CONFIDENTIAL TREATMENT REQUESTED LICENSE AND OPTION AGREEMENT between EMORY UNIVERSITY and ALIMERA SCIENCES, INC.
Exhibit 10.16
LICENSE AND OPTION AGREEMENT
between
EMORY UNIVERSITY
and
ALIMERA SCIENCES, INC.
TABLE OF CONTENTS
ARTICLE 1. DEFINITIONS
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2 | |||
ARTICLE 2. GRANT OF LICENSE
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8 | |||
ARTICLE 3. CONSIDERATION FOR LICENSE
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12 | |||
ARTICLE 4. REPORTS AND ACCOUNTING
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17 | |||
ARTICLE 6. DILIGENCE AND COMMERCIALIZATION
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21 | |||
ARTICLE 7. PATENT PROSECUTION
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22 | |||
ARTICLE 8. INFRINGEMENT
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24 | |||
ARTICLE 9. LIMITED WARRANTY AND EXCLUSION OF WARRANTIES
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26 | |||
ARTICLE 10. DAMAGES, INDEMNIFICATION AND INSURANCE
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28 | |||
ARTICLE 11. CONFIDENTIALITY
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30 | |||
ARTICLE 12. TERM AND TERMINATION
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32 | |||
ARTICLE 13. ASSIGNMENT
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35 | |||
ARTICLE 14. ARBITRATION
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36 | |||
ARTICLE 15. MISCELLANEOUS
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36 | |||
ARTICLE 16. NOTICES
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39 | |||
APPENDIX A COMPANY’S DEVELOPMENT PLAN
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00 | |||
XXXXXXXX X LICENSED PATENTS
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42 | |||
APPENDIX C U.S. GOVERNMENT LICENSE(S)
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43 | |||
APPENDIX D AMENDMENT TERMS
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00 | |||
XXXXXXXX X ISSUE OF EQUITY
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47 | |||
APPENDIX F RUNNING ROYALTY PERCENTAGES
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48 | |||
APPENDIX G MINIMUM ROYALTIES
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49 | |||
APPENDIX H NON-ROYALTY PAYMENTS FROM SUBLICENSEES
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50 | |||
APPENDIX I MILESTONE PAYMENTS
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51 | |||
APPENDIX J LICENSE MAINTENANCE FEES
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52 | |||
APPENDIX K DEVELOPMENT MILESTONES AND DATES
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53 |
THIS LICENSE AND OPTION AGREEMENT is made and entered into as of the 16th day of
July, 2009, (hereinafter referred to as the “Effective Date”) by and between EMORY UNIVERSITY, a
nonprofit Georgia corporation with offices located at 0000 Xxxxxxx Xxxx XX, 0xx Xxxxx,
Xxxxxxx, Xxxxxxx 00000 (hereinafter referred to as “EMORY”) and Alimera Sciences, Inc., a Delaware
corporation having a principal place of business located at 0000 Xxxxxxxx Xxxxxxx, Xxxxx 000,
Xxxxxxxxxx, Xxxxxxx 00000 (hereinafter referred to as “ALIMERA”).
WHEREAS, EMORY is the assignee of all right, title, and interest in inventions, including
related technology, developed by employees of EMORY and is responsible for the protection and
commercial development of such inventions; and
WHEREAS, EMORY has developed certain inventions and technology related to fulvene and
fulvalene compounds and their methods of use (Emory Ref. No. 07027) (the “Technology”); and
WHEREAS, EMORY and ALIMERA entered into that certain Option Agreement related to Emory Ref.
No. 07027 having an effective date August 31, 2007 (the “Option Agreement”), pursuant to which
ALIMERA notified EMORY prior to the expiration of the option period of its intent to exercise its
option to enter into this License and Option Agreement;
WHERERAS, the United States Department of Veterans Affairs (the “VA”) has asserted ownership
rights to the Technology and is a co-owner of the Technology with EMORY;
WHERERAS, EMORY and the VA have entered into an Inter-Institutional Agreement dated January 5,
2009 and amended by the First Amendment dated February 20, 2009, (collectively the “IIA”) whereby
VA has granted EMORY the exclusive (even as to the VA) and final authority to enter into
negotiations for and execute license agreements granting rights to the Technology and to prepare,
file, prosecute and maintain all patent rights covering the Technology on behalf of the VA;
WHEREAS, ALIMERA represents that it has the necessary expertise and will, as appropriate,
acquire the necessary resources to fully evaluate, develop and commercialize the Technology; and
WHEREAS, EMORY wants to have such Technology developed, commercialized, and made available in
commerce for use by the public; and
WHEREAS, ALIMERA wishes to obtain certain rights to pursue the evaluation, development and
commercialization of the Technology; and
WHEREAS, EMORY wishes to grant ALIMERA such rights in accordance with the terms and conditions
of this Agreement.
NOW, THEREFORE, for and in consideration of the mutual covenants and the promises herein
contained, the parties, intending to be legally bound, hereby agree as follows.
ARTICLE 1. DEFINITIONS
The following terms as used herein shall have the following meaning:
1.1 “Additional Invention” shall have the meaning set forth in Article 2.9.
1.2 “Affiliate” shall mean any corporation or non-corporate business entity which controls, is
controlled by, or is under common control with a party to this Agreement only for so long as such
control continues to exist. A corporation or non-corporate business entity shall be regarded as in
control of another corporation if it owns, or directly or indirectly controls, at least fifty (50%)
percent of the voting stock of the other corporation, or (i) in the absence of the ownership of at
least fifty (50%) percent of the voting stock of a corporation or (ii) in the case of a
non-corporate business entity, or non-profit corporation, if it possesses, directly or indirectly,
the power to direct or cause the direction of the management and policies of such corporation or
non-corporate business entity, as applicable.
1.3 “Agreement” or “License Agreement” shall mean this License and Option Agreement, including
all APPENDICES attached to this Agreement.
1.4 “ALIMERA” shall have the meaning set forth in the preamble.
1.5 “ALIMERA’s Development Plan” shall mean APPENDIX A of this Agreement.
1.6 “Amendment Terms” shall have the meaning set forth in Article 2.4.
1.7 “Auditor” shall have the meaning set forth in Article 4.4.
1.8 “Board” shall have the meaning set forth in Article 3.1.
1.9 “Calendar Year” shall mean January 1 though December 31.
1.10 “Claims” shall have the meaning set forth in Article 10.2.
1.11 “Combination Product” shall have the meaning set forth in Article 1.41(b).
1.12 [*]
1.13 “Development Information” shall have the meaning set forth in Article 12.7.
1.14 “Development Milestone Deadline” shall have the meaning set forth in Article 6.2.
1.15 “Distributor” shall mean any third party (i) to which a Seller has granted (at any time
during the term) a right to sell or distribute a Licensed Product, (ii) that sells Licensed
Products to hospitals and/or pharmacies for their sale to or use with patients (rather than to
other third parties for resale to hospitals and/or pharmacies for their sale to or use with
patients), and (iii) that does not make payments to ALIMERA or its Affiliates that are calculated
on the basis of a percentage of, or profit share on, such third party’s sales of Licensed Products.
1.16 “Dollars” shall mean United States dollars.
1.17 “Effective Date” shall have the meaning set forth in the preamble.
1.18 “EMORY” shall have the meaning set forth in the preamble.
1.19 “FDA” shall mean the United States Food and Drug Administration.
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1.20 “Final Regulatory Approval” shall mean in relation to any Licensed Product, the approval
by the regulatory authority in a given country as may be required before such Licensed Product may
be sold in such country.
1.21 “Fully Absorbed Costs” shall mean an amount equal to ALIMERA’s and/or its Affiliate’s
costs directly allocated to the Licensed Products distributed for, as the case may be, test
marketing, sampling and promotional uses, clinical trial purposes, regulatory approval or
compliance, compassionate uses, global access programs intended to provide Licensed Product at
reduced prices in the developing world, or other similar uses, consisting of: (i) direct labor,
including all resources utilized in support of ALIMERA’s and/or its Affiliate’s manufacturing
operations; (ii) materials; (iii) a reasonable allocation of overhead, facilities expense
(including depreciation over the expected life of the buildings and equipment), and administrative
costs directly in support of such manufacturing operations calculated by ALIMERA and/or its
Affiliate in accordance with reasonable cost accounting methods consistent with the way ALIMERA
and/or its Affiliate allocates such costs to other products; and (iv) third-party costs. For the
sake of clarity, in no event shall ALIMERA incur an obligation to pay royalties to EMORY for
Licensed Products distributed for test marketing, sampling and promotional uses, clinical trial
purposes, regulatory approval or compliance, compassionate uses, global access programs intended to
provide Licensed Product at reduced prices in the developing world, or other similar uses, if
payment of such royalty would cause ALIMERA to realize a loss; however, should ALIMERA realize a
profit on such distributions, it is the intent of the parties that ALIMERA would incur an
obligation to pay royalties to EMORY on such profit.
1.22 “Governmental Authority” means any court, tribunal, arbitrator, agency, legislative body,
commission, official or other instrumentality of (i) any government of any country, (ii) a federal,
state, province, county, city or other political subdivision thereof or (iii) any supranational
body.
1.23 “IIA” shall have the meaning set forth in the recitals.
1.24 “IND” shall mean an Investigational New Drug application filed with the FDA in the U.S.
1.25 “Indemnitees” shall mean the Inventors, EMORY, its directors, officers, employees and
students, and their heirs, executors, administrators, successors and legal representatives.
1.26 “Information” shall have the meaning set forth in Article 11.1(ii).
1.27 “Initial Option Period” shall have the meaning set forth in Article 2.4.
1.28 “Initial Option Period Extension” shall have the meaning set forth in Article 2.4.
1.29 “Initiation of Phase I Clinical Trials” shall mean the date of commencement of the first
human clinical trial phase I study of a Licensed Product for a certain disease(s), as applicable,
sponsored by ALIMERA, the principal purpose of which is preliminary determination of safety in
healthy
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individuals or patients as required in 21 C.F.R. §312.21(a). Such phase I clinical trial shall be
deemed to have commenced when such Licensed Product is first administered to any patient enrolled
in such phase I clinical trial. For the purposes of this definition, the term “ALIMERA” shall
include Alimera Sciences, Inc., its Affiliates, sublicensees or any party in a co-promotion or
co-marketing relationship with ALIMERA pertaining to such Licensed Product.
1.30 “Initiation of Phase II Clinical Trials” shall mean the date of commencement of the first
human clinical trial phase II study, including the phase II portion of a phase I/II trial, of a
Licensed Product for a certain disease(s), as applicable, sponsored by ALIMERA, the principal
purpose of which is preliminary evaluation of clinical efficacy and safety, and/or to obtain an
indication of the dosage regimen required as more fully defined in 21 C.F.R. §312.21(b). Such
phase II clinical trial shall be deemed to have commenced when such Licensed Product is first
administered to any patient enrolled in such phase II clinical trial. For the purposes of this
definition, the term “ALIMERA” shall include Alimera Sciences, Inc., its Affiliates, sublicensees
or any party in a co-promotion or co-marketing relationship with ALIMERA pertaining to such
Licensed Product.
1.31 “Initiation of Phase III Clinical Trials” shall mean the date of commencement of the
first human clinical trial phase III study, including the phase III portion of a phase II/III, of a
Licensed Product for a certain disease(s), as applicable, sponsored by ALIMERA, the principal
purpose of which is to establish safety and efficacy in patients with the disease being studied as
required in 21 C.F.R. §312.21(c). Such phase III clinical trial shall be deemed to have commenced
when such Licensed Product is first administered to any patient enrolled in such phase III clinical
trial. For the purposes of this definition, the term “ALIMERA” shall include Alimera Sciences,
Inc., its Affiliates, sublicensees or any party in a co-promotion or co-marketing relationship with
ALIMERA pertaining to such Licensed Product.
1.32 “Inventors” shall mean the named inventors of the Licensed Patents.
1.33 “Know-How” shall have the meaning set forth in Article 1.38.
1.34 “Licensed Active” shall have the meaning set forth in Article 1.41(b).
1.35 “Licensed Field of Use” shall mean therapeutic and prophylactic uses for the treatment of
diseases and disorders of the eye in humans.
1.36 “Licensed Patents” shall mean the patent applications identified in APPENDIX B, together
with any and all substitutions, extensions, divisionals, continuations, continuations-in-part (to
the extent that (i) the subject matter added in such continuations-in-part applications if
practiced would, but for the license granted herein, infringe a Valid Claim of the patent
applications identified in APPENDIX B or (ii) the claimed subject matter of such
continuations-in-part are disclosed and enabled in the parent Licensed Patent patent application;
and are not, as of the Effective Date, obligated exclusively to a third
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party, all to the extent such continuations-in-part are owned and/or controlled by EMORY or VA),
foreign counterparts of such patent applications and patents which issue on any of the foregoing
anywhere in the world, including reexamined and reissued patents.
1.37 “Licensed Product(s)” shall mean any process, service or product, the manufacture, use,
or sale of which is covered [*]. A Licensed Product can be a pharmaceutical formulation
containing one or more active ingredients that are covered by a Valid Claim within the Licensed
Patents, alone or in combination with other active ingredients, or as a kit in which the
pharmaceutical formulation is Sold together with a medical device, such as a medical device useful
for implanting the pharmaceutical formulation.
1.38 “Licensed Technology” shall mean all formulations, designs, technical information,
know-how, knowledge, data, specifications, test results and other information, whether or not
patented or patentable (“Know-How”), which are known, learned, invented, or developed by the
Inventors as of the Effective Date to the extent that (i) such Know-How is required, used or useful
for the manufacture, use, development, testing, marketing, export, import, offer for sale or sale
of any process, product or service covered by any Valid Claim of the Licensed Patents in the
Licensed Field of Use and (ii) EMORY possesses the right to license the use of such Know-How to
ALIMERA for commercial purposes, but excluding any and all such Know-How to the extent claimed by a
Valid Claim of the Licensed Patents.
1.39 “Licensed Territory” means the world.
1.40 “Losses” shall have the meaning set forth in Article 10.2.
1.41 “Net Selling Price” of a product (including a Licensed Product) shall mean, with respect
to a particular [*], the [*], plus, if applicable, [*], less only:
i) [*]
ii) [*]
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iii) [*]
iv) [*]
(a) For purposes of calculating Net Selling Price, no [*] shall be deemed to be a [*] of
ALIMERA or its Affiliates. Net Selling Price for the quantities of Licensed Product sold by [*]
shall be calculated based on the amount [*] rather than [*].
(b) Where Licensed Product is sold in the form of a combination or kit product containing an
active ingredient covered by a Valid Claim within the Licensed Patents (“Licensed Active”) in
addition to another active ingredient or, as applicable, a medical device (collectively, the
“Combination Product”), the Net Selling Price for such Combination Product for purposes of
determining royalties payable under this Agreement will be calculated by [*]. If, on a
country-by-country basis, the other active ingredient in the Combination Product or, as applicable,
the medical device, is not sold separately in such country, the Net Selling Price for the purpose
of determining royalties payable under this Agreement for the Combination Product shall be
calculated by [*]. If, on a country-by-country basis, the Licensed Product containing a Licensed
Active as the sole active ingredient is not sold separately in such country during the relevant [*]
but the other active ingredient in the Combination Product or, as applicable, the medical device,
is sold separately in such country during the relevant [*], the Net Selling Price for the
Combination Product shall be calculated by [*]
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[*]. If, on a country-by-country basis, the Licensed Product containing a Licensed Active as the
sole active ingredient is not sold separately and the other active ingredient in the Combination
Product or, as applicable, the medical device, is not sold separately in such country during the
relevant [*], the Net Selling Price for the purpose of determining royalties of the Combination
Product shall be [*].
c) Notwithstanding the foregoing in this Article 1.41, amounts received by ALIMERA, its
Affiliates or sublicensees of ALIMERA for the sale of Licensed Products among ALIMERA, its
Affiliates and sublicensees for resale shall [*].
1.42 “Notice of Exercise” shall have the meaning set forth in Article 2.5.
1.43 “Option Agreement” shall have the meaning set forth in the recitals.
1.44 “Optioned Field of Use” shall mean all therapeutic and prophylactic uses for the
treatment of diseases and disorders in humans excluding the Licensed Field of Use.
1.45 “Option Period” shall have the meaning set forth in Article 2.4.
1.46 “Option Proposal” shall have the meaning set forth in Article 2.5.
1.47 “Prosecution and Maintenance” and “Prosecute and Maintain” shall have the meanings set
forth in Article 7.1.
1.48 “Recovery” shall have the meaning set forth in Article 8.1.
1.49 “Royalty Term” shall mean, on a country by country basis, the time period from the first
Sale of Licensed Product in the Licensed Field of Use in the country within the Licensed Territory
(or the corresponding first sale by a sublicensee of Alimera) and ending, on a country by country
basis, on the later of (a) ten (10) years after that date of such first Sale (or sale) of Licensed
Product in such country or (b) the expiration of the last-to-expire Licensed Patent in such
country.
1.50 “Sale” or “Sold” shall mean the sale, transfer, exchange, or other disposition of Licensed
Products whether by gift or otherwise (including, but not limited to, the use of Licensed Products
by a Seller to provide services to any party that is not a Seller) by a Seller to any party that is
not a Seller. Sales of Licensed Products shall be deemed consummated upon the first to occur of:
(i) receipt of payment from the purchaser; (ii) delivery of Licensed Products to the purchaser or a
common carrier; (iii) release of Licensed Products from consignment; (iv) if deemed Sold by use,
when the subject Licensed Product is first put to such use; or (v) if deemed Sold by transfer,
exchange, gift or other disposition, when such transfer, exchange, gift or other disposition
occurs. Notwithstanding the foregoing definition
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of Sale or Sold, to the extent ALIMERA, its Affiliates or sublicensees distribute any Licensed
Product for test marketing, sampling and promotional uses, clinical trial purposes, regulatory
approval or compliance, compassionate uses, global access programs intended to provide Licensed
Product at reduced prices in the developing world, or other similar uses, only to the extent that
the actual Net Selling Price of such Licensed Product exceeds Fully Absorbed Costs will such
distribution be considered a Sale or Sold. If the actual Net Selling Price exceeds the Fully
Absorbed Costs, the distribution shall be deemed to be a Sale with a deemed Net Selling Price for
the purposes of Article 3.2 of the difference between the actual Net Selling Price and the Fully
Absorbed Cost therefor. For the sake of clarity and because EMORY receives a percentage of the
royalty that ALIMERA receives from sales of Licensed Product(s) by its sublicensee(s) pursuant to
Article 3.2 and Appendix F, sale of Licensed Product from ALIMERA to a sublicensee is not a Sale.
1.51 “Seller” shall mean ALIMERA or its Affiliates.
1.52 “Stockholder Agreements” shall have the meaning set forth in Article 3.1.
1.53 “Sublicensee Milestone Payment” shall have the meaning set forth in Article 3.6.
1.54 “Technology” shall have the meaning set forth in the recitals.
1.55 “U.S. Government Licenses” shall mean the non-exclusive license to the U.S. Government or
agencies thereof pursuant to NIH grant No.: AR47901, a copy of which is attached hereto as APPENDIX
C.
1.56 “VA” shall have the meaning set forth in the recitals.
1.57 “Valid Claim” shall mean any pending claim in a pending patent application or an issued
claim of an unexpired patent that has not been held invalid or unenforceable by a court or other
Governmental Authority of competent jurisdiction, unappealable or unappealed within the time
allowed for appeal, that has not been admitted to be invalid or unenforceable through reissue or
disclaimer, and that has not expired, lapsed, or been withdrawn, cancelled or abandoned.
ARTICLE 2. GRANT OF LICENSE AND OPTION
2.1 License. EMORY hereby grants ALIMERA and its Affiliates an exclusive right and
license to make, have made, develop, use, import, export, offer for sale, sell, have sold and
otherwise exploit Licensed Products and practice Licensed Technology and Licensed Patents in the
Licensed Field of Use in the Licensed Territory during the term of this Agreement.
2.2 Government Rights. The Licensed Patents, Licensed Technology or portions thereof
are co-owned by EMORY and the VA (assigned to the U.S. Government as represented by the Department
of Veterans Affairs) and were developed with financial or other assistance through grants or
contracts funded by the United States government. ALIMERA acknowledges that in accordance with
Public Law
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CONFIDENTIAL TREATMENT REQUESTED
96-517, 35 U.S.C. §§ 200-212, 15 U.S.C. § 3710a and other statutes, regulations, and Executive
Orders as now exist or may be amended or enacted, the United States government has certain rights
in the Licensed Patents and Licensed Technology, including the rights granted pursuant to 37 C.F.R.
§ 501.6, 38 C.F.R. § 1.655 and the U.S. Government License attached hereto in APPENDIX C, and EMORY
has certain obligations under the Licensed Patents and Licensed Technology to the United States
government. As provided in this Agreement or following receipt of a reasonable request from EMORY,
ALIMERA shall cooperate as reasonably necessary to assist EMORY in satisfying such obligations and
shall take all actions necessary (as an exclusive licensee of intellectual property owned/funded by
the United States government) under any federal law, statute, regulation or Executive Order
applicable to the Licensed Patents or Licensed Technology. Pursuant to these laws, statutes,
regulations and Executive Orders, the United States government may impose certain requirements or
exercise its rights regarding such intellectual property, including but not limited to the
requirement that products resulting from such intellectual property sold in the United States be
substantially manufactured in the United States. If the United States government should take
action which renders it impossible or impractical for EMORY to grant the rights and license, or
which conditions or reduces the rights and licenses granted herein to ALIMERA under this Agreement,
EMORY and ALIMERA may cause the terms of such rights and licenses to be equitably reformed upon the
mutual agreement of the parties to reflect such conditioned or reduced rights and licenses
(including without limitation with respect to the value and price of such rights and licenses) and
if such equitable reformation is not possible, without limiting ALIMERA’s right to terminate this
Agreement at any time pursuant to Article 12.6, the parties may terminate the Agreement upon their
mutual consent. ALIMERA shall not have any right to the return of any payments of any kind made by
it to EMORY prior to the date of such action; however, any payments made prior to the date of such
action shall be considered in any reformation of this Agreement.
2.3 Retained License. The license granted in Article 2.1 above is further
conditional upon and subject to a right and license retained by EMORY and the VA on behalf of each
of themselves and their research collaborators to make, use and transfer Licensed Products and
practice Licensed Technology for non-commercial research, educational or internal uses only.
2.4 Grant of Option. EMORY hereby grants ALIMERA an exclusive option to expand the
exclusive license granted under Article 2.1 to include the Optioned Field of Use under terms and
conditions materially similar to the terms and conditions of this Agreement, as modified by the
terms and conditions contained in the Amendment Terms attached hereto as APPENDIX D (hereinafter
the “Amendment Terms”). The initial term of the option shall be for a period of two (2) years from
the Effective Date (hereinafter referred to as “Initial Option Period”). ALIMERA may extend the
Initial Option Period for a total of four (4) one (1) year periods (each hereinafter referred to as
an “Initial Option
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CONFIDENTIAL TREATMENT REQUESTED
Period Extension,” and the Initial Option Period plus each and every Initial Option Period
Extension are collectively hereinafter referred to as the “Option Period”) by paying EMORY an
option maintenance fee within [*] prior to the applicable anniversary of the Effective Date for the
four (4) additional one-year extension periods as follows:
| Anniversary of Effective Date | Option Maintenance Fee | |
2nd
|
[*] | |
| 3rd | [*] | |
| 4th | [*] | |
| 5th | [*] |
2.5 Exercise of Option. Prior to the expiration of Option Period, ALIMERA may
exercise the option by notifying EMORY in writing that it is exercising its option (“Notice of
Exercise”) and concurrently providing a proposed development plan and proposed diligence milestones
for the development and commercialization of Licensed Products in the Optioned Field of Use
(“Option Proposal”). EMORY and ALIMERA shall negotiate in good faith and agree upon a development
plan and diligence milestones with respect to such Option Proposal, which will be included, along
with the Amendment Terms, in an amendment to this Agreement executed by both parties. If ALIMERA
and EMORY have not executed the amendment contemplated by this Article 2.5 for such Option Proposal
within [*] after the date of the corresponding Notice of Exercise is first presented to EMORY (or a
longer period if mutually agreed upon by the parties), either party may discontinue negotiations
with respect to such Option Proposal and amendment; provided, however, that so long as ALIMERA
continues to pay the option maintenance fee to the extent required by Article 2.4 above, ALIMERA
may submit additional Notices of Exercise (along with different Option Proposals) until the earlier
of (i) the date on which ALIMERA and EMORY execute an amendment to this Agreement in connection
with a Notice of Exercise and (ii) the end of the Option Period. If ALIMERA chooses to not
exercise its option during the Option Period or if no amendment as contemplated by this Article 2.5
is executed by the parties within [*] after the end of the Option Period (or a longer period if
mutually agreed upon by the parties), EMORY shall be free to license the Licensed Patents and the
Licensed Technology within the Optioned Field of Use to third parties.
2.6 Sublicenses. ALIMERA may grant sublicenses to sublicensees that are consistent
with the terms and conditions of this Agreement, provided that [*]. Unless otherwise consented to
in writing by EMORY (such consent not to be unreasonably withheld or delayed), [*]
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CONFIDENTIAL TREATMENT REQUESTED
[*]. ALIMERA shall include in any sublicense granted pursuant to this Agreement, (i) a provision
requiring the sublicensee to indemnify EMORY and maintain liability coverage substantially to the
same extent that ALIMERA is so required pursuant to Articles 10.2 and 10.4 of this Agreement and
(ii) the right for EMORY or ALIMERA to audit the sublicensee to the same extent that ALIMERA is so
required pursuant to Article 4.4 of this Agreement. Notwithstanding the foregoing, [*]. ALIMERA
shall provide EMORY with complete copies of all sublicense agreements within [*] after their
execution date, provided that ALIMERA shall have the right, prior to disclosing to EMORY, to redact
such copies to remove the confidential business information of the sublicensee to the extent that
such information does not relate to the Licensed Patents and/or Licensed Technology, including the
business plans and research plans of the sublicensee related solely to technology other than the
Licensed Patents and/or Licensed Technology. For the avoidance of doubt, ALIMERA may not remove
the economic terms of such sublicense agreements to the extent that such information relates to the
Licensed Patents and/or Licensed Technology. EMORY shall treat all copies of sublicense agreements
and other sublicensee (or potential sublicensee) information received from ALIMERA as Information
pursuant to Article 11 below. Upon termination of this Agreement for any reason, any sublicensee
shall have the right to seek a license from EMORY to the Licensed Patents and the Licensed
Technology, and EMORY agrees to negotiate such licenses in good faith under reasonable terms and
conditions (e.g., under terms and conditions substantially similar to those herein). At the
request of ALIMERA, EMORY agrees to [*]. ALIMERA shall ensure that any sublicense agreement it
enters into with any sublicensee includes a provision that requires ALIMERA to terminate such
sublicense in the event such sublicensee challenges, directly or indirectly, the validity,
enforceability and/or scope of any claim within the Licensed Patents in a court or other
governmental agency of competent jurisdiction.
2.7 No Implied License. The license and rights granted in this Agreement shall not be
construed to confer any rights upon ALIMERA by implication, estoppel, or otherwise as to any
technology not identified in this Agreement as Licensed Patents or Licensed Technology.
2.8 [*]. ALIMERA agrees that any Licensed Products used or sold in the United States will be
manufactured [*].
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CONFIDENTIAL TREATMENT REQUESTED
2.9 Option to Add Additional Inventions. If EMORY identifies an Additional Invention
(as defined below), then, subject to any conflicting third party rights, EMORY agrees to promptly
disclose such Additional Invention to ALIMERA in reasonable detail and such disclosure by EMORY
will be treated as Information pursuant to Article 11. If ALIMERA decides within [*] after receipt
of such disclosure that it would like to license such Additional Invention, then EMORY and ALIMERA
shall negotiate the terms of such license in good faith for a period not to exceed [*] (unless
otherwise agreed upon by the parties). For the purposes of this Agreement, an “Additional
Invention” shall mean any invention in the Licensed Field of Use which (i) is an improvement to the
Licensed Patents and (a) is dominated by the Licensed Patents and (b) is developed or invented by
one or more Inventors and (ii) is not already included in Licensed Patents or Licensed Technology.
2.10 Dominant Intellectual Property Right. To the extent that it is determined
jointly by EMORY and ALIMERA that EMORY, individually or jointly with any other party, owns any
right, title or interest in any Valid Claim that dominates or reads on a Valid Claim in the
Licensed Patents (hereinafter a “Dominating Valid Claim”), EMORY agrees to grant and hereby does
grant to ALIMERA the right and license (i) to make, have made, develop, use, import, export, offer
for sale, sell, have sold and otherwise exploit any process, service or product, the manufacture,
use, or sale of which is covered by any Dominating Valid Claim, and (ii) to practice such
Dominating Valid Claim in the Licensed Field of Use in the Licensed Territory during the term of
this Agreement. EMORY and ALIMERA shall each discuss such matter regarding a potential Dominating
Valid Claim in good faith and shall each act reasonably in considering such matter. If the parties
are unable to come to an agreement regarding such matter, then such dispute shall be settled by
arbitration pursuant to Article 14.
ARTICLE 3. CONSIDERATION FOR LICENSE
3.1 License Fee. As partial consideration for the license granted to ALIMERA under
this Agreement, ALIMERA shall, following (i) execution of this Agreement, (ii) receipt of required
approvals from ALIMERA’s board of directors (the “Board”) and preferred stockholders, and (iii)
EMORY’s execution of that certain Second Amended and Restated Stock Sale Agreement and that certain
Second Amended and Restated Investor Rights Agreement (in the form provided to EMORY and together,
the “Stockholder Agreements”), in each case as a “Common Holder” (as defined in the Stockholder
Agreements), a stock purchase agreement and any other ancillary agreements as reasonably required
by the Board, issue to EMORY that number of shares of ALIMERA’s common stock with a fair market
value equal to One Hundred Fifty Thousand Dollars ($150,000) on the date of issuance. Fair market
value shall be determined as set forth in Article 3.6. Should ALIMERA’s Board and/or the preferred
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CONFIDENTIAL TREATMENT REQUESTED
stockholders fail to approve the issuance of such common shares to EMORY within [*] after the
Effective Date of this Agreement, ALIMERA will pay EMORY One Hundred Fifty Thousand Dollars
($150,000) as the license fee in lieu of the issuance of such common shares within [*] after the
Effective Date. ALIMERA acknowledges that in accordance with EMORY’s Intellectual Property Policy,
the Inventors are to receive a portion of the ALIMERA common stock received as consideration
hereunder. Notwithstanding any transfer restrictions imposed on such shares of ALIMERA common
stock, ALIMERA agrees to the transfer of a portion of the ALIMERA common stock to such Inventors;
provided, that (a) such Inventors qualify as “accredited investors” within the meaning of Rule 501
of Regulation D of the Securities Act of 1933, as presently in effect and (b) such Inventors agree
to become a party to and to be bound by the Stockholder Agreements as “Common Holders” and any
other agreements respecting such transfer as reasonably required by the Board. Subject to this
Article 3.1, ALIMERA shall issue directly to EMORY and to the Inventors the number of shares of
ALIMERA common stock with a fair market value equal to One Hundred Fifty Thousand Dollars
($150,000) on the date of issuance as stated in APPENDIX E. ALIMERA shall issue such common stock
within [*] after the Effective Date. The shares of ALIMERA common stock issued pursuant to this
Agreement shall be subject to the same terms and conditions under the Stockholder Agreements as the
shares of ALIMERA common stock held by the other “Common Holders” party thereto, and shall be
subject to the same rights, preferences, privileges, restrictions and other matters relating to the
shares of ALIMERA common stock under ALIMERA’s certificate of incorporation, as in effect from time
to time, as all other shares of ALIMERA common stock. ALIMERA shall provide EMORY with [*].
3.2 Running Royalties. As partial consideration for the license granted to ALIMERA
under this Agreement, during the Royalty Term, ALIMERA shall pay EMORY a total royalty equal to the
appropriate percentage set forth on APPENDIX F attached hereto times, as appropriate, either (i)
the Net Selling Price of all Licensed Products Sold during the term of this Agreement by [*].
Royalties shall be due and payable on a [*]. For the sake of clarity, to the extent that ALIMERA
pays EMORY, pursuant to Article 3.6, a percentage of minimum royalty payments paid by sublicensees
to ALIMERA, ALIMERA shall owe EMORY no royalty payments under this Article 3.2 with respect to such
minimum royalty payments. Notwithstanding anything to the contrary herein, only one royalty
payment shall be due with respect to the same unit of Licensed Product regardless of, for example,
whether such Licensed Product is covered by [*]
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CONFIDENTIAL TREATMENT REQUESTED
[*].
3.3 Reduction of Running Royalties-Compulsory Licenses. Should a compulsory
license be granted to a third party with respect to Licensed Products in the Licensed Field of Use
in any country in the Licensed Territory with a royalty rate lower than the royalty rate provided
by Article 3.2, then the royalty rate to be paid by ALIMERA on Sales of Licensed Product in that
country under Article 3.2 shall be [*]. ALIMERA shall provide EMORY with prompt written notice of
any governmental or judicial procedures initiated in any country to impose a compulsory license of
which it is aware. If permitted by law, ALIMERA shall use commercially reasonable efforts to
oppose such compulsory license. At ALIMERA’s request, EMORY will cooperate reasonably with ALIMERA
in any legal action which ALIMERA may wish to take to oppose such compulsory license, which action
shall be at ALIMERA’s sole expense.
3.4 Reduction of Royalties-Third Party Royalties. In the event it becomes necessary
for ALIMERA, in the reasonable opinion of its counsel, to obtain a license from a third party in
order to make, have made, develop, import, export, use, sell, offer for sale, have sold or
otherwise exploit any Licensed Product, ALIMERA may, on a Licensed Product-by-Licensed Product and
country-by-country basis, offset against the royalties due and payable by ALIMERA to EMORY under
Article 3.2 in any calendar quarter (or portion thereof) by [*] of the amount of the royalties paid
by ALIMERA to third parties in such country during the same calendar quarter (or portion thereof);
provided however, in no event shall the royalties otherwise due and payable under Article 3.2 with
respect to any Licensed Product be reduced by more than [*] of the amount that would otherwise be
due to EMORY but for this Article 3.4.
3.5 Minimum Royalties. In the event that, following the first Final Regulatory
Approval of a Licensed Product for Sale in the Licensed Field of Use in a Major Market Country
(wherein “Major Market Country” means the United States, Japan, China, India or any European
country), the aggregate royalties paid to EMORY during any Calendar Year pursuant to Article 3.2
hereof do not equal or exceed the minimum royalty for such Calendar Year in accordance with the
schedule set forth in APPENDIX G, ALIMERA shall pay to EMORY no later than [*] following the last
day of such Calendar Year a dollar amount equal to the difference between such minimum royalty
amount and the actual accrued and paid royalties. Upon termination of this Agreement pursuant to
Article 12.6 in Japan, China or India, the minimum royalty shall increase in the Calendar Year in
which the date of termination occurred, and in each subsequent Calendar Year thereafter, by two
hundred fifty thousand dollars ($250,000) for each such country in which termination has occurred.
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CONFIDENTIAL TREATMENT REQUESTED
For the purpose of clarity and by way of an example, if ALIMERA has terminated its rights
hereunder in Japan and China during the second (2nd) Calendar Year following first Final
Regulatory Approval, the minimum royalty for the second and each subsequent Calendar Year would be
as follows:
| Calendar Year after first Final Regulatory Approval | ||
| of a Licensed Product Approved Within the | ||
| Licensed Field of Use in a Major Market Country | Minimum Royalty | |
Year 1 (1st full Calendar Year following first Final Regulatory Approval)
|
Not Applicable | |
Year 2
|
[*] | |
Year 3
|
[*] | |
Year 4 and subsequent years
|
[*] |
3.6 Non-Royalty Payments From Sublicensees. Within [*] after receipt by ALIMERA,
ALIMERA shall pay EMORY the appropriate percentage set forth on APPENDIX H attached hereto times
any fees or payments paid to ALIMERA by a sublicensee [*], to the extent any such payment is
directly attributable to the sublicense of the Licensed Patents and Licensed Technology. Such
payments shall not include [*]. For purposes of this Agreement, [*]. The per share fair market
value of ALIMERA’s equity shall be (i) if publicly traded and listed on a national exchange, the
per share fair market value as listed on such exchange, (ii) if not publicly traded, the per share
amount paid by an investor to ALIMERA in the most recent round of financing within the [*] period
immediately preceding an equity purchase by a sublicensee, or (iii), if not publicly traded and no
round of financing occurred in the immediately preceding [*] period, the per share fair market
value of ALIMERA’s equity shall be agreed upon by the parties in good faith. In the event that
ALIMERA and EMORY cannot agree on a per share price within [*], said price shall be determined by
the appraiser
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CONFIDENTIAL TREATMENT REQUESTED
last used by ALIMERA. In the event ALIMERA owes EMORY [*], ALIMERA shall have the option of
remitting payment to EMORY in the form of equity in ALIMERA in accordance with APPENDIX E, with the
per share market value of such equity determined as set forth above.
Notwithstanding anything to the contrary herein, in no event shall the portion of any
non-royalty cash payment that ALIMERA pays to EMORY for achievement of a certain milestone
specified in Article 3.7 below by a sublicensee (hereinafter referred to as “Sublicensee Milestone
Payment”) be less than the amount of such milestone payment specified in Article 3.7. If the
Sublicensee Milestone Payment is less than the amount of such milestone payment, then ALIMERA shall
also pay EMORY the difference between the applicable milestone payment and the Sublicensee
Milestone Payment. Any payments made by ALIMERA to EMORY for receipt of non-royalty cash payments
from a sublicensee for achievement of the milestones under a sublicense agreement shall be
creditable towards the milestone payments in Article 3.7 that have not yet been paid by ALIMERA.
For the purpose of clarity, if one or more phases of a clinical trial does not occur, but a later
phase of a clinical trial is begun, then for the purposes of this Article 3.6, the one or more
phases of a clinical trial that does not occur will have been deemed to have ended.
3.7 Milestone Payments. ALIMERA shall pay EMORY milestone payments in the amount
specified in APPENDIX I attached hereto no later than [*] after the first occurrence of the
corresponding event designated in APPENDIX I attached hereto. For the purpose of clarity, if one
or more milestone(s) (a) though (c) (as listed in APPENDIX I) is not achieved, but a later
milestone (b) — (d) is achieved, then ALIMERA shall pay EMORY the milestone payment not only for
the later milestone achieved, but also for the one or more earlier milestone(s) that were not
achieved, provided that ALIMERA has not yet made the milestone payment(s) associated with such
earlier milestone(s). Each milestone payment shall be payable only the first time such milestone
is achieved, regardless of the number of Licensed Products, the number of indications for a
Licensed Product or the number of IND submissions, clinical trials initiated or regulatory
approvals for a Licensed Product.
3.8 License Maintenance Fees. In the event no milestone payment has been paid to
EMORY prior to the anniversary of the Effective Date as set forth on APPENDIX J attached hereto,
ALIMERA shall pay to EMORY, within [*] from the pertinent anniversary date, the maintenance fee set
forth opposite such anniversary in APPENDIX J attached hereto. No maintenance fee pursuant to this
Article 3.8 shall be payable by ALIMERA in the event it or its Affiliates or sublicensees have
achieved at least one milestone and EMORY has been paid the corresponding milestone payment.
3.9 Reimbursement for Patent Expenses. ALIMERA shall reimburse EMORY for all
reasonable external out-of-pocket fees, costs, and expenses incurred by EMORY after the Effective
Date during the
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CONFIDENTIAL TREATMENT REQUESTED
term of this Agreement in filing, prosecuting, and maintaining the Licensed Patents in the Licensed
Territory; provided, however, that if the Option Period expires, ALIMERA has not exercised the
option, and thereafter EMORY grants one or more commercial licenses to the Licensed Patents, the
reimbursement to EMORY of such fees, costs and expenses for work performed subsequent to any such
grant(s) shall be equally divided among ALIMERA and the other licensee(s). Notwithstanding the
foregoing, ALIMERA shall not be obligated to reimburse EMORY for any such fees, costs, and expenses
if ALIMERA notifies EMORY of such desire to not pay expenses for such fees, costs and expenses in
accordance with Article 7.2 or 7.3. ALIMERA shall deliver reimbursements to EMORY within [*] after
EMORY, from time to time, notifies ALIMERA in writing of the amount of such fees, costs, and
expenses which have been paid or incurred by EMORY and provide copies of invoices with backup
support.
3.10 Tax Payments. Each party shall comply with applicable laws and regulations
regarding filing and reporting for income tax purposes. Neither party shall treat their
relationship under this Agreement as a pass through entity or partnership for tax purposes. All
payments made under the Agreement shall be free and clear of any and all taxes, duties, levies,
fees or other charges, except for withholding taxes, value-added taxes or similar taxes. Each
party shall be entitled to deduct from its payments to the other party under this Agreement the
amount of any withholding taxes required to be withheld under any applicable law or regulation, and
all withheld amounts shall be paid to the appropriate governmental authority on behalf of the other
party (and not refunded or reimbursed). Each party shall deliver to the other party, upon
reasonable request, proof of payment of all such withholding taxes. Each party shall provide
reasonable assistance to the other party in seeking any benefits available to such party with
respect to government tax withholdings by any relevant law, regulation or double tax treaty.
Notwithstanding the foregoing, in the event that ALIMERA withholds any value-added-tax or similar
tax imposed by a country other than the United States on Sales of a Licensed Product, and ALIMERA
determines such tax to be recoverable by ALIMERA through a foreign tax credit, ALIMERA will pay the
amount that EMORY would have otherwise received but for the withholding in the period during which
such tax credit is actually recovered by ALIMERA, but only to the extent any such tax credit
actually reduces ALIMERA’s taxes due.
ARTICLE 4. REPORTS AND ACCOUNTING
4.1 Progress Reports. Within [*] after each June 30 and December 31 for the first [*]
after the Effective Date, ALIMERA shall provide EMORY with a written semi-annual progress report
detailing the activities of ALIMERA relevant to ALIMERA’s Development
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CONFIDENTIAL TREATMENT REQUESTED
Plan and the development and commercialization of Licensed Products. ALIMERA will thereafter
provide such progress reports on an annual basis within [*] after December 31.
4.2 Royalty Reports. During the Royalty Term, ALIMERA shall furnish, or cause to be
furnished to EMORY, written reports governing each of ALIMERA and ALIMERA’s Affiliates calendar
quarters showing:
(i) [*] and the number of units of all Licensed Products (identified by product number/name)
Sold by the Sellers and sold by the sublicensees, in each country of the Licensed Territory during
the reporting period, together with the calculations of Net Selling Price in accordance with
Article 1.41 (for Licensed Products Sold by Sellers) and the royalties received by ALIMERA from
sublicensees for such sales of Licensed Products by such sublicensees; and
(ii) the royalties pursuant to Article 3.2 payable in Dollars, which shall have accrued
hereunder in respect to such Sales (or sales by sublicensees) together with the calculation of how
such royalties were determined; and
(iii) the exchange rates, if any, in determining the amount of Dollars; and
(iv) a summary of all reports provided to ALIMERA by ALIMERA’s sublicensees, including the
names and addresses of all sublicensees; and
(v) the amount of any consideration received by ALIMERA from sublicensees and an explanation
of the contractual obligation satisfied by such consideration; and
(vi) the occurrence of any event triggering a Milestone Payment obligation or any other
payment in accordance with Article 3.
Reports shall be made semiannually until the first Sale of a Licensed Product and quarterly
thereafter. Semiannual reports shall be due within [*] after the close of every second and fourth
calendar quarter. Quarterly reports shall be due within [*] after the close of every calendar
quarter. ALIMERA shall use commercially reasonable efforts to keep accurate records in sufficient
detail to enable royalties and other payments payable hereunder to be determined. [*].
4.3 Records. During the term of this Agreement and for a period of [*] thereafter,
ALIMERA shall keep at its principal place of business (and shall ensure that its sublicensees keep
at their principal places of business) true and accurate records of all Sales and sales by
sublicensees in accordance with GAAP in the respective country where such Sales or sales occur and
in such form and manner so that all royalties owed to EMORY may be readily and accurately
determined.
4.4 Right to Audit. EMORY shall have the right, upon at least [*] prior written
notice to ALIMERA, not more than [*] in each ALIMERA fiscal year during the term of this Agreement
and
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CONFIDENTIAL TREATMENT REQUESTED
the calendar year immediately following termination of the Agreement, through an independent
certified public accountant selected by EMORY and reasonably acceptable to ALIMERA (“Auditor”), to
have access during normal business hours of ALIMERA to examine the records of ALIMERA to include,
but not be limited to, sales invoice registers, sales analysis reports, original invoices,
inventory records, price lists, sublicense and distributor agreements, accounting general ledgers,
and sales tax returns, as may be reasonably necessary in order to verify the accuracy of the
reports required under Article 4.2 herein and the calculation of any payment due under this
Agreement. ALIMERA shall include in any sublicenses granted pursuant to this Agreement, a
provision requiring the sublicensee to keep and maintain records of sales made pursuant to such
sublicense and to grant access to such records by an Auditor. The Auditor’s report shall be
disclosed to both parties. ALIMERA or its sublicensee may require the Auditor to execute a
reasonable nondisclosure agreement prior to conducting any audits contemplated under this Article
4.4. If the Auditor’s report shows any underpayment of royalties or other payments by ALIMERA, its
Affiliates or sublicensees, within [*] after ALIMERA’s receipt of such report, ALIMERA shall remit
or shall cause its sublicensees to remit to EMORY:
(i) the amount of such underpayment; and
(ii) if such underpayment exceeds [*] percent of the total royalties owed for the fiscal year
then being reviewed, the reasonably necessary fees and expenses of such Auditor. Otherwise, the
Auditor’s fees and expenses shall be borne by EMORY.
ARTICLE 5. PAYMENTS
5.1 Payment Due Dates. Unless otherwise specified in this Agreement, royalties and
sublicense fees payable to EMORY as a result of activities occurring during the period covered by
each royalty report provided for under Article 4 of this Agreement shall be due and payable on the
date such royalty report is due. Payments of royalties in whole or in part may be made in advance
of such due date. All other payments required under this Agreement, if not specified otherwise in
this Agreement, shall be payable within [*] after the due date for each payment. All payments due
to EMORY under this Agreement shall be made in person or via the United States mail or private
carrier to the following address:
Emory University
Attn: Director, Office of Technology Transfer
0000 Xxxxxxx Xxxx XX, 0xx Xxxxx
Mailstop 1599/001/1AZ
Xxxxxxx, Xxxxxxx 00000
Facsimile: (000) 000-0000
Attn: Director, Office of Technology Transfer
0000 Xxxxxxx Xxxx XX, 0xx Xxxxx
Mailstop 1599/001/1AZ
Xxxxxxx, Xxxxxxx 00000
Facsimile: (000) 000-0000
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CONFIDENTIAL TREATMENT REQUESTED
Any payment in excess of one hundred thousand ($100,000.00) dollars or originating outside of
the United States shall be made by wire transfer to an account of EMORY designated by EMORY in
writing from time to time and royalty reports shall be sent by facsimile or express courier to the
Director, Office of Technology Transfer on the same date.
5.2 Currency Conversion. Except as hereinafter provided in this Article 5.2, all
royalties shall be paid in Dollars. If any Licensed Products are Sold for consideration other than
Dollars, the Net Selling Price of such Licensed Products shall first be determined in the foreign
currency of the country in which such Licensed Products are Sold and then converted to Dollars
using a [*] trailing average rate published by the Wall Street Journal (U.S. editions) for
conversion of the foreign currency into Dollars on the last day of the quarter for which such
payment is due.
5.3 Interest. Royalties and other payments required to be paid by ALIMERA pursuant to
this Agreement shall, if overdue, bear interest until payment at a per annum rate of [*] above the
average of the prime rate as published in the Wall Street Journal during the [*]
immediately preceding the due date of such overdue payment. The payment of such interest shall not
foreclose EMORY from exercising any other rights it may have because any payment is overdue.
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CONFIDENTIAL TREATMENT REQUESTED
ARTICLE 6. DILIGENCE AND COMMERCIALIZATION
6.1 Diligence and Commercialization. ALIMERA shall use [*], either directly or
through Affiliates or sublicensees, throughout the term of this Agreement to comply with ALIMERA’s
Development Plan, as may be modified by the mutual agreement of EMORY and ALIMERA from time to
time, and to bring Licensed Products to market for the Licensed Field of Use. [*]. The
obligations set forth in this Article 6.1 are expressly conditioned upon the absence of any serious
adverse conditions or event relating directly to the safety or efficacy of the Licensed Product
including the absence of any action by the FDA or any other similar Governmental Authority or any
independent data safety monitoring board limiting the development or commercialization of Licensed
Product. ALIMERA shall include substantially similar diligence and commercialization terms in any
sublicense agreement.
6.2 Development Milestones. ALIMERA shall adhere to the schedule of development
milestones and dates set forth in APPENDIX K (each, a “Development Milestone Deadline”). If
ALIMERA misses or reasonably believes it is likely to miss any Development Milestone Deadline due
to any circumstance beyond its reasonable control, then the parties shall negotiate in good faith a
revised Development Milestone Deadline. Any Development Milestone Deadline set forth in APPENDIX K
shall be extended for [*] period of [*] (or longer if mutually agreed upon by the parties) if
ALIMERA pays EMORY a development milestone extension fee of [*] at least [*] prior to such
Development Milestone Deadline, and in each such event, each subsequent milestone deadline shall be
extended by [*] (or longer if mutually agreed upon by the parties). If ALIMERA fails to meet any
Development Milestone Deadline set forth in APPENDIX K (as may have been extended as provided in
this Article 6.2 by payment of the development milestone extension fee), EMORY may, upon at least
[*] prior written notice, terminate or partially terminate this Agreement and grant third parties
identical or lesser rights in the Licensed Patents and Licensed Technology as granted to ALIMERA
hereunder, unless within such [*] period, ALIMERA meets such Development Milestone Deadline.
Notwithstanding the foregoing, EMORY shall not unreasonably withhold its consent and shall not
require a payment in connection with its consent to an extension to a Development Milestone
Deadline if the reason for missing or likely missing such
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CONFIDENTIAL TREATMENT REQUESTED
Development Milestone Deadline is caused by any action or delay in action by the FDA or similar
Governmental Authority as documented in writing to EMORY by ALIMERA prior to the relevant
Development Milestone Deadline (as extended, if applicable).
6.3 Sublicensee Performance. EMORY agrees that a sublicensee’s performance of its
diligence obligations regarding a Licensed Product as set forth in the sublicense agreement shall
be deemed to be performance by ALIMERA towards fulfillment of its diligence obligations for such
Licensed Product under this License Agreement, including, but not limited to, those set forth in
this Article 6.
ARTICLE 7. PATENT PROSECUTION AND IMPROVEMENTS
7.1 Prosecution and Maintenance. [*] shall select an outside counsel (“Outside
Patent Counsel”), who is reasonably qualified, to be responsible for the Prosecution and
Maintenance of the Licensed Patents. For the purposes of this Agreement, “Prosecution and
Maintenance” or “Prosecute and Maintain”, with respect to a particular patent application or
patent, means the preparation, filing, prosecution and maintenance of such patent or patent
application, as well as re-examinations, reissues, applications for patent term extensions and the
like with respect to such patent or patent application, together with the conduct of interferences,
the defense of oppositions and other similar proceedings with respect to such patent or patent
application.
7.2 Licensed Patents. The Prosecution and Maintenance of the Licensed Patents shall
be the primary responsibility of [*], and [*] shall use diligent efforts in its Prosecution and
Maintenance of the Licensed Patents. [*] shall instruct Outside Patent Counsel to (and shall be
diligent in ensuring that Outside Patent Counsel does) promptly provide [*] with copies of all
filings and correspondence pertaining to such Prosecution and Maintenance activities so as to give
[*] reasonable opportunities to comment and advise [*] and Outside Patent Counsel and cooperate
with [*] in such Prosecution and Maintenance. Each party shall advise and consult with the other
party promptly after receiving any action or development in the Prosecution and Maintenance of any
patent application or patent being Prosecuted and Maintained (including issues regarding the scope
of, the issuance of, the rejection of, an interference involving, or an opposition to any such
patent application or resulting patent). [*]. In no event shall [*] agree to consider the
comments of or incorporate the comments of another licensee in connection with the Prosecution and
Maintenance of the Licensed Patents in a manner that would (i) prevent [*] from [*] in the
Prosecution and Maintenance of the Licensed Patents or (ii) otherwise have the effect of placing
[*] at a disadvantage in
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CONFIDENTIAL TREATMENT REQUESTED
[*]. [*] may [*] in connection with the Prosecution and Maintenance of the Licensed Patents,
provided that [*], acting reasonably and in good faith, also [*] in connection with the Prosecution
and Maintenance of the Licensed Patents. In the event [*] desires to transfer the Prosecution or
Maintenance of any of the Licensed Patents to new patent counsel, [*] written consent shall be
obtained prior to the commencement of such transfer, which consent shall not be unreasonably
withheld. [*] shall notify [*] in writing of the countries in which [*] wishes additional patent
applications to be filed, including but not limited to divisionals, continuations, national phase
filings and registrations in countries from regional filings. [*] shall file such additional
patent applications and reimbursement of related patent filing expenses shall be made by [*]
pursuant to Article 3.9. [*] may, at its own expense, file patent applications in those countries
in which [*] elects not to file such applications and such applications shall not be subject to any
license granted to [*] hereunder. If [*] should fail to timely make reimbursement for undisputed
patent expenses as required in Article 3.9 of this Agreement, [*], in addition to its other
remedies under the Agreement, shall have no further obligation to Prosecute and Maintain such
Licensed Patents for which [*] failed to make timely reimbursement, provided that such failure to
make timely reimbursement is not cured by [*] within [*] after written notice thereof by [*] to
[*]. [*], upon [*] advance written notice to [*], may advise [*] that it no longer wishes to pay
expenses for filing, prosecuting or maintaining one or more Licensed Patents in one or more
jurisdictions in the Licensed Territory. [*] may, at its option, elect to pay such expenses or
permit such Licensed Patents to become abandoned or lapsed in such jurisdiction(s). If [*] elects
to pay such expenses, such patents/patent applications shall not be subject to any license granted
to [*] hereunder. If [*] declines to Prosecute and Maintain any Licensed Patent in any country for
which [*] is making timely reimbursement for undisputed patent expenses or for which [*] has
requested [*] to file a patent application, [*] shall give timely (in light of any applicable
filing deadlines) notice to [*] of any such determination so as to give [*] reasonable
opportunities to undertake such action. In such event, [*] shall have the right (but shall not be
obligated) to undertake such action in respect of any such Licensed Patents, at [*] sole expense.
7.3 Extension of Licensed Patents. Following the filing of each new drug
application (NDA), or comparable application in jurisdictions other than the United States, by [*]
in connection with a Licensed Product in a particular country, EMORY and ALIMERA shall in good
faith consult with each other regarding the extension of the normal term of the Licensed Patents if
such Licensed Product is
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CONFIDENTIAL TREATMENT REQUESTED
granted regulatory approval in such country. [*] may request that [*] have the normal term of any
Licensed Patents extended or restored under a country’s procedure of extending patent term for time
lost in government regulatory approval processes, and the expense of the same shall be borne in
accordance with the terms of Article 3.9. [*] shall use diligent efforts to extend the term of the
Licensed Patents as requested by [*]. [*] shall assist [*] to take whatever action is necessary to
obtain such extension. In the case of such extension, royalties pursuant to Article 3 hereof shall
be payable [*]. In the event that [*] does not elect to extend Licensed Patents with respect to a
particular country following consultation by the parties per the first sentence of this Article
7.3, [*] may, at its own expense or at the expense of one or more commercial licensees, affect the
extension of such Licensed Patents with respect to the applicable country. If [*] or such
commercial licensees elect to pay such expenses and affect the extension of such Licensed Patents
with respect to the applicable country, such extended Licensed Patents shall [*].
7.4 Copying VA on Patent Correspondence. [*] acknowledges [*] obligation under the
terms of the IIA to provide VA with copies of all filings and correspondence pertaining to the
Prosecution and Maintenance activities.
ARTICLE 8. INFRINGEMENT
8.1 ALIMERA shall promptly notify EMORY, and EMORY shall promptly notify ALIMERA, of any
suspected infringement of any Licensed Patents in the Licensed Field of Use. During the term of
this Agreement, EMORY and ALIMERA shall have the right to institute an action for infringement of
the Licensed Patents against a third party in accordance with the following:
[*] shall have the first right, but not the obligation, to enforce any Licensed Patents in the
Licensed Field of Use against such infringement, including without limitation by initiation of
proceedings, settlement or compromise, and shall bear the entire cost of such action, including
defending any counterclaims brought against [*] and paying any judgments rendered against [*]. To
the extent [*] takes any such action, [*] shall control such action, and [*] may, upon prior
written notice to [*], enter into settlements, stipulated judgments or other arrangements with
respect to such infringement; provided that if such proposed settlement, stipulated judgment or
other arrangement adversely affects [*] interests and/or adversely affects a field of use other
than the Licensed Field of Use, [*] shall not enter into such settlement, stipulated judgment or
other arrangement without [*] prior written consent, such consent not to be unreasonably withheld
or delayed. The parties acknowledge that it may be reasonable for [*] to [*]
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CONFIDENTIAL TREATMENT REQUESTED
[*]. [*] shall cooperate with [*] in such effort, at [*] reasonable expense, including being
joined as a party to such action, if necessary. Any recovery or settlement received as the result
of such action (whether for punitive or exemplary damages, or any other recovery or settlement
received, including compensatory damages or damages based on a loss of revenues (hereinafter
referred to as “Recovery”)), shall first be used to reimburse the documented out-of-pocket costs
and expenses incurred by ALIMERA and EMORY in pursuing such action, and to the extent any portion
of the balance of the Recovery represents [*] damages directly related to the Licensed Field of
Use, for example, [*], such portion shall be deemed to be [*], and ALIMERA shall pay to EMORY an
amount representing [*]. Any remaining amounts of such Recovery that represents, for example, [*]
damages (such as [*] or [*] damages) shall be paid [*] to ALIMERA and [*] EMORY.
If [*] shall fail, within [*] after receiving notice from [*] of a potential infringement in
the Licensed Field of Use, or providing [*] with notice of such infringement, to either (i)
terminate such infringement or (ii) institute an action to prevent continuation thereof and
thereafter to prosecute such action diligently or (iii) obtain [*] consent not to institute an
action to prevent continuation thereof, or if [*] notifies [*] that it does not plan to terminate
the infringement or institute such action, then [*] shall have the right to do so at its own
expense. [*] shall cooperate with [*] in such effort, at [*] reasonable expense, including being
joined as a party to such action if necessary. [*].
8.2 Should either EMORY or ALIMERA commence a suit under the provisions of this Article 8
and thereafter elect to abandon such suit, the abandoning party shall give timely notice to the
other party who may, if it so desires, continue prosecution of such suit, provided that the sharing
of expenses and any recovery in such suit shall be as agreed upon between EMORY and ALIMERA.
8.3 Third Party Claims. In the event that any action, suit or proceeding is brought
against, or written notice or threat thereof, is provided to [*] by a third party alleging
infringement of any patent or unauthorized use or misappropriation of technology arising out of [*]
practice of Licensed Technology or Licensed Patents in the Licensed Field of Use or manufacturing,
development, use, import, export, sale or other exploitation of Licensed Products, [*] shall have
the right to
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CONFIDENTIAL TREATMENT REQUESTED
defend and control the defense of such action, suit or proceeding as well as to initiate and
control any counterclaim or other similar action. [*] shall fully cooperate with [*] (at [*]
reasonable expense) in defense of such action, suit or proceeding, counterclaim or other similar
action, including being joined as a party, if necessary. [*] shall have the right to settle or
compromise such action, suit or proceeding, provided that if such settlement or compromise
adversely affects [*] shall not settle or compromise without [*] prior written consent, such
consent not to be unreasonably withheld or delayed. [*].
ARTICLE 9. LIMITED WARRANTY AND EXCLUSION OF WARRANTIES
9.1 Limited Warranty. EMORY hereby represents and warrants that, as of the
Effective Date;
(i) it has the right, power and authority to enter into this Agreement on behalf of both the
VA and EMORY and to grant the exclusive option, rights and licenses set forth in this Agreement;
and
(ii) except for the rights retained by and/or granted to the United States Government as set
forth in Article 2.2 above and the retained license as set forth in Article 2.3, there are no
outstanding options, licenses or agreements relating to Licensed Technology or Licensed Patents
with respect to the Licensed Field of Use or Optioned Field of Use other than as set forth in the
IIA and those granted to ALIMERA herein; and
(iii) the IIA is a valid and binding obligation of the parties thereto, enforceable against
the parties in accordance with its terms; and
(iv) EMORY has provided ALIMERA with a true and complete copy of the IIA; and
(v) EMORY is not in default under the terms of the IIA, nor is EMORY aware of the occurrence
of any event or circumstance that could reasonably be expected to constitute any event of default
thereunder; and
(vi) none of the non-provisional patent applications listed in Appendix B, Licensed Patents,
has lapsed, expired or been cancelled, abandoned, opposed or the subject of a reexamination
request; and
(vii) to the best of EMORY’s Office of Technology Transfer’s knowledge, after good faith and
reasonably thorough consultation with the Inventor, there are no threatened or pending actions,
lawsuits, claims or arbitration or administrative proceedings in any way relating to the Licensed
Patents or
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CONFIDENTIAL TREATMENT REQUESTED
Licensed Technology; and
(viii) EMORY’s Office of Technology Transfer has communicated to ALIMERA any and all bases on
which an action, lawsuit or claim may be made, challenging the inventorship or ownership, scope,
validity or enforceability of any of the Licensed Patents or Licensed Technology of which it is
aware, to the best of its knowledge, following good faith and reasonably thorough consultation with
the Inventor; and
(ix) to the best of EMORY’s Office of Technology Transfer’s knowledge, EMORY’s right, title
and interest in the Licensed Patents and the Licensed Technology are free and clear of any lien,
encumbrance or security interest; and
(x) to the best of EMORY’s Office of Technology Transfer’s knowledge, EMORY does not,
individually or jointly with any other party, own any right, title or interest in any invention,
technology or intellectual property right that dominates or reads on the subject matter of the
claims set forth in the Licensed Patents.
In addition, EMORY hereby represents and warrants that (i) except for the rights retained by
and/or granted to the United States Government as set forth in Article 2.2 above and the retained
license as set forth in Article 2.3, there will be no outstanding options, licenses or agreements
relating to Licensed Technology or Licensed Patents with respect to the Licensed Field of Use
(during the term of this Agreement) or Optioned Field of Use (during the Option Period or, if
applicable, the term of the amendment to this Agreement to account for the rights and licenses in
the Optioned Field of Use) other than as set forth in the IIA and those granted to ALIMERA herein
and (ii) EMORY will provide to ALIMERA true and complete copies of any and all amendments, side
letters and other documents that amend, modify and/or change the terms of the IIA, and EMORY will
not enter into any amendment, side letter or other document that amends, modifies and/or changes
the terms of the IIA in a manner that adversely affects the rights of ALIMERA hereunder without the
prior written consent of ALIMERA.
EMORY DOES NOT WARRANT [*] AND MAKES NO REPRESENTATION WHATSOEVER WITH REGARD TO [*].
9.2 Alimera. ALIMERA represents and warrants that:
(i) it possesses the reasonably necessary expertise and skill in the technical areas
pertaining to the Licensed Patents, Licensed Products and Licensed Technology to make its own
evaluation of the capabilities, safety, utility and commercial application of the Licensed Patents,
Licensed Products and Licensed Technology; and
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CONFIDENTIAL TREATMENT REQUESTED
(ii) ALIMERA has the right, power and authority to enter into this Agreement and has obtained
all approvals, permits, and consents necessary to enter into this Agreement and [*]; and
(iii) the execution, delivery and to ALIMERA’s knowledge, [*] does not violate any applicable
law or regulation of any court, governmental body or administrative or other agency having
jurisdiction over it.
9.3 Merchantability and Exclusion of Warranties. OTHER THAN THE WARRANTIES IN THIS
ARTICLE 9, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO THE
LICENSED PATENTS, LICENSED TECHNOLOGY, LICENSED PRODUCTS OR ANY OTHER SUBJECT MATTER OF THIS
AGREEMENT AND EXPRESSLY DISCLAIMS ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE [*].
ARTICLE 10. DAMAGES, INDEMNIFICATION AND INSURANCE
10.1 No Liability. EMORY shall not be liable to ALIMERA or ALIMERA’s Affiliates, or
customers and/or sublicensees of ALIMERA or ALIMERA’s Affiliates for [*]. For the avoidance of
doubt, this Article 10.1 shall not be construed to limit EMORY’s liability with respect to its
breach of any covenant, representation or warranty under this Agreement.
10.2 Indemnification. ALIMERA shall defend, indemnify, and hold harmless the
Indemnitees, from and against any and all claims, demands, loss, liability, expense, or damage
(including investigative costs, court costs and reasonable attorneys’ fees) payable to third
parties (“Losses”) Indemnitees may suffer, pay, or incur as a result of claims, suits, demands,
judgments or actions by third parties (“Claims”) against any of the Indemnitees arising or alleged
to arise by reason of, or in connection with, [*]
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CONFIDENTIAL TREATMENT REQUESTED
[*]. An Indemnitee shall promptly, but in no event more than [*] after receiving any Claim, notify
ALIMERA in writing of any such Claim and provide reasonable assistance to ALIMERA in the defense of
such Claim. ALIMERA shall have the right to control such defense to the extent it relates to its
obligations under this Article 10, but shall not settle or compromise any such Claim in a manner
that does not include the complete release of EMORY from liability and does not harm Emory in any
other material way without the prior written consent of EMORY, such consent not to be unreasonably
withheld or delayed. ALIMERA agrees, at its own expense, to provide attorneys [*] to defend
against any Claim with respect to which ALIMERA has agreed to provide indemnification hereunder.
ALIMERA’s obligations under this Article shall survive the expiration or termination of this
Agreement for any reason. The obligations set forth in this Article 10.2 shall not apply to any
Losses to the extent that such Losses results from EMORY’s breach of any of its representations and
warranties contained in this Agreement or the gross negligence or willful misconduct of EMORY or
any of the other Indemnitees.
10.3 Limitation on Damages. Notwithstanding anything in this Agreement to the
contrary, in no event shall either party be liable to the other for any [*] whether based upon
breach of warranty, breach of contract, negligence, strict tort or any other legal theory, even if
such party has been advised of the same, except in connection with [*].
10.4 Insurance. Without limiting ALIMERA’s indemnity obligations under the
preceding paragraph, ALIMERA shall, prior to any human clinical trial or Sale of any Licensed
Product, cause to be in force and maintain, an “occurrence based type” liability insurance policy
or, if ALIMERA is unable to obtain “occurrence based type” liability insurance, a “claims made
type” (with at least [*] tail coverage) liability insurance policy which includes the following:
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CONFIDENTIAL TREATMENT REQUESTED
(i) contains coverage for (i) product liability, (ii) broad form contractual liability for
ALIMERA’s indemnification obligations under Article 10.2 of this Agreement and (iii) tort
liability, in each case, assumed under an insured contract; and
(ii) names EMORY as an additional insured for all Claims set forth in Article 10.2 of this
Agreement, except for Claims to the extent that they result from EMORY’s breach of any of its
representations and warranties contained in this Agreement or its gross negligence or willful
misconduct; and
(iii) requires the insurance carrier to provide EMORY with no less than [*] written notice of
any materially adverse change in the terms or coverage of the policy or its cancellation; and
(iv) provides product liability coverage in an amount no less than [*], subject to a
reasonable aggregate amount.
10.5 Notification. ALIMERA shall notify EMORY prior to its first human clinical
trial or commercial Sale of any Licensed Product, of all insurance coverage available to ALIMERA to
meet ALIMERA’s obligations under Articles 10.2 and 10.4 of this Agreement.
10.6 Insurance Term. ALIMERA shall maintain the insurance required to be maintained
under Article 10.4 for (i) the period that any Licensed Product is in any clinical trial or is
being commercially distributed or Sold by a Seller and (ii) a period of [*] thereafter.
10.7 Notice of Claims. ALIMERA shall promptly notify EMORY of all Claims that names
the Indemnitees for which ALIMERA becomes aware.
ARTICLE 11. CONFIDENTIALITY
11.1 Treatment of Confidential Information. Except as otherwise provided hereunder,
during the term of this Agreement and for a period of [*] thereafter:
(i) ALIMERA and its Affiliates and sublicensees shall retain in confidence and use only for
purposes of this Agreement, any written information and data supplied by EMORY to ALIMERA under
this Agreement that is marked as confidential or proprietary;
(ii) EMORY shall retain in confidence and use only for purposes of this Agreement any
information and data supplied by ALIMERA, its employees or independent contractors under this
Agreement [*]. The terms of sublicenses (other than the granting clause(s) directly related to the
Licensed Patents, the existence of such sublicense, the identity of the sublicensee and a brief
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CONFIDENTIAL TREATMENT REQUESTED
and general description of the technology sublicensed that is directly related to the Licensed
Patents), Option Proposals, Article 4.1 progress reports, Article 4.2 royalty reports, ALIMERA’s
Development Plans, and records belonging to ALIMERA or its sublicensees disclosed to EMORY pursuant
to an audit (but not the existence of such audit or the general description of the audit results
only to the extent that such information is required to be included in an EMORY financial report
and has been approved for disclosure in such a manner in writing by ALIMERA, such approval not to
be unreasonably withheld or delayed) and Summary Development Information (as defined below) shall
be subject to the foregoing obligation. [*].
For purposes of this Agreement, all information and data, including without limitation any
copies, extracts and derivatives thereof, which a party is obligated to retain in confidence shall
be called “Information.”
11.2 Right to Disclose. To the extent that it is reasonably necessary to fulfill its
obligations or exercise its rights under this Agreement, or any rights which survive termination or
expiration hereof, each party may disclose Information to its Affiliates, sublicensees,
consultants, legal and/or financial advisors, outside contractors, governmental regulatory
authorities and clinical investigators on condition that such entities or persons agree:
(i) to be bound by confidentiality obligations materially similar to those herein; and
(ii) to use the Information only for such purposes as such parties are authorized to use the
Information.
Each party or its Affiliates or sublicensees may disclose Information to the government or
other regulatory authorities to the extent that such disclosure is necessary for the prosecution
and enforcement of Licensed Patents, or to comply with reporting obligations under Article 2.2
herein, or to obtain authorizations to conduct clinical trials for or commercially market Licensed
Products, provided that such party is otherwise entitled to engage in such activities under this
Agreement.
11.3 Release from Restrictions. The obligation not to disclose Information shall not
apply to any part of such Information that:
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CONFIDENTIAL TREATMENT REQUESTED
(i) is or becomes part of an issued patent or a patent application published pursuant to
patent office rules, otherwise published or otherwise part of the public domain, other than by
unauthorized acts of the party obligated not to disclose such Information (for purposes of this
Article 11 the “receiving party”) or its Affiliates or sublicensees in contravention of this
Agreement; or
(ii) is disclosed to the receiving party or its Affiliates or sublicensees by a third party
provided that such Information was not obtained by such third party directly or indirectly from the
other party under this Agreement; or
(iii) prior to disclosure under this Agreement, was already in the possession of the receiving
party, its Affiliates or sublicensees, without any obligations of confidentiality, provided that
such Information was not obtained directly or indirectly from the other party under this Agreement;
or
(iv) results from research and development by the receiving party or its Affiliates or
sublicensees, independent of disclosures from the other party of this Agreement, provided that the
persons developing such information do not use or reference Information received from the
disclosing party; or
(v) to the extent that it is required by law, regulation, court order or other legal
requirement to be disclosed by the receiving party, provided that the receiving party promptly
notifies the other party upon learning of such requirement in order to give the other party
reasonable opportunity to oppose such requirement, and receiving party cooperates with disclosing
party (at disclosing party’s request and expense) to obtain a protective order or otherwise limit
disclosure; or
(vi) ALIMERA and EMORY agree in writing may be disclosed.
ARTICLE 12. TERM AND TERMINATION
12.1 Term. Unless sooner terminated as otherwise provided in this Agreement, the term
of this Agreement shall commence on the Effective Date and shall continue in full force and effect
on a country by country basis until the later of (i) expiration of the last to expire of the
Licensed Patents in a particular country, or (ii) the expiration of the Royalty Term in such
country. If no Valid Claim within the Licensed Patents should issue within [*] of the date of this
Agreement, ALIMERA may terminate this Agreement upon written notice to EMORY at any time after the
[*] of the Effective Date. Expiration of this Agreement in a particular country under this
provision shall not preclude ALIMERA from continuing to develop, have developed, make, have made,
use, sell, have sold, offer for sale, and import Licensed Product in such country without further
remuneration to EMORY.
12.2 Termination. Subject to Article 12.4 herein, EMORY shall have the right to
terminate this Agreement upon the occurrence of any one or more of the following:
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(i) failure of ALIMERA to make any payment required pursuant to this Agreement when due; or
(ii) lack of diligence as set forth in Article 6 herein; or
(iii) failure of ALIMERA to render reports to EMORY as required by this Agreement; or
(iv) the institution of any material proceeding against or by ALIMERA under any bankruptcy,
insolvency, moratorium or dissolution law whether by voluntary act of ALIMERA or otherwise which is
not dismissed within ninety (90) days; or
(v) any assignment by ALIMERA of substantially all of its assets for the benefit of creditors;
or
(vi) placement of ALIMERA’s assets in the hands of a trustee, assignee or a receiver, whether
by voluntary act of ALIMERA or otherwise, unless the receivership or trust is dissolved or such
placement is otherwise reversed within sixty (60) days thereafter; or
(vii) a written decision by ALIMERA or ALIMERA’s assignee of rights under this Agreement to
quit the business of developing or selling of all Licensed Products; or
(viii) ALIMERA challenges, directly or indirectly, the validity, enforceability and/or scope
of any claim within the Licensed Patents in a court or other governmental agency of competent
jurisdiction; or
(ix) the breach by ALIMERA of any other material term of this Agreement.
12.3 Notice of Bankruptcy. ALIMERA must inform EMORY of (a) its intention to file a
voluntary petition in bankruptcy, such notice to be provided at least [*] prior to filing such a
petition or (b) if known to ALIMERA, another’s intention to file an involuntary petition in
bankruptcy with respect to ALIMERA promptly after ALIMERA becomes aware of such intention. A
party’s filing without conforming to this requirement shall be deemed a material, pre-petition
incurable breach.
12.4 Exercise. For occurrences described in Articles 12.2(iv), 12.2(v) or 12.2(vi),
this Agreement shall [*]. For occurrences described in Articles 12.2(i) through 12.2(iii) and
Articles 12.2(vii) through 12.2(ix), EMORY may exercise its right of termination by giving ALIMERA,
its trustees, receivers or assigns, [*] prior written notice of EMORY’s election to terminate. Upon
the expiration of such period, this Agreement shall automatically terminate unless ALIMERA (or its
sublicensee) has removed the condition(s) of termination. Notwithstanding the foregoing, EMORY may
not terminate this Agreement under this Article 12.4 if the alleged breach by ALIMERA is the
subject of pending dispute resolution proceedings that are being pursued in good faith pursuant to
Article 14. If the dispute is resolved in favor of XXXXX, XXXXX may terminate this Agreement
immediately upon written notice to ALIMERA following completion of such dispute resolution process.
Any notice provided and termination
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pursuant to this Article 12.4 shall not prejudice EMORY’s right to receive royalties or other sums
due hereunder that accrued prior to the effective date of termination and shall not prejudice any
cause of action or claim of EMORY accrued or to accrue on account of any breach or default by
ALIMERA.
12.5 Failure to Enforce. The failure of either party, at any time, or for any period
of time, to enforce any of the provisions of this Agreement, shall not be construed as a waiver of
such provisions or as a waiver of the right of such party thereafter to enforce each and every such
provision of this Agreement. All waivers must be in writing.
12.6 Termination by ALIMERA. ALIMERA shall have the right to terminate this
Agreement, on a product-by-product, country-by-country or field of use-by-field of use basis, at
its sole discretion, upon [*] written notice to EMORY, provided, however, should ALIMERA terminate
this Agreement pursuant to this Article 12.6 in [*], this Agreement will simultaneously terminate
in all countries.
12.7 Regulatory Data. Upon early termination of this Agreement for any reason (but
not expiration), and for a period of [*] after the effective date of such termination (or for such
other period of time mutually agreed to by the parties in writing), EMORY shall have the right to
review, and/or have a third party review on its behalf, subject to EMORY entering into a
confidentiality agreement with such third party containing provisions at least as restrictive as
those contained in this Agreement (hereinafter referred to as the “3rd Party CDA”) and
subject to EMORY being responsible and liable to ALIMERA for any breaches of the terms of
confidentiality under the 3rd Party CDA by such third party, [*] (the “Summary
Development Information”). For the avoidance of doubt, the parties acknowledge and agree that the
Summary Development Information does not contain all [*]. The Summary Development Information
shall be made available by ALIMERA for review at a location to be designated by ALIMERA and for a
reasonable period of time. In the event that EMORY enters into a license agreement with a third
party covering a Licensed Product(s) after EMORY or the third party has reviewed the Summary
Development Information, and Emory or such third party requests that ALIMERA provide all [*] (the
“Development Information”), ALIMERA shall use reasonable efforts to provide EMORY or such third
party with full and complete copies of all Development Information in its possession or control,
which EMORY or such third party may use and
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reference, only after (x) EMORY or such third party reimburses ALIMERA for all the documentable
costs incurred by ALIMERA and ALIMERA’s Affiliates and sublicensees in connection with the clinical
development, regulatory approval process and commercialization with respect to such Licensed
Product(s) and (y) ALIMERA and EMORY and/or such third party, as applicable, agree to reasonable
terms related to the use of the Development Information, including an agreement by EMORY and/or
such third party, as applicable, to indemnify ALIMERA in connection with EMORY’s or such third
party’s use of the Development Information. For the purpose of clarity, the 3rd Party
CDA will expire upon the fulfillment of Subarticles 12.7(x) and 12.7(y) herein by EMORY and/or such
third party.
12.8 Effect. If this Agreement is earlier terminated as a whole for any reason
whatsoever, ALIMERA shall return, or at EMORY’s direction, destroy, all plans, drawings, papers,
notes, data, writings and other documents, samples, organisms, biological materials, models and
other tangible materials that pertain solely to the Licensed Patents or Licensed Technology
supplied to ALIMERA by EMORY, retaining one archival paper copy in its corporate legal department
as required so that compliance with any continuing obligations may be determined. In addition,
EMORY shall return, or at ALIMERA’s direction, destroy, all ALIMERA Information, provided that
EMORY may retain one archival paper copy in its corporate legal department as required solely so
that compliance with any continuing obligations may be determined. Upon termination of this
Agreement (but not expiration), ALIMERA shall cease manufacturing, processing, producing, using,
importing or Selling any Licensed Products for which ALIMERA’s rights have terminated; provided,
however, that ALIMERA may continue to Sell in the ordinary course of business for a period of [*]
reasonable quantities of Licensed Products which are [*]. However, nothing herein shall be
construed to release either party of any obligation which matured prior to the effective date of
such termination.
ARTICLE 13. ASSIGNMENT
ALIMERA may, without EMORY’s consent, grant, transfer, convey, or otherwise assign any or all
of its rights and obligations under this Agreement in conjunction with the transfer of all, or
substantially all, of the business interests of ALIMERA. EMORY’s written consent, which shall not
be unreasonably withheld or delayed, shall be required prior to any other assignment of ALIMERA’s
rights or obligations under this Agreement. This Agreement shall be assignable by EMORY to any
other nonprofit corporation which promotes the research purposes of EMORY. In the case of any
permitted
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assignment or transfer of or under this Agreement, this Agreement or the relevant provisions shall
be binding upon, and inure to the benefit of, the successors and permitted assigns of the parties
hereto.
ARTICLE 14. ARBITRATION
Any dispute related to this Agreement shall be settled by arbitration. Arbitration shall be
conducted under the [*]. Arbitration shall take place in Atlanta, Georgia, and the decision of the
arbitrators shall be enforceable, but not appealable, in any court of competent jurisdiction. The
arbitrators’ decision shall be in accordance with and subject to the terms and conditions of this
Agreement. The fees and expenses incurred in connection with such arbitration shall be borne by
the party initiating the arbitration proceeding (or equally by both parties if both parties jointly
initiate such proceeding) subject to reimbursement by the party which does not prevail in such
proceeding promptly upon the termination thereof in the event that the party initiating such
proceeding is the prevailing party. Notwithstanding the foregoing, neither party shall be
prohibited from seeking preliminary relief in any court of competent jurisdiction.
ARTICLE 15. MISCELLANEOUS
15.1 Export Controls. ALIMERA acknowledges that Licensed Products and Licensed
Technology may be subject to United States laws and regulations controlling the export of technical
data, biological materials, chemical compositions, computer software, laboratory prototypes and
other commodities and that EMORY’s obligations under this Agreement are contingent upon compliance
with applicable United States export laws and regulations. The transfer of technical data and
commodities may require a license from the cognizant agency of the United States government or
written assurances by ALIMERA that ALIMERA shall not export data or commodities to certain foreign
countries without the prior approval of certain United States agencies. EMORY neither represents
that an export license shall not be required nor that, if required, such export license shall
issue. EMORY shall cooperate with ALIMERA as reasonably necessary to obtain any necessary export
licenses.
15.2 Legal Compliance. ALIMERA shall comply with all applicable laws and regulations
relating to its manufacture, processing, producing, using, importing, Selling, labeling or
distribution of Licensed Products and Licensed Technology and shall not take any action which would
cause EMORY or ALIMERA to violate any applicable laws or regulations.
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15.3 Independent Contractor. ALIMERA’s relationship to EMORY shall be that of a
licensee only. Neither party shall be the agent of the other party and neither party shall have
any authority to act for, or on behalf of, the other party in any matter. Persons retained by
either party as employees or agents shall not, by reason thereof, be deemed to be employees or
agents of the other party.
15.4 Patent Marking. ALIMERA shall xxxx Licensed Products (or the package or
documentation thereof, as reasonably practicable) Sold in the United States with United States
patent numbers. Licensed Products manufactured or Sold in other countries shall be marked in
compliance with the intellectual property laws in force in such foreign countries.
15.5 Use of Names. Except as otherwise expressly allowed under Article 11 or under
this Article 15.5, neither party shall disclose, issue any press release or publicity materials,
use any names, logos or trademark of the other party or the VA or any of their respective trustees,
directors, officers, staff members, employees, students or agents or make any public presentation
with respect to the Agreement, or any of the terms or conditions hereof, without the prior written
consent of the entity or person whose name is to be used. As an exception to the foregoing,
ALIMERA and EMORY (and the VA pursuant to Section 5.2 of the IIA) shall have the right to publicize
that a license was granted (this Agreement) to technology developed by VA and EMORY and to briefly
describe the Technology; however, neither ALIMERA nor EMORY (or the VA pursuant to Sections 5.2 and
10.8 of the IIA) shall disclose the terms and conditions of this Agreement other than the granting
clauses without each of the other parties’ consent, except (i) as required by any legally
enforceable order or other applicable law or regulation (subject to Article 11.3(v)), (ii) as
needed in any filings required by the United States Securities and Exchange Commission (the “SEC”),
other governmental authority or securities exchange in which case the other party is free to
disclose that which the disclosing party disclosed to the SEC, other such governmental authority or
securities exchange that is then made publicly available by such party(ies), (iii) under
confidentiality obligations materially similar to those in Article 11 herein, to a prospective
sublicensee, development and/or commercialization partner or acquirer or in connection with any
financing transaction or due diligence inquiry and (iv) as required by the terms in the IIA for
EMORY to provide VA with a copy of license agreements granting rights to the Technology. For
avoidance of doubt, ALIMERA may, without EMORY’s consent, refer to published, peer-reviewed
scientific publications by EMORY employees or inventors as required or helpful in regulatory or
other development filings associated with a Licensed Product.
15.6 Place of Execution. This Agreement and any subsequent modifications or
amendments hereto shall be deemed to have been executed in the State of Georgia, U.S.A.
15.7 Governing Law. This Agreement and all amendments, modifications, alterations, or
supplements hereto, and the rights of the parties hereunder, shall be construed under and governed
by the
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CONFIDENTIAL TREATMENT REQUESTED
laws of the State of Georgia and the United States of America. Only courts in the State of
Georgia, U.S.A., shall have jurisdiction to hear and decide any controversy or claim between the
parties arising under or relating to this Agreement.
15.8 Entire Agreement. This Agreement constitutes the entire agreement between EMORY
and ALIMERA, and supersedes all prior negotiations and agreements, written and oral (including,
without limitation, the Option Agreement), with respect to the subject matter hereof and this
Agreement shall not be modified, amended or terminated, except as herein provided or except by
another agreement in writing executed by the parties hereto.
15.9 Survival. Articles 9, 10, 11, 12.7, 12.8, 13, 14, 15.5, 15.7, 15.8, 15.9, 15.10
and 16 shall survive termination or expiration of this Agreement for any reason. Upon expiration
of this Agreement, ALIMERA shall have a fully paid up license to use the Licensed Technology.
15.10 Severability. All rights and restrictions contained herein may be exercised and
shall be applicable and binding only to the extent that they do not violate any applicable laws and
are intended to be limited to the extent necessary so that they will not render this Agreement
illegal, invalid or unenforceable. If any provision or portion of any provision of this Agreement,
not essential to the commercial purpose of this Agreement, shall be held to be illegal, invalid or
unenforceable by a court of competent jurisdiction, it is the intention of the parties that the
remaining provisions or portions thereof shall constitute their agreement with respect to the
subject matter hereof, and all such remaining provisions, or portions thereof, shall remain in full
force and effect. To the extent legally permissible, any illegal, invalid or unenforceable
provision of this Agreement shall be replaced by a valid provision which shall implement the
commercial purpose of the illegal, invalid, or unenforceable provision.
15.11 Force Majeure. Any delays in, or failure of performance of any party to this
Agreement, shall not constitute a default hereunder, or give rise to any claim for damages, if and
to the extent caused by occurrences beyond the reasonable control of the party affected, including,
but not limited to, acts of God, strikes or other concerted acts of workmen, civil disturbances,
fires, floods, explosions, riots, war, rebellion, sabotage, acts of governmental authority or
failure of governmental authority to issue licenses or approvals which may be required.
15.12 Counterparts. This Agreement may be executed by facsimile and in counterparts,
each of which is deemed an original, but all of which together shall constitute one and the same
instrument
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CONFIDENTIAL TREATMENT REQUESTED
ARTICLE 16. NOTICES
All notices, statements, and reports required to be given by one party to the other shall be
in writing and shall be hand delivered, sent by private overnight mail service, or sent by
registered or certified U.S. mail, postage prepaid, return receipt requested and addressed as
follows:
If to EMORY:
|
Emory University | |
| Office of Technology Transfer | ||
| 0000 Xxxxxxx Xxxx XX, 0xx Xxxxx | ||
| Mailstop 1599/001/1AZ | ||
| Xxxxxxx, Xxxxxxx 00000 | ||
| ATTN: Director | ||
| Facsimile: (000) 000-0000 | ||
If to ALIMERA:
|
Alimera Sciences, Inc. | |
| 0000 Xxxxxxxx Xxxxxxx, Xxxxx 000 | ||
| Xxxxxxxxxx, XX 00000 | ||
| Attn: Xx. Xxxx Xxxxxxxx, Chief Financial Officer | ||
| Facsimile: (000) 000-0000 |
Such notices or other communications shall be effective upon receipt by an employee, agent or
representative of the receiving party authorized to receive notices or other communications sent or
delivered in the manner set forth above. Either party hereto may change the address to which
notices to such party are to be sent by giving written notice to the other party at the address and
in the manner provided above. Any notice may be given, in addition to the manner set forth above,
by facsimile provided that the party giving such notice obtains acknowledgement by facsimile that
such notice has been received by the party to be notified. Notice made in this manner shall be
deemed to have been given when such acknowledgement has been transmitted.
[SIGNATURE PAGE FOLLOWS — REMAINDER OF PAGE INTENTIONALLY BLANK]
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CONFIDENTIAL TREATMENT REQUESTED
IN WITNESS WHEREOF, EMORY and ALIMERA have caused this Agreement to be signed by their duly
authorized representatives as of the day and year indicated below.
| EMORY UNIVERSITY | ALIMERA SCIENCES, INC. | |||||
By:
|
/s/ [*] | |||||
Name:
|
[*] | By: | /s/ Xxxxxxx X. Xxxxxxxx, Xx. | |||
Title:
|
Associate Vice President for Research and | Name: | Xxxxxxx X. Xxxxxxxx, Xx. | |||
| Director Office of Technology Transfer | Title: | Chief Financial Officer | ||||
Date:
|
Date: | |||||
| READ AND ACKNOWLEDGED | By: | /s/ Xxx Xxxxx, Ph.D. | ||||
| Name: | Xxx Xxxxx, Ph.D. | |||||
By:
|
/s/ [*] | Title: | Sr. Vice President and Chief Scientific | |||
Name:
|
[*] | Officer | ||||
Date:
|
Date: | |||||
| LIC.08.019 | ||||||
| * | Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
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CONFIDENTIAL TREATMENT REQUESTED
APPENDIX A
ALIMERA’S DEVELOPMENT PLAN
Activities Leading Up To IND Filing:
[*]
[*]
[*]
Clinical Development:
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
Activities Ongoing In Parallel With The Clinical Development Activities:
[*]
[*]
[*]
| * | Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
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CONFIDENTIAL TREATMENT REQUESTED
APPENDIX B
LICENSED PATENTS
Emory File No. 07027 “Fulvene and Fulvalene Analogs and Their Use in Treating Cancers
[*]
| * | Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
42
CONFIDENTIAL TREATMENT REQUESTED
APPENDIX C
U. S. GOVERNMENT LICENSE(S)
U. S. GOVERNMENT LICENSE(S)
[*]
| * | Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
43
CONFIDENTIAL TREATMENT REQUESTED
APPENDIX D
AMENDMENT TERMS
Running Royalties for Sales of Licensed Products by ALIMERA and its Affiliates within the Optioned
Field of Use
| [*] | ||
[*]
|
[*] | |
[*]
|
[*] | |
Notwithstanding the foregoing, such [*] royalty for Sales [*] shall not be payable by
ALIMERA to EMORY until [*].
Royalties paid to EMORY for Sales of any Licensed Products by Sublicensees of ALIMERA within the
Optioned Field of Use
| [*] | [*] | |
[*]
|
[*] | |
[*]
|
[*] | |
[*]
|
[*] | |
Minimum royalties for Licensed Product with an approved indication within the Optioned Field of Use
| [*] | [*] | |
[*]
|
[*] | |
| * | Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
44
CONFIDENTIAL TREATMENT REQUESTED
[*]
|
[*] | |
[*]
|
[*] | |
[*]
|
[*] |
Non-royalty payments received from sublicensees under sublicenses granting rights under the
Optioned Field of Use
| [*] | [*] | |
[*]
|
[*] | |
[*]
|
[*] | |
[*]
|
[*] | |
[*]
Milestone Payments for Licensed Products for indications within the Optioned Field of Use
| [*] | [*] | |
[*]
|
[*] | |
[*]
|
[*] | |
[*]
|
[*] | |
[*]
|
[*] | |
[*]
|
[*] | |
[*]
|
[*] | |
| * | Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
45
CONFIDENTIAL TREATMENT REQUESTED
[*]
|
[*] |
Each such milestone payment will be payable by ALIMERA only the first time such milestone is
achieved in connection with each of the first [*] for a Licensed Product within the Optioned Field
of Use, provided that [*].
License maintenance fees pertaining to Licensed Products for indications within the Optioned Field
of Use
In the event no milestone payment for Licensed Products within the Optioned Field of Use has been
paid to EMORY prior to the anniversary of the execution date of the amendment to the License
Agreement in connection with the Optioned Field of Use set forth below, ALIMERA shall pay to EMORY,
within [*] from the pertinent anniversary date, the maintenance fee set forth opposite such
anniversary shown below. No maintenance fee shall be payable by ALIMERA in the event it has
achieved at least one milestone and paid the corresponding milestone payment.
| [*] | [*] | |
[*]
|
[*] | |
[*]
|
[*] | |
[*]
|
[*] |
Development Milestones and Development Milestone Dates
To be agreed upon by EMORY and ALIMERA. The agreed-upon development milestones and development
milestone dates shall only apply to the [*] to be developed for an indication within the Optioned
Field of Use.
Development Plan for a Licensed Product under the Option Field of Use
ALIMERA shall submit a draft development plan for a Licensed Product under the Optioned Field of
Use to be negotiated and agreed by the parties pursuant to Article 2.5 herein and the final
development plan shall be incorporated into the amendment to the Agreement as a condition of EMORY
executing the amendment.
| * | Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
46
CONFIDENTIAL TREATMENT REQUESTED
APPENDIX E
ISSUE OF EQUITY
ISSUE OF EQUITY
[*]
| * | Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
47
CONFIDENTIAL TREATMENT REQUESTED
APPENDIX F
RUNNING ROYALTY PERCENTAGES
RUNNING ROYALTY PERCENTAGES
| (a) | For Sales of Licensed Products by ALIMERA and its Affiliates |
| [*] | ||
[*]
|
[*] | |
[*]
|
[*] | |
| Notwithstanding the foregoing, such [*] royalty for Sales in countries in which a Valid Claim of the Licensed Patents do not exist shall not be payable by ALIMERA to EMORY until at least one Licensed Patent has issued in the United States. For the sake of clarity, the issuance of a Licensed Patent shall mean the issuance of a patent. The publication of a patent application shall not be deemed to be the issuance of a Licensed Patent. | ||
| (b) | For sales of any Licensed Products by sublicensees of ALIMERA | |
| 25% of royalties received by ALIMERA from such sublicensees for sales of such Licensed Product | ||
| [*]. |
| * | Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
48
CONFIDENTIAL TREATMENT REQUESTED
APPENDIX G
MINIMUM ROYALTIES
MINIMUM ROYALTIES
| Calendar Year after first Final Regulatory Approval | ||||
| of a Licensed Product Approved Within the | ||||
| Licensed Field of Use in a Major Market Country | Minimum Royalty | |||
Year 1 (1st full Calendar Year following first Final Regulatory Approval) |
$ | 250,000 | ||
Year 2 |
$ | 500,000 | ||
Year 3 |
$ | 1,000,000 | ||
Year 4 and subsequent years |
$ | 2,500,000 | ||
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CONFIDENTIAL TREATMENT REQUESTED
APPENDIX H
NON-ROYALTY PAYMENTS FROM SUBLICENSEES
[*]
| * | Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
50
CONFIDENTIAL TREATMENT REQUESTED
APPENDIX I
MILESTONE PAYMENTS
MILESTONE PAYMENTS
| Event Relating to a Licensed Product | Milestone Payment | |
[*] |
[*] | |
[*] |
[*] | |
[*] |
[*] | |
[*] |
[*] | |
[*] |
[*] | |
[*] |
[*] | |
[*] |
[*] |
| * | Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
51
CONFIDENTIAL TREATMENT REQUESTED
APPENDIX J
LICENSE MAINTENANCE FEES
| Effective Date Anniversary | License Maintenance Fee | |
[*] |
[*] | |
[*] |
[*] | |
[*] |
[*] |
| * | Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
52
CONFIDENTIAL TREATMENT REQUESTED
APPENDIX K
DEVELOPMENT MILESTONES AND DEVELOPMENT MILESTONE DATES
[*]
| * | Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
53
