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EXCLUSIVE LICENSE AGREEMENT

License Agreement

EXCLUSIVE LICENSE AGREEMENT | Document Parties: Abbott Laboratories | VIA Pharmaceuticals, Inc You are currently viewing:
This License Agreement involves

Abbott Laboratories | VIA Pharmaceuticals, Inc

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Title: EXCLUSIVE LICENSE AGREEMENT
Governing Law: Illinois     Date: 8/14/2007
Industry: Biotechnology and Drugs     Law Firm: Wilson Sonsini     Sector: Healthcare

EXCLUSIVE LICENSE AGREEMENT, Parties: abbott laboratories , via pharmaceuticals  inc
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Exhibit 10.4

EXCLUSIVE LICENSE AGREEMENT

This Agreement, effective August 10, 2005 ( the “Effective Date”) is between VIA Pharmaceuticals, Inc. a corporation organized and existing under the laws of the State of Delaware and having its principal place of business at 750 Battery Street, Suite 400, San Francisco CA 94111 (“ VIA ”) and Abbott Laboratories, a corporation organized and existing under the laws of the State of Illinois and having its principal place of business at 100 Abbott Park Road, Abbott Park, IL 60064 (“ Abbott ”).

WITNESSETH THAT:

WHEREAS, Abbott owns certain intellectual property relating to the Compound as hereinafter later defined; and

WHEREAS, VIA wishes to obtain a worldwide exclusive license under such intellectual property to develop and commercialize the Compound in the Field, as hereinafter later defined; and

WHEREAS Abbott is willing to grant such a license to VIA on the terms and subject to the conditions set forth herein.

NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements herein contained, Abbott and VIA agree as follows:

ARTICLE I

DEFINITIONS

As used in this Agreement, each capitalized term listed below shall have the meaning that is given after it:

ABT-761 ” means the active ingredient ((R)-{3-[5-(4-fluorophenylmethyl)-2-thienyl]-1-methyl-2-propynyl}N-hydroxyurea) together with all salts, esters, non-covalent complexes, chelates, hydrates, stereo isomers, crystalline or amorphous forms or prodrugs of the molecule, as more frilly described in the Patent Rights.

Affiliate ” means a corporation or any other entity that directly, or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with, the designated Party. As used herein, the term “control” means possession of power to direct or cause the direction of the management and policies of a corporation or other entity whether through the ownership of voting securities, by contract or otherwise; provided, however, that for purposes of this Agreement, TAP Pharmaceutical Products, Inc. and its subsidiaries, which comprises Abbott Laboratories joint venture with Takeda Chemical Industries, Ltd., shall not be considered an “Affiliate” of Abbott unless and until Abbott has elected to include TAP Pharmaceutical Products, Inc., as an Affiliate hereunder by providing VIA written notice of the same.

 


Alleged Infringement Action ” shall have the meaning ascribed to it under the provisions of Section 7.4(b)(1).

Backup Compound(s) ” means any compound included in Patented Compounds, providing that such Patented Compound is determined by Abbott to be available for licensing under the provisions of Section 2.5.

Commercially Reasonable Efforts ” means continuous and diligent efforts of a degree and kind, including the level of attention and care and providing of funding and manpower, as are consistent with a company similarly situated as VIA with the then current stage of product life cycle, and such efforts will in no event be less than the efforts that VIA applies with respect to its own products of similar commercial potential and stage of product life cycle to the maximum extent feasible, consistent with the exercise of good business judgment.

Compound ” means ABT-761 or, if a Backup Compound is substituted for ABT-761 under the provisions of Section 2.5, Compound shall mean such Backup Compound and not ABT-761.

Confidential Information ” means all data, information, or Licensed Technology (and all tangible and intangible embodiments thereof), which is controlled and disclosed by a Party (“Disclosing Party”) to the other Party (“Receiving Party”) pursuant to this Agreement, except, and only to the extent a Receiving Party can establish by written documentation, that which:

 

  (a) is or becomes part of the public domain without the fault of the Receiving Party;

 

  (b) has been received by the Receiving Party at any time from a source, other than the Disclosing Party, rightfully having possession of and the right to disclose such information free of confidentiality obligations;

 

  (c) has been otherwise known by the Receiving Party free of confidentiality obligations prior to disclosure of such information by the Disclosing Party to the Receiving Party; or

 

  (d) has been independently developed by employees or others on behalf of the Receiving Party without access to, use of, reference to, or reliance upon the Confidential Information.

(Each of the categories under (a),(b), (c) and (d) are defined as a “Confidentiality Exception”).

Notwithstanding the above, specific aspects or details of Confidential Information will not be deemed to be within the public domain or in the prior possession of the Receiving Party merely because the aspects or details of the Confidential Information are embraced by general disclosures in the public domain. In addition, any combination of Confidential Information will not be considered in the public domain or in the prior possession of the Receiving Party merely because individual elements thereof are in the public domain or in the prior possession of the Receiving Party unless the combination is in the public domain or in the prior possession of the Receiving Party.

 

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Further, for avoidance of doubt, Confidential Information will include Confidential Information received by the Disclosing Party from a Third Party. Prior to disclosure of such Third Party Confidential Information to the Receiving Party, the Disclosing Party will determine that it has the right to make such disclosure, advise the Receiving Party that the disclosure includes Third Party Confidential Information and provide the Receiving Party with the terms and conditions of any agreement between the Third Party and the Disclosing Party respecting such Third Party Confidential Information.

Contact Person ” shall have the meaning ascribed to it under the provisions of Section 2.7.

Development Data ” means all preclinical toxicology, stability study and related production, clinical and regulatory information or data related to the Licensed Product that supports any MAA for the Licensed Product.

Extension ” shall have the meaning ascribed to it under the provisions of Section 6.3(a).

FDA ” means the United States Food and Drug Administration, or any successor agency having substantially the same functions and/or any foreign equivalents.

Field ” means the treatment and/or prevention of diseases in humans.

First Commercial Sale ” means the first sale by VIA or its Sublicensees of a Licensed Product in a country within the Territory to any Third Party following Regulatory Approval.

HSR Act ” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (see 15 U.S.C. § 18a).

IND ” shall mean any Investigational New Drug Application and any amendments thereto filed with the FDA.

Invention ” means any technology, discovery, know-how, invention (including new uses and substances) or data (whether or not protectable under state, federal or foreign patent, trademark, copyright or similar laws) that is conceived, made, discovered or reduced to practice during the course of this Agreement, or results in whole or in part from activities carried out under this Agreement that were reduced to practice within ninety (90) days following expiration or termination of this Agreement.

Licensed Product ” means any formulation containing the Compound.

Licensed Technology ” means information, trade secrets, data, Inventions (whether patentable or unpatentable), trademarks and know-how relating to Licensed Product, which is owned or controlled by or licensed to Abbott as of the Effective Date, including the USAN name for ABT-761, manufacturing technology, analytical and process techniques, regulatory filings, research and development reports, methods, protocols, clinical and safety data in both paper and electronic formats, statistical programs, preclinical data, research data, manufacturing data, analytical data, batch records, standard operating procedures, improvements related to the Compound or Licensed Product or useful in the manufacture, use, sale or registration of the

 

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Compound or Licensed Product. Licensed Technology shall also include inventory, reagents, samples, analytical standards, metabolites, serum samples, tissue samples, active pharmaceutical ingredients, drug product stocks, and other materials and compositions related to the Compound or Licensed Product or useful for the manufacture, use, sale or registration of the Compound or Licensed Product (sometimes also referred to as “Tangible Licensed Technology”). For the avoidance of doubt, Licensed Technology does not include any Patents Rights.

MAA ” means a marketing authorization application filed with the relevant regulatory authority.

Manufacturing Agreement ” means the Agreement entered into on the Effective Date between Abbott and VIA concurrent with this Agreement that is aimed at supplying the Compound as active pharmaceutical ingredients only and not as finished commercial product.

Net Sales ” means the amount invoiced by VIA or its Sublicensee(s) on sales of Licensed Products to unrelated Third Parties, less the following:

 

  (a) discounts, including cash discounts, customary trade allowances or rebates actually taken, governmental rebates, chargebacks, commissions, and group purchasing management fees for formulary access;

 

  (b) credits or allowances given or made for rejection, recall or return of previously sold Product actually taken;

 

  (c) any tax or government charge, duty or assessment (including any tax such as a value added or similar tax or government charge) levied on the sale, transportation or delivery of Licensed Product when included on the invoice or other written document between the parties as payable by the purchaser and collectable by VIA, its Affiliate or Sublicensee;

 

  (d) freight, postage, transportation, insurance and duties on shipment of Licensed Product when included on the invoice or other written document between the parties as payable by the purchaser and collectable by VIA, its Affiliates or Sublicensees; and

 

  (e) credit losses, up to 1% of the total amount invoiced.

With respect to a Licensed Product which contains one or more Compounds combined as a single pharmaceutical product with one or more other therapeutically active ingredients (a “ Combination Product ”), the Net Sales of such Combination Product shall first be calculated in accordance with the definition of Net Sales under paragraphs (a), (b), (c),(d) and (e), and then the Net Sales of such Combination Product shall be determined on a country-by-country basis as follows:

(i) multiply the Net Sales of such Combination Product by the fraction A/(A+B), where A is the total of the average selling prices of such Compound(s) when sold separately as a pharmaceutical product in such country and B is the total of the average selling prices of each other active ingredient when sold alone as a pharmaceutical product in such country; or

 

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(ii) if either the average selling price of all Compound(s) in such Combination Product or the average selling price of all other active ingredients in such Combination Product is not available, multiply the Net Sales of such Combination Product by a percentage, determined by mutual agreement of the Parties, which represents the proportionate economic value contributed by all other active ingredients in such Combination Product.

NDA ” means a New Drug Application filed with the FDA, or any similar filing with any Regulatory Authority.

Party ” or “ Parties ” mean(s) VIA and/or Abbott, depending on the context.

Patented Compound(s) ” means any compound claimed in US Patent No. 5,288,751.

Patent Rights ” mean those claims pertaining to the Compound in the patents and patent applications listed in Appendix A attached hereto, including any division, continuation or continuation-in-part, substitute, renewal, reissue, extension, confirmation, reexamination or registration thereof and any patent issuing thereon, including any substitute, renewal, reissue, extension, confirmation, reexamination, registration or foreign counterpart thereof, including any Patent Term Extensions or Supplementary Protection Certificates.

Phase III Clinical Trial ” means a trial on sufficient numbers of patients that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed, and to support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product, as more fully defined in 21 CFR § 312.21(c), or its foreign equivalent.

Press Release ” means the press release set forth in Appendix D.

Regulatory Approval ” means (a) the governmental authorization and/or approval required by a Regulatory Authority of such country to commence sale of a Licensed Product and (b) any required pricing or reimbursement approval outside of the United States of America (“Pricing Reimbursement”). For the purpose of Section 4.2(a), a Licensed Product will be deemed to have met the definition of Regulatory Approval at the earlier of meeting the requirements of (a) and (b) of this definition or if such Licensed Product met the provisions of section (a) of this definition then nine months from such date, whether or not Pricing Reimbursement has been received by such date.

Regulatory Authority(ies) ” means any of the FDA or any comparable national or territorial regulatory entity within the Territory having substantially the same functions.

Reporting Period ” begins on the first day of each calendar quarter and ends on the last day of such calendar quarter.

 

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Royalty Term ” means the period of time for which VIA’s royalty obligations are due to Abbott hereunder, which shall commence, on a country by country basis, upon the First Commercial Sale of the Licensed Product and shall terminate, on a country by country basis, upon the expiration of all Valid Claims covering the researching, developing, making, having made, using, offering to sell, selling, and importing/exporting of Licensed Product in such country, including any Extension(s) thereto.

Step-Down Royalty Term ” means a period of time, if any, for which VIA’s step down royalty obligations are due to Abbott hereunder, which shall commence, on a country by country basis, after the Royalty Term but in no event shall exceed 10 years from the date of the First Commercial Sale of the Licensed Product.

Sublicensee ” means any Third Party, including Affiliates of VIA that is granted a sublicense pursuant to Section 2.2.

Third Party ” or “ Third Parties ” means any party other than VIA or Abbott.

Term ” shall have the meaning ascribed to it under the provisions of Section 12.1.

Territory ” means the entire world.

Valid Claim ” means a claim of any issued and unexpired patent or any claim or product definition or equivalents thereof in any patent term extension or supplementary protection certificate thereof or pending patent term extension or supplementary protection certificate application thereof, included within the Patent Rights which claim or product definition or equivalents thereof has not been invalidated by one or more of any of the following: (l) irretrievable lapse, revocation or abandonment and/or (2) holding of unenforceability or invalidity by a decision of a court or other appropriate body of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and/or (3) disclaimed or declared invalid or unenforceable through reissue or re-examination or opposition, nullity action or invalidation suit by a decision beyond review by a court or other appropriate body of competent jurisdiction.

ARTICLE II

LICENSE GRANT; OWNERSHIP

2.1 (a) License Grant to Patent Rights and Licensed Technology . Subject to the terms of this Agreement, Abbott hereby grants to VIA for the Term an exclusive, milestone and royalty-bearing license to the Patent Rights and Licensed Technology to research, develop, make, have made, use, offer to sell, sell, and import/export Licensed Products in the Field in the Territory, subject to a non-transferable right by Abbott and its Affiliates to utilize the Compound for internal research purposes and derivatization of new compounds. For the avoidance of doubt, Abbott shall not grant to TAP Pharmaceutical Products (“TAP”), Inc. any rights to conduct internal research or derivation by use of the Compound, even if TAP is later designated by Abbott to be an Affiliate. Abbott and its Affiliates shall not have the right to conduct pre-clinical or clinical development of the Compound in any clinical trials nor shall Abbott and its Affiliates submit any reports with regulatory authorities seeking regulatory approval of the Compound. Abbott and its Affiliates also shall not publish nor otherwise disclose to any Third Party any data generated by using the Compound for internal research purposes.

 

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(b) Assignment of Tangible Licensed Technology . Abbott hereby assigns to VIA all right, title and interest to all Tangible Licensed Technology. Abbott shall take all necessary actions, including executing documents of assignment, to vest title to all Tangible Licensed Technology with VIA.

2.2 Sublicenses . VIA shall have the right to grant sublicenses of its rights under Section 2.1, provided:

(a) VIA shall incorporate terms and conditions into its sublicense agreements to ensure that both VIA and its Sublicensee comply with the terms of this Agreement.

(b) VIA shall promptly furnish Abbott with an appropriately redacted photocopy of any sublicense agreement. VIA shall not redact any information that is necessary for Abbott to determine that VIA has incorporated applicable requirements of this agreement in the sublicense.

2.3 No Additional Rights . Nothing in this Agreement shall he construed to confer any rights upon VIA by implication, estoppel, or otherwise to any technology or patent rights of Abbott other than the grant of license to Patent Rights and Licensed Technology pursuant to Section 2.1, regardless of whether such technology or patent rights shall be dominant or subordinate to any Patent Rights.

2.4 (a) Transfer of Licensed Technology .

Abbott will use commercially reasonable and diligent efforts to transfer all available Licensed Technology listed in Appendix B within the timeframes specified therein. These activities shall commence upon execution of this Agreement. If, after the transfer of Licensed Technology, Abbott becomes aware of any additional Licensed Technology, it will notify VIA and the Parties shall arrange for the transfer of such Licensed Technology. VIA agrees to reimburse Abbott for up to a maximum of $40,000 in direct costs incurred by Abbott in carrying out the transfer of Licensed Technology, upon presentation by Abbott of invoices showing the time spent and costs incurred.

(b) Access to Regulatory Filings .

Consistent with the requirements of 21 CFR 312, Abbott will transfer to VIA the complete IND file for ABT-761 (“Original IND”) and all such available documentation relevant to the Original IND as is necessary to enable VIA to transfer the Original IND under its own name and assume regulatory responsibility for development of ABT-761 after transfer of the Original IND into VIA’s name becomes effective, including all supplements to the Original IND, all regulatory tiles and FDA correspondence related thereto, and all records and reports required to be kept that are necessary to enable VIA to effect the transfer (but excluding, for the avoidance of doubt, records of Abbott that arc not so necessary such as confidential personnel records, facility design records or quality assurance batch records). Within ten (10) days after VIA confirms in writing the receipt of the IND file from Abbott, Abbott will execute and deliver a letter to the FDA authorizing the transfer of the Original IND filings to VIA and authorizing

 

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VIA to do and take all actions that are necessary to transfer the Original IND filings for the Compound in the name of VIA. Abbott shall use commercially reasonable and diligent efforts to ensure that it has located and provided to VIA all such documentation related to the Original IND and all other Licensed Technology and Abbott shall immediately convey to VIA any such documentation or other Licensed Technology that Abbott locates after the Effective Date.

2.5 (a) Procedure for Requesting Substitution of Backup .

If VIA, at its sole discretion, determines that it wishes to substitute a Backup Compound for the Compound, then VIA shall notify Abbott which Patented Compound it would like to nominate as a Backup Compound. If the Non-Use Period, (as defined in Section 2.9) has not expired, then VIA shall have the right to substitute any Patented Compound. If the Non-Use Period has expired, Abbott shall review whether or not such compound: (i) is already subject to any grant of rights to a third party, or (ii) is under active consideration by Abbott for an internal research or development program or (iii) is currently being researched or developed by Abbott.

(b) Substitution of Backup Compound .

If after following the procedures in 2.5(a), Abbott finds the compound is available for a grant of rights to VIA then, (i) VIA’s rights to the original Compound shall cease and (ii) all rights granted to the original Compound shall immediately terminate and (iii) the Backup Compound shall immediately be classified as the Compound and shall be so treated for all rights granted and duties owed under this Agreement.

2.6 Supply of Compound . Supply of the Compound by Abbott to VIA shall be exclusively governed under the terms and conditions contained in the Manufacturing Agreement.

2.7 Contacts for Technology Transfer . Abbott and VIA shall each designate a contact person (the “Contact Person(s)”) for the transfer activities to be undertaken under the provisions of Section 2.4. Abbott’s initial Contact Person shall be Director, Technology Licensing and VIA’s Contact Person shall be Vice President of Business Development. Either Party may change the Contact Person named above by written notification to the other Party. Routine correspondence relevant to the transfer activities to be undertaken under the provisions of Section 2.4 shall be sent to the above-named Contact Persons. All notices or similar communications in regard to the terms or a proposed change of terms of this Agreement are to be sent to the Parties named in Section 13,1, Notice .

2.8 Covenant Not to Sue . In the event the making, having made, use, offer for sale, sale or import by VIA, its Affiliates, Sublicensees or distributors of Licensed Product, would infringe during the Term of this Agreement a claim of an issued patent which is owned by or licensed to Abbott and which issued patent is not covered by the grant in Section 2.1 (the “Issued Patent(s)”), Abbott hereby covenants not to sue VIA, its Affiliates, Sublicensees or distributors under such Issued Patent solely for VIA, its Affiliates, Sublicensees or distributors to develop, make, have made, use, sell, offer for sale or import Licensed Product in the Field, to the extent that Abbott has the authority to grant such a non-suit to any such Issued Patent(s). Notwithstanding any other provisions of this Agreement, if Abbott’s authority to grant such a non-suit to any such Issued Patents is subject to any Third Party restrictions and: (a) if a royalty,

 

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or any other consideration, would be owed to a Third Party for any grant of rights to such Issued Patent that would otherwise be covered under this Section 2.8, and (b) Abbott has the ability to grant an unlimited number of sublicenses to such Issued Patent then (i) Abbott shall not grant VIA a non-suit to such Issued Patent and (ii) at VIA’s option, Abbott and VIA shall enter into a sublicense for such Issued Patent and (iii) VIA shall be responsible for all payments and other obligations to such Third Party that are required under the sublicense for such Issued Patent. If Third Party restrictions on Issued Patents do not allow Abbott to grant either a non-suit or a license then no non-suit or license shall be granted.

2.9 Restriction on Use of Patented Compound(s) . For a period of five years (the “Non-Use Period”) from the Effective Date, Abbott: (i) shall not license a Patented Compound to a Third Party in the Field and (ii) Abbott and its Affiliates shall also not undertake pre-clinical or clinical development on a Patented Compound. Abbott may, however, conduct internal research and make derivatives of Patented Compounds during the Non-Use Period.

ARTICLE III

UNDERTAKING AND DUE DILIGENCE

3.1 Diligence Requirements .

At all times during the Term, VIA shall use and will cause its Sublicensees to use Commercially Reasonable Efforts, at its own expense, to (a) initiate and complete the clinical development of the Licensed Product, (b) obtain Regulatory Approvals for the Licensed Product in major markets, and (c) obtain and carry out subsequent worldwide marketing, distribution and sale of the Licensed Product in such major markets.

3.2 Pre-clinical/clinical Development Plan . Within three (3) months after the Effective Date, VIA shall furnish Abbott with a summary written pre-clinical/clinical development plan. Any material modifications to the original pre-clinical/clinical development plan shall be furnished to Abbott in summary form within thirty (30) days of making the change. VIA shall use Commercially Reasonable Efforts to perform in accordance with pre-clinical/clinical development plan.

3.3 Reporting of Development Activities . Within sixty (60) days after the end of each annual calendar period, until First Commercial Sale of Licensed Product, VIA shall furnish Abbott with a summary written report on the progress of its efforts during the immediately preceding calendar quarter to implement the pre-clinical/clinical development plan and the related Development Data.

3.4 Adverse Events . Within ninety (90) days after the date of this Agreement, the Parties shall use good faith efforts to enter into an agreement to initiate a process for the exchange of adverse event safety data in a mutually agreed format, including but not limited to, postmarketing spontaneous reports received by a Party or its Affiliates in order to monitor the safety of the Compound or the Licensed Product and to meet reporting requirements with any applicable Regulatory Authority.

 

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3.5 Compliance with Laws and Regulations . VIA shall comply with all present and future laws, including, without limitation, the Federal Food, Drug and Cosmetic Act, rules, orders, ordinances, regulations, statutes, requirements, codes, executive orders, rules of common law, and any judicial interpretations thereof, extraordinary as well as ordinary, of all governmental authorities, including, without limitation, the FDA. Furthermore, each Party acknowledges and understands that it has no authority to represent the other Party in any way before the FDA and as such each Party will not make any representations or commitments in the other Party’s name with the FDA.

ARTICLE IV

PAYMENTS; ROYALTIES; PAYMENT TERMS

4.1 License Issue and Technology Transfer Fees .

(a) License Issue Fee . In consideration of the rights granted hereunder, VIA shall pay to Abbott within thirty (30) days of the Effective Date a non-refundable, non-creditable license issue fee of One Million United States Dollars (US$1,000,000). In addition VIA shall pay Abbott a non-refundable, non-creditable fee of One Million United States Dollars (US$1,000,000), at the later of (i) six months after the Effective Date or (ii) the date the Technology Transfer Fee described in Section 4.1(b) below becomes payable.

(b) Technology Transfer Fee . VIA shall pay Abbott a non-refundable, non-creditable fee of One Million United States Dollars (US$1,000,000) within thirty (30) days of completion of the transfer of the Licensed Technology listed in Appendix B.

4.2 Milestone Payments .

(a) Development Milestone Payments . Within thirty (30) days following the achievement of each of the following milestones with respect to the first Licensed Product, (for clarification, each milestone shall be paid only once), VIA shall give written notice to Abbott thereof and VIA shall pay to Abbott the corresponding milestone payments for the events set out below:

 

Milestone

   Payment

First dosing of a patient in a Phase III clinical trial

   $ 1,000,000

Acceptance of the filing of the first NDA in the U.S.

   $ 3,000,000

Acceptance of the first filing of an MAA in Europe

   $ 2,000,000

Regulatory Approval in the U.S.

   $ 6,000,000

First Regulatory Approval in one of the following countries*: United Kingdom, France, Italy, Germany, Spain

   $ 4,000,000

First Regulatory Approval in Japan*

   $ 3,000,000

 

* The applicable milestone shall be paid, if at the time of achieving the milestone in any of the listed countries, a Valid Claim claiming the composition of matter for the Compound exists in that country.

 

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(b) Sales Milestone Payments . VIA shall pay Abbott the following sales milestones upon the first achievement of annual worldwide Net Sales at the levels shown below within thirty (30) days following said achievement. For clarification, each milestone is to be paid a maximum of one time, and, if more than one sales level is first achieved in a single calendar year, then only the highest applicable milestone shall be paid. For example, if in the first calendar year $l10,000,000 of worldwide Net Sales are achieved, $5,000,000 would be payable by VIA to Abbott. If in the subsequent calendar year, $410,000,000 of worldwide Net Sales were achieved, only the $13,000,000 milestone would be due and payable by VIA to Abbott.

 

Sales Level

   Payment

Annual worldwide sales of $100 million

   $ 5,000,000

Annual worldwide sales of $250 million

   $ 9,000,000

Annual worldwide sales of $400 million

   $ 13,000,000

4.3 VIA shall promptly notify Abbott upon the achievement of any milestone for which a payment is due under this Agreement. All milestone payments payable under the provisions of Sections 4.2 shall be non-refundable and non-creditable and shall be due to Abbott within thirty (30) days of the achievement of the stated event. If at any time VIA abandons the development of the first Product, after the payment of one or more milestone payments and subsequently commences or continues the development of another Product, then VIA shall have no obligation to pay a milestone payment upon the occurrence of a milestone event for the subsequent Product, for which VIA previously has paid a milestone payment for the abandoned Product.

4.4 Royalties . During the Royalty Term, VIA shall pay to Abbott a royalty on annual aggregate worldwide Net Sales on the following schedule, which is based on incremental levels of annual Net Sales subject to the royalty step down provisions of Section 4.5 and t


 
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