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EXCLUSIVE LICENSE AGREEMENT

License Agreement

EXCLUSIVE LICENSE AGREEMENT | Document Parties: Critical Therapeutics, Inc | Innovative Metabolics, Inc You are currently viewing:
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Critical Therapeutics, Inc | Innovative Metabolics, Inc

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Title: EXCLUSIVE LICENSE AGREEMENT
Governing Law: Massachusetts     Date: 1/30/2007
Industry: Biotechnology and Drugs     Law Firm: Goodwin Procter     Sector: Healthcare

EXCLUSIVE LICENSE AGREEMENT, Parties: critical therapeutics  inc , innovative metabolics  inc
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Exhibit 99.1

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

 

EXCLUSIVE LICENSE AGREEMENT

This Exclusive License Agreement (this "Agreement"), dated as of

January 29, 2007 (the "Effective Date"), is made by and between Critical

Therapeutics, Inc., a Delaware corporation ("Licensor"), and Innovative

Metabolics, Inc., a Delaware corporation ("IMI"). Licensor and IMI are sometimes

hereinafter referred to each as a "Party" and collectively as the "Parties."

WHEREAS, Licensor has been engaged in the development of certain

technology to stimulate the vagus nerve, and owns and otherwise controls certain

patent rights and know-how with respect thereto;

WHEREAS, IMI desires to acquire exclusive rights under the Licensed

Patents and Licensed Know-How in the Field (each as defined below); and

WHEREAS, the Parties desire to enter into an agreement pursuant to

which Licensor will grant an exclusive license to IMI under the Licensed Patents

and Licensed Know-How for IMI to research, develop and commercialize Licensed

Products & Methods (as defined below).

NOW, THEREFORE, the Parties hereby agree as follows:

Section 1. Definitions.

For the purpose of this Agreement, the following words and phrases and

their correlatives shall have the meanings set forth below:

1.1 "Affiliate" of an entity means any other entity which (directly or

indirectly) is controlled by, controls or is under common control with such

entity. For the purposes of this definition, the term "control" (including, with

correlative meanings, the terms "controlled by" and "under common control with")

as used with respect to an entity means (i) in the case of a corporate entity,

direct or indirect ownership of voting securities entitled to cast at least

fifty percent (50%) of the votes in the election of directors or (ii) in the

case of a non-corporate entity, direct or indirect ownership of at least fifty

percent 50%) of the equity interests with the power to direct the management and

policies of such entity, provided that if local law restricts foreign ownership,

control shall be established by direct or indirect ownership of the maximum

ownership percentage that may, under such local law, be owned by foreign

interests.

1.2 "Confidential Information" shall have the meaning assigned in the

Confidential Disclosure Agreement dated as of the Effective Date by and between

CRTX and IMI (the "CDA").

1.3 "Controlled", when used in reference to Patent Rights or other

intellectual property rights or Technology or tangibles materials, means the

legal authority or right of a person or entity to grant a license or sublicense

or covenant not to sue of Patent Rights or other intellectual property rights to

another entity, or to disclose or provide Technology or tangible materials to

such other entity, in each case by ownership, license, sublicense, contract or

otherwise, without breaching the terms of any agreement with a Third Party as of

the time that such person or entity would be first required under this Agreement

to make such grant, disclosure or provision (subject in all events to the terms

of Section 2.3(b)).

For clarity and without limitation, it is understood and agreed that

because of Third Party agreements any of the foregoing may be partially and not

fully "Controlled" for purposes of the licenses and other rights granted herein,

such as, for example, Licensor only has a covenant not to sue or other

non-exclusive right or license to a Patent Right or Technology, or does not have

all the rights specified in the prosecution and enforcement provisions set forth

in Section 6 for any Patent Right, and in any such case then the applicable

Patent Right, other intellectual property rights, Technology or tangible

materials shall be made available to IMI hereunder to the extent and only to the

extent permitted by the applicable Third Party agreements.

1.4 "Excluded Field" means direct or indirect modulation by a

pharmacological agent of the activity of a cholinergic receptor (including the

nicotinic [alpha]7 cholinergic receptor). It is understood that a

 

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EXCLUSIVE LICENSE AGREEMENT

 

change in a response to a pharmacological agent resulting solely from use of any

medical device (including any Licensed Product & Method as licensed hereunder)

is not in the Excluded Field.

1.5 "Field" means vagal nerve stimulation by any means, but does not

include the Excluded Field. Exemplary vagal nerve stimulation modalities within

the Field include mechanical (such as massage, needle, acoustic or other

vibrational), electrical, thermal, magnetic, and electromagnetic, or as produced

by any other energy source.

1.6 "First Financing" means one or more financing transactions whereby

IMI first receives aggregate gross proceeds in excess of five million dollars

(US$5,000,000).

1.7 "Licensed Know-How" means (i) the NS Licensed Know-How, and (ii)

all Technology (other than the NS Licensed Know-How) Controlled by Licensor or

any of its Affiliates as of the Effective Date or during the term of this

Agreement, that in each case (1) is reasonably necessary or useful to make, use,

sell, offer to sell, and/or import any Licensed Products & Methods and (2)

qualifies as "Confidential Information" under the CDA.

1.8 "Licensed Methods" means any method that, absent the licenses

granted hereunder, the practice of which would infringe one or more Valid Claims

of the Licensed Patents in the Field.

1.9 "Licensed Patents" means (i) the NS Licensed Patents, and (ii) all

Patent Rights (other than the NS Licensed Patents) Controlled by Licensor or any

of its Affiliates as of the Effective Date or during the term of this Agreement,

each of which Patent Rights under this clause (ii) is reasonably necessary or

useful to make, use, sell, offer to sell, and/or import any Licensed Products &

Methods. The Patent Rights under the foregoing clause (ii) that are in existence

as of the Effective Date are listed in Exhibit A. For clarity, all Patent Rights

that arise from, or otherwise claim priority (directly or indirectly) to, any of

the Patent Rights listed as of the Effective Date or thereafter on Exhibit A

shall be treated as "Licensed Patents" hereunder.

1.10 "Licensed Product" means any article or device that (i) absent the

licenses granted hereunder, would infringe one or more Valid Claims of the

Licensed Patents in the Field, (ii) is manufactured by using a Licensed Method,

or (iii) when used as directed, practices a Licensed Method.

1.11 "Licensed Products & Methods" means Licensed Products and Licensed

Methods. For clarity, "Licensed Products & Methods" and those two subsidiary

definitions include, without limitation, combination products discussed in the

last paragraph of the "Net Sales" definition, and those products and services

described in Section 2.1(b).

1.12 "Material Adverse Effect" means a material adverse effect on the

operations or proposed business of the other Party.

1.13 "Net Sales" means, with respect to any Licensed Product or

Licensed Method, the amount received by IMI and its Sublicensed Affiliates (but

no Sublicensed Third Parties) for bona fide sales of such Licensed Product to,

or bona fide performances of such Licensed Method for, a Third Party (other than

Sublicensees but including any Third Party distributors for resale), less:

(a) discounts (including cash, quantity and patient program

discounts), retroactive price reductions, charge-back payments and rebates

granted to managed health care organizations or to federal, state and local

governments, their agencies, or to distributors and other trade customers,

reimbursers and customers and purchasers to the extent actually given or

allowed and consistent with industry standard practices for products or

services similar to the applicable Licensed Product or Licensed Method;

(b) credits or allowances actually granted upon claims,

damaged goods, rejections or returns of such Licensed Product or Licensed

Method, including in connection with any recalls or withdrawals;

 

 

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EXCLUSIVE LICENSE AGREEMENT

 

(c) freight out, postage, shipping and insurance charges

for delivery if and to the extent included in the amount invoiced to the

Third Party; and

(d) taxes or duties levied on, absorbed or otherwise

imposed on such sale or performance, including value-added taxes, or other

governmental charges otherwise imposed upon the billed amount, as adjusted

for rebates and refunds, to the extent not paid by the Third Party.

Net Sales shall not include any payments among IMI, its Affiliates and

Sublicensed Third Parties. Net Sales shall be determined in accordance with

generally accepted accounting principles, consistently applied. Net Sales shall

not include sales or performances of Licensed Products & Methods for clinical

studies (including post-approval studies), as donations to non-profit

institutions or government agencies, for promotional or demonstration purposes

(but not to exceed three percent (3%) of Net Sales in any calendar year for such

purposes), or for research or development by IMI or any Sublicensees.

In the event that a Licensed Product is sold, or a Licensed Method is

performed, in any country in the form of a combination product or service

containing or using, respectively, one or more articles, devices, components or

methods that are not Licensed Products & Methods hereunder (each, a "Non-Product

Component"), Net Sales of such combination product/service shall be adjusted as

follows:

(1) First, actual Net Sales of such combination product/

service in such country for the applicable calendar quarter calculated pursuant

to this Section 1.13 shall be multiplied by the fraction A/(A+B), where A is the

average price in such country for such calendar quarter of the Licensed Products

& Methods and B is the invoice price in such country for such calendar quarter

of all Non-Product Components in such combination product/service, provided that

all such Licensed Products & Methods and Non-Product Components are

sold/performed separately in such country in such calendar quarter.

(2) Second, if in a specific country over such calendar

quarter, such Non-Product Components in such combination product/service are not

sold/performed separately in such country in such calendar quarter, Net Sales

shall be calculated by multiplying actual Net Sales of such combination

product/service calculated pursuant to this Section 1.13 by the fraction A/C,

where A is the average price in such country for such calendar quarter of such

Licensed Products & Methods and C is the average price in such country for such

calendar quarter of such combination product/service.

(3) Third, if in a specific country over such calendar

quarter, such Licensed Products & Methods are not sold /performed separately,

Net Sales shall be calculated by multiplying actual Net Sales of such

combination product/service calculated pursuant to Section 1.13 by the fraction

(C-B)/C, where B is the average price in such country for such calendar quarter

of all such Non-Product Components in such combination product/service and C is

the average price in such country for such calendar quarter of such combination

product/service

(4) Fourth, if, in a specific country over such calendar

quarter, both such Licensed Products & Methods and such Non-Product Components

are not sold separately, a market price for such Licensed Products & Methods and

all such Non-Product Components shall be negotiated by the parties in good faith

based upon the costs, overhead and profit as are then incurred for such

combination product/service, the apportionment of Net Sales as provided in

clauses (1) to (3) above in other countries for such calendar quarter if

available, and all other products, articles, devices, components or methods then

being sold or performed by IMI and its Sublicensees and having an ascertainable

market price.

1.14 "NS" means the Feinstein Institute for Medical Research, formerly

known as North Shore Long Island Jewish Research Institute.

1.15 "NS License" means that certain Sponsored Research and License

Agreement, effective as of January 1, 2003, by and between Licensor and NS, as

amended by (i) that certain Amendment No. 1 dated June 1, 2006 and (ii) that

certain Amendment No. 2 dated January 8, 2007, and as may further be amended,

restated, waived or changed as contemplated by Section 2.3(d).

 

 

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EXCLUSIVE LICENSE AGREEMENT

 

1.16 "NS Licensed Patents" means all Patent Rights licensed as of the

Effective Date or during the term of this Agreement to Licensor under the NS

License, defined as of the Effective Date as the "North Shore Patent Rights" in

the NS License, which Patent Rights in existence as of the Effective Date that

contain Valid Claims that apply to the Field (in whole or in part) are listed in

Exhibit B.

1.17 "NS Licensed Know-How" means all "North Shore Technology" as

defined in the NS License.

1.18 "Patent Rights" mean (i) any patents and patent applications, (ii)

any substitutions, divisionals, continuations, continuations-in-part, reissues,

renewals, registrations, confirmations, re-examinations, extensions,

supplementary protection certificates, term extensions (under patent or other

law), certificates of invention and the like, of any patents or patent

applications, and (iii) any foreign or international equivalents of any of the

foregoing.

1.19 "Technology" means know-how, trade secrets, materials,

formulations, information, documents, studies, results, data (including

pre-clinical, clinical and assay data), manufacturing processes and data,

specifications, sourcing information, assays, and quality control and testing

procedures, whether or not patented or patentable.

1.20 "Third Party" means any person or entity, other than IMI or

Licensor or any of their Affiliates.

1.21 "Valid Claim" means a claim of (i) an issued and unexpired patent,

which claim has not been revoked or held invalid or unenforceable by a court or

other government agency of competent jurisdiction from which no appeal can be or

has been taken and has not been held or admitted to be invalid or unenforceable

through re-examination or disclaimer, reissue, opposition procedure, nullity

suit or otherwise, or (ii) a pending patent application that was filed in good

faith and has not been cancelled, withdrawn or abandoned without the possibility

of appeal or refiling.

Section 2. License Grants by Licensor.

2.1 Exclusive License and Covenant Not to Sue. Licensor, for itself and

on behalf of its Affiliates, hereby grants to IMI a non-transferable (except in

accordance with Section 10.1), exclusive (even as to Licensor and its

Affiliates, unless otherwise provided hereunder), worldwide license or

sublicense (as the case may be), with the right to sublicense in accordance with

Section 2.2, under the Licensed Patents and Licensed Know-How, to practice and

otherwise exploit the same in the Field only, to make, have made, use, sell,

offer to sell, and/or import Licensed Products & Methods. In addition, Licensor,

for itself and on behalf of its Affiliates and licensees and sublicensees,

hereby covenants not to sue, or cause or support any other person or entity to

sue, IMI, any of its Affiliates or Sublicensees, or any of their manufacturers,

suppliers, distributors or customers, for using Licensed Know-How to develop and

commercialize products and services in the Field, which covenant not to sue

shall apply to all activities occurring while the license/sublicense granted in

the immediately previous sentence remains in force. For purposes of this

Agreement, references to the "licenses granted above", "licenses granted in

Section 2.1" and the like in this Agreement shall refer to both the

license/sublicense and covenant not to sue contained in this Section 2.1. For

clarity:

(a) with respect to the NS Licensed Patents and NS Licensed

Know-How, the licenses granted above shall grant all rights available to

Licensor under the NS License, again only in the Field, and IMI expressly

acknowledges that NS has retained rights under the NS License for itself and

the US government and such retention of rights limits IMI's rights under the

NS Licensed Patents and NS Licensed Know-How;

(b) the licenses granted above shall further cover Licensed

Products & Methods that act in the Field, as well as also cause other

therapeutic effect(s) by acting outside of the Field (for example, by

combining a pharmacological agent with a Licensed Product & Method), provided

that the

 

 

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EXCLUSIVE LICENSE AGREEMENT

 

use or sale of the device, article, or pharmacological agent responsible for

such other therapeutic effects, when sold or used alone without the

applicable Licensed Product & Method, does not infringe any Valid Claims of

the Licensed Patents outside of the Field (e.g., the manufacture, use or sale

of such pharmacological agent alone does not infringe any such Valid Claims);

and

(c) in all events, the licenses granted above shall not

apply to any pharmacological agents acting in the Excluded Field that are

covered by any Valid Claims of the Licensed Patents or Licensed Know-How,

whether or not used in combination with any Licensed Product & Method,

provided that this exclusion in this clause (c) and the foregoing clause (b)

shall not be understood to allow Licensor or any of its Affiliates or

licensees or sublicensees to use any Licensed Product & Method in the Field

in combination with any pharmacological agent acting in the Excluded Field.

2.2 Sublicenses.

(a) The licenses granted in Section 2.1 include the right

to grant sublicenses (through multiple tiers) by IMI to its Affiliates and

Third Parties (each such sublicensed Affiliate, a "Sublicensed Affiliate",

each such Third Party sublicensee, a "Sublicensed Third Party", and together

collectively the "Sublicensees"), provided that (i) any such sublicense

agreement shall be subject to and subordinate to this Agreement, (ii) IMI

shall remain responsible for the performance of its Sublicensees hereunder,

and (iii) IMI shall have no right to sublicense unless and until the payments

to Licensor set forth in Section 5.1 have been made in full.

(b) IMI shall provide to each of Licensor and NS timely

notification of each substantive negotiation to sublicense rights hereunder

and shall thereafter keep each of Licensor and NS reasonably informed as to

the substantive progress of such negotiations by providing each of Licensor

and NS with significant drafts of term sheets, any final term sheets and

drafts of any contracts or sublicense agreements prior to execution thereof

so that each of Licensor and NS shall have any opportunity to review the

same. All such information, drafts, term sheets, contracts and agreements,

and the execution copies thereof referred to in Section 2.2(c), shall be

treated as IMI's Confidential Information under the CDA.

(c) IMI shall provide to each of Licensor and NS an

unredacted execution copy of the sublicense agreement for its Sublicensees

and any documents evidencing the consideration paid to IMI or its Affiliates

within [**] business days of execution.

(d) Each sublicense granted to any Sublicensee hereunder

shall terminate immediately upon the termination of the licenses granted in

Section 2.1, provided that any such sublicense shall not terminate, on a

Sublicensee-by-Sublicensee basis, if, as of the effective date of termination

of this Agreement pursuant to Section 9, (i) all outstanding amounts owed

Licensor by IMI hereunder as of such date are paid in full within [**] days

of such date (whether by IMI, its Affiliates or Sublicensees), (ii) a

Sublicensee is not in material default of its obligations to IMI under its

sublicense agreement, and (iii) within [**] days of such termination the

Sublicensee agrees in writing to be bound directly to Licensor under a

license agreement substantially similar to this Agreement with respect to the

rights sublicensed to such Sublicensee hereunder, substituting such

Sublicensee for IMI. Licensor and such Sublicensee shall promptly memorialize

such direct license.

2.3 NS License and Other In-Licenses.

(a) NS License. During the term of this Agreement, IMI

hereby agrees to be responsible for those obligations of Licensor under the

NS License that are set forth on Exhibit C attached hereto, and to comply

with and otherwise satisfy those obligations as required by the terms of the

NS License. Apart from those obligations, IMI and its Affiliates shall not

assume any other obligations of Licensor under the NS License, except and

only to the extent that IMI is a sublicensee of the rights licensed to

Licensor thereunder.

 

 

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EXCLUSIVE LICENSE AGREEMENT

 

(b) Future Third Party Agreements.

(i) After the Effective Date, if (A) Licensor or any

of its Affiliates, in its sole discretion, determines to enter into any

agreement with one or more Third Parties whereby IMI gains rights in or

to any Patent Rights or Technology that would amount to Licensed

Patents or Licensed Know-How, respectively, hereunder, and (B) the

practice of such Patent Rights and Technology in the Field by IMI or

any of its Sublicensees would give rise to royalties payable by

Licensor or its applicable Affiliates, then such Patent Rights and

Technology shall only be treated as "Controlled" and thus Licensed

Patents and Licensed Know-How hereunder if and only if IMI agrees by

amendment to this Agreement to reimburse Licensor and such Affiliate

for the amount payable to such Third Party for activities by IMI and

its Sublicensees.

(ii) Licensor shall notify IMI of any such Third

Party agreements, shall provide an unredacted copy of same to IMI for

IMI to consider (subject to any applicable Third Party confidentiality

requirements), and shall enter into any such amendment upon IMI's

reasonable request.

(iii) For clarity, this Section 2.3(b) shall not

apply to the NS License or any NS Licensed Patents or NS Licensed

Know-How, and further shall not apply to any Patent Rights or

Technology owned in whole or in part by Licensor or any of its

Affiliates (except to the extent Licensor or any of its Affiliates are

required to account to any non-NS Third Party that jointly owns such

Patent Rights or Technology for revenues generated from the licensing

of such rights).

(c) Maintenance. Licensor shall take commercially

reasonable steps to maintain in full force and effect the NS License and all

other Third-Party agreements whereby IMI gains rights hereunder in or to any

of the Licensed Know-How or Licensed Patents, including subject to and as

provided in Section 2.3(b) (collectively, "Third Party In-Licenses").

Licensor shall provide IMI with prompt notice (and in any event substantially

before the end of any applicable cure period under the applicable Third Party

In-License) of any written claim of breach of any Third Party In-License.

Subject to any applicable Third Party confidentiality requirements (except

with respect to the NS License), Licensor shall provide IMI with copies of

all notices and other documents Licensor receives or sends pursuant to each

Third Party In-License that affects IMI's rights hereunder (including any

termination notice).

(d) Amendment. Licensor shall not amend, restate, waive or

otherwise change any of the terms and conditions of the NS License, nor shall

Licensor enter into any other agreement or understanding with NS, that in

either case would have a material adverse impact on IMI's rights under this

Agreement without the prior written consent of IMI.

(e) Bankruptcy. Licensor agrees that if any party to any

Third Party In-License seeks relief under any bankruptcy, reorganization,

insolvency or similar laws, Licensor shall act in good faith to take all

reasonably necessary action, at IMI's expense, to preserve the rights granted

to IMI (via Licensor) hereunder (including seeking to preserve Licensor's and

IMI's rights under any such laws, including under the US Bankruptcy Code,

Title 11 of the U.S. Code). Should any Third Party In-License terminate,

Licensor shall reasonably assist IMI, at IMI's expense, in obtaining all

rights granted to IMI hereunder under such terminated agreement, including by

having the licensor thereof treat IMI as a direct licensee thereunder.

(f) Payments. Licensor shall be solely responsible for all

amounts owed to any Third Party arising from the NS License and any other

Third Party In-License, except as provided in Section 2.3(a) for the NS

License and subject to compliance with Section 2.3(b) as applicable to any

such other Third Party In-License.

 

 

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(g) Proposed Letter Agreement with NS. Without limiting the

foregoing contained in this Section 2.3, with respect to the NS License,

Licensor shall, at IMI's expense, assist IMI in its efforts to negotiate and

execute a letter agreement with NS, and shall execute such documents as IMI

may reasonably request amending the NS License, whereby, in the event of

termination of the NS License, NS shall grant a direct license to IMI in the

Field under the NS Licensed Know-How and NS Licensed Patents on the same

terms as this Agreement with NS in place of Licensor hereunder, provided that

IMI is then in good standing as a sublicensee under the NS License.

2.4 Other Restrictions. Licensor shall not enter into any agreement or

otherwise take any actions or omit to take any actions in conflict with the

licenses granted in Section 2.1 and the other rights granted to IMI hereunder.

2.5 License Limitations. No licenses or other rights are granted by

Licensor hereunder to use any trademark, trade name, trade dress or service mark

Controlled by Licensor or any of its Affiliates. All licenses and other rights

are or shall be granted only as expressly provided in this Agreement, and no

other licenses or other rights are or shall be created or granted hereunder by

implication, estoppel or otherwise.

Section 3. Transfer of Licensed Know-How.

Within [**] days of the Effective Date, upon IMI's written request

within [**] days of the Effective Date, Licensor shall provide to IMI, at IMI's

expense, one (1) copy (in electronic form, if available) of all documents in

Licensor's or its Affiliates' possession as of the Effective Date to the extent

that such documents describe or contain Licensed Know-How, other than NS

Licensed Know-How, which NS Licensed Know-How the Parties acknowledge and agree

may be disclosed and provided by Dr. Kevin J. Tracey directly to IMI and its

Sublicensed Affiliates instead of through Licensor, provided that such NS

Licensed Know-How shall be treated as Confidential Information of Licensor under

the CDA. Licensor shall provide and transfer to IMI all additional Licensed

Know-How that may from time to time become available to Licensor.

Section 4. Development and Commercialization.

4.1 Commercially Reasonable Efforts. IMI, or one of its Sublicensees,

as applicable, shall use Commercially Reasonable Efforts to develop and

commercialize at least one Licensed Product & Method prior to [**], wherein

"Commercially Reasonable Efforts" means, with respect to Licensed Products &

Methods, the carrying out of development and commercialization activities in a

sustained manner using good faith commercially reasonable and diligent efforts,

using the efforts and resources that a company within the medical device

industry and similarly situated to IMI would reasonably devote to a product of

similar market potential or profit potential resulting from its own research

efforts, based on conditions then prevailing and taking into account, without

limitation, issues of safety and efficacy, product profile, the proprietary

position, the then current competitive environment for such product and the

likely timing of such product's entry into the market, the regulatory

environment and status of such product, and other relevant scientific, technical

and commercial factors.

4.2 Responsibilities and Costs. As between the Parties:

(a) IMI and its Sublicensees shall have sole responsibility

for, and shall bear all their costs of conducting, all research, development

and commercialization of Licensed Products & Methods (including manufacturing

all materials required therefor);

(b) IMI and its Sublicensees shall own the results of all

such development and commercialization activities; and

(c) All regulatory filings and approvals for any Licensed

Products & Methods shall be obtained by, in the name of, and solely owned by

IMI and its Sublicensees.

 

 

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Section 5. IMI Payments.

5.1 Initial License Fee.

(a) IMI shall pay to Licensor five hundred thousand US

dollars (US$500,000) in cash, which payment shall be due within fifteen (15)

days of IMI or any of its Affiliates completing the First Financing.

(b) In connection with the First Financing and at the same

time as shares of preferred stock of IMI are sold in the First Financing (the

"Series A Preferred"), IMI shall issue to Licensor that number of shares of a

series of preferred stock ("Junior Preferred") equal to the number of shares

of Series A Preferred that could be purchased for $500,000 in connection with

the First Financing, provided that prior to such issuance, upon Licensor's

written instruction to IMI, IMI shall issue a portion of such Junior

Preferred shares directly to NS. The Junior Preferred shares shall have the

following rights:

(i) Dividend. Non-cumulative dividends shall be paid

on the Junior Preferred shares in an amount equal to eight cents

(US$0.08) per share of Junior Preferred as, if and when declared by the

board of directors of IMI.

(ii) Conversion. The Junior Preferred shares shall be

convertible into common stock of IMI by the holder at any time at an

original conversion ratio of one share of such common stock per share

of Junior Preferred, subject to anti-dilution protection as provided

below.

(iii) Automatic Conversion. The Junior Preferred

shares shall automatically convert into common stock of IMI upon the

closing of a firm underwritten public offering of common stock with

proceeds of at least forty million US dollars (US$40,000,000) at a

price per share of at least three US dollars (US$3.00) or, upon the

conversion of all outstanding shares of Series A Preferred shares.

(iv) Anti-dilution Protection. If IMI issues

additional shares (except for customary carve-outs such as shares

issued under IMI equity plans and the like) at a purchase price less

than the applicable conversion prices of the Series A Preferred shares,

the Junior Preferred shares conversion prices shall be reduced, based

on a broad-based weighted average formula (i.e., the total number of

shares authorized for issuance under IMI equity plans are included in

the numerator and the denominator of the adjustment calculation), so

that in sum the Junior Preferred shall have essentially the same

anti-dilution protection as the Series A Preferred.

(v) Liquidation Preference. In the event of a

Liquidation of IMI, the Series A Preferred shares shall receive, in

preference to all other stockholders, an amount equal to the number of

shares times the conversion price plus any declared but unpaid

dividends. Next, the Junior Preferred shares shall receive in

preference to all common stockholders an amount equal to the number of

shares times the conversion price plus any declared but unpaid

dividends (the "Liquidation Amount"). "Liquidation" means a merger,

acquisition, consolidation, sale of the company, sale of significant

assets of the company, or similar transaction.

(vi) Registration Rights. The Junior Preferred shall

receive from IMI piggyback (i.e., supplemental and not demand)

registration rights equal to the piggyback rights held by holders of

the Series A Preferred.

Licensor shall further agree in connection with receiving those shares of Junior

Preferred (i) to have its shares of Junior Preferred treated for all voting

purposes the same as the Series A Preferred, and (ii) to become subject to the

following customary obligations contained in the applicable financing agreements

on the same basis as the purchasers of Series A Preferred as a whole: (1) voting

obligations related to the election of directors, (2) up to a 180 day lock-up in

connection with an initial public offering of IMI, and (3) a drag-along right.

 

 

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EXCLUSIVE LICENSE AGREEMENT

 

5.2 Milestone Payment. IMI shall pay Licensor one million US dollars

(US$1,000,000) upon IMI or any its Sublicensees first achieving all regulatory

approvals from the United States Food and Drug Administration (or any successor

agency thereto) or any foreign counterpart governmental agency required for the

marketing and sale of any Licensed Product & Method in the applicable country.

Such milestone payment shall be payable to Licensor within thirty (30) days

after such achievement. Only one such milestone payment shall be due under this

Agreement.

5.3 Royalties.

(a) Royalties from Net Sales of IMI and its Sublicensed

Affiliates. Subject to the terms and conditions of this Agreement, IMI shall

pay to Licensor a flat royalty, of [**] percent ([**]%) based upon worldwide

annual Net Sales made by IMI and its Sublicensed Affiliates (but not

Sublicensed Third Parties) of any Licensed Products & Methods sold or

performed in the Field while covered in the country of actual or intended use

by a Valid Claim of the Licensed Patents.

(b) Sublicensed Third Party Payments. Subject to the terms

and conditions of this Agreement, IMI shall pay to Licensor [**] percent

([**]%) of all sublicensing royalties, fees and payments actually received by

IMI and its Affiliates from Sublicensed Third Parties in consideration of

sublicenses granted under Section 2.2, excluding (i) the fair market value of

any equity investments made in IMI and its Affiliates by Sublicensed Third

Parties and their Affiliates, which fair market value shall be determined

upon the written request of Licensor by a valuation firm selected by IMI and

reasonably acceptable to Licensor (the cost of which firm shall be shared

equally by IMI and Licensor, unless the valuation determined by such firm is

more than [**]%) greater than the valuation proposed by IMI before such firm

valuation, whereupon IMI shall pay such cost), with any premium paid for such

equity investments over such fair market value subject to IMI's [**]% payment

obligation above, (ii) payments by Sublicensed Third Parties and their

Affiliates to pay or reimburse for out-of-pocket patent prosecution,

maintenance, defense, enforcement and other related expenses of IMI and its

Affiliates, (iii) payments by Sublicensed Third Parties and their Affiliates

for full-time equivalents ("FTEs") of IMI and its Affiliates not to exceed

more than [**] FTEs at a rate of [**] per FTE during the first [**] years of

the applicable sublicense agreement, with any excess over such FTE limits

subject to IMI's [**]% payment obligation above, and (iv) payments by

Sublicensed Third Parties and their Affiliates for manufacturing payments.

(c) Royalty Limitations. Royalties on sales and

performances of Licensed Products & Methods shall be payable to or shared

with Licensor under Section 5.3(a) and Section 5.3(b) only for those Licensed

Products & Methods that infringe a Valid Claim of the Licensed Patents upon

sale or performance in the country of actual or intended use. Only one

royalty shall be due with respect to the sale or performance of the same unit

of Licensed Product & Method. Only one royalty shall be due hereunder on the

sale or performance of any Licensed Product & Method, even if the

manufacture, use, sale, offer for sale or importation of such Licensed

Product & Method infringes more than one Valid Claim of the Licensed Patents.

5.4 Minimum Royalties Payable.

(a) If and only if the amount payable by IMI to Licensor

for sales and performances of Licensed Products & Methods by IMI and its

Sublicensees under Sections 5.3(a) and 5.3(b) is for any calendar quarter

less than what Licensor owes to NS under the NS License Agreement for those

same sales and performances (but not any other activities of Licensor or any

other sublicensee under the NS License), IMI shall increase the royalty

payment required by Section 5.5(b) to equal such amount owed NS by Licensor.

Thereafter, in any subsequent royalty payment hereunder, IMI may deduct from

the amount owed Licensor the amount required for such increase. This Section

5.4(a) shall only apply while IMI has a sublicense to the NS Licensed Patents

and NS Licensed Know-How from Licensor under the NS License.

 

 

9

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EXCLUSIVE LICENSE AGREEMENT

 

(b) Once IMI or any of its Sublicensees first sells or

performs any Licensed Product & Method that gives rise to royalty payments

from Licensor to NS under the NS License Agreement, the Parties shall meet

and agree on an appropriate means of monitoring payments owed NS by Licensor

based on activities of IMI and its Sublicensees for each calendar quarter and

upon any audit under Section 5.5(c) so as to comply with Section 5.4(a).

(c) All other payments, if any, required of Licensor or any

of its Affiliates for any Third Party In-Licenses other than the NS License

shall be addressed by Section 2.3(b) and any amendment to this Agreement.

5.5 Payment Terms.

(a) Manner of Payment. All payments to be made by IMI

hereunder shall be made in US dollars by wire transfer to such bank account

as Licensor may designate.

(b) Reports and Royalty Payments.

(i) For as long as payments are due under Section

5.3(a) or 5.3(b), IMI shall furnish to Licensor a written report,

within thirty (30) days after the end of each calendar quarter, showing

the payments owed to Licensor for such calendar quarter. Payments for

each calendar quarter shall be due at the same time as such written

report for such calendar quarter.

(ii) The report shall include, at a minimum, the

following information for the applicable calendar quarter, each listed

by Licensed Product & Method and by country of sale: (i) the number of

units of Licensed Products & Methods sold and performed by IMI and its

Sublicensed Affiliates on which royalties are owed Licensor hereunder;

(ii) the gross amount received for such sales; (iii) deductions taken

from Net Sales as specified in the definition thereof; (iv) Net Sales;

(v) the gross amount of any payments received by IMI from Sublicensed

Third Parties subject to sharing with Licensor under Section 5.3(b);

(vi) the royalties owed to Licensor under Section 5.3(a); (vii) the

payments owed to Licensor under Section 5.3(b); (viii) the computations

for any applicable currency conversions pursuant to Section 5.5(d); and

(ix) any other information expressly required by the terms of this

Agreement. All such reports shall be treated as Confidential

Information of IMI.

(iii) IMI shall include terms in each sublicense

agreement it enters hereunder granting IMI permission from each

Sublicensee to share with each of Licensor and NS the information

listed in the numbered clauses of Section 5.5(b)(ii) as they relate to

net sales of Licensed Products & Methods sold or performed by such

Sublicensee.

(c) Records and Audits.

(i) IMI shall keep, and shall cause each of its

Sublicensees to keep, adequate books and records of accounting for the

purpose of calculating all amounts payable to Licensor hereunder. For

the [**] years next following the end of the calendar year to which

each shall pertain, such books and records of accounting (including

those of IMI's Sublicensees) shall be kept at each of their principal

place of business and shall be open for inspection at reasonab


 
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