Exhibit 10.3.2.1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
LICENSE AGREEMENT
Effective May 31, 2001, (the "Effective Date"), Research Corporation
Technologies, Inc., a Delaware nonprofit corporation, with offices at 000 X.
Xxxxxx Xxxx, Xxxxx 000, Xxxxxx, XX XXX 00000-0000 ("RCT"), and BioVex Ltd., a
corporation organized under the laws of the United Kingdom, with offices at The
Windeyer Institute, 00 Xxxxxxxxx Xx., Xxxxxx X0X 0XX, Xxxxxxx ("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 a nonexclusive
license under the LICENSED PATENTS in the LICENSED FIELD to make and have made
LICENSED PRODUCTS, to USE LICENSED PRODUCTS, to SELL LICENSED PRODUCTS, to offer
to SELL LICENSED PRODUCTS, and to import LICENSED PRODUCTS, free from suit by
RCT for infringement of the PATENT CLAIMS in the LICENSED FIELD in all countries
of the world in which RCT has LICENSED PATENTS. Licensee covenants and agrees
that its activities under this Agreement shall be limited to activities in the
LICENSED FIELD above. Any right granted above to SELL or offer to SELL is
restricted in that Licensee may only SELL or offer to SELL LICENSED PRODUCTS to
health care professionals, those distributing to health care professionals, and
health maintenance organizations that intend and agree to use such LICENSED
PRODUCT in the LICENSED FIELD. Licensee covenants that its activities under this
Agreement shall be so limited. No license or rights are granted or implied under
any patent application or patent not a LICENSED PATENT. Except as provided in
SECTION 1.2, Licensee shall have neither the right nor the power to grant any
sublicenses. Licensee shall have no right or license to make, USE, SELL, offer
to SELL, or import any CLAIMED DNA or CLAIMED CELL intended or suitable for the
ex vivo production of proteins or polypeptides (which, for the avoidance of
doubt, does not include ex vivo gene therapy), or for use in transgenic animals.
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. 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 Subsection 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, offer for SALE, USE (including R&D USES) or
importation of LICENSED PRODUCTS by Licensee's AFFILIATES shall be considered
the manufacture, SALE, offer for SALE, USE, or importation of such LICENSED
PRODUCT by Licensee.
May 31, 2001
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Subsection 1.2.3. Reports and Payments. 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 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: (a) at the same earned royalty rate and the annual minimum
royalty payment amounts provided in this Agreement; and (b) as to other
financial terms, 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 or right is granted or implied.
ARTICLE II
FINANCIAL TERMS
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 shall pay to RCT a
non-refundable, non-creditable license issue fee of US$[**].
Subsection 2.1.2. License Maintenance Fee. Licensee shall pay to RCT a
non-refundable, non-creditable annual license maintenance fee. In recognition of
the date on which this Agreement is signed, the first annual maintenance fee
shall be US$[**] due on or before March 30, 2002. Subsequent annual maintenance
fees shall be US$[**] and shall be paid on or before every January 30 occurring
after the year 2002 during the term of this Agreement and before the January 30
on which the annual minimum royalty payments under SECTION 2.3 are first made.
SECTION 2.2. Earned Royalties.
Subsection 2.2.1. Accrual, Amount, and Payment. Licensee shall pay to
RCT earned royalties of [**]% of the NET SALES VALUE of each LICENSED PRODUCT
USED or SOLD by or for Licensee or its AFFILIATES during the term of this
Agreement. Licensee shall also pay to RCT earned royalties of [**]% of the NET
SALES VALUE of each LICENSED PRODUCT made or imported by or for Licensee or its
AFFILIATES during the term of this Agreement but USED or SOLD after the term of
this Agreement.
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Subsection 2.2.2. One Royalty. Only one earned royalty will accrue and
be paid on a given 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 USE, SALE, or importation in another country is covered by the
LICENSED PATENTS.
Subsection 2.2.3. Transactions with Other Licensees. If Licensee SELLS
a LICENSED PRODUCT to a third party under circumstances where such third party
will RESELL such LICENSED PRODUCT and where such third party has a license under
the LICENSED PATENTS to make, USE, SELL, offer to SELL, or import LICENSED
PRODUCTS (a "third-party licensee"), the earned royalty on such SALE shall
accrue and be paid with respect to such third-party licensee's RESALE of such
LICENSED PRODUCT under such third-party licensee's license. If Licensee
purchases a LICENSED PRODUCT from a third-party licensee for RESALE by Licensee,
the earned royalty on such SALE shall accrue and be paid with respect to
Licensee's RESALE of such LICENSED PRODUCT under this Agreement.
Subsection 2.2.4. 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 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.
SECTION 2.3. Annual Minimum Royalties.
Subsection 2.3.1. Amount and Payment Date. Licensee shall pay to RCT a
prepaid, non-refundable annual minimum royalty of $[**]. The first annual
minimum royalty payment is due on or before the January 30 immediately following
the date of first SALE of a LICENSED PRODUCT. Subsequent annual minimum royalty
payments shall be payable on each successive January 30 on which this Agreement
is in effect. Licensee's payment of the annual minimum royalty for each calendar
year shall accompany Licensee's report to RCT for the last quarter of the
immediately preceding calendar year.
Subsection 2.3.2. Credits. Licensee may credit the annual minimum
royalty payment actually made in a given calendar year only against the amount
of the earned royalties
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payable by Licensee to RCT for Licensee's activities in the same calendar year.
Licensee may not credit any earned royalties paid for any calendar year that
exceed the annual minimum royalties paid in that calendar year against any
annual minimum royalty payment due in any other calendar year.
SECTION 2.4. Periodic Reports and Payments.
Subsection 2.4.1. 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 2.4.3 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 2.4.3 below as
they pertain to the calendar quarter just ended. Licensee's payment of the
earned royalties based on Licensee's or its AFFILIATES' activities 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., Xxxxx Fargo Bank, N.A.,
Tucson Main Office, 000 X. Xxxxx Xxx., X.X. Xxx 0000, Xxxxxx, XX 00000, ABA &
Transit No. 000000000, 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 90 days after the end
of the calendar quarter in which this Agreement is terminated, Licensee shall
provide to RCT a written report that complies in all respects with this SECTION
2.4. Licensee shall require each AFFILIATE to which this Agreement is extended
under SECTION 1.3 to make appropriate reports to Licensee to enable Licensee to
comply with this SECTION 2.4.
Subsection 2.4.2. Certification. 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.
Subsection 2.4.3. Content of Quarterly Reports. Each report shall
provide the following information as its pertains to the preceding calendar
quarter just ended:
(a) the quantities of LICENSED PRODUCTS billed by Licensee or its
AFFILIATES during the previous calendar quarter in each country in
which such billing occurred (separately stated for each entity and
each country); and
(b) the United States dollar value of the xxxxxxxx on such
quantities in (a) above;
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(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) a detailed accounting of any credits against earned royalties
permitted under SECTION 2.3.
SECTION 2.5. Books and Records. Licensee shall keep complete and accurate
books and reasonable supporting documentation to determine the accuracy of the
items reported under SECTION 2.4 and Licensee's compliance in other respects
with this Agreement. Licensee shall keep such books and documentation at its
principal place of business for five 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, reasonably acceptable to Licensee, to inspect, during reasonable
business hours, and copy such books and documentation to verify Licensee's
earned royalty statements or Licensee's compliance in other respects with this
Agreement. RCT shall provide Licensee with 30 days' written notice before any
such inspection is conducted. RCT shall not undertake such inspection more than
once per calendar year. 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 xxxx/invoice for such inspection.
Licensee shall require its AFFILIATES to keep such books and documentation to
enable Licensee to comply with this SECTION 2.5.
SECTION 2.6. 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. 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 2.7. Late Payment.
Subsection 2.7.1. Late Fees. Licensee hereby acknowledges that late
payment by Licensee to RCT of sums due under this Agreement will cause RCT to
incur certain costs including additional costs for legal, accounting and other
professional services to manage and administer this Agreement, the exact amount
of which will be extremely difficult to ascertain. Accordingly, 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, in
addition to
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any other remedy available under this Agreement and any remedy available at law
or equity, Licensee shall pay to RCT a late payment fee equal to the lesser of
$5,000 or 5% of such overdue amount (in addition to any interest charges
required or permitted below). The parties hereby agree that such late charge
represents a fair, reasonable and administratively simple estimate, at the time
of execution of this Agreement, of the costs RCT will incur by reason of
Licensee's late payment.
Subsection 2.7.2. Interest Charges. 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 Xxxxx 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.
Subsection 2.7.3. Application of Payments. Any payments received shall
be applied first to any late charges, second to the satisfaction of any unpaid,
accrued interest and finally to the satisfaction of any unpaid principal.
ARTICLE III
[RESERVED]
ARTICLE IV
LICENSED PATENTS
At its sole cost and expense, RCT shall maintain the LICENSED PATENTS,
although RCT may, in its sole discretion, abandon any LICENSED PATENT. If RCT
abandons any LICENSED PATENT, RCT shall promptly provide to Licensee written
notification of such fact.
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, as RCT may request, fully cooperate with
RCT, at no out-of-pocket expense to Licensee, in connection with any such
action.
ARTICLE VI
TERMINATION
SECTION 6.1. Automatic Termination. The term of this Agreement shall expire
on the TERMINATION DATE unless sooner terminated.
SECTION 6.2. At Licensee's Election. Licensee may terminate this Agreement
at any time by giving RCT three months' written notice of Licensee's election to
terminate.
SECTION 6.3. Licensee's Breach of Agreement.
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Subsection 6.3.1. Breach. Upon any 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 letter, and provided in Subsection 6.3.2
below, unless Licensee has cured such breach on or before the expiration of such
period.
Subsection 6.3.2. 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 ninety days to cure, the notice and cure period shall be extended
to ninety days so long as Licensee has, throughout the ninety day period,
diligently undertaken substantive and progressive efforts to cure such breach on
or before the date the ninety days expire.
Subsection 6.3.3. 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. "Procedural
Default" means a lawsuit, reexamination or protest proceeding (or the
equivalent) filed by Licensee against RCT seeking a declaratory judgment or
determination, as the case may be, that any of the PATENT CLAIMS are invalid or
unenforceable or otherwise not patentable or reduced in scope. A Financial
Default or a Procedural Default shall constitute an immediate default under, and
breach of, this Agreement and, upon the occurrence of a Financial Default or
Procedural Default, this Agreement shall immediately terminate. On or before the
date 30 days before the occurrence of a Financial Default or a Procedural
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 breach of this Agreement. The
laws of the country of the patent in question shall govern the interpretation
and enforcement of this Subsection 6.3.3.
SECTION 6.4. Surviving Obligations and Provisions. Licensee's obligations
to pay, and report to RCT on, the SALE of any LICENSED PRODUCT made or imported
before termination of this Agreement or expiration of the pertinent LICENSED
PATENTS (even if such LICENSED PRODUCT is USED or 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 2.4 ("Reports and Payments")and 2.5
("Books and Records") (to the extent provided therein) and SECTION 6.4 and
ARTICLE VII shall survive the termination of this Agreement.
ARTICLE VII
GENERAL
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SECTION 7.1. Integration. This Agreement, and EXHIBIT A attached to this
Agreement, constitutes the entire agreement between the parties as to the
subject matter of such documents. All prior and contemporaneous negotiations,
representations, warranties, agreements, statements, and promises 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, requests, reports, and
other communications provided in this Agreement 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.
000 X. Xxxxxx Xx., Xxxxx 000 The Windeyer Institute
Tucson, Arizona USA 85711-3365 00 Xxxxxxxxx Xxxxxx
Fax: 000-000-0000 Xxxxxx X0X 0XX
Xxxxxxx
Fax: 00-0000-000 893
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 Delaware concerning the
conflicts of laws, except as to any issue which by the law of Delaware depends
upon the validity, scope or enforceability of any PATENT CLAIM, which issue
shall be determined in accordance with the applicable patent laws of the country
of such LICENSED PATENT.
SECTION 7.4. Dispute Resolution. 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. 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.
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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.
Subsection 7.6.1. Authority and Binding Agreement; Interfering Patent
Rights. 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 party are within such party's corporate power, and
have been duly authorized by all necessary corporate action. RCT represents and
warrants that it has the right to grant licenses under the LICENSED PATENTS.
Subsection 7.6.2. Limitations. Nothing contained in this Agreement
shall be construed as a representation or warranty by RCT 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. Nothing contained in this Agreement
shall be construed as a representation or warranty by RCT: (a) as to the scope
or validity of any LICENSED PATENT or any PATENT CLAIM; or (b) 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
any employee or agent thereof) 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 of the LICENSED PATENTS, none of the provisions of
this Agreement shall be for the benefit of, or enforceable by, any third-party.
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)
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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 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. RCT shall
have no right to control the manner in which any product licensed under this
Agreement is made or practiced. RCT shall not be required to provide any
know-how or operating instructions or other information with respect to any such
product. RCT makes no 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 "INDEMNITIES")
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, 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
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License Agreement between RCT' and BioVex Ltd.;
RCT Project No. 213-1734; Xxxxxxx [Xxxx Therapy]
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.
SECTION 7.15. Insurance. On or before the earlier of the date Licensee
begins clinical trials involving the use of any LICENSED PRODUCTS, or marketing
of any LICENSED PRODUCT, Licensee shall obtain and, thereafter throughout the
term of this Agreement, and for a period of 15 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. 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 certificate of insurance evidencing
coverage and, when requested, a copy of such policy. The requirements of this
SECTION 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 necessarily 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 xxxx 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.
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. If Licensee is not then in default under this Agreement,
RCT's consent shall not be required if this Agreement is assigned to an
AFFILIATE of Licensee or as part of a sale or transfer pursuant to other bona
fide business arrangements 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 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
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License Agreement between RCT' and BioVex Ltd.;
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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 FIELD at the same
earned royalty rate and the annual minimum royalty payment amounts provided in
this Agreement but, as to other financial terms, 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 of the LICENSED PATENTS, the INSTITUTION, RCT, or any adaptation of any
of them, in any advertising, promotional or sales literature, without prior
written consent obtained from such 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, more than 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.
SECTION 8.2. "BULK PRODUCT FORM" means a LICENSED PRODUCT in a form other
than FINAL PRODUCT FORM.
SECTION 8.3. "CLAIMED CELL" means a eukaryotic cell or cell line comprising
a CLAIMED DNA.
SECTION 8.4. "CLAIMED DNA" means a DNA molecule the manufacture, USE, SALE,
offer for SALE, or importation of which directly infringes, contributorily
infringes or induces the infringement of a PATENT CLAIM.
SECTION 8.5. "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 8.6. "INSTITUTION" means Case Western Reserve University.
SECTION 8.7. "INVENTION" means the certain invention pertaining to the
bgh-polyadenylation signal and its use in the expression of polypeptides, which
is the subject of the LICENSED PATENTS.
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RCT Project No. 213-1734; Xxxxxxx [Xxxx Therapy]
SECTION 8.8. "LICENSED FIELD" means the manufacture, USE and SALE of DNA
molecules or eukaryotic cells in a form intended and suitable for use only in
gene therapy (in vivo) or (ex vivo) and vaccines (and other such
immunotherapies) for humans. LICENSED FIELD does not include: (a) the ex vivo
production or expression, through the use of CLAIMED DNA or CLAIMED CELLS, of
proteins or polypeptides for SALE; or (b) the use of CLAIMED DNA or CLAIMED
CELLS for any purpose in non-human transgenic animals. The preceding sentence is
not intended, and shall not be construed to exclude ex vivo gene therapy from
the LICENSED FIELD.
SECTION 8.9. "LICENSED PATENTS" means the patents listed in EXHIBIT A, and
any and all issued and unexpired reissues, reexaminations, renewals or
extensions that may be based on any of such patents.
SECTION 8.10. "LICENSED PRODUCT' means a CLAIMED DNA or a CLAIMED CELL.
SECTION 8.11. "NET SALES VALUE" of any product means the gross xxxxxxxx for
the SALE of a product less the deductions identified below.
Subsection 8.11.1. Determining Gross Xxxxxxxx. The xxxxx xxxxxxxx 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 in
FINAL PRODUCT FORM:
1. To a third party that is not a RELATED PARTY, xxxxxxxx
shall be Licensee's or its AFFILIATE's actual gross xxxxxxxx, as
the case may be;
2. To a RELATED PARTY for subsequent SALE by such RELATED
PARTY, gross xxxxxxxx shall be such RELATED PARTY's actual gross
xxxxxxxx for such subsequent SALE;
3. To a RELATED PARTY for USE by such RELATED PARTY, except
as provided in paragraph (b) below, gross xxxxxxxx shall be the
gross xxxxxxxx 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,
except in the manner contemplated in the following sentence, gross
xxxxxxxx shall be the gross xxxxxxxx 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. The NET SALES
VALUE of any LICENSED PRODUCT that is USED only for, and produced only
in, internal research or internal scale-up studies or manufacturing
testing or validation conducted by or on behalf of Licensee,
or in quality assurance efforts conducted by or on behalf of Licensee,
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License Agreement between RCT' and BioVex Ltd.;
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none of which are part of the production of goods for SALE or goods
for USE in producing other goods for SALE, shall be zero dollars.
(c) If Licensee or its AFFILIATE SELLS or USES the LICENSED
PRODUCT in BULK PRODUCT FORM, the gross xxxxxxxx determined in (a) or
(b) above shall be adjusted in the following manner:
1. convert the quantity of such LICENSED PRODUCT SOLD or
USED in BULK PRODUCT FORM (the "Bulk Quantity") into the quantity
of LICENSED PRODUCT in FINAL PRODUCT FORM (the "Final Quantity")
that the Bulk Quantity would typically be made or converted into;
2. multiply the gross xxxxxxxx determined in (a) or (b)
above by a fraction, the numerator of which is the Final Quantity
and the denominator of which is the Bulk Quantity.
Subsection 8.11.2. Allowable Deductions. When factually applicable,
the following deductions may be deducted from gross xxxxxxxx as determined
above:
(a) rebates, volume, quantity, trade or cash discounts, allowed
and taken, in amounts customary in the trade;
(b) sales taxes and/or use taxes and/or duties imposed upon, and
with specific reference to, particular SALES to the extent included in
the amount of gross xxxxxxxx;
(c) amounts allowed or credited on returns, rejections or
recalls, voluntary or otherwise (not exceeding the original gross
xxxxxxxx); and
(d) charges for freight, freight allowances, and outbound
transportation costs prepaid to the extent included in gross xxxxxxxx.
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 8.12. "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 8.13. "PATENT COUNTRY" means a country in which a LICENSED PATENT
is pending or issued.
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SECTION 8.14. "PERSON" means an individual or a corporation, partnership,
trust, unincorporated organization, association, or any other entity, or a
government, or any department or agency of a government.
SECTION 8.15. "RELATED PARTY" means any one of Licensee or its AFFILIATES,
or any PERSON enjoying a special course of dealing with Licensee or its
AFFILIATES. By way of example but not limitation, a "special course of dealing"
includes co-marketing arrangements between Licensee and a third party wherein
the third party may SELL LICENSED PRODUCTS, distribution arrangements with third
parties in which Licensee or its AFFILIATE shares, directly or indirectly, in
the proceeds from such distributor's SALES of LICENSED PRODUCT, supply contracts
in which Licensee agrees with a third party to supply or manufacture LICENSED
PRODUCTS for SALE by the third party under such third party's name or xxxx,
arrangements under which a third party will SELL LICENSED PRODUCTS under a
private labelling arrangement with Licensee, or barter arrangements in which
Licensee exchanges LICENSED PRODUCTS for other products in kind. A distributor
of LICENSED PRODUCTS under Licensee's name or xxxx 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 8.16. "SELL" (and any noun form and conjugated verb form thereof)
means to sell, or otherwise part with or dispose of, for value.
SECTION 8.17. "TERMINATION DATE" shall be 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.
SECTION 8.18. "USE" (and any noun form and conjugated verb form thereof)
means to use for commercial purposes.
IN WITNESS WHEREOF, the parties hereto have each caused a duly authorized
officer to sign this Agreement to be effective the Effective Date.
Bio Vex Ltd. Research Corporation Technologies, Inc.
By: /s/ Xxxxxx Xxxxxx By: /s/ Xxxx X. Xxxxxxxxx,
---------------------------------- -----------------------------------
Name and Title: Xxxxxx Xxxxxx Xxxx X. Xxxxxxxxx, President
Director
Date: illegible Date: May 31, 2001
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BNC:TJR License Agreement between RCT' and BioVex Ltd.;
RCT Project No. 213-1734; Xxxxxxx [Gene Therapy]
EXHIBIT A
RCT PROJECT NO. 213-1734
INVENTOR: Xx. Xxxxx X. Xxxxxxx
INVENTION TITLE: "bgh-Polyadenylation Signal"
PATENT RIGHTS
ISSUED PATENTS
Country Patent No. Issue Date
------- ---------- ----------
United States 5,122,458 06/16/92
Japan 0000000 07/28/95
Belgium EPO173552 10/09/91
France EPO173552 10/09/91
Great Britain EPO173552 10/09/91
Germany P3584341.1 10/09/91
Italy EPO173552 10/09/91
Netherlands EPO173552 10/09/91
Sweden EPO173552 10/09/91
Switzerland EPO173552 10/09/91
May 31, 2001
16
