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LICENSE AGREEMENT

License Agreement

LICENSE AGREEMENT | Document Parties: NITROMED INC | Archemix Corp | Regado Biosciences, Inc You are currently viewing:
This License Agreement involves

NITROMED INC | Archemix Corp | Regado Biosciences, Inc

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Title: LICENSE AGREEMENT
Governing Law: Delaware     Date: 12/19/2008
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AGREEMENT, Parties: nitromed inc , archemix corp , regado biosciences  inc
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Exhibit 10.39 LICENSE AGREEMENT      THIS LICENSE AGREEMENT (this "Agreement"), dated as of October ___, 2003 (the "Effective Date"), is entered into between Archemix Corp., a Delaware corporation, having a place of business at 1 Hampshire Street, Cambridge, MA 02139 ("Archemix"), and Regado Biosciences, Inc., a Delaware corporation, having a place of business at 7030 Kit Creek Road, RTP, NC 27560, ("Regado").      WHEREAS, Archemix owns or has rights in certain technology regarding aptamers and their modifications; and      WHEREAS, Regado desires to obtain a worldwide license under Archemix’s rights in such technology to develop and commercialize Licensed Products for use in therapeutics.      NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the parties agree as follows:

1

 

DEFINITIONS

 

1.1

 

" Affiliate " shall mean, with respect to any Person, any other Person which directly or indirectly controls, is controlled by, or is under common control with, such Person. A Person shall be regarded as in control of another Person if it owns, or directly or indirectly controls, at least fifty percent (50%) of the voting stock or other ownership interest of the other Person, or if it directly or indirectly possesses the power to direct or cause the direction of the management and policies of the other Person by any means whatsoever.

 

     

 

1.2

 

" Anti-Fibrin Activity " shall mean the elimination or modulation of fibrin deposition, platelet adhesion and/or platelet aggregation in humans.

 

     

 

1.3

 

" Anti-Fibrin Antidote Activity " shall mean the termination or modulation of Anti-Fibrin Activity.

 

     

 

1.4

 

" Aptamers " shall mean oligonucleotides, including any structural variations and modifications, derivatives, homologs, analogs and/or mimetics thereof, identified through the SELEX Process.

 

     

 

1.5

 

" Commercial License " shall have the definition set forth in Section 2.1(b).

 

     

 

1.6

 

" Controlled " shall mean, with respect to a particular item of information or intellectual property right, that the applicable Party owns or has a license to such item or right and has the ability to grant to the other Party access to and a license or sublicense (as applicable) under such item or rights as provided for in this Agreement without violating the terms of any agreement or other arrangement with any Third Party.

 

     

 

1.7

 

" Damages " shall mean any and all costs, losses, claims, liabilities, fines, penalties, damages and expenses, court costs, and reasonable fees and

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

 




 

 

 

 

disbursements of counsel, consultants and expert witnesses incurred by a Party hereto (including any interest payments which may be imposed in connection therewith).

 

     

 

1.8

 

" Excluded Aptamers " shall mean (a) [***], (b) [***] , and (c) any Aptamer directed to a target for use outside the Field and (d) the following targets:

 

i.

 

[***];

 

     

 

ii.

 

[***];

 

     

 

iii.

 

[***];

 

     

 

iv.

 

[***];

 

     

 

v.

 

[***];

 

     

 

vi.

 

[***];

 

     

 

vii.

 

[***] ;

 

     

 

viii.

 

[***]; and

 

     

 

ix.

 

[***].

 

1.9

 

" Field " shall mean the use of a Licensed Product for the treatment of diseases or conditions in humans caused or characterized by factors involved in, and the modulation of, fibrin deposition, platelet adhesion and/or platelet aggregation; provided , however , that the Field shall not include the treatment of any conditions or diseases of the [***] and [***], the [***] or the [***]. The Field shall not include the diagnosis of any diseases or conditions nor any uses relating to the [***].

 

     

 

1.10

 

" First Commercial Sale " shall mean, with respect to any Licensed Product, the first sale for use or consumption by the general public of such Licensed Product.

 

     

 

1.11

 

" Gilead-Archemix License Agreement " shall mean the License Agreement Between Gilead Sciences, Inc. and Archemix Corp. dated October 21, 2001.

 

     

 

1.12

 

" Interested Party " shall mean Regado, Archemix or Gilead and " Interested Parties " shall mean Regado, Archemix and Gilead.

 

     

 

1.13

 

" In Vitro Diagnostics " shall mean the use of the SELEX Process or Aptamers identified through the use of the SELEX process in the assay, testing or determination outside of a living organism, of a substance in a test material.

 

     

 

1.14

 

" In Vivo Diagnostic Agent " shall mean any Licensed Product containing one or more Aptamers that is used for any human in vivo diagnostic purpose related to,

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

2




 
 

 

 

 

inter alia, the identification, quantification or monitoring of the propensity toward, or actual existence of, any disease state.

 

     

 

1.15

 

" Licensed IP Rights " shall mean, collectively, the Licensed Patent Rights and the Licensed Know-How Rights.

 

     

 

1.16

 

" Licensed Know-How Rights " shall mean all trade secrets, know-how, information and data Controlled by Archemix during the Term that is not generally known (including, but not limited to, information and data regarding formulae, procedures, protocols, techniques and results of experimentation and testing), which is necessary or useful for Regado to practice within the Field any invention, composition of matter, method or process claimed or disclosed in any issued patent or pending patent application within the Licensed Patent Rights.

 

     

 

1.17

 

" Licensed Patent Rights " shall mean any and all patents or patent applications Controlled during the Term by Archemix that are necessary or useful for the performance of the SELEX Process or the manufacture, sale, offer for sale, importation or use of Aptamers, excluding the Excluded Aptamers, within the Field, including, without limitation, the Licensed SELEX Patent Rights; provided , however , that patents and patent applications claiming the composition or use of specific Aptamers shall not be included within the definition of "Licensed Patent Rights" except to the extent they are included within the Licensed SELEX Patent Rights.

 

     

 

1.18

 

" Licensed Product " shall mean a product that contains an Aptamer, other than an Excluded Aptamer, with Anti-Fibrin Activity, and that has, as another component, a nucleic acid that has Anti-Fibrin Antidote Activity, wherein the discovery, development, manufacture, use, sale or importation of such product would infringe a Valid Claim within the Licensed Patent Rights but for the grant and continuing validity of the license granted by Archemix to Regado in Section 2.1 hereof. In addition, if Regado manufactures, uses, sells, offers for sale, has sold or imports a product that would constitute a Licensed Product but for the fact that Regado did not discover or develop the Aptamer contained within such product, then, that product shall be deemed to be within the definition of the term "Licensed Product" for all purposes hereunder. For avoidance of doubt, in addition to the foregoing requirements, a product must have therapeutically significant levels of both Anti-Fibrin Activity and Anti-Fibrin Antidote Activity in order to be a "Licensed Product."

 

     

 

1.19

 

" Licensed SELEX Patent Rights " shall mean (a) those certain patent applications and patents listed on Schedule A hereto and any patent or patent application claiming priority therefrom; (b) all patents that have issued or in the future issue from such patent applications, including utility, model and design patents and certificates of invention; and (c) all divisionals, continuations, continuations-in-part, reissues, renewals, extensions or foreign counterparts or additions to any such patent applications and patents.

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

3




 
 

 

1.20

 

" NDA " shall mean a New Drug Application, as defined in the United States Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any successor application thereto.

 

     

 

1.21

 

" Net Sales " shall mean, with respect to any Licensed Product, the invoiced sales price of such Licensed Product billed to independent customers by Regado and its Affiliates, less (a) credits, allowances, discounts and rebates to, and chargebacks from the account of, such independent customers for spoiled, damaged, out-dated, rejected or returned Licensed Product or bad debts; (b) actual freight and insurance costs incurred by Regado in transporting such Licensed Product to such customers; (c) cash, quantity and trade discounts and other price reductions; (d) sales, use, value-added and other direct taxes incurred; and (e) customs duties, surcharges and other governmental charges incurred by Regado in connection with the exportation or importation of such Licensed Product.

 

     

 

1.22

 

" Party " shall mean Regado or Archemix and " Parties " shall mean Regado and Archemix.

 

     

 

1.23

 

" Person " shall mean an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.

 

     

 

1.24

 

" Phase III Trial " shall mean a clinical trial designed to demonstrate the safety and efficacy of a Licensed Product as more fully defined in 21 CFR 312.21(c) or any successor regulation thereto.

 

     

 

1.25

 

" Proprietary Information " shall mean, subject to the limitations set forth in Section 9.1 hereof, any confidential information of a Party disclosed by such Party to the other Party in the course of negotiating or performing under this Agreement that is identified as confidential by the disclosing party at the time of its disclosure.

 

     

 

1.26

 

" Radio Therapeutic " shall mean any Licensed Product for human therapeutic use that contains one or more Aptamers that target specifically any diseased tissue, cells or disease-specific molecules or any tissue or cells which are affected by a disease or located in the close neighborhood of a disease process and linked to or incorporates (a) radionucleotides or (b) any structure or elements which develop therapeutic effects similar to the effect of linking or incorporating radionucleotides after submission of any kind of radiation.

 

     

 

1.27

 

" Regado Improvements " shall mean any inventions, patentable or not, information and/or data Controlled by Regado after the Effective Date and during the term of this Agreement, that were derived from the practice of the Licensed IP Rights, and that relate to (a) improvements in the SELEX Process and (b) improvements made to the Licensed IP Rights.

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

4




 
 

 

1.28

 

" Regado SELEX Technology " shall mean any know-how, technology, inventions, information or data Controlled by Regado as of the Effective Date of this Agreement or during the Term, that constitute a modification or improvement to the SELEX Process.

 

     

 

1.29

 

" Research License " shall have the definition set forth in Section 2.1(a).

 

     

 

1.30

 

" Royalty Term " shall mean, as determined on a Licensed Product-by-Licensed Product and country-by-country basis, the period of time commencing on the date of the First Commercial Sale of such Licensed Product in such country, and ending upon the expiration or termination of the last Valid Claim within the Licensed Patent Rights that covers the development, manufacture, use, sale or importation into such country of such Licensed Product.

 

     

 

1.31

 

" SELEX Process " means any process for the identification of a nucleic acid, which process is disclosed in or falls within the claimed scope of the Licensed SELEX Patent Rights.

 

     

 

1.32

 

" Sublicense Income " shall mean the consideration payable to Regado in connection with a sublicense of any or all of the rights granted hereunder to Regado by Archemix, including without limitation, any and all upfront payments, annual fees, milestone payments, royalties but excluding (a) payment for research or development to be conducted by Regado or its Affiliates for the benefit of the Sublicensee to the extent not in excess of the actual direct cost of performing such research and development, and (b) proceeds from the sale and issuance of Regado securities to a Sublicensee to the extent not in excess of the fair market value of said securities.

 

     

 

1.33

 

" Sublicensee " shall mean a Third Party to whom Regado grants a sublicense of any or all of the rights granted hereunder to Regado by Archemix

 

     

 

1.34

 

" Territory " shall mean the world.

 

     

 

1.35

 

" Third Party " shall mean any Person other than Archemix, Regado and their respective Affiliates.

 

     

 

1.36

 

" URC License Agreement " shall mean the Restated Assignment and License Agreement, dated July 17, 1991, by and between University Research Corporation and Gilead as successor in interest to NeXstar.

 

     

 

1.37

 

" UTC " shall mean University Technology Corporation, the successor to the University Research Corporation.

 

     

 

1.38

 

" Valid Claim " shall mean (a) a claim of an issued and unexpired patent within the Licensed Patent Rights, which has not been held permanently revoked, found unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

5




 
 

reissue or disclaimer or otherwise, or (b) a claim of a pending patent application so long as there exists an issued and unexpired patent meeting the criteria of clause (a) above that includes a claim covering the discovery, development, manufacture, use, sale or importation into the country of the Licensed Product.

2

 

LICENSE GRANT

 

2.1

 

License Grants to Regado . Subject to the terms and conditions set forth herein (including Section 2.5), Archemix hereby grants to Regado the following licenses during the term of this Agreement (a) a non-exclusive, non-sublicenseable license under the Licensed IP Rights, to use the SELEX Process, for the purpose of identifying and developing anti-protein Aptamers for use solely as part of a Licensed Product (the "Research License") and (b) an exclusive, worldwide license under the Licensed IP Rights, with the right to grant Sublicenses as set forth in Section 2.2, to develop, manufacture, use, sell, offer for sale, have sold, and import Licensed Products solely for use in the Field (the "Commercial License"). For the avoidance of doubt the Research License shall include the right to test potential Licensed Products in animal.

 

     

 

2.2

 

Sublicense Rights . Subject to Archemix’s rights under Article 8, Regado shall have the right to grant sublicenses solely under the Commercial License. Regado shall give Archemix prompt written notice of each sublicense under this Agreement along with a copy of such sublicense. Any such sublicense shall contain provisions for the assignment to Archemix of Regado’s interest therein upon termination of this Agreement, subject to the last sentence of this Section 2.2, unless the termination of this Agreement arises out of the action or inaction of such Sublicensee or the Sublicensee is then in breach of its obligations under such sublicense, in which case Archemix, at its option, may terminate such sublicense. Notwithstanding this, if in Regado’s opinion, sublicensee did not materially breach the agreement, Regado may challenge the termination under the provisions of Section 8.3. Each sublicense shall also contain provisions which obligate such Sublicensee to comply with terms, conditions, agreements and obligations that are consistent with the terms, conditions, agreements and obligations to which Regado is subject under this Agreement. Archemix hereby agrees to accept such assignment and that such sublicense, as assigned, will remain in full force and effect, provided that Archemix shall have no obligation thereunder except to maintain the continued effectiveness of the sublicense.

 

     

 

2.3

 

Negative Covenants.

 

2.3.1

 

Without limiting any of the other terms, conditions and limitations contained herein, Regado shall not (a) use the SELEX Process or otherwise select Aptamers against targets for use outside the Field, (b) perform any research or development on any Aptamer for use outside the Field (c) provide Aptamers for use outside the Field to any party that does not possess a valid license to the Licensed SELEX Patent Rights for the intended use of the Aptamer, except for evaluation of the aptamer as a

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

6




 
 

 

 

 

therapeutic; (d) make, use, sell, offer for sale, import or export any Licensed Products containing any Excluded Aptamers, (e) make, use, sell, offer for sale, import or export any Excluded Aptamers, or (f) make, use, sell, offer for sale, import or export any Aptamers for In Vitro Diagnostics, as In Vivo Diagnostic Agents or as Radio Therapeutics.

 

     

 

2.3.2

 

Subject to the terms and conditions set forth herein, Archemix hereby agrees not to develop, or grant to any Third Party the right, under the Licensed IP Rights, to develop therapeutic aptamers to modulate the Factor [***] or the Factor [***] [***]. The foregoing restriction shall terminate on the first to occur of the following events: (a) the [***] anniversary of the Effective Date; (b) at any time after the [***] anniversary of the Effective Date upon [***] months prior written notice from Archemix to Regado, or (c) on a target-by-target basis, if Regado discontinues active development of Licensed Products against aptamers used to modulate Factor [***] or the Factor [***].

 

2.4

 

License Grants to Archemix .

 

2.4.1

 

Subject to the terms and conditions hereof, Regado hereby grants to Archemix, a royalty-free, paid-up, and non-exclusive nontransferable license under Regado’s intellectual property rights relating to the Regado Improvements (a) to conduct internal research solely within Archemix.

 

     

 

2.4.2

 

Subject to the terms and conditions set forth herein (including Section 2.5), Regado hereby grants to Archemix a royalty-free, paid-up, non-exclusive license, with the right to grant sublicenses solely as provided in this Section 2.4.2, under intellectual property rights Controlled by Regado, as of the Effective Date and during the Term, that relate to Regado SELEX Technology, for any and all uses outside of the Field. The license granted under this Section 2.4.2 shall remain in effect following the expiration or termination of this Agreement for any reason other than a termination by Regado under Section 11.2 due to a material breach by Archemix.

 

2.5

 

Third Party Agreements . The Parties each hereby acknowledge that certain of the intellectual property rights which are subject to the licenses granted herein may be Controlled by the Party granting such license (the "Licensor" and the other Party under such circumstances is the "Licensee") by virtue of a license (a "Third Party Agreement") granted to the Licensor by a Third Party. Except as otherwise set forth in this Section 2.5, the Parties hereby agree to pay, either to the Licensor or directly to such Third Party as the Licensor shall determine, any and all incremental costs (including without limitation, milestones and royalties) required to be paid under a Third Party Agreement due to the grant of the license of such rights to the Licensee or the exercise of those rights by the Licensee (such amounts are "Third Party Royalties"). Notwithstanding the foregoing, and subject to the terms and conditions set forth herein, Archemix shall be responsible for all

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

7




 
 

amounts payable to Third Parties for the rights to the Licensed SELEX Patent Rights and Regado shall be responsible for all amounts payable to Third Parties for the rights to the intellectual property licensed to Regado by Duke University (or any of its Affiliates or agents). The Parties further agree (a) to provide notice and copies to each other of all Third Party Agreements that require the payment of Third Party Royalties (with terms and conditions that are not relevant to the Licensee redacted), (b) to refrain from breaching, or causing the Licensor to breach, any Third Party Agreements, and (c) when acting as Licensor, to refrain from charging or attempting to charge any fee or royalty to the Licensee in connection with the grant or exercise of such license, other than Third Party Royalties, or the amounts due under Section 3 of this Agreement. The Parties further acknowledge and agree that either of them, when acting as Licensee, may, by notice to the Licensor, reject or terminate the licenses granted to them hereunder with respect to rights under any Third Party Agreement(s), at any time during the term, without effecting the ongoing effectiveness of this Agreement.

3

 

TECHNOLOGY ACCESS FEE; ROYALTIES; MILESTONES

 

3.1

 

Technology Access Fee . In consideration of the licenses and rights granted to Regado herein, Regado shall, as of the date immediately preceding the closing (the "Closing") of the first equity financing of Regado in which Regado is assigned a pre-money valuation of not less than [***] dollars ($[***]), issue to Archemix fully-paid and non-assessable shares of common stock of Regado equal to [***] percent ([***]%) of the total number of equity shares of Regado, on a fully diluted basis, immediately prior to the issuance of shares at the Closing. Regado shall deliver written notice of the Closing to Archemix at least [***] business days prior to such Closing in accordance with the notice provisions contained in Section 14.1 of this Agreement. Archemix and Regado shall enter into such agreements relating to the issuance of the common stock as are customary under such circumstances.

 

     

 

 

 

For the purpose of this Agreement, "fully diluted basis" shall mean the aggregate of (a) the number of shares of common stock issued and outstanding on the determination date, (b) the number of shares of common stock issuable upon exercise, exchange or conversion of all exercisable, exchangeable or convertible securities outstanding on the determination date, assuming such securities were exercised, exchanged or converted on the determination date (without regard to whether such securities are actually exercisable, exchangeable or convertible on the determination date) and (c) the number of shares of common stock issuable pursuant to any other obligation or agreement of, or right granted by, Regado, whether vested or unvested, contingent or otherwise.

 

     

 

3.2

 

Royalty Payments . In consideration for the licenses granted to Regado herein, Regado shall pay royalties to Archemix equal to [***] percent ([***]%) of Net Sales of Licensed Products beginning with the First Commercial Sale by Regado or its Affiliates and continuing during the Royalty Term, and (ii) [***] percent

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

8




 
 

([***]%) of all Sublicense Income received by Regado or its Affiliates during the Term. If Regado grants a sublicense to a Third Party to develop therapeutic aptamers that modulate the Factor [***] or the Factor [***], then Regado shall pay to Archemix, an additional [***] percent ([***]%) of all Sublicense Income received by Regado in connection with that sublicense, for a total of [***] percent ([***]%) of such Sublicense Income. However, if Regado grants this sublicense after the completion of a [***], or if Archemix terminates the period described under Section 2.3.2 prior to [***] anniversary of the Effective Date by notice to Regado, then such additional [***] percent ([***]%) will not be payable hereunder. As further consideration for the term of exclusivity granted in Section 2.3.2, Regado shall provide Archemix with an additional [***] percent ([***]%) of all Sublicense Income. If Archemix terminates the period described under Section 2.3.2 prior to [***] of the Effective Date by notice to Regado, then such additional [***] percent ([***]%) will not be payable hereunder.

 

3.3

 

Milestones . In consideration for the licenses granted to Regado herein, Regado shall pay the amounts indicated below to Archemix within [***] days following the achievement of each of the events indicated below for Licensed Products developed by Regado to achieve each such event:

 

 

 

Event

 

Milestone Payment Amount

[***]*

 

$[***]

[***]

 

$[***]

[***]

 

$[***]

[***]

 

$[***]

*[***] is [***] upon [***] of the [***] in such [***]. Regado shall provide no less than [***] days prior written notice to Archemix of the anticipated achievement of each of the above-described milestone events with respect to each Licensed Product and written notice of the actual achievement of each of the above milestone events with respect to each Licensed Product no later than [***] days following each such achievement. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

9




 

4

 

ROYALTY REPORTS AND ACCOUNTING

 

4.1

 

Royalty Reports . Following the First Commercial Sale of a Licensed Product and continuing throughout the term, Regado shall furnish to Archemix a [***] written report showing in reasonably specific detail the calculation of royalties owing with respect to the sale of Licensed Products by Regado and its Affiliates for the prior quarter. With respect to sales of Licensed Products invoiced in United States dollars, all amounts shall be expressed in United States dollars. With respect to sales of Licensed Products invoiced in a currency other than United States dollars, all amounts shall be expressed in the domestic currency of the party making the sale together with the United States dollar equivalent. The United States dollar equivalent shall be calculated using the average of the exchange rate (local currency per US$1) published in The Wall Street Journal, Eastern Edition, under the heading "Currency Trading" on the last business day of each month during the applicable calendar quarter. Reports shall be due on the [***] day following the close of each [***]. Regado shall also furnish to Archemix a report promptly upon receipt of any Sublicense Income, showing in reasonably specific detail the calculation of Sublicense Income (including any deductions from the gross amount received from the Sublicensee) and the amounts owing with respect to such Sublicense Income. Regado shall keep complete and accurate records in sufficient detail to enable the royalties payable hereunder to be determined.

 

     

 

4.2

 

Audits .

 

4.2.1

 

Upon the written request of Archemix and not more than [***] in each [***], Regado shall permit an independent certified public accounting firm of nationally recognized standing selected by Archemix and reasonably acceptable to Regado, at Archemix’ expense, to have access during normal business hours to such of the records of Regado as may be reasonably necessary to verify the accuracy of the royalty reports for any year ending not more than [***] months prior to the date of such request. The accounting firm shall disclose to Archemix only whether or not the reports are correct and the amount of any discrepancies. No other information shall be shared.

 

     

 

4.2.2

 

If such accounting firm concludes that additional royalties were owed during such period, Regado shall pay the additional royalties within [***] days of the date Archemix delivers to Regado such accounting firm’s written report so concluding. The fees charged by such accounting firm shall be paid by Archemix; provided , however , if the audit discloses that the royalties payable by Regado for the audited period are more than [***] percent ([***]%) of the royalties actually paid for such period, then Regado shall, in addition to paying the overdue amounts, pay the reasonable fees and expenses charged by such accounting firm.

 

4.3

 

Confidential Financial Information . Archemix shall treat all financial information subject to review under this Section 5 as confidential, and shall cause its

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

10




 
 

accounting firm to retain all such financial information in confidence under Section 9 below.

5

 

PAYMENT TERMS

 

5.1

 

Payment Terms . Royalties shown to have accrued by each royalty report provided for under Section 5.1 above shall be due on the date such royalty report is due. Payment of royalties in whole or in part may be made in advance of such due date. Overdue amounts shall bear interest at the rate of [***] percent ([***]%) per month. Acceptance of overdue amounts plus interest shall not constitute a waiver by Archemix of any other remedies it may have hereunder or otherwise.

 

     

 

5.2

 

Exchange Control . If at any time legal restrictions prevent the prompt remittance of part or all royalties with respect to any country where a Licensed Product is sold, Regado shall promptly notify Archemix of such fact and shall make such payments by depositing the amount thereof in local currency in a bank or other depository institution in such country indicated by Archemix.

 

     

 

5.3

 

Withholding Taxes . Regado shall be entitled to deduct the amount of any withholding taxes, value-added taxes or other taxes, levies or charges with respect to such amounts, payable by Regado, its Affiliates or Sublicensees, or any taxes required to be withheld by Regado, its Affiliates or Sublicensees, to the extent Regado, its Affiliates or Sublicensees pay to the appropriate governmental authority on behalf of Archemix such taxes, levies or charges. Regado shall use reasonable efforts to minimize any such taxes, levies or charges required to be withheld on behalf of Archemix by Regado, its Affiliates or Sublicensees. Regado promptly shall deliver to Archemix proof of payment of all such taxes, levies and other charges, together with copies of all communications from or with such governmental authority with respect thereto.

 

     

 

5.4

 

Limitations Imposed by Law . If any amount payable under Section 3 or Section 5.1 are limited by any applicable laws, regulations or government order, then the amount payable shall be deemed to be the highest amount payable under such law, regulation or government order.

6

 

FUNDING REQUIREMENT

 

6.1

 

Funding Requirement . Regado shall close an equity financing, or series of financings, having aggregate proceeds of at least [***] dollars ($[***]) on or before the first anniversary of the Effective Date. Failure of Regado to close such a financing in accordance with this Section 6.1 will constitute a material breach of this Agreement.

7

 

PROGRESS REPORT AND COMMERCIAL APPLICATION

 

7.1

 

Progress Report. On or before February 28 and August 30 of each year, commencing as of February 28, 2004 and ending on August 30 of the calendar

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.

11




 
 

 

 

 

year following the calendar year in which Regado, its Affiliates or Sublicensees first begins to market any Licensed Product, Regado shall provide a semi-annual progress report to Archemix, each report covering the [***] month period preceding the due date of the report. Thereafter, Regado shall provide such reports on an annual basis covering the [***] month period preceding the due date of the report. Each report shall describe any Regado Improvements, notice of any patents filed by Regado in connection with any Regado Improvements and the progress made by Regado, its Affiliates or Sublicensees toward the commercial development of any Licensed Products or services utilizing the Licensed IP Rights. Such report shall include at a minimum, information reasonably sufficient to enable Archemix to satisfy its reporting obligations to Gilead under the Gilead-Archemix License Agreement with respect to this Agreement, including any reporting obligations of the U.S. Government, and to assess the progress made by Regado toward meeting the diligence requirements of Section 7.2 below.

 

     

 

7.2

 

Commercial Application. Regado, either directly or with and through the efforts of its Affiliates and Sublicensees, shall at all times use commercially reasonable efforts to proceed with the development, manufacture and sale of Licensed Products, including, without limitation, maintaining sufficient facilities, resources and personnel to fulfill its obligations under this Agreement. In the event that Regado, its Affiliates and Sublicensees cease reasonable efforts to develop the commercial applications of the Licensed Products for a period of at least [***] months Archemix will have the option, at its sole discretion, to terminate this Agreement pursuant to Section 11.2 below. In such event, Archemix may exercise its option; provided , however , that (a) Archemix delivers advance written notice of its decision to exercise such option to force a reversion of the technology to Archemix, and (b) for a period of [***] months following Regado’s receipt of such notice, Regado, its Affiliates, and Sublicensees, shall have the right and opportunity to cure the alleged cessation of such reasonable commercial development. Further, if Regado or its sublicensee disagrees that it has ceased reasonable efforts to commercialize a Licensed Product, or disagrees that it has not sufficiently cured a cessation of reasonable efforts, it can request arbitration of the termination decision under the terms of Section 8.3 by written notice to Archemix within [***] month of a written notice of termination. Regado acknowledges and agrees that under the URC License Agreement and the Gilead-Archemix License Agreement, Archemix rights in the Licensed IP Rights may revert to Gilead or the UTC if Archemix, its Affiliates and all assignees and sublicensees cease reasonable efforts to develop the commercial applications of the Licensed Products and services utilizing the Licensed IP Rights.

 

     

 

 

 

Regado further acknowledges and agrees that, in the event of any termination of the URC License Agreement, the licenses granted to Regado hereunder shall remain in full force and effect in accordance with Section 3.4 of the URC License Agreement, provided that


 
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