Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
Exhibit 10.3.2.2
LICENSE AGREEMENT
Effective May 31, 2001 (the "Effective Date"), Research Corporation
Technologies, Inc., a Delaware nonprofit corporation, with offices at ▇▇▇ ▇.
▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇, ▇▇ ▇▇▇ ▇▇▇▇▇-▇▇▇▇, ("RCT"), and BioVex Ltd., a
corporation organized under the laws of the United Kingdom, with offices at The
Windeyer Institute, ▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇ ("Licensee"),
agree as follows (fully-capitalized terms are defined in ARTICLE VIII):
ARTICLE I
LICENSE
SECTION 1.1 Grant of License. RCT hereby grants to Licensee, and Licensee
hereby accepts from RCT, a non-exclusive license under the LICENSED PATENTS to
make and have made, to USE, to SELL, to offer to SELL, and to import LICENSED
PRODUCTS in the LICENSED TERRITORY for any use free from suit by RCT for
infringement of the PATENT CLAIMS in the LICENSED TERRITORY. No license or
rights are granted or implied under any patent application or patent not a
LICENSED PATENT. The foregoing license does not in any way include the license
or right to SELL or offer to SELL (or export out of the LICENSED TERRITORY): (a)
any PROTEIN PRODUCT; or (b) any GENE, GENE construct, or any cell transfected
with a GENE that is intended for use in the in vivo production of protein in any
non-human animal, or the production of a PROTEIN PRODUCT. Licensee covenants
that its activities under this Agreement shall be so limited. Licensee shall
have neither the right nor the power to grant sublicenses except as provided in
SECTION 1.2 below.
SECTION 1.2 Extensions to AFFILIATES.
Subsection 1.2.1. Grant of Right. RCT hereby grants to Licensee the
right to extend to Licensee's AFFILIATES the license granted under SECTION 1.1
of this Agreement but with no right to further extend the license granted
thereunder. Licensee shall notify RCT in writing before any extension to an
AFFILIATE is made. If an AFFILIATE ceases to be an AFFILIATE, any license
extended to such AFFILIATE under this SECTION 1.2 shall terminate concurrently
with such AFFILIATE's ceasing to be an AFFILIATE.
Subsection 1.2.2. Licensee Responsible for Performance. Licensee shall
be responsible for the performance of its AFFILIATES to which it extends this
license. For assessing, reporting and paying earned royalties under this
Agreement, the manufacture, SALE, USE or importation of LICENSED PRODUCTS by
Licensee's AFFILIATES shall be considered the manufacture, SALE, USE, or
importation of such LICENSED PRODUCTS by Licensee. Each AFFILIATE may make the
pertinent reports and royalty payments specified in ARTICLE II ("Financial
Terms") directly to RCT on behalf of Licensee if Licensee provides RCT prior
written notice. Otherwise, Licensee shall make such payments and reports
separately showing the AFFILIATE's USE, SALE, and importation of LICENSED
PRODUCTS.
SECTION 1.3 RCT's Obligations to Offer Licenses. Licensee may desire to
have LICENSED PRODUCTS, that have been introduced into human beings in the
course of clinical trials conducted under the sponsorship or direction of
Licensee, marketed and SOLD by a commercial partner, co-promoter or developer (a
"Qualified License Prospect"). From time to
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time, Licensee may provide to RCT a written request that RCT grant a license
under the LICENSED PATENTS to such Qualified License Prospect. Promptly after
receiving each such written request, RCT shall offer to the pertinent Qualified
License Prospect a license under the LICENSED PATENTS at the then-prevailing
terms offered by RCT to others for such a license. RCT shall negotiate each such
license in good faith but shall not have any obligation to enter into such
license if RCT and the pertinent Qualified License Prospect are unable to agree
upon the terms of such license.
SECTION 1.4 No Further Rights. Except as expressly provided in this ARTICLE
I, no further or different license, option, or right is granted or implied.
ARTICLE II
FINANCIAL TERMS
SECTION 2.1 License Fees. Licensee shall pay to RCT a non-refundable,
non-creditable license issue fee of US$[**] upon execution and delivery of this
Agreement. In addition to the foregoing, Licensee shall pay to RCT a
non-refundable, non-creditable milestone fee of $[**] on or before the date
thirty days after the first SALE of a each type of LICENSED PRODUCT. For
purposes of the foregoing, a LICENSED PRODUCT shall be deemed to be a different
"type" of LICENSED PRODUCT if a separate Investigational New Drug Application
("IND") is required to be filed with the U.S. Food and Drug Administration in
accordance with 21 CFR Part 312 to conduct clinical trials for such LICENSED
PRODUCT in the United States.
SECTION 2.2 Earned Royalties.
Subsection 2.2.1. Earned Royalty Amount. Licensee shall pay to RCT an
earned royalty equal to [**]% of the NET SALES VALUE of each LICENSED PRODUCT in
FINAL PRODUCT FORM SOLD, or imported into the LICENSED TERRITORY, by or for
Licensee or its AFFILIATES during the term of this Agreement, including without
limitation each LICENSED PRODUCT in FINAL PRODUCT FORM made or imported during
the term of this Agreement but SOLD after the termination of this Agreement. If
A LICENSED PRODUCT is SOLD in BULK PRODUCT FORM, Licensee shall pay to RCT an
earned royalty equal to [**]% of the NET SALES VALUE of each LICENSED PRODUCT in
BULK PRODUCT FORM SOLD, or imported into the LICENSED TERRITORY, by or for
Licensee or its AFFILIATES during the term of this Agreement, including without
limitation each LICENSED PRODUCT in BULK PRODUCT FORM made or imported during
the term of this Agreement but SOLD after the termination of this Agreement.
Subsection 2.2.2. Taxes. Licensee shall bear all taxes and charges
assessed or imposed by a governmental authority, including withholding taxes
imposed on payments under this Agreement (collectively, "Non-deductible Taxes").
However, Licensee shall have no accountability for any income tax imposed on RCT
by the United States (or other country) or a political or governmental
subdivision thereof, or for any maintenance fees or annuity payments for keeping
any LICENSED PATENT in force. In addition, Licensee may, in determining NET
SALES VALUE, deduct taxes or duties imposed on SALES of LICENSED PRODUCT and
expressly permitted as deductions under this Agreement. All payments hereunder
shall be made undiminished by any Non-deductible Tax. Licensee shall cooperate
with and assist RCT in
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obtaining any exemption from Non-deductible Taxes imposed by any government (or
instrumentality) on royalty payments made by Licensee to RCT. If such an
exemption is not available, the earned royalty rate provided above shall be
increased an amount such that the amount actually remitted to RCT after Licensee
withholds any Non-deductible Taxes is no less than the above percentage of the
NET SALES VALUE of such LICENSED PRODUCTS. If the earned royalty rate is grossed
up in the foregoing manner, Licensee may retain any refund of Non-deductible
Taxes and RCT shall reasonably cooperate with Licensee in obtaining, through
ordinary administrative procedures, such refund without out-of-pocket expense to
RCT.
Subsection 2.2.3. One Royalty. Only one earned royalty will accrue and
be paid on a given unit of LICENSED PRODUCT, even if such LICENSED PRODUCT is
SOLD or transferred between RELATED PARTIES for subsequent USE or RESALE, or if
the manufacture of such LICENSED PRODUCT in one country is covered by the
LICENSED PATENTS and the SALE or importation in another country is covered by
the LICENSED PATENTS.
Subsection 2.2.4. Transactions with Other Licensees. If Licensee or
its AFFILIATE SELLS a LICENSED PRODUCT to a third party which RCT has licensed
under the LICENSED PATENTS, the earned royalty shall be payable under the
third-party license upon the USE, SALE, or importation of such LICENSED PRODUCT
by such third party and not by Licensee under this Agreement. If a third party
which RCT has licensed under the LICENSED PATENTS SELLS LICENSED PRODUCT to
Licensee or its AFFILIATE, the earned royalty shall be payable under this
Agreement upon the USE, SALE, or importation of such LICENSED PRODUCT by
Licensee, and not by such third party.
Subsection 2.2.5. Credit for Third-Party Royalties.
(a) OPTION TO ELECT CREDIT. Anytime after June 30, 2003, License
shall have the option of taking the credit provided in this Subsection
2.2.5 for calendar quarters ending after the date on which Licensee
elects such option. Licensee shall make such election by providing RCT
written notice of its election and concurrently paying to RCT a
non-refundable, non-creditable election fee of $[**]. Along with such
written notice, Licensee shall present evidence reasonably acceptable
to RCT showing that:
(i) the commercialization of LICENSED PRODUCTS by Licensee or its
AFFILIATE is technically or economically viable (as reasonably
determined by Licensee) only if or its AFFILIATE practices an
invention claimed by a valid claim of a BLOCKING PATENT in a country
in the LICENSED TERRITORY. The written notice shall include a copy of
the BLOCKING PATENT; and
(ii) neither Licensee nor its AFFILIATE has any reasonable
alternative to obtaining a license under such BLOCKING PATENT under
which Licensee or its AFFILIATE must pay royalties for the SALE of
LICENSED PRODUCTS in the LICENSED TERRITORY ("Third-Party Royalties");
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Licensee or its AFFILIATE shall be entitled to credit against any earned royalty
payable to RCT for a particular calendar quarter for the SALE of any such
LICENSED PRODUCT [**]% of the Third-Party Royalties actually paid in the same
calendar quarter for the same LICENSED PRODUCT. The Third-Party Royalties paid
for the SALE of LICENSED PRODUCTS in a particular country may only be credited
against royalties payable to RCT for the SALE of LICENSED PRODUCTS in the same
country. In any event, the credit provided by this Subsection 2.2.5 shall not
reduce the earned royalty payable to RCT below [**]% of the NET SALES VALUE of
such LICENSED PRODUCT.
(b) PROCEDURE. On or before the date sixty days after ACT's
receipt of a copy of the patent that Licensee asserts is a BLOCKING
PATENT, RCT shall determine whether such patent is indeed a BLOCKING
PATENT and communicate its conclusion to Licensee. If RCT fails to
timely communicate its conclusion, RCT shall be deemed to have agreed
that such patent constitutes a BLOCKING PATENT. If RCT determines that
such patent is not a BLOCKING PATENT, RCT shall communicate its
analysis supporting its assertion that such patent is not a BLOCKING
PATENT. If RCT and Licensee are unable to agree upon the appropriate
treatment of such patent on or before the date ninety days after RCT
communicates its analysis to Licensee, RCT and Licensee shall submit
the matter to the dispute resolution procedures in accordance with
Subsection 7.4.2 below.
SECTION 2.3 Periodic Reports and Payments.
Subsection 2.3.1. Frequency of Reports. On or before each January 30
occurring before the first SALE of a LICENSED PRODUCT under this Agreement,
Licensee shall deliver to RCT a true and accurate report showing the items
specified in Subsection 2.3.2 below as they pertain to the calendar year just
ended. On or before the first January 30, April 30, July 30 or October 30
immediately following the first SALE of a LICENSED PRODUCT under this Agreement
and on or before each January 30, April 30, July 30 and October 30 thereafter
during the term of this Agreement,, Licensee shall deliver to RCT a true and
complete written report, showing the items specified in Subsection 2.3.2 below
as they pertain to the calendar quarter just ended. A responsible financial
officer of Licensee (or that officer's responsible designee), Licensee's
independent accounting firm, or the head of Licensee's internal audit committee
shall certify in writing that each such report is correct and complete.
Licensee's payment of the earned royalties due in respect of the SALE or
importation of LICENSED PRODUCTS by Licensee and its AFFILIATES in the calendar
quarter covered by the written report shall accompany the report. If no earned
royalties are due, Licensee shall so report. Licensee shall pay all amounts due
to RCT under this Agreement in United States currency collectible at par
(without deduction of exchange, collection or other charges) by wire transfer
to: RESEARCH CORPORATION TECHNOLOGIES, INC., ▇▇▇▇▇ Fargo Bank, NA., Tucson Main
Office, ▇▇▇ ▇. ▇▇▇▇▇ ▇▇▇., ▇.▇. ▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, ABA & Transit No.
▇▇▇▇▇▇▇▇▇, Acct. 4159-527159--RCT CHECKING; or to the account of RCT at such
other bank as RCT may from time to time designate in writing. Licensee shall pay
the cost of any wire transfer fees. If the amount is less than $100,000,
Licensee may elect to pay by company check, instead of wire transfer, at the
address shown in SECTION 7.2. On or before the date ninety days after the end of
the calendar
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quarter in which this Agreement is terminated, Licensee shall provide to RCT a
written report that complies in all respects with this SECTION. Licensee shall
require each AFFILIATE to make appropriate reports to Licensee or RCT to enable
Licensee to comply with this SECTION. Failure to satisfy the foregoing shall be
a material default under this Agreement.
Subsection 2.3.2. Content of Quarterly Reports. Each report delivered
under Subsection 2.3.1 above shall provide the following information as it
pertains to the preceding calendar quarter just ended:
(a) the quantities of LICENSED PRODUCTS billed for any SALE
thereof by Licensee and its AFFILIATES during the previous calendar
quarter in each country in which such billing occurred (separately
stated for each entity and each country);
(b) the United States dollar value of the ▇▇▇▇▇▇▇▇ on such
quantities in (a) above;
(c) the computation of the NET SALES VALUE based on the dollar
value determined in (b) above including a detailed accounting of any
allowed deductions from the invoice amounts to arrive at the NET SALES
VALUE;
(d) the computation of earned royalties based on the NET SALES
VALUE computed under Paragraph (c) above;
(e) the quantities of such LICENSED PRODUCTS transferred between
RELATED PARTIES or USED by RELATED PARTIES; and
(f) the computation of earned royalties thereon.
SECTION 2.4 Books and Records. Licensee shall keep complete and accurate
books and reasonable supporting documentation to determine the accuracy of the
items reported under SECTION 2.3 and Licensee's compliance in other respects
with this Agreement. Licensee shall keep such books and documentation at its
principal place of business for three years following the end of the calendar
year to which they pertain (and access shall not be denied thereafter if
reasonably available). RCT may retain an independent certified public accountant
(the "CPA"), reasonably acceptable to Licensee, to inspect, during reasonable
business hours and not more than once per calendar year, and copy such books and
documentation to verify Licensee's earned royalty statements or Licensee's
compliance in other respects with this Agreement. The CPA will enter into a
confidentiality agreement with Licensee regarding the information obtained in
connection with such inspection, it being understood however that disclosure of
such information to RCT shall be expressly permitted thereunder. RCT shall
provide Licensee with thirty days' written notice before any such inspection is
conducted. If any such inspection discloses an underpayment of earned royalties
of 5% or more of the amount of royalties actually due for any quarterly period,
then Licensee shall promptly pay the reasonable cost of such inspection after
Licensee's receipt of the ▇▇▇▇/invoice for such inspection. Licensee shall
require its AFFILIATES to keep such books and documentation to enable Licensee
to comply with this SECTION. Failure to satisfy the foregoing shall be a
material default under this Agreement.
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SECTION 2.5 Sales Outside The U.S. If Licensee or an AFFILIATE SELL any
LICENSED PRODUCTS for currency other than United States currency, Licensee shall
determine the earned royalty payable for such LICENSED PRODUCT in such currency
and then convert the earned royalty into its equivalent in United States
currency at the New York foreign exchange selling rate for such currency for the
last business day of the calendar quarter for which payment is made, as
published by The Wall Street Journal (Western edition). If such rate is not so
published, the conversion shall be at the selling rate for such currency for the
last business day of the calendar quarter for which payment is made, as
published by a leading New York, New York bank chosen by Licensee and reasonably
acceptable to RCT. If Licensee is late in making any payment, the applicable
exchange rate obtained from the sources described above shall be the greater of
the rate on the date payment was actually made or the rate on the date on which
payment was due.
SECTION 2.6 Late Payment. If Licensee fails to make any payment required
under this Agreement on or before the date ten days after Licensee's receipt of
RCT's written notice of such failure, Licensee shall pay interest on the unpaid
portion of such amount at an annual rate equal to the prime rate, as quoted by
the ▇▇▇▇▇ Fargo Bank, N.A., plus 5%, which shall accrue from the date the
payment not timely made became due until the date such payment is paid in full.
The interest shall be compounded on the last day of each calendar quarter. If
such rate exceeds the rate allowed by applicable law, then the highest rate
allowed by law shall apply. Any payments received shall be applied first to the
satisfaction of any unpaid, accrued interest and then to the satisfaction of any
unpaid principal.
ARTICLE III
[RESERVED]
ARTICLE IV
LICENSED PATENTS
At its sole cost and expense, RCT will endeavor to maintain and prosecute
the LICENSED PATENTS. RCT does not make any representation or warranty
whatsoever with respect to the LICENSED PATENTS. RCT may, in its sole
discretion, abandon any LICENSED PATENT. RCT shall not have any liability nor be
subject to any claim for damages if it abandons any LICENSED PATENT. From time
to time, upon written request from Licensee not more frequently than once per
calendar month, RCT shall apprise Licensee of the status of the prosecution and
maintenance of the LICENSED PATENTS, including any reexamination, reissue, or
extension filings, any interference or opposition proceedings, pertaining
thereto, and any election by RCT to abandon any LICENSED PATENT.
ARTICLE V
INFRINGEMENT
RCT will protect the LICENSED PATENTS from infringement and prosecute
alleged infringers when, in its sole judgment, such action may be necessary,
proper, and justified. Licensee shall fully cooperate with RCT, as RCT may
request, in connection with any such action but at no out-of-pocket expense to
Licensee.
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ARTICLE VI
TERMINATION
SECTION 6.1 Automatic Expiration; Elective Termination. The term of this
Agreement shall expire on the EXPIRATION DATE unless sooner terminated. Licensee
may terminate this Agreement at any time by giving RCT three months' written
notice of Licensee's election to terminate.
SECTION 6.2 Licensee's Breach of Agreement.
Subsection 6.2.1. Breach. Upon any material breach of this Agreement
by Licensee, RCT, in addition to any other remedy available at law or equity,
may elect to terminate this Agreement by giving Licensee written notice of RCT's
election to terminate this Agreement. This Agreement shall terminate upon the
expiration of the period stated in the written notice, as provided in Subsection
6.2.2 below, unless Licensee has cured such breach on or before the expiration
of such period. A material breach of this Agreement includes, without
limitation, any failure to timely pay any amount, in full, when due under this
Agreement.
Subsection 6.2.2. Notice and Cure Period. If the breach is a monetary
breach (i.e., failure to timely pay amounts to RCT required to be paid under
this Agreement), the notice and cure period shall be thirty days. If the breach
is a nonmonetary breach (i.e., not involving the payment to RCT of any amounts
required to be paid under this Agreement), the notice and cure period shall be
sixty days. If the nonmonetary breach is of a type that requires more than sixty
but less than 120 days to cure, the cure period shall be extended to 120 days so
long as Licensee has, throughout the 120 day period, diligently undertaken
substantive and progressive efforts to cure such breach on or before the date
the 120 days expire.
Subsection 6.2.3. Immediate Default. "Financial Default" means any
voluntary or involuntary dissolution, bankruptcy, insolvency of Licensee or
assignment of Licensee's assets for the benefit of creditors. The filing of an
involuntary petition in bankruptcy or an involuntary petition for dissolution
shall only be deemed a Financial Default if the petition is not dismissed with
prejudice on or before the date sixty days after the date it was filed.
"Procedural Default" means a lawsuit filed by Licensee or its AFFILIATE against
RCT seeking a declaratory judgment or determination, as the case may be, that
any of the PATENT CLAIMS is invalid or unenforceable or otherwise not patentable
or reduced in scope. Financial Defaults and Procedural Defaults shall constitute
immediate and material breaches of this Agreement and, upon the occurrence of
either a Financial Default or Procedural Default, this Agreement shall
immediately terminate. Anytime before the occurrence of a Financial Default or
the filing of a bankruptcy petition concerning Licensee, Licensee shall notify
RCT in writing of Licensee's intention to file the petition or of another's
intention to file an involuntary petition in bankruptcy or the impending
Financial Default. Failure to provide such written notice shall be deemed to be
an immediate, pre-petition, incurable, and material breach of this Agreement.
The laws of the country of the patent in question shall govern the
interpretation and enforcement of this Subsection 6.2.3.
SECTION 6.3 Surviving Obligations and Provisions. Licensee's obligations to
pay, and report to RCT on, the SALE of any LICENSED PRODUCT made, or imported
before
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termination of this Agreement or expiration of the pertinent LICENSED PATENTS
(even if such LICENSED PRODUCT is SOLD after the termination of this Agreement
or expiration of the pertinent LICENSED PATENT), shall survive such termination
or expiration. In addition to any provision of this Agreement that expressly
survives the termination of this Agreement or expiration of the LICENSED
PATENTS, the provisions of SECTIONS 2.3 ("Periodic Reports and Payments") and
2.4 ("Books and Records") (to the extent provided therein) and SECTION 6.3 and
ARTICLE VII shall survive the termination of this Agreement.
ARTICLE VII
GENERAL
SECTION 7.1 Integration. This Agreement constitutes the entire agreement
between the parties as to its subject matter. All prior and contemporaneous
negotiations, representations, warranties, agreements, statements, promises, and
understandings are superseded and merged into, extinguished by, and completely
expressed by such documents. No party shall be bound by or charged with any
written or oral agreements, representations, warranties, statements, promises,
or understandings not specifically set forth in such documents.
SECTION 7.2 Addresses and Notices. All notices, demands, requests, reports,
and other communications provided in this Agreement or under applicable law
shall be in writing and shall be deemed to have been made or given: (a) when
delivered, if delivered by hand or sent by facsimile; (b) on the day following
deposit with an overnight courier; or (c) on the date five days following
deposit with the United States Mail, certified or registered:
If to RCT: If to Licensee:
President President
Research Corporation Technologies, Inc. BioVex Ltd.
▇▇▇ ▇. ▇▇▇▇▇▇ ▇▇., ▇▇▇▇▇ ▇▇▇ The Windeyer Institute
Tucson, Arizona USA 85711-3365 ▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
Fax: ▇▇▇-▇▇▇-▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇ ▇▇▇
▇▇▇▇▇▇▇
Fax: ▇▇-▇▇▇▇-▇▇▇ 893
Such addresses may be altered by notice so given. Payments by Licensee to RCT
under this Agreement shall be delivered to RCT at the foregoing address.
SECTION 7.3 Applicable Law. This Agreement and its effect are subject to
and shall be construed and enforced in accordance with the law of the State of
Delaware, U. S. A., without regard to the law of Arizona concerning the
conflicts of laws, except as to any issue which by the law of Arizona depends
upon the validity, scope or enforceability of any PATENT CLAIM, and except as to
the provisions of Subsection 6.3.3 as they apply to any given LICENSED PATENT,
which issue and provisions shall be determined in accordance with the applicable
patent laws of the country of such LICENSED PATENT.
SECTION 7.4 Dispute Resolution.
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Subsection 7.4.1. Venue for Unresolved Differences. The parties shall
make all reasonable efforts to resolve any dispute concerning this Agreement,
its construction, or its actual or alleged breach, by face-to-face negotiations
between senior executives. Except as provided in Subsection 7.4.2 below, should
such negotiation fail to resolve the matter, either party may bring judicial
proceedings to resolve the matter in any state or federal court of competent
jurisdiction sitting in the State of Arizona, Pima County. By executing and
delivering this Agreement, each party, for itself and in respect of its
property, irrevocably consents and submits to the exclusive jurisdiction and
venue of such courts in any such proceeding and otherwise waives any objection
or defense, including any objection or defense based on forum non conveniens or
improper venue, which it may now or hereafter have to the bringing of any such
proceedings in such courts. Each party further agrees that service of process of
notice in any such proceeding shall be effective if in writing and sent in the
manners provided in SECTION 7.2 of this Agreement, or in any other manner
permitted by Arizona law.
Subsection 7.4.2. Arbitration. Any dispute between the parties
concerning the extent to which Licensee is entitled to a credit against earned
royalties due hereunder as provided in Subsection 2.2.5 above shall be resolved
pursuant to this Subsection 7.4.2. If the parties have a dispute over such
matter, the parties shall make all reasonable efforts to resolve such dispute by
face-to-face negotiations between senior executives. Should such negotiation
fail to resolve the matter, the parties shall pursue mediation in accordance
with the Center for Public Resources' Model Procedure for Mediation of Business
Disputes. Should such mediation fail to resolve the matter, the matter shall be
finally decided by binding arbitration (the "Arbitration") by and in accordance
with the Rules then in effect of the American Arbitration Association ("AAA"),
and judgment upon the award rendered may be entered in the highest court of the
forum, state or federal, having jurisdiction. The Arbitration will be conducted
in the New York, New York metropolitan area. In the Arbitration, the arbitrator
shall be a mutually acceptable independent expert in the area of the dispute. If
the parties are unable to agree on an arbitrator, the arbitrator shall be an
independent expert as described in the previous sentence selected by the chief
executive of the New York, New York office of the AAA. The parties and
arbitrator shall use their reasonable best effort to complete the Arbitration on
or before the date thirty days following the appointment of the arbitrator. The
parties shall bear equally the costs of the Arbitration and each party shall
bear its own expenses in connection with the Arbitration. Nothing in this
Subsection 7.4.2 shall be construed to waive any of either party's rights or
timely performance of any of either party's obligations existing under this
Agreement.
SECTION 7.5 Compliance With Law; Severability. Nothing in this Agreement
shall be construed to require the commission of any act contrary to law. If this
Agreement conflicts with any statute, law, ordinance, or treaty concerning the
legal right of the parties to contract, the latter shall prevail. In such event,
the affected provisions of this Agreement shall be curtailed and limited only to
the extent necessary to bring it within the applicable legal requirements and
the validity, legality, and enforceability of the remaining provisions of this
Agreement shall not in any way be affected or impaired thereby.
SECTION 7.6 Representations. Each party represents and warrants to the
other that this Agreement constitutes a valid and binding agreement of the
representing and warranting party, that execution, delivery and performance of
this Agreement by the representing and warranting
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party are within such party's corporate power, have been duly authorized by all
necessary corporate action, and that it shall exercise its good faith in
performing under this Agreement. RCT represents and warrants that it has the
right to grant licenses under the LICENSED PATENTS. Nothing contained in this
Agreement shall be construed as a representation or warranty by RCT: (a) that
the LICENSED PATENTS or any PATENT CLAIM can be or will be used to prevent the
importation, sale or use by a third party of a product in any country of the
LICENSED PATENTS where such product is placed in commerce under circumstances
which applicable laws or treaties preclude the use of the LICENSED PATENTS or
any PATENT CLAIM to prevent such importation, sale, or use; (b) as to the scope
or validity of any LICENSED PATENT or any PATENT CLAIM; or (c) that any
performance or practice under any LICENSED PATENT or any PATENT CLAIM is not an
infringement of any patent of others.
SECTION 7.7 Independent Contractor. In its performance under this
Agreement, each party shall be an independent contractor and neither party (nor
its employee or agent) shall be an agent or partner of the other party.
SECTION 7.8 Headings. The headings of the various ARTICLES, SECTIONS and
Subsections of this Agreement are used solely for the convenience of the
parties, do not form a part of this Agreement, do not affect the interpretation
or meaning of this Agreement, and do not define, limit, extend, or describe its
scope or intent.
SECTION 7.9 No Third-Party Beneficiaries. Except for SECTIONS 7.14, 7.15,
and 7.19, which shall also be for the benefit of, and enforceable by, the
INSTITUTION and the INVENTORS, none of the provisions of this Agreement shall be
for the benefit of, or enforceable by, any third party. The agreements herein
contained are made for the sole benefit of the parties hereto and no other
person or entity is intended to or shall have any rights or benefits hereunder,
whether as a third party beneficiary or otherwise.
SECTION 7.10 Waiver. A party's express or implied consent or waiver of the
other party's breach of its obligations hereunder shall not be deemed to be, or
construed as, a consent to, or waiver of, any other breach of the other party. A
party's failure, no matter how long, to: (a) complain of any act, or failure to
act, by the other party; (b) declare the other party in default; (c) insist upon
the strict performance of any obligation or condition of this Agreement; or (d)
exercise any right or remedy consequent upon a breach thereof; shall not
constitute a waiver by such party of its rights, such breach, or any other
obligation or condition. A party's consent in any one instance shall not limit
or waive the necessity to obtain such party's consent in any future instance. No
single or partial exercise of any right, power or privilege by a party hereunder
shall preclude any other or further exercise thereof or the exercise of any
other right, power or privilege by such party. In any event, no consent or
waiver shall be effective for any purpose hereunder unless such consent or
waiver is in writing and signed by the party granting such consent or waiver.
SECTION 7.11 Computation of Time. In computing any period of time pursuant
to this Agreement, the day or date of the act, notice, event, or default from
which the designated period of time begins to run will not be included. The last
day of the period so computed will be
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included, unless it is a Saturday, Sunday, or federal holiday in which event the
period runs until the end of the next day which is not a Saturday, Sunday, or
federal holiday.
SECTION 7.12 Registration of Agreement. Licensee agrees to take all
reasonable and necessary steps to register this Agreement in any country of the
LICENSED PATENTS where such is required to permit the transfer of funds and/or
payment of royalties to RCT hereunder or is otherwise required by the government
or law of such country to effectuate or carry out this Agreement. Licensee shall
not be relieved of any obligations under this Agreement because it failed to
register this Agreement in any country of the LICENSED PATENTS.
SECTION 7.13 Disclaimer. It shall be the full and sole responsibility of
Licensee and its AFFILIATES to use appropriate care in the practice, manufacture
or use of any product under any license granted under this Agreement. None of
RCT, the INSTITUTION, or any INVENTOR: (a) shall have the right to control the
manner in which any product licensed under this Agreement is made or practiced;
(b) shall be required to provide any know-how or operating instructions or other
information with respect to any such product; and (c) makes any representation
or warranty whatsoever with respect to any such product.
SECTION 7.14 Indemnity. LICENSEE AGREES TO INDEMNIFY, DEFEND AND HOLD
HARMLESS RCT, THE INVENTORS, THE INSTITUTION, AND ALL OFFICERS, DIRECTORS,
EMPLOYEES, AND AGENTS OF RCT AND INSTITUTION (COLLECTIVELY, THE "INDEMNITEES")
FROM AND AGAINST ANY AND ALL CLAIMS, DAMAGES AND LIABILITIES, INCLUDING LEGAL
COSTS AND FEES, OF OR ASSERTED BY LICENSEE, ITS AFFILIATES, ANY RELATED PARTIES,
AND/OR ANY THIRD PARTIES (WHETHER GOVERNMENTAL OR PRIVATE) ARISING FROM THE
MANUFACTURE, USE, SALE, OR IMPORTATION OF ANY LICENSED PRODUCT BY OR FOR
LICENSEE OR ITS AFFILIATES, OR ARISING FROM THE USE OF ANY SUCH LICENSED PRODUCT
BY ANY THIRD PARTY INCLUDING ANY CONSUMER OR ANY CUSTOMER OF LICENSEE OR ITS
AFFILIATES. IN NO EVENT SHALL AN INDEMNITEE BE LIABLE UNDER THIS AGREEMENT FOR
ANY DIRECT (OTHER THAN FOR AMOUNTS PAID UNDER THIS AGREEMENT), INDIRECT,
SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING BUT NOT LIMITED TO LOST
REVENUE, LOST PROFITS, OR LOST SAVINGS), EVEN IF AN INDEMNITEE HAS NOTICE OF THE
POSSIBILITY OF SUCH DAMAGES. THE FOREGOING INDEMNITY SHALL NOT BE AVAILABLE TO
ANY INDEMNITEE TO THE EXTENT ANY CLAIM, DAMAGE, OR LIABILITY ARISES SOLELY FROM
GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF SUCH INDEMNITEE IN THE MANUFACTURE,
USE, SALE, OR IMPORTATION OF SUCH LICENSED PRODUCT, ALTHOUGH ANY INDEMNITEE NOT
GUILTY OF SUCH ACTS SHALL NOT BE SUBJECT TO THIS LIMITATION AND SHALL CONTINUE
TO BENEFIT FROM SUCH INDEMNITY. IF AN INDEMNITEE INTENDS TO CLAIM
INDEMNIFICATION UNDER THIS SECTION, SUCH INDEMNITEE SHALL: (A) PROMPTLY PROVIDE
LICENSEE WRITTEN NOTIFICATION OF ANY CLAIM, ACTION, SUIT OR PROCEEDING FOR WHICH
THE INDEMNITEE INTENDS TO CLAIM SUCH INDEMNIFICATION; (B) GIVE LICENSEE SOLE
CONTROL OF THE DEFENSE AND/OR SETTLEMENT THEREOF; AND (C) PROVIDE LICENSEE, AT
LICENSEE'S EXPENSE, WITH REASONABLE ASSISTANCE AND ALL PERTINENT INFORMATION IN
SUCH
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INDEMNITEE'S POSSESSION CONCERNING SUCH MATTER. NOTWITHSTANDING THE FOREGOING,
LICENSEE SHALL HAVE NO OBLIGATIONS FOR ANY CLAIM, ACTION, SUIT, OR PROCEEDING IF
THE INDEMNITEE SEEKING INDEMNIFICATION MAKES ANY MATERIAL ADMISSION IN WRITING
OR ANY SETTLEMENT REGARDING SAME WITHOUT THE LICENSEE'S PRIOR WRITTEN CONSENT
WHICH SHALL NOT BE UNREASONABLY WITHHELD OR DELAYED.
SECTION 7.15 Insurance. On or before the date on which Licensee first
commences an experiments or trials involving human subjects and concerning a
LICENSED PRODUCT, Licensee shall obtain and, thereafter throughout the term of
this Agreement, and for a period of 10 years after termination of this
Agreement, maintain in force products liability insurance and other insurance
coverages typically carried by entities engaged in Licensee's business in
amounts not less than L1,000,000 per accident or occurrence to the extent such
insurance and other coverages are commercially available on reasonable terms.
Such insurance policies shall name the Indemnitees as additional insureds as
respects this Agreement. Such policies shall provide or be endorsed to provide
that such insurance is primary and any other insurance carried by any of the
Indemnitees shall be excess and not contributing with the insurance required
hereunder. The policies shall contain Cross Liability and/or Severability of
Interests provisions so as to not impair the right of one insured against
another insured. The insurance policies shall provide or be endorsed to provide
that written notice by registered mail shall be given to the Indemnitees at
least thirty days before termination, cancellation, or reduction of coverage.
The insurance policies required to be carried by Licensee under this Agreement
shall be with companies that are reasonably acceptable to, and approved by, RCT.
Licensee shall furnish RCT and the INSTITUTION with a certificates of insurance
evidencing coverage and, when requested, a copy of such policy. The requirements
of this SECTION 7.15 shall survive termination of this Agreement.
SECTION 7.16 Construction. The parties agree that each party has reviewed
this Agreement and that any rule of construction to the effect that ambiguities
are to be resolved against the drafting party shall not apply to the
interpretation of this Agreement.
SECTION 7.17 Patent Marking. When practicable, Licensee shall ▇▇▇▇ all
LICENSED PRODUCTS with a legible notice indicating that the LICENSED PRODUCTS
are covered by claims in a pending patent application or an issued LICENSED
PATENT, as the case may be. Licensee further covenants and agrees that it shall
place on the packaging of each LICENSED PRODUCT (or the package insert
accompanying such LICENSED PRODUCT) a legible notice indicating that the
LICENSED PRODUCTS are licensed, suitable, and intended only for use in humans
for in vivo therapeutic purposes.
SECTION 7.18 Assignment. This Agreement, and the license, rights, and
duties contained in this Agreement, shall not be assigned by Licensee without
the prior written consent of RCT, which consent shall not be unreasonably
withheld or delayed. RCT's consent shall not be required if this Agreement is
assigned to an AFFILIATE or as part of a sale or transfer pursuant to other bona
fide business arrangements (e.g., merger or otherwise) of all or substantially
all of Licensee's business. Licensee shall give RCT prior written notice of such
assignment and obtain Licensee's assignee's agreement to abide by the terms of
this Agreement
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and assume all of Licensee's obligations under this Agreement. Upon assignment,
the term "Licensee" as used in this Agreement shall thereafter mean the assignee
of Licensee. If Licensee should sell or otherwise transfer the portion of its
business pertaining to the production of a particular LICENSED PRODUCT(S) or to
all LICENSED PRODUCTS and does not, as part of such sale or transfer, also
assign this Agreement to the purchaser or transferee, RCT shall, promptly after
receipt from Licensee of its written request therefor, offer to such purchaser
or transferee a non-exclusive license to practice under the LICENSED PATENTS in
the LICENSED TERRITORY at the terms then offered by RCT to commercial entities.
SECTION 7.19 Non-Use of Names. Licensee shall not use the name of any
INVENTOR, the INSTITUTION, RCT, or any adaptation of any of them, in any
advertising, promotional or sales literature, without prior written consent
obtained from the INVENTOR, the INSTITUTION, or RCT, as applicable. Licensee
shall require its AFFILIATES to comply with the foregoing.
ARTICLE VIII
DEFINITIONS
When fully capitalized in this Agreement, the following terms shall have
the meanings set forth below:
SECTION 8.1 "AFFILIATE" means any entity which directly or indirectly
controls, is controlled by, or is under common control with, a party to this
Agreement. "Control" shall constitute the right to cast, or the right to direct
the casting of, at least fifty percent (50%) of the votes at a meeting of such
owners, or at a meeting of the entity's directors or governing body, or the
right to designate a majority of the entity's directors or members of the
entity's governing body, or the power to direct or cause the direction of the
management or policies of an entity, whether through the ownership of voting
securities, by contract, or otherwise. In addition to, and without limiting the
generality of, the foregoing, the parties agree that a Collaboration Partner of
Licensee shall be deemed to be an AFFILIATE of Licensee for purposes of this
Agreement. As used herein, "Collaboration Partner" means any third party that is
a party with Licensee to a collaboration and/or other development and/or license
agreement pursuant to which such third party has any right or obligation to
conduct research and/or development related to a LICENSED PRODUCT and/or to
market and/or distribute a LICENSED PRODUCT. If such agreement is terminated,
such third party shall no longer be a Collaboration Partner unless and until
such third party and Licensee enter into a new collaboration and/or other
development and/or license agreement pursuant to which such third party has such
right(s).
SECTION 8.2 "BLOCKING PATENT" means a patent that: (a) is not owned by RCT,
Licensee, or an AFFILIATE of Licensee; and (b) is not licensed to Licensee under
this Agreement but covers an essential component or element of such LICENSED
PRODUCT such that such LICENSED PRODUCT would not be technically or commercially
viable (as the parties may reasonably determine) without such component or
element.
SECTION 8.3 "BULK PRODUCT FORM" means a LICENSED PRODUCT in a form other
than FINAL PRODUCT FORM.
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SECTION 8.4 "COMBINATION PRODUCT" means a LICENSED PRODUCT comprising: (a)
one or more products or vaccines ("Approved Licensed Products") each of which
have been subject to a separate Biologics License Application (or foreign
equivalent) before the FDA or a corresponding foreign regulatory authority that
if made, USED, SOLD, offered for SALE or imported alone would infringe, but for
this Agreement, a PATENT CLAIM; and (b) one or more products or vaccines
("Unapproved Licensed Products") each of which have been subject to a separate
Biologics License Application (or foreign equivalent) before the FDA or a
corresponding foreign regulatory authority that if made, USED, SOLD, offered for
SALE or imported alone would not infringe a PATENT CLAIM. An example of a
Approved Licensed Product is a vaccine containing a GENE or a vaccine containing
a vector containing a GENE.
SECTION 8.5 "EXPIRATION DATE" means the date on which the LICENSED PATENT
that has the latest expiration date expires, after accounting for any extensions
of any LICENSED PATENTS. A patent shall be understood to expire at midnight of
the date of its expiration. References herein to the "term of this Agreement
shall refer to the period commencing as of the Effective Date and ending as of
the EXPIRATION DATE.
SECTION 8.6 "FINAL PRODUCT FORM" means a LICENSED PRODUCT in a form
intended or suitable for final use in the final consumer by the administering
physician or health professional.
SECTION 8.7 "GENE" means a DNA encoding a mammalian granulocyte macrophage
colony stimulating factor which DNA would, if made, USED, SOLD, offered for
SALE, or imported into the LICENSED TERRITORY, in the absence of this Agreement,
directly infringe, contributorily infringe, or induce the infringement of a
PATENT CLAIM.
SECTION 8.8 "INSTITUTION" means the ▇▇▇▇▇▇ Institute for Cancer Research.
SECTION 8.9 "INVENTOR" means a person identified as such on a LICENSED
PATENT.
SECTION 8.10 "LICENSED PATENTS" means:
(a) United States Patent No. 5,602,007 issued February 11, 1997,
Canadian Application No. 495,255 filed November 13, 1985; Japanese
Application 501426/85 filed March 19, 1985, Japanese Application
8-095743 filed April 17, ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ Patent 594014 issued June
18, 1990, and Australian Patent 629938 issued February 5, 1993;
(b) any divisional or continuation, in whole or in part,
application based on any of the foregoing;
(c) any and all issued and unexpired patents resulting from any
of the applications described in Paragraph (a) or (b) above; and
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(d) any and all issued and unexpired reissues, reexaminations,
renewals or extensions that may be based on any of the patents
described in Paragraphs (a) or (c) above.
The parties acknowledge and agree that the LICENSED PATENTS do not include any
patents or patent applications assigned to RCT issued or pending in countries in
the European continent (the "European Patent Rights"). The right to practice
under the European Patent Rights is exclusive to a third party to which RCT has
granted a license to practice thereunder.
SECTION 8.11 "LICENSED PRODUCT" means a GENE, GENE construct, or cell
containing a GENE or GENE construct: (a) suitable and intended for use in humans
for in vivo therapeutic purposes; (b) labeled and SOLD for use in humans for in
vivo therapeutic purposes; and (c) not intended for use in the in vivo
production of protein in any non-human animal, or the production of a PROTEIN
PRODUCT. If a LICENSED PRODUCT is SOLD in a form other than a dosage form
suitable for final use by the administering physician or the consumer, the gross
▇▇▇▇▇▇▇▇ shall be determined by multiplying the number of doses in final dosage
form that such LICENSED PRODUCT would provide or be converted into by the
average price in the same calendar quarter for a single dose in final dosage
form of a LICENSED PRODUCT
SECTION 8.12 "LICENSED TERRITORY" means Australia, Canada, Japan, and the
United States of America and their respective territories and possessions.
SECTION 8.13 "NET SALES VALUE" of any product means the gross ▇▇▇▇▇▇▇▇ for
the SALE of a LICENSED PRODUCT less the deductions identified below.
Subsection 8.13.1. Determining Gross ▇▇▇▇▇▇▇▇. Except in the case of
COMBINATION PRODUCTS, the gross ▇▇▇▇▇▇▇▇ used for calculating NET SALES VALUE of
any LICENSED PRODUCT shall be determined as follows:
(a) If Licensee or its AFFILIATE SELLS the LICENSED PRODUCT:
1. To a third party that is not a RELATED PARTY, gross
▇▇▇▇▇▇▇▇ shall be Licensee's or its AFFILIATE's actual gross
▇▇▇▇▇▇▇▇, as the case may be;
2. To a RELATED PARTY for subsequent SALE by such RELATED
PARTY, gross ▇▇▇▇▇▇▇▇ shall be such RELATED PARTY's actual gross
▇▇▇▇▇▇▇▇ for such subsequent SALE.;
3. To a RELATED PARTY for USE by such RELATED PARTY, gross
▇▇▇▇▇▇▇▇ shall be the gross ▇▇▇▇▇▇▇▇ that would result from a
hypothetical arm's length SALE to a third party (that is not a
RELATED PARTY) by Licensee or its AFFILIATE, as the case may be;
(b) If Licensee or its AFFILIATE USES the LICENSED PRODUCT, gross
▇▇▇▇▇▇▇▇ shall be the gross ▇▇▇▇▇▇▇▇ that would result from a
hypothetical arm's length SALE to a third party (that is not a RELATED
PARTY) by Licensee
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or its AFFILIATE, as the case may be. However, the ▇▇▇▇▇▇▇▇ for any
LICENSED PRODUCT:
1. (i) used only for, and produced only in, internal
scale-up studies or manufacturing testing or validation conducted
by or on behalf of Licensee or a RELATED PARTY, or in quality
assurance efforts or internal research conducted by or on behalf
of Licensee or a RELATED PARTY; or (ii) distributed, free of
charge, or at fully-allocated manufacturing costs only, but with
no profit to Licensee or any RELATED PARTY, in the course of
pre-clinical or clinical trials conducted in furtherance of
registration requirements imposed by a regulatory or governmental
authority, such as the U.S. Food and Drug Administration or
similar competent regulatory authority in any country, to obtain
approval to market such LICENSED PRODUCT; or
2. distributed, free of charge, to the drug trade as a
therapeutic product as part of Licensee's promotional effort
(such as samples), compassionate use or any indigent patient
program;
shall be zero dollars. The foregoing sentence shall be narrowly construed
and interpreted.
Subsection 8.13.2. Determining Actual ▇▇▇▇▇▇▇▇ -- COMBINATION
PRODUCTS. The ▇▇▇▇▇▇▇▇ used for calculating NET SALES VALUE of any LICENSED
PRODUCT that is a COMBINATION PRODUCT shall be determined as follows:
(a) calculate a fraction, the numerator of which is the number of
Approved Licensed Products in such COMBINATION PRODUCT and the
denominator of which is the sum of the number of Approved Licensed
Products and the number of Unapproved Licensed Products in such
COMBINATION PRODUCT. Such fraction, however, shall in no event be less
than one-third; then
(b) multiply the actual ▇▇▇▇▇▇▇▇ by Licensee or its AFFILIATE for
such COMBINATION PRODUCT (determined in accordance with Subsection
8.13.1 above) by the foregoing-fraction.
In determining the NET SALES VALUE of any COMBINATION PRODUCTS, before
applying any deduction permitted under Subsection 8.13.3 to the amount received
as determined hereunder, such deduction shall likewise be multiplied by the
fraction determined in (a) above.
Subsection 8.13.3. Allowable Deductions. When factually applicable,
the following deductions may be deducted from actual ▇▇▇▇▇▇▇▇ as determined
above:
(a) rebates, volume, quantity, trade or cash discounts, allowed
and taken, in amounts customary in the trade;
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(b) sales taxes, use taxes, value added tax, and/or duties
imposed upon, and with specific reference to, particular SALES to the
extent included in the amount of actual ▇▇▇▇▇▇▇▇;
(c) amounts allowed or credited on returns, rejections or
recalls, voluntary or otherwise (not exceeding the original billing);
and
(d) charges for freight, packaging, handling, and freight
allowances, and outbound transportation costs prepaid to the extent
included in such actual ▇▇▇▇▇▇▇▇.
No other allowance or deduction shall be made including without limitation
allowances or deductions for any commissions or sales fees by whatever name
known.
SECTION 8.14 "PATENT CLAIM" means a valid claim in an unexpired LICENSED
PATENT. A PATENT CLAIM shall be presumed to be valid unless and until it has
been held to be invalid by a final judgment of a court of competent jurisdiction
from which no appeal can be or is taken. For the purposes of this Agreement, and
especially for purposes of royalty determination and payment under ARTICLE II
("Financial Terms"), any claim being presented in a pending patent application
shall be deemed to be the equivalent of a valid claim of an issued, unexpired
patent and in consideration of RCT's agreement to grant a license under any
patent issuing thereon earned royalties shall be payable in respect thereto as
though it were a valid patent claim.
SECTION 8.15 "PROTEIN PRODUCT" means any isolated, recombinant protein,
suitable or intended for subsequent use or sale, comprising a mammalian
granulocyte macrophage colony stimulating factor or analog or homolog thereof
that would directly infringe, contributorily infringe, or induce the
infringement of a PATENT CLAIM. For purposes of clarity, it is understood that a
cancer vaccine in which a cell is transfected or infected with a GENE or GENE
construct for use in the in vivo production of a protein in any human is not a
PROTEIN PRODUCT.
SECTION 8.16 "RELATED PARTY" means any one of Licensee, AFFILIATES of
Licensee, or any third party that is not an AFFILIATE of Licensee to which: (a)
Licensee or its AFFILIATE has granted the right to distribute a LICENSED PRODUCT
and such third party either is responsible for the marketing and promotion of
such LICENSED PRODUCT or shares with Licensee or its AFFILIATE the proceeds from
such third party's SALES of LICENSED PRODUCT; (b) Licensee has granted
co-marketing rights wherein the third party may SELL LICENSED PRODUCTS,; or (c)
Licensee is under an obligation to a third party to supply or manufacture
LICENSED PRODUCTS for SALE by the third party under such third party's name or
▇▇▇▇. A distributor of LICENSED PRODUCTS under Licensee's name or ▇▇▇▇ shall not
be considered a RELATED PARTY if neither Licensee nor its AFFILIATE shares,
directly or indirectly, in the proceeds from such distributor's SALES of such
LICENSED PRODUCT.
SECTION 8.17 "SELL" (and any cognate noun form and conjugated verb form
thereof) means to sell, or otherwise part with or dispose of, for value.
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SECTION 8.18 "USE" (and any cognate noun form and conjugated verb form
thereof) shall mean to use for commercial purposes.
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IN WITNESS WHEREOF, the parties hereto have each caused a duly authorized
officer to sign this Agreement to be effective the Effective Date.
BioVex Ltd. Research Corporation Technologies, Inc.
By: /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇ By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇
--------------------------------- ------------------------------------
Director President
Date: 10/7/01 Date: May 31, 2001
19
FIRST AMENDMENT TO LICENSE AGREEMENT
Effective January 1, 2003 (the "Amendment Effective Date"), Research
Corporation Technologies, Inc., a Delaware nonprofit corporation with offices at
▇▇▇ ▇. ▇▇▇▇▇▇ ▇▇., ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇ ("RCT"), and BioVex
Ltd., an entity organized under the laws of the United Kingdom, with offices at
the Windeyer Institute, ▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇
("Licensee") agree as follows:
ARTICLE I
BACKGROUND
RCT and Licensee are parties to a certain license agreement made effective
May 31, 2001 (the "License Agreement") under which RCT granted to Licensee a
non-exclusive license under certain LICENSED PATENTS, as defined in the License
Agreement. RCT and Licensee desire to amend the License Agreement as set forth
below.
ARTICLE II
AMENDMENT
SECTION 2.1 Amendment to SECTION 2.1 of the License Agreement. SECTION 2.1
of the License Agreement is hereby changed by deleting it in its entirety and
replacing it with the following:
SECTION 2.1. License Fees.
Subsection 2.1.1. License Issue Fee. On or before the date thirty days
after the execution and delivery of this Agreement, Licensee must pay to RCT a
non-refundable, non-creditable license issue fee of US$[**]. RCT acknowledges
receipt of US$[**] in satisfaction of the foregoing obligation of Licensee.
Subsection 2.1.2. License Maintenance Fee. Licensee must pay to RCT a
non-refundable, non-creditable, pre-paid annual license maintenance fee of
$[**]. Licensee must pay the first maintenance fee on or before January 30,
2003, and must pay subsequent maintenance fees on or before January 30 of each
year thereafter during the term of this Agreement through and including the
January 30 immediately preceding the first SALE of a LICENSED PRODUCT under this
Agreement.
Subsection 2.1.3. Milestone Fees. In addition to the foregoing,
Licensee shall pay to RCT a non-refundable, non-creditable milestone fee of
$[**] on or before the date thirty days after the first SALE of a each type of
LICENSED PRODUCT. For purposes of the foregoing, a LICENSED PRODUCT shall be
deemed to be a different "type" of LICENSED PRODUCT if a separate
Investigational New Drug Application ("IND") is required to be filed with the
U.S. Food and Drug Administration in accordance with 21 CFR Part 312 to conduct
clinical trials for such LICENSED PRODUCT in the United States.
SECTION 2.2 Amendment to SECTION 2.2 of the License Agreement. SECTION 2.2
of the License Agreement is hereby amended by: (a) changing the reference to
"[**]%"
05/22/03
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appearing in the second line of Subsection 2.2.1 to read "[**]%"; (b) by
changing the reference to "[**]%" appearing in the sixth line of Subsection
2.2.1 to read "[**]%"; and (c) by deleting Subsection 2.2.5 in its entirety.
SECTION 2.3 Continued Effect. The License Agreement shall continue in force
and effect unchanged, except as specifically set forth in this document.
IN WITNESS WHEREOF, the parties have each caused a duly authorized officer
to sign this Agreement on the date(s) indicated below, to be effective the
Amendment Effective Date.
BioVex, Ltd. Research Corporation Technologies, Inc.
By: /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇-▇▇▇▇▇▇ By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇
--------------------------------- ------------------------------------
Title: CFO Title: President
Date: 24/1/2003 Date: January 23, 2003
2