Back to top

RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

Research and Development Agreement

RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT | Document Parties: VIA PHARMACEUTICALS, INC. | Hoffmann-La Roche Inc You are currently viewing:
This Research and Development Agreement involves

VIA PHARMACEUTICALS, INC. | Hoffmann-La Roche Inc

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Governing Law: Delaware     Date: 12/23/2008
Industry: Biotechnology and Drugs     Sector: Healthcare

RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT, Parties: via pharmaceuticals  inc. , hoffmann-la roche inc
50 of the Top 250 law firms use our Products every day

Exhibit 10.2 RESEARCH, DEVELOPMENT
AND COMMERCIALIZATION AGREEMENT
     This Research, Development and Commercialization Agreement (" Agreement ") is signed 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.  

     

***

 

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.

 




 

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

     

***

 

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.

 




 

ARTICLE 2 GRANT OF LICENSE AND ASSIGNMENTS      2.1 Grants and Assignments .           (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 , under the 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 Roche Know-How for any other purpose.           (c) Subject to the terms and conditions of this Agreement, Roche hereby assigns to VIA all of its rights, title and interest in and to the Roche Patent Rights. VIA shall be solely responsible for preparing and filing appropriate assignments with the various patent offices in the Territory.           (d) If 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, then Roche will not unreasonably deny granting such a direct license under Roche Know-How, 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.      2.2 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.      2.3 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 license granted to VIA or its Affiliates, knowingly (i) practice any Roche Know-How outside the scope of the licenses granted by Roche in Section 2.1(a) or (ii) practice any Roche Patent Rights within the scope of the licenses granted by VIA in Section 2.1(d).

 




 

     2.4 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:

 

 

 

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.  

     

***

 

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.

 




 

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 royalty rate of *** percent (***%), subject to reduction as provided in Sections 4.3, 4.4, 4.5 and 4.6.      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 Territory, then the royalty rate otherwise applicable to any Net Sales of such Licensed Product under Section 4.1 in such country shall be reduced by *** percent (***%) of the royalty rate otherwise applicable to such Net Sales.      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.  

     

***

 

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.

 




 

     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.      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  

     

***

 

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.

 




 

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 records to confirm gross sales, Net Sales, royalty reductions, 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  

     

***

 

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.

 




 

such audit. Roche shall bear the full cost of such audit 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  

     

***

 

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.

 




 

               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.      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) 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) and VIA shall reassign the Roche Patent Rights to Roche. 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) and VIA shall reassign the Roche Patent Rights to Roche with respect to such sub-territory.

 




 

ARTICLE 7 PATENT RIGHTS      7.1 Patent Prosecution and Maintenance .           (a) VIA shall, at its sole expense, prosecute any and all patent applications within the Roche Patent Rights and 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 a

                     
 
SITE SEARCH

AGREEMENTS / CONTRACTS

Document Title:

Entire Document: (optional)

Governing Law:(optional)


Try our advanced search >>
 

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates
Email:
This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more