This Development and License Agreement (this “Agreement”) is entered into and effective as of the 8th day of May, 2016 (the “Effective Date”), by and between EirGen Pharma Limited, an entity formed under the laws of Ireland with registered seat at Westside Business, Old Kilmeaden, Waterford, Ireland (“OPKO”), and Vifor Fresenius Medical Care Renal Pharma Ltd, a corporation formed under the laws of Switzerland with registered seat at Rechenstrasse 37, 9014 St. Gallen, Switzerland (“VF”), for the development and marketing of OPKO’s Product in the Territory (as such terms are defined below).

1.Definitions

1.1    “Accounting Standards” means generally accepted accounting standards in the United States and International Financial Reporting Standards as adopted in Switzerland, in each case as applicable and consistently applied by the relevant Person.

1.2    “Additional Indication” shall mean an indication set forth in or proposed to be set forth in the label for the Product for the prevention or treatment of diseases other than or in addition to the Initial Indication, including without limitation the use of the Product in combination with any other active ingredient.

1.3    “Adverse Event(s)” shall mean those events as defined by the FDA and published in the U. S. Code of Federal Regulations, as amended from time to time and published in the Federal Register, or by the EMA or any similar definitions under laws of other jurisdictions within the Territory relating to adverse drug experiences relating to the use of the Product in the Territory.

1.4    “Affiliate” shall mean any Person that directly or indirectly owns, is owned by or is under common ownership with a Party to the extent of at least 50% of the equity or other ownership interest having the power to vote on or direct the affairs of the Person actually controlled by, controlling or under common control with a Party.

1.5    “Agreement Year” shall mean each twelve month period ending on December 31 during the Term.

1.6    “Applicable Law” means any law (including common law), statute, rule, regulation, order, judgment, or ordinance of any Governmental Authority, including those concerning environmental, health, and safety matters.

1.7    “Bioequivalent” means, inside the United States, "therapeutically equivalent" as evaluated by the FDA, applying the definition of "therapeutically equivalent" set forth in the preface to the then-current edition of the FDA publication "Approved Drug Products With Therapeutic Equivalence Evaluations" and, outside the United States, such equivalent determination by the applicable Regulatory Authorities as is necessary to permit pharmacists or other individuals authorized to dispense pharmaceuticals under Applicable Law to substitute one product for another product in the absence of specific instruction from a physician or other authorized prescriber under Applicable Law.

1.8    “Business Day” shall mean a day on which commercial banks are open for business in New York City and Zurich, Switzerland. References in this Agreement to “days” other than Business Days shall mean calendar days.

1.9    “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.

1.10    “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party with respect to any objective, those reasonable and good faith efforts and resources to accomplish such objective as a similarly-situated company within the pharmaceutical industry would normally use to accomplish a similar objective under similar circumstances, in each case taking into account all Relevant Factors in effect at the time such efforts are to be expended. With respect to any efforts relating to the development, Regulatory Approval and/or commercialization of a Product, generally in the Territory, such Party will be deemed to have exercised Commercially Reasonable Efforts if such Party has exercised those efforts normally used by a similarly-situated company within the pharmaceutical industry, in the relevant country, with respect to a compound, product or product candidate which is of [***], in each case taking into account all Relevant Factors in effect at the time such efforts are to be expended. [***].

1.11    “Competitive Product” means any product that: (a) is marketed in a country or region in the Territory by one or more Persons that is not VF, an Affiliate of VF, a Sublicensee, Fresenius or any Affiliate of Fresenius; (b) [***].

1.12    “Cover(ed)” means, with respect to any Patent and the subject matter at issue, that, but for a license granted under such Patent, the manufacture, development, use, sale, offer for sale or importation of the subject matter at issue would infringe such Patent, or in the case of a Patent that is a patent application, would infringe such patent application if it were to issue as a patent.

1.13    “Drug Approval Application” shall mean an application for marketing authorization or clearance required to be approved before commercial sale or use of a Product as a drug in a regulatory jurisdiction (i.e. NDA, MAA or equivalent).

1.14    “Effective Date” shall have the meaning set forth in the first paragraph of this Agreement.

1.15    “EMA” shall mean the European Medicines Agency, or any successor agency.

1.16    “Europe” shall mean the countries which are members of the European Union, as such membership may change from time to time.

1.17    “FDA” shall mean the United States Food and Drug Administration and any successor agency thereto.

1.18    “Field” shall mean all therapeutic and prophylactic uses of the Product in humans except for any Additional Indications that are excluded from the Field in accordance with Section 4.1.

1.19    “Fresenius” means Fresenius Medical Care AG & Co KGaA, a partnership organized and existing under the laws of Germany with an interest in VF as of the Effective Date of forty-five percent (45%). For purposes of this Agreement, Fresenius is not an Affiliate of VF.

1.20    “Galenica” shall mean Galenica AG with its registered seat at Untermattweg 8, 3000 Bern, Switzerland. As of the Effective Date, Galenica holds a fifty-five percent (55%) ownership interest in VF.

1.21    “Good Clinical Practices” or “GCP” means all applicable good clinical practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable, (a) the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other applicable guidelines for good clinical practice for clinical trials on medicinal products; (b) the Declaration of Helsinki (2004), as last amended at the 52nd World Medical Association General Assembly in October 2000, and any further amendments or clarifications thereto; and (c) the equivalent Applicable Laws in any relevant country, each as may be amended and applicable from time to time and, in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

1.22    “Governmental Authority” means any court, agency, department, authority or other instrumentality of any national, state, county, city or other political subdivision.

1.23    “Government Official” means (a) any elected or appointed government official (e.g., a member of a ministry of health), (b) any employee or Person acting for or on behalf

1.24    “HD Trial” shall mean the phase 3 clinical trial contemplated by the Development Plan for treatment of secondary hyperparathyroidism in dialysis (HD) chronic kidney disease (CKD) patients.

1.25    “Initial Indication” shall mean the use of the Product for the treatment or prevention of secondary hyperparathyroidism related to patients with chronic kidney disease and vitamin D insufficiency/deficiency (or if broader, as such may be defined by the wording of the label approved by Regulatory Authorities in the Territory for the Product).

1.26    “Major Country” shall mean any of [***].

1.27    “Marketing Material” shall mean the written, printed, electronic or graphic materials related to strategy, communications and programs associated with the marketing or promotion of the Product, including such strategy, communications, programs and any promotional and marketing materials that (a) specifically identify or describe the Product or (b) otherwise support the Product or raise awareness of the Product.

1.28    “Net Sales” shall mean, on a country-by-country basis, the gross amounts invoiced by VF and its Affiliates and any Sublicensees for sales of Product in a particular country to Third Parties in the Territory during the Royalty Term, in each case, to the extent related to the Product and recognized and allowed in accordance with the Accounting Standards, less the following deductions:

If a Product is sold in combination (“Combination Product”) with another product (as a separate dosage form) or device having an independent or supplementary therapeutic effect, diagnostic utility or device (a “Supplemental Component”), then “Net Sales,” for purposes of determining royalty payments on the Combination Product, shall be calculated using one of the methods listed below and then deducting the amounts listed in Sections 1.28(a) through (e) above to the extent not previously deducted.

1.29    “New Drug Approval” shall mean an approval by a Governmental Authority of a Drug Approval Application.

1.30    “OPKO Technology” shall mean all present and future information developed solely by OPKO or its Affiliates, or owned or controlled by OPKO or its Affiliates, whether or not in written form, that is not in the public domain and that relates to the Product and shall include, without limitation, all biological, chemical, pharmacological, toxicological, medical or clinical, analytical, quality, manufacturing, research, or sales and marketing information including all processes, methods, procedures, techniques, plans, programs, and data stored or maintained in any form, including electronic, and any other information relating to the Product or useful for the development or commercialization of the Product in the Territory.

1.31    “OPKO Trademark(s)” shall mean Rayaldee^TM, a trademark owned or controlled by OPKO in the Territory, and any other trademark, service mark or logo developed, applied for, registered, or to be applied for or registered by OPKO or its Affiliates for use in connection with the sale of the Product in the Territory.

1.32    “Party(ies)” shall mean each of OPKO and VF.

1.33    “Patents” shall mean all patents and patent applications in the Territory that are or become owned or controlled by OPKO or its Affiliates, or to which OPKO or its Affiliates otherwise has, now or in the future, the right to grant licenses and license rights or sublicense rights, that Cover the Product or a use or a formulation of the Product. Included within the definition of Patents are all continuations, continuations‑in‑part, divisionals, patents of addition, reissues, renewals or extensions thereof, and patent term extensions, supplementary protection certificates and pediatric extensions. The current list of patents and patent applications included in the OPKO Patents is set forth in Appendix A attached hereto.

1.34    “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision or department or agency of a government.

1.35    “Product” shall mean a modified release product containing calcifediol (25-hydroxyvitamin D₃) and/or calcifediol monohydrate as an active pharmaceutical ingredient.

1.36    “Product First Commercial Sale” shall mean, after all necessary Regulatory Approvals, including pricing and reimbursement approvals, by the appropriate Regulatory Authority(ies), on a country-by-country basis, the first sale of Product Covered by a Valid Claim in a particular country in the Territory by VF, any of its Affiliates, or any permitted Sublicensee to a Third Party for end use or consumption of such Product. A Product First Commercial Sale excludes any sale or other distribution for clinical and pre-clinical research and trials, promotional samples, compassionate sales or use, indigent programs, or on a named patient basis.

1.37    “Quality Agreement” shall mean the quality control and assurance agreement to be mutually agreed upon by the Parties as set forth in Section 10.2.

1.38    “Regulatory Approval” shall mean any approvals, product and/or establishment licenses, registrations, permits, or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity or Regulatory Authority, necessary for the manufacture, distribution, use, storage, importation, export, transport and sale of the Product in a regulatory jurisdiction.

1.39    “Regulatory Authority” shall mean any national, supra-national (e.g., the European Commission, the Council of the European Union, or the EMA), regional, state or local regulatory agency, department, bureau or other governmental entity in the Territory responsible for issuing any technical, medical and scientific licenses, registrations, authorizations and/or approvals of the Product including any marketing authorizations based upon such approvals and pricing, third party reimbursement or labeling approvals that are necessary for the manufacture, distribution, use, storage, importation, export, transport and sale of the Product in a regulatory jurisdiction.

1.40    “Relevant Factors” means all relevant factors that may affect the development, Regulatory Approval or commercialization of a Product, including (as applicable): actual and potential issues of safety, efficacy or stability; product profile (including product modality, category and mechanism of action); stage of development or life cycle status; actual and projected development, Regulatory Approval, manufacturing, and commercialization costs; any issues regarding the ability to manufacture or have manufactured any Product; the likelihood of obtaining Regulatory Approvals; the timing of such approvals; the current guidance and requirements for Regulatory Approval for the Product and similar products and the current and projected regulatory status; labeling or anticipated labeling; the then-current competitive environment and the likely competitive environment at the time of projected entry into the market and thereafter; past performance of the Product or similar products; present and future market potential; existing or projected pricing, sales, reimbursement and profitability; pricing or reimbursement changes in relevant countries; proprietary position, strength and duration of patent protection and anticipated exclusivity; the commercialization by VF after expiration of the Royalty Term of both the Product that uses the OPKO Trademarks and a generic Product; and other relevant scientific, technical, operational and commercial factors.

1.41    “Sublicensee” means a Third Party who has been granted a sublicense as permitted under Section 2.2 of this Agreement.

1.42    “Term” shall have the meaning set forth in Article 3.

1.43    “Territory” shall mean worldwide, except the Territory shall not include (i) the U.S., (ii) any country in Central America or South America (excluding Mexico), (iii) Russia, (iv) China, (v) Japan, (vi) Ukraine, (vii) Belorussia, (viii) Azerbaijan, (ix) Kazakhstan, and (x) Taiwan.

1.44    “Third Party(ies)” shall mean any Person other than OPKO and VF or their Affiliates.

1.45    “Third Party Payments” shall mean all upfront payments, milestone payments, license fees, royalties or other payments paid or payable to any Third Party under any agreement with a Third Party.

1.46    “U.S.” shall mean the United States of America, its territories and possessions, including without limitation the Commonwealth of Puerto Rico.

1.47    “Valid Claim” means a claim of (a) an issued and unexpired patent included in the Patents that has not been (i) held unpatentable or unenforceable by a final decision of a court or other governmental body of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and (ii) abandoned or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise, or (b) a pending patent application included in the Patents that has been pending for no longer than [***] from the publication date for the particular patent application, that continues to be actively prosecuted in good faith unless and until such claim has been granted. For clarity, any pending claim in an application in any country that has not been granted within [***] from the publication date shall not be included as a Valid Claim until such claim is granted. A claim of a Patent or patent application having a priority date following the Effective Date of this Agreement, to the extent that the claim solely claims an alternate manufacturing process to produce the Bulk Product, including any of its components, shall not be included as a “Valid Claim”; provided that [***].

2.1    Patents and OPKO Technology.

2.2    Subcontracting and Sublicensing.

2.3    Ex-Territory and Ex-Field Activities.

(a)    VF hereby covenants and agrees that, on a country-by-country basis during the Royalty Term, it shall not (and shall cause its Affiliates, Sublicensees and subcontractors not to), either itself or through a Third Party, market, promote or actively offer for sale the Product outside the Field in the Territory in such country or outside of the Territory in or outside of the Field. Without limiting the generality of the foregoing, with respect to countries outside of the Territory, VF shall not (a) engage in any advertising activities relating to the Product directed solely to customers outside the Territory (e.g., participation in conferences, congresses or scientific or medical meetings held throughout the world), or (b) solicit orders from any prospective purchaser located outside the Territory. To the extent permitted by Applicable Law, including applicable antitrust laws, if VF receives any order from a prospective purchaser located in a country outside of the Territory, VF shall immediately refer that order to OPKO and shall not accept any such order or deliver or tender (or cause to be delivered or tendered) any Product under such order. If VF should reasonably know that a customer or distributor is engaged itself or through a Third Party in the sale or distribution of the Product outside of the Territory or outside the Field within the Territory, then VF shall (a) within five (5) Business Days of gaining knowledge of such activities notify OPKO

3.1    Term.

The term of this Agreement shall commence on the Effective Date and shall continue with respect to the Product in each country of the Territory, on a country by country basis, until the date on which VF shall have no further payment obligations to OPKO under the terms of this Agreement, unless earlier terminated pursuant to Section 16.1 or Article 18 (the “Term”).

3.2    Expiration.

4.1    Additional Indications.

5.1    Up-front Payment.

5.2    Milestone Payments.

Milestone    Milestone Payment

First New Drug Approval in [***] for the

[***] patients with vitamin D insufficiency    [***]

First New Drug Approval in [***] for the

[***] patients with vitamin D insufficiency    [***]

First New Drug Approval in [***] for the

[***] patients with vitamin D insufficiency    [***]

First New Drug Approval in [***] for the

[***] patients with vitamin D insufficiency    [***]

First New Drug Approval in [***] for the

[***] patients with vitamin D insufficiency    [***]

First New Drug Approval in [***] for the

[***] patients with vitamin D insufficiency    [***]

Product First Commercial Sale in the Territory    [***]

in the Territory exceed [***]

in an Agreement Year    [***]

in the Territory exceed [***]

in an Agreement Year    [***]

in the Territory exceed [***] in an

Agreement Year    [***]

5.3    Royalty Payments.

During each Agreement Year, VF shall pay to OPKO royalty payments (the “Royalty Payments”) on a [***] basis in an amount equal to the aggregate annual Net Sales of the Product within the Territory multiplied by the Applicable Percentage, as may be adjusted as set forth in this Agreement. The “Applicable Percentage” shall be as follows:

Aggregate Net Sales        Applicable Percentage

5.4    Minimum Royalty.

Beginning on the first day of the first Calendar Quarter after the Product First Commercial Sale, for the periods set forth in the table below, VF shall be obligated to pay OPKO a minimum royalty (the “Minimum Royalty”) to the extent the aggregate Royalty Payments due for the applicable period are below the following amounts:

Period    Minimum Royalty

5.5    Royalty Term.

The Royalty Payments due under Section 5.3, will be determined on a country by country basis beginning from the Product First Commercial Sale in a country only until the later of (a) expiration of the last to expire Valid Claim Covering the Product sold in such country, (b) expiration of all regulatory and data exclusivity applicable to the Product in the country of sale, and (c) ten (10) years after the Product First Commercial Sale in such country (with respect to each country in the Territory, the “Royalty Term”).

5.6    Competitive Products.

5.7    Third Party Payments.

5.8    Late Payments.

5.9    Reports and Timing of Payments.

5.10    Taxes.

5.11    Currency Exchange.

If any Product sold by VF under this Agreement is invoiced in a currency other than U.S. Dollars, all royalty payments by VF to OPKO shall be converted into U.S. Dollars at the average rate of exchange for the Calendar Quarter for which payments are being remitted based on the middle market spot rate therefore published in The Wall Street Journal (U.S. Edition).

6.1    Development Responsibilities.

6.2    Funding of Product Development.

6.3    Publications.

6.4    Access to Data and Information.

6.5    Development Plan.

(a)    The development of the Product shall be governed by a plan setting forth the proposed overall program of development of the Product and the respective development responsibilities of the Parties with respect to such program (the “Development Plan”), as it may be amended from time to time in accordance with this Agreement. The initial Development Plan is

attached hereto as Exhibit A and shall cover the development plan for the Product for the Initial Indication. To the extent any terms or conditions of the Development Plan expressly conflict with the terms or conditions of this Agreement, the terms and provisions of this Agreement shall control.

7.1    New Drug Approval Applications.

7.2    Reference to Regulatory Filings.

7.3    Cooperation.

7.4    No Third Party Rights.

During the Term and except as provided in Sections 2.2 and 18.1, VF shall not assign, license or grant any rights in or to any rights or obligations under this Agreement (including, without limitation, terms relating to confidentiality, intellectual property, non-competition) or to the Drug Approval Applications that are held by VF pursuant to this Agreement to any Third Party that is not an Affiliate or Sublicensee of VF, or Fresenius or an Affiliate of Fresenius identified on Exhibit 2.2(b), without the prior written consent of OPKO, which will not be unreasonably withheld. Any such assignment, license or grant of rights to an Affiliate or Sublicensee of VF, or Fresenius or an Affiliate of Fresenius identified on Exhibit 2.2(b) shall be made only pursuant to a written agreement that is entered into in compliance with all of the material terms of this Agreement and that specifically requires such Person’s compliance with all material rights and obligations under this Agreement (including, without limitation, terms relating to confidentiality, intellectual property, non-competition).

7.5    Clinical Trial Registries.

(a)    From and after the Effective Date, VF will be responsible, in consultation with the JDC, for registering, maintaining and updating any registries pertaining to any trial for the Product conducted pursuant to this Agreement to the extent required by any Applicable Laws (collectively, the “Clinical Trial Registries”) in all countries in the Territory.

8.1    VF Efforts.

8.2    Promotional Activities.

(c)    VF shall use Commercially Reasonable Efforts to commercialize the Product in the Field in the Territory under an OPKO Trademark and under the trade dress or such other trademark or trade dress as mutually agreed by the Parties, including, if applicable, any alternative trademark and any alternative trade dress (the “Product Trade Dress”, respectively). Notwithstanding the foregoing, in the event that VF believes that the use or registration of any OPKO Trademark or the use of the Product Trade Dress in a particular country in the Territory would be inappropriate due to such country’s linguistic or cultural particularities or against the Applicable Laws of such country, or is rejected by local Regulatory Authorities, or in conflict with any Third Party’s intellectual property rights in that country, based on a review of market research, regulatory research, legal searches, investigation results, and any other relevant information that may have been collected by either Party that is relevant to the clearance for use and registration of a trademark or for use and registration of a trade dress (it being understood that there is no obligation for either Party to perform any such review or research), VF shall present such concern to OPKO, and the Parties shall agree on an alternative trademark and trade dress for use and registration, as

(d)    Global Branding Strategy. Subject to Section 9.2(b)(vi), OPKO shall have the right, from time to time during the Term, to implement (and thereafter modify and update) a global branding strategy, including global messaging, for the Product for use in the Field throughout the world (the “Global Branding Strategy”). The Parties intend to collaborate in developing and updating the Global Branding Strategy. To the extent OPKO determines to utilize such Global Branding Strategy, VF shall adhere to the Global Branding Strategy in its commercialization of the Product, including with respect to any newly designed promotional materials; provided, that, in the event that VF believes that the application of the Global Branding Strategy in a particular country or a region in the Territory would be inappropriate whether because of such country’s linguistic or cultural particularities, competitive environment, clinical practices, because it is against the Applicable Laws of such country or because VF reasonably determines it would be inconsistent with VF’s obligation to use Commercially Reasonable Efforts to commercialize the Territory, VF shall present such concern to OPKO, and the Parties shall discuss whether appropriate revisions to the Global Branding Strategy may make it appropriate for use in such country. If the the Parties do not reach consensus on the application of the Global Branding Strategy, [***]; provided, however, that the matter may be referred by either Party for resolution as provided under Section 21.3 and both Parties shall abide by such resolution.

8.3    Identification of OPKO.

8.4    Product Pricing.

9.1    Joint Development Committee and Joint Steering Committee.

(a)    Within [***] days following the date of this Agreement, the Parties shall form: (a) a joint steering committee (the “JSC”) with responsibility for the overall coordination and oversight of activities under this Agreement and the Supply Agreement and (b) a specialized joint committee focusing on development and Regulatory Approval of Products (the “JDC”). The JSC and JDC shall have the responsibilities and authority allocated to it in this Article 9 and elsewhere in this Agreement. The JSC and JDC may be referred to separately as a “Committee” and jointly as the “Committees”.

(c)    Each Party’s designees on a Committee shall, collectively, have [***] vote (the “Party Vote”) on all matters brought before the Committee, which Party Vote shall be determined by consensus of such Party’s designees present (in person or otherwise) at the meeting. Except as expressly provided in this Section 9.1(c), each Committee shall operate as to matters within its jurisdiction by [***] Party Vote. Any disagreement between the representatives of the Parties on the JDC as to matters within the JDC’s jurisdiction shall be submitted for discussion and resolution by the JSC. Except as otherwise required by this Agreement, any disagreement between the representatives of the Parties on the JSC as to matters within the JSC’s jurisdiction shall be submitted for discussion and resolution in accordance with Article 21 and any disagreement with respect to matters set forth in Sections [***] shall be resolved as provided under Section 21.3. Notwithstanding the foregoing, any decisions to amend the [***] (for clarity, if the JSC does not reach consensus, the matter will be resolved as provided under Section 21.3).

9.2    Joint Steering Committee.

9.3    Committee Meetings.

9.4    Responsibilities of JDC.

9.5    Alliance Managers.

under this Agreement (each, an “Alliance Manager”). Each Party may change its designated Alliance Manager from time to time upon written notice to the other Party. Any Alliance Manager may designate a substitute to temporarily perform the functions of that Alliance Manager by written notice to the other Party.

10.1    OPKO Manufacturing and Supply Responsibilities.

Subject to Section 10.2, OPKO will supply, directly or through a Third Party, bulk capsules of Product (“Bulk Product”) to support the development, sale and commercialization of the Product in the Territory, unless and until VF, VF’s Affiliates, or any of its Third Party contract manufacturers is qualified as an additional qualified manufacturer for the Territory. The binding terms and conditions for the commercial manufacture and supply of Bulk Product shall be set forth in a Manufacturing and Supply Agreement to be entered into as set forth in Section 10.2 (the “Supply Agreement”).

10.2    Manufacturing and Supply Agreement for Commercial Supply of Products.

The Parties shall agree in good faith to execute a mutually satisfactory Supply Agreement containing the terms set forth on Exhibit 10.2 for OPKO’s supply of Bulk Product. The Supply Agreement shall provide that the Parties will discuss and cooperate to [***] of Bulk Product for supply thereof for the Territory within a specified time period following the effective date of the Supply Agreement (which may include OPKO, itself or through a Third Party contractor, or VF or its Affiliates). The Parties shall also enter into a Quality Agreement within [***] days after the Effective Date. The

Supply Agreement shall contain terms and conditions set forth in Exhibit 10.2 and other terms and conditions typically contained in agreements governing the commercial manufacture of similar products for similar purposes at similar volumes.

10.3    Clarification.

11.1    Reporting.

11.2    Adverse Events.

11.3    Medical Inquiries.

11.4    Recall, Withdrawal, or Market Notification of Product.

12.1    Audit Rights.

13.1    Ownership of Intellectual Property.

(a)    OPKO shall have and retain sole and exclusive right, title and interest in and to any and all OPKO Technology and all intangible property rights, including, without limitation, any and all inventions, discoveries, writings, trade secrets, methods, practices, procedures, engineering information, designs, devices, improvements, manufacturing information and other technology, including any derivatives of any of the foregoing, whether or not patentable or copyrightable, and any patent applications, patents, or copyrights based therein, thereon and therefrom (“Inventions”) that are made, discovered, conceived, reduced to practice or generated by OPKO (or its employees or representatives), solely or with a Third Party, in connection with any activity carried out pursuant to this Agreement and that is related to the Product (“OPKO Inventions”) and all rights, titles and interests with respect to the OPKO Trademarks and Patents.

or Sublicensees (or their respective employees or representatives), with or without a Third Party (“Joint Inventions”).

(c)    VF shall own the right, title and interest in and to all Inventions made, discovered, conceived, reduced to practice or generated solely by VF, or its Affiliates or Sublicensees (or their respective employees or representatives), with or without a Third Party (“VF Inventions”).

13.2    Product Inventions.

(a)    Notwithstanding the terms of Section 13.1, any Joint Inventions or VF Inventions in connection with the Product directly relating to (i) [***], (ii) [***], (iii) [***], (iv) [***] (collectively, [***], the "Product Inventions"), each shall be the exclusive property of OPKO and the corresponding intellectual property rights shall be owned by OPKO. For the avoidance of doubt, Product Inventions will be included in the OPKO Technology and any resulting patents or patent applications will be included in the OPKO Patents; provided however, that [***]. VF hereby assigns such Product Inventions to OPKO. The provisions of this Section 13.2 shall not apply to any [***]. Any such Inventions will be considered Joint Inventions under this Agreement. As a result, each Party will be free to commercialize their own products using such Joint Inventions without interference from, accounting to or paying a royalty to the other Party with respect to such Joint Inventions; provided however, that [***] and that nothing in this Section 13.2 shall relieve either Party of its obligations under this Agreement with respect to Products (including VF’s royalty obligations hereunder with respect to Products, except as provided in the second sentence of this Section 13.7).

13.3    Patent Prosecution.

13.4    Notification of Patent Litigation.

(b)    If an action, claim, demand, suit, or proceeding (a “Claim”) alleging infringement involving the manufacture, use, sale, license or marketing of the Product anywhere in the Territory is commenced against either Party or their Affiliates, licensees or Sublicensees, then the Parties [***]. [***] Business Days, and [***] to continue such defense at its own expense, except for the expenses for which [***] is to indemnify [***] pursuant this Agreement or pursuant to OPKO’s indemnification obligations set forth in the Supply Agreement related to manufacturing. In that case, OPKO shall cooperate with VF and provide any documentation or other assistance reasonably requested by VF at OPKO’s expense.

13.5    Patent Infringement.

13.6    Title to Trademarks.

13.7    Trademark License.

13.8    Maintenance of Trademarks.

13.9    Notification of Trademark Litigation.

13.10    Trademark Infringement.

13.11    Information and Settlements.

13.12    Employees.

13.13    Third Party Licenses.

(a)    If Third Party patent applications or patents are identified by either Party [***], and the Parties [***] under such identified Third Party patent applications or patents (for patent applications, assuming pending claims therein had issued) for the development, manufacture or commercialization of the Product in the Field in the Territory (“Relevant Patents”), [***] to obtain a license to such Relevant Patents, with the right to sublicense, in order to permit [***] to conduct their obligations and exercise their rights under this Agreement. The Parties will consult with each other with respect to the negotiation and the final form of such terms and conditions and discuss [***] upon which such Parties [***] to obtain the license.

14.1    Disclosure of OPKO Technology.

14.2    Confidential Information.

14.3    Public Announcements.

15.1    Non-solicitation.

15.2    Non-competition.

16.1    Early Termination.

16.2    Continuing Obligations.

16.3    Remedies.

16.4    Effects of Termination.

17.1    Mutual Representations and Warranties.

17.2    Representations and Warranties of OPKO.

Except as disclosed on Schedule 17.2, OPKO represents and warrants to VF that:

17.3    Representations and Warranties of VF.

17.4    Compliance with Law and Ethical Business Practices.

17.5    Indemnification by OPKO.

OPKO shall defend, indemnify and hold harmless VF and its Affiliates and their officers, directors, shareholders, employees, agents, representatives, successors and assigns from and against all claims, complaints, or lawsuits for damages (collectively referred to as “Claims”) arising out of (i) any negligent act or omission, or willful wrongdoing by OPKO, its Affiliates or representatives in the performance of this Agreement, (ii) the failure by OPKO, its Affiliates or representatives to comply with any Applicable Law, (iii) the infringement or misappropriation by OPKO of any patent, copyright, trademark, or service mark, as a result of OPKO’s marketing or promotion of the Product in the Territory which is not pursuant to the terms of this Agreement or in conformity with the direction of the JDC, (iv) any breach of any representation or warranty or covenant of OPKO, and (v) the sale of the Product outside the Territory by OPKO, its Affiliates or its licensees/sublicensees. OPKO shall not be obligated under this Section to the extent that the Claim was the result of the non-performance, negligence or willful misconduct of any employee or agent of VF or anyone acting on behalf of VF, including its Affiliates and their officers, directors, shareholders, employees, agents, representatives, successors and assigns.

17.6    Indemnification by VF.

17.7    Limitations on Indemnification.

The obligations to indemnify, defend, and hold harmless set forth in Sections 17.5 and 17.6 shall be contingent upon the Party seeking indemnification (the “Indemnitee”): (i) notifying the indemnifying Party of a claim, demand or suit within [***] Business Days of receipt of same; provided, however, that Indemnitee’s failure or delay in providing such notice shall not relieve the indemnifying Party of its indemnification obligation except to the extent the indemnifying Party is materially prejudiced thereby; (ii) allowing the indemnifying Party and/or its insurers the right to assume direction and control of the defense of any such claim, demand or suit; (iii) using its Commercially Reasonable Efforts to cooperate with the indemnifying Party and/or its insurers in the defense of such claim, demand or suit; and (iv) agreeing not to settle or compromise any claim, demand or suit without prior written authorization of the indemnifying Party. The Indemnitee shall have the right to participate in the defense of any such claim, demand or suit referred to in this Section utilizing attorneys of its choice, at its own expense, provided, however, that the indemnifying Party shall have full authority and control to handle any such claim, demand or suit.

17.8    Insurance.

17.9    Limitation of Liability.

18.1    Assignment.

Neither Party shall assign or transfer its rights or obligations under this Agreement without the prior written consent of the other Party, except to (a) any of its respective Affiliates or (b) to a Third Party successor or purchaser of all or substantially all of its business or assets to which this Agreement relates, whether in merger, sale of stock, sale of assets or similar transaction. In the event of a Change of Control of VF, OPKO shall have the right to terminate this Agreement [***]; provided, however, that the matter will be resolved as provided under Section 21.3 in the event of dispute. For the avoidance of doubt, OPKO shall have [***] in the event of a [***] so long as such restructuring does not result in the effective sale or transfer, directly or indirectly, of this Agreement to a Third Party. A “Change of Control” shall mean if: (i) any Person acquires directly or indirectly the beneficial ownership of any voting security of a Party and immediately after such acquisition such Person is, directly or indirectly, the beneficial owner of voting securities representing 50% or more of the total voting power of all of the then-outstanding voting securities of such Party; (ii) the stockholders or equity holders of a Party shall approve a merger, consolidation, recapitalization, or reorganization of such Party, a reverse stock split of outstanding voting securities, or consummation of any such transaction if stockholder or equity holder approval is not obtained, other than any such transaction which would result in stockholders of equity holders of such Party immediately prior to such transaction owning at least 80% of the outstanding securities of the surviving entity in such transaction immediately following such transaction, with the voting power of each such continuing holder relative to other such continuing holders not substantially altered in the transaction; or (iii) the stockholders or equity holders of a Party shall approve a plan of complete liquidation of the Party or an agreement for the sale or disposition by the Party of all or a substantial portion of the Party’s assets.

19.1    Notices.

20.1    Force Majeure.

20.2    No Partnership or Joint Venture.

20.3    Execution In Counterparts.

20.4    Governing Law.

20.5    Waiver Of Breach.

20.6    Severability.

20.7    Entire Agreement.

20.8    Currency.

20.9    Form of Payments.

20.10    Good Faith.

21.1    Internal Resolution.

Any dispute, controversy or claim arising out of or relating to a breach or alleged breach of this Agreement, excluding termination, (collectively referred to as “Dispute”) shall be attempted to be settled by the Parties, in good faith, by submitting each such Dispute to the designated senior management representatives of each Party, who shall meet within [***] Business Days as reasonably requested by either Party to review any Dispute. If the Dispute is not resolved by the designated representatives by mutual agreement within [***] Business Days after a meeting to discuss the Dispute, either Party may at any time thereafter provide the other written notice specifying the terms of such Dispute in reasonable detail. Within [***] Business Days of receipt of such notice, the chief executive officer (or other top executive officer with authority to resolve the dispute) of each Party shall meet at a mutually agreed upon time and location for the purpose of resolving such Dispute. They will discuss the problems and/or negotiate for a period of up to [***] Business Days in an effort to resolve the Dispute or negotiate an acceptable interpretation or revision of the applicable portion of this Agreement mutually agreeable to both Parties, without the necessity of formal procedures relating thereto. Except as set forth in Section 21.3 and Section 9.1(c), any

21.2    Arbitration.

21.3    Expert Arbitrator if no JSC Consensus on Certain Matters.

may ask the American Arbitration Association to promptly appoint the expert on behalf of the Parties) (the “Expert Arbitrator”). Both Parties shall submit their respective proposals with respect to such matter to the Expert Arbitrator within [***] Business Days of learning of such Expert Arbitrator’s appointment, either through agreement of the Parties or by the American Arbitration Association. If a Party fails to submit a proposal within such timeframe, then the proposal of the submitting Party shall prevail.

22.1    Performance.

By:/s/ Patsy Carney                    

By:/s/ Chris Springer                    

By:/s/ Stefan Schulze                    

As an inducement to Vifor Fresenius Medical Care Renal Pharma Ltd (“VF”) to enter the foregoing Agreement (this “Agreement”) with EirGen Pharma Limited (“OPKO”), OPKO Health, Inc., a Delaware corporation (“Guarantor”), hereby irrevocably and unconditionally guarantees payment (including amounts that would become due but for the operation of the automatic stay under Section 362(a) of the United States Bankruptcy Code) and performance obligations of OPKO to VF under this Agreement and each of the documents contemplated hereunder, subject to any and all rights and defenses that OPKO has or may have under the terms of this Agreement or such document. Guarantor is a party to this Agreement solely for purposes of this guaranty. Guarantor understands that this guaranty is continuing in nature and extends to future obligations of OPKO to VF related to this Agreement and each of the documents contemplated hereunder.

(a)Guarantor is a corporation duly organized, validly existing and in good standing under the laws of Delaware and Guarantor has all requisite power and authority to execute, deliver and perform this guaranty.

(b)The execution, delivery and performance by Guarantor of this guaranty have been duly authorized by all necessary corporate action and do not and will not contravene its certificate or organizational documents.

(c)The execution, delivery and performance by Guarantor of this guaranty do not and will not contravene any law or governmental regulation or any contractual restriction binding on or affecting Guarantor or any of its affiliates.

(d)No authorization or approval or other action by, and no notice to or filing with, any governmental authority or other regulatory body or third party is required for the due execution, delivery and performance by Guarantor of this guaranty.

(e)This guaranty is a legal, valid and binding obligation of Guarantor, enforceable against Guarantor in accordance with its terms except as limited by bankruptcy, insolvency or similar laws of general application relating to the enforcement of creditors’ rights.

(f)There is no action, suit or proceeding pending or, to the knowledge of Guarantor, threatened against or otherwise affecting Guarantor before any court, arbitrator or governmental department, commission, board, bureau, agency or instrumentality that may materially and adversely affect Guarantor’s financial condition or its ability to perform its obligations hereunder.

(g)The direct or indirect value of the consideration received and to be received by Guarantor in connection herewith is reasonably worth at least as much as the liability and obligations of Guarantor hereunder, and the incurrence of such liability and obligations in return for such consideration may reasonably be expected to benefit Guarantor, directly or indirectly.

By:/s/ Kate Inman