Exhibit 10.5
CONFIDENTIAL TREATMENT REQUESTED
LICENSE AGREEMENT
BETWEEN
-----------------
ADEZA BIOMEDICAL CORPORATION
AND
THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
(PENN)
L217
JULY 25, 1997
THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement ("AGREEMENT") is between The
Trustees of the University of Pennsylvania, a Pennsylvania nonprofit
corporation, with offices located at 0000 Xxxxxx Xxxxxx, Xxxxx 000,
Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000-0000 ("PENN") and Adeza Biomedical Corporation,
a corporation organized and existing under the laws of California ("ADEZA")
having a place of business at 0000 Xxxx Xxxxx, Xxxxxxxxx, XX 00000 and Xx. Xxxxx
Xxxxxx, formerly of PENN's School of Medicine and now with the University of
North Carolina, Department of Obstetrics and Gynecology ("XXXXXX").
This AGREEMENT is effective as of July 1, 1997 ("EFFECTIVE DATE").
RECITALS
WHEREAS, XXXXXX has developed certain technologies described as: [***] and
[***] and related U.S. and foreign patent filing for diagnostic applications;
and
WHEREAS, PENN has developed antibodies against the [***] and other PENN
antibodies (attachment 1) against the [***] owned by PENN (collectively, the
"PENN ANTIBODIES"); and
WHEREAS, PENN has developed viable cell lines with titer capable of producing
sufficient quantities of the PENN ANTIBODIES which ADEZA wishes to utilize for
the purpose of ADEZA's commercialization hereunder (collectively, the "PENN CELL
LINES" (see attachment 1); and
WHEREAS, PENN owns [***], [***], the PENN ANTIBODIES and the PENN CELL LINES;
and
WHEREAS, PENN desires such technology to be commercially used for the benefit of
the public good, and wishes to grant an exclusive worldwide license; and
WHEREAS, XXXXXX is an employee of the University of North Carolina and is not
currently an employee or agent of PENN.
NOW, THEREFORE, in consideration of the mutual covenants and promises herein
contained, the parties hereto agree as follows:
1. DEFINITIONS
1
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
1.1 DEVELOPMENT and MARKETING PLAN means ADEZA's plan for the
development and marketing of the PENN PATENT RIGHTS that demonstrate ADEZA's
capability to bring the PENN PATENT RIGHTS to practical application and is
described in summary fashion in Attachment 2.
1.2 FAIR MARKET VALUE means the cash consideration which ADEZA or its
sublicensee would realize from an unaffiliated, unrelated buyer in an arm's
length sale of in identical item sold in the same quantity and at the same time
and place of the transaction.
1.3 FIELD means diagnostic applications or uses of PENN PATENT RIGHTS
involving dysfunctions or diseases of the female reproductive system; provided,
however, that applications or uses of the PENN ANTIBODIES and the PENN CELL
LINES capable of producing such PENN ANTIBODIES shall be limited to the specific
claims of the patents included within the definition of PENN PATENT RIGHTS.
1.4 ADEZA means ADEZA and its AFFILIATES.
1.5 AFFILIATE means, any legal entity directly or indirectly
controlling, controlled by or under common control with ADEZA. For
purposes of this AGREEMENT, "control" means the direct or indirect
ownership of more than fifty percent (50%) of the outstanding voting
securities of a legal entity or the right to receive more than fifty
percent (50%) of the profits or earnings of a legal entity, or the right
to control the policy decisions of a legal entity.
1.6 NET SALES means the greater of the consideration or FAIR MARKET
VALUE attributable to the SALE of any PENN LICENSED PRODUCT, or the
provision of any PENN LICENSED SERVICE less qualifying costs
directly attributable to such SALE and actually identified on the
invoice and borne by ADEZA or its sublicensee.
1.6.1 Such qualifying costs shall be limited to the following:
1.6.1.1 [***]
1.6.1.2 [***]
1.6.1.3 [***]
1.6.1.4 [***]
2
THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
1.7 PENN LICENSED PRODUCT means any product which is made, made for,
used or sold or otherwise distributed by ADEZA, or any sublicensees and which:
(1) in the absence of this AGREEMENT would infringe at least one claim of PENN
PATENT RIGHTS or. (2) use a process or machine covered by a claim of PENN PATENT
RIGHTS.
1.8 PENN LICENSED SERVICE means the provision of any service by ADEZA or
any sublicensee which, (1) in the absence of this AGREEMENT would infringe at
least one claim of PENN PATENT RIGHTS or (2) use a process or machine covered by
a claim of PENN PATENT RIGHTS.
1.9 PENN PATENT RIGHTS means all patents issuing from those United
States patent applications, and any foreign counterpart and extension, including
continuation, continuation-in-part, divisional and re-issue application listed
in Attachment 1.
1.10 SALE means any bona fide transaction for which consideration is
received for the sale, use, lease, transfer or other disposition of any PENN
LICENSED PRODUCT or for the provision of any PENN LICENSED SERVICE
notwithstanding any PENN LICENSED PRODUCT or PENN LICENSED SERVICE for market
research, market promotion, and clinical trials. A SALE of any PENN LICENSED
PRODUCT or PENN LICENSED SERVICE shall be deemed completed at the time ADEZA or
its sublicensee receives payment for such PENN LICENSED PRODUCT or PENN LICENSED
SERVICE.
2. LICENSE GRANT
2.1 PENN grants to ADEZA for the term of this AGREEMENT an exclusive,
world-wide right and license, with the right to grant sublicenses, to make, have
made, use, import, sell and otherwise distribute and offer for sale PENN
LICENSED PRODUCT(S) and to provide or have provided PENN LICENSED SERVICES in
the FIELD. No other rights or licenses are granted.
2.2 PENN agrees to provide ADEZA [***] within twenty-one (21) days of
the EFFECTIVE DATE of this AGREEMENT and other PENN CELL LINES from time to time
at ADEZA's request if PENN is reasonably able to do so.
2.3 This license grant is exclusive except that PENN may use and permit
other nonprofit organizations to use the PENN PATENT RIGHTS for educational and
research purposes.
2.4 ADEZA acknowledges that pursuant to Public Laws 96-517, 97-256 and
98-620, codified at 35 U.S.C. 200-212, the United States government retains
certain rights in intellectual property funded in whole or part under any
contract, grant or similar agreement with a Federal agency. Pursuant to these
laws, the government may
3
THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
impose certain requirements regarding such intellectual property, including but
not limited to the requirement that products resulting from such intellectual
property sold in the United States must be substantially manufactured in the
United States. This license grant is expressly subject to all applicable United
States government rights as provided in the above-mentioned laws and any
regulations issued under those laws, as those laws or regulations may be amended
from time to time.
2.5 The right to sublicense granted to ADEZA under this AGREEMENT is
subject to the following conditions:
2.5.1 In each such sublicense, ADEZA must prohibit the sublicensee
from further sublicensing and require that the sublicensee is subject to the
terms and conditions of the license granted to ADEZA under this AGREEMENT.
2.5.2 Within thirty (30) days after ADEZA enters into any
sublicense, ADEZA must send to PENN a complete copy of the sublicense written in
the English language.
2.5.3 If ADEZA enters bankruptcy proceedings, voluntarily or
involuntarily, all payments of sublicense royalties due PENN from ADEZA then or
thereafter, pursuant to Sections 3.1.3, 3.1.4 and 3.1.5 herein shall be paid by
ADEZA's sublicensee(s) directly to PENN. Such direct payment(s) shall be made
incumbent upon ADEZA's sublicensee(s) by express written terms within ADEZA's
sublicense agreement(s) which shall include reporting requirements similar to
Section 3.4 herein, and shall name PENN as a direct recipient of such reports
during ADEZA's bankruptcy term. Such direct payments shall continue until the
bankruptcy trustee arranges otherwise or ADEZA has cleared its responsibilities
to the bankruptcy court.
4
THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
2.5.4 Even if ADEZA enters into sublicenses, ADEZA remains primarily
liable to PENN for all of ADEZA's duties and obligations contained in this
AGREEMENT and any act or omission of a sublicensee, which would be a breach of
this AGREEMENT if performed by ADEZA, shall be deemed to be a breach by ADEZA of
this AGREEMENT. If ADEZA is unable to cure such breach within the sixty (60) day
period pursuant to Section 5.3.2, ADEZA may cure such breach by termination of
the sublicense with such sublicencee. ADEZA will contractually require its
sublicensees to act in a manner consistent with ADEZA's duties and obligations
under this AGREEMENT.
3. FEES AND ROYALTIES
3.1 LICENSE INITIATION FEE AND ROYALTIES
3.1.1 In partial consideration of the exclusive license granted to
ADEZA, ADEZA must pay to PENN a non-refundable license initiation fee of [***]
less a credit of the total monthly option fees paid by ADEZA to PENN under the
EXCLUSIVE OPTION AGREEMENT between the parties effective as of June 3, 1996.
3.1.2 In further consideration of the exclusive license granted to
ADEZA, ADEZA must pay to PENN a royalty of [***] of the NET SALES of PENN
LICENSED PRODUCTS or PENN LICENSED SERVICE sold by ADEZA or any of its agents
(excluding sublicenses). PENN shall not be due any royalty on any part of a PENN
LICENSED PRODUCT or PENN LICENSED SERVICE which does not infringe PENN PATENT
RIGHTS.
3.1.3 With respect to any PENN LICENSED PRODUCT which is sold in
combination with other products which are made without using the PENN PATENT
RIGHTS (collectively, a "Combination Product"). ADEZA shall pay PENN a reduced
royalty which shall be calculated by [***]. If any portion of any Combination
Product does not have a readily ascertainable list price, then the parties shall
negotiate in good faith to determine fair value therefor. Such reduced royalty
shall in no event be less than the product of the royalty rate set forth in
section 3.1.2 and the actual cost to ADEZA of such PENN LICENSED PRODUCT
included in such Combination Product. ADEZA shall allocate its profit on
each-product included in the Combination Product in a fair and equitable manner
in proportion to tile contribution of each product.
With respect to any PENN LICENSED SERVICE which is provided in
combination with other services which are provided without using the PENN PATENT
RIGHTS (collectively, a "Combination Service"), ADEZA shall pay PENN a reduced
royalty which shall be calculated by [***]. If any portion of any Combination
Service does not have a readily ascertainable list price, then the parties shall
negotiate in good faith to determine fair value therefor. Such reduced royalty
shall in no event be less than the product of the royalty rate set forth in
section 3.1.2 and the actual cost to ADEZA of such PENN LICENSED SERVICE
included in such Combination Service.
5
THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
ADEZA shall allocate its profit on each service included in the Combination
Service in a fair and equitable manner in proportion to the contribution of each
service.
3.1.4 ADEZA must pay to PENN [***] of any royalty fees ADEZA
receives from any sublicensee in connection with the sale of any PENN LICENSED
PRODUCT and any PENN LICENSED SERVICE (such payments to PENN hereinafter
referred to as "SUBLICENSE ROYALTIES"); provided that, for each sublicensee, the
SUBLICENSE ROYALTIES shall be paid in an amount not less than [***] of any
sublicensee's NET SALES. If ADEZA receives consideration from any sublicensee in
lieu of royalties, ADEZA must pay to PENN an amount equal to the SUBLICENSE
ROYALTIES that ADEZA would have paid had such consideration been received by
ADEZA in cash (in accordance with section 3.1.6).
3.1.5 ADEZA must pay to PENN [***] of all non-royalty sublicense
fees or consideration received by ADEZA from its sublicensees.
3.1.6 Any non-cash consideration received by ADEZA under Sections
3.1.2, 3.1.3 and 3.1.4 shall be valued at its FAIR MARKET VALUE as of the date
of receipt.
3.1.7 NET SALES of any PENN LICENSED PRODUCT or any PENN LICENSED
SERVICE shall not be subject to more than one assessment of the scheduled
royalty; such assessment shall be the highest applicable royalty.
3.1.8 No royalty shall be payable under this Section 3.1 with
respect to SALES of any PENN LICENSED PRODUCT or any PENN LICENSED SERVICE among
ADEZA and its sublicensees, nor shall a royalty be payable under this Article 3
with respect to any PENN LICENSED PRODUCT or any PENN LICENSED SERVICE for which
no consideration is received in excess of fully burdened costs and which are
distributed (i) for use in research and/or development, (ii) for use in clinical
trials by or on behalf of ADEZA or its sublicensees, or (iii) as promotional
Samples.
3.2 ANNUAL LICENSE MAINTENANCE FEE
ADEZA shall pay to PENN an annual license maintenance fee of [***]
on the first anniversary of the EFFECTIVE DATE and [***] dollars on each
anniversary of the EFFECTIVE DATE thereafter. Royalty Payments, including annual
minimum royalties, shall be fully creditable against the annual license
maintenance fee.
3.2.1 ADEZA must use commercially reasonable efforts to develop for
commercial use and to market PENN LICENSED PRODUCTS and/or PENN LICENSED
SERVICES as soon as practicable, consistent with the DEVELOPMENT and MARKETING
PLAN. ADEZA must provide PENN with annual updates of the
6
THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
DEVELOPMENT and MARKETING PLAN beginning on the fifteenth (15th) day of August
1999 and continuing annually thereafter until August 15, 2000.
3.2.2 ADEZA must provide PENN on the fifteenth (15th) day of August
1998 and continuing annually thereafter, written progress reports, setting forth
in such detail as PENN may reasonably request, the progress of the development,
evaluation, testing and commercialization of each PENN LICENSED PRODUCT and each
PENN LICENSED SERVICE. ADEZA shall also notify PENN, within thirty (30) days of
the first commercial sale of each PENN LICENSED PRODUCT or PENN LICENSED
SERVICE, that such sale has occurred.
3.3 MINIMUM ROYALTIES
3.3.1 PENN LICENSED PRODUCT.
ADEZA must pay to PENN a non-refundable minimum royalty for
each PENN LICENCED PRODUCT made, made for, used or sold by ADEZA., its agents or
sublicensees for the following periods in the corresponding amounts:
7
THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
Due Date - within
forty-five (45) days
Period after the following dates: Minimum Royalty
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1. July 1 - June 30 of the The first June 30th after [***] This payment
period which includes the first commercial sale. shall be prorated
the first commercial beginning from the date
sale. of the first commercial
sale.
2. July 1 - June 30 of the June 30th at the end of [***]
period following Period Period 2.
1.
3. July 1 - June 30 of the June 30th at the end of [***]
period following Period Period 3.
2.
4. July 1 - June 30 of the June 30th at the end of [***]
period following Period Period 4 and each
3. successive anniversary
thereafter for the term
of this AGREEMENT.
3.3.2 PENN LICENSED SERVICE
ADEZA must pay to PENN a non-refundable minimum royalty for each
PENN LICENSED SERVICE provided by ADEZA, its agents or sublicensees for the
following periods in the corresponding amounts:
Due Date - within
forty-five (45) days
Period after the following dates: Minimum Royalty
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July 1, 1997 - June 30, June 30, 1998 [***] This payment
1998 shall be prorated
beginning from the date
of the first commercial
sale.
July 1, 1998 - June 30, June 30, 1998 [***]
1999
July 1, 1999 - June 30, June 30, 2000 [***]
2000
July 1, 2000 - June 30, June 30, 2001 and each [***]
2001 successive anniversary
thereafter for the term
of this AGREEMENT.
8
THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
Due Date - within
forty-five (45) days
Period after the following dates: Minimum Royalty
------ -------------------------- ---------------
3.3.3 For any PENN LICENSED PRODUCT or PENN LICENSED SERVICE, no
separate minimum royalty payment will be made for any twelve (12) month period
referred to in Section 3.3.1 and 3.3.2, as applicable, in the event that for
such twelve (12) month period royalties payable under Section 3.4 exceed the
applicable minimum royalty payable under Section 3.3.1 or 3.3.2. For any PENN
LICENSED PRODUCT or PENN LICENSED SERVICE, in the event that royalties payable
under Section 3.4 for any such twelve (12) month period are less than the
minimum royalty payable under Section 3.3.1 or 3.3.2, as applicable, for such
twelve (12) month Period, ADEZA shall pay PENN the difference on or prior to the
applicable due date set forth in Section 3.3.1 or 3.3.2. For each PENN LICENSED
PRODUCT or PENN LICENSED SERVICE, all minimum royalty payments under Section
3.3.1 or 3.3.2 are paid for the year preceding the Due Date of that PENN
LICENSED PRODUCT or PENN LICENSED SERVICE. The minimum royalty payments due for
the year in which the AGREEMENT terminates under Article 5 shall be pro-rated
for the period between the most recent anniversary of that first commercial sale
and the date of termination.
3.4 REPORTS AND RECORDS
3.4.1 ADEZA must deliver to PENN within forty-five (45) days after
the end of each six (6)-month period starting on January 1, 1998 a report,
certified by the chief financial officer of ADEZA, setting forth the calculation
of the royalties due to PENN for such six (6)-month period, including without
limitation:
3.4.1.1 Number of PENN LICENSED PRODUCTS and PENN LICENSED
SERVICES involved in SALES, listed by country.
3.4.1.2 Gross consideration for SALES of PENN LICENSED
PRODUCTS and PENN LICENSED SERVICES, including all
amounts invoiced or received.
3.4.1.3 Qualifying costs, as defined in Section 1.7, listed by
category of cost.
3.4.1.4 NET SALES of PENN LICENSED PRODUCTS and PENN LICENSED
SERVICES listed by country.
3.4.1.5 Royalties owed to PENN, listed by category, including
without limitation earned sublicensee-derived, and
minimum royalty categories.
3.4.1.6 Earned royalty amounts credited against minimum
royalty payments.
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THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
3.4.2 ADEZA must pay the royalties due under Sections 3.1 within
forty-five (45) days following the last day of the six (6)-month period, in
which the royalties payable for such six (6) month period accrue. ADEZA must
send with the royalties the report described in Section 3.4.1 starting on
January 1, 1998.
3.4.3 ADEZA must maintain and cause its sublicensees to maintain,
complete and accurate books and records which enable the royalties payable under
this AGREEMENT to be verified. The records for each six (6)-month period,
starting after January 1, 1998, must be maintained for three years after the
submission of each report under Article 3. Upon reasonable prior notice to
ADEZA, ADEZA must provide PENN with access to all books and records relating to
the SALES of any PENN LICENSED PRODUCT and any PENN LICENSED SERVICE by ADEZA
and its sublicensees to conduct a review or audit of those books and records.
Access to ADEZA's books and records must be available at least once each
CALENDAR YEAR, during normal business hours, and for each of three years after
the expiration or termination of this AGREEMENT. If PENN determines that ADEZA
has underpaid royalties by eight percent (8%) or more, ADEZA must pay the costs
and expenses of PENN and its accountants in connection with their review or
audit.
3.5 CURRENCY, PLACE OF PAYMENT, INTEREST
3.5.1 All dollar amounts referred to in this AGREEMENT are expressed
in United States dollars. All payments to PENN under this AGREEMENT must be made
in United States dollars by check payable to "The Trustees of the University of
Pennsylvania." If ADEZA receives revenues from SALES of any PENN LICENSED
PRODUCT or any PENN LICENSED SERVICE in currency other than United States
dollars, revenues shall be converted into United States dollars at the
conversion rate for the foreign currency as published in the eastern edition of
The Wall Street Journal as of the last business day of the applicable six (6)
month period, starting on January 1 or July 1, in which the royalty accrued.
3.5.2 Amounts that are not paid when due shall accrue interest from
the due date until paid, at a rate equal to one and one-half percent (1.5%) per
month (or the maximum allowed by law, if less).
4. CONFIDENTIALITY
4.1 CONFIDENTIAL INFORMATION means and includes all technical
information, inventions, developments, discoveries, software, know-how, methods,
techniques, formulae, data, processes and other proprietary ideas whether or not
patentable or copyrightable, that any party identifies as confidential or
proprietary at the time it is delivered or communicated to the receiving
party(s).
4.2 Subject to Section 4.3, any party hereto receiving CONFIDENTIAL
INFORMATION hereunder from any other party hereto agrees to maintain in
confidence and not disclose to any third party such
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THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL INFORMATION. Each party hereto agrees to ensure that its employees
or agents have access to CONFIDENTIAL INFORMATION received from another party
hereto only on a need-to-know basis and are obligated in writing to abide by its
obligations under this AGREEMENT. The foregoing obligation shall not apply to:
4.2.1 information that is known to the receiving party or
independently developed by the receiving party prior to the time of disclosure,
in each case, to the extent evidenced by written records promptly disclosed to
the disclosing party upon receipt of the CONFIDENTIAL INFORMATION;
4.2.2 information disclosed to the receiving party by a third party
that has a right to make such disclosure;
4.2.3 information that becomes patented, published or otherwise part
of the public domain as a result of acts by PENN or a third person obtaining
such information as a matter of right; or
4.2.4 information that is required to be disclosed by order of
United States governmental authority or a court of competent jurisdiction;
provided that the receiving party must use best efforts to obtain confidential
treatment of such information by the agency or court.
4.3 PENN shall not be obligated to accept any confidential information
from ADEZA except for the information required to be sent to PENN in Sections
2.5.2, 3.2.1, 3.2.2, 3.2.3, 3.4, 8.9.4, 10 and the DEVELOPMENT and MARKETING
PLAN in Attachment 2. PENN shall use reasonable efforts not to disclose those
reports to any third party (subject to the exceptions of Section 4.2). PENN
bears no institutional responsibility for maintaining the confidentiality of any
other information of ADEZA other than financial records and projections required
in Sections 2.5.2, 3.2.1, 3.2.2, 3.2.3, 3.4, 8.9.4, 10, and the DEVELOPMENT and
MARKETING PLAN in Attachment 2 provided by ADEZA.
5. TERM AND TERMINATION
5.1 This AGREEMENT, unless sooner terminated as provided in this
AGREEMENT, terminates upon: expiration of the last to expire or become abandoned
of the PENN PATENT RIGHTS.
5.2 ADEZA may, upon thirty (30) days written notice to PENN, terminate
this AGREEMENT by doing all of the following:
5.2.1 ceasing to make, have made, performed or have performed, use,
import, sell and offer for sale all PENN LICENSED PRODUCTS and PENN LICENSED
SERVICES; and
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THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
5.2.2 terminating all sublicenses, and causing all sublicensees to
cease making, having made, using, importing, selling and offering for sale all
PENN LICENSED PRODUCTS and PENN LICENSED SERVICES; and
5.2.3 paying all monies owed to PENN under this AGREEMENT.
5.3 PENN may terminate this AGREEMENT upon written notice if any of the
following occur:
5.3.1 ADEZA is more than sixty (60) days late in paying to PENN
royalties, expenses, or any other monies due under this AGREEMENT and ADEZA does
not pay PENN in full within seven (7) days of receiving notice of the amount
due, or
5.3.2 ADEZA breaches this AGREEMENT and does not cure the breach
within sixty (60) days after written notice of the breach.
5.4 If ADEZA enters bankruptcy proceedings under Chapter 7 of the U.S.
Bankruptcy Act, PENN may terminate this AGREEMENT upon written notice.
5.5 Upon termination of this AGREEMENT, the recipient party must, at the
provider party's request, return all CONFIDENTIAL INFORMATION received by the
recipient party from the provider party. PENN may notify ADEZA within a period
of thirty (30) days after termination of this AGREEMENT that PENN wishes to
obtain a nonexclusive, royalty-bearing license to use data generated by ADEZA
during the term of this AGREEMENT utilizing the technology licensed under this
AGREEMENT, and the parties will negotiate the terms of such license for a period
of up to sixty (60) days after ADEZA's receipt of such notification from PENN.
5.6 ADEZA's obligation to pay all monies owed accruing under this
AGREEMENT shall survive termination of this AGREEMENT. In addition, the
provisions of Article 4 - Confidentiality, Article 5 - Term and Termination,
Article 9 - Disclaimer of Warranties; Indemnification, Article 9 - Use of Penn's
Name and Article 11 - Additional Provisions shall survive such termination.
6. PATENT MAINTENANCE AND REIMBURSEMENT
6.1 PENN shall control, with input from ADEZA, the prosecution and
maintenance of PENN PATENT RIGHTS. PENN's Patent Counsel shall be selected and
agreed upon to the satisfaction of PENN and ADEZA. ADEZA shall be permitted to
communicate directly with PENN's Patent Counsel to maintain and prosecute the
PENN PATENT RIGHTS provided that ADEZA, PENN, and PENN's Patent Counsel shall
copy one another on all correspondence and documents pertaining to the PENN
PATENT RIGHTS within the FIELD and
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
shall not file any document pertaining to the PENN PATENT RIGHTS within the
FIELD with the U.S. or any other country patent office without PENN's prior
review and approval.
6.2 ADEZA shall enter into a billing agreement, in form and substance
reasonably satisfactory to PENN, ADEZA, and PENN's Patent Counsel with respect
to all of the PENN PATENT RIGHTS within the FIELD, pursuant to which ADEZA shall
agree to pay directly to such counsel on behalf of PENN such counsel's
attorneys' fees, expenses, official fees and other charges in connection with
the filing and prosecution of the patent applications and maintenance of PENN
PATENT RIGHTS within the FIELD that PENN and ADEZA have mutually agreed to
prosecute and maintain. PENN may at PENN's own expense continue to prosecute
such claims that ADEZA does not decide to pursue.
6.3 PENN shall retain all right, title and interest in and to the PENN
PATENT RIGHTS and other intellectual property protection related thereto except
those rights of ADEZA pursuant to this AGREEMENT.
7. INFRINGEMENT AND LITIGATION
7.1 PENN and ADEZA are responsible for notifying each other promptly of
any infringement of PENN PATENT RIGHTS which may come to their attention. PENN
and ADEZA shall consult one another in a timely manner concerning any
appropriate response to the infringement.
7.2 ADEZA may prosecute such infringement at its own expense. ADEZA must
not settle or compromise any such suit in a manner that imposes any obligations
or restrictions on PENN or grants any rights to the PENN PATENT RIGHTS, without
PENN's prior written permission. Financial recoveries from any such litigation
will first be retained by ADEZA; provided, that ADEZA will pay PENN a royalty on
that portion of the financial recoveries which corresponds to ADEZA's lost
SUBLICENSE ROYALTIES or ADEZA's lost profits from the foregone distribution of
PENN LICENSED PRODUCTS or from the foregone provision of PENN LICENSED SERVICES.
Such royalty shall be based on the provisions of Section 3.1, taking into
account the fact that royalties specified in Section 3.1 are expressed in terms
of revenues received by ADEZA instead of profits made by ADEZA.
7.3 ADEZA's rights under Section 7.2 are subject to the continuing right
of PENN to intervene at PENN's own expense and assert separately PENN's claim
for infringement of the PENN PATENT RIGHTS or PENN may join ADEZA in any claim
or suit for infringement of the PENN PATENT RIGHTS, subject to ADEZA's control
of such claim or suit. Any consideration received by either party in settlement
of any claim or suit shall first be used to reimburse the parties for their
respective litigation expenses. Any excess over the total litigation expenses of
both parties shall be shared in accordance with Section 7.2. In the event that
the total consideration
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
received by the parties in settlement of any claim or suit is less than the
total litigation expenses of both parties, the consideration will be allocated
between the parties in proportion to their respective litigation expense.
7.4 If ADEZA fails to prosecute any infringement, PENN may prosecute
such infringement at its own expense. In such event financial recoveries will be
entirely retained by PENN.
7.5 In any action to enforce any of the PENN PATENT RIGHTS, either
party, at the request and expense of the other party shall cooperate to the
fullest extent reasonably possible. This provision shall not be construed to
require either party to undertake any activities. including legal discovery, at
the request of any third party except as may be required by lawful process of a
court of competent jurisdiction.
8. DISCLAIMER OF WARRANTIES; INDEMNIFICATION
8.1 THE PENN PATENT RIGHTS, PENN LICENSED PRODUCTS, PENN LICENSED
SERVICES, AND ALL OTHER TECHNOLOGY LICENSED UNDER THIS AGREEMENT, ARE PROVIDED
ON AN "AS IS" BASIS AND PENN MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR
IMPLIED, WITH RESPECT THERETO. BY WAY OF EXAMPLE BUT NOT OF LIMITATION, PENN
MAKES NO REPRESENTATIONS OR WARRANTIES (i) OF COMMERCIAL UTILITY; (ii) OF
MERCHANTABILlTY OR FITNESS FOR A PARTICULAR PURPOSE; OR (iii) THAT THE USE OF
THE PENN PATENT RIGHTS, PENN LICENSED PRODUCTS, PENN LICENSED SERVICES, AND ALL
TECHNOLOGY LICENSED UNDER THIS AGREEMENT WILL NOT INFRINGE ANY PATENT, COPYRIGHT
OR TRADEMARK OR OTHER PROPRIETARY RIGHTS OF OTHERS. PENN shall NOT BE LIABLE TO
ADEZA, ADEZA's SUCCESSORS OR ASSIGNS OR ANY THIRD PARTY WITH RESPECT TO ANY
CLAIM ARISING FROM ADEZA'S USE OF THE PENN PATENT RIGHTS, PENN LICENSED
PRODUCTS, PENN LICENSED SERVICES, AND ALL TECHNOLOGY LICENSED UNDER THIS
AGREEMENT OR FROM THE MANUFACTURE, USE OR SALE OF PENN LICENSED PRODUCTS OR PENN
LICENSED SERVICES; OR ANY CLAIM FOR LOSS OF PROFITS, LOSS OR INTERRUPTION OF
business OR FOR INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY KIND.
8.2 Xxxxxx personally represents and warrants that he has assigned his
entire right, title, and interest in and to the PENN PATENT RIGHTS to PENN and
that he has not assigned and will not assign any interest in the PENN PATENT
RIGHTS to any other party. Xxxxxx further represents that he has the right to
make such assignment to PENN.
8.3 Xxxxxx personally represents and warrants that Xxxxxx has no actual
knowledge that any claim has been asserted against Xxxxxx concerning the PENN
PATENT RIGHTS, and Xxxxxx has no reason to believe that ADEZA's use of the PENN
PATENT RIGHTS hereunder infringes any third party proprietary rights.
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
8.4 Xxxxxx personally represents and warrants that his entire right,
title and interest in and to the PENN PATENT RIGHTS has been assigned to PENN,
and Xxxxxx has not granted and will not grant any interest in the PENN PATENT
RIGHTS to any third party that conflicts with the LICENSE granted to ADEZA under
this AGREEMENT.
8.5 To the actual knowledge of PENN, without independent investigation,
the entire right, title and interest in and to the PENN PATENT RIGHTS has been
assigned to PENN, and PENN has not granted and will not grant any interest in
the PENN PATENT RIGHTS to any third party that conflicts with the LICENSE
granted to ADEZA under this AGREEMENT. PENN represents and warrants to ADEZA
that PENN has the right to grant exclusive licenses to the PENN PATENT RIGHTS.
8.6 To the actual knowledge of PENN's Center for Technology Transfer and
PENN's Office of the General Counsel, without independent investigation, PENN
has not received any written notice or claim contesting PENN's rights in the
PENN PATENT RIGHTS asserted against PENN concerning the PENN PATENT RIGHTS, and,
based upon ADEZA's disclosure to PENN regarding ADEZA's permitted use of the
PENN PATENT RIGHTS, PENN has no reason to believe that ADEZA's use of the PENN
PATENT RIGHTS hereunder infringes any third party proprietary rights.
8.7 ADEZA must defend, indemnify and hold harmless PENN, its trustees,
officers, agents and employees (individually, an "Indemnified Party", and
collectively, the "Indemnified Parties"), from and against any and all
liability, loss, damage, action, claim or expense suffered or incurred by the
Indemnified Parties (including attorney's fees) (individually, a "Liability",
and collectively, the "Liabilities") that result from or arise out of (a) the
development, use, manufacture, promotion, sale or other disposition of any PENN
PATENT RIGHTS, PENN LICENSED PRODUCT or PENN LICENSED SERVICE by ADEZA, its
assignees, sublicensees, vendors or other third parties; (b) any breach by ADEZA
of this AGREEMENT; and (c) the enforcement by an Indemnified Party of this
Section. Without limiting the foregoing. ADEZA must defend, indemnify and hold
harmless the Indemnified Parties from and against any Liabilities resulting
from:
8.7.1 any product liability or other claim of any kind related to
the use by a third party of a PENN LICENSED PRODUCT that was manufactured, sold
or otherwise disposed by ADEZA, its assignees, sublicensees, vendors or other
third parties;
8.7.2 a claim by a third party that ADEZA's design, composition,
manufacture, use, sale or other disposition of any PENN LICENSED PRODUCT or the
provisions of any PENN LICENSED SERVICE infringes or violates any patent,
copyright, trademark or other intellectual property rights of such third party;
provided, that ADEZA shall have no obligation to defend or indemnify PENN to the
extent that such claim is due to the sole negligence or willful misconduct of
PENN.
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
8.7.3 clinical trials or studies conducted by or on behalf of ADEZA
relating to the PENN PATENT RIGHTS, PENN LICENSED PRODUCT or PENN LICENSED
SERVICE, including, without limitation, any claim by or on behalf of a human
subject of any such clinical trial or study.
8.8 ADEZA is not permitted to settle or compromise any claim or action
giving rise to Liabilities in a manner that imposes any restrictions or
obligations on PENN or grants any rights to the PENN PATENT RIGHTS. PENN
LICENSED PRODUCT or PENN LICENSED SERVICE without PENN's prior written consent,
which shall not be unreasonably withheld. If ADEZA fails or declines to assume
the defense of any such claim or action within thirty (30) days after notice
thereof, PENN may assume the defense of such claim or action for the account and
at the risk of ADEZA, and any Liabilities related thereto shall be conclusively
deemed a liability of ADEZA if such claim or action is held by a court of
competent jurisdiction to be within ADEZA's indemnification obligation. The
indemnification rights of PENN or other Indemnified Party contained herein are
in addition to all other rights which such Indemnified Party may have at law or
in equity or otherwise.
8.9 INSURANCE
8.9.1 ADEZA must procure and maintain a policy or policies of
comprehensive general liability insurance, including broad form and contractual
liability, in a minimum amount of [***] combined single limit per occurrence and
in the aggregate as respects personal injury, bodily injury and property damage
arising out of ADEZA's performance of this AGREEMENT.
8.9.2 ADEZA must, upon commencement of clinical trials involving
PENN LICENSED PRODUCTS, procure and maintain a policy or policies of product
liability insurance in a minimum amount of [***] combined single limit per
occurrence and in the aggregate as respects bodily injury and property damage
arising out of ADEZA's performance of this AGREEMENT.
8.9.3 The policy or policies of insurance described in this Section
8.4 must be issued by an insurance carrier with an A.M. Best rating of "A" or
better. ADEZA must provide PENN with certificates evidencing the insurance
coverage required herein and all subsequent renewals thereof.
8.9.4 PENN may periodically review the adequacy of the minimum
limits of liability insurance specified in this Section. At PENN's request,
ADEZA and PENN shall confer to discus the adequacy of the coverage figures in
Sections 8.9.1 and 8.9.2 and shall adjust those coverage figures together to a
commercially reasonable level as circumstances warrant. The specified minimum
insurance amounts do not constitute a limitation on ADEZA's obligation to
indemnify PENN under this AGREEMENT.
9. USE OF PENN'S NAME
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
ADEZA and its employees and agents must not use and ADEZA must not
permit its sublicensees to use PENN's name or any adaptation thereof, or any
PENN seal, logotype, trademark or service xxxx, or the name, xxxx, or logotype
of any PENN representative or organization in any way without the prior written
consent of PENN.
10. ADEZA is not permitted to assign this AGREEMENT or any part of it, either
directly or by merger or other operation of law, without the prior written
consent of PENN which shall not be unreasonably withheld. To the extent
permitted by ADEZA's Confidential Disclosure Agreement with the proposed
ASSIGNEE, ADEZA shall provide to PENN under a confidentiality agreement, at
least 120 days prior to such proposed assignment background, information
reasonably sufficient for PENN to make an initial assessment of the proposed
assignment for a period of thirty (30) days and any further information
regarding such proposed assignment as PENN may reasonably request to make a
final decision in a timely manner not to exceed forty-five (45) days from the
completion of the initial assessment. Any prohibited assignment of this
AGREEMENT or the rights hereunder shall be null and void. No assignment relieves
ADEZA of responsibility for the performance of any accrued obligations which it
has prior to such assignment.
11. ADDITIONAL PROVISIONS
11.1 Nothing in this AGREEMENT shall be deemed to establish a
relationship of principal and agent between PENN and ADEZA, nor any of their
agents or employees for any purpose whatsoever, nor shall this AGREEMENT be
construed as creating any other form of legal association or arrangement which
would impose liability upon one party for the act or failure to act of the other
party.
11.2 A waiver by either party of a breach of any provision of this
AGREEMENT will not constitute a waiver of any subsequent breach of that
provision or a waiver of any breach of any other provision of this AGREEMENT.
11.3 If any provision of this AGREEMENT is found by a court to be void,
invalid or unenforceable, that provision shall be reformed to comply with
applicable law or stricken if not so conformable, so as not to affect the
validity or enforceability of the remainder of this AGREEMENT.
11.4 Notices, payments, statements reports and other communications under
this AGREEMENT shall be in writing and shall be deemed to have been received as
of the date sent if sent by public courier (e.g. Federal Express), or by Express
Mail, receipt requested, and addressed as follows:
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
If for PENN: with a copy to:
University of Pennsylvania Office of General Counsel
Center for Technology Transfer University of Pennsylvania
0000 Xxxxxx Xxxxxx, Xxxxx 000 000 Xxxxxxx Xxxx
Xxxxxxxxxxxx, XX 00000-0000 Xxxxxxxxxxxx, XX 00000-0000
Attention: Managing Director Attention; General Counsel
If for ADEZA:
Attention: The President
Adeza Biomedical Corporation
0000 Xxxx Xxxxx
Xxxxxxxxx, XX 00000
Attention:
Either party may change its official address upon written notice to the other
party.
11.5 This AGREEMENT shall be construed and governed in accordance with
the laws of the Commonwealth of Pennsylvania, without giving effect to conflict
of law provisions. In the event that a party to this AGREEMENT perceives the
existence of a dispute with the other party concerning any right or duty
provided for herein, the parties will, as soon as practicable, confer in an
attempt to resolve the dispute. If the parties are unable to resolve such
dispute amicably within thirty (30) days of the inception of the dispute, then
the parties hereby submit to the exclusive jurisdiction of and venue in the
courts located in the Eastern District of the Commonwealth of Pennsylvania with
respect to any and all disputes concerning the subject of this AGREEMENT.
11.6 PENN and ADEZA shall not discriminate against any employee or
applicant for employment because of race, color, sex, sexual or affectional
preference, age, religion, national or ethnic origin, handicap, of because he or
she is a disabled veteran or a veteran of the Vietnam Era.
11.7 ADEZA must comply with all prevailing laws, rules and regulations
that apply to its activities or obligations under this AGREEMENT. Without
limiting the foregoing, it is understood that this AGREEMENT may be subject to
United States laws and regulations controlling the export of technical data,
computer software, laboratory prototypes and other commodities, articles and
information, including the Arms Export Control Act as
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
amended in the Export Administration Act of 1979, and that the parties'
obligations are contingent upon compliance with applicable United States export
laws and regulations. The transfer of certain technical data and commodities may
require a license from the cognizant agency of the United States Government
and/or written assurances by ADEZA that ADEZA shall not export data or
commodities to certain foreign countries without prior approval of such agency.
PENN neither represents that a license is not required nor that, if required, it
will issue.
11.8 This AGREEMENT constitutes the entire agreement of the parties. Any
modification of this AGREEMENT must be in writing and signed by an authorized
representative of each party.
IN WITNESS WHEREOF, the parties have caused duly authorized
representatives to execute this Agreement.
THE TRUSTEES OF THE UNIVERSITY ADEZA BIOMEDICAL CORPORATION
OF PENNSYLVANIA
By: /s/ Xxxxx X. Xxxxxxxx By: /s/ Xxxxx Xxxxxxxx
Name: Xxxxx X. Xxxxxxxx Name: Xxxxx Xxxxxxxx
Title: Managing Director, Center for Technology Transfer Title: President
Date: Date: 8/22/97
XX. XXXXX X. XXXXXX
By: /s/ Xxxxx X. Xxxxxx
Name: Xxxxx X. Xxxxxx, Ph.D., M.D.
Title: Associate Professor & Medical Doctor
Date:
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
ATTACHMENT 1
PENN PATENT RIGHTS
PATENTS
Domestic
1. U. S. Serial No. [***].
2. U. S. Serial No. [***].
3. U.S. Serial No. [***].
4. U.S. Serial No. [***].
5. U.S. Serial No. [***].
6. U.S. Serial No. [***].
Foreign
U.S. - Serial No. [***] was foreign filed as follows:
Penn Ref.: [***] PCT Germany
filed 11/19/94 Greece
PCT/US94/13299 Ireland
Abstract Italy
Canada Luxembourg
EPO Monaco
95902592.5 Netherlands
Australia Portugal
Belgium Spain
Denmark Sweden
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BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
France Switzerland
G. Britain Japan
PENN ANTIBODIES and CELL LINES
X. XXXX ANTIBODIES
[***]
Other ANTIBODIES against the [***] owned by PENN which use of such
ANTIBODIES shall be limited to the claims of the patents included in the
definition of PENN PATENT RIGHTS under Section 1.10 of this AGREEMENT.
II. CELL LINES
1. Cell Line producing [***]
2. Cell lines producing [***] owned by PENN as of the EFFECTIVE DATE of
this AGREEMENT, which use of such call line shall be limited to the claims of
the patents included in the definition of PENN PATENT RIGHTS under Section 1.10
of this AGREEMENT.
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
CONFIDENTIAL TREATMENT REQUESTED
ATTACHMENT 2
ADEZA BIOMEDICAL CORPORATION
DEVELOPMENT AND MARKETING PLAN
[***] has already been transferred and approved by the Laboratory Director, CLIA
and the State of California. The following action items are listed below.
- [***]
- [***]
- [***]
- [***]
- [***]
- [***]
- [***]
- [***]
- [***]
- [***]
- [***]
- [***]
- [***]
- [***]
22
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
