CONFIDENTIAL MATERIAL OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
Exhibit 10.27
EXCLUSIVE LICENSE AGREEMENT
BY AND BETWEEN
TESARO, INC.
AND
OPKO HEALTH, INC.

 

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Table of Contents

              Page  
Article I DEFINITIONS
    1  
 
       
Article II LICENSE GRANT
    8  
 
       
2.1 License Grant
    8  
2.2 Sublicenses
    8  
2.3 Covenant Not to Sue
    9  
2.4 Responsibility; Decision-making
    9  
2.5 Diligence
    9  
2.6 Joint Steering Committee
    10  
2.7 Latin America
    10  
 
       
Article III TECHNOLOGY TRANSFER AND TRANSITION ACTIVITIES
    11  
 
       
3.1 Know-how Transfer
    11  
3.2 Cooperation
    11  
3.3 Regulatory Transition
    11  
3.4 Supply of Material
    12  
3.5 Costs
    12  
 
       
Article IV FINANCIAL PROVISIONS
    12  
 
       
4.1 License Fee
    12  
4.2 Intentionally Left Blank
    12  
4.3 Milestones Payments by TESARO
    12  
4.4 Royalty Payments by TESARO
    13  
4.5 Japan
    15  
4.6 Royalty and Income Sharing Term
    15  
4.7 Reduction for No Valid Claim
    15  
4.8 Third Party Payments
    16  
4.9 Payments; Reports
    16  
4.10 Taxes
    16  
4.11 United States Dollars
    17  
4.12 Currency Conversion
    17  
4.13 Blocked Payments
    17  
4.14 Late Payments
    17  
4.15 Records and Audits
    17  
 
       
Article V INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS
    18  
 
       
5.1 Prosecution and Maintenance of Patent Rights
    18  
5.2 Patent Term Extensions
    19  
5.3 Third Party Infringement
    19  
5.4 Patent Invalidity Claim
    20  
5.5 Patent Marking
    21  
 
       
Article VI CONFIDENTIALITY
    21  
 
       
6.1 Confidential Information
    21  

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              Page  
6.2 Permitted Disclosures
    22  
6.3 Limitation on OPKO Disclosure of OPKO Know-how
    22  
6.4 Publicity
    22  
6.5 Publications
    23  
6.6 Return of Confidential Information
    23  
 
       
Article VII REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS
    23  
 
       
7.1 Mutual Representations
    23  
7.2 OPKO’s Representations and Warranties
    24  
7.3 No Warranty
    25  
 
       
Article VII. INDEMNIFICATION
    25  
 
       
8.1 Indemnification by TESARO
    25  
8.2 Indemnification by OPKO
    26  
8.3 Indemnification Procedure
    26  
8.4 Limitation of Liability
    26  
8.5 Insurance
    27  
 
       
Article IX TERM AND TERMINATION
    27  
 
       
9.1 Term
    27  
9.2 Termination for Convenience
    27  
9.3 Termination for Cause
    27  
9.4 OPKO Termination
    27  
9.5 Effect of Termination
    27  
9.6 Survival
    29  
 
       
Article X DISPUTE RESOLUTION
    29  
 
       
10.1 Continuance of Rights and Obligations During Pendency of Dispute Resolution
    29  
10.2 Referral of Unresolved Matters to Senior Executives
    29  
10.3 Arbitration
    29  
10.4 Equitable Relief
    30  
 
       
Article XI MISCELLANEOUS
    30  
 
       
11.1 Governing Law and Jurisdiction
    30  
11.2 Force Majeure
    30  
11.3 Further Assurances
    31  
11.4 Notices
    31  
11.5 Assignment
    31  
11.6 Affiliate Performance
    32  
11.7 Amendment
    32  
11.8 Entire Agreement
    32  
11.9 No Benefit to Third Parties
    32  
11.10 Waiver
    32  
11.11 No Implied Licenses
    32  
11.12 Relationship of the Parties
    32  
11.13 Severability
    32  

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              Page  
11.14 Interpretation
    33  
11.15 Counterparts
    34  
 
       
Exhibit A — Description of SCH 619734
       
Exhibit B — Description of SCH 900978
       
Exhibit C — Existing OPKO Patent Rights
       
Exhibit D — Technology Transfer Plan
       
Exhibit E — Form of Press Release
       
Exhibit F — Third Party Agreements
       

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EXCLUSIVE LICENSE AGREEMENT
     This Exclusive License Agreement, made this 10th day of December, 2010 (the
“Effective Date”), is by and between TESARO, Inc., a Delaware company, with
principal offices located at 309 Waverley Oaks Rd., Suite 101, Waltham, MA 02452
(“TESARO”) and OPKO Health, Inc., a Delaware corporation, with principal offices
located at 4400 Biscayne Blvd., Miami, FL 33137 (“OPKO”). Each of TESARO and
OPKO may be referred to, individually, as a “Party”, and, collectively, as the
“Parties”.
RECITALS
     WHEREAS, OPKO owns or controls certain patent rights and know-how related
to the neurokinin-l (NK-l) receptor antagonists, SCH 619734 (Rolapitant) and SCH
900978;
     WHEREAS, TESARO is interested in obtaining an exclusive license under such
patent rights and to such know-how to develop and commercialize pharmaceutical
products incorporating either or both of the foregoing compounds, and OPKO is
willing to grant TESARO such a license, in each case on the terms and conditions
set forth in this Agreement.
     NOW, THEREFORE, in consideration of the foregoing and the mutual covenants
contained in this Agreement, OPKO and TESARO, intending to be legally bound,
hereby agree as follows:
ARTICLE I
DEFINITIONS
     When used in this Agreement, each of the following capitalized terms,
whether used in the singular or plural, shall have the meaning set forth in this
Article I.
     1.1. “Affiliate” of an entity means any person or entity which, directly or
indirectly, controls, is controlled by or is under common control with such
entity. For the purposes of this definition, “control” refers to any of the
following: (i) direct or indirect ownership of fifty percent (50%) or more of
the voting securities entitled to vote for the election of directors in the case
of a corporation, or of fifty percent (50%) or more of the equity interest with
the power to direct management in the case of any other type of legal entity;
(ii) status as a general partner in any partnership; or (iii) any other
arrangement where a person or entity possesses, directly or indirectly, the
power to direct the management or policies of an entity, whether through
ownership of voting securities, by contract or otherwise. Notwithstanding the
foregoing, the term “Affiliate” with respect to TESARO shall not include New
Enterprise Associates.
     1.2. “Agreement” means this Exclusive License Agreement, including any and
all exhibits, schedules, appendices and other addenda to it and as it may be
amended from time to time in accordance with the provisions of this document.
     1.3. “API” means the active pharmaceutical ingredient contained in Licensed
Product.
     1.4. “API Cost” means the Cost of Goods of API.
     1.5. “Asset Purchase Agreement” means that certain Asset Purchase Agreement
between OPKO and Schering Corporation (now Merck & Co., Inc.) dated as of
October 12, 2009, as amended by letter agreement dated June 29, 2010, under
which OPKO purchased certain assets related to the Compounds.
     1.6. “Combination Product” means any pharmaceutical product containing both
a Licensed Product component and one or more other active pharmaceutical
ingredients or other significant components.

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     1.7. “Commercially Reasonable Efforts” means the level of efforts and
resources, including financial resources, at least equal to those normally used
by a company to conduct the relevant activity, including, in the case of
research, development or commercialization, the level of effort and resources at
least equal to those normally used by such a company to research, develop,
manufacture or commercialize, as the case may be, a product owned by such
company or to which it has rights, which product is at a similar stage in its
development or product life and is of a similar market and profitability
potential to Licensed Product, taking into account all relevant factors
including the patent and other proprietary position of the product, product
labeling or anticipated labeling, market potential, financial return, medical
and clinical considerations, regulatory environment and competitive market
conditions, and other technical, legal, scientific, medical or commercial
factors that such a company would deem to be relevant.
     1.8. “Compounds” means SCH 619734 (Rolapitant) and SCH 900978.
     1.9. “Confidential Information” means any and all information, data and
materials of a confidential or proprietary nature, which are provided by or on
behalf of one Party or any of its Affiliates to the other Party or any of its
Affiliates in connection with this Agreement.
     1.10. “Control” or “Controlled”, other than for purposes of Section 1.1,
means the possession of the right to grant licenses or sublicenses or to
disclose proprietary or trade secret information without violating the terms of
any agreement or other arrangement with a Third Party and without
misappropriating or infringing the proprietary or trade secret information of a
Third Party.
     1.11. “Cost of Goods” means, with respect to API or Licensed Product, as
the case may be, the aggregate of costs of TESARO or any of its Affiliates or
Sublicensees to manufacture, package, label and release such API or Licensed
Product, calculated as follows: (i) to the extent that the API or Licensed
Product is manufactured, packaged, labeled or released by TESARO or any of its
Affiliates or Sublicensees, their actual direct material costs and direct labor
costs plus manufacturing overhead, directly and exclusively attributable to such
API or Licensed Product (including the API incorporated into such Licensed
Product), all calculated in accordance with GAAP; or (ii) to the extent that API
or Licensed Product is manufactured, packaged, labeled or released by a Third
Party, the actual amounts paid by TESARO or any of its Affiliates or
Sublicensees to such Third Party for such activities performed on a specified
quantity of such API or Licensed Product plus the costs of any materials
(including API and raw materials) provided by TESARO or any of its Affiliates or
Sublicensees to such Third Party for such activities, and any manufacturing
overhead, quality control and distribution costs incurred by TESARO or any of
its Affiliates or Sublicensees with respect to such materials provided or such
Licensed Product, as calculated in accordance with clause (i) of this
Section 1.11.
     1.12. “Cover”, “Covering” or “Covered” means, with respect to a Patent
Right and invention, that, in the absence of ownership of, or a license under,
such Patent Right, the practice of such invention would infringe a Valid Claim
of such Patent Right (including in the case of a Patent Right that is a patent
application, a Valid Claim of such patent application as if such patent
application were an issued patent).
     1.13. “EMA” means the European Medicines Agency or any successor agency.
     1.14. “EU” means the countries of the European Union, as it is constituted
as of the Effective Date and as it may be expanded from time to time.
     1.15. “FDA” means the United States Food and Drug Administration or any
successor agency thereto.
     1.16. “Field” means with respect to SCH 619734 (Rolapitant) all
therapeutic, prophylactic, palliative and diagnostic uses in humans, and means,
with respect to SCH 900978, treatment of nausea or

2

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vomiting of any cause; (ii) treatment of disease or treatment of symptoms or
side effects of disease in oncology indications; (iii) treatment of side effects
of oncology treatments or therapies; and (iv) any other supportive care
indications in oncology.
     1.17. “First Commercial Sale”, as to a particular country, means the first
commercial sale of a Licensed Product by TESARO or any of its Affiliates or
Sublicensees to a Third Party in such country after approval of the NDA, or if
approval of an NDA is not required in such country, then following receipt of
Marketing Approval required to market such Licensed Product in such country.
     1.18. “GAAP” means United States generally accepted accounting principles
applied on a consistent basis, or any other accounting principles generally
accepted for public companies in the United States such as International
Financial Reporting Standards (“IFRS”). Unless otherwise defined or stated,
financial terms shall be calculated under GAAP.
     1.19. “IND” means an Investigational New Drug Application filed with FDA or
a similar application filed with an applicable Regulatory Authority outside of
the United States such as a clinical trial application (CTA) or a clinical trial
exemption (CTX).
     1.20. “Japan Income” **** received from a Sublicensee with respect to
development or commercialization of Licensed Product in Japan, less applicable
**** of Licensed Product in Japan, provided that, if a royalty payment made by
such Sublicensee to TESARO or any of its Affiliates includes the purchase price
of a Licensed Product, then only **** of such Licensed Product will be included
as Japan Income. For the sake of clarity, Japan Income will not include any of
the following amounts received by TESARO or any of its Affiliates from a
Sublicensee: (i) ****, which is **** or any of its Affiliates for expenditures
actually incurred by **** or such Affiliate and which are directly attributable
to development and commercialization of Licensed Product ****;
(iii) reimbursement for **** or any of its Affiliates; and (iv) amounts paid by
a **** or any of its Affiliates as **** actually incurred by TESARO or such
Affiliate and which are directly attributable to ****, including reimbursement
of ****, and the costs of maintaining the ****.
     1.21. “Japan Income Sharing Term” has the meaning set forth in
Section 4.6(b).
     1.22. “Know-how” means all biological materials and other tangible
materials, inventions, practices, methods, protocols, formulas, knowledge,
know-how, trade secrets, processes, procedures, specifications, assays, skills,
experience, techniques, data and results of experimentation and testing,
including pharmacological, toxicological, safety, stability and pre-clinical and
clinical test data and analytical and quality control data, patentable or
otherwise.
     1.23. “Licensed Product” means any product comprising, incorporating or
containing any Compound, or an alternate form of any Compound, including, but
not limited to, a pharmaceutically acceptable salt, polymorph, crystal form,
prodrug, or solvate of any Compound to the extent such alternate form is claimed
in the OPKO Patent Rights.
     1.24. “Major EU Markets” means the United Kingdom, France, Italy, Spain and
Germany.
     1.25. “Marketing Approval” means any approval, including price approval,
registration, license or authorization from any Regulatory Authority required to
market and sell a Licensed Product in a jurisdiction and shall include an
approval, registration, license or authorization granted in connection with an
NDA.

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     1.26. “NDA” means a New Drug Application, Biologics License Application or
equivalent submission filed with the FDA in connection with seeking Marketing
Approval of a Licensed Product, or an equivalent application filed with any
equivalent regulatory agency or governmental authority in any jurisdiction other
than the United States.
     1.27. “Net Sales” means the gross amount invoiced on sales of Licensed
Product in the Territory (not including sales of Licensed Product by a
Sublicensee in Japan) by TESARO, its Affiliates or Sublicensees to any Third
Party, less the following deductions with respect to the sale of such Licensed
Product:
               (i) normal trade, cash and quantity discounts and other customary
discounts actually given to customers in the ordinary course of business;
               (ii) rebates, credits and allowances given by reason of
rejections, returns, damaged or defective product or recalls;
               (iii) government-mandated rebates and any other compulsory
payments, credits, adjustments and rebates actually paid or deducted;
               (iv) price adjustments, allowances, credits, chargeback payments,
discounts, rebates, fees, reimbursements or similar payments granted to managed
care organizations, group purchasing organizations or other buying groups,
pharmacy benefit management companies, health maintenance organizations and any
other providers of health insurance coverage, health care organizations or other
health care institutions (including hospitals), health care administrators or
patient assistance or other similar programs, or to federal, state/provincial,
local and other governments, including their agencies, or to wholesalers,
distributors or other trade customers;
               (v) reasonable and customary freight, shipping, insurance and
other transportation expenses, if actually borne by such TESARO or its
Affiliates or Sublicensees without reimbursement from any Third Party;
               (vi) sales, value-added, excise taxes, tariffs and duties, and
other taxes and government charges directly related to the sale, delivery or use
of Licensed Product (but not including taxes assessed directly against the
income derived from such sale) net of any credits or allowances received by
TESARO or its Affiliates or Sublicensees with respect to such taxes or charges;
               (vii) amounts previously included in Net Sales of Licensed
Product that are written off as uncollectible after reasonable collection
efforts, in accordance with standard practices of the applicable party; and
               (viii) any item, substantially similar in character or substance
to any of the foregoing, calculated in accordance with GAAP consistently applied
and customary in the pharmaceutical industry to be deducted in the definition of
net sales in a license agreement of this type.
Notwithstanding anything in this Agreement to the contrary, the transfer of a
Licensed Product between or among TESARO, its Affiliates and Sublicensees will
not be considered a sale.
Net Sales will include the cash consideration received on a sale and the fair
market value of all non-cash consideration.
Disposition of Licensed Product for, or use of the Licensed Product in, clinical
trials or other scientific testing, as free samples, or under compassionate use,
patient assistance, or test marketing programs or other similar programs or
studies where a Licensed Product is supplied without charge shall not result in

4

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any Net Sales however if TESARO or any of its Affiliates or Sublicensees charges
for such Licensed Product, the amount billed will be included in the calculation
of Net Sales.
Net Sales will be determined from books and records maintained in accordance
with GAAP, consistently applied throughout the organization and across all
products of the entity whose sales of Licensed Product are giving rise to Net
Sales.
In the event a Licensed Product is sold in the form of a Combination Product,
then the Net Sales for any such Combination Product shall be determined by
multiplying the Net Sales of the Combination Product during the applicable
royalty reporting period, by the fraction, A/(A+B), where A is the weighted (by
sales volume) average sale price of the Licensed Product component when sold
separately in finished form in the country in which the Combination Product is
sold and B is the weighted (by sales volume) average sale price of the other
active pharmaceutical ingredients or significant components included in the
Combination Product when sold separately in finished form in the country in
which the Combination Product is sold, in each case during the applicable
royalty reporting period or, if sales of both the Licensed Product component and
the other active pharmaceutical ingredients or significant components did not
occur in such period, then in the most recent royalty reporting period during
the preceding twelve (12) months in which sales of both occurred, if any. In the
event that such average sale price cannot be determined for both the Licensed
Product and all other active pharmaceutical ingredients or significant
components included in the Combination Product, then the Parties will in good
faith discuss and agree on a pro-rata allocation of the Net Sales that reflects
the Licensed Product’s contribution to the Combination Product on an equitable
basis. TESARO covenants that neither it nor any of its Affiliates or
Sublicensees will intentionally manipulate the fraction A/(A+B) to avoid or
reduce royalty payments or obligations that would otherwise be due for sales of
Licensed Product in combination form or otherwise
     1.28. “OPKO Patent Rights” means (i) any and all patents and patent
applications owned or otherwise Controlled by OPKO or any of its Affiliates on
the Effective Date or at any time during the Term anywhere in the Territory that
Cover OPKO Know-how or that otherwise Cover the research, formulation,
development, manufacture, import, marketing, sale or use of Licensed Product in
the Field; and (ii) any and all extensions or restorations of the foregoing
patents or patent applications by existing or future extension or restoration
mechanisms, including revalidations, reissues, re-examinations and supplementary
protection certificates and the like. OPKO Patent Rights includes the patents
and patent applications listed in Exhibit C.
     1.29. “OPKO Japan Share” has the meaning set forth in Section 4.5, subject
to adjustment as set forth in Section 4.7.
     1.30. “OPKO Know-how” means any Know-how owned or otherwise Controlled by
OPKO or any of its Affiliates as of the Effective Date or any time during the
Term that (i) is incorporated into Licensed Product or the manufacturing process
for Licensed Product; (ii) was used or generated in the development, manufacture
or use of Licensed Product; or (iii) is otherwise reasonably necessary or useful
to the research, formulation, development (including filing for and obtaining
Marketing Approval), manufacture, import, marketing, sale or use of Licensed
Product in the Field.
     1.31. “Patent Rights” means patents and patent applications and all
substitutions, divisions, continuations, continuations-in-part, reissues,
reexaminations, supplemental protection certificates and extensions and the like
thereof, and all counterparts thereof in any country.
     1.32. “Regulatory Authority” means any federal, national, multinational,
state, county, city, provincial, or local regulatory agency, department, bureau
or other governmental entity with authority over the marketing,
commercialization, manufacture or sale of a pharmaceutical product in the
Territory, including the FDA in the United States and the EMA in the EU.

5

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     1.33. “Royalty Term” has the meaning set forth in Section 4.6 (a).
     1.34. “SCH 619734” (Rolapitant) means the compound described in Exhibit A.
     1.35. “SCH 900978” means the compound described in Exhibit B.
     1.36. “Sublicensee” means a Third Party to whom TESARO or any of its
Affiliates or another Sublicensee grants an express sublicense under the OPKO
Patent Rights and OPKO Know-how to develop, manufacture, commercialize or use
Licensed Product in the Field, provided that the term “Sublicensee” does not
include any wholesaler or third party distributor who re-sells a Licensed
Product purchased from TESARO or any of its Affiliates or Sublicensees in final
finished form (but not necessarily in final packaged, and labeled form),
provided that OPKO is paid the royalty specified in Section 4.4 on the purchase
price of such Licensed Product paid by such wholesaler or distributor to TESARO
or any of its Affiliates or Sublicensees.
     1.37. “Technology Transfer Plan” means the plan for transfer to TESARO of
OPKO Know-how attached to this Agreement as Exhibit D.
1.38. “Term” means the term of this Agreement determined in accordance with
Section 9.1.
1.39. “Territory” means worldwide.
1.40. “TESARO Improvement” means any Know-how owned or otherwise Controlled by
TESARO or any of its Affiliates that constitutes an improvement of the OPKO
Know-how developed during the Term and is incorporated into the Licensed Product
by TESARO or any of its Affiliates.
1.41. “TESARO Improvement Patent Rights” means Patent Rights owned or Controlled
by TESARO or any of its Affiliates Covering any TESARO Improvement.
1.42. “Third Party” means any person other than a Party or any of its Affiliates
or their respective employees.
1.43. “Third Party Agreements” has the meaning set forth in Section 7.2(k).
1.44. “Third Party Payments” means all **** under licenses to intellectual
property or to acquire intellectual property that is necessary for the
development, manufacture, import, sale or use of Licensed Product in the Field.
For purposes of this definition, the term “necessary” shall mean that, in the
reasonable determination ****, if the relevant Patent Right of the Third Party
were to be found to be valid, there would be **** that the manufacture, use or
sale of Licensed Product would be found to infringe such Patent Right, provided
that nothing in the foregoing requires a court or other legal determination of
validity or infringement.
1.45. “United States” or “U.S.” means the United States of America and its
territories and possessions.
1.46. “Valid Claim” means (i) a claim of an issued and unexpired patent that has
not been revoked or held unenforceable or invalid by a decision of a court or
other governmental agency of competent jurisdiction from which no appeal can be
taken or with respect to which an appeal is not taken within the time allowed
for appeal, and that has not been disclaimed or admitted to be invalid or
unenforceable through reissue, disclaimer or otherwise or been dedicated to the
public, and (ii) a claim in a pending patent application that is being
prosecuted and that has not been abandoned, disclaimed, allowed to lapse or
finally determined to be unallowable by the

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applicable governmental authority in a decision from which no appeal can be
taken or from which no appeal is taken within the time allowed for appeal.
ARTICLE II
LICENSE GRANT
     2.1. License Grant. Subject to the terms and conditions of this Agreement,
OPKO and its Affiliates grant to TESARO an exclusive license (or sublicense, as
the case may be) under the OPKO Patent Rights and the OPKO Know-how, in each
case with the right to grant sublicenses, to the extent provided in Section 2.2,
to research, develop, make, have made, use, import, export, market, offer for
sale, sell and have sold, Licensed Product in the Territory within the
applicable Field.
     2.2. Sublicenses.
          (a) Sublicensing. The rights granted to TESARO by OPKO under
Section 2.1, may be extended to an Affiliate or sublicensed, in whole or in
part, to a Third Party (through multiple levels of sublicensing); provided, that
any sublicense that includes commercialization rights will require the prior
consent of OPKO which such consent OPKO shall not unreasonably withhold,
condition or delay. Notwithstanding anything in this Agreement to the contrary,
OPKO shall be deemed to have granted its consent to any sublicense under this
Section if OPKO has not provided TESARO with written notice of OPKO’s reasonable
objection to the sublicense within **** business days of receipt of a written
request for such consent from TESARO, along with an unredacted copy of the
relevant term sheet for an agreement which transfers rights granted hereunder so
that OPKO may consider granting consent. In addition, TESARO will, promptly
after signature, provide OPKO with an unredacted copy of each agreement with a
Sublicensee executed by TESARO or any of its Affiliates. Permitted Sublicensees
may also extend the rights granted under Section 2.1 to any of their Affiliates.
          (b) Performance by Sublicensees. TESARO will be fully responsible for
performance by each Sublicensee of its obligations under this Agreement. Each
sublicense granted by TESARO pursuant to this Section 2.2 will contain terms and
conditions consistent with those sections of this Agreement applicable to
Sublicensees. Each sublicense agreement will contain the following provisions:
(i) a requirement that any Sublicensee selling Licensed Product submit
applicable sales or other reports to TESARO to the extent necessary or relevant
to the reports required to be made or records required to be maintained under
this Agreement; (ii) an audit requirement as to those Sublicensees selling
Licensed Product consistent with that set forth in Section 4.15; and (iii) a
requirement that such Sublicensee comply with the confidentiality provisions and
restrictions on use of Confidential Information consistent with Article VI with
respect to Confidential Information of OPKO. If TESARO becomes aware of a
material breach by a Sublicensee of the rights granted to TESARO under
Section 2.1, TESARO will promptly notify OPKO of the particulars of the same,
and will use Commercially Reasonable Efforts to enforce the terms of such
sublicense.
     2.3. Covenant Not to Sue. At the request of TESARO, OPKO will use
Commercially Reasonable Efforts to enforce the covenant not to sue obligations
of Merck & Co., Ltd. under Section 7.7 of the Asset Purchase Agreement with
respect to the activities of TESARO and its Affiliates and Sublicensees under
this Agreement; provided, that TESARO will promptly reimburse all out-of-pocket
expenses (including reasonable attorneys’ fees and expenses) incurred by OPKO in
connection with such requested efforts.
     2.4. Responsibility; Decision-making. During the Term, **** will, including
through **** Affiliates and Sublicensees, have **** responsibility for and ****
decision-making authority with respect to, the research, development,
manufacture, marketing, sale and use of Licensed Product in the Field, and
except as otherwise expressly set forth in this Agreement, will be responsible
for **** associated with such activities during the Term.

7

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     2.5. Diligence. TESARO will use Commercially Reasonable Efforts during the
Term to develop and obtain Marketing Approval for a Licensed Product in the
United States and in each Major EU Market, and to commercialize such Licensed
Product in the United States and each Major EU Market if the relevant Marketing
Approval is obtained. TESARO shall keep OPKO informed as to TESARO’s progress in
these efforts. In addition, TESARO will use Commercially Reasonable Efforts to
secure any data and market exclusivity, including New Chemical Entity
exclusivity, for a Licensed Product for which Marketing Approval is obtained to
the extent available from the applicable Regulatory Authorities. TESARO agrees
to register this Agreement with any foreign governmental agency, which requires
such registration and where the failure to so register would have a material
adverse impact on commercialization of Licensed Product in a major market, and
**** in connection therewith. TESARO shall not be relieved of any of its
obligations under this Agreement by any failure to register this Agreement in
any country, and, specifically, shall not be relieved of its obligation to make
any payment due to OPKO where such payment is blocked due to any failure to
register this Agreement.
     2.6. Joint Steering Committee.
          (a) Formation. Within **** days after the Effective Date, the parties
will form a committee (the “Joint Steering Committee”) comprising at least ****
representatives from each party.
          (b) Responsibilities. The Joint Steering Committee will be responsible
for (i) reviewing the status and progress of efforts related to the development,
manufacture and registration of the Licensed Product; and (ii) discussing other
matters related to this Agreement referred to it by agreement of the Parties.
Each Party’s representatives to the Joint Steering Committee shall communicate
with one another as necessary to perform the Parties’ respective obligations
under this Agreement.
          (c) Meetings. The Joint Steering Committee shall hold its first
meeting in person within forty-five (45) days after the Effective Date.
Thereafter, the Joint Steering Committee will meet as often as necessary either
in person or by telephone at mutually acceptable times and locations. Either
party may call a Joint Steering Committee meeting upon reasonable written
notice, but not more than twice each year, unless both Parties mutually agree.
          (d) Development Plan. The parties agree that **** shall prepare a
written development plan (the “Development Plan”) for the development of the
Licensed Product within forty-five (45) days after the Effective Date. The
Development Plan shall include schedules and milestones for the development
activities of TESARO. **** may amend the Development Plan at any time ****. ****
shall present the Development Plan and any material amendments to the Joint
Steering Committee for review.
     2.7. Latin America. OPKO will have the option to become the exclusive
distributor of Licensed Product in Latin America on terms to be mutually agreed
upon by the Parties (the “Latin America Option.” To exercise its Latin America
Option, OPKO must give written notice of such exercise to TESARO within ****
after **** for Licensed Product in the **** . In the event OPKO does not give
notice of its exercise of the Latin America Option within the foregoing time
period or the Parties are unable, despite good faith negotiation, to agree on
mutually acceptable terms of a distribution agreement, OPKO will have no further
rights under this Section, and TESARO will be free to distribute Licensed
Product in Latin America itself or through an Affiliate, Sublicensee or a Third
Party distributor. Notwithstanding the foregoing, in the event the Parties are
unable, despite good faith negotiation, to agree on mutually acceptable terms of
a distribution Agreement, TESARO agrees that it will not enter into a final
agreement with any Third Party regarding the rights to distribute Licensed
Product in all of or any territory within Latin America (a “Latin American
Opportunity”) without first giving OPKO a good faith opportunity to agree to
such Latin American Opportunity on material terms substantially similar to those
offered (or intended to be offered) by TESARO to the Third Party (or offered by
the Third Party to

8

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TESARO) (“Right to Match”). OPKO’s Right to Match with regard to Latin American
Opportunities operates as follows:
          (a) When a Latin American Opportunity arises, TESARO shall give OPKO
prompt written notice of the material financial, intellectual property, term and
termination, indemnification, governing law and other material terms of the
Latin American Opportunity. Within **** after receiving TESARO’s written notice
under this Subsection 2.7(a), OPKO shall respond in writing to TESARO regarding
whether it will substantially match or decline to substantially match the
material terms of TESARO’s proposed agreement.
          (b) If, in its response, OPKO indicates its interest in substantially
matching the material terms of TESARO’s proposed agreement, the Parties shall
negotiate in good faith a definitive agreement (with material terms
substantially similar to those set forth in TESARO’s proposed agreement) for a
period of up to **** after TESARO received OPKO’s response. If, after such time,
a final agreement cannot be reached and the Parties do not mutually extend the
negotiation period, TESARO shall be free to execute its proposed agreement with
the Third Party on material terms no more favorable to the Third Party than the
material terms presented to OPKO under subsection (a) above were to OPKO.
However, if such material terms are more favorable to the Third Party, then
TESARO must offer, and OPKO has a Right to Match, such terms in accordance with
the procedures and restrictions contained in this Section 2.7.
ARTICLE III
TECHNOLOGY TRANSFER AND TRANSITION ACTIVITIES
     3.1. Know-how Transfer. OPKO agrees to transfer to TESARO the OPKO Know-how
specified in the Technology Transfer Plan in accordance with the time-lines and
other requirements set forth in such plan, and to transfer such other OPKO
Know-how, as TESARO may from time to time reasonably request during the Term,
promptly after such request. In addition, OPKO will, as part of transfer of OPKO
Know-how, assign to TESARO those Third Party Agreements as to which TESARO
specifically requests assignment and which by their terms may be assigned. To
the extent the consent of any Third Party is required to assign a Third Party
Agreement to TESARO, OPKO will use Commercially Reasonable Efforts to obtain
such consent. In the event a Third Party Agreement is not assigned to TESARO,
OPKO will, as set forth in the Technology Transfer Plan, or as otherwise
requested by TESARO, use Commercially Reasonable Efforts to obtain any
information or other benefits under such agreement related to access to OPKO
Know-how as would be available to OPKO.
     3.2. Cooperation. OPKO shall make its personnel reasonably available to
TESARO to respond to questions related to the OPKO Know-how, and to provide such
ongoing support and assistance as TESARO may reasonably request in the
transition of development and manufacturing responsibility for Licensed Products
to TESARO. In connection with the foregoing, at the request of TESARO, OPKO will
seek the assistance of Merck & Co., Ltd. to the extent such support continues to
be available under Section 2.5 of the Asset Purchase Agreement.
     3.3. Regulatory Transition. Within **** after the Effective Date, or as
otherwise mutually agreed, the Parties will file with applicable Regulatory
Authorities such documentation as may be required to transfer any IND to TESARO,
and the Parties will use Commercially Reasonable Efforts to take such actions as
any such Regulatory Authority may request to effect any such transfer. Prior to
transfer of the IND, OPKO will continue to perform such obligations as are
required under applicable law with respect to an IND holder, but under the
direction of TESARO.
     3.4. Supply of Material. OPKO will, **** transfer to TESARO in accordance
with the Technology Transfer Plan all quantities of API and Licensed Product in
OPKO’s possession or control. To the extent such API or Licensed Product is
identified as GMP-grade materials in the Technology Transfer Plan,

9

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OPKO represents that (i) since OPKO’s acquisition of such materials, OPKO has
handled and stored such materials in accordance with current Good Manufacturing
Practices as defined in the U.S. (“GMP”), and (ii) nothing has come to OPKO’s
attention which leads it to believe that any such material has not been
manufactured and stored in accordance with GMP, that it would not conform in all
material respects to the applicable specifications or would not be fit for use
in clinical trials pursuant to FDA guidelines and requirements. OPKO will
provide copies of batch records and certificates of compliance in its possession
with respect to such material. In addition, OPKO will, at the request of TESARO,
require Merck & Co., Inc. to deliver the Hold Back API, as defined in the Asset
Purchase Agreement, to TESARO or its designee, and to supply addition quantities
of API to the extent consistent with Merck & Co., Inc.’s obligation under
Section 7.11(b) of the Asset Purchase Agreement on terms to be approved by
TESARO.
     3.5. Costs. Each Party **** associated with technology transfer activities
to be provided under this Section. To the extent any technology transfer
activities to be provided under this Section require **** bear the costs of such
external resources, provided that such activities and costs are expressly set
forth in the Technology Transfer Plan or are otherwise approved in writing in
advance by ****.
ARTICLE IV
FINANCIAL PROVISIONS
     4.1. License Fee. Within ten (10) days of the Effective Date, TESARO will
pay to OPKO a non-creditable, non-refundable license fee of $6,000,000, as
compensation for past and future research and development expenses, patent
prosecution and maintenance fees, and for exclusive rights to the Licensed
Product in the U.S.
     4.2. Intentionally Left Blank
     4.3. Milestones Payments by TESARO. Subject to the terms and conditions of
this Agreement, TESARO will pay OPKO a milestone payment upon the first
occurrence of each of the following events, no later than thirty (30) days after
the occurrence of the event:

          Event Milestone   Event Milestone Payment  
(i) Acceptance by the FDA of the first NDA for Marketing Approval of Licensed
Product in the United States
  $ ****,000,000  
(ii) First Commercial Sale of Licensed Product in the U.S.
  $ ****,000,000  

          Event Milestone   Event Milestone Payment  
(iii) First Commercial Sale of Licensed Product in the EU
  $ ****,000,000  

Each of the above milestone payments will be payable only upon the first
occurrence of the applicable event, regardless of how many times the event is
ultimately achieved.
In addition, TESARO will pay to OPKO the following commercial milestone payments
upon the first achievement of the corresponding event:

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First achievement of calendar year Net Sales in excess of $**** million
  $ ****,000,000  
First achievement of calendar year Net Sales in excess of $**** million
  $ ****,000,000  
First achievement of calendar year Net Sales in excess of $**** million
  $ ****,000,000  

     4.4. Royalty Payments by TESARO. Subject to the adjustment, if any, to be
made under Sections 4.7 and 4.8, TESARO will pay to OPKO royalties on Net Sales
of Licensed Product in the Field in the Territory (other than sales of Licensed
Product by a Sublicensee in Japan) by TESARO and its Affiliates and
Sublicensees, calculated using the following royalty rates:
          (a) U.S. and EU. For the sale of Licensed Product in the U.S. and the
EU, the royalty rate will be the Tier One Royalty Rate or the Tier Two Royalty
Rate, as set forth below, depending on the applicable ****. The Tier One royalty
rates will apply if the average **** of Licensed Product sold by TESARO and its
Affiliates and Sublicensees during the preceding calendar year was equal to or
greater than ****. The Tier Two royalty rates will apply if the average **** of
Licensed Product sold by TESARO and its Affiliates and Sublicensees during the
preceding calendar year was less than ****. Notwithstanding the foregoing, the
**** used to determine whether to apply the Tier One Royalty Rate or the Tier
Two Royalty Rate in the launch year will be based the average **** for the ****
during the **** preceding the date of First Commercial Sale.

                  Portion of Calendar Year Net Sales   Tier One Royalty     Tier
Two Royalty   in the United States   Rates     Rates  
On that portion of calendar year Net Sales in the U. S. less than or equal to
$**** million
    ****%       ****%  
On that portion of calendar year Net Sales in the U. S. greater than $****
million but less than or equal to $**** million
    ****%       ****%  
On that portion of calendar year Net
    ****%       ****%  

                  Portion of Calendar Year Net Sales   Tier One Royalty     Tier
Two Royalty   in the United States   Rates     Rates  
Sales in the U.S. greater than $**** million but less than or equal to $****
million
               
On that portion of calendar year Net Sales in the U.S. greater than
$**** million
    ****%       ****%  

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                    Tier One     Tier Two   Portion of Calendar Year Net Sales
in the   Royalty     Royalty   EU   Rate     Rate  
On that portion of calendar year Net Sales in the EU less than or equal to $****
million
    ****%       ****%  
On that portion of calendar year Net Sales in the EU greater than $**** million
but less than or equal to $**** million
    ****%       ****%  
On that portion of calendar year Net Sales in the EU greater than $**** million
but less than or equal to $**** million
    ****%       ****%  
On that portion of calendar year Net Sales in the EU greater than $**** million
    ****%       ****%  

          (b) Rest of World Other than Japan. The royalty rate outside the U.S.,
EU and Japan will be ****%.
          (c) Minimum Annual Royalty. If the aggregate amount of royalties paid
or payable by TESARO to OPKO on sales of Licensed Products under this Section
during each of the first **** calendar years commencing with the **** calendar
year following the **** of Licensed Product in the **** and ending with the
calendar year in which the **** anniversary of the **** occurs (the “Measurement
Period”) is less than **** (the “Minimum Annual Royalty”), then within
forty-five (45) days of the end of each such calendar year, TESARO will pay OPKO
an amount equal to the difference between the **** and the aggregate amount of
royalties paid or payable to OPKO on sales of the Licensed Product during such
calendar year (the “Annual Royalty Shortfall”). During the Measurement Period,
any Annual Royalty Shortfall paid or payable by TESARO **** the aggregate amount
of royalties **** Measurement Period that exceeded **** and any royalties
payable during the Measurement Period that exceed **** by the amount of any
Annual Royalty Shortfall payments made in any **** and not ****. The Minimum
Annual Royalty will not apply, and no Annual Royalty Shortfall will be due, in
the event the commercial potential of any Licensed Product in the U.S. has been
materially adversely affected by: (i) the ****; (ii) **** identified in the
course of **** or commercialization of Licensed Product; (iii) **** of an issued
patent within OPKO Patent Rights Covering the Licensed Product in the United
States.
     4.5. Japan. TESARO will pay OPKO **** of all Japan Income (the “OPKO Japan
Share”). In the event OPKO is required to make payments to a Third Party under
an agreement in existence as of the Effective Date, based on the OPKO Japan
Share of the Japan Income (the “OPKO Third Party Obligation”), TESARO will pay
up to **** of such OPKO Third Party Obligation, provided that, in no event will
TESARO’s share of the OPKO Third Party Obligation exceed **** of the amounts
that would otherwise be payable to OPKO **** Obligation. In the event sales of
Licensed Product in Japan **** any of its Affiliates and are **** a Sublicensee,
TESARO will pay to OPKO royalties on Net Sales of Licensed Product in Japan at
the rate of ****, subject to the adjustments set forth in Section 4.7 and 4.8 to
the same extent as applicable to royalties on Net Sales payable under
Section 4.4.
     4.6. Royalty and Income Sharing Term.
          (a) Royalties. Royalties under Section 4.4 will be payable on a
country by country and Licensed Product-by-Licensed Product basis during the
period commencing on the First Commercial Sale of such Licensed Product in the
applicable Field in such country and ending upon the later of (i) the date of
expiration, unenforceability or invalidation of the last Valid Claim of OPKO
Patent Rights

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Covering such Licensed Product in such country, and (ii) **** years from the
date of First Commercial Sale in such country (the “Royalty Term”).
          (b) Japan Income Sharing. TESARO’s obligation to share Japan Income
under Section 4.5 will be payable on a Licensed Product-by-Licensed Product
basis during the period commencing on the Effective Date and ending upon the
later of (i) the date of expiration, unenforceability or invalidation of the
last Valid Claim of OPKO Patent Rights Covering Licensed Product in Japan, and
(ii) **** from the date of First Commercial Sale in Japan (“Japan Income Sharing
Term).
          (c) End of Royalty Term or Japan Income Sharing Term. Upon expiration
of the Royalty Term or Japan Income Sharing Term, as the case may be, in the
country of sale, the license granted to TESARO and its Affiliates and
Sublicenses under Article II will convert to a fully paid-up,
non-royalty-bearing, license in the applicable country.
     4.7. Reduction for No Valid Claim. The royalties payable under Section 4.4
with respect to Net Sales of a Licensed Product will be reduced, on a country by
country and Licensed Product-by-Licensed Product basis, by **** of the amounts
otherwise payable under Section 4.4, during any portion of the Royalty Term when
there is no Valid Claim of an issued patent within OPKO Patent Rights Covering
such Licensed Product in the country of sale or other protective data or
marketing exclusivity. Notwithstanding the foregoing, in the event there is no
Valid Claim of an issued patent within OPKO Patent Right Covering a Licensed
Product being sold in a country and a Third Party has obtained Marketing
Approval in such country for a product containing the same active ingredient as
contained in Licensed Product, the reduction on royalties under the preceding
sentence will be increased to ****.
     4.8. Third Party Payments.
          (a) OPKO Payments. Except as specifically set forth in Section 4.5,
**** will pay all milestones and other payments due under ****, and under any
other agreement to which OPKO or any of its Affiliates is a party.
          (b) Other Third Party Payments. **** will have the right to deduct
from **** payable to **** under Section 4.4 (after application of the deductions
set forth in Section 4.7), **** of Third Party Payments, provided that in no
event will the royalty payable to OPKO on Net Sales of Licensed Product be
reduced as a result of application of this paragraph, to less than **** of the
amount otherwise payable under Section 4.4, as reduced by Section 4.7. Amounts
available for offset under this Section and not used as a credit against
royalties in the period incurred may be carried over to future periods until
fully utilized.
     4.9. Payments; Reports. TESARO will pay royalties due on Net Sales and
amounts due with respect to Japan Income received in a calendar quarter within
**** days of the end of such calendar quarter. Within **** days after the end of
each calendar quarter for which amounts are payable by TESARO under Section 4.4
or 4.5, TESARO will submit to OPKO a report, on a country-by-country basis,
providing in reasonable detail an accounting of all Net Sales by TESARO and its
Affiliates and Sublicensees in the Territory (including, in each case, an
accounting of all unit sales of the Licensed Product and a calculation of the
deductions from gross invoice price to Net Sales in accordance with
Section 1.27) made during such calendar quarter and all Japan Income and the
calculation of the applicable amounts due under Section 4.4 and 4.5. TESARO
will, at the time TESARO submits a report under this Section, pay to OPKO all
amounts due to OPKO under Sections 4.4 and 4.5, as indicated in the applicable
report.
     4.10. Taxes. TESARO will make all payments to OPKO under this Agreement
without deduction or withholding except to the extent that any such deduction or
withholding is required by applicable law to be made on account of Taxes (as
that term is defined below). Any Tax required to be

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withheld under applicable law on amounts payable under this Agreement will
promptly be paid by TESARO or its Affiliates or Sublicensees on behalf of OPKO
to the appropriate governmental authority, and TESARO will furnish OPKO with
proof of payment of such Tax. Any such Tax required to be withheld will be an
expense of and borne by OPKO. TESARO will give notice of its intention to begin
withholding any such Tax in advance and cooperate to use reasonable and legal
efforts to reduce such Tax on payments made to OPKO hereunder. The Parties will
cooperate with respect to all documentation required by any relevant government
taxing authority or reasonably requested by either Party to secure a reduction
in the rate of applicable withholding Taxes. Solely for purposes of this
Section 4.10, “Tax” or “Taxes” means any present or future taxes, levies,
imposts, duties, charges, assessments or fees of any nature (including interest,
penalties and additions thereto) that are imposed by a government authority, but
not including TESARO income taxes.
     4.11. United States Dollars. All dollar ($) amounts specified in this
Agreement are United States dollar amounts.
     4.12. Currency Conversion. All payments to be made by TESARO to OPKO will
be made in U.S. Dollars, to a bank account designated by OPKO. In the case of
sales outside the United States, payments received by TESARO will be expressed
in the U.S. Dollar equivalent calculated on a quarterly basis in the currency of
the country of sale and converted to their U.S. Dollar equivalent using the
average rate of exchange over the applicable calendar quarter to which the sales
relate, in accordance with GAAP and the then current standard methods of TESARO
or the applicable Sublicensee, to the extent reasonable and consistently
applied. TESARO will inform OPKO as to the specific exchange rate translation
methodology used for a particular country or countries.
     4.13. Blocked Payments. If, by reason of applicable laws or regulations in
any country, it becomes impossible or illegal for TESARO or any of its
Affiliates or Sublicensees to move revenues related to Licensed Product out of
such country, TESARO will promptly notify OPKO of the conditions preventing such
transfer, and royalties on the affected Net Sales or amounts payable on Japan
Income shall, in lieu of payment under Section 4.9, be deposited in local
currency in the relevant country to the credit of OPKO in a recognized banking
institution in such county designated by OPKO or, if none is designated by OPKO
within a period of thirty (30) days, in a recognized banking institution in such
county selected by TESARO or its Affiliates or Sublicensees, as the case may be,
and identified in a notice given to the Party on whose account the funds are
deposited.
     4.14. Late Payments. TESARO will pay interest to OPKO on the aggregate
amount of any payments that are not paid on or before the date such payments are
due under this Agreement at a rate per annum equal to the lesser of one and ****
per month or the highest rate permitted by applicable law, calculated based on
the number of days such payments are paid after the date such payments are due.
     4.15. Records and Audits. TESARO will keep complete and accurate records
relating to the calculations of Net Sales and Japan Income generated in the then
current calendar year, and during the preceding ****. OPKO will have the right,
**** at its ****, to have a nationally recognized, independent, certified public
accounting firm, selected by it and reasonably acceptable to TESARO, review any
such records of TESARO and its Affiliates and Sublicensees (the “Audited Party”)
in the location(s) where such records are maintained by the Audited Party upon
reasonable written notice (which shall be no less than thirty (30) days’ prior
written notice) and during regular business hours and under obligations of
strict confidence, for the sole purpose of verifying the basis and accuracy of
payments made under Section 4.4 and 4.5 within the **** period preceding the
date of the request for review. No **** will be subject to audit under this
Section more than once. TESARO will receive a copy of each such report
concurrently with receipt by OPKO. Should such inspection lead to the discovery
of a discrepancy to OPKO’s detriment, TESARO will, within thirty (30) days after
receipt of such report from the accounting firm, pay any undisputed amount of
the discrepancy, plus interest on the underpayment at a rate per annum equal to
the lesser of **** per month or the highest rate permitted by applicable law,

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calculated from the date the underpayment was made until the date of payment to
OPKO of the underpayment. **** will pay the full cost of the review unless the
underpayment of amounts due to **** is greater than **** of the amount due for
the entire period being examined, in which case **** will pay the reasonable
cost charged by such accounting firm for such review. Any undisputed overpayment
of royalties by TESARO revealed by an examination will be paid by OPKO within
**** of OPKO’s receipt of the applicable report. Any disagreement regarding the
results of any audit conducted under this Section will be subject to the dispute
resolution provisions set forth in Article X.
ARTICLE V
INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION
AND RELATED MATTERS
     5.1. Prosecution and Maintenance of Patent Rights. Within **** after the
Effective Date, OPKO will transfer to TESARO responsibility for filing,
prosecuting and maintaining all OPKO Patent Rights (other than the OPKO Patent
Rights, if any, that were licensed but not assigned to OPKO under the Asset
Purchase Agreement) in such a way that there is not any loss of rights during
such **** day period or in connection with the transition, including consulting
with TESARO and cooperating with TESARO related to such activities prior to
completion of the transition, and contacting the foreign agents of OPKO to
assist in the transfer of power of attorney as required by the relevant patent
offices for TESARO to assume prosecution of such files. Commencing after
notification to the USPTO and OPKO foreign agent of the change in prosecution
status, TESARO will have responsibility, at TESARO’s cost, for filing,
conducting prosecution, and maintaining (including the defense of any
interference or opposition proceedings) all such OPKO Patent Rights as to which
OPKO has assumed and maintains responsibility under this Section, and shall use
Commercially Reasonable Efforts in the conduct of such activities. TESARO will
provide to OPKO copies of all prosecution filings and material submissions and
correspondence related to OPKO Patent Rights for which TESARO has assumed and
maintains responsibility under this Section sent to or received from patent
offices, and other service providers including maintenance fee providers, and,
with respect to patent applications, and material submissions, will use
reasonable efforts to provide OPKO with a draft of each such filing or material
submission reasonably in advance of submission, and will consider in good faith
any comments that OPKO may timely provide. In addition, TESARO will provide to
OPKO such other information related to prosecution of the OPKO Patent Rights for
which TESARO has assumed and maintains responsibility under this Section as OPKO
may from time to time reasonably request to allow OPKO to track prosecution and
maintenance of such OPKO Patent Rights including docket reports of all pending
and issued patents and patent applications within OPKO Patent Rights. In the
event TESARO decides to abandon prosecution in any country with respect to an
OPKO Patent Right for which TESARO is responsible under this Section in a
particular country or decides to not otherwise maintain or extend any OPKO
Patent Right for which TESARO is responsible under this Agreement in a
particular country, in either case where a substitute is not filed for such OPKO
Patent Right (such OPKO Patent Right in the applicable country being referred to
in this Agreement as an “Abandoned Patent Right”), TESARO will give OPKO written
notice, and will transfer the relevant files and authority to OPKO, sufficiently
in advance of any loss of rights to allow OPKO to file, prosecute, maintain or
extend, as the case may be, claims with respect to such Abandoned Patent Rights
in the relevant country, and such Abandoned Patent Right in the relevant country
will no longer be included as an OPKO Patent Right licensed to TESARO under
Agreement.
     5.2. Patent Term Extensions. TESARO will use Commercially Reasonable
Efforts to obtain patent term extensions (including those extensions available
under U.S. Drug Price Competition and Patent Term Restoration Act of 1984, the
Supplementary Certificate of Protection of Member States of the EU and other
similar measures in any other country) wherever applicable to licensed OPKO
Patent Rights as to which TESARO controls prosecution that Cover Licensed
Product in the Field in the Territory, and OPKO will cooperate, at TESARO’s
request and expense in connection with such activities. All filings for such
extensions shall be made by the Party responsible for filing, prosecuting and
maintaining the relevant Patent Rights in accordance with this Section.

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     5.3. Third Party Infringement.
          (a) Notices. Each Party will promptly report in writing to the other
Party any (i) known or suspected infringement of any OPKO Patent Rights, or
(ii) unauthorized use or misappropriation of any OPKO Know-how by a Third Party,
of which such Party becomes aware, in each case only to the extent relevant to
Licensed Product or the development, manufacture, commercialization or use of
Licensed Product in the Field in the Territory, and will provide the other Party
with all available information evidencing such infringement, or unauthorized use
or misappropriation.
          (b) TESARO First Right to Enforce Certain OPKO Patent Rights. TESARO
or its designated Affiliate or Sublicensee will have the first right, but not
the obligation, to initiate a suit or take other appropriate action that it
believes is reasonably required to prevent or abate actual or threatened
infringement or misappropriation of, or otherwise protect or enforce, the OPKO
Patent Rights as to which TESARO controls prosecution against a Third Party who
is researching, developing, making, using or selling a product in the Field in a
country within the Territory. OPKO and its Affiliates will join such suit if the
relevant court would lack jurisdiction if OPKO or such Affiliate were absent
from such suit and OPKO and such Affiliates will execute such legal papers and
cooperate in the prosecution of such suit as may be reasonably requested by
TESARO; provided, that **** incurred by **** and such Affiliates in connection
with such requested cooperation.
          (c) OPKO Rights if TESARO Elects Not to Proceed. If TESARO does not
initiate a suit or take other appropriate action pursuant to Section 5.3(b)
within **** days after knowledge of such infringement or misappropriation or, in
the case of receipt of a notice letter sent by a Third Party pursuant to the
requirements of 21 U.S.C. § 355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) or under
any analogous provisions, within **** before any statutory or regulatory
deadline for filing such suit, then OPKO will have the immediate right to
initiate a suit or take other appropriate action that it believes is reasonably
required to prevent or abate actual or threatened infringement or
misappropriation of, or otherwise to protect or enforce the relevant OPKO Patent
Rights. TESARO and its Affiliates will join such suit if the relevant court
would lack jurisdiction if TESARO or such Affiliates were absent from such suit
and TESARO and such Affiliates will execute such legal papers and cooperate in
the prosecution of such suit as may be reasonably requested by OPKO; provided,
that **** (including ****) incurred by **** and such Affiliates in connection
with such requested cooperation.
          (d) Enforcement Against Other Infringement of OPKO Patent Rights.
Except as provided in Section 5.3(b), OPKO will have the sole right, but not the
obligation, to initiate a suit or take other appropriate action that it believes
is reasonably required to prevent or abate actual or threatened infringement or
misappropriation of, or otherwise to protect or enforce, OPKO Patent Rights
during the Term.
          (e) Right to Enforce Know-how. Responsibility for preventing or
abating actual or threatened infringement or misappropriation of, or otherwise
protecting or enforcing OPKO Know-how will be determined in the same manner as
the right to enforce OPKO Patent Rights under paragraph (b) and (c). The
enforcing Party shall keep the other Party informed of the status of all
enforcement activities, and shall consider in good faith all comments of the
other Party regarding any aspect of such enforcement.
          (f) Conduct of Certain Actions; Costs. The Party initiating suit under
this Section 5.3 will have the sole and exclusive right to select counsel for
any suit initiated by it pursuant to this Section. The initiating Party will
assume and **** incurred in connection with any litigation or proceedings
initiated by it pursuant to this Section, including the **** selected by it.

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          (g) Recoveries.
          (i) If TESARO initiates suit as permitted in accordance with
Section 5.3(b) or, with respect to OPKO Know-how, in the same manner as set
forth in Section 5.3(b), any damages, settlements, accounts of profits, or other
financial compensation actually paid to TESARO by a Third Party based upon such
suit, after deducting TESARO’s actual out of pocket expenses (including
reasonable attorneys’ fees and expenses) incurred in pursuing such suit (such
net amount, the “Recovery”), will be treated as Net Sales, and will be subject
to the royalty payment obligations under Section 4.4 (provided that, for
purposes of calculating the applicable royalty rate, such Recovery will not be
combined with any calendar year Net Sales), with TESARO retaining the balance
after such payment.
          (ii) If OPKO initiates suit pursuant to Section 5.3(b) or with respect
to OPKO Know-how, in the same manner as set forth in Section 5.3(b), OPKO may
retain any damages, settlements, accounts of profits, or other financial
compensation recovered from a Third Party based upon such suit.
     5.4. Patent Invalidity Claim. Each of the Parties will promptly notify the
other Party in the event of any legal or administrative action by any Third
Party against an OPKO Patent Right, or any certification filed pursuant to 21
U.S.C. § 355(b)(2)(A)(iv) or 355G)(2)(A)(vii)(IV) or any notice under any
analogous provisions, with respect to such Patent Rights, of which it becomes
aware, including any nullity, revocation, reexamination or compulsory license
proceeding. Responsibility for defending against any such action shall be
determined in the same manner as enforcement of the relevant Patent Rights
pursuant to Section 5.3.
     5.5. Patent Marking. TESARO agrees to comply with the patent marking
statutes in each country in which the Licensed Product is sold by TESARO or its
Affiliates or Sublicensees.
ARTICLE VI
CONFIDENTIALITY
     6.1. Confidential Information. During the Term and for a period of ****
after any termination or expiration of this Agreement, each Party agrees to keep
in confidence and not to disclose to any Third Party, or use for any purpose,
except pursuant to, and in order to carry out, the terms and objectives of this
Agreement (which, in the case of TESARO and its Affiliates and Sublicensees,
includes activities contemplated by the licenses granted in Sections 2.1) or as
otherwise specifically permitted under this Agreement, any Confidential
Information of the other Party. The terms of this Agreement will be considered
Confidential Information of both Parties, subject to permitted disclosures as
set forth in this Article VI. The restrictions on the disclosure and use of
Confidential Information set forth in the first sentence of this Section 6.1
will not apply to any Confidential Information that:
          (i) was known by the receiving Party prior to disclosure by the
disclosing Party hereunder (as evidenced by the receiving Party’s written
records or other competent evidence);
          (ii) is or becomes part of the public domain through no fault of the
receiving Party;
          (iii) is disclosed to the receiving Party by a Third Party having a
legal right to make such disclosure without violating any confidentiality or
non-use obligation that such Third Party has to the disclosing Party and
provided such Third Party is not disclosing such information on behalf of the
disclosing Party; or

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          (iv) is independently developed by personnel of the receiving Party
who did not have access to the Confidential Information (as evidenced by the
receiving Party’s written records or other competent evidence).
In addition, if either Party is required to disclose Confidential Information of
the other Party by regulation, law or legal process, including by the rules or
regulations of the United States Securities and Exchange Commission or similar
regulatory agency in a country other than the United States or of any stock
exchange or Nasdaq, such Party shall provide prior written notice and a copy of
such intended disclosure to such other Party if possible under the
circumstances, will consider in good faith the other Party’s comments, will
disclose only such Confidential Information of such other Party as is required
to be disclosed and will cooperate in the disclosing Party’s efforts to obtain a
protective order or to limit the scope of the required disclosures.
Notwithstanding anything in this Agreement to the contrary, either Party may
disclose to bona fide potential or existing investors or lenders, potential
acquirors/acquirees, and, in the case of TESARO, to potential and existing
sublicensees and collaborators, and to such Party’s consultants and advisors,
the existence and terms of this Agreement to the extent necessary in connection
with a proposed equity or debt financing of such Party, or a proposed
acquisition or business combination or transaction, so long as such recipients
are bound in writing to maintain the confidentiality of such information.
     6.2. Permitted Disclosures. Each Party agrees that it and its Affiliates
will provide or permit access to Confidential Information received from the
other Party and such Party’s Affiliates and representatives only to the
receiving Party’s employees, consultants, advisors and bona fide potential
acquirors, and, in the case of TESARO as the receiving Party, to service
providers, investigators, Third Party contractors, potential and existing
Sublicensees and distributors, in each case who, in such Party’s reasonable
judgment, have a need to know such Confidential Information to assist the
receiving Party with the activities contemplated by this Agreement (which, in
the case of TESARO and its Affiliates and Sublicensees, includes activities
contemplated by the license granted in Sections 2.1) or in connection with a
potential business relationship or investment that would encompass Licensed
Product, and who are subject to obligations of confidentiality and non-use with
respect to such Confidential Information similar to the obligations of
confidentiality and non-use of the receiving Party under Section 6.1. OPKO and
TESARO shall each remain responsible for any failure by its Affiliates, and its
and its Affiliates’ respective employees, consultants, advisors and permitted
contractors, sublicensees and distributors, to treat such Confidential
Information as required under Section 6.1 (as if such Affiliates, employees,
consultants, advisors, contractors, sublicensees and distributors were Parties
directly bound to the requirements of Section 6.1). TESARO may also disclose
Confidential Information of OPKO to Regulatory Authorities and other
governmental authorities, but solely in connection with the activities
contemplated by this Agreement.
     6.3. Limitation on OPKO Disclosure of OPKO Know-how. During the Term of
this Agreement, OPKO will not disclose OPKO Know-how that is specific to
Licensed Product or the development, manufacture, commercialization or use of
Licensed Product to any Third Party without the express written consent of
TESARO.
     6.4. Publicity. Neither Party will issue a press release or public
announcement relating to the terms of this Agreement without the prior written
approval of the other Party, which approval shall not be unreasonably withheld
or delayed, except that (i) either or both of the Parties may issue a press
release in the form attached as Exhibit E; (ii) a Party may issue such press
release or public announcement if the contents of such press release or public
announcement are consistent with a previously approved press release or have
otherwise previously been made public other than through a breach of this
Agreement, and (ii) a Party may issue such a press release or public
announcement if required by applicable law, including by the rules or
regulations of the United States Securities and Exchange Commission (SEC) or
similar regulatory agency in a country other than the United States or of any
stock exchange or Nasdaq; provided that such Party complies with the notice and
review provisions set forth in this Section. In no

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event will OPKO make any public disclosure related to TESARO’s activities under
this Agreement or related to the results generated by TESARO or any of its
Affiliates or Sublicensees with respect to Licensed Product without the prior
written consent of TESARO except to the extent required by applicable law. In
the event OPKO is required by applicable law to publicly disclose any of the
results generated by TESARO or any of its Affiliates or Sublicensees or any
information provided by TESARO related to Licensed Product or either Party is
required by applicable law to disclose the terms of this Agreement, such Party
will give the other Party at least two (2) business days’ prior written notice,
will provide to such other Party a copy of the required disclosure, will, if
requested by such other Party, to the extent permitted by applicable law,
request confidential treatment of any financial and other materials terms of
this Agreement not previously disclosed under this Section, and will consider in
good faith any other comments of such other Party on such public disclosure.
     6.5. Publications. TESARO and its Affiliates and Sublicensees shall have
the sole right to publish the results of development, manufacture,
commercialization and use of Licensed Product during the Term.
     6.6. Return of Confidential Information. Upon termination of this Agreement
prior to the end of the Term, the receiving Party shall, at the request of, and
as directed by, the disclosing Party, return or destroy Confidential Information
of the disclosing Party in the receiving Party’s possession, and shall destroy
any reports or notes in receiving Party’s possession t6 the extent containing
the disclosing Party’s Confidential Information, and any electronic copies of
any of the foregoing, provided that (i) the receiving Party may retain one copy
of Confidential Information of the disclosing Party for archival purposes, and
(ii) neither Party shall be required to return or destroy copies of the other
Party’s Confidential Information stored on automatically created system back-up
media.
ARTICLE VII
REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS
     7.1. Mutual Representations. Each Party hereby represents and warrants to
the other Party, as of the Effective Date, as follows:
          (a) It is duly organized and validly existing under the laws of its
jurisdiction of incorporation and has the corporate power and authority to
execute and deliver this Agreement and to perform its obligations hereunder.
          (b) The execution, delivery and performance of this Agreement by such
Party has been duly and validly authorized and approved by proper corporate
action on the part of such Party. Such Party has taken all other action required
by applicable law, its certificate of incorporation or by-laws or any agreement
to which it is a party or by which it or its assets are bound, to authorize such
execution, delivery and performance. Assuming due authorization, execution and
delivery on the part of the other Party, this Agreement constitutes a legal,
valid and binding obligation of such Party.
          (c) The execution and delivery of this Agreement, and the performance
as contemplated hereunder, by such Party will not violate any applicable law.
          (d) Neither the execution and delivery of this Agreement nor the
performance hereof by such Party requires such Party to obtain any permit,
authorization or consent from any governmental authority (except for any
Regulatory Approvals, pricing or reimbursement approvals, manufacturing-related
approvals or similar approvals necessary for development, manufacture or
commercialization of Licensed Products), or from any other person, and such
execution, delivery and performance by such Party, including the granting of the
licenses granted under this Agreement, will not result in the breach of or give
rise to any conflict, termination of, rescission, renegotiation or acceleration
under or trigger any

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other rights under any agreement or contract to which such Party may be a party
existing as of the Effective Date.
          (e) Neither Party nor any of its Affiliates has been debarred or is
subject to debarment, and OPKO has not used in any capacity in connection with
the development or manufacture of Licensed Product prior to the Effective Date,
any person or entity who has been debarred pursuant to Section 306 of the United
States Federal Food, Drug, and Cosmetic Act, or who is the subject of a
conviction described in such section.
     7.2. OPKO’s Representations and Warranties. OPKO hereby makes the following
representations and warranties to TESARO as of the Effective Date:
          (a) OPKO has the right to grant to TESARO the rights and licenses
described in this Agreement.
          (b) Exhibit C contains a complete and correct list of all existing
OPKO Patent Rights.
          (c) To OPKO’s knowledge, no Third Party is infringing any of the OPKO
Patent Rights identified on Exhibit C.
          (d) To OPKO’s knowledge, except as discussed with TESARO, the making,
using or selling of a Licensed Product will not infringe any Third Party Patent
Rights.
          (e) OPKO has not received any written notice of (i) any claim that any
patent or trade secret right owned or controlled by a Third Party would be
infringed or misappropriated by the manufacture, use, sale, offer for sale or
importation of Licensed Products in the Field, or (ii) any threatened claims or
litigation seeking to invalidate or otherwise challenge the OPKO Patent Rights
or OPKO’s rights therein.
          (f) OPKO’s rights to OPKO Patent Rights and OPKO Know-how are held
free and clear of any liens, security interests and similar encumbrances.
          (g) None of the OPKO Patent Rights owned by OPKO are the subject of
any pending re-examination, opposition, interference or litigation proceedings.
          (h) To OPKO’s knowledge, there have been no inventorship or ownership
challenges with respect to any of the OPKO Compound Patent Rights.
          (i) The OPKO Patent Rights that are pending patent applications as of
the Effective Date are being diligently prosecuted at the respective patent
offices. To OPKO’s knowledge, the OPKO Patent Rights that are issued patents
have been maintained properly and correctly and all applicable fees have been
paid on or before the due date for payment.
          (j) There are no agreements pursuant to which a Third Party has
licensed to OPKO any OPKO Patent Rights or OPKO Know-how or pursuant to which
OPKO or any of its Affiliates has otherwise acquired any OPKO Patent Rights or
OPKO Know-how from a Third Party other than the Asset Purchase Agreement or
other Third Party Agreements.
          (k) A complete list of material agreements to which OPKO or any of its
Affiliates is a Party related to the development, manufacture, use or sale of
Licensed Product or under which OPKO may otherwise be required to make payments
to Third Parties related to this Agreement is attached as Exhibit F (the “Third
Party Agreements”). OPKO will not amend, allow to terminate, or waive any of its

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rights or obligations under the Asset Purchase Agreement in a manner which would
adversely impact the rights licensed to TESARO under this Agreement, except as
approved in writing in advance by TESARO.
          (l) To OPKO’s knowledge, the research, development and manufacture of
Licensed Product in the Territory on or before the Effective Date has been
conducted by OPKO and its Affiliates and its subcontractors, in compliance (in
all material respects) with all applicable laws.
          (m) Neither OPKO nor its Affiliates has received written notice from
any Regulatory Authority threatening any proceedings with respect to the
research, development or manufacture of any Licensed Product in the Field in the
Territory.
          (n) To OPKO’s knowledge, OPKO has not intentionally withheld any
material information relating to the subject matter of this Agreement.
     7.3. No Warranty. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS
AGREEMENT, NEITHER PARTY HERETO MAKES ANY REPRESENTATIONS AND NEITHER PARTY
EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS, IMPLIED, STATUTORY OR
OTHERWISE, WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT (INCLUDING ANY
LICENSED PRODUCT), INCLUDING ANY WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT,
OR FITNESS FOR A PARTICULAR PURPOSE. EXCEPT AS EXPRESSLY PROVIDED IN THIS
AGREEMENT, OPKO MAKES NO WARRANTY OR REPRESENTATION AS TO THE VALIDITY OR SCOPE
OF THE OPKO PATENT RIGHTS OR OPKO KNOW HOW, OR THAT ANY LICENSED PRODUCT WILL BE
FREE FROM AN INFRINGEMENT ON PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF
THIRD PARTIES, OR THAT NO THIRD PARTIES ARE IN ANY WAY INFRINGING OR NOT
INFRINGING THE OPKO PATENT RIGHTS OR OPKO KNOW HOW COVERED BY THIS AGREEMENT.
TESARO DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT THE DEVELOPMENT,
MANUFACTURE AND COMMERCIALIZATION OF LICENSED PRODUCT PURSUANT TO THIS AGREEMENT
WILL BE SUCCESSFUL OR THAT, IF COMMERCIALIZED, ANY PARTICULAR SALES LEVEL WILL
BE ACHIEVED.
ARTICLE VIII
INDEMNIFICATION
     8.1. Indemnification by TESARO. TESARO will indemnify, hold harmless, and
defend OPKO, its Affiliates, and their respective directors, officers, employees
and agents (the “OPKO Indemnitees”) from and against any and all damages,
liabilities, costs, expenses and amounts paid in settlement (collectively,
“Losses”) incurred in connection with any Third Party claim arising out of or
resulting from, directly or indirectly; (i) any breach of, or inaccuracy in, any
representation or warranty made by TESARO in this Agreement, or any breach or
violation of any term of this Agreement by TESARO; (ii) the negligence or
willful misconduct of TESARO, its Affiliates and their respective Sublicensees,
and their respective directors, officers, employees and agents; and (iii) the
research, development, manufacture, commercialization, or use of Licensed
Product by TESARO and its Affiliates and Sublicensees in the Territory in the
Field under this Agreement. Notwithstanding the foregoing or anything in this
Agreement to the contrary, TESARO will have no obligation to indemnify the OPKO
Indemnitees to the extent that the Losses arise out of or result from, directly
or indirectly, any breach of, or inaccuracy in, any representation or warranty
made by OPKO in this Agreement; any breach or violation of any term of this
Agreement by OPKO; the negligence or willful misconduct of any of the OPKO
Indemnitees or any other Losses as to which OPKO is obligated to indemnify
TESARO under Section 8.2.
     8.2. Indemnification by OPKO. OPKO will indemnify, hold harmless, and
defend TESARO, its Affiliates and their respective directors, officers,
employees and agents (the “TESARO Indemnitees”)

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from and against any and all Losses incurred in connection with any Third Party
Claim arising out of or resulting from, directly or indirectly, (i) any breach
of, or inaccuracy in, any representation or warranty made by OPKO in this
Agreement, or any breach or violation of any term of this Agreement by OPKO;
(ii) the negligence or willful misconduct of any OPKO Indemnitee; (iii) the
research, development, manufacture or use of Licensed Product by or on behalf of
OPKO or any of its Affiliates prior to commencement of the Term; or (iv) the
research, development, manufacture, commercialization, or use of Licensed
Product by OPKO or any of its Affiliates or licensees (other than TESARO) or any
other activities of OPKO and its Affiliates and licensees (other than TESARO)
outside the Field. Notwithstanding the foregoing, or anything in this Agreement
to the contrary, OPKO will have no obligation to indemnify the TESARO
Indemnitees for any Losses as to which TESARO is obligated to indemnify OPKO
under Section 8.1.
     8.3. Indemnification Procedure. In the event of any such claim against any
TESARO Indemnitee or OPKO Indemnitee (individually, an “Indemnitee”), the
indemnified Party shall promptly notify the other Party in writing of the claim
and the indemnifying Party shall manage and control, at its sole expense, the
defense of the claim and its settlement. The indemnified Party will cooperate
with the indemnifying Party and may, at the indemnifying Party’s option and
expense, be represented in any such action or proceeding. The indemnifying Party
will not be liable for any settlements, litigation costs or expenses incurred by
any Indemnitee without the indemnifying Party’s prior written authorization.
Notwithstanding the foregoing, if the indemnifying Party believes that any of
the exceptions to its obligation of indemnification of the Indemnitees set forth
in this Article 8 may apply, the indemnifying Party will promptly notify the
Indemnitees, who shall then have the right to be represented in any such action
or proceeding by separate counsel at their expense; provided that the
indemnifying Party will be responsible for payment of such expenses if the
Indemnitees are ultimately determined to be entitled to indemnification from the
indemnifying Party.
     8.4. Limitation of Liability. NEITHER PARTY HERETO WILL BE LIABLE FOR
SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING OUT OF THIS
AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING LOST PROFITS
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY
NOTICE OF SUCH DAMAGES, EXCEPT AS A RESULT OF A PARTY’S WILLFUL MISCONDUCT.
NOTHING IN THIS SECTION 8.4 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION
RIGHTS OR OBLIGATIONS OF EITHER PARTY.
     8.5. Insurance. During the Term and for a period of at least **** years
after the last commercial sale of a Licensed Product in the Field under this
Agreement, TESARO will maintain insurance, with a reputable, solvent insurer in
an amount appropriate for its business and products of the type that are the
subject of this Agreement, and for its obligations under this Agreement,
including, commencing immediately prior to the first human clinical trial,
product and clinical trial liability insurance of at least **** per occurrence
and **** in the aggregate on a worldwide basis.
ARTICLE IX
TERM AND TERMINATION
     9.1. Term. This Agreement will become effective as of the Effective Date,
and will continue in full force and effect until the last to expire Royalty Term
and Japan Income Sharing Term, unless earlier terminated in accordance with this
Article IX (“Term”). Upon expiration of the Term under the preceding sentence
(but not earlier termination of this Agreement) the licenses granted to TESARO
under Section 2.1 will convert to perpetual, fully paid-up, non-royalty-bearing
licenses with the same scope as set forth in such Section.
     9.2. Termination for Convenience. TESARO will have the right to terminate
this Agreement at any time and for any reason upon at least three (3) months’
prior written notice to OPKO.

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     9.3. Termination for Cause. This Agreement may be terminated at any time
during the Term upon written notice by either Party if the other Party is in
material breach of its obligations hereunder, and has not cured such material
breach within sixty (60) days after written notice describing the nature of such
material breach is provided to the breaching Party.
     9.4. OPKO Termination. To the extent permitted by applicable law, OPKO may
terminate this Agreement by giving written notice of termination to TESARO
within thirty (30) days of the filing of bankruptcy or bankruptcy of TESARO or
the making by TESARO of any assignment for the benefit of creditors. Termination
shall be effective upon the date specified in such notice.
     9.5. Effect of Termination.
          (a) Pre-Termination Obligations; Transfer of Information and Filings.
Upon the termination of this Agreement for any reason, nothing herein shall be
construed to release either party from any obligation that matured prior to the
effective date of such termination. TESARO shall remain obligated to provide an
accounting for and to pay Royalties earned. In the event of termination, (i) the
licenses granted hereunder shall terminate; (ii) TESARO shall have no further
right under OPKO Patent Rights or OPKO Know-how to develop, manufacture or
market the Licensed Product or any product containing Licensed Product for use
in the Field, or otherwise to use the OPKO Patent Rights or OPKO Know How;
(iii) all rights granted hereunder shall revert to OPKO for the benefit of OPKO;
and (iv) TESARO shall, as promptly as practicable, transfer to OPKO or OPKO’s
designee: (a) possession and ownership of all governmental or regulatory
correspondence, conversation logs, filings and approvals (including all
Marketing Approvals and pricing and reimbursement approvals) relating to the
development, manufacture or commercialization of the Licensed Product in the
Field and all product trademarks then being used in connection with Licensed
Product, other than TESARO’s corporate trademarks; and (b) all safety data and
other adverse event data in TESARO’s possession or Control. In addition, OPKO
shall have the right to purchase all API and Licensed Product in TESARO’S
possession or control at **** or Licensed Product (other than **** pursuant to
this Agreement, which will be ****). Notwithstanding the foregoing, TESARO shall
be entitled to sell any completed inventory of Licensed Product which remain on
hand as of the date of the termination, and to sell new inventory to the extent
necessary to satisfy its contractual and legal obligations, so long as TESARO
pays to OPKO the royalties applicable to said subsequent sales in accordance
with the terms and conditions as set forth in this Agreement; provided that no
sales shall be permitted after the expiration of six (6) months after the date
of termination. TESARO will execute all documents and take all such further
actions, as may be reasonably requested by OPKO in order to give effect to the
preceding sentences as soon as practicable.
          (b) License Grant. In the event of termination of this Agreement by
OPKO under Section 9.3 or 9.4 or termination by TESARO under Section 9.2, TESARO
will be deemed to have granted to OPKO a royalty-bearing (but solely to the
extent set forth below), worldwide, exclusive, sublicensable, license under any
TESARO Improvement Patent Rights and TESARO Improvement to the extent necessary
or reasonably useful to manufacture, market, sell or use Licensed Product in the
Field in the Territory and solely for such purpose. Except in the event of
termination by OPKO under Section 9.3 or 9.4, OPKO will pay to TESARO a royalty
on the sale of any Licensed Product in the Field that incorporates a TESARO
Improvement and is Covered by a Valid Claim of a TESARO Improvement Patent
Right, as follows:

      Development Stage as of Date of Termination   Royalty Rate
**** filing of a Licensed Product in the US or EU but **** of a Licensed Product
in the US or EU
  ****
**** of a Licensed Product in the US or EU
  ****

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          In addition, in the event TESARO or any of its Affiliates or
Sublicensees is required to make payments to any Third Party by reason of the
licenses granted to OPKO under this paragraph (b) and based on the development,
manufacture or sale of Licensed Product by or on behalf of OPKO or any of its
Affiliates or sublicensees, OPKO will pay such amounts due by TESARO or any of
its Affiliates or Sublicensees to such Third Party by reimbursing TESARO or
paying such amounts directly to such Third Party, as directed by TESARO, in each
case based on supporting documentation provided by TESARO. OPKO may elect not to
accept the grant of the license to TESARO Improvement Patent Rights upon thirty
(30) days written notice to TESARO from the date of termination.
     9.6. Survival. Any expiration or termination of this Agreement will be
without prejudice to the rights of either Party against the other accrued or
accruing under this Agreement prior to expiration or termination, including
payment obligations arising prior to such expiration or termination. The
provisions of Articles VI, VIII, IX, X and XI will survive any expiration or
termination of this Agreement and all other provisions contained in this
Agreement that by their explicit terms survive expiration or termination of this
Agreement, will survive. Except as set forth in this Article IX, upon
termination or expiration of this Agreement all other rights and obligations of
the Parties under this Agreement terminate.
ARTICLE X
DISPUTE RESOLUTION
     10.1. Continuance of Rights and Obligations During Pendency of Dispute
Resolution. If there are any disputes in connection with this Agreement,
including disputes related to termination of this Agreement under Article IX,
all rights and obligations of the Parties shall continue until such time as any
dispute has be resolved in accordance with the provisions of this Article X.
     10.2. Referral of Unresolved Matters to Senior Executives. In the event
that the Parties are unable to resolve a dispute within fifteen (15) days from
the date such dispute is first brought to the other Party’s attention, the
matter shall be referred to a senior executive of each Party to be resolved by
negotiation in good faith as soon as is practicable but in no event later than
thirty (30) days after referral.
     10.3. Arbitration. Any dispute, controversy or claim arising out of or
relating to this Agreement which the Parties have not resolved under
Section 10.2, will be decided by arbitration in accordance with the Rules of the
American Arbitration Association for Commercial Arbitration in effect at the
time the dispute arises, unless the Parties hereto mutually agree otherwise. To
the extent such rules are inconsistent with this provision, this provision will
control. The following rules will apply to any such arbitration:
          (a) Any demand for arbitration must be made in writing to the other
Party.
          (b) There will be three arbitrators, one of whom shall be appointed by
each party and a third of whom shall be the chairman of the panel and be
appointed by mutual agreement of the two arbitrators appointed by the Parties.
If the two arbitrators cannot agree on the appointment of the third arbitrator
within thirty (30) days, then the AAA shall select the arbitrator. Any
arbitration involving patent rights, other intellectual property rights or
intellectual property will be heard by arbitrators who are expert in such areas.
          (c) The arbitration will be held in the State of Delaware, or such
other place as the Parties agree. The arbitrators will apply the substantive law
of the State of Delaware in accordance with Section 11.1, without regard to
conflicts of laws and except that the interpretation and enforcement of this
arbitration provision will be governed by the Federal Arbitration Act, 9 U.S.C.
Section 1 et. seq.
          (d) Neither Party will have the right independently to seek recourse
from a court of law or other authorities in lieu of arbitration, but each Party
has the right before or during the arbitration to seek and obtain from the
appropriate court provisional remedies to avoid irreparable harm, maintain the

24

--------------------------------------------------------------------------------

 

status quo or preserve the subject matter of the arbitration. There shall be a
stenographic record of the proceedings. The decision of the arbitrators will be
final and binding upon both Parties. The arbitrators will render a written
opinion setting forth findings of fact and conclusions of law.
          (e) The expenses of the arbitration will be borne by the Parties in
proportion as to which each Party prevails or is defeated in arbitration. Each
Party will bear the expenses of its counsel and other experts.
     10.4. Equitable Relief. Notwithstanding anything to the contrary, each of
the Parties hereby acknowledges that a breach of their respective obligations
under this Agreement may cause irreparable harm and that the remedy or remedies
at law for any such breach may be inadequate. Each of the Parties hereby agrees
that, in the event of any such breach, in addition to all other available
remedies hereunder, the non-breaching Party shall have the right, through the
arbitration process described in Section 10.3, to seek equitable relief to
enforce the provisions of this Agreement.
ARTICLE XI
MISCELLANEOUS
     11.1. Governing Law and Jurisdiction. The validity, construction and
performance of this Agreement will be governed by and construed in accordance
with the substantive laws of the State of Delaware excluding any conflicts or
choice of law rule or principle that might otherwise refer construction or
interpretation of this Agreement to the substantive law of another jurisdiction.
     11.2. Force Majeure. Neither Party will 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, other than an
obligation to make payments hereunder, when such failure or delay is caused by
or results from fire, floods, embargoes, government regulations, prohibitions or
interventions, war, acts of war (whether war be declared or not), insurrections,
riots, civil commotions, acts of God or any other cause beyond the reasonable
control of the affected Party to anticipate, prevent, avoid or mitigate (a
“Force Majeure Event”); provided that (i) the affected Party provides prompt
written notice to the other Party of such failure or delay, (ii) the affected
Party uses Commercially Reasonable Efforts to mitigate the effects of the Force
Majeure Event, and (iii) the affected Party immediately resumes performance upon
cessation of the Force Majeure Event. Notwithstanding the foregoing, any failure
or delay in fulfilling a term shall not be considered a result of a Force
Majeure Event if it arises from a failure of TESARO or OPKO to comply with
applicable laws.
     11.3. 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.
     11.4. Notices. Any notice required or permitted to be given under this
Agreement will be in writing and will be deemed to have been properly given if
delivered in person by a internationally recognized overnight courier, or by fax
(and promptly confirmed by overnight courier), 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.
     In the case of TESARO:
TESARO, Inc.
309 Waverley Oaks Rd., Suite 101
Waltham, MA 02452
Attention: Chief Financial Officer
Fax No.: 339-469-8966

25

--------------------------------------------------------------------------------

 

With a copy to:
Anne Marie Cook
Choate, Hall & Stewart LLP
Two International Place
Boston, MA 02110
Fax No.: 617-248-4000
In the case of OPKO:
OPKO Health Inc.
4400 Biscayne Blvd.
Miami, FL 33137
Attention: Executive Vice President
Fax No.: 305-575-6444
With a copy to: Deputy General Counsel
     11.5. Assignment. This Agreement may not be assigned or otherwise
transferred by either Party, without the written consent of the other Party such
consent not to be unreasonably withheld, conditioned or delayed; provided,
however, that either Party may, without such consent, assign this Agreement, in
whole or in part, (i) to any of its Affiliates, and (ii) to a Third Party
successor or purchaser of all or substantially all of its business or assets to
which this Agreement relates, whether in a merger, sale of stock, sale of assets
or other similar transaction, provided that, (i) the Third Party successor or
purchaser provides written notice to the other Party that such Third Party
agrees to be bound by the terms of this Agreement, and (ii) OPKO will not assign
this Agreement unless the assignee is also assigned ownership owns or Controls
of the OPKO Patent Rights and OPKO Know-how. Any purported assignment in
violation of this Section 11.5 will be void. Any permitted assignee shall assume
all obligations of its assignor under this Agreement.
     11.6. Affiliate Performance. Any obligation of TESARO under or pursuant to
this Agreement may be satisfied, met or fulfilled, in whole or in part, at
TESARO’s sole and exclusive option, either by TESARO directly or by any
Affiliate or Sublicensee of TESARO that TESARO causes to satisfy, meet or
fulfill such obligation, in whole or in part.
     11.7. Amendment. The Parties hereto may amend, modify or alter any of the
provisions of this Agreement, but only by a written instrument duly executed by
both Parties hereto.
     11.8. Entire Agreement. This Agreement, along with all schedules and
exhibits attached hereto, contains the entire understanding of the Parties with
respect to the subject matter hereof and supersedes all prior agreements,
whether written or oral. Each Party confirms that it is not relying on any
representations, warranties or covenants of the other Party except as
specifically set out in this Agreement.
     11.9. No Benefit to Third Parties. The provisions of this Agreement are for
the sole benefit of the Parties and their successors and permitted assigns, and
they shall not be construed as conferring any rights in any other Persons.
     11.10. Waiver. The failure of a Party to enforce at any time for any period
any of the provisions of this Agreement will not be construed as a waiver of
such provisions or of the rights of such Party thereafter to enforce each such
provision.
     11.11. 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

26

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Party’s current or future patents, trade secrets, copyrights, moral rights,
trade or service marks, trade dress, or any other intellectual property rights.
     11.12. Relationship of the Parties. The Parties agree that their
relationship established by this Agreement is that of independent contractors.
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 in this Agreement, 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.
     11.13. Severability. If any provision of this Agreement is held
unenforceable by a court or tribunal of competent jurisdiction in a final
unappealable order because it is invalid or conflicts with any law of any
relevant jurisdiction, then such provision will be inoperative in such
jurisdiction and the remainder of this Agreement shall remain binding upon the
Parties hereto.
     11.14. Interpretation.
          (a) General. Unless the context of this Agreement otherwise requires,
(a) words of one gender include the other gender; and (b) words using the
singular or plural number also include the plural or singular number,
respectively. Whenever this Agreement refers to a number of days, unless
otherwise specified, such number shall refer to calendar days.
          (b) Other Definitional and Agreement References. References to any
agreement, contract, statute, act, or regulation are to that agreement,
contract, statute, act, or regulation as amended, modified or supplemented from
time to time in accordance with the terms hereof and thereof.
          (c) Capitalization. Any capitalized terms used in any Exhibit or
Schedule but not otherwise defined therein, shall have the meaning as defined in
this Agreement.
          (d) Date References. References from or through any date mean, unless
otherwise specified, from and including or through and including, respectively.
          (e) Schedules and Exhibits. All Schedules and Exhibits annexed hereto
or referred to herein are hereby incorporated in and made a part of this
Agreement as if set forth in full herein.
          (f) Person References. References to any Person include the successors
and permitted assigns of that Person.
          (g) References to Parts of this Agreement. References to Articles,
Sections, Schedules, and Exhibits are to Articles, Sections, Schedules, and
Exhibits of this Agreement unless otherwise specified.
          (h) Other Definitional and Interpretative Provisions. The words
“hereof’, “herein” and “hereunder” and words of like import used in this
Agreement shall refer to this Agreement as a whole and not to any particular
provision of this Agreement. Whenever the words “include”, “includes” or
“including” are used in this Agreement, they shall be deemed to be followed by
the words “without limitation”, whether or not they are in fact followed by
those words or words of like import. The word “or” is used in the inclusive
sense (and/or). “Writing”, “written” and comparable terms refer to printing,
typing and other means of reproducing words (including electronic media) in a
visible form.
          (i) Headings. The Article and Section headings contained in this
Agreement are for reference purposes only and shall not affect in any way the
meaning or interpretation of this Agreement.

27

--------------------------------------------------------------------------------

 

          (j) Expenses. Except as otherwise expressly provided in this
Agreement, each Party shall pay the fees and expenses of its respective lawyers
and other experts and all other expenses and costs incurred by such Party
incidental to the negotiation, preparation, execution and delivery of this
Agreement.
     11.15. Counterparts. This Agreement may be executed in any number of
counterparts (including by facsimile), each of which shall be deemed an
original, but all of which together shall constitute one and the same document.
[Signature Page Follows]

28

--------------------------------------------------------------------------------

 

     IN WITNESS WHEREOF, TESARO and OPKO have caused this Agreement to be duly
executed by their authorized representatives under seal, in duplicate on the
Effective Date.

            TESARO, Inc.
      By:           Name:           Title:           OPKO Health, Inc.
      By:           Name:           Title:      

29

--------------------------------------------------------------------------------

 

         

Exhibit A
Description of SCH 619734 (Rolapitant)
Chemical Structure of Rolapitant:
(GRAPHIC) [g26471g2647100.gif]

 

--------------------------------------------------------------------------------

 

Exhibit B
Description of SCH 900978
Chemical Structure of SCH 900978:
(GRAPHIC) [g26471g2647101.gif]

 

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Exhibit C
OPKO Patent Rights
[Attached]

 

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Monday, November 22, 2010       Page 1 of 28     Patent Status by Division    
             Division: OPKO OPKO        

Docket           Status     Application Number     Filing Date              
Country   SubCase   Case Type     Division Reference     Patent Number     Issue
Date     Next Action(s)     Due Date(s)  
****
                                                     

 

--------------------------------------------------------------------------------

 

         
Monday, November 22, 2010
  Report Selection   Page 2 of 28
Record Count: 187

           
 
  Sort Order: by Division   Print Remarks?: No  
 
         
 
      Print Inventors?: No  
 
         
 
      Print Abstract: No  
 
         
 
      Actions Due: All  

                  Filing Date:   From:   To:
Docket Number:
  Status Code: All
 
           
Division: OPKO
      Case Type(s):   Status(es):
 
           
Agent:
           
 
           
Attorney:
           
 
           
Assignee:
           
 
           
Country:
           
 
           
Area:
           
 
           
Inventor:
           

 

--------------------------------------------------------------------------------

 

Exhibit D
Technology Transfer Plan
[Attached]

 

--------------------------------------------------------------------------------

 

TECHNOLOGY TRANSFER PLAN
This Technology Transfer Plan is an exhibit to the Exclusive License Agreement
entered into between TESARO, Inc. (“TESARO”) and OPKO Health, Inc. (“OPKO”) (the
“Agreement”), and is incorporated by reference into the Agreement. Capitalized
terms used in this Technology Transfer Plan will have the meaning set forth in
the Agreement.
Part A -General
1. Technology Transfer Services. OPKO will transfer to TESARO (or TESARO’s
designees) all OPKO Know How and related technical information, and provide such
support, as is reasonably necessary to enable TESARO to assume responsibility
for the research, formulation, development, testing and manufacture of Licensed
Product, and, during the period commencing on the Effective Date and continuing
until the later of the completion of all Technical Transfer Services (as defined
below) or **** from the Effective Date (such period being hereafter referred to
as the “Transfer Period”), will provide reasonable ongoing assistance to TESARO
in connection with such transfer and use of the OPKO Know-how. In connection
with the foregoing, OPKO will perform the activities set forth in Parts Band C
of this Technology Transfer Plan (the “Technology Transfer Services”). In
addition, during the Transfer Period, OPKO will make its personnel reasonably
available to TESARO to respond to questions related to the OPKO Know-how in
connection with any of the activities described in this Technology Transfer
Plan, and will provide such ongoing support and assistance as TESARO may
reasonably request in the transition of development and manufacturing
responsibility for Licensed Products to TESARO. TESARO acknowledges that OPKO
and OPKO personnel were not involved in the discovery, manufacture, formulation,
sourcing, research or development of the Licensed Product or any API and have
only gained information relating to the Licensed Product in connection with the
Asset Purchase Agreement and its research and development efforts undertaken
since the consummation of the Asset Purchase Agreement in November 2009, much of
which has been undertaken through the assistance of Third Party consultants.
OPKO intended to use Third Parties for, and therefore had not engaged in, the
development or formulation of dosage forms or the manufacture of drug product or
API in support of the clinical development program or commercialization of
Licensed Product. Accordingly, OPKO’s efforts, support and assistance and
TESARO’s expectations under this Technology Transfer Plan must be considered in
light of OPKO’ s limited level of expertise, knowledge and familiarity with
Licensed Product. Additionally, in making the decision to enter into the
Exclusive License Agreement, TESARO has conducted its own independent
investigation, review and analysis of the Licensed Product, OPKO Patent Rights
and OPKO Know-how, and has had complete access to all of OPKO’s files,
information, materials and data, and records relating to the Licensed Product.
In connection with the foregoing, at the request of TESARO, OPKO will seek the
assistance of Merck & Co., Inc. to the extent such support continues to be
available under Section 2.5 of the Asset Purchase Agreement, and any other Third
Party support, as specified in paragraph 2 of this Part A. To the extent
information, data or materials referred to in this Technology Transfer Plan are
not in the possession of OPKO, or cannot be obtained from Merck under the Asset
Purchase Agreement pursuant to OPKO’s rights thereunder, OPKO will have no
obligations hereunder or in the Agreement to provide or transfer such requested
information, data or materials. Notwithstanding anything herein to the contrary,
this Technology Transfer Plan will not be considered a limitation on, or a
narrowing of, the obligations of either Party under the Agreement.
2. Third Party Support. If any materials or information to be provided under
this Technology Transfer Plan or otherwise under the Agreement are in the
possession or control of Merck & Co., Inc. or any other Third Party who provided
services to OPKO, OPKO will use Commercially Reasonable Efforts to obtain such
materials and information from Merck & Co., Inc. or such other Third Party, as
the case may be. In the case of materials and information in the possession or
control of Merck & Co., Inc., “Commercially Reasonable Efforts” under the
preceding sentence will include an obligation on the part of

1

--------------------------------------------------------------------------------

 

OPKO to enforce its rights under the Asset Purchase Agreement. With respect to
any provision under this Technology Transfer Plan requiring OPKO to provide
support or information from, or access to, personnel, OPKO will, at the request
of TESARO, arrange for, and facilitate, direct communication between TESARO and
any Third Party who was responsible for generating or implementing the
applicable OPKO Know-how. In particular, and especially with respect to the
development, implementation, transfer, provision or explanation of production
manufacturing or formulation processes for API or drug substance (for which OPKO
has no direct knowledge), OPKO will, within ten (10) days of the Effective Date,
send written notice to Merck & Co., Inc. under which OPKO shall specify TESARO
as its designee under Section 2.5 of the Asset Purchase Agreement and
authorizing Merck & Co., Inc. to provide information, support and assistance to
TESARO to the same extent as available to OPKO under Section 2.5 of the Asset
Purchase Agreement.
3. Technical Transfer Team. Commencing as of the Effective Date, the Parties
will form a technical transfer team (the “Technical Transfer Team”) comprised of
the functions and individuals identified below to coordinate and oversee the
Technology Transfer Services.

          OPKO Representatives         Functional Area Represented   Role  
Initial Designee
Team Leader
  Act as primary interface with respect to OPKO’s technology transfer activities
  ****
 
       
Regulatory
  Implement transfer of the INDs, IMPDs and correspondence with health
authorities   ****
 
       
Clinical Research
  Address questions related to completed clinical studies and those under
planning or in start-up; oversee transfer of all clinical data (including but
not limited to efficacy, safety, PK, ECG and pharmacovigilence), study
documentation, safety reports, advisory meeting minutes, and inventoried
biospecimens   ****
 
       
Chemistry, Manufacturing, and Controls
  Oversee transfer of all pharmaceutical development data, technical and
manufacturing documentation and inventoried non-GMP and GMP materials (Role is
inclusive of API, starting materials, raw materials, retains, and stability
programs in OPKO’s possession or control)   ****

2

--------------------------------------------------------------------------------

 

          OPKO Representatives         Functional Area Represented   Role  
Initial Designee
Preclinical Research
  Address questions related to completed nonclinical studies and those under
planning or in start-up; oversee transfer of all nonclinical data, study
documentation and inventoried specimens (Role is inclusive of all toxicology,
pharmacology, and pharmacokinetic and other preclinical activities)   ****
 
       
Analytical Methods
  Oversee transfer of all clinical, nonclinical and pharmaceutical analytical
method development reports, final SOPs and associated reference standards   ****
 
       
Quality
  Oversee transfer of all quality audit and inspection reports, quality release
documentation and other all associated quality memorandums in support of
completed and planned development activities   ****
 
       
General
  Oversee transfer of all agreements, if any, to be assigned; transfer of any
general program information and commercial information; and transfer of project
team meeting minutes   ****
 
       
Commercial
  Oversee transfer of all market survey data and reports   ****
 
       
IT (electronic files)
  Information transfer   ****
 
       
Patents
  Oversee transfer of OPKO Patent Rights   ****

3

--------------------------------------------------------------------------------

 

          TESSARO Representatives         Functional Area Represented   Role  
Initial Designee
Team Leader
  Act as primary interface with respect to TESARO activities under Technology
Transfer Plan   ****
 
       
Regulatory
  Receipt of IND and other regulatory docs   ****
 
       
Clinical Research
  Oversee receipt of technology related to clinical development   ****
 
       
Chemistry, Manufacturing and Controls
  Oversee receipt and implementation of technology related to TESARO’s CMC
efforts and activities   ****
 
       
Preclinical Research
  Oversee receipt of technology transfer related to preclinical research
activities   ****
 
       
Analytical Methods
  Act as primary interface with respect to transfer of analytical methods   ****
 
       
Quality
  Act as primary interface with respect to quality matters   ****
 
       
General
  Oversee transfer of all agreements, if any, to be assigned; transfer of any
general program information and commercial information; and transfer of project
team meeting minutes   ****
 
       
Commercial
  Act as primary interface   ****
 
       
IT
  Oversee information transfer   ****
 
       
Patents
  Oversee transfer of OPKO Patent Rights   ****

Either Party may replace its representatives on the Technical Transfer Team,
provided that the OPKO representatives on the Technical Transfer Team will have
comparative level of expertise, knowledge and familiarity with Licensed Product
to the listed representative.
The responsibilities of the Technical Transfer Team will include, but not be
limited to the following:

  a.   Establish a complete and reasonably detailed accounting of all materials,
samples, documents, data, contracts, CD/DVDs and other electronic files that
constitute the technical information embodying the OPKO Know-how, and assist in
the complete and accurate transfer of all items to TESARO and/or any of TESARO’S
designees. Provide reasonable explanation to TESARO and/or any of TESARO’S
designees how items are related, filed, and what supportive software programs
are required to enable any of the electronic files and data sets.

  b.   Facilitate the reasonable assistance of OPKO’s then current employees and
reasonable access to its other internal resources and to Third Parties who
generated or possess or control OPKO Know-how, to provide TESARO and/or any of
TESARO’s designees with a reasonable level of technical assistance and
consultation in connection with the transfer of the OPKO Know-

4

--------------------------------------------------------------------------------

 

      how to TESARO and/or any of TESARO’S designees, including the provision
and explanation, upon request, to TESARO and/or any of its designees of all
relevant technology, materials, reports, data, documents and materials
describing or embodying the OPKO Know How.

  c.   Facilitate the provision and explanation to TESARO and/or any of TESARO’s
designees, of all production outlines, materials sourcing, specifications, and
testing, standard testing requirements (release, in process, characterization
and stability), standard operating procedures (e.g. analytical testing,
equipment cleaning), technology, documents (e.g. Certificates of Analysis,
Specifications, technical reports, development reports and memorandums, Material
Safety Data Sheets, qualification and validation reports, master manufacturing
batch records, executed batch records), data, notebooks or other information
that constitutes the OPKO Know-how for manufacture of starting materials, API
and Licensed Product and intermediates of any of the foregoing.

  d.   Facilitate the development and implementation of a technology transfer
protocol for the transfer of the manufacturing process (including in-process
methods) and formulation process for API, final drug substance and final drug
product for the Licensed Products to TESARO and/or its designees.

  e.   Implement transfer of clinical drug assay methodologies and know-how for
the Licensed Products, including parent and metabolites, inventoried samples and
completed or partial analyses (e.g. toxicokinetics, pharmarcokinetics) to TESARO
and/or its designees.

  f.   Implement transfer of all regulatory filings and sponsor of the INDs as
promptly as practicable following the Effective Date.

  g.   Establish a plan for and implement transfer of all electronic data and
confirmation of data integrity and completeness and accuracy following transfer.

  h.   Introduce TESARO and/or any of TESARO’S designees, at TESARO’s request,
to consultants, contractors or other vendors currently engaged or involved in
future planning activities related to the Licensed Products.

  i.   Implement transfer to TESARO’s designee all patent files related to OPKO
Patent Rights in accordance with Section 5.1 of the License Agreement as
necessary to allow TESARO to assume prosecution and maintenance of such OPKO
Patent Rights without any loss of rights in the transition.

4. Costs. **** associated with technology transfer activities to be provided
under this Technology Transfer Plan, including, but not limited to the ****. To
the extent any Technology Transfer Services to be provided under this Section
require external resources, including consultation with Third Party consultants,
**** of such external resources, provided that such activities and costs are
expressly set forth in this Technology Transfer Plan or are otherwise approved
in writing in advance by ****.
Part B -Activities.
The activities to be performed by OPKO under this Technology Transfer Plan, by
technical area, are as follows:

5

--------------------------------------------------------------------------------

 

              Function   Service to be Provided by OPKO   Comments
Technical Operations
  OPKO shall provide the reasonable assistance of OPKO’s then current employees
and reasonable access to its other internal resources to provide TESARO (and/or
TESARO’s designees)with a reasonable level of technical assistance and
consultation in connection with the transfer and implementation of OPKO Know How
to TESARO, including the provision and explanation, on request, to TESARO and
its Affiliates of all technology, electronic files, materials, reports, data,
documents, standard testing requirements, standard operating procedures,
notebooks and materials describing or embodying the OPKO Know How. TESARO will
be given the reasonable opportunity to meet with, and receive assistance and
services of, the OPKO’s knowledgeable personnel in connection with TESARO
gaining competent knowledge of the contents of the OPKO Know How and OPKO’s
activities related to Licensed Product. As stated above, OPKO personnel were not
involved in the discovery, manufacture, formulation, sourcing, research or
development of the Licensed Product or any API and have only gained information
relating to the Licensed Product in connection with the Asset Purchase Agreement
and its research and development efforts undertaken since the consummation of
the Asset Purchase Agreement in November 2009, much of which has been undertaken
through the assistance of Third Party consultants. OPKO intended to use Third
Parties for, and therefore had not engaged in, the development or formulation of
dosage forms or the manufacture of drug product or API in support of the
clinical development program or commercialization of Licensed Product. OPKO will
seek the assistance of Merck & Co., Inc. to the extent such support continues to
be available under Section 2.5 of the Asset Purchase Agreement to provide the
Technical Operations Support, including discussion with appropriate Merck & Co.,
Inc. personnel, as outlined in the Technical Transfer Services included as
Schedule 2.5 to the Asset
 
   
 
  Purchase Agreement, to:

             
 
  •   Identify the identity and location of all archived development samples for
transfer to TESARO and/or TESARO designees    

6

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              Function   Service to be Provided by OPKO   Comments
 
  •   Discuss regulatory files and correspondence with regulatory authorities,
including an outline of open obligations    
 
           
 
  •   Discuss the rationale of Phase 3 dose and formulation and clinical utility
of the current IV formulation. Personnel shall also identify the identity and
location of all archived study samples for transfer to TESARO and/or TESARO
designees.    
 
           
 
  -   Discuss key completed toxicology studies including but not limited to
carcinogenicity studies, oral chronic toxicology, development and reproductivity
studies, and IV studies, as well as safety pharmacology studies,. Personnel
shall also identify the identity and location of all archived study samples for
transfer to TESARO and/or TESARO designees.    
 
           
 
  -   Discuss past and current research and development efforts specific for the
Licensed Product, including the status of study reports, data and analyses for
each study completed as well as available biospecimens for transfer to TESARO
and/or TESARO designees.    
 
           
 
  -   Assist in the transfer of the current bioanalytical methods to TESARO
and/or any of TESARO’S designees, as well as available biospecimens for transfer
to TESARO and/or TESARO designees.    
 
           
 
  -   Provide relevant information particularly audit reports related to the
Licensed Products to ensure all studies were conducted in accordance with GLP,
GMP & GCP, to provide certification that appropriate storage conditions for all
inventoried materials has been met at all locations of storage and during all
periods of transit, and to provide appropriate documentation to support the
chain of custody to OPKO and then to TESARO and/or any of TESARO’S designees.  
 
 
           
 
  -   IT personnel to discuss format, systems utilized and transfer of
nonclinical, clinical and CMC data.    
 
           
 
  (Note: all such meetings and communication will be coordinated through the
Team Leaders).    

7

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              Function   Service to be Provided by OPKO   Comments
Regulatory Services
  OPKO and TESARO shall establish a prompt communication and interaction process
to ensure the orderly transfer of all regulatory filings related to Licensed
Product (“Regulatory Filings”) as promptly as practicable following the
Effective Date. Within thirty (30) days following the Effective Date, or as
otherwise agreed by the Parties, the Parties shall file with the FDA and any
other applicable Regulatory Authority, such information as may be required to
transfer the Regulatory Filings from OPKO to TESARO. Both OPKO and TESARO agree
to use Commercially Reasonable Efforts to take any actions required by the FDA
or other applicable Regulatory Authority to affect the transfer of the
Regulatory Filings to TESARO.    
 
       
Manufacturing Process
  Seek the assistance of Merck & Co., Inc. under Section 2.5 of the Asset
Purchase Agreement towards the development and implementation of a technology
transfer protocol for the transfer of the manufacturing process (including
in-process methods) and formulation process for API and formulated drug
substance for the Licensed Product to TESARO and/or its designees.    
 
       
 
  Seek the assistance of Merck & Co., Inc. under Section 2.5 of the Asset
Purchase Agreement to provide training to TESARO and/or TESARO’S designees in
the manufacturing and testing of the Licensed Product.    
 
       
Intellectual Property
  OPKO shall transfer to TESARO responsibility for filing and prosecuting any
patent applications and patents included in the OPKO Patent Rights and
maintaining any patents included in the OPKO Patent Rights, and shall
(a) execute any legal documents, such for recordation in any U.S. or foreign
offices or agencies, to evidence TESARO’s control of prosecution and maintenance
of the applicable OPKO Patent Rights, (b) performing all reasonable actions that
may be necessary or useful to complete the assignment to TESARO of such
responsibilities, and (c) provide reasonable cooperation to TESARO in connection
with such activities in accordance with Section 5.1 of the Exclusive License
Agreement.    

Part C-Technology Transfer Schedule.
The schedule for performance of certain specified Technology Transfer Services
and form of transfer of certain OPKO Know-how are set forth in the Table I below
(the “Technology Transfer Schedule”). The

8

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Parties’ representatives comprising the Technical Transfer Team will have the
ability, by mutual written agreement of the Team Leaders from both Parties, to
modify in writing the Technology Transfer Schedule, provided that no such
modification shall amend the terms of the Agreement other than to specifically
amend the timelines and format set forth in the Technology Transfer Schedule
unless both Parties agree in writing to amend this Agreement in accordance with
Section 11.7 of the Agreement.

9

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Table 1
Technology Transfer Schedule

                  Delivery Time (or such later         OPKO Know-how   time as
TESARO may request)   Delivery Method   Discussion/Comments
Records related to Licensed Product in the Data Room
  OPKO will provide within **** calendar days of the Effective Date   To be
delivered in such form as currently exists via commercial carrier.   Will
contain the entire contents of the data room that was available to TESARO during
due diligence.
 
           
IND 77,044
  OPKO will provide within **** calendar days of the Effective Date   To be
delivered on CD or DVD via commercial carrier.   **** which shall, in no event,
be greater than 60 calendar days after the Effective Date.
 
           
IND 72,754
  OPKO will provide within **** calendar days of the Effective Date   To be
delivered on CD or DVD via commercial carrier.   **** which shall, in no event,
be greater than 60 calendar days after the Effective Date.
 
           
Regulatory Documents
           
 
           
• ****
  To be delivered within **** days of the Effective Date.   Hard copy (and
electronic as may be available) of all correspondence to and from regulatory
agencies and attachments arranged in chronological order. The original IND and
IMPD to be delivered on CD or DVD.    
 
           
Pharmacovigilance
           
 
           
• ****
  To be transferred to TESARO within **** calendar days of the Effective Date.  
To be delivered on CD or DVD via commercial carrier   ****
 
           
Discovery Biology
           
 
           
• ****
  To be delivered within **** days of the Effective Date.   To be delivered on
CD or DVD via commercial carrier   If hard copy signatures were obtained for
final report, the original signed report should be provided. Should include any
draft reports that may be in process.

10

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                  Delivery Time (or such later         OPKO Know-how   time as
TESARO may request)   Delivery Method   Discussion/Comments
Drug Metabolism & Pharmacokinetics
           
 
           
• ****
 
•     To be delivered within **** days of the Effective Date.

•  
•     To be delivered on CD or DVD via commercial carrier
  If hard copy signatures were obtained for final report, the original signed
report should be provided. Should include any draft reports that may be in
process, as well as associated raw data analyses.
 
           
Drug Safety
           
 
           
• ****
 
•     To be delivered within **** days of the Effective Date.
 
•     To be delivered on CD or DVD via commercial carrier
  If hard copy signatures were obtained for final report, the original signed
report should be provided. Should include any draft reports that may be in
process, as well as associated raw data analyses.
 
           
****
 
•     To be delivered within **** days of the Effective Date.
 
•     To be delivered on CD or DVD via commercial carrier
  If hard copy signatures were obtained for final report, the original signed
report should be provided. Should include any draft reports that may be in
process, as well as associated raw data analyses.

11

--------------------------------------------------------------------------------

 

                  Delivery Time (or such later         OPKO Know-how   time as
TESARO may request)   Delivery Method   Discussion/Comments
• ****
  To be delivered within **** days of the Effective Date.   To be delivered on
CD or DVD as electronic transport file via commercial carrier   Software that
may be required to access the data will need to be specified by OPKO.
 
           
Early Clinical Research & Experimental Medicine
           
 
           
• ****
 
•     To be delivered within **** days of the Effective Date.
 
•     To be delivered on CD or DVD via commercial carrier
  If hard copy signatures were obtained for final report, the original signed
report should be provided. Should include any draft reports that may be in
process, as well as associated raw data analyses.
 
           
• ****
  To be delivered within **** days of the Effective Date.   To be delivered on
CD or DVD as a SAS transport file via commercial carrier   Software that may be
required to access the data will need to be specified by OPKO.

12

--------------------------------------------------------------------------------

 

                  Delivery Time (or such later         OPKO Know-how   time as
TESARO may request)   Delivery Method   Discussion/Comments
Clinical Research
           
 
           
• ****
  ****

-     To be delivered within **** calendar days of the Effective Date

****

•     To be delivered within **** calendar days of the Effective Date

****

•     To be delivered within **** calendar days of the Effective Date.
 
•     To be delivered on CD or DVD via commercial carrier

•     Delivery conditions to be specified per sample requirements
  If hard copy signatures were obtained for final report, the original signed
report should be provided. Should include any draft reports that may be in
process, as well as associated raw data analyses.
 
           
• ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD as a SAS transport file via commercial carrier   Software
that may be required to access the data will need to be specified by OPKO.
 
           
Chemistry, Manufacturing, and Controls
           
 
           
• ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD via commercial carrier   If hard copy signatures were
obtained for final report, the original signed report should be provided. Should
include any draft reports that may be in process, as well as associated raw data
analyses.

13

--------------------------------------------------------------------------------

 

                  Delivery Time (or such later         OPKO Know-how   time as
TESARO may request)   Delivery Method   Discussion/Comments
• ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD via commercial carrier    
 
           
• ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD via commercial carrier    
 
           
• ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD via commercial carrier    
 
           
• ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD via commercial carrier   ****
 
           
•
           
 
           
Occupational & Environmental
Toxicology
           
 
           
• ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD via commercial carrier    
 
           
Market Research
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD via commercial carrier    
 
           
• ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD via commercial carrier    

14

--------------------------------------------------------------------------------

 

                  Delivery Time (or such later         OPKO Know-how   time as
TESARO may request)   Delivery Method   Discussion/Comments
• ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD via commercial carrier    
 
           
• ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD via commercial carrier    
 
           
• ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD via commercial carrier    
 
           
• ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD via commercial carrier    
 
           
• ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD via commercial carrier    
 
           
• ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD via commercial carrier    
 
           
Physical chemical inventory
           
 
           
API ****
  To be delivered within **** calendar days of TESARO providing OPKO with the
shipping instructions and location, or as otherwise agreed by the parties.  
OPKO will ship via commercial carrier under appropriate sample storage and
control conditions per sample requirements   ****

15

--------------------------------------------------------------------------------

 

                  Delivery Time (or such later         OPKO Know-how   time as
TESARO may request)   Delivery Method   Discussion/Comments
****
  To be delivered within **** calendar days of TESARO providing OPKO with the
shipping instructions and location, or as otherwise agreed by the parties.  
OPKO will ship via commercial carrier under appropriate sample storage and
control conditions per sample requirements    
 
           
****
  To be delivered within **** calendar days of TESARO providing OPKO with the
shipping instructions and location, or as otherwise agreed by the parties.  
OPKO will ship via commercial carrier under appropriate sample storage and
control conditions per sample requirements    
 
           
****
  To be delivered within **** calendar days of TESARO providing OPKO with the
shipping instructions and location, or as otherwise agreed by the parties.  
OPKO will ship via commercial carrier under appropriate sample storage and
control conditions per sample requirements    
 
           
****
  To be delivered within **** calendar days of TESARO providing OPKO with the
shipping instructions and location, or as otherwise agreed by the parties.  
OPKO will ship via commercial carrier under appropriate sample storage and
control conditions per sample requirements    
 
           
****
  To be delivered within **** calendar days of TESARO providing OPKO with the
shipping instructions and location, or as otherwise agreed by the parties.  
OPKO will ship via commercial carrier under appropriate sample storage and
control conditions per sample requirements    

16

--------------------------------------------------------------------------------

 

                  Delivery Time (or such later         OPKO Know-how   time as
TESARO may request)   Delivery Method   Discussion/Comments
****
  To be delivered within **** calendar days of TESARO providing OPKO with the
shipping instructions and location, or as otherwise agreed by the parties.  
OPKO will ship via commercial carrier under appropriate sample storage and
control conditions per sample requirements    
 
           
Samples
           
 
           
****
  At TESARO’s direction, to be provided with **** days of the Effective Date or
retained by OPKO   Delivery conditions to be specified per sample requirements  
 
 
           
OPKO Patent Rights
           
 
           
All **** art (whether **** prosecution counsel relating to any or all OPKO
Patent Rights, all **** tile each issued patent under the OPKO Patent Rights).
  Transfer of the patent portfolio will occur within **** calendar days of the
Effective Date   To be delivered on CD or DVD or hard copy via commercial
carrier    
 
           
Notebooks or all other relevant data or material (even draft form).
           
 
           
Originals or copies of ****
  To be delivered within **** calendar days of the Effective Date.   To be
delivered on CD or DVD or hard copy via commercial carrier   Materials will need
to be redacted for information not relevant to the OPKO Know How.

17

--------------------------------------------------------------------------------

 

Exhibit E
Form of Press Release
[Attached]

 

--------------------------------------------------------------------------------

 

(TESARO OPKO LOGO) [g26471g2647102.gif]
FOR IMMEDIATE RELEASE
TESARO and OPKO Health Sign Exclusive License Agreement for Rolapitant

  •   Rolapitant is a Phase III-ready neurokinin-l (NK-l) receptor antagonist in
development for chemotherapy induced nausea and vomiting (CINV)     •   TESARO
responsible for worldwide development and commercialization of rolapitant

Boston, MA and Miami, FL -December 13, 2010 -TESARO, Inc. and OPKO Health, Inc.
(NYSE Amex:OPK), today announced that they have signed a definitive agreement
granting TESARO exclusive rights to the development, manufacture,
commercialization and distribution of rolapitant and a related compound.
Rolapitant is a potent and selective neurokinin-1 (NK-1) receptor antagonist
with an extended plasma half-life that has the potential to improve the
management of nausea and vomiting experienced by cancer patients undergoing
chemotherapy. Rolapitant, which is Phase III ready, demonstrated promising
efficacy in Phase II testing for prevention of nausea and vomiting in patients
undergoing highly emetogenic chemotherapy.
Under the terms of the agreement, OPKO will acquire an approximately 10% equity
investment in TESARO. OPKO is eligible for payments of up to over $120 million,
including an up-front payment and additional payments based upon achievement of
specified regulatory and commercialization milestones; in addition, OPKO will
receive tiered royalties on sales. Under the agreement, OPKO and TESARO will
share future profits from the commercialization of licensed products in Japan
and OPKO will have an option to market the products in Latin America.
“TESARO is very pleased to announce this agreement with OPKO and to advance the
development of this important product candidate, rolapitant,” said Lonnie
Moulder, Chief Executive Officer of TESARO. “Our leadership team has a deep
understanding of the unmet need that still exists in oncology supportive care,
given our successful commercialization of the market-leading therapy for CINV
prevention at the helm of MGI PHARMA. We believe that rolapitant is a
differentiated product with great potential to help cancer patients undergoing
chemotherapy.”

 

--------------------------------------------------------------------------------

 

TESARO was co-founded by former executives of MGI PHARMA, an oncology and
acute-care focused specialty biopharmaceutical company that Eisai Co., Ltd.
acquired in 2008 for $3.9 billion. While at MGI PHARMA, TESARO executives led
the clinical development and commercialization of numerous drugs, including
commercialization of Aloxi® (palonosetron HCI), the leading drug in the 5-HT3
receptor antagonist class for prevention of CINV.
“We are pleased to complete this important transaction and look forward to
seeing rolapitant progress towards registration in key markets throughout the
world,” said Phillip Frost, M.D., OPKO’s Chairman and Chief Executive Officer.
“The TESARO team’s successful experience with the development and
commercialization of oncology supportive care products will be of special
benefit in making rolapitant a commercial success.”
About Rolapitant:
Rolapitant, a potent and selective neurokinin-1 (NK-1) receptor antagonist with
an extended plasma half-life, has completed Phase II clinical testing for
prevention of chemotherapy induced nausea and vomiting indications. NK-1
receptors are highly concentrated in the brain and bind substance P, a
neurokinin that elicits an emetogenic response. Activation ofNK-1 receptors
plays a central role in nausea and vomiting induced by emetogenic cancer
chemotherapy.
About Chemotherapy Induced Nausea and Vomiting (CINV):
CINV is estimated to afflict over 70% of cancer patients undergoing chemotherapy
and, if not prevented, may possibly result in a delay or even discontinuation of
chemotherapy treatment. NK-1 receptor antagonists have been demonstrated to
improve the management of nausea and vomiting experienced by cancer patients
undergoing chemotherapy.
About OPKO Health, Inc.
Miami-based OPKO is a specialty healthcare company involved in the discovery,
development, and commercialization of proprietary pharmaceutical products,
medical devices, vaccines, diagnostic technologies and imaging systems.
Initially focused on the treatment and management of ophthalmic diseases, OPKO
has since expanded into other areas of major unmet medical need. For more
information, visit www.opko.com.

 

--------------------------------------------------------------------------------

 

About TESARO, INC.
Founded in 2010, TESARO is a privately held oncology-focused biopharmaceutical
company dedicated to improving the lives of cancer patients by developing and
commercializing safer and more effective therapeutics. Earlier this year, TESARO
secured $60 million in start-up funding from New Enterprise Associates (NEA) and
the TESARO founders. TESARO is headquartered in Boston, Massachusetts. For more
information, visit www.tesarobio.com.
For Further Information Contact:

      For TESARO   For OPKO Health
Richard Rodgers
  Steve Rubin
EVP & Chief Financial Officer
  EVP -Administration
+1.339.970.0903
  +1.305.575.6015
rrodgers@tesarobio.com
  srubin@opko.com

This press release contains “forward-looking statements,” as that term is
defined under the Private Securities Litigation Reform Act of1995 (PSLRA), which
statements may be identified by words such as “expects,” “plans,” “projects,”
“will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and
other words of similar meaning, including statements regarding product
development efforts, including the ability to develop and commercialize
rolapitant for chemotherapy-induced nausea and vomiting, the ability to obtain
registration for rolapitant in key markets and the timing thereof, and the
potential for rolapitant to help cancer patients undergoing chemotherapy, as
well as other non-historical statements about expectations, beliefs or
intentions regarding business, technologies and products, financial condition,
strategies or prospects. These forward-looking statements are not guarantees of
OPKO’s or TESARO’s future performance and involve a number of risks and
uncertainties that may cause actual results to differ materially from the
results discussed in these statements. Many factors could cause either Company’s
actual activities or results to differ materially from the activities and
results anticipated in forward-looking statements. These factors include, an
inability to successfully develop and commercialize rolapitant and the NK-1
program assets, that rolapitant may not achieve the expected results or
effectiveness and may not generate data that would support the approval or
marketing of this product, that others may develop products, including other
NK-1 receptor antagonists, which are superior to rolapitant, and that the
acquired compounds may not have advantages over presently marketed products. In
addition, forward-looking statements may also be adversely affected by risks
inherent in funding, developing and obtaining regulatory approvals of new,
commercially-viable and competitive products and treatments, general market
factors, competitive product development, product availability, federal and
state regulations and legislation, the regulatory process for new products and
indications, manufacturing issues that may arise, patent positions and
litigation, among other factors. The forward-looking statements contained in
this press release speak only as of the date the statements were made, and OPKO
and TESARO do not undertake any obligation to update forward-looking statements.
The Companies’ intend that all forward-looking statements be subject to the
safe-harbor provisions of the PSLRA.
###

 

--------------------------------------------------------------------------------

 

Exhibit F
Material Agreements
Asset Purchase Agreement, dated October 12,2009, by and among Schering
Corporation and OPKO Health, Inc., as amended by letter agreement dated June 29,
2010
Clinical Research Services Agreement, dated October 7,2010, by and among OPKO
Health, Inc. and ****.
Clinical Research Services Agreement, dated October 7, 2010, by and among OPKO
Health, Inc. and ****.
Clinical Research Services Agreement, dated October 7, 2010, by and among OPKO
Health, Inc. and ****.
****
Cost Proposal Regarding Retention of Radiolabeled and Stable Isotope Labeled
Test Articles, dated June 7, 2010, by and among OPKO Health, Inc. and ****.
Consulting Agreement, dated October 9, 2009, as amended on October 15,2010, by
and among OPKO Health, Inc. and ****.
Consulting Agreement, dated October 9,2009, as amended on October 15,2010, by
and among OPKO Health, Inc. and ****.
Consulting Agreement, dated November 30,2009, by and among OPKO Health, Inc. and
****.
Consulting Agreement, dated February 11,2010, by and among OPKO Health, Inc. and
****.
Consulting Agreement, dated September 15,2010, by and among OPKO Health, Inc.
and ****.
Consulting Agreement, dated October 11, 2010, by and among OPKO Health, Inc. and
****.