EXHIBIT 10.26
PURCHASE AGREEMENT
Agreement made as of the 10 day of October, 2005 (the "Agreement Date"),
between Altus Pharmaceuticals Inc., a Delaware corporation with its principal
office at 000 Xxxxxx Xxxxxx, Xxxxxxxxx, XX 00000, XXX ("ALTUS"), and Sandoz
GmbH, a company organized under the laws of Austria with its principal office at
Xxxxxxxxxxxxxxxx 00, Xxxxx, XXXXXXX ("XXXXXX").
WHEREAS, ALTUS desires to purchase, and SANDOZ desires to sell, certain
quantities of human growth hormone ("HGH"), for the consideration set forth
below, subject to the terms and conditions of this Agreement;
WHEREAS, ALTUS desires to use the HGH in its research and development
program for ALTU-238, including preclinical and clinical activities, which may
take place both inside and outside the United States; and
WHEREAS, ALTUS and SANDOZ anticipate [***] between the parties regarding
the [***] [***] with respect to HGH.
NOW, THEREFORE, in consideration of the mutual promises hereinafter set
forth and other good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the parties hereby agree as follows:
1. Sale and Delivery of HGH
1.1 Orders. Upon SANDOZ's receipt of a purchase order (an "Order")
from ALTUS submitted in accordance with the terms set forth on Exhibit B, SANDOZ
shall sell, based on EXW (INCOTERM 2000) - Kundl plant to ALTUS such quantities
of HGH specified in each such Order. Unless otherwise agreed to by the parties,
the aggregate amount of HGH covered by all Order(s) shall not [***] of [***] HGH
and [***] [***] [***]HGH, except as stated in Exhibit B. ALTUS shall have right
to submit Orders based on conditions as set forth in Exhibit B to this contract.
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 406 OF THE SECURITIES ACT.
1.2 Supply of HGH. SANDOZ shall fill each Order submitted by ALTUS
after ALTUS' submission of the Order in accordance with Exhibit B. [***] SANDOZ
shall include with each [***] shipment a Certificate of Analysis confirming that
such shipment conforms to the specifications set forth on Exhibit A. The [***]
shipments will be chosen from SANDOZ Batch [***] (Exhibit C) or Batch [***]
(Exhibit D). The HGH shall be frozen and packaged for shipment in appropriate
amounts of dry ice and supplied by SANDOZ ex works Kundl plant for delivery to
ALTUS. Shipment shall be arranged by SANDOZ utilizing a commercial carrier
approved by ALTUS. All packages shall contain a data logger to monitor package
disposition during shipping, and such information shall be accessible by both
parties.
1.3 Purchase Price. The purchase price (the "Purchase Price") for
HGH shall be as follows: [***] HGH purchased by ALTUS hereunder shall be [***]
per gram and [***]HGH purchased by ALTUS hereunder shall be [***] per gram.
Upon ALTUS having purchased [***] [***] [***] [***] HGH hereunder
according to Exhibit B, SANDOZ shall supply [***] [***] [***] HGH [***] in
accordance with Exhibit B. Upon ALTUS having purchased [***] [***] [***] HGH
hereunder according to Exhibit B, SANDOZ shall supply [***] [***] in accordance
with Exhibit B.
The Purchase Price for each shipment of HGH delivered under ALTUS'
Orders shall be payable at [***] after acceptance of an individual Order by
Sandoz 30 days prior to scheduled delivery and at [***] within 30 days of the
invoice date, being understood that invoicing will be done upon shipment of the
material; provided, however, that if ALTUS reasonably determines that any [***]
HGH delivered by SANDOZ does not conform to the specifications set forth in
Exhibit A or was not prepared under cGMP, and notifies SANDOZ of such
non-conformity within 30 days after receipt and provides supporting
documentation, (i) SANDOZ shall immediately replace at SANDOZ' expense the
non-conforming [***] HGH with conforming [***] HGH, (ii) the cost of shipping
and any other costs associated with the supply of the replacement [***] HGH will
be borne by [***] and (iii) ALTUS shall not be obligated to pay for the shipment
of non-conforming HGH but shall be obligated to pay for the
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 406 OF THE SECURITIES ACT.
replacement HGH within 30 days from the date of its receipt thereof. If ALTUS
reasonably determines that any [***] HGH delivered by SANDOZ does not conform to
the specifications set forth in Exhibit C or D, as appropriate, and notifies
SANDOZ of such non-conformity within 30 days after receipt and provides
supporting documentation, Altus shall be entitled to a refund of any invoices
paid.
2. Covenants by SANDOZ. SANDOZ hereby covenants that:
2.1 Prior to December 31, 2005, SANDOZ will provide ALTUS with a
written authorization (a Letter of Authorization) to reference [***]has
previously filed or files with the U.S. Food and Drug Administration ("FDA")
with respect to their HGH product. In the event that ALTUS decides to conduct a
clinical trial in a non-U.S. jurisdiction, ALTUS shall notify SANDOZ of the
information required for regulatory purposes regarding the HGH. It is likely
such information will include at least information comparable to and present in
a US FDA Drug Master File. SANDOZ shall provide such information to the extent
existing in Sandoz and access to such information where filed with regulatory
authorities via a Letter of Authorisation to the appropriate regulatory
authorities as soon as reasonably practicable after receiving notice of ALTUS'
intent to conduct such trial. ALTUS shall reimburse SANDOZ for the reasonable
costs incurred in providing such assistance in accordance with Section 4.3.
2.2 SANDOZ agrees to allow ALTUS to inspect SANDOZ' hGH
manufacturing facility [***] per year and limited to [***] days and to cooperate
with requests from the FDA and other regulatory authorities relating to the HGH
sold to ALTUS hereunder. The parties shall mutually agree in good faith on the
appropriate scope and timing of any audit or audits initiated by ALTUS. Only
ALTUS employees shall conduct such audit(s) unless SANDOZ consents to the use of
a specific consultant or consultant(s) identified by ALTUS, such consent not to
be unreasonably withheld or conditioned.
2.3 SANDOZ shall keep ALTUS informed of any warning letters relating
to the manufacture of HGH received from any national regulatory authorities
(e.g. US, EU, Australian) and shall keep ALTUS informed of any responses
thereto.
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 406 OF THE SECURITIES ACT.
3. Representations and Warranties
3.1 Ownership of the HGH. SANDOZ warrants that with respect to any
HGH supplied to ALTUS hereunder, SANDOZ is the true and lawful owner of such
HGH, and has the right to sell and transfer to ALTUS good and clear title to the
HGH.
3.2 Conformance With Specifications and Regulatory Requirements. The
[***] HGH supplied hereunder shall (i) conform to the specifications set forth
in Exhibit A and any Certificate of Analysis which accompanies such shipment
through the product expiration date for such shipment, which expiration date
shall not be earlier than [***] HGH manufactured and shipped under this Purchase
Agreement, (ii) shall have been manufactured in accordance with Current Good
Manufacturing Practices as defined in Title 21 Code of Federal Regulations Parts
210 and 211, and in compliance with all applicable laws, rules and regulations,
and (iii) conform to the product characteristics and manufacturing procedures
set forth in the DMF. The [***] HGH supplied hereunder shall conform to the
Exhibit C or D Certificate of Analyses, as appropriate.
SANDOZ warrants that the HGH delivered hereunder will not be adulterated or
misbranded within the meaning set forth in Federal Food, Drug, and Cosmetic Act
(FDCA) or any state or local law or regulation substantially similar to FDCA.
SANDOZ further warrants that any [***] HGH supplied hereunder will conform to
the specifications set forth in Exhibit A upon release by SANDOZ.
3.3 No Clinical Hold. SANDOZ represents that as of the date of this
Agreement, there is no clinical hold in the United States or the EU based on the
suitability of the HGH for human use.
3.4 No Implied Warranties. EXCEPT FOR THE WARRANTIES IN 3.1 AND 3.2
SANDOZ DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO THE
HGH PROVIDED HEREUNDER, INCLUDING ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.
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 406 OF THE SECURITIES ACT.
4. Covenants by ALTUS. ALTUS here by covenants that:
4.1 The [***] HGH covered by this Agreement will only be used in
ALTUS' [***], which activities may take place inside or outside of the United
States. The [***] HGH covered by this Agreement will only be used in ALTUS'
[***] activities, which activities may take place inside or outside of the
United States.
4.2 The HGH will not be resold.
4.3 ALTUS agrees to reimburse SANDOZ for the reasonable time spent
by SANDOZ personnel in handling FDA requests relating exclusively to ALTUS' use
of the HGH sold to ALTUS hereunder and/or in assisting an inspection conducted
by ALTUS pursuant to Section 2.2, such assistance to be reimbursed at a rate of
[***] per man-hour; provided, however, upon request, SANDOZ shall provide ALTUS
with a good faith estimate of the number of man-hours required to accommodate
ALTUS' requests in advance of any such inspection. VAT shall be added if
required by law.
5. Indemnification; Limitation of Liability.
5.1 ALTUS shall indemnify SANDOZ and hold SANDOZ harmless from and
against any and all liability for death, illness or injury to any third party or
for loss or damage to any third party's property and against all claims,
demands, proceedings and causes of action resulting directly or indirectly
therefrom and arising out of any act or default on the part of ALTUS, its
employees, agents or sub-contractors in the performance of or in compliance with
any of their obligations under this Agreement, including without limitation any
and all loss in relation to defective HGH including any liability arising under
any relevant product liability legislation which may apply from time to time due
to defective HGH, except to the extent any such loss or damage is caused by a
breach of SANDOZ's representations or warranties to ALTUS hereunder.
5.2 SANDOZ shall indemnify ALTUS and hold ALTUS harmless from and
against any and all loss or liability for claims, demands, proceedings and
causes of
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 406 OF THE SECURITIES ACT.
action arising from, relating to or caused by a breach of SANDOZ's
representations or warranties to ALTUS in 3.1 and 3.2 hereunder.
5.3 In no event shall either party in any circumstances be liable to
the other for any consequential or indirect loss or damage or loss of profit of
whatsoever nature, including damage to goodwill, loss of market share, existing
or prospective.
6. Confidentiality. Each party shall during the term of this Agreement and
for 5 years thereafter keep strictly confidential information disclosed by the
other party under this Agreement, not disclose the information to any third
party without the prior written consent of the other party and exclusively use
such information for no other purpose than its performance under this Agreement;
however, the above provisions shall not apply to any information which falls
into any of the following exceptions:
(a) information already in the public domain at the time of disclosure;
(b) information which has become part of the public domain due to reasons
other than the fault of receiving party;
(c) information already in the possession of receiving party at the time
of disclosure, which fact the receiving party shall prove by documentary
evidence;
(d) information disclosed to the receiving party by a third party
authorized to do so; or
(e) information whose disclosure to the appropriate governmental
authorities is necessary in connection with the performance of the parties'
obligations and rights under this Agreement, including, without limitation,
disclosure in connection with the clinical development and regulatory approval
of products developed by ALTUS.
7. Term; Termination. This Agreement shall take effect as of the date
first above written and shall remain in effect until December 31, 2006, or such
later date as shall be mutually agreed upon by the parties. Either party may
terminate this Agreement upon written notice in the event the other party shall
have breached this Agreement and failed to cure such breach within 30 days of
receipt of written notice
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 406 OF THE SECURITIES ACT.
thereof. Notwithstanding any termination or expiration of this Agreement,
neither party shall be relieved of any obligations incurred prior to such
termination or expiration and the obligations of the parties with respect to
confidentiality, indemnification and any other provision which by its nature is
intended to survive any such termination or expiration, shall survive and
continue to be enforceable.
8. Notices. Any notices or other communications required or permitted
hereunder shall be sufficiently given if delivered personally or sent by telex,
federal express, registered or certified mail, postage prepaid, addressed as
follows or to such other address of which the parties may have given notice:
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 406 OF THE SECURITIES ACT.
To SANDOZ:
Sandoz GmbH
Xxxxxxxxxxxxxxxx 00
X- 0000 Xxxxx
XXXXXXX
Telecopier No.:
Attn: Head Biotech Cooperations
To ALTUS:
Altus Pharmaceuticals Inc.
000 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
XXX
Telecopier No.: 000-000-000-0000
Attn: President
Unless otherwise specified herein, such notices or other communications shall be
deemed received (a) on the date delivered, if delivered personally; or (b) three
business days after being sent, if sent by registered or certified mail.
9. Successors and Assigns. This Agreement shall be binding upon and inure
to the benefit of the parties hereto and their respective successors and
permitted assigns.
10. Entire Agreement. This Agreement, and all Exhibits hereto, represent
the entire understanding and agreement between the parties hereto with respect
to the subject matter hereof and supersede all prior oral and written and all
contemporaneous oral negotiations, commitments and understandings between such
parties.
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 406 OF THE SECURITIES ACT.
11. Expenses. Except as otherwise expressly provided herein, ALTUS and
SANDOZ shall each pay their own expenses in connection with this Agreement and
the transactions contemplated hereby.
12. Governing Law; Arbitration. This Agreement shall be governed by and
construed in accordance with the laws of the state of New York, USA. Any dispute
hereunder shall be resolved through binding arbitration under the rules of the
International Chamber of Commerce in Paris. Any such arbitration shall be held
in Zurich/Switzerland in the English language. The arbitrator(s) shall also
allocate the cost of such proceedings including reasonable attorneys' fees.
13. Section Headings. The section headings are for the convenience of the
parties and in no way alter, modify, amend, limit, or restrict the contractual
obligations of the parties.
14. Severability. The invalidity or unenforceability of any provision of
this Agreement shall not affect the validity or enforceability of any other
provision of this Agreement.
15. Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed to be an original, but all of which
shall be one and the same document.
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 406 OF THE SECURITIES ACT.
IN WITNESS WHEREOF, this Agreement has been duly executed by the parties
hereto as of and on the date first above written.
ALTUS PHARMACEUTICALS INC. SANDOZ GMBH
By:_________________________ By:________________________
Name:_______________________ Name:______________________
Title:______________________ Title:_____________________
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 406 OF THE SECURITIES ACT.
Exhibit A
HUMAN GROWTH HORMONE DRUG SUBSTANCE SPECIFICATIONS
The specifications for the HGH to be supplied by SANDOZ under this Agreement are
as follows:
TEST ANALYTICAL PROCEDURE ACCEPTANCE CRITERIA
---- -------------------- -------------------
1. DESCRIPTION
1.1. Appearance Visual inspection [***]
1.2. pH Potentiometry [***]
1.3. Clarity Ph. Eur. [***]
2. IDENTITY OF EP2000
2.1. Primary structure Peptide map by RP-HPLC [***]
2.2. Hydrophobicity Reversed phase chromatography [***]
2.3. Isoelectric point Isoelectric focusing [***]
2.4. Molecular size Size exclusion chromatography [***]
2.5. Molecular size SDS-PAGE [***]
3. PURITY
3.1. Product related substances and impurities by RP-HPLC Reversed phase chromatography (RP-HPLC) [***]
3.1.1 Product related substances (deamidated, succinimide, oxidized) Reversed phase chromatography (RP-HPLC) [***]
3.1.2 Product related impurities (clipped and other variants) Reversed phase chromatography (RP-HPLC) [***]
3.1.3. Product related substances and impurity by CZE Capillary zone electrophoresis [***]
3.2. High molecular weight proteins Size exclusion chromatography [***]
3.3. Charge isoforms Isoelectric focusing [***]
3.4. High and low molecular weight SDS-PAGE [***]
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 406 OF THE SECURITIES ACT.
proteins
3.5. Residual acetonitrile Headspace GC [***]
3.6. E. coli host cell proteins Immuno ligand assay (XXX) [***]
3.7. Residual DNA Threshold method [***]
3.8. Bioburden Microbial limit test filtration method
Specify microorganism if found [***]
3.9. Bacterial endotoxins LAL, kinetic chromogenic [***]
3.10. Residual urea Enzymatic determination with urease [***]
4. CONTENT
4.1. Assay Size exclusion chromatography [***]
4.3. Phosphate Photometry [***]
--------
* To be provided to ALTUS prior to or upon shipment
Storage and transport conditions: < or = -20 degrees C
The HGH shall have been manufactured in accordance with current good
manufacturing practices ("cGMP") for pharmaceuticals as described in applicable
regulations promulgated by the U.S. Food and Drug Administrative, including
those set forth in 21 CFR Parts 210 and 211.
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 406 OF THE SECURITIES ACT.
Exhibit B
Order Schedule and Shipping Details
1. No order will be considered placed and no HGH will be shipped without ALTUS
submitting an Order for the HGH.
2. SANDOZ shall have no obligation to fill Orders for [***] HGH scheduled for
delivery in [***] unless ALTUS has placed such Order(s) prior to [***]. It is
currently anticipated that Orders for cGMP HGH will be placed to meet the
following delivery schedule:
- [***] [***]
3. Additional [***] HGH may be purchased by ALTUS [***] with the submission of
an Order. SANDOZ will fill these orders as Sandoz may have commercial quantities
of HGH available for sale to third parties up to a maximum of [***] g.
4. Orders for [***] HGH will be placed by ALTUS by [***] the latest to meet the
following delivery schedule:
- [***]
Unless otherwise specified in an Order, all HGH shall be shipped to:
Altus Pharmaceuticals Inc.
Attn: Xxxxx Xxxx, PhD.
000 Xxxxxx Xxx.
Xxxxxxxxx, XX 00000
XXX
2. SANDOZ shall ship such HGH corresponding to above mentioned delivery schedule
after ALTUS' submission of the corresponding Order. The purchase order will
contain instructions as to where the [***] HGH is to be shipped and how the
shipment is to be labeled.
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 406 OF THE SECURITIES ACT.
Exhibit C
[***]
[***]
[SANDOZ LOGO]
CERTIFICATE OF ANALYSIS Order No.
Material No. 454994
KNGL
Product
[***]
Batch Manufacture date Expiry date
[***] [***] [***]
Tests Specifications Results
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The manufacturing records have been reviewed, the batch was manufactured [***]
We certify that the above mentioned product conforms with the
specifications: PAGE 1/1
[***]
SANDOZ GmbH
DATE OF RELEASE [***] X-0000 XXXXX/XXXXXXX Rejected
Xx. Xxxxxxxx Xxxxx
XXXXX, SANDOZ QUALITY ASSURANCE
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SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
Exhibit D
[***]
[***]
[SANDOZ LOGO]
CERTIFICATE OF ANALYSIS Order No.
Material No. 454994
KNGL
Product
[***]
Batch Manufacture date Expiry date
[***] [***] [***]
Tests Specifications Results
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The manufacturing records have been reviewed, the batch was manufactured [***]
We certify that the above mentioned product conforms with the
specifications: PAGE 1/1
[***]
SANDOZ GmbH
DATE OF RELEASE [***] X-0000 XXXXX/XXXXXXX Rejected
Xx. Xxxxxxxx Xxxxx
XXXXX, SANDOZ QUALITY ASSURANCE
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 406 OF THE SECURITIES ACT.
