RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Exhibit
10.2
RESEARCH, DEVELOPMENT
AND COMMERCIALIZATION AGREEMENT
AND COMMERCIALIZATION AGREEMENT
This Research, Development and Commercialization Agreement (“Agreement”) is
entered into as of this 20th day of April, 2005, by and between:
on the one hand,
Xxxxxxxx-Xx Xxxxx Inc., a corporation organized and existing under the laws of the State of New
Jersey, with its principal place of business at 000 Xxxxxxxxx Xxxxxx, Xxxxxx Xxx Xxxxxx 00000
(“Roche Nutley”), and X.Xxxxxxxx-Xx Xxxxx Ltd, a Swiss corporation, with its principal
office at Xxxxxxxxxxxxxxxxx 000, XX-0000 Xxxxx, Xxxxxxxxxxx (“Roche Basel”; Roche Nutley
and Roche Basel are collectively referenced as “Roche”),
and on the other hand,
Miikana Therapeutics Inc., a corporation organized and existing under the laws of the State of
California, with its principal place of business at 0000 Xxxxxxxxx Xxxxxx, Xxxxxxx, XX 00000 XXX
(“Miikana”). Miikana and Roche each may be referred to herein as a “Party,” and
collectively as “Parties.’
WHEREAS, Roche owns or possesses certain patent rights, know-how and regulatory filings with
respect to various orally active cell cycle inhibitors (“CCI”), including the CCI compounds known
as * ;
WHEREAS, Roche believes that * and related compounds have the potential to become a
drug with significant worldwide annual sales, and that Miikana has the ability to realize the
potential of certain of these compounds;
WHEREAS, Miikana desires to develop * , and/or * and ensure that it is
diligently developed and commercialized worldwide so as to realize promptly its therapeutic and
commercial potential;
WHEREAS, Miikana desires to obtain rights from Roche so that Miikana, either on its own
* , and/or * and realizes its therapeutic and commercial potential;
WHEREAS, Miikana desires to obtain an exclusive license under Roche’s patent rights, know-how
and regulatory filings to begin development and commercialization * , * and/or
* ; and
WHEREAS, Roche is willing to grant an exclusive license to Miikana under such patent rights
and know-how.
NOW THEREFORE, in consideration of the foregoing and of the mutual covenants hereinafter set
forth and other good and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the Parties mutually agree as follows:
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ARTICLE 1
DEFINITIONS
As used in this Agreement, the following terms shall have the following meanings, and singular
forms, plural forms and derivative forms, (i.e. other parts of speech) shall be interpreted
accordingly:
1.1 “Affiliate” means any corporation or non-corporate business entity that directly
or indirectly controls, is controlled by, or is under common control with a Party to this
Agreement. As used in this definition, the term “control” (with correlative meanings for the
terms “controlled by” and “under common control with”) means that an entity owns greater than fifty
percent (>50%) of the voting stock of the subject entity with the ability to elect a majority of
the board (or managing members) of such entity, or otherwise has the power to govern and control
the financial and the operating policies and management of the subject entity, whether through the
ownership or control of voting securities, by contract or otherwise. With respect to Roche, the
term “Affiliate” shall not include Genentech, Inc., nor Chugai Pharmaceutical Co., Ltd, unless
Roche opts for such inclusion by giving written notice to Miikana.
1.2 “Combination Product” means a finished product containing a Compound or Derivative
in combination with one or more other active pharmaceutical ingredients, devices, equipment or
components that are not themselves Licensed Products.
1.3 “Commencement” means, with respect to a clinical trial, the date upon which the
first patient receives the first dose of an item that is the subject of such clinical trial.
1.4 “Commercialize” means to make, have made, develop, use, sell, have sold, offer for
sale, and import.
1.5 “Compound” means (a) the compound known as * and/or , or (b) any compound
that is a salt, ester or polymorph of * and/or * .
1.6 “Controlled” means, with respect to Know-How or patents, that the applicable Party
has licensed (or otherwise obtained rights to or under) such Know-How or patents from a Third Party
and such Party has the right to grant sublicenses to such Know-How or patents.
1.7 “Derivative” means a metabolite, prodrug or regioisomer * and *
that is claimed, generically or specifically, in the Roche Patent Rights.
1.8 “Development Plan” means the model plan for guiding the development of Licensed
Products, the first draft of which is set forth in Appendix C.
1.9 “Dollars” or “$” means US dollars.
1.10 “Effective Date” means the date first mentioned above.
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1.11 “FDA” means the United States Food and Drug Administration and any successor
entity thereto.
1.12 “FD&C Act” means the US Federal Food, Drug and Cosmetic Act, as amended, and the
equivalent laws and regulations in any foreign countries or jurisdictions.
1.13 “Field” means all therapeutic, prophylactic, and other pharmaceutical uses,
applications and indications.
1.14 “First Commercial Sale” means the first sale of a Licensed Product in a
particular country to a Third Party following its approval for marketing and sale by the applicable
Regulatory Agency in such country.
1.15 “Global Alliance Director” means an employee of Roche who is selected by Roche to
be the point person with primary responsibility for communications and interactions with Miikana.
1.16 “IND” means an Investigational New Drug Application filed with the FDA and
covering administration of a Compound or Derivative.
1.17 “Inventions” means any and all useful ideas, concepts, methods, procedures,
processes, improvements, inventions, discoveries, and reductions to practice, whether or not
patentable, which arise from or are first made, conceived or first reduced to practice in the
course of the activities conducted pursuant to or in exercise of a right granted under this
Agreement.
1.18 “Know How” means all non-patented data, information, methods, procedures,
processes, materials and other know-how. Know-How includes but is not limited to: biological,
chemical, biochemical, toxicological, pharmacological, metabolic, formulation, clinical,
regulatory, manufacturing, analytical and stability information and data (other than such
information and data which is or becomes the subject of a patent or patent application).
1.19 “Licensed Product” means any product containing a Compound or a Derivative,
including all formulations, dosages, and dosage forms thereof.
1.20 “Maior Market” means any of the * .
1.21 Miikana Group” means Miikana, its Affiliates and sublicensees under this
Agreement.
1.22 “Miikana Know-How” means all Know-How that is related to the Compound, a
Derivative, or a Licensed Product, and is owned or Controlled by the Miikana Group and in which the
Miikana Group has a transferable interest.
1.23 “Miikana Patent Rights” means all Patents in the Territory that (a) claim a
Compound, Derivative or Licensed Product, or the manufacture or use thereof, and (b) are owned or
Controlled by Miikana or any of its Affiliates during the term of this Agreement.
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1.24 “NDA” means a New Drug Application accepted for filing with a Regulatory Agency
for a Compound or Derivative.
1.25 “Net Sales” means, with respect to Miikana, the amount of gross sales of all
Licensed Products in the Territory invoiced by the Miikana Group to Third Parties, as reduced by
the following deductions to the extent actually allowed or incurred with respect to such sales: (a)
transportation charges, and other shipping charges, such as insurance, (b) sales, value-added and
excise taxes, customs, duties, and any other governmental charges, to the extent imposed upon the
sale of the Licensed Product and paid by the selling party, provided that no income taxes shall be
deducted from gross sales of Licensed Product to calculate Net Sales, (c) distributors fees,
rebates or allowances actually granted or allowed, including government and managed care rebates,
(d) quantity discounts, cash discounts or chargebacks actually granted, allowed or incurred, (e)
allowances or credits to customers, not in excess of the selling price of Licensed Product, on
account of governmental requirements, rejections, recalls or returns, and (f) allowances for bad
debt actually documented to have occurred solely as a result of sale of the Licensed Product.
If a Licensed Product is contained within a Combination Product then Net Sales for such
Combination Product, for purposes of calculating the royalties owed on sale of such Combination
Product, shall be reduced by multiplying Net Sales of such Combination Product (as determined
above) by the fraction A/(A+B) where A is the selling price of the Compound-containing unit if sold
separately and B is the selling price of the other active pharmaceutical ingredients, devices,
equipment or components in the Combination Product if sold separately. If the Compound-containing
unit or one or more of such active pharmaceutical ingredients, devices, equipment or components in
the Combination Product are not sold separately, then the parties shall negotiate in good faith a
formula for adjusting Net Sales to reflect the relative value of the contribution of the
Compound-containing unit to the total sales price of the Combination Product.
1.26 “Patent” means (a) any patent, including re-examinations, reissues, renewals,
extensions and term restorations thereof, and any foreign counterpart of any of the foregoing, and
(b) any pending application for patent, including, without limitation, provisional applications,
continuations, continuations-in-part, divisional and substitute applications, inventors’
certificates, and extensions, and any foreign counterpart of any of the foregoing.
1.27 “Phase I” means, with respect to the United States, the first phase of human
clinical trials using a limited number of human subjects to gain evidence of the safety and
tolerability of a Licensed Product and information regarding pharmacokinetics and potentially
pharmacological activity for such Licensed Product, Compound or Derivative, which human clinical
trials are completed prior to the initiation of Phase II, as described in 21 C.F.R. § 312.21(a), as
may be amended, or, with respect to any other country or jurisdiction, the equivalent of such a
clinical trial in such other country or jurisdiction.
1.28 “Phase II” means, with respect to the United States, the second phase of human
clinical trials of a Licensed Product in human subjects to gain evidence of the efficacy in one or
more indications and expanded evidence of the safety of such Licensed Product, Compound or
Derivative, as well as an indication of the dosage regimen required, as described in
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21 C.F.R.§ 312.21(b), as may be amended, or, with respect to any other country or
jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction.
1.29 “Phase III` means, with respect to the United States, the third phase of
human clinical trials of a Licensed Product, which are large-scale trials to gain evidence of the
efficacy and safety in a number of human subjects sufficient to support Registration for such
Licensed Product, Compound or Derivative with the FDA, as described in 21 C.F.R. § 312.21(c), as
may be amended, or, with respect to any other country or jurisdiction, the equivalent of such a
clinical trial in such other country or jurisdiction.
1.30 “Registration” in relation to any Licensed Product means such approvals by the
applicable Regulatory Agency in a country (or community or association of countries) included in
the Territory (including, where applicable, price approvals) that are required to be obtained prior
to marketing and selling such Licensed Product in such country or jurisdiction.
1.31 “Regulatory Agency” means, with respect to any particular country or
jurisdiction, the governmental authorities, bodies, commissions, agencies and/or other
instrumentalities of such country or jurisdiction (the EMEA with respect to the EU), with the
primary responsibility for the evaluation or approval of pharmaceutical products before such
product can be tested, marketed, promoted, distributed or sold in such country, including such
governmental bodies that have jurisdiction over the conduct of clinical trials and/or the pricing
of such pharmaceutical product. The term “Regulatory Agency” includes the FDA.
1.32 “Regulatory, Filing means any filing with a Regulatory Agency relating to or to
permit or request, as applicable, the clinical evaluation or Registration of a Licensed Product.
Regulatory Filings include without limitation INDs and NDAs.
1.33 “Roche Know-How” means all Know-How which on the Effective Date is owned or
Controlled by Roche and in which Roche has a transferable interest.
1.34 “Roche Patent Rights” means all Patents in the Territory listed on Appendix A,
and any future Patents that claim priority from or the benefit of the filing date of any of the
patents and applications listed in Appendix A, and including any and all extensions, supplementary
protection certificates and the like with respect to any of the foregoing.
1.35 “Territory” means the entire world, subject to Section 12.7(a).
1.36 “Third Party” means any party other than Roche, Roche’s Affiliates, Miikana, or
Miikana’ Affiliates.
1.37 “Transfer Know-How” means the Roche Know-How identified on Appendix B.
1.38 “US” means the United States of America, its territories and possessions.
1.39 “Valid Claim” means a claim contained in (i) an issued and unexpired patent
included within the Roche Patent Rights or Miikana Patent Rights that has not been held
unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of
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competent jurisdiction, which decision is not subject to any further appeal, and that has not
been admitted to be invalid or unenforceable through abandonment, reissue, disclaimer or otherwise
or (ii) a patent application which is included within the Roche Patent Rights or Miikana Patent
Rights and has been pending for less than * from
the priority date. If a claim of a patent application that ceased to be a Valid
Claim under item (ii) because of the passage of time later issues as a part of a patent
within item (i), then it shall again be considered to be a Valid Claim effective as of the issuance of such patent.
ARTICLE 2
GRANT OF LICENSE
2.1 Grant. Subject to the terms and conditions of this Agreement, Roche hereby
grants to Miikana and its Affiliates, and Miikana hereby accepts on its and their behalf, a sole
and exclusive license, with full rights to sublicense as provided in Section 2.2, under the Roche
Patent Rights and Roche Know-How, to (a) develop, use, sell, offer for sale, and import Licensed
Products in the Territory, and (b) make and have made Licensed Products in the Territory for such
development, use, sale, offering for sale, and importation. Notwithstanding anything to the
contrary in this Section 2.1, Roche shall retain all rights under the Roche Patent Rights and Roche
Know How for any other purpose. Miikana’s rights to import in the Territory shall not include
* . Subject to the terms and conditions of this Agreement, Roche also grants to Miikana,
its Affiliates and sublicensees immunity from suit from Roche and its Affiliates under any Patent
owned or controlled by Roche or its Affiliates on the Effective Date, and any other Patent that
claims priority from or the benefit of the filing date of any of the foregoing Patents, with
respect to making, using, selling, offering for sale or importing of Licensed Product in a
formulation in existence as of the Effective Date (which includes without limitation any additional
dosages, dosage forms, and separate packagings thereof).
2.2 Right to Sublicense. Miikana and its Affiliates shall have the right to
sublicense the rights granted under Section 2.1 to Third Parties (which will have no right to
further sublicense, except to the Affiliates of such Third Party sublicensees). If Miikana grants
such sublicenses, then all such sublicenses shall conform to and be in accordance with the terms of
this Agreement. Miikana assumes full responsibility for the performance of all obligations under
this Agreement and will remain obligated to Roche for all royalties due under this Agreement by
reason of the operations of any such sublicense.
2.3 Covenant Regarding License Scope. Miikana hereby covenants and agrees that it
and its Affiliates shall not, during the term of this Agreement, knowingly practice any Roche
Patent Rights or Roche Know How outside the scope of the license granted by Roche in Section 2.1.
2.4 Diligence. If Miikana has not
completed a * clinical trial within
___ * ___years after the Effective Date with respect to any Licensed Product, then Roche may
terminate all licenses granted herein. Following such termination by Roche under this Section 2.4
* .
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ARTICLE 3
RESEARCH AND DEVELOPMENT REIMBURSEMENT AND MILESTONE
PAYMENTS
PAYMENTS
3.1 Fees. Miikana shall pay to Roche in consideration for the rights granted herein
a fee which shall be non-refundable, and non-creditable, and shall consist of (a) * shares
of Miikana Series A Preferred stock, issued on the Effective Date pursuant to the Stock Purchase
Agreement attached hereto as Appendix E, and (b) * in cash, owing as of the Effective Date and
payable on or before the dates set forth below:
| Time | Amount | |
By the earlier of either (a) June 30, 2005, or (b) the closing date
of Miikana’s Series B Financing
|
* | |
By September 30, 2005
|
* |
Of the above, the * shares of Miikana Series A Preferred stock and Dollars
___ * ___shall be issued and paid to X.Xxxxxxxx-Xx Xxxxx Ltd and the
remaining * Dollars ( $ * ) shall be paid to Xxxxxxxx-Xx Xxxxx Inc.
3.2 Milestone Payments. Miikana shall pay to Roche non-refundable, non-creditable
milestone payments in the amounts specified in tabular form below (each a “Milestone Payment”) no
later than * days after the first occurrence of each of the following events with respect
to each Licensed Product, as they occur:
| Milestones | Payments (Dollars) | |
Commencement Phase III
|
* | |
NDA Filing in the USA
|
* | |
NDA Filing outside the USA
|
* | |
First Commercial Sale in the USA
|
* | |
First Commercial Sale outside the USA
|
* | |
First time annual sales in the Territory exceed *
|
* | |
First time annual sales in the Territory exceed *
|
* |
All milestones payments set forth under this Section 3.2 shall be paid to Roche only once for a
given Licensed Product containing a particular Compound or particular Derivative, and once
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paid shall be non-refundable. For clarity, once any milestone payment is paid to Roche under this
Section 3.2 for a given Licensed Product, such payment shall not be owed with respect to any other
Licensed Product containing the same Compound or Derivative even if such milestone is subsequently
achieved again by the Licensed Product having a different dosage, dosage form, package,
formulation, modes of administration or intended indication. Of course, if another Licensed
Product has a different Compound or Derivative than the previous Licensed Product, then Miikana
shall pay to Roche the milestones set forth under this Section 3.2 with respect to such other
Licensed Product. If development of a Licensed Product is terminated prior to First Commercial
Sale of such Licensed Product, then Miikana may credit such milestone payments paid to Roche with
respect to such Licensed Product against milestone payments that become due for a subsequent
Licensed Product. The term “annual sales” shall mean Net Sales in a given calendar year.
ARTICLE 4
ROYALTIES
4.1 Royalties in General. For each Licensed Product, the obligation of Miikana to
pay Roche royalties based on sales of the Licensed Product in a given country shall commence on the
date of the First Commercial Sale of such Licensed Product by the Miikana Group in such country and
shall continue until the * of (a) the date upon which there no longer exists in such
country a Patent within the Roche Patent Rights having a Valid Claim that claims the manufacture,
use or sale of such Licensed Product in such country, or (b) subject to Section 4.3, the date which
is * years after the date of First Commercial Sale of such Licensed Product in
such country. Miikana shall pay or cause to be paid to Roche a royalty based on Net Sales made by
the Miikana Group in the Territory, on a country-by-country basis, at the applicable incremental
royalty rate as provided for in the table below in this Section 4.1, subject to reduction as
provided in Section 4.3.
| Total, Territory wide Annual Net Sales in a single calendar year | Royalty Rate | |
Amount of Net Sales up to and including *
|
* | |
Amount of Net Sales over * and up to and including *
|
* | |
Amount of Net Sales over * and up to and including *
|
* | |
Amount of Net Sales over *
|
* |
4.2 Accrual of Royalties. No royalty shall be due or owing from the use or
distribution of a Licensed Product in transactions where no consideration is received by the
Miikana Group, such as when a Licensed Product is made or used for tests or development purposes or
is distributed as samples. No royalties shall be payable on sales among entities within the
Miikana Group, but royalties shall be payable on subsequent sales by entities within the Miikana
Group to a Third Party. No multiple royalties shall be payable under this Agreement because a
commercialized Licensed Product is covered by more than one Valid Claim or is covered by both a
claim with respect to Know-Haw and a Valid Claim.
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4.3 Reduction for Third Party Licenses.
(a) If Miikana pays royalties, upfront fees or milestone payments to Third Parties pursuant to
intellectual property license agreements covering the manufacture, use or sale of Licensed Products
and negotiated at arm’s length, then Miikana may credit * of such payments paid to such
Third Parties against the amounts otherwise payable pursuant to Section 4.1.
(b) Likewise, if no Patent within the Roche Patent Rights has a Valid Claim that claims the
manufacture, use or sale of such Licensed Product in a country, then Miikana may credit *
of the royalties otherwise due from sales in such country against the amounts otherwise payable
pursuant to Section 4.1.
(c) The credit provided by Section 4.3(a) shall be effective only for Licensed Products sold
after any payments required by the licenses from such Third Parties are incurred. Miikana shall
provide Roche with written notice of such a requirement within * after it becomes
effective, and such notice shall include the name of the Third Party, the patents under which
payments are being paid to the Third Party, and the element of the Licensed Product to which the
third-party intellectual property applies. In no event shall royalties payable pursuant to
Section 4.1 be reduced, due to application of this Section 4.3, by more than * of the
amount that otherwise would be owed.
ARTICLE 5
ROYALTY REPORTS AND ACCOUNTING
5.1 Royalty Payments; Royalty Reports. After the First Commercial Sale and for the
remaining term of this Agreement, Miikana shall submit with each payment of royalties to Roche a
written royalty report (“Royalty Report”) covering sales of Licensed Product for each
Miikana fiscal quarter (currently ending on or about the last day of March, June, September, and
December) with the following information provided on a country-by-country basis for the Major
Market countries and for the rest of the world as a whole:
(a) Net Sales showing all deductions starting with gross sales;
(b) the royalties, payable in Dollars, which shall have accrued hereunder in respect to such
Net Sales;
(c) withholding taxes, if any, required by law to be deducted in respect of such sates;
(d) the exchange rates used in determining the amount of Dollars; and
(e) the royalty rates applied to calculate royalties due hereunder.
Royalty Reports shall be due for the entire Territory no later than * days after the
end of the fiscal quarter to which they pertain.
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5.2 Exchange Rate; Manner of Payment. All payments due under this Agreement shall be
made in Dollars via wire transfer of immediately available funds, or by such other commercially
reasonable means as may be designated by Roche. Royalty payments due on Net Sales in countries
in the Territory outside the US shall be made in Dollars, after being converted by Miikana using
the average rate of exchange for such currencies during the applicable calendar quarter, as
retrieved from * system for the applicable period. If by law, regulations or fiscal
policies, remittance of royalties in Dollars, or removal of currency from the country, is
prohibited or restricted, Miikana will notify Roche and payment of the royalty obligation shall be
made by deposit thereof in local currency to the credit of Roche in a recognized banking
institution in such country designated by Rode. If in any country or jurisdiction, the law,
regulations or fiscal policies prohibit both the transmittal and deposit of royalties on sales in
such country, royalty payments calculated as a percentage of Net Sales in that country shall be
suspended for as long as such prohibition is in effect and as soon as such prohibition ceases, all
royalties that Roche would have otherwise been entitled to shall be transmitted or deposited to the
extent allowable.
5.3 Payment Due Dates. Royalties shown to have accrued by each Royalty Report
provided for under Article 5 of this Agreement shall be due and payable * after the end of
the fiscal quarter to which they pertain. Payment of royalties in whole or in part may be made in
advance of such due date. All royalty and other payments due to Roche hereunder, shall be made in
Dollars and delivered to the account specified below or to any other account specified by Roche:
WIRE PAYMENT TO:
Account of.
|
Xxxxxxxx-Xx Xxxxx Inc | |
Account No.:
|
* | |
Bank Name:
|
* | |
| * | ||
ABA Routing No:
|
* |
5.4 Right to Audit
(a) Upon written request to Miikana and at least * prior notice from Roche, at Roche’s
expense and not more that * a calendar year, Roche’s independent certified public
accountants may perform, on the behalf of Roche, an audit in accordance with GAAP standards of such
of Miikana’ books and records during normal business hours as may be reasonably necessary to verify
the accuracy of the Royalty Reports furnished by Miikana and to confirm payments made hereunder
with respect to any quarterly period ending not more than * prior to the date of such
request. Audits may be performed no more than once for a given audit period.
(b) Miikana shall keep, and shall cause its Affiliates, sublicensees, and Affiliates’
sublicensees to keep, complete and accurate records pertaining to the sale of Licensed Products and
the royalties and other amounts payable under this Agreement in sufficient detail to permit Roche
to confirm the accuracy of all payments due hereunder for no less than *
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after the time periods to which such records relate. Miikana shall include in each written
sublicense granted by it 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 Roche’s auditor subject to the same terms and conditions as stated in this Section 5.4. Such
records shall be sufficient for Roche to determine Net Sales on a country-by-country basis.
(c) Upon the expiration of * following the end of any quarterly royalty payment
period, the calculation of royalties payable with respect to such quarter shall be binding and
conclusive upon Roche (except with respect to any audit then underway, and except for fraud or
intentional misrepresentation), and the Miikana Group shall be released from any liability or
accountability with respect to royalties for such fiscal year.
(d) Any report prepared by the auditor, shall disclose only the conclusions of the auditor
regarding the audit and the amount of any underpayment or overpayment of royalties, if any, without
disclosure of or reference to supporting documentation. A copy of such report shall be sent or
otherwise provided to Miikana by the auditor at the same time it is sent or otherwise provided to
Roche.
(e) If an auditor’s report shows any underpayment of royalties, Miikana shall remit, or shall
cause its Affiliates, sublicensees, or Affiliates’ sublicensees to remit, to Roche the amount of
such underpayment within * after Roche’s receipt of the auditor’s report. If the amount
of any underpayment of royalties is in excess of * of the total royalties due to Roche with
respect to the period covered by the Auditor’s report, then Miikana shall reimburse Roche for the
cost of the audit in which the underpayment was discovered, the underpayment, and interest on the
underpayment at the * rate plus * . Any overpayment of royalties shall be fully
creditable against future royalties payable in subsequent royalty periods.
5.5 Confidentiality of Records. Roche agrees that all information subject to review
under this Article 5 or under any sublicense agreement (other than the reported results of such
review) is confidential and that Roche and the auditor shall retain all such information in
confidence, although this condition is not intended to restrict Roche from enforcing any term or
provision of this Agreement in arbitration or court.
5.6 Recruiting of forecasted sales. Commencing after the First Commercial Sale, each
year in June, Miikana shall provide Roche with a good faith Net Sales forecast for the following
* . This annual forecast shall be for informational purposes only and shall not confer
any right or obligation on either Party with respect to projected sakes figures. The forecast
will consist of Miikana’s reasonable estimate of the quarterly Net Sales for the two remaining
quarters in the then current year and the four quarters in the following year. * * .
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ARTICLE
6
RESEARCH, DEVELOPMENT AND MARKETING
6.1 Development. Prior to the Effective Date, Roche has conducted research and
development of the Compound. Miikana has drafted a Development Plan to guide the further clinical
development of the Compound and have appended it at Appendix C. The Development Plan merely
serves as a guide and may undergo substantive changes as it is implemented.
6.2 Liaison.
(a) At the Effective Date of this Agreement, Roche shall assign a Global Alliance Director to
be the liaison with Miikana. The Global Alliance Director will be the Roche point person with
primary responsibility for communications and interactions with Miikana related to:
(i) *
(ii) *
(iii) *
(iv) *
(v) *
(b) Similarly and for reasons including those set out in Section 6.2(a). Miikana shall
assign a liaison with Roche.
6.3 Development Program.
(a) Miikana shall, at its expense, conduct a clinical and commercial development program
relating to the use of a Licensed Product using commercially reasonable efforts (“Development
Program”) consistent with the Development Plan. Miikana shall provide
___ * ___written reports to the Global Alliance Director on the progress of the
Development Program, and * shall provide to the Global Alliance Director a written status
report of all Development Program activities.
(b) At a minimum, the Development Plan shall include a Phase-to-Phase progression of the
program that is results- and regulatory-based. Miikana shall conduct a Phase II clinical program
in accordance with the Development Plan. The clinical portion of the Development Plan shall be
designed to obtain sufficient data to support progressing to one or
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more pivotal clinical trials designed to obtain sufficient data to support Registration in at
least one indication in the Field.
(c) Based on the Phase II clinical data and correspondence from Regulatory Agencies concerning
such Phase II data, Miikana shall, * after completion of all Phase II clinical trials,
either (i) commence one or more pivotal clinical trials designed to obtain sufficient data to
support Registration in at least one indication in the Field or (ii) notify Roche that it is
terminating the Agreement.
(d) The Development Plan may be reasonably modified and updated at any time as is deemed
necessary at the discretion of Miikana.
(e) Reversion to Roche. Notwithstanding anything in this Agreement to the contrary, if at
any time and for any reason, whether scientific, technical, medical, economic, commercial or
otherwise, Miikana shall determine that it is not reasonable to continue clinical trials or other
development of Licensed Products, it may deliver a written notice of such determination to Roche,
and its election to cease further development, in which event, Roche may terminate the Agreement
and all licenses granted herein pursuant to Section 12.3(b). Likewise, if Miikana determines not
to pursue the development or commercialization of a Licensed Product in any of the following
sub-territories: (i) the US, (ii) Japan, (iii) the European Union (in such case at least *
of the Major Markets in the European Union), then Miikana shall provide Roche with written notice
of its decision and shall terminate this Agreement with respect to such sub-territory, within
* following Roche’s receipt of such notice, in which event, Roche may terminate the
Agreement and all licenses granted herein solely for such sub-territory pursuant to Section
12.3(b).
ARTICLE
7
PATENT RIGHTS
7.1 Patent Prosecution and Maintenance.
(a) Roche shall, at its sole expense, prosecute any and all patent applications within the
Roche Patent Rights to obtain patents thereon and to maintain all patents included in the Roche
Patent Rights. Interferences, nullification proceedings and oppositions shall be considered a
part of the prosecution and maintenance of the Roche Patent Rights.
(b) Miikana shall, at its sole expense, prosecute any and all patent applications within the
Miikana Patent Rights, to obtain patents thereon and to maintain all patents included in the
Miikana Patent Rights using patent counsel of its choice. Interferences, nullification
proceedings and oppositions shall be considered a part of the prosecution and maintenance of the
Miikana Patent Rights.
(c) Miikana and Roche shall each keep the other reasonably informed of its prosecution of the
Miikana Patent Rights or Roche Patent Rights, as the case may be. Each Party agrees to provide
the other Party with a written report no less frequently than once each year updating
the other Party with respect to the status of its prosecution of the Miikana Patent Rights or Roche
Patent Rights. If either Party fails to perform its obligations under Section
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7.9(a) or (b), then the other shall have the right to perform such activities on its behalf.
At the request of the other Party at anytime during the term of this Agreement each Party shall
execute such documents as the other Party may deem necessary or advisable to protect or perfect its
rights in the relevant Patent Rights, and shall assist the other party in obtaining, defending and
enforcing such Party’s rights therein. Each Party hereby appoints the other as its
attorney-in-fact to execute on its behalf any documents deemed necessary or advisable by the other
Party to protect or perfect its rights to any relevant Patent Rights.
7.2 Discontinuance/Abandonment. Notwithstanding won 7.1, each of Roche and Miikana
shall have the right to discontinue the prosecution of any patent application, or to abandon any
patent, encompassed within the Roche Patent Rights or Miikana Patents, as the case may be. If a
party (“Abandoning Party”) decides to abandon or allow to lapse any patent application or
patent within its patent rights (Roche Patent Rights or Miikana Patent Rights, as the case may be),
then the Abandoning Party shall inform the other party (“Non-Abandoning Party”) at least *
prior to such abandonment or lapse and the Non-Abandoning Party shall be given the opportunity to
have such patent assigned to it from the Abandoning Party. If a Roche patent application or
patent is assigned to Miikana, then for so long as such patent application or patent remains in
effect it shall be considered Roche Patent Rights for purposes of royalty payments under Article 4;
provided, however, Miikana shall be entitled to credit * of its costs actually incurred in
prosecuting and maintaining such patents against any future payments under Article 4, subject to
audit by Roche under Section 5.4.
7.3 Status of Patent Rights. Within * after each anniversary of the
Effective Date, each of Roche and Miikana shall advise the other Party as to the then-current
status of any patent applications or patents within the advising Party’s Patent Rights
specifically relevant to any Licensed Product.
7.4 Ownership of Future Inventions and Know-How.
(a) Miikana shall disclose to Roche any Inventions related to the Compound, Derivatives,
Licensed Products, or any data generated through their use with respect to which it intends to file
a patent application. Disclosure pursuant to this Section 7.4(a) shall be made not later than one
month prior to filing a patent application with respect to such items.
(b) Patentable and unpatentable Inventions or Know-How made, developed or conceived by Miikana
personnel alone (or jointly with one another) shall be the sole property of Miikana (“Miikana
Inventions”). Miikana shall have sole discretion and responsibility to prepare file,
prosecute and maintain patent applications for Miikana Inventions, and shall be responsible for
related interference proceedings.
(c) Patentable and unpatentable Inventions or Know-How made, developed or conceived by Roche
personnel alone (or jointly with one another) shall be the sole property of Roche (“Roche
Inventions”). Roche shall have sole discretion and responsibility to prepare file, prosecute
and maintain patent applications for Roche Inventions, and shall be responsible for related
interference proceedings.
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(d) Patentable or unpatentable Inventions or Know-How jointly made, developed or conceived by
Miikana and Roche personnel shall be jointly owned, unless the Parties agree otherwise. Patent
applications for joint inventions shall be prepared and prosecuted jointly.
(e) In no event shall any disclosure of compounds, inventions or other information in
accordance with this Section 7.4 be construed as an offer to sell those compounds, inventions or
other information. Any disclosure under this Section 7.4 shall be subject to the confidentiality
provisions of this Agreement.
ARTICLE
8
INFRINGEMENT
8.1 Applicability. The provisions of this Article 8 shall govern the Parties’ rights
and obligations, as between themselves, with respect to actions against Third Parties for
infringement of the patents or misappropriation of the Know-How licensed under this Agreement.
Notwithstanding the foregoing, in the case of patents and Know-How licensed under this Agreement
that is owned by a Third Party, then the Parties’ rights to enforce such patents or any right in
such Know-How shall be subject to the rights of such Third Party set forth in its agreement with
the Party that Controls such patents or Know-How.
8.2 Third Party Infringement.
(a) If either Miikana or Roche becomes aware of any product made, used, sold or imported in
the Territory which it believes to (i) infringe a Valid Claim within the Roche Patent Rights
(“Field Infringement”) or the Miikana Patent Rights, (ii) or constitute a misappropriation
of Know-How owned or Controlled by either Party covering or relating to a Licensed Product or its
manufacture or use, then such Party (the “Notifying Party”) shall promptly ( * in
the event of receiving a Paragraph IV Certification described in 21 C.F.R. § 314.50(i)(A)(4))
advise the other Party of all the relevant facts and circumstances known by the Notifying Party in
connection with the infringement or misappropriation.
(b) The Parties agree that Roche shall have the right, at its own expense, but not the
obligation, to enforce Roche Patent Rights against Field Infringement and Miikana shall have the
right, at its own expense, but not the obligation, to enforce Miikana Patent Rights against
infringement. Miikana and its Affiliates shall fully cooperate with Roche with respect to the
investigation and prosecution of such alleged Field Infringement or misappropriation including
(without limitation) the joining of Miikana and its Affiliates as a party to such action, as may be
required by the law of the particular forum where enforcement is being sought. Roche and its
Affiliates shall fully cooperate with Miikana with respect to the investigation and prosecution of
such alleged infringement of the Miikana Patent Rights or misappropriation including (without
limitation) the joining of Roche and its Affiliates as a party to such action, as may be required
by the law of the particular forum where enforcement is being sought.
(c) If Roche elects to proceed with an enforcement action pursuant to Section 8.2(b), then
Miikana shall have the right to intervene and pursue its own damages claim
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against any alleged Field Infringement if such Field Infringement is caused by the
manufacture, use or sale of a product containing a Compound or Derivative. Any such intervention
by Miikana under this Section 8.2(c) shall be controlled by Miikana with respect to such damages
claim; however, Roche shall remain in control of the defense against any claim, counterclaim or
defense of patent invalidity or unenforceability related to any such Field Infringement.
(d) Roche grants to Miikana the right to enforce the Roche Patent Rights against Field
Infringement, if:
(i) Roche fails, within * ( * in the event of the filing of a Paragraph IV
Certification) after receiving notice from Miikana of the Field Infringement to (1) notify Miikana
that Roche elects to proceed with an enforcement action pursuant to Section 8.2(b), (2) take
reasonable action to investigate such alleged infringement, and (3) promptly thereafter, institute
an action to xxxxx such alleged infringement and to prosecute such action diligently (i.e. within
* or * in the event of the filing of a Paragraph IV Certification), or
(ii) Roche earlier notifies Miikana that Roche does not plan to terminate the infringement or
institute such action solely pursuant to Section 8.2(b).
Roche and its Affiliates shall fully cooperate with Miikana, at Miikana’s expense, with respect to
the investigation and prosecution of such alleged infringement including (but not limited to) the
joining of Roche and its Affiliates as a party to such action, as may be required by the law of the
particular forum where enforcement is being sought. Any such enforcement action by Miikana under
Roche Patent Rights shall be limited to enforcement against Field Infringement caused by the
manufacture, use or sale of a product containing a Compound or Derivative, and shall not without
the advance written consent of Roche extend to any other infringement.
(e) If Roche is prosecuting an infringement action under Section 8.2(b), then Roche shall have
the right to control such litigation and shall bear all legal expenses (including court costs and
legal fees and expenses), including settlement thereof. If a claim for damages is brought by
Miikana pursuant to Section 8.2(c), then Miikana shall have such right to control such claim for
damages and shall bear all its legal expenses (except as provided otherwise in the event that Roche
should join as a party to such action). No settlement or consent judgment or other voluntary
final disposition of any infringement action brought by a Party pursuant to this Section 8.2 may be
entered into without the prior written consent of the other Party if such settlement would require
the other Party to be subject to an injunction or to make a monetary payment or would restrict the
claims in or admit any invalidity of any of the Roche Patent Rights or Miikana Patent Rights or
significantly adversely affect the rights of the other Party to this Agreement.
Roche shall be entitled to keep, out of all damages or costs recovered by Roche in connection with
any action filed by Roche under Section 8.2(b), and after first reimbursing both parties for any
out-of-pocket costs and expenses incurred in bringing the action (“Roche Net Recovery”), an amount
equal to: (i) * of such Roche Net Recovery for actions against a Field Infringement that do
not involve manufacture, use or sate of a product containing a Compound or Derivative, and (ii)
* of the Roche Net Recovery from any action to the extent
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involving manufacture, use or sale of a product containing a Compound or Derivative, and the rest
of such Roche Net Recovery shall be provided to Miikana. Miikana shall be entitled to keep
* of all damages or costs recovered by Miikana in connection with any claim for damages
brought by Miikana under Section 8.2(c) or 8.2(d), after first reimbursing both parties for any
out-of-pocket costs and expenses incurred in bringing the action (“Miikana Net Recovery”), and the
rest of such Miikana Net Recovery * shall be provided to Roche. If the Parties jointly
prosecute such infringement action and jointly share expenses, then the Parties will split
* all damages or costs recovered, after first reimbursing each Party pari passu for any
out-of-pocket expenses in such action. If the recovery of a Party prosecuting an action solely
under this Section 8.2 does not exceed the Parties’ costs in such action, then each Party shall be
reimbursed pari passu for any out-of-pocket expenses incurred in such action.
(f) Sections 8.2(b)-(e) shall apply mutatis mutandis to trade secret misappropriation actions
relating to activities as it does to enforcement of Valid Claims against Field Infringement.
(g) Neither Party shall be entitled to grant covenants not to xxx or other similar rights
under patents owned or controlled by the other Party, provided, however, Miikana
may grant licenses and sublicenses in accordance with Section 2.2.
ARTICLE
9
REPRESENTATIONS AND WARRANTIES
9.1 Representations and Warranties of Roche. Roche hereby represents and warrants to
Miikana as of the Effective Date that:
(a) Roche Nutley and Roche Basel are duty incorporated, validly existing and in good standing,
with the corporate power and authority to enter into this Agreement and to perform their
obligations hereunder. The execution and delivery of this Agreement and the consummation of the
transactions contemplated hereby have been duly authorized by all requisite corporate action on the
part of Roche. This Agreement has been duly executed and delivered by Roche and constitutes the
valid, binding and enforceable obligation of Roche, subject to applicable bankruptcy,
reorganization, insolvency, moratorium and other laws affecting creditors’ fights generally from
time to time in effect and to general principles of equity.
(b) Roche is not subject to, or bound by, any provision of
(i) any articles or certificates of incorporation or by-laws;
(ii) any mortgage, deed of trust, lease, note, shareholders’ agreement, bond, indenture,
license, permit, trust, custodianship, or other instrument, agreement or restriction; or
(iii) any judgment, order, writ, injunction or decree or any court, governmental body,
administrative agency or arbitrator;
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that would prevent, or be violated by, or under which there would be a default as a result of, nor
is the consent of any Third Party required for, the execution, delivery and performance by Roche of
this Agreement and the obligations contained herein, including without limitation, the grant to
Miikana of the license described in Section 2.1 hereof.
(c) ___ * under the Roche Patent Rights for purposes other than the manufacture,
use, offer for sale, importation or sale of a Compound or Derivative, or any product containing a
Compound or Derivative; (ii) with the exception of license rights that may have been or may be
granted under the Roche Patent Rights for purposes other than the manufacture, use, offer for sale,
importation or sale of a Compound or Derivative, or any product containing a Compound or Derivative
* ; and (iii) other than facts made available to Miikana during due diligence and facts
contained in patent oppositions and other publicly available records (such as prosecution histories
and the like), there * .
9.2 Representations and Warranties of Miikana. Miikana hereby represents and
warrants to Roche as of the Effective Date that:
(a) Miikana is a corporation duly incorporated, validly existing and in good standing under
the laws of the jurisdiction of its organization, with the corporate power and authority to enter
into this Agreement and to perform its obligations hereunder. The execution and delivery of this
Agreement and the consummation of the transactions contemplated hereby have been duly authorized by
all requisite corporate action on the part of Miikana. This Agreement has been duly executed and
delivered by Miikana and constitutes the valid, binding and enforceable obligation of Miikana,
subject to applicable bankruptcy, reorganization, insolvency, moratorium and other laws affecting
creditors’ rights generally from time to time in effect and to general principles of equity.
(b) Miikana is not subject to, or bound by, any provision of:
(i) any articles or certificates of incorporation or by-laws;
(ii) any mortgage, deed of trust, lease, note, shareholders’ agreement, bond, indenture,
license, permit, trust, custodianship, or other instrument, agreement or restriction, or
(iii) any judgment, order, writ, injunction or decree or any court, governmental body,
administrative agency or arbitrator,
that would prevent, or be violated by, or under which there would be a default as a result of, nor
is the consent of any Third Party required for, the execution, delivery and performance by Miikana
of this Agreement and the obligations contained herein.
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9.3 Disclaimer of Warranties. EXCEPT AS SET FORTH EXPRESSLY IN THIS AGREEMENT, EACH
PARTY HEREBY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESSED OR IMPLIED,
INCLUDING WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, NON-INFRINGEMENT OF THE INTELLECTUAL RIGHTS OF THIRD PARTIES. WITHOUT LIMITING THE
GENERALITY OF THE FOREGOING, BOTH PARTIES ACKNOWLEDGE AND DISCLAIM ANY WARRANTY AS TO: (1) THE
SUCCESS OF ANY DEVELOPMENT OR CLINICAL TRIAL, STUDY OR TEST COMMENCED BY UNDER THIS AGREEMENT; OR
(11) REGULATORY APPROVAL, PRODUCT INTRODUCTION, SAFETY, USEFULNESS OR COMMERCIAL SUCCESS OF ANY
LICENSED PRODUCT.
ARTICLE
10
CONFIDENTIALITY
10.1 Treatment of Confidential Information. Except as otherwise provided in this
Article 10, during the term of this Agreement and for a period of * thereafter, Miikana and
its Affiliates will retain in confidence and use only for purposes of this Agreement any
information, data, and materials supplied by Roche or on behalf of Roche to Miikana and its
Affiliates under this Agreement, and Roche will retain in confidence and use only for purposes of
this Agreement any information, data, and materials supplied by Miikana or on behalf of Miikana to
Roche under this Agreement. For purposes of this Agreement, all such information and data which a
Party is obligated to retain in confidence shall be called “Confidential Information” of the
disclosing Party.
10.2 Right to Disclose. To the extent it is reasonably necessary or appropriate to
fulfill its obligations or exercise its rights under this Agreement or any rights which survive
termination or expiration hereof, Miikana and Roche each may disclose the Confidential Information
of the other Party to their respective Affiliates, sublicensees, consultants, outside contractors,
clinical investigators or other Third Parties provided that such entities or persons agree in
writing (a) to keep the Confidential Information confidential for the same time periods and to the
same extent as Miikana and Roche are required to keep the Confidential Information confidential and
(b) to use the Confidential Information only for such purposes as Miikana and Roche (as applicable)
are entitled to use the Confidential Information. Each Party or its Affiliates or sublicensees
may disclose such Confidential Information of the other Party to government or other regulatory
authorities to the extent that such disclosure (i) is reasonably necessary to obtain patents or
authorizations to conduct clinical trials with or to market commercially the Licensed Products,
provided such Party is otherwise entitled to engage in such activities under this Agreement; (ii)
is otherwise legally required; (iii) is in facilitation of a Party’s relationship with its existing
or prospective investors; or (iv) is permitted pursuant to Section 14.7; provided that if a Party
is legally required to make such a disclosure under (ii), it shall first have given prompt notice
to the other Party hereto to enable it to seek any available exemptions from or limitations on such
a disclosure, or to apply for confidential treatment or a protective order.
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10.3 Release From Restrictions. The foregoing obligations in respect of disclosure
and use of Confidential Information shall not apply to any part of such Confidential Information
that the receiving Party, or its Affiliates (all collectively referred to as the “Receiving Party”)
can demonstrate by competent evidence:
(a) is or becomes publicly available other than by acts of the Receiving Party in breach of
this Agreement;
(b) is disclosed to the Receiving Party or its Affiliates or-sublicensees by a Third Party who
had the right to disclose such Confidential Information to the Receiving Party;
(c) prior to disclosure under this Agreement, was already in the possession of the Receiving
Party or its Affiliates or-sublicensees, provided such Confidential Information was not obtained,
directly or indirectly, from the other Party under this Agreement; or
(d) was independently discovered or developed by the Receiving Party without resort to or use
of any Confidential Information of the disclosing Party.
10.4 Confidentiality of Agreement. Except as otherwise required by law or the terms
of this Agreement or mutually agreed upon by the Parties hereto, each Party shall treat as
confidential the terms; and conditions of this Agreement, except that Roche and Miikana may each
disclose such terms and conditions and the achievement of milestone and other significant events
under this Agreement to its Affiliates and sublicensees, and to current and potential investors,
merger partners or acquirors. Furthermore, either Party in connection with its current or future
status as a public company may disclose the terms of this Agreement to the extent required by the
federal securities laws, and provided, that the disclosing Party shall seek confidential treatment
of key business terms contained in this Agreement, including but not limited to the royalty rates,
the research and development reimbursement and the milestone payments; provided, however, that the
disclosing Party shall duly consider reasonable and timely suggestions, advice and input from the
non-disclosing Party with respect to seeking confidential treatment of key business terms contained
in the Agreement. After execution of this Agreement, the Parties shall release the joint press
release, the text of such shall be mutually agreeable to each Party, announcing the execution of
the Agreement. In addition, the Parties have agreed to the publicity-related provisions that are
set forth in Section 14.7.
10.5 Return of Confidential Information. Upon termination of this Agreement by
either Party for any reason, the rights of each Party to retain and use the Confidential
Information of the other shall be as provided in Article 12, provided, however, that each Party may
retain a single archival copy of the other Party’s Confidential Information solely for the purpose
of determining the extent of disclosure of Confidential Information hereunder and assuring
compliance with the surviving provisions of this Agreement.
ARTICLE
11
TRANSFERS AND ACCESS- REGULATORY
11.1 Transfer of Know-How. Within * after the Effective Date, Roche shall
transfer to Miikana all of the Transfer Know-How to the extent available.
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Within
* after the Effective Date, Roche shall transfer to Miikana the remainder of the Transfer
Know-How. Roche agrees to provide to Miikana upon Miikana’s reasonable request and at Miikana’s
sole expense the prosecution files and histories of the Roche Patent Rights that are not publicly
available.
11.2 Support. During the period beginning * thereafter, Roche shall allow
Miikana to have * with available Roche key personnel at Roche’s facilities to answer
questions pertaining to the Roche Know-How. During this * , Roche shall provide Miikana
with reasonable access to key employees, if any, who are available at the time of request. All
such requests by Miikana shall be made to the Roche employee designated to coordinate such
requests. Such access shall not exceed * , of which no more than * shall be from any one of
the following groups: * .
11.3 Regulatory Affairs.
(a) During the Term, Miikana shall (i) control and be solely responsible for making all needed
Regulatory Filings relating to the development of Licensed Products and for seeking and maintaining
Registrations of Licensed Products in the Field throughout the Territory, in such countries as it
selects; and (ii) own and be responsible for preparing and submitting all Regulatory Rulings,
including preparing all applications and reports necessary as part of an IND, NDA, DMF, BLA or
other necessary filing required for Registration. Roche shall assign to Miikana all rights, title
and interest in and to all Regulatory Filings that Roche has made with respect to any Compound or
Derivative and all licenses, authorizations and permits that Roche has obtained with respect to
clinical trials of any Compound or Derivative. Roche shall permit Miikana to access, and shall
provide Miikana with sufficient rights to reference and use in association with exercising its
rights and performing its obligations under this Agreement, all records pertaining to Compounds,
Derivatives or Licensed Products as are in the possession and Control of Roche and are reasonably
necessary for obtaining Registrations for Licensed Products.
(b) In conducting any research or development activities under this Agreement, Miikana shall
(i) ensure that its employees, agents, clinical institutions and clinical investigators comply with
all FDA statutory and regulatory requirements with respect to Licensed Products, including but not
limited to the Federal Food, Drug and Cosmetic Act, as amended, the Public Health Service Act,
Institutional Review Boards, GCP, GLP, IND regulations, and any conditions imposed by a reviewing
IRB or the FDA; and (ii) not utilize, in conducting studies on Licensed Products, any person or
entities that at such time are debarred by the FDA, or that, at such time, are under investigation
by the FDA for debarment action pursuant to the provisions of 21 U.S.C. § 335.
11.4 Meetings with Regulatory Authorities. Miikana shall inform Roche of any meeting
between Miikana and any Regulatory Authority to the extent that such meeting relates to the
development of the Licensed Product. Roche shall be entitled, at its own expense, to have a Roche
representative attend any such meeting.
11.5 Supply of Active Compound. Miikana shall purchase from Roche at least
___ * ___of
*
Compound (“ * ”) for *
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* payable within * days after the Effective Date. Roche shall deliver such
MBP to Miikana within * days after receiving Miikana’s payment. Roche shall retain in
storage * of MBP for a period of * beginning on the Effective Date. If Miikana
wants Roche to store MBP beyond the * of the Effective Date, then Miikana shall pay to
Roche * and Roche shall store such MBP until the second anniversary of the Effective Date.
If Miikana wants to purchase the entire * of MBP at any time during the time in which such
MBP is stored by Roche, then Miikana may do so by paying Roche * and Roche shall deliver
such MBP to Miikana within * days after receiving Miikana’s payment. MBP supplied to
Miikana under this Section 11.5 shall comply with the specifications set forth in Appendix D.
Transfer shall be * at a location identified by Roche. If the MBP fails to comply with
the specifications set forth in Appendix D, then Miikana shall dispose of the
non-complying-MBP at its own cost and Roche shall reimburse Miikana for the payment made
for such MBP.
11.6 Product Recalls. Each Party shall advise the other if it determines that an
event, incident, or circumstance has occurred which may result in the need for a recall or other
removal of any Licensed Product, or a lot or lots thereof, from the market.
ARTICLE
12
TERM AND TERMINATION
12.1 Term. This Agreement shall become binding upon the Effective Date. This
Agreement shall continue thereafter in full force and effect, unless terminated sooner pursuant to
Sections 12.2 or 12.3 below, until it expires upon the expiration of both Parties’ obligation to
pay royalties to the other hereunder (such expiration of the term of this Agreement without
termination, “Expiration”).
12.2 Miikana Right to Terminate.
(a) For Material Breach at any Time. Miikana may terminate this Agreement, as a
whole, at any time if (i) Roche materially breaches the Agreement and (ii) such material breach is
not cured by Roche within * after Miikana provides Roche with written notice of such
breach, or, if such breach cannot be cured through commercially reasonable efforts within such
* , and Roche has (within such time period) submitted a plan for cure as promptly as is
reasonably practicable through the application of commercially reasonable efforts with a cure date
reasonably acceptable to Miikana, after the earlier of the cure date agreed to by Miikana or the
date Roche ceases commercially reasonable efforts to cure such breach.
(b) For Convenience. Miikana may terminate this Agreement for convenience, upon
* days prior written notice to Roche, provided that such notice of termination may not
occur until * . Miikana may commence to wind down all of its activities under this
Agreement immediately upon such notice. Mikana may terminate this Agreement pursuant to this
Section 12.2(b) either in its entirety or in any or the following areas: (1) the US as a whole; (2)
the European Union and
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the territories and possessions of its member countries as a whole; (3) Japan and its
territories and possessions as a whole; and (4) for countries not encompassed within (1), (2) and
(3), in individual countries (and their territories and possessions) on a country-by-country basis.
(c) EU Termination. As regards termination for convenience in the European Union
pursuant to this Section 12.20, such termination shall be initially effective as of the expiration
of the * notice period in each country that is at that time a member of the European Union
(together with their territories and possessions), and within each country (together with its
territories and possessions) that subsequently becomes a member of the European Union, *
after it becomes such a member.
12.3 Roche’s Right to Terminate.
(a) For Material Breach at any Time. Roche may terminate this Agreement, as a whole,
at any time if (i) Miikana materially breaches the Agreement and (ii) such material breach is not
cured by Miikana within * after Roche provides Miikana with written notice of such breach,
or, if such breach cannot be cured through commercially reasonable efforts within such * ,
and Miikana has (within such time period) submitted a plan for cure as promptly as is reasonably
practicable through the application of commercially reasonable efforts with a cure date reasonably
acceptable to Roche, after the earlier of the cure date agreed to by Roche or the date Miikana
ceases commercially reasonable efforts to cure such breach. If Miikana files a petition for
bankruptcy, dissolution, liquidation or winding up of affairs, then such petition shall not relieve
Miikana of its obligation for continued performance under this Agreement pending a decision on such
petition.
(b) For Miikana’s Discontinuance of the Development Plan. Notwithstanding anything
in this Agreement to the contrary, Roche may terminate the Agreement and all licenses granted
herein following receipt of written notice from Miikana of Miikana’s decision to discontinue all of
Miikana’s activities under the Development Plan pursuant to Section 6.3(c) in either the Territory
or a sub-territory (as defined in Section 6.3(e)), as applicable. Following such termination and
at Roche’s request, Miikana shall negotiate in good faith with Roche to license on commercially
reasonable terms to Roche the Miikana Patent Rights and Miikana Know-How related solely to the
Licensed Products.
12.4 General Effect of Expiration or Termination. Upon Expiration or termination of
this Agreement for any reason, all rights and obligations of the Parties hereunder shall cease,
except as explicitly provided for below in this Article 12 or elsewhere in this Agreement.
Expiration or termination of this Agreement shall not relieve the Parties of any obligation to make
payments or otherwise to the extent related to events or other facts in existence prior to such
Expiration or termination.
12.5 Rights Upon Expiration or Any Termination.
(a) Upon Expiration of this Agreement in any country, Miikana shall continue to have a
royalty-free, perpetual right to Commercialize Licensed Products in the Territory, as the license
granted Miikana in Section 2.1 shall automatically become royalty-free, non-exclusive and perpetual
in the country of Expiration.
| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
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(b) Upon Expiration or termination of this Agreement for any reason, the following Sections
and Articles shall survive such expiration or termination, subject to any later termination dates
provided for therein: Sections 5.1 and 5.2 (with respect to payments having accrued during the term
of this Agreement); Sections 5.4; 5.5; and 9.3, and Articles 1, 8 (as relates to infringement
occurring during the term of this Agreement), 10, 12, 13 and 14.
12.6 Rights Upon Certain Miikana Terminations.
(a) Upon termination by Miikana for Roche’s uncured material breach of this Agreement pursuant
to Section 12.2(a), the following Sections shall survive such termination in addition to the
Sections and Articles set forth to survive in Section 12.5(b): Sections 2.1; and 3.1, 3.2 and 3.3
(with continued milestone payments); Article 4 (with continued royalty payments) and all other
Sections and Articles governing the mechanics of milestone and royalty payments hereunder. The
licenses granted by Roche to Miikana shall become * if Miikana terminates under Section
12.2(a).
(b) If Miikana terminates this Agreement for any reason, other than Roche’s uncured material
breach of this Agreement pursuant to Section 12.2(a), then Miikana’s obligations pursuant to
Section 3.1 shall survive such termination.
12.7 Rights Upon Roche Termination for Cause and Other Miikana Terminations. If
Roche terminates this Agreement pursuant to Section 12.3, or Miikana terminates this Agreement for
convenience pursuant to Sections 12.2(b), 12.2(c) or 12.2(4), then:
(a) Reverted Territory: Reverted Products. The Territory, in the case of a
termination in whole, and the terminated country or countries (together with their territories and
possessions) in the case of a partial termination, shall be deemed to be the “Reverted Territory”
effective as of the effective date of such termination. In the case of a partial termination, the
Reverted Territory shall thereafter be excluded from the Territory for all purposes under this
Agreement, but this Agreement will remain in effect in the remaining Territory. All Licensed
Products in the Reverted Territory shall, effective upon the effective date of such termination, be
deemed “Reverted Products.”
(b) No Further Representations. The Miikana Group shall discontinue making any
representation regarding its status as a licensee of or distributor for Roche in the Reverted
Territory, for all Reverted Products. The Miikana Group shall cease conducting any activities with
respect to the marketing, promotion, sale or distribution of the Reverted Products in the Reverted
Territory.
(c) Technology License. Miikana hereby grants to Roche, effective upon such
termination, the right to negotiate a license on commercially reasonable terms under (i) any patent
or patent application owned by Miikana (or any Miikana Affiliate) covering the Reverted Products
having been developed or commercialized by the Miikana Group during the term of this Agreement, and
(ii) all Know-How owned or Controlled by Miikana and its Affiliates relevant to Reverted Products,
solely for Roche to Commercialize Reverted Products in the Reverted Territory, and to manufacture
Reverted Products anywhere in the world for such Commercialization, and (iii) any Regulatory
Filings of Miikana in the Reverted Territory.
| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
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(d) Remaining Quantities. At Roche’s request, Miikana shall sell to Roche
___ * ___quantities of Compound or Derivative related to Reverted Products in
the possession of the Miikana Group, in the case of a Territory-wide termination, or in their
possession and labeled for sale in any country of the Reverted Territory, in the case of a partial
termination, subject to all the disclaimers in Section 9.3. Such sale shall be * at a
location identified by Miikana.
(e) No Further Sales. Miikana covenants that promptly upon such termination it and
its Affiliates and former sublicensees hereunder shall cease to sell, and thereafter shall not
sell, any Reverted Product in the Reverted Territory prior to * after the effective date of
termination.
(f) Cross-Border Sales After Partial Termination. To the extent permitted by law,
Miikana shall take reasonable measures to prevent any sales of Licensed Product originally sold by
it in the Territory into the Reverted Territory. Such measures shall include without limitation,
to the extent permitted by law: (i) refraining from selling quantities of Licensed Products to any
entity Miikana has reason to believe (including as a result of written notice from Roche) may cause
such quantities to be resold in the Reverted Territory, and (ii) contractually requiring each of
its sublicensees and distributors of Licensed Produces to refrain from selling quantities of
Licensed Products to any entity that the sublicensee or distributor has reason to believe may cause
such quantities to be resold in the Reverted Territory. If Roche believes that Licensed Product
originally sold by Miikana in the Territory is being sold in the Reverted Territory, senior
executives of the Parties shall meet to discuss the situation. If such resale is occurring, then
the Parties shall mutually agree on an equitable mechanism to compensate Roche for lost sales of
Reverted Products in the Reverted Territory. In addition, this Section 12.7(f) shall apply to
Roche mutatis mutandis to require that Roche must guard against Reverted Product originally sold in
the Reverted Territory being resold into the Territory.
ARTICLE
13
INDEMNIFICATION
13.1 Indemnification by Miikana. Subject to Sections 13.3 and 14.14 hereof, Miikana
hereby agrees to defend, indemnify and hold harmless Roche and its Affiliates and licensors, and
their directors, officers, employees and agents (“Roche Indemnitees”) from and against any
liabilities, losses, fines, penalties, damages, expenses (including reasonable attorney’s fees and
expenses and expenses incurred in connection with the enforcement of this provision), resulting
from any Third Party suits, actions, or claims brought or threatened after the Effective Date of
this Agreement and which arise out of claims against Roche brought by Third Parties after the
Effective Date of this Agreement, including but not limited to, any actions in contract (including
breach of warranty) tort (including negligence, strict liability or commercial torts) which arise,
result from, or relate to:
(i) any breach of any of the representations or warranties of Miikana contained in
Section 9.2 hereof,
| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
-25-
(ii) the gross negligence, recklessness or willful misconduct of the Miikana and its
Affiliates; and
(iii) any development or Commercialization (including without limitation; any
manufacture, storage, use or possession) of Compound, Derivative or Licensed Product by
Miikana, its Affiliates, sublicensees and distributors.
Items (i) through (iv) are hereinafter collectively referred to as a “Roche Loss.” Miikana shall
have no obligation to indemnify Roche, to the extent that any Roche Loss arises out of the gross
negligence or willful misconduct of any Roche Indemnitee or Roche’s breach of this Agreement.
13.2 Indemnification by Roche. Subject to Sections 13.3 and 14.14 hereof, Roche
hereby agrees to indemnify and hold harmless Miikana and its Affiliates and, sublicensees, and
their directors, officers, employees and agents (Miikana Indemnitees”) from and against any
liabilities, losses, fines, penalties, damages, expenses (including reasonable attorney’s fees and
expenses and expenses incurred in connection with the enforcement of this provision), resulting
from any Third Party suits, actions, or claims brought or threatened after the Effective Date of
this Agreement and which arise out of claims against Miikana brought by Third Parties after the
Effective Date of this Agreement, including but not limited to, any actions in contract (including
breach of warranty), tort (including negligence, strict liability or commercial torts) which arise,
result from, or relate to:
(i) any breach of any of the representations or warranties of Roche contained in Section 9.1
hereof, and
(ii) the gross negligence, recklessness or willful misconduct of Roche, its Affiliates or
agents.
Items (i) through (ii) are hereinafter collectively referred to as an “Mikkana Loss.” Roche shall
have no obligation to indemnify Miikana, to the extent that any Miikana loss arises out of the
gross negligence or willful misconduct of any Miikana Indemnitee or Miikana breach of this
Agreement.
13.3 Indemnification Procedures With Respect to Third Party Claims.
(a) To be eligible to seek indemnification under this Article 13 in respect to a liability,
loss, fine, penalty, damage, expense, action, or claim brought against such Indemnitee by a Third
Party (such claim hereinafter referred to as a “Third Party Claim”), a Miikana Indemnitee or Roche
Indemnitee (each, an “Indemnitee”) shall promptly give written notice thereof to the Party from
whom indemnification is sought (such Party hereinafter referred to as the “Indemnitor”) within a
reasonable period of time after the assertion of such Third Party Claim by such Third Party;
provided, however, that the failure to provide written notice of such Third Party Claim within a
reasonable period of time shall not relieve the Indemnitor of any of its obligations hereunder,
except to the extent that the Indemnitor is prejudiced by such failure. The Indemnitor shall have
the right to assume the complete control of the defense, compromise or settlement of any Third
Party Claim (provided that no settlement of any Third Party Claim shall include any admission of
wrongdoing on the part of an Indemnitee, without the prior written consent of such Indemnitee,
which consent shall not be unreasonably withheld),
| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
-26-
including, at its own expense, employment of legal counsel. At any time thereafter the
Indemnitor shall be entitled to exercise, on behalf of the Indemnitee, any rights which may
mitigate the extent or amount of such Third Party Claim; provided, however, that if the Indemnitor
shall have exercised its right to assume control of such Third Party Claim, the Indemnitee (i) may,
in its sole discretion and at its own expense (which expense shall not be subject to
indemnification hereunder), employ legal counsel to represent it (in addition to the legal counsel
employed by the Indemnitor) in any such matter, and in such event legal counsel selected by the
Indemnitee shall be required to confer and cooperate with such counsel of the Indemnitor in such
defense, compromise or settlement for the purpose of informing and sharing information with the
Indemnitor; (ii) shall, at its own expense, make available to Indemnitor those employees, officers
and directors or Indemnitee whose assistance, testimony or presence is necessary or appropriate to
assist the Indemnitor in evaluating and in defending any such Third Party Claim (provided, however,
that any such access shall be conducted in such a manner as not to interfere unreasonably with the
operations of the businesses of Indemnitee); and (iii) shall otherwise fully cooperate with the
Indemnitor and its legal counsel in the investigation and defense of such Third Party Claim.
(b) If the Parties acting in good faith cannot agree as to the applicability of Section 13.1
and/or 13.2 to a particular Third Party Claim, then each Party (and its respective Indemnitees)
reserves the right to conduct its own defense of such Third Party Claim and seek indemnification
from the applicable Party upon its resolution.
ARTICLE
14
GENERAL PROVISIONS
14.1 Force Maieure. Neither Party shall be held liable or responsible to the other
Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in
fulfilling or performing any term of this Agreement, other than an obligation to make payments
hereunder, when such failure or delay is caused by or results from fire; flood; earthquake;
tornado; embargo; government regulation; prohibition or intervention; war; act of war (whether war
be declared or not); insurrection; act of terrorism; riot; civil commotion; strike; lockout; act of
God or any other cause beyond the reasonable control of the affected Party to anticipate, prevent,
avoid or mitigate (a “Force Majeure Event”) so long as the affected Party uses commercially
reasonable efforts to overcome the effects of the Force Majeure Event; provided, however, that any
failure or delay in fulfilling a term of this Agreement shall not be considered a result of a Force
Majeure Event if it arises from a knowing=failure of Miikana or Roche to comply with
applicable laws and regulations.
14.2 Further Assurances. Each Party hereto agrees to perform such acts, execute such
further instruments, documents or certificates, and provide such cooperation in proceedings and
actions as may be reasonably requested by the other Party in order to carry out the intent and
purpose of this Agreement, including without limitation the registration or recordation of the
rights granted hereunder.
14.3 Severabilitv. Both Parties hereby expressly acknowledge and agree that it is
the intention of neither Party to violate any public policy, statutory or common law, rules,
| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
-27-
regulations, treaty or decision of any government agency or executive body thereof of any
country or community or association of countries and specifically agree that if any word, sentence,
paragraph, clause or combination thereof in this Agreement is found by a court or executive body
with judicial powers having jurisdiction over this Agreement or any of the Parties hereto in a
final unappealed order, to be in violation of any such provisions in any country or community or
association of countries, then in such event such words, sentences, paragraphs, clauses or
combination shall be inoperative in such country or community or association of countries (or
reformed, for example but without limitation, to apply for a shorter period of time, such that
their effect is in compliance with law) and the remainder of this Agreement shall remain binding
upon the Parties hereto.
14.4 Notices. Any notice required or permitted to be given hereunder shall be in
writing and shall be deemed to have been properly given if delivered in person, or if mailed by
registered or certified mail (return receipt requested) postage prepaid, or by a nationally
recognized overnight courier, or by facsimile (and promptly confirmed by registered, certified
mail, overnight courier or fax receipt), to the addresses given below or such other addresses as
may be designated in writing by the Parties from time to time during the term of this Agreement.
Any notice sent by overnight courier or facsimile shall be deemed received on the first business
day after posted with the courier or transmittal. Any notice sent by registered, certified mail
shall be deemed received on * business day following the date of posting.
In the case of Miikana:
Miikana Therapeutics
0000 Xxxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attention: President
0000 Xxxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attention: President
Telephone No.: (000) 000-0000
Facsimile No.: (000) 000-0000
Facsimile No.: (000) 000-0000
and:
Cooley Godward LLP
Five Palo Alto Square
0000 Xx Xxxxxx Xxxx
Xxxx Xxxx, XX 00000
Attention: Xxxxxxx Xxxxx Xxxx, Esq.
Five Palo Alto Square
0000 Xx Xxxxxx Xxxx
Xxxx Xxxx, XX 00000
Attention: Xxxxxxx Xxxxx Xxxx, Esq.
Telephone No.: (000) 000-0000
Facsimile No.: (000) 000-0000
Facsimile No.: (000) 000-0000
In the case of Roche:
Xxxxxxxx-Xx Xxxxx Inc.
000 Xxxxxxxxx Xxxxxx
000 Xxxxxxxxx Xxxxxx
| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
Xxxxxx, XX 00000
Attention: Corporate Secretary
Attention: Corporate Secretary
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and:
X. Xxxxxxxx-Xx Xxxxx Ltd
Xxxxxxxxxxxxxxxxx 000
XX-0000 Xxxxx
Xxxxxxxxxxx
Attention: Corporate Law
Xxxxxxxxxxxxxxxxx 000
XX-0000 Xxxxx
Xxxxxxxxxxx
Attention: Corporate Law
14.5 Assignment. All of the terms and provisions of this Agreement shall be binding
upon and inure to the benefit of and be enforceable by the respective successors and permitted
assigns of the Parties hereto, but neither this Agreement nor any of the rights, interests or
obligations hereunder of any Party hereto shall be assigned without the prior written consent of
the other Party (which may be withheld for any reason), provided, however, that either Party may,
without such consent, assign this Agreement in whole or in part-(i) to a successor corporation in
connection with the transfer or sale of all or substantially all of its business to which this
Agreement pertains or in the event of the merger or consolidation with another corporation; and
(ii) to an Affiliate. Any purported assignment in violation of the preceding sentence shall be
void. Any permitted assignee shall assume all obligations of its assignor under this Agreement.
14.6 Performance by Affiliates. Each of Roche and Miikana acknowledge that their
obligations and rights under this Agreement may be performed and exercised by Affiliates of Roche
and Miikana, respectively. Obligations of the Party for which one of its Affiliates is performing
hereunder shall be deemed to extend to such performing Affiliate. Each of Roche and Miikana
guarantee performance of this Agreement by its Affiliates. Wherever in this Agreement the Parties
delegate responsibility to Affiliates or local operating entities, the Parties agree that such
entities shall not make decisions inconsistent with this Agreement, amend the terms of this
Agreement or act contrary to its terms in any way. Further, if a Party’s Affiliate breaches any
aspect of this Agreement performance of which has been delegate to such Affiliate or acts in any
way inconsistently with the foregoing sentence, then the other Party shall be entitled to proceed
against the Party whose Affiliate so breached, and shall not first be required to proceed against
the Affiliate that so breached.
14.7 Publicity. Except for the details in the press release to be agreed upon by the
Parties, and as required by law, stock exchange or regulatory authority, except to the extent
otherwise required by law or regulation, neither Party, nor any of its Affiliates, shall originate
any publicity, news release or other public announcement, written or oral, relating to the
confidential terms or conditions contained in this Agreement without the prior written approval of
the other Party.
14.8 Amendment. The Parties hereto may amend, modify or after any of the provisions
of this Agreement, but only by a written instrument that explicitly refers to this Agreement and is
duly executed by both Parties hereto.
| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
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14.9 Entire Agreement. This Agreement contains the entire understanding of the
Parties with respect to the subject matter hereof. All express or implied agreements and
understandings, either oral or written, heretofore made with respect to such subject matter are
expressly superceded by this Agreement.
14.10 Waiver. The failure of a Party to enforce at any time for any period any of
the provisions hereof shall not be construed as a waiver of such provisions or of the rights of
such Party thereafter to enforce each such provisions.
14.11 No Implied Licenses. Except as expressly and specifically provided under this
Agreement, the Parties agree that neither Party is granted any implied rights to or under any of
the other Party’s current or future patents, trade secrets, copyrights, moral rights, trade or
service marks, trade dress, or any other intellectual property rights.
14.12 No Joint Venture. The Parties agree that the relationship of Roche and Miikana
established by this Agreement is that of independent licensee and licensor. Furthermore, the
Parties agree that this Agreement does not, is not intended to, and shall not be construed to,
establish a partnership or joint venture, and nor shall this Agreement create or establish an
employment, agency or any other relationship. Except as may be specifically provided herein,
neither Party shall have any right, power or authority, nor shall they represent themselves as
having any authority to assume, create or incur any expense, liability or obligation, express or
implied, on behalf of the other Party, or otherwise act as an agent for the other Party for any
purpose.
14.13 No Third Party Beneficiaries. All rights, benefits and remedies under this
Agreement are solely intended for the benefit of Roche and Miikana, and no Third Party shall have
any rights whatsoever to (i) enforce any obligation contained in this Agreement; (ii) seek a
benefit or remedy for any breach of this Agreement; or (iii) take any other action relating to this
Agreement under any legal theory, including but not limited to, actions in contract, tort
(including but not limited to negligence, gross negligence and strict liability), or as a defense,
setoff or counterclaim to any action or claim brought or made by the Parties.
14.14 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER
PARTY FOR ANY LOSS OF PROFITS, LOSS OF BUSINESS OR INTERRUPTION OF BUSINESS, OR FOR ANY OTHER
INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES OF ANY KIND, EVEN If SUCH PARTY
HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGES. IN NO CASE SHALL EITHER PARTY BE
LIABLE FOR ANY REPRESENTATION OF WARRANTY MADE BY THE OTHER PARTY TO ANY THIRD PARTY.
14.15 Governing Law. This Agreement is to be construed in accordance with, and
governed by, Swiss law, except in relation to the principles governing conflict of laws. This
Agreement shall not be governed by the United Nations Convention of International Contracts on the
Sale of Goods (Vienna Convention), except that questions affecting the construction and effect of
any patent shall be determined by the laws of the country in which such patent has been
| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
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granted. Litigation relating to the subject matter of this Agreement shall be brought in a
court in Basel, Switzerland.
14.16 Headings. The article, section and paragraph headings contained in this
Agreement are for reference purposes only and shall not affect in any way the meaning or
interpretation of this Agreement.
14.17 Counterparts. This Agreement may be executed in any number of counterparts,
each of which shall be deemed an original but all of which together shall constitute one and the
same document.
14.18 Dispute Resolution. The Parties recognize that disputes as to certain matters
may from time to time arise during the term of this Agreement which relate to either Party’s rights
and/or obligations hereunder. The Parties shall seek to amicably resolve disputes arising under
this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To
reach amicable resolution, the Parties agree to refer such disputes to the senior management of
each Party for them to seek joint resolution before resorting to litigation.
Remainder of this page intentionally left blank
In Witness Hereof, the Parties have executed this Agreement effective as of the Effective
Date.
| Xxxxxxxx-Xx Xxxxx Inc. | ||||||||||
By:
|
/s/ Xxxxxxxx Xx-Xxxxx Inc. | |||||||||
| Name: | ||||||||||
| Title: | ||||||||||
| X. Xxxxxxxx-Xx Xxxxx Ltd X. | Xxxxxxxx-Xx Xxxxx Ltd | |||||||||
By:
|
/s/ X. Xxxxxxxx-Xx Xxxxx Ltd. | By: | /s/ X. Xxxxxxxx-Xx Xxxxx Ltd | |||||||
| Name: | Name: | |||||||||
| Title: | Title: | |||||||||
| Miikana Therapeutics Inc. | ||||||||||
By:
|
/s/ Xxxxxx X. Xxxxx | |||||||||
| Name: Xxxxxx X. Xxxxx, Ph.D. | ||||||||||
| Title: President | ||||||||||
| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
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Appendix A
List of Roche Patent Rights
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| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
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Appendix A
List of Roche Patent Rights (continued)
Roche Patent Series 20077
| Count Code | Application No. | Patent No. | ||
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| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
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| Count Code | Application No. | Patent No. | ||
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| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
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| Count Code | Application No. | Patent No. | ||
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| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
-5-
Appendix A
List of Roche Patent Rights (continued)
| Country Code | Application No. | Patent No. | ||
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| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
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| * | * | * | ||
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| * | * | * | ||
| * | * | * |
| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
-7-
| Country Code | Application No. | Patent No. | ||
| * | * | * | ||
| * | * | * | ||
| * | * | |||
| * | * | |||
| * | * | |||
| * | * | * | ||
| * | * | |||
| * | * | * | ||
| * | * |
| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
-8-
Appendix A
List of Roche Patent Rights (continued)
Roche Patent Series 20524
| Country Code | Application No. | Patent No. | ||
| * | * | |||
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| * | * | * | ||
| * | * | * |
| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
-9-
| Country Code | Application No. | Patent No. | ||
| * | * | |||
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| * | * | * | ||
| * | * |
| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
-10-
Appendix A
List of Roche Patent Rights (continued)
Roche Patent Series 20690
| Country Code | Application No. | Patent No. | ||
| * | * | |||
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| * | * | |||
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| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
-11-
Appendix A
List of Roche Patent Rights (continued)
Roche Patent Series 20798
| Country Code | Application No. | Patent No. | ||
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| * | * | * | ||
| * | * | * |
| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
-12-
Appendix A
List of Roche Patent Rights (continued)
Roche Patent Series 20865
| Country Code | Application No. | Patent No. | ||
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| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
-00-
XXXXXXXX X
Transfer of Know How
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2
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3
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| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
4
Appendix C
Development Plan
Phase 2:
| Ø | * | |||||
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| Ø | * | |||||||
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| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
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| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
Glossary Of Abbreviations
*
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| * | The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission. |
Appendix D
Active Compound Specifications
Appendix E
Stock Purchase Agreement
