EXHIBIT 10.31
LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
THIS LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the "Agreement"),
effective as of January 15, 2007 (the "Effective Date"), is entered into by and
between BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, a German corporation having
its principal place of business at Xxxxxxxxxxxxxx 000, 00000 Xxxxxx, Xxxxxxx
("Schering"), and MOLECULAR INSIGHT PHARMACEUTICALS, INC., a Delaware
corporation having its principal place of business at 000 Xxxxxx Xxxxxx,
Xxxxxxxxx, Xxxxxxxxxxxxx 00000, XXX ("Molecular Insight"). Schering and
Molecular Insight both may be referred to herein individually as a "Party" and
collectively as the "Parties".
BACKGROUND
WHEREAS:
A. Schering owns certain intellectual property rights relating to I-131
labeled ZK-BA, a new class of proprietary benzamide compounds highly
accumulating in metastatic melanoma, that may be of use in the field of
oncology, in particular for the diagnosis and treatment of metastatic
melanoma.
B. Molecular Insight desires to obtain from Schering an exclusive, worldwide
license in such intellectual property rights to make, use, sell, offer for
sale, and import pharmaceutical products; and
C. Schering is willing to grant such license to Molecular Insight on the terms
and conditions hereinafter set forth.
NOW, THEREFORE, the Parties hereby agree as follows:
1. DEFINITIONS
As used in this Agreement, the following terms shall have the meanings
indicated:
1.1 "Affiliate" means, with respect to a Party, any person, corporation,
firm, joint venture or other entity which, directly or indirectly,
through one or more intermediates, controls, is controlled by or is
under common control with such Party. As used in this definition,
"control" means possession of the power to direct or cause the
direction of the management and policies of an entity, whether through
the ownership of the outstanding voting securities or by contract or
otherwise.
1.2 "Agreement" shall mean this Agreement.
1.3 "Business Day" means any day that is not a Saturday, a Sunday or other
day on which banks are required or authorized by law to be closed in
Berlin, Germany or Cambridge, MA, USA.
1.4 "Clinical Trial" means a Phase I Clinical Trial, Phase II Clinical
Trial or a Phase III Clinical Trial utilizing the Compounds in the
Field.
1.5 "Commercialization" and "Commercialize" shall refer to all activities
undertaken relating to the manufacture, pre-marketing, marketing,
distribution and sale of a Product, and the process of
Commercialization, respectively.
1.6 "Commercially Reasonable Efforts" means the level of endeavor which a
company in the prescription pharmaceutical industry comparable in size
to Molecular Insight and active in development and commercialization
of pharmaceutical compositions would ordinarily expend for a product
with an equivalent sales and profit potential to a relevant Product.
1.7 "Compounds" means the ZK-BA compounds and derivatives thereof, a new
class of benzamide compounds highly accumulating in metastatic
melanoma, that may be of use in the field of oncology, and in
particular for the diagnosis and treatment of metastatic melanoma as
more fully described in ANNEX 1.7 attached hereto and made a part
hereof.
1.8 "Confidential Information" means all information belonging to or in
the possession of the Parties and their Affiliates which they consider
confidential including, without limitation, information concerning the
study, discovery, design, development, manufacture, formulation,
extraction, compounding, mixing, processing, testing, control,
preservation, storage, finishing, packing, packaging, use,
administration, distribution, sale, reimbursement and/or marketing of
pharmaceutical products or compounds and potential products or
compounds, and shall further include, without limitation, all
information marked "confidential" by a Party, data from and
methodology of pre-clinical and clinical studies, the contents of any
submissions to regulatory authorities worldwide, marketing plans or
computer hardware and software systems and designs and plans for same.
Confidential Information may be conveyed in written, graphical,
physical or oral form
1.9 "Control" or "Controlled" shall mean possession of the ability to
grant the licenses or sublicenses as provided for herein without
violating the terms of any agreement or other arrangement with any
Third Party.
1.10 "Development" means all activities, or the performance thereof,
relating to preclinical development and clinical development, as are
customary in the pharmaceutical industry as part of the process of
obtaining Regulatory Approval.
1.11 "Development Plan" has the meaning contained in Section 6.1.
1.12 "Drug Approval" means the regulatory approval required before
commercial sale or use of a Product as a drug in a regulatory
jurisdiction, including, for purposes of Regulatory Approval in the
US, a New Drug or a Biological License and all supplements filed
pursuant to the requirements of the FDA (including all documents, data
and other information concerning a Product that are necessary for, or
included in, FDA approval to market a Product) and, for purposes of
Regulatory Approval in the EU, all and any regulatory approval by the
EMEA or any other applicable national regulatory authority.
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1.13 "Effective Date" shall have the meaning set forth at the head of this
Agreement.
1.14 "EMEA" means the European Medicines Evaluation Agency, or any
successor agency with responsibility for regulating the development,
manufacture and sale of human pharmaceutical products.
1.15 "EU" means the countries of the European Union, as constituted from
time to time.
1.16 "FDA" means the United States Food and Drug Administration of the
Department of Health and Human Services, or any successor agency with
responsibility for regulating the development, manufacture and sale of
human pharmaceutical products.
1.17 "FDA Equivalent" means the equivalent of FDA, but in a legal
jurisdiction other than the US.
1.18 "Field" means any use in the diagnosis, cure, mitigation, treatment or
prevention of disease in human beings in the field of oncology.
1.19 "Final Milestone Payment" has the meaning contained in Section 4.2.
1.20 "First Commercial Sale" means the date Molecular Insight or an
Affiliate or Sublicensee of Molecular Insight first sells, or
otherwise disposes of, commercially to a third party, a Product
pursuant to a Regulatory Approval.
1.21 "GCP" means the Good Clinical Practices guidelines published by FDA,
and published standards of FDA (or other standards of FDA that are
generally recognized within the United States pharmaceutical industry)
that relate to the conduct of clinical studies in humans. GCP also
includes similar standards, guidelines and regulations promulgated or
otherwise required by the European Commission, and published standards
of the European Commission (or other standards of the European
Commission that are generally recognized within the European
pharmaceutical industry), including the ICH Harmonised Tripartite
Guideline for Good Clinical Practice, as amended from time to time.
1.22 "GLP" means the Good Laboratory Practices Regulations promulgated by
FDA, as they may be amended from time to time. GLP also includes
published standards of FDA (or other standards of FDA that are
generally recognized within the United States pharmaceutical industry)
that relate to the conduct of preclinical studies in animals. GLP also
includes similar standards, guidelines and regulations promulgated or
otherwise required by the European Commission, and published standards
of the European Commission (and other standards of the European
Commission that are generally recognized within the European
pharmaceutical industry), including Council Directive 2001/83/EC, as
amended from time to time.
1.23 "GMP" means the Good Manufacturing Practices regulations and General
Biologics Products Standards promulgated by FDA, as they may be
amended from time to time. GMP also includes published standards of
FDA (or other
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standards of FDA that are generally recognized within the United
States pharmaceutical industry) that relate to the testing,
manufacturing, processing, packaging, holding or distribution of drug
or biologic drug substances and finished drugs or biologics. GMP also
includes similar standards, guidelines and regulations promulgated or
otherwise required by the European Commission, and published standards
of the European Commission (and other standards of the European
Commission that are generally recognized within the European
pharmaceutical industry), including the Guide to Good Manufacturing
Practices for Medicinal Products as promulgated under European
Directive 91/356/EEC, as amended from time to time.
1.24 "IND" means an Investigational New Drug application filed with FDA
pursuant to 21 CFR 312.1 et seq., as such regulations may be amended
from time to time.
1.25 "IND Equivalent" means the equivalent of an IND, but in a legal
jurisdiction other than the US.
1.26 "Know-How" means Information relating to the Technology in the Field
and the development of Products in the Field, including, but not
limited to, inventions, techniques, practices, methods, knowledge,
know-how, skill, trade secrets, experience and test data (including
pharmacological, toxicological, preclinical and clinical test data);
data, records and information derived from research, preclinical
development and clinical development; regulatory submissions, adverse
reactions, CMC/process development, analytical and quality control
data, and Commercialization, marketing, pricing, distribution, cost,
sales and manufacturing data or descriptions and provided to Molecular
Insight as set forth in Annex 1.39.
1.27 "Technology" shall mean benzamide compounds highly accumulating in
metastatic melanoma controlled by Schering.
1.28 "Molecular Insight Intellectual Property" means Molecular Insight
Patents and Molecular Insight Know-How.
1.29 "NDA" means a New Drug Application filed with the FDA, for approval by
such agency for the sale of Products in the US pursuant to 21 CFR 200
et seq., as such regulations may be amended from time to time.
1.30 "NDA Equivalent" means the equivalent of an NDA, but in a legal
jurisdiction other than the US.
1.31 "Net Sales" means with respect to any Product, the gross revenues
received by Molecular Insight or its Affiliates or Sublicensees or
distributors from worldwide sales of such Product, less deductions
for: (a) transportation charges, including insurance actually paid;
(b) sales and excise taxes and duties paid or allowed by a selling
party and any other governmental charges imposed upon the production,
inspection, use or sale of such Product; (c) any distributors fees,
rebates or allowances, quantity or cash discounts, chargebacks, or
fees actually granted in the ordinary course of business; (d)
allowances or credits to customers, not in excess of the selling price
of the Product, on account of governmental requirements, rejection,
outdating or return of such Product. For the purpose of
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calculating Molecular Insight's Net Sales, the Parties recognize that
(i) Molecular Insight's customers may include parties in the chain of
commerce who enter into agreements with Molecular Insight as to price
even though legal title to the Product does not pass directly from
Molecular Insight to such customers, and even though payment for such
Product is not made by such customers to Molecular Insight, and (ii)
in such cases, chargebacks paid by Molecular Insight to or through a
Third Party (such as a wholesaler) can be deducted by Molecular
Insight from gross revenues in order to calculate Molecular Insight's
Net Sales. Sales between Molecular Insight and Affiliates shall be
excluded from the computation of Net Sales, except where such entities
are end users in which case Net Sales shall include Net Sales to such
entities; provided however, if such entities are using such Products
solely for research or clinical testing purposes, indigent or other
public support programs, then such sales between Molecular Insight and
Affiliates shall be excluded from the computation of Net Sales.
Upon the sale or other disposal of a Product other than in a bona fide
arms length transaction exclusively for money or upon any use of a
Product for purposes which do not result in a disposal of that Product
in consideration of sales revenue customary in the country of use that
sale, other disposal or use shall be deemed to constitute a sale at
the relevant open market price in the country in which the sale, other
disposal or use occurs, or, if that price is not ascertainable, a
reasonable price assessed on an arms length basis for the goods or
services provided in exchange of the supply.
1.32 "Patents" means: (i) any United States and foreign patent
applications and patents; (ii) any national, regional and
international patent applications filed from patent applications and
patents included in (i), including any divisional and continuation
applications of the patent applications and patents included in (i)
and any continuation-in-part applications to the extent dominated by
patent applications and patents included in (i); (iii) any and all
patents that have issued or in the future issue from patent
applications included in (i) and (ii); and (iv) any and all extensions
or restorations by existing or future extension or restoration
mechanisms, including substitutions, reexaminations, revalidations,
reissues, renewals, and extensions thereof.
1.33 "Phase I Clinical Trials" has the meaning described in 21 CFR 300 et
seq.
1.34 "Phase II Clinical Trials" has the meaning described in 21 CFR 300 et
seq.
1.35 "Phase III Clinical Trials" has the meaning described in 21 CFR 300 et
seq. or such other pivotal clinical trial that will serve as a basis
for FDA approval.
1.36 "Product" means any pharmaceutical product the manufacture, use, sale,
offer for sale, or import of which would infringe a Valid Claim of
Schering Patents in the absence of a license.
1.37 "Regulatory Approval" means any approval, product and/or establishment
license, registration or authorization of any federal, state or local
regulatory agency, department, bureau or other governmental entity,
necessary for the commercial manufacture, use, storage, import,
export, transport, commercialization or sale of a Product in a
regulatory jurisdiction.
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1.38 "Schering Intellectual Property" means Schering Know-How and Schering
Patents.
1.39 "Schering Know-How" means Know-How within the control of Schering as
of the Effective Date relating to the development of Products as
contained in the documentation listed in ANNEX 1.39, excluding
Schering's know-how in relation to the administration of the Compounds
and the use of blood-supply modulators to reduce eye uptake in order
to minimize potential side effects of the Compounds. Notwithstanding
anything herein to the contrary, Schering Know-How shall exclude
Schering Patents.
1.40 "Schering Patents" means the patents and patent applications listed in
ANNEX 1.40.
1.41 "Sublicensee" shall mean a Third Party (except an Affiliate) to whom
Molecular Insight has granted a sublicense to make, import, use, sell,
offer for sale Products in the Territory.
1.42 "Territory" shall mean all countries of the world.
1.43 "Third Party" means any entity other than Schering or Molecular
Insight and its respective Affiliates.
1.44 "US" means the United States of America and its territories and
commonwealths, including, without limitation, the Commonwealth of
Puerto Rico.
1.45 "Valid Claim" means a claim of (a) any unexpired Patent that has not
been withdrawn, canceled or disclaimed nor held to be invalid or
unenforceable by a court or tribunal of competent jurisdiction in an
unappealed or unappealable decision or, (b) of any pending patent
application, that has not been finally rejected in an unappealed or
unappealable decision by the relevant patent office or court.
2. LICENSE GRANTS AND CONVEYANCE OF MATERIALS
2.1 Exclusive License to Molecular Insight. Subject to the terms and
conditions of this Agreement, Schering hereby grants to Molecular Insight an
exclusive (even as to Schering) worldwide, royalty-bearing license under the
Schering Patents and Schering Know-How to make, use, sell, offer to sell and
import Products in the Field in the Territory. Such licenses shall include the
right to grant sublicenses under the Schering Intellectual Property, subject to
the provisions of Section 2.3.
2.2 Grant of Option. Subject to the filing of a patent application by
Schering in relation to the administration of Compounds and the use of
blood-supply modulators to reduce eye uptake in order to minimize potential side
effects of the Compounds (such intellectual property rights collectively herein
referred to as "Eye Technology"), Schering hereby grants to Molecular Insight an
Option to obtain a non-exclusive license to the Eye Technology in the Field at
fair market value. Molecular Insight may exercise the Option within four (4)
months after Schering notifies Molecular Insight in writing that the Eye
Technology patent application has been filed ("Option Period"). During the
Option Period, Schering grants Molecular Insight a non-
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exclusive license under the Eye Technology for the purpose of evaluation and
research only.
2.3 Sublicenses. Subject to the terms and conditions of this Agreement,
Molecular Insight shall have the right to sublicense the rights granted in
Section 2.1 above. Each such sublicense shall be consistent with all the terms
and conditions of this Agreement. Molecular Insight shall remain responsible to
Schering for all of each such Sublicensee's applicable financial and other
obligations under each sublicense.
2.4 No Further Rights. Only the licenses granted pursuant to the express
terms of this Agreement shall be of any legal force or effect. No other license
rights shall be granted or created by implication, estoppel or otherwise.
2.5 Transfer of Schering Know-How. Schering undertakes to physically
transfer the items described in ANNEX 1.39 within 15 days of the effective date
of this Agreement to Molecular Insight at its address set forth above.
2.6 Conveyance of Materials. Within thirty (30) days after the Effective
Date, Schering will transfer to Molecular Insight the materials in relation to
the Schering Patent, including as examples benzamide compound samples and
lyophilized vials as listed in ANNEX 2.6 to this Agreement, which are in
Schering's possession on the Effective Date.. Delivery shall be FOB Schering AG
or any other location at which Schering stores such materials, but will be,
otherwise, free of additional charge. Schering will provide the materials to
Molecular Insight without warranty of quality or fitness for a particular
purpose or any other warranty, express or implied.
3. CONSIDERATION
3.1 Up-front Payment. In partial consideration of the rights granted to it
by Schering under this Agreement, Molecular Insight shall pay to Schering an
up-front fee in the amount of one million US dollars (USD$1,000,000) upon the
Effective Date. The said up-front payment will be unconditional and as such
shall not be subject to any offset, credit, reduction or repayment for any
reason whatsoever, whether provided for in this Agreement or not.
3.2 Milestone Payments. Upon the occurrence of the relevant events
specified below with respect to each Product, Molecular Insight shall pay to
Schering the following amounts:
Milestone Amount
--------- ------
Commencement of Phase II Clinical Trial USD **
Commencement of Phase III Clinical Trial USD **
Receipt of first Drug Approval for marketing of a Product
from FDA or FDA Equivalent (the "Final Milestone
Payment") USD **
A Clinical Trial will be deemed to have commenced upon the dosing of the
first patient.
The Final Milestone Payment is payable in ** installments: The first
installment in the amount of ** US dollars (USD ** ) shall be
paid promptly after the first Drug Approval of a Product. The remaining **
** US dollars (USD ** ) are payable in
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*Confidential Treatment Requested*
** installments starting three (3) months after the date of the
first Drug Approval for marketing of a Product.
3.3 Royalties.
3.3.1 Royalty on Net Sales. In partial consideration for the license
granted hereunder, Molecular Insight shall pay to Schering royalties for the
sale of Products, on a country-by-country basis, for a period from the date of
First Commercial Sale of a particular Product until the later of the expiration
of the last to expire Patent containing a Valid Claim or ten (10) years from the
date of First Commercial Sale.
3.3.2 Royalty Rates. The royalty rates payable by Molecular Insight on
Net Sales of Products are as follows:
Net Sales Rate
--------- ----
Sales of less than USD ** **%
Sales equal or greater than USD ** but less than USD ** **%
Sales equal or greater than USD ** **%
4. PAYMENT
4.1 Royalty Reports and Payments. Molecular Insight shall make royalty
payments to Schering within sixty (60) days after the end of each calendar
quarter in which Net Sales occurred. A report summarizing the Net Sales of each
Product during the relevant quarter on a country-by-country basis shall be
delivered to Schering within sixty (60) days following the end of each calendar
quarter for which royalties are due.
4.2 Payments; Interest. Any payments due under this Agreement shall be due
on such date as specified in this Agreement and, in the event such date is not a
Business Day, then the next succeeding Business Day. Any failure by Molecular
Insight to make a payment within ten (10) Business Days after the date when due
shall obligate Molecular Insight to pay computed interest, the interest period
commencing on the due date and ending on the payment date, to Schering at a rate
per annum equal to the EURIBOR or USD LIBOR, as the case may be (according to
the underlying payment due), for one month quoted on the due date by the
European Central Bank plus a premium of three percent (3%). The interest rate
shall be adjusted monthly and interest shall be compounded monthly in arrears.
In addition, interest shall be computed on the basis of a 360 day year actual
days elapsed, and shall be due and payable on the tender of the underlying
principal payment.
4.3 Taxes. Schering shall pay any and all taxes levied on account of all
payments it receives under this Agreement. If laws or regulations require that
taxes be withheld, Molecular Insight will (a) deduct those taxes from the
remittable payment, (b) timely pay the taxes to the proper taxing authority, and
(c) send proof of payment to Schering within thirty (30) days of receipt of
confirmation of payment from the relevant taxing authority. Molecular Insight
agrees to make reasonable efforts to minimize such taxes to Schering. If
Molecular Insight is so required then Schering and Molecular Insight shall
co-operate in all respects and take reasonable steps to lawfully avoid the
making of any such deductions.
4.4 Payment Currency. All payments due hereunder will be paid to Schering
in US Dollars. All payments shall be paid by wire transfer of immediately
available funds to an account
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*Confidential Treatment Requested*
at a commercial bank designated by Schering at least ten (10) Business Days
before payment is due. Where payments are based on Net Sales in countries other
than in the USA, the amount of such payments expressed in the currency of each
country shall be converted into US Dollar at the exchange rate of the last
Business Day of the applicable calendar quarter. The applicable exchange rate
will be the 12PM Buying Rates published by the Federal Reserve Bank of New York
on REUTERS screen (FEDSPOT). If no 12PM Buying Rate is determined for the
relevant currency, the Parties shall agree upon another reference rate.
4.5 Records of Revenues. Molecular Insight shall keep for five (5) years
from the date of each payment of royalties complete and accurate records of
sales by Molecular Insight of each Product in sufficient detail to allow the
accruing royalties to be determined accurately. Schering shall have the right
for a period of five (5) years after receiving any report or statement with
respect to royalties due and payable to appoint at its expense an independent
certified public accountant reasonably acceptable to Molecular Insight to
inspect the relevant records of Molecular Insight to verify such report or
statement. Molecular Insight shall make its records available for inspection by
such independent certified public accountant during regular business hours at
such place or places where such records are customarily kept, upon reasonable
notice from Schering, to verify the accuracy of the reports and payments. Such
inspection right shall not be exercised more than once in any calendar year nor
more than once with respect to sales in any given period. The failure of
Schering to request verification of any report or statement during said
three-year period shall be considered acceptance of the accuracy of such report,
and Molecular Insight shall have no obligation to maintain records pertaining to
such report or statement beyond said three-year period. The findings of each
inspection, if any, shall be binding on both parties.
Schering shall bear its own costs related to such audit; provided, that for any
underpayments greater than five percent (5%) by Molecular Insight, Molecular
Insight shall pay Schering the amount of underpayment, interest as provided for
in Section 4.2 from the time the amount was due and Schering's out-of-pocket
expenses. For any underpayments less than five percent (5%) by Molecular Insight
found under this Section 5.5(a), Molecular Insight shall pay Schering the amount
of such underpayment. Any overpayments by Molecular Insight will, at Schering's
option, be refunded to Molecular Insight or credited to future royalties. Any
records or accounting information received from Molecular Insight shall be
confidential information for purposes of Sections 5.1 and 5.2. Results of any
such audit shall be provided to both Parties and shall be confidential
information for purposes of Sections 5.1 and 5.2.
5. CONFIDENTIALITY
5.1 Confidential Information. Except as expressly provided herein, the
Parties agree that, for the term of this Agreement and for ten (10) years
thereafter, the receiving Party shall keep confidential and shall not publish or
otherwise disclose and shall not use for any purpose except for the purposes
contemplated by this Agreement, any Information furnished to it by the
disclosing Party hereto pursuant to this Agreement, except that to the extent
that it can be established by the receiving Party by competent proof that such
Information:
5.1.1 is or becomes public or available to the general public
otherwise than through the act or default of the receiving Party;
5.1.2 is obtained by the receiving Party from a Third Party who is not
subject to an obligation of confidentiality or non-use owed to the disclosing
Party;
5.1.3 is previously known to the receiving Party prior to disclosure
to the
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receiving Party by the disclosing Party under this Agreement, as shown by
written evidence, and is not obtained or derived directly or indirectly from the
disclosing Party;
5.1.4 is disclosed by the receiving Party pursuant to the requirement
of law, provided that the receiving Party has complied with the provisions set
forth in Section 6.3; or
5.1.5 is independently developed by the receiving Party without the
use of or reliance on any Information provided by the disclosing Party
hereunder, as shown by contemporaneous written evidence.
5.2 Legal Disclosure. If the receiving Party becomes legally required to
disclose any Information provided by the disclosing Party, the receiving Party
will give the disclosing Party prompt notice of such fact so that the disclosing
Party may obtain a protective order or other appropriate remedy concerning such
disclosure and/or waive compliance with the non-disclosure provision of this
Agreement. The receiving Party will reasonably cooperate with the disclosing
Party in connection with the disclosing Party's efforts to obtain any such order
or other remedy. If any such order or other remedy does not fully preclude
disclosure or the disclosing Party waives such compliance, the receiving Party
will make such disclosure only to the extent that such disclosure is legally
required and will use its reasonable efforts to have confidential treatment
accorded to the disclosed Information.
5.3 Public Disclosure. Except as otherwise required by law, neither Party
shall issue a press release or make any other public disclosure concerning this
Agreement or the subject matter hereof without the prior written approval of
such press release or public disclosure by the other Party. Each Party shall
submit any such press release or public disclosure to the other Party for its
prior review and approval, which approval shall not be unreasonably withheld. If
the receiving Party does not respond within fifteen (15) days from submission,
the press release or public disclosure shall be deemed approved. The contents of
any such announcement or similar publicity that has been reviewed and approved
by the reviewing Party can be re-released by either Party without a requirement
for re-approval. The principles to be observed by Schering and Molecular Insight
in public disclosures with respect to this Agreement shall be: accuracy,
compliance with applicable legal requirements, the requirements of
confidentiality under this Section 5 and normal business practice in the
pharmaceutical industry for disclosures by companies comparable to Schering and
Molecular Insight. Notwithstanding the foregoing, either Party may issue such
press releases as it determines, based on advice of counsel, are reasonably
necessary to comply with law or for appropriate market disclosure. It is
understood, however, that unless required by law, the Parties shall not disclose
the specific financial terms and conditions of this Agreement. In addition, if a
public disclosure is required by law, with the exception of any filing with the
US Securities and Exchange Commission, and provided, however, that such
exception does not apply to the disclosure of this Agreement and/or its Annexes,
nor any documents or data related to this Agreement, or the cooperation
hereunder, the disclosing Party shall provide copies of the disclosure
reasonably in advance of such filing or other disclosure for the non-disclosing
Party's prior review and comment and shall give due consideration to any
reasonable comments by the non-filing Party relating to such filing, including
without limitation the provisions of this Agreement for which confidential
treatment should be sought.
5.4 Scientific Publications. Schering shall be permitted to publish
scientific publications in relation to the Compounds, provided that Schering
notifies Molecular Insight of any proposed publication forty-five (45) days in
advance of the proposed submission date to
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enable Molecular Insight to examine the proposal and evaluate whether such
publication would endanger any patent claim Molecular Insight wishes to seek
patent protection for, in which case the Parties shall agree on a modification
of such publication which meets the interests of both Parties. In case Schering
notifies Molecular Insight that it has no interest in a patent application,
Molecular Insight shall have an additional forty-five (45) days to file any
relevant patent applications.
5.5 Confidential Terms. Except as expressly provided herein, each Party
agrees not to disclose any terms of this Agreement to any Third Party without
the consent of the other Party; except that disclosures may be made as required
by securities or other applicable laws, or to actual or prospective investors,
corporate partners or acquirers, or to a Party's accountants, attorneys and
other professional advisors. For the avoidance of doubt, each Party may disclose
the terms of this Agreements to its Affiliates.
5.6 Survival. This Section 5 will survive expiry or termination of this
Agreement for any reason.
6. DILIGENCE
6.1. Development Plan. An outline of the development plan is attached to
this Agreement as Annex 6.1.
Within ninety (90) days of the Effective Date, Molecular Insight shall
prepare a detailed development plan outlining its proposed development
activities, including anticipated timescales. The activities described in the
development plan, as amended from time to time given the exigencies of
pharmaceutical product development, shall be consistent with Molecular Insight's
diligence obligations pursuant to Section 6.2, below.
6.2 Diligence. Molecular Insight agrees to use Commercially Reasonable
Efforts to develop and Commercialize Products in the Field in the Territory, and
obtain such approvals as may be necessary to manufacture and sell such Products.
Molecular Insight shall have full responsibility for the Development and
Commercialization of Products. All INDs and IND Equivalents and all Drug
Approval Applications will be submitted in the name of Molecular Insight, its
Affiliates or Sublicensees, and all Regulatory Approvals will belong to
Molecular Insight, its Affiliates or Sublicensees. Failure by Molecular Insight
to use Commercially Reasonable Efforts as described in this Section 6.2 will
constitute a breach of a material obligation and will permit Schering - without
prejudice to other remedies - to terminate this Agreement in accordance with
Section 10.2.
6.3 Compliance with Standards. In respect of any Development activities to
be performed by Molecular Insight, unless expressly agreed with Schering
otherwise, Molecular Insight agrees to perform its obligations in compliance
with applicable laws, regulations and guidances, including without limitation
GCP, GLP and GMP, and the manufacturing and other commitments made in INDs, IND
Equivalents, NDAs and NDA Equivalents.
6.4 Reports. Molecular Insight shall keep Schering informed of its
development and Commercialization activities with respect to the Compounds and
Products by semi-annually providing Schering with a written report stating the
status of development of, and Commercialization activities relating to, such
Compounds and Products.
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6.5 Development cooperation with Third Parties. In the event that Molecular
Insight considers a cooperation or partnering with Third Parties in regard to
the development of Products, it shall inform Schering accordingly. Such
information to Schering shall not be later than the first contact with a Third
Party to this regard.
7. REPRESENTATIONS AND WARRANTIES
7.1 General Representations. Each Party hereby represents and warrants to
the other Party as follows:
7.1.1 Such Party is a corporation duly organized, validly existing and
in good standing under the laws of the jurisdiction in which it is incorporated;
7.1.2 Such Party has the corporate power and authority and the legal
right to enter into this Agreement and to perform its obligations hereunder and
the execution, delivery and performance by such Party of this Agreement have
been duly authorized by all necessary corporate action. This Agreement has been
duly executed and delivered on behalf of such Party, and constitutes a legal,
valid, binding obligation, enforceable against such Party in accordance with its
terms except as enforceability may be limited by (A) any applicable bankruptcy,
insolvency, reorganization, moratorium or similar law affecting creditor's
rights generally, or (B) general principles of equity, whether considered in a
proceeding in equity or at law;
7.1.3 All necessary consents, approvals and authorizations of all
governmental authorities and other persons required to be obtained by such Party
in connection with this Agreement have been obtained; and
7.1.4 The execution and delivery of this Agreement and the performance
of such Party's obligations hereunder (a) do not conflict with or violate any
requirement of applicable laws or regulations or any judgment, injunction,
decree, determination or award presently in effect having applicability to it,
and (b) do not conflict with, or constitute a default under, any agreement of
such Party with any Third Party.
7.2 Additional Schering Representations and Warranties. Schering represents
and warrants to Molecular Insight as of the Effective Date as follows:
7.2.1 The Schering Intellectual Property in the Territory is owned and
controlled solely and exclusively by Schering free and clear of any liens,
charges and encumbrances, and no Third Party has any claim of ownership with
respect to the Schering Intellectual Property in the Territory, whatsoever;
7.2.2 Schering has not previously granted, and will not grant during
the term of this Agreement, any right, license or interest in and to the
Schering Intellectual Property in the Field in the Territory, or any portion
thereof, inconsistent or in conflict with the license granted to Molecular
Insight herein;
7.2.3 To the best of Schering's knowledge, all patent applications
included in the Schering Patents (i) meet the best mode requirement for
obtaining a patent on the specific compound(s) BA-[list leads], pharmaceutical
compositions thereof and methods of treating or diagnosing cancer therewith,
imposed by the European Patent Office, Japanese Patent Office and the United
States Patent and Trademark Office, as applicable, and (ii) have had paid as of
the
12
Effective Date all maintenance and/or annuity fees necessary to keep all such
patent applications in good standing in the various jurisdictions within the
Territory in which they have been filed.
7.2.4 There are no pending or threatened actions, suits,
investigations, claims, judgments or proceedings relating to the Schering
Intellectual Property. Schering is not aware of any issued patent that is or
would be infringed by the development or commercialization of a Product as
contemplated by this Agreement;
7.2.5 Schering is not aware of any information relating to the
institution or threatened institution of any interference, opposition,
re-examination, reissue, revocation, nullification, or any official proceeding
challenging a Schering Patent;
7.2.6 Annex 1.401 contains a complete and accurate list of all
Schering Patents in the Territory;
7.2.7 Schering has disclosed to Molecular Insight or allowed Molecular
Insight access to any facts known to Schering as of the Effective Date that
Schering reasonably believes in good faith to be material regarding: (i)
preclinical and clinical study results and protocols for Compounds and/or
Products; (ii) any communications to and from any Regulatory Authority with
respect to Compounds and/or Products, including, but not limited to, any
regulatory submissions and filings, correspondence with, and minutes of meetings
and telephone conferences with Regulatory Authorities; and (iii) adverse drug
experiences and other IND safety reports with respect to Compounds and/or
Products; and
7.3 Effect of Representations and Warranties. It is understood that if the
representations and warranties made by a Party under this Article 7 are not true
and accurate, and the other Party incurs damages, liabilities, costs or other
expenses as a result, the Party making such representations and warranties shall
indemnify and hold the other Party harmless from and against any such damages,
liabilities, costs or other expenses incurred as a result.
7.4 Limitation of Liability. NOTWITHSTANDING ANY OTHER PROVISION CONTAINED
HEREIN TO THE CONTRARY, MOLECULAR INSIGHT SPECIFICALLY WAIVES ANY AND ALL CLAIMS
FOR DAMAGES AGAINST SCHERING OTHER THAN DIRECT DAMAGES, INCLUDING BUT NOT
LIMITED TO PUNITIVE OR EXEMPLARY DAMAGES, HOWEVER DENOMINATED, AND INDIRECT,
CONSEQUENTIAL, OR INCIDENTAL DAMAGES, WHETHER ARISING IN CONTRACT, IN TORT
(INCLUDING WITHOUT LIMITATION NEGLIGENCE), OR ANY OTHER THEORY EVEN IF INFORMED
OF THE POSSIBILITY OF SUCH DAMAGES AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL
PURPOSE OF ANY LIMITED REMEDY PROVIDED HEREIN. IN NO EVENT SHALL SCHERING'S
LIABILITY FOR DIRECT DAMAGES EXCEED THE AMOUNTS RECEIVED FROM MOLECULAR INSIGHT
HEREUNDER IN THE CONTRACT YEAR DURING WHICH THE CLAIM AROSE.
7.5 Disclaimer. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT NOTHING IN
THIS AGREEMENT IS OR SHALL BE CONSTRUED AS:
7.5.1 A REQUIREMENT THAT SCHERING SHALL FILE ANY PATENT APPLICATION,
SECURE ANY PATENT, OR MAINTAIN ANY PATENT IN FORCE; OR
7.5.2 AN OBLIGATION TO BRING OR PROSECUTE ACTIONS OR SUITS AGAINST
13
THIRD PARTIES FOR INFRINGEMENT (EXCEPT TO THE EXTENT AND IN THE CIRCUMSTANCES
STATED IN ARTICLE 10); OR
7.5.3 GRANTING BY IMPLICATION, ESTOPPEL, OR OTHERWISE, ANY LICENSES OR
RIGHTS UNDER PATENTS OR KNOW-HOW OF SCHERING OTHER THAN THE SCHERING PATENTS AND
THE SCHERING KNOW-HOW AND SCHERING'S INTEREST IN THE JOINT PATENTS, IF ANY; OR
7.5.4 A REPRESENTATION OR WARRANTY BY SCHERING OF THE ACCURACY,
SAFETY, OR USEFULNESS FOR ANY PURPOSE OF ANY SCHERING KNOW-HOW AT ANY TIME MADE
AVAILABLE BY SCHERING OR OF THE PATENTABILITY OF THE CLAIMS FILED.
7.5.5 NO GUARANTEE BY SCHERING THAT ANY PRODUCT WILL EVER BE
DEVELOPED, APPROVED FOR MARKETING, SOLD OR OFFERED FOR SALE, OR IF SOLD, WILL
GENERATE REVENUES OR PROFITS FOR LICENSEE.
8. INTELLECTUAL PROPERTY
8.1 Filing, Prosecution and Maintenance by Schering. With respect to
Schering Patents, Schering shall have the exclusive right:
(a) to take all reasonable steps to prosecute all pending patent
applications included within Schering Patents;
(b) to respond to oppositions, nullity actions, re-examinations,
revocation actions, interference proceedings and similar
proceedings filed by third parties against the grant of letters
patent for such applications;
(c) to maintain in force any letters patent included in Schering
Patents by duly filing all necessary papers and paying any fees
required by the patent laws of the particular country in which
such letters patent were granted; and
(d) subject to the provisions of Section 8.1.1 herein, to cooperate
fully with and take all necessary actions requested by Molecular
Insight in connection with the prosecution and maintenance of any
letters patent included in Schering Patents, including but not
limited to (i) the filing of any continuation and/or division
application, (ii) the filing of any patent or patent application
in one or more extension states, and (iii) the validation of any
regional patent in at least those regional states requested by
Molecular Insight.
Schering shall notify Molecular Insight in a timely manner of any decision
to not pursue an action or to abandon a pending patent application or an issued
patent included in Schering Patents. Thereafter, Molecular Insight shall have
the option, at its expense, of taking such action or continuing to prosecute any
such pending patent application or of keeping the issued patent in force, or all
of these.
14
8.1.1 Copies of Documents. Schering shall in a timely manner provide
to Molecular Insight copies of all material documents received or filed in
connection with the prosecution of all Schering Patents, including office
actions, substantive responses, notices of opposition, interference and the
like, notices of allowance or grant, payments of maintenance or annuity fees,
and notices of abandonment. Prior to filing any substantive (i.e., not the mere
perfection of a formality) document in response to an office action issued
during prosecution of any Schering Patent (such as responses or amendments,
affidavits, declarations or the like), for the purpose of informing and
obtaining substantive comment from Molecular Insight patent counsel, Schering
shall in a timely manner provide drafts of such documents to Molecular Insight
so that the Parties' respective patent counsel may proceed in a cooperative
manner to formulate the content of the final version of such documents. In the
event of an initial disagreement between the Parties' respective patent counsel
as to content of such documents or related patent prosecution strategy, the
Parties hereby agree to refer such initial disagreement first to each Parties'
respective business development executives having responsibility over the
administration of this Agreement. Failing resolution of the disagreement by the
Parties' respective business development executives, the disagreement shall be
referred to and resolved by an Executive Vice President level officer of each
Party. Schering shall also provide to Molecular Insight at the end of each
calendar mid-year updates of Annex 1.41., which will include a column indicating
the next action due for each entry and the deadline for completing such next
action.
8.1.2 Patent Extensions. Molecular Insight shall have the right to
obtain a patent term extension pursuant to 35 USC Section 156 and counterparts
in other countries with respect to one Schering Patent per country and per
Product to the extent that such extensions are available by reason of regulatory
approval of a Product under the Agreement during the period the Agreement is in
effect. Schering shall file requests for such extensions cooperatively with
Molecular Insight and, where necessary, as agent for Molecular Insight.
8.2 Disclaimer. Neither party may disclaim a Valid Claim within Schering
Patent Rights without the consent of the other.
8.3 Disclosure of Actual or Threatened Infringement. When information comes
to the attention of either Party to the effect that any Schering Patent has been
or is threatened to be unlawfully infringed by a Third Party, such Party shall
promptly notify the other Party and provide such other Party with the details of
all such information. Molecular Insight shall have the first right at its sole
expense to take or bring such action as it may deem necessary to prosecute or
prevent such unlawful infringement, including the right to bring or defend any
lawsuit, action and/or proceeding involving any such infringement (collectively,
hereinafter "Proceeding"). Molecular Insight shall notify Schering promptly of
the commencement of any such Proceeding. If the law of the jurisdiction of such
Proceeding provides that it is necessary for Schering to join any such
Proceeding, Schering shall, at Molecular Insight's expense, execute all papers
and perform such other acts as may be reasonably required to permit Molecular
Insight to commence and prosecute such Proceeding, in which case Molecular
Insight shall hold Schering free, clear and harmless from any and all costs and
expenses of litigation, including attorneys fees. The Parties acknowledge that
Molecular Insight shall have full control over the prosecution and any possible
settlement of such Proceeding Schering shall have the right, at its own expense,
to be independently represented in such Proceeding by counsel of its own choice.
Notwithstanding the foregoing, whether or not Schering is independently
represented by counsel, Molecular Insight shall not take a position in such
Proceeding conceding the invalidity of any claim included in a Schering Patent
without first obtaining a written consent from Schering, which consent shall not
be unreasonably withheld. Molecular Insight will also timely submit its
proposals for claim interpretation to Schering for approval prior to a Xxxxxxx
hearing in US
15
litigation or an analogous time point in any other such Proceeding, Schering's
approval not to be unreasonably withheld. Molecular Insight shall not agree to
any settlement of such Proceeding, which would include a stipulation as to the
validity or scope of any claim included in a Schering Patent without first
obtaining a written consent from Schering, which consent shall not be
unreasonably withheld. If Molecular Insight brings such Proceeding, it shall
have the right first to reimburse itself out of any recovery from such
Proceeding or settlement thereof for all of Molecular Insight's costs and
expenses, including attorneys fees, related to such Proceedings or settlement.
The remainder, if any, of such recovery, shall be treated as Net Sales in the
calendar quarter in which any such recovery was received, entitling Schering to
receive a proportion of such remainder according to the applicable royalty rate
provided in Section 3.3.2, above. If Molecular Insight does not, within one
hundred twenty (120) days of receiving notice from or giving notice to Schering
initiate such Proceeding, Schering shall have the right, but not the obligation,
to initiate a Proceeding for such alleged infringement. Schering may join
Molecular Insight as a party plaintiff, if necessary to initiate or prosecute
such Proceeding, in which event Molecular Insight will cooperate fully to become
a party in such Proceeding and Schering shall hold Molecular Insight free, clear
and harmless from any and all costs and expenses of such litigation, including
attorneys fees. Any sums recovered in any such Proceeding or in its settlement
shall belong to Schering. The Parties acknowledge that Schering shall have full
control over the prosecution and any possible settlement of such Proceeding that
Schering initiates. Molecular Insight shall have the right to be represented by
counsel of its own selection and at its own expense in any such Proceeding
instituted by Schering.
8.4 Defense of Infringement Claims. Molecular Insight shall have full
responsibility for any third party infringement claims against it for
Commercialization of Products, including defending against or settling such
claims, all at its own expense. Schering shall have no liability for any third
party infringement claim raised against Molecular Insight.
8.5 New Schering patent application(s). For the avoidance of doubt, the
Parties acknowledge that Schering **
inter alia in relation to the Eye Technology as described in Section 2.2.
9. INDEMNIFICATION
9.1 Schering. Schering shall indemnify, defend and hold harmless Molecular
Insight and its directors, officers, employees and agents (each a "Molecular
Insight Indemnitee") from and against any and all liabilities, damages, losses,
costs or expenses (including attorneys' and professional fees and other expenses
of litigation and/or arbitration) (a "Liability") resulting from a claim, suit
or proceeding made or brought by a Third Party against a Molecular Insight
Indemnitee arising from or occurring as a result of any breach of
representations and warranties set forth by Schering. Section 7.4 shall apply
mutatis mutandis.
9.2 Molecular Insight. Molecular Insight shall indemnify, defend and hold
harmless Schering and its directors, officers, employees and agents (each a
"Schering Indemnitee") from and against any and all liabilities, damages,
losses, costs or expenses (including attorneys' and professional fees and. other
expenses of litigation and/or arbitration) (a "Liability") resulting from a
claim, suit or proceeding made or brought by a Third Party against a Schering
Indemnitee, arising from or occurring as a result of (i) any breach of
representations and warranties; (ii) the practice by Molecular Insight of any
right granted herein, or (iii) any development, testing,
16
*Confidential Treatment Requested*
manufacture, importation, use, offer for sale, sale or other distribution of any
Product by Molecular Insight or its Affiliates and Sublicensee (including,
without limitation, product liability claims).
9.3 Procedure. In the event that any Indemnitee intends to claim
indemnification under this Section 10 it shall notify the other Party (the
"Indemnitor") without undue delay in writing of such alleged Liability. The
Indemnitor shall have the sole right to control the defense and settlement
thereof. The Indemnitee shall cooperate with the Indemnitor and its legal
representatives in the investigation of any action, claim or liability covered
by this Section 10 and do nothing which would adversely affect such defense or
settlement. The Indemnitee shall not, except at its own cost, voluntarily make
any payment or incur any expense with respect to any claim or suit without the
prior written consent of the Indemnitor, which the Indemnitor shall not be
required to give.
9.4 Challenge. Schering may on thirty (30) days written notice terminate
this Agreement if Molecular Insight takes any action, serves any notice or
commences any proceedings seeking to revoke or challenge the validity of the
Schering Patent or if it procures or assists a Third Party to take such action.
9.5 FOR THE AVOIDANCE OF DOUBT, SCHERING SHALL HAVE NO LIABILITY WHATSOEVER
TO MOLECULAR INSIGHT OR ANY OTHER PERSON FOR OR ON ACCOUNT OF ANY INJURY; LOSS;
OR DAMAGE; OF ANY KIND OR NATRUE; SUSTAINED BY; OR ANY DAMAGE ASSESSED OR
ASSERTED AGAINST; OR ANY OTHER LIABILITY INCURRED BY OR IMPOSED ON MOLECULAR
INSIGHT OR ANY OTHER PERSON; ARISING OUT OF OR IN CONNECTIONWITH OR RESULTING
FROM (A) THE PRODUCTION; USE OR SALE OF ANY PRODUCT; OR THE PRACTICE OF THE
SCHERING PATENTS; OR (B) THE USE OF ANY SCHERING KNOW HOW; AND MOLECULAR INSIGHT
SHALL HOLD SCHERING; OR ITS OFFICERS; EMPLOYEES; OR AGENTS; HARMLESS IN THE
EVENT SCHERING; OR ITS OFFICERS; EMPLOYEES; OR AGENTS IS HELD LIABLE.
9.6 Survival. This Section 10 will survive expiry or termination of this
Agreement for any reason.
10. TERM AND TERMINATION
10.1 Term. The term of this Agreement shall commence on the Effective Date
and unless earlier terminated as provided in this Section 11, this Agreement
shall continue in full force and effect on a country-by-country and
Product-by-Product basis until there are no remaining royalty payment
obligations in a country, at which time the Agreement shall expire in its
entirety in such country.
10.2 Termination for Cause. Failure of Molecular Insight or Schering to
comply with any of the respective material obligations and conditions contained
in this Agreement shall entitle the other Party to give the Party in default
notice requiring it to cure such default. If such default is not cured within
ninety (90) days after receipt of such notice, the notifying Party shall be
entitled (without prejudice to any of its other rights conferred on it by the
Agreement) to terminate this Agreement by giving a notice to take effect
immediately. Notwithstanding the foregoing, in the event of a non-monetary
default, if the default is not reasonably capable of being cured within the
ninety (90) day cure period by the defaulting Party and such defaulting Party is
making a good faith effort to cure such default, the notifying Party may not
terminate this Agreement, provided
17
however, that the notifying Party may terminate this Agreement if such default
is not cured within one hundred and eighty (180) days of such original notice of
default. The right of either Party to terminate this Agreement as herein above
provided shall not be affected in any way by its waiver of, or failure to take
action with respect to, any previous default.
10.3 Termination for Insolvency. If voluntary or involuntary proceedings by
or against a Party are instituted in bankruptcy under any insolvency law
(including Chapter 11), or a receiver or custodian is appointed for such Party,
or proceedings are instituted by or against such Party for corporate
reorganization or the dissolution of such Party, which proceedings, if
involuntary, shall not have been dismissed within sixty (60) days after the date
of filing, or if such Party makes an assignment for the benefit of creditors, or
substantially all of the assets of such Party are seized or attached and not
released within sixty (60) days thereafter, the other Party, may immediately
terminate this Agreement effective upon notice of such termination.
10.4 Effect of Termination and Expiration.
10.4.1 Accrued Rights and Obligations. Termination of this Agreement
for any reason shall not release any Party hereto from any liability which, at
the time of such termination, has already accrued to the other Party or which is
attributable to a period prior to such termination nor preclude either Party
from pursuing any rights and remedies it may have hereunder or at law or in
equity with respect to any breach of this Agreement.
10.4.2 Return of Schering Know-How. Upon any termination of this
Agreement, Molecular Insight shall promptly return to Schering all Schering
Intellectual Property in tangible form; provided Molecular Insight may retain
one (1) copy of such tangible Schering Intellectual Property for archival
purposes and for ensuring compliance with Section 6.
10.4.3 Stock on Hand. In the event this Agreement is terminated for
any reason, Molecular Insight shall have the right to sell or otherwise dispose
of the stock of any Product subject to this Agreement then on hand until the
first anniversary of the effective date of such termination. Sales made pursuant
to this clause shall be treated as Net Sales and royalty thereon shall be paid
to Schering.
10.5 Survival. Sections 11.4.1 and 11.4.2 as well as Sections 5 and 9 of
this Agreement shall survive expiration or termination of this Agreement for any
reason.
11. MISCELLANEOUS
11.1 Governing Law. This Agreement and any dispute, arising from the
performance or breach hereof shall be governed by and construed in accordance
with the laws of the state of New York. Place of proceedings shall be New York,
NY.
11.2 Independent Contractors. The relationship of the Parties hereto is
that of independent contractors. The Parties hereto are not deemed to be agents,
partners or joint ventures of the others for any purpose as a result of this
Agreement or the transactions contemplated thereby.
11.3 Assignment. This Agreement shall not be assignable by Molecular
Insight to any Third Party, in whole or in part, without the written consent of
Schering which consent shall not be unreasonably withheld; provided, however,
Molecular Insight may assign this Agreement without said consent if it sells all
or most of its business. Schering may assign this Agreement
18
with prior notice to Molecular Insight. This Agreement shall be binding upon and
inure to the benefit of the Parties and their successors and assigns.
11.4 Notices. All notices, requests and other communications hereunder
shall be in writing and shall be personally delivered, sent by courier or by
facsimile transmission or by registered or certified mail, return receipt
requested, postage prepaid, in each case to the respective address specified
below, or such other address as may be specified in writing to the other Party
hereto:
If to Schering: If to Molecular Insight:
Bayer Schering Pharma Aktiengesellschaft Molecular Insight Pharmaceuticals,
13342 Berlin Inc.
Germany 000 Xxxxxx Xxxxxx
Attn. Xx. Xxxxxxxx Xxxxxxxx Xxxxxxxxx, XX 00000
Fax: x00-00-000-00000 USA
Attn. VP, Commercial & Business
With a copy to: Development
Fax: 000-000-0000
Bayer Schering Pharma Aktiengesellschaft
13342 Berlin With a copy to:
Germany
Attn. Legal Department Xxxxxx X. Xxxxxxxxx, Esp.
Fax: x00-00-000-00000 Xxxxxxxx & Xxxx, LLP
Xxx Xxxxxx Xxxxx
Xxxxxx, XX 00000
XXX
11.5 Force Majeure. Neither Party shall lose any rights hereunder or be
liable to the other Party for damages or losses (except for payment obligations)
on account of failure of performance by the defaulting Party if the failure is
occasioned by war, fire, act of God, earthquake, flood, embargo, or any other
reason where failure to perform is beyond the reasonable control and not caused
by the negligence, intentional conduct or misconduct if the non-performing Party
has exerted all reasonable efforts to avoid or remedy such force majeure. If the
force majeure continues for a period of more than 12 months, the Party not
relying on force majeure shall be entitled to terminate this Agreement forthwith
by written notice to the other.
11.6 Compliance with Laws. Each Party shall furnish to the other Party any
information requested by that Party during the term of this Agreement or any
extensions hereof to enable that Party at its expense to comply with the
requirements of any government agency.
11.7 Severability. In the event that any provisions of this Agreement are
determined to be invalid or unenforceable by a court of competent jurisdiction,
the remainder of the Agreement shall remain in full force and effect without
said provision. In such event the Parties shall, in good faith, negotiate a
substitute clause for any provision declared invalid or unenforceable, which
shall most nearly approximate the intent of the Parties entering this Agreement.
11.8 Waiver. It is agreed that no waiver by either Party hereto of any
breach of default of any of the covenants or agreements herein set forth shall
be deemed a waiver as to any
19
subsequent and/or similar breach or default.
11.9 Complete Agreement. This Agreement, with its Schedules, constitutes
the entire agreement between the Parties with respect to the subject matter
hereof, and that all prior agreements respecting the subject matter hereof,
either written or oral, expressed or implied, are merged and canceled, and are
null and void and of no effect. No amendment or change hereof or addition hereto
shall be effective or binding on either of the Parties hereto unless reduced to
writing and duly executed on behalf of both Parties.
11.10 Use of Name. Neither Party shall use the name or trademarks of the
other Party, without the prior written consent of such other Party except in
connection with the disclosure of the existence of this Agreement, in which case
Schering shall be referred to as "Schering AG, Berlin" or as otherwise
instructed by Schering.
11.11 Headings. The captions to the several Sections and Articles hereof
are not a part of this Agreement, but are included merely for convenience of
reference only and shall not affect its meaning or interpretation.
11.12 Counterparts. This Agreement may be executed in two counterparts,
each of which shall be deemed an original and which together shall constitute
one instrument.
11.13 Third Party Beneficiaries. No person, other than Schering, Molecular
Insight, their Affiliates and their assignees hereunder, shall be deemed an
intended beneficiary hereunder or have any right to enforce any obligation of
this Agreement.
IN WITNESS WHEREOF Schering and Molecular Insight have executed this
Agreement by their respective duly authorized representatives.
BAYER SCHERING PHARMA MOLECULAR INSIGHT
AKTIENGESELLSCHAFT PHARMACEUTICALS, INC.
By: /s/ Mattias Braentigan By: /s/ Xxxxx X. Xxxxxx
--------------------------------- ------------------------------------
Print Name: Mattias Braentigan Print Name: Xxxxx X. Xxxxxx
------------------------- ----------------------------
Title: Head of TRGDG Title: Chairman and CEO
------------------------------ ---------------------------------
By: /s/ Xxxxxxxx Xxxxxxxxx
---------------------------------
Print Name: Xxxxxxxx Xxxxxxxxx, Ph.D.
-------------------------
Title: Senior Manager, Out Partnering
------------------------------
20
ANNEX 1.39
SCHERING KNOW-HOW
Schering Know-how consists of all data disclosed in the due diligence folders
provided at the meeting on June 1, 2006 with the exception of know-how in
relation to the administration of the Compounds and the use of blood-supply
modulators to reduce eye uptake in order to minimize potential side effects of
the Compounds. Included in Schering Know-how are the raw data from all
preclinical research studies, all issued and draft reports from all preclinical
studies, and all information Schering has in its possession about chemical
synthesis and formulation related to the Compounds.
Table of content
Folder content raw data and summary (chronologically per folder)
I
Compound Experiment Model
BA63 Bio-d(i) C57BL6-B16/F1(ii)
IMBA (Eisenhurt et al.) Bio-d C57BL6-B16/F1
BA40 Bio-d Black nude XX-Xxx-3(ii)
BA40 Bio-d XX0X0(XX)
XX00 Bio-d C57BL6-B16/F1
BA60 Bio-d C57BL6-B16/F1
BA61 Bio-d C57BL6-B16/F1
BA44 Bio-d C57BL6-B16/F1
BA45 Bio-d C57BL6-B16/F1
BA45 Bio-d CD-1 nu/nu(II)
BA44 Bio-d CD-1 nu/nu
BA40 Bio-d NMRI XX-Xxx-1 & 3 & 28(ii)
- Growth kinetics CD-1 nu/nu XX-Xxx 3 & 28
BA40 RX(iii) C57BL6-B16/F1
- Growth kinetics C57BL6-B16/F1
- Growth kinetics NMRI XX-Xxx-1 & 3 & 28
BA50 Bio-d C57BL6-B16/F1
BA40 Bio-d C57BL6-B16/F1
II
Compound Experiment Xxxxx
XX00 Bio-d NMRI XX-Xxx-3
BA40 RX NMRI XX-Xxx-3
BA52 Bio-d C57BL6-B16/F1
BA52 Eye uptake calculations C57BL6-B16/F1
BA40 Blocking of eye uptake Mini pig
BA68 Bio-d C57BL6-B16/F1
BA69 Bio-d C57BL6-B16/F1
BA65 Bio-d C57BL6-B16/F1
Dacarbazin MTD(iv) study NMRI XX-Xxx-0
XX00 Bio-d + imaging C57BL6-B16/F1
BA66 Bio-d C57BL6-B16/F1
BA40 + IMBA Bio-d + imaging C57BL6-B16/F1
BA81 Bio-d C57BL6-B16/F1
BA56 Bio-d C57BL6-B16/F1
III
Compound Experiment Model
BA101 Bio-d C57BL6-B16/F1
BA52 Imaging C57BL6-B16/F1 + NMRI XX-Xxx-3
BA100 Bio-d C57BL6-B16/F1
BA95 Bio-d C57BL6-B16/F1
BA93 Bio-d C57BL6-B16/F1
BA91 Bio-d C57BL6-B16/F1
BA52 Eye tox C57BL6-B16/F1
BA52 Bio-d NMRI XX-Xxx-0
XX00 RX NMRI XX-Xxx-3
BA67 Bio-d C57BL6-B16/F1
BA59 Bio-d C57BL6-B16/F1
BA40 Bio-d NMRI XX-Xxx-0
XX00 Bio-d; imaging; eye blocking C57BL6-B16/F1
BA40 Microautoradiography C57BL6-B16/F1
BA80 Bio-d C57BL6-B16/F1
IV
Compound Experiment Xxxxx
XX00 Imaging Mini pig
BA52 Imaging NMRI XX-Xxx-3
BA52 Bio-d CB6F1
V
Compound Experiment Model
BA52 Microautoradiography C57BL6-B16/F1
BA52 Eye uptake Human vs. mini pig
VI
Compound Experiment Model
BA52 Confidential summary -
BA52 Case reports Patients - VI
21
ANNEX 1.40
SCHERING PATENTS
Country Type Filing Filing Number Publication Process Date Nature Expiration
------- ---- ------ ------------- ----------- ------- ---- ------ ----------
AR NP1 10/Mar/2005 P 050100925 FLG 10/03/2005 P 050100925 10/03/2025
BO NP1 10/Mar/2005 SP-250047 FLG 10/03/2005 SP-250047 10/03/2025
CL NP1 10/Mar/2005 0507-2005 FLG 10/03/2005 0507-2005
DE NP1 10/Mar/2004 102004011720.9 29/Sep/2005 PUB 29/09/2005 DE 10/03/2024
102004011720A1
GT NP1 10/Mar/2005 PI-2005-0046 FLG 10/09/2005 PI-2005-0046 10/03/2025
MT NP1 03/Mar/2005 2654 FLG 03/03/2005 2654 03/03/2025
MY NP1 08/Mar/2005 PI20050946 FLG 08/03/2005 PI20050946
PA NP1 10/Mar/2005 86260-01 FLG 10/03/2005 86260-01 10/03/2025
PE NP1 10/Mar/2005 000276-2005 FLG 10/03/2005 000276-2005 10/03/2025
SV NP1 10/Mar/2005 E-3385-2005 FLG 10/03/2005 E-3385-2005 10/03/2025
TH NP1 08/Mar/2005 098358 FLG 08/03/2005 098358 08/03/2025
TW NP1 10/Mar/2005 094107360 FLG 10/03/2005 094107360 10/03/2025
US NP1 10/Mar/2005 11/076023 22/Sep/2005 PUB 22/09/2005 US 2005- 10/03/2025
0207972A1
US PSP1 10/Mar/2004 60/551356 FLG 10/03/2004 60/551356 10/03/2005
UY NP1 10/Mar/2005 28801 19/Aug/2005 FLG 10/03/2005 28801 10/03/2025
VE NP1 10/Mar/2005 2005-000421 FLG 10/03/2005 2005-000421
WO PCT1 10/Mar/2005 PCT/EP2005/002 553 29/Sep/2005 PUB 29/09/2005 WO2005/089815A2
22
ANNEX 1.7
DESCRIPTION OF COMPOUNDS
Compounds are benzamides structurally identical to BA 43-BA 102 or derivatives
thereof as disclosed in the due diligence folders provided to Molecular Insight
on June 1, 2006.
23
ANNEX 2.6
GENERAL NUMBERING SCHEME FOR BENZAMIDE COMPOUNDS
COMPOUND PRECURSOR AMOUNT I-127 REF. AMOUNT
CODE (ZK-NUMBER) (MG) (ZK-NUMBER) (MG)
-------- ----------- ------ ----------- ------
BA40 Bromopride 25 304261 --
BA41 304257 -- 307504 --
BA42 304258 -- 307504 --
BA43 304259 -- -- --
BA44 253063 20 308747 10
BA45 253062 3 308748 --
BA50 253060 50 251428 50
BA52 316027 -- 319402 20
BA53 319401 -- 319400 --
BA56 253061 60 201854 --
BA59 264376 5 268968 10
BA60 253065 15 262591 15
BA61 253066 30 262594 18
BA62 253067 10 262583 10
BA63 802105 10 262597 --
BA65 253069 20 268969 15
BA66 266104 30 268970 20
BA67 267714 15 269270 5
BA68 268815 5 342087 10
BA69 268814 20 342088 15
BA70 268813 20 342089 17
BA71 268818 10 KQ 265 --
BA72 259754 30 KQ 266 --
BA73 268819 25 342101 10
BA80 253064 30 --
BA81 253068 40 264450 --
BA90 279328 5 342100 --
BA91 325910 25 358344 20
BA92 325914 45 358345 34
BA93 325915 10 358346 28
BA94 325917 30 K.Q.276 10
BA95 325916 10 358358 14
BA96 325918 40 358350 20
BA97 325919 50 K.Q.278 20
BA98 343960 50 358367 30
BA99 343968 -- K.Q.291 --
BA100 343969 10 358368 20
BA101 343971 -- 358369 20
BA102 343973 10 358370 25
All precursors and non-radioactively iodinated compounds were characterized by
HPLC, (1)H-NMR-, MS, IR- and UV-spectroscopy. The radioiodinated benzamides
were characterized by HPLC comparison to the non-radioactive I-127 benzamide
standard.
24
ANNEX 6.1
OUTLINE DEVELOPMENT PLAN
ANNEX 6.1 --ZK-BA DEVELOPMENT PLAN
[PERFORMANCE GRAPH]
25
