Document:

Exhibit 10.3

 

Grandparents.com, Inc.

589 EIGHTH AVENUE, 6TH FLOOR

NEW YORK, NY 10018

 

June 10, 2016

 

John Sweeney

19 Lawson Lane

Ridgefield, CT 06877

 

		Re:	Consulting Services Agreement

 

Dear John,

 

Grandparents.com, Inc. a Delaware corporation
(the “Company”), desires to engage you (“you” or “Consultant”) to provide
the professional services as described below. Accordingly, the Company has offered and Consultant has accepted the terms and conditions
for consulting services set forth in this letter agreement (the “Agreement”).

 

1.     Term. The term of this Agreement
shall commence on September 10, 2015 and shall continue in effect, unless terminated pursuant to Paragraph 5 of this Agreement
(the “Term”).

 

2.     Services
to be Provided. During the Term, Consultant shall provide various services (the “Services”) set forth on
Exhibit A attached hereto. All Services shall be performed in a skillful and professional manner, in compliance
with all applicable laws and regulations, and in accordance with the Consultant’s and Company’s Code of Conduct, as
applicable.

 

3.     Fees,
Warrants, and Other Related Matters. 

 

(a)     As
compensation for accepted Services the Term, the Company will pay Consultant the amount of $1,000 per day (the “Fees”))
during the Term. Fees will be payable on presentation of a Bill. Consultant will receive no compensation, payment of fees or charges
or reimbursement of expenses other than as set forth in this Paragraph or Paragraph 4.

 

(b)     As
soon as practicable following the October 5, 2105 (“Start Date”) the Company will recommend to the Board of
Directors to grant to you an option (the “Option”) to purchase 1,000,000 shares of the Company Common Stock
pursuant to the Grandparents.com Inc. 2012 Stock Incentive Plan (the “Plan”). The Option will have an exercise
price equal to the highest of (1.) the fair market value of the Common Stock on the grant date determined in accordance with the
Plan or (2.) thirty ($0.30) cents per share. The Option shall be initially unvested and shall vest in full on the first to occur
of (i) the first anniversary of the Start Date, and (ii) the consummation of a Corporate Transaction of the Company (as such term
is defined in the Plan) or (iii) a change in control, in each case subject to your continued employment through the vesting date.
The Option will be subject to and governed by the Plan and a form of option agreement with an exercise period of 10 years.

 

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(c)     Consultant
agrees to work from the Company’s offices and may occasionally work from other locations. The Company will issue to Consultant
a Form 1099 on or before January 31 of the year following each tax year falling in the Term for any Fee paid to Consultant for
the Services. Consultant shall be responsible for the payment of all local, state, and federal taxes and fines resulting from the
payment of any Fees. In addition, Consultant agrees to indemnify and hold harmless the Company from and against any and all claims,
liabilities, suits and penalties for any amounts assessed by or due to any federal, state or local government with respect to such
Fees, if any. The Company may offset any amounts due and payable by Consultant to the Company against any amounts the Company owes
Consultant under this Agreement.

 

(d)     Following
the completion of 6 months of consulting, the Chief Executive Officer will review your employment status, equity awards, and compensation
terms.

 

4.     Expenses.

 

(a)     The
Company shall reimburse Consultant for all reasonable, pre-approved out-of-pocket expenses incurred by Consultant in the performance
of the Services hereunder, provided that Consultant properly accounts for them as required by the Company. The Company shall not
reimburse any expense incurred by Consultant that is related to Consultant’s business overhead, including, but not limited
to, office space, telephone use and/or service, computer equipment, office supplies or any employees or agents whom Consultant
may hire. Under no circumstances will Company reimburse Consultant for excessive or unreasonable expenses.

 

(b)     Detailed
receipts and back-up materials for expenses must be submitted. Consultant agrees to provide Company with access to such receipts,
and other records as may be reasonably necessary for Company or its agents to verify the amount and nature of any such expenses.
Except as provided in paragraph 3 and 4, Consultant shall be responsible for all costs and expenses incident to the performance
of services for Company.

 

5.     Termination.
Your services with the Company are performed on an “At-Will” basis. This means
that you and the Company each have the right to terminate this Agreement at any time, for any reason. The Company and you shall
have the right to terminate this Agreement upon 30-days prior written notice, provided, however, that the Company may terminate
this Agreement immediately for Cause upon notice. As used herein, “Cause” means dishonesty, fraud, misconduct,
unauthorized use or disclosure of confidential information, trade secrets or other intellectual property, or conviction or confession
(including a plea of no contest) of a crime punishable by law (except minor violations) or conduct that adversely affects the
Company’s business or reputation. 

 

6.     Other
Services. Consultant will perform the Services required by this Agreement. This is a non-exclusive Agreement and Consultant
is free to perform services for other parties.

 

7.     Insurance.
The Company will cover Consultant under its various insurance policies for his actions performed as a consultant for the Company.

 

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8.     Relationship
of the Parties. Nothing herein contained shall be construed to constitute the parties to this Agreement as partners or as
joint venturers, or either as agent of the other, or as employer and employee. By virtue of the relationship described herein
Consultant’s relationship to the Company during the Term shall only be that of an independent contractor and Consultant
shall perform all Services pursuant to this Agreement as an independent contractor. Consultant has no authority (and shall not
hold itself out has having authority) to bind the Company. Consultant shall not incur any indebtedness, enter into any undertaking,
make any representation or make any agreement or commitment in the Company’s name or purporting to be on the Company’s
behalf without the Company’s prior written approval. At no time shall Consultant identify itself as an employee of the Company.
Neither Consultant nor Consultant’s employees may cite services under this Agreement in support of any claim to be an employee
of the Company for the purpose of claiming any statutory or common law benefit.

 

9.     Without limiting Paragraph 8(a), Consultant
will not be eligible under this Agreement to participate in any vacation, group medical, life or other insurance, disability, profit
sharing or retirement benefits or any other fringe benefits or benefit plans offered by the Company to its employees, and the Company
will not be responsible for withholding or paying any income, payroll, Social Security or other federal, state or local taxes,
making any insurance contributions, including unemployment or disability, or obtaining worker’s compensation insurance on
Consultant’s behalf. Consultant shall be responsible for, and shall indemnify the Company against, all such taxes or contributions,
including penalties and interest. Any persons employed by Consultant in connection with the performance of the Services shall be
Consultant’s employees and Consultant shall be fully responsible for them. Work for Hire.

 

(a)     All
Services shall be considered “work(s) made for hire” for Company and shall belong exclusively to Company and its designees.
To the extent that under applicable law, any such Services may not be considered a “work(s) made for hire”, Consultant
agrees to assign and upon its creation, automatically assigns exclusively to Company, for the full period allowable under law,
all its right, title and interest, including all statutory and common law copyright, and any other intellectual property in such
Services, without the necessity of any further consideration. Consultant agrees to take such further actions and execute and deliver
such further agreements and other instruments as Company may reasonably request to give effect to this paragraph. Unless otherwise
provided by this Agreement, Consultant shall mark all copyrightable deliverables with the following notice: “© Copyright
2014 Grandparents.com. All rights Reserved”. This notice shall be in such manner and location as to give reasonable notice
of Company’s copyright claim.

 

(b)     Consultant
may include in the Services pre-existing work or materials only if either they are provided by Company or they are owned or licensable
by Consultant without restriction. To the extent that pre-existing work or materials owned or licensable by Consultant are included
in the Services, Consultant shall identify such work or materials upon their submission to Company. Consultant grants to Company
(as an exception to the transfer and assignment provided for above) an irrevocable, unrestricted, nonexclusive, royalty-free license
to use, execute, reproduce, display, perform, and distribute (internally and externally and regardless of media or mediums) copies
of, and the right to prepare derivative works based upon, such pre-existing work and materials, with or without attribution, and
the right to authorize others to do the same. Consultant’s performance of the Services called for by this Agreement shall
not violate any contracts with third parties; or any third party rights in any patent, trademark, copyright, trade secret, or similar
right.

 

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10.     Proprietary
Information.

 

(a)     Consultant
understands that Consultant’s work as a consultant will involve access to and creation of confidential and proprietary information
and trade secrets of the Company (collectively, “Proprietary Information”). Proprietary Information includes,
but is not limited to, information that is not generally known to the public and that is used, developed or obtained by the Consultant
in connection with its Services whether in written, oral, electronic or other form, including but not limited to, information and
facts concerning business plans, financial models, forecasts and plans, members, membership information, customers, future customers,
suppliers, licensors, licensees, partners, investors, affiliates or others, training methods and materials, financial information,
sales prospects, client lists, inventions, or any other scientific, technical or trade secrets of the Company or of any third party
provided to Consultant or the Company. The term “trade secrets,” as used in this Agreement, will be given its broadest
possible interpretation under the law of the State of New York and will include, without limitation, anything tangible or intangible
or electronically kept or stored, which constitutes, represents, evidences or records or any secret scientific, technical, merchandising,
production or management information, or any design, process, procedure, formula, invention, improvement or other confidential
or proprietary information or documents. Proprietary Information will not include any information previously published in a form
generally available to the public. Proprietary Information will be deemed published only if all material features comprising such
information have been published in combination to a person under no obligation of confidentiality to the Company.

 

(b)     Consultant
agrees to keep all Proprietary Information in trust for the sole benefit of the Company, and also agrees that all information will
remain the sole property of the Company. Consultant further agrees to hold all Proprietary Information in strictest confidence,
and to never use, distribute, reproduce, disclose or otherwise disseminate any Proprietary Information, except as required to perform
the Services, even after termination of Consultant’s Services under this Agreement. In order to prevent actual or apparent
conflicts of interest and to ensure full compliance with the Company’s policies and procedures and with applicable law, this
confirms Consultant’s agreement that no such Proprietary Information will be disseminated to persons outside the Company
without obtaining prior written approval from an authorized person of the Company.

 

(c)     Upon
termination of the Term for any reason, Consultant agrees that all Proprietary Information in Consultant’s possession, directly
or indirectly, that is in written or other tangible form (together with all duplicates thereof) will forthwith be returned to the
Company and will not be retained by Consultant or furnished to any third party, either by sample, facsimile, film, audio or video
cassette, electronic data, verbal communication or any other means of communication.

 

(d)     Consultant
agrees that Consultant will not breach any agreements to keep in confidence, or to refrain from using, the confidential, and proprietary
or trade secret information of a former employer, client or any other person. Consultant will not bring any such information of
a former employer, client or other person to the Company, nor will Consultant use any such information in Consultant work for the
Company, without written authorization from the Company and from such other person.

 

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11.     Competition;
Non-Solicitation. Intentionally Omitted.

 

12.     Consultant’s
Representations. Consultant represents, warrants and covenants that: (i) Consultant has the full right, authority and capacity
to enter into this Agreement and perform fully all of Consultant’s obligations hereunder; (ii) Consultant is not bound by
any agreement that conflicts with or prevents or restricts the full performance by Consultant of its duties and obligations to
the Company hereunder during or after the Term; (iii) the execution and delivery of this Agreement shall not result in any
breach or violation of, or a default under, any existing obligation, commitment or agreement to which Consultant is subject; (iv)
Consultant shall perform the Services in a professional and workmanlike manner in accordance with industry standards for similar
services and Consultant will devote sufficient resources and time to ensure that the Services are performed in a timely and reliable
manner; (v) Consultant is, and shall at all times continue to be, in compliance with the performance terms hereunder and will
not violate, any applicable federal, state or local law or regulation; (vi) Consultant has obtained, or will timely obtain and
maintain, all permits, licenses, and approvals required in connection with its performance hereunder, including, without limitation,
all permits, licenses and approvals required to comply with any applicable federal, state or local law or regulation; (vii) Consultant
shall, and shall ensure that its employees, agents and other representatives shall, comply with all policies and procedures of
the Company in the performance of the Services and at all times while on or using the premises or systems of the Company; and
the representations in Exhibit B are true and correct.

 

13.     Indemnification.
Each Party (the “Indemnifying Party”) hereby agrees to indemnify, defend, and hold harmless the other Party,
its affiliates, and its and their respective current, future and former directors, officers, employees, representatives, successors,
and assigns (each an “Indemnified Party”) from and against any and all judgments, settlements, awards, losses,
liabilities, penalties, interest claims (including taxes and all related interest and penalties incurred with respect thereto),
damages, deficiencies and costs (including, without limitation, attorney’s fees and expenses and court costs) (collectively
“Losses”) and any and all civil, criminal, administrative or investigative actions, proceedings, or claims
(a “Claim”) arising out of, related to, or due to any breach of this Agreement, any negligent act or omission,
or willful misconduct by the Indemnifying Party or any of its employees, agents or representatives. The Indemnifying Party shall
not, without the consent of the Indemnified Party, effect any settlement of any Claim if such settlement involves (i) any form
of relief other than payment of money or involves any finding or admission of any violation of any law, regulation, order, or
rights of any person or has any adverse effect on any other Claims, or (ii) only the payment of money, unless it includes an unconditional
release of such Indemnified Party of all liability on such Claim. In the event any Indemnified Party is entitled to indemnification
in accordance with this Paragraph 13, and the Claim giving rise to such indemnification materially relates to the Indemnified
Party’s business, then such

 

Indemnified Party may, without the Indemnifying
Party’s consent, assume exclusive control of the defense of such Claim (including, without limitation, retaining appropriate
counsel and/or settling or otherwise resolving the Claim in the sole discretion of the Indemnified Party), and the Indemnifying
Party shall not be entitled to participate in the defense of such Claim unless requested to do so by the Indemnified Party. The
exercise by any Indemnified Party of its right to assume exclusive control of the defense of Claims pursuant to this Paragraph
13 shall not in any way alter or prejudice the rights of the Company and each Indemnified Party to the indemnity obligation owed
by such Indemnifying Party, and the Indemnifying Party shall be liable for the reasonable fees of such counsel and for any Losses
incurred by any Indemnified Party by reason of any settlement or judgment related to such Claims.

 

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14.     Disputes.
Except as provided for herein, any controversy or claim arising out of or relating to this Agreement, or any breach hereof, shall
be settled by submitting the matter to binding arbitration in New York, New York by and pursuant to the commercial rules of the
American Arbitration Association then in effect. The determination of the arbitrator shall be conclusive and binding on the Company
and Consultant, and judgment may be entered on the arbitrator’s award in any court of competent jurisdiction. The arbitrator
shall not have the power to award punitive or exemplary damages. Issues of arbitrability shall be determined in accordance with
the United States federal substantive and procedural laws relating to arbitration. Each party shall bear its own attorneys’
fees; the other costs and expenses of the arbitration shall be borne as provided by the rules of the American Arbitration Association.
If court proceedings to compel arbitration are necessary, the party who unsuccessfully opposes such proceedings shall pay all
associated costs, expenses and attorneys’ fees that the other party reasonably incurs.

 

Notwithstanding the foregoing, if Consultant
breaches or attempts to breach any of Consultant’s obligations under Paragraphs 10, 11, 12 or 13 of this Agreement, Consultant
acknowledges that such a breach would irreparably damage the Company and its business. Accordingly, in addition to any other remedies,
the Company is entitled to temporary, preliminary and permanent relief enjoining Consultant to prevent such harm from a court and
the Company shall not be compelled to submit a dispute under Paragraphs 10, 11, 12 or 13 to arbitration. Consultant specifically
consents to the exclusive jurisdiction of the Supreme Court of the State of New York, New York County, for this purpose, or if
that court is unable to exercise jurisdiction for any reason, to the exclusive jurisdiction of the United States District Court
for the Southern District of New York. Consultant waives Consultant’s right to any claim of improper or inconvenient venue
or forum.

 

Each party hereto hereby waives, to the fullest
extent permitted by applicable law, any right it may have to a trial by jury in respect of any suit, action or proceeding arising
out of or relating to this Agreement. 

 

15.     Cooperation.
Consultant agrees that, upon reasonable notice and without the necessity of the Company obtaining a subpoena or court order, Consultant
shall provide reasonable cooperation in connection with any suit, action or proceeding (or any appeal from any suit, action or
proceeding), and any investigation and/or defense of any claims asserted against the Company or its affiliates, which relates
to events occurring during the provision of Consultant’s services for the Company and its affiliates as to which Consultant
may have relevant information (including but not limited to furnishing relevant information and materials to the Company or its
designee and/or providing testimony at depositions and at trial), provided that the Company shall reimburse Consultant for expenses
reasonably incurred in connection therewith and pay the Consultants fees for time expended.

 

16.     Assignability.
This Agreement shall not be assignable by Consultant without the prior written consent of the Company, and any assignment in violation
of this Agreement shall be void. The Company may assign this Agreement, and its rights and obligations hereunder, at any time.
This Agreement shall be binding on, and shall inure to the benefit of, the parties to it and their respective heirs, legal representatives,
successors and permitted assigns. Consultant acknowledges and agrees that all of Consultant’s covenants and obligations
to the Company, as well as the rights of the Company hereunder, shall run in favor of and shall be enforceable by the Company
and its successors and assigns.

 

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17.     Miscellaneous.

 

(a)     This
Agreement, including, without limitation the Exhibits attached hereto, embodies the entire agreement of the parties on the subject
matter hereof. This Agreement supersedes any and all prior agreements and discussions of the parties relating to the Services or
any other subject matter hereof.

 

(b)     No
provision of this Agreement may be modified, waived or discharged unless such waiver, modification or discharge shall be agreed
to in writing and signed by Consultant and the Company.

 

(c)     No
waiver by either party hereto at any time of any breach by the other party hereto of, or compliance with, any condition or provision
of this Agreement to be performed by such other party shall be deemed a waiver of similar or dissimilar provisions or conditions
at the same or at any prior or subsequent time.

 

(d)     No
agreements or representations, oral or otherwise, express or implied, with respect to the subject matter hereof have been made
by either party which are not expressly set forth in this Agreement.

 

(e)     All
descriptive headings in this Agreement are inserted for convenience only and shall be disregarded in construing or applying any
provision of this Agreement.

 

(f)     The
laws of the State of New York shall govern the validity, interpretation, construction and performance of this Agreement.

 

(g)     The
parties agree that service of process accomplished by the methods specified for notices in Paragraph 18 shall be deemed good and
sufficient service of process in the State of New York.

 

(h)     Consultant
agrees that in the performance of this Agreement it will not discriminate or permit discrimination against any person or group
of persons on the grounds of age, disability, sex, race, color, religion, national origin or any other protected classification,
or in any other manner prohibited by law.

 

(i)     The
obligations under Paragraphs 10, 11 and 13 shall survive the expiration of this Agreement or the termination of the Term.

 

18.     Notices.
All notices or other communications required or permitted to be given hereunder shall be in writing and shall be delivered by
hand or sent by facsimile or sent, postage prepaid, by registered, certified or express mail or overnight courier service and
shall be deemed given when so delivered by hand or facsimile, or if mailed, three days after mailing (one business day in the
case of express mail or overnight courier service) to the parties at the following addresses or facsimiles (or at such other address
for a party as shall be specified by like notice):

 

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	If to the Company:	 
	 	 
	Steve Leber	 
	Chief Executive Officer	 
	Grandparents.com, Inc.	 
	589 Eighth Avenue, 6th Floor	 
	New York, NY 10018	 
	 	 
	If to the Consultant:	 
	 	 
	John J. Sweeney	 
	19 Lawson Lane	 
	Ridgefield, CT 06897	 
	SweeneyJohnJ@mns.com	 

 

19.     Validity.
The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other
provision of this Agreement, which shall remain in full force and effect.

 

20.     Counterparts.
This Agreement may be executed in several counterparts, each of which shall be deemed to be an original but all of which together
will constitute one and the same instrument. A signed copy of this Agreement delivered by facsimile, e-mail or other means of
electronic transmission shall be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.

 

If Consultant agrees that this letter sets forth
our agreement on the subject matter hereof, please sign and return to the Company.

 

	 	Sincerely,
	 	 
	 	GRANDPARENTS.COM, INC.
	 	 
	 	By:	 /s/ Steven E. Leber
	 	Name: Steve Leber
	 	Title: Chairman/CEO

 

	Agreed to and accepted	 
	this    day of June, 2016	 
	 	 
	John J. Sweeney	 
	 	 
	/s/ John J. Sweeney	 
	 	 
	Taxpayer Id Number:  	 

 

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EXHIBIT A

DESCRIPTION OF SERVICES

 

Consultant will be responsible for the duties and responsibilities
typically associated with the title of Chief Financial Officer, including, without limitation, responsibility for management of
the Company’s financial, tax, accounting, and investor relations matters. He will also be responsible for general office
matters, assist in legal matters and any other areas of responsibility as determined or assigned to you by the Company from time
to time. Consultant represents that he has the necessary skill, knowledge and training required to fulfill his duties and responsibilities
to the Company. Consultant will report to the CEO.

 

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                                         9
                                         of 9Exhibit 10.5

 

RESEARCH, DEVELOPMENT

AND COMMERCIALIZATION AGREEMENT

 

This Research, Development and Commercialization Agreement (“Agreement”) is entered into as of this 18th day of December, 2008, by and between:

 

on the one hand,

 

Hoffmann-La Roche Inc., with its principal place of business at 340 Kingsland Street, Nutley, New Jersey 07110 USA (“Roche Nutley”), and F. Hoffmann-La Roche Ltd, a Swiss corporation, with its principal office at Grenzacherstrasse 124, CH-4070 Basel, Switzerland (“Roche Basel”; Roche Nutley and Roche Basel are collectively referenced as “Roche”),

 

and on the other hand,

 

VIA Pharmaceuticals, Inc., with its principal place of business at 750 Battery Street, Suite 330, San Francisco California 94111 USA (“VIA”).  VIA and Roche each may be referred to herein as a “Party,” and collectively as “Parties.”

 

WHEREAS, Roche owns certain patent rights, know-how and regulatory filings with respect to the Compound (as defined below);

 

WHEREAS, Roche believes that the Compound has the potential to be incorporated into a drug with significant worldwide annual sales, and that VIA has the ability to realize the potential of this compound;

 

WHEREAS, VIA desires to develop the Compound and ensure that it is diligently developed and commercialized worldwide so as to realize promptly its therapeutic and commercial potential;

 

WHEREAS, VIA desires to obtain an exclusive license under Roche’s patent rights, know-how and regulatory filings to begin development and commercialization of products containing the Compound; and

 

WHEREAS, Roche is willing to grant an exclusive license to VIA under such patent rights and know-how.

 

NOW THEREFORE, in consideration of the foregoing and of the mutual covenants hereinafter set forth and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties mutually agree as follows:

 

ARTICLE 1

 

DEFINITIONS

 

As used in this Agreement, the following terms shall have the following meanings, and singular forms, plural forms and derivative forms, (i.e. other parts of speech) shall be interpreted accordingly:

 

 

1.1                               “Additional Licensed Compound” means any compound other than the Compound or a Derivative, the composition or use of which is claimed in the Roche Patent Rights, including any salt, ester, non-covalent complex, chelate, hydrate, and stereoisomer thereof, and other forms of any such compound.

 

1.2                               “Affiliate” means any corporation or non-corporate business entity that directly or indirectly controls, is controlled by, or is under common control with a Party to this Agreement.  As used in this definition, the term “control” (with correlative meanings for the terms “controlled by” and “under common control with”) means that an entity owns greater than fifty percent (>50%) of the voting stock of the subject entity with the ability to elect a majority of the board (or managing members) of such entity, or otherwise has the power to govern and control the financial and the operating policies and management of the subject entity, whether through the ownership or control of voting securities, by contract or otherwise.  With respect to Roche, the term “Affiliate” shall not include Genentech, Inc. or Chugai Pharmaceutical Co., Ltd, unless Roche opts for such inclusion by giving written notice to VIA.  With respect to VIA, the term “Affiliate” shall not include any corporation or non-corporate business entity that VIA does not directly or indirectly control.

 

1.3                               “Commencement” means, with respect to a clinical trial, the date upon which the first patient receives the first dose of an item that is the subject of such clinical trial.

 

1.4                               “Commercialize” means to make, have made, develop, use, sell, have sold, offer for sale, and import.

 

1.5                               “Compound” means the compound ***, also known as RO***.

 

1.6                               “Derivative” means any salt, ester, non-covalent complex, chelate, hydrate, and stereoisomer of the Compound, and any compound generated by modifying the structure of the Compound so as to optimize its activity.

 

1.7                               “Development Plan” means the plan for guiding development of Licensed Products.

 

1.8                               “Dollars” or “$” means US dollars.

 

1.9                               “Effective Date” means January 5, 2009.

 

1.10                        “FDA” means the United States Food and Drug Administration and any successor entity thereto.

 

1.11                        “FD&C Act” means the US Federal Food, Drug, and Cosmetic Act, as amended, and the equivalent laws and regulations in any foreign countries or jurisdictions.

 

1.12                        “Field” means all therapeutic, prophylactic, and other pharmaceutical uses and applications.

 

1.13                        “First Commercial Sale” means the first invoiced sale by the VIA Group of a Licensed Product in a particular country to a Third Party in such country.

 

*** Certain information on this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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1.14                        “Global Liaison” means an employee of Roche who is selected by Roche to be the point person with primary responsibility for communications and interactions with VIA.

 

1.15                        “IND” means an Investigational New Drug Application filed with the FDA and covering administration of a Compound, Derivative or Additional Licensed Compound.

 

1.16                        “Inventions” means any and all useful ideas, concepts, methods, procedures, processes, improvements, inventions, discoveries, and reductions to practice, whether or not patentable, which arise from or are first made, conceived or first reduced to practice in the course of the activities conducted pursuant to or in exercise of a right granted under this Agreement.

 

1.17                        “Know-How” means all non-patented data, information, methods, procedures, processes, materials and other know-how.

 

1.18                        “Licensed Product” means any product containing a Compound, a Derivative or an Additional Licensed Compound, including all formulations, dosages, and dosage forms thereof.

 

1.19                        “Major Market” means any of the US, Japan, the United Kingdom, Germany, France, Spain or Italy.

 

1.20                        “NDA” means a new drug application, including all necessary documents, data, and other information concerning a Licensed Product, required for Regulatory Approval of the Licensed Product as a pharmaceutical product by the FDA or an equivalent application to the equivalent agency in any other country or group of countries (e.g. the marketing authorization application (MAA) in the European Union).

 

1.21                        “Net Sales” means, with respect to VIA, the amount of gross sales of all Licensed Products in the Territory invoiced by the VIA Group to Third Parties, as reduced by the following deductions to the extent actually allowed or incurred with respect to such sales:  (a) transportation charges, and other shipping charges, such as insurance, (b) sales, value-added and excise taxes, customs, duties, and any other governmental charges, to the extent imposed upon the sale of the Licensed Product and paid by the selling party, provided that no income taxes shall be deducted from gross sales of Licensed Product to calculate Net Sales, (c) distributor fees, rebates or allowances actually granted, allowed or incurred, including government and managed care rebates, (d) quantity discounts, cash discounts or chargebacks actually granted, allowed or incurred, and (e) allowances or credits to customers or write offs of invoiced amounts, not in excess of the selling price of Licensed Product, on account of governmental requirements, rejections, recalls, or returns.

 

If Licensed Product is sold as part of a Combination Product (as defined below), then the parties shall meet approximately one (1) year prior to anticipated First Commercial Sale to negotiate, on a country-by-country basis, in good faith and agree to an appropriate adjustment to Net Sales, on a country-by-country basis, to reflect the relative significance of the Compound, Derivative or Additional Licensed Compound and other pharmaceutically active ingredients contained in the Combination Product.  If the parties cannot reach agreement, then the Net Sales of the Combination Product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales of the Combination Product (as defined in the portion of the Net Sales definition preceding this paragraph) on a country-by-country basis, during the applicable royalty reporting period, by the fraction, A/(A+B), where A is the average sale price of the Licensed Product when sold separately in finished form and B is the average sale price of the other pharmaceutical product(s) included in the

 

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Combination Product when sold separately in finished form, in each case during the applicable royalty reporting period or, if sales of both the Licensed Product and the other product(s) did not occur in such period, then in the most recent royalty reporting period in which sales of both occurred.

 

In the event that such average sale price cannot be determined for both the Licensed Product and all other pharmaceutical products(s) included in the Combination Product, Net Sales for the purposes of determining royalty payments shall be calculated by multiplying the Net Sales of the Combination Product by the fraction of C/(C+D) where C is the fair market value of the Licensed Product and D is the fair market value of all other pharmaceutical product(s) included in the Combination Product.

 

“Combination Product” shall mean any product that contains, in addition to a Compound, a Derivative or an Additional Licensed Compound, one or more other pharmaceutically active ingredients.

 

1.22                        “Patent” means (a) any patent, including re-examinations, reissues, renewals, extensions and term restorations thereof, and any foreign counterpart of any of the foregoing, and (b) any pending application for patent, including, without limitation, provisional applications, continuations, continuations-in-part, divisional and substitute applications, inventors’ certificates, and extensions, and any foreign counterpart of any of the foregoing.

 

1.23                        “Phase I” means, with respect to the United States, the first phase of human clinical trials using a limited number of human subjects to gain evidence of the safety and tolerability of a Licensed Product and information regarding pharmacokinetics and potentially pharmacological activity for such Licensed Product, Compound, Derivative or Additional Licensed Compound, which human clinical trials are completed prior to the initiation of Phase II, as described in 21 C.F.R. § 312.21(a), as may be amended, or, with respect to any other country or jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction.

 

1.24                        “Phase II” means, with respect to the United States, the second phase of human clinical trials of a Licensed Product in human subjects to gain evidence of the efficacy in one or more indications and expanded evidence of the safety of such Licensed Product, Compound, Derivative or Additional Licensed Compound, as well as an indication of the dosage regimen required, as described in 21 C.F.R.§ 312.21(b), as may be amended, or, with respect to any other country or jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction.

 

1.25                        “Phase III” means, with respect to the United States, the third phase of human clinical trials of a Licensed Product, which are large-scale trials to gain evidence of the efficacy and safety in a number of human subjects sufficient to support Registration for such Licensed Product, Compound, Derivative or Additional Licensed Compound with the FDA, as described in 21 C.F.R. § 312.21(c), as may be amended, or, with respect to any other country or jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction.

 

1.26                        “Registration” in relation to any Licensed Product means such approvals by the applicable Regulatory Agency in a country (or community or association of countries) included in the Territory (including, where applicable, price approvals) that are required to be obtained prior to marketing and selling such Licensed Product in such country or jurisdiction.

 

1.27                        “Regulatory Agency” means, with respect to any particular country or jurisdiction, the governmental authorities, bodies, commissions, agencies and/or other instrumentalities of such

 

4

 

country or jurisdiction (the EMEA with respect to the EU), with the primary responsibility for the evaluation or approval of pharmaceutical products before such product can be tested, marketed, promoted, distributed or sold in such country, including such governmental bodies that have jurisdiction over the conduct of clinical trials and/or the pricing of such pharmaceutical product.  The term “Regulatory Agency” includes the FDA.

 

1.28                        “Regulatory Filing” means any filing with a Regulatory Agency relating to or to permit or request, as applicable, the clinical evaluation or Registration of a Licensed Product.  Regulatory Filings include without limitation INDs and NDAs.

 

1.29                        “Roche Know-How” means all Know-How which on the Effective Date is owned or controlled by, or licensed to, Roche and in which Roche has a cost-free transferable interest.

 

1.30                        “Roche Patent Rights” means all Patents in the Territory listed on Appendix A, and any future Patents that claim priority from or the benefit of the filing date of any of the Patents listed in Appendix A, and including any and all extensions, supplementary protection certificates and the like with respect to any of the foregoing.

 

1.31                        “Signing Date” means December 18, 2008.

 

1.32                        “Territory” means the entire world, subject to Section 12.7(a).

 

1.33                        “Third Party” means any party other than Roche, Roche’s Affiliates, or a member of the VIA Group.

 

1.34                        “Transfer Know-How” means the Roche Know-How identified on Appendix B.

 

1.35                        “VIA Group” means VIA, its Affiliates and sublicensees under this Agreement.

 

1.36                        “VIA Know-How” means all Know-How that is related to the Compound, a Derivative, an Additional Licensed Compound or a Licensed Product, and is owned or controlled by VIA Group and in which VIA has a transferable interest.

 

1.37                        “VIA Patent Rights” means all Patents in the Territory that (a) claim a Compound, Derivative, Additional Licensed Compound or Licensed Product, or the manufacture or use thereof, and (b) are owned or controlled by VIA during the term of this Agreement.

 

1.38                        “US” means the United States of America, its territories and possessions.

 

1.39                        “Valid Claim” means a claim contained in (i) an issued and unexpired patent included within the Roche Patent Rights or VIA Patent Rights that has not been held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which decision is not subject to any further appeal, and that has not been admitted to be invalid or unenforceable through abandonment, reissue, disclaimer or otherwise or (ii) a patent application which is included within the Roche Patent Rights or VIA Patent Rights and has been pending for less than *** (***) years from the priority date.  If a claim of a patent application that ceased to be a Valid Claim under item (ii) because of the passage of time later issues as a part of a

 

*** Certain information on this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

5

 

patent within item (i), then it shall again be considered to be a Valid Claim effective as of the issuance of such patent.

 

ARTICLE 2

 

GRANT OF LICENSE

 

2.1                               Grants.

 

(a)                                 Subject to the terms and conditions of this Agreement, Roche hereby grants to VIA and its Affiliates, and VIA hereby accepts on its and their behalf, a sole and exclusive license, with full rights to sublicense as provided in Section 2.2, under the Roche Patent Rights and Roche Know-How, to (a) develop, use, sell, offer for sale, and import Licensed Products containing the Compound, Derivative or Additional Licensed Compound in the Field, in the Territory, and (b) make and have made Licensed Products in the Territory for such development, use, sale, offering for sale, and importation.

 

(b)                                 Roche shall retain all rights under the Roche Patent Rights and Roche Know-How for any other purpose.

 

2.2                               Right to Sublicense.  After the Commencement of a Phase I clinical trial with a Licensed Product containing the Compound (“Lead Product”) or replacement of the Lead Product by another Licensed Product, VIA and its Affiliates shall have the right to sublicense the rights granted under Section 2.1 to Third Parties, subject to Section 2.5.  If VIA grants such sublicenses, then all such sublicenses shall conform to and be in accordance with the terms of this Agreement.  VIA assumes full responsibility for the performance of all obligations under this Agreement and will remain obligated to Roche for all royalties due under this Agreement by reason of the operations of any such sublicense.  VIA shall have the right to use Third Party contract research and development organizations at any time during the term of this Agreement.  If, prior to expiration or termination of this Agreement, VIA has or would like to sublicense a Third Party under Roche Know-How and Roche Patent Rights and would prefer that Roche grant a direct license to such Third Party under Roche Know-How and Roche Patent Rights, then Roche will not unreasonably deny granting such a direct license under Roche Know-How and Roche Patent Rights, provided that such Third Party agrees to the applicable terms and conditions of this Agreement and covenants to make the applicable financial payments under this Agreement to Roche.

 

2.3                               Covenant Not to Sue.  If the making, having made, using, offering for sale, selling, or importing in any country in the Territory in the Field by the VIA Group of any composition described in the Patent Rights which contains Compound manufactured using a process set forth in the Patent Rights would, during the term of the Agreement in such country, infringe a claim of an issued patent owned or controlled by Roche (other than the Roche Patent Rights), Roche hereby grants to the VIA Group, to the extent Roche is legally able to do so, a covenant not to sue under such patent, as may be necessary to enable the VIA Group to make, have made, use, offer for sale, sell and import such composition in such country.  Roche shall cause such covenant to be binding on any assignee of any such patent and VIA shall have the right to grant or assign its rights under such covenant to any of its permitted sublicensees or assignees.

 

2.4                               Covenant Regarding License Scope.  VIA hereby covenants and agrees that it and its Affiliates shall not, during the term of this Agreement, in the absence of any other valid right or

 

6

 

license granted to VIA or its Affiliates, knowingly practice any Roche Patent Rights or Roche Know-How outside the scope of the licenses granted by Roche in Section 2.1.

 

2.5                               Minimal Diligence.  If VIA has not completed a Phase I clinical trial within three (3) years after the Effective Date with respect to the Lead Product, then either (i) VIA shall commit to developing an Additional Licensed Compound or a Derivative or (ii) Roche may terminate this Agreement.  VIA shall have the burden of proving it has complied with its diligence obligations under Section 6.1.  If VIA did not comply with such obligations, then Roche may terminate all licenses granted herein.  Following such termination by Roche under this Section 2.5 and if requested by Roche within thirty (30) days after such termination, VIA shall negotiate in good faith with Roche, for a period of sixty (60) days from the date of Roche’s request, regarding granting a license to Roche on commercially reasonable terms for the VIA Patent Rights and VIA Know-How related solely to the Licensed Products.

 

2.6                               Roche Right of First Negotiation.  If VIA seeks to out-license any Licensed Product to a Third Party (“Out-License”), then, before approaching any such Third Party, VIA shall inform Roche and afford Roche the opportunity to negotiate an Out-License under which Roche would obtain a sole and exclusive license to such Licensed Product.  If Roche is interested in such negotiation, then Roche shall inform VIA of its interest within forty-five (45) days (“Review Period”).  If Roche indicates that it is not interested in negotiation or if Review Period expires, then VIA shall have the right to grant an Out-License to a Third Party.  If Roche indicates that it is interested in negotiation within the Review Period, then Roche and VIA shall negotiate in good faith for a period of time not to exceed sixty (60) days for an Out-License (“Negotiation Period”).  If Roche indicates that it is not interested in continuing negotiation or if the Negotiation Period expires, then VIA shall have the right to grant a license to a Third Party.

 

2.7                               Section 365(n) of the Bankruptcy Code.  The licenses granted under this Article 2 shall be treated as licenses of rights to “intellectual property” (as defined in Section 101(56) of Title 11 of the United States Code, as amended (the “Bankruptcy Code”)) for purposes of Section 365(n) of the Bankruptcy Code.  The Parties agree that VIA may elect to retain and may fully exercise all of its rights and elections under the Bankruptcy Code; provided that VIA complies with the terms of this Agreement.

 

ARTICLE 3

 

RESEARCH AND DEVELOPMENT REIMBURSEMENT AND MILESTONE PAYMENTS

 

3.1                               Fees.  VIA shall pay to Roche in consideration for the rights granted herein a fee of *** Dollars ($***) which shall be non-refundable, and non-creditable, and payable by VIA within thirty (30) days after receipt of an invoice from Roche after the Signing Date.

 

3.2                               Milestone Payments.  VIA shall pay to Roche non-refundable, non-creditable milestone payments in the amounts specified in tabular form below (each a “Milestone Payment”) no later than thirty (30) days after the first occurrence of each of the following events, as they occur:

 

*** Certain information on this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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Milestones
    	
 
    	
Payments (Dollars)
    	
 
    
	
Commencement of Phase I
    	
 
    	
$
    	
***
    	
 
    
	
Commencement of Phase II
    	
 
    	
$
    	
***
    	
 
    
	
Commencement Phase III
    	
 
    	
$
    	
***
    	
 
    
	
NDA Approval in the USA
    	
 
    	
$
    	
***
    	
 
    
	
NDA Approval in a Major Market   country in Europe
    	
 
    	
$
    	
***
    	
 
    

 

Each milestone payment set forth under this Section 3.2 shall be paid to Roche no more than once, and once paid shall be non-refundable.  For clarity, once any milestone payment is paid to Roche under this Section 3.2, such payment shall not be owed with respect to any other Licensed Product even if such milestone is subsequently achieved again by any Licensed Product.

 

ARTICLE 4

 

ROYALTIES

 

4.1                               Royalties in General.  For each Licensed Product, the obligation of VIA to pay Roche royalties based on sales of the Licensed Product in a given country shall commence on the date of the First Commercial Sale of such Licensed Product by the VIA Group in such country and shall continue until the later of (a) the date upon which there no longer exists in such country Roche Patent Rights having a Valid Claim that claims the manufacture, use or sale of such Licensed Product in such country, or (b) the date which is ten (10) years after the date of First Commercial Sale of such Licensed Product in such country.  VIA shall pay or cause to be paid to Roche a royalty based on Net Sales made by the VIA Group in the Territory, on a country-by-country basis, at the applicable incremental royalty rate as provided for in the table below in this Section 4.1, subject to reduction as provided in Sections 4.3, 4.4, 4.5 and 4.6.

 

	
Total, Territory-wide Annual Net Sales in a single calendar year
    	
 
    	
Royalty Rate
    	
 
    
	
Amount of Net Sales up to and   including $***
    	
 
    	
***
    	
%
    
	
Amount of Net Sales over $*** and   up to and including $***
    	
 
    	
***
    	
%
    
	
Amount of Net Sales over $*** and   up to and including $***
    	
 
    	
***
    	
%
    
	
Amount of Net Sales over $***
    	
 
    	
***
    	
%
    

 

4.2                               Accrual of Royalties.  No royalty shall be due or owing from the use or distribution of a Licensed Product in transactions where no consideration is received by the VIA Group, such as when a Licensed Product is made or used for tests or development purposes or is distributed as samples.  No royalties shall be payable on sales among entities within the VIA Group, but royalties shall be payable on the first subsequent sale by entities within the VIA Group to a Third Party.  No multiple royalties shall be payable under this Agreement because a commercialized Licensed Product is covered by more than one Valid Claim or is covered by both a claim with respect to Know-How and a Valid Claim.

 

4.3                               Reduction for No Patent.  If, but for this Agreement, no Valid Claim of Roche Patent Rights would be infringed by the making, using or selling of a Licensed Product in a country in the

 

*** Certain information on this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

8

 

Territory, then the Net Sales of such Licensed Product in such country shall be reduced by *** percent (***%) for the purpose of determining the royalties payable under Section 4.1.

 

4.4                               Reduction for Third Party License Fees.  VIA shall be entitled to deduct from its payment obligations under Section 4.1 hereunder *** percent (***%) of any license fees, milestone payments and royalties that VIA pays to a Third Party in respect of any license to Third Party Patents that VIA reasonably concludes is required for the manufacture, use, offer for sale, sale or importation of the Compound, any Derivative or any Additional Licensed Compound; provided that no such deduction shall reduce the amount of any quarterly royalty payment under Section 4.1 by more than *** percent (***%) of the amount otherwise payable.  If VIA is prevented from deducting any amount by the proviso in the immediately preceding sentence, then VIA shall be entitled to carry forward such amount for deduction from subsequent payments to Roche under Section 4.1.

 

4.5                               Reduction for Generic Competition.  If a Third Party sells a product that contains the same Compound, Derivative or Additional Licensed Compound as found in the Licensed Product sold in a country in the Territory, then VIA’s royalty obligations to Roche under Sections 4.1 and 4.3 with respect to sales in such country shall be reduced as follows:  ***.

 

4.6                               Cap on Royalty Reductions.  In no case shall the royalties otherwise payable under Section 4.1 be reduced by more than *** percent (***%) regardless of the number of reductions otherwise available under Sections 4.3-4.5.

 

ARTICLE 5

 

ROYALTY REPORTS AND ACCOUNTING

 

5.1                               Royalty Payments; Royalty Reports.  After the First Commercial Sale and for the remaining term of this Agreement, VIA shall submit with each payment of royalties to Roche a written royalty report (“Royalty Report”) covering sales of Licensed Product for each VIA fiscal quarter (currently ending on or about the last day of March, June, September, and December) with the following information provided on a country-by-country basis for the Major Market countries and for the rest of the world as a whole:

 

(a)                                 gross sales;

 

(b)                                 Net Sales;

 

(c)                                  the royalties, payable in Dollars, which shall have accrued hereunder in respect to such Net Sales;

 

(d)                                 withholding taxes, if any, required by law to be deducted in respect of such sales;

 

(e)                                  the exchange rates used in determining the amount of Dollars; and

 

(f)                                   the royalty rates applied to calculate royalties due hereunder.

 

*** Certain information on this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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Royalty Reports shall be due for the entire Territory no later than sixty (60) days after the end of the fiscal quarter to which they pertain.  The Parties will cooperate with each other with regard to the handling of withholding taxes.

 

5.2                               Exchange Rate; Manner of Payment.  All payments due under this Agreement shall be made in Dollars via wire transfer of immediately available funds, or by such other commercially reasonable means as may be designated by Roche.  Royalty payments due on Net Sales in countries in the Territory outside the US shall be made in Dollars, after being converted by VIA using the average rate of exchange for such currencies during the applicable calendar quarter, as retrieved from Reuters’ system for the applicable period.  If by law, regulations or fiscal policies, remittance of royalties in Dollars, or removal of currency from the country, is prohibited or restricted, VIA will notify Roche and payment of the royalty obligation shall be made by deposit thereof in local currency to the credit of Roche in a recognized banking institution in such country designated by Roche.  If in any country or jurisdiction, the law, regulations or fiscal policies prohibit both the transmittal and deposit of royalties on sales in such country, royalty payments calculated as a percentage of Net Sales in that country shall be suspended for as long as such prohibition is in effect, and as soon as such prohibition ceases, all royalties that Roche would have otherwise been entitled to shall be transmitted or deposited to the extent allowable.

 

5.3                               Payment Due Dates.  Royalties shown to have accrued by each Royalty Report provided for under Article 5 of this Agreement shall be due and payable sixty (60) days after the end of the fiscal quarter to which they pertain.  Payment of royalties in whole or in part may be made in advance of such due date.  All royalty and other payments due to Roche hereunder, shall be made in Dollars and delivered to the account specified below or to any other account specified by Roche:

 

	
Bank Name:
    	
Citibank, n.a.
    
	
 
    	
New York, NY
    
	
ABA Routing No.:
    	
xxxxxxxxx
    
	
Account Name:
    	
Hoffmann-La Roche Inc.
    
	
Account No.:
    	
xxxxxxxx
    

 

VIA shall provide Roche with an annual non-binding forecast of anticipated Net Sales for each calendar year by September 30 of the preceding calendar year.

 

5.4                               Right to Audit.  During the Term and for a period of *** (***) years thereafter, VIA shall keep (and shall cause its Affiliates, licensees and sublicensees to keep) complete and accurate records pertaining to the purchase, storage, sale, or other disposition of Licensed Products in sufficient detail to permit Roche to confirm the accuracy of all royalty and other payments due hereunder.  Records will include, at a minimum, master files, product numbers, description, quantities purchased, shipped, sold and on-hand at period end, customer or supplier name, address, customer agreements, date of purchase or sale, cost of purchase or sale price, and delivery address.  Roche shall have the right to cause an independent, certified public accountant to audit such royalty payments, and milestone payments related to Net Sales for a period covering not more than the preceding *** (***) years.  Such audits may be exercised no more than once per calendar year during normal business hours upon reasonable prior written notice to VIA.  Prompt adjustments shall be made by the parties to reflect the results of such audit.  Roche shall bear the full cost of such audit

 

*** Certain information on this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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unless such audit discloses an underpayment by VIA of more than five percent (5%) of the amount of royalty or other payments due under this Agreement, in which case, VIA shall bear the full cost of such audit and shall promptly remit to the auditing party the amount of any underpayment, plus interest calculated at the three month US Dollar LIBOR rate plus *** percent (***%).  If requested by Roche, VIA shall provide to Roche within thirty (30) days after such request any and all financial information relating to VIA that is controlled by VIA and necessary for Roche to prepare its financial statements and to make governmental filings, including full monthly reporting of data to Roche by the third work day of each month and maintaining a set of accounting records, based on Roche Financial Group Accounting and Reporting Requirements (“FGAR”) and International Financial Reporting Standards (“IFRS”).

 

5.5                               Late Payments.  In the event that any payment due under this Agreement is not made when due, the payment shall accrue interest from the date due at the rate of the one-month LIBOR plus *** percent (***%); provided, however, that in no event shall such rate exceed the maximum legal annual interest rate.  The payment of such interest shall not limit Licensor from exercising any other rights it may have as a consequence of the lateness of any payment.

 

5.6                               Confidentiality of Records.  Roche agrees that all information subject to review under this Article 5 or under any sublicense agreement (other than the reported results of such review) is confidential and that Roche and the auditor shall retain all such information in confidence, although this condition is not intended to restrict Roche from enforcing any term or provision of this Agreement in arbitration or court.

 

ARTICLE 6

 

RESEARCH, DEVELOPMENT AND MARKETING

 

6.1                               Development.  Prior to the Effective Date, Roche has conducted research and development of the Compound.  VIA shall use commercially reasonable efforts to develop and commercialize Licensed Products, including obtaining the necessary approvals from Regulatory Agencies.  In no case shall commercially reasonable efforts be less than those efforts that would be exerted by a comparable biotech company with a drug of similar commercial potential.

 

(a)                                 At the Effective Date of this Agreement, Roche shall assign a Global Liaison to be the liaison with VIA.  The Global Liaison will be the Roche point person with primary responsibility for communications and interactions with VIA related to:

 

i)                                         General Inter-Company Communication

 

ii)                                      VIA Group due diligence

 

iii)                                   Technology and Data Transfer.

 

(b)                                 Similarly and for reasons including those set out in Section 6.2(a).  VIA shall assign a liaison with Roche.

 

*** Certain information on this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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6.2                               Development Program.

 

(a)                                 VIA shall, at its expense, conduct a clinical and commercial development program relating to the use of a Licensed Product using commercially reasonable efforts (“Development Program”) consistent with a Development Plan that is to be provided to Roche as soon as practicable after creation by VIA.  VIA shall provide on a once yearly basis written reports to the Global Liaison on the progress of the Development Program, and annually shall provide to the Global Liaison a written overview of material Development Program activities.

 

(b)                                 VIA shall maintain a clinical trials database in accordance with the standards of Regulatory Agencies.

 

(c)                                  The Development Plan may be reasonably modified and updated at any time as is deemed necessary at the discretion of VIA.

 

(d)                                 Upon completion of a Phase I clinical trial for each Licensed Product, VIA shall present to Roche (i) a summary presentation of the data generated by such Phase I clinical trial, and (ii) a Development Plan for Phase II.

 

(e)                                  Notwithstanding anything to the contrary hereunder (including without limitation under Section 6.1 and this Section 6.2), VIA’s sole and exclusive liability and Roche’s sole and exclusive remedy for any failure by VIA to exercise any required level of efforts to research, develop, obtain Registrations or commercialize the Licensed Products shall be for Roche to exercise any termination right that Roche might have pursuant to Section 12.3 on account of such failure.

 

6.3                               Reversion to Roche.  Notwithstanding anything in this Agreement to the contrary, if at any time and for any reason, whether scientific, technical, medical, economic, commercial or otherwise, VIA shall determine that it is not reasonable to continue clinical trials or other development of Licensed Products (whether directly or through one or more Affiliates or sublicensees), it may deliver a written notice of such determination to Roche, and its election to cease further development, in which event, Roche may terminate the Agreement and all licenses granted herein pursuant to Section 12.3(b).  Likewise, if VIA determines not to pursue the development or commercialization of a Licensed Product (whether directly or through one or more Affiliates or sublicensees) in any of the following sub-territories:  (i) the US, (ii) Japan, (iii) the European Union (in such case at least three (3) of the Major Markets in the European Union), then VIA shall provide Roche with written notice of its decision and shall terminate this Agreement with respect to such sub-territory, within thirty (30) days following Roche’s receipt of such notice, in which event, Roche may terminate all licenses granted herein solely for such sub-territory pursuant to Section 12.3(b).

 

ARTICLE 7

 

PATENT RIGHTS

 

7.1                               Patent Prosecution and Maintenance.

 

(a)                                 Roche shall, at its sole expense, prosecute any and all patent applications within the Roche Patent Rights to obtain patents thereon and to maintain all patents included in the Roche Patent Rights.  Interferences, nullification proceedings and oppositions shall be considered a part of the prosecution and maintenance of the Roche Patent Rights.

 

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(b)                                 VIA shall, at its sole expense, prosecute any and all patent applications within the VIA Patent Rights, to obtain patents thereon and to maintain all patents included in the VIA Patent Rights using patent counsel of its choice.  Interferences, nullification proceedings and oppositions shall be considered a part of the prosecution and maintenance of the VIA Patent Rights.

 

(c)                                  Roche shall keep VIA reasonably informed of its prosecution of the Roche Patent Rights.  Roche agrees to provide VIA with a written report no less frequently than once each year updating VIA with respect to the status of its prosecution of the Roche Patent Rights.  Prior to making any submissions, such as patent applications and responses to office actions, to a patent office wherein Roche Patent Rights are being prosecuted, Roche shall allow VIA to comment on such submissions.

 

7.2                               Discontinuance/Abandonment.  Notwithstanding Section 7.1, Roche shall have the right to discontinue the prosecution of any patent application, or to abandon any patent, encompassed within the Roche Patent Rights.  If Roche decides to abandon or allow to lapse any patent application or patent within the Roche Patent Rights, then Roche shall inform VIA at least thirty (30) days prior to such abandonment or lapse and VIA shall be given the opportunity to have such Patent assigned to it from Roche.  If a Roche patent application or patent is assigned to VIA, then such Patent shall cease to be considered Roche Patent Rights for purposes of royalty payments under Article 4.

 

7.3                               Status of Patent Rights.  Within thirty (30) days after each anniversary of the Effective Date, Roche shall advise VIA as to the then-current status of any patent applications or patents within the Roche Patent Rights.

 

7.4                               Ownership of Future Inventions and Know-How.

 

(a)                                 Patentable and unpatentable Inventions or Know-How made, developed or conceived by VIA personnel alone (or jointly with one another) shall be the sole property of VIA (“VIA Inventions”).  VIA shall have sole discretion and responsibility to prepare file, prosecute and maintain patent applications for VIA Inventions, and shall be responsible for related interference proceedings.

 

(b)                                 Patentable and unpatentable Inventions or Know-How made, developed or conceived by Roche personnel alone (or jointly with one another) shall be the sole property of Roche (“Roche Inventions”).  Roche shall have sole discretion and responsibility to prepare file, prosecute and maintain patent applications for Roche Inventions, and shall be responsible for related interference proceedings.

 

(c)                                  Patentable or unpatentable Inventions or Know-How jointly made, developed or conceived by VIA and Roche personnel shall be jointly owned, unless the Parties agree otherwise.  Patent applications for joint inventions shall be prepared and prosecuted jointly.  Subject to any exclusivity obligations set forth in this Agreement, each Party shall be free to use and exploit jointly owned Inventions, Patents and Know-How without the consent of, or any duty to account to, the other Party.

 

(d)                                 In no event shall any disclosure of compounds, inventions or other information in accordance with this Section 7.4 be construed as an offer to sell those compounds, inventions or other information.  Any disclosure under this Section 7.4 shall be subject to the confidentiality provisions of this Agreement.

 

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ARTICLE 8

 

INFRINGEMENT

 

8.1                               Applicability.  The provisions of this Article 8 shall govern the Parties’ rights and obligations, as between themselves, with respect to actions against Third Parties for infringement of the Patents or misappropriation of the Know-How licensed under this Agreement.

 

8.2                               Third Party Infringement.

 

(a)                                 If either VIA or Roche becomes aware of any product made, used, sold or imported in the Territory which it believes to (i) infringe a Valid Claim within the Roche Patent Rights (“Roche Patent Infringement”) or the VIA Patent Rights, (ii) or constitute a misappropriation of Know-How owned by either Party covering or relating to a Licensed Product or its manufacture or use, then such Party (the “Notifying Party”) shall promptly (and, in the event of receiving a Paragraph IV Certification described in 21 C.F.R. § 314.50(i)(A)(4), within ten (10) days) advise the other Party of all the relevant facts and circumstances known by the Notifying Party in connection with the infringement or misappropriation.

 

(b)                                 Roche shall have the right, at its own expense, but not the obligation, to enforce Roche Patent Rights against Roche Patent Infringement and VIA shall have the right, at its own expense, but not the obligation, to enforce VIA Patent Rights against infringement.  VIA and its Affiliates shall, at Roche’s sole expense, fully cooperate with Roche with respect to the investigation and prosecution of such alleged Roche Patent Infringement or misappropriation including (without limitation) the joining of VIA and its Affiliates as a party to such action, as may be required by the law of the particular forum where enforcement is being sought.  Roche and its Affiliates shall, at VIA’s sole expense, fully cooperate with VIA with respect to the investigation and prosecution of such alleged infringement of the VIA Patent Rights or misappropriation including (without limitation) the joining of Roche and its Affiliates as a party to such action, as may be required by the law of the particular forum where enforcement is being sought.

 

(c)                                  If Roche elects to proceed with an enforcement action pursuant to Section 8.2(b) with respect to infringement of the Roche Patent Rights that is or can reasonably be expected to be competitive with a Licensed Product (“Competitive Infringement”), then VIA shall have the right to intervene and pursue its own damages claim against any alleged Competitive Infringement, and Roche shall, at VIA’s sole expense, take all such actions and execute all such documents as may be necessary to enable VIA to pursue such claim, including by taking actions and executing documents at VIA’s direction on VIA’s behalf.  Any such intervention by VIA under this Section 8.2(c) shall be controlled by VIA with respect to such damages claim; however, Roche shall remain in control of the defense against any claim, counterclaim or defense of patent invalidity or unenforceability related to any such Roche Patent Infringement.  Notwithstanding the foregoing provisions of this Section 8.2(c), if VIA is unable to intervene and pursue its own damages claim because VIA lacks standing (e.g., because VIA does not own the Roche Patent Rights) or for any other reason, Roche shall pursue such damages claim directly for VIA’s benefit as VIA may reasonably request.

 

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(d)                                 Roche grants to VIA the right to enforce the Roche Patent Rights against Competitive Infringement, if:

 

(i)                                     Roche fails, within sixty (60) days (twenty (20) days in the event of the filing of a Paragraph IV Certification) after receiving notice from VIA of the Roche Patent Infringement to (1) notify VIA that Roche elects to proceed with an enforcement action pursuant to Section 8.2(b), (2) take reasonable action to investigate such alleged infringement, and (3) promptly thereafter, institute an action to abate such alleged infringement and to prosecute such action diligently, or

 

(ii)                                  Roche earlier notifies VIA that Roche does not plan to terminate the infringement or institute such action solely pursuant to Section 8.2(b).

 

If VIA notifies Roche that there are circumstances that require the enforcement of the Roche Patent Rights against a Competitive Infringement within a shorter period than contemplated by Section 8.2(d)(i) above in order to avoid any loss of rights or compromising any potential claims, then Roche shall in good faith discuss with VIA avenues for instituting an action (or allowing VIA to institute an action) more rapidly than contemplated by Section 8.2(d)(i) above.

 

Roche and its Affiliates shall fully cooperate with VIA, at VIA’s expense, with respect to the investigation and prosecution of such alleged infringement including (but not limited to) the joining of Roche and its Affiliates as a party to such action, as may be required by the law of the particular forum where enforcement is being sought.  Any such enforcement action by VIA under Roche Patent Rights shall be limited to enforcement against Competitive Infringement.

 

(e)                                  If Roche is prosecuting an infringement action under Section 8.2(b), then Roche shall have the right to control such litigation and shall bear all legal expenses (including court costs and legal fees and expenses), including settlement thereof.  If a claim for damages is brought by VIA or VIA requests that Roche pursue such a claim for VIA’s benefit pursuant to Section 8.2(c), then VIA shall have such right to control (or direct, if VIA is not able to intervene and pursue its own damages claim and requests that Roche pursue such claim for VIA’s benefit) such claim for damages and shall bear all its and Roche’s legal expenses (except as provided otherwise in the event that Roche should join as a party to such action).  No settlement or consent judgment or other voluntary final disposition of any infringement action brought by a Party pursuant to this Section 8.2 may be entered into without the prior written consent of the other Party if such settlement would require the other Party to be subject to an injunction or to make a monetary payment or would restrict the claims in or admit any invalidity of any of the Roche Patent Rights or VIA Patent Rights or significantly adversely affect the rights of the other Party to this Agreement.

 

Roche shall be entitled to keep, out of all damages or costs recovered by Roche in connection with any action filed by Roche under Section 8.2(b), and after first reimbursing both parties for any out-of-pocket costs and expenses incurred in bringing the action (“Roche Net Recovery”), an amount equal to (i) one hundred percent (100%) of such Roche Net Recovery for actions against Roche Patent Infringement that are not Competitive Infringement, and (ii) twenty-five percent (25%) of the Roche Net Recovery from any action to the extent involving Competitive Infringement, and the rest of such Roche Net Recovery shall be provided to VIA.  VIA shall be entitled to keep seventy-five percent (75%) of all damages or costs recovered by VIA in connection with any claim for damages brought by VIA under Section 8.2(c) or 8.2(d), after first reimbursing both parties for any out-of-pocket costs and expenses incurred in bringing the action (“VIA Net Recovery”), and the rest of such

 

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VIA Net Recovery (25%) shall be provided to Roche.  If the Parties agree to jointly prosecute such infringement action and jointly share expenses, then the Parties will split 50:50 all damages or costs recovered, after first reimbursing each Party for any out-of-pocket expenses in such action.  If the recovery of a Party or Parties prosecuting an action solely under this Section 8.2 does not exceed the Parties’ costs in such action, then each Party shall be reimbursed pari passu for any out-of-pocket expenses incurred in such action.

 

(f)                                   Sections 8.2(b)-(e) shall apply mutatis mutandis to trade secret misappropriation actions relating to competitive Third Party activities involving Roche Know-How as it does to enforcement of Roche Patent Rights against Competitive Infringement.

 

(g)                                  Neither Party shall be entitled to grant covenants not to sue or other similar rights under Patents owned by the other Party, provided, however, VIA may grant licenses and sublicenses in accordance with Section 2.2.

 

ARTICLE 9

 

REPRESENTATIONS AND WARRANTIES

 

9.1                               Representations of Roche.  Roche hereby represents to VIA as of the Effective Date that:

 

(a)                                 Roche is duly formed and/or incorporated, validly existing and in good standing, with the corporate power and authority to enter into this Agreement and to perform its obligations hereunder.  The execution and delivery of this Agreement and the consummation of the transactions contemplated hereby have been duly authorized by all requisite corporate action on the part of Roche.  This Agreement has been duly executed and delivered by Roche and constitutes the valid, binding and enforceable obligation of Roche, subject to applicable bankruptcy, reorganization, insolvency, moratorium and other laws affecting creditors’ rights generally from time to time in effect and to general principles of equity.

 

(b)                                 Roche owns the Roche Patent Rights and owns, controls, or licenses the Roche Know-How and owns all of the Transfer Know-How (as defined in Section 11.1);

 

(c)                                  Except for the Roche Patent Rights, Roche and its Affiliates do not own or control any Patents claiming the Compound;

 

(d)                                 Roche has the right to grant VIA the rights and licenses granted under this Agreement; and

 

(e)                                  Roche is not subject to, or bound by, any provision of:

 

(i)                                     any articles or certificates of incorporation or by-laws;

 

(ii)                                  any mortgage, deed of trust, lease, note, shareholders’ agreement, bond, indenture, license, permit, trust, custodianship, or other instrument, agreement or restriction; or

 

(iii)                               any judgment, order, writ, injunction or decree or any court, governmental body, administrative agency or arbitrator;

 

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that would prevent, or be violated by, or under which there would be a default as a result of, nor is the consent of any Third Party required for, the execution, delivery and performance by Roche of this Agreement and the obligations contained herein, including without limitation, the grant to VIA of the license described in Section 2.1 hereof.

 

9.2                               Representations of VIA.  VIA hereby represents to Roche as of the Effective Date that:

 

(a)                                 VIA is a corporation duly incorporated, validly existing and in good standing under the laws of the jurisdiction of its organization, with the corporate power and authority to enter into this Agreement and to perform its obligations hereunder.  The execution and delivery of this Agreement and the consummation of the transactions contemplated hereby have been duly authorized by all requisite corporate action on the part of VIA.  This Agreement has been duly executed and delivered by VIA and constitutes the valid, binding and enforceable obligation of VIA, subject to applicable bankruptcy, reorganization, insolvency, moratorium and other laws affecting creditors’ rights generally from time to time in effect and to general principles of equity.

 

(b)                                 VIA is not subject to, or bound by, any provision of:

 

(i)                                     any articles or certificates of incorporation or by-laws;

 

(ii)                                  any mortgage, deed of trust, lease, note, shareholders’ agreement, bond, indenture, license, permit, trust, custodianship, or other instrument, agreement or restriction, or

 

(iii)                               any judgment, order, writ, injunction or decree or any court, governmental body, administrative agency or arbitrator,

 

that would prevent, or be violated by, or under which there would be a default as a result of, nor is the consent of any Third Party required for, the execution, delivery and performance by VIA of this Agreement and the obligations contained herein.

 

9.3                               Disclaimer of Warranties.  EXCEPT AS SET FORTH EXPRESSLY IN THIS AGREEMENT, EACH PARTY HEREBY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THE INTELLECTUAL RIGHTS OF THIRD PARTIES.  WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, BOTH PARTIES ACKNOWLEDGE AND DISCLAIM ANY WARRANTY AS TO:  (I) THE SUCCESS OF ANY DEVELOPMENT OR CLINICAL TRIAL, STUDY OR TEST COMMENCED BY UNDER THIS AGREEMENT; OR (II) REGULATORY APPROVAL, PRODUCT INTRODUCTION, SAFETY, USEFULNESS OR COMMERCIAL SUCCESS OF ANY LICENSED PRODUCT.

 

ARTICLE 10

 

CONFIDENTIALITY

 

10.1                        Treatment of Confidential Information.  Except as otherwise provided in this Article 10, during the term of this Agreement and for a period of five (5) years thereafter, VIA and its

 

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Affiliates will retain in confidence and use only for purposes of this Agreement any information, data, and materials supplied by Roche or on behalf of Roche to VIA and its Affiliates under this Agreement, and Roche will retain in confidence and use only for purposes of this Agreement any information, data, and materials supplied by VIA or on behalf of VIA to Roche under this Agreement.  For purposes of this Agreement, all such information and data which a Party is obligated to retain in confidence shall be called “Confidential Information” of the disclosing Party.

 

10.2                        Right to Disclose.  To the extent it is reasonably necessary or appropriate to fulfill its obligations or exercise its rights under this Agreement or any rights which survive termination or expiration hereof, VIA and Roche each may disclose the Confidential Information of the other Party to their respective Affiliates, sublicensees, consultants, outside contractors, clinical investigators or other Third Parties provided that such entities or persons agree in writing (a) to keep the Confidential Information confidential for the same time periods and to the same extent as VIA and Roche are required to keep the Confidential Information confidential and (b) to use the Confidential Information only for such purposes as VIA and Roche (as applicable) are entitled to use the Confidential Information.  Each Party or its Affiliates or sublicensees may disclose such Confidential Information of the other Party to government or other regulatory authorities to the extent that such disclosure (i) is reasonably necessary to obtain Patents or authorizations to conduct clinical trials with or to market commercially the Licensed Products, provided such Party is otherwise entitled to engage in such activities under this Agreement; (ii) is otherwise legally required; (iii) is in facilitation of a Party’s relationship with its existing or prospective investors; or (iv) is permitted pursuant to Section 14.7; provided that if a Party is legally required to make such a disclosure under (ii), it shall, if practicable under the circumstances, first have given prompt notice to the other Party hereto to enable it to seek any available exemptions from or limitations on such a disclosure, or to apply for confidential treatment or a protective order.

 

10.3                        Release From Restrictions.  The foregoing obligations in respect of disclosure and use of Confidential Information shall not apply to any part of such Confidential Information that the receiving Party, or its Affiliates (all collectively referred to as the “Receiving Party”) can demonstrate by competent evidence:

 

(a)                                 is or becomes publicly available other than by acts of the Receiving Party in breach of this Agreement;

 

(b)                                 is disclosed to the Receiving Party or its Affiliates or sublicensees by a Third Party who had the right to disclose such Confidential Information to the Receiving Party;

 

(c)                                  prior to disclosure under this Agreement, was already in the possession of the Receiving Party or its Affiliates or sublicensees, provided such Confidential Information was not obtained, directly or indirectly, from the other Party under this Agreement; or

 

(d)                                 was independently discovered or developed by the Receiving Party without resort to or use of any Confidential Information of the disclosing Party.

 

10.4                        Confidentiality of Agreement.  Except as otherwise required by law or the terms of this Agreement or mutually agreed upon by the Parties hereto, each Party shall treat as confidential the terms, and conditions of this Agreement, except that Roche and VIA may each disclose such terms and conditions and the achievement of milestone and other significant events under this Agreement to its Affiliates and sublicensees, and to current, and potential investors, merger partners

 

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or acquirors.  Furthermore, either Party in connection with its current or future status as a public company (or in connection with its initial public offering registration activities) may disclose the terms of this Agreement to the extent required by the federal securities laws or regulations or the rules or regulations of any stock exchange or NASDAQ, and provided, that the disclosing Party shall seek confidential treatment of key business terms contained in this Agreement, including but not limited to the royalty rates; provided further, that the disclosing Party shall duly consider reasonable and timely suggestions, advice and input from the non-disclosing Party with respect to seeking confidential treatment of key business terms contained in the Agreement.  After execution of this Agreement, the Parties shall release the joint press release, the text of such shall be mutually agreeable to each Party, announcing the execution of the Agreement.  In addition, the Parties have agreed to the publicity-related provisions that are set forth in Section 14.7.

 

10.5                        Return of Confidential Information.  Upon termination of this Agreement by either Party for any reason, the rights of each Party to retain and use the Confidential Information of the other shall be as provided in Article 12, provided, however, that each Party may retain a single archival copy of the other Party’s Confidential Information solely for the purpose of determining the extent of disclosure of Confidential Information hereunder and assuring compliance with the surviving provisions of this Agreement.

 

ARTICLE 11

 

TRANSFERS AND ACCESS; REGULATORY

 

11.1                        Transfer of Know-How.  Immediately after the Effective Date, but not later than sixty (60) days after the Effective Date, Roche shall transfer (originals or copies) to VIA all of the Roche Know-How listed in Appendix B (the “Transfer Know-How”).  If Roche identifies any Roche Know-How in the future that should have been included in the Transfer Know-How, then Roche shall provide such Roche Know-How to VIA in a timely manner.  Roche agrees to provide to VIA upon VIA’s reasonable request and at VIA’s sole expense copies of the prosecution files and histories of the Roche Patent Rights that are not publicly available.  At VIA’s request, Roche shall participate in up to two (2) telephone conferences designed to answer questions related to the Roche Know-How, provided that Roche shall not be obligated to provide more that one (1) person day of effort related to these telephone conferences.

 

11.2                        Tissue Samples.  Roche has certain tissue samples related to the subject matter of this Agreement (“Samples”).  Upon the request of VIA, Roche shall provide VIA with access to these Samples or transfer such Samples to VIA.  Once Roche’s right of first negotiation under Section 2.6 is exhausted, Roche shall have the right to transfer such Samples to VIA.

 

11.3                        Regulatory Affairs.

 

(a)                                 During the Term, VIA shall (i) control and be solely responsible for making all needed Regulatory Filings relating to the development of Licensed Products and for seeking and maintaining Registrations of Licensed Products developed by VIA throughout the Territory, in such countries as it selects; and (ii) own and be responsible for preparing and submitting all Regulatory Rulings, including preparing all applications and reports necessary as part of an IND, NDA, DMF (“Drug Master File”), or other necessary filing required for Registration.  Roche shall assign to VIA all rights, title and interest in and to all Regulatory Filings that Roche has made with respect to any Compound or Derivative and all licenses, authorizations and permits that Roche has obtained with

 

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respect to clinical trials of any Compound or Derivative.  Roche shall permit VIA to access, and shall provide VIA with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement, all records pertaining to Compounds, Derivatives or Licensed Products as are in the possession of Roche and are reasonably necessary for obtaining Registrations for Licensed Products.

 

(b)                                 In conducting any research or development activities under this Agreement, VIA shall (i) ensure that its employees, agents, clinical institutions and clinical investigators comply with all Regulatory Agency statutory and regulatory requirements with respect to Licensed Products, including but not limited to the Federal Food, Drug and Cosmetic Act, as amended, the Public Health Service Act, Institutional Review Boards, GCP, GLP, IND regulations, and any conditions imposed by a reviewing IRB or Regulatory Agency; and (ii) not utilize, in conducting studies on Licensed Products, any person or entities that at such time are debarred by a Regulatory Agency, or that, at such time, are under investigation by the FDA for debarment action pursuant to the provisions of 21 U.S.C. § 335.

 

ARTICLE 12

 

TERM AND TERMINATION

 

12.1                        Term.  This Agreement shall become binding upon the Effective Date.  This Agreement shall continue thereafter in full force and effect, unless terminated sooner pursuant to Sections 12.2 or 12.3 below, until it expires upon the expiration of VIA’s obligation to pay royalties to Roche hereunder (such expiration of the term of this Agreement without termination, “Expiration”).

 

12.2                        VIA’s Right to Terminate.

 

(a)                                 For Material Breach at any Time.  VIA may terminate this Agreement, as a whole, at any time if (i) Roche materially breaches the Agreement and (ii) such material breach is not cured by Roche within ninety (90) days after VIA provides Roche with written notice of such breach, or, if such breach cannot be cured through commercially reasonably efforts within such ninety (90) days, and Roche has (within such time period) submitted a plan for cure as promptly as is reasonably practicable through the application of commercially reasonable efforts with a cure date reasonably acceptable to VIA, after the earlier of the cure date agreed to by VIA or the date Roche ceases commercially reasonable efforts to cure such breach.

 

(b)                                 For Convenience.  VIA may terminate this Agreement for convenience, upon sixty (60) days prior written notice to Roche, provided that such notice of termination may not occur until after the one year anniversary of the Effective Date.  VIA may commence to wind down all of its activities under this Agreement immediately upon such notice.

 

12.3                        Roche’s Right to Terminate.

 

(a)                                 For Material Breach at any Time.  Roche may terminate this Agreement, as a whole, at any time if (i) VIA materially breaches the Agreement and (ii) such material breach is not cured by VIA within ninety (90) days after Roche provides VIA with written notice of such breach, or, if such breach cannot be cured through commercially reasonably efforts within such ninety (90) days, and VIA has (within such time period) submitted a plan for cure as promptly as is reasonably

 

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practicable through the application of commercially reasonable efforts with a cure date reasonably acceptable to Roche, after the earlier of the cure date agreed to by Roche or the date VIA ceases commercially reasonable efforts to cure such breach.  If VIA files a petition for bankruptcy, dissolution, liquidation or winding up of affairs, then such petition shall not relieve VIA of its obligation for continued performance under this Agreement pending a decision on such petition.

 

(b)                                 For VIA’s Discontinuance of the Development Plan.  Notwithstanding anything in this Agreement to the contrary, Roche may terminate the Agreement and all licenses granted herein following receipt of written notice from VIA of VIA’s decision to discontinue all of VIA’s activities under the Development Plan pursuant to Section 6.3 in either the Territory or a sub-territory (as defined in Section 6.3), as applicable; provided that any such termination for a sub-territory shall only be effective for such sub-territory (i.e., this Agreement shall remain in force for all remaining sub-territories that are not subject to such termination).  Following such termination and at Roche’s request within thirty (30) days after such termination, VIA shall negotiate in good faith with Roche, for a period of sixty (60) days from the date of Roche’s request, to license on commercially reasonable terms to Roche the VIA Patent Rights and VIA Know-How related solely to the Licensed Products in the Territory or terminated sub-territory, as applicable.

 

12.4                        General Effect of Expiration or Termination.  Upon Expiration or termination of this Agreement for any reason, all rights and obligations of the Parties hereunder shall cease, except as explicitly provided for below in this Article 12 or elsewhere in this Agreement.  Expiration or termination of this Agreement shall not relieve the Parties of any obligation to make payments or otherwise to the extent related to events or other facts in existence prior to such Expiration or termination.

 

12.5                        Rights Upon Expiration or Any Termination.

 

(a)                                 Upon Expiration of this Agreement in any country, VIA shall continue to have a royalty-free, perpetual right to Commercialize Licensed Products in the Territory, as the license granted VIA in Section 2.1 shall automatically become royalty-free, non-exclusive and perpetual in the country of Expiration.

 

(b)                                 Upon Expiration or termination of this Agreement for any reason, the following Sections and Articles shall survive such expiration or termination, subject to any later termination dates provided for therein:  Sections 5.1 and 5.2 (with respect to payments having accrued during the term of this Agreement); Sections 5.4; 5.5; and 9.3, and Articles 1, 8 (as relates to infringement occurring during the term of this Agreement), 10, 12, 13 and 14.

 

12.6                        Rights Upon Certain VIA Terminations.

 

(a)                                 Upon termination by VIA for Roche’s uncured material breach of this Agreement pursuant to Section 12.2(a), the following Sections shall survive such termination in addition to the Sections and Articles set forth to survive in Section 12.5(b):  Sections 2.1; and 3.1, 3.2 and 3.3 (with continued milestone payments reduced by *** percent (***%)); Article 4 (with continued royalty payments reduced by *** percent (***%)) and all other Sections and Articles governing the

 

*** Certain information on this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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mechanics of milestone and royalty payments hereunder.  The licenses granted by Roche to VIA shall become perpetual and irrevocable if VIA terminates under Section 12.2 (a).

 

(b)                                 If VIA terminates this Agreement for any reason other than Roche’s uncured material breach of this Agreement pursuant to Section 12.2(a), then VIA’s obligations pursuant to Section 3.1 shall survive such termination.

 

(c)                                  Termination of this Agreement by VIA shall not limit VIA’s ability to seek any remedies that may be available for any breaches of the terms hereof by Roche prior to such termination.

 

12.7                        Rights Upon Roche Termination for Cause and Other VIA Terminations.  If Roche terminates this Agreement pursuant to Section 12.3, or VIA terminates this Agreement for convenience pursuant to Section 12.2(b), then:

 

(a)                                 Reverted Territory; Reverted Products.  The Territory, in the case of a termination in whole, and the terminated country or countries (together with their territories and possessions) in the case of a partial termination, shall be deemed to be the “Reverted Territory” effective as of the effective date of such termination.  In the case of a partial termination, the Reverted Territory shall thereafter be excluded from the Territory for all purposes under this Agreement, but this Agreement will remain in effect in the remaining Territory.  All Licensed Products in the Reverted Territory shall, effective upon the effective date of such termination, be deemed “Reverted Products.”

 

(b)                                 No Further Representations.  The VIA Group shall discontinue making any representation regarding its status as a licensee of or distributor for Roche in the Reverted Territory, for all Reverted Products.  The VIA Group shall cease conducting any activities with respect to the marketing, promotion, sale or distribution of the Reverted Products in the Reverted Territory.

 

(c)                                  Technology License.  VIA hereby grants to Roche, if Roche notifies VIA within thirty (30) days after such termination that Roche desires to negotiate such a license, the right to negotiate for a period of sixty (60) days thereafter a license on commercially reasonable terms under (i) any patent or patent application owned by VIA (or any VIA Affiliate) covering the Reverted Products having been developed or commercialized by the VIA Group during the term of this Agreement, and (ii) all Know-How owned or controlled by VIA and its Affiliates relevant to Reverted Products, solely for Roche to commercialize Reverted Products in the Reverted Territory, and to manufacture Reverted Products anywhere in the world for such Commercialization, and (iii) any Regulatory Filings of VIA in the Reverted Territory.

 

(d)                                 No Further Sales.  VIA covenants that promptly upon such termination it and its Affiliates and former sublicensees hereunder shall cease to sell, and thereafter shall not sell, any Reverted Product in the Reverted Territory prior to three (3) years after the effective date of termination.

 

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ARTICLE 13

 

INDEMNIFICATION

 

13.1                        Indemnification by VIA.  Subject to Sections 13.3 and 14.14 hereof, VIA hereby agrees to defend, indemnify and hold harmless Roche and its Affiliates and licensors, and their directors, officers, employees and agents (“Roche Indemnitees”) from and against any liabilities, losses, fines, penalties, damages, expenses (including reasonable attorney’s fees and expenses and expenses incurred in connection with the enforcement of this provision), resulting from any Third Party suits, actions, or claims brought or threatened after the Effective Date of this Agreement and which arise out of claims against Roche Indemnitees brought by Third Parties after the Effective Date of this Agreement, including but not limited to, any actions in contract (including breach of warranty) tort (including negligence, strict liability or commercial torts) which arise, result from, or relate to:

 

(i)                                     any breach of any of the representations of VIA contained in Section 9.2 hereof,

 

(ii)                                  the gross negligence, recklessness or willful misconduct of the VIA and its Affiliates; and

 

(iii)                               any development or commercialization (including without limitation, any manufacture, storage, use or possession) of Compound, Derivatives, Additional Licensed Compounds or Licensed Product by VIA, its Affiliates, sublicensees and distributors.

 

Items (i) through (iii) are hereinafter collectively referred to as a “Roche Loss.”  VIA shall have no obligation to indemnify Roche, to the extent that any Roche Loss arises out of the gross negligence or willful misconduct of any Roche Indemnitee or Roche’s breach of this Agreement.

 

13.2                        Indemnification by Roche.  Subject to Sections 13.3 and 14.14 hereof, Roche hereby agrees to defend, indemnify and hold harmless VIA, its Affiliates and sublicensees, and their directors, officers, employees and agents (“VIA Indemnitees”) from and against any liabilities, losses, fines, penalties, damages, expenses (including reasonable attorney’s fees and expenses and expenses incurred in connection with the enforcement of this provision), resulting from any Third Party suits, actions, or claims which arise out of claims against VIA Indemnitees brought by Third Parties after the Effective Date of this Agreement, including but not limited to, any actions in contract (including breach of warranty), tort (including negligence, strict liability or commercial torts) which arise, result from, or relate to:

 

(i)                                     any breach of any of the representations of Roche contained in Section 9.1 hereof,

 

(ii)                                  the gross negligence, recklessness or willful misconduct of Roche, its Affiliates or agents, and

 

(iii)                               any development or commercialization (including without limitation, any manufacture, storage, use or possession) of Compound, Derivatives, Additional Licensed Compounds or Licensed Product by Roche or its Affiliates.

 

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Items (i) through (iii) are hereinafter collectively referred to as an “VIA Loss.”  Roche shall have no obligation to indemnify VIA, to the extent that any VIA Loss arises out of the gross negligence or willful misconduct of any VIA Indemnitee or VIA’ breach of this Agreement.

 

13.3                        Indemnification Procedures With Respect to Third Party Claims.

 

(a)                                 To be eligible to seek indemnification under this Article 13 in respect to a liability, loss, fine, penalty, damage, expense, action, or claim brought against such Indemnitee by a Third Party (such claim hereinafter referred to as a “Third Party Claim”), a VIA Indemnitee or Roche Indemnitee (each, an “Indemnitee”) shall promptly give written notice thereof to the Party from whom indemnification is sought (such Party hereinafter referred to as the “Indemnitor”) within a reasonable period of time after the assertion of such Third Party Claim by such Third Party; provided, however, that the failure to provide written notice of such Third Party Claim within a reasonable period of time shall not relieve the Indemnitor of any of its obligations hereunder, except to the extent that the Indemnitor is prejudiced by such failure.  The Indemnitor shall have the right to assume the complete control of the defense, compromise or settlement of any Third Party Claim (provided that no settlement of any Third Party Claim shall include any admission of wrongdoing on the part of an Indemnitee, without the prior written consent of such Indemnitee, which consent shall not be unreasonably withheld), including, at its own expense, employment of legal counsel.  At any time thereafter the Indemnitor shall be entitled to exercise, on behalf of the Indemnitee, any rights which may mitigate the extent or amount of such Third Party Claim; provided, however, that if the Indemnitor shall have exercised its right to assume control of such Third Party Claim, the Indemnitee (i) may, in its sole discretion and at its own expense (which expense shall not be subject to indemnification hereunder), employ legal counsel to represent it (in addition to the legal counsel employed by the Indemnitor) in any such matter, and in such event legal counsel selected by the Indemnitee shall be required to confer and cooperate with such counsel of the Indemnitor in such defense, compromise or settlement for the purpose of informing and sharing information with the Indemnitor; (ii) shall, at its own expense, make available to Indemnitor those employees, officers and directors or Indemnitee whose assistance, testimony or presence is necessary or appropriate to assist the Indemnitor in evaluating and in defending any such Third Party Claim (provided, however, that any such access shall be conducted in such a manner as not to interfere unreasonably with the operations of the businesses of Indemnitee); and (iii) shall otherwise fully cooperate with the Indemnitor and its legal counsel in the investigation and defense of such Third Party Claim.

 

(b)                                 If the Parties acting in good faith cannot agree as to the applicability of Section 13.1 and/or 13.2 to a particular Third Party Claim, then each Party (and its respective Indemnitees) reserves the right to conduct its own defense of such Third Party Claim and seek indemnification from the applicable Party upon its resolution.

 

ARTICLE 14

 

GENERAL PROVISIONS

 

14.1                        Force Majeure.  Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement, other than an obligation to make payments hereunder, when such failure or delay is caused by or results from fire; flood; earthquake; tornado; embargo; government regulation; prohibition or intervention; war; act of war (whether war be declared or not); insurrection; act of terrorism; riot; civil commotion; strike; lockout; act of God or any other cause

 

24

 

beyond the reasonable control of the affected Party to anticipate, prevent, avoid or mitigate (a “Force Majeure Event”) so long as the affected Party uses commercially reasonable efforts to overcome the effects of the Force Majeure Event; provided, however, that any failure or delay in fulfilling a term of this Agreement shall not be considered a result of a Force Majeure Event if it arises from a knowing failure of VIA or Roche to comply with applicable laws and regulations.

 

14.2                        Further Assurances.  Each Party hereto agrees to perform such acts, execute such further instruments, documents or certificates, and provide such cooperation in proceedings and actions as may be reasonably requested by the other Party in order to carry out the intent and purpose of this Agreement, including without limitation the registration or recordation of the rights granted hereunder.

 

14.3                        Severability.  Both Parties hereby expressly acknowledge and agree that it is the intention of neither Party to violate any public policy, statutory or common law, rules, regulations, treaty or decision of any government agency or executive body thereof of any country or community or association of countries and specifically agree that if any word, sentence, paragraph, clause or combination thereof in this Agreement is found by a court or executive body with judicial powers having jurisdiction over this Agreement or any of the Parties hereto in a final unappealed order, to be in violation of any such provisions in any country or community or association of countries, then in such event such words, sentences, paragraphs, clauses or combination shall be inoperative in such country or community or association of countries (or reformed, for example but without limitation, to apply for a shorter period of time, such that their effect is in compliance with law) and the remainder of this Agreement shall remain binding upon the Parties hereto.

 

14.4                        Notices.  Any notice required or permitted to be given hereunder shall be in writing and shall be deemed to have been properly given if delivered in person, or if mailed by registered or certified mail (return receipt requested) postage prepaid, or by a nationally recognized overnight courier, or by facsimile (and promptly confirmed by registered, certified mail, overnight courier or fax receipt), to the addresses given below or such other addresses as may be designated in writing by the Parties from time to time during the term of this Agreement.  Any notice sent by overnight courier or facsimile shall be deemed received on the first business day after posted with the courier or transmittal.  Any notice sent by registered, certified mail shall be deemed received on the fourth (4th) business day following the date of posting.

 

	
In the case of VIA:
    	
VIA Pharmaceuticals, Inc.
    
	
 
    	
750 Battery Street,   Suite 330
    
	
 
    	
San Francisco California 94111   USA
    
	
 
    	
Attention: President
    
	
 
    	
 
    
	
In the case of Roche:
    	
Hoffmann-La Roche Inc.
    
	
 
    	
340 Kingsland Street
    
	
 
    	
Nutley, New Jersey 07110
    
	
 
    	
Attention: Corporate Secretary
    
	
 
    	
 
    
	
and:
    	
F. Hoffmann-La Roche Ltd
    
	
 
    	
Grenzacherstrasse 124
    
	
 
    	
CH-4070 Basel
    
	
 
    	
Switzerland
    
	
 
    	
Attention: Corporate Law
    

 

25

 

14.5                        Assignment.  All of the terms and provisions of this Agreement shall be binding upon and inure to the benefit of and be enforceable by the respective successors and permitted assigns of the Parties hereto, but neither this Agreement nor any of the rights, interests or obligations hereunder of any Party hereto shall be assigned without the prior written consent of the other Party (which may be withheld for any reason), provided, however, that either Party may, without such consent, assign this Agreement in whole or in part (i) to a successor corporation in connection with the transfer or sale of all or substantially all of its business or assets to which this Agreement pertains or in the event of the merger or consolidation with another corporation; and (ii) to an Affiliate.  Any purported assignment in violation of the preceding sentence shall be void.  Any permitted assignee shall assume all obligations of its assignor under this Agreement.

 

14.6                        Performance by Affiliates.  Each of Roche and VIA acknowledge that their obligations and rights under this Agreement may be performed and exercised by Affiliates of Roche and VIA, respectively.  Obligations of the Party for which one of its Affiliates is performing hereunder shall be deemed to extend to such performing Affiliate.  Each of Roche and VIA guarantee performance of this Agreement by its Affiliates.  Wherever in this Agreement the Parties delegate responsibility to Affiliates or local operating entities, the Parties agree that such entities shall not make decisions inconsistent with this Agreement, amend the terms of this Agreement or act inconsistently with the foregoing sentence, then the other Party shall be entitled to proceed against the Party whose Affiliate so breached, and shall not first be required to proceed against the Affiliate that so breached.

 

14.7                        Publicity.  Except for the details in the press release to be agreed upon by the Parties, and as required by the rules or regulations of any stock exchange or regulatory authority or otherwise required by law or regulation, neither Party, nor any of its Affiliates, shall originate any publicity, news release or other public announcement that identifies the other Party, written or oral, relating to the confidential terms or conditions contained in this Agreement without the prior written approval of such other Party.  In addition, VIA shall have the right to originate publicity, news releases and other public announcements relating to Licensed Products if such publicity, news releases and other public announcements do not identify Roche; provided that VIA shall provide Roche with an opportunity to review a draft of any such publicity, news release or other public announcement at least five (5) business days prior to releasing such publicity, news release or other public announcement (unless a quicker release is mandated by law).

 

14.8                        Roche Publications.  The Parties recognize the importance of allowing Roche scientists to have the ability to publish their results but recognize that such publications have the potential for disclosing intellectual property.  Accordingly, Roche shall have the right to publish all documents that (i) have been approved for publication in compliance with Roche’s internal procedures and (ii) submitted for publication prior to the Effective Date (drafts of which were disclosed to VIA).  After the Effective Date, Roche shall not submit for publication any document without the written consent of VIA, which consent shall be at VIA’s sole discretion.

 

14.9                        Amendment.  The Parties hereto may amend, modify or alter any of the provisions of this Agreement, but only by a written instrument that explicitly refers to this Agreement and is duly executed by both Parties hereto.

 

14.10                 Entire Agreement.  This Agreement contains the entire understanding of the Parties with respect to the subject matter hereof.  All express or implied agreements and understandings,

 

26

 

either oral or written, heretofore made with respect to such subject matter are expressly superseded by this Agreement.

 

14.11                 Waiver.  The failure of a Party to enforce at any time for any period any of the provisions hereof shall not be construed as a waiver of such provisions or of the rights of such Party thereafter to enforce each such provisions.

 

14.12                 No Implied Licenses.  Except as expressly and specifically provided under this Agreement, the Parties agree that neither Party is granted any implied rights to or under any of the other Party’s current or future Patents, trade secrets, copyrights, moral rights, trade or service marks, trade dress, or any other intellectual property rights.

 

14.13                 No Joint Venture.  The Parties agree that the relationship of Roche and VIA established by this Agreement is that of independent licensee and licensor.

 

Furthermore, the Parties agree that this Agreement does not, is not intended to, and shall not be construed to, establish a partnership or joint venture, and nor shall this Agreement create or establish an employment, agency or any other relationship.  Except as may be specifically provided herein, neither Party shall have any right, power or authority, nor shall they represent themselves as having any authority to assume, create or incur any expense, liability or obligation, express or implied, on behalf of the other Party, or otherwise act as an agent for the other Party for any purpose.

 

14.14                 No Third Party Beneficiaries.  Except as otherwise set forth in Article 13, all rights, benefits and remedies under this Agreement are solely intended for the benefit of Roche and VIA, and no Third Party shall have any rights whatsoever to (i) enforce any obligation contained in this Agreement; (ii) seek a benefit or remedy for any breach of this Agreement; or (iii) take any other action relating to this Agreement under any legal theory, including but not limited to, actions in contract, tort (including but not limited to negligence, gross negligence and strict liability), or as a defense, setoff or counterclaim to any action or claim brought or made by the Parties.

 

14.15                 Limitation of Liability.  IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES OF ANY KIND, EVEN If SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGES.  IN NO CASE SHALL EITHER PARTY BE LIABLE FOR ANY REPRESENTATION OF WARRANTY MADE BY THE OTHER PARTY TO ANY THIRD PARTY.

 

14.16                 Governing Law.  This Agreement is to be construed in accordance with, and governed by, the laws of the state of Delaware, except in relation to the principles governing conflict of laws.  This Agreement shall not be governed by the United Nations Convention of International Contracts on the Sale of Goods.  Notwithstanding the foregoing, questions affecting the construction and effect of any Patent shall be determined by the laws of the country in which such Patent has been granted.

 

14.17                 Headings.  The article, section and paragraph headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.

 

27

 

14.18                 Counterparts.  This Agreement may be executed in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same document.

 

14.19                 Dispute Resolution.  The Parties recognize that disputes, controversies or claims arising out of or relating to this Agreement, or the breach, termination, or invalidity thereof (each, a “Dispute”) which relate to either Party’s rights and/or obligations hereunder may from time to time arise during the term of this Agreement.  The Parties shall seek to amicably resolve such a Dispute in an expedient manner by mutual cooperation.  To reach amicable resolution, the Parties agree to first refer the Dispute to their respective senior-level management, or their designees, for attempted resolution through good faith negotiations.

 

If the Dispute cannot be resolved within sixty (60) days after the referral to the senior-level management referred to above, all such disputes shall be finally resolved and settled in accordance with the provisions of this section:

 

(a)                                 Arbitration Request.  If a party intends to begin arbitration it must provide written notice (the “Arbitration Request”) to the other party that the Dispute arising under this Agreement is to be referred to arbitration administered by the American Arbitration Association (the “AAA”).  From the date of the Arbitration Request and until such time as any matter has been finally settled, the running of the time periods as to which party must cure a breach of this Agreement shall be suspended as to the subject matter of the Dispute.

 

(b)                                 No Arbitration of Patent Issues.  Unless otherwise agreed by the parties, a Dispute relating to the validity, infringement or enforceability of Patents shall not be subject to arbitration, and shall be submitted to a court of competent jurisdiction.

 

(c)                                  Arbitration Procedure.  The Arbitration shall be held in New York, New York in accordance with the Commercial Arbitration Rules of the AAA.  The Parties shall each be responsible for one-half of any fees or other amounts payable to the AAA or the arbitrator, and each Party shall bear its own attorneys’ fees and other expenses in connection with the arbitration.

 

The Parties agree that the procedures set forth in this paragraph shall be the sole and exclusive means of resolving any and all Disputes.  Judgment on any award rendered by the arbitrator may be entered in any court having competent jurisdiction thereof.

 

Remainder of this page intentionally left blank.

 

28

 

In Witness Hereof, the Parties have executed this Agreement effective as of the Effective Date.

 

 

	
Hoffmann-La Roche Inc.
    	
 
    
	
 
    	
 
    
	
By:
    	
/s/ Frederick C Kentz III
    	
 
    	
 
    
	
 
    	
Name: Frederick C Kentz III
    	
 
    
	
 
    	
Title: VP SECY & GE
    	
 
    
	
 
    	
 
    
	
F. Hoffmann-La Roche Ltd
    	
F. Hoffmann-La Roche Ltd
    
	
 
    	
 
    
	
By:
    	
/s/ Nigel Shedil
    	
 
    	
By:
    	
/s/ Stefan Arnold
    
	
 
    	
Name: Nigel Shedil
    	
 
    	
Name: Stefan Arnold
    
	
 
    	
Title: Vice President
    	
 
    	
Title: Legal Counsel
    
	
 
    	
Global Head Licensing
    	
 
    
	
 
    	
 
    
	
VIA Pharmaceuticals, Inc.
    	
 
    
	
 
    	
 
    
	
By:
    	
/s/   Lawrence Cohen
    	
 
    	
 
    
	
 
    	
Name: Lawrence Cohen, PHD
    	
 
    
	
 
    	
Title: Chief Executive Officer
    	
 
    

 

[Signature Page to Research, Development and Commercialization Agreement]

 

 

Appendix A

 

List of Roche Patent Rights

 

A-1

 

	
Case
   22191
    	
 
    	
Application
   Date
    	
 
    	
Application No.
    	
 
    	
Grant
   Date
    	
 
    	
Patent No.
    	
 
    	
Expiry
   Date
    	
 
    	
Holder
    
	
AR
    	
 
    	
19.07.2006
    	
 
    	
P060103084
    	
 
    	
 
    	
 
    	
 
    	
 
    	
19.07.2026
    	
 
    	
Roche Basel
    
	
AU
    	
 
    	
11.07.2006
    	
 
    	
2006271721
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Basel
    
	
BR
    	
 
    	
11.07.2006
    	
 
    	
PI0613754-7
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Basel
    
	
CA
    	
 
    	
11.07.2006
    	
 
    	
2614529
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Basel
    
	
CL
    	
 
    	
18.07.2006
    	
 
    	
1863-2006
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
CN
    	
 
    	
11.07.2006
    	
 
    	
200680026731.7
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Basel
    
	
CO
    	
 
    	
11.07.2006
    	
 
    	
08-002.797
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
CR
    	
 
    	
11.07.2006
    	
 
    	
9644
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
EC
    	
 
    	
11.07.2006
    	
 
    	
08-8120
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
EG
    	
 
    	
21.01.2008
    	
 
    	
PCT108/2008
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Basel
    
	
EP
    	
 
    	
11.07.2006
    	
 
    	
06792493.6
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Basel
    
	
GC
    	
 
    	
19.07.2006
    	
 
    	
6611
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
IN
    	
 
    	
11.07.2006
    	
 
    	
658/DELNP/2008
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Basel
    
	
ID
    	
 
    	
11.07.2006
    	
 
    	
W-00200800220
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Basel
    
	
IL
    	
 
    	
11.07.2006
    	
 
    	
188476
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Basel
    
	
JP
    	
 
    	
11.07.2006
    	
 
    	
2008-521935
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
MY
    	
 
    	
19.07.2006
    	
 
    	
PI20063456
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
MX
    	
 
    	
11.07.2006
    	
 
    	
MX/A/2008/000818
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
MA
    	
 
    	
11.07.2006
    	
 
    	
30618
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Basel
    
	
NZ
    	
 
    	
11.07.2006
    	
 
    	
565190
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Basel
    
	
NO
    	
 
    	
11.07.2006
    	
 
    	
20080058
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Basel
    
	
PH
    	
 
    	
11.07.2006
    	
 
    	
1-2008-500147
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
RU
    	
 
    	
11.07.2006
    	
 
    	
2008106058
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Base!
    
	
SG
    	
 
    	
11.07.2006
    	
 
    	
200800416-0
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
ZA
    	
 
    	
11.07.2006
    	
 
    	
2008/00405
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
KR
    	
 
    	
11.07.2006
    	
 
    	
2008-7001480
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Basel
    
	
TW
    	
 
    	
18.07.2006
    	
 
    	
095126242
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
TH
    	
 
    	
19.07.2006
    	
 
    	
0601003388
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
US
    	
 
    	
21.07.2005
    	
 
    	
60/701215 Priority
    	
 
    	
 
    	
 
    	
 
    	
 
    	
21.07.2006
    	
 
    	
Roche Nutley
    
	
US1
    	
 
    	
18.07.2006
    	
 
    	
11/488870
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Nutley
    
	
US2
    	
 
    	
20.08.2008
    	
 
    	
12/194643
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Nutley
    
	
UA
    	
 
    	
11.07.2006
    	
 
    	
A200801933
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
VE
    	
 
    	
20.07.2006
    	
 
    	
1684-06
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    
	
VN
    	
 
    	
11.07.2006
    	
 
    	
1-2008-00403
    	
 
    	
 
    	
 
    	
 
    	
 
    	
11.07.2026
    	
 
    	
Roche Basel
    
	
WO
    	
 
    	
11.07.2006
    	
 
    	
PCT/EP2006/064093
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    

 

	
Case
   24361
    	
 
    	
Application
   Date
    	
 
    	
Application No.
    	
 
    	
Grant
   Date
    	
 
    	
Patent No.
    	
 
    	
Expiry
   Date
    	
 
    	
Holder
    
	
US
    	
 
    	
20.09.2007
    	
 
    	
60/973846 Priority
    	
 
    	
 
    	
 
    	
 
    	
 
    	
20.09.2008
    	
 
    	
Roche Nutley
    
	
US1
    	
 
    	
02.09.2008
    	
 
    	
12/202552
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Nutley
    
	
wo
    	
 
    	
11.09.2008
    	
 
    	
PCT/EP2008/062017
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Roche Basel
    

 

*** Certain information on this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

2

 

Appendix B

 

Transfer of Know How

 

B-1

 

	
Document
   No
    	
 
    	
Title
    	
 
    	
Author(s)
    	
 
    	
Document
   Date
    	
 
    	
Pages
    	
 
    	
Document
   Class
    	
 
    	
Center
    	
 
    	
Division
    	
 
    	
Language
    	
 
    
	
1015946
    	
 
    	
Results of the in vitro micronucleus test (MNT) with RO*** using   a microscale screening protocol with L5178Y tk mouse lymphoma cells (Study   Plan No. 2057M04, NON-GLP)
    	
 
    	
Kirchner S
    	
 
    	
7/21/2004
    	
 
    	
16
    	
 
    	
research
    	
 
    	
Basel
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1004034
    	
 
    	
Results of the Ames microsuspension assay with RO*** (Study   No. 2060M04, non-GLP screening test for genotoxic activity)
    	
 
    	
Muster W
    	
 
    	
1/5/2005
    	
 
    	
10
    	
 
    	
research
    	
 
    	
Basel
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1024256
    	
 
    	
RO*** THRA: A Two-Week Oral (Intubation) Toxicity and   Toxicokinetic Range-Finding Study in Dogs (Study No. 09925)
    	
 
    	
Visalli T, Lamb M, Pamidimukkala A, Herrott C, Braen A
    	
 
    	
11/20/2007
    	
 
    	
280
    	
 
    	
regular
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1023567
    	
 
    	
RO*** [THR]: A Two-Week Oral (Intubation) Range-Finding Toxicity   and Toxicokinetic Study in Rats (Study No.09924)
    	
 
    	
Rusin G, Lamb M, Pamidimukkala A, Herrott C, Braen A
    	
 
    	
12/18/2007
    	
 
    	
337
    	
 
    	
regular
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    

 

*** Certain information on this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

B-1

 

	
Document
   No
    	
 
    	
Title
    	
 
    	
Author(s)
    	
 
    	
Document
   Date
    	
 
    	
Pages
    	
 
    	
Document
   Class
    	
 
    	
Center
    	
 
    	
Division
    	
 
    	
Language
    	
 
    
	
1028177
    	
 
    	
RO*** [THR Agonist]: Evaluation of the Covalent Protein Binding   in Rat, Dog, Monkey and Human Liver Microsomal Incubations Using [14C]RO***   (Study No. 09757)
    	
 
    	
Nangia A, Olejnik N, Yang T J
    	
 
    	
1/14/2008
    	
 
    	
16
    	
 
    	
regular
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1024674
    	
 
    	
RO***: In Vitro Plasma Protein Binding, Blood to Plasma Ratios   and Partitioning to Red Blood Cells in Human and Various Animal Species   (Study No. 10018).
    	
 
    	
Costanza S, Cotler S
    	
 
    	
1/24/2008
    	
 
    	
19
    	
 
    	
regular
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1028100
    	
 
    	
RO*** [THR Agonist]: Evaluation of the Cytochrome P450   Inhibition (Study No. 10315) and Time Dependent Inactivation by RO***   Using Human Liver Microsomal Incubations (Study No. 10315)
    	
 
    	
Chang M, Olejnik N, Yang T J
    	
 
    	
1/28/2008
    	
 
    	
30
    	
 
    	
regular
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1025882
    	
 
    	
RO***: Evaluation of Thyroid Hormone Agonist for In Vitro   Induction Potential in Primary Human Hepatocyte Cultures (Study No 10182)
    	
 
    	
Frank K B, Ryan A L
    	
 
    	
2/14/2008
    	
 
    	
24
    	
 
    	
regular
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    

 

*** Certain information on this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

B-2

 

	
Document
   No
    	
 
    	
Title
    	
 
    	
Author(s)
    	
 
    	
Document
   Date
    	
 
    	
Pages
    	
 
    	
Document
   Class
    	
 
    	
Center
    	
 
    	
Division
    	
 
    	
Language
    	
 
    
	
1027865
    	
 
    	
RO***: Respiratory Assessment of Orally Administered RO*** to   Plethysmograph Restrained Male Wistar Rats (WIL Study No. WIL-30039,   Roche Study Reference No. 10349)
    	
 
    	
Staudner H A
    	
 
    	
3/3/2008
    	
 
    	
164
    	
 
    	
regular
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1028777
    	
 
    	
RO*** (THRA): In Vitro Effect on hERG Current (IKr) Expressed in   Human Embryonic Kidney (HEK) Cells (Roche Study No. 08757)
    	
 
    	
Staudner H A
    	
 
    	
3/4/2008
    	
 
    	
13
    	
 
    	
regular
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1027864
    	
 
    	
RO***: The Acute Central Nervous System Pharmacological Study of   RO*** Following Oral Administration in Rats Using a Modified Functional   Observational Battery (Roche Study No. 10348, WIL Research Study   No. WIL-30040)
    	
 
    	
Staudner H A
    	
 
    	
3/5/2008
    	
 
    	
217
    	
 
    	
regular
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1027916
    	
 
    	
RO***: Bacterial reverse mutation test (Ames test) - Study   No. 2363M07; RCC Analytic phase No. B69096
    	
 
    	
Gocke E, Flade D
    	
 
    	
5/5/2008
    	
 
    	
56
    	
 
    	
regular
    	
 
    	
Basel
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    

 

*** Certain information on this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

B-3

 

	
Document
   No
    	
 
    	
Title
    	
 
    	
Author(s)
    	
 
    	
Document
   Date
    	
 
    	
Pages
    	
 
    	
Document
   Class
    	
 
    	
Center
    	
 
    	
Division
    	
 
    	
Language
    	
 
    
	
1026150
    	
 
    	
RO*** (THRA): Cardiovascular Assessment in Conscious   Radiotelemetry-Implanted Beagle Dogs Following Oral Gavage Administration   (Study No. 09979)
    	
 
    	
Staudner H A, Hirkaler G, Pamidimukkala A, Braen A
    	
 
    	
6/4/2008
    	
 
    	
251
    	
 
    	
regular
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1026453
    	
 
    	
RO*** (THRA): A Two-Week Oral (Intubation) Exploratory Metabolic   and Pharmacokinetic Study of RO*** with a 2-Week Recovery Period (Study   No. 10135)
    	
 
    	
Visalli T, Pamidimukkala A, Herrott C, Braen A P J M
    	
 
    	
7/8/2008
    	
 
    	
310
    	
 
    	
regular
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1025069
    	
 
    	
RO*** (THR): Evaluation of the Interaction between Drug Efflux   Transporters and RO*** (Study No. 09989)
    	
 
    	
Veerasammy S, Guo A
    	
 
    	
7/30/2008
    	
 
    	
27
    	
 
    	
regular
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1026833
    	
 
    	
Induction of chromosome aberrations in cultured human peripheral   blood lymphocytes
    	
 
    	
Lloyd M, Flade D, Chételat A A
    	
 
    	
8/7/2008
    	
 
    	
65
    	
 
    	
regular
    	
 
    	
Basel
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1025400
    	
 
    	
Method for determination of RO*** in Dog Plasma by LC/MS/MS (BA   Method MS-121)
    	
 
    	
Egan T, Kolis S
    	
 
    	
6/4/2007
    	
 
    	
18
    	
 
    	
method
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1026961
    	
 
    	
Synthesis of RO***, A Thyroid Hormone Receptor Agonist
    	
 
    	
Shu L, Wang P
    	
 
    	
11/27/2007
    	
 
    	
18
    	
 
    	
method
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1028106
    	
 
    	
Method for determination of RO*** in Dog and Rat Plasma by   LC/MS/MS (BA Method MS-121)
    	
 
    	
Vidal N, Egan T, Liang Z, Kolis S
    	
 
    	
12/11/2007
    	
 
    	
22
    	
 
    	
method
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    
	
1027730
    	
 
    	
(Case 24361) PRODRUGS OF THYROID HORMONE ANALOGS (RO***)
    	
 
    	
Haynes N E, Scott N R, Tilley J W
    	
 
    	
9/20/2007
    	
 
    	
55
    	
 
    	
patent
    	
 
    	
Nutley
    	
 
    	
Pharma
    	
 
    	
English
    	
 
    

 

*** Certain information on this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested with respect to the omitted portions.

 

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