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EXHIBIT 10.1
Confidential treatment has been requested for portions of this
exhibit. The copy filed herewith omits the information subject to
the confidentiality request. Omissions are designated as **. A
complete version of this exhibit has been filed separately with the
Securities and Exchange Commission.
OPTION AND LICENSE AGREEMENT
THIS AGREEMENT (the "Agreement") is made and is effective the
10th day of June, 1998 (the "Effective Date") by and between:
Adolor Corporation, a Delaware corporation having its principal
place of business at 371 Phoenixville Pike, Malvern, Pennsylvania
19355 ("ADOLOR") and Roberts Laboratories Inc., a New Jersey
corporation, having its principal place of business at 4 Industrial
Way West, Eatontown, New Jersey 07724 ("ROBERTS").
RECITALS
1. ADOLOR is engaged in the development and marketing of
therapeutic products utilizing opiate receptor-mediated
pathways.
2. ROBERTS has acquired from Eli Lilly and Company ("Lilly"), in
an agreement dated November 5, 1996 (the "Lilly License"), an
exclusive, world-wide license to make, have made, use or sell
(+)-[2(S)-[4(R)-(3-hydroxyphenyl)-
3(R),4-dimethyl-1-piperidinyl]methyl]-1-oxo-3-phenylpropyl]amino]-acetic
acid and all pharmaceutically acceptable salts and solvates thereof
(the "Compound"), with the right to sublicense, which Lilly License
and its Appendices A and B are appended hereto as Exhibit A.
3. An Investigational new Drug Application ("IND"), made to the
United States Food and Drug Administration ("FDA"), was initiated
for the Compound, but currently there is no activity pursuant to
this Application.
4. As ADOLOR believes the Compound may provide the basis for a
therapeutic product utilizing opiate receptor-mediated pathways,
ADOLOR desires to obtain and ROBERTS desires to provide an
exclusive, world-wide license including (a) a "Phase A" during
which ADOLOR will seek to establish the therapeutic index of the
Compound, and (b), provided the therapeutic index is satisfactory
to ADOLOR at its sole discretion, a "Phase B" during which ADOLOR
will pursue development and commercialization of the Compound.
5. Assuming ADOLOR proceeds to Phase B, ADOLOR further desires
to seek to convert the license to an assignment of the Lilly
License to ADOLOR subject to the same duties as between ADOLOR and
ROBERTS as are set forth below, and ROBERTS desires to deliver such
assignment to ADOLOR and to exert best efforts to obtain for ADOLOR
the required permission from Lilly, though in the absence of such
an assignment the license provided herein shall be maintained.
NOW THEREFORE, in consideration of the mutual
covenants and obligations hereinafter set forth the parties agree
to be legally bound as follows:
ARTICLE I - DEFINITIONS
Section 1.1 . "Affiliate," "Compound," "End User," "Lilly
Intellectual Property Rights," "Net Sales" and "Product" shall have
the meanings, respectively, set forth in the Lilly License.
Section 1.2. "First Commercial Sale" shall mean the
first time sales are made of Product by ADOLOR to an unrelated
third party on a country by country basis.
Section 1.3. "Lilly Know-How" shall have the meaning
set forth for "Know- How" in the Lilly License.
Section 1.4. "NDA" shall mean an application filed
with the FDA for the approval of the manufacturing, marketing or
importation of a therapeutic product for use in humans. The
references below to "similar filing" shall encompass, for example,
Product License Applications ("PLAs") and Pre-Marketing
Applications ("PMAs").
Section 1.5. "Technical Information" shall mean
Technology which is owned, discovered or developed by or licensed
to ROBERTS which is embodied or employed in the composition,
manufacture or use of the Compound or Product, or components,
reagents, parts or elements thereof. "ADOLOR Technical Information"
shall mean Technology which is owned, discovered or developed by
ADOLOR which is embodied or employed in the composition,
manufacture or use of the Compound or Product, or components,
reagents, parts or elements thereof.
Section 1.6. "Technology" shall mean know-how,
protocols, processes, instruments, machines, materials,
compositions, tests procedures, manufacturing procedures,
techniques, formulations, methodologies and data, inventions,
observations and information, related to the Compound or the
Product.
ARTICLE II - LICENSE
Pursuant to the Lilly Intellectual Property Rights or any
ROBERTS Technical Information, ROBERTS grants ADOLOR an exclusive,
world-wide license to make, have made, use, sell or import Product
pursuant to the Lilly Intellectual Property Rights or any other
ROBERTS Technical Information. The term of the license shall be
either the term of Phase A or, if ADOLOR elects to proceed with
Phase B, the sum of the terms of Phase A and Phase B.
The rights acquired hereunder shall include all rights licensed
to ROBERTS pursuant to the Lilly License.
ARTICLE III - PHASE A
Section 3.1. - Phase A Consideration
In consideration for Phase A, ADOLOR shall deliver to ROBERTS a
non-refundable payment of $300,000 on the Effective Date.
Section 3.2. - Phase A Term
The term of Phase A shall be from the Effective date until the
earlier of (a) the date on which ADOLOR delivers to ROBERTS notice
of ADOLOR’s completing studies sufficient to establish the
therapeutic index of the Compound and of whether ADOLOR intends to
initiate Phase B and (b) July 31, 1999. The parties
acknowledge that there are areas of risk to ADOLOR’s ability
to meet this timetable including:
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the risk that the pharmaceutical
composition of the Compound or Product provided by ROBERTS be
insufficient in quality or quantity to conduct the studies
necessary to establish the therapeutic index; and
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the risk that the FDA will suspend
or place on hold any activity pursuant to the IND for the
Compound.
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The parties further acknowledge that the above
exemplified risks, should they become realities, would provide
cause for the July 31, 1999 term expiration date to be
extended. Should an event outside of ADOLOR’s control give
rise to a reasonable basis to extend the July 31, 1999 term
expiration date, meaning that it is reasonable to expect that
ADOLOR acting with commercially reasonable diligence shall not have
completed studies to establish the therapeutic index of the
Compound by July 31, 1999, an extension of time will be
provided to enable ADOLOR to complete the studies and the parties
shall negotiate in good faith and arrive at a reasonable period of
extension.
Section 3.3. - ADOLOR’s Phase A Duties
In addition to any other duties imposed by this Agreement,
during the term of Phase A, ADOLOR shall use commercially
reasonable efforts to conduct studies, including Phase I clinical
studies, to establish the therapeutic index of the Compound. All
costs associated therewith shall be borne by ADOLOR. While the
Phase A is in effect, ADOLOR agrees to undertake the obligations
incumbent on ROBERTS under the Lilly License, with the exception of
the milestone payments set forth in Section 3.01 of the Lilly
License and the costs associated with prosecuting or maintaining
patents under the Lilly Intellectual Property Rights, which shall
continue to be borne by ROBERTS.
Section 3.4. - ROBERTS’ Phase A
Duties
In addition to any other duties imposed by this Agreement,
ROBERTS shall:
(a) provide ADOLOR its stocks of the Compound, in the amount
ROBERTS possesses in whatever condition that such Compound may be
as of the Effective Date; and
(b) during the term of Phase A, refrain from discussing,
negotiating or agreeing to, with a third party, a license or
assignment of rights in the Compound, or its use, manufacture, sale
or import.
ARTICLE IV - PHASE B
Section 4.1. - Term and Contingency
The term of Phase B begins on the last day of Phase A through to
the end of the term defined in Section 8.01 of the Lilly
License. Entrance into Phase B is contingent on ADOLOR delivering
to ROBERTS during the term of Phase A notice of ADOLOR’s
intent to proceed with Phase B.
Section 4.2. - Phase B Consideration
Subject to the foregoing, in consideration for Phase B, ADOLOR
shall pay ROBERTS:
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$300,000 payable within five
(5) business days of the expiration of Phase A;
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$500,000 payable within five
(5) business days of the filing of a first application for a
NDA or similar filing in the United States, Canada, Japan or the
European Community that seeks permission to market a
Product;
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$900,000 payable within five
(5) business days of receiving notice of acceptance of a first
NDA or similar filing in the United States, Canada, Japan or the
European Community that seeks permission to market a Product;
and
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a royalty equal to **% of Net
Sales.
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ADOLOR shall pay Lilly, on behalf of ROBERTS,
$500,000 upon acceptance of a first NDA or similar filing in the
United States, Canada, Japan or the European Community that seeks
permission to market a Product, in accordance with
Section 3.01(v) the Lilly License. ADOLOR agrees to pay Lilly,
on behalf of ROBERTS, a royalty equal to ** % of Net Sales in
accordance with the Lilly License. For any payment made on behalf
of ROBERTS, ADOLOR shall deliver proof of such payment to
ROBERTS.
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Certain information on this page has
been omitted and filed separately with the Commission. Confidential
treatment has been requested with respect to the omitted
portions.
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Section 4.3. - ADOLOR’s Phase B
Duties
While Phase B is in effect, ADOLOR agrees to undertake the
obligations incumbent on ROBERTS under the Lilly License and
accruing during Phase B, with the exception of the execution
milestone payment set forth in Section 3.01(a)(i) of the Lilly
License. Except for costs associated with Robert’s duties
under this Agreement, all costs associated with developing and
commercializing the Compound or Product shall be borne by
ADOLOR.
ARTICLE V - SUBLICENSES OF THIS AGREEMENT
(a) ADOLOR shall have the right to grant sublicenses hereunder
consistent with the terms of the Lilly License, provided ,
however , that should ADOLOR grant a sublicense hereunder
within seventy-five (75) days of the Effective Date, ROBERTS
shall receive 25% of any payments made to ADOLOR in consideration
of such sublicense.
(b) Should ADOLOR decide to actively seek to sublicense
marketing rights in the Compound or seriously consider a good faith
offer by a third party to sublicense such marketing rights, ADOLOR
shall notify ROBERTS of its intention to seriously seek to
sublicense the marketing rights and shall provide ROBERTS with an
opportunity to negotiate in good faith for a sublicense to the
marketing rights. However, nothing herein shall imply that ROBERTS
has a right of priority or preference in such negotiations, or
imply any restraints whatsoever on ADOLOR’s business judgment
as to partners in marketing the Compound.
ARTICLE VI - TECHNOLOGY TRANSFER
Section 6.1. - From ROBERTS to ADOLOR
Following execution and payment under Section 3.1 ROBERTS
shall deliver to ADOLOR copies of the Lilly Know-how, ROBERTS
Technical Information, and its inventory of Compound and
intermediates for the production of Compound.
Section 6.2. - From ADOLOR to ROBERTS
(a) Should ADOLOR establish the therapeutic index of the
Compound but nonetheless decline to initiate Phase B, ADOLOR shall
deliver to ROBERTS copies of ADOLOR data on the therapeutic index
of the Compound and any other ADOLOR data on the therapeutic
efficacy of the Compound as well as any dosage forms containing the
Compound.
(b) Should ADOLOR fail to establish the
therapeutic index and should ADOLOR not dispute that the term of
Phase A, taking into consideration any extensions thereto under
Section 3.2, has expired, then ADOLOR shall deliver to ROBERTS
copies of ADOLOR data on the therapeutic index of the Compound and
any other ADOLOR data on the therapeutic efficacy of the Compound
as well as any dosage forms containing the Compound.
(c) All such materials delivered to ROBERTS pursuant to this
Section 6.2 shall thus become the sole and exclusive property
of ROBERTS.
ARTICLE VII - REPORTS, RECORDS, PAYMENTS
Section 7.1. - Quarterly Reports
(a) ADOLOR shall give ROBERTS prompt written notice of-the first
acceptance of a NDA or similar filing in t
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