DEVELOPMENT FUNDING AGREEMENT
Exhibit 10.2
*Confidential Treatment Requested Under
17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2
17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2
This Development Funding Agreement (this “Agreement”) is entered into on November 7, 2006
(“Effective Date”) between AKORN, INC., a Louisiana corporation having a principal place of
business at 0000 Xxxxxxxxx Xxxxx, Xxxxxxx Xxxxx, Xxxxxxxx 00000-0000, Xxxxxx Xxxxxx of America
(“AKORN”) and SERUM INSTITUTE of INDIA, LTD., a Company incorporated under the laws of India laws,
having its principal place of business at S. Xx. 000/0, Xxx Xxxx Xxxxxxxxxx Xxxx, Xxxxxxxx, Xxxx —
411 028, Maharashtra, INDIA, (“SII”) (each a “Party” and collectively, the “Parties”).
A. The Parties have entered into a Development and Exclusive Distribution Agreement of even
date (“Distribution Agreement”) that provides for the grant to AKORN of exclusive marketing and
distribution rights in North, Central and South America for the rabies monoclonal antibody
(“Product”); and
B. In connection with the Distribution Agreement, the Parties desire to set forth their
agreement with respect to development funding payments to be paid to SII in respect of Product
development, pursuant to the term and conditions set forth below.
NOW, THEREFORE, in consideration of the mutual promises herein, and other valuable
consideration, the receipt and sufficiency of which are hereby acknowledged by the Parties, the
Parties agree as follows:
ARTICLE 1
DEFINITIONS
DEFINITIONS
1.1 All capitalized terms used herein shall have the same meanings set forth in the
Distribution Agreement, unless otherwise defined in this Amendment.
1.2 Distribution Agreement. The term “Distribution Agreement” has the meaning
ascribed to it in the Recitals above.
1.3 Payments. The term “Payments” means the payments set forth on the Payment
Schedule, that are due and payable to SII as provided herein.
1.4 Payment Schedule. The term “Payment Schedule” means the payment schedule, set
forth in Exhibit A, attached hereto and fully incorporated herein.
1.5 Triggering Event. The term “Triggering Events” means the objectives and
deliverables described and set forth in the Payment Schedule.
ARTICLE 2
MILESTONE PAYMENTS
MILESTONE PAYMENTS
2.1 Payments. AKORN shall pay to SII the corresponding Payment within ten (10)
calendar days the Parties’ reasonable verification that a specific Triggering Event has occurred.
* CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with
the Securities and Exchange Commission.
*Confidential Treatment Requested Under
17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2
17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2
2.2 U.S. Dollars. All payments to be made pursuant to this Agreement shall be
in United States Dollars.
2.3 Late Payments. Any late payments hereunder shall be subject to annual interest at
the rate of ten percent (10%) compounded on a monthly basis, until paid in full.
ARTICLE 3
WARRANTIES
WARRANTIES
3.1 Representations and Warranties. Each of AKORN and SII represents, warrants and
covenants that it has the full power, right and authority to execute and deliver this Agreement and
perform its obligations hereunder.
3.2 Limitation of Liability. NOTWITHSTANDING ANYTHING TO THE CONTRARY HEREIN, NEITHER
PARTY SHALL BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, PUNITIVE, OR EXEMPLARY
DAMAGES, WHETHER FORESEEABLE OR NOT, THAT ARE IN ANY WAY RELATED TO THIS AGREEMENT.
ARTICLE 4
TERMINATION
TERMINATION
4.1 Term. This Agreement shall commence on the Effective Date and shall continue for
so long as the Distribution Agreement remains in full force and effect, unless earlier terminated
under Section 4.2.
4.2 Termination. This Agreement will terminate:
4.2.1 on the thirtieth (30th) calendar day after SII gives written notice to AKORN of a
material breach by AKORN of any term or condition of this Agreement, unless the breach is cured
before the thirtieth (30th) calendar day; or
4.2.2 automatically and immediately upon any termination of the Distribution Agreement.
4.3 Effect of Termination.
4.3.1 In the event of termination all Parties shall remain liable for each of their respective
obligations hereunder that accrued prior to the date of termination.
4.3.2 All rights and remedies conferred herein shall be cumulative and in addition to all of
the rights and remedies available to each Party at law, equity or otherwise.
4.3.3 Upon any termination of the Distribution Agreement solely as a result of [...***...]’s
material breach of the Collaboration Agreement, then SII shall promptly repay to AKORN, without
interest, fifty percent (50%) of all Payments paid by AKORN to SII other than
* CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with
the Securities and Exchange Commission.
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*Confidential Treatment Requested Under
17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2
17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2
the nonrefundable
amount indicated on Exhibit A. Upon any termination of the Distribution Agreement prior to CBER
approval for Product sales solely as a result of SII’s material breach of the Distribution
Agreement or the Collaboration Agreement or in the event SII permanently stops developing Product
under the Collaboration Agreement, then SII shall promptly repay to AKORN, without interest, fifty
percent (50%) of all Payments paid by AKORN to SII other than the nonrefundable amount indicated on
Exhibit A. This Section 4.3.3 shall be of no force or effect in the event of the termination of
the Distribution Agreement or this Agreement due to a material breach by AKORN. Upon any such
termination of the Distribution Agreement or this Agreement due to a material breach by AKORN, SII
shall have no liability to repay to AKORN any of the Payments, in whole or in part. Subject to the
immediately prior sentence, to the extent that SII appoints any other party as distributor for
Products in the Territory, then SII shall promptly repay to AKORN, without interest, one hundred
percent (100%) all Payments paid by AKORN to SII other than the nonrefundable amount indicated on
Exhibit A (and any amounts previously refunded by SII under this Section 4.3.3), subject to the
amortisation schedule stated in 4.3.4.
4.3.4 Should SII appoint any other party as distributor for Products in the Territory, then
the amount payable by SII under Section 4.3.3 shall be adjusted such that SII is only required to
pay based on the unamortized balance of the Payments paid by AKORN to SII (other than the
nonrefundable amount indicated on Exhibit A) based upon a twenty (20) year amortization schedule
beginning on the date of CBER approval for Product.
ARTICLE 5
GENERAL TERMS
GENERAL TERMS
5.1 Relationship of Parties. The relationship between SII and AKORN, with respect to
this Agreement, is only that of independent contractors notwithstanding any activities set forth in
this Agreement. Neither Party is the agent or legal representative of the other Party, and neither
Party has the right or authority to bind the other Party in any way. This Agreement creates no
relationship as partners or a joint venture, and creates no pooling arrangement.
5.2 Confidentiality. This Agreement hereby incorporates the confidentiality
provisions of the Distribution Agreement, including Section 8.2 thereof. For the sake of clarity,
the terms of this Agreement will be kept confidential by the parties, except as permitted under the
exceptions set forth in Sections 8.2.1 — 8.2.6 of the Distribution Agreement.
5.3 Governing Law; Dispute Resolution. This Agreement is governed by and shall be
construed in accordance with the law of the State of New York, excluding any conflict-of-laws rule
or principle that might refer the governance or the construction of this Agreement to the law of
another jurisdiction. Each Party hereby agrees to resolve all disputes between the Parties
relating to this Agreement in accordance with the mediation and arbitration provisions set forth in
the Distribution Agreement.
5.4 Counterparts. This Agreement may be executed in several counterparts that
together shall be originals and constitute one and the same instrument.
* CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with
the Securities and Exchange Commission.
Page 3
*Confidential Treatment Requested Under
17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2
17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2
5.5 Waiver. The failure of any Party to enforce any of its rights hereunder or at law
shall not be deemed a waiver or a continuing waiver of any of its rights or remedies against
another Party, unless such waiver is in writing and signed by the Party to be charged.
5.6 Severability. If any provision of this Agreement, or part thereof, is declared by
a court of competent jurisdiction to be invalid, void or unenforceable, each and every other
provision, or part thereof, shall nevertheless continue in full force and effect.
5.7 Attorneys’ Fees. In the event that any dispute between the Parties should result
in litigation or arbitration, the prevailing Party in such dispute shall be entitled to recover
from the other Party all reasonable fees, costs and expenses of enforcing any right of the
prevailing Party, including reasonable attorneys’ fees and expenses.
5.8 Notice. Any notice given under this Agreement shall be in writing and shall be
delivered personally or by reputable international 3-day courier. Notices may also be delivered by
fax transmittal or email (with valid confirmation of successful transmission), with confirmation
sent by reputable international 3-day courier. A notice shall be deemed delivered upon receipt,
unless the notice is received on a day other than a business day in the jurisdiction of the
recipient or after 5:30 p.m. at the location of delivery, in which case delivery shall be deemed to
be the next business day after receipt (in the jurisdiction of recipient). Notices shall be
directed to Parties at their addresses as specified on page 1 of this Agreement, provided a Party
may change such Party’s address for notice by giving written notice to the other Party in
accordance with this Section. Fax numbers and emails for notices shall be exchanged by the Parties
prior to reaching the first Triggering Event and shall be updated by the Parties as needed
thereafter.
5.9 Entire Agreement. This Agreement constitutes the entire agreement between the
Parties regarding the subject matter hereof, and supersedes all prior or contemporaneous
understandings or agreements regarding the subject matter hereof, whether oral or written. This
Agreement shall be modified or amended only by a writing signed by both AKORN and SII.
5.10 Authority. The Parties executing this Agreement on behalf of AKORN and SII
represent and warrant that they have the authority from their respective governing bodies to enter
into this Agreement and to bind their respective companies to all the terms and conditions of this
Agreement.
5.11 Captions. The captions of the Articles and Sections in this Agreement are for
convenience only and shall not be used to interpret the provisions of this Agreement.
5.12 English Language. This Agreement is executed in the English language. The
language used in this Agreement shall be deemed to be the language chosen by the Parties hereto to
express their mutual intent and no rule of strict construction against either Party shall apply to
any term or condition of this Agreement.
5.13 Headings and Construction. No rule of construction will be applied to the
disadvantage of a Party because that Party was responsible for the preparation of this Agreement
* CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with
the Securities and Exchange Commission.
Page 4
*Confidential Treatment Requested Under
17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2
17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2
or
any part of this Agreement. The Article and Section headings in this Agreement are for convenient
reference only, and will be given no substantive or interpretive effect. With respect to all terms
used in this Agreement, words used in the singular include the plural and words used in the plural
include the singular. The word ‘including’ means including without limitation, and the words
‘herein’, ‘hereby’, ‘hereto’ and ‘hereunder’ refer to this Agreement as a whole. Unless the
context otherwise requires, references found in this Agreement: (i) to Articles and Sections mean
the Articles and Sections of this Agreement; (ii) to an agreement, instrument or other document
means such agreement, instrument or other document as amended, supplemented and modified from time
to time, to the extent provided by the provisions thereof and by this Agreement; and (iii) to a
statute or a regulation mean such statute or regulation as amended from time to time.
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.
Akorn, Inc. | Serum Institute Of India, Ltd. | |||||||||
By:
|
/s/ Xxxxxx X. Xxxxxxx | By: | /s/ Xxxxxxx X. Xxxxx | |||||||
Name:
|
Xxxxxx X. Xxxxxxx | Name: | Xxxxxxx X. Xxxxx | |||||||
Title:
|
President and CEO | Title: | Executive Director | |||||||
* CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with
the Securities and Exchange Commission.
Page 5
*Confidential Treatment Requested Under
17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2
17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2
EXHIBIT A
PAYMENT SCHEDULE
FOR [...***...]
PAYMENT SCHEDULE
FOR [...***...]
Triggering Event | Payment | |||
1.
|
Execution of this Agreement | [...***...] | ||
2.
|
January 1, 2007 | [...***...], which amount is non-refundable notwithstanding Section 4.3 | ||
3.
|
Clinical Batch manufacture of [...***...] | [...***...] | ||
4.
|
Satisfactory Completion of Phase I Clinical Trials for [...***...] for U.S. filing | [...***...] | ||
5.
|
Satisfactory Completion of Phase II Clinical Trials for [...***...] for U.S. filing | [...***...] | ||
6.
|
Satisfactory Completion of Phase III Clinical Trials for [...***...] for U.S. filing | AKORN to reimburse SII for all actual direct costs of Phase III Clinical Trials conducted pursuant to budget approved by AKORNf | ||
6.
|
Receipt of CBER approval for [...***...] | [...***...] | ||
f Budget for Phase III Clinical Trial must be approved in writing by AKORN prior to commencement of Phase III Clinical Trial. Following FDA approval of protocol, SII shall submit a budget to AKORN and shall negotiate in good faith with AKORN to resolve any AKORN objections to such budget. Once the budget for Phase III Clinical Trial is approved by AKORN in writing, SII shall not deviate from such budget without obtaining AKORN’s written approval. |
* CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with
the Securities and Exchange Commission.
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