EX-10.23
AMENDED AND RESTATED
COLLABORATION AGREEMENT
BY AND AMONG
GENETICS INSTITUTE, INC.
AND
THE XXXXX XXXXXXX UNIVERSITY
AND
METAMORPHIX, INC.
JANUARY 26, 1999
TABLE OF CONTENTS
1. DEFINITION
1.1 "ADDITIONAL BMPS"
1.2 "ADDITIONAL COLLABORATIVE FACTORS"
1.3 "ADDITIONAL FACTORS"
1.4 "ADDITIONAL FACTOR JOINT KNOW-HOW"
1.5 "ADDITIONAL FACTOR JOINT PATENT RIGHTS"
1.6 "ADDITIONAL FACTOR JOINT RIGHTS
1.7 "ADDITIONAL FACTOR KNOW-HOW"
1.8 "ADDITIONAL FACTOR PATENT RIGHTS"
1.9 "ADDITIONAL FACTOR RIGHTS"
1.10 "ADDITIONAL GDFS"
1.11 "AFFILIATE"
1.12 "AVAILABLE FACTORS"
1.13 "BAYLOR"
1.14 "BAYLOR AGREEMENT"
1.15 "BONE MORPHOGENETIC PROTEINS" OR "BMPS"
1.16 "COLLABORATIVE FACTORS"
1.17 "COLLABORATIVE RESEARCH"
1.18 "COMMERCIALLY REASONABLE EFFORTS"
1.19 "COLLABORATIVE RESEARCH TERM"
1.20 "CONFIDENTIAL INFORMATION"
1.21 "CONTROL" OR "CONTROLLED"
1.22 "DATA"
1.23 "DISCOVER", "DISCOVERED" AND "DISCOVERY"
1.24 "EFFECTIVE DATE"
1.25 "EVALUATION PERIOD"
1.26 "FACTOR"
1.27 "FACTOR KNOW-HOW"
1.28 "FACTOR PATENT RIGHTS"
1.29 "FACTOR RIGHTS"
1.30 "FDA"
1.31 "GDF-8 DERIVATIVE PRODUCT"
1.32 "GDF-16"
1.33 "GDF-16 PRODUCT(S)"
1.34 "GDF-17"
1.35 "GDF-17 PRODUCT(S)"
1.36 "GI ADDITIONAL FACTOR(S)"
1.37 "GI ADDITIONAL FACTOR KNOW-HOW"
1.38 "GI ADDITIONAL FACTOR PATENT RIGHTS"
1.39 "GI FACTORS"
1.40 "GI FIELD"
1.41 "GI KNOW-HOW"
1.42 "GI PATENT RIGHTS"
1.43 "GI PRODUCTS"
1.44 "GI TYPE A PRODUCT"
1.45 "GI TYPE B PRODUCT"
1.46 "GI TYPE C PRODUCT"
1.47 "GI RIGHTS"
1.48 "GPDC FACTORS"
1.49 "GROWTH AND DIFFERENTIATION FACTORS" OR "GDFS"
1.50 "INAD"
1.51 "IND"
1.52 "INVENTION AND DISCLOSURE AGREEMENT"
1.53 "JHU ADDITIONAL FACTOR KNOW-HOW"
1.54 "JHU ADDITIONAL FACTOR PATENT RIGHTS"
1.55 "JHU KNOW-HOW"
1.56 "JHU PATENT RIGHTS"
1.57 "JHU RIGHTS"
1.58 "JOINT KNOW-HOW"
1.59 "JOINT PATENT RIGHTS"
1.60 "JOINT RIGHTS"
1.61 "LETTER OF INTENT"
1.62 "METAMORPHIX FACTORS"
1.63 "METAMORPHIX FIELD"
1.64 "METAMORPHIX KNOW-HOW"
1.65 "METAMORPHIX PATENT RIGHTS"
1.66 "METAMORPHIX PRODUCT"
1.67 "METAMORPHIX RIGHTS"
1.68 "NET SALES"
1.69 "ORIGINAL RESEARCH"
1.70 "OTHER TGF-(BETA) FACTORS"
1.71 "OTHER TGF-(BETA) PRODUCTS"
1.72 "PATENTS"
1.73 "PLA"
1.74 "PRODUCT(S)"
1.75 "PROMISSORY NOTE"
1.76 "RESEARCH MANAGEMENT COMMITTEE" OR "RMC"
1.77 "SPONSORED RESEARCH"
1.78 "SPONSORED RESEARCH TERM"
1.79 "TGF-(BETA) ADDITIONAL FACTOR CLASS"
1.80 "TGF-(BETA) CLASS"
1.81 "TGF-(BETA) FACTOR CLASS"
1.82 "TGF-(BETA) FACTORS"
1.83 "TGF-(BETA) SUPERFAMILY"
1.84 "THIRD PARTY(IES)"
1.85 "USE PATENT"
1.86 "VALID CLAIM"
2. CONDITIONS PRECEDENT; THE CLOSING
2.1 GOVERNMENT APPROVALS
2.1.1 THE PARTIES' OBLIGATIONS
2.1.2 ADDITIONAL APPROVALS
2.2 CORPORATE APPROVALS
2.2.1 METAMORPHIX DIRECTOR AND SHAREHOLDER APPROVAL
2.2.2 GENETICS INSTITUTE APPROVAL
2.3 THE CLOSING
2.3.1 TIME AND PLACE
2.3.2 GI DELIVERABLES
2.3.3 METAMORPHIX DELIVERABLES
2.3.4 JHU DELIVERABLES
2.3.5 XX. XXX DELIVERABLES
3. THE RESEARCH
3.1 BACKGROUND AND GOALS
3.2 THE ORIGINAL RESEARCH
3.2.1 FUNDING
3.2.2 DISCLOSURE OF INFORMATION
3.2.2.1 DISCLOSURE OF SEQUENCES
3.2.2.2 DISCLOSURE OF OTHER INFORMATION
3.3 THE SPONSORED RESEARCH
3.3.1 SPONSORED RESEARCH TERM
3.3.2 FUNDING
3.3.3 USE OF FUNDS; BUDGETS
3.3.4 SPONSORED RESEARCH PLAN
3.3.5 SPONSORED RESEARCH ACTIVITIES
3.3.6 INVENTION AND DISCLOSURE AGREEMENT
3.3.7 DISCLOSURE OF INFORMATION
3.3.7.1 DISCLOSURE OF SEQUENCES
3.3.7.2 DISCLOSURE OF OTHER INFORMATION
3.3.7.3 MANDATORY DISCLOSURE OF OTHER INFORMATION
3.3.8 ANNUAL REPORTS
3.3.9 EQUIPMENT
3.3.10 EXCLUSIVITY OF RESEARCH
3.4 THE COLLABORATIVE RESEARCH
3.4.1 THE COLLABORATIVE RESEARCH TERM
3.4.2 COLLABORATIVE RESEARCH PLAN
3.4.3 RESEARCH MANAGEMENT COMMITTEE
3.4.4 COLLABORATIVE RESEARCH ACTIVITIES
3.4.5 DISPUTE RESOLUTION
3.4.6 DISCLOSURE OF INFORMATION
3.4.6.1 DISCLOSURE OF SEQUENCES
3.4.6.2 DISCRETIONARY DISCLOSURE OF OTHER INFORMATION
3.4.6.3 MANDATORY DISCLOSURE OF OTHER INFORMATION
3.4.7 ANNUAL REPORTS
3.5 DISCLOSURE OF INFORMATION BY AND TO JHU
3.5.1 JHU DISCLOSURES
3.5.2 GI AND METAMORPHIX DISCLOSURES
3.6 OWNERSHIP OF RESULTS
3.7 RESEARCH LICENSE
3.8 ACKNOWLEDGEMENT
3.9 METAMORPHIX SPONSORED RESEARCH
3.10 XX. XXX AS CONSULTANT TO METAMORPHIX
4. SUPPLY OF MATERIALS
4.1 SUPPLY OF MATERIALS IN CONNECTION WITH THE SPONSORED RESEARCH
4.2 SUPPLY OF MATERIALS TO METAMORPHIX
4.2.1 UNASSIGNED BMPS, GDFS AND COLLABORATIVE FACTORS
4.2.2 METAMORPHIX FACTORS
4.2.3 SUPPLY OF REAGENTS AND ANTIBODIES
4.2.4 SUPPLY OF FACTORS, REAGENTS AND ANTIBODIES AFTER
COLLABORATIVE RESEARCH TERM
4.3 SUPPLY OF MATERIALS BY METAMORPHIX
4.4 SUPPLY OF CERTAIN MATERIALS TO XX. XXX
4.5 LIMITATIONS ON USE OF FACTORS
5. EVALUATION AND SELECTION OF FACTORS
5.1 EVALUATION
5.2 AVAILABLE FACTORS
5.3 SELECTION OF AVAILABLE FACTORS
5.3.1 ORDER OF SELECTION
5.3.1.1 METAMORPHIX HAS FIRST SELECTION
5.3.1.2 GI HAS NEXT SELECTION
5.3.1.3 ALTERNATING SELECTIONS
5.3.2 TRIGGERING A SELECTION
5.3.2.1 GI'S RIGHT TO TRIGGER A SELECTION
5.3.2.2 METAMORPHIX' RIGHT TO TRIGGER A SELECTION
5.3.2.3 LIMITATION ON RIGHT TO TRIGGER A SELECTION
5.3.3 COMPLETION OF SELECTION PROCESS
6. LICENSES
6.1 RESTATEMENT OF RIGHTS
6.2 LICENSES FROM JHU TO METAMORPHIX
6.3 LICENSES FROM JHU TO GI
6.3.1 GI TYPE A PRODUCTS
6.3.2 GI TYPE B PRODUCTS
6.3.3 GI TYPE C PRODUCTS
6.4 LICENSES FROM METAMORPHIX TO GI
6.4.1 GI TYPE A PRODUCTS
6.4.2 GI TYPE B PRODUCTS
6.5 LICENSES FROM GI TO METAMORPHIX
6.6 RESERVATION OF RIGHTS
6.7 FACTOR RIGHTS LICENSED FROM THIRD PARTIES
6.8 NON COMPETE
6.8.1 BY METAMORPHIX
6.8.2 BY GI
6.9 OPTION TO CERTAIN GDF-8 DERIVATIVE PRODUCTS
7. CONSIDERATION
7.1 LICENSE FEES
7.1.1 INITIAL LICENSE PROCESSING FEE
7.1.2 ADDITIONAL LICENSE PROCESSING FEES
7.1.3 LICENSE MAINTENANCE FEES
7.2 ADDITIONAL LICENSE FEES
7.3 ROYALTIES
7.3.1 METAMORPHIX PRODUCTS
7.3.1.1 PAYABLE BY METAMORPHIZ TO JHL
7.3.1.2 PAYABLE BY METAMORPHIX TO GI
7.3.2 GI TYPE A PRODUCTS
7.3.2.1 PAYABLE BY GI TO METAMORPHIX
7.3.2.2 PAYABLE BY GI TO JHU
7.3.3 GI TYPE B PRODUCTS
7.3.3.1 PAYABLE BY GI TO METAMORPHIX
7.3.3.2 PAYABLE BY GI TO JHU
7.3.4 GI TYPE C PRODUCTS
7.3.5 OTHER TGF(BETA) beta FACTORS
7.3.5.1 PAYABLE BY METAMORPHIX TO JHU
7.3.5.2 PAYABLE BY METAMORPHIX TO GI
7.3.5.3 PAYABLE BY GI TO JHU
7.3.5.3 PAYABLE BY CI TO METAMORPHIX
7.3.5.4 PATENT INTERFERENCE
7.4 ROYALTY CALCULATIONS
7.4.1 COUNTRY-BY-COUNTRY BASIS
7.4.2 ADVANCED PRODUCTS
7.4.3 THIRD PARTY ROYALTIES
7.4.4 LIMITATIONS ON ROYALTY DEDUCTIONS
7.5 REPORT AND PAYMENT
7.6 FOREIGN ROYALTIES
7.7 TAXES
7.8 RECORDS
8. ADDITIONAL CONSIDERATION
8.1 ASSIGNMENT OF METAMORPHIX STOCK
8.2 AMENDMENT OF PROMISSORY NOTE
8.3 PUT OPTION
8.4 PURCHASE OF EQUIPMENT
8.5 BAYLOR AGREEMENT
8.6 SHAREHOLDER AGREEMENTS
9. PRODUCT DEVELOPMENT AND COMMERCIALIZATION
9.1 METAMORPHIX'S OBLIGATIONS
9.1.1 GENERAL DILIGENCE OBLIGATION
9.1.2 DEVELOPMENT MILESTONES
9.1.3 SATISFACTION OF DILIGENCE AND DEVELOPMENT MILESTONE OBLIGATIONS
9.1.4 FAILURE TO ACHIEVE DEVELOPMENT MILESTONES
9.2 GI'S DILIGENCE OBLIGATIONS
9.2.1 GENERAL DILIGENCE OBLIGATION
9.2.2 MILESTONES
9.2.3 SATISFACTION OF DILIGENCE AND DEVELOPMENT MILESTONE OBLIGATIONS
9.2.4 FAILURE TO ACHIEVE DEVELOPMENT MILESTONES
9.3 RIGHT OF FIRST REFUSAL
10. PATENT PROSECUTION AND INFRINGEMENT
10.1 RESPONSIBILITY FOR PATENTING FACTOR RIGHTS
10.1.1 GI PATENT RIGHTS AND CERTAIN JOINT PATENT RIGHTS
10.1.2 METAMORPHIX PATENT RIGHTS
10.1.3 JHU PATENT RIGHTS AND CERTAIN JOINT PATENT RIGHTS
10.1.4 PATENT COOPERATION
10.1.5 USE OF INFORMATION
10.1.6 DIVISION OF CLAIMS
10.1.7 INTERFERENCES
10.2 EXPENSES
10.2.1 PREVIOUSLY INCURRED EXPENSES - GI FACTORS
10.2.2 PREVIOUSLY INCURRED EXPENSED - METAMORPHIX FACTORS AND
UNASSIGNED FACTORS
10.2.3 CONTINUING EXPENSES - GI FACTORS AND ADDITIONAL FACTORS
10.2.4 CONTINUING EXPENSES - METAMORPHIX FACTORS
10.2.5 CONTINUING EXPENSES - UNASSIGNED FACTORS
10.2.5 CONTINUING EXPENSES - GDF-16 AND GDF-17
10.3 INFRINGEMENT
10.3.1 NOTICE
10.3.2 FIRST RIGHT TO INITIATE SUITS - GI FACTORS AND ADDITIONAL FACTORS
10.3.3 FIRST RIGHT TO INITIATE SUITS - METAMORPHIX FACTORS, GDF-16 AND
GDF-17
10.3.4 FIRST RIGHT TO INITIATE SUITS - UNASSIGNED FACTORS
10.3.5 DETERMINATION OF RIGHT TO PARTICIPATE IN, AND SECOND RIGHT TO
INITIATE, SUITS
10.3.6 RIGHT TO PARTICIPATE IN SUIT
10.3.7 SECOND RIGHT TO INITIATE SUIT
10.3.8 ROYALTY DEDUCTION
10.4 CLAIMED INFRINGEMENT
10.4.1 NOTICE; COOPERATION
10.4.2 LIMITATION OF LIABILITY
11 CONFIDENTIAL INFORMATION
11.1 NONDISCLOSURE OF CONFIDENTIAL INFORMATION
11.2 USE OF CONFIDENTIAL INFORMATION
11.3 AGREEMENTS WITH PERSONNEL AND THIRD PARTIES
11.4 PUBLICATION
11.4.1 RIGHT TO PUBLISH
11.4.2 NOTICE AND REVIEW
11.4.3 DELETION OF CONFIDENTIAL INFORMATION; PATENT PROTECTION
11.4.4 GDFS DISCOVERED BY JHU
11.5 NON-USE OF CERTAIN CONFIDENTIAL INFORMATION
12 REPRESENTATION AND WARRANTIES
12.1 REPRESENTATIONS AND WARRANTIES OF GI AND METAMORPHIX
12.2 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF GI
12.2.1 PATENT RIGHTS AND KNOW-HOW
12.2.2 NO CONFLICTING AGREEMENTS
12.3 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF METAMORPHIX
12.3.1 PATENT RIGHTS AND KNOW-HOW.
12.3.2 NO CONFLICTING AGREEMENTS
12.3.3 EQUIPMENT
12.4 REPRESENTATIONS AND WARRANTIES OF JHU
12.4.1 AUTHORITY
12.4.2 COMPLIANCE WITH LAWS AND ORGANIZATIONAL DOCUMENTS
12.4.3 PATENT RIGHTS AND KNOW-HOW
12.4.4 NO CONFLICTING AGREEMENTS
12.5 REPRESENTATION BY LEGAL COUNSEL
12.6 MATERIALITY
12.7 DISCLAIMER
13 PRODUCT LIABILITY INDEMNIFICATION
13.1 METAMORPHIX INDEMNIFICATION
13.2 GI INDEMNIFICATION
13.3 NOTICE; COOPERATION
13.4 LIABILITY LIMITATION
13.5 INSURANCE
14. TERM AND TERMINATION
14.1 TERM
14.2 TERMINATION FOR BREACH
14.3 BREACH OF OR WITHDRAWAL FROM AGREEMENT
14.3.1 BY METAMORPHIX
14.3.2 BY GI
14.4 SURVIVAL OF OBLIGATIONS; RETURN OF CONFIDENTIAL INFORMATION
15 MISCELLANEOUS
15.1 NO ASSUMPTION OF OBLIGATIONS
15.2 PUBLICITY
15.3 EXPORT CONTROL
15.4 CONDUCT OF' STUDIES
15.5 NO IMPLIED LICENSES
15.6 NO AGENCY
15.7 NOTICE
15.8 ASSIGNMENT
15.9 ENTIRE AGREEMENT
15.10 NO MODIFICATION
15.11 HEADINGS
15.12 WAIVER
15.13 SEVERABILITY
15.14 SUCCESSORS AND ASSIGNS
15.15 COUNTERPARTS
15.16 APPLICABLE LAW
AMENDED AND RESTATED COLLABORATION AGREEMENT
THIS AMENDED AND RESTATED COLLABORATION AGREEMENT (together with the
attached Schedules, the "Agreement") is entered into as of January 26. 1999 by
and among Genetics Institute, Inc., a Delaware corporation with a business
address at 00 XxxxxxxxxXxxx Xxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000 ("GI"), The
Xxxxx Xxxxxxx University, a non-profit educational institution with a business
address at 000 Xxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxx 00000 ("JHU") and
MetaMorphix, Inc., a Delaware corporation with a business address at 0000 Xxxxx
Xxxxxxx Xxxx, Xxxxxxxxx, Xxxxxxxx 00000 ("MetaMorphix"). GI, JHU and MetaMorphix
may each be referred to herein individually as a "Party" and collectively as the
"Parties".
WHEREAS, JHU, as a center for research and education, is interested in
licensing discoveries made by JHU researchers in a manner that will benefit the
public by facilitating the commercialization of useful products, but is without
capacity to commercially develop, manufacture and sell any such products;
WHEREAS, MetaMorphix was formed in 1994 for the purposes, INTER ALIA,
OF funding research at JHU under the direction OF Se-Xxx Xxx, M.D., Ph.D. ("Xx.
Xxx") to characterize certain previously-discovered factors, and discover and
characterize new factors, in the TGF-(beta) Superfamily (referred to by JHU as
"GDFs", as more fully defined below) and commercializing such GDFs, either on
its own, or by sublicense to GI and other Third Parties;
WHEREAS, GI also has ongoing research to discover, characterize and
develop factors in the TGF- Superfamily (referred to by GI as "BMPs", as more
fully defined below);
WHEREAS, on December 1, 1994, the Parties entered into a Collaboration
Agreement (the" 1994 Collaboration Agreement") pursuant to which, during the
Research Term (as such term is defined in the 1994 Collaboration Agreement)
thereof, which Research Term is now expired, they collaborated on the
characterization of theretofore previously discovered GDFs and BMPs. and the
discovery and characterization OF new GDFs and BMPs;
WHEREAS, pursuant to the 1994 Collaboration Agreement, JHU agreed to
license to MetaMorphix certain GDFs discovered by JHU; GI agreed to license to
MetaMorphix certain BMPs discovered by GI; and MetaMorphix agreed to license
and/or sublicense to GI certain GDFs discovered by MetaMorphix:
WHEREAS, MetaMorphix desires to restructure its business to focus on
the development and commercialization of products for agricultural and
veterinary uses;
WHEREAS, in order to facilitate MetaMorphix' desire to so restructure
its business, and to further development and commercialization of those BMPs,
GDFs and Collaborative Factors that were discovered pursuant to or which are
otherwise subject to the 1994
Collaboration Agreement, the Parties have agreed to amend. restate and replace
the 1994 Collaboration Agreement as set forth herein:
NOW THEREFORE. in consideration of the foregoing premises and the
mutual promises, covenants and conditions set forth below, the Parties,
intending to be legally bound, hereby agree as follows:
1. DEFINITIONS.
1.1 "ADDITIONAL BMPS" shall mean the Factors in the TGF-(beta)
Superfamily Discovered solely by GI after May 31, 1998, which
Factors include, without limitation, those Factors identified
in Schedule 1.1, attached hereto. Notwithstanding the
foregoing, Additional BMPs shall exclude (i) the BMPs and (ii)
the GPDC Factors.
1.2 "ADDITIONAL COLLABORATIVE FACTORS" shall mean the Factors in
the TGF-(beta) Superfamily Discovered by JHU jointly with GI
after May 31, 1998 and on or before the end of the six (6)
month period which begins on the day after the end of the
Sponsored Research Term. The Additional Collaborative Factors
shall not include BMPs. GDFs, Collaborative Factors,
Additional BMPs, Additional GDFs or Other TGF-beta Factors.
For JHU, Additional Collaborative Factors shall be restricted
to those Factors Discovered after May 31, 1998 in Xx. Xxx'x
JHU laboratory jointly by (i) Xx. Xxx and/or other JHU
faculty. students, fellows and/or employees who have signed an
Invention and Disclosure Agreement and (ii) employees of GI.
13 "ADDITIONAL Factors" shall mean the Additional BMPs, the
Additional GDFs and the Additional Collaborative Factors.
1.4 "ADDITIONAL FACTOR JOINT Know-How" shall mean any tmpatented
information specifically relating to any Additional BMP,
Additional GDF or Additional Collaborative Factor produced by
GI and JHU after May 31, 1998 and on or before the end of the
six (6) month period which begins on the day after the end of
the Sponsored Research Term, and for which each named Party
has a licensable interest, which information is reasonably
useful, necessary, or required for GI and/or its Affiliates,
to manufacture, use and/or sell GI Products. For JHU, the
Joint Know-How shall be restricted to the information produced
by Xx. Xxx and other JHU faculty, students, fellows, and
employees who have signed an Invention and Disclosure
Agreement.
1.5 "ADDITIONAL FACTOR JOINT PATENT RIGHTS" shall mean with
respect to each Additional BMP. Additional GDF or Additional
Collaborative Factor, (a) all Patents covering inventions (as
such term is defined under United States Patent Law) made by
GI and JHU jointly, after May 31, 1998 and on or before the
end of the six (6) month period which begins on the day after
the
end of the Sponsored Research Term, which inventions or
Patents are reasonably useful, necessary or required for GI
and/or its Affiliates, to manufacture, use and/or sell GI
Products for any use and (b) all Patents Controlled by or
coming into the Control of GI and JHU jointly during the term
of this Agreement. and for which each named Party has a
licensable interest, which, but for the inclusion of such
acquired Patents under this clause (b), would prevent GI
and/or its Affiliates, from practicing under one or more of
the Patents under clause (a), above. The Additional Factor
Joint Patent Rights believed by the Parties to be existing as
of the Effective Date are listed in Schedule 1.5 attached
hereto. For JHU, the Joint Patent Rights shall be restricted
to the Patents covering inventions made by Xx. Xxx and other
JHU faculty, students, fellows. and employees who have signed
an Invention and Disclosure Agreement.
1.6 "ADDITIONAL FACTOR JOINT RIGHTS"-shall mean the Additional
Factor Joint Know-How and the Additional Factor Joint Patent
Rights.
1.7 "ADDITIONAL FACTOR KNOW-HOW" shall mean the GI Additional
Factor Know-How, the JHU Additional Factor Know-How and the
Additional Factor Joint Know-How.
1.8 "Additional Factor Patent RIGHTS" shall mean the GI Additional
Factor Patent Rights. the JHU Additional Factor Patent Rights
and the Additional Factor Joint Patent Rights.
1.9 "ADDITIONAL FACTOR RIGHTS" shall mean the Additional Factor
Know-How and the Additional Factor Patent Rights.
1.10 "ADDITIONAL GDFS" shall mean the Factors in the TGF-(beta)
Superfamily Discovered by JHU solely after May 31, 1998 and on
or before the end of the six (6) month period which begins on
the day after the end of the Sponsored Research Term. The
Additional GDFs shall not include BMPs, GDFs, Collaborative
Factors, Additional BMPs, Additional Collaborative Factors or
Other TGF-(beta) Factors. For JHU, Additional GDFs shall be
restricted to those Factors listed on Schedule 1.10, together
with any additional Factors Discovered after May 31, 1998, in
(or in collaboration with) Xx. Xxxx JHU laboratory by Xx. Xxx
and other JHU faculty, students, fellows, and employees who
have signed an Invention and Disclosure Agreement.
1.11 "AFFILIATE" shall mean any corporation, company, partnership,
joint venture and/or firm which controls. is controlled by or
is under common control with a Party. For purposes of this
Section 1.11, "control" means (a) in the case of corporate
entities, direct or indirect ownership of at least fifty
percent (50%) of the stock or shares entitled to vote for the
election of directors; and (b) in the case of non-corporate
entities, direct or indirect ownership of at least fifty
percent (50%) of the equity interest with the power to direct
the management and policies of such noncorporate entities.
Notwithstanding the foregoing. (a) the term "Affiliate" shall
not include subsidiaries in which a Party or its Affiliates
owns a majority of the ordinary voting power to elect a
majority of the board of directors but is restricted from
electing such majority by contract or otherwise, until such
time as such restrictions are no longer in effect; (b) only
upon designation by GI and written notice to the other Parties
shall American Home Products Corporation and/or any of its
affiliates be Affiliates of GI for purposes of this Agreement;
and (c) unless the context expressly provides otherwise, a
Party shall not be treated as an Affiliate of the another
Party or another Party's Affiliates for purposes of this
Agreement.
1.12 "AVAILABLE FACTORS" shall mean those BMPs, GDFs and
Collaborative Factors that have been determined to be
available for selection by GI or MetaMorphix pursuant to the
Factor selection process described Article 5 of this
Agreement.
1.13 "BAYLOR" shall mean the Baylor College of Medicine.
1.14 "BAYLOR AGREEMENT" shall mean that certain Research
Collaboration Agreement entered into on February 1, 1998, by
and between MetaMorphix and Baylor, pursuant to which
MetaMorphix sponsored research relating to GDF-9 in the
laboratory of Xx. Xxxxxx Xxxxxx for a term of three (3) years.
1.15 "BONE MORPHOGENETIC PROTEINS" or "BMPS" shall mean the Factors
in the TGF-(beta) Superfamily Discovered solely by GI on or
before May 31, 1998, which Factors include, without
limitation, those Factors identified in Schedule 1.15 which is
attached hereto. Notwithstanding the foregoing, BMPs shall
exclude (a) the GPDC Factors and (b) any Factors in the
TGF-beta Superfamily, the sequences for which are identified
solely by GI using research strategies that do not use
sequence homology with previously sequenced TGF-P Factors. The
BMPs may be assigned to or selected by either GI (as a GI
Factor) or MetaMorphix (as a MetaMorphix Factor) under this
Agreement. BMPs shall not include Additional BMPs, GDFs,
Additional GDFs, Collaborative Factors, Additional
Collaborative Factors or Other TGF-beta Factors.
1.16 "COLLABORATIVE FACTORS" shall mean the Factors in the
TGF-(beta) Superfamily Discovered by (a) GI and MetaMorphix
jointly or (b) GI and JHU jointly or (c) JHU and MetaMorphix
jointly, as the case may be, on or before May 31, 1998,
including, without limitation, those Factors identified on
Schedule1.16 attached hereto. The Collaborative Factors may be
assigned to or selected by either GI (as a GI Factor) or
MetaMorphix (as a MetaMorphix Factor) under this Agreement.
Collaborative Factors shall not include
BMPs, GDFs. Additional BMPs. Additional GDFs, Additional
Collaborative Factors or Other TGF-beta Factors. For JHL,
Collaborative Factors shall be restricted to those Factors
Discovered on or before May 31, 1998 in Xx. Xxx'x JHU
laboratory jointly by (i) Xx. Xxx and/or other JHU faculty,
students, fellows and/or employees who have signed an
Invention and Disclosure Agreement and (ii) employees of GI
and/or MetaMorphix.
1.17 "COLLABORATIVE RESEARCH" shall mean the collaborative research
activities conducted by the GI and MetaMorphix, from June 1,
1998 through the end of the Collaborative Research Term, to
rapidly characterize and evaluate, for commercial development,
those BMPs, GDFs and Collaborative Factors that have not yet
been selected or designated as either GI Factors or
MetaMorphix Factors. Collaborative Research shall not include
the Sponsored Research or internal or collaborative research
conducted by GI or MetaMorphix on matters other than BMPs,
GDFs or Collaborative Factors that have not yet been selected
or designated as GI Factors or MetaMorphix Factors.
1.18 "COMMERCIALLY REASONABLE EFFORTS" shall mean efforts and
resources normally used by a Party for a product owned by it
or to which it has rights, which is of similar market
potential at a similar stage in its development or product
life, taking into account issues of safety and efficacy,
product profile, the competitiveness of the marketplace, the
proprietary position of the compound or product, the
regulatory structure involved, the profitability of the
applicable products, and other relevant factors.
1.19 "COLLABORATIVE RESEARCH TERM" shall have the meaning set forth
in Section 3.4.1 hereof.
1.20 "CONFIDENTIAL Information" includes, without limitation, any
scientific, technical, trade or business information disclosed
by one Party to one or more of the other Parties which is (a)
disclosed in writing or other tangible form and labeled or
otherwise identified in writing as "CONFIDENTIAL" at the time
of disclosure or (h) disclosed verbally and identified as
"CONFIDENTIAL" at the time of disclosure and subsequently
reduced to writing or other tangible form. labeled or
otherwise identified in writing as "CONFIDENTIAL" and
delivered to the receiving Party within thirty (30) days of
verbal disclosure. Notwithstanding the foregoing,
"Confidential Information" does not include information which
(a) was known to the receiving Xxx' at the time it was
disclosed. other than by previous disclosure by the disclosing
Party, as evidenced by written records at the time of
disclosure; (b) is at the time of disclosure or later becomes
publicly known under circumstances involving no breach of this
Agreement; (c) is lawfully and in good faith made available to
the receiving Party by a Third Party who did not derive it
from the disclosing Party and who imposes no obligation of
confidence on the receiving Party: or (d) is developed by the
receiving Party independent of any disclosure by the
disclosing Party, as evidenced by written records.
1.21 "CONTROL" OR "CONTROLLED" shall mean with respect to any (i)
item of information, including, without limitation, any Factor
Know-How or Additional Factor-Know-How, or (ii) intellectual
property right, the possession (whether by purchase.
assignment or license) by a Party of the ability to grant to
one or both of the other Parties access and/or a license as
provided herein under such item or right without violating the
terms of any agreement or other arrangements with any Third
Party.
1.22 "DATA" with respect to any Party, shall mean any and all
laboratory, animal and other scientific data (including,
without limitation, cloning, expression, purification,
refolding, analysis of bioactivity IN VITRO and IN VIVO,
physical characterization and formulation, IN SITU
hybridization and genetic mapping) in that Party's Control
arising either (a) from the Original Research on or before May
31, 1998, (b) from the Collaborative Research during the
Collaborative Research Term and/or (c) from the Sponsored
Research during the Sponsored Research Term, as applicable.
1.23 "DISCOVER", "DISCOVERED" AND "DISCOVERY" (and any other
variations thereof) shall mean, with respect to a BMP, a GDF,
a Collaborative Factor, an Additional BMP, an Additional GDF
or an Additional Collaborative Factor, the first sequencing by
a Party's employees or agents of the mature protein coding
region of that BMP, GDF. Collaborative Factor, Additional BMP,
Additional GDF or Additional Collaborative Factor. A Party
shall be deemed to have Discovered a Factor hereunder
regardless of whether such Party's employees or agents
Discovered such Factor solely or jointly with a Third Party.
In the event that, prior to the end of (i) the term of the
Original Research, with respect to BMPs, GDFs or Collaborative
Factors, or (ii) the Sponsored Research Term, with respect to
Additional BMPs, Additional GDFs or Additional Collaborative
Factors, one Party Discovers a Factor within twenty (20) days
following Discovery of the same Factor by another Party, such
Factor shall be deemed to be a Collaborative Factor or an
Additional Collaborative Factor, as the case may be, jointly
Discovered by the first and second Discovering Parties for
purposes of this Agreement. Determination of the utility or
activity of a Factor is not relevant in identifying the Party
which Discovered that Factor under this Agreement. Similarly,
inventorship on a Patent claiming a Factor may include a Party
which provided utility or other data, without changing the
identity of the Party which Discovered that Factor for
purposes of this Agreement. Under this Agreement, the identity
of the Party (or Parties) which Discovered a Factor determines
(a) whether that Factor will be classified as a BMP (under
Section 1.15), a GDF (under Section 1.49) or a Collaborative
Factor (under Section 1.16). an Additional BMP (under Section
1.1), an Additional GDF
(under Section 1.10) or an Additional Collaborative Factor
(under Section 1.2); (b) the Party (or Parties) to which
additional license fees will be made under Section 7.2; (c)
the Party (or Parties) to which license maintenance fees would
be owed in the event a Party fails to meet a Milestone under
Article 9; and (d) royalties payable among the Parties under
Section 7.3 of this Agreement.
1.24 "EFFECTIVE DATE" shall mean the next business day after the
Closing occurs in accordance with Section 2.3 hereof.
1.25 "EVALUATION PERIOD" shall have the meaning set forth in
Section 5.1 of this Agreement.
1.26 "FACTOR" shall mean (a) the proteins, peptides or polypeptides
corresponding to a molecule within the TGF-(beta) Superfamily;
(b) the polynucleotides which encode those proteins, peptides
or polypeptides, and any sub-sequences thereof; (c) any
modified form of those proteins, peptides or polypeptides: or
(d) variant or mutant forms of those proteins, peptides or
polypeptides, or of the polynucleotides encoding such variant
or mutant forms.
1.27 "FACTOR KNOW-HOW" shall mean the GI Know-How, the JHU
Know-How, the MetaMorphix Know-How and the Joint Know-How.
1.28 "FACTOR Patent Rights" shall mean the GI Patent Rights, the
JHU Patent Rights, the Metamorphix Patent Rights and the Joint
Patent Rights.
1.29 "FACTOR Rights" shall mean the Factor Patent Rights and the
Factor Know-How.
1.30 "FDA" shall mean the United States Food and Drug
Administration.
1.31 "GDF-8 DERIVATIVE Product" shall mean any pharmaceutical
product which primarily acts as
(i) an antagonist or agonist of GDF-8 or the GDF-8
receptor,
(ii) a vaccine against GDF-8,
(iii) a modifier of GDF-8 synthesis, or
(iv) a modulator of the GDF-8 signal transduction pathway,
only to the extent that such pharmaceutical product
is developed or sold for the purposes of modulating
the effects of GDF-8.
1.32 "GDF-16" shall mean the TGF-(beta) Factor known to MetaMorphix
and JHU as GDF-16, PROVIDED, HOWEVER, that GDF-16 shall not
include any TGF-(beta) Factor which is owned or Controlled by
GI.
1.33 "GDF-16 PRODUCT(S)" shall mean GDF-16, including any and all
(i) formulations, mixtures or compositions of GDF-16,
(ii) antibodies targeted against GDF-16,
(iii) receptors for which GDF-16 is a ligand,
(iv) antisense molecules or ribozymes that modulate the IN
VIVO production of GDF-16, and
(v) other products for research, diagnostic or
therapeutic use containing GDF- 16 or any of (i)
through (iv) above,
which, or which the manufacture use-Or sale of which, is
covered by a Valid Claim included within JHU's or MetaMorphix'
interest in the Factor Patent Rights.
1.34. "GDF-17" shall mean the TGF-(beta) Factor known to MetaMorphix
and JHU as GDF-17, PROVIDED HOWEVER, that GDF-17 shall not
include any TGF-(beta) Factor which is owned or Controlled by
GI.
1.35 "GDF-17 PRODUCT(S)" shall mean GDF-17, including any and all
(i) formulations, mixtures or compositions of GDF-17,
(ii) antibodies targeted against GDF-17,
(iii) receptors for which GDF-17 is a ligand,
(iv) antisense molecules or ribozymes that modulate the IN
VIVO production of GDF-17. and
(v) other products for research, diagnostic or
therapeutic use containing GDF-17 or any of (i)
through (iv) above, which, or which the manufacture
use or sale of which, is covered by a Valid Claim
included within JHU's or MetaMorphix' interest in the
Factor Patent Rights.
1.36 "GI ADDITIONAL FACTOR(S)" shall mean each Additional BMP.
Additional GDF or Additional Collaborative Factor, PROVIDED
HOWEVER, that GI Additional Factors shall not include any GPDC
Factors or any GI Factors.
1.37 "GI ADDITIONAL FACTOR KNOW-HOW" shall mean any unpatented
information specifically relating to any GI Additional Factor
produced by or on behalf of GI.
1.38 "GI ADDITIONAL FACTOR PATENT RIGHTS" shall mean with respect
to each GI Additional Factor, all Patents covering inventions
(as such term is defined under United States Patent Law) made
solely by GI which are reasonably useful, necessary or
required for GI and its Affiliates to manufacture, use and/or
sell GI Type C Products.
1.39 "GI FACTORS" shall mean (a) each GDF listed on Schedule 1.39
as of the Effective Date; (b) each BMP, GDF or Collaborative
Factor subsequently selected by GI and added to Schedule 1.39;
(c) each BMP, GDF or Collaborative Factor belonging to a
TGF-13 Class which includes one or more of the BMPs, GDFs or
Collaborative Factors identified in clauses (a) or (b) of this
Section; and (d) each BMP, GDF or Collaborative Factor
belonging to a TGF-(beta) Class which includes the Factors
known to GI as BMPs 2 and 4, BMPs 5.6. and 7, BMP 9, or BMP
12; PROVIDED, HOWEVE, the specific Factors themselves which
are listed in this clause (d) shall not be considered GI
Factors for purposes of this Agreement. BMPs, GDFs and
Collaborative Factors which would belong to both (x) a
TGF-(beta) Factor Class which includes a GI Factor and (y) a
TGF-(beta) Factor Class which includes a MetaMorphix Factor,
based on the definition of TGF-(beta) Factor Class set FORTH
in this Agreement, are classified pursuant to Section 1.80,
below.
1.40 "GI FIELD" shall mean all potential uses in humans, including,
without limitation, the diagnosis and/or the prophylactic or
therapeutic treatment of diseases or disorders in humans.
1.4I "GI KNOW-HOW" shall mean any unpatented information
specifically relating to a BMP. GDF or Collaborative Factor
produced by GI (i) on or before May 31. 1998 in performing the
Original Research or (ii) during the Collaborative Research
Term with respect only to those BMPs, GDFs and Collaborative
Factors that have not yet been selected or designated as
either a GI Factor or a MetaMorphix Factor, and for which GI
has a licensable interest, which is reasonably useful,
necessary or required for MetaMorphix and its Affiliates to
manufacture, use and/or sell MetaMorphix Products for use in
the MetaMorphix Field under this Agreement.
1.42 "GI PATENT Rights" shall mean, with respect to each BMP, GDF
or Collaborative Factor, (a) all Patents covering inventions
(as such term is defined under United States Patent Law) made
solely by GI
(i) on or before May 31. 1998 in performing the Original
Research or
(ii) during the Collaborative Research Term with respect
only to those BMPs. GDFs and Collaborative Factors
which have not yet been selected or designated as GI
Factors or MetaMorphix Factors.
which inventions or Patents are reasonably useful, necessary
or required for MetaMorphix and its Affiliates to manufacture,
use and/or sell MetaMorphix Products for use in the
MetaMorphix Field and (b) all Patents coming into the Control
of GI during the term of this Agreement, which, but for the
inclusion of such acquired Patents under this clause (b),
would prevent MetaMorphix and its Affiliates from practicing
under one or more of the Patents included under clause (a),
above. The GI Patent Rights believed to be existing by the
Parties as of the Effective Date are listed on Schedule 1.42
to this Agreement.
1.43 "GI PRODUCTS" shall mean GI Type A Products, GI Type B
Products and GI Type C Products.
1.44 "GI TYPE A PRODUCT" shall mean each GI Factor, including any
and all
(i) formulations, mixtures or compositions of such GI
Factor,
(ii) antibodies targeted against such GI Factor,
(iii) receptors for which such GI Factor is a ligand,
(iv) antisense molecules or ribozymes that modulate the IN
VIVO production of such GI Factor, and
(v) other products for research diagnostic or therapeutic
use containing such GI Factor or any of (i) through
(iv) above,
which, or which the manufacture use or sale of which, is
covered by a Valid Claim included within the Factor Patent
Rights.
1.45 "GI TYPE B PRODUCT" shall mean each MetaMorphix Factor,
including any and all
(i) formulations, mixtures or compositions of such .
MetaMorphix Factor,
(ii) antibodies targeted against such MetaMorphix Factor,
(iii) receptors for such MetaMorphix Factor is a ligand.
(iv) antisense molecules or ribozymes that modulate the IN
VIVO production of such MetaMorphix Factor. and
(v) other products for research, diagnostic or
therapeutic use containing such MetaMorphix Factor or
any of (i) through (iv) above,
which, or which the manufacture use or sale of which, is
covered by a Valid Claim included within the Factor Patent
Rights.
1.46 "GI TYPE C PRODUCT" shall mean each Additional GDF or each
Additional Collaborative Factor, including any and all
(i) formulations, mixtures or compositions of such
Additional GDF Factor or Additional Collaborative
Factor.
(ii) antibodies targeted against such Additional GDF
Factor or Additional Collaborative Factor,
(iii) receptors for which such Additional GDF or Additional
Collaborative Factor is a ligand,
(iv) antisense molecules or ribozymes that modulate the IN
VIVO production of such Additional GDF or Additional
Collaborative Factor, and
(v) other products for research, diagnostic or
therapeutic use containing such Additional GDF or
Additional Collaborative Factor or any of (i) through
(iv) above,
which, or which the manufacture use or sale of which, is
covered by a Valid Claim included within the Factor Patent
Rights.
1.47 "GI RIGHTS" shall mean the GI Know-How, the GI Patent Rights,
the GI Additional Factor Know-How, and the GI Additional
Factor Patent Rights.
1.48 "GPDC FACTORS" shall mean the Factors identified on Schedule
1.48 attached hereto.
1.49 "GROWTH AND DIFFERENTIATION FACTORS" or "GDFs" shall mean the
Factors in the TGF-(beta) Superfamily Discovered by (a) JHU
solely or (b) MetaMorphix solely on or before May 31, 1998 in
performing the Original Research, including, without
limitation, those Factors listed on Schedule1.49 attached
hereto. The GDFs shall not include GDF-16, GDF-17, BMPs,
Collaborative Factors, Additional BMPs, Additional GDFs,
Additional Collaborative Factors or Other TGF-beta Factors.
The GDFs may be assigned to or selected by either GI (as a GI
Factor) or MetaMorphix (as a MetaMorphix Factor) under this
Agreement. For JHU, GDFs shall be restricted to those Factors
listed on Schedule 1.49, together with any additional Factors
Discovered, on or before May 31, 1998, in (or in collaboration
with) Xx. Xxx'x JHU laboratory by Xx. Xxx and/or other JHU
faculty, students, fellows, and/or employees who have signed
an Invention and Disclosure Agreement.
1.50 "INAD" shall mean an Investigational New Animal Drug
application or its equivalent for initiating clinical trials
of a product in non-human animals in the United States or any
corresponding or equivalent foreign application, registration
or certification.
1.51 "IND" shall mean a Investigational New Drug application or its
equivalent for initiating clinical trials of a product in
humans in the United States or any corresponding or equivalent
foreign application, registration or certification.
1.52 "INVENTION AND DISCLOSURE AGREEMENT" shall mean the form
agreement attached hereto as Schedule 1.52.
1.53 "JHU ADDITIONAL FACTOR KNOW-HOW" shall mean any unpatented
information specifically relating to any Additional BMP,
Additional GDF or Additional Collaborative Factor produced in
Xx. Xxx'x JHU laboratory after May 31, 1998, and on or before
the end of the six (6) month period which begins on the day
after the end of the Sponsored Research Term, and for which
JHU has a licensable interest, which is reasonably useful,
necessary or required for GI, and its Affiliates, to
manufacture, use and/or sell GI Products as permitted under
this Agreement. For JHU, the JHU Know-How shall be restricted
to the information produced by Xx. Xxx and other JHU faculty,
students, fellows, and employees who have signed an Invention
and Disclosure Agreement.
1.54 "JHU Additional Factor PATENT RIGHTS" shall mean, with respect
to each Additional BMP. Additional GDF or Additional
Collaborative Factor, (a) all Patents covering inventions (as
such term is defined under United States Patent Law) made
solely by JHU after May 31, 1998 and on or before the end of
the six (6) month period which begins on the day after the end
of the Sponsored Research Term, which inventions or Patents
are reasonably useful, necessary or required for GI and its
Affiliates, to manufacture, use and/or sell GI Products as
permitted hereunder and (b) all Patents Controlled by or
coming into the Control of JHU (other than those Patents
assigned to JHU by faculty, students. fellows or employees who
are not working in (or in support of) Xx. Xxx'x JHU
laboratory) during the term of this Agreement, which, but for
the inclusion of such acquired Patents under this clause (b),
would prevent GI and/or any of its Affiliates, from practicing
under one or more of the Patents under clause (a) above. The
JHU Additional Factor Patent Rights believed by the Parties to
be existing as of the Effective Date are listed on Schedule
1.54 to this Agreement. The JHU Additional Factor Patent
Rights shall be restricted to the Patents covering inventions
made by Xx. Xxx and/or other JHU faculty, students, fellows,
and/or employees who have signed an Invention and Disclosure
Agreement.
1.55 "JHU KNOW-HOW" shall mean any unpatented information
specifically relating to a BMP, GDF, Collaborative Factor,
GDF-16 or GDF-17, which information is produced in Xx. Xxx'x
JHU laboratory
(i) on or before May 31, 1998 in performing the Original
Research, or
(ii) with respect to the license granted by JHU to
(x) GI hereunder, during the Sponsored Research
Term in performing.the Sponsored Research
(except to the extent that such information
relates specifically to GDF-16 or GDF-17),
or
(y) MetaMorphix hereunder, during the
Collaborative Research Term in performing
the Sponsored Research, only to the extent
that such information relates directly to
those BMPs, GDFs or Collaborative Factors
that have not been selected or designated as
either GI Factors or MetaMorphix Factors.
and for which JHU has a licensable interest, which is
reasonably useful, necessary or required for MetaMorphix or
GI, and their respective Affiliates, to manufacture, use
and/or sell their respective Products under this Agreement.
For JHU, the JHU Know-How shall be restricted to the
information produced by Xx. Xxx and/or other JHU faculty,
students, fellows, and/or employees who have signed an
Invention and Disclosure. Notwithstanding the forgoing, the
JHU Know-How shall also include any data and information
deemed to be included within this definition pursuant to
Sections 3.9 and/or 3.10 hereof.
1.56 "JHU PATENT Rights" shall mean, with respect to each BMP, GDF,
Collaborative Factor. GDF-16 or GDF-17, (a) all Patents
covering inventions (as such term is defined under United
States Patent Law) made solely by JHU
(i) on or before May 31, 1998 in performing the Original
Research or
(ii) with respect to the licensed granted by JHU to
(x) GI hereunder, during the Sponsored Research
Term in performing the Sponsored Research
(except to the extent that such inventions
relate specifically to GDF16 or GDF-17) or
(y) MetaMorphix hereunder, during the
Collaborative Research Term in performing
the Sponsored Research, only to the extent
that such information relates directly to
those BMPs, GDFs or Collaborative Factors
that have not been selected or designated as
either GI Factors or MetaMorphix Factors,
which inventions or Patents are reasonably useful, necessary
or required for GI or MetaMorphix and their respective
Affiliates, to manufacture, use and/or sell their Products as
permitted hereunder and (b) all Patents coming into the
Control of JHU (other than those Patents assigned to JHU by
faculty, students, fellows or employees who are not working in
(or in support of) Xx. Xxx'x JHU laboratory) during the term
of this Agreement, which, but for the inclusion of such
acquired Patents under this clause (b), would prevent GI or
MetaMorphix, and their respective Affiliates, from practicing
under one or more of the Patents under clause (a) above. The
JHU Patent Rights believed by the Parties to be existing as of
the Effective Date are listed on Schedule 1.56 to this
Agreement. The JHU Patent Rights shall be restricted to the
Patents covering inventions made by Xx. Xxx and/or other JHU
faculty, students, fellows, and/or employees who have signed
an Invention and Disclosure Agreement.
1.57 "JHU RIGHTS" shall mean the JHU Know-How and JHU Patent
Rights.
1.58 "JOINT KNOW-HOW" shall mean any unpatented information
specifically relating to a BMP. GDF or Collaborative Factor
(and in the case where such unpatented information was
produced by JHU and MetaMorphix, GDF-16 or GDF-17) which
information is produced by
(i) GI and MetaMorphix, or GI and JHU, or JHU and
MetaMorphix, as the case may be, on or before May 31,
1998 in performing the Original Research,
(ii) GI and MetaMorphix, during the Collaborative Research
Term. in performing the Collaborative Research, only
to the
extent that such information relates to those BMPs.
GDFs or Collaborative Factors that have not yet been
selected or designated as either a GI Factor or a
MetaMorphix Factor.
(iii) GI and JHU., during the Sponsored Research Term. in
performing the Sponsored Research, only to the extent
that, with respect to the licenses granted by
(x) JHU or GI to MetaMorphix hereunder, such
information relates to those BMPs, GDFs or
Collaborative Factors that have not yet been
selected or designated as either a GI Factor
or a MetaMorphix Factor, or
(y) JHU to GI hereunder, such information
relates to any. BMP, GDF or Collaborative
Factor, or
(iv) JHU and MetaMorphix, during the Sponsored Research
Term, in performing any collaborative or sponsored
research (as permitted in accordance with Section 3.9
hereof),
and for which each named Party has a licensable interest,
which is reasonably useful, necessary or required for GI or
MetaMorphix, and their respective Affiliates, to manufacture,
use and/or sell their Products under this Agreement. For JHU,
the Joint Know-How shall be restricted to the information
produced by Xx. Xxx and/or other JHU faculty, students,
fellows, and/or employees who have signed an Invention and
Disclosure Agreement.
1.59 "JOINT PATENT RIGHTS" shall mean, with respect to each BMP,
GDF or Collaborative Factor (arid in the case of inventions
made jointly by JHU and MetaMorphix. GDF-16 or GDF-17), (a)
all Patents covering inventions (as such term is defined under
United States Patent Law) made by
(i) GI and MetaMorphix jointly, or GI and JHU jointly, or
JHU and MetaMorphix jointly, as the case may be, on
or before May 31, 1998 in performing the Original
Research,
(ii) GI and MetaMorphix, during the Collaborative Research
Term, in performing the Collaborative Research, only
to the(.) extent that such inventions relate to those
BMPs, GDFs or Collaborative Factors that have not yet
been selected or designated as either a GI Factor or
a MetaMorphix Factor,
(iii) GI and JHU, during the Sponsored Research Term, in
performing the Sponsored Research, only to the extent
that, with respect to the licenses granted by
(x) JHU or GI to MetaMorphix hereunder, such
inventions relate to those BMPs, GDFs or
Collaborative Factors that have not yet been
selected or designated as either a GI Factor
or a MetaMorphix Factor, or
(y) JHU to GI hereunder, such inventions relate
to any BMP, GDF or Collaborative Factor, or
(iv) JHU and MetaMorphix, during the Sponsored Research
Term, in performing any collaborative or sponsored
research (as permitted in accordance with Section 3.9
hereof),
which inventions or Patents are reasonably useful, necessary
or required for GI or MetaMorphix, and their respective
Affiliates, to manufacture, use and/or sell their Products for
any use and (b) all Patents coming into the Control of GI and
MetaMorphix jointly, or GI and JHU jointly, or JHU and
MetaMorphix jointly, as the case may-be, during the term of
this Agreement, and for which each named Party has a
licensable interest, which, but for the inclusion of such
acquired Patents under this clause (b), would prevent GI or
MetaMorphix. and their respective Affiliates, from practicing
under one or more of the Patents under clause (a) above. The
Joint Patent Rights believed by the Parties to be existing as
of the Effective Date are listed on Schedule 1.59 to this
Agreement. For JHU, the Joint Patent Rights shall be
restricted to the Patents covering inventions made by Xx. Xxx
and/or other JHU faculty, students, fellows, and/or employees
who have signed an Invention and Disclosure Agreement.
1.60 "JOINT RIGHTS" shall mean the Joint Know-How and Joint Patent
Rights.
1.61 "LETTER OF INTENT" shall mean that certain Letter of Intent
entered into by GI, MetaMorphix and JHU as of January 4, 1999,
which Letter of Intent sets forth, INTER ALIA, the Parties
intention to enter into this Agreement and the obligation of
GI to make a certain payment to JHU.
1.62 "METAMORPHIX FACTORS" shall mean (a) each GDF listed on
Schedule 1.62 as of the Effective Date: (b) each BMP, GDF or
Collaborative Factor subsequently selected by MetaMorphix,
which upon such selection shall be listed on Schedule 1.62 and
(c) each BMP, GDF or Collaborative Factor belonging to a TGF-R
Class which includes one or more of the BMPs, GDFs or
Collaborative Factors identified in clauses (a) or (b). BMPs,
GDFs and Collaborative Factors which would belong to both (x)
a TGF-(beta) Factor Class which includes a MetaMorphix Factor
and (y) a TGF-(beta) Factor Class which includes a GI Factor,
based on the definition of TGF-(beta) Factor Class set forth
in this Agreement. are classified pursuant to Section 1.81,
below. For the
sake of clarity. MetaMorphix Factors shall not include GDF-I6
or GDF-1 7 notwithstanding the fact that JHU is granting to
MetaMorphix a license hereunder with respect to GDF-16 and
GDF-17.
1.63 "METAMORPHIX FIELD" shall mean all potential uses in non-human
animals, including, without limitation, (i) non-human animal
health. (ii) livestock . products, (iii) the diagnosis and/or
the prophylactic or therapeutic treatment of diseases or
disorders in non-human animals, and/or (iv) the development
and production of transgenic non-human animals for use as
agricultural products.
1.64 "METAMORPHIX KNOW-HOW" shall mean any unpatented information
specifically relating to a BMP, GDF or Collaborative Factor
which information is (a) produced by MetaMorphix
(i) on or before May 31, 1998 in performing the Original
Research, or
(ii) during the Collaborative Research Term in performing
the Collaborative Research only to the extent that
such information relates to those BMPs, GDFs or
Collaborative Factors which have not yet been
selected or designated as either GI Factors or
MetaMorphix Factors,
and for which MetaMorphix has a licensable interest and (b) is
reasonably useful, necessary or required for GI and its
Affiliates to manufacture, use and/or sell its Products under
this Agreement. Notwithstanding the foregoing. the MetaMorphix
Know-How shall also include any data and information deemed to
be included within this definition pursuant to Sections 3.9
and/or 3.1 0 hereof.
1.65 "METAMORPHIX PATENT RIGHTS" shall mean, with respect to each
BMP, GDF or Collaborative Factor, (a). all Patents covering
inventions (as such term is defined under United States Patent
Law) made solely by MetaMorphix
(i) on or before May 31 , 1998 in performing the Original
Research or
(ii) during the Collaborative Research Term in performing
the Collaborative Research, to the extent such
inventions relate to those BMPs, GDFs or
Collaborative Factors that have not yet been selected
or designated as either GI Factors or MetaMorphix
Factors,
which inventions are reasonably useful, necessary or required
for GI and its Affiliates to manufacture, use and/or sell GI
Products for any use and (b) all Patents coming into the
Control of MetaMorphix during the term of this Agreement,
which. but for the inclusion of such Patents under this clause
(h) would prevent GI and its Affiliates from practicing under
one or more of the Patents under clause (a) above. The
MetaMorphix Patent Rights believed by the Parties to be
existing as of the Effective Date are listed in Schedule 1.65
attached hereto. -
1.66 "METAMORPHIX PRODUCT" shall mean each MetaMorphix Factor,
including any and all
(i) formulations, mixtures or compositions of such
MetaMorphix Factor,
(ii) antibodies targeted against such MetaMorphix Factor,
(iii) receptors for which such MetaMorphix Factor is a
ligand,
(iv) antisense molecules or ribozymes that modulate the in
vivo production of such MetaMorphix Factor, and
(v) other products for research, diagnostic or
therapeutic use containing such MetaMorphix Factor or
any of (i) through (iv) above.
Which, or which the manufacture use or sale of which, is
covered by a Valid Claim included within the Factor Patent
Rights.
1.67 "METAMORPHIX Rights" shall mean the MetaMorphix Know-How and
MetaMorphix Patent Rights.
1.68 "NET SALES" shall mean, with respect to any Product or Other
TGF-(beta) Product, the aggregate United States dollar
equivalent of gross revenues derived by or payable to a
selling Party, its Affiliates and sublicensees from or on
account of the sale or distribution of such Product or Other
TGF-(beta) Product, as applicable, to Third Parties, less (a)
reasonable credits or allowances, if any, actually granted on
account of price adjustments, recalls, rejection or return of
items previously sold, (b) excises, sales taxes, value added
taxes, consumption taxes, duties or other taxes imposed upon
and paid with respect to such sales (excluding income or
franchise taxes of any kind) and (c) separately itemized
insurance and transportation costs incurred in shipping such
Products or Other TGF-(beta) Products, as applicable, to such
Third Parties. No deduction shall be made for any item of cost
incurred by a selling Parry, its Affiliates or sublicensees in
preparing, manufacturing, shipping or selling Products or
Other TGF-beta Products, as applicable, except
as permitted pursuant to clauses (a). (b) and (c) of the
foregoing sentence. Net sales shall not include any transfer
between a selling Party and any of its Affiliates or
sublicensees for resale, but shall include the resale price to
a Third Party payable to such Affiliates or sublicensees.
Notwithstanding the provisions of the first paragraph of this
Section 1.68. (a) if a selling Party or an Affiliate or
sublicensee sells Products or Other TGF-(beta) Products, as
applicable, to a distributor which is not an Affiliate, the
gross revenues derived by or payable to that selling Party or
the applicable Affiliate or sublicensee on account of such
sale shall be the gross revenues received by the selling Party
and/or the applicable Affiliate or sublicensee from the sale
of such Products or Other TGF-(beta) Products, as applicable,
to the distributor, and (b) if the distributor is an
Affiliate, then gross revenues derived by or payable to that
selling Party or the applicable Affiliate or sublicensee shall
be those received from the sale to the first Third Party which
is not an Affiliate.
In addition, in order to ensure the full royalty payments
contemplated under this Agreement, in the event any Product or
Other TGF-(beta) Product, as applicable, is sold to any
corporation, firm or association with which GI or MetaMorphix,
as the case may be, has an agreement, understanding or other
arrangement with respect to other forms of consideration (for
example, an option to purchase stock or actual stock
ownership; an arrangement involving division of profits or
special rebates or allowances) royalties shall be calculated
for sales of such Products or Other TGF-(beta) Products, as
applicable, based upon the greatest of (a) the price at which
the purchaser of such Products or Other TGF-(beta) Products,
as applicable, resells such Products or Other TGF-(beta)
Products to the end user or (b) the fair market value of such
Products or Other TGF-(beta) Products, as applicable, or (c)
the price of such Products or Other TGF-(beta) Products, as
applicable, paid by the purchaser.
In the event that a selling Party or any of its Affiliates or
sublicensees shall make any transfer of Products or Other
TGF-(beta) Products to Third Parties for other than monetary
value, such transfer shall be considered a sale hereunder for
accounting and royalty purposes. Net sales for any such
transfers shall be determined on a country-by-country basis
and shall be the average price of "arms length" sales by that
selling Party, its Affiliates or sublicensees in such country
during the royalty reporting period in which such transfer
occurs or, if no such "arms length" sales occurred in such
country during such period, during the last period in which
such "arms length" sales occurred. If no "arms length" sales
have occurred in a particular country, Net Sales for any such
transfer in such country shall be the average price of "arms
length" sales in all countries by that selling Party.
Notwithstanding the foregoing, no transfer of Products or
Other TGF-(beta) Products for testing, pre-clinical, clinical
or developmental purposes or as
samples shall be considered a sale hereunder for accounting
and royalty purposes.
1.69 "ORIGINAL RESEARCH" shall mean the research activities
conducted, pursuant to the 1994 Collaboration Agreement. by
the Parties prior to June 1. 1998, to rapidly Discover,
characterize and evaluate the BMPs, GDFs and Collaborative
Factors for commercial development. For JHU, the Original
Research was restricted -to the research sponsored by
MetaMorphix under Section 6.1 of the 1994 Collaboration
Agreement and conducted in (or in collaboration with) Xx.
Xxx'x JHU laboratory by Xx. Xxx and other JHU faculty,
students, fellows, and employees who had signed an Invention
and Disclosure Agreement.
1.70 "OTHER TGF-(BETA) FACTORS" shall mean the Factors in the
TGF-(beta) Superfamily which are not BMPs, GDFs, Collaborative
Factors, Additional BMPs, Additional GDFs or Additional
Collaborative Factors. Other TGF-(beta) Factors shall include,
without limitation, (a) Factors acquired by a Party from a
Third Party; (b) Factors first sequenced by a Party (either
solely or jointly) pursuant to a preexisting collaboration
with a Third Party (for example, without limitation, the GPDC
Factors, which were FIRST sequenced by GI pursuant to a
preexisting collaboration with its Japanese partner,
Yamanouchi Pharmaceutical Company Ltd., and any Factors first
identified by GI using "gene chip" technology developed
pursuant to an agreement with Affymetrix. Inc.): (c) with
respect to MetaMorphix, only for determining royalties that
may be payable by MetaMorphix to GI, the TGF(beta) Factors
known to JHU and MetaMorphix as GDF-16 or GDF-17; and (d)
Factors first sequenced by a Party (either solely or jointly)
pursuant to any future collaborations with Third Parties.
1.71 "OTHER TGF-(BETA) PRODUCTS" shall mean each Other TGF-(beta)
Factor, including any and all
(i) formulations, mixtures or compositions of such Other
TGF-(beta) Factor,
(ii) antibodies targeted against such Other TGF-(beta)
Factor,
(iii) antisense molecules or ribozymes that modulate the IN
VIVO production of such Other TGF-(beta) Factor, and
(iv) other products for research, diagnostic or
therapeutic use containing such Other TGF-(beta)
Factor or any of (i) through (iii) above.
1.72 "PATENTS" shall mean all patents and patent applications and
foreign counterparts thereof (which for all purposes of this
Agreement shall be
deemed to include certificates of invention and applications
for certificates of invention and priority rights), together
with any reissues, extensions or other governmental acts which
effectively extend the period of exclusivity by the patent
holder. substitutions, confirmations, registrations,
revalidations, additions, continuations,
continuations-in-part, or divisions of or to any of the
foregoing.
1.73 "PLA" shall mean a Product License Application or its
equivalent in the United States or any corresponding foreign
application, registration, or certification.
1.74 "PRODUCT(S)" shall mean the MetaMorphix Products, the GI Type
A Products, the GI Type B Products, and/or the GI Type C
Products, as applicable.
1.75 "PROMISSORY NOTE" shall mean that certain promissory note
dated February 9, 1998, executed by MetaMorphix as the maker,
where GI is the lender, together with the First Allonge (dated
August 18, 1998) and the Second Allonge (dated October 30,
1998) thereto.
1.76 "RESEARCH MANAGEMENT COMMITTEE" or "RMC" is defined in Section
3.4.3 of this Agreement.
1.77 "SPONSORED RESEARCH" shall mean the research activities
conducted, pursuant to this Agreement, (i) by JHU, to rapidly
characterize and evaluate the BMPs. GDFs and Collaborative
Factors for commercial development by GI and/or MetaMorphix
and (ii) by JHU and GI to rapidly Discover characterize and
evaluate the Additional BMPs, Additional GDFs and Additional
Collaborative Factors for commercial development by GI. For
JHU, the Sponsored Research to be conducted hereunder shall be
limited to the research sponsored by GI under Section 3.3
hereof and conducted in (or in collaboration with) Xx. Xxx'x
JHU laboratory by Xx. Xxx and/or other JHU faculty, students,
fellows, and/or employees who have signed an Invention and
Disclosure Agreement.
1.78 "SPONSORED RESEARCH TERM" shall have the meaning set forth in
Section 3.3.1 hereof.
1.79 "TGF-(BETA) ADDITIONAL FACTOR CLASS" shall mean all Additional
Factors and Other TGF-(beta) Factors which share eighty
percent (80%) amino acid sequence identity within their mature
protein coding regions. The first Additional BMP, Additional
GDF or Additional Collaborative Factor in a TGF-(beta) Class
Discovered by a GI and/or JHU is the "First Member"; any other
Factors Discovered by GI and/or JHU in that TGF-(beta) Class
are "Subsequent Members."
1.80 "TGF-(BETA) CLASS" shall mean a TGF-(beta) Factor Class or a
TGF-(beta) Additional Factor Class, as applicable.
1.81 "TGF-(BETA) FACTOR CLASS" shall mean all BMPs, GDFs,
Collaborative Factors, Other TGF-(beta) Factors and, as
between JHU and MetaMorphix only. GDF-I6 and GDF-17, which
share eighty percent (80%) amino acid sequence identity within
their mature protein coding regions. The first BMP, GDF or
Collaborative Factor in a TGF-(beta) Class Discovered by a
Party (or Parties) is the "First Member"; any other Factors
Discovered by a Party (or Parties) in that TGF-(beta) Class
are "Subsequent Members." However, any BMP. GDF or
Collaborative Factor which shares eighty percent (80%) amino
acid sequence identity within its mature protein coding region
with both (a) a previously classified GI Factor and (b) a
previously classified MetaMorphix Factor shall be classified,
at the RMC's discretion after consultation with JHU, as (x) a
Subsequent Member of the TGF-(beta) Class containing the GI
Factor referred to in Subsection (a) of this Section or (y) a
Subsequent Member of the TGF-(beta) Class containing the
MetaMorphix Factor referred to in Subsection (b) of this
Section or (z) the First Member of a new TGF-(beta) Class for
purposes of this Agreement.
1.82 "TGF-(BETA) FACTORS" shall mean the BMPs, the GDFs, the
Collaborative Factors, the Additional BMPs. the Additional
GDFs, the Additional Collaborative Factors. GDF-16. GDF-17 and
the Other TGF-(beta) Factors, being all of the Factors in the
TGF-(beta) Superfamily.
1.83 "TGF-(BETA) SUPERFAMILY" shall mean (a) all of the molecules
containing the amino acid pattern which reflects the conserved
cysteine structure CX{24,29}CX{3}CX{25.38}CX{30.35}CXC and (b)
any other molecules which the RMC, after consultation with
JHU, reasonably determines are properly considered members of
the TGF-(beta) Superfamily.
1.84 "THIRD PARTY(IES)" shall mean any person(s) or entity(ies)
other than JHU, MetaMorphix. GI and their respective
Affiliates.
1.85 "USE PATENT" shall mean, with respect to GI. a Patent within
the GI Patent Rights or the Joint Patent Rights, and with
respect to MetaMorphix, a Patent within the MetaMorphix Patent
Rights or Joint Patent Rights, and with respect to JHU, a
Patent within the JHU Patent Rights or the Joint Patent
Rights, which Patent contains claims directed to a use of, or
method of treatment using, a Product, and which does not
contain composition claims directed to such Product.
1.86 "VALID CLAIM" shall mean, with respect to the manufacture, use
or sale of a Product, (a) a claim of an unexpired patent which
shall not have been withdrawn, canceled or disclaimed, nor
held invalid or unenforceable by a court of competent
jurisdiction in an unappealed or unappealable decision or
(b) a claim of a patent application which is either (i) the
subject of a pending patent interference proceeding or (ii)
supported by the disclosure of such application or any prior
filed patent application for a cumulative period not exceeding
seven (7) years from the earliest date of such supporting
disclosure for such claim in any such patent application.
2. CONDITIONS PRECEDENT; THE CLOSING.
2.1 GOVERNMENT APPROVALS.
2.1.1 THE PARTIES' OBLIGATIONS. Each Party shall use its
good faith efforts to eliminate any concern on the
part of any court or government authority regarding
the legality of the proposed transaction, including,
if required by federal or state antitrust
authorities, promptly taking all steps to secure
government antitrust clearance, including, without
limitation, cooperating in good faith with any
government investigation including the prompt
production of documents and information demanded by a
second request for documents and of witnesses if
requested.
2.1.2 ADDITIONAL APPROVALS. Each Party will cooperate and
use respectively all reasonable efforts to make all
other registrations, filings and applications, to
give all notices and to obtain as soon as practicable
all governmental or other consents, transfers,
approvals, orders, qualifications, authorizations,
permits and waivers, if any, and to do. all other
things necessary or desirable for the consummation of
the transactions as contemplated hereby. Neither
Party shall be required, however, to divest products
or assets or materially change its business if doing
so is a condition of obtaining any governmental
approvals of the transactions contemplated by this
Agreement.
2.2 CORPORATE APPROVALS.
2.2.1 METAMORPHIX DIRECTOR AND SHAREHOLDER APPROVAL.
MetaMorphix represents and warrants to GI that each
member of its board of directors (excluding those
Directors who are employed by GI and, for such reason
recuse themselves from voting on this transaction)
and each of its shareholders that hold twenty-five
thousand (25.000) or more shares of MetaMorphix
common or preferred stock of any series or class has
approved MetaMorphix entering into this Agreement,
performing its obligations hereunder and consummating
the transactions contemplated hereby.
2.2.2 GENETICS INSTITUTE APPROVAL. GI represents and
warrants that it has obtained all necessary
management approvals to enter into this
Agreement, including, without limitation, any
approvals from GI's parent company. American Home
Products Corporation.
2.3 THE CLOSING.
2.3.1 TIME AND PLACE. The Closing of the transactions
contemplated hereby shall take place at the offices
of the Wyeth-Ayerst Laboratories Division of American
Home Products Corporation. St. Davids, Pennsylvania,
at 10:00 A.M. (local time) on a date to be mutually
agreed upon by the Parties, which date shall be
within three (3) business days after the execution of
this Agreement by each of the Parties and the
delivery of such fully executed Agreement to each of
the Parties.
2.3.2 GI DELIVERABLES. At the Closing, GI shall
(i) pay to MetaMorphix the amounts set forth in
Sections 8.4, 10.2.1 and 10.2.2 hereof. to
the extent such amounts have-not been paid
by GI prior to the Closing;
(ii) in accordance with Section 8.1 hereof,
deliver to MetaMorphix an executed
Assignment Agreement (substantially in the
form of Schedule 8.IA hereof) and an
executed Stock Power (substantially in the
form of Schedule 8.IB attached hereto) for
each MetaMorphix stock certificate, along
with the original stock certificate, held by
GI, for the assignment to MetaMorphix of two
million seven hundred thousand (2,700,000)
shares of its MetaMorphix Series A
Convertible Preferred Stock and nine hundred
thousand shares (900,000) shares (i.e.. all)
of its MetaMorphix Series B Convertible
Preferred Stock, each of which are owned by
GI as of the date this Agreement was signed
by the Parties;
(iii) in accordance with Section 8.2 hereof, sign
the Third Allonge to the Promissory Note
(substantially in the form of Schedule 8.2
hereof); and
(iv) in accordance with Section 8.6 hereof, sign
and deliver to MetaMorphix, JHU and Xx. Xxx,
the Termination Agreement (substantially in
the form of Schedule 8.6 hereof)
2.3.3 METAMORPHIX DELIVERABLES. At the Closing, MetaMorphix
shall
(i) in accordance with Section 8.2 hereof, sign
and deliver to GI the Third Allonge to the
Promissory Note (substantially in the form
of Schedule 8.2 hereof:
(ii) in accordance with Section 8.1 hereof and
the Assignment Agreement to be signed at the
Closing, after receipt of the Assignment
Agreement, the Stock Power and the original
MetaMorphix stock certificates, a new
original stock certificate in GI's name
representing the two hundred thousand
(200,000) shares of the MetaMorphix Series A
Convertible Preferred Stock to be retained
by GI:
(iii) in accordance with Section 8.6 hereof, sign
and deliver to GI, JHU and Xx. Xxx, the
Termination Agreement (substantially in the
form of Schedule 8.6 hereof); deliver to GI
a written opinion of MetaMorphix' legal
counsel that (a) this Agreement and the
transactions contemplated hereby have been
unanimously approved by (x) MetaMorphix'
Board of Directors and (y) those MetaMorphix
shareholders that own twenty-five thousand
(25,000) or more shares of MetaMorphix stock
of any class or series. and (b) MetaMorphix
has the requisite authority and right to
enter into this Agreement and perform all of
its obligations hereunder, which opinion
shall be in a form customary in like
transactions.
2.3.4 JHU DELIVERABLES. At the Closing, JHU shall in
accordance with Section 8.6 hereof, sign and deliver
to GI, MetaMorphix and Xx. Xxx, the Termination
Agreement (substantially in the form of Schedule 8.6
hereof).
2.3.5 XX. XXX DELIVERABLES. At the Closing, Xx. Xxx shall
in accordance with Section 8.6 hereof, sign and
deliver to GI, MetaMorphix and JHU, the Termination
Agreement (substantially in the form of Schedule 8.6
hereof).
3. THE RESEARCH.
3.1 BACKGROUND and Goals. In conducting the Original Research in
accordance with the 1994 Collaboration Agreement, a number of
GDFs, BMPs and/or Collaborative Factors were Discovered by the
Parties. The Parties desire to continue their efforts to
evaluate and characterize such Factors and any other
Factors that were otherwise subject to the terms and
conditions of the 1994 Collaboration Agreement. but wish to
conduct such activities under a restructured relationship.
Under such restructured relationship. GI-and JHU hereby form a
sponsored research relationship whereby GI will provided
certain sponsored research funding to JHU for use by JHU in
evaluating and characterizing the GDFs, BMPs and Collaborative
Factors and in Discovering, evaluating and characterizing
Additional Factors. Additionally. until the expiration of the
Collaborative Research Term, GI and MetaMorphix will continue
to collaborate with respect to the evaluation and
characterization of the GDFs, BMPs and Collaborative Factors
which have not yet been selected or designated as either GI
Factors or MetaMorphix Factors so that GI and MetaMorphix may
utilize such information in selecting such Factors as either
GI Factors or MetaMorphix Factors. As part of such
collaboration GI will make available to MetaMorphix relevant
information it receives from JHU under the Sponsored Research
regarding such GDFs, BMPs and Collaborative Factors.
3.2 THE ORIGINAL RESEARCH.
3.2.1 FUNDING. JHU acknowledges and agrees that it has
received all payments due to it from MetaMorphix
and/or GI with respect to its conduct of the Original
Research.
3.2.2 DISCLOSURE OF INFORMATION.
3.2.2.1 DISCLOSURE OF SEQUENCES. Each Party
represents and warrants to the other Parties
that, prior to the Effective Date, it has
reported and disclosed to the other Parties
the cDNA sequence(s) encoding the
mature/processed protein region of any BMPs,
GDFs or Collaborative Factors Discovered by
that Party in conducting the Original
Research on or before May 31, 1998.
3.2.2.2 DISCLOSURE OF OTHER INFORMATION. Each Party
shall promptly report and disclose to the
other Parties, in writing, the applicable
(x) Factor Rights developed in conducting
the Original Research and (y) Data developed
in conducting the Original Research as
follows:
(i) in connection with the preparation,
filing and maintenance by a Party
of a Patent covering such Factor
Rights, or a review of information
by the Parties prior to public
disclosure, the disclosure of such
Factor Rights and Data may be
limited to that Factor (or those
Factors) which is (are) the
subject of the Patent action or
public disclosure: and
(ii) in connection with notice by GI or
MetaMorphix of its intention to
select, or trigger the selection
of, any Available Factor under
Article 5, below, the disclosure of
such Factor Rights and Data shall
not be limited to a particular
Factor, but shall include
information on ALL then-Available
Factors which the disclosing Party,
acting in good faith, determines is
likely to be material to the
selecting Party in making its
selection decision, all according
to the procedures set forth in
Article 5 of this Agreement.
3.3 THE SPONSORED RESEARCH.
3.3.1 SPONSORED RESEARCH TERM. The Sponsored Research shall
be conducted by JHU as set forth herein beginning on
June 1, 1998 and shall continue through November 30,
1999 or until such later date as JHU and GI may
mutually agree in writing (the "Sponsored Research
Term"). Any such extension of the Sponsored Research
Term shall have no effect upon the length of the
Collaborative Research Term, and shall not be
considered to be an extension of the Original
Research Term.
3.3.2 FUNDING. GI shall provide to JHU a total of one
million one hundred eighty-two thousand four hundred
sixty two dollars ($1,182,462) in sponsored research
funding, four hundred fifty six thousand one hundred
thirty eight dollars ($456.138) of which was paid to
JHU on or about January 7. 1999 pursuant to the
Letter of Intent. The remaining seven hundred twenty
six thousand three hundred twenty four dollars
($726.324) will be provided to JHU in installments as
follows:
Amount of Payment Date Payment Is Due
----------------- -------------------
$181.581 within ten (10) days after
the Effective Date
$181,581 March 1, 1999
$181.581 June 1, 1999
$181.581 September 1, 1999
Additionally. MetaMorphix had agreed to purchase and
donate to JHU for use by Xx. Xxx'x laboratory in
carrying out research activities that MetaMorphix had
agreed to sponsor at JHU during the period commencing
on December 1. 1997 and ending on November 30. 1998.
up to two hundred fifty thousand dollars ($250.000)
worth of equipment and supplies. GI agrees to
partially reimburse MetaMorphix for such supply
purchased by paying to MetaMorphix thirty seven
thousand four hundred ninety dollars ($37.490) which
amount will be paid on the Effective Date. Each of
GI. JHU and MetaMorphix acknowledge and agree that
the payment (in the amount of $456,138) made to JHU
pursuant to the Letter of Intent and the thirty seven
thousand four hundred ninety dollars ($37.490)
payment to be made to MetaMorphix are being made by
GI to assume previously unpaid sponsored research
funding obligations of MetaMorphix to JHU and that,
inconsideration of GI's assuming such obligations.
MetaMorphix relinquishes all rights and licenses to
any inventions, discoveries, Patents and know-how
relating to any Additional GDFs or Additional
Collaborative Factors Discovered by JHU on or after
June 1. 1998. 'MetaMorphix further acknowledges that,
as provided in Section 6.3.3 below, JHU has the right
to grant and is granting to GI an exclusive license
with respect to any such Additional Factors.
3.3.3 USE OF FUNDS; BUDGETS. JHU shall use the funds
provided under Section 3.3.2 solely in support of
activities in Xx. Xxx'x JHU laboratory, or in such
other JHU laboratories or core facilities which are
supporting Xx. Xxx'x laboratory, under the Sponsored
Research to (i) characterize GDFs and Collaborative
Factors for commercialization by GI and/or
MetaMorphix and their respective sublicensees, and
(ii) to Discover and characterize Additional GDFs and
Additional Collaborative Factors for
commercialization by GI and its sublicensees, as
provided herein. During the Sponsored Research Term.
JHU. except as expressly permitted under Section 3.9
hereof. shall not use funds provided by a commercial
entity, other than GI to support Xx. Xxx'x activities
under the Sponsored Research. JHU, acting through Xx.
Xxx, has prepared an initial budget to guide JHU's
expenditures for its Sponsored Research activities
during the Sponsored Research Term, a copy of which
is attached hereto as Schedule 3.3.3. The Sponsored
Research funding may be increased only by written
agreement of GI and JHU. In the event that GI and JHU
agree to extend the Sponsored Research Term, any
unexpended funds will be carried over for use in the
following year.
3.3.4 SPONSORED RESEARCH PLAN. A' Sponsored Research Plan,
which sets forth JHU's specific activities under the
Sponsored Research and
coordinates JHU's and GI's respective activities
under the Sponsored Research. is attached hereto as
Schedule 3.3.4. With respect to JHU's activities
under the Sponsored Research. the Sponsored Research
Plan sets forth Xx. Xxx'x research activities for the
full Sponsored Research Term: this portion of the
Sponsored Research Plan has been reviewed and
approved by GI. and shall be updated on an as needed
basis as agreed in writing by Xx. Xxx and GI. With
respect to coordination of the Parties' activities
under the Sponsored Research, the Sponsored Plan
shall be reviewed each calendar quarter by the Xx.
Xxx and GI. JHU and GI each shall endeavor to carry
out their portion of the Sponsored Research Plan
consistent with the descriptions of Schedule 3.3.4.
33.5 SPONSORED RESEARCH ACTIVITIES. For JHU, the Sponsored
Research shall be conducted in Xx. Xxx'x JHU
laboratory, only by Xx. Xxx and other JHU faculty,
students, fellows and employees who have signed an
Invention and Disclosure Agreement, using Sponsored
Research funding provided by GI under this Section
3.3; PROVIDED, HOWEVER, that (i) JHU may utilize its
genetics core sequencing facility and other core
facilities in support of its Sponsored Research
activities under this Agreement and (ii) Xx. Xxx may
collaborate with other JHU laboratories in performing
the Sponsored Research, PROVIDED THAT (x) such
collaboration is consistent with both the Sponsored
Research Plan and JHU's representations and
warranties set forth in Section 12.4 of this
Agreement and (y) prior to commencement of such
collaboration, JHU, acting through Xx. Xxx, gives GI
written notice of such proposed collaboration and (z)
the JHU faculty, students, fellows and employees
working in such other JHU laboratory have signed an
Invention and Disclosure Agreement. GI shall review
JHU's activities under the Sponsored Research. During
the Sponsored Research Term and any extension of the
Sponsored Research Term that JHU and GI may agree
upon and for a period of six (6) months thereafter.
JHU shall not collaborate or otherwise, directly or
indirectly, work with MetaMorphix or any Third Party
with respect to the Discovery of any Factor or
characterization of any Additional Factor.
3.3.6 INVENTION and Disclosure Agreement. JHU, acting
through Xx. Xxx, shall require all JHU faculty,
students, fellows and employees working in Xx. Xxx'x
JHU laboratory or in any other JHU laboratory with
which Xx. Xxx collaborates, as provided in Section
3.3.4. above, who are engaged in the Discovery,
evaluation and/or characterization of TGF-R Factors
to sign an Invention and Disclosure Agreement. In the
event Xx. Xxx desires to disclose
specific GI and/or MetaMorphix Confidential
Information to any such JHU faculty, students.
fellows or employees, prior to such disclosure JHU,
acting through Xx. Xxx shall require such JHU
faculty, students, fellows and employees to sign a
Confidentiality Agreement in the form appearing as
Schedule 3.3.6 to this Agreement covering such
specific Confidential Information. JHU agrees to
promptly provide to GI a copy of each such Invention
and Disclosure Agreement and Confidentiality
Agreement that is entered into in accordance with
this Section 3.3.5 or any other provision of this
Agreement. Additionally, within thirty (30) days
after the Closing; JHU shall provide to GI a copy of
each Invention and Disclosure Agreement and
Confidentiality Agreement that had been entered into
prior to the Closing.
3.3.7 DISCLOSURE OF INFORMATION.
3.3.7.1 DISCLOSURE OF SEQUENCES. JHU agrees to
promptly (within twenty-five (25) days after
Discovery) report and disclose to GI the
cDNA sequence(s) encoding the
mature/processed protein region of any
Additional GDFs or Additional Collaborative
Factors Discovered by JHU during the
Sponsored Research Term or the six (6) month
period following the end of the Sponsored
Research Term.
3.3.7.2 DISCLOSURE OF OTHER INFORMATION. Subject to
Section 3.3.7.3, below, JHU, from time to
time, but no less often than once each
Calendar Quarter, during the Sponsored
Research Term (including any extensions
thereof), shall disclose to GI (x) any
Factor Rights (other than the cDNA sequences
promptly disclosed under Section 3.3.7.1,
above) and (y) any Data which relates to the
Sponsored Research. GI may, at its sole
option, either (i) disclose toMetaMorphix or
(ii) require JHU to disclose toMetaMorphix.
any such Factor Rights and Data which
relates to one or more of the BMPs, GDFs or
Collaborative Factors that have not yet
become either a GI Factor or a MetaMorphix
Factor in accordance with the selection
process set forth in Article 5 below,
PROVIDED, HOWEVER, that JHU shall not
disclose any such Factor Rights or Data to
MetaMorphix without GI's prior consent,
which consent shall not be unreasonably
withheld. Notwithstanding the foregoing,
upon GI's request, which request may be made
from time to time, JHU shall promptly
(within fourteen (14) days of such request)
disclose to GI all such Factor Rights and
Data which JHU has not previously disclosed
to GI.
Notwithstanding the foregoing. JHU agrees
that it will not disclose to MetaMorphix any
Factor Rights or Data pertaining to any GI
Factor (after such Factor has been selected
by GI in accordance with Article 5 hereof)
or to any Additional Factor without GI's
prior written consent. which consent may be
provided or withheld in GI's sole
discretion.
3.3.7.3 MANDATORY DISCLOSURE OF OTHER INFORMATION.
Notwithstanding Section 3.3.7.2, above, JHU
shall promptly report and disclose to GI
and, if GI requests JHU to do so, to
MetaMorphix, in writing, the applicable (x)
Factor Rights and (y) Data, as follows:
i. in connection with the preparation,
filing and maintenance by JHU of a
Patent covering the Factor Patent
Rights, or a review of information
by the Parties prior to public
disclosure, the disclosure of such
Factor Rights and Data may be
limited to that Factor (or those
Factors) which is (are) the subject
of the Patent action or public
disclosure;
ii. in connection with notice by GI or
MetaMorphix of its intention to
select, or trigger the selection
of, any Available Factor under
Section 5, below, the disclosure of
such Factor Rights and Data shall
not be limited to a particular
Factor, but shall include
information on all then-Available
Factors which the disclosing Party,
acting in good faith, determines is
likely to be material to the
selecting Party in making its
selection decision, all according
to the procedures set forth in
Section 5 of this Agreement; and
iii. in connection with submission of
JHU's annual report, as provided in
Subsection 3.3.8, below.
3.3.8 ANNUAL REPORTS. Each of GI and JHU shall prepare and
submit to the other, within thirty (30) days of the
end of the Sponsored Research Term and within thirty
(30) days of the end of each year of any extension of
the Sponsored Research Term, a report summarizing
that Party's activities under the Sponsored Research
during the preceding year.
3.3.9 EQUIPMENT. Pursuant to the 1994 Collaboration
Agreement, JHU, utilizing a portion of the funds it
received from MetaMorphix,
purchased tissue culture equipment, molecular biology
equipment and protein test equipment identified in
Schedule 3.3.9 attached hereto. In accordance with
the terms of the 1994 Collaboration Agreement. JHU
owns such equipment and shall continue to own such
equipment. JHU agrees that during the Sponsored
Research Term, such equipment will be located in Xx.
Xxx'x JHU laboratory and will be used primarily by
JHU personnel engaged in the . Sponsored Research
under this Agreement.
3.3.10 EXCLUSIVITY OF RESEARCH. During the Sponsored
Research Term and for a period of six (6) months
following the expiration of the Sponsored Research
Term, Xx. Xxx, except as expressly permitted under
Sections 3.9 and/or 3.10 hereof, will not participate
(as a researcher, consultant or advisor) in any
research sponsored or otherwise funded by a
commercial entity (except a Party) which is intended
to characterize previously-Discovered TGF-(beta)
Factors (except for GDF 1), and Discover and
characterize new Factors, in the TGF-(beta)
Superfamily. During the Sponsored Research Term and
for such time as they are engaged in the Discovery
and characterization of TGF-(beta) Factors in (or in
collaboration with) Xx. Xxx'x JHU laboratory, the JHU
faculty, students, fellows and employees who have
signed an Invention and Disclosure Agreement shall
give JHU immediate notice of any formal affiliations
they are negotiating or may have (as researchers,
consultants or advisors) with a commercial entity
(except GI) which is intended to discover, identify
and/or characterize Factors in the TGF-(beta)
Superfamily. JHU, acting through Xx. Xxx, shall
describe to GI any such notice its receives under an
Invention and Disclosure Agreement, and thereafter,
JHU shall have no further obligation, PROVIDED that
such Invention and Disclosure Agreement remains in
effect, and FURTHER PROVIDED, that JHU, acting
through Xx. Xxx, notifies such commercial entity of
the existence of such Invention and Disclosure
Agreement between JHU and such JHU faculty, student,
fellow or employee.
3.4 THE COLLABORATIVE RESEARCH.
3.4.1 THE COLLABORATIVE RESEARCH TERM. The Collaborative
Research began as of June 1. 1998 and shall be
conducted by GI and MetaMorphix through November 30,
1999 or such later date as may be mutually agreed
upon in writing by the Parties (the "Collaborative
Research Term"). Any such extension of the
Collaborative Research Term shall have no effect on
the length of the Sponsored Research Term.
3.4.2 COLLABORATIVE RESEARCH PLAN. A Collaborative Research
Plan. which sets forth GI's and MetaMorphix's
specific activities under the Collaborative Research
and coordinates the GI's and MetaMorphix's respective
activities under the Collaborative Research, is
attached hereto as Schedule 3.4.2. With respect to
coordination of the GI's and MetaMorphix's activities
under the Collaborative Research, the Collaborative
Research Plan shall be reviewed each calendar quarter
by the RMC. The Parties shall endeavor to carry out
their portion of the Collaborative Research Plan
consistent with the descriptions of Schedule 3.4.2.
3.4.3 RESEARCH MANAGEMENT COMMITTEE. Pursuant to the 1994
Collaboration Agreement, GI and MetaMorphix formed a
Research Management Committee (the "RMC") which
committee shall continue to exist during the
Collaborative Research Term of this Agreement. The
function of the RMC shall be to (i) advise GI and
MetaMorphix on the direction of the Collaborative
Research, (ii) coordinate GI's and MetaMorphix's
activities under the Collaborative Research, (iii)
facilitate the exchange of ideas and information by
GI and MetaMorphix under this Agreement and (iv)
mediate any disputes between GI and MetaMorphix, as
provided in Sections 1.81 and Article S. The RMC
shall consist of four (4) members, two (2) of whom
shall be designated by GI and two (2) of whom shall
be designated by MetaMorphix (with only the non-GI
representatives on the MetaMorphix board of directors
voting in the selection of such. representatives).
Communications between GI and MetaMorphix with
respect to the Discovery, characterization,
evaluation and selection of BMPs, GDFs and
Collaborative Factors shall be directed to each of
GI's and MetaMorphix's respective RMC members and
confirmed with copies to each of GI's and
MetaMorphix's respective RMC members, subject to
Section 3.4.6, below, GI and MetaMorphix may assign
its members to the RMC as it deems appropriate, and
designated substitutes may represent RMC members at
regularly scheduled meetings at the discretion of the
substituting Party. The RMC will meet at least once
per calendar quarter during the Collaborative
Research Term, alternating between GI and MetaMorphix
locations, to review their progress under the
Collaborative Research and other activities under
this Agreement subject to Section 3.4.6, below.
Actions by and decisions of the RMC shall require the
affirmative vote of at least three (3) RMC members.
GI and MetaMorphix shall each designate an overall
project manager to coordinate preparation of short
written reports summarizing each of GI's and
MetaMorphix's Collaborative Research efforts, to be
provided to each of the RMC members in advance of
each quarterly RMC meeting, subject to
Section 3.4.6, below. It is contemplated that, in
addition to reports to, and meetings of the RMC there
will be frequent communications among the scientists
and project managers to keep GI and MetaMorphix
advised of current Collaborative Research activities,
subject to Section 3.4.6, below.
3.4.4 COLLABORATIVE RESEARCH ACTIVITIES. In conducting its
activities under the Collaborative Research, GI, at
its own expense, shall allocate at least one (1) full
time equivalent scientist to the Collaborative
Research, together with such technical staff,
equipment and supplies as are reasonably necessary to
support those GI scientists. In conducting its
activities under the Collaborative Research,
MetaMorphix, at its own expense, shall allocate at
least one (1) full time equivalent scientist to the
Collaborative Research, together with such technical
staff, equipment and supplies as are reasonably
necessary to support such MetaMorphix scientist.
During the Collaborative Research Term and any
extension of the Sponsored Research Term that JHU and
GI may agree upon and for a period of six (6) months
thereafter. MetaMorphix shall not collaborate or
otherwise, directly or indirectly, except through the
Collaborative Research or as otherwise expressly
permitted under Sections 3.9 and/or 3.10 hereof work
with JHU with respect to the Discovery or
characterization of any Factor.
3.4.5 DISPUTE RESOLUTION. In the event the RMC is unable to
resolve any issue which properly comes before it
within sixty (60) days, senior executives from each
of GI and MetaMorphix shall meet promptly following a
notice from either such Party in order to discuss and
resolve, within sixty (60) days, the outstanding
issues facing the RMC.
3.4.6 DISCLOSURE OF INFORMATION.
3.4.6.1 DISCLOSURE OF SEQUENCES. Each of GI and
MetaMorphix represents and warrants to the
other Parties that, on or before the
Effective Date, it has reported and
disclosed to the other Parties the cDNA
sequence(s) encoding the mature/processed
protein region of any BMPs, GDFs or
Collaborative Factors Discovered by that
Party.
3.4.6.2 DISCRETIONARY DISCLOSURE OF OTHER
INFORMATION. Subject to Section 3.3:6.3,
below, each of GI and MetaMorphix may, at
its discretion, from time to time disclose
to the other Parties during the
Collaborative Research Term (x) any Factor
Rights (other than the cDNA sequences
promptly disclosed under Section 3.4.6.1,
above) and (y) any Data which relates to the
Collaborative Research.
3.4.6.3 MANDATORY DISCLOSURE OF OTHER INFORMATION.
Notwithstanding Section 3.4.6.2 above, each
of GI and MetaMorphix shall promptly report
and disclose to the other Parties, in
writing, the applicable (x) Factor Rights
and (y) Data, (in each case, including any
Data received from JHU) as follows:
i. in connection with the preparation,
filing and maintenance by such
Party of a Patent covering the
Factor Patent Rights, or a review
of information by the Parties prior
to public disclosure, the
disclosure of such Factor Rights
and Data may be limited to that
Factor (or those Factors) which: is
(are) the subject of the Patent
action or public disclosure;
ii. in connection with notice by GI or
MetaMorphix of its intention to
select, or trigger the selection
of, any Available Factor under
Article 5, below, the disclosure of
such Factor Rights and Data shall
not be limited to a particular
Factor, but shall include
information on ALL then-Available
Factors which the disclosing Party,
acting in good faith, determines is
likely to be material to the
selecting Party in making its
selection decision, all according
to the procedures set forth in
Article 5 of this Agreement; and
iii. in connection with submission of
each Party's annual report, as
provided in Section 3.4.7, below.
3.4.7 ANNUAL Reports. Each of GI and MetaMorphix shall
prepare and submit to the other, within thirty (30)
days of the end of the Collaborative Research Term,
and if the Collaborative Research Term is extended in
accordance with Section 3.4.1 hereof, within thirty
(30) days after the end of each year of such
extension of the Collaborative Research Term, a
report summarizing that Party's activities under the
Collaborative Research during the preceding year. No
such annual_ reports are due by GI or by MetaMorphix
with respect to the Original Research.
3.5 DISCLOSURE OF INFORMATION BY AND TO JHU.
3.5.1 JHU DISCLOSURES. For JHU, the information and data it
discloses to GI and/or MetaMorphix shall be limited
to information and data developed in Xx. Xxx'x JHU
laboratory by Xx. Xxx and other JHU faculty,
students, fellows and employees who are conducting
the Sponsored Research under this Agreement.
3.5.2 GI AND METAMORPHIX DISCLOSURES. Any Confidential
Information which GI or MetaMorphix desires to
disclose to JHU shall be disclosed to (and only to)
Xx. Xxx. As provided in Section 3.3.6, above, JHU,
acting through Xx. Xxx, shall require all JHU
faculty, students, fellows and employees to whom
specific GI and/or MetaMorphix Confidential
Information is to be disclosed to first sign a
Confidentiality Agreement in the form appearing as
Schedule 3.3.6 to this Agreement covering such
specific Confidential Information.
3.6 OWNERSHIP OF RESULTS. GI shall own all GI Rights resulting
from the conduct of the Original Research, the Collaborative
Research and/or the Sponsored Research, even though use of
MetaMorphix' and/or JHU's Confidential Information may have
been incidental to the development of such GI Rights.
MetaMorphix shall own all MetaMorphix Rights resulting from
the conduct of the Original Research and/or the Collaborative
Research, even though use of GI's and/or JHU's Confidential
Information may have been incidental to the development of
such MetaMorphix Rights. JHU shall own all JHU Rights
resulting from the conduct of the Original Research, the
Collaborative Research and/or the Sponsored Research even
though use of GI's and/or MetaMorphix' Confidential
Information may have been incidental to the development of
such JHU Rights. GI and MetaMorphix, or GI and JHU, or JHU and
MetaMorphix, as applicable, - shall jointly own all Joint
Rights or Additional Factor Joint Rights resulting from the
conduct of the Collaborative Research. Should any issue of
inventorship of a BMP. GDF or Collaborative Factor arise among
the Parties regarding inventions made prior to June 1, 1998,
the chief patent counsel or other designee of each Party shall
attempt to resolve such issue. Failing resolution, the
inventorship issue shall be referred to an independent,
outside patent expert, mutually acceptable to all Parties,
whose determination of inventorship shall be binding on GI and
MetaMorphix, or GI and JHU, or JHU and MetaMorphix, as
applicable. The costs of such outside patent expert shall be
shared equally by the Parties involved in the dispute.
3.7 RESEARCH LICENSE. During the Collaborative Research Term, each
Party grants to the other Parties a royalty-free,
non-exclusive license under their
respective interests in the Factor Rights solely for the
purposes of performing their Collaborative Research activities
under this Agreement. During the Sponsored Research Term, GI
and JHU grant to each other a royalty-free, non-exclusive
license under their respective interests in the Factor Rights
and the Additional Factor Rights, solely for the purposes of
performing the Sponsored Research activities under this
Agreement. At the end of the Collaborative Research Term JHU
shall have a royalty-free. non-exclusive, non-transferable,
perpetual license under the Factor Rights existing as of the
end of the Collaborative Research Term, without the right to
grant sublicenses except as provided in Section 6.6, below,
solely for academic, non-commercial research purposes. At the
end of the Sponsored Research Term, JHU shall have a
royalty-free, non-exclusive, nontransferable license under the
Additional Factor Rights existing as of the end of the
Sponsored Research Term, without the right to grant
sublicenses except as provided in Section 6.6, below, solely
for academic, noncommercial research purposes.
3.8 ACKNOWLEDGEMENT. Each Party acknowledges that its promise to
fully disclose in a timely manner information to the other
Parties related to the Collaborative Research and/or the
Sponsored Research, as provided in this Article 3, was
material to the other Parties' decisions to enter this
Agreement and is crucial to the Parties' success hereunder.
3.9 METAMORPHIX SPONSORED RESEARCH. So long as the confidentiality
requirements and other restrictions and obligations
(including, without limitation, the obligation to disclose and
license to GI certain intellectual property relating to
Additional Factors and BMPs, GDFs and Collaborative Factors as
set forth in this Article 3 and in Article 6 hereof) of the
JHU/GI Sponsored Research relationship are recognized and
adhered to. MetaMorphix may sponsor research in Xx. Xxx'x
laboratory at JHU, which research may relate to the
characterization of MetaMorphix Factors, GDF-16. GDF-17 and
unassigned BMPs, GDFs and Collaborative Factors but may not
relate to any GI Factor, any Additional Factor, or the
Discovery evaluation or characterization of any other
TGF(beta) Factor, PROVIDED HOWEVER, that (i) any and all
information or data developed or generated by Xx. Xxx. JHU or
MetaMorphix in performing such sponsored research, which
information or data relates to any TGF-(beta) Factor or the
Collaborative Research or Sponsored Research activities
conducted by the Parties under this Agreement, shall be
disclosed to GI as if such information and data were developed
or generated by Xx. Xxx of JHU as part of or in connection
with the GI/JHU Sponsored Research relationship and (ii) all
such data and information shall be deemed to be included
within the definition of the JHU Know-How or the MetaMorphix
Know-How as applicable and GI and MetaMorphix shall each have
the
right and license to use all such data and information in
accordance with and subject to the terms and conditions of
this Agreement.
3.10 XX. XXX AS CONSULTANT TO METAMORPHIX. During the Sponsored
Research Term, Xx. Xxx shall be permitted to continue to serve
as a consultant to MetaMorphix should Xx. Xxx and MetaMorphix
agree to continue such relationship, PROVIDED, HOWEVER, that,
upon and after the execution of this Agreement, (i) the
confidentiality requirements and other restrictions and
obligations (including, without limitation, the obligation to
disclose and license to GI certain intellectual property
relating to Additional Factors and BMPs, GDFs and
Collaborative Factors as set forth in this Article 3 and in
Article 6 hereof) of the JHU/GI Sponsored Research
relationship are recognized and adhered to, (ii) such
consulting services shall not relate to the Discovery of any
TGF-(beta) Factor, to any GI Factor or to any Additional
Factors, (iii) any information, data, or inventions, made or
developed by Xx. Xxx or MetaMorphix in connection with such
consulting services, shall be deemed to be included within the
JHU Know-How or the MetaMorphix Know-How as applicable, would
be included in the rights licensed by MetaMorphix or JHU, as
applicable, and, to the extent such information, data. or
inventions relate to the Collaborative Research, GI shall have
the right to use all such data and information in accordance
with and subject to the terms and conditions of this
Agreement.
4. SUPPLY OF MATERIALS.
4.1 SUPPLY OF Materials in Connection WITH THE SPONSORED RESEARCH.
Except as otherwise expressly provided by this Agreement,
during the Sponsored Research Term, each of JHU and GI shall,
at its respective sole cost and expense, use reasonable and
diligent efforts to supply to the other such reasonable
quantities and types of GDFs, Collaborative Factors,
Additional GDFs or Additional Collaborative Factors (or cell
lines that express such GDFs, Collaborative Factors,
Additional GDFs and/or Additional Collaborative Factors) and
other materials in that Party's possession and control as GI
and JHU may agree are reasonably required to carry out their
respective obligations under this Agreement. GI, in turn,
shall have the right to supply any such GDFs or Collaborative
Factors (or cell lines that express such GDFs or Collaborative
Factors) received from JHU hereunder to MetaMorphix in
accordance with Section 4.2 hereof, or, alternatively, to
require JHU to supply any such GDFs or Collaborative Factors
(or cell lines that express such GDFs or Collaborative
Factors) directly to MetaMorphix. GI shall permit two (2) JHU
students, working under Xx. Xxx'x supervision, to visit GI
facilities during the Sponsored Research Term (subject to
those students signing appropriate confidentiality agreements
required by GI) for the sole purpose of expressing and
purifying proteins expressed from unassigned GDFs and
Collaborative
Factors and from Additional GDFs and Additional Collaborative
Factors for subsequent evaluation and characterization at JHU
in accordance with the Sponsored Research Plan. Any GDFs,
Collaborative Factors. Additional GDFs, Additional
Collaborative Factors and other materials delivered to a Party
in accordance with this Section 3.1 shall remain the property
of the furnishing Party.
4.2 SUPPLY OF MATERIALS TO METAMORPHIX.
4.2.1 UNASSIGNED BMPS, GDFS AND COLLABORATIVE FACTORS.
During the Collaborative Research Term, GI shall, at
its sole cost and expense, use commercially
reasonable and diligent efforts to supply MetaMorphix
with reasonable quantities of protein expressed from
unassigned BMPs, GDFs and Collaborative Factors which
GI has elected to evaluate, for MetaMorphix to
perform its own evaluations. The quantity (which,
subject to the limitations set forth below, shall be
no less than 50% of the amount GI produces for its
own use in evaluating such Factors), quality and
purity of any protein so provided to MetaMorphix
under this Section 4.2.1 shall be substantially
equivalent to the quantity (if any), quality and
purity of such protein GI produces for its own use in
its evaluation of such unassigned BMPs, GDFs and
Collaborative Factors, PROVIDED, HOWEVER, that in no
event shall GI be obligated to supply to MetaMorphix
more than two (2) milligrams of protein for each such
BMP. GDF or Collaborative Factor. In addition, GI
may, but shall not be obligated, to supply
MetaMorphix, at MetaMorphix's cost and expense. with
protein expressed from unassigned BMPs, GDFs and
Collaborative Factors which GI has not yet elected to
evaluate, for MetaMorphix to perform its evaluations
in accordance with the Collaborative Research Plan
and Section 5.1 of this Agreement. MetaMorphix agrees
to make no other use of any protein supplied to it
under this Section 4.2.1 (unless and until
MetaMorphix may select such Factor as a MetaMorphix
Factor, in which event MetaMorphix may use any
remaining stocks of such protein supplied to
MetaMorphix hereunder for the continued research and
development of such MetaMorphix Factor. Any BMPs,
GDFs. Collaborative Factors and other materials
delivered to MetaMorphix in accordance with this
Section 4.2.1 shall remain the property of the
furnishing Party (GI or JHU, as applicable).
4.2.2 METAMORPHIX FACTORS. During the Collaborative
Research Term, GI, subject to GI's manufacturing
capabilities, limitations, schedules and priorities,
will use its Commercially Reasonable Efforts to
supply MetaMorphix, at GI's cost, with reasonable
quantities of protein expressed from GDF-8, GDF-11
and GDF-12
for use by MetaMorphix in developing MetaMorphix
Products based on such MetaMorphix Factors for use in
the MetaMorphix Field. The quantity (which. subject
to the limitation set forth below, shall be no less
than 50% of the amount GI produces for its own use),
quality and purity of any protein so provided to
MetaMorphix under this Section 4.2.1 shall be
substantially equivalent to the quantity (if any),
quality and purity of such protein GI produces for
its own use in the research and development of GI
Type B Products based on such Factors, PROVIDED,
HOWEVER, that in no event shall GI be obligated to
supply to MetaMorphix more than two (2) milligrams of
protein for each such MetaMorphix Factor. MetaMorphix
shall not request unreasonable quantities of any such
MetaMorphix Factor or impose unreasonable time or
other constraints on GI, it being understood that GI
has and will have other products which place demands
on its protein expression capacity and that GI will
endeavor to supply such protein to MetaMorphix during
the six (6) month period following the Effective
Date. GI shall consider, in good faith, MetaMorphix'
requests for such MetaMorphix Factors at the time GI
is evaluating its other protein expression
priorities. In the event GI is unable or unwilling to
supply MetaMorphix with such quantities of such
MetaMorphix Factors for such development purposes as
required above in this Section 4.2.2, GI will use its
Commercially Reasonable Efforts to provide
MetaMorphix, at GI's cost and expense, WITH vectors
and/or cell Lines, if available, which are necessary
for MetaMorphix to express, or have expressed, such
MetaMorphix Factors for use by MetaMorphix in
developing MetaMorphix Products based on such
MetaMorphix Factors in the MetaMorphix Field. Any
BMPs, GDFs, Collaborative Factors, vectors, cell
lines and other materials delivered to MetaMorphix in
accordance with this Section 4.2.2 shall remain the
property of GI, PROVIDED, HOWEVER, that GI shall have
no right or license to any intellectual property
right arising from MetaMorphix' use of such BMPs.
GDFs. Collaborative Factors, vectors, cell lines and
other materials, except as expressly provided in this
Agreement.
4.2.3 SUPPLY of Reagents and ANTIBODIES. During the
Collaborative Research Term GI, subject to GI's
manufacturing capabilities, limitations, schedules
and priorities, shall use its Commercially Reasonable
Efforts to supply, at its expense, MetaMorphix with
up to thirty (30) liters of GDF-8 conditioned media,
up to ten (10) liters of GDF-9 conditioned media, up
to ten (10) liters of GDF-11 conditioned media, up to
ten (10) liters of GDF-12 conditioned media, up to
five (5) milligrams of monoclonal antibodies targeted
against GDF-8, up to five (5) milligrams of
monoclonal antibodies
targeted against GDF-9, up to five (5) milligrams of
monoclonal antibodies targeted against GDF-11 and up
to two (2) milliliters of polyclonal antibodies
targeted against GDF-12. GI will endeavor to supply
such reagents and antibodies to MetaMorphix during
the six (6) month period following the Effective
Date, PROVIDED, HOWEVER. that any failure to supply
such quantities of reagents and/or antibodies to
MetaMorphix shall not be considered to be a material
breach of GI's obligations under this Agreement. Any
reagents and antibodies delivered to MetaMorphix in
accordance with this Section 4.2.2 shall remain the
property of GI, provided, however, that GI shall have
no right or license to any intellectual property
rights arising from MetaMorphix' use of such reagents
and antibodies, except as expressly provided in this
Agreement.
4.2.4 SUPPLY OF FACTORS, REAGENTS AND ANTIBODIES AFTER
COLLABORATIVE RESEARCH TERM. GI shall have no
obligation to supply any Factors, reagents or
antibodies to MetaMorphix after the expiration or
earlier termination of the Collaborative Research
Term. In the event that, after the expiration or
earlier termination of the Collaborative Research
Term, MetaMorphix desires to continue purchasing
MetaMorphix Factors, related reagents and/or
antibodies from GI for use in the development and
commercialization of MetaMorphix Factors for use in
the MetaMorphix Field and GI, in its sole discretion,
is willing to continue supplying MetaMorphix with
such MetaMorphix Factors, reagents and/or antibodies
for such purpose, GI and MetaMorphix, with no
obligation as to outcome, will each use its
respective good faith efforts to negotiate a supply
agreement pursuant to which GI would manufacture and
MetaMorphix would purchase from GI such MetaMorphix
Factors, reagents and/or antibodies.
4.3 SUPPLY OF MATERIALS BY METAMORPHIX. In the event that, during
the Collaborative Research Term, MetaMorphix expresses or
otherwise has obtained (other than from GI) or has excess
quantities of any BMP, GDF or Collaborative Factor that has
not yet been selected, in accordance with Article 5 hereof, as
either a MetaMorphix Factor or a GI Factor, MetaMorphix, upon
GI's request, shall supply to GI a reasonable quantity of such
Factors (or, if available, cell lines expressing such
Factors), for use by GI in conducting its evaluation of such
Factors in accordance with the Collaborative Research Plan and
Section 5.1 hereof. The quantity, quality and purity of any
protein so provided to GI under this Section 4.3 shall be
substantially equivalent to the quantity, quality and purity
of such protein MetaMorphix produces or obtains for its own
use in its evaluation of such Factors. GI will, in turn, have
the right to supply to JHU any such Factors (or cell lines
expressing such Factors) received from MetaMorphix in
accordance with this Section 4.3 or, alternatively,
MetaMorphix. upon GI's request, shall supply such Factors (or
cell lines expressing such Factors) directly to JHU for
subsequent evaluation and characterization of such Factors in
accordance with the Sponsored Research Plan. Any BMPs. GDFs,
Collaborative Factors and other materials delivered by
MetaMorphix to GI or JHU in accordance with this Section 4.3
shall remain the property of MetaMorphix, unless such Factors
or materials were previously provided to MetaMorphix by GI or
JHU in accordance with Sections 4.2 hereof, in which case,
such Factors or Materials shall remain the property of the
Party that supplied such Factors or materials to MetaMorphix.
4.4 SUPPLY OF CERTAIN MATERIALS TO XX. Xxx. During the term of
this Agreement, each of GI and MetaMorphix shall provide
reasonable quantities of GDFs Discovered by JHU, if available
in excess of such Party's own needs, to Xx. Xxx (whether or
not Xx. Xxx is then affiliated with JHU) solely for academic,
non-commercial research purposes, pursuant to GI's or
MetaMorphix's standard material transfer agreement, as
applicable. Additionally, during the term of this Agreement,
GI shall have a continuing obligation to provide reasonable
quantities of Additional GDFs Discovered by JHU, if available,
to Xx. Xxx (whether or not Xx. Xxx is then affiliated with
JHU) solely for academic, non-commercial research purposes,
pursuant to GI's standard material transfer agreement.
4.5 LIMITATIONS ON USE OF Factors. Unless the furnishing Party
shall otherwise give its prior written consent, the receiving
Party shall not use the BMPs, GDFs, Collaborative Factors,
Additional GDFs, Additional Collaborative Factors or other
materials provided to it under this Article 4 for any purposes
other than to conduct (a) the Sponsored Research during the
Sponsored Research Term or the Collaborative Research during
the Collaborative Research Term, as applicable, and (b)
following the Sponsored Research Term or the Collaborative
Research Term, as applicable, such other activities as are
expressly permitted under this Article 4, including, without
limitation, JHU's continuing right to use such Factors solely
for academic, non-commercial research. Any other uses of the
BMPs, GDFs, Collaborative Factors, Additional GDFs or
Additional Collaborative Factors or other materials by a
receiving Party shall be governed by the terms of separate
material transfer agreements, if any, executed by the
furnishing Party and the receiving Party.
5. EVALUATION AND SELECTION OF FACTORS.
5.1 EVALUATION. During the Collaborative Research Term, GI and
MetaMorphix each shall evaluate those BMPs. GDFs and
Collaborative Factors which, it, in its sole discretion
chooses to evaluate, for purposes of ascertaining which
Factors such Party desires to select in accordance with
Section 5.3 below. The RMC shall determine when sufficient
quantities of protein are available for GI and MetaMorphix to
evaluate a particular BMP, GDF or Collaborative Factor. The
Parties shall have up to six (6) months. or such shorter
period of time as the RMC may determine. (the "Evaluation
Period" to perform their evaluations of such Factors. The
RMC's determination that sufficient quantities of a particular
Factor are available may be made at any time during the term
of this Agreement. and need not be made at a bi-annual meeting
of the RMC.
5.2 AVAILABLE FACTORS. As of the Effective Date, the BMPs, GDFs
and Collaborative Factors listed on Schedule 5.2 are available
for selection by GI or MetaMorphix in accordance with the
selection procedures set forth in Section 5.3 hereof (each, an
"Available Factor"). Upon completion of the Evaluation Period
described in Section 5.1 hereof with respect to any BMP. GDF
or Collaborative Factor that has not yet been selected by GI
as a GI Factor or MetaMorphix as a MetaMorphix Factor or which
has not yet been included on the list of Available Factors
referenced in the preceding sentence, such Factor shall, at
such time, become an Available Factor and shall be added to
the list of Available Factors appearing in Schedule 5.2.
Notwithstanding the foregoing, any BMP, GDF or Collaborative
Factor that has not yet been selected by GI as a GI Factor or
MetaMorphix as a MetaMorphix Factor and which has not become
an Available Factor as of November 30. 1999. or such later
date as GI and MetaMorphix may mutually agree upon. in
writing, shall, as of such date, be deemed to be an Available
Factor and added to the list of Available Factors appearing in
Schedule 5.2.
5.3 SELECTION OF AVAILABLE FACTORS.
5.3.1 ORDER OF SELECTION.
5.3.1.1 METAMORPHIX HAS FIRST SELECTION. MetaMorphix
shall be the first Party to select an
Available Factor from among the
then-Available Factors, by giving written
notice to the other Parties of its intention
to make a selection. Following receipt of
such notice, the other Parties shall
promptly disclose Factor Rights and Data to
MetaMorphix, as provided in Section 3.4.6,
above, and thereafter, MetaMorphix shall
promptly (within thirty (30) days) make its
selection. Upon its selection by
MetaMorphix, that Available Factor shall be
designated a MetaMorphix Factor by deleting
it from Schedule 5.2 and listing it on
Schedule 1.62. The Parties acknowledge that
on September 28, 1998 MetaMorphix provided
written notice. to the other Parties of its
intention to make the first selection of an
Available
Factor, and agree that, to the extent the
Factor Rights and Data required to be
disclosed by each Party to the other Parties
in response to such notice has not been
disclosed to such other Parties as of the
Effective Date, such undisclosed Factor
Rights and Data shall be disclosed to
MetaMorphix and GI as soon as practicable
after the Effective Date..
5.3.1.2 GI HAS NEXT SELECTION. GI shall be the
second Party to select an Available Factor
from among the then-Available Factors, by
giving written notice to the other Parties
of its intention to make a selection.
Following receipt of such notice, the other
Parties shall promptly disclose Factor
Rights and Data to GI, as provided in
Sections 3.3.7 and 3.4.6, above, and
thereafter, GI shall promptly (within thirty
(30) days) make its selection. Upon its
selection by GI, that Available Factor shall
be designated a GI Factor by deleting it
from Schedule 5.2 and listing it on Schedule
1.39.
5.3.1.3 ALTERNATING SELECTIONS. Thereafter,
MetaMorphix and GI shall alternate in their
selections from the Available Factors. If it
is a Party's turn to select an Available
Factor, it may do so at any time, subject to
the other Party's right to trigger the
selection procedure, as set forth in Section
5.3.2, below.
5.3.2 TRIGGERING A SELECTION.
5.3.2.1 GI'S RIGHT TO TRIGGER A SELECTION. Where
MetaMorphix has the next selection, GI can
trigger the selection procedure for an
Available Factor by giving MetaMorphix
written notice of GI's desire to select from
among the then Available Factors. Following
receipt of such notice, the Parties shall
promptly disclose to one another Factor
Rights and Data, as provided in Sections
3.3.7 and 3.4.6, above. Following such
disclosure, MetaMorphix shall have thirty
(30) days to exercise its turn to select an
Available Factor from among the
then-Available Factors. If MetaMorphix
selects an Available Factor, then the
selection procedure continues, on an
alternating basis, with GI having the right
to make the next selection. If, at the end
of the thirty (30) day period. MetaMorphix
has not exercised its turn to select an
Available Factor, then GI shall have the
right to select from among the
then-Available Factors, and the selection
process continues, on an alternating basis,
with MetaMorphix having the right to make
the next selection.
5.3.2.2 METAMORPHIX' RIGHT TO TRIGGER A SELECTION.
Where GI has the next selection. MetaMorphix
can trigger the selection procedure for an
Available Factor, by giving GI written
notice of MetaMorphix's desire to select
from among the then-Available Factors.
Following receipt of such notice, the
Parties shall promptly disclose to one
another Factor Rights and Data, as provided
in Section 3.4.6, above. Following such
disclosure, GI shall have thirty (30) days
to exercise its turn to select an Available
Factor from among the then-Available
Factors. If GI selects an Available Factor,
then the selection procedure continues, on
an alternating basis, with MetaMorphix
having the right to make the next selection.
If, at the end of the thirty (30) day
period, GI has not exercised its turn to
select an Available Factor, then MetaMorphix
shall have the right to select from among
the then-Available Factors, and the
selection process continues, on an
alternating: basis, with GI having the right
to make the next selection.
5.3.2.3 LIMITATION ON RIGHT TO TRIGGER A SELECTION.
A Party which triggers a selection under
Sections 5.3.2.1 or 5.3.2.2 may not trigger
a subsequent selection until three (3)
months has lapsed from the date it triggered
the prior selection, unless the other Party
has made an intervening selection (including
a selection made as a result of the
triggering of a selection under this Section
5.3.2.
5.3.3 COMPLETION OF SELECTION PROCESS. During the thirty
(30) day period following the expiration of the
Collaborative Research Term (i.e., on or before
December 30, 1999 if the Collaborative Research Term
is not extended past November 30, 1999 in accordance
with Section 3.4.1 hereof) GI and MetaMorphix shall
meet, at a time and location to be mutually agreed
upon by GI and MetaMorphix. to select GI Factors and
MetaMorphix Factors from the then Available Factors,
with such selections alternating between GI and
MetaMorphix until all such Factors have been
selected. The first selection during such meeting
will be made by GI if MetaMorphix had made the most
recent selection prior to such meeting or by
MetaMorphix if GI had made the most recent selection
prior to such meeting.
6. LICENSES.
6.1 RESTATEMENT OF RIGHTS. GI. MetaMorphix and JHU hereby restate
all obligations assumed by each such Party and all rights and
licenses
previously granted to any of them. whether under the 1994
Collaboration Agreement or otherwise, by JHU, MetaMorphix or
GI with respect to any MetaMorphix Factors. MetaMorphix
Products. GI Factors. Additional Factors, GI Products, GDF-16.
GDF-17. GDF-16 Products and GDF-17 Products so that each
Party. as of the Effective Date is able to grant the licenses
to MetaMorphix and GI as set forth below in this Article 6.
6.2 LICENSES FROM JHU TO METAMORPHIX. Subject to (i) the terms and
conditions of this Agreement. (ii) the licenses granted by JHU
to GI under Section 6.3 hereof, (iii) the reservation of
rights set forth in Section 6.6 of this Agreement, and (iv)
any rights retained by the United States government in
accordance with P.L. 96-517, as amended by P.L. 98-620. JHU
grants to MetaMorphix and its designated Affiliates which
agree in writing to comply with the terms and conditions of
this Agreement (with a copy of such written agreement being
provided to JHU):
a. an exclusive, royalty-bearing license to
JHU's interest under the Factor Patent
Rights; and
b. a non-exclusive, perpetual, royalty-free
license to use JHU's interest in the Factor
Know-How relating to the subject matter
disclosed or claimed in such Factor Patent
Rights,
including the right to grant sublicenses, (i) to make, have
made, use, import, market, offer for sale and sell MetaMorphix
Products in the Territory, in each case only for use in the
MetaMorphix Field, (ii) to make, have made and use MetaMorphix
Products for MetaMorphix's and/or its designated Affiliates'
internal research and development purposes and (iii) to make,
have made, use, import, market, offer for sale and sell GDF-16
Products and GDF-17 Products in the Territory. The license
granted pursuant to Section 6.2(a) shall continue in effect
until the expiration of the last patent licensed to
MetaMorphix under this Section 6.2.
6.3 LICENSES FROM JHU TO GL
6.3.1 GI TYPE A PRODUCTS. Subject to (i) the terms and
conditions of this Agreement, (ii) the reservation of
rights set forth in Section 6.6 of this Agreement,
and (iii) any rights retained by the United States
government in accordance with P.L. 96-517, as amended
by P.L. 98-620, JHU grants to GI and its designated
Affiliates which agree in writing to comply with the
terms and conditions of this Agreement (with a copy
of such written agreement being provided to JHU):
a. an exclusive royalty-bearing license to
JHU's interest under the Factor Patent
Rights and the Additional Factor Patent
Rights; and
b. a non-exclusive, perpetual, royalty-free
license to use JHU's interest in the Factor
Know-How and the Additional Factor Know-How
relating to the subject matter disclosed or
claimed in such Factor Patent Rights and/or
Additional Factor Patent Rights,
including the right to grant sublicenses, to make,
have made, import, market, use, offer for sale and
sell GI Type A Products in the Territory. The license
granted pursuant to Section 6.3.1(a) shall continue
in effect until the expiration of the last patent
licensed to GI under this Section 6.3.1.
6.3.2. GI TYPE B PRODUCTS. Subject to (i) the terms and
conditions of this Agreement, (ii) the licenses
granted by JHU to MetaMorphix under Section 6.2
hereof, (iii) the reservation of rights set forth in
Section 6.6 of this Agreement, and (iv) any rights
retained by the United States government in
accordance with P.L. 96-517, as amended by P.L.
98-620, JHU grants to GI and its designated
Affiliates which agree in writing to comply with the
terms and conditions of this Agreement (with a copy
of such written agreement being provided to JHU):
a. an exclusive, royalty-bearing
license to JHU's interest under the
Factor Patent Rights and the
Additional Factor Patent Rights;
and
b. a non-exclusive, perpetual,
royalty-free license to use JHU's
interest in the Factor Know-How and
Additional Factor Know-How relating
to the subject matter disclosed or
claimed in such Factor Patent
Rights and/or Additional Factor
Patent Rights,
including the right to grant sublicenses, (i) to
make, have made, use, import, market, offer for sale
and sell GI Type B Products in the Territory, in each
case only for use in the GI Field and (ii) to make,
have made and-use GI Type B Products for GI's and/or
its designated Affiliates' internal research and
development purposes. The license granted pursuant to
Section 6.3.2(a) shall continue in effect until the
expiration of the last patent licensed to GI under
this Section 6.3.2.
6.3.3 GI TYPE C PRODUCTS. Subject to (i) the terms and
conditions of this Agreement. (ii) the reservation of
rights set forth in Section 6.6 of this Agreement,
and (iii) any rights retained by the United States
government in accordance with P.L. 96-517, as amended
by P.L. 98-620, JHU grants to GI and its designated
Affiliates which agree in writing to comply with the
terms and conditions of this Agreement (with a copy
of such written agreement being provided to JHU):
a. an exclusive, royalty-bearing
license to JHU's interest under the
Factor Patent Rights and Additional
Factor Patent Rights; and
b. a non-exclusive, perpetual,
royalty-free license to use JHU's
interest in the Factor Know-How and
Additional Factor Know-How relating
to the subject matter disclosed or
claimed in such Factor Patent
Rights and/or-Additional Factor
Patent Rights,
including the right to grant sublicenses, (i) to
make, have made, import, market use, offer for sale
and sell GI Type C Products in the Territory. The
license granted pursuant to Section 6.3.3(a) shall
continue in effect until the expiration of the last
patent licensed to GI under this Section 6.3.3.
6.4 LICENSES FROM METAMORPHIX TO GL
6.4.1 GI TYPE A Products. Subject to (i) the terms and
conditions of this Agreement, (ii) the reservation of
rights set forth in Section 6.6 of this Agreement and
(iii) any rights retained by the United States
government in accordance with P.L. 96-517, as amended
by P.L. 98-620, MetaMorphix grants to GI and its
designated Affiliates which agree in writing to
comply with the terms and conditions of this
Agreement (with a copy of such written agreement
being provided to MetaMorphix):
a. an exclusive, royalty-bearing
license to MetaMorphix's interest
under the Factor Patent Rights;
b. a non-exclusive, perpetual,
royalty-free license to use
MetaMorphix's interest in the
Factor Know-How relating to the
subject matter disclosed or claimed
in such Factor Patent Rights;
including the right to grant sublicenses, to make,
have made, import, market, use, offer for sale and
sell GI Type A Products in the Territory. The license
granted pursuant to Section 6.4.1(a) shall continue
in effect until the expiration of the last patent
licensed to GI under this Section 6.4.1.
6.4.2 GI TYPE B PRODUCTS. Subject to (i) the terms and
conditions of this Agreement, (ii) the reservation of
rights set forth in Section 6.6 of this Agreement and
(iii) any rights retained by the United States
government in accordance with P.L. 96-517, as amended
by P.L. 98-620, MetaMorphix grants to GI and its
designated Affiliates which agree in writing to
comply with the terms and conditions of this
Agreement (with a copy of such written agreement
being provided to MetaMorphix):
a. an exclusive, royalty-bearing
license to MetaMorphix's interest
under the Factor Patent Rights;
b. a non-exclusive, perpetual,
royalty-free license to use
MetaMorphix's interest in the
Factor Know-How relating to the
subject matter disclosed or claimed
in such Factor Patent Rights;
including the right to grant sublicenses, (i) to
make, have made, use, import, market, offer for sale
and sell GI Type B Products in the Territory, in each
case only for use in the GI Field and (ii) to make,
have made and use GI Type B Products for GI's and/or
its designated Affiliates' internal research and
development purposes. The license granted pursuant to
Section 6.4.2(a) shall continue in effect until the
expiration of the last patent licensed to GI under
this Section 6.4.2.
6.5 LICENSES FROM GI TO METAMORPHIX. Subject to (i) the terms and
conditions of this Agreement and (ii) the reservation of
rights set forth in Section 6.6 of this Agreement, GI grants
to MetaMorphix and its designated Affiliates which agree in
writing to comply with the terms and conditions of this
Agreement (with a copy of such written agreement being
provided to GI):
a. an exclusive, royalty-bearing license to
GI's interest under the Factor Patent
Rights; and
b. a non-exclusive, perpetual, royalty-free
license to use GI's interest in the Factor
Know-How relating to the subject matter
disclosed or claimed in such Factor Patent
Rights,
including the right to grant sublicenses. (i) to make, have
made, use. import, market, offer for sale and sell MetaMorphix
Products in the Territory, in each case only for use in the
MetaMorphix Field and (ii) to make, have made and use
MetaMorphix Products for MetaMorphix's and/or its designated
Affiliates' internal research and development . purposes. The
license granted pursuant to Section 6.5(a) shall continue in
effect until the expiration of the last patent licensed to
MetaMorphix under this Section 6.5. Notwithstanding the
foregoing, nothing in this Agreement shall constitute a grant
by GI to MetaMorphix of any right or license under GI's
interest in any Joint Factor Rights, Additional Joint Factor
Rights, or any Factor Patent Rights, Factor Know-How,
Additional Factor Patent Rights, Additional Factor Know-How or
any other intellectual property that GI may own, Control or
otherwise have rights to which relate to GDF-16 and/or GDF-17.
6.6 RESERVATION OF RIGHTS. Each Party retains the right under its
interest in the Factor Rights to use all BMPs, GDFs, and
Collaborative Factors in its internal research. In addition,
each of GI and JHU retains the right under its interest in the
Additional Factor Rights to use all Additional BMPs,
Additional GDFs and Additional Collaborative Factors in its
internal research. Further, JHU, for itself and The Xxxxx
Xxxxxxx Health System, retains the right under its interest in
the Factor Rights and its interest in the Additional Factor
Rights to use, and sublicense the use of, all GDFs and
Additional GDFs solely for academic, non-profit purposes;
PROVIDED, HOWEVER, neither JHU nor any of its sublicensees
shall have any right to (a) sell Products or (b) make, have
made or use Products for (i) toxicology or other IN vivo
studies in non-human primates or (ii) administration to human
subjects (in clinical trials or otherwise) without the prior
written consent of MetaMorphix, for Products licensed to
MetaMorphix under this Agreement and/or GI. for Products
licensed to GI under this Agreement, which consent shall be
forthcoming unless the Party from which consent is required
has determined that use of such Products for (x) toxicology or
other in VIVO studies in non-human primates could interfere
with that Party's existing or planned clinical trials or
commercialization of that Product or (y) administration to
human subjects raises regulatory or health and safety
concerns. JHU, acting through Xx. Xxx, shall use reasonable
efforts to promptly notify GI, in writing, of any proposed and
permitted JHU preclinical studies in non-human primates. JHU
retains the right under the applicable Factor Rights to
distribute the GDFs Discovered by JHU and under the applicable
'Additional Factor Rights to distribute the Additional GDFs
Discovered by JHU, each under JHU's standard Material Transfer
Agreement, a copy of which is attached hereto as Schedule
6.6A; and GI and MetaMorphix shall have no rights, absent
JHU's prior written consent, to distribute such GDFs or
Additional GDFs. Notwithstanding
the foregoing, (i) commencing six (6) months after the date
such GDF becomes a GI Factor or such Additional GDF is
Discovered by JHI:. GI shall have the right to distribute such
GI Factor or Additional GDF. under a standard material
transfer agreement which is reasonably acceptable to JHU or
MetaMorphix shall' have the right to distribute such GI Factor
or MetaMorphix Factor, under a standard material transfer
agreement which is reasonably acceptable to JHU and (ii)
commencing six (6) months after the date such GDF becomes a
MetaMorphix Factor, GI and MetaMorphix each shall have the
right to distribute such MetaMorphix Factor under a standard
material transfer agreement which is reasonably acceptable to
JHU. GI retains the right under its interest in the Factor
Rights to distribute the BMPs and the Additional BMPs under
GI's standard Material Transfer Agreement, a copy of which is
attached hereto as Schedule 6.6B to this Agreement; and JHU
and MetaMorphix shall have no rights, absent GI's prior
written consent, to distribute such BMPs or Additional BMPs.
6.7 FACTOR RIGHTS LICENSED FROM THIRD PARTIES. In the event that
the license to MetaMorphix or GI under Sections 6.2, 6.3, 6.4
or 6.5 includes rights acquired by the licensor Party from a
Third Party which involve the payment of royalties, fees or
other payments to such Third Party, the licensor Parry shall
notify the licensee Party of the obligation to make such
payment(s) prior to (a) the selection of a GI Factor or a
MetaMorphix Factor, as the case may be or (b) a subsequent
acquisition of such rights by the licensor Party. The licensee
Party promptly shall elect in writing whether to exclude such
Third Party rights from the licenses under this Agreement, and
if the licensee Party fails to exclude such rights, it shall
be fully responsible for the payment of any such royalties,
fees and other payments to such Third Party.
6.8 NONCOMPETE.
6.8.1 BY METAMORPHIX. MetaMorphix and GI agree that, for so
long as the licenses granted to GI, under Sections
6.3.2(a) and 6.4.2(a), with respect to the
development and commercialization of Products based
on GDF-8. remain in effect, MetaMorphix will not sell
or otherwise distribute any GDF-8 Derivative Product
for use in the GI Field (only to the extent that the
intended goal of such GDF-8 Derivative Product is to
modulate the effects of GDF-8). The preceding
sentence shall not apply to any products that
MetaMorphix obtains from a Third Party who has
developed (or obtained from another Third Party who
has developed) such products without infringing
issued patents of another Party included within such
other Party's Patent Rights under this Agreement,
which products were fully developed by or on behalf
of such Third Parry without the use of any of the JHU
Know-How, the GI Know-
How or any Confidential Information of JHU or GI.
GI's right to enforce this Section 6.8.1 shall not be
assignable, except to its Affiliates.
6.8.2 BY GI. GI and MetaMorphix agree that, for so long as
the licenses granted to MetaMorphix, under Sections
6.2(a) and 6.5(a), with respect to the development
and commercialization of Products based on GDF-8,
remain in effect, GI will not sell or otherwise
distribute any GDF-8 Derivative Product for use in
the MetaMorphix Field (only to the extent that the
intended goal of such GDF-8 Derivative Product is to
modulate the effects of GDF8). The preceding sentence
shall not apply to any products that GI obtains from
a Third Party who has developed (or obtained from
another Third Party who has developed) such products
without infringing issued patents of another Party
included within such other Party's Patent Rights
under this Agreement, which products were fully
developed by or on behalf of such Third Party without
the use of any of the IHU Know-How, the MetaMorphix
KnowHow or any Confidential Information of JHU or
MetaMorphix. MetaMorphix's right to enforce this
Section 6.8.2 shall not be assignable, except to its
Affiliates.
6.9 OPTION TO CERTAIN GDF-8 DERIVATIVE PRODUCTS. In the event that
either GI or MetaMorphix develops or otherwise acquires rights
to any GDF-8 Derivative Products and such Party determines, in
its sole reasonable discretion. that the grant by it of rights
to confidential data, know-how and/or Patents owned or
Controlled by it covering or relating to such GDF-8 Derivative
Product would not interfere with its development and/or
commercialization of its own Products based on GDF-8 or GDF-8
Derivative Products, such Party (the "Offering Party") agrees
to extend to the other Party, by written notice, the
opportunity to negotiate a royalty bearing license to some or
all of such GDF-8 Derivative Product rights, which license
would he restricted to the GI Field or the MetaMorphix Field,
as applicable. Within thirty (30) days of receiving such
notice, such other Party may elect to negotiate such an
agreement by providing the Offering Party written notice of
such election, in which event the Parties would promptly
commence good faith negotiations of the license terms
(including, without limitation. royalty rates and other
financial terms). If MetaMorphix and G1 are unable to agree on
the terms and conditions of such a license within ninety (90)
days after the Offering Party receives such notice from the
other Party. the Offering Party shall thereafter be free to
grant such rights and licenses to any Third Party.
7. CONSIDERATION.
7.1 LICENSE FEES.
7.1.1 INITIAL LICENSE PROCESSING FEE. JHU acknowledges and
agrees that, as required by the 1994 Collaboration
Agreement. it has received from MetaMorphix a Forty
Thousand Dollar ($40,000) non-refundable,
non-deductible license processing fee, as required by
JHU policies for JHU licenses to stare-up companies.
7.1.2 ADDITIONAL LICENSE PROCESSING FEES. JHU acknowledges
and agrees that, as required by the 1994
Collaboration Agreement and except as provided in
this Section 7.1.2, it has received from MetaMorphix
all additional license processing fees required to be
paid thereunder, which additional license processing
fees were in the amount of Two Thousand Dollars
($2,000) for each Patent filed by JHU claiming a new
GDF Discovered by JHU following the effective date of
the 1994 Collaboration Agreement, which Patents were
licensed to MetaMorphix thereunder. MetaMorphix shall
pay to JHU the remaining eighteen thousand dollars
($18,000.00) due for such fees within ninety (90)
days of the Effective Date.
7.1.3 LICENSE MAINTENANCE FEES. JHU acknowledges and agrees
that it has received from MetaMorphix all annual
license maintenance fees due under the 1994
Collaboration Agreement prior to the Effective Date
of this Agreement. The Parties agree that during the
term of this Agreement, as required by JHU policies
for its licensees,
(i) in partial consideration for the
JHU's grant of licenses to
MetaMorphix under Section 6.2
hereof, MetaMorphix shall pay JHU
an annual license maintenance fee
of Two Thousand Five Hundred
Dollars ($2,500), which payment
shall be made within thirty (30)
days of each December 1 during the
term of this Agreement.
(ii) in partial consideration for the
JHU's grant of licenses to GI under
Section 6.3 hereof, GI shall pay
JHU an annual license maintenance
fee of Seven Thousand Five Hundred
Dollars ($7,500), which payment
shall be made within thirty (30)
days of each December 1 during the
term of this Agreement.
7.2 ADDITIONAL LICENSE FEES. In addition to any Sponsored Research
payments payable by GI under Sections 3.3 above and any
royalties
payable by GI under Sections 7.3.2. 7.3.3. and 7.3.4 below. GI
shall, with respect to its development of GI Factors or
Additional Factors, pay to MetaMorphix or JHU, as applicable,
the amounts set forth in Schedule 7.2A and. with respect to
its development of MetaMorphix Factors, pay to MetaMorphix or
JHU, as applicable, the amounts set forth in Schedule 7.2B.
Payments to JHU and/or MetaMorphix under this Section 7.2
shall be (i) fully creditable against royalty payments by GI
to JHU and/or MetaMorphix, as applicable under Section 7.3 and
(ii) paid within thirty (30) days following occurrence of the
applicable benchmark, by check payable to, in the case of
payments to JHU, The Xxxxx Xxxxxxx University and sent to the
Director of the Office for Technology Licensing, The Xxxxx
Xxxxxxx University School of Medicine, 0000 Xxxx Xxxxxxxx
Xxxxxx, Xxxxx 0-000, Xxxxxxxxx, Xxxxxxxx 00000 and shall be
labeled "Additional License Fees" and in the case of payments
to MetaMorphix, MetaMorphix,-Inc. 0000 Xxxxx Xxxxxxx Xxxx,
Xxxxxxxxx, Xxxxxxxx 00000.
7.3 ROYALTIES.
7.3.1 METAMORPHIX PRODUCTS.
7.3.1.1 PAYABLE BY METAMORPHIX TO JHU. MetaMorphix
shall pay to JHU a royalty on sales made by
MetaMorphix, its Affiliates or sublicensees
of each MetaMorphix Product, the
manufacture, use or sale of which is covered
by a Valid Claim under applicable Factor
Patent Rights, which royalty shall be
calculated using the following formula:
royalty =A+B+C+D+E
where
A equals either (i) three and one-half
percent (3 1/2%) of Net Sales obtained from
such sales of such MetaMorphix Product, if
the First Member of such MetaMorphix
Product's TGF-(beta) Class is a GDF
Discovered by JHU; OR (ii) one and three
quarters percent (1 3/4%) of MetaMorphix's
Net Sales of such MetaMorphix Product, if
the First Member of such MetaMorphix
Product's TGF-(beta) Class is a
Collaborative Factor Discovered jointly by
JHU and MetaMorphix or a Collaborative
Factor Discovered jointly by JHU and GI;
B equals seven-eighths percent (7/8%) of Net
Sales obtained from such sales of such
MetaMorphix Product, multiplied by the
number (if any) of Subsequent Members in
such MetaMorphix Product's TGF-(beta) Class
(not to exceed three (3)) which are GDFs
Discovered by JHU:
C equals seven-sixteenths percent (7/16%) of
Net Sales obtained from such sales of such
MetaMorphix Product, multiplied by the
number (if any) of Subsequent Members in
such MetaMorphix Product's TGF-(beta) Class
(not to exceed three (3) which are either
Collaborative Factors Discovered jointly by
JHU and MetaMorphix or Collaborative Factors
Discovered jointly by JHU and GI;
D equals seven-eighths percent (7/8%) of Net
Sales obtained from such sales of such
MetaMorphix Product, if such MetaMorphix
Product is labeled for an indication which
is covered by a Valid Claim of a Use Patent
within the JHU Patent Rights;
E equals seven-sixteenths percent (7/16%) of
Net Sales obtained from such sales of such
MetaMorphix Product, if such MetaMorphix
Product is labeled for an indication which
is covered by a Valid Claim of a Use Patent
within the Joint Patent Rights of JHU and
MetaMorphix, or JHU and GI;
PROVIDED, HOWEVER, that in no event shall
the sum of A, B and C exceed six percent
(6%).
7.3.1.2 PAYABLE BY METAMORPHIX TO GI. MetaMorphix
shall pay to GI royalties on sales made by
MetaMorphix, its Affiliates or sublicensees,
of each MetaMorphix Product, the
manufacture, use or sale of which is covered
by a Valid Claim under the applicable Factor
Patent Rights, which royalty shall be
calculated using the following formula:
royalty = A+B+C+D+E
where
A equals either (i) four percent (4%) of Net
Sales obtained from such sales of such
MetaMorphix Product, if the First Member of
that Product's TGF-(beta)
Class is a BMP: OR (ii) two percent (2%) of
Net Sales obtained from such sale of such
MetaMorphix Product, if the First Member of
that Product's TGF(beta) Class is a
Collaborative Factor of GI and(.) JHlU or a
Collaborative Factor of GI and MetaMorphix;
B equals one percent (1 %) of the Net Sales
obtained from such sales of such MetaMorphix
Product, multiplied by the number (if any)
of Subsequent Members in such MetaMorphix
Product's TGF-(beta) Class (not to exceed
three (3)) which are BMPs;
C equals one-half percent (1/2%) of Net
Sales obtained from such sales of such
MetaMorphix Product, multiplied by the
number (if any) of Subsequent Members in
that MetaMorphix Product's TGF-(beta) Class
(not to exceed three (3)) which are either
Collaborative Factors of GI and JHU or
Collaborative Factors of GI and MetaMorphix;
D equals one percent (1 %) of Net Sales
obtained from such sales of such MetaMorphix
Product, if such MetaMorphix Product is
labeled for an indication which is covered
by a Valid Claim of a Use Patent within the
GI Patent Rights; and
E equals one-half percent (1/2%) of Net
Sales obtained from such sales of such
MetaMorphix Product, if such MetaMorphix
Product is labeled for an indication which
is covered by a Valid Claim of a Use Patent
within the Joint Patent Rights of GI and
JHU. or GI and MetaMorphix;
PROVIDED, HOWEVER, that In no event shall
the sum of A, B and C exceed seven percent
(7%).
7.3.2 GI TYPE A PRODUCTS.
7.3.2.1 PAYABLE BY GI TO METAMORPHIX. GI shall pay
to MetaMorphix a royalty on sales made by
GI, its Affiliates or sublicensees of each
GI Type A Product, the manufacture, USE or
sale of which is covered by a Valid Claim
under the applicable Factor Patent Rights,
which royalty shall be calculated using the
following formula:
(A+B+C+D+E)-F
where
A equals either (i) four percent (4%) of the
Net Sales obtained from such sales of such
GI Type A Product. if the First Member of
such GI Type A Product's TGF-(beta) Class is
a GDF or a Collaborative Factor of JHU and
MetaMorphix. or (ii) two percent (2%) of Net
Sales of such GI Type A Product. if the
First Member of such GI Type A Product's
TGF-(beta) Class is a Collaborative Factor
of GI and JHU or GI and MetaMorphix;
B equals one percent (1%) of Net Sales
obtained from such sales of such GI Type A
Product, multiplied by the number (if any)
of Subsequent Members in that GI Type A
Product's TGF-(beta) Class (not to exceed
three (3) which are GDFs or Collaborative
Factors of JHU and-MetaMorphix;
C equals one-half percent (1/2%) of Net
Sales obtained from such sales of such GI
Type A Product, multiplied by the number (if
any) of Subsequent Members in that Product's
TGF-(beta) Class (not to exceed three (3)
which are Collaborative Factors of GI and
JHU or GI and MetaMorphix;
D equals one percent (1 %) of Net Sales
obtained from such sales of such GI Type A
Product, if that GI Type A Product is
labeled for an indication which is covered
by a Valid Claim of a Use Patent within the
MetaMorphix Patent Rights, the JHU Patent
Rights or the Joint Patent Rights of JHU and
MetaMorphix;
E equals one-half percent (1/2%) of the Net
Sales obtained from such sales of such GI
Type A Product, if that Product is labeled
for an indication which is covered by a
Valid Claim of a Use Patent within the Joint
Patent Rights of GI and JHU or GI and
MetaMorphix: and
F equals the royalty payable by GI to JHU
under Section 7.3.2.2 below,
PROVIDED. HOWEVER, that In no event shall
the sum of A. B and C exceed seven percent
(7%).
7.3.2.2 PAYABLE BY GI to JHU. GI shall pay to JHU a
royalty on sales made by GI, its Affiliates
or sublicensees of each GI Type A Product,
the manufacture, use or sale of which is
covered by a Valid Claim under applicable
Factor Patent Rights, which royalty shall be
calculated using the following formula:
A+B+C+D+E
where
A equals either (i) three and one-half
percent (3 1/2%) of the Net Sales obtained
from such sales of such GI Type A Product,
if the First Member of such GI Type A
Product's TGF-(beta) Class is a GDF
Discovered by JHU; OR (ii) one and three
quarters percent (1 3/4%) of GI's Net Sales
of such GI Type A Product, if the First
Member of such GI Type A Product's
TGF-(beta) Class is a Collaborative Factor
Discovered jointly by JHU and MetaMorphix or
a Collaborative Factor Discovered jointly by
JHU and GI;
B equals seven-eighths percent (7/8%) of the
Net Sales obtained from such sales of such
GI Type A Product, multiplied by the number
(if any) of Subsequent Members IN SUCH GI
Type A Product's TGF-(beta) Class (not to
exceed three (3) which are GDFs Discovered
by JHU;
C equals seven-sixteenths percent (7/16%) of
the Net Sales obtained from such sales of
such GI Type A Product, multiplied by the
number (if any) of Subsequent Members in
such GI Type A Product's TGF-(beta) Class
(not to exceed three (3) which are either
Collaborative Factors Discovered jointly by
JHU and MetaMorphix or Collaborative Factors
Discovered jointly by JHU and GI;
D equals seven-eighths percent (7/8%) of the
Net Sales obtained from such sales of such
GI Type A Product, if such GI Type A Product
is labeled for an
indication which is covered by a Valid Claim
of a Use Patent within the JHU Patent
Rights:
E equals seven-sixteenths percent (7/16%) of
the Net Sales obtained from such sales of
such GI Type A Product, if such GI Type A
Product is labeled for an indication which
is covered by a Valid Claim of a Use Patent
within the Joint Patent Rights of JHU and
MetaMorphix, or JHU and GI;
PROVIDED, HOWEVER, that in no event shall
the sum of A. B and C exceed six percent
(6%).
7.3.3 GI TYPE B PRODUCTS.
7.3.3.1 PAYABLE BY GI TO METAMORPHIX. GI shall pay
to MetaMorphix a royalty on sales made by
GI, its Affiliates or sublicensees of each
GI Type B Product, the manufacture, use or
sale of which is covered by a Valid Claim
under the applicable Factor Patent Rights,
which royalty shall be calculated using the
following formula:
royalty =A-(B+C+D+E+F+G)
where
A equals eight percent (8%) of the Net Sales
obtained from such sales of such GI Type B
Product;
B equals the royalty payable by GI to JHU
under Section 7.3.3.2 below;
C equals either (i) four percent (4%) of Net
Sales obtained from such sales of such GI
Type B Product, if the First Member of that
Product's TGF-(beta) Class is a BMP; OR (ii)
two percent (2%) of Net Sales obtained from
such sale of such MetaMorphix Product, if
the First Member of that Product's
TGF-(beta) Class is a Collaborative Factor
of GI and JHU or a Collaborative Factor of
GI and MetaMorphix;
D equals one percent (1 %) of the Net Sales
obtained from such sales of such GI Type B
Product, multiplied by the number (if any)
of Subsequent Members in such GI Type B
Product's TGF-(beta) Class (not to exceed
three (3) which are BMPs;
E equals one-half percent (1/2%) of Net
Sales obtained from such sales of such GI
Type B Product, multiplied by the number (if
any) of Subsequent Members in that GI Type B
Product's TGF-(beta) Class (not to exceed
three (3) which are either Collaborative
Factors of GI and JHU or Collaborative
Factors of GI and MetaMorphix:
F equals one percent (1%) of Net Sales
obtained from SUCH sales of such GI Type B
Product, if such GI Type B Product is
labeled for an indication which is covered
by a Valid Claim of a Use Patent within the
GI Patent Rights; and
G equals one-half percent (1/2%) of Net
Sales obtained from SUCH sales of such GI
Type B Product, if such GI Type B Product is
labeled for an indication which-is covered
by a Valid Claim of a Use Patent within the
Joint Patent Rights of GI and JHU, or GI,
and MetaMorphix;
PROVIDED, HOWEVER, that in no event shall
the sum of C, D and E exceed six percent
(6%) or shall the sum of B, C, D, E, F and G
exceed seven percent (7%).
7.3.3.2 PAYABLE BY GI TO JHU. GI shall pay to JHU a
royalty on sales made by GI, its Affiliates
or sublicensees of each GI Type B Product,
the manufacture, use or sale of which is
covered by a Valid Claim under the
applicable Factor Patent Rights, which
royalty shall be calculated using the
following formula:
royalty =A+B+C+D+E
where
A equals either (i) three and one-half
percent (3 1/2%) of the Net Sales obtained
from such sales of such GI Type B Product,
if the First Member of such GI Type B
Product's TGF-(beta) Class is a GDF
Discovered by JHU; OR (ii) one and three
quarters percent (1 3/4%) of GI's Net Sales
of such GI Type B Product, if the First
Member of such GI Type A Product's
TGF-(beta) Class is a Collaborative Factor
Discovered jointly by JHU and MetaMorphix or
a Collaborative Factor Discovered jointly by
JHU and GI;
B equals seven-eighths percent (7/8%) of the
Net Sales obtained from such sales of such
GI Type B Product, multiplied by the number
(if any) of Subsequent Members in such GI
Type B Product's TGF-(beta) Class (not to
exceed three (3) which are GDFs Discovered
by JHU;
C equals seven-sixteenths percent (7/16%) of
the, Net Sales obtained from such sales of
such GI Type B Product, multiplied by the
number (if any) of Subsequent Members in
such GI Type B Product's TGF-(beta) Class
(not to exceed three (3)) which are either
Collaborative Factors Discovered jointly by
JHU and MetaMorphix or Collaborative Factors
Discovered jointly by JHU and GI;
D equals seven-eighths percent (7/8%) of the
Net Sales obtained from such sales of such
GI Type A Product, if such GI Type B Product
is labeled for an indication which is
covered by a Valid Claim of a Use Patent
within the JHU Patent Rights;
E equals seven-sixteenths percent- (7/16%)
of the Net Sales obtained from such sales of
such GI Type B Product, if such GI Type B
Product is labeled for an indication which
is covered by a Valid Claim of a Use Patent
within the Joint Patent Rights of JHU and
MetaMorphix or JHU and GI;
PROVIDED, HOWEVER, that in no event shall
the sum of A, B and C exceed six percent
(6%).
7.3.4 GI TYPE C PRODUCTS. GI shall pay to JHU a royalty on
sales made by GI, its Affiliates or sublicensees of
each GI Type C Product, the manufacture, use or sale
of which is covered by a Valid Claim under the JHU
Patent Rights or the Joint Patent Rights of JHU and
GI, which royalty shall be calculated using the
following formula:
royalty =A+B+C+D+E
where
A equals either (i) three and one-half percent (3
1/2%) of the Net Sales obtained from such sales of
such GI Type C
Product, if the First Member of such GI Type
C Product's TGF-(beta) Class is a Additional
GDF Discovered by JHU: OR (ii) one and three
quarters percent (1 3/4%) of GI's Net Sales
of such GI Type C Product, if the First
Member of such GI Type C Product's
TGF-(beta) Class is a Additional
Collaborative Factor Discovered jointly by
JHU and GI;
B equals seven-eighths percent (7/8%) of the
Net Sales obtained from such sales of such
GI Type C Product, multiplied by the number
(if any) of Subsequent Members in such GI
Type C Product's TGF-(beta) Class (not to
exceed three (3) which are Additional GDFs
Discovered by JHU;
C equals seven-sixteenths percent (7/16%) of
the Net Sales obtained from such sales of
such GI Type C Product, multiplied by the
number (if any) of Subsequent Members in
such GI Type C Product's TGF-(beta) Class
(not to exceed three (3) which are
Additional Collaborative Factors Discovered
jointly by JHU and GI;
D equals seven-eighths percent (7/8%) of the
Net Sales obtained from such sales of such
GI Type C Product, if such GI Type C Product
is labeled for an indication which is
covered by a Valid Claim of a USE PATENT
WITHIN THE JHU PATENT RIGHTS;
E equals seven-sixteenths percent (7/16%) of
the Net Sales obtained from such sales of
such GI Type A Product, if such GI Type C
Product is labeled for an indication which
is covered by a Valid Claim of a USE PATENT
WITHIN THE JOINT PATENT RIGHTS OF JHU AND
GI;
PROVIDED, HOWEVER, that in no event shall
the sum of A, B and C exceed six percent
(6%).
7.3.5 OTHER TGF-(BETA) FACTORS.
7.3.5.1 PAYABLE BY METAMORPHIX TO JHU. MetaMorphix
shall pay to JHU a royalty on the sales,
made by MetaMorphix, its Affiliates or
sublicensees, of each Other TGF-(beta)
Product, which royalty shall be calculated
using the following formula:
royalty = A + B
where
A equals one percent (1 %) of the Net Sales
obtained from such sales of such Other
TGF-(beta) Product, multiplied by the number
(if any) of GDFs of JHU (not to exceed three
(3) for each TGF-(beta) Class), the
manufacture, use or sale of which is covered
by a Valid Claim under the applicable Factor
Patent Rights, which GDFs belong to the
TGF-(beta) Class containing the Other
TGF-(beta) Factor that such Other TGF-(beta)
Product is based on; and
B equals one-half percent (1/2%) of the Net
Sales obtained from such sales of such Other
TGF-(beta) Product, multiplied by the number
(if any) of Collaborative Factors of JHU and
GI, or JHU and MetaMorphix (not to exceed
three (3) for each TGF-(beta) Class), the
manufacture, use or sale of which is covered
by a Valid Claim under the applicable Factor
Patent Rights, which Collaborative Factors
belong to a TGF-(beta) Class containing the
Other TGF-(beta) Factor that such Other
TGF-(beta) Product is based on.
7.3.5.2 PAYABLE BY METAMORPHIX TO GI. MetaMorphix
shall pay to GI royalties on the sales made
by MetaMorphix, its Affiliates or
sublicensees of each Other TGF-(beta)
Product, which royalty shall be calculated
using the following formula:
royalty = A + B
where
A equals one percent (1 %) of the Net Sales
obtained from the sale of such Other
TGF-(beta) Product, multiplied by the number
(if any) of BMPs (not to exceed three (3)
for each TGF-(beta) Class), the manufacture,
use or sale of which is covered by a Valid
Claim under the applicable Factor Patent
Rights. which BMPs belong to a TGF-(beta)
Class containing the Other TGF-(beta) Factor
that such Other TGF-(beta) Product is based
on; and
B equals one-half percent (1/2%) of the Net
Sales obtained from the sale of such Other
TGF-(beta) Product. multiplied by the number
(if any) of Collaborative Factors of GI and
JHU. or GI and MetaMorphix (not to exceed
three (3) for each TGF(beta) Class), the
manufacture, use or sale of which is covered
by a Valid Claim under the applicable Factor
Patent Rights, which Collaborative Factors
belong to a TGF-(beta) Class containing the
Other TGF-(beta) Factor that such Other
TGF-(beta) Product is based on.
7.3.5.3 PAYABLE BY GI TO JHU. GI shall pay to JHU a
royalty on the sales by GI, its Affiliates
or sublicensees of Other TGF-(beta)
Products, which royalty shall be calculated
by using the formula:
royalty =A+B+C+D
where
A equals (i) seven-sixteenths percent
(7/16%) of the Net Sales obtained from such
sales made in North America of any Other
TGF-(beta) Product based on a Factor known
to GI as BMPs 2, 4, 5, 6, 7, 9 or 12,
multiplied by the number (if any) of GDFs
discovered by JHU which belong to a
TGF-(beta) Class containing the Other
TGF-(beta) Factor on which the Other
TGF-(beta) Product being sold is based, plus
(ii) seven-thirty-seconds percent (7/32%) of
the Net Sales obtained .from such sales made
in North America of any Other TGF-(beta)
Product based on a Factor known to GI as
BMPs 2, 4, 5, 6, 7, 9 or 12, multiplied by
the number (if any) of Collaborative Factors
of JHU and MetaMorphix which belong to a
TGF-(beta) Class containing the Other
TGF-(beta) Factor on which the Other
TGF-(beta) Product being sold is based, in
each case only where the manufacture, use or
sale of such GDFs or Collaborative Factors
is covered by a Valid Claim under the
applicable Factor Patent Rights, PROVIDED,
HOWEVER, that the aggregate number of such
GDFs and Collaborative Factors considered in
making such calculation shall not exceed
three (3) AND, PROVIDED FURTHER, that if
more
than three (3) of such GDFs and
Collaborative Factors that exist in the
aggregate, each such GDF shall be considered
in making such calculation prior to the
consideration of any Collaborative Factor in
making such calculation;
B equals seven-thirty seconds percent
(7/32%) of the Net Sales obtained from such
sales made in North America of Other
TGF-(beta) Products based on any Factor
known to GI as BMPS 2, 4, 5, 6, 7, 9 and 12,
multiplied by the number (if any) of
Collaborative Factors of GI and JHU (not to
exceed three (3) for each TGF-(beta) Class)
which belong to a TGF-(beta) Class
containing the Other TGF-(beta) Factor on
which the Other TGF-(beta) Product being
sold is based, where the manufacture, use or
sale: of such Collaborative Factors is
covered by a Valid Claim under the
applicable Factor Patent Rights;
C equals (i) seven-eighths percent (7/8%) of
the Net Sales obtained from such sales of
any Other TGF-(beta) Product (excluding
Other TGF-(beta) Products based on the
Factors known to GI as BMPs 2, 4, 5, 6, 7, 9
and 12), multiplied by the number (if any)
of GDFs Discovered by JHU which belong to a
TGF-(beta) Class containing the Other
TGF-(beta) Factor on which such Other TGF-R
Product is based, plus (ii) sevensixteenths
percent (7/16%) of the Net Sales obtained
from such sales of any Other TGF-(beta)
Product (excluding Other TGF-(beta) Products
based on the Factors known to GI as BMPs 2,
4, 5, 6, 7, 9 and 12), multiplied by the
number (if any) of Collaborative Factors of
JHU and MetaMorphix which belong to a
TGF-(beta) Class containing the Other
TGF-(beta) Factor on which such Other
TGF-(beta) Product is based, in each case
only where the manufacture, use or sale of
such GDFs or Collaborative Factors is
covered by a Valid Claim under the
applicable Factor Patent Rights, PROVIDED,
HOWEVER, that the aggregate number of such
GDFs and Collaborative Factors considered in
making such calculation shall not exceed
three (3) and, PROVIDED FURTHER, that if
more than three (3) of such GDFs and
Collaborative Factors that exist, in the
aggregate, each such GDF
shall be considered in making such
calculation prior to the consideration of
any Collaborative Factor in making such
calculation and
D equals seven-sixteenths percent (7/16%) of
the Net Sales obtained from the sales of any
Other TGF(beta) Product (excluding Other
TGF-(beta) Products based on the Factors
known to GI as BMPs 2. 4, 5., 6. 7. 9 and
12), multiplied by the number (if any) of
Collaborative Factors of GI and JHU (not to
exceed three (3) for each TGF-(beta) Class)
which belong to a TGF-(beta) Class
containing the Other TGF-(beta) Factor on
which such Other TGF-(beta) Product is
based, where the manufacture, use or sale of
such Collaborative Factor is covered by a
Valid Claim under the applicable Factor
Patent Rights.
7.3.5.4 PAYABLE BY GI TO METAMORPHIX. GI shall pay
to MetaMorphix a royalty on the sales made
by GI, its Affiliates or sublicensees of
Other TGF-(beta) Products, which royalty
shall be calculated using the formula:
royalty =(A+B+C+D)-E
where
A equals one-half percent (1/2%) of the Net
Sales obtained from sales made in North
America of any Other TGF-(beta) Product
based on a Factor known to GI as BMPs 2, 4,
5, 6, 7, 9 or 12, multiplied by the number
(if any) of GDFs or Collaborative Factors of
JHU and MetaMorphix (not to exceed three (3)
for each TGF-beta Class), the manufacture,
use or sale of which is covered by a Valid
Claim under the applicable Factor Patent
Rights, which belong to a TGF-(beta) Class
containing the Factor on which the Other
TGF-(beta) Product being sold is based;
B equals one-quarter percent (1/4%) of the
Net Sales obtained from sales made in North
America of any Other TGF-(beta) Product
based on a Factor KNOWN to GI as BMPs 2, 4,
5, 6, 7, 9 and 12, multiplied by the number
(if any) of Collaborative Factors of GI and
JHU, or GI and MetaMorphix (not to exceed
three (3) for each TGF-(beta) Class), the
manufacture. use or sale of which is covered
by a Valid Claim under the applicable Factor
Patent Rights, which belong to a TGF-(beta)
Class containing the Other TGF-(beta) Factor
on which the Other TGF-(beta) Product being
sold is based:
C equals one percent (1 %) of the Net Sales
obtained from the sale of any Other
TGF-(beta) Product (excluding Other TGF-P
Products based on the Factors known to GI as
BMPs 2, 4, 5, 6, 7, 9 and 12), multiplied by
the number (if any) of GDFs and
Collaborative Factors of JHU and MetaMorphix
(not to exceed three (3) for each TGF-beta
Class), the manufacture, use or sale of
which is covered by a Valid Claim under the
applicable Factor Patent Rights, which
belong to a TGF-(beta) Class .containing the
Other TGF-(beta) Factor on which the Other
TGF-(beta) Product being sold is based;
D equals one-half percent (1/2%) of the Net
Sales obtained from the sale of any Other
TGF-(beta) Product (excluding Other
TGF-(beta) Products based on the Factors
known to GI as BMPs 2, 4, 5, 6, 7, 9 and
12), multiplied by the number (if any) of
Collaborative Factors of GI and JHU, or GI
and MetaMorphix (not to exceed three (3) for
each TGF-(beta) Class), the manufacture, use
or sale of which is covered by a Valid Claim
under the applicable Factor Patent Rights,
which belong to a TGF-(beta) Class
containing the Other TGF-(beta) Factor on
which the Other TGF-(beta) Product being
sold is based; and
E equals the royalty payable by GI to JHU
under Section 7.3.5.3 above.
7.3.5.5 PATENT INTERFERENCE. The Parties acknowledge
that an interference proceeding has been
declared and is currently pending in the
United States Patent and Trademark Office
with respect to patent applications filed by
GI claiming BMP12 and patent applications
filed by JHU claiming GDF-7. In the event
that it is finally determined that the
inventions claimed in the GDF-7 patent
applications have priority (i.e., were
invented prior to) the inventions claimed in
the BMP-12
patent applications and a patent is issued from
the GDF-7 patent applications, then this
Agreement thereupon shall be deemed to be
automatically amended such that all references
to BMP-12 in Sections 7.3.5.3 and 7.3.5.4 shall
be deleted.
7.4 ROYALTY CALCULATIONS.
7.4.1 COUNTRY-BY-COUNTRY BASIS. For each Product, royalties
shall be payable by a Party on a country-by-country
basis solely with respect to Net Sales for any
country where such Product is manufactured or sold in
which there is a Valid Claim under the applicable
Factor Patent Rights or Additional Factor Patent
Rights. However, for sales of a Product which is
manufactured in a country in which there is a Valid
Claim under the applicable Factor Patent Rights or
Additional Factor Patent Rights, but sold in a
country where the applicable Factor Patent Rights or
Additional Factor. Patent Rights do not exist, the
royalties payable by the Parties for sales in that
country shall be reduced by fifty percent (50%) if
products are being sold in that country which
directly compete with such Product.
7.4.2 ADVANCED PRODUCTS. For Products which are not
finished formulations, mixtures or compositions of a
Factor (that is, for Products which could not have
been developed by a Party but for the application of
substantial advanced technologies developed by that
Party (e.g., WITHOUT LIMITATION, Products which are
antibodies, antisense molecules or ribozymes to, a
Factor)), the royalty payable by that developing
Party on Net Sales of that Product shall be reduced
to reflect the fair market value contribution of that
advanced technology to the Product, as determined by
mutual agreement of the Parties. In the event that
the Parties are unable to calculate or agree Upon the
fair market value contribution of the advanced
technology to the Product, then the royalty payable
by the developing Party on Net Sales of that Product
shall be reduced by fifty percent (50%)-
7.4.3 THIRD PARTY Royalties If it becomes necessary, in
order for a Party or its Affiliates or sublicensees
to make, use or sell Products or products based upon
Other TGF-p Factors, to pay royalties under a Third
Party's patent rights (including amounts, if any,
payable to Third Parties, under Section 6.7, above;
and with respect to MetaMorphix. excluding amount
payable by MetaMorphix to JHU and/or GI under this
Agreement; and with respect to GI, excluding amount
payable by GI to MetaMorphix under this Agreement),
then the licensee Party shall have the right to
deduct
fifty percent (50%) of the amounts so paid to Third Parties up
to a total of fifty percent (50%) of the amount due the
licensor Party on account of such particular Products or
products based on Other TGF-(beta) Factors.
7.4.4 LIMITATION ON ROYALTY DEDUCTIONS. Total royalty
deductions under this Section 7.4 shall not exceed
fifty percent (50%) of the amount due the licensor
Party on account of Net Sales of the Product or Other
TGF-(beta) Product, for which royalty payments are
owed.
7.5 REPORTS AND PAYMENT. Each Party shall deliver to the Party to
which royalties are owed, within sixty (60) days after the end
of each calendar quarter, a written report showing its
computation of royalties due under this Agreement upon Net
Sales by such Party, its Affiliates and sublicensees during
such calendar quarter. All Net Sales shall be segmented in
each such report according to sales by such Party, each
AFFILIATE and each sublicensee, as well as on a
country-by-country basis, including the rates of exchange used
to convert such royalties to United States Dollars from the
currency in which such sales were made. Subject to the
provisions of Sections 7.6 and 7.7 of this Agreement,
simultaneously with the delivery of each such report, the
paying Party shall tender payment in United States Dollars of
all royalties shown to be due therein.
For purposes hereof, the rates of exchange to be used for
convening royalties hereunder to United States Dollars shall
be the closing price published for the purchase of United
States Dollars in the East Coast Edition of the Wall Street
Journal for the last business day of the calendar quarter for
which payment is due.
7.6 FOREIGN Royalties. Where royalties are due hereunder for sales
of Products or products based on Other TGF-(beta) Factors in a
country where, by reason of currency regulations or taxes of
any kind, it is impossible or illegal for such Party, any
Affiliate or sublicensee to transfer royalty payments to the
licensor Party for Net Sales in that country, such royalties
shall be deposited in whatever currency is allowable by the
person or entity not able to make the transfer for the benefit
or credit of the licensor Party in an accredited bank in that
country that is reasonably acceptable to the licensor Party.
7.7 TAXES. Any and all income or similar taxes imposed or levied
on account of the receipt of royalties payable under this
Agreement which are required to be withheld by a Party shall
be paid by such Party, its Affiliates or sublicensees on
behalf of the licensor Party and shall be paid to the proper
taxing authority. Proof of payment shall be secured and sent
to the licensor. Party by such Party, its Affiliates or
sublicensees as evidence of such payment in such form as
required by the tax authorities having jurisdiction over such
Party, its Affiliates or sublicensees. Such taxes shall be
deducted from the royalty that would otherwise be remittable
by the Parry, its Affiliates or sublicensees.
7.8 RECORDS. Each Party shall keep, and shall require all
Affiliates and sublicensees to keep, for a period of at least
two (2) years, full, true and accurate books of accounts and
other records containing all information and data which may be
necessary to ascertain and verify the royalties payable
hereunder. During the term of this Agreement and for a period
of two (2) years following its termination, each Party shall
have the right from time to time (not to exceed once during
each calendar year) to inspect in confidence, or have an
agent, accountant or other representative inspect in
confidence, such books, records and supporting data.
8. ADDITIONAL CONSIDERATION.
8.1 ASSIGNMENT OF METAMORPHIX STOCK. At the Closing, GI would
assign to MetaMorphix two million seven hundred thousand
(2.700,000) shares of the MetaMorphix Series A Convertible
Preferred Stock and nine hundred thousand (900.000) shares of
the MetaMorphix Series B Convertible Preferred Stock,
currently owned by GI, which assignment will be substantially
in the form as the assignment form attached hereto as Schedule
8.1A. At the Closing, GI also will deliver to MetaMorphix an
executed Stock Power, substantially in the form as attached
hereto as Schedule 8.1 B, for each MetaMorphix stock
certificate held by GI for the purpose of effecting such
assignment. After making such assignment, GI would still own
two hundred thousand (200,000) shares of MetaMorphix Series A
Convertible Preferred Stock and, at the Closing, MetaMorphix
shall, upon receiving the executed Assignment Agreement and.
Stock Powers, issue to GI a new stock certificate representing
such shares. Upon making such assignment, in accordance with
Section 8.6 hereof GI (i) shall acknowledge that it no longer
owns the minimum number of shares of MetaMorphix Stock such
that the MetaMorphix shareholders would be required to elect 2
or 3 persons designated by GI to serve as Directors on the
MetaMorphix Board of Directors, and (ii) would irrevocably
waive its right to exercise its purchase options under the
April 18, 1995 Stock Restriction Agreement and each of the
April 18, 1995 Right of First Refusal Agreements to which it.
MetaMorphix and JHU are parties.
8.2 AMENDMENT OF PROMISSORY NOTE. At the Closing, GI and
MetaMorphix would execute a Third Allonge to the Promissory
Note, which shall be substantially in the form as the Third
Allonge appearing in Schedule 8.2 attached hereto. Such Third
Allonge shall provide, INTER ALIA, (I) for an
extension of the due date for the payment of the note until
January 1. 2005, (ii) that MetaMorphix will he permitted to
repay the principal and interest at any time. (iii) that at
the end of the loan term. if MetaMorphix's stock is publicly
traded, MetaMorphix will be permitted to pay off the then
outstanding principal and interest with shares of
MetaMorphix's stock valued at the then current market price.
and (iv) that GI will be permitted, at any time and at its
sole election, to convert the outstanding principle and
interest of the loan to MetaMorphix stock. which stock shall
be valued at either (x) 125% of the IPO price if the stock is
then publicly traded or (y) a price to be negotiated in good
faith by MetaMorphix and GI if the stock is not then publicly
traded.
8.3 PUT OPTION. Subject to the terms and conditions of this
Agreement, after the Closing, GI would enter into put option
agreements with qualified and accredited Third Party
investors, which put option agreements collectively, would
permit such investors to require GI to purchase up to
$2,000,000. in the aggregate, of the MetaMorphix stock
purchased by such Third Party investors. Each such put option
agreement shall be substantially in the form as the sample put
option agreement appearing in Schedule 8.3 attached hereto.
The per share purchase price to be paid by GI upon the
exercise of such put option shall be the per share price paid
by such Third Party investors to MetaMorphix for the purchase
of such stock. Such Third Party investors would be permitted
to exercise such put options between January 1, 2000 and
December 31, 2001 only if MetaMorphix (i) has voluntarily
filed for bankruptcy under Chapter 7 of the U.S. Bankruptcy
Code or (ii) is placed into bankruptcy under Chapter 7 of the
U.S. Bankruptcy Code by a petition of a Third Party and such
proceeding is not lifted within sixty (60) days of the filing
of such petition for bankruptcy, in either event on or before
December 31, 2001. Notwithstanding the foregoing, each such
put option shall automatically expire if, prior to December
31, 2001. MetaMorphix raises an aggregate of eight million
dollars ($8.000.000) or more, in cash and/or non-cash
consideration, through financing from one or more Third
Parties and/or the transfer to one or more Third. Parties of
any rights relating to one or more MetaMorphix Factors,
MetaMorphix shall promptly notify GI, in writing, upon
entering each such transaction, which notice shall include a
copy of the transaction agreements and a summary of all
consideration received or to be received and the dates on
which such consideration was or is to be received. In
determining whether such eight million dollars ($8,000,000)
has been raised, only consideration actually received by
MetaMorphix on or before December 31, 2001 shall be counted,
PROVIDED, HOWEVER, that, with respect to any consideration
received in a form other than cash, the fair market value, as
determined in good faith by GI and MetaMorphix' Board of
Directors, of such consideration shall be utilized in
calculating whether such eight million dollars ($8,000,000)
has been raised. In the event that MetaMorphix becomes
insolvent and desires to
seek protection under U.S. Bankruptcy laws, MetaMorphix shall
use its good faith and diligent efforts to seek such
protection under Chapter 1 1 of' the U.S. Bankruptcy Code and,
if a bankruptcy petition is filed against MetaMorphix by any
Third Party. MetaMorphix shall uses its good faith diligent
efforts to have such petition dismissed as soon as possible.
MetaMorphix shall promptly notify. in writing. GI and each
such Third Party investor upon the occurrence of any events
which result in the expiration of the put options, provided,
however, that any failure to give or delay in giving such
notice shall have no effect upon the expiration of any such
put option. Notwithstanding, the foregoing. the obligation to
grant any put option to any Third Party investor pursuant to
this Section 8.3 shall be subject to GI's receiving, from
MetaMorphix' legal counsel. a written opinion (which written
opinion shall be prepared and given at no cost or expense to
GI) to the effect that the sale of the shares of the capital
stock of MetaMorphix which are to be the subject of such put
option and the issuance of the put option by GI to such Third
Party Investor, each are exempt from registration under
applicable federal and state securities laws.
8.4 PURCHASE OF EQUIPMENT. At the Closing, GI and MetaMorphix
shall enter into an Asset Purchase Agreement, substantially in
the form of the Asset Purchase Agreement attached hereto as
Schedule 8.4A, pursuant to which GI will purchase from
MetaMorphix the equipment identified in Schedule 8.4B attached
hereto. Pursuant to such Asset Purchase Agreement, in
consideration of such purchase, GI will pay to MetaMorphix two
hundred eighty four thousand five hundred twenty four dollars
($284,524), such amount payable to MetaMorphix upon Closing
for immediate payment by MetaMorphix to Transamerica Business
Credit Corporation (from which MetaMorphix leases such
equipment) as payment in full for the exercise of MetaMorphix'
option to purchase such equipment from Transamerica Business
Corporation. Such purchase price is inclusive of all costs
associated with the purchase of such equipment, PROVIDED,
HOWEVER, that GI also shall pay any (i) sales tax, use tax or
any other federal, state of local tax (but not any income tax)
measured solely by the equipment price and required to be paid
by MetaMorphix by virtue of the sale and/or delivery of the
equipment to GI and (ii) freight, packing, shipping and
insurance costs. GI shall select a carrier and arrange for
such carrier to deliver such equipment to the location(s)
designated by GI within thirty (30) days after the Closing. GI
shall (i) prepay all freight, packing, shipping and insurance
costs required for the shipment of the equipment to GI and
(ii) bear the risk of loss until the equipment is safely
delivered to GI's premises. Simultaneously with the delivery
of the equipment to GI, MetaMorphix shall provide to GI all
manuals, documents, specifications, and spare parts that
relate to such equipment and are in MetaMorphix' possession.
GI has had the opportunity, prior to the signing of this
Agreement to inspect such equipment which shall be delivered
to GI in "as is" condition, PROVIDED, HOWEVER, that until such
equipment is
delivered by MetaMorphix to GI's carrier. MetaMorphix shall
use all reasonable efforts to maintain such equipment in the
condition as it was in at the time of GI's inspection.
8.5 BAYLOR AGREEMENT. As of the date this Agreement was signed by
each of the Parties, MetaMorphix has paid to Baylor
forty-eight thousand dollars ($48,000) of the total amount to
be paid by MetaMorphix to Baylor under the Baylor Agreement,
which payments are sufficient to cover the research activities
to be performed thereunder by Baylor during the period
commencing on February 1, 1998 and ending on July 31, 1998. As
of the date this Agreement was signed by each of the Parties,
MetaMorphix is in arrears in the additional amount of
forty-eight thousand dollars ($48,000) of the payments to be
made to Baylor under the Baylor Agreement. GI. on the
Effective Date, shall pay to MetaMorphix, forty-eight thousand
dollars ($48,000) which amount is to be used by MetaMorphix to
immediately pay Baylor the past due amount under the Baylor
Agreement, and in consideration therefor, MetaMorphix shall
assign to GI all rights and licenses to any data, information
or intellectual property arising from the Baylor Agreement on
or after August 1, 1998 and prior to February 1, 1999, which
assignment shall be represented by an Intellectual Property
Assignment Agreement which is substantially in the form of the
Intellectual Property Assignment Agreement attached hereto as
Schedule 8.5. If MetaMorphix elects to terminate the Baylor
Agreement and should Baylor be willing to do so, GI hereby
agrees to enter into good faith negotiations with Baylor for a
sponsored research agreement which agreement would replace the
Baylor Agreement.
8.6 SHAREHOLDER AGREEMENTS. At the Closing, GI, MetaMorphix, JHU
and Xx. Xxx each shall execute and deliver to the others a
Termination Agreement, which shall be substantially in the
form of the Termination Agreement appearing in Schedule 8.6
attached hereto., pursuant to which the 1995 Voting Agreement,
the 1995 Stock Restriction Agreements and the 1995 Right of
First Refusal Agreements will be terminated.
9. PRODUCT DEVELOPMENT AND COMMERCIALIZATION.
9.1 METAMORPHIX'S OBLIGATIONS.
9.1.1 GENERAL Diligence Obligation. MetaMorphix shall use
its Commercially Reasonable Efforts, in its
reasonable scientific and business judgment, as
permitted by the licenses granted to it under Article
6 hereof, to further characterize, evaluate, select,
conduct all necessary and appropriate preclinical and
clinical trials and seek regulatory approvals for at
least one (1) product based on each TGF-(beta) Factor
Class selected by MetaMorphix under Section 5.3
hereof. Additionally, MetaMorphix shall use its
Commercially
Reasonable Efforts to manufacture or have
manufactured, market and sell such products in those
countries of the Territory where MetaMorphix has
obtained Regulatory Approval for such products.
9.1.2 DEVELOPMENT MILESTONES. As a measure of the diligence
obligations set forth in Section 9.1.1. MetaMorphix
shall either (i) spend an average of five hundred
thousand dollars ($500,000) per year over the five
(5) year period commencing with the Effective Date
(for a total of two million five hundred thousand
dollars ($2,5000,000) in the aggregate over such five
(5) year period) or (ii) meet the following
development milestones with respect to at least one
(1) product based on each at least one (1) of the
TGF-0 Factor Classes selected by MetaMorphix under
Section 5.3 hereof:
(a) within three (3) years from the date all
Available Factors have been selected as
MetaMorphix Factors or GI Factors pursuant
to Section 5.3, above, MetaMorphix-shall
perform initial pre-clinical
characterization and demonstrate efficacy in
an animal model, for at least one (1)
product based on a Factor from at least one
(1) of the TGF-(3 Factor Classes selected by
MetaMorphix;
(b) within five (5) years from the date set
forth in Section 9.1.2(a), above,
MetaMorphix shall submit an INAD for at
least one (1) product based on at least one
(I) of the TGF-f3 Factor Classes selected by
MetaMorphix under Section 5.3 hereof; and
(c) within seven (7) years from the date set
forth in Section 9.1.2(a), above,
MetaMorphix shall apply for approval from
the United States Department of Agriculture
and/or the FDA for at least one (1) product
based on at least one (1) of the TGF-J3
Factor Classes selected by MetaMorphix under
Section 5.3 hereof.
9.1.3 SATISFACTION OF DILIGENCE AND DEVELOPMENT MILESTONE
OBLIGATIONS. MetaMorphix may satisfy the diligence
obligations under Section 9.1.1 hereof and achieve
the development milestones under Section 9.1.2, in.
either case, on its own account, or through an
Affiliate or sublicensee, or by forming a partnership
or other venture to satisfy such diligence
obligations, all as permitted under the terms and
conditions of this Agreement. While MetaMorphix is
committed to satisfying such diligence obligations
and achieving such development milestones.
MetaMorphix does not represent, warrant or guarantee
that a product based on each TGF-(beta) Factor Class
selected by MetaMorphix will or can be successfully
developed or that the applicable development
milestones for any product based on such TGF-(beta)
Factor Class can be met.
9.1.4 FAILURE TO ACHIEVE DEVELOPMENT MILESTONES. Where
MetaMorphix fails to both (i) make the minimum
expenditures and (ii) meet a development milestone as
required under Section 9.1.2 hereof, JHU, in its sole
discretion and upon thirty (30) days prior written
notice to MetaMorphix and GI, may terminate the
licenses granted by it to MetaMorphix under Section
6.2 hereof, PROVIDED, HOWEVER, in the event
MetaMorphix fails to meet any such Milestone,
MetaMorphix may, at its option, retain its licenses
to such Factor Rights if MetaMorphix, thereafter,
pays to JHU a license maintenance fee in the amount
of five thousand dollars ($5,000) per calendar
quarter, the first such quarterly payment (which
payment shall be prorated based on the number of days
remaining between the end of such thirty (30) day
notice period and the end of the calendar quarter in
which such payment becomes due) being due at the end
of such thirty (30) day notice period, and each
subsequent payment being due on the last day of each
subsequent calendar quarter.. Notwithstanding the
foregoing, MetaMorphix' obligation to make such
payments shall cease if MetaMorphix has either (i)
increased its spending to the minimum levels required
under Section 9.1.2 hereof or (ii) achieved such
development milestone. In the event that, pursuant to
this Section 9.1, JHU terminates the licenses granted
to MetaMorphix under Section 6.2 hereof. GI. at its
sole option, within sixty (60) days after the end of
the thirty (30) day notice period provided for in
this Section 9.1.4, may. by written notice to JHU,
assume such licenses and MetaMorphix' obligations to
JHU with respect to such licenses, PROVIDED, HOWEVER,
that GI's obligations under the development
milestones set forth in Section 9.1.2(a) hereof shall
be measured beginning on the date of such assumption
of rights and obligations rather than the date all
Available Factors have been selected as MetaMorphix
Factors of GI Factors.
9.2 GI'S DILIGENCE OBLIGATIONS.
9.2.1 GENERAL DILIGENCE OBLIGATION. GI shall use its
Commercially Reasonable Efforts, in its reasonable
scientific and business judgment, as permitted by the
licenses granted to it under Article 6
hereof, to further Discover, characterize, evaluate,
select, conduct all necessary and appropriate
preclinical and clinical trials and seek regulatory
approvals for at least one (1) product based on each
TGF-beta Factor Class to which GI has received a
license from J IU under Section 6.3 hereof.
Additionally, GI shall use its Commercially
Reasonable Efforts to manufacture or have
manufactured, market and sell such products in those
countries of the Territory where GI has obtained
Regulatory Approval for such products.
9.2.2 MILESTONES. As a measure of the diligence obligations
set forth in Section 9.2.1, GI shall either (i) spend
an average of five hundred thousand dollars
($500,000) per year over the five (5) year period
commencing with the Effective Date (for a total of
two million five hundred thousand dollars
($2,500,000) in the aggregate over such five (5) year
period) or (ii) meet the following development
milestones with respect to at least one (1) product
based on at least one (1) of the TGF-(3 Classes to
which GI has rights under this Agreement: _
(a) within three (3) years from the date all
Available Factors have been selected as GI
Factors or MetaMorphix Factors pursuant to
Section 5.3, above, GI shall perform initial
pre-clinical characterization, and
demonstrate efficacy in an animal model, for
at least one (1) product based on a Factor
from at least one (1) TGF-(beta) Class to
which GI has rights under this Agreement;
(b) within five (5) years from the date GI
achieves the development milestone set forth
in Section 9.2.2(a), above. GI shall submit
an IND for a Phase I clinical study of at
least one (1) product based on a Factor from
at least one (1) TGF-(beta) Class to which
GI has rights under this Agreement; and
(c) within seven (7) years from the date GI
achieves the development milestone set forth
in Section 9.2.2(b), above. GI shall submit
a PLA seeking commercial approval of at
least one (1) product based on a Factor from
at least one (1) TGF-beta Class to which GI
has rights under this Agreement.
9.2.3 SATISFACTION OF DILIGENCE AND DEVELOPMENT MILESTONE
OBLIGATIONS. GI may satisfy the diligence obligations
under Section 9.2.1 hereof and achieve the
development milestones under Section 9.2.2, in either
case, on its own account. or through an Affiliate or
sublicensee, or by forming a partnership or other
venture to satisfy such diligence obligations, all as
permitted under the terms and conditions of this
Agreement. While GI is committed to satisfying such
diligence obligations and achieving such development
milestones, GI does not represent, warrant or
guarantee that a product based on each TGF-(beta)
Class selected by GI will or can be successfully
developed or that the applicable development
milestones for any product based on such TGF-(beta)
Class can be met.
9.2.4 FAILURE TO ACHIEVE DEVELOPMENT MILESTONES. Where GI
fails to both (i) make the minimum expenditures and
(ii) meet a development milestone as required under
Section 9.2.2 hereof, JHU may, in its sole discretion
and upon thirty (30) days prior written notice to GL
may terminate the licenses granted by it to GI under
Section 6.3 hereof; PROVIDED, HOWEVER, GI may, at its
sole option, retain its licenses to such Factor
Rights and Additional Factor Rights if GI,
thereafter, pays to JHU a license maintenance fee in
the amount of twenty five thousand dollars ($25,000)
per calendar quarter, the first such quarterly
payment (which payment shall be prorated based on the
number of days remaining between the end of such
thirty (30) day notice period and the end of the
calendar quarter in which such payment becomes due)
being due at the end of such thirty (30) day notice
period, and each subsequent payment being due on the
last day of each subsequent calendar quarter.
Notwithstanding the foregoing, GI's obligation to
make such payments shall cease if GI has either (i)
increased its spending to the minimum levels required
under Section 9.2.2 hereof or (ii) achieved such
development milestone. In the event that, pursuant to
this Section 9.1, JHU terminates the licenses granted
to GI under Section 6.3 hereof. MetaMorphix, at its
sole option, within sixty (60) days after the end of
the thirty (30) day notice period provided for in
this Section 9.2.4, may, by written notice to JHU,
assume such licenses and GI's obligations to JHU with
respect to such licenses, PROVIDED, HOWEVER, that
MetaMorphix' obligations under the development
milestones set forth in Section 9.2.2(a) hereof shall
be measured beginning on the date of such assumption
of rights and obligations rather than the date all
Available Factors have been selected as MetaMorphix
Factors of GI Factors.
9.3 RIGHT OF FIRST REFUSAL. GI, for itself and its parent company,
American Home Products Corporation, hereby waives and shall
have no further rights under any Right of First Refusal Offer
made by MetaMorphix pursuant to Section 9.2 of the 1994
Collaboration Agreement prior to the Effective Date, which
offer has not yet been accepted by GI or American Home
Products Corporation. Additionally, no right of first refusal
is provided to GI or American Home Products Corporation
hereunder with respect to MetaMorphix' licensing to any Third
Party the right to develop. make. use and/or sell any
MetaMorphix Product for use in the MetaMorphix Field.
10. PATENT PROSECUTION AND INFRINGEMENT.
10.1 RESPONSIBILITY FOR PATENTING FACTOR RIGHTS.
10.1.1 GI PATENT RIGHTS AND CERTAIN JOINT PATENT RIGHTS. GI
shall have the first right, but not the obligation,
to seek or continue to seek or maintain Patent
protection on any GI Patent Rights, any Joint Patent
Rights OF GI and MetaMorphix, and any Joint Patent
Rights of GI and JHU, any GI Additional Factor Patent
Rights and any Additional Factor Joint Patent Rights,
in any country. If GI elects, in any country not to
seek or continue to seek or maintain Patent
protection on any such Factor Patent Rights (but not
any GI Additional Factor Patent Right or Additional
Factor Joint Patent Rights), to the extent the
manufacture use or sale of a MetaMorphix Factor would
infringe such Factor Patent Rights Factor in such
country, MetaMorphix shall have the right, but not
the obligation, at its expense, to file, procure and
maintain in such countries Patents on such Factor
Patent Rights in such country.
10.1.2 METAMORPHIX PATENT Rights. MetaMorphix shall have the
first right, but not the obligation, to seek or
continue to seek or maintain Patent protection on any
MetaMorphix Patent Rights in any country. If
MetaMorphix elects not to seek or continue to seek or
maintain Patent protection on any MetaMorphix Patent
Rights in any country, GI shall have the right, but
not the obligation, at its expense, to file, procure
and maintain in such countries Patents on such
MetaMorphix Patent Rights, in which event,
MetaMorphix shall assign its entire right, title and
interest in and to those of such MetaMorphix Patent
Right(s) that relate to any of the GI Factors in such
country(ies) to GI and such MetaMorphix Patent
Right(s) shall thereafter be excluded from the
definitions of MetaMorphix Patent Right(s) and GI
Patent Rights for all purposes of this Agreement.
10.1.3 JHU PATENT RIGHTS AND CERTAIN JOINT PATENT RIGHTS.
JHU shall have the first right to seek or continue to
seek or maintain Patent protection on any JHU Patent
Rights. any Joint Patent Rights of JHU and
MetaMorphix, and any JHU Additional Factor Patent
Rights in any country. If JHU elects not to seek or
continue to seek or maintain Patent protection on any
such Factor Patent Rights or Additional Factor Patent
Rights in any country. GI shall have the right, but
not the obligation, at its expense, to file, procure
and maintain in such countries Patents on such Factor
Patent Rights or Additional Factor Patent Rights,
PROVIDED, HOWEVER, that if GI does not exercise such
right with respect to any Factor Patent Right (but
not with respect to any Additional Factor Patent
Right), which, but for this Agreement, would be
infringed by MetaMorphix' making. using or selling of
a MetaMorphix Factor or a MetaMorphix Product, then
MetaMorphix shall have the right, but not the
obligation, at its expense, to file, procure and
maintain such Patents in such country(ies).
10.1.4 PATENT COOPERATION. Each Party shall advise the other
applicable Party of all decisions taken under this
Section in a timely manner in order to allow the
other applicable Party to protect its rights under
this Section. Each Party shall provide the other
applicable Party (or Parties) with copies of all
substantive communications from all patent offices
regarding Patents on Joint Patent Rights, and Patents
on Factors selected or assigned to the other
applicable Party under this Agreement, promptly after
the receipt thereof. Each Party shall provide the
other applicable Party with copies of all proposed
substantive communications to such patent offices
regarding Patents on any Joint Patent Rights, and
Patents on Factors selected or assigned to the other
applicable Party under this Agreement, in sufficient
time before the due date in order to enable the other
applicable Party an opportunity to comment on the
content thereof. Each Party shall make available to
the other applicable Party, or its authorized
attorneys, agents or representatives, such of its
employees whom the other applicable Party, in its
reasonable judgment, deems necessary in order to
assist it in obtaining Patent protection for the
applicable Factor Patent Rights, in the event the
Party with first rights to seek or continue to seek
or maintain Patent protection on any such Factor
Patent Rights chooses not to do so. Each Party shall
sign or use its best efforts to have signed all legal
documents necessary to file and prosecute Patents or
to obtain or maintain Patents at no cost to the other
Parties. Except as provided in Section 10.2 below,
each Party shall bear all costs incurred by it in
exercising the foregoing rights.
10.1.5 USE OF INFORMATION. Information, data and materials
resulting from the Collaborative Research or
Sponsored Research disclosed pursuant to this
Agreement or the 1994 Collaboration Agreement, may be
used by a receiving Party to support utility or
activity hypothecations made in a Patent application
filed by that Party directed to a BMP, GDF or
Collaborative Factor. The Parties shall collaborate
to assure that relevant data is used to support the
Factor Patent Rights (with a preference for
supporting composition of matter claims) through
affidavits and/or continuation applications or
continuation-in-part applications. Inventorship under
such Factor Patent Rights or Additional Factor Patent
Rights will be determined according to U.S. patent
law. Information and materials relating to (a) a GDF
or Additional GDF Discovered by JHU or (b) a
Collaborative Factor or Additional Collaborative
Factor jointly Discovered by JHU and another Party,
as applicable, which are supplied by JHU to GI or
MetaMorphix pursuant to this Agreement, shall not be
distributed by GI or MetaMorphix to Third Parties
(even under a duty of confidentiality) without JHU's
written consent, which consent shall not be
unreasonably withheld or delayed, until JHU has had
an opportunity to publish on such GDF, Additional
GDF. Collaborative Factor or Additional Collaborative
Factor.
10.1.6 DIVISION OF CLAIMS. With respect to any Patents
included within a Party's 'Patent Rights or the Joint
Patent Rights, which Patents would, but for this
Agreement, be infringed by either GI's or
MetaMorphix' making, using or selling of a
MetaMorphix Factor, a MetaMorphix Product or a GI
Type B Product, the Parties will use good faith
efforts to take all necessary action, to the extent
possible, to file divisional patent applications that
are directed to the manufacture, use or sale of the
MetaMorphix Factors solely in the GI Field and to the
manufacture, use or sale of the MetaMorphix Factors
in the MetaMorphix Field.
10.1.7 INTERFERENCES. The Parties shall each, in good faith,
use its respective Commercially Reasonable Efforts to
resolve any patent interferences between any of the
Parties relating to Patents directed to any Factor or
Additional Factor.
10.2 EXPENSES.
10.2.1 PREVIOUSLY INCURRED EXPENSES - GI FACTORS. At the
Closing, GI will pay to MetaMorphix one hundred fifty
five thousand dollars ($155,000) which amount is
being paid to reimburse MetaMorphix for a portion of
the expenses incurred by MetaMorphix, between
December 1. 1994 and the Effective Date, in the
prosecution (whether such prosecution is conducted by
MetaMorphix directly or by JHU and, pursuant to the
1994 Collaboration Agreement. reimbursed by
MetaMorphix) of Patents claiming any Factors that
prior to the Effective Date have been selected or
otherwise identified as GI Factors.
10.2.2 PREVIOUSLY INCURRED EXPENSED -- METAMORPHIX FACTORS
AND UNASSIGNED FACTORS. At the Closing, GI will pay
to MetaMorphix sixty thousand dollars ($60,000),
which amount is to be used by MetaMorphix for out of
pocket patent expenses that MetaMorphix incurred, on
or after January 1, 1998 and prior to January 4,
1999, but, as of the Closing has not yet paid to
either JHU or any Third Party, for the prosecution of
Patents claiming any Factors that, prior to such
date, have not been selected or otherwise identified
as GI Factors.
10.2.3 CONTINUING EXPENSES -- GI FACTORS AND ADDITIONAL
FACTORS. With respect to each (i) Factor that has,
prior to the Effective Date been selected as or
otherwise identified as a GI Factor, (ii) Factor
that, after the Effective Date, is selected as a GI
Factor, (iii) Factor that, after the Effective Date,
becomes an Additional GDF or an Additional
Collaborative Factor. GI shall, as of (x) the
Effective Date for Factors that, prior to the
Effective Date, have been selected by GI or otherwise
identified as a GI Factor, or (y) the date such
Factor becomes a GI Factor, an Additional GDF or an
Additional Collaborative Factor, and thereafter,
reimburse JHU for one hundred (100%) of the expenses
incurred by JHU for the prosecution of Patents
claiming such GI Factors, Additional GDFs or
Additional Collaborative Factors. Such reimbursements
shall be made by GI, from time to time, within thirty
(30) days after GI receives from JHU an invoice
detailing such incurred expenses, which invoice shall
he accompanied by copies of invoices JHU has received
from Third Parties for such Patent prosecution.
10.2.4 CONTINUING EXPENSES -- METAMORPHIX FACTORS. With
respect to each Factor that (i) has been identified
as a MetaMorphix Factor prior to the Effective Date
or (ii) is, after the Effective Date, selected as a
MetaMorphix Factor, GI and MetaMorphix each shall
reimburse JHU for fifty percent (50%) of the
out-of-pocket expenses incurred by JHU in prosecuting
Patents claiming such MetaMorphix Factors, which
expenses were incurred on or after (i) the Effective
Date for each Factor that has been identified as a
MetaMorphix Factor prior to the Effective Date, or
(ii) the date that such Factor becomes a MetaMorphix
Factor for those Factors that,
as of the Effective Date, have not been identified as
either a MetaMorphix Factor or a GI Factor.
Notwithstanding the foregoing, if the Parties, after
the Effective Date, are able to divide out the claims
of such Patents, as provided in Section 10.1.6 above,
such that separate Patents respectively claim such
MetaMorphix Factors for use in the GI Field only and
such MetaMorphix Factors for use in the MetaMorphix
Field only, GI, shall reimburse JHU for one hundred
percent (100%) of the out-of-pocket expenses incurred
by JHU, after such Patents are so divided, in
prosecuting those Patents which claim such
MetaMorphix Factors for use in the GI Field only and
MetaMorphix, shall reimburse JHU for one hundred
percent (100%) of the out-of-pocket expenses incurred
by JHU, after such Patents are so divided, in
prosecuting those Patents which claim such
MetaMorphix Factors for use in the MetaMorphix Field
only. Each reimbursement under this Section 10.2.4
shall be made by GI or MetaMorphix, as applicable,
from time to time, within thirty (30) days after GI
or MetaMorphix, as applicable, receives from JHU 'an
invoice detailing such incurred expenses, which
invoice shall be accompanied by copies of invoices
JHU has received from Third Parties for such Patent
prosecution.
10.2.5 CONTINUING EXPENSES - UNASSIGNED FACTORS. GI and
MetaMorphix shall each reimburse JHU for fifty
percent (50%) of the out-of-pocket expenses incurred
by JHU after January 4, 1999 in prosecuting any
Patents claiming any Factor that has not yet been
identified as either a GI Factor or a MetaMorphix
Factor. Expenses incurred by JHU after the date a
Factor is identified as either a GI Factor or a
MetaMorphix Factor shall be reimbursed to JHU in
accordance with the provisions of Sections 10.2.3 or
10.2.4 above, as applicable.
10.2.5 CONTINUING EXPENSES - GDF-16 AND GDF-17. MetaMorphix
shall reimburse JHU for one hundred percent (100%) of
the out of pocket expenses incurred by JHU, whether
incurred before or after the Effective Date. in
prosecuting any JHU Patent Rights claiming (i) GDF-16
and/or GDF-17. (ii) any GDF-16 Product and/or GDF17
Product, or (iii) the-manufacture or use of (i) or
(ii).
10.3 INFRINGEMENT.
10.3.1 NOTICE. With respect to the BMPs, the GDFs and the
Collaborative Factors, each Parry shall promptly
report in writing to the other Parties during the
term of this Agreement any (i) known infringement or
suspected infringement of any of the Factor Patent
Rights or (ii) unauthorized use or misappropriation
of the
Confidential Information by a Third Party of which it
becomes aware, and shall provide the other Parties
with all available evidence supporting said
infringement, suspected infringement or unauthorized
use or misappropriation. With respect to the
Additional Factors, JHU and GI shall promptly report
in writing to each other during the term of this
Agreement any (i) known infringement or suspected
infringement of any of the Additional Factor Patent
Rights or (ii) unauthorized use or misappropriation
of the Confidential Information by MetaMorphix or a
Third Xxx of which it becomes aware, and shall
provide such other Party with all available evidence
supporting said infringement, suspected infringement
or unauthorized use or misappropriation.
10.3.2 FIRST RIGHT TO INITIATE SUITS - GI FACTORS AND
ADDITIONAL FACTORS. GI shall have the first right to
initiate an infringement or other appropriate suit
against any Third Party who at any time has
infringed, or is suspected of infringing, any Factor
Patent Rights or Additional Factor Patent Rights, as
applicable, of using without proper authorization all
or any Confidential Information, where such
infringement, suspected infringement or unauthorized
use is determined by GI to have an adverse affect on
its ability to make, have made, use and/or sell
products based on any GI Factor or any Additional
Factor. GI and MetaMorphix agree to consult with each
other prior to instituting any such suit and to
provide the other Party a reasonable opportunity to
participate, at its own expense, in any such suit to
protect its respective interests.
10.3.3 FIRST RIGHT TO INITIATE SUITS - METAMORPHIX FACTORS,
GDF-16 AND GDF-17. MetaMorphix shall have the first
right to initiate an infringement or other
appropriate suit against any Third Party who at any
time has infringed, or is suspected of infringing,
any Factor Patent Rights or of using without proper
authorization all or any Confidential Information,
where such infringement, suspected infringement or
unauthorized use is determined by MetaMorphix to have
an adverse affect on its ability to make, have made,
use and/or sell products based on MetaMorphix
Factors, GDF-16 Products or GDF-17 Products,
PROVIDED, HOWEVER, that GI shall have the first right
to initiate such infringement or other appropriate
suit against any such Third Party, where the actual
or suspected infringement is occurring only in the GI
Field. GI and MetaMorphix agree to consult with each
other prior to instituting any such suit and to
provide the other Party a reasonable opportunity to
participate, at its own expense, in any such suit to
protect its respective interests.
10.3.4 FIRST RIGHT TO INITIATE SUITS - UNASSIGNED FACTORS.
With respect to any BMP. GDF or Collaborative Factor
that has not yet been identified as either a
MetaMorphix Factor or a GI Factor, the Parties shall
jointly determine which Party (or Parties) shall have
the first right to initiate an infringement or other
appropriate suit against any Third Party who at any
time has infringed, or is suspected of infringing,
any Factor Patent Rights or of using without proper
authorization all or any Confidential Information, in
order to preserve GI's or MetaMorphix' ability to
make, have made, use and/or sell Products based on GI
Factors or MetaMorphix Factors, as the case may be,
following the selection of such Available Factors
pursuant to Article 5 of this Agreement.
10.3.5 DETERMINATION OF RIGHT TO PARTICIPATE IN, AND SECOND
RIGHT TO INITIATE, SUITS. The Parties shall jointly
determine which Party (or Parties) shall have the
right to (i) participate in any infringement or other
appropriate suit brought by a Party against a Third
Parry pursuant to Sections 10.3.2, 10.3.3 pr 10.3.4,
above, as applicable, by contributing costs AND
sharing in any recovery, as provided in Section
10.3.6, below, and (ii) initiate an infringement or
other appropriate suit against a Third Party in the
event the Party with the first right to initiate a
suit, as provided in Section 10.3.2, 10.3.3, or
10.3.4, above, as applicable, elects not to do so. In
making this determination, the Parties shall take
into consideration which Party (or Parties) owns the
Factor Patent Rights and/or Confidential Information
which has been, or is suspected of being, infringed
or misappropriated by a Third Party. Notwithstanding
the foregoing, MetaMorphix shall have no right to
participate in or initiate any infringement or other
suit against any Third Party who (a) has infringed or
is suspected of infringing any Additional Factor
Patent Rights (b) has infringed or is suspected of
infringing any GI Patent Rights relating to BMPs that
have not been selected by MetaMorphix as a
MetaMorphix Factor, or (c) of using, without proper
authorization, any of GI's or JHU's Confidential
Information which relates solely to one or more
Additional Factors or to any BMPs which have not been
selected by MetaMorphix as a MetaMorphix Factor.
10.3.6 Right to Participate in Suit. The Party initiating a
suit pursuant to Section 10.3.2, 10.3.3, or 10.3.4,
above, as applicable, (the "first Party") shall give
the Party which has rights to participate in that
suit pursuant to Subsection 10.3.5(i), above (the
"second Party") sufficient advance notice of its
intent to file said suit and the reasons therefor,
and shall provide the second Party with an
opportunity to make suggestions and comments
regarding such suit, including,
without limitation, the initiation thereof and the
selection of counsel therefor. The first Party shall
keep the second Party promptly informed, and shall
from time to time consult with the second Party
regarding the status of any such suit and shall
provide the second Party with copies of all documents
filed in, and all written communications relating to,
such suit. Except as provided herein, the first Party
shall have the sole and exclusive right to select
counsel for any suit and shall pay all expenses of
the suit, including without limitation attorneys'
fees and court costs. The second Party, in its sole
discretion, may elect, within sixty (60) days after
the commencement of such litigation, to contribute a
fixed percentage of up to fifty percent (50%) of the
costs incurred by the first Party in connection with
such litigation, including, without limitation,
reimbursement of the first Party's expenses
hereunder. If it so elects, any damages, royalties,
settlement fees or other consideration received by
the first Party or any of its Affiliates for past
infringement or misappropriation as a result of such
litigation shall be shared by the first and second
Parties pro-rata based on their respective sharing of
the costs of such litigation, subject to Section
10.3.8, below. In the event that the second Party
elects not to contribute to the costs of such
litigation, the first Party and/or its Affiliates
shall be entitled to retain any damages, royalties,
settlement fees or other consideration for past
infringement or misappropriation resulting therefrom,
subject to Section 10.3.8, below. If necessary or
desirable, the second Party shall join as a party to
the suit but shall be under no obligation to
participate except to the extent that such
participation is required as the result of being a
named parry to the suit. The second Party shall offer
reasonable assistance to the first Party in
connection therewith at no charge to the first Party
except for reimbursement of reasonable out-of-pocket
expenses; PROVIDED, HOWEVER, if JHU is joined in the
suit as an indispensable party, any costs incurred by
JHU in joining such suit will be reimbursed by the
Party (or Parties) initiating such suit. The second
Party shall have the right to participate and be
represented in any such suit by its own counsel at
its own expense. The first Party shall not settle any
such suit involving rights of the second Party
without obtaining the prior written consent of the
second Parry, which consent shall not be unreasonably
withheld.
10.3.7 SECOND RIGHT TO INITIATE SUIT. In the event that the
first Party elects not to initiate an infringement or
other appropriate suit pursuant to Sections 10.3.2,
10.3.3, or 10.3.4, above, as applicable, the first
Party shall promptly advise the second Party of its
intent not to initiate such suit, and the second
Party shall have the right, at its expense, of
initiating an infringement or other
appropriate suit against any Third Party who at any
time has infringed, or is suspected of infringing,
any of the Factor Patent Rights or Additional Factor
Patent Rights or of using without proper
authorization all or any portion of the Confidential
Information. In exercising its rights pursuant to
this Section 10.3.7, the second Parry shall have the
sole and exclusive right to select counsel and shall,
except as provided below, pay all expenses of the
suit including without limitation attorneys' fees and
court costs. The first Party, in its sole discretion,
may elect, within sixty (60) days after the
commencement of such litigation, to contribute a
fixed percentage of up to fifty percent (50%) of the
costs incurred by the second Party in connection with
such litigation, including, without limitation,
reimbursement of the second Party's expenses
hereunder. If it so elects, any damages, royalties,
settlement fees or other consideration received by
the second Party or any of its Affiliates for past
infringement or misappropriation as a result of such
litigation shall be shared by the second and first
Parties prorata based on their respective sharing of
the costs of such litigation, subject to Section
10.3.8, below. In the event that the first Party
elects not to contribute to the costs of such
litigation, the second Party and/or its Affiliates
shall be entitled to retain any damages, royalties,
settlement fees or other consideration for past
infringement or misappropriation resulting therefrom,
subject to Section 10.3.8, below. If necessary or
desirable, the first Party shall join as a party to
the suit but shall be under no obligation to
participate except to the extent that such
participation is required as a result of being a
named party to the suit. At the second Party's
request, the first Party shall offer reasonable
assistance to the second Party in connection
therewith at no charge to the second Parry except for
reimbursement of reasonable out-of-pocket expenses:
PROVIDED. HOWEVER, IF JHU is joined in the suit as an
indispensable parry, any costs incurred by JHU in
joining such suit will be reimbursed by the Party (or
Parties) initiating such suit. The first Party shall
have the right to participate and be represented in
any such suit by its own counsel at its own expense.
10.3.8 ROYALTY DEDUCTION. Any damages, royalties, settlement
fees or other consideration for past infringement or
misappropriation awarded to and/or collected by a
Party (or Parties) resulting from an infringement or
other appropriate suit against a Third Party or a
settlement thereof shall: after deduction of all
costs and expenses associated with such suit or
settlement, be deemed to reflect a loss OF commercial
sales, and royalties shall be payable thereon to the
Parry (or Parties) to which royalties would have been
owed under Section 7.3 of this Agreement, provided
that such Party (or Parties)
is not otherwise entitled to receive a portion of any
recovery other than reimbursement of its litigation
expenses) obtained from such suit or settlement
pursuant to this Section 10.3.
10.4 CLAIMED INFRINGEMENT.
10.4.1 NOTICE; COOPERATION. In the event that a Third Party
at any time provides written notice of a claim to, or
brings an action. suit or proceeding against, any
Party or any of their respective Affiliates or
sublicensees, claiming infringement of its patent
rights or copyrights or unauthorized use or
misappropriation of its Confidential Information,
based upon an assertion or claim arising out of the
manufacture, use and/or sale of any Product, such
Party shall promptly notify the other Parties of the
claim or the commencement of such action, suit or
proceeding, enclosing a copy of the claim and/or all
papers served, PROVIDED, HOWEVER, that GI and JHU
shall have no obligation to provide such notice to
MetaMorphix to the extent that such assertion or
claim arises-out of or relates to the manufacture,
use or sale of GI Type C Products. Each Party agrees
to make available to the other Parties its advice and
counsel regarding the technical merits of any such
claim at no cost to the other Party.
10.4.2 LIMITATION OF LIABILITY. EXCEPT FOR BREACHES OF
SECTIONS 12.1, 12.2. 12.3 AND 12.4 OF THIS AGREEMENT,
THE FOREGOING STATES THE ENTIRE RESPONSIBILITY OF THE
PARTIES IN THE CASE OF ANY CLAIMED INFRINGEMENT OR
VIOLATION OF ANY THIRD PARTY'S PATENT RIGHTS OR
COPYRIGHTS OR UNAUTHORIZED USE OR MISAPPROPRIATION OF
ANY THIRD PARTY'S KNOW-HOW.
11. CONFIDENTIAL INFORMATION.
11.1 NONDISCLOSURE OF Confidential Information. Neither Party may
directly or indirectly publish, disseminate or otherwise
disclose, deliver or make available to any person outside its
organization any of the other Parties' Confidential
Information. Each Party may disclose the other Parties'
Confidential Information to persons within its organization
and to its Affiliates and sublicensees who/which have a need
to receive such Confidential Information in order to further
the purposes of this Agreement and who/which are bound to
protect the confidentiality of such Confidential Information,
as set forth in Section 11.3 below. Each Party may disclose
the other Parties' Confidential Information to a governmental
authority or by order of a court of competent jurisdiction,
provided that such disclosure
is subject to all applicable governmental or judicial
protection available for like material and reasonable advance
notice is given to the other Parties.
11.2 USE OF CONFIDENTIAL INFORMATION. Each Party shall use the
other Parties' Confidential Information solely for the
purposes contemplated in this Agreement or for such other
purposes as may be agreed upon by the Parties in writing.
11.3 AGREEMENTS WITH PERSONNEL and Third PARTIES. The Parties have
or shall obtain agreements with all personnel and Third
Parties who will have access to the other Parties'
Confidential Information which impose comparable
confidentiality obligations as are set forth in this Agreement
on such personnel and Third Parties.
11.4 PUBLICATIONS.
11.4.1 RIGHT TO PUBLISH. Any Party may publish any
manuscripts or other scientific papers on work
conducted exclusively by that Party as part of the
Original Research or under the Collaborative Research
Plan or the Sponsored Research Plan, as applicable,
without the written consent of the other Parties.
However, a Party may not publish (or permit a Third
Party to publish) any manuscript or other scientific
paper that discloses or uses any Confidential
Information of another Parry without first obtaining
that other Party's written consent; and a Parry may
.not publish any manuscript or other scientific paper
that would prejudice any Patent rights of another
Party (including, without limitation, prospective
Patent rights covering an Available Factor) without
first complying with the provisions of this Section
11.4 and Section 10.1, above.
11.4.2 NOTICE AND REVIEW. In order to balance the Parties'
interests in securing Patents covering the Factor
Rights with each Party's right to publish any
manuscripts or other scientific papers on work
conducted exclusively by that Party under the
Research Plan, prior to the publication or other
public disclosure of any manuscripts or other form of
disclosure describing the results of its work
hereunder, the publishing Party shall provide (a) the
data to be disclosed in that manuscript or other form
of public disclosure to the other Parties as soon as
practicable, but at least four (4) weeks prior to
intended submission for publication or other method
of public disclosure. (b) a(.) copy of the draft
manuscript to be published, or a detailed summary of
any other public disclosure to the other Parties as
soon as practicable, but at least two (2) weeks prior
to intended submission for publication or other
method of public disclosure, (c) a copy of the
completed manuscript or other
form of public disclosure at the time of submission
and (d) a copy of any reviewer's comments on the
manuscript or other form of public disclosure with a
revised copy thereof at least two (2) weeks prior to
publication.
11.4.3 DELETION OF CONFIDENTIAL INFORMATION; PATENT
PROTECTION. A Parry may request that the publishing
Party delete from its manuscripts or other scientific
papers or other forms of public disclosure reference
to that Parry's Confidential Information. In
addition, if a Party notifies another Party that it
desires patent applications to be filed on any Factor
Rights to be disclosed by that other Party in a
public forum other than in manuscripts or other
scientific papers, the presenting Party will defer
such presentation for a period, not to exceed thirty
(30) additional days, sufficient to permit the Party
with rights to file any desired patent applications
to do so.
11.4.4 GDFS DISCOVERED BY JHU..GI and/or MetaMorphix. shall
not publish a scientific paper on a GDF Discovered by
JHU until JHU has published a scientific paper on
that GDF, unless written permission to so publish has
been given by Xx. Xxx. GI acknowledges that providing
purified protein to another Party would not
necessarily warrant authorship on a JHU publication.
Authorship on a publication by another Party requires
significant - scientific contributions to that other
Party's research. Disputes as to the appropriate
authorship of papers resulting from the Original
Research, the Collaborative Research or the Sponsored
Research will be referred to (i) the RMC, in the case
of disputes between GI and MetaMorphix, (ii) Xx. Xxx
and a senior GI scientist to be designated by GI, in
the case of disputes between GI and JHU and (iii) Xx.
Xxx and a senior MetaMorphix scientist or scientific
advisor, to be designated by MetaMorphix, in the case
of disputes between MetaMorphix and JHU.
11.5 NON-USE OF Certain Confidential INFORMATION. GI shall not use
information of which it learned in reviewing (a) JHU's GDF 12
patent application to support GI's BMP 14 patent application,
(b) JHU's GDF 11 patent application to support GI's BMP 11
patent application or (c) JHU's GDF 3 patent application to
support GI's Vgr 2 patent application.
12. REPRESENTATION AND WARRANTIES.
12.1 Representations and Warranties of GI AND METAMORPHIX. As of
the Effective Date, each of GI and MetaMorphix hereby
represents, warrants and covenants to the other Parties hereto
as follows:
(a) it is a corporation or entity duly organized and
validly existing under the laws of the state or other
jurisdiction of incorporation or formation:
(b) the execution, delivery and performance of this
Agreement by such Party has been duly authorized by
all requisite corporate action and do not require any
shareholder action or approval:
(c) it has the power and authority to execute and deliver
this Agreement and to perform its obligations
hereunder;
(d) the execution, delivery and performance by such Party
of this Agreement and its compliance with the terms
and provisions hereof does not and will not conflict
with or result in a breach of any of the terms and
provisions of or constitute a default under (i) a
loan agreement, guaranty, financing agreement,
agreement affecting a product or other agreement or
instrument binding or affecting it or its property:
(ii) the provisions of its charter or operative
documents or bylaws; or (iii) any order, writ,
injunction or decree of any court or governmental
authority entered against it or by which any of its
property is bound; and
(e) it shall at all times comply with all applicable
material laws and regulations relating to its
activities under this Agreement.
12.2 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF GI.
12.2.1 Patent Rights and Know-How. To the best of GI's
knowledge, information and belief, GI represents and
warrants that it owns the GI Patent Rights and GI
Know-How in existence on the Effective Date and/or
has the right to grant the licenses under the GI
Patent Rights and to the GI Know-How in existence on
the Effective Date subject to the terms of this
Agreement. The foregoing representation and warranty
shall not be construed as a warranty as to the scope
and/or validity of any claims in the GI Patent
Rights.
12.2.2 No Conflicting Agreements. GI represents and warrants
that (a) the execution of, and performance of the
transactions contemplated by, this Agreement will not
conflict with or result in any breach of any of the
terms, conditions or provisions of, or constitute a
default under, any agreement to which GI is a party
or by which GI is bound; and (b) as of the Effective
Date, other than its preexisting collaborations with
Yamanouchi Pharmaceutical Company Ltd. and
Affymetrix. Inc., GI has not entered a collaboration
or other
arrangement with a commercial Third Party for the
specific purpose of identifying sequences for Factors
in the TGF-(beta) Superfamily.
12.3 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF METAMORPHIX.
12.3.1 PATENT RIGHTS AND KNOW-HOW. To the best of
MetaMorphix' knowledge, information and belief,
MetaMorphix represents and warrants that it owns the
MetaMorphix Patent Rights and MetaMorphix Know-How in
existence on the Effective Date and/or has the right
to grant the licenses under the MetaMorphix Patent
Rights and to the MetaMorphix Know-How in existence
on the Effective Date subject to the terms of this
Agreement. The foregoing representation and warranty
shall not be construed as a warranty as to the scope
and/or validity of any claims in the MetaMorphix
Patent Rights.
12.3.2 NO CONFLICTING AGREEMENTS. MetaMorphix represents and
warrants that the execution of; and performance of
the transactions contemplated by, this Agreement will
not conflict with or result in any breach of any of
the terms, conditions or provisions of, or constitute
a default under, any agreement to which MetaMorphix
is a party or by which MetaMorphix is bound.
12.3.3 EQUIPMENT. MetaMorphix represents and warrants to GI
that, as of the Effective Date and the date that the
equipment is delivered to GI in accordance with
Section 8.4 hereof, such equipment shall be in
working order, merchantable, and fit for the purpose
for which it was intended to be used when
manufactured. MetaMorphix further represents and
warrants to GI that Transamerica Business Credit
Corporation (subject to that certain October 14, 1997
Master Lease Agreement with MetaMorphix) owns such
equipment, that no Third Party has any right, title
or interest in or to such equipment, and that at
Closing, upon GI's MetaMorphix directed payment to
Transamerica Business Credit Corporation, such
equipment shall be free and clear of such Master
Lease Agreement and any right, title or interest that
Transamerica Business Credit Corporation may have
therein.
12.4 Representations and Warranties of JHU.
12.4.1 AUTHORITY. JHU represents and warrants to each of GI
and MetaMorphix that it is a university duly
organized and validly existing under the laws of the
state of Maryland and that it has the
power and authority to execute and deliver this
Agreement and to perform all of its obligations
hereunder.
12.4.2 COMPLIANCE WITH LAWS AND ORGANIZATIONAL DOCUMENTS.
JHU represents and warrants to GI and MetaMorphix
that (i) it shall at all times comply with all
applicable material laws and regulations relating to
its activities under this Agreement (ii) the
execution, delivery and performance by JHU of this
Agreement and its compliance with the terms and
provisions hereof does not and will not conflict with
or result in a breach of any of the terms and
provisions of or constitute a default under (i) the
provisions of its charter or operative documents or
bylaws; or (ii) any order writ injunction or decree
of any court or governmental authority entered
against it or by which any of its property is bound
12.4.3 PATENT RIGHTS AND KNOW-HOW. To the best of JHU'
knowledge, information and belief, JHU represents and
warrants that it owns the JHU Patent Rights and JHU
Know-How, the JHU Additional Factor Patent Rights and
the JHU Additional Factor Know-How in existence on
the Effective Date and/or has the right to grant the
licenses under the JHU Patent Rights and the JHU
Additional Factor Patent Rights, and to the JHU
Know-How and JHU Additional Factor Know-How in
existence on the Effective Date subject to the terms
of this Agreement. The foregoing representation and
warranty shall not be construed as a warranty as to
the scope and/or validity of any claims in the JHU
Patent Rights.
12.4.4 NO CONFLICTING AGREEMENTS. JHU further represents and
warrants that the execution of, and performance of
the transactions contemplated by, this Agreement will
not conflict with or result in any breach of any of
the terms, conditions or provisions of, or constitute
a default under, any agreement to which JHU is a
party or by which JHU is bound.
12.5 REPRESENTATION BY Legal Counsel. Each Party hereto represents
that it has been represented by legal counsel in connection
with this Agreement and acknowledges that it has participated
in the drafting hereof. In interpreting and applying the terms
and provisions of this Agreement, the Parties agree that no
presumption shall exist or be implied against the Party which
drafted such terms and provisions.
12.6 MATERIALITY. EACH PARTY EXPRESSLY WAIVES ANY RIGHTS TO SEEK
DAMAGES OR OTHER RELIEF FOR BREACH OF THE REPRESENTATIONS AND
WARRANTIES IN SECTIONS 12.1, 12.2
AND 12.3 UNLESS SUCH BREACH HAS A MATERIAL AND ADVERSE EFFECT
ON SUCH PARTY.
12.7 DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT,
NO PARTY MAKES ANY WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
BUT NOT LIMITED TO IMPLIED WARRANTIES OR MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT.
13. PRODUCT LIABILITY INDEMNIFICATION.
13.1 METAMORPHIX INDEMNIFICATION. MetaMorphix agrees to defend GI
and JHU and their respective Affiliates, sublicensees, agents,
directors, officers, employees, students and licensees of
rights to a Product, as applicable (the "indemnitees")(other
than in settlement of a claim of infringement), at
MetaMorphix' cost and expense, and will indemnify and hold
harmless such indemnitees from and against any and all
liabilities, losses, costs, damages, fees, or expenses claimed
by or paid to a Third Party attributable to injury to persons
or damage to property (collectively, "Losses") arising out of
or in connection with the manufacture, use and/or sale of any
MetaMorphix Product by MetaMorphix, its Affiliates, or
sublicensees (other than GI); provided that such Losses do not
arise out of the gross negligence or willful misconduct of GI
(with respect to MetaMorphix' obligations to the GI
indemnitees under this Section) or JHU (with respect to
MetaMorphix' obligations to the JHU indemnitees under this
Section).
13.2 GI INDEMNIFICATION. GI agrees to defend MetaMorphix and JHU
and their respective Affiliates, permitted sublicensees,
agents, directors, officers, employees, students and licensees
of rights to a Product, as applicable (the
"indemnitees")(other than in settlement of a claim of
infringement), at GI's cost and expense, and will indemnify
and hold harmless such indemnitees from and against any and
all Losses arising out of or in connection with the
manufacture, use and/or sale of any GI Product by GL its
Affiliates, or sublicensees (other than MetaMorphix); provided
that such Losses do not arise out of the gross negligence or
willful misconduct of MetaMorphix (with respect to GI's
obligations to the MetaMorphix indemnitees under this Section)
or JHU (with respect to GI's obligations to the JHU
indemnitees under this Section).
13.3 NOTICE; Cooperation. In the event of any such indemnifiable
claim, the indemnified Party shall promptly notify the
indemnifying Party in writing of the claim and the
indemnifying Party shall manage and control, at its sole
expense, the defense of the claim and its settlement. The
indemnified Party shall cooperate with the indemnifying Party
and may, at its option and expense, be represented in any such
action or proceeding. The
indemnifying Party shall not be liable for any settlements,
litigation costs. or expenses incurred by the indemnified
Party without the indemnifying Party's written consent, such
consent to be promptly given and not unreasonably withheld.
13.4 LIABILITY LIMITATION. Neither GI nor MetaMorphix shall be
liable for special, incidental or consequential damages or for
loss of profit or lost revenue, even another Party had been
advised of the possibility of such damages.
13.5 INSURANCE. Prior to initial human testing or first commercial
sale of any Product in any particular country, GI and
MetaMorphix each shall secure and maintain at its own expense
during the term of this Agreement either self insurance or an
insurance policy or policies with an insurer or insurers
acceptable to the other Parties, in either case, protecting
the Parties against any and all risks typically insured
against by businesses comparable to the Party, including
without limitation general and products liability, arising or
occurring upon or in connection with-each Party's business.
Such policy or policies shall include general and products
liability coverage in an amount typically secured by
businesses comparable to the Party. Each Party shall furnish
the other Parry and JHU with certificates evidencing all such
insurance. Each Parry shall name the other Party and JHU as
additional insureds in such policy or policies.
14. TERM AND TERMINATION.
14.1 TERM. This Agreement shall remain in effect until terminated
in accordance with the provisions of this Section 14 or until
the last to expire of any of the licenses granted pursuant to
this Agreement.
14.2 TERMINATION FOR BREACH. In the event that a Party shall be in
default of any of its material obligations to another Party
hereunder, and shall fail to remedy any such default within
sixty (60) days. after notice thereof by the non-breaching Xxx
to whom such obligations are owed, such nonbreaching Party
shall, by written notice to each of the other Parties, be
entitled to terminate the rights it granted to the breaching
Party under this Agreement and its obligations to the
breaching Party under this Agreement. Any such notice shall
specifically describe the alleged default and expressly state
that the non-breaching Party intends to terminate the rights
it has granted to the breaching Party-under this Agreement in
the event that the breaching Party shall fail to remedy the
default. Notwithstanding anything contained in this Agreement
to the contrary, GI, at its option, shall have the right, but
not the obligation, to remedy any default of MetaMorphix
hereunder, as provided in Section 14.3, below. Upon any
termination of this Agreement pursuant to this Section 14.2,
none of the Parties shall be
relieved of any obligations incurred prior to such
termination. Notwithstanding the foregoing. (i) the breach
(including, without limitation, the failure to make any
payment when due) of this Agreement by GI shall not affect the
licenses granted by JHU to MetaMorphix under Article 6 hereof
or result in any right of JHU to take any action, including
without limitation, termination of rights granted by JHU to
MetaMorphix. against MetaMorphix and (ii) the breach
(including, without limitation. the failure to make any
payment when due) of this Agreement by MetaMorphix shall not
affect the licenses granted by JHU to GI under Article 6
hereof or result in any right of JHU to take any action,
including, without limitation, termination of rights granted
to GI by JHU, against GI.
14.3 BREACH OF OR WITHDRAWAL FROM AGREEMENT.
14.3.1 BY METAMORPHIX. In the event MetaMorphix breaches and
fails to cure such breach within the sixty (60) day
cure period or otherwise withdraws from, or ceases to
be a Party to, this Agreement, GI, at its option,
within thirty (30) days after the expiration of the
sixty (60) day cure period or GI's receipt of written
notice that MetaMorphix has ceased to be a Party to
this Agreement, as applicable, may assume
MetaMorphix' rights and obligations under this
Agreement, including, without limitation,
MetaMorphix' rights under the license from JHU set
forth in Section 6.2, above, and MetaMorphix's
obligation to pay royalties and fees to JHU, at the
rates and in the amounts set forth in this Agreement,
or at such other rates and amounts as JHU and GI
shall agree are appropriate under the circumstances.
An assignment in accordance with Section 15.8 shall
not constitute a withdrawal.
14.3.2 BY GI. In the event that, (i) pursuant to Section
14.2 hereof, JHU terminates the licenses it granted
to GI hereunder, or (ii) GI otherwise withdraws from.
or ceases to be a Party to this Agreement,
MetaMorphix, at its option, within thirty (30) days
after the effective date of such termination or
MetaMorphix's receipt of written notice that GI has
ceased to be a Party to this Agreement, as
applicable, may assume GI' rights and obligations
under this Agreement, including, without limitation,
GI's rights under the license from JHU set forth in
Section 6.3, above, and GI's obligation to pay
royalties and fees to JHU, at the rates and in the
amounts set forth in this Agreement, or at such other
rates and amounts as JHU and MetaMorphix shall agree
are appropriate under the circumstances. An
assignment in accordance with Section 15.8 shall not
constitute a withdrawal.
14.4 SURVIVAL OF OBLIGATIONS; RETURN OF CONFIDENTIAL INFORMATION.
Notwithstanding any termination of this Agreement, the
obligations of the Parties under Sections 3.6, 7.8, 11. 12. 13
and 15.2, as well as under any other provisions which by their
nature are intended to survive any such termination, shall
survive and continue to be enforceable. Upon any termination
of this Agreement pursuant to Section 14.2 hereof, the
breaching Party shall promptly return to the non-breaching
Party all written Confidential Information, and all copies
thereof, of the non-breaching Party which is not covered by a
license surviving such termination.
15. MISCELLANEOUS.
15.1 NO ASSUMPTION OF OBLIGATIONS. Except as expressly provided in
this Agreement, GI is not assuming and shall have no
obligation to assume any preexisting or future obligations
that MetaMorphix has or owes to JHU or to any Third Party,
including, without limitation, Baylor.
15.2 PUBLICITY. No Party, nor any of its Affiliates, shall
originate any publicity, news release or other public
announcement, written or oral, relating to this Agreement
without the prior written approval of the other Parties, which
approval shall not be unreasonably withheld, except as
otherwise required by law. It is expressly understood that
nothing in this Section 15.1 shall prevent a Party from making
a disclosure in connection with any required filings with the
Securities and Exchange Commission or in connection with the
offering of securities or any financing. In addition, neither
GI nor MetaMorphix shall use the name of The Xxxxx Xxxxxxx
University or The Xxxxx Xxxxxxx Health System or any of its
constituent parts and affiliated hospitals (e.g., The Xxxxx
Xxxxxxx Hospital) or the name of inventors of any Factor
Patent Rights licensed from JHU to MetaMorphix and/or GI in
any advertising, promotional, sales literature or fundraising
documents without the prior written consent from an officer of
JHU. JHU shall have not less than five (5) business days to
review any proposed use of its name(s).
15.3 EXPORT CONTROL. The Parties acknowledge that the export of
technical data, materials, or products is subject to the
exporting Parry receiving the necessary export licenses and
that the Parties cannot be responsible for any delays
attributable to export controls which are beyond the
reasonable control of either Party. The Parties agree that
regardless of any disclosure made by the Party receiving an
export of an ultimate destination of any technical data,
materials, or products, the receiving Party will not reexport
either directly or indirectly, any technical data, material,
or products without first obtaining the applicable validated
or general license from the United States Department of
Commerce, United States Food and Drug Administration, and/or
any other agency or department of the United States
Government, as required. The receiving Party shall provide the
exporting Party with any information, materials,
certifications, or other documents which may be reasonably
required in connection with such exports under the Export
Administration Act of 1979, as amended, its rules and
regulations, the Federal Food, Drug and Cosmetic Act, and
other applicable export laws.
15.4 CONDUCT OF STUDIES. All studies, research and testing done by
or on behalf of each Party under this Agreement shall be
performed in strict compliance with any applicable federal,
state, or local laws, rules, and regulations governing the
conduct of studies, research, and testing at the site where
such studies, research, and testing are being conducted. .
15.5 NO IMPLIED LICENSES. Only the licenses granted pursuant to the
express terms of this Agreement shall be of any legal force
and effect. No license rights shall be created by implication
or estoppel.
15.6 NO AGENCY. Nothing herein shall be deemed to constitute any
Party as the agent or representative of the other Parties, or
the Parties as joint venturers or partners for any purpose.
Each Party shall be an independent contractor, not an employee
or partner of the other Parties, and the manner in which each
Party renders its services under this Agreement shall be
within its sole discretion. No Party shall be responsible for
the acts or omissions of the other Parties, and no Party will
have authority to speak for, represent or obligate the other
Parties in any way without prior written authority from the
other Party or Parties.
15.7 NOTICE. All notices required under this Agreement to be given
by one Party to another shall be in writing and shall be given
by addressing the same to the other at the address or
facsimile number set forth below, or at such other addresses
or facsimile numbers as the Parties may specify in writing.
All notices shall become effective when deposited in the
United States Mail with proper postage for first class
registered or certified mail prepaid, return receipt
requested, or when delivered personally, or, if promptly
confirmed by mail as provided above, when dispatched by
facsimile.
GI: Genetics Institute, Inc.
00 XxxxxxxxxXxxx Xxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Telecopier (000) 000-0000
Attn: Legal Department
JHU: Xxxxx Xxxxxxx University School of Medicine
Office of Technology Licensing
0000 X. Xxxxxxxx Xxxxxx. Xxxxx 0-000 Xxxxxxxxx.
Xxxxxxxx 00000
Telecopier (000) 000-0000
Attn: Director
MetaMorphix: MetaMorphix, Inc.
0000 Xxxxx Xxxxxxx Xxxx Xxxxxxxxx, Xxxxxxxx
00000 Telecopier (000) 000-0000
Attn: President
with copies to:
American Home Products Corporation
0 Xxxxxxx Xxxxx
Xxxxxxx, Xxx Xxxxxx 00000
Telecopier (000) 000-0000
Attn: Senior Vice President and General Counsel
Xxxxx Xxxxxxx University School. of Medicine Office of
Technology Licensing
0000 X. Xxxxxxxx Xxxxxx, Xxxxx 0-000 Xxxxxxxxx.
Xxxxxxxx 00000
Telecopier (000) 000-0000
Attn: Director
Xxxxxxx and Xxxxxxx
0000 Xxxxxxx Xxxxxx Xxxxx 00 Xxxxx
Xxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
Telecopier (000) 000-0000
Attn: Xxxxxxx X. Xxxxxxx, .Esq.
15.8 ASSIGNMENT. This Agreement. and the rights and obligations
hereunder, may not be assigned or transferred, in whole or in
part, by any Party without the prior written consent of the
other Parties, except that (a) upon notice to the other
Parties. GI may assign this Agreement to an Affiliate
controlled by GI, and MetaMorphix may assign this Agreement to
an Affiliate which is majority controlled by MetaMorphix,
provided that each such Party remains primarily liable and/or
responsible for the performance of such obligations and such
controlled Affiliate, and provided further that such
controlled Affiliate agrees to be bound to the terms and
conditions of this Agreement and (b) upon notice to the other
Parties, GI may assign this Agreement in connection with the
merger, consolidation or sale of all or
substantially all of GI's assets and MetaMorphix may assign
this Agreement in connection with the merger. consolidation or
sale of all or substantially all of MetaMorphix' assets.
15.9 ENTIRE AGREEMENT. This Agreement, the exhibits and schedules
attached hereto, the Promissory Note (including each of the
allonges thereto), and the agreements to be executed and
delivered in accordance with Article 8 hereof, together
constitute the entire agreement of the Parties with regard to
its subject matter, and supersedes all previous written or
oral representations, agreements and understandings between
the Parties, including, without limitation, the 1994
Collaboration Agreement and the Letter of Intent. Nothing
herein shall affect the continued effect of that
Confidentiality and Non-Disclosure agreement date September 9,
1998 by and between MetaMorphix and American Home Products
Corporation, acting through its Wyeth-Ayerst Laboratories
Division and that Confidentiality Agreement dated October 13,
1997 by and between MetaMorphix and Fort Dodge Animal Health,
a division of American Home Products Corporation.
15.10 NO MODIFICATION. This Agreement may be changed only by a
writing signed by the Parties.
15.11 HEADINGS. The headings contained in this Agreement are for
convenience of reference only and shall not be considered in
construing this Agreement.
15.12 WAIVER. The waiver by any Party of a breach or a default of
any provision of this Agreement by another Party shall not be
construed as a waiver of any succeeding breach of the same or
any other provision, nor shall any delay or omission on the
part of any Party to exercise or avail itself of any right,
power or privilege that it has or may have hereunder operate
as a waiver of any right, power, or privilege by such Party.
(REMAINDER OF PAGE INTENTIONALLY LEFT BLANK)
15.13 SEVERABILITY. In the event that any one or more of the
provisions contained in this Agreement shall, for any reason,
be held to be invalid, illegal or unenforceable in any
respect, such invalidity, illegality or unenforceability shall
not affect any other provisions of this Agreement, and all
other provisions shall remain in full force and effect. If any
of the provisions of this Agreement is held to be excessively
broad or invalid, illegal or unenforceable in any
jurisdiction, it shall be reformed and construed by limiting
and reducing it so as to be enforceable to the maximum extent
permitted by law in conformance with its original intent. In
the event that after such reformation, a Party's rights or
obligations are materially changed, then such Party may
terminate this Agreement.
15.14 SUCCESSORS AND ASSIGNS. This Agreement shall be binding upon
and inure to the benefit of the Parties hereto and their
successors and permitted assigns.
15.15 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but
all of which together shall constitute one and the same
instrument.
15.16 APPLICABLE LAW. This Agreement shall in all events and for all
purposes be governed by, and construed in accordance with, the
law of the State of Maryland without regard to any choice of
law principle that would dictate the application of the law of
another jurisdiction.
IN WITNESS WHEREOF, duly-authorized representatives of the parties have
signed this Agreement as a document under seal as of the Effective Date.
GENETICS INSTITUTE, INC. METAMORPHIX I C.
By /s/ Xxxxxxxxx Xxxxxx By /s/ Xxxxx X. Xxxxxxxxxxx
-------------------------- -----------------------------
Name: Xxxxxxxxx Xxxxxx Xxxxx X. Xxxxxxxxxxx, Ph.D.
Title: Vice President President and Chief Executive Officer
THE XXXXX XXXXXXX UNIVERSITY SCHOOL OF MEDICINE
By
Name:
Title:
I HAVE READ AND UNDERSTAND, AND AGREE TO COMPLY WITH, THE TERMS OF THIS
AGREEMENT:
________________________________
Se-Xxx Xxx, M.D., Ph.D.
15.13 SEVERABIIITY. In the event that any one or more of the
provisions contained in this Agreement shall, for any reason,
BE held to be invalid, illegal or unenforceable in any
respect, such invalidity, illegality or unenforceability shall
not affect any other provisions of this Agreement, and all
other provisions shall remain in full force and effect. If any
of the provisions of this Agreement is held to be excessively
broad or invalid, illegal or unenforceable in any
jurisdiction, it SHALL be reformed and construed BY limiting
and reducing IT so as to be enforceable to the MAXIMUM extent
permitted by law in conformance with its original INTERN. In
the event that after such reformation, a Parry's rights or
obligations are materially changed, then such Party may
terminate this Agreement.
15.14 SUCCESSORS AND ASSIGNS. This Agreement SHALL be binding upon
and inure to the benefit of the Parties hereto and their
successors and permitted assigns.
15.15 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but
all of which together SHALL constitute one and. THE SAME
instrument.
15.16 APPLICABLE LAW. This Agreement shall in all events and for all
purposes be governed by, and construed in accordance with, the
law of the State of Maryland without regard to any choice of
law principle that would dictate the application of the law of
another jurisdiction.
IN WITNESS WHEREOF, duly-authorized representatives of the parties have
signed this Agreement as a document. under seal as of the Effective Date.
GENETICS INSTITUTE INC. METAMORPHIX, INC.
By________________________________________ By _____________________________
Name: Xxxxx X. Xxxxxxxxxxx,Ph.D.
Title: President and Chief Executive Officer
THE XXXXX XXXXXXX UNIVERSITY SCHOOL OF MEDICINE
BY
Name: Xxxx Xxxxxxx, M.D.
Title: Vice Xxxx for Research and Technology
Professor of Medicine, Anesthesiology and Critical Care
I HAVE READ AND UNDERSTAND, AND AGREE TO COMPLY WITH, THE
TERMS OF THIS AGREEMENT:
_______________________________________________
Se-Xxx Xxx, M.D., Ph.D.
SCHEDULE 1.1
ADDITIONAL BMPS
None as of the Effective Date.
Schedule 1.1 -- Page 1 of 1
SCHEDULE 1.5
ADDITIONAL FACTOR JOINT PATENT RIGHTS
None as of the Effective Date.
Schedule 1.5 -- Page 1 of 1
SCHEDULE 1.10
ADDITIONAL GDFS
None as of the Effective Date.
Schedule 1.10 -- Page 1 of 1
SCHEDULE 1.15
BMPS
***
Schedule 1.15 -- Page 1 of 1
SCHEDULE 1.16
COLLABORATIVE FACTORS
***
Schedule 1.16 -- Page 1 of 1
SCHEDULE 1.39
GI FACTORS
***
Schedule 1.39 -- Page 1 of 1
SCHEDULE 1.42
GI PATENT RIGHTS
FACTOR/
SUBJECT APPLICATION FILING DATE PATENT ISSUE DATE
MATTER
--------------------------------------------------------------------------------
*** *** 09/18/96
*** *** 12/10/97
*** ***
*** *** 03/09/98
*** *** (Note: GI has obtained an exclusive worldwide
license, with the right to sublicense, to this
application FROM Protegene, Inc. and, as such, if
MetaMorphix selects *** as a MetaMorphix Factor,
MetaMorphix's rights to this application will be
subject to Section 6.7 of the Agreement.)
(Note: As of the Effective Date, this application is not
*** *** yet a GI Patent Right, as GI does not yet have a
license to it, however, pursuant to a Material Transfer
Agreement between GI and Baylor, GI has the option
to acquire an exclusive license to this intellectual
property and is currently in discussions with *** as
to the terms of such license)
Schedule 1.42 -- Page 1 of 1
SCHEDULE 1.42
GI PATENT RIGHTS
(TO BE ATTACHED AT OR PROMPTLY AFTER THE CLOSING)
Schedule 1.42 -- Page 1 of 1
SCHEDULE 1.48
GPDC FACTORS
***
Schedule 1.48 -- Page 1 of 1
SCHEDULE 1.49
GDFS
***
***
***
***
GDF-8
GDF-9
***
GDF-11
GDF-12
***
***
Schedule 1.49 -- Page 1 of 1
SCHEDULE 1.52
FORM OF
INVENTION AND DISCLOSURE AGREEMENT
INVENTION AND DISCLOSURE AGREEMENT
The undersigned, being a faculty member, student, fellow or other
employee of The Xxxxx Xxxxxxx University ("JHU"), assigns and agrees to assign
to JHU all of my right, title and interest in and to any and all inventions I
might make during the course of my research or work at JHU to characterize
certain previously-discovered factors, and discover and characterize new
factors, in the TGF-a Superfamily, including, without limitation, any of my
research or work which is funded, in whole or in part, by Genetics, Institute,
Inc., ("GI") which funds research at JHU under the direction of Se-Xxx Xxx,
M.D., Ph.D. ("Xx. Xxx") under that January 26, 1999 Amended and Restated
Collaboration Agreement (the "1999 Collaboration Agreement") by and among JHU,
GI and MetaMorphix, Inc. ("MetaMorphix). During and after the course of my
research or work at JHU (whether or not I am still employed or associated with
JHU), I will cooperate fully in obtaining patent and other proprietary
protection for such inventions, all in JHU's name and at JHU's cost and expense,
and, without limitation, shall execute and deliver all requested applications,
assignments and other documents, and take such other measures as JHU shall
reasonably request, in order to perfect and enforce JHU's rights in such
inventions.
I acknowledge that any such inventions shall be exclusively licensed
and/or sublicensed to GI and/or MetaMorphix pursuant to the 1999 Collaboration
Agreement. I understand that I may participate in royalties, if any, received by
JHU from GI or MetaMorphix and their licensees from the commercialization of any
such inventions, pursuant to the JHU School of Medicine's Intellectual Property
Guidelines.
Finally, during the course of my research or work at JHU, for such time
as I am engaged in the discovery and characterization of TGF-(beta) factors in
Xx. Xxx'x laboratory, I will give JHU immediate notice of any affiliations that
I am considering or may have (as a researcher, consultant or advisor) with a
commercial entity (except GI) that is intended to discover, identify and/or
characterize factors in the TGF-(beta) Superfamily.
Name:
Title:
Date:
---------------
Schedule 1.52 -- Page 1 of 1
SCHEDULE 1.54
JHU ADDITIONAL FACTOR PATENT RIGHTS
(NONE AS OF CLOSING DATE)
Schedule 1.54 -- Page 1 of 1
Schedule 1.56
JHU PATENT RIGHTS
(as of the Effective Date)
A. BMPs: None
B. GDFs:
1. U.S. Application S/N *** filed January 12, 1993, entitled ***;
corresponding International PCT Application *** filed January
12, 1994 designating Europe, Japan and Canada. (JHU Case No.
***)
2. PCT Application *** filed January 21, 1994, entitled ***;
International PCT Application S/N *** filed July 11, 1995;
International PCT Application *** designating Canada;
International PCT Application *** filed July 12, 1995
designating Japan; International PCT Application *** filed July
11, 1997 designating Europe; DIV Application *** filed
September 15, 1998; and Patent No. *** issued September 15,
1998. (JHU Case No. ***)
3. U. S. Application S/N *** filed January 12, 1993, entitled ***;
corresponding continuation-in-part Application *** filed as
International PCT Application on January 12, 1994 designating
U.S., Europe, Japan and Canada; International
PCT-continuation-in-part Application S/N *** filed May 31,
1995; International PCT Application *** filed July 12, 1995
designating Canada; International PCT Application filed July
12, 1995 designating Japan; Patent No. *** issued September 1,
1998, entitled ***; DIV Application *** filed September 1,
1998. (JHU Case No. ***)
4. U. S. Application S/N *** filed July 9, 1993, entitled ***;
corresponding *** filed July 8, 1994 designating U.S.,
Australia, Europe, Japan and Canada; International PCT
Application *** filed July 8, 1994 designating Japan;
International PCT Application *** filed July 8, 1994
designating Australia; and International PCT *** filed July 8,
1994 designating Europe; International PCT Application ***
filed January 9, 1996; DIV Application S/N *** filed June 15,
1998; Patent No. *** issued June 23, 1998 entitled "***". (JHU
Case No. ***)
5. U. S. Application S/N *** filed July 9, 1993, entitled "***";
corresponding *** filed July 8, 1994 designating U.S.,
Australia, Europe, Japan and Canada; International PCT
Application *** filed July 8, 1994 designating Japan; Patent
No. *** issued January 19, 1995; U.S. Application S/N *** filed
interference January 9, 1996; International PCT Application ***
filed July 8, 1994 designating Europe; and Patent No. ***
entitled "***" issued on July 2, 1998. (JHU Case No. ***)
6. U. S. Application S/N *** filed March 19, 1993, entitled "***";
corresponding PCT Application S/N PCT *** filed March 18, 1994
designating U.S., Europe, Japan and Canada; International PCT
Application *** filed September 19, 1995; continuation-in-part
Application S/N *** filed February 5, 1997;
continuation-in-part Application *** filed April 28, 1997, and
International PCT-continuation-in-part Application *** filed
May 23, 1997; U.S. Application *** filed November 10, 1997,
entitled "***" PCT Application *** filed on February 5, 1998;
International PCT Application *** filed March 18, 1994
designating Canada; continuation-in-part Application *** filed
February 5, 1998; continuation-in-part Application *** filed
July 28, 1998; patent no. ***
issued on August 6, 1998; DIV Application *** filed October 23,
1998; Patent No. *** issued on October 27, 1998 entitled "***"
(JHU Case No. ***)
7. U.S. Application S/N *** filed January 12, 1993, entitled
"***"; corresponding continuation-in-part Application filed as
International PCT Application US *** on January 12, 1994
designating U.S., Europe, Japan, and Canada; International PCT
*** filed July 12, 1995 designating Japan; `International PCT
Application *** filed October 23, 1995; PCI Application ***
filed June 27, 1996 designating Canada; DIV Application ***
filed September 26, 1997; continuation-in-part Application S/N
*** filed October 6, 1997; PCT Application *** filed January
12, 1994; PCT Application *** filed October 6, 1998; DIV
Application *** filed on October 13, 1998; Patent No. ***
issued October 31, 1998. (JHEJ Case No. ***)
8. U. S. Application S/N *** filed October 8, 1993, entitled
"***"; PCT Application *** filed October 7, 1994; International
PCT Application S/N *** filed August 16, 1996; International
PCT Application *** filed July 25, 1996 designating Japan; and
International PCT Application *** filed July 25, 1996
designating Europe. (JHU Case No. ***)
9. U. S. Application S/N *** filed July 8, 1994, entitled "***";
PCT Application *** filed July 7, 1995; International PCT
Application *** filed July 7, 1995; International PCT
Application *** filed July 7, 1995 designating Japan;
International PCT Application *** filed July 7, 1995
designating Canada; FWC Application *** filed September 3,
1996; continuation-in-part Application *** filed February 6,
1997; PCT Application *** filed February 6, 1998;
continuation-in-part Application *** filed February 6, 1998;
International PCT Application *** filed September 3, 1996
designating Europe; continuation-in-part Application S/N ***
filed July 28, 1998. (JHU Case No. ***)
10. U. S. Application S/N *** filed July 13, 1994, entitled "***";
continuation-in-part filed September 26, 1994 as U.S.
Application S/N ***; International PCT Application *** filed
July 12, 1995 designating Europe; International PCT Application
*** filed July 12, 1995 designating Canada; PCT Application ***
filed July 12, 1995; International PCT Application ***filed
July 13, 1995 designating Japan; International PCT Application
*** filed April 28, 1997; DIV Application S/N *** filed
November 2, 1998; and Patent No. *** issued November 13, 1998.
(JHU Case No. ***)
11. U.S. Application *** filed March 29, 1996, entitled "***" and
corresponding International PCT Application *** filed March 31,
1997. (JHU Case No. ***)
12. PCT Application *** filed July 24, 1998, entitled "***" (JHU
Case No. ***)
13. PCT Application *** filed June 3, 1998, entitled "***"; PCT
Application *** filed July 28, 1998 (JHU Case No. ***)
C. Collaborative Factors:
1. PCT Application *** filed July 24, 1998, entitled "***" (JHU
Case No. ***)
2. PCT Application *** filed July 24, 1998, entitled "***" (JHU
Case No. ***)
D. ***:
1. PCT Application *** filed July 24, 1998, entitled "***" (JHU
Case No. ***)
E. ***: None
1. None.
GENETICS INSTITUTE, INC. THE XXXXX XXXXXXX UNIVERSITY
SCHOOL OF MEDICINE
/s/ Xxxxxxxxx X. Xxxxxx /s/ Bart Cherhow, M.D.
Xxxxxxxxx X. Xxxxxx Xxxx Xxxxxxx, M.D.
Vice President Vice Xxxx for Research and Technology
Protein Discovery Research Professor of Medicine, Anesthesiology and
Critical Care
SCHEDULE 1.59
JOINT PATENT RIGHTS
None as of the Effective Date.
Schedule 1.59 -- Page 1 of 1
SCHEDULE 1.62
METAMORPHIX FACTORS
GDF-8
GDF-11
GDF-12
Schedule 1.62 -- Page 1 of 1
SCHEDULE 1.65
METAMORPHIX PATENT RIGHTS
None as of the Effective Date.
Schedule 1.65 -- Page 1 of 1
SCHEDULE 3.3.3
SPONSORED RESEARCH BUDGET
***
Schedule 3.3.3 -- Page 1 of 1
SCHEDULE 3.3.4
SPONSORED RESEARCH PLAN
RESEARCH PROPOSAL
Specific Aim 1: Generation of inducible cre transgenic mice.
Specific Aim 2: Construction and characterization of GDF-l0/BMP-3 double
knockout mice.
Specific Aim 3: Construction and characterization of GDF-12-/-,
inhibin-(beta)C -/-, and GDF-12/inhibin- (beta)C double
knockout
mice.
Specific Aim 4: Construction and characterization of GDF-2 -/- mice.
Specific Aim 5: Construction and characterization of GDF-l5 -/- mice.
Specific Aim 6: Search for human myostatin mutations.
Specific Aim 7: Search for novel cysteine knot-containing factors.
Specific Aim 1: Generation of inducible cre transgenic mice.
For a variety of reasons, the ability to induce mutations in members of
the TGF-B superfamily in neonatal or adult animals would be quite useful for
identifying potential therapeutic applications for these molecules. For example.
a number of knockout mice containing targeted mutations in members of the TGF-l3
superfamily have turned out to have be embryonic lethal, making it impossible to
determine the roles that these genes play during postnatal development or in
adult animals. Similarly, even in certain cases where the knockout animals are
viable, such as the myostatin knockout mice, the ability to shut off the gene in
adult animals would be invaluable in further evaluating potential applications.
As a first step toward achieving this goal, we propose to generate transgenic
lines in which the expression of the cre recombinase can be induced at defined
times either during development or postnatally. Our strategy will be to generate
mouse lines carrying two different transgenes. One transgene will contain the
cre recombinase cloned downstream of minimal promoter containing let operator
sequences. The second transgene will contain the reverse-tel hybrid protein that
can be activated by tetracycline. The reverse-tel coding sequence will initially
be cloned downstream of a promoter that is active in a wide range of tissues,
such as the CMV or metallothionein promoter. Eventually, constructs could be
made in which tissue-specific promoters are used. The initial goal will be to
simply demonstrate the feasibility of this approach. If expression of crc can be
induced in these mice, we will then attempt to use these mice to generate
postnatal knockouts of specific TGF-(beta) family members.
Schedule 3.3.4 -- Page 1 of 4
Specific Aim 2: Construction and characterization of GDF-l0/BMP-3 double
knockout mice.
We have shown that GDF-I0 is expressed at highest levels in developing
skeletal structures and inner ear during embryogenesis and in the uterus.
cerebellum, and adipose tissue in adult mice. We have also shown that GDF-I0 -/-
mice that we generated by gene targeting appear to be normal with respect to
skeletal development, fertility, and cerebellar development. These results
suggest that the activities of other factors may be compensating for the loss of
GDF- 10 function in GDF-l0 -/- mice. The most likely candidate for a molecule
with redundant activity to GDF-10 is BMP-3, which is the highly related to
GDF-l0, BMP-3 -/- mice generated and characterized by scientists at GI and by
Xxxxx Xxxxx now at UCLA also appear to be indistinguishable from wild type mice.
We propose to generate GDF-lO/BMP-3 double knockout mice to determine
whether these molecules are, in fact, functionally redundant. We will send
GDF-I0 -I- mice to Xxxxx Xxxxx, and she will send BMP-3 -I- mice to us. We will
then breed these mice together to generate the double mutants. The double
mutants will be examined thoroughly for any abnormalities, which particular
focus on those tissues that we have extensively analyzed in the GDF-l0-/- mice.
Specific Aim 3: Construction and characterization of GDF-l2-/-,
inhibin-BC /-. and GDF-l2/inhibin- (beta)C double knockout
mice.
We have shown that both GDF- 12 and inhibin-(beta)C are expressed
specifically in the developing and adult liver and pancreas. In a number of
liver injury models examined, we have found that inhibin-(beta)C is dramatically
and transiently down-regulated following partial hepatectomy. We have generated
both GDF-12 -/- mice and inhibin- (beta)C -/- mice by gene targeting. Our
analysis thus far has shown that these are relatively normal. We do have some
preliminary data suggesting that these mice may be predisposed to developing
fatty liver. However, because the development of fatty liver even in wild type
mice appears to be highly variable among individual mice, we have delayed
further analysis of this phenotype until the mice have been bred into
genetically pure backgrounds.
We propose to further analyze these mice particularly with respect to
liver and pancreas function in the pure genetic backgrounds. With respect to
liver function, we will examine the livers of these animals not only under
normal conditions but also following a variety of different liver injuries. With
respect to pancreatic function, we will examine the tissue histologically and
examine a variety of serum parameters under normal conditions and response to
exogenously administered glucose (glucose tolerance test).
We also propose to generate GDF- 12/inhibin- (beta)C double mutants.
The rationale for this experiment is that GDF-12 and inhibin- (beta)C are the
two members of the TB (beta) superfamily that are most highly related to each
other, and the two genes have identical patterns of expression, suggesting the
possibility that they may have similar biological functions. Unfortunately,
because the two genes are only several kilobases apart in the genome, it will
not be practically possible to generate the double mutant simply by breeding the
two individual mutants. We have generated a new targeting vector to
simultaneously delete both genes. and we are ready to electroporate embryonic
stem cells with this construct. Once we have generated the double mutant, these
mice will be analyzed in a similar manner as the individual mutants.
Schedule 3.3.4 -- Page 2 of4
Specific Aim 4: Construction and characterization of GDF-2 -/-- mice.
GDF-2 (identical to BMP-9) is expressed most prominently in the liver
both during development and in adult animals. We have demonstrated a variety of
activities for GDF-2 in culture and in animals. including induction of alkaline
phosphatase activity and bone formation and regulation of branching
morphogenesis in lung explants. We have also generated a GDF-2 mutation in
embryonic xxxxx cells, and from blastocvst injection of these clones, we now
have several germ-line chimeras.
We propose to examine the phenotype of GDF-2 -/-mice. We will
thoroughly examine these mice for abnormalities. We will first determine whether
GDF-2 -/- mice are viable. If so. we will have complete necropsies performed on
these mice and will analyze a wide range of serum parameters. We will also carry
out an extensive analysis of liver function in these mice using approaches
similar to those that we will use for the GDF-12 and inhibin-(beta)C -/- mice.
If the mutant animals are not viable, we will determine the stage at which the
animals die and then analyze the animals or embryos histologically. Further
analysis will, of course. depend on the specific abnormalities that we find.
Specific Aim 5: Construction and characterization of GDF-15 -/- mice.
GDF-15 is expressed widely in adult tissues, but most prominently in
the liver. We have shown that the expression of GDF-15 is induced in a variety
of liver injury models. We also have preliminary evidence that the expression of
GDF-15 is induced in other tissues as well in response to injury. These data
raise the possibility that GDF- 15 may be an important mediator of the
regenerative response in a variety of' cell types and tissues. We have also
generated a GDF-15 mutation in embryonic stem cells, and from blastocyst
injection of these clones, we now have at leas one germ-line chimera.
We propose to examine the phenotype of GDF-15 -/- mice. We will analyze
these mice as described above for the GDF-2 -/- mice. In addition, if the GDF-15
-/- mice are viable, we will subject the mice to a variety of different injury
models for different tissues.
Specific Aim 6: Search for human myostatin mutations.
We have shown that myostatin functions as a negative regulator of
muscle growth both in mice and in cattle, suggesting that inhibition of
mvostatin function or expression may have important applications for the
treatment of muscle wasting diseases. We would like to extend these studies to
demonstrate that myostatin carries out the same function in humans. We propose
to examine the myostatin gene in heavily-muscled individuals, such as
professional bodybuilders, for the presence of mutations. We have already
accumulated over 100 blood samples form heavily-muscled individuals. We will
complete our preparation of DNA from these blood samples and then sequence the
C-terminal coding region from each sample. Depending on the results of this
study, we may also sequence the other exons encoding the pre-region.
Specific Aim 7: Search for novel cvsteine knot-containing factors.
All members of the TGF-B superfamily as well as a variety of other
growth factors and hormones have a cysteine pattern that has been shown in a
number of cases to form a cysteine knot structure. Our search for new factors
has been focused to date almost entirely for new
Schedule 3.3.4 -- Page 3 of 4
members of the TGF-B superfamily. We propose to continue this search, primarily
focusing on a low stringency approach. and to expand this search to include new
members of the XXX family While all of the published studies on the XXX family
have focused on their ability to bind and inhibit members of the TGF-(beta)
superfamily, we believe that the possibility that these molecules may signal
through their own receptors still has not been ruled out. We also believe that
whatever their mechanism of action may be these molecules also have the
potential to be important therapeutic agents.
Schedule 3.3.4 Page 4 of 4
SCHEDULE 3.3.6
FORM OF
CONFIDENTIALITY AGREEMENT
CONFIDENTIALITY AGREEMENT
The undersigned, being a faculty member, student, fellow or other
employee of The Xxxxx Xxxxxxx University ("JHU"), agrees not to directly or
indirectly publish, disseminate or otherwise disclose, deliver or make available
to any third party any scientific, technical, trade or business information
specifically related to _______________, as more fully described in the Exhibit
attached to this Confidentiality Agreement. Such information is `CONFIDENTIAL"
to MetaMorphix, Inc. (a corporation formed in 1994 for the purposes of funding
research at JHU under the direction of Se-Xxx Xxx, M.D., Ph.D. to characterize
certain previously-discovered factors, and discover and characterize new
factors, in the TGF-(beta) Superfamily and commercializing such factors) and/or
Genetics Institute, Inc., a JHU licensee which also has provided funding for
TGF-(beta) Superfamily research at JHU.
This duty of confidentiality shall not apply to all or part of the
above-described information if (a) such information was known to the undersigned
at the time it was disclosed, as evidenced by written records at the time of
disclosure; (b) at the time of disclosure or later becomes publicly known under
circumstances involving no breach of this Confidentiality Agreement: or (C) is
lawfully and in good faith made available to the undersigned by a third party
who did not derive it from the undersigned and who imposes no obligation of
confidence on the undersigned. For each disclosure of confidential information,
this duty of confidentiality shall last five (5) years from the date of
disclosure of such confidential information.
I further understand that general know-how and research skills are not
considered confidential by JHU, MetaMorphix and/or GI.
Print Name
---------------
Title
--------------------
Date
--------------
Schedule 3.3.6 -- Page 1 of 1
SCHEDULE 3.3.9
JHU EQUIPMENT
EQUIPMENT PRICE PAID TO PURCHASE
Thermal cvcler $ 6,000
Microcentrifuges (3) 5,100
New Brunswick incubator/
Shaker and accessories 5,200
Macintosh computer, monitor, etc. 2,500
Shimadzu spectrophotometer 8,000
Belico hot shaker 1,900
Tissue culture incubators (2) 15,000
Crvostat 20,000
Miscellaneous 6,000
Schedule 3.3.9 -- Page 1 of 1
SCHEDULE 3.4.2
COLLABORATIVE RESEARCH PLAN
GI and MetaMorphix each shall conduct research on their own and/or
through the efforts of collaborators (which efforts shall be subject to the
terms and conditions of the Agreement) to evaluate and characterize those
BMPs, GDFs and Collaborative Factors that have not yet been designated or
selected as either GI Factors or MetaMorphix Factors, so that GI and
MetaMorphix may each utilize the information gained from conducting such
research to select GI Factors and MetaMorphix Factors, respectively, from the
Available Factors in accordance with Article 5 of the Agreement. Information
gained from conducting such research shall be shared among the Parties as
provided in the Agreement.
Schedule 3.4.2 -- Page 1 of 1
SCHEDULE 5.2
AVAILABLE FACTORS
***
Schedule 5.2 -- Page 1 of 1
SCHEDULE 6.6A
JHU STANDARD MATERIAL TRANSFER AGREEMENT
[JHU LETTERHEAD]
[date]
Dear
-------------------
Xxxxx Xxxxxxx University (JHU) agrees to provide you the material(s)
indicated below which you requested from Dr. Se-Xxx Xxx for your nonclinical
research studies. in order to protect JHU's proprietary rights in the
material(s) or its (their) progeny, portions. and derivatives thereof
(hereinafter "Materials"), we request that you and an authorized official of
your institution sign, date, and return this letter agreement to us.
Material(s) identification:
Acceptance of the Material(s) by your institution confirms your
agreement to the following conditions:.
I) This agreement and the resulting transfer of the Material(s) constitute a
nonexclusive license to use the Material(s) for nonprofit. nonclinical
research purposes only. The Material(s) will not be used in humans and
will be stored, used, and disposed of in accordance with applicable law
and regulations. The Material(s) will not be used for any commercial
purpose. This agreement is not assignable and the Material(s) may not be
transferred to another party.
2) Nothing in this Letter Agreement grants you any rights under any patents
claiming the Material(s) nor any rights to use Materials for profit-making
or commercial purposes.
3) Subject to Paragraph 4 below, you are free to publish your work involving
this Material(s). You agree to provide JHU with a copy of any publication
which contains results obtained from use of the Material(s), as provided
in Paragraph 4 below.
4) INVENTIONS.
a. DISCLOSURE. You will promptly and fully disclose in writing to JHU any
and all inventions, know-how and other rights (whether or not
protected under state, federal, or foreign intellectual property laws)
related to the Material(s) or its (their) use which are conceived
and/or reduced to practice by you, alone or jointly with others, in
the course of your research (the "lnventions").
b. LICENSE AND OPTION. You and your institution grant to JHU (I) a
non-exclusive royalty-free license to Inventions for non-commercial
academic research purposes (ii) a non-exclusive, royalty bearing (not
to exceed 1% of JHU's licensee's net sales) transferable license to
Inventions which are new uses of the Material(s) (for example, new
therapeutic indications for, and new methods of administration of, the
Material(s) and (iii) a first option to obtain an exclusive,
royalty-bearing transferable license to any or all of your interests
in the Inventions, all with the right to grant sublicenses. For each
Invention, JHU's first option must be exercised within ninety (90)
days of your disclosure of that Invention to JHU. The royalty payable
to you and other terms of the
Schedule 6.6A -- Page 1 of 2
exclusive license will be negotiated by the parties in good faith.
5) JHU makes no representations whatsoever as to the Material(s). They are
experimental in nature and are provided WITHOUT WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PRUPOSE OR ANY OTHER
WARRANTY. EXPRESS OR IMPLIED. JHU MAKES NO REPRESENTATION OR WARRANTY
THAT THE USE OF
THE MATERIAL(S) WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY
RIGHT.
6) Except where precluded by Federal law and to the extent allowed by State
law, you and our institution agree to defend, indemnify, and hold
harmless JHU its trustees, officers, employees, and agents FROM any loss,
claim, damage, or liability, of any kind whatsoever. which may arise for
you or your institution's use, storage. or-disposal of the Material(s) or
any other material that could not have been made but for the Material(s),
except to the extent such arise due to the gross negligence of JHU.
7) You shall not use the name of THE XXXXX XXXXXXX UNIVERSITY or THE XXXXX
XXXXXXX HEALTH SYSTEM or any of its constituent parts such as the Xxxxx
Xxxxxxx Hospital or any contraction thereof or the name of its employees
in any advertising, promotional, sales literature or fundraising documents
without prior written consent from an officer of JHU.
To indicate you and your institution's agreement to these conditions,
you and an authorized official should sign and date this letter in the spaces
indicated below and return it to me. If you have any questions concerning this
agreement, you may call me at 000-000-0000.
Sincerely,
Xxxxxx X. Xxxxxxxx. Esq.
Assistant Xxxx and Director
Office of Technology Licensing
HWC:spa
Signature:
------------------------------------------------------------
(Recipient lnvestigator Signature)
Name:
Title:
Date:
RECIPTIENT INSTITUTLON'S AUTHORIZED OFFICIAL
AN AUTHORIZED SIGNATURE IS THAT OF AN INSTITUTIONAL OFFICIAL OR COMPANY OFFICER
SPECIFICALLY AUTHORIZED TO EXECUTE DOCUMENTS OF THIS TYPE ON BEHALF OF THE
INSTITUTION.
Institution/Company:
-------------------------------------------
Signature:
----------------------------------------------------
NAME:
Title:
Date:
Schedule 6.6A -- Page 2 of 2
SCHEDULE 6.6B
GI STANDARD MATERIAL TRANSFER AGREEMENT
***
SCHEDULE 7.2A
ADDITIONAL LICENSE FEES PAYABLE BY GI
FOR GI FACTORS AND ADDITIONAL FACTORS
ADDITIONAL LICENSE FEES FOR GI's DEVELOPMENT OF GI FACTORS
-------------------------------------------------------------------------------------------------------
EVENT ADDITIONAL LICENSE FEE
-------------------------------------------------------------------------------------------------------
PAYABLE TO PAYABLE TO
JHU METAMORPHIX
-------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------
Commencement of the first Phase III clinical trial in the U.S. a $*** $***
European country or Japan sponsored by GI. or its Affiliates or
sublicensees, for each GI Factor that is a GDF Discovered by JHU
-------------------------------------------------------------------------------------------------------
Commencement of the first Phase III clinical trial in the U.S.. a $*** $***
European country or Japan sponsored by GI, or its Affiliates or
sublicensees, for each GI Factor that is a GDF Discovered by
MetaMorphi.x
-------------------------------------------------------------------------------------------------------
Commencement of the first Phase 111 clinical trial in the U.S., $*** $***
a European country or Japan sponsored by GI. or its
Affiliates or sublicensees. for each GI Factor that is a
Collaborative Factor of JHU and MetaMorphix
-------------------------------------------------------------------------------------------------------
Commencement of the first Phase III clinical trial in the U.S., $*** $***
a European country or Japan sponsored by Gl. or its Affiliates or
sublicensees, for each Collaborative Factor of 01 and MetaMorphix
-------------------------------------------------------------------------------------------------------
Commencement of the first Phase III clinical trial in the U.S.. $*** $***
a European country or Japan sponsored by one of its Affiliates
or sublicensees, for each Collaborative Factor of GI and JHU
-------------------------------------------------------------------------------------------------------
Approval of the first PLA filed by 01, or its Affiliates or $*** $***
sublicensees, in the U.S., a European country or Japan. for each
GI Factor that is a GDF Discovered by JHU
-------------------------------------------------------------------------------------------------------
Approval of the first PLA filed by GI or its Affiliates or $*** $***
sublicensees in the U.S., a European country or Japan for each
GI Factor that is a GDF Discovered by MetaMorphix
-------------------------------------------------------------------------------------------------------
Approval of the first PLA filed by GI, or its Affiliates or $*** $***
sublicensees. in the U.S.. a European country or Japan. for each
GI Factor that is a Collaborative Factor of JHU and MetaMorphix
-------------------------------------------------------------------------------------------------------
Approval of the first PLA filed by GI or its Affiliates or $*** $***
sublicensees in the U.S.. a European country or Japan, for each
GI Factor that is a Collaborative Factor of GI and MetaMorphix
-------------------------------------------------------------------------------------------------------
Approval of the first PLA filed by GI or its Affiliates or $*** $***
sublicensees. in the U.S., a European country or Japan. for each
GI Factor that is a Collaborative Factor of GI and JHU
-------------------------------------------------------------------------------------------------------
Schedule 7.2A -- Page I of 2
ADDITIONAL LICENSE FEES FOR
GI's DEVELOPMENT OF ADDITIONAL FACTORS
---------------------------------------------------------------------------------------------------
ADDITIONAL LICENSE FEE
EVENT PAYABLE TO JHU
---------------------------------------------------------------------------------------------------
Commencement of the first Phase III clinical trial in the US, a $***
European country or Japan sponsored by GI or its Affiliates or
Sublicensees for each Additional GDF that is Discovered by JHU
---------------------------------------------------------------------------------------------------
Commencement of the first Phase III clinical trial in the US, a $***
European country or Japan sponsored by GI or its Affiliates or
sublicensees, for each Additional Collaborative Factor
----------------------------------------------------------------------------------------------------
Approval of the first PLA filed by GI or its Affiliates or $***
sublicensees. in the U.S., a European country or Japan for each
Additional GDF that is Discovered by JHU
---------------------------------------------------------------------------------------------------
Approval of the first PLA filed by GI its Affiliates or $***
sublicensees, in the U.S., a European country or Japan for each
Additional Collaborative Factor
---------------------------------------------------------------------------------------------------
Schedule 7.2A -- Page 2 of 2
SCHEDULE 7.2B
ADDITIONAL LICENSE FEES PAYABLE BY GI
FOR METAMORPHIX FACTORS
---------------------------------------------------------------------------------------------------
ADDITIONAL LICENSE FEES FOR
GI'S DEVELOPMENT OF METAMORPHIX FACTORS IN THE GI FIELD
---------------------------------------------------------------------------------------------------
LICENSE FEE
EVENT PAYABLE TO PAYABLE TO
JHU METAMORPHIX
---------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------
Filing, by GI, its Affiliates or sublicensees of the first IND $*** $***
for the MetaMorphix Factor known as GDF-8
---------------------------------------------------------------------------------------------------
Filing, by GI, its Affiliates or sublicensees of the first IND $*** $***
for each MetaMorphix Factor, other than the MetaMorphix Factor
known as GDF-8, which is a GDF
---------------------------------------------------------------------------------------------------
Commencement of the first Phase III clinical trial in the U.S., a $*** $***
European country or Japan sponsored by GI or its Affiliates or
Sublicensees. for the MetaMorphix Factor known as GDF-8
---------------------------------------------------------------------------------------------------
Commencement of the first Phase III clinical trial in the U.S., a $*** $***
European country or Japan sponsored by GI or its Affiliates or
sublicensees, for each MetaMorphix Factor, other than the
MetaMorphi.x Factor known as GDF-8 which is a GDF Discovered
byJHU
---------------------------------------------------------------------------------------------------
Commencement of the first Phase III clinical trial in the U.S., $*** $***
a European country or Japan sponsored by GI or its Affiliates
or sublicensees, for each MetaMorphix Factor, other than the
MetaMorphix Factor known as GDF-8 which is a GDF Discovered
by MetaMorphix
---------------------------------------------------------------------------------------------------
Commencement of the first Phase III clinical trial in the U.S., $*** $***
a European country or Japan sponsored by GI or its Affiliates
or Sublicenisees for each MetaMorphix Factor, other than the
MetaMorphix Factor known as GDF-8 which is a Collaborative
Factor of JHU and MetaMorphix
---------------------------------------------------------------------------------------------------
Commencement of the first Phase III clinical trial in the U.S., $*** $***
a European country or Japan sponsored by GI or its Affiliates
or sublicensees, for each MetaMorphix Factor other than the
MetaMorphix Factor known as GDF-8 which is a Collaborative
Factor OF JHU and GI
---------------------------------------------------------------------------------------------------
Commencement of the first Phase Ill clinical trial in the U.S., $*** $***
a European country or Japan sponsored by GI or its Affiliates
or sublicensees, for each MetaMorphix Factor, other than the
MetaMorphix Factor known as GDF-8, which is a Collaborative
Factor of MetaMorphix and GI
---------------------------------------------------------------------------------------------------
Schedule 7.2B -- Page 1 of 2
----------------------------------------------------------------------------------------------------
Filing by GI, its Affiliates or sublicensees, and acceptance for $*** $***
review By the applicable Regulatory Authorities in the U.S., a
European country or Japan. of the first PLA for the MetaMorphix
Factor known as GDF-8
----------------------------------------------------------------------------------------------------
Filing by GI, its Affiliates or sublicensees. and acceptance for $*** $***
review by the applicable Regulatory Authorities in the U.S.. a
European country or Japan. of the first PLA for each Met.aMorphix
Factor other than the MetaMorphix Factor known as GDF-8
----------------------------------------------------------------------------------------------------
Receipt of Regulatory Approval of the first PLA filed by GI, $*** $***
Factor known Affiliates or sublicensees in the U.S., a
European country or Japan for the MetaMorphix Factor known
as GDF-8
----------------------------------------------------------------------------------------------------
Receipt of Regulatory Approval of the first PLA filed by GI its $*** $***
Affiliates or sublicensees in the U.S., a European country or
Japan for each MetaMorphix Factor, other than the MetaMorphix
Factor known as GDF-8 which is a GDF Discovered by JHU
----------------------------------------------------------------------------------------------------
Receipt of Regulatory Approval of the first PLA filed by CI, $*** $***
its Affiliates or sublicensees in the U.S.. a European country
or Japan for each MetaMorphix Factor, other than the MetaMorphix
Factor known as GDF-8, which is a GDF Discovered by MetaMorphix
----------------------------------------------------------------------------------------------------
Receipt of Regulatory Approval of the first PLA filed by GI its $*** $***
Affiliates or sublicensees in the U.S., a European country or
Japan for each MetaMorphi.x Factor, other than the MetaMorphtx
Factor known as GDF-8, which is a Collaborative Factor of JHU
and MetaMorphix
----------------------------------------------------------------------------------------------------
Receipt of Regulatory Approval of the first PLA filed by GI, $*** $***
its Affiliates or sublicensees in the U.S. a European country
or Japan for each MetaMorphix Factor, other than the MetaMorphix
Factor known as GDF.8 which is a Collaborative Factor of JHU
and GI
----------------------------------------------------------------------------------------------------
Receipt of Regulatory Approval of the first PLA filed by GI $*** $***
its Affiliates or sublicensees in the U.S.. a European country
or Japan for each MetaMorphix Factor, other than the MetaMorphix
Factor known as GDF-8, which is a Collaborative Factor of
MetaMorphix and GI
----------------------------------------------------------------------------------------------------
Schedule 7.2B -- Page 2 of 2
SCHEDULE 8.IA
FORM FOR ASSIGNMENT OF SHARES
ASSIGNMENT AGREEMENT
For value received (as set forth in that Amended and Restated
Collaboration Agreement of even date herewith among Genetics Institute Inc.,
The Xxxxx Xxxxxxx University and MetaMorphix. Inc. Genetics Institute, Inc.
does hereby sell, assign, transfer, and permit the redemption unto
MetaMorphix. Inc. Three Million Six Hundred Thousand (3,600,000) of its shares
of Convertible Preferred Stock of MetaMorphix, Inc., i.e. Two Million Seven
Hundred Thousand (2,700,000) shares of its Series A Convertible Preferred
Stock and Nine Hundred Thousand (900,000) shares (or all) of its Series B
Convertible Preferred Stock, standing in the name of Genetics Institute, Inc.
on the books of MetaMorphix. Inc., represented by stock certificate nos. A-102
arid A-104 through A-111 (collectively representing Two Million Seven Hundred
Thirty-eight Thousand Nine Hundred (2,738,900) shares of Series A Convertible
Preferred Stock, there having been A stock split of 50-to-1 on May 27, 1997)
and certificate no. B-101 (representing Nine Hundred Thousand (900,000)
shares of Series B Convertible Preferred Stock, there having been a stock
split of 50-to-1 on May 27, 1997), the originals of which are attached hereto
as EXHIBIT A.
An opinion of counsel under Section 3 of the April 18, 1995
Registration Agreement is not being provided as MetaMorphix, Inc. has waived
such requirement for this sale and redemption.
In consideration for such sale and redemption. MetaMorphix. Inc. shall
issue, in the name of Genetics Institute, Inc., a replacement stock certificate
no. A-112, for Thirty-eight Thousand Nine Hundred (38,900) shares of Series A
Convertible Preferred Stock owned by Genetics Institute, Inc. formerly
represented by stock certificate no. A-111 (leaving Genetics Institute, Inc.
with a total of Two Hundred Thousand (200,000) shares of Series A Convertible
Preferred Stock). Such remaining shares. i.e., as represented by stock
certificate nos. A-103 and A-111, shall continue to benefit from and be subject
to the terms of the April 18, 1995 Registration Agreement and the replacement
stock certificate shall be legended in accordance with such Agreement.
Dated: January ____, 1999
ATTEST: GENETICS INSTITUTE, INC.
------------------- By: (SEAL)
---------------------------------
Name:
Date:
ACCEPTED THIS -- DAY OF JANUARY. 1999
BY METAMORPHIX, INC.
By:
--------------------------------------------------------------
Xxxxx X. Xxxxxxxxxxx Ph.D. President and Chief Executive Officer
Schedule 0.xX -- Page l of l
SCHEDULE 8.1B
FORM FOR STOCK POWER
STOCK POWER
FOR VALUED RECEIVED, Genetics Institute Inc.. a Delaware corporation
("GI"). hereby sells. assigns, transfers and conveys to MetaMorphix, Inc., a
Delaware corporation, _______________ shares of __________________________ stock
[which have not been surrendered to permit an adjustment for a prior stock
split], ______ par value per share, of MetaMorphix. Inc. a Delaware corporation
(the "Corporation") registered in the name of GI on the books of the
Corporation, represented by Certificate No. and does hereby irrevocably
constitute and appoint Xxxxxxx X. Xxxxxxx as attorney to transfer such shares on
the books of the Corporation, with full power of substitution in the premises.
Dated: GENETICS INSTITUTE, INC.
January, , 1999
-----------
By:
-----------------------------------
Name:
Title:
In the presence of:
-----------------------------------
Schedule 8.1B -- Page 1 of 1
SCHEDULE 8.2
FORM FOR THIRD ALLONGE TO PROMISSORY NOTE
THIS THIRD ALLONGE TO PROMISSORY NOTE ("Third Allonge"). is effective
the ________ day of January, 1999, by and between METAMORHIX. INC.. a Delaware
Corporation (the "Maker") and GENETICS INSTITIUTE. INC. a Delaware Corporation
(the "Lender').
WHEREAS, on or about February 9, 1998 the Maker executed and delivered
a Promissory Note (the "Original Note") to Lender in the original principal sum
of Two Million Dollars ($2,000,000) which is repayable by the Maker to the
Lender on demand at any time after December 31, 1998 ("Original Demand Date")
and which, in the event certain conditions are met provides for the conversion
of the debt represented by the Note to equity on or before December 31. 1998
("Original Conversion Date"): and
WHEREAS, on or about August 18, 1998 the Maker executed and delivered a
First Allonge to Promissory Note ("First Allonge") to Lender modifying the Note
such that the principal sum due and owing on account of the Note as of the date
of the First Allonge was, and is, Two Million Two Hundred Thousand Dollars
($2,200,000), plus any and all interest that has accrued in accordance with the
terms of the Note:
and
WHEREAS, on or about October 30, 1998 the Maker executed and delivered
a Second Allonge to Promissory Note ("Second Allonge") to Lender modifying the
Nate, as modified by the First Allonge, such that: (I) the principal sum, plus
any and all interest, was to be paid by Maker to Lender on demand at any time on
or after June 30, 1999 (the "Second Demand Date"); (2) the debt created by the
Note, and the payment of principal and interest thereunder, was, and is, to be
subordinate to any new debt incurred by Maker up to One Million Dollars
($1,000,000) provided that certain conditions were. arid are, met; and (3) if
Maker closed an equity financing such that it raised Two Million Dollars
($2,000,000) from investors other than the Lender on or before June 30. 1999
(the "Second Conversion Date") in a transaction approved by Maker's Board of
Directors. the unpaid principal balance of the Note, plus any and all interest,
was to be converted into fully paid and non-assessable shares of the capital
stock of Maker issued in connection with such equity financing, concurrently
with the first closing of such equity financing, at the same price as is paid by
the investors in such financing: and
WHEREAS, as of December 31. 1998. Two Million Two Hundred Thousand
Dollars ($2,200,000) remains unpaid and One Hundred Fifty-Three Thousand Six
Hundred Ninety-Two Dollars arid Seventy-Four Cents ($153,692.74) of interest has
accrued and remains unpaid: and
WHEREAS, the Maker has requested. and Lender has agreed, to extend the
Second Demand Date and, in effect, to eliminate the Second Conversion Date,
provided that the Maker agrees to the execution of this Third Allonge; wherefore
Maker and Lender now agree to modify the Original Note, as modified by the First
and Second Allonges and now this Third Allonge (hereinafter collectively the
"Note"), as follows:
1. The Maker may prepay the principal sum, plus any and all interest
that has accrued in accordance with the terms of the Note, in pan or in whole,
at any time without penalty; and
2. The principal sum, plus any and all interest that has accrued in
accordance with the terms of the Note, shall be paid by Maker to Lender. without
any notice or demand on January 1, 2005 ("Third Due Date"), if not sooner paid;
and
3. Upon the Third Due Date, in lieu of a payment of cash, the Maker
may pay the principal balance of the Note, plus any and all interest that has
accrued in accordance with the terms of the Note, by issuing to Lender fully
paid and non-assessable shares of the common stock of Maker, if such stock is
then publicly traded, at the then market price of such stock, calculated at the
average closing price for the ten (10) trading days up to and including the
fifth trading day preceding the Third Due Date.
Schedule 8.2 -- Page 1 of 2
4. At the Lender's sole election, on or before December 31, 2004.
provided that the Lender has provided the Maker with at least ninety (90) days
prior written notice of such election, the Lender may convert the outstanding
principal and interest under this Note into fully paid and non-assessable shares
of common stock of the Maker, at a per-share price valued at either (a) one
hundred twenty-five percent (125%) of the IPO price if the stock is then
publicly traded, or (b) a price to be negotiated in good faith by the Maker and
the Lender if the stock is not then publicly traded. This right of conversion is
personal to Genetics, Institute, Inc. and may not be assigned except upon full
transfer and assignment of this Note, to American Home Products Corporation or
other affiliate of Genetics Institute. Inc.
5. In the event of a stock issuance under either Paragraphs 3 or 4 of
this Third Allonge. no fractional shares of the common stock shall be issuable
upon conversion of this Note but an adjustment in cash shall be made in respect
of any fraction of a share which would otherwise be issuable upon the surrender
of this Note for conversion.
6. The third and fourth paragraphs of this Original Note, i.e. the
provisions for automatic conversion upon a certain equity financing, are
hereafter null and void and of no effect.
7. The parties hereto do not intend that a novation of the loan
shall be created or effectuated because of the modifications described in this
Third Allonge. The parties in this Third Allonge do not intend that the
execution of this Third Allonge and the transaction described herein shall
affect the validity or priority of any indebtedness created by the Note. This
Third Allonge (a) is being physically attached to the Note simultaneously with
the entry into this Third Allonge by the parties hereto to evidence the
modification of the provisions of the Note and (b) shall upon such attachment be
deemed to be apart of the Note as fully and completely as if the provisions were
set forth at length in the body of the Note.
8. All other terms, covenants, and conditions contained in the Note,
except as herein modified, shall remain in full force and effect and the Maker
by the execution hereof hereby ratifies and confirms each and every other term,
covenant, and condition of the Note.
IN WITNESS WHEREOF, the Maker and the Lender have set their hands and
seals to this Third Allonge to Promissory Note upon the day hereinabove first
written.
[SEAL]
ATTEST: METAMORPHIX. INC.
By: (SEAL)
------------------------- ------------------------------
Xxxxxxx X. Xxxxxxx Xxxxx X. Xxxxxxxxxxx, Ph.D
Secretary President and Chief Executive Officer
ATTEST: GENETICS INSTITUTE, INC.
-------------------------------- By. (SEAL)
-------------------------------
Name:
Title:
Schedule 8.2 -- Page 2 of 2
SCHEDULE 8.3
FORM FOR PUT OPTION AGREEMENTS
PUT OPTION AGREEMENT
THIS PUT OPTION AGREEMENT (the "Agreement") is made and entered into
this day of _________________+, (the "Effective Date") by and between Genetics
Institute. Inc., a Delaware corporation, with a business address at 00
Xxxxxxxxxx Xxxx Xxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000 ("GI") and
________________________, a ________________ having an address at
___________________ ([collectively,] the "Investor[s]"). GI and the Investor[s]
may each be referred to herein individually as a Party and collectively as the
Parties. MetaMorphix, Inc., a Delaware corporation, having offices at 0000 Xxxxx
Xxxxxxx Xxxx, Xxxxxxxxx, Xxxxxxxx 00000 ("MetaMorphix") joins in this Agreement
to evidence its approval of the terms and conditions contained herein.
RECITALS
WHEREAS, MetaMorphix, GI and the Xxxxx Xxxxxxx University entered into
an .Amended and Restated Collaboration Agreement on January 26, 1999 (the "1999
Collaboration Agreement") pursuant to which GI agreed, INTER ALIA, to provide
put options to certain accredited investors who each purchase one hundred
thousand dollars ($100,000) or more of the capital stock of MetaMorphix, which
options would permit such investors, upon certain conditions, to require GI to
purchase up to two million dollars ($2,000,000), in the aggregate, of such
capital stock purchased by such investors from MetaMorphix;
WHEREAS, simultaneously herewith, Investor is purchasing from
MetaMorphix ____________ shares of _________________ capital stock of
MetaMorphix (together with all other securities issued as a dividend upon, in
exchange for or otherwise in connection with such shares, the "Purchased Stock")
for a total cash purchase price of ________________ dollars ($________) (the
"Investor Purchase Price"), which amount equates to a per share purchase price
of _______________ dollars ($_______ (the "Per Share Purchase Price") which
purchase is conditioned upon the execution and delivery by GI of this Agreement
on the terms and conditions set forth herein; and
WHEREAS, GI and Investor desire to enter into this Agreement to set
forth the terms and conditions under which the Investor may require to purchase
the Purchased Stock, or a portion thereof.
NOW THEREFORE, in consideration of the premises set forth above and the
respective covenants and agreements of the Parties contained herein, and
intending to be legally bound, the Parties hereby agree as follows:
1. Grant of Put Option. Subject to the terms and conditions of this
Agreement, GI hereby grants to Investor a put option (the "Put Option")
pursuant to which the Investor may require Gl to purchase from such
Investor, the Purchased Stock [or X% of the Purchased Stock, if the Put
Option is being granted only with respect to a portion of the Purchased
Stock purchased by such Investor] at the price calculated in accordance
with Section 3 below, provided, however, that the grant of this Put
Option is conditioned upon GI
Schedule 8.3 -- Page 1 of 9
receiving, from MetaMorphix's attorneys, a written opinion to the
effect that the sale of' the Purchased Stock and the issuance of this
Put Option. each are exempt from registration under applicable federal
and state securities laws.
2. EXERCISE OF PUT OPTION.
2.1 Exercise Period. This Put Option may be exercised b submission
to and receipt by GI of a BONAFIDE Exercise Notice (made in
accordance with Sections 2.4 and 7.4 hereof) on or after
January 1, 2000 and before December 31, 2001 only in the event
that MetaMorphix (a) has voluntarily filed for Bankruptcy
under Chapter 7 of the United States Bankruptcy Code (the
"Bankruptcy Code") or (b) is placed into bankruptcy under
Chapter 7 of the Bankruptcy Code by a petition of a third
party and such proceeding is not lifted within sixty (60) days
of the filing of such petition for bankruptcy, in either event
prior to December 31, 2001. GI shall have no obligation to
purchase any such Purchased Shares prior to January I. 2000 or
after December 31, 2001.
2.2 AUTOMATIC EXPIRATION. Notwithstanding Section 2.I above, the
Put Option shall automatically expire prior to December 31,
2001 in the event that MetaMorphix has raised an aggregate of
Eight Million Dollars ($8,000,000) or more, in cash and/or
non-cash consideration. through(a) an equity financing or
equity financings or (b) the transfer to Investor and/or one
or more third parties of any rights or assets relating to one
or more MetaMorphix Factors (as that term is defined in the
1999 Collaboration Agreement). Only consideration actually
received by MetaMorphix on or before December 31, 2001 shall
be considered in determining whether such Eight Million
Dollars ($8,000,000) has been raised. Any consideration
received by MetaMorphix in a form other than cash shall, for
purposes of this Agreement. be considered to have been
received as cash in an amount equivalent to the fair market
value, as determined in good faith by GI and MetaMorphix'
Board of Directors, of such non-cash consideration at the time
received. MetaMorphix shall promptly notify, in writing,
Investor and GI upon the occurrence of any events which result
in the expiration of this Put Option, PROVIDED, HOWEVER, that
any failure to give or delay in giving such notice shall have
no effect upon the expiration of the Put Option. Upon notice
of expiration of the Put Option pursuant to this Agreement.
Investor shall promptly surrender and return this original
Agreement to CI for cancellation.
2.3 PURCHASE LIMIT. The obligation of GI to purchase the Purchased
Stock [or X% of the Purchased Stock if the Put Option is being
granted only with respect to a portion of the Purchased Stock
purchased by such Investor], when aggregated with the shares
of capital stock that GI is or may be obligated to purchase
from other investors who have purchased the capital stock of
MetaMorphix, shall be limited to Two Million Dollars
($2,000,000) in the aggregate.
2.4 EXERCISE NOTICE. In the event that the Investor elects to
exercise this Put Option as permitted under this Article 2.
Investor shall give written notice (the "Exercise Notice") to
GI of its intention to exercise the Put Option, specifying the
time and date, not earlier than thirty (30) business days from
the date such Exercise Notice is given, for the closing of
such sale (the "Closing"), which written notice shall be
substantially in the form that is attached hereto as
Exhibit A.
Schedule 8.3 -- Page 2 of 9
3. PURCHASE PRICE. In the event that the Investor exercises the Put
Option as permitted hereunder. the purchase price payable by Cl to the
Investor for the purchase of the Purchased Stock [or X% of such
Purchased Stock the Put Option is being granted only with respect to a
portion of the Purchased Stock purchased by such Investor] shall be
calculated by multiplying the number of shares of the Purchased Stock
to be purchased by GI from such Investor hereunder by the Per Share
Purchase Price paid by such Investor for the purchase of the Purchased
Stock (the "Option Price").
4. CLOSING. The Closing shall be held at 10:00 am. (local time) on the
date specified in the Exercise Notice, or at such other time as may be
mutually agreed by the Parties, at the offices of Genetics Institute
in Cambridge, Massachusetts, or such other location in the United
States as may be designated by Genetics Institute, unless, on such
date, there shall be any preliminary or permanent injunction or other
order by any court of competent jurisdiction or any other legal
restraint or prohibition preventing the consummation of such sale, in
which event such Closing shall be held as soon as practicable
following the lifting, termination or suspension of such injunction,
order, restraint or prohibition (each Party agreeing to use its
reasonable efforts to have such injunction, order, restraint or
prohibition lifted, terminated or suspended), but in any event within
five (5) business days thereof. At the Closing. Investor shall deliver
an original certificate or certificates representing the Purchased
Stock duly endorsed for transfer or with duly endorsed stock powers
(which in form and substance are acceptable to GI) in blank and Gl
shall deliver cash, by certified check or wire transfer in immediately
available funds, to an account specified in writing by the investor,
in the amount equal to the Option Price.
5. FEES AND EXPENSES. Except as expressly provided otherwise in this
Agreement, all costs and expenses incurred in connection with this
Agreement and the consummation of the transactions contemplated
hereby. including, without limitation, the legal fees and expenses of
the investor and any taxes that may be imposed upon the Investor as a
result of the purchase of such Purchased Stock from MetaMorpkiix or
the transfer of such Purchased Stock to GI shall be paid by the Party
incurring such expenses.
6. Representations and Warranties.
6.1 GI. GI hereby represents, warrants and covenants to the
Investor that, as of the Effective Date:
(a) it is a corporation or entity duly organized and
validly existing under the laws of the state or other
jurisdiction of incorporation or formation;
(b) the execution, delivery and performance of this
Agreement by GI has been duly authorized by all
requisite corporate action and does not require any
shareholder action or approval;
(c) it has the power and authority to execute and deliver
this Agreement and to perform its obligations
hereunder:
(d) the execution, delivery and performance by GI of this
Agreement and its compliance with the terms and
provisions hereof does not and will not conflict with
or result in a material breach of any of the terms and
provisions of or constitute a material default under
(i) any material loan agreement. guaranty, financing
agreement, agreement affecting a product
Schedule 8.3 -- Page 3 of 9
or other agreement or instrument binding or affecting
it or its property. (ii) the provisions of its charter
or operative documents or bylaws. or (iii) any
material order, writ, injunction or decree of any
court or governmental authority entered against it or
by which any of its property is bound; and
(e) it shall at all times comply with all applicable
material laws and regulations relating to its
activities under this Agreement.
IT IS EXPRESSLY UNDERSTOOD BY ALL PARTIES THAT GI IS MAKING NO
REPRESENTATIONS OR WARRANTIES OF ANY KIND. EXPRESS OR IMPLIED.
WITH RESPECT TO ANY OF THE PURCHASED STOCK.
6.2 INVESTOR. Investor hereby represents. warrants and covenants
to GI that, as of the Effective Date, during the term of this
Agreement and, as of the Closing:
(a) it is an "accredited investor" as that term is defined
in Rule 501(a) of Regulation D, promulgated under the
Securities Act of 1933. as amended:
(b) it has the power and authority to execute and deliver
this Agreement and to perform its obligations
hereunder:
(c) the execution. delivery and performance by Investor of
this Agreement and its compliance with the terms and
provisions hereof does not and will not conflict with
or result in a breach of any of the terms and
provisions of or constitute a default under (i) any
MATERIAL LOAN agreement. guaranty, financing
agreement, agreement affecting a product or other
agreement or instrument binding or affecting it or its
property, (ii) the provisions of' its charter or
operative documents or bylaws, if applicable, or (iii)
any material order, writ, injunction or decree of any
court or governmental authority entered against it or
by which any of its property is bound:
(d) it has good and marketable title to each of the shares
of the Purchased Stock to be purchased by GI pursuant
to this Agreement, free and clear of all securities
interests, options, or rights of any nature;
(e) [insert reciprocal reps and warranties 6.1(a) and
6.1(b) if Investor is an entity]
7. MISCELLANEOUS,
7.1 APPLICABLE LAW. This Agreement shall in all events and for all
purposes be governed by and construed in accordance with the
laws of the State of Delaware without regard to any choice of
law principle that would dictate the application of the law of
another jurisdiction.
Schedule 8.3 -- Page 4 of 9
7.2 AMENDMENT; MODIFICATION. Subject to applicable law, this
Agreement may be amended, modified and supplemented IN any and
all respects only in a writing signed by each of the Parties.
7.3 ASSIGNMENT. Neither this Agreement nor any of the rights,
interests or obligations hereunder shall be assigned by any of
the Parties hereto without the other Party's prior written
consent, Subject to the preceding sentence, this Agreement
shall be binding upon and inure to the benefit of the Parties
hereto and their successors and permitted assigns: provided,
however, that any permitted assignee of Investor shall agree
to be bound to the terms and conditions of this Agreement and
a notice of assignment. in the form attached hereto as Exhibit
B. shall be duly executed by Investor and his assignee and
provided to GI promptly after such assignment. Notwithstanding
the foregoing, GI shall not require the prior consent of
Investor in the event that it assigns this Agreement or any or
its rights, interests or obligations hereunder to any of its
affiliated or subsidiary companies or to another entity in
connection with a merger, consolidation or acquisition of all
or substantially all of GI's assets, provided, however, that
GI shall provide Investor with written notice of such
assignment promptly after IT is made, Any assignment not made
in accordance with the provisions of this Section 7.3 shall be
null, void and of no effect.
7.4 NOTICES. All notices and other communications required or
permitted to be given hereunder by one Party to any other
Party shall be in writing and shall be deemed given upon
personal delivery, facsimile transmission (with receipt
confirmed). telex or delivery by an overnight express courier
service (delivery, postage or freight charges prepaid). or on
the fourth day following deposit in the United States mail (if
sent by registered or certified mail, return RECEIPT
REQUESTED. delivery, postage and/or freight charges prepaid),
addressed to the Party to whom the notice is to be given at
the following addresses (or at such other address for a Party
as shall be specified by like notice):
If to GI to:
Genetics Institute, Inc.
00 Xxxxxxxxx Xxxx Xxxxx
Xxxxxxxxx. Xxxxxxxxxxxxx 00000
Attn: Legal Department
Fax: (000)000-0000
with a copy to:
American Home Products Corporation
Five Xxxxxxx Xxxxx
Xxxxxxx, Xxx Xxxxxx 00000
Attn: Senior Vice President and General Counsel
Fax: (000) 000.0000
Schedule 8.3 -- Page 5 of 9
If to Investor, to:
[Investor]
[Address]
[City. State. Zip code]
Attn:
FAX:
with a copy to:
[Name] [Address] [City, State, Zip code]
Attn:
Fax:
WITH COPIES OF all notices to:
MetaMorphix, Inc.
0000 Xxxxx Xxxxxxx Xxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attn: President
Fax: (000) 000-0000
and
Xxxxxxx and 0lander
2000 Xxxxxxx Center South
00 Xxxxx Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attn: Xxxxxxx X. Xxxxxxx, Esquire
Fax: (000) 000-0000
7.5 SEVERABILITY, In the event that one or more of the provisions
contained in this Agreement shall, for any reason, be held to
be invalid, illegal or unenforceable in any respect. such
invalidity, illegality or unenforceability shall not affect
any other provision of this Agreement, and all other
provisions shall remain in full force and effect.
(remainder of page intentionally LEFT BLANK)
Schedule 8.3 -- Page 6 of 9
7.6 ENTIRE AGREEMENT. This Agreement, the Exhibits, and Schedules,
if any hereto. constitute the entire agreement of the Parties
with regard to the subject matter hereof, and supersedes and
replaces all previous written or oral representations.
agreements and understandings between the Parties.
IN WITNESS WHEREOF. GI and Investor have caused this Agreement to be
executed by their duly authorized representatives as of the date first written
above.
WTTNESS/ATTEST: GENETICS INSTITUTE. INC.
Name: Name:
Title: Title:
WITNESS/ATTEST [INVESTOR]
Name: Name:
Title: [Title:]
Address:
ACKNOWLEDGEMENT OF METAMORPHIX, INC.
MetaMorphix, Inc. hereby acknowledges the entering into of this
Agreement and its agreement with the terms and conditions contained herein.
WITNESS/ATTEST METAMORPHIX, INC.
By: [SEAL]
-------------------------------
Xxxxxxx X. Xxxxxxx Xxxxx X. Xxxxxxxxxxx, Ph.D.
Secretary President and Chief Executive Officer
Schedule 8.3 -- Page 7 of 9
EXHIBIT A
FORM OF EXERCISE NOTICE
PUT OPTION EXERCISE NOTICE
Dated [______]
THE UNDERSIGNED Investor, pursuant to that certain Put Option
Agreement made by and between Investor and Genetics Institute. Inc. ("GI") on
_____________ (the "Agreement") hereby notifies GI. pursuant to Section 2 of the
Agreement, of its election to exercise the Put Option granted by GI to such
Investor under the Agreement and hereby requests that on the day of ___________
(the "Closing Date"), GI pay to Investor _______________ dollars ($___________),
which amount represents the Option Price pursuant to Section 3 of the Agreement,
in exchange for which Investor, on the Closing Date, will deliver to GI an
original certificate or certificates representing _______________ shares of the
Purchased Stock (as defined in the Agreement) of MetaMorphix, Inc., duly
endorsed for transfer or with duly endorsed stock powers (which in form and
substance are acceptable to GI) in blank.
INVESTOR
Name:
Address:
Date:
Schedule 8.3 -- Page 8 of 9
EXHIBIT B
FORM OF ASSIGNMENT NOTICE
THE UNDERSIGNED Investor (the "Investor"), hereby notifies Genetics
Institute, Inc. ("GI"), that, pursuant to Section 7.3 of the Put Option
Agreement (the "Agreement") entered into by GI and the Investor on
_______________. Investor, on the -- day of ______________________ has
transferred and assigned the Agreement and all of its rights and obligations
thereunder to ____________________________ ("Assignee"), having an address at
____________________________________.
THE UNDERSIGNED Assignee, hereby acknowledges that it has received and
accepts from Investor, the transfer and assignment of the Agreement and all of
Investor's rights and obligations thereunder and agrees to be bound by all of
the terms and conditions set forth in the Agreement.
INVESTOR
--------------------------------------------
Name:
Address:
ASSIGNEE
--------------------------------------------
Name:
Address:
ACKNOWLEGED AND ACCEPTED
THIS ________ DAY OF ___________
BY GENETICS, INSTITUTE. INC.
By: ---------------------------------------------------------
Date: -------------------------------------------------------
Schedule 8.3 -- Page 9 of 9
SCHEDULE 8.4A
FORM OF ASSET PURCHASE AGREEMENT
ASSET PURCHASE AGREEMENT
THIS ASSET PURCHASE AGREEMENT (this "Agreement") is made as of January
--, 1999, by and between MetaMorphix. Inc.. a Delaware corporation ("Seller")
and Genetics Institute, Inc.. a Delaware corporation ("Buyer").
WHEREAS, pursuant to that Master Lease Agreement dated as of October
14, 1997 (the "Master Lease Agreement") by and between the Seller and
Transamerica Business Credit Corporation ("Transamerica"), Seller is the
leasehold owner of the equipment more particularly described on Exhibit A
attached hereto and incorporated by reference (the "Equipment");
WHEREAS, pursuant to the Letter Agreement dated January 25, 1999 by
and between Seller and Transamerica (a copy of which is attached hereto as
Exhibit B). Transamerica provided Seller an option to purchase the Equipment for
Two Hundred Seventy-Six Thousand Three Hundred Seven Dollars ($276,307) (the
"Option").
WHEREAS, in accordance with that Amended and Restated Collaboration
Agreement entered into on January 26. 1999 by and among Seller. Buyer and the
Xxxxx Xxxxxxx University (the "1999 Collaboration Agreement") Buyer is desirous
of buying the Equipment and Seller is desirous of selling the Equipment, once
Seller has exercised its Option and received legal title to the Equipment.
NOW, THEREFORE. in consideration of the premises herein contained and
other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the parties hereto hereby agree as follows:
SECTION 1. AMOUNT AND TERMS OF PURCHASE.
(a) Subject to the terms and conditions of this
Agreement, and in reliance upon the representations and warranties of the Seller
herein set forth, the Buyer agrees to purchase and Seller agrees to sell all of
the Seller's right, title and interest in and to the Equipment (including.
without limitation, all manuals, documentation, specifications and spare parts
in Seller's possession that relate to such Equipment) such that the Buyer will
become the owner of all such Equipment for all purposes whatsoever.
(b) The price to be paid by the Buyer with respect
to the purchase of the Equipment (the "Purchase Price") is Two Hundred
Seventy-Six Thousand Three Hundred Seven Dollars ($276,307). The Purchase Price
shall be payable to the Seller in cash or by certified check on the date
hereinabove first written.
Schedule 8.4 -- Page 1 of 10
(c) The Buyer shall pay any and all applicable
federal, slate. county or local taxes and any and all present or future taxes or
other governments charges arising in Connection with the sale of the Equipment
hereunder, including sales. use or occupation taxes due upon the purchase, but
EXCLUDING any income tax realized by Seller as a result of the Sale.
(d) The Buyer shall select a carrier and arrange for
such carrier to deliver the Equipment to the location(s) designated by the Buyer
within thirty (30) days of this Agreement arid shall prepay all freight,
packing. Shipping, and insurance costs associated with the delivery of the
Equipment to Buyer.
SECTION 2. APPLICATION OF PURCHASE PRICE, TRANSFER OF TITLE,
AND DELIVERY.
(a) Within one (I) business day of the date upon
which Seller receives the Purchase Price, the Seller shall deliver the same to
Transamerica, as payment toward the Option to purchase the Equipment, and legal
title shall be transferred to Seller from Transamerica and the Equipment shall
be free and clear of the Master Lease Agreement and any right, title, or
interest that Transarnerica has therein to the Equipment.
(b) Seller shall transfer legal title to the
Equipment to the Buyer within one (I) business day of receiving same. Transfer
of title to Buyer shall be evidenced by a Xxxx of Sale. in substantially the
form as is attached hereto as Exhibit "C". The Xxxx of Sale shall be dated the
day upon which title to the Equipment is transferred (the "Date of Purchase").
(c) Buyer shall assume the risk of loss with respect
to the Equipment as of the later of (i) the date legal title is transferred to
Buyer as provided in Section 2(b) above or (ii) the date the Equipment is
delivered to Buyer's carrier. Buyer shall cause its carrier to promptly remove,
or cause to be removed, from Seller's possession, the Equipment (and all
manuals, documents, specifications, and spare parts provided to it by the
Seller) within thirty (30) days of the Date of Purchase.
(d) In the event that Seller has delivered the
Purchase Price to Transamerjca and Transamerica is unable, for whatever reason
(other than an act or omission which is in Seller's control). to transfer title
to the Equipment to Seller within thirty (30) days of the date hereinabove first
written, and therefore Seller is unable to transfer title to the Equipment as
contemplated by this Agreement, Buyer, prior to exercising any other remedies it
may have at law or in equity, shall reasonably cooperate with Seller's efforts
to transfer title, including bringing legal action, at Seller's expense, if
necessary, to obtain legal title to the Equipment.
SECTION 3. REPRESENTATION AND WARRANTIES OF SELLER. To induce
the Buyer to enter into this Agreement. the Seller represents and warrants to
the Buyer that:
Schedule 8.4 -- Page 2 of 10
(a) The Seller is duly authorized to execute,
deliver and perform its obligations under this Agreement and all corporate.
action required on its pan for the due execution. delivery and performance of
the transactions contemplated herein have been duly and effectively taken.
(b) The execution, delivery and performance by the
Seller of this Agreement and the consummation of the transactions contemplated
herein does not and will not violate any provision of. or result in a default
under, the Seller's Certificate of Incorporation, as amended or By-laws. as
amended, or any indenture or agreement to which the Seller is a party or to
which its assets are bound or any order, permit, law, statute, code, ordinance,
rule, regulation, certificate or any other requirement of any governmental
authority or regulatory body to which the Seller is subject.
(c) To the best of Buyer's knowledge, no
authorization or approval or other action by, and no notice to or filing with,
any governmental authority or regulatory body is required for the due execution,
delivery and performance by the Seller of this Agreement.
(d) This Agreement constitutes or will constitute,
when delivered hereunder, the legal, valid and binding obligation of the Seller
enforceable against the Seller in accordance with its respective terms, except
as such enforceability may be (i) limited by the effect of applicable
bankruptcy, insolvency, reorganization or similar laws affecting the enforcement
of creditors' rights generally or (ii) subject to the effect of general
principles of equity (regardless of whether such enforceability is considered in
a proceeding at equity or at law).
(e) There are no actions, suits, or proceedings
pending, threatened against or affecting the Seller which seek to enjoin,
prohibit or restrain the consummation of any of the transactions contemplated
hereby.
(f) Seller shall use all reasonable and good faith
efforts to ensure that title to the Equipment is promptly passed from
Transamerica to Seller.
(g) All representations and warranties herein shall
survive the execution of this Agreement and the purchase of the Equipment.
(h) Upon payment of the Purchase Price to
Transamerica, the Equipment shall be owned by Seller and no third party shall
have any right, title, or interest in the Equipment.
(i) THE EQUIPMENT IS PROVIDED BY SELLER "AS IS"; AND
WITHOUT WARRANTY. EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE: provided. however, that the Seller shall
use all reasonable efforts to maintain such Equipment in the condition as it was
at the time of the inspection by Buyer.
Schedule 8.4 -- Page 3 of 10
SECTION 4. REPRESENTATION AND WARRANTIES OF BUYER. To induce
the Seller to enter into this Agreement. the Buyer represents and warrants to
the Seller that:
(a) The Buyer is duly authorized to execute, deliver
and perform its obligations under this Agreement and all corporate action
required on its pan for the due execution, delivery and performance of the
transactions contemplated herein have been duly and effectively taken.
(b) The execution, delivery and performance by the
Buyer of this Agreement and the consummation of the transactions contemplated
herein does not and will not violate any provision of. or result in a default
under, the Buyers's Articles or Certificate of Incorporation or By-laws or any
indenture or agreement to which the Buyer is a party or to which its assets are
bound or any order, permit, law, statute, code. ordinance, rule, regulation,
certificate or any other requirement of any governmental authority or regulatory
body to which the Buyer is subject.
(c) To the best of Buyer's knowledge, no
authorization or approval or other action by. and no notice to or filing with,
any governmental authority or regulatory body is required for the due execution,
delivery and performance by the Buyer of this Agreement.
(d) This Agreement constitutes or will constitute,
when delivered hereunder, the legal, valid and binding obligation of the Buyer
enforceable against the Buyer in accordance with its respective terms, except as
such enforceability may be (i) limited by the effect of applicable bankruptcy,
insolvency, reorganization or similar laws affecting the enforcement of
creditors' rights generally or (ii) subject to the effect of general principles
of equity (regardless of whether such enforceability is considered in a
proceeding at equity or at law).
(e) To the best of Buyer's knowledge, there are no
actions. suits, or proceedings pending. threatened against or affecting the
Buyer which seek to enjoin, prohibit or restrain the consummation of any of the
transactions contemplated hereby.
(f) All representations and warranties herein shall
survive the execution of this Agreement and the purchase of the Equipment.
SECTION 5. AMENDMENTS. No amendment or waiver of any provision
of this Agreement. nor consent to any departure therefrom shall in any event be
effective unless the same shall be in writing and signed by the Buyer, and then
such waiver or consent shall be effective only in the specific instance and for
the specific purpose for which given.
SECTION 6. NOTICES. All notices and other communications
provided for hereunder shall be in writing and sent:
Schedule 8.4 -- Page 4 of 10
if to the Seller. at its address at:
MetaMorphix. Inc.
0000 Xxxxx Xxxxxxx Xxxx
Xxxxxxxxx, XX 00000
Attention: President
Telephone No.: 000-000-0000
Telecopy No.: 000-000-0000
with a copy to:
Xxxxxxx and Xxxxxxx
2000 Xxxxxxx Center South
00 Xxxxx Xxxxxxx Xxxxxx
Xxxxxxxxx. Xxxxxxxx 00000-0 147
Attention: Xxxxxxx X. Xxxxxxx. Esquire
Telecopy No.: 410-539-7611~
if to the Buyer, at its address at:
Genetics Institute, Inc.
00 Xxxxxxxxx Xxxx Xxxxx
Xxxxxxxxx. Xxxxxxxxxxxxx 00000
Attention: Legal Department
Telecopy No.: 000-000-0000
with a copy to:
American Home Products Corporation
Five Giraida Farms
Madison, New Jersey 07940
Attention: Senior Vice President and General Counsel
Telecopy No.: 000-000-0000
or to such other address as shall be designated by such party in a written
notice to the other party. All such notices shall be deemed given (i) if sent by
certified or registered mail, three days after being postmarked. (ii) If sent by
overnight delivery service, when received at the above stated addresses or when
delivery is refused and (iii) if sent by facsimile transmission, when receipt of
such transmission is confirmed by the sender.
Section 7. NO WAIVER/REMEDIES. No failure on the part of the
Buyer to exercise and no delay in exercising, any right hereunder shall operate
as a waiver thereof, nor shall any single or partial exercise of any such right
preclude any other or further exercise thereof or the exercise of any other
right. The remedies herein provided are cumulative and not exclusive of any
remedies provided by law.
Schedule 8.4 -- Page 5 of 10
SECTION 8. BENEFIT. Without the prior written consent of the
other party hereto. this Agreement may not be transferred, assigned or.
delegated any of its rights, duties or obligations hereunder.
SECTION 9. BINDING EFFECT. This Agreement shall be binding upon
and inure to the benefit of the Seller and the Buyer and their respective
successors and assigns.
SECTION 10. GOVERNING LAW. This Agreement shall be governed by,
and shall be construed in accordance with, the laws of the state of Maryland
without giving effect to the conflicts of law principles thereof.
SECTION 11. EXECUTION IN COUNTERPARTS. This Agreement may be
executed in any number of counterparts, each of which shall constitute an
original and all of which taken together shall constitute one and the same
agreement.
SECTION 12. SEVERABILITY. If one or more of the provisions
contained in this Agreement shall be invalid, illegal, or unenforceable in any
respect, the validity. legality, and enforceability of the remaining provisions
contained herein, and any other application thereof shall not in any way be
affected or impaired thereby.
SECTION 13. JURY TRIAL. The parties hereto each hereby waive to
the fullest extent permitted by law any right to a trial by jury in any action
or proceeding arising under or in connection with this Agreement.
IN WITNESS WHEREOF, the parties hereto have caused this
Agreement to be executed by their respective officers hereunto duly authorized
as of the first date written above.
METAMORPHIX INC.
By:
----------------------------------------------
Xxxxx X. Xxxxxxxxxxx, President
GENETICS INSTITUTE, INC.
By:
---------------------------------------------
Name:
Title:
Schedule 8.4 -- Page 6 of 10
EXHIBIT A
EQUIPMENT
See attached pages.
Schedule 8.4 -- Page 7 of 10
EXHIBIT B
LETTER AGREEMENT
BETWEEN
METAMORPHIX, INC.
AND
TRANSAMERICA BUSINESS CREDIT CORPORATION
See attached pages.
Schedule 8.4 -- Page 8 of 10
XXXXXXX and XXXXXXX
January 25,1999
SENT VIA TELECOPIER
Mr. Xxxxxxx Xxxxx
Transamerica Business Credit
Technology Finance Division
00 Xxxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, XX 00000.0000
Re: Sale of equipment by MetaMorphix, Inc. Pursuant to Master
LEASE AGREEMENT WITH TRANSAMERICA BUSINESS CREDIT
CORPORATION
Dear Xxxx:
As we discussed on Friday, MetaMorphix, inc. ("MMI") is in the
process of licensing certain human pharmaceutical and therapeutic
applications OF its Growth Differentiation Factors to Genetics Institute
Inc. ("GI"), We anticipate closing this transaction by Monday, January
25, 1999 or as soon thereafter as practicable (THE "Closing"). In
connection with that transaction GI desires to purchase equipment that
it subject to the Master Lease Agreement dated October 24, 1997 and
attached Lease Schedules between Transamerica Business Credit
Corporation ("TBCC") and MMI (the "Master Lease"), as act forth on the
attached List of Equipment (the "Equipment).
Because there is no pre-purchase right contained in the Master
Lease, we hereby request that TBCC confirm its agreement to consent to
the transaction and agree to sell and transfer the Equipment to MMI,
free and clear of all liens and encumbrances, contingent upon receipt of
payment to MMI in the amount of $276,307 and the payment by MMI to TBCC
of such amount as prepayment for the Equipment under the Master Lease.
We need this a consent prior to Closing. Following our payment to TBCC,
will need to amend the Lease Schedules and file a partial release of
TBCC's UCC-1 filing for the Equipment.
To evidence the consent and agreement of TBCC to the sale of
the Equipment as described herein, please sign below and return a signed
original of this letter via facsimile and Federal Express, to my
attention at your earliest Convenience I have enclosed a federal express
envelope for your convenience.
Additionally, given the tight time schedule on this transaction
I would appreciate your promptly adjusting the equipment schedules on
the remaining Lease and preparing the partial
XXXXXXX AND OLANER
Mr. Xxxxxxx Xxxxx
January 25. 1999
Page 2
releases of the UCC's on the Equipment. In the event I can be of
any assistance to you in preparing the above described
documents, please advise me. I will happy to assist. I have
assumed, given that the documents are on your system, that you
would prefer controlling the revisions of the documents.
Many thanks In advance for your assistance.
Very truly yours,
/s/ A. Xxxxx Xxxxxxx
A. Xxxxx Xxxxxxx
ALP/mms
Enclosures
Cc: Xxxxxxxxx Xxxx, Controller and Director of Operations (via facsimile)
Xxxxxxx X. Xxxxxxx. Esquire
ACKNOWLEDGED AND AGREED TO
THIS ________ DAY OF JANUARY, 1999
TRANSAMERICA BUSINESS
CREDIT CORPORATION
BY: /S/ XXXX X. XXXX
XXXX X. XXXX
TITLE: VICE President
EXHIBIT C
XXXX OF SALE
KNOW ALL PERSONS BY THESE PRESENTS METAMORPHIX INC. (the
"Seller"), for Two Hundred Seventy-Six Thousand Three Hundred Seven Dollars
($276,307) and other valuable consideration to it in hand paid receipt of which
is hereby acknowledged, does unconditionally, absolutely and irrevocably grant
sell assign, transfer and convey unto GENETICS INSTITUTE. INC. and its assignees
or successors (collectively, the "Buyer"), all of the Seller's right, title and
interest in and to the equipment described on SCHEDULE I hereto (collectively,
the "Equipment").
TO HAVE AND TO HOLD said Equipment unto the said Buyer to and
for its use forever.
AND, the Seller hereby warrants. covenants and agrees that it
(a) has good and marketable title to the Equipment, free and clear of any liens
and other encumbrances: and (b) will warrant and defend the sale of the
Equipment against any and all persons claiming against such title.
IN WITNESS WHEREOF the Seller has caused this instrument to be
duly executed and delivered as of this ___________ day of _____________________,
1999.
METAMORPHIX, INC.
By:
---------------------------------------------
Xxxxx X. Xxxxxxxxxxx, President
Schedule 8.4 -- Page 9 of 10
SCHEDULE I
to Xxxx of Sale
EQUIPMENT
See attached pages.
SCHEDULE 8.4B
METAMORPHIX EQUIPMENT TO BE PURCHASED BY GI
See attached pages.
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
ID Qty Vendor Manufacturer Equipment Model Serial Cost
Number
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
1 1 APPLIED XXXXXX XXXXX GENE AMP 1000 PCR I 00 $9,000.00
BIOSYSTEMS
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
2 BARBERA BUSINESS PANASONIC FAX MACHINE Uf-550 $1,200.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
3 SYSTEM SOURCE LEXMARK PRINTER OPRTA $1,588.65
LEXMARK
PRINT~ P - CPRTA
P N 4:9820
5:
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
4 XXXX ATLANTIC MOTOROLA PAGER BRAVO $100.02
FLX/SKYTEL
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
5 BEST BUY CARRYING CASE $62.99
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
6 BEST BUY COMPAQ Laptop-Compaq 1210 $2,414.99
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
7 BEST BUY MC MOUSE-Compaq $31.49
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
8 BEST BUY TOSHIBA POLICY-COMPAQ $129.99
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
9 BIO RAD BIO RAD PROTEAN GEL CELL PROTEAN II $841.50
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
10 BIO RAD BIO RAD SUB-CELL GT BASIC $391.50
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
11 BIO RAD BIO RAD SUB-CELL GT MINI $664.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
12 BIO RAD BIO RAD CAPACITIANCE EXTENDER II 25-1075MFD $873.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
13 BIO RAD BIO RAD GENE PULSE CONTROLLER MODEL $634.5
165-2109
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
14 BIO RAD BIO RAD GENE PULSER II $2,932.75
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
15 BIO RAD BIO RAD MINI PROTEAN II 2-D CELL $580.50
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
16 BIO RAD BIO RAD READY GEL CELL/MINI TRANS $1,098.00
BLOT MOD
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
17 BIO RAD BIO RAD READY GEL CELL/MINI TRANS $1,098.00
BLOT MOD
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
18 CELERIUS HITACHI LAPTOP PENTIUM 133 HITACHI M133T $3,984.75
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
19 CELERIUS 3COM 100 BASE T NETWORK CARD $115.50
HITACHI
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
00 XXXXXXXX XXXXXXXX XXXXXXX XXXXXXX 0XX LI+ MX $183.75
SERIES
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
21 OXFORD MOLECULAR OMIGA 1 0 SOFTWARE LICENSE (HITACHI) $1,605.50
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
22 COMP USA MAC 6400/200 16/2 4 MMMT $2,288.97
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
23 COMP USA CANON PRINTER BUBBLEJET XXXX $524.97
BJC-4550
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
24 IMAGE SYSTEMS XXX-0X XXXX XXXX XXX-00 $1,696.48
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
25 IMAGE SYSTEMS NIKON MICROSCOPE ALPHAPHOT $1,519.80
BODY
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
26 LABREPCO SANYO CENTRIFUGE (TABLE TOP) HARIER $2,750.00
15/80
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
27 LABREPCO 24X2ML FIXED ANGLE ROTOR 43117-611 $550.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
28 LABREPCO MICROTITRE CARRIER 41159-1322 $635.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
29 LABREPCO BLUE ADAPTER 37X12MM (2PK) 43155-1322 $600.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
30 LABREPCO YELLOW ADAPTER 37X12MM 43155-1369 $600.00
(2PK)
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
31 LABREPCO GREEN ADAPTER 37X12MM (2PK) 43155-134A $600.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
32 LABREPCO BIOMETRA HYBRIDIZATION OV4 $1,667.55
OVEN/INCUBATORS
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
33 LABREPCO BARNSTEAD/THERMO NONPURE INFINITY UV/UF MODEL D8991 $4,045.83
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
34 LABREPCO JENWAY PH METER MODEL 3305 $350.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
35 OFFICE DEPOT EPSON PRINTER STYLUS $480.88
COLOR 800
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
36
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
37 XXXXXXX XXXX DC-1560 PHOTO COPIER DC-1560 $3,100.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
38 BAMANT COMPANY PUMP EASY LOAD MASTER FLEX $395.73
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
39 BAMANT COMPANY PUMP EASY LOAD MASTER FLEX PUMP HEAD $395.73
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
40
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
41 XXXXXX-XXXXXXXXX XXXXXX-XXXXXXXXX FACSCAN AND FAC STATION FACSCAN $17,583.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
42 XXXXXX-XXXXXXXXX XXXXXX-XXXXXXXXX FACSCAN AND FAC STATION FAC STATION $20,350.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
43 BIO-RAD BIO-RAD MINI-TRANSBIO $991.45
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
44 COMPUTER MASTERS DAEWOO SCGA MONITORS 15" 15" VGA $290.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
45 COMPUTER MASTERS DAEWOO SCGA MONITORS 15" 15" VGA $290.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
46 COMPUTER MASTERS DAEWOO SCGA MONITORS 15" 15" VGA $290.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
47 COMPUTER MASTERS DAEWOO SCGA MONITORS 15" 15" VGA $290.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
48 COMPUTER MASTERS DAEWOO SCGA MONITORS 15" 15" VGA $290.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
49 COMPUTER MASTERS DAEWOO SCGA MONITORS 17" 17" VGA 500.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
50 COMPUTER MASTERS DAEWOO SCGA MONITORS 17" 17" VGA $500.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
51 COMPUTER MASTERS COMPUTER MASTERS 200 PENTIUM MMX COMPUTERS PENTIUM 200 $1,704.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
52 COMPUTER MASTERS COMPUTER MASTERS 200 PENTIUM MMX COMPUTERS PENTIUM 200 $1,650.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
53 COMPUTER MASTERS COMPUTER MASTERS 200 PENTIUM MMX COMPUTERS PENTIUM 200 $1,610.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
54 COMPUTER MASTERS COMPUTER MASTERS 200 PENTIUM MMX COMPUTERS PENTIUM 200 $1,610.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
55 COMPUTER MASTERS COMPUTER MASTERS 200 PENTIUM MMX COMPUTERS PENTIUM 200 $1,610.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
56 COMPUTER MASTERS COMPUTER MASTERS 200 PENTIUM MMX COMPUTERS PENTIUM 200 $1,704.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
57 COMPUTER MASTERS COMPUTER MASTERS 200 PENTIUM MMX COMPUTERS PENTIUM 200 $1,704.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
58 COMPUTER MASTERS COMPUTER MASTERS 200 PENTIUM MMX COMPUTERS PENTIUM 200 $1,705.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
59 XXXX & XXXX MICROEDGE ROTARY MICTOTOME AO 820 $1,370.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
60 EDVOTEK EDVOTEK VAR DUPLEX POWER PACK EDV105 $280.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
00 XXXXXXXX XXXXXXXX XXXXXXXXX/XXXX $300.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
00 XXXXXXXX XXXXXXXX XXXXX BATH WITH LID $100.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
63 FERMTECH LABCONO PUNTYER CLEAN BENCH $1,100.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
64 XXXXXX SCIENTIFIC XXXXXX SCIENTIFIC TISSUE FLOAT BATH 120V $678.82
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
65 XXXXXX SCIENTIFIC XXXXXX SCIENTIFIC PH ELECTRODE $468.25
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
66 LEICA LEICA HISTOEMBEDDER 120.60HZ $4,000.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
67 LEICA LEICA TISSUE PROCESSOR 95-125 VAC $36,538.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
68 LIFE TECHNOLOGIES LIFE TECHNOLOGIES SEG GEL ELECTRO APPAR S2 $908.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
69 MCMASTER XXXX XXXXXXXX XXXX TABLE TOP HUMIDIFIER 5 GALLON $100.38
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
70 MJ RESEARCH INC PELTBER THERMAL CYCLE HOT BONNET 96V $4,347.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
71 MJ RESEARCH INC PELTBER THERMAL CYCLE HOT BONNET 96V $4,347.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
72 PGC SCIENTIFIC PGC SCIENTIFIC POLY HEAT SEALER $118.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
73 XXXX SCIENTIFIC MICRO MICRO 4000 MON SYS $3,396.75
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
74 SCANALYTICS INC SCANALYTICS INC ONE-DSCAN (SOFTWARE) $1,510.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
75
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
76 VWR SCIENTIFIC VWR SCIENTIFIC ONE-TOUCH HOLDER/ACCESS ACCU-EDGE $598.50
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
77 VWR SCIENTIFIC BIOFUGE MICROCENTNFUGE & ROTOR $1,357.25
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
78 VWR SCIENTIFIC FALCON PIPET AID PORTABLE $219.07
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
79 VWR SCIENTIFIC FALCON PIPET AID PORTABLE $219.07
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
80 VWR SCIENTIFIC FALCON PIPET AID PORTABLE $219.07
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
81 VWR SCIENTIFIC FALCON PIPET AID PORTABLE $219.07
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
82 SORVALL SORVALL ULTRA CENTRAFUGE $38,900.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
83 SORVALL SORVALL ULTRA CENTRAFUGE W ROUTER $10,460.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
84 SORVALL SORVALL ULTRACRIMP ROOTER $9,550.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
85 SORVALL SORVALL CRIMPER TOOL $945.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
86 IMAGE SYSTEMS NIKON MICROSCOPE $25,284.10
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
87 IMAGE SYSTEMS NIKON MICROSCOPE $3,391.20
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
88 RAININ XXXXXX PIPET MODEL P1000 $209.04
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
89 RAININ XXXXXX PIPET MODEL P1000 $240.46
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
90 RAININ XXXXXX PIPET MODEL P1000 $209.04
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
91 RAININ XXXXXX PIPET MODEL P1000 $209.04
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
92 RAININ XXXXXX PIPET MODEL P1000 $209.04
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
93 RAININ RAININ PIPET MODEL P200 $209.87
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
94 XXXXX XXXXXX PIPET MODEL P100 $209.04
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
95 RAININ RAININ PIPET MODEL P200 $209.87
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
96 RAININ RAININ PIPET P-10 $246.18
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
97 RAININ RAININ PIPETMAN 10ML P-10ML $238.97
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
98 RAININ RAININ PIPETMAN 200UL P-200 $209.04
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
99 RAININ RAININ PIPETMAN 200UL P-200 $209.04
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
100 RAININ RAININ PIPETMAN 200UL P-200 $209.04
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
101 RAININ RAININ PIPETMAN P-20 $252.05
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
102 RAININ RAININ PIPET P-20 $209.04
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
103 RAININ RAININ PIPET P-1000 $209.04
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
104 SORVALL SORVALL SWIGING BUCKET ROTOR TH-660 $8,185.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
105 VWR SCIENTIFIC VWR SCIENTIFIC SHALLOW WATER BATH $321.35
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
106
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
107 LABREPCO AIRFILTRONIX MINI CLEAN ROOM RF-1000 $1,995.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
108 LABREPCO AIRFILTRONIX MINI CLEAN ROOM RF-1000 $1,995.00
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
109 RAININ RAININ PIPETMAN 1000UL P-1000 $209.04
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
110 RAININ RAININ PIPETMAN 20UL P-20 $210.53
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
111 VWR SCIENTIFIC VWR SCIENTIFIC BIOFUGE MICROCENTERFUGE $1,318.42
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
112
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
113 RAININ RAININ PIPETMAN 20UL P-20 $210.53
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
114 COMP USA HP XXX XXXXXXX 0X 0X $892.49
------- ----- ------------------ ---------------------- ---------------------------- ------------ ---------- ----------
SCHEDULE 8.5
FORM OF INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT
INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT
THIS INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT (this "Assignment") is
made this day of January, 1999, by and between MetaMorphix, Inc., a Delaware
corporation (hereinafter referred to as "the Assignor"), and Genetics Institute,
a Delaware corporation (hereinafter referred to as "the Assignee').
EXPLANATORY STATEMENT
WHEREAS, on February 1, 1998 the Assignor and Baylor College of
Medicine, a Texas non-profit corporation ("Baylor"), entered into a Research
Collaboration Agreement, a copy of which is attached hereto as EXHIBIT A and
incorporated herein by reference (the "Agreement").
WHEREAS, in accordance with the provisions of that certain Amended and
Restated Collaboration Agreement entered into on January 26, 1999 by and among
Assignor, Assignee and the Xxxxx Xxxxxxx University (the "1999 Collaboration
Agreement"), Assignor desires by this Assignment to assign to the Assignee its
rights and licenses, if any, arising under the Agreement afler August 1, 1998
and prior to February 1, 1999, in consideration of the payment of Forty-eight
Thousand Dollars ($48,000) to Assignee, which amount is equal to the amount owed
by Assignor to Baylor under the terms of the Agreement; and
WHEREAS, the Assignee desires to accept such assignment, all upon the
terms and subject to the conditions which are hereinafter set forth.
AGREEMENT
NOW, THEREFORE. FOR AND IN CONSIDERATION of the mutual ently into this
Assignment by the parties hereto. and for other good and valuable consideration,
the receipt and adequacy of which are hereby acknowledged by each party hereto,
the parties hereto hereby agree as follows:
Section 1. ASSIGNMENT. The Assignor hereby assigns to the Assignee, and
the Assignee hereby accepts from the Assignor. all of the Assignors right,
title, interest and licenses, if any, in and to any data, information, or
intellectual property arising after August 1, 1998 and prior to February 1.
1999, including, without limitation, the right to require Baylor to grant to
Assignee an exclusive license to Baylor's interest in any such data,
Schedule 8.5 -- Page 1 of 4
information and intellectual property. (collectively, the "Assigned Rights")
under the provisions of the Agreement upon receipt of Forty-eight Thousand
Dollars ($48,000) from Assignee, by check or wire transfer. Notwithstanding the
foregoing. Assignor is not assigning to Assignee and Assignee is not assuming
any obligations Assignor may have to Baylor under the Agreement with respect to
the Assigned Rights or otherwise.
SECTION 2. REPRESENTATIONS, WARRANTIES, AND COVENANTS.
2.1. BY ASSIGNOR. The Assignor hereby represents, warrants and
covenants to the Assignee that,
2.1.1. the Assignor has not heretofore assigned, transferred,
or encumbered any or all, of its rights under the provisions of the Agreement;
and
2.1.2. as of the date of this Assignment. the Assignor has
paid to Baylor Forty-eight Thousand Dollars ($48,000) and shall remit the
balance of the amount it owes Baylor promptly after the execution of this
Assignment.
2.2. BY EACH PARTY'. Each party hereto hereby represents and
warrants to the other that it has been duly authorized to execute and deliver
this Assignment. and to perform its obligations hereunder.
SECTION 3. NOTICES. All notices and other communications provided
for hereunder shall be in writing and sent:
if to the Assignor, at its address at:
MetaMorphix. Inc. 0000 Xxxxx Xxxxxxx Xxxx Xxxxxxxxx.
XX 00000 Attention: President Telephone No.:
410-455-5880 Telecopy No.: 000-000-0000
with a copy to:
Xxxxxxx and Xxxxxxx
2000 Xxxxxxx Center South
00 Xxxxx Xxxxxxx Xxxxxx
Xxxxxxxxx. Xxxxxxxx 00000-0000
Attention: Xxxxxxx X. Xxxxxxx. Esquire
Schedule 8.5 -- Page 2 of 4
if to the Assignee. at its address at:
Genetics Institute. Inc.
00 XxxxxxxxxXxxx Xxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: Legal Department
Telecopy No.: 000-000-0000
with a copy to:
American Home Products Corporation
Five Giralda Farms
Madison. New Jersey 07940
Attention: Senior Vice President and General Counsel
Telecopy No.: 000-000-0000
or to such other address as shall be designated by such party in a written
notice to the other party. All such notices shall be deemed given (i) if sent by
certified or registered mail, three days after being postmarked, (ii) if sent by
overnight `delivery service, when received at the above stated addresses or when
delivery is refused and (iii) if sent by facsimile transmission. when receipt of
such transmission is confirmed by the sender.
SECTION 4. GENERAL.
4.1. EFFECTIVENESS. This Assignment shall become effective on and
only on its execution and delivery by each party hereto.
4.2. AMENDMENT. This Assignment may be amended by and only by an
instrument executed and delivered by each party, hereto.
4.3. WAIVER. No party hereto shall be deemed to have waived the
exercise of any right which it holds hereunder unless such waiver is made
expressly and in writing (and. without limiting the generality olthe foregoing.
no delay or omission by any party hereto in exercising any such right shall be
deemed a waiver of its future exercise). No such waiver made in any instance
involving the exercise of any such right shall be deemed a waiver as to any
other such instance, or arty other such right.
4.4.APPLICABLE LAW. This Assignment shall be given effect and
construed by application of the law of Maryland except in regard to its choice
of law provisions.
4.5. ASSIGNMENT. This Assignment shall be binding upon and shall
inure to the benefit of the parties hereto and their successors and assigns
hereunder.
4.6. SEVERABILITY. No determination b any court, governmental body
or otherwise that any provision of this Assignment or any amendment hereof is
invalid or unenforceable in any instance shall affect the validity or
enforceability of (a) any other provision thereof, or
Schedule 8.5 -- Page 3 of 4
(b) such provision in any circumstance not controlled by such determination.
Each such provision shall be valid and enforceable to the fullest extent allowed
by and shall be construed wherever possible as being consistent with. applicable
law.
4.6. ENTIRE AGREEMENT. This Assignment. together with the Agreement
constitutes the entire agreement of the parties with regard to its subject
matter. and supercedes all previous written or oral agreements and
understandings. other than the 1999 Collaboration Agreement, between Assignor
and Assignee.
IN WITNESS WHEREOF. each party hereto has executed and sealed this
Assignment or caused it to be executed and sealed on its behalf by its duly
authorized representatives, the day and year first above written.
(SEAL)
ATTEST: METAMORPHIX. INC.
----------------------------- By:
(SEAL) --------------------------------------
Xxxxxxx X. Xxxxxxx, Secretary Xxxxx X. Xxxxxxxxxxx, President
WITNESS/ATTEST: GENETICS INSTITUTE. INC.
------------------------------ By:
(SEAL) --------------------------------------
Name:
Title:
Schedule 8.5 -- Page 4 of 4
SCHEDULE 8.6
FORM OF TERMINATION AGREEMENT
TERMINATION AGREEMENT
THIS TERMINATION AGREEMENT is made this _______ day of January, 1999
by and among MetaMorphix Inc. a Delaware corporation (the Corporation"). The
Xxxxx Xxxxxxx University ("JHU"). Genetics Institute. Inc. ("GI"). *** and the
*** 1997 Irrevocable Trust (the "Trust").
Explanatory Statement
WHEREAS, as of April 18, 1995, JHU, GI, and *** (collectively the
"Stockholders") entered into a Voting Agreement (the "1995 Voting Agreement")
which provided for among other matters, the method by which the Stockholders
would vote their securities to elect persons as members of the Board of
Directors of the Corporation.
WHEREAS, as of April 18, 1995, the Corporation. JHU, GI, and ***
entered into a Stock Restriction Agreement (the "1995 Stock Restriction
Agreement") and a Right of First Refusal Agreement (the "1995 Right of First
Refusal Agreement"). both of which provided for, among other matters, the
Corporation or JHU and GI to have the right to purchase a portion of Xx. Xxx'x
shares in certain circumstances:
WHEREAS, in 1997. *** transferred 80,000 shares of his stock to the
Trust, which Trust agreed to be bound by the 1995 Voting Agreement, the 1995
Stock Restriction Agreement, and the 1995 Right of First Refusal Agreement:
WHEREAS, on January _________, 1999, in connection with the
Corporation's sale of certain human and diagnostic rights in certain Growth and
Differentiation Factors, the Corporation has purchased and redeemed from GI
Three Million Six Hundred Thousand (3,600,000) shares of the Corporation's
Convertible Preferred Stock, leaving GI with Two Hundred Thousand (200,000)
shares of Series A Convertible Preferred Stock and no shares of Series B
Convertible Preferred Stock:
WHEREAS. as a result of such redemption. and as a condition thereto,
the Corporation. JHU, GI. *** and the Trust desire to terminate the Voting
Agreement and to modify the 1995 Stock Restriction Agreement and the 1995 Right
of First Refusal Agreement.
AGREEMENT
NOW, THEREFORE in consideration of the Explanatory Statement, which is hereby
made a substantive part of this Termination Agreement and other good and
valuable consideration the receipt and sufficiency of which is hereby
acknowledged, the parties hereto agree as follows:
Schedule 8.6 -- Page 1 of 3
1. TERMINATION OF VOTING AGREEMENT. Pursuant to Section 1 0 of the
Voting Agreement. the 1995 Voting Agreement is hereby terminated and shall be of
no further force and effect. The Corporation shall promptly give written notice
of such termination to ***.
2. WAIVER OF RIGHT TO PURCHASE STOCK UNDER 1995 STOCK RESTRICTION
AGREEMENT AND 1995 RIGHT OF FIRST REFUSAL AGREEMENT. GI hereby waives any and
all rights to purchase any shares under the 1995 Stock Restriction Agreement and
the 1995 Right of First Refusal Agreement and for all intents and purposes the
1995 Stock Restriction Agreement and the 1995 Right of First Refusal Agreement
shall be amended to the effect that GI is no longer a "Purchaser" and/or a party
to such 1995 Stock Restriction Agreement or 1995 Right of First Refusal
Agreement.
3. EFFECTIVE DATE. The Effective Date for the termination of the
Voting Agreement and the amendments of the 1995 Stock Restriction Agreement and
the 1995 Right of First Refusal Agreement shall be the date as of which this
Termination Agreement is executed and delivered.
4. STOCK CERTIFICATES. Any stock certificates evidencing voting
securities hereafter returned to the Corporation by the Stockholders shall have
the legend placed upon such certificates in accordance with Section 8 of the
Voting Agreement removed.
5. GOVERNING LAW. This Termination Agreement shall be governed in
accordance with the laws of the State of Delaware.
6. COUNTERPARTS. This Termination Agreement may be executed in
counterparts. each of which shall be deemed and original, but all of which
together shall constitute one and the same instrument.
7. ENTIRE AGREEMENT. This Termination Agreement constitutes the
entire agreement of the parties with respect to the subject matter contained
herein.
WITNESS the hands and seals of the parties.
[SEAL]
ATTEST: METAMORPHIX. INC.
Xxxxxxx X. Xxxxxxx, Esq. Xxxxx X. Xxxxxxxxxxx, Ph.D.
Secretary President
(signatures continued on next page)
Schedule 8.6 -- Page 2 of 3
WITNESS: THE XXXXX XXXXXXX UNIVERSITY
------------------------------ By: (SEAL)
--------------------------------
Xxxxxx X. Xxxxxxxx. Esq.
Director. The Xxxxx Xxxxxxx University
Office of Technology Licensing
WITNESS/ATTEST: GENETICS INSTITUTE. INC.
By: (SEAL)
--------------------------------- --------------------------------
Name:
Title:
WITNESS: SE-XXX XXX, M.D. PH.D.
--------------------------------- -----------------------------------------
Se-Xxx Xxx. M.D., Ph.D.
WITNESS: ***
By:
--------------------------------- --------------------------------------
Xxxxxxx X. Xxxxxxx
Trustee
Schedule 8.6 -- Page 3 of 3
