Exhibit 10.29
First Amendment
With reference to the License Agreement dated the 3rd day of November, 2006 (the
"Execution Date") entered into by and between Novartis Pharma AG (referred to as
"Novartis"), a corporation organized and existing under the laws of the
Switzerland and having its principal offices at Xxxxxxxxxxxx 00, XX-0000 Xxxxx,
Xxxxxxxxxxx and Molecular Insight Pharmaceuticals Inc., a corporation organized
and existing under the laws of Delaware, with an office at 000 Xxxxxx Xxxxxx,
Xxxxxxxxx, XX 00000 XXX (hereinafter "MIP"); MIP and Novartis hereby enter into
this First Amendment to amend the License Agreement as follows:
1. IN SECTION 2.4.1 OF THE LICENSE AGREEMENT, A NEW PARAGRAPH 2.4.1.B SHALL BE
ADDED. THE SECTION 2.4 SHALL NOW READ:
2.4.1.a) Novartis undertakes to physically transfer the content of its
investigational new drug application in the United States or equivalent
documents for other countries, and all related amendments, correspondence,
meeting minutes and any other documents (hereinafter collectively referred
to as "IND") upon the effective date of this Agreement. For the avoidance
of doubt, this does not include those parts of the IND Controlled by MMI or
any information related to the manufacture of the Tyr-3 octreotide.
(UNCHANGED)
2.4.1 b) Novartis will provide a drug substance Drug Master File (DMF) to
the FDA by May 2007 in support of a proposed June 2007 submission by
Molecular Insight Pharmaceuticals.
2. EXHIBIT 3:
The Exhibit 3 attached to the License Agreement shall be replaced by the
Exhibit 3 attached hereto as Annex 1.
3. EFFECTIVE DATE
3.1 This Amendment shall become retroactively effective at the Effective Date,
as defined in the License Agreement, and shall remain effective until the
expiration or termination of the License Agreement.
4. ENTIRE AGREEMENT
4.1 This Amendment intends to amend the License Agreement to the extent
provided hereunder. The License Agreement as modified by this Amendment
shall constitute the entire agreement between the parties hereto with
respect to the subject matter hereof and shall supersede, cancel and annul
any prior written or oral agreements.
4.2 Except for the terms and conditions amended in this Amendment, all other
terms and conditions of the License Agreement and its related agreements
shall remain in full force and effect.
5. TITLES
5.1 Titles in this Amendment have been inserted for convenience only and shall
in no way be used in the interpretation hereof.
IN WITNESS WHEREOF, the Parties have executed this Amendment as of the dates
indicated below.
MOLECULAR INSIGHT CORPORATION NOVARTIS PHARMA AG
Date: December 21, 2006 Date: 04 January 2007
By: /s/ Xxxxx Xxxxxx By: /s/ Xxxx-Xxxx Sequier
--------------------------------- ------------------------------------
Name/title: Chairman & Chief Name/title: Xxxx-Xxxx Sequier
Executive Officer
By: /s/ Emmanuelle Ferrari
------------------------------------
Name/title: Emmanuelle Ferrari
Legal Counsel
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ANNEX 1
EXHIBIT 3
ADDENDUM TO THE LICENSE AGREEMENT BETWEEN NOVARTIS PHARMA AG AND MOLECULAR
INSIGHT PHARMACEUTICALS INC.
Upon execution of the Xxxxxxxx License, this Addendum by and between Novartis
Pharma AG (referred to as "Novartis"), a corporation organized and existing
under the laws of the Switzerland and having its principal offices at
Xxxxxxxxxxxx 00, XX-0000 Xxxxx, Xxxxxxxxxxx, and Molecular Insight
Pharmaceuticals Inc., a corporation organized and existing under the laws of
Delaware, with an office at 000 Xxxxxx Xxxxxx, Xxxxxxxxx, XX 00000 XXX
(hereinafter "MIP") shall become immediately and automatically effective
("Effective Date").
WHEREAS, Xx. Xxxxxxxx, Professor Dr. S.W.J. Lamberts ("Lamberts") and Sandoz
Pharma Ltd ("Sandoz") have made joint inventions relating to labelled
somatostatin analogues covered in the Patent Case 100-7382 and 118-7595
(hereinafter the "Generic Patent"), as set out on Exhibit 1a of the License
Agreement;
WHEREAS, Xxxxxxxx, Lamberts and Sandoz entered into a contractual relationship
dated 10 October 1989 (the "Letter Agreement") under which Xxxxxxxx granted
Sandoz exclusivity to the Generic Patent in return of a royalty to be determined
within a subsequent agreement ("Xxxxxxxx License");
WHEREAS, Novartis Pharma AG is the successor to the rights and obligations of
Sandoz;
WHEREAS, Novartis and Xxxxxxxx have now executed the Xxxxxxxx License;
WHEREAS, Novartis and MIP have entered into a license agreement (hereinafter the
"License Agreement") under which MIP as granted a non-exclusive license to the
Generic Patent to develop, sale and promote the Product;
WHEREAS, MIP wishes now to be granted an exclusive license under the Generic
Patent;
WHEREAS, Novartis agrees to grant MIP an exclusive license provided MIP pays
additional considerations to Xxxxxxxx in addition to the royalties due to
Novartis under the License Agreement;
WHEREAS, the License Agreement shall be amended accordingly;
NOW, THEREFORE, in consideration of the promises, covenants and agreements
hereinafter set forth, the sufficiency of which is hereby acknowledged, the
parties to this Agreement all agree as follows:
1. DEFINITIONS:
"COMMERCIALIZATION" or "COMMERCIALIZE" shall mean activities conducted by a
Party either by itself or through a Third Party and directed to marketing,
promoting, distributing, importing,
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exporting, offering for sale or selling a Product, which may include pre-launch
market preparation, whether undertaken by a Party alone or with a partner or a
sub-licensee. When used as a verb, "Commercialize" means to engage in
Commercialization.
"COMPOUND" shall mean the DOTA-chelated somatostatin peptide analogue known as
edotreotide.
"FIRST COMMERCIAL SALES" shall mean the first shipment of the Product to an
independent Third Party by MIP, its Affiliates, its sub-licensee, in a country
following applicable Marketing Authorization of Product in such country.
"GENERIC PATENT" shall mean the patent application GB 8828364.3, referred to as
case 100-7382, referred to as Case 118-7595 and any corresponding patent
applications or patents including any and all substitutions, extensions,
re-examination, or supplementary protection certificates, reissues, renewals,
divisions, continuations or continuations-in-part thereof, provisional patents,
patents of addition, or registrations of any kind.
"XXXXXXXX" shall mean Xx Xxxx X. Xxxxxxxx at the Erasmus Hospital in Rotterdam.
"XXXXXXXX DESIGNEE" OR "DESIGNEE" shall mean an individual, corporation,
partnership, association, joint-stock company, trust, which is designated by
Xxxxxxxx pursuant to lawful purposes as the beneficiary of Xxxxxxxx
considerations defined under clause 3 and which is approved as such by Novartis
in writing and communicated to MIP. For the sake of clarity, Novartis will
authorize to have payments assigned to a single Designee one time for the
duration of the Xxxxxxxx Agreement, except that Xxxxxxxx may be entitled to ask
the payments to revert to him upon a three months prior written notice.
"XXXXXXXX LICENSE" shall mean the agreement executed by and between Xxxxxxxx and
Novartis, completing the Letter Agreement, in which Xxxxxxxx and Novartis have
agreed on the ownership of the Generic Patent, on the share of the rights under
such Generic Patent and on payments of some considerations to one another.
"XXXXXXXX MILESTONES" shall mean the milestone payments due by MIP to Xxxxxxxx
as set forth in clause 2 below.
"XXXXXXXX ROYALTIES" shall mean the royalty payments due by MIP to Xxxxxxxx, as
set forth in clause 2 below.
"MAJOR EUROPEAN COUNTRY" shall mean either one of France, Germany, UK, Spain or
Italy.
"MARKETING AUTHORIZATION" shall mean the approval necessary for the
Commercialization of a Product in a specific country.
"MIP FIELD" shall mean human oncology therapeutic use.
"NET SALES" shall mean with respect to the Product the gross amount invoiced by
or on behalf of the relevant Party and its Affiliates and sublicensees for the
Product sold to Third Parties other than licensees or sublicensees in bona fide,
arms-length transactions, less customary deductions, determined in accordance
with the Party's Accounting Standards as generally and consistently applied by
that Party, to the extent included in the gross invoiced sales price of
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any Product or otherwise directly paid or incurred by such Party, its Affiliates
or sublicensees with respect to the sale of such Product, such as:
(i) normal and customary trade and quantity discounts actually allowed and
properly taken directly with respect to sales of the Product;
(ii) amounts actually repaid or credited by reasons of defects, rejection
recalls, returns, rebates and allowances of goods;
(iii) chargebacks and other amounts paid on sale or dispensing of such
Product;
(iv) rebate amounts payable resulting from governmental mandated rebate
programs;
(v) tariffs, duties, excise, sales, value- added and other taxes (other
than taxes based on income);
(vi) customary cash discounts for timely payment;
(vii) delayed ship order credits;
(viii) discounts pursuant to indigent patient programs and patient discount
programs, including coupon discounts; and
(x) all freight, postage and insurance included in the invoice price.
Sales from a Party to its Affiliates shall be disregarded for purposes of
calculating Net Sales. Any of the items set forth above that would
otherwise be deducted from the invoice price in the calculation of Net
Sales but which are separately charged to Third Parties shall not be
deducted from the invoice price in the calculation of Net Sales.
(a) In the case of any sale or other disposal of the Product between or
among a Party and its Affiliates or sublicensees, for resale, Net
Sales shall be calculated as above only on the value charged or
invoiced on the first arm's-length sale thereafter to a Third Party;
(b) In the case of any sale which is not invoiced or is delivered before
invoice, Net Sales shall be calculated at the time of shipment or when
the Product is paid for, if paid for before shipment or invoice;
"PARTY" OR "PARTIES" shall mean MIP or Novartis, or MIP and Novartis, whichever
the context admits.
"PERSON" shall mean any individual, corporation, partnership, association,
joint-stock company, trust, unincorporated organization or government or
political subdivision thereof.
"PRODUCT" shall mean the yttrium 90 radiolabeled Compound for therapeutic use
and indium 111 radiolabeled Compound for dosimetry purposes , both in a form
ready for use in human clinical trials and/or by the ultimate consumer with the
possible trademark of OctreoTher(R).
"THIRD PARTY" shall mean any Person or other entity other than MIP, Novartis or
their respective Affiliates or Sublicensees of rights conveyed under this
Agreement
2. GRANT OF AN EXCLUSIVE LICENSE
2.1 Subject to the terms and conditions of this Addendum Agreement, Novartis
hereby grants to MIP a world-wide, exclusive, royalty-bearing license under the
Generic Patent to use, make, offer to sell, sell and import the Compound and the
Product in the MIP Field, as well as to use the Indium 111 labelled Compound for
dosimetry purposes in relation to the Product therapy administration.
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2.2 Clause 2.1 of the License Agreement is amended accordingly.
3. CONSIDERATIONS
(A) XXXXXXXX LICENSE FEE. Upon the Effective Date, MIP shall pay to Xxxxxxxx or
his Designee, the amount of USD six hundred thousand ($600,000). Such payment
will be non-refundable and will not be subject to any claims by MIP, an
Affiliate or any Third Party for any reason, except that such payment shall be
credited against royalty payments as set forth in clause 3c) below.
(B) XXXXXXXX MILESTONE PAYMENT. In addition, following execution of the Xxxxxxxx
License, MIP shall pay to Xxxxxxxx or his Designee a milestone payment of USD
six hundred thousand ($600,000) upon the grant of a Marketing Authorization
either by the FDA, by a Major European Country Health Authority or by the
Japanese Health Authority. Such payment will be non-refundable and will not be
subject to any claims by MIP, an Affiliate, or any Third Party for any reason.
(C) XXXXXXXX ROYALTIES. Following the execution of the Xxxxxxxx License and
further to the lump sum payments above, MIP shall pay to Xxxxxxxx or his
Designee the following percentages in return for an exclusive license on the
annual world-wide Net Sales of such exclusively licensed Product:
- ** % (** percent) of the annual Net Sales of the Product for Net Sales
amounting less than USD ** ($**) annually.
- ** % (** percent) of the annual Net Sales of the Product on the incremental
sales between USD ** ($**) and USD ** ($**)
- **% (** percent) of the annual Net sales of the Product on the incremental
sales over USD ** ($**).
Payments to Xxxxxxxx or his Designee by MIP shall be made in Euros for all Net
Sales invoiced in Euros by MIP, without currency conversion, and in US Dollars
for all other Net Sales. Such payments will be non-refundable and will not be
subject to any claims by MIP or any Third Party, for any reason, except for the
first USD ** ($**) which are offset against the first half payment of the
License Fee as set forth in 3a).
(D) ROYALTY TERM
The duration of the royalty obligation shall be determined on a country by
country basis. Royalties shall be payable quarterly from the First Commercial
Sales of the Product in such country (i) for the period such Product's use or
sale is Covered by a Valid Patent Claim in such country, or (ii) for a period of
ten (10) years from First Commercial Sales; and if both (i) and (ii) are
applicable, for the longer of either.
(E) REPORTS.
MIP shall generate a report to submit to Xxxxxxxx within sixty (60) days of the
end of each calendar quarter and, after receipt of invoice from Xxxxxxxx, a
sample of which is attached hereto as Schedule I, MIP shall make payment in full
to Xxxxxxxx or his Designee within sixty (60) days. The report shall set forth
by country, (i) the Net Sales of Product, (ii) the number of units of Product
sold and the royalties payable hereunder, (iii) the withholding
*Confidential Treatment Requested*
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taxes, if any, required by law to be deducted in respect of such sales; (iv) the
date of the First Commercial Sales of the Product in each country during the
reporting period; and (v) the exchange rates used in determining the amount of
US Dollars, for such payments that are to be made in US Dollars. With respect to
sales of the Product invoiced in Euros, the Net Sales, and royalties payable
shall be expressed in Euros. With respect to sales of the Product invoiced in a
currency other than U.S. Dollars ("USD"), the Net Sales and amounts due to
Xxxxxxxx hereunder will be expressed in the US Dollars equivalent calculated on
a monthly basis in the currency of the country of sale and converted to their US
Dollar equivalent using the following method: the Net Sales in each country in
the Territory at each quarterly period in US Dollars shall be calculated by
translating the cumulative Net Sales in local currency in each country in the
Territory into those in US Dollars using the exchange rate mechanism in
accordance with General Accounting Practice (GAP) as generally and consistently
applied by U.S. Commercial Pharmaceutical Companies, normally used and approved
by MIP accountants for such currency calculations.
(F) AUDITS.
Upon the written request of Xxxxxxxx, and not more than once in each calendar
year, MIP shall permit an independent certified public accounting firm of
nationally recognized standing, selected by Xxxxxxxx and reasonably acceptable
to MIP, at Xxxxxxxx'x expense, to have access during normal business hours to
such records of MIP as may be reasonably necessary to verify the accuracy of the
royalty reports hereunder for any years ending not more than twenty-four (24)
months prior to the date of such request. The accounting firm shall disclose to
Xxxxxxxx only whether the records are correct or not and the specific details
concerning any discrepancies. All other confidential information of the
accounting firm, including working papers, shall be shared exclusively with the
legal counsel representing the requesting party, and its subcontractors, for the
purpose of analysis and verification, on a confidential basis, such that
information provided by the accounting firm shall not be disclosed to the
requesting party.
If such accounting firm concludes that additional royalties were owed
during such period, MIP shall pay the additional royalties within thirty (30)
days of the date of Xxxxxxxx delivery to MIP such accounting firm's written
report so concluding. The fees charged by such accounting firm shall be paid by
Xxxxxxxx, provided however, that if the audit discloses that the royalties
payable by MIP for the audited period are more than one hundred and five ten
percent (105%) of the royalties actually paid for such period, then MIP shall
pay the reasonable and direct fees and expenses charged by such accounting firm.
Any overpayment determined pursuant to this provision shall be credited to the
next payment due hereunder from MIP. If no further payments by MIP will be due
hereunder then a refund of any such overpayment will be made within thirty (30)
days of the delivery of a detailed written accountants' report to the Parties
hereto.
(G) UNDERPAYMENTS.
If at any time during the term of the Agreement and thereafter, it is determined
that MIP underreported sales to Xxxxxxxx, then any royalty payments related to
such under reporting of sales shall be reported and paid to Xxxxxxxx or his
Designee within sixty (60) days of MIP's first knowledge of such underpayment
with Interest.
(G) INTEREST.
Payments due by MIP under the Agreement, when overdue, shall bear interest at a
rate per annum equal to LIBOR (London Interbank Offered Rate) plus one percent
(1%) at the time
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such payment is due, and for the time period until payment is received by
Xxxxxxxx or his Designee.
(H) CONFIDENTIAL FINANCIAL INFORMATION.
Xxxxxxxx shall treat all financial information subject to review under this
Article 3 as confidential and shall cause its accounting firm to retain all such
financial information in confidence.
(I) PAYMENT METHOD.
Royalty, License Fee and Milestone Payment and Interest payments by MIP under
the Agreement shall be paid in US Dollars and/or in Euros, by bank wire transfer
or bank check in immediately available funds to such account as Xxxxxxxx shall
designate before such payment is due.
(J) EXCHANGE CONTROL. If at any time legal restrictions prevent the prompt
remittance of part or all royalties with respect to any country where each
Product is sold, payment shall be made through such lawful means or methods as
MIP shall reasonably shall determine after consultation with Xxxxxxxx.
(K) ROYALTY ACCRUAL. There shall be no obligation to pay Xxxxxxxx royalties on a
reasonable amount of samples lawfully used in the Territory and on Product used
(and not sold) during pre-clinical or clinical testing, or for physician
preference testing, teaching or experimental purposes, or for any other similar
pre-commercial uses of Product.
(L) DESIGNEE. Novartis MIP payment to Xxxxxxxx Designee shall relieve MIP of any
identical payment to Xxxxxxxx. MIP shall not be liable for any additional tax or
costs that such Third Party beneficiary payment may cause.
4. SUPPLY OF THE PRODUCT
Commercial Supply to Erasmus Hospital. In the event that the Product is
commercialised in Europe, including in the Netherlands, MIP shall discuss in
good faith with Xxxxxxxx and the Erasmus Hospital the supply procedure of the
Product to the Hospital under which the Hospital shall be granted a reasonable
quantity of the Product for its commercialisation requirements for a price which
shall in no event be greater than the price agreed with other hospitals in
Europe with similar size and stature.
5. PATENT MAINTENANCE AND DEFENSE
In the event that Novartis has lost interests in the Generic Patent and has
offered it to MIP, MIP undertakes the following:
a) MIP will keep Xxxxxxxx informed before taking any major decision
relating to the maintenance of the Generic Patent, and shall provide
written notification of such change no less than ninety (90) days prior to
any change relating to the maintenance of the Patents in a country.
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b) in the event that MIP decides to abandon the Generic Patent in one or
several countries, it shall provide written notice to Xxxxxxxx thereof no
less than ninety (90) days prior to the final date for filing a response or
submitting a payment to the relevant governmental office regarding such
Generic Patent after which the Generic Patent would become abandoned. After
receiving such notice, Xxxxxxxx may, but is not obligated to, elect to
continue preparation, filing and prosecution or maintenance of the
discontinued Generic Patent at his sole expense. Ownership of any such
discontinued Generic Patent shall at the request of Xxxxxxxx be fully
assigned by MIP to Xxxxxxxx and MIP shall promptly prepare and execute such
documents and perform such acts as may be reasonably necessary for
assigning such sole ownership to Xxxxxxxx at MIP's sole expense and at no
cost to Xxxxxxxx. Xxxxxxxx shall be responsible for the filing of any such
documents, and the expenses related to such filings.
c) MIP shall have the first right, but not the obligation to take,
institute and prosecute legal proceedings in case of Generic Patent rights
infringement or to control the defense of any declaratory judgment action
relating to the Generic Patent.
6. CONFIDENTIALITY
Except for the right to disclose the terms of this Addendum Agreement to
Xxxxxxxx, the terms and conditions of this Addendum Agreement shall be
confidential and subject to the conditions as set forth in Article 9 of the
License Agreement.
7. ENTIRE AGREEMENT
Except as set forth in Section 2,3 and 5, this Addendum Agreement and its
Schedule I shall not replace, amend, supersede or be in lieu of any provisions
set forth in the License Agreement.
8. ADDITIONAL AGREEMENT
Novartis agrees that MIP shall be entitled to enter into a separate agreement
with Xxxxxxxx setting forth further terms and conditions of their collaboration.
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Schedule I
Sample of Invoice
INVOICE
SENDER'S LOGO
Street INVOICE DATE:
Town, Country XXXXX, 200X
Phone and Fax Nr.
INVOICE NO.: XXXX
XXXX TO: FOR:
Molecular Insight Pharmaceuticals Inc. Product X Royalties 1st Quarter 200X
000 Xxxxxx Xxxxxx, (xx Xxxxxxxxx for event Y)
Xxxxxxxxx, XX 00000 XXX
DESCRIPTION AMOUNT (USD)
----------- -------------
Product X royalties January - March US$000,000.00
200X calculated based on Novartis
provided sales report (see attached
worksheet)
(Or milestone payment for event Y,
according to paragraph XY of agreement
ZZZZ dated ____________)
Novartis/MIP Contract Code
Please specify the event for which the
invoice is due, and add any copies of
invoices from third parties in case
reimbursement for third party work is
agreed to
PLEASE REMIT BY WIRE TRANSFER WITHIN 60 DAYS TO:
Receiving Bank - __________
Swift Code - __________
IBAN Number - __________
Credit Account - __________
Beneficiary - __________
TOTAL 000,000.00
If you have any questions concerning this invoice, contact __________ or e-mail
to __________
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VAT -Reg. No. Xxxxxxxxxx (only if applicable)
BEST REGARDS,
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