SUPPLY AGREEMENT
EXHIBIT 10.20
This Supply Agreement (“Agreement”) is effective as of this 20th day of July, 2009 (“Effective Date”), by and between Mylan Pharmaceuticals Inc., a corporation duly organized under the laws of the state of West Virginia (MYLAN”), and Raptor Therapeutics Inc., a corporation duly organized under the laws of Delaware (“RAPTOR”). RAPTOR and MYLAN may be referred to herein as the “Party” or “Parties.”
WHEREAS, RAPTOR desires to enter into this Agreement for the supply of the Active Pharmaceutical Ingredient (“API”) from MYLAN; and
WHEREAS, MYLAN desires to enter into this Agreement and grant such supply of the API to RAPTOR.
NOW, THEREFORE, WITNESSETH that for and in consideration of the mutual promises and covenants set forth herein and for other good and valuable consideration, the receipt and sufficiency of all of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:
| I. |
SCOPE OF AGREEMENT
|
| 1. |
RAPTOR shall purchase from MYLAN Active
Pharmaceutical Ingredient (“API”) that meets the specifications, as
further defined in ATTACHMENT I, as may be ordered by RAPTOR in
accordance with the terms and conditions herein.
|
| 2. |
MYLAN shall supply API to RAPTOR that meets
the specifications, as further defined in ATTACHMENT I. MYLAN shall
procure all supplies of API from [*****]. MYLAN shall not change or modify the
specifications set forth on ATTACHMENT I in any manner that would impact
the manufacturing or processing activities related to the supply of API herein
without first giving RAPTOR prior written notice of no less than [*****]. MYLAN
shall notify RAPTOR of any notice of change or modification issued by CAMBREX
within [*****] of the receipt of said notice.
|
[*****]
| 3. |
MYLAN shall support the filing of
RAPTOR’s New Drug Application(s) (“NDA(s)”) for products
containing API and commercial production thereof by providing API, technical
documentation, and regulatory information as requested by RAPTOR to RAPTOR.
MYLAN shall authorize RAPTOR (or its designees) the right to reference all such
technical documentation and regulatory information to support any RAPTOR NDA,
including all Drug Master Files provided to a regulatory authority by or on
behalf of MYLAN or its permitted contractors [*****].
|
| II. |
FORECAST AND SUPPLY
|
| 1. |
MYLAN shall supply the API to RAPTOR pursuant
to the product, price, volume, and time period listed in ATTACHMENT
II.
|
| 2. |
RAPTOR shall provide a non-binding, [*****]
rolling forecast [*****] for the supply of API (“PO”) to MYLAN,
[*****] in advance of delivery to RAPTOR.
|
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| 3. |
MYLAN shall schedule the purchase of the API
based on [*****] shall accept such binding POs received from RAPTOR at least
[*****] in advance of delivery.
|
| 4. |
In the event of a supply shortage of the API
where MYLAN is unable to fulfill RAPTOR’S requirements set forth in a
particular PO, MYLAN shall immediately notify RAPTOR. RAPTOR may modify or
cancel such Purchase Orders accordingly, without penalty, upon written notice
of no less than [*****]before the delivery date specified in such PO to
MYLAN.
|
| 5. |
[*****] A “DELAY” shall mean any
shipment of API delivered pursuant to a PO of which more than [*****] of the
quantities ordered in the applicable PO is delivered later than [*****] after
the delivery date specified in the applicable PO through no fault of
MYLAN.
|
| III. |
PAYMENT
|
| 1. |
RAPTOR shall remit payment for the API [*****]
after RAPTOR’s receipt and approval of MYLAN’s invoice therefor.
Notwithstanding the foregoing, RAPTOR may withhold payment for any shipment or
portion thereof that has been rejected by RAPTOR for nonconformance under
Section IV.3 below.
|
| IV. |
SHIPPING AND RETURNS
|
| 1. |
All shipments of API from MYLAN to RAPTOR will
be shipped [*****].
|
| 2. |
RAPTOR will receive and test API within
[*****] of delivery. RAPTOR will notify MYLAN of non-conforming results within
[*****].
|
| 3. |
MYLAN shall accept and replace returns of API
that are not in conformance with the applicable specifications or standards set
forth under this agreement when identified by RAPTOR, or refund the purchase
price of the API, within [*****] of receipt of the API by RAPTOR.
|
| V. |
QUALITY CONTROL
|
| 1. |
MYLAN shall provide API that meets the United
States Pharmacopeia (“USP”) and International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use (“ICH”) requirements.
|
| 2. |
MYLAN shall provide API in accordance with
ATTACHMENT I, the Drug Master Files (“DMF”) for the
manufacture of API provided by or on behalf of MYLAN or its permitted
contractors and current Good Manufacturing Practices (“cGMPs”) set
forth by the FDA or other regulatory authorities. The Parties shall use
commercially reasonable efforts to negotiate and execute a mutually agreeable
quality agreement prior RAPTOR issuing its first purchase order for API to
MYLAN pursuant to the Agreement.
|
| 3. |
MYLAN shall promptly provide the necessary
resources to respond to the FDA or other regulatory authority determined
deficiencies and information requests regarding the API and the process used by
the manufacturer to manufacture the API (including providing access to the
applicable manufacturing facilities used to manufacture the API). MYLAN
|
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shall provide to RAPTOR copies of all such determined deficiencies, information requests, inspection reports and other correspondence of the FDA or other regulatory authority related to the manufacture of API within [*****] after obtaining knowledge thereof.
| 4. |
MYLAN will allow RAPTOR to audit MYLAN’s
storage and shipping facilities annually during normal business hours and after
receiving at least [*****] prior written notice. In addition, MYLAN shall use
commercially reasonable efforts to facilitate an annual request by RAPTOR to
audit other facilities not owned by MYLAN that are directly related to the
manufacture of API, upon receiving at least [*****] prior written notice.
|
| 5. |
MYLAN shall generate and maintain complete and
accurate records (including files, certificates and authorizations) and samples
as necessary to evidence compliance with this Agreement, and applicable laws,
regulatory requirements, and other requirements of applicable governmental
authorities relating to the manufacture of API. All such records and samples
shall be securely maintained for a period of not less than [*****] from the
date received or generated by MYLAN or such period as may be required by
regulatory requirements. Upon RAPTOR’S request, MYLAN shall provide
RAPTOR with reasonable access to, and copies and portions of, such records and
samples and any supporting data relating thereto, and MYLAN shall not dispose
of such records or samples without first offering to transfer such records or
samples to RAPTOR at RAPTOR’S expense.
|
| VI. |
WARRANTIES AND REPRESENTATIONS
|
| 1. |
MYLAN warrants and represents the
following:
|
| (i) |
MYLAN is a corporation duly organized, validly
existing and in good standing under the laws of West Virginia;
|
| (ii) |
MYLAN has all requisite power and authority to
enter into this Agreement and to carry out its obligations hereunder;
|
| (iii) |
The person signing this Agreement has the
necessary corporate authority to legally bind MYLAN to the terms set forth
herein;
|
| (iv) |
The execution by MYLAN of this Agreement and
the performance by MYLAN of the terms set forth herein will not cause MYLAN to
be in material conflict with or constitute a material breach of any agreement
or understanding with any third party;
|
| (v) |
To MYLAN’s knowledge and belief, there
are no suits, adverse third party allegations or actions, claims, proceedings,
or investigations pending or threatened by or before any court, by or before
any government body or agency, or any individual related, to the matters set
forth herein;
|
| (vi) |
The execution of this Agreement and
MYLAN’s performance hereunder do not and will not be in material conflict
with any law, ordinance, statute or regulation or any current Good Laboratory
Practice (“cGLP”), cGMP, or FDA guidelines or policies;
|
Page 3 of 9
| (vii) |
MYLAN is not debarred and MYLAN has not and
will not use in any capacity the services of any person debarred under
subsection 306(a) or (b) of the Generic Drug Enforcement Act of 1992. If
at any time this representation and warranty is no longer accurate, MYLAN shall
immediately notify RAPTOR of such fact;
|
| (viii) |
MYLAN has and will maintain throughout the
term of this Agreement all permits, licenses, registrations and other forms of
governmental authorization and approval as required by law in order for MYLAN
to execute and deliver this Agreement and to perform its obligations hereunder
in accordance with all applicable laws;
|
| (ix) |
MYLAN represents and warrants that the API
supplied to MYLAN shall meet the agreed specifications, as further defined in
ATTACHMENT I; the United States Pharmacopeia (“USP”)
requirements; and the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use
(“ICH”) requirements
|
| 2. |
RAPTOR warrants and represents the
following:
|
| (i) |
RAPTOR is a corporation duly organized,
validly existing and in good standing under the laws of the state of
Delaware;
|
| (ii) |
RAPTOR has all requisite power and authority
to enter into this Agreement and to carry out its obligations hereunder;
|
| (iii) |
The person signing this Agreement has the
necessary corporate authority to legally bind RAPTOR to the terms set forth
herein;
|
| (iv) |
The execution by RAPTOR of this Agreement and
the performance by RAPTOR of the terms set forth herein will not cause RAPTOR
to be in material conflict with or constitute a material breach of any
agreement or understanding with any third party;
|
| (v) |
To RAPTOR’s knowledge and belief, there
are no suits, adverse third party allegations, actions, claims, proceedings, or
investigations pending or threatened by or before any court, by or before any
government body or agency, or any individual, related to the matters set forth
herein;
|
| (vi) |
The execution of this Agreement and
RAPTOR’s performance hereunder do not and will not be in material
conflict with any law, ordinance, statute or regulation;
|
| (vii) |
RAPTOR is not debarred and RAPTOR has not and
will not use in any capacity the services of any person debarred under
subsections 306(a) or (b) of the Generic Drug Enforcement Act of 1992. If
at any time this representation and warranty is no longer accurate, RAPTOR
shall immediately notify MYLAN of such fact; and
|
| (viii) |
RAPTOR has and will maintain throughout the
term of this Agreement all federal, state and local permits, licenses,
registrations and other forms of governmental authorization and approval as
required by law in order for
|
Page 4 of 9
RAPTOR to execute and deliver this Agreement and to perform its obligations hereunder in accordance with all applicable laws.
| VII. |
TERM AND TERMINATION
|
| 1. |
This Agreement shall begin on the Effective
Date written above and shall continue in full force and effect for a period of
[*****] (“Initial Term”). Thereafter, the term of this Agreement
shall continue in full force and effect until terminated in accordance with
this Section VII.
|
| 2. |
After the Initial Term, either Party may
terminate this Agreement with [*****] prior written notice to the
non-terminating Party.
|
| 3. |
This Agreement shall be subject to immediate
termination in the event the manufacture, distribution, or sale of the API
would materially contravene any applicable law [*****].
|
| 4. |
Upon the termination of this Agreement;
pursuant to Section VII(3), due to a material breach of the terms of this
Agreement by MYLAN, or a unilateral termination by MYLAN pursuant to
Section VII, RAPTOR shall have no obligation to purchase any API ordered
in any PO. Termination of this Agreement shall not affect the rights and
obligations of either Party that may have accrued prior to the date of
termination, or any right or obligation contained in Sections III, IV,
V.1, V.2 (with respect to outstanding POs to be fulfilled) and
Xxxxxxxx X.0, X.0, X.0, XX, XXX.0, VIII, IX, X, XI, XII, XIII, XIV,
XV.
|
| VIII. |
INDEMNIFICATION
|
| 1. |
RAPTOR agrees to indemnify, defend and hold
MYLAN harmless from and against any losses resulting from or arising out of
[*****].
|
| 2. |
MYLAN agrees to indemnify, defend and hold
RAPTOR harmless from and against any losses resulting from or arising out of
[*****].
|
| IX. |
CONFIDENTIALITY
|
Information exchanged pursuant to this Agreement, shall be subject to the terms and conditions of that certain Confidentiality Agreement executed and entered into on the 7th day of April, 2009, by and between Raptor Pharmaceuticals Corp., the parent company of Raptor Therapeutics Inc., and Mylan Pharmaceuticals Inc. (the “CDA”). The terms and conditions of the CDA notwithstanding, a Party may disclose the Confidential Information of the disclosing Party to extent required to exercise its rights or perform its obligations hereunder.
| X. |
ASSIGNMENT
|
RAPTOR may not assign this Agreement or any of its rights or obligations hereunder, to a third party, without the express, prior, written consent of MYLAN; except that RAPTOR may assign this Agreement without such consent to any successor to all or substantially all of RAPTOR’S assets or business to which this Agreement relates. Any assignment in violation of this Section X shall be null and void.
Page 5 of 9
| XI. |
GOVERNING LAW
|
Any and all actions between the Parties regarding the interpretation or application of any term or provision contained herein shall be governed by and interpreted in accordance with the laws of the State of New York, excluding its conflict of laws principles. MYLAN and RAPTOR each do hereby respectively consent and agree that the courts of the State of New York shall have jurisdiction with respect to any and all actions brought hereunder.
| XII. |
LIMITATION OF LIABILITY
|
In no event shall either Party be liable to the other Party or its Affiliates for special, punitive, indirect, incidental, exemplary or consequential loss or damage, or for lost profits, based on a contract, tort, or any other legal theory, arising out any breach of this Agreement or otherwise relating to the subject matter of this Agreement, except as may be specifically and expressly stated in this Agreement.
[*****]
| XIII. | NOTICES |
Any notice of communication to be given hereunder shall be in writing and be delivered personally, mailed, or sent via facsimile transmission, as follows:
| If to MYLAN: | Mylan Pharmaceuticals Inc. | |||
| 000 Xxxxxxxx Xxxxx Xxxx | ||||
| Xxxxxxxxxx, Xxxx Xxxxxxxx 00000 | ||||
| Attention: | ||||
| Facsimile No.: | ||||
| With a copy to: | ||||
| Deputy General Counsel | ||||
| Mylan Inc. | ||||
| 0000 Xxxxxxxxx Xxxxx | ||||
| Xxxxxxxxxx, XX 00000 | ||||
| Facsimile No.: (000) 000-0000 | ||||
If to RAPTOR: |
||||
| Raptor Therapeutics Inc. | ||||
| 0 Xxxxxxxxxx Xxxxxxxxx | ||||
| Xxxxx 000 | ||||
| Xxxxxx, XX 00000 | ||||
| XIV. | SEVERABILITY |
If any provision of this Agreement is found invalid or unenforceable by a court of law, the remainder of this Agreement shall continue in full force and effect.
Page 6 of 9
| XV. |
WAIVER
|
A waiver by either Party of any terms, provisions, or condition of this Agreement shall not constitute a precedent or bind either Party to a waiver of any succeeding default or other breach of the same of any other term, provision, or conditions of this Agreement.
| XVI. |
COUNTERPARTS
|
This Agreement may be executed in two or more counterparts, each of which shall be considered an original but all of which shall constitute one agreement.
| XVII. |
ENTIRE AGREEMENT
|
The terms and conditions of this Agreement, ATTACHMENT I, ATTACHMENT II, and the CDA, express the entire agreement between MYLAN and RAPTOR and supersede all prior drafts and/or understandings between the Parties.
IN WITNESS of their agreement to the terms and conditions contained herein, MYLAN and RAPTOR, intending to be legally bound, have caused the following signatures to be affixed hereto:
| MYLAN PHARMACEUTICALS INC. | RAPTOR THERAPEUTICS INC. | |
BY: /s/ Xxxxx X. Xxxxxx |
BY: /s/ Xxxxxx X. Xxxxx | |
PRINT NAME: Xxxxx X. Xxxxxx |
PRINT NAME: Xxxxxx X. Xxxxx | |
TITLE: President, North America |
TITLE: President |
[*****] Raptor Pharmaceutical Corp. has requested confidential treatment of certain portions of this agreement which have been omitted and filed separately with the U.S. Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934.
Page 7 of 9
ATTACHMENT I
[*****]
Page 8 of 9
ATTACHMENT II
[*****]
Page 9 of 10
