms not expressly defined in this Termination Agreement shall have
the meaning assigned to them in the Agreement.

AGREEMENT

     NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements
herein contained, and for other good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the Parties, intending to be legally bound, agree as follows:

ARTICLE 1.

TERMINATION

     1.1 Effective Date. As of the Effective Date, the Agreement is terminated, and except as
expressly provided for in Section 1.3 below, all licenses, rights and obligations of the Parties
under the Agreement are terminated.

     1.2 Payments. ALTUS agrees to make the following payments on the following dates to FALK:

	 	1.2.1	 	Five Million Euros (€5,000,000) thirty (30) days following
the Effective Date.
	 
	 	1.2.2	 	Two Million Euros (€2,000,000) on the first anniversary of
the Effective Date.

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	 	1.2.3	 	Two Million Euros (€2,000,000) on the second anniversary of
the Effective Date.
	 
	 	1.2.4	 	Three Million Euros (€3,000,000) on the third anniversary of
the Effective Date.

ALTUS shall have the option, in its discretion, to prepay the payments set forth in clauses 1.2.2,
1.2.3, and 1.2.4. Any late payments shall accrue interest, to the extent permitted by applicable
law, with such interest payment calculated at the Prime rate as reported in the Wall Street
Journal.

     1.3 Surviving Obligations. Notwithstanding Article 14 of the Agreement, the sole surviving
rights and obligations of the Parties shall consist of:

	 	1.3.1	 	The express rights and obligations of the Parties under this
Termination Agreement.
	 
	 	1.3.2	 	The obligations and rights of the Parties set forth in the
Agreement in Articles 10, 15 (solely as to Losses arising out of the surviving
rights and obligations after the Effective Date), and 16, and in Sections
17.1, 17.4, 17.5, 17.6, 17.7, 17.8, 17.9, 17.10, 17.11, 17.12, 17.13 and
17.14.

     1.4 Return or Destruction of Confidential Information; Transfer of Regulatory File and Orphan
Medicinal Product Designation. FALK agrees to deliver copies of all written communications with
the EMEA in its files pertaining to the Licensed Product within thirty (30) days of receiving the
payment specified in subsection 1.2.1 above (the “First Payment”). FALK agrees to make all
reasonable efforts within its control to assign and transfer, to the extent permitted under
applicable law, to ALTUS or its designee within ninety (90) days of the First Payment, the July 22,
2004 Orphan Medicinal Product Designation granted to FALK by the EMEA with respect to the Licensed
Product and any amendments thereto. Each of the Parties agrees to return or destroy all other
Confidential Information of the other Party in its possession within thirty (30) days of the First
Payment, subject to ALTUS having the right to retain any Confidential Information of Falk that is
the subject of the license grant in Section 1.5.1, below.

1.5 Freedom to Operate.

	 	1.5.1	 	FALK hereby grants ALTUS a fully-paid, perpetual, worldwide
non-exclusive license, with the right to sublicense, under (a) any
Confidential Information or know-how provided to ALTUS under the Agreement in
connection with the Licensed Product prior to the date of this Termination
Agreement or (b) any patent or patent rights arising out of the Agreement and
existing as of the date of

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	 	 	 	this Termination Agreement for making, using, importing or selling or
offering to sell the Licensed Product.

	 	1.5.2	 	For avoidance of doubt, the license grant in Section 1.5.1
does not obligate FALK to transfer any information, know-how or technology to
ALTUS.

     1.6 Due Authority. Each Party represents and warrants that it possesses the requisite
corporate right, power and authority to execute and deliver this Termination Agreement and to
perform its obligations under this Termination Agreement.

     1.7 Mutual Releases.

	 	1.7.1	 	As a material inducement to enter into this Termination
Agreement, and for the good and valuable consideration described herein, ALTUS
hereby releases and forever discharges FALK, its affiliates and subsidiaries,
and the representatives, agents, servants, officers, directors, and employees
of the foregoing, from any and all actions, causes of action, costs, damages,
losses, claims, liabilities or demands, of whatsoever character, nature, and
kind, whether known, unknown, suspected, or unsuspected, matured or
contingent, whether specifically mentioned herein or not, which ALTUS now owns
or holds, or any time heretofore held or owned, by and between the Parties
hereto arising directly or indirectly from and/or in connection with the
Agreement.
	 
	 	1.7.2	 	As a material inducement to enter into this Termination
Agreement, and for the good and valuable consideration described herein, FALK
hereby releases and forever discharges ALTUS, its affiliates and subsidiaries,
and the representatives, agents, servants, officers, directors and employees
of the foregoing, from any and all actions, causes of action, costs, damages,
losses, claims, liabilities or demands, of whatsoever character, nature, and
kind, whether known, unknown, suspected, or unsuspected, matured or
contingent, whether specifically mentioned herein or not, which FALK now owns
or holds, or any time heretofore held or owned, by and between the Parties
hereto arising directly or indirectly from and/or in connection with the
Agreement.

[Signatures on next page]

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     IN WITNESS WHEREOF, the parties hereto have executed this Termination Agreement as of the date
set forth above.

	 	 	 	 	 
	ALTUS PHARMACEUTICALS, INC.

 	 	 
	By:  	/s/ Sheldon Berkle
 	 	 
	 	Name:  	Sheldon Berkle 	 	 
	 	Title:  	President and Chief Executive Officer 	 	 
	 
	DR. FALK PHARMA GMBH

 	 	 
	By:  	/s/ Ursula Falk
 	 	 
	 	Name:  	Ursula Falk 	 	 
	 	Title:  	Managing Director 	 	 
	 

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