Portions of this exhibit, indicated by [***], have been omitted in accordance with Item 601(b)(10) (iv) of Regulation S-K. The omitted information is (i) not material and (ii) treated by the
Registrant as private or confidential.
Portions of this exhibit have been omitted in accordance with Item 601(a)(5) of Regulation S-K.
The Registrant undertakes to furnish a copy of all omitted information, schedules, and exhibits to the U.S. Securities and Exchange Commission upon its request.
Execution Version
Confidential
Research Collaboration and License Agreement
This Agreement is entered into with effect as of the Effective Date (as defined below)
by and between
F. Hoffmann-La Roche Ltd
with an office and place of business at [***] (“Roche Basel”)
and
Hoffmann-La Roche Inc.
with an office and place of business at [***] (“Roche US”; Roche Basel and Roche US together referred to as “Roche”) on the one hand
and
Remix Therapeutics, Inc.
with an office and place of business at [***] (“Remix”) on the other hand.
Table of Contents
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1.
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Definitions
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3
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|
2.
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Grant of License
|
20
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3.
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Exclusivity
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21
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4.
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Research Collaboration
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22
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5.
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Diligence
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31
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6.
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Governance
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31
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7.
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Development, Regulatory Affairs, Manufacturing and Commercialization
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35
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8.
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Data Privacy
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35
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9.
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Payment
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35
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10.
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Accounting and Reporting
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40
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11.
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Taxes
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41
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12.
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Auditing
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42
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13.
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Intellectual Property
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43
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14.
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Remix Representations and Warranties
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50
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15.
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Roche Representations and Warranties
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52
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16.
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Indemnification
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53
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17.
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Limitation of Liability
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53
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18.
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Confidential Information; Information Security Incident
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54
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19.
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Term and Termination
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56
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20.
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Effects of Change of Control
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63
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21.
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Bankruptcy
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63
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22.
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Miscellaneous
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64
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Research Collaboration and License Agreement
WHEREAS, Remix has expertise in the discovery and development of small molecule RNA splice modifiers and owns and controls the Remix Platform Technology (as defined below) which is designed to identify such splice
modifiers; and
WHEREAS, Roche has expertise in the research, development, manufacture and commercialization of small molecules across different disease areas, including oncology, immunology, rare blood disorders and neurosciences;
and
WHEREAS, the Parties wish to collaborate on the identification and research of Compound(s) (as defined below) that meet certain criteria, after which Roche will take over all further pre-clinical, clinical
development and commercialization with respect such Compounds;
NOW, THEREFORE, in consideration of the mutual covenants and promises contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties
hereto, intending to be legally bound, do hereby agree as follows:
As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:
The term “Affiliate” shall mean any individual, corporation, association or other business entity that directly or indirectly controls, is controlled by, or is under common control with the Party in question. As used
in this definition of “Affiliate,” the term “control” shall mean the direct or indirect ownership of more than fifty percent (>50%) of the stock having the right to vote for directors thereof or the ability to otherwise control the management of
the corporation or other business entity whether through the ownership of voting securities, by contract, resolution, regulation or otherwise. Anything to the contrary in this paragraph notwithstanding, [***] or its subsidiaries (if any) shall not
be deemed as Affiliates of Roche unless Roche provides written notice to Remix of its desire to include [***] as Affiliate(s) of Roche.
The term “Agreement” shall mean this document, including any and all appendices and amendments to it as may be added or amended from time to time in accordance with the provisions of this Agreement.
The term “Agreement Term” shall mean the period of time commencing on the Effective Date and, unless this Agreement is terminated in its entirety sooner as provided in Article 19, expiring on the date when no royalty
or other payment obligations under this Agreement are or will become due from Roche to Remix.
The term “Applicable Law” shall mean any law, statute, ordinance, code, rule or regulation that has been enacted by a government authority (including without limitation, any Regulatory Authority) and is in force as
of the Effective Date or comes into force during the Agreement Term, in each case to the extent that the same is applicable to the performance by the Parties of their respective obligations under this Agreement.
The term “Arising Know-How” means all Know-How that, as between the Parties, is conceived, discovered, developed, or otherwise made after the Effective Date by or on behalf of either or both Parties in connection
with their performance of their respective activities under this Agreement.
The term “Business Day” shall mean 9:00 am to 5:00 pm local time on a day other than a Saturday, Sunday or bank or other public or federal holiday in Basel, Switzerland or Massachusetts, U.S.A.
The term “Calendar Quarter” shall mean each period of three (3) consecutive calendar months, ending March 31, June 30, September 30, and December 31.
The term “Calendar Year” shall mean the period of time beginning on January 1 and ending December 31, except for the first year which shall begin on the Effective Date and end on December 31.
The term “Change of Control” shall mean, with respect to a Party: (a) the acquisition by any Third Party of beneficial ownership of more than fifty percent (50%) of the then outstanding common shares or voting power
of such Party, other than acquisitions by employee benefit plans sponsored or maintained by such Party; (b) the consummation of a business combination involving such Party, unless, following such business combination, the stockholders of such Party
immediately prior to such business combination beneficially own directly or indirectly more than fifty percent (50%) of the then-outstanding common shares or voting power of the entity resulting from such business combination; or (c) the sale of
all or substantially all of such Party’s assets or business relating to the subject matter of this Agreement.
| 1.10 |
Change of Control Group
|
The term “Change of Control Group” shall mean with respect to a Party, the person or entity, or group of persons or entities, that is the acquirer of, or a successor to, a Party in connection with a Change of
Control, together with affiliates of such persons or entities that are not Affiliates of such Party immediately prior to the completion of such Change of Control of such Party.
The term “Clinical Study” shall mean a Phase I Study, a Phase II Study or a Phase III Study, as applicable.
The term “CLS Criteria” shall mean the criteria specified as “CLS Criteria” for a given Program in the Research Plan.
| 1.13 |
Collaboration Target
|
The term “Collaboration Target” shall mean any of the [***] biological targets listed in Appendix 1.13. For clarity, “Collaboration Targets” includes all Priority Targets and all Reserved Targets (in each case, as
defined below) designated by Roche in accordance with Section 4.4.2.1 until such time as the Program associated with each such target has expired in accordance with Section 4.4.2.1, Section 4.4.2.2, or Section 4.4.2.3 or is terminated in accordance
with Section 19.2.1, Section 19.2.2 or Section 19.2.3 following which it shall cease to be a Collaboration Target for all purposes under this Agreement.
The term “Collaboration Term” shall mean, on a Program-by-Program basis, the period starting at the Effective Date of this Agreement and ending upon completion of all the activities under the Research Plan pertaining
to such Program.
The term “Combination Product” shall mean any product which is
| (a) |
a single pharmaceutical formulation, containing as its active pharmaceutical ingredients both a Compound and one or more other therapeutically or prophylactically active pharmaceutical ingredients, or
|
| (b) |
a combination therapy comprised of a Compound and one or more other therapeutically or prophylactically active pharmaceutical ingredients, priced and sold in a single package containing such multiple products or
packaged separately but sold together for a single price,
|
in each case ((a) and (b)), including all dosage forms, formulations, presentations, line extensions, and package configurations. All references to Product in this Agreement shall be deemed to include Combination
Product.
| 1.16 |
Commercially Reasonable Efforts
|
The term “Commercially Reasonable Efforts” shall mean [***].
| 1.17 |
Companion Diagnostic
|
The term “Companion Diagnostic” shall mean any product that is used for predicting or monitoring the response of a human being to treatment with a Product (e.g., a device, compound, kit, biomarker or service that
contains a component that is used to detect or quantify the presence or amount of an analyte in body or tissue that affects the pathogens of the disease).
|
1.18
|
Composition of Matter Claim
|
The term “Composition of Matter Claim” shall mean, for a given Product in a given country of the Territory, [***].
The term “Compound” shall mean:
| (a) |
On a Program by Program basis, during the period commencing on the Effective Date and ending upon the earlier to occur of [***],
|
| (b) |
On a Program by Program basis, from and after the selection of the Preferred Chemical Series for such Program in accordance with Section 4.4.6, [***] (“Preferred Chemical Series
Compounds”),
|
| (c) |
any derivative or modification of any compound in clause (b) that has been [***] (“Late Derivative”).
|
For clarity, the term “Compound” does not include [***].
| 1.20 |
Compulsory Sublicense Compensation
|
The term “Compulsory Sublicense Compensation” shall mean, for a given country or region in the Territory, the compensation paid to Roche by a Third Party (a “Compulsory Sublicensee”)
under a license or sublicense of Remix Patent Rights and Joint Patent Rights granted to the Compulsory Sublicensee (the “Compulsory Sublicense”) through the order, decree or grant of a governmental authority
having competent jurisdiction in such country or region, authorizing such Third Party to manufacture, use, sell, offer for sale, import or export a Product in such country or region.
|
1.21
|
Confidential Information
|
The term “Confidential Information” shall mean any and all information (including business or financial information), data or know-how (including Know-How), whether technical or non-technical, oral or written, that
is disclosed by one Party or its Affiliates (“Disclosing Party”) to the other Party or its Affiliates (“Receiving Party”). Confidential Information shall not include
any information, data or know-how that:
| (a) |
was generally available to the public at the time of disclosure, or becomes available to the public after disclosure by the Disclosing Party other than through fault (whether by action or inaction) of the
Receiving Party or its Affiliates,
|
| (b) |
can be evidenced by written records to have been already known to the Receiving Party or its Affiliates prior to its receipt from the Disclosing Party,
|
| (c) |
is obtained at any time lawfully from a Third Party under circumstances permitting its use or disclosure,
|
| (d) |
is developed independently by the Receiving Party or its Affiliates as evidenced by written records other than through access or reference to or use of Confidential Information, or
|
| (e) |
is approved in writing by the Disclosing Party for release by the Receiving Party.
|
Notwithstanding the foregoing, Know-How generated under this Agreement that specifically relates to the Remix Platform Technology shall be considered Confidential Information of Remix. The terms of
this Agreement shall be considered Confidential Information of the Parties. Remix shall not disclose any Confidential Information relating Compounds and Products to Third Parties without Roche’s prior consent, such consent not to be unreasonably
withheld, conditioned or delayed.
| 1.22 |
Continuation Election Notice
|
The term “Continuation Election Notice” shall mean the notice Remix provides to Roche under Section 19.3.1 indicating Remix’s desire to continue to research, develop or commercialize the applicable terminated
Compound or Product(s) in accordance with Section 19.3.1.
The term “Control” shall mean (as an adjective or as a verb including conjugations and variations such as “Controls” “Controlled” or “Controlling”) (a) with respect to Patent Rights or Know-How, the possession by a
Party (other than as a result of the rights or licenses granted to such Party herein) of the ability to grant a license or sublicense of such Patent Rights or Know-How without violating the terms of any agreement or arrangement between such Party
and any Third Party and (b) with respect to proprietary materials, the possession by a Party (other than as a result of the licenses or rights granted to a Party herein) of the ability to supply such proprietary materials to the other Party as
provided herein without violating the terms of any agreement or arrangement between such Party and any Third Party. [***].
The term “Cover” shall mean (as an adjective or as a verb including conjugations and variations such as “Covered,” “Coverage” or “Covering”) that the developing, making, using, offering for sale, promoting, selling,
exporting or importing of a given compound, formulation or product would infringe a Valid Claim in the absence of a license under or ownership in the Patent Rights to which such Valid Claim pertains. The determination of whether a compound,
formulation, process or product is Covered by any Valid Claim shall be made on a country-by-country basis.
The term “Effective Date” shall mean the date of the last signature on this Agreement.
The term “EU” shall mean the European Union and all its then-current member countries.
The term “Excluded Compounds” shall mean:
The term “Expert” shall mean a person with no less than ten (10) years of pharmaceutical industry experience and expertise having occupied at least one senior position within a large pharmaceutical company relating
to product commercialization or licensing, but excluding any current or former employee or consultant of either Party. Such person shall be fluent in the English language.
The terms “Exploit”, “Exploitation”, “Exploiting”, or “Exploited” shall mean to research, have researched, develop, have developed, make, have made, import, export, use, have used, sell, have sold, or offer for sale,
including to conduct pre-clinical development, clinically develop, commercialize, register, modify, enhance, improve, manufacture, have manufactured, hold, or keep (whether for disposal or otherwise), or otherwise dispose of.
The term “FDA” shall mean the Food and Drug Administration of the United States of America.
The term “FDCA” shall mean the Food, Drug and Cosmetics Act of the United States of America.
The term “Field” shall mean all uses.
| 1.33 |
First Commercial Sale
|
The term “First Commercial Sale” shall mean, on a country-by-country basis, [***].
The term “Force Majeure Event” shall mean an event beyond the reasonable control of the affected Party not caused by the fault or negligence of such Party, which may include, but is not limited to, an embargo, war,
act of war (whether war be declared or not), act of terrorism, insurrection, riot, civil commotion, strike, lockout or other labor disturbance, fire, flood, earthquake, epidemic, pandemic or other act of God or act, omission or delay in acting by
any governmental authority or the other Party.
The term “FTE” shall mean a full-time equivalent person-year, based upon a total of no less than [***] working hours per year, undertaken in connection with the conduct of activities under this Agreement. In no
circumstance can the work of any given person exceed one (1) FTE.
The term “Gatekeeper” shall mean the external patent attorney mutually agreed upon by the Parties and is a counterparty to a Gatekeeper Agreement.
The term “Generic Product” shall mean a generic version of the Product that (a) in the US, is approved under 21 U.S.C. 505(j) and has an “AB” rating with respect to the Product (or the equivalent of such statute if
amended), or (b) in countries of the EU, is authorized to be placed on the market in accordance with Article 10(1)(a)(iii) of Directive 2001/83/EC (or the equivalent of such statute if amended), or (c) in countries of the Territory other than the
US or countries of the EU, a generic version of the Product that (i) contains the same active pharmaceutical ingredient as the Compound in the Product and (ii) is approved by an expedited process that relies in whole or in part on safety and
efficacy data generated for the first approval of the Product, and (iii) has the same or substantially the same labeling as the Product for at least one Indication of the Product.
| 1.38 |
Good Laboratory Practice
|
The term “Good Laboratory Practice” or “GLP” means the current standards for laboratory activities for pharmaceuticals, as set forth in the FDA’s Good Laboratory Practice regulations or the Good Laboratory Practice
principles of the Organization for Economic Co-Operation and Development, as amended from time to time, and such standards of good laboratory practice as are required by the European Union and other organizations and governmental agencies in
countries in which a product is intended to be sold, to the extent such standards are not less stringent than United States Good Laboratory Practice.
The term “Handle” shall mean, with respect to Patent Rights, preparing, filing, prosecuting (including interferences, reissue, re-examination, post-grant reviews, inter-parties reviews, derivation proceedings and
opposition proceedings), maintaining, and abandoning.
The term “IFRS” shall mean International Financial Reporting Standards.
The term “IND” shall mean an application as defined in the FDCA and applicable regulations promulgated by the FDA, or the equivalent application to the equivalent agency in any other country or group of countries,
the filing of which is necessary to commence clinical testing of any therapeutic products in humans.
The term “Indication” shall mean a disease (a) for which the Product is indicated for treatment and (b) that is described in the Product label as required by the Regulatory Approval granted by the applicable
Regulatory Authority.
| 1.43 |
Information Security Incident
|
The term “Information Security Incident” shall mean, with respect to Confidential Information, any unauthorized use, unauthorized disclosure, corruption (including ransomware attack) or loss of such Confidential
Information.
The term “Initiation” shall mean the date that a human is first dosed with any Product in any Clinical Study.
| 1.45 |
Initiation of GLP Tox Study
|
The term “Initiation of GLP Tox Study” shall mean the date that an animal is first dosed with any Product in a study of the relationship between dose and its effects on the exposed animal, where (i) the study is to
be conducted in accordance with Good Laboratory Practice standards and (ii) the study has been designed in expectation that the results may support establishment of a safe starting dose of such Product in Clinical Studies.
The term “Insolvency Event” shall mean circumstances under which a Party (i) has a receiver or similar officer appointed over all or a material part of its assets or undertaking; (ii) passes a resolution for
winding-up (other than a winding-up for the purpose of, or in connection with, any solvent amalgamation or reconstruction) or a court makes an order to that effect or a court makes an order for administration (or any equivalent order in any
jurisdiction); (iii) enters into any composition or arrangement with its creditors (other than relating to a solvent restructuring); (iv) ceases to carry on business without any successor; or (v) is judicially declared to be insolvent and thus is
unable to pay its debts as they become due in the ordinary course of business.
The term “Invention” shall mean an invention that is discovered or conceived in connection with any activity carried out pursuant to this Agreement. Under this definition, an Invention may be made by employees of
Remix solely or jointly with a Third Party (a “Remix Invention”), by employees of Roche, its Affiliates solely or jointly with a Third Party, including any Sublicensee or subcontractor (a “Roche Invention”), or jointly by employees of Remix and employees of Roche or its Affiliates with or without a Third Party, including any Sublicensee or subcontractor (a “Joint
Invention”).
The term “IRA Subject Product” shall mean a Product upon such Product becoming eligible for drug price negotiation under the Inflation Reduction Act of 2022.
| 1.49 |
Joint Intellectual Property
|
The term “Joint Intellectual Property” shall mean collectively (a) Joint Inventions, (b) Joint Patent Rights, and (c) Joint Know-How.
The term “Joint Know-How” shall mean Know-How that is made jointly by employees of Remix and Roche or its Affiliates, with or without a Third Party (including any Sublicensee or subcontractor) in connection with any
activity carried out pursuant to this Agreement.
The term “Joint Patent Rights” shall mean all Patent Rights Covering a Joint Invention.
The term “JOT” shall mean a joint operating team described in Section 6.2.
The term “JRC” shall mean the joint research committee described in Section 6.1.
The term “Know-How” shall mean data, knowledge and information, including materials, samples, chemical manufacturing data, toxicological data, pharmacological data, preclinical and clinical data, assays, platforms,
formulations, specifications, and quality control testing data that are confidential and necessary or useful for the discovery, manufacture, development or commercialization of Compounds or Products.
The term “LIGo Criteria” shall mean the criteria specified as “LIGo Criteria” for a given Program in the Research Plan.
The term “LI Phase” shall mean the lead identification phase of a given Program of the Research Collaboration specified as the “LI Phase” for such Program in the Research Plan.
The term “LOGo Criteria” shall mean the criteria specified as “LOGo Criteria” for a given Program in the Research Plan.
The term “LO Phase” shall mean the lead optimization phase of a given Program of the Research Collaboration specified as the “LO Phase” for such Program in the Research Plan.
The term “Major Countries” or “Major Country” shall mean USA, Canada, UK, Germany, France, Italy, Spain, and China.
The term “Net Sales” shall mean, for any Product in a particular period:
| (a) |
the amount calculated by subtracting from the Sales of such Product by or on behalf of any member of the Roche Group for such period: [***]. For clarity, no deductions taken in calculating Sales under Section
1.105 may be taken a second time in calculating Net Sales; and
|
| (b) |
any Compulsory Sublicense Compensation received by the Roche Group in such period.
|
The term “Nomination Criteria” shall mean the criteria specified as “Nomination Criteria” for a given Program in the Research Plan.
| 1.62 |
Operational-Level Decisions
|
The term “Operational-Level Decisions” shall mean those decisions concerned with the day-to-day execution of activities allocated to a Party pursuant to an existing Research Plan.
The term “Party” shall mean Remix or Roche, as the case may be, and “Parties” shall mean Remix and Roche, collectively.
The term “Patent Rights” shall mean all rights under any patent or patent application, in any country of the Territory, including any patents issuing on such patent application, and further including any
substitution, extension or supplementary protection certificate, reissue, reexamination, renewal, divisional, continuation or continuation-in-part of any of the foregoing.
The term “Phase 0” shall mean the Initiation of GLP Tox Studies with respect to any Program of the Research Collaboration.
The term “Ph0Go Criteria” shall mean the criteria specified as “Ph0Go Criteria” for a given Program in the Research Plan.
The term “Phase I Study” shall mean a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA) and the foreign equivalent thereof.
The term “Phase II Study” shall mean a human clinical trial, for which the primary endpoints include a determination of dose ranges or a preliminary determination of efficacy in patients being studied as described in
21 C.F.R. § 312.21(b) (FDCA) and the foreign equivalent thereof. Notwithstanding anything in this Agreement to the contrary, a Phase II Study of a Product which is determined by a Regulatory Authority to be sufficient to support an application for
Regulatory Approval for such Product shall be deemed a Phase III Study for purposes of this Agreement.
The term “Phase III Study” shall mean a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain
Regulatory Approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA) and the foreign equivalent thereof.
| 1.70 |
Preferred Chemical Series
|
The term “Preferred Chemical Series” shall, on a Program-by-Program basis, [***].
The term “Product” shall mean any product, including without limitation any Combination Product, containing a Compound as a pharmaceutically active ingredient, regardless of their finished forms or formulations or
dosages.
The term “Program” shall mean, with regard to a given Collaboration Target, [***].
The term “Regulatory Approval” shall mean any approvals, licenses, registrations or authorizations by a Regulatory Authority necessary for the development, manufacture, sale or use of a Product in the Field in any
regulatory jurisdiction in the Territory.
| 1.74 |
Regulatory Authority
|
The term “Regulatory Authority” or “Regulatory Authorities” shall mean any national, supranational (e.g., the European Commission, the Council of the European Union, the European Medicines Agency), regional, state or
local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA, in each country involved in the granting of Regulatory Approval for the Product.
|
1.75
|
Remix Active Program
|
[***]
| 1.76 |
Remix Arising Patents
|
[***]
[***]
| 1.78 |
Remix Arising Know-How
|
[***]
| 1.79 |
Remix Background Patents
|
The term “Remix Background Patents” means all Patent Rights that Remix or its Affiliates Control as of the Effective Date or at any time during the Term (excluding any Remix Arising Patents or Joint Patent Rights)
that (a) are necessary for the Exploitation of a Compound or Product or (b) that otherwise Cover a Compound or Product.
The term “Remix Background IP” shall mean the Remix Background Patents and the Remix Background Know-How.
| 1.81 |
Remix Background Know-How
|
The term “Remix Background Know-How” shall mean all Know-How that Remix or its Affiliates Control as of the Effective Date or at any time during the Term (excluding any Remix Arising Know-How or Joint Know-How), and
that is necessary or useful for the Exploitation of a Compound or Product.
The term “Remix Compound” shall mean a Compound originating from the Remix compound library and any derivatives thereof.
The term “Remix IP” shall mean the Remix Know-How, the Remix Patent Rights and Remix’s interest in the Joint Intellectual Property.
The term “Remix Know-How” shall mean the Remix Arising Know-How and the Remix Background Know-How.
The term “Remix Patent Rights” shall mean the Remix Background Patent Rights and the Remix Arising Patent Rights.
| 1.86 |
Remix Partnered Program
|
[***]
| 1.87 |
Remix Platform Technology
|
[***]
| 1.88 |
Research Collaboration
|
The term “Research Collaboration” shall mean the activities undertaken by the Parties pursuant to and in accordance with the Research Plan to identify and develop Compounds, and such other activities with regard to
Compounds and Products as the Parties may agree in writing.
The term “Research Plan” shall mean the plan of research attached as Appendix 1.89 outlining the work expected to be performed by Remix with regard to the Programs for each of the Collaboration Targets, as such plan
may be updated from time to time as provided in this Agreement.
| 1.90 |
Roche Arising Know-How
|
The term “Roche Arising Know-How” shall mean all Arising Know-How that is conceived, discovered, developed, or otherwise made solely by or on behalf of Roche.
[***]
[***]
[***]
| 1.94 |
Roche Compound Know-How
|
[***]
|
1.95
|
Roche Compound Patent Right
|
[***]
The term “Roche Group” shall mean collectively Roche, its Affiliates and its Sublicensees.
The term “Roche IP” shall mean the Roche Know-How, the Roche Patent Rights and Roche’s interest in the Joint Intellectual Property.
The term “Roche Know-How” shall mean all Know-How that Roche Controls during the Agreement Term that is necessary or useful for the Exploitation of any Compound or Product.
[***]
| 1.100 |
Roche LOGo Decision
|
[***]
| 1.101 |
Roche Nomination Decision
|
The term “Roche Nomination Decision” shall mean the decision made by Roche in accordance with Section 4.4.2.1 to nominate [***] for Step 2 of the Screening and Hit Generation Phase.
| 1.102 |
Roche Patent Rights
|
The term “Roche Patent Rights” shall mean all Patent Rights Covering a Compound or Product that Roche Controls during the Agreement Term, but (for clarity) excluding Roche’s interest in any Joint Patent Rights.
| 1.103 |
Roche Ph0Go Decision
|
[***]
The term “Royalty Term” shall mean, with respect to a given Product and for a given country, the period of time commencing on the date of First Commercial Sale of such Product in such country and ending on the later
of the date that is (a) twelve (12) years after the date of the First Commercial Sale of such Product in such country, or (b) the expiration of the last to expire issued and unexpired Remix Patent Right, Joint Patent Right or Roche Compound Patent
Right in such country containing a Composition of Matter Claim.
The term “Sales” shall mean, for a Product in a particular period, the sum of (a) and (b):
| (b) |
for Sublicensees that are not Roche Affiliates (and excluding Compulsory Sublicensees), the sales amounts reported to Roche and its Affiliates in accordance with the Sublicensee contractual terms and their
then-currently used accounting standards. For the purpose of clarity, any such Sublicensee sales as reported to Roche in accordance with Compulsory Sublicense agreements shall be excluded from the sales amount.
|
| 1.106 |
Screening and Hit Generation Phase
|
The term “Screening and Hit Generation Phase” shall mean the phase of a given Program of the Research Collaboration during which Remix will seek to identify compounds directed to the Collaboration Target associated
with such Program [***].
The term “Sublicensee” shall mean an entity to which Roche has sublicensed the rights granted to it by Remix under Section 2.1 (through one or multiple tiers) in accordance with Section 2.2 of this Agreement, other
than through a Compulsory Sublicense.
The term “Territory” shall mean all countries of the world.
The term “Third Party” shall mean a person or entity other than (i) Remix or any of its Affiliates or (ii) Roche or any of its Affiliates.
The term “US” shall mean the United States of America and its territories and possessions.
The term “US$” shall mean US dollars.
The term “Valid Claim” shall mean on a country-by-country basis, any claim of (a) any issued, unexpired, and uncancelled patent that has not been (i) held permanently revoked, unenforceable, unpatentable, or invalid
by a decision of a court or governmental body of competent jurisdiction, unappealable, or unappealed within the time allowed for appeal in the country of issuance, (ii) rendered unenforceable through disclaimer or otherwise, (iii) withdrawn or
abandoned, [***].
| 1.113 |
Additional Definitions
|
Each of the following definitions is set forth in the Section of this Agreement indicated below:
|
Definition
|
Section
|
|
Accounting Period
|
10.1
|
|
Acquired Party
|
20
|
|
Affinity Compound
|
1.19
|
|
Alliance Director
|
6.5
|
|
Bankruptcy Code
|
21
|
|
Baseball Expert
|
19.3.1(d)
|
|
Breaching Party
|
19.2.1
|
|
Chairperson
|
6.1.1
|
|
Certification Notice
|
13.10
|
|
Chugai
|
1.1
|
|
CLS Data Package
|
4.4.2.3
|
|
Competitive Infringement
|
13.7.1
|
|
Compulsory Sublicense
|
1.20
|
|
Compulsory Sublicensee
|
1.20
|
|
Data Subjects
|
8
|
|
Decision Period
|
13.7.2
|
|
Disclosing Party
|
1.21
|
|
Enforcement Action
|
13.7.2
|
|
Definition
|
Section
|
|
Expert Committee
|
9.5.3.1
|
|
FP
|
1.87
|
|
Gatekeeper Agreement
|
4.4.7
|
|
H-W Enforcement Action
|
13.10
|
|
H-W Suit Notice
|
13.10
|
|
Indemnified Party
|
16.3
|
|
Indemnifying Party
|
16.3
|
|
Initiating Party
|
13.7.4
|
|
Joint Invention
|
1.47
|
|
JPCT
|
6.3
|
|
Late Derivative
|
1.19
|
|
LIGo Data Package
|
4.4.2.1
|
|
LOGo Data Package
|
4.4.2.2
|
|
Materials
|
4.6
|
|
Members
|
6.1.1
|
|
Minimum Transfer Payment
|
19.3.4.3
|
|
Nomination Data Package
|
4.4.2.1
|
|
Nomination Fee
|
4.4.2.1
|
|
Non-Acquired Party
|
20
|
|
Non-Breaching Party
|
19.2.1
|
|
Patent Term Extensions
|
13.11
|
|
Payment Assignment
|
22.4
|
|
Payment Currency
|
10.3
|
|
Payment Rights Transfer
|
22.3
|
|
Peremptory Notice Period
|
19.2.1
|
|
Ph0Go Data Package
|
4.4.2.3
|
|
PII/Samples
|
19.3.4.3
|
|
Post-CLS Step
|
4.4.2.3
|
|
Pre-CLS Step
|
4.4.2.3
|
|
Preferred Chemical Series Compound
|
1.19
|
|
Priority Target
|
4.4.2.1
|
|
Publishing Notice
|
18.4
|
|
Publishing Party
|
18.4
|
|
Receiving Party
|
1.21
|
|
Relative Commercial Value
|
9.5.3.1
|
|
Remix
|
cover page
|
|
Remix Excluded Program List
|
4.4.7
|
|
Remix Indemnitees
|
16.1
|
|
Remix Invention
|
1.47
|
|
Remix-Originated Transfer Activities
|
19.3.4.3
|
|
Remix Prosecuted Research Patent Rights
|
13.2
|
|
REMseq
|
1.87
|
|
Representative
|
6.2.1
|
|
Reserved Target
|
4.4.2.1
|
|
Reversion License Terms
|
19.3.1
|
|
Roche
|
cover page
|
| Definition |
Section |
|
Roche Basel
|
cover page
|
|
Roche Indemnitees
|
16.2
|
|
Roche Invention
|
1.47
|
|
Roche Transfer Activities
|
19.3.4.3
|
|
Roche US
|
cover page
|
|
Royalty Floor
|
9.7
|
|
Selected Roche Employees
|
4.4.4
|
|
Sensitive Information
|
20
|
|
Settlement
|
13.7.7
|
|
SPCs
|
13.11
|
|
Step 1
|
4.4.2.1
|
|
Step 2
|
4.4.2.1
|
|
Step 3
|
4.4.2.1
|
|
Sublicense
|
2.2
|
|
Suit Notice
|
13.7.3
|
|
Tolerability Study
|
9.2
|
|
Transfer
|
22.4
|
|
Validation Request
|
4.4.7
|
| 2.1.1 |
Non-Exclusive Cross Licenses
|
Subject to the terms and conditions of this Agreement, each of Remix and Roche hereby grants to the other Party during the Collaboration Term a non-exclusive, non-transferable, right and license, with the right to
sublicense in accordance with Section 2.2, under the Remix IP and Roche IP, respectively, solely to enable the other Party to perform its respective activities contemplated for each Program of the Research Collaboration under the Research Plan
during the Collaboration Term. For clarity, the foregoing license grant from Remix excludes any license or right to use the Remix Platform Technology.
| 2.1.2 |
Research, Development and Commercial License
|
Subject to the terms and conditions of this Agreement, Remix hereby grants to Roche an exclusive (subject to Remix’s right to conduct any activities expressly contemplated by this Agreement, but otherwise even as to
Remix), non-transferable (except as expressly set forth in Section 22.4), right and license, including the right to sublicense in accordance with Section 2.2, under the Remix IP, to research, have researched, develop, have developed, register, have
registered, use, have used, make, have made, import, have imported, export, have exported, market, have marketed, distribute, have distributed, sell and have sold Compounds and Products and Companion Diagnostic in the Field in the Territory. For
clarity, the foregoing license grant from Remix excludes any license or right to use the Remix Platform Technology.
|
2.1.3
|
Companion Diagnostic License
|
Subject to the terms and conditions of this Agreement, Remix hereby grants to Roche an exclusive (subject to Remix’s to conduct any activities expressly contemplated by this Agreement, but otherwise even as to
Remix), non-transferable (except as expressly set forth in Section 22.4), right and license, including the right to sublicense in accordance with Section 2.2, under the Remix Arising IP and Remix’s interest in the Joint Intellectual Property, to
use, have used, make, have made, import, have imported, export, have exported, market, have marketed, distribute, have distributed, sell and have sold Companion Diagnostics in the Field in the Territory solely in conjunction with the development,
sale or use of a Product in accordance with the terms and conditions of this Agreement, and not on a stand-alone basis.
During the Collaboration Term, Roche shall have the right to grant sublicenses (each, a “Sublicense”) under the rights licensed to Roche under this Article 2 to Affiliates,
[***], subcontractors and other Third Party service providers solely to complete those activities assigned to Roche under the Research Plan. After the completion of the Collaboration Term with respect to any Program, Roche shall have the right, in
its sole discretion, to grant Sublicenses, through multiple tiers, in the Territory in the Field under the rights licensed to Roche under this Article 2 to research, have researched, develop, have developed, register, have registered, use, have
used, make, have made, import, have imported, export, have exported, market, have marketed, distribute, have distributed, sell and have sold in the Field and the Territory the Compounds and Products generated during such Program, without Remix’s
consent. Roche shall remain liable for the performance of all its obligations under this Agreement and shall be responsible and liable for compliance by its Sublicensees with the applicable provisions of this Agreement. Any Sublicense granted in
accordance with this Section 2.2 to a Sublicensee shall be in writing, subject and subordinate to, and consistent with the applicable terms and conditions of this Agreement. Upon request of Remix, Roche shall provide Remix with a copy of such
Sublicense other than a Sublicense to an Affiliate of Roche or [***], which copy may be redacted solely as needed to protect confidential information, including but not limited to the financial terms of such sublicense, provided that no such
redactions impair Remix’s ability to confirm compliance with this Agreement.
| 2.3 |
Compulsory Sublicenses.
|
In the event that Roche or Remix receives a request for a Compulsory Sublicense anywhere in the Territory during the Royalty Term, it shall promptly notify the other Party. If any Third Party obtains a Compulsory
Sublicense in any country in the Territory during the Royalty Term, then Remix or Roche (whichever has first notice) shall promptly notify the other Party.
Other than in the performance of activities under this Agreement, on a Collaboration Target-by-Collaboration Target basis, commencing upon the Effective Date and ending upon the earliest of: [***], Remix will not
conduct any activities outside this Agreement to research, develop, commercialize or otherwise Exploit any compound (including any Excluded Compound) that [***].
For the avoidance of doubt, upon expiration or termination of any Program associated with a Collaboration Target, Remix will be free to research, develop, commercialize or otherwise Exploit any compound (including
any Excluded Compound) that [***], without any limitations or obligations to Roche or otherwise under this Agreement. In addition, [***], any Collaboration Targets which are still Reserved Targets as of such date will cease to be a Collaboration
Targets for purposes of this Article 3 and Remix will be free to research, develop, commercialize or otherwise Exploit any compound (including any Excluded Compound) that [***], without any limitations or obligations to Roche or otherwise under
this Agreement.
| 4. |
Research Collaboration
|
During the Collaboration Term, Roche and Remix shall conduct the mutually agreed Research Collaboration pursuant to the Research Plan and this Article 4. The activities conducted in connection with the Research
Collaborations will be overseen by the JRC and, if applicable, the JOTs and the JPCT. The activities associated with each Program will be conducted in three phases: [***].
| 4.2 |
Research Plan; Updates to Research Plan
|
On a Program-by-Program basis, the Research Plan will set forth (a) the scope of the Programs and the responsibilities of each Party in connection with each Program, (b) specific objectives and criteria [***]
associated with each Program, and (c) information and data exchange associated with each Program. The JRC shall review the Research Plan on an ongoing basis and may amend the Research Plan in accordance with Section 6.1.2. Any such changes shall be
reflected in written amendments to the Research Plan.
Roche may subcontract any work performed by it under the Research Plan. Remix may subcontract any work performed by it under the Research Plan to any subcontractors listed in Appendix 4.3. If Remix wishes to
subcontract any work performed under the Research Plan to a subcontractor that is not listed in Appendix 4.3, Remix will notify Roche that it wishes to engage any additional subcontractor prior to such engagement. To the extent Roche objects to any
such proposed subcontractor, it must notify Remix promptly, but in any event within [***] following receipt of Remix’s notice, and the Parties shall promptly meet to discuss such objection. Remix shall not engage such additional subcontractor for
which Roche has provided Remix with a timely notice of its objection without Roche’s prior written consent, which shall not be unreasonably withheld or delayed. Appendix 4.3 will be revised to include any subcontractor which has been approved by
Roche in accordance with this Section 4.3; provided, however, that a failure to so include a subcontractor on Appendix 4.3 that has otherwise been approved in writing (including by email) by Roche shall not preclude such subcontractor from being
deemed an authorized subcontractor for purposes of this Section 4.3.
Each Party shall have written agreements with their respective subcontractors performing activities under the Research Plan which shall contain terms sufficient for such Party to comply with all provisions of this
Agreement and to support all grants and assignments of rights and ownership hereunder and shall include restrictions on the use and disclosure of the other Party’s Confidential Information at least as protective as this Agreement. Each Party shall
be liable for the actions or omissions of its subcontractors in performing work hereunder and the compliance of its subcontractors with the terms and conditions of this Agreement. The engagement of any subcontractor, whether or not in compliance
with this Section 4.3, shall not relieve a Party of its obligations under this Agreement. The JRC will maintain a list of Remix’s approved subcontractors (including those listed in Appendix 4.3).
| 4.4.1 |
Conduct of Programs
|
On a Program-by-Program basis, the Parties shall use Commercially Reasonable Efforts to perform their respective tasks and obligations as ascribed to them for the phases of the Programs in the then-current Research
Plan and in accordance with the timelines set forth therein.
[***] Upon completion of each phase of a Program, the JOT will prepare and deliver to the JRC the applicable data package, as further described below. Upon receipt of the applicable data package by the JRC, Roche, in
its sole discretion, shall decide, whether to proceed to the next phase of the Program, independent of whether or not the criteria for the particular Program phase have been met, by issuing timely written notice of its decision to Remix.
| 4.4.2.1 |
Screening and Hit Generation Phase
|
During the Screening and Hit Generation Phase, Remix and Roche, where applicable, shall on a Program-by-Program basis, perform all activities assigned to them under the Research Plan, with the objective to meet the
LIGo Criteria with respect to each such Program.
[***]
On a Program-by-Program Phase, upon completion of Step 1 with respect to such Program, Remix shall provide all resulting information and data for such Program to the relevant JOT and such JOT shall prepare and
deliver to the JRC a data package containing (i) a summary of all activities, data and results generated during Step 1 for each Program, and (ii) [***]. Within [***] of presentation of the Nomination Data Package [***] to the JRC and prior to
entering Step 2, Roche has the right, but no obligation, to nominate up [***] for Step 2 and Step 3 of the Screening and Hit Generation Phase by providing written notice of its decision to Remix, subject to Roche’s timely payment of the applicable
fee on a Collaboration Target-by-Collaboration Target basis as set forth in Section 9.2 (each such fee, the “Nomination Fee”).
Upon completion of Step 2 and Step 3 of the Screening and Hit Generation Phase, Remix shall, on a Program-by-Program basis, provide all information and data resulting from Step 2 and Step 3 of the Screening and Hit
Generation Phase for all of the Collaboration Targets, for which Roche has paid the Nomination Fee, to the relevant JOT, and such JOT shall prepare and deliver to the JRC a data package containing (A) a summary of all activities, data and results
generated during Step 2 and Step 3 of the Screening and Hit Generation Phase with respect to all of the Collaboration Targets for which Roche has paid the Nomination Fee, (B) a list of all compounds generated during Step 2 or Step 3 of the
Screening and Hit Generation Phase for all of the Collaboration Targets for which Roche has paid the Nomination Fee [***] as confirmed in the dose response [***], including all such data and results indicating whether or not each designated
criteria as set forth in the Research Plan have been met and Remix’s assessment of whether or not any such compounds are or might be Excluded Compounds, (C) all data, results and chemical structures [***] resulting from Step 2 and Step 3 of the
Screening and Hit Generation Phase for all of the Collaboration Targets for which Roche has paid the Nomination Fee, (D) upon Roche’s written request to Remix and subject to Section 4.4.4, chemical structures of compounds referenced in clause (B)
above, [***]. Roche may also ask Remix to provide it with any other information generated during the Screening and Hit Generation Phase and in Remix’s possession and control as of the date Roche makes such a request which Roche determines is
reasonably required to issue a Roche LIGo Decision.
If the JRC determines that the LIGo Criteria have been met by any of the Programs described in the LIGo Package, Roche, in its sole discretion, shall have the right to issue a Roche LIGo Decision for such Program
(and the associated Collaboration Target), up to a total [***] of such Programs, (each such Collaboration Target for which a LIGo Decision is made by Roche, a “Priority Target”) within [***] following the
JRC’s determination by providing written notice of its decision to Remix. The remaining Collaboration Targets (each a “Reserved Target”) will be reserved for Roche’s selection as a Priority Target up to and
until such time as the Programs associated with any [***] Priority Targets (including any Reserved Targets which have been promoted to a Priority Target by Roche in accordance with Section 4.4.2.2) have commenced Phase 0.
If the JRC determines that the LIGo Criteria have not been met with respect to any Program submitted to the JRC pursuant to this Section 4.4.2.1, then,
| (aa) |
the Parties may, by mutual agreement only (including via a written amendment to the Research Plan, as appropriate), agree to continue work with an extension of the Screening and Hit Generation Phase for such Program, or
|
| (bb) |
Roche may, in its sole discretion, issue a Roche LIGo Decision with respect to such Program, up to a maximum of [***] total Programs, and their associated Collaboration Targets, as outlined above by providing written notice of its
decision to Remix.
|
If neither of the foregoing (aa) or (bb) occur within [***] following the JRC’s determination that the LIGo Criteria have not been met with respect to any Program, or if the JRC determines that the LIGo Criteria have
been met with respect to any Program, but Roche decides not to advance such Program to the LI Phase, either by providing written notice of its decision to Remix or failing to advance such Program to the LI Phase within [***] following the JRC’s
determination, the Program with respect to the applicable Collaboration Target shall expire as set forth in Section 4.4.8.
During the LI Phase, Remix and Roche, as applicable, shall, on a Program-by-Program basis perform all activities assigned to them under the Research Plan for each Program (and the associated Priority Target), with
the objective to meet the LOGo Criteria for such Program.
During the LI Phase and up until the completion of the LI Phase with respect to any Program Remix may elect to designate one or more compounds identified, conceived or reduced to practice [***].
Upon completion of all activities of the LI Phase with respect to any Program, Remix shall, on a Program-by-Program basis, provide all information and data resulting from activities during the LI Phase for such
Program to the relevant JOT responsible for overseeing such Program and such JOT shall prepare and deliver to the JRC a data package containing (a) all data and results [***] and (b) an evaluation of whether or not the LOGo Criteria have been met
for any Compounds generated or tested during the LI Phase (the “LOGo Data Package”).
If the JRC determines that the LOGo Criteria have been met by any of the Compounds generated or tested during the LI Phase of any Program associated with a Priority Target, then Roche, in its sole discretion, shall
have the right to issue a Roche LOGo Decision for such Program, and to advance such Program to the LO Phase, by providing written notice of its decision to Remix within [***] following the JRC’s determination. For clarity, if Roche does not issue a
Roche LOGo Decision for any Program determined by the JRC to have met the LOGo Criteria within [***] following the JRC’s determination, then such Program shall expire as set forth in Section 4.4.8.
If the JRC determines that the LOGo Criteria have not been met with regard to any Program submitted to it pursuant to this Section 4.4.2.2, then,
| (i) |
the Parties may, by mutual agreement only (including via a written amendment to the Research Plan, as appropriate), agree to continue work with an extension of the LI Phase for such Program, or
|
| (ii) |
Roche may, in its sole discretion, issue a Roche LOGo Decision with respect to such Program and their associated Priority Targets, as outlined above.
|
If neither of the foregoing (i) or (ii) occur within [***] following the JRC’s determination that the LOGo Criteria have not been met with respect to any Program associated with a Priority Target, such Program shall
expire as set forth in Section 4.4.8, and Roche shall have the right to issue a Roche LIGo Decision for any Collaboration Target which is still classified as a Reserved Target as of the date such LIGo Decision is issued by Roche to Remix by
providing written notice of its decision to Remix within [***] following the JRC’s determination. Any Reserved Target for which Roche issues a LIGo Decision pursuant to this Section 4.4.2.2 will then become a Priority Target and will be researched
by the Parties according to the Program for such Collaboration Target set forth in the Research Plan, subject to Roche making the LIGo milestone payment for such Collaboration Target to Remix in accordance with the last sentence of Section 9.2.
During the LO Phase, Remix and Roche, where applicable, shall, on a Program-by-Program basis, perform all activities assigned to them under the Research Plan for a given Program associated with a Priority Target,
with the objective to meet (a) the CLS Criteria (“Pre-CLS Step”) and (b) the Ph0Go Criteria (“Post-CLS Step”) for such Program.
Upon completion of all activities of the Pre-CLS Step of the LO Phase for each Program, Remix shall, on a Program-by-Program basis, provide all information and data resulting from activities during the Pre-CLS Step
of the LO Phase for such Program to the relevant JOT responsible for overseeing such Program and such JOT shall prepare and deliver to the JRC a data package containing (i) all data and results (including, upon Roche’s request to Remix, chemical
structures) generated or tested during the Pre-CLS Step of the LO Phase for such Program, and (ii) an evaluation of whether or not the CLS Criteria have been met by any Compounds generated or tested during the Pre-CLS Step of the LO Phase for such
Program (the “CLS Data Package”). The JRC shall have [***] following receipt of such data package to determine whether the CLS Criteria have been met by any Compounds generated or tested during the Pre-CLS
Step of the LO Phase for any Program.
If the JRC determines that the CLS Criteria have been met by any Compounds generated or tested during the Pre-CLS Step of the LO Phase for any Program, the JRC will select Compounds to advance into the Post-CLS Step
of the LO Phase for such Program.
If the JRC determines that the CLS Criteria have not been met by any Compounds generated or tested during the Pre-CLS Step of the LO Phase for a given Program, then
| (A) |
the Parties may, by mutual agreement only (including via an amendment to the Research Plan), agree to continue work with an extension of the LO Phase for such Program, or
|
| (B) |
The JRC may select Compounds from such Program to advance into the Post-CLS Step of the LO Phase for such Program.
|
If neither of the foregoing (A) or (B) occur within [***] following the JRC’s determination that the CLS Criteria have not been met by any Compounds generated or tested during the Pre-CLS Step of the LO Phase for a
given Program, the Program shall expire as set forth in Section 4.4.8, and Roche shall have the right to issue a Roche LIGo Decision for any Collaboration Target which is still classified as a Reserved Target as of the date such LIGo Decision is
issued by Roche to Remix by providing written notice of its decision to the JRC within [***] following the JRC’s determination. Any Reserved Target for which Roche issues a LIGo Decision pursuant to this Section 4.4.2.3 which will then become a
Priority Target and will be researched by the Parties according to the Program for such Collaboration Target set forth in the Research Plan, subject to Roche making the LIGo milestone payment for such Reserved Target in accordance with the last
sentence of Section 9.2.
Upon completion of all activities of the Post-CLS Step of the LO Phase for any Program, Remix shall provide all information and data resulting from activities during the Post-CLS Step of the LO Phase for such
Program, including all safety data, to the relevant JOT responsible for overseeing such Program and such JOT shall prepare and deliver to the JRC a data package containing (aa) all data and results [***] generated or tested during the Post-CLS Step
of the LO Phase for such Program, and (bb) an evaluation of whether or not the Ph0Go Criteria have been met for any Compounds generated or tested during the Post-CLS Step of the LO Phase for such Program (the “Ph0Go
Data Package”).
If the JRC determines that the Ph0Go Criteria have been met, Roche, in its sole discretion, has the right to issue a Roche Ph0Go Decision for a given Program from the LO Phase, within [***] of presentation of the
Ph0Go Data Package to the JRC.
If the JRC determines that the Ph0Go Criteria have not been met by any Compounds generated or tested during the Post-CLS Step of the LO Phase for a given Program, then
| (I) |
the Parties may, by mutual agreement only (including via an amendment to the Research Plan), agree to continue work with an extension of the LO Phase for such Program, or
|
| (II) |
Roche, in its sole discretion, may issue a Roche Ph0Go Decision for such Program.
|
If neither of the foregoing (I) or (II) occur within [***] following the JRC’s determination that the Ph0Go Criteria have not been met by any Compounds generated or tested during the Post-CLS Step of the LO Phase for
a given Program, the Program shall expire as set forth in Section 4.4.8, and Roche shall have the right to issue a Roche LIGo Decision for any Collaboration Target which is still classified as a Reserved Target as of the date such LIGo Decision is
issued by Roche to Remix by providing written notice of its decision to the JRC within [***] following the JRC’s determination. Any Reserved Target for which Roche issues a LIGo Decision pursuant to this Section 4.4.2.3 will then become a Priority
Target and will be researched by the Parties according to the Program for such Collaboration Target set forth in the Research Plan, subject to Roche making the LIGo milestone payment for such Reserved Target in accordance with the last sentence of
Section 9.2.
During the Collaboration Term and in accordance with the Research Plan, Remix shall be responsible for the generation of “back-up” Compounds.
Following, Roche’s Ph0Go Decision with respect to a given Program, the Parties may agree to extend the Collaboration Term to generate [***].
| 4.4.4 |
Disclosure of Remix Chemical Structures to Roche
|
If Roche requests to review chemical structures of compounds derived from the Remix compound library from a given Program prior to the Roche LOGo Decision with respect such Program in accordance with Section 4.4.2.1
and Section 4.4.2.2, Roche’s review of such chemical structures will be limited to:
| (a) |
[***] Roche employees previously selected by the JRC (“Selected Roche Employees”). The Selected Roche Employees will be segregated from (i) the personnel working on any
other Roche programs involving [***], and (ii) information relating to any other Roche programs involving [***]. Upon Roche’s reasonable request, Remix may, at its discretion, allow a certain number of additional Roche employees to review
the chemical structures, provided that such additional reviewers are subject to the same segregation as the Selected Roche Employees, and
|
| (b) |
Roche’s designated internal and external patent attorneys who are subject to the same segregation as the Selected Roche Employees.
|
For clarity, such limitations will not be applicable to any [***].
| 4.4.5 |
Disclosure of Roche Chemical Structures to Remix
|
The Parties intend to use [***] for Screening and Hit Generation, as outlined in the Research Plan. Any subset of the [***] will be shared with Remix in a blinded fashion [***] and unblinding/disclosure of [***] is
gated to compounds that regulate the expression of a Collaboration Target [***].
| 4.4.6 |
Preferred Chemical Series
|
On a Program-by-Program basis, promptly following Roche’s issuance of a Roche LOGo Decision for such Program, the JOT responsible for such Program shall, with input from the JPCT, select the Preferred Chemical Series
for such Program and submit that selection to the JRC for approval. The Preferred Chemical Series for any Program must be approved by the JRC prior to Roche initiating any Phase 0 activities with respect to such Program; provided, however, that the
[***]. Any such modifications to the Preferred Chemical Series shall be jointly discussed and agreed by the Parties except that, [***].
Upon the JRC’s approval of the initial Preferred Chemical Series selected for any Program, any Affinity Compounds which are not included within the scope of such Preferred Chemical Series shall thereafter cease to be
considered “Compounds” for all purposes of this Agreement and all such Affinity Compounds shall immediately revert to and be owned by Remix. Except in the event that any Affinity Compounds transferred to Remix under this Section are subsequently
included in any modified version of the initial Preferred Chemical Series for a Program as contemplated above, in which case such Affinity Compounds shall be deemed to be a “Compound” pursuant to clause (b) of Section 1.19, Roche shall have no
rights or licenses with respect to any such Affinity Compounds.
[***]
| 4.4.8 |
Expiration of Program
|
Following the expiration of a Program pursuant to Section 4.4.2.1, Section 4.4.2.2, and Section 4.4.2.3, each Party shall return or destroy, as agreed between the Parties, all copies of the Confidential Information
or Material it has received from the other Party specifically for such Program.
For the avoidance of doubt, the expiration of a Program pursuant to Section 4.4.2.1, Section 4.4.2.2, or Section 4.4.2.3 shall occur immediately and automatically upon the occurrence of the relevant expiration event
specified in such Sections and shall not require the prior written notice periods referenced in Section 19.2.3.
| 4.4.9 |
Limitation on Number of Programs
|
Notwithstanding anything to the contrary in this Agreement, the total number of Programs which are the subject of any ongoing activities under the LI Phase or LO Phase at any one time shall not exceed [***] Programs.
Each Party shall prepare and provide to the JRC [***] ahead of each JRC meeting a detailed written report (which may be in the form of a slide deck) summarizing the progress of the work performed by such Party in the
course of the Research Collaboration since the last JRC meeting.
Each Party shall maintain records of the Research Collaboration (or cause such records to be maintained by Third Parties providing services on behalf of such Party) in sufficient detail and in good scientific manner
as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of the Research Collaboration. Each Party shall maintain its laboratory notebooks related to the Research Collaboration for a reasonable
period of time in accordance with customary industry practices.
| 4.6 |
Transfer of Materials
|
The Parties shall provide each other with sufficient quantities of certain physical materials as set forth in the Research Plan and other materials as a Party may elect to provide to the other Party from time to time
under this Agreement (collectively, the “Materials”). Neither Party shall transfer, deliver or disclose any such Materials, or any derivatives, analogs, modifications or components thereof, to any Third Party
without the prior written approval of the Party providing the Material, except to subcontractors performing any activities as contemplated in the Research Plan in accordance with Section 4.3.
The Parties will use the Materials supplied under this Agreement with appropriate caution in any experimental work as not all of their characteristics may be known, and in no event will they be administered to
humans.
Remix will deliver Materials to Roche under [***]. Remix will provide to Roche prior to Material deliveries all the necessary import documentation including but not limited to licenses and other permissions.
Roche will deliver Materials to Remix under [***]. Roche will provide to Remix prior to Material deliveries all the necessary import documentation including but not limited to licenses and other permissions.
If and to the extent such transfer has not yet taken place with respect to any Program for which Roche has paid the milestone associated with the LOGo Decision, Remix shall, upon Roche’s request, initiate a transfer
to Roche of [***].
Unless otherwise specified in this Agreement or as agreed to by the Parties, the shipment by Remix of the above Roche Compounds and Materials shall be at Roche’s cost and expense and shall be shipped [***].
On a Program-by-Program basis, from and after the Initiation of GLP Tox Studies with respect to such Program, Roche shall use Commercially Reasonable Efforts to [***].
| 6.1 |
Joint Research Committee
|
Within [***] after the Effective Date of this Agreement, the Parties shall establish a JRC to oversee the Research Collaboration carried out under this Agreement.
The JRC shall be composed of [***] persons (“Members”). Roche and Remix shall each be entitled to appoint up to [***] Members to the JRC, each of whom shall be employees of the
respective Party with appropriate seniority and functional expertise to carry out their responsibilities on the JRC. Subject to the previous sentence, each Party may replace any of its Members and appoint a person to fill the vacancy arising from
each such replacement. A Party that replaces a Member shall notify the other Party at least [***] prior to the next scheduled meeting of the JRC. Both Parties shall use reasonable efforts to keep an appropriate level of continuity in
representation. Both Parties may invite a reasonable number of additional Experts or scientific advisors or consultants to attend part or the whole JRC meeting with prior notification to the JRC, provided that any non-employee attending the JRC is
bound by written obligations of confidentiality and non-disclosure substantially equivalent to those set forth in Article 18 and that the other Party has provided its prior written approval for such non-employee to attend (such approval not to be
unreasonably withheld, delayed, or conditioned. Members may be represented at any meeting by another person designated by the absent Member, provided that such person is also an employee of the same company as the absent Member. The JRC shall be
chaired by one (1) of the Members of a Party (“Chairperson”), which shall rotate on a yearly basis. The initial Chairperson shall be a Roche Member and will be designated by Roche within [***] after the
Effective Date.
|
6.1.2
|
Responsibilities of the JRC
|
The JRC shall have the responsibility and authority to:
| (a) |
review and approve any amendments to the Research Plan;
|
| (b) |
review and oversee the execution of the Research Plan (excluding Operational-Level Decisions)
|
| (c) |
approve timelines and criteria for decision points;
|
| (d) |
review [***] and determine whether the respective criteria have been met;
|
| (e) |
review the CLS Package to determine whether success criteria have been met and prioritize Compounds that should undergo dose range finding toxicology studies;
|
| (f) |
review and approve the scope of the genus formula representing Preferred Chemical Series proposed by any JOT;
|
| (g) |
identify and allocate appropriate resources necessary to conduct the Research Plan across Programs;
|
| (h) |
establish and set expectations and mandates for any JOT;
|
| (i) |
create or disband any JOT as deemed appropriate;
|
| (j) |
oversee the activities of any JOT;
|
| (k) |
monitor the technology transfer activities; and
|
| (l) |
attempt to resolve any disputes at the JOTs or the JPCT on an informal basis.
|
The JRC shall have no responsibility and authority other than that expressly set forth in this Section 6.1.2.
The Chairperson or his/her delegate will be responsible for sending invitations and agendas for all JRC meetings to all Members at least [***] before the next scheduled meeting of the JRC. The venue for the meetings
shall be agreed by the JRC. The JRC shall hold meetings at least [***], either in person or by tele-/video-conference, and in any case as frequently as the Members of the JRC may agree shall be necessary, but not more than [***].
The Chairperson will be responsible for designating a Member to record in reasonable detail, and circulate, draft minutes of JRC meetings to all Members for comment and review within [***] after the relevant meeting.
The Members of the JRC shall have [***] to provide comments. The Party preparing the minutes shall incorporate timely received comments and distribute the revised minutes to all Members within [***] of the relevant meeting. The Members shall review
and agree on the minutes of each meeting promptly following receipt of such revised copy; provided that such minutes shall be deemed approved if no Members have objected to such minutes within [***] after having received such revised meeting
minutes.
| 6.1.5.1 |
Decision Making Authority
|
The JRC shall decide matters within its responsibilities set forth in Section 6.1.2. The JRC shall have no authority to amend or waive any terms of this Agreement.
| 6.1.5.2 |
Decision Making and Escalation
|
The Members of the JRC shall act in good faith to cooperate with one another and seek agreement with respect to issues to be decided by the JRC. The Parties shall endeavor to make decisions by consensus, with each of
the up to [***] Members of each Party having collectively one (1) vote. In the event of a deadlock at the JRC, the Parties will attempt to resolve by the Parties’ respective senior executives [***] for resolution, who together shall use reasonable
and good faith efforts to reach a decision by consensus within [***] after the date such matter is referred to them. If the Parties still fail to reach a decision within such [***], then Remix shall have the final decision making authority on
[***]; whereas Roche shall have the final decision authority on [***], provided, however, that Roche may not exercise its final decision-making authority to [***].
Upon [***] the JRC shall be disbanded.
The JRC shall have the right to establish one (1) or more Joint Operation Teams (each, a “JOT”) which would be responsible for overseeing the conduct and the execution of each
current Program under the Research Plan and for reviewing the Parties’ progress thereunder and for any additional responsibilities assigned to it by the JRC.
| 6.2.1 |
Representatives; Meetings; Minutes
|
The JOTs shall be composed of employees or consultants (each, a “Representative”) designated by each of Remix and Roche. Each such Representative must be appropriate for the
tasks then being undertaken under the Research Plan in terms of their seniority, availability, and function in their respective organizations, training and experience. Each Party shall designate one (1) of its Representatives on each JOT as its
primary point of contact for such JOT. Each Party may replace its Representatives on any JOT from time to time upon written notice to the other Party; provided, however, if a Party’s Representative is unable to attend a meeting, such Party may
designate a knowledgeable alternate Representative of such Party to attend such meeting and perform the functions of such Representative. If a Representative is a non-employee, such non-employee shall be bound by written obligations of
confidentiality and non-disclosure substantially equivalent to those set forth in Article 18 and shall not be an employee of any company that is researching, developing or commercializing small molecule splice modulators.
Each JOT shall meet as often as reasonably necessary to carry out its duties by audio or video teleconference or as otherwise agreed by such JOT. The JOT shall keep minutes of its meetings that record in writing all
decisions made, action items assigned or completed and other appropriate matters. The Meeting minutes shall be finalized promptly after a meeting.
| 6.2.2 |
Limitations of Authority
|
The JOT shall have no authority to make decisions under this Agreement or to amend or waive any terms of this Agreement.
Unless disbanded earlier by the JRC, upon [***] all of the existing JOTs shall be disbanded.
| 6.3 |
Joint Patent Coordination Team
|
Within a reasonable period of time following the Effective Date the Parties shall establish a Joint Patent Coordination Team (“JPCT”) to jointly devise the IP filing and
handling strategy. The JPCT shall consist of at least [***] patent counsel from each of Remix and Roche, who will manage the contact between the Parties and oversee all matters related to intellectual property included in Article 13, including
making good faith efforts to agree on strategies for the Handling of Remix Patent Rights for all countries, and will have such other responsibilities as the Parties may agree in writing, to fulfil each Party’s obligations under this Agreement. In
the event that the JPCT cannot agree on the filing and handling strategy, the parties will choose a mutually agreeable outside counsel who will advise the JPCT. The JPCT shall remain in place for the duration of the Agreement Term.
Remix and Roche shall exchange the information in relation to their respective activities under the Research Collaboration through the JRC. The JRC may determine other routes of information exchange.
Each Party shall appoint one employee to be its point of contact with responsibility for facilitating communication and collaboration between the Parties (each, an “Alliance Director”).
The Alliance Directors shall be permanent non-voting participants of the JRC meetings (but not Members of the JRC) and may attend JOT meetings as appropriate. The Alliance Directors shall facilitate resolution of potential and pending issues and
potential disputes to enable the JRC to reach consensus and avert escalation of such issues or potential disputes.
Each Party shall be responsible for its own expenses including travel and accommodation costs incurred in connection with their respective participation on the JRC, the JOTs and the JPCT.
|
6.7
|
Operational-Level Decisions
|
Notwithstanding the foregoing or anything in this Agreement to the contrary, as between the Parties each Party shall have the right to make its own Operational-Level Decisions relating to any Research Plan.
| 7. |
Development, Regulatory Affairs, Manufacturing and Commercialization
|
Following a Roche Ph0Go Decision with respect to any Program, Roche, at its sole cost and expense, shall be solely responsible for all further activities with respect to any Compounds generated during such Program,
including pre-clinical development, clinical development, manufacturing, Regulatory Approval and commercialization of such Compounds and any related Products.
Without limiting Roche’s obligations under Section 10.6, approximately [***], Roche shall provide Remix, upon Remix’s request, with a written report summarizing the pre-clinical and clinical development,
manufacturing, Regulatory Approval and commercialization of the Compound(s) or Product(s) under such Program by Roche, its Affiliates or Sublicensees during the preceding [***] period, and a high-level summary of the development, manufacturing,
Regulatory Approval and commercialization activities for Compounds and Products under such Program planned for the subsequent [***]. Following Roche’s delivery of such report to Remix or at time during each Calendar Year, but in no case more
frequently than once per Calendar Year, Roche will be available for a video conference or telephone call with Remix to discuss any such summary provided by Roche pursuant to this Section 7.2, in each case as reasonably requested by Remix.
If necessary, the Parties will enter into the relevant agreements under applicable data privacy laws (such as a data transfer agreement) when required. The terms of such agreement will be agreed upon by the Parties
when the requirement to enter into such agreement has been confirmed by the Parties. Under such an agreement each Party will agree to provide any personal data collected in any Clinical Study from patients, study participants, or specimen donors
(collectively, “Data Subjects”) to the other Party in a pseudonymized or de-identified manner as required by Applicable Law and not to disclose or otherwise make available to the other Party or give access to
the other Party any code allowing identification of Data Subjects.
Within [***] after Roche’s receipt of a corresponding invoice from Remix, which invoice may be provided by Remix to Roche as of the Effective Date, Roche shall pay to Remix a one-time upfront payment of thirty
million US dollars (US$ 30,000,000).
|
9.2
|
Research Event Payments
|
On a Program-by-Program basis, Roche shall pay up to a maximum total of [***] in relation to the achievements of research events. The research event payments under this Section 9.2 shall be paid by Roche according to
the following schedule:
[***]
*If a research milestone event is first reached by a Product containing a Late Derivative, the corresponding payment in this column shall be reduced by [***]. For clarity, if the research milestone event is reached
with a Product containing a Late Derivative derived from a Compound that has undergone at least one Tolerability Study the payments in this column shall not be subject to any reduction.
Each research event payment shall be paid only once per Program, the first time the Program reaches the applicable triggering event, regardless of the number of times such event is reached and regardless of the
number of Compounds from such Program later achieve the respective event.
The above event payments shall be paid by Roche to Remix within [***] of notice of achievement of the applicable milestone event and receipt of a corresponding invoice from Remix.
| 9.3 |
Development and Commercial Event Payments
|
On a Program-by-Program basis, Roche shall pay up to a maximum total of [***] in relation to the achievements of development and commercial events. The development and commercial event payments under this Section 9.3
shall be paid by Roche according to the following schedule:
[***]
* If the development or commercial milestone event is first reached by a Product containing a Late Derivative, the payments in this column shall be reduced by [***]. For clarity, if the development or commercial
milestone event is reached with a Product containing a Late Derivative derived from a Compound that has undergone at least one Tolerability Study the payments in this column shall not be subject to any reduction.
Each of the above development and commercial event payments shall be paid only once per Program, the first time the first Compound or Product from such Program, as applicable, reaches the applicable triggering event,
regardless of the number of Compounds or Products from such Program, as applicable, later achieve the respective event.
Upon achievement of a development or commercial event, Roche shall timely notify Remix, and the applicable event payments shall be paid by Roche to Remix within [***] after Roche’s receipt of a corresponding invoice
from Remix.
On a Product-by-Product basis, Roche shall pay Remix sales-based event payments on Calendar Year Net Sales of such Product during the Royalty Term applicable to such Product, up to a maximum total of [***].
[***]
* If the sales-based milestone event is reached by a Product containing a Late Derivative, the payments in this column shall be reduced by [***]. For clarity, if the sales-based milestone event is reached with a
Product containing a Late Derivative derived from a Compound that has undergone at least one Tolerability Study the payments in this column shall not be subject to any reduction.
Each of the sales based event payments shall be paid no more than once per Product. Upon the first achievement of each sales-based event set forth in this Section 9.4, Roche will promptly notify Remix after such
Calendar Year-end and will make the sales based event payment corresponding to such sales based event within [***] following Roche’s receipt of a corresponding invoice from Remix with respect thereto.
On a Product-by-Product and country-by-country basis, Roche shall pay to Remix royalties on Net Sales of Products during the applicable Royalty Term. As of the expiration of the Royalty Term with respect to a given
Product and country in the Territory, the license granted to Roche under Section 2.1.2 with respect to such Product and such country in the Territory shall automatically convert to a royalty-free, perpetual, exclusive and sublicensable license
under the Remix IP.
The following royalty rates shall apply during the applicable Royalty Term to the respective tiers of aggregate Calendar Year Net Sales of a Product in the Territory, on an incremental basis:
[***]
*If the Net Sales tier is reached by a Product containing a Late Derivative, the payments in this column shall be reduced by [***]. For clarity, if the Net Sales tier is reached by a Product containing a Late
Derivative derived from a Compound that has undergone at least one Tolerability Study the payments in this column shall not be subject to any reduction.
|
9.5.3
|
Royalty Adjustments
|
For the purpose of calculating royalties of a Product and subject to Section 9.7, Calendar Year Net Sales and the royalty rates shall be subject to the following adjustments, as applicable:
| 9.5.3.1 |
Combination Product
|
If Roche or its Affiliates intend to sell a Combination Product, then the Parties shall meet approximately [***] prior to the anticipated First Commercial Sale of such Combination Product in the Territory to
negotiate in good faith and agree to an appropriate adjustment to Net Sales to reflect the relative commercial value contributed by the components of the Combination Product (the “Relative Commercial Value”).
If, after such good faith negotiations not to exceed [***], the Parties cannot agree to an appropriate adjustment, the dispute shall be initially referred to the executive officers of the Parties in accordance with Section 22.2.
If the Parties are unable to agree on the Relative Commercial Value within [***] of such referral, then the Relative Commercial Value shall be determined by the following procedure. Roche will select one (1)
individual who would qualify as an Expert, Remix will select (1) individual who would qualify as an Expert, and those two (2) individuals shall select one (1) individual who would qualify as an Expert and who shall be chairman of a committee of the
three (3) Experts (the “Expert Committee”), each with a single deciding vote. The Expert Committee will promptly hold a meeting to review the issue under review, at which it will consider memoranda submitted
by each Party at least [***] before the meeting, as well as reasonable presentations that each Party may present at the meeting. The determination of the Expert Committee as to the issue under review will be binding on both Parties. The Parties
will share equally the costs of the Expert Committee. Unless otherwise agreed to by the Parties, the Expert Committee may not decide on issues outside the scope mandated under terms of this Agreement.
If no Valid Claim of a Remix Patent Right, Roche Compound Patent Right or Joint Patent Right would be infringed by the sale or approved use of a Product in a given country, then the royalty rates in Section 9.5.2
shall be [***].
| 9.5.3.3 |
Generic Competition
|
On a Product-by-Product and country-by-country basis, upon first market entry of a Generic Product in a given country prior to the end of the Royalty Term, if Net Sales of such Product in such country subsequently
decrease for [***], then the royalty rate due to Remix for such Product in such country pursuant to Section 9.5.2 shall be [***].
| 9.5.3.4 |
IRA Subject Product
|
If, as a direct result of any reduction in the price charged by Roche for any IRA Subject Product in the US which is mandated by the US government, the Net Sales of such IRA Subject Product in the US subsequently
[***], then the royalty rate due to Remix for such Product in the US pursuant to Section 9.5.2 shall be [***].
|
9.5.3.5
|
Third Party Payments
|
Roche shall be responsible for and pay or have paid any consideration owed by Roche to any Third Party as consideration for a license to Third Party intellectual property rights necessary to develop, make, use or
sell Products. Roche shall have the right to deduct [***], from any royalty payments otherwise due and payable by Roche to Remix under this Agreement. Any such deduction shall be permitted on a Product-by-Product and country-by-country basis.
| 9.6 |
Disclosure of Payments
|
Remix acknowledges that Roche may be obligated to disclose this financial arrangement, including all fees, payments and transfers of value, as may be advisable or required under Applicable Law, including the US
Sunshine Act.
In no event shall cumulative royalty reductions set forth in Section 9.5.3.3, Section 9.5.3.4, and Section 9.5.3.5 ever exceed [***] of the total royalties payable to Remix under this Agreement with respect to any
Calendar Quarter (“Royalty Floor”). [***].
| 10. |
Accounting and Reporting
|
Roche shall calculate royalties on Net Sales quarterly as of March 31, June 30, September 30 and December 31 (each being the last day of an “Accounting Period”) and shall pay
royalties on Net Sales within [***] after the end of each Accounting Period in which such Net Sales occur.
Any payment under this Agreement that is not paid on or before the date such payment is due shall bear interest, to the extent permitted by Applicable Law, at [***] above the average one-month Euro Interbank Offered
Rate (EURIBOR), as reported by Reuters from time to time, calculated on the number of days such payment is overdue.
Royalties on Net Sales and all other amounts payable by Roche hereunder shall be paid by Roche in US dollars (the “Payment Currency”) to account(s) designated by Remix.
When calculating the Sales of any Product that occur in currencies other than the Payment Currency, [***].
In a given country, if by reason of Applicable Law (for example governmental restrictions on foreign exchange trade) the local currency is blocked and cannot be removed from such country, Roche will notify Remix in
writing and
| (a) |
Remix will have the right to receive the applicable royalties of Net Sales in such country in local currency by deposit in a local bank designated by Remix, or
|
| (b) |
if such local currency payment is not allowed by reason of Applicable Law or if otherwise requested by Remix, then the royalties related to such Net Sales in such country shall continue to be accrued and shall
continue to be reported, but such royalties will not be paid until the sales proceeds related to such Net Sales may be removed from such country. At such time as Roche, its Affiliates or their Sublicensees, as the case may be, is able to
remove the sales proceeds related to such Net Sales from such country, Roche shall also pay such accrued royalties in Payment Currency using the actual exchange rate which is used to remove such sales proceeds from such country.
|
With each payment Roche shall provide Remix in writing for the relevant Calendar Quarter on a Product-by-Product basis the following information:
| (a) |
Sales in Swiss Francs;
|
| (b) |
Net Sales in Swiss Francs;
|
| (c) |
adjustments made pursuant to Section 9.5.3.1;
|
| (d) |
Net Sales in Swiss Francs after adjustments made pursuant to Section 9.5.3.1 in Swiss Francs;
|
| (e) |
exchange rate used for the conversion of Net Sales from Swiss Francs to the Payment Currency pursuant to Section 10.4;
|
| (f) |
Net Sales after adjustments made pursuant to Section 9.5.3.1 in the Payment Currency;
|
| (g) |
royalty rate pursuant to Section 9.5.2;
|
| (h) |
adjustments made pursuant to Sections 9.5.3.2 through 9.5.3.4 and 9.5.3.5; and
|
| (i) |
total royalty payable in the Payment Currency after adjustments made pursuant to Sections 9.5.3.2 through 9.5.3.4 and 9.5.3.5.
|
Remix shall pay all sales, turnover, income, revenue, value added, and other taxes levied on account of any payments accruing or made to Remix under this Agreement.
If provision is made in law or regulation of any country for withholding of taxes of any type, levies or other charges with respect to any royalty or other amounts payable under this Agreement to Remix, then Roche
shall promptly pay such tax, levy or charge for and on behalf of Remix to the proper governmental authority, and shall promptly furnish Remix with receipt of payment. Roche shall be entitled to deduct any such tax, levy or charge actually paid from
royalty or other payment due Remix or be promptly reimbursed by Remix if no further payments are due to Remix. Each Party agrees to reasonably assist the other Party in claiming exemption from such deductions or withholdings under double taxation
or similar agreement or treaty from time to time in force and in minimizing the amount required to be so withheld or deducted.
| 12.1 |
Remix Right to Audit
|
Roche shall keep, and shall require its Affiliates and Sublicensees to keep, full, true and accurate books of account containing all particulars that may be necessary for the purpose of calculating all royalties
payable under this Agreement. Such books of accounts shall be kept at their principal place of business. At the expense of Remix, Remix shall have the right to engage an internationally recognized independent public accountant reasonably acceptable
to Roche to perform, on behalf of Remix, an audit of such books and records of Roche and its Affiliates and Sublicensees that are deemed necessary by the independent public accountant to report on Net Sales of Product for the period or periods
requested by Remix and the correctness of any financial report or payments made under this Agreement.
| 12.1.1 |
Timeframe for Audits
|
Upon timely request and at least [***] prior written notice from Remix, such audit shall be conducted for those countries Remix has specifically requested, during regular business hours in such a manner as to not
unnecessarily interfere with Roche’s normal business activities. Such audit shall be limited to results in the [***] prior to audit notification, and if Remix requests an audit for a given Calendar Year, no additional audits may be conducted in the
Territory for such Calendar Year. If Remix does not request an audit of a given Calendar Year on or before the [***] of the end of such Calendar Year, then Remix will be deemed to have accepted the royalty payments and reports in such Calendar
Year.
Such audit shall not be performed more frequently than [***] per Calendar Year nor more frequently than [***] with respect to records covering any specific period of time.
| 12.1.3 |
Protection of Information
|
All information, data documents and abstracts herein referred to shall be used only for the purpose of verifying royalty statements, shall be treated as Roche’s Confidential Information subject to the obligations of
this Agreement and need neither be retained more than [***] after completion of an audit hereof, if an audit has been requested; nor more than [***] from the end of the Calendar Year to which each shall pertain; nor more than [***] after the date
of termination of this Agreement.
The auditors shall only state factual findings in the audit reports and shall not interpret this Agreement. The auditors shall share all draft audit findings first with Roche and then with Remix before the final
audit report is issued. The final audit report shall be shared with Roche at the same time it is shared with Remix.
| 12.3 |
Over-or Underpayment
|
If the audit reveals an overpayment, Remix shall reimburse Roche for the amount of the overpayment within [***]. If the audit reveals an underpayment, Roche shall make up such underpayment with the next royalty
payment or, if no further royalty payments are owed by Roche, Roche shall reimburse Remix for the amount of the underpayment within [***]. Roche shall pay for the audit costs if the underpayment of Roche exceeds [***] of the aggregate amount of
royalty payments owed with regard to the royalty statements subject to the audit. Section 10.2 shall apply to this Section 12.3.
| 13. |
Intellectual Property
|
| 13.1 |
Ownership of Inventions
|
Remix shall remain the owner of Remix Background IP and Roche shall remain the owner of the Roche Background IP.
Remix shall own (a) all Inventions and Know-How, including any Patent Rights claiming such Inventions or Know-How, specifically relating to Remix Platform Technology made and generated by or on behalf of either Party
or both Parties in the course of conducting the Research Collaboration during the Collaboration Term, and (b) all Inventions and Know-How, including any Patent Rights claiming such Inventions or Know-How, [***].
[***]
With regard to all other Inventions and Know-How, ownership shall follow inventorship and Remix shall own all Remix Inventions, Roche shall own all Roche Inventions, and Remix and Roche shall jointly own all Joint
Inventions. For that purpose, the determination of inventorship for Inventions shall be in accordance with US inventorship laws as if such Inventions were made in the US. For the avoidance of doubt, any Inventions or Know-How, including any
“back-up” compositions of matter, which Remix makes or generates at the request of Roche following a Roche Ph0Go Decision with respect to any Program, as documented in an amendment to the Research Plan and an extension of the Collaboration Term for
such Program, shall not be [***] and ownership of such Inventions and Know-How shall follow inventorship.
During the Agreement Term, each Party will disclose to the other Party all Inventions and Know-How generated during the Collaboration Term of which such Party becomes aware. Such disclosure shall (A) be made promptly
and in any event reasonably prior to the filing of any patent application with respect to such Inventions and Know-How, and (B) include all invention disclosures or other similar documents submitted to such Party by its or its Affiliates’
employees, independent contractors, or other agents relating thereto. In addition, each Party shall execute and deliver all documents and instruments reasonably requested by the other Party to evidence or record any assignments of intellectual
property contemplated herein.
Remix and Roche shall each have an equal undivided share in the Joint Intellectual Property, and, subject to (a) any exclusivity obligations under this Agreement and (b) any licenses granted by one Party to the other
Party under this Agreement, without obligation to account to the other for exploitation thereof, or to seek consent of the other Party for the grant of any license thereunder. The Parties will have the right to enforce such Joint Intellectual
Property as set forth in Section 13.7 or as otherwise agreed by the Parties in writing. To the extent necessary in any jurisdiction to give effect to the foregoing, each Party hereby grants to the other Party a non-exclusive, royalty-free,
fully-paid, worldwide license, with the right to grant sublicenses, to practice such Joint Intellectual Property for any and all purposes, subject to (aa) any exclusivity obligations under this Agreement and (bb) any licenses granted by one Party
to the other Party under this Agreement.
| 13.2 |
Prosecution of Patent Rights
|
During the Collaboration Term for a given Program, except as expressly provided below, Remix shall have the first right to Handle, at Remix’s cost and expense, the Remix Arising Patent Rights, the Joint Patent Rights
and the Remix Background Patent Rights, if any, that relate to such Program (collectively, the “Remix Prosecuted Research Patent Rights”). Remix will inform the JPCT before making any decisions, filings,
submissions, notices, payments, abonnements, etc., with respect to any Remix Prosecuted Research Patent Rights claiming Compounds or Products and shall provide Roche via the JPCT with copies of all documents relevant to the Handling of Remix
Prosecuted Research Patent Rights claiming Compounds or Products. Remix shall provide such documents to and consult with Roche in sufficient time before any action by Remix is due to allow Roche to review the matter and provide comments, which
Remix must consider in good faith. If the JPCT is unable to reach agreement regarding the Handling of Remix Prosecuted Research Patent Right claiming Compounds or Products, then Remix will have the decision-making authority for such matters.
If Remix determines to finally abandon, to not maintain, or to otherwise cease prosecution and maintenance of any Remix Arising Patent Rights or Joint Patent Rights that disclose, claim or Cover any Compounds or
Products, then Remix shall provide Roche with written notice of such determination within a period of time sufficiently in advance (which shall be no later than [***] prior to any final deadline for any pending action or response that may be due
with respect to such Patent Right with the applicable patent authority) to enable Roche to assume responsibility for the Handling of such Patent Right. Following such notification by Remix, Roche shall have the right to assume responsibility for
such Patent Right at its cost and expense. Upon completion of such transfer of responsibility, Roche shall have the right to Handle such Patent Right in such country at its cost and expense, in Remix’s name or in both Remix’s and Roche’s names, as
applicable, and such Patent Right shall not be considered a Remix Patent Right or Joint Patent Right for purposes of calculating Roche’s royalty obligations to Remix under Section 9.5.2.
On a Program-by-Program basis, from and after the Roche Ph0Go Decision for any Compounds generated in such Program, [***]. Roche shall provide such documents to and consult with Remix in sufficient time before any
action by Roche is due to allow Remix to review the matter and provide comments, which Roche must consider in good faith. If the JPCT is unable to reach agreement regarding the Handling of Remix Arising Patent Right claiming Compounds or Products,
then Roche will have the decision-making authority for such matters.
If Roche determines to finally abandon, to not maintain, or to otherwise cease prosecution and maintenance of any Remix Arising Patent Rights or Joint Patent Rights for a given Program, then Roche shall provide Remix
with written notice of such determination within a period of time sufficiently in advance (which shall be no later than [***] prior to any final deadline for any pending action or response that may be due with respect to such Patent Right with the
applicable patent authority) to enable Remix to assume responsibility for the Handling of such Patent Right. Following such notification by Roche, Remix shall have the right to assume responsibility for the Handling of such Patent Right in such
country at its cost and expense. Upon completion of the transfer of responsibility for the Handling of such Patent Right to Remix, such Patent Right shall cease to be a Remix Patent Right or Joint Patent Rights for all purposes of this Agreement,
including the license grant to Roche under Section 2.1.2 and Roche shall assign all of its right, title and interest in and to such Joint Patent Right(s) to Remix, at no charge.
[***]
| 13.3 |
Prosecution of Roche Patent Rights and Joint Patent Rights
|
Roche shall, at its own expense and discretion, Handle all Roche Patent Rights.
Should Roche decide that it does not desire to Handle a Roche Compound Patent Right for a given Program, it shall promptly advise Remix thereof. At the written request of Remix, Roche shall then assist Remix at
Remix’s cost, and Remix may thereafter Handle the same in Roche’s name and at Remix’s own cost, to the extent that Remix desires to do so.
Each Party will reasonably cooperate with the other Party in the Handling of Patent Rights pursuant to this Agreement. Such cooperation includes participation in the JPCT, promptly executing all documents, or
requiring inventors, subcontractors, Sublicensees, employees, former employees (to the extent reasonably available) and consultants and agents to execute all documents, as reasonable and appropriate so as to effect the Parties’ respective ownership
rights and enable the Handling of any such Patent Rights in any country.
| 13.5 |
Unified Patent Court (Europe)
|
At any time prior to the end of the “transitional period” as such term is used in Article 83 of the Agreement on a Unified Patent Court between the participating Member States of the European Union, for a given
relevant Remix Patent Right filed in the EU, Roche may request in writing that Remix (i) opt out from the exclusive competence of the Unified Patent Court or (ii) if applicable, withdraw a previously-registered opt-out, and Remix shall consider
such request in good faith. In the event Remix elects to accept Roche’s request it shall notify the Registry, pay any such registry fee and take such other action as may be necessary to effect the opt-out or opt-out withdrawal, as applicable, in a
timely manner.
It is the intention of the Parties that this Agreement is a “joint research agreement” as that phrase is defined in 35 USC § 102(c) (AIA). In the event that either Party to this Agreement intends to overcome a
rejection of a claimed invention Covered by Joint Patent Rights or the Remix Patent Rights pursuant to the provisions of 35 USC §§ 102(a)-(d), such Party shall first obtain the prior written consent of the other Party. Following receipt of such
written consent, such Party shall limit any amendment to the specification or statement to the patent office with respect to this Agreement to that which is strictly required by the applicable subsection of 35 USC § 102 and the rules and
regulations promulgated thereunder and which is consistent with the terms and conditions of this Agreement (including the scope of the Research Collaboration). To the extent that the Parties agree that, in order to overcome a rejection of a claimed
invention Covered by Joint Patent Rights or the Remix Patent Rights pursuant to the provisions of the applicable subsection of 35 USC § 102, if the filing of a terminal disclaimer is required or advisable, the Parties shall first agree on terms and
conditions under which the patent application subject to such terminal disclaimer and the patent or application over which such application is disclaimed shall be jointly enforced, to the extent that the Parties have not previously agreed to such
terms and conditions. In the event that Roche enters into an agreement with a Third Party with respect to the further research, development or commercialization of a Product, Remix shall, upon Roche’s request, similarly enter into such agreement
with such Third Party for the sole purpose of furthering the Parties’ objectives under this Agreement as a “joint research agreement” under this Section 13.6, provided that such agreement does not place any material obligation on Remix.
Each Party shall promptly provide written notice to the other Party during the Agreement Term of any known infringement or suspected infringement or violation by a Third Party of [***] in the Field in the Territory
as a result of the making, using, offering to sell, selling or importing of a product or compound that would be competitive with a Product or Compound (a “Competitive Infringement”), and shall provide the
other Party with all evidence in its possession supporting such Competitive Infringement. The Parties will consult with each other regarding any actions to be taken with respect to such Competitive Infringement. For the avoidance of doubt, the term
“Competitive Infringement” includes any counterclaims alleging that a [***] is invalid or unenforceable or that a product or process does not infringe or misappropriate a [***].
| 13.7.2 |
Enforcement Actions
|
Within [***] after Roche provides or receives the aforementioned written notice of a Competitive Infringement (“Decision Period”), Roche, in its sole discretion, shall decide
whether or not to initiate a suit or action in the Territory to enforce any [***] against such Competitive Infringement with respect to any Compound or Product or the Exploitation thereof and to defend any declaratory judgment action with respect
thereto, in the Territory as it reasonably determines appropriate, at its own expense and in the name of Roche or any of its Affiliates (an “Enforcement Action”); provided, however,
that Roche may not bring any Enforcement Action to enforce any Remix Background Patent Right under this Section 13.7.2 unless [***]. In the event Remix does not provide its consent for Roche to bring an Enforcement Action to enforce any Remix
Background Patent Right under clause (c) of this Section 13.7.2, Roche shall be entitled to a [***] reduction in the applicable royalty rates for the Net Sales occurring in the Territory where, and during any Calendar Quarter in which, the
Competitive Infringement results in [***]. Notwithstanding the foregoing, if the Royalty Term of a given Product in a given country is continuing solely on the basis of Section 1.104(b) (and it has been more than twelve (12) years since the date of
the First Commercial Sale in such country of the Product impacted by the Competitive Infringement) when Remix does not provide its consent for Roche to bring an Enforcement Action to enforce any Remix Background Patent Right under clause (c) of
this Section 13.7.2, the Royalty Term for such Product in such country shall immediately end upon Remix’s notice that it does not consent for Roche to bring an Enforcement Action and the license granted to Roche under Section 2.1.2 with respect to
such Product and such country in the Territory shall automatically convert to a royalty-free, perpetual exclusive and sublicensable license under the Remix IP.
| 13.7.3 |
Remix Right to Enforce
|
Roche shall notify Remix of its decision whether or not to initiate an Enforcement Action in writing (“Suit Notice”), subject to Section 13.7.2, within the Decision Period. If
Roche decides to bring an Enforcement Action, once Roche provides Suit Notice, Roche may immediately commence such suit or take such action. In the event that Roche (a) does not in writing advise Remix within the Decision Period that Roche will
commence suit or take action, or (b) fails to commence suit or take action within a reasonable time after providing Suit Notice, Remix shall thereafter have the right to (i) commence suit or take action in the Major Countries and shall provide
written notice to Roche of any such suit commenced or action taken by Remix, and (ii) subject to Roche’s written consent, which shall not be unreasonably withheld, commence suit or take action in a country that is not a Major Country and shall
provide written notice to Roche of any such suit commenced or action taken by Remix. It would be unreasonable for Roche to withhold such consent unless Roche has a bona fide strategic reason for such
decision (as an example, intention to avoid or reduce any payments payable to Remix as set forth in Article 9 is not a bona fide strategic reason), after considering, reasonably and in good faith, all
input received from Remix.
The Party bringing an Enforcement Action (“Initiating Party”) shall keep the other Party reasonably informed of the status and progress of any such Enforcement Action and shall
provide the other Party with copies, to the extent the Initiating Party is lawfully permitted to do so, of all substantive documents or communications filed in such Enforcement Action. The Initiating Party shall have the sole and exclusive right to
select counsel for any such suit or action.
| 13.7.5 |
Expenses and Recoveries
|
The Initiating Party shall, except as provided below, pay all expenses of the suit or action, including the Initiating Party’s attorneys’ fees and court costs. Unless otherwise agreed by the Parties, and subject to
the Parties’ respective obligations under Article 16, all monies recovered upon the final judgment or settlement of any Enforcement Action described in this Section 13.7.5 or H-W Enforcement Action shall be used as follows:
| (a) |
First, to reimburse the Parties for their respective costs and expenses in making such recovery (which amounts shall be allocated pro rata based on each Party’s
respective costs and expenses if insufficient to cover the totality of such expenses); and
|
|
(i) |
if a member of the Roche Group is the Initiating Party, any remaining amount that represents compensation for lost sales, a reasonable royalty or lost profits, shall be retained by the Initiating Party and, after
relevant adjustment to convert to Net Sales of Products, shall be subject to the royalty obligations set forth in Section 9.5;
|
|
(ii) |
if Remix is the Initiating Party, any remaining amount that represents compensation for lost sales, a reasonable royalty or lost profits shall be allocated [***] to the Initiating Party, and [***] to the other
Party; and
|
|
(iii) |
any remaining amount that represents additional damages (e.g., enhanced or punitive damages) shall be retained by the Initiating Party.
|
If the Initiating Party believes it is reasonably necessary or desirable to obtain an effective remedy, upon written request the other Party agrees to be joined as a party to the Enforcement Action but shall be under
no obligation to participate except to the extent that such participation is required as the result of its being a named party to the Enforcement Action. At the Initiating Party’s written request, the other Party shall offer reasonable assistance
to the Initiating Party in connection therewith at no charge to the Initiating Party except for reimbursement of reasonable out-of-pocket expenses incurred by the other Party in rendering such assistance. The other Party shall have the right to
participate and be represented in any such suit or action by its own counsel at its own expense.
The Initiating Party may settle, consent judgment or otherwise voluntarily dispose of the suit or action (“Settlement”) without the written consent of the other Party but only
if such Settlement can be achieved without (a) imposing any monetary restriction or obligation on or admit fault of the other Party, (b) adversely affecting the other Party’s rights under this Agreement to any such Patent Right being enforced or
defended, including any abandonment or intentional failure to maintain such Patent Right then being enforced or defended, in which case ((a) or (b)), written consent of the other Party would be required, which shall not be unreasonably withheld.
| 13.7.8 |
Roche Patent Rights other than [***]
|
[***]
| 13.7.9 |
Remix Patent Rights
|
Subject to Section 13.7.2, Remix will have the sole right, but not the obligation, to bring and control any legal action to enforce any Remix Background Patent Rights against any Third Party infringement of any such
Patent Right that is not a Competitive Infringement. In addition, Remix will have the sole right, but not the obligation, to bring and control any legal action to enforce any Remix Arising Patent Rights against any Third Party infringement of any
such Patent Right that is not a Competitive Infringement; provided, however, that if Remix wishes to bring and control any legal action to enforce any Remix Arising Patent Rights containing a royalty-bearing Composition of Matter Claim against any
Third Party infringement of any such Patent Right that is not a Competitive Infringement, Remix shall obtain Roche’s prior written consent, which shall not be unreasonably withheld, conditioned or delayed.
If an action for infringement is commenced against either Party related to the conduct of the Research Collaboration or the discovery, development, manufacture, use or sale of a Product, then such Party shall have
the right (but not the obligation) to defend such action at its own expense, and the other Party shall assist and cooperate with such Party, at such Party’s expense, to the extent necessary in the defense of such suit. The Party defending against
the action shall have the right to settle the suit or consent to an adverse judgment thereto, in its sole discretion, so long as such settlement or adverse judgment does not adversely affect the rights of the other Party (including any Patent
Rights Controlled by such Party). Subject to Section 9.5.3.5 and without limiting either Party’s obligations under Article 16, the Party defending against any such action shall assume full responsibility for the payment of any award for damages, or
any amount due pursuant to any settlement entered into by it with such Third Party.
| 13.9 |
Common Interest Disclosures
|
With regard to any information or opinions disclosed pursuant to this Agreement by one Party to each other regarding intellectual property or technology owned by Third Parties, the Parties agree that they have a
common legal interest in determining whether, and to what extent, Third Party intellectual property rights may affect the conduct of the Research Collaboration or Compounds or Products, and have a further common legal interest in defending against
any actual or prospective Third Party claims based on allegations of misuse or infringement of intellectual property rights relating to the conduct of the Research Collaboration or Compounds or Products. Accordingly, the Parties agree that all such
information and materials obtained by Remix and Roche from each other will be used solely for purposes of the Parties’ common legal interests with respect to the conduct of this Agreement. All information and materials will be treated as protected
by the attorney-client privilege, the work product privilege, and any other privilege or immunity that may otherwise be applicable. By sharing any such information and materials, neither Party intends to waive or limit any privilege or immunity
that may apply to the shared information and materials. Neither Party shall have the authority to waive any privilege or immunity on behalf of the other Party without such other Party’s prior written consent, nor shall the waiver of privilege or
immunity resulting from the conduct of one Party be deemed to apply against any other Party. Notwithstanding the foregoing, neither Party’s attorney represents the other Party.
Notwithstanding anything herein to the contrary, should a Party receive a certification for a Product pursuant to paragraph IV of the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417,
known as the Hatch-Waxman Act), as amended, or its equivalent in a country other than the US (“Certification Notice”), then such Party shall immediately (in any case within [***]) provide the other Party with
a copy of the Certification Notice. Roche shall have [***] from the date on which it receives or provides the copy of the Certification Notice, to provide written notice to Remix (“H-W Suit Notice”) that
Roche intends to bring suit (“H-W Enforcement Action”), at its expense, within the [***] set forth in paragraph IV of the Hatch-Waxman Act. Should such [***] expire without Roche bringing suit or providing
such H-W Suit Notice, then Remix shall be free to immediately bring an H-W Enforcement Action, at its expense, in its name.
| 13.11 |
Patent Term Extensions
|
The Parties shall use Commercially Reasonable Efforts to obtain all available patent term extensions, adjustments or restorations, or supplementary protection certificates (“SPCs”,
and together with patent term extensions, adjustments and restorations, “Patent Term Extensions”) with regard to any Remix Patent Rights, Joint Patent Rights or Roche Compound Patent Rights Covering each
Product. Remix shall execute such authorizations and other documents and take such other actions as may be reasonably requested by Roche to obtain such Patent Term Extensions, including designating Roche as its agent for such purpose as provided in
35 USC § 156. All filings for such Patent Term Extensions shall be made by Roche; provided, that in the event that Roche elects not to file for a Patent Term Extension, Roche shall (a) promptly inform Remix of its intention not to file and (b)
grant Remix the right to file for such Patent Term Extension. Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain such extensions.
| 14. |
Remix Representations and Warranties
|
Remix hereby represents and warrants, as of the Effective Date, that:
| 14.1 |
Third Party Licenses
|
Remix has not entered into any Third Party agreements pursuant to which it has in-licensed any of the intellectual property licensed to Roche under this Agreement.
|
14.2
|
Ownership of Patent Rights
|
Remix is the sole and exclusive owner of the Remix Patent Rights. No other parties have any right, title or interest in or to the Remix Patent Rights. The Remix Patent Rights are free and clear of all liens, claims,
security interests and other encumbrances of any kind or nature.
The execution, delivery and performance of this Agreement by Remix and all instruments and documents to be delivered by Remix hereunder: (a) are within the corporate power of Remix; (b) have been duly authorized by
all necessary or proper corporate action; (c) are not in contravention of any provision of the certificate of incorporation of Remix; (d) to the knowledge of Remix, will not violate any law or regulation or any order or decree of any court of
governmental instrumentality to which Remix is bound; (e) will not violate the terms of any indenture, mortgage, deed of trust, lease, agreement, or other instrument to which Remix is a party or by which Remix or any of its property is bound, which
violation would have an adverse effect on the financial condition of Remix or on the ability of Remix to perform its obligations hereunder; and (f) do not require any filing or registration with, or the consent or approval of, any Regulatory
Authority which has not been made or obtained previously (other than Regulatory Approvals from Regulatory Authorities required for the sale of Products).
| 14.4 |
Validity of Patent Rights
|
Remix is not in possession of any information that would, in Remix’s reasonable opinion, render invalid or unenforceable any claims in any Remix Patent licensed to Roche pursuant to this Agreement. Remix has no
knowledge of any inventorship disputes concerning any Remix Patent Rights.
| 14.5 |
Ownership and Legitimacy of Know-How
|
The Remix Know-How is owned by Remix and has not been misappropriated from any Third Party. Remix has taken reasonable measures to protect the confidentiality of the Remix Know-How which it considers to be Remix
Confidential Information.
To Remix’s knowledge here are no claims or investigations, pending or threatened against Remix or any of its Affiliates, at law or in equity, or before or by any governmental authority relating to the matters
contemplated under this Agreement or that would materially adversely affect Remix’s ability to perform its obligations hereunder.
Neither Remix nor any of its Affiliates is under any obligation to any person, contractual or otherwise, that is conflicting with the terms of this Agreement or that would impede the fulfillment of Remix’s
obligations hereunder.
Remix represents and warrants that neither Remix nor Remix’s employees have ever been debarred under 21 U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal Health Care Program (as
defined in 42 U.S.C §1320 a-7b(f)), including without limitation the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar Federal or state agency or program. Remix
will notify Roche immediately in writing if any such investigation, disqualification, debarment or ban occurs.
| 14.9 |
No Other Representations and Warranties
|
THE FOREGOING REPRESENTATIONS AND WARRANTIES IN THIS ARTICLE 14 ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, AND REMIX HEREBY DISCLAIMS ALL OTHER WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF PRODUCTS. MATERIALS PROVIDED UNDER SECTION 4.6 ARE PROVIDED “AS IS”.
| 15. |
Roche Representations and Warranties
|
Roche hereby represents and warrants, as of the Effective Date, that:
The execution, delivery and performance of this Agreement by Roche and all instruments and documents to be delivered by Roche hereunder: (a) are within the corporate power of Roche; (b) have been duly authorized by
all necessary or proper corporate action; (c) are not in contravention of any provision of the certificate of incorporation or similar governing document of Roche; (d) to the knowledge of Roche, will not violate any law or regulation or any order
or decree of any court of governmental instrumentality to which Roche is bound; (e) will not violate the terms of any indenture, mortgage, deed of trust, lease, agreement, or other instrument to which Roche is a party or by which Roche or any of
its property is bound, which violation would have an adverse effect on the financial condition of Roche or on the ability of Roche to perform its obligations hereunder; and (f) do not require any filing or registration with, or the consent or
approval of, any Regulatory Authority which has not been made or obtained previously (other than Regulatory Approvals from Regulatory Authorities required for the sale of Products).
Neither Roche nor any of its Affiliates is under any obligation to any person, contractual or otherwise, that is conflicting with the terms of this Agreement or that would impede the fulfillment of Roche’s
obligations hereunder.
Roche Controls the Roche Background IP.
| 15.4 |
No Other Representations and Warranties
|
THE FOREGOING REPRESENTATIONS AND WARRANTIES IN THIS ARTICLE 15 ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, AND ROCHE HEREBY DISCLAIMS ALL OTHER WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF PRODUCTS. MATERIALS PROVIDED UNDER SECTION 4.6 ARE PROVIDED “AS IS”.
| 16.1 |
Indemnification by Roche
|
Roche shall indemnify, hold harmless and defend Remix, Remix’s Affiliates and their respective directors, officers, employees and agents, successors and assigns (collectively, “Remix
Indemnitees”) from and against any and all losses, expenses, and costs (including without limitation reasonable attorneys’ fees, damages, judgments, fines and amounts paid in settlement) Remix’s Indemnitees become legally obligated to pay
to Third Parties, all to the extent resulting from claims, suits, proceedings or causes of action brought by any Third Party against such Remix Indemnitee that arise out of, or are based on, the breach of this Agreement by Roche, activities related
to this Agreement conducted by or on behalf of Roche or its Affiliates or Sublicensees and for which Roche is expressly responsible, or activities related to the Product (e.g. product liability claims) conducted by or on behalf of Roche or its
Affiliates or Sublicensees, and in each case except if and to the extent such losses, expenses, and costs are due to the breach of this Agreement by Remix or the negligent acts or omissions or willful misconduct of Remix Indemnitees.
| 16.2 |
Indemnification by Remix
|
Remix shall indemnify, hold harmless and defend Roche, Roche’s Affiliates and their respective directors, officers, employees and agents, successors and assigns (collectively, “Roche
Indemnitees”) from and against any and all losses, expenses, and costs (including without limitation reasonable attorneys’ fees, damages, judgments, fines and amounts paid in settlement) Roche Indemnitees become legally obligated to pay to
Third Parties, all to the extent resulting from claims, suits, proceedings or causes of action brought by any Third Party against such Roche Indemnitee that arise out of, or are based on, the breach of this Agreement by Remix or activities related
to this Agreement conducted by or on behalf of Remix and for which Remix is expressly responsible, and except if and to the extent such losses, expenses, costs and amounts are due to the breach of this Agreement by Roche or its Affiliates or the
negligent acts or omissions or willful misconduct of Roche Indemnitees.
In the event of a claim by a Third Party against a Party entitled to indemnification under this Agreement (“Indemnified Party”), the Indemnified Party shall promptly notify the
other Party (“Indemnifying Party”) in writing of the claim and the Indemnifying Party shall undertake and solely manage and control, at its sole expense, the defense of the claim and its settlement. The
Indemnified Party shall cooperate with the Indemnifying Party and may, at its option and expense, be represented in any such action or proceeding by counsel of its choice. The Indemnifying Party shall not be liable for any litigation costs or
expenses incurred by the Indemnified Party without the Indemnifying Party’s written consent. The Indemnifying Party shall not settle any such claim unless such settlement fully and unconditionally releases the Indemnified Party from all liability
relating thereto, unless the Indemnified Party otherwise agrees in writing.
| 17. |
Limitation of Liability
|
EXCEPT FOR INDEMNIFICATION UNDER ARTICLE 16 AND IN THE EVENT OF DAMAGES CAUSED BY GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF THE DAMAGING PARTY, NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY
SPECIAL, INCIDENTAL, INDIRECT, CONSEQUENTIAL OR PUNITIVE DAMAGES, OR ANY LOST PROFITS IN CONNECTION WITH THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY, OR OTHERWISE,
IN CONNECTION WITH OR ARISING IN ANY WAY OUT OF THE TERMS OF THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR IF ANY SPECIFIED REMEDY FAILS OF ITS ESSENTIAL PURPOSE.
| 18. |
Confidential Information; Information Security Incident
|
| 18.1 |
Non-Use and Non-Disclosure
|
During the Agreement Term and for [***] thereafter, a Receiving Party shall (a) treat Confidential Information provided by Disclosing Party as it would treat its own information of a similar nature, (b) take all
reasonable precautions not to disclose such Confidential Information to Third Parties, without the Disclosing Party’s prior written consent, and (c) not use such Confidential Information other than for fulfilling its obligations under this
Agreement.
| 18.2 |
Permitted Disclosure
|
Notwithstanding the obligation of non-use and non-disclosure set forth in Section 18.1, the Parties recognize the need for certain exceptions to this obligation, specifically set forth below, with respect to press
releases, Patent Rights, publications, certain commercial considerations or court or administrative order.
Remix may issue a press release announcing the existence and selected key terms of this Agreement, in the form attached as Appendix 18.3, within [***] following the Effective Date.
Roche may issue press releases in accordance with its internal policy that typically does not issue a press release until proof of concept has been achieved for a Compound. If Roche intends to make reference to Remix
in the press release, Roche shall provide Remix with a copy of any draft press release related to the activities contemplated by this Agreement at least [***] prior to its intended publication for Remix’s review. Remix may provide Roche with
suggested modification to the draft press release. Roche shall consider Remix’s suggestions in issuing its press release.
Remix shall only issue press releases related to the activities contemplated by this Agreement that either (a) have been approved by Roche or (b) are required to be issued by Remix as a matter of law and Remix has a
competent legal opinion to that effect. In all circumstances, Remix shall provide Roche with a draft press release at least [***] prior to its intended publication for Roche’s review. During such period, Roche shall (i) if applicable to such
release, approve the draft press release and permit Remix to issue the press release, (ii) contact Remix to discuss modification to the draft press release, or (iii) if applicable to such release, contact Remix and disapprove the press release. If
Roche asks for modification, then Remix shall either make such modification or work with Roche to arrive at a press release that Roche approves, if applicable. If Remix issues a press release which expressly requires Roche’s prior approval
hereunder without Roche’s approval, then Remix must obtain a competent legal opinion that the release was required to be issued by Remix as a matter of law.
To ensure communication alignment, responses (if any) to inquiries by media or other Third Parties after issuance of a permitted press release by Remix (solely or jointly with Roche) shall consist solely of the press
release language or shall follow the response guidelines that may be mutually developed by the Parties.
During the Agreement Term, the following restrictions shall apply with respect to disclosure by any Party of Confidential Information relating to the Product in any publication or presentation:
| (a) |
Both Parties acknowledge that it is their policy for the studies and results thereof to be registered and published in accordance with their internal guidelines. Roche, in accordance with its internal policies and
procedures, shall have the right to publish all studies, clinical trials and results thereof on the clinical trial registries that are maintained by or on behalf of Roche. Remix shall not publish any studies, clinical trials or results
thereof on its clinical trial registry, provided however, that Roche’s clinical trial registry can be accessed via a link from Remix’s clinical trial registry.
|
| (b) |
A Party (“Publishing Party”) shall provide the other Party with a copy of any proposed publication or presentation at least [***] prior to submission for publication so as
to provide such other Party with an opportunity to recommend any changes it reasonably believes are necessary to continue to maintain the Confidential Information disclosed by the other Party to the Publishing Party in accordance with the
requirements of this Agreement. The incorporation of such recommended changes shall not be unreasonably refused; and if such other Party notifies (“Publishing Notice”) the Publishing Party in writing,
within [***] after receipt of the copy of the proposed publication or, that such publication or presentation in its reasonable judgment (i) contains an invention, solely or jointly conceived or reduced to practice by the other Party, for
which the other Party reasonably desires to obtain patent protection or (ii) could be expected to have a material adverse effect on the commercial value of any Confidential Information disclosed by the other Party to the Publishing Party,
the Publishing Party shall prevent such publication or delay such publication for a mutually agreeable period of time. In the case of inventions, a delay shall be for a period reasonably sufficient to permit the timely preparation and
filing of a patent application(s) on such invention, and in no event less than [***] from the date of the Publishing Notice.
|
| 18.5 |
Commercial Considerations
|
Nothing in this Agreement shall prevent Roche or its Affiliates from disclosing Confidential Information of Remix to (a) governmental agencies to the extent required or useful to secure Regulatory Approval for the
development, manufacture or sale of Product in the Territory, (b) Third Parties acting on behalf of Roche, to the extent reasonably necessary or useful for the in connection with Roche’s development, manufacture or sale of Product in the Territory,
(c) Third Parties requesting clinical trial data information (in accordance with Roche’s then-current data sharing policy) or (d) Third Parties to the extent reasonably necessary or useful to market the Product in the Territory; provided, however,
that in the case of any disclosures pursuant to (b), (c) or (d) above, such Third Parties are subject to confidentiality and non-use obligations with respect to the Remix Confidential Information for at least [***] and which are otherwise
equivalent to those set forth in Article 18. The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with
Applicable Law, to defend or prosecute litigation or to comply with governmental regulations, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party and, to the extent practicable, takes
reasonable and lawful actions to minimize the degree of such disclosure.