AMENDMENT NO. 1 TO THE AMENDED AND RESTATED AGREEMENT
Exhibit 10.1
This
AMENDMENT NO. 1 TO THE AMENDED AND RESTATED AGREEMENT (this “Amendment No. 1”) is made
effective as of May 27, 2009 (this “Amendment No. 1 Effective
Date”) by and between TEKMIRA PHARMACEUTICALS CORPORATION (formerly INEX
PHARMACEUTICALS CORPORATION), a company duly incorporated under the laws of
British Columbia having an office at #200 – 0000 Xxxxxxxx Xxxxxxx, Xxxxxxx,
Xxxxxxx Xxxxxxxx, Xxxxxx X0X 0X0 (“TEKMIRA”) and HANA
BIOSCIENCES, INC., a company duly incorporated under the laws of Delaware having
an office at 0000 Xxxxxxxxx Xxxxx, Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, XX 00000,
X.X.X. (“HANA”) (each of
HANA and TEKMIRA a “Party,” and collectively, the
“Parties”).
BACKGROUND
A. HANA
and TEKMIRA have entered into that certain Amended and Restated Agreement by and
between the Parties effective as of April 30, 2007 (the “Restated Agreement”).
B. The
Parties wish to enter into an amendment to the Restated Agreement in order to
amend certain rights and obligations therein, including, without limitation to
(i) delay certain milestone payments due to Tekmira in consideration for
increasing later-stage milestone payments, and (ii) modify certain terms
relating to Licensing/Sublicensing Revenue payable to Tekmira all on the terms
and conditions set forth herein below.
C. The
Parties agree that in connection with this Amendment No. 1, the Parties will
also amend the UBC Sublicense Agreement to conform with the amendments to the
Restated Agreement made herein.
NOW,
THEREFORE, for good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the Parties agree as follows:
1. Definitions. All
capitalized terms not defined in this Amendment shall have the meanings given to
them in the Restated Agreement.
2. References to
Inex. “Tekmira Pharmaceuticals Corporation” or “TEKMIRA”
acquired the business of INEX in 2007. As such, all references to
“Inex Pharmaceuticals Corporation” or “INEX” are deleted in their entirety and
replaced with “Tekmira Pharmaceuticals Corporation” or “TEKMIRA”, as
applicable.
3. Defined
Terms.
3.1 Section
1.1.4 of the Restated Agreement is amended in its entirety to read as
follows:
1.1.4 “Agreement” means the Restated
Agreement, all amendments and supplements to the Restated Agreement (including,
without limitation, Amendment No. 1) and all exhibits and schedules to the
forgoing.
3.2 Section
1.1.44 of the Restated Agreement is amended in its entirety to read as
follows:
1.1.44 “Hana Intellectual Property”
means:
(a) all
Intellectual Property Rights patents and patent applications (whether complete
or incomplete or whether filed or unfiled), including registrations, in any
jurisdiction world-wide, as well as any patents and patent applications owned or
Controlled by Hana; and
(b) all
Confidential Information owned or Controlled by Hana at any time during the Term
of this Agreement
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.
(c) “Controlled” for purposes of
this Section 1.1.44 means that Hana has the ability to grant a license to
TEKMIRA with respect to such Intellectual Property Rights, patents, patent
applications and Confidential Information, and shall exclude, for clarity any
Intellectual Property acquired or licensed by Hana during the term of this
Agreement from a Third Party.
3.3 Section
1.1.56 of the Restated Agreement is amended in its entirety to read as
follows:
1.1.56 “Licensing/Sublicensing
Revenue” means all transaction closing payments, milestone payments,
license fees and any other pre-Commercialization payments (excluding royalties,
sales revenue, sales commissions and any monies and proceeds derived from the
sale of licensed or sublicensed Product) collected or received by Hana or its
Affiliates pursuant to each License or Sublicense with any Third Party
(excluding, for clarity, any Affiliate of Hana) to the extent received in
consideration for sublicensing, or licensing, as applicable:
(a) the
Technology (which, for clarity, excludes “Technology” sublicensed to
Hana under the UBC Sublicense Agreement as such term is defined
therein);
(b) the
Licensed Patents (which, for clarity, excludes “Technology” sublicensed to
Hana under the UBC Sublicense Agreement as such term is defined therein);
and/or
(c) the
Assigned Patents.
Except as
otherwise expressly provided below, “Licensing/Sublicensing Revenue” shall not
include:
(d) any
loan or other debt financing instrument issued to Hana or an Affiliate by a
Licensee or Sublicensee, except to the extent that the interest charged for such
loan or other debt instrument is less than Fair Market Value (in which case only
such difference between the interest rate charged to Hana or its Affiliate and
the interest rate at Fair Market Value shall constitute Licensing/Sublicensing
Revenue) or to the extent that the principal of a loan or other debt instrument
is forgiven (in which case only such forgiven amount shall constitute
Licensing/Sublicensing Revenue); or
(e) any
equity investment in Hana or an Affiliate by a Licensee or Sublicensee, or
equity of the Licensee or Sublicensee, except to the extent that such investment
is made at greater than Fair Market Value measured at the time the shares,
options or other securities evidencing any such investment are granted (in which
case only the excess premium shall constitute Licensing/Sublicensing
Revenue). For the purposes of this Section, if the shares of either
Hana, its Affiliate or its Licensee or Sublicensee are not listed on any stock
exchange, the Fair Market Value shall be based on the price at which shares of
either Hana, its Affiliate or its Licensee or Sublicensee, as the case may be,
have been issued to investors (who are not industry-related strategic investors
or collaborative research partners) in the then most recent bona fide arm’s
length private placement financing completed within the preceding twelve (12)
months having gross proceeds of at least Ten Million Dollars
($10,000,000). If no such private placement financing has been
completed, the Parties shall appoint a mutually acceptable Person as an
independent evaluator, and if the Parties cannot agree on an evaluator, the Fair
Market Value shall be determined as provided in Article 13;
(f) an
exchange of rights, assets, liabilities or other interest of any kind, except to
the extent that the economic benefit conferred upon Hana or its Affiliates by
reason of such exchange exceeds the Fair Market Value of the consideration which
would have been paid by Hana or its Affiliates for such rights, assets,
liabilities or interests, as determined by: (i) the mutual agreement of the
Parties following the application of U.S. GAAP, or failing mutual agreement;
(ii) the binding decision of an arbitrator pursuant to the procedures set forth
in Article 13; and
(g) any
amounts paid: (1) as reimbursements of actual costs reasonably
incurred including patent prosecution and maintenance costs; (2) withholding
taxes and other amounts actually withheld from or deducted against the amounts
paid to such party; (3) for the supply of goods or materials to the extent any
payment for the supply of goods or materials does not exceed the Fair Market
Value for comparable goods or materials supplied, (4) as royalties or otherwise
based upon the sale of such Product (including the profit on supply of Products
or materials for commercial sale), (5) for research, development, or other
services, to the extent such payments do not exceed the Fair Market Value of
such activities, and Eligible Expenses, or (6) for any permitted assignment of
this Agreement, or for an agreement to assign this Agreement, in either case to
the extent such assignment is, or will be, resulting from the sale of
substantially all of the business or assets of Hana, whether by merger, sale of
stock, sale of assets or otherwise; provided, however, that any amounts paid for
any permitted assignment of this Agreement to any Third Party or for an
agreement to assign this Agreement to any Third Party, which does not result
from the sale of substantially all of the business or assets of Hana, whether by
merger, sale of stock, sale of assets or otherwise, shall constitute
Licensing/Sublicensing Revenue. For the avoidance of doubt, and
without limiting the generality of the foregoing, “Licensing/Sublicensing
Revenue” shall include any Development funding in excess of the Fair
Market Value of such activities.
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.
“Eligible Expenses” of a Party
means (i) the documented costs and expenses reasonably incurred by such Party or
its Affiliates in performing such Party’s or its Affiliate’s responsibilities
under a License or Sublicense with respect to Products; (ii) documented costs
and expenses reasonably incurred by such Party or its Affiliates in performing
any other research, development, and manufacture of Products (including prior to
the date of the License or Sublicense); and (iii) a reasonable amount for the
costs and expenses that a Party expects to incur, but has not yet incurred, in
the performance of its responsibilities under any agreement with a Sublicensee
or Licensee; to the extent that (i), (ii) and (iii) do not include a premium in
excess of Hana’s costs, whether such costs are measured (a) as a market FTE
rate, (b) as a project cost, (c) as a pass-through cost, or (d) as costs
incurred in Development.
To the
extent Licensing/Sublicensing Revenue represents an unallocated combined payment
for both a License and/or Sublicense of the Patents and/or Technology as well as
other intellectual property, undertakings or subject matter, proceeds from such
licensing and/or sublicensing arrangement for calculating payments due to
Tekmira shall be reasonably allocated by agreement of the Parties between such
Patents and/or Technology and such other intellectual property, undertakings or
subject matter.
If a
dispute between the parties arises as to the amount of the
Licensing/Sublicensing Revenue above, then, upon written notice by either party
to the other, such dispute shall be referred to resolution by final, binding
arbitration as described in Article 13 of the Agreement.
4. Licensing and
Sublicensing
Section
2.4.2(h) of the Restated Agreement is amended in its entirety to read as
follows:
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(h)
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within
ten (10) Business Days after execution of each License or Sublicense, as
the case may be, Hana shall provide Tekmira with a copy thereof, without
redaction of any financial terms of each License or
Sublicense. The terms of each License or Sublicense Agreement
shall be deemed to constitute “Confidential Information” of Hana for all
purposes of this Agreement, and Tekmira shall not disclose the information
contained in such Sublicense or License Agreement to any Third Party
except to the University of British Columbia and as authorized pursuant to
Article 10 of this Agreement.
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5. Development
Efforts
Section
4.2.2 of the Restated Agreement is amended in its entirety to read as
follows:
4.2.2
Hana will provide Tekmira with written reports every six (6) months, on or
before June 30 and December 31 of each and every year, beginning June 30, 2009,
to keep Tekmira fully informed of the progress of the Development of each
Product, all of which semi-annual Development reports shall contain, on a
Product by Product basis, a reasonably detailed accounting of Sublicensing
Revenues received by Hana or its Affiliate during the six (6) month period
covered by such Development report.
6. Sphingosomal
Vincristine.
6.1 Section
3.1.1(b) of the Restated Agreement is amended in its entirety to read as
follows:
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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(b)
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[***]
Dollars ($[***]) within ten (10) days following Hana’s receipt of the
approval by the FDA of the Sphingosomal Vincristine NDA, which payment
shall be made by Hana issuing to TEKMIRA a number of additional shares of
Common Stock determined by dividing [***] Dollars ($[***]) by the FMV as
of the date of such approval; provided however, if a Regulatory Submission
equivalent to an NDA is approved in any of the Designated EU States before
the Sphingosomal Vincristine NDA is approved by the FDA, [***] ([***]) the
milestone payment due under this Section 3.1.1(b) will be paid by Hana to
TEKMIRA immediately upon the approval of that equivalent filing in any of
the Designated EU States, and the remaining balance will be paid by Hana
to TEKMIRA immediately upon the approval of the Sphingosomal Vincristine
NDA by the FDA.
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6.2 Section
3.1.2 of the Restated Agreement is amended in its entirety to read as
follows:
3.1.2 Royalties
Hana
shall pay royalties to TEKMIRA based on [***] Net Sales of Sphingosomal
Vincristine as follows:
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(a)
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With
respect to Net Sales made by of Hana and/or its Affiliates only (the
“Hana Net
Sales”) of Sphingosomal Vincristine in the United States , a
royalty no greater than [***] percent ([***]%) of Hana Net Sales comprised
of the sum of one or more of the following percentages: (i) [***] percent
([***]%) of Hana Net Sales in consideration of Patents if the Product sold
is embraced within any Valid Claim under the Patents in the United States;
(ii) [***] percent ([***]%) of Hana Net Sales in consideration of, and
during any period of Product exclusivity provided by the laws of the
United States of America, including but not limited to marketing
exclusivity in the form of data exclusivity, pediatric exclusivity, and
orphan drug designation exclusivity; and (iii) [***] percent ([***]%) of
Hana Net Sales in consideration of Technology; provided,
however, that the total royalty paid shall be limited to [***] percent
([***]%) on that portion of [***] Hana Net Sales up to, and including,
[***] Dollars ($[***]), and limited to [***] percent ([***]%) on that
portion of [***] Hana Net Sales exceeding [***] Dollars
($[***]);
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(b)
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With
respect to Hana Net Sales of Sphingosomal Vincristine in each country of
the Territory other than the United States, a royalty of [***] percent
([***]%) of Hana Net Sales in consideration of Patents and Technology;
provided, however, that the total royalty paid shall be limited to [***]
percent ([***]%) on that portion of [***] Hana Net Sales up to, and
including, [***] Dollars ($[***]), and increased to [***] percent ([***]%)
on that portion of [***] Hana Net Sales in excess of [***] Dollars
($[***]);
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(c)
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With
respect to Net Sales in the United States made by Hana’s Licensees and
Sublicensees only (the “Licensee/Sublicensee
Net Sales”) of Sphingosomal Vincristine, a royalty equal to the
lesser of (1) [***] percent ([***]%) of the royalty received by Hana on
Licensee/Sublicensee Net Sales in the United States pursuant to a License
and/or Sublicense, as applicable, and (2) the royalty rate set forth in
Section 3.1.2(a) above with respect to Hana Net Sales in the United States
as applied to Licensee/Sublicensee Net Sales of Sphingosomal Vincristine
in the United States; and
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(d)
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With
respect to Licensee/Sublicensee Net Sales of Sphingosomal Vincristine in
each country of the Territory other than the United States, a royalty
equal to the lesser of (1) [***] percent ([***]%) of the royalty received
by Hana on Licensee/Sublicensee Net Sales pursuant to a License and/or
Sublicense, as applicable, in each country of the Territory other than the
United States, and (2) the royalty rate set forth in Section 3.1.2(b)
above with respect to Hana Net Sales in each country of the Territory
other than the United States as applied to Licensee/Sublicensee Net Sales
of Sphingosomal Vincristine in each country of the Territory other than
the United States.
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INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.
6.3 Sections
3.1.3 and 3.1.4 of the Restated Agreement is amended in its entirety to read as
follows:
3.1.3 Generic
Competition
If,
during a given calendar year, there is sale of a generic Sphingosomal
Vincristine or sale of an approved equivalent to Sphingosomal Vincristine
(collectively, “Approved
Sphingosomal Vincristine Equivalents”) in any country in the Territory,
then, for such country, the total amount of royalties payable to TEKMIRA for the
Hana Net Sales of Sphingosomal Vincristine in such country during such calendar
year will be reduced to [***] percent ([***]%) of the royalties payable to
TEKMIRA pursuant to Section 3.1.2(a) and 3.1.2(b) for such calendar year, in
such country.
3.1.4 Deductions:
Notwithstanding
the schedule of royalty payments set forth in Sections 3.1.2(a) and 3.1.2(b),
Hana shall be entitled to deduct from such Sphingosomal Vincristine royalty
obligations owed by Hana to TEKMIRA set forth in Sections 3.1.2(a) and 3.1.2(b),
an amount equal to [***] percent ([***]%) of the research and development
expenses Hana incurs in connection with the Development of Sphingosomal
Vincristine (the “Sphingosomal
Vincristine R&D Expenses”); provided however, that such deduction
shall not exceed the lesser of:
(a) [***]
Dollars ($[***]); or
(b) [***]
Dollars ($[***]) per patient treated in a Registrational Clinical
Trial;
provided
further, however, that such deduction for Sphingosomal Vincristine R&D
Expenses shall not exceed [***] percent ([***]%) of the royalty amount otherwise
payable by Hana to TEKMIRA for Sphingosomal Vincristine set forth in Section
3.1.2(a) or 3.1.2(b), as applicable, in each calendar year, provided that Hana
shall be entitled to carry over into succeeding years any amount of Sphingosomal
Vincristine R&D Expenses that were ineligible for deduction as a result of
such limitation. All Sphingosomal Vincristine R&D Expenses shall be subject
to audits by TEKMIRA using reasonable and customary audit procedures in order to
verify the amounts thereof.
7. Sphingosomal
Vinorelbine
7.1 Section
3.2.1(b) and Section 3.2.1(c) of the Restated Agreement are amended in their
entirety to read as follows:
3.2.1 Milestone
Payments:
Hana
shall pay to TEKMIRA milestone payments in respect of Sphingosomal Vinorelbine
as follows:
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(b)
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[***]
Dollars ($[***]) within ten (10) days following the FDA’s acceptance for
review of an NDA submission by Hana relating to Sphingosomal Vinorelbine
(the “Sphingosomal
Vinorelbine NDA”), which payment
shall be satisfied by Hana issuing to TEKMIRA a number of additional
shares of Common Stock determined by dividing [***] Dollars ($[***]) by
the FMV as of the Sphingosomal Vinorelbine NDA filing date; provided
however, if a Regulatory Submission equivalent to an NDA is accepted in
any of the Designated EU States before the Sphingosomal Vinorelbine NDA is
accepted, then [***] ([***]) the milestone payment due under this Section
3.2.1(b) will be paid by Hana to TEKMIRA immediately upon the acceptance
of that equivalent filing in any of the Designated EU States, and the
remaining balance will be paid by Hana to TEKMIRA immediately upon the
acceptance of the Sphingosomal Vinorelbine NDA by the FDA;
and
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INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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(c)
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[***]
Dollars ($[***]) upon the approval by the FDA a Sphingosomal Vinorelbine
NDA, which payment shall be made by Hana issuing to TEKMIRA a number of
additional shares of Common Stock determined by dividing [***] Dollars
($[***]) by the FMV as of the date of such FDA approval; provided however,
if a Regulatory Submission equivalent to an NDA is approved in any of the
Designated EU States before an NDA relating to Sphingosomal Vinorelbine is
approved by the FDA, [***] the milestone due under this Section 3.2.1(c)
will be paid by Hana to TEKMIRA immediately upon approval of that
equivalent filing and the remaining balance will be paid by Hana to
TEKMIRA immediately upon the approval of an NDA relating to Sphingosomal
Vinorelbine by the FDA.
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7.2 Section
3.2.2 of the Restated Agreement is amended in its entirety to read as
follows:
3.2.2 Royalties
Hana
shall pay to TEKMIRA royalty payments based on [***] Net Sales of Sphingosomal
Vinorelbine as follows:
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(a)
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With
respect to Hana Net Sales of Sphingosomal Vinorelbine in the United
States, a royalty no greater than [***] percent ([***]%) of Hana Net Sales
comprised of the sum of one or more of the following percentages: (i)
[***] percent ([***]%) of Hana Net Sales in consideration of Patents if
the Product sold is embraced within any Valid Claim under the Patents in
the United States; (ii) [***] percent ([***]%) of Hana Net Sales in
consideration of, and during any period of Product exclusivity provided by
the laws of the United States of America, including but not limited to
marketing exclusivity in the form of data exclusivity, pediatric
exclusivity, and orphan drug designation exclusivity; and (iii) [***]
percent ([***]%) of Hana Net Sales in consideration
of Technology; provided, however, that the total royalty paid
shall be limited to [***] percent ([***]%) on that portion of [***] Hana
Net Sales up to, and including, [***] Dollars ($[***]), and limited to
[***] percent ([***]%) on that portion of [***] Hana Net Sales exceeding
[***] Dollars ($[***]);
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(b)
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With
respect to Hana Net Sales of Sphingosomal Vinorelbine in each country of
the Territory other than the United States, a royalty of [***] percent
([***]%) of Hana Net Sales in consideration of Patents and Technology;
provided, however, that the total royalty paid shall be limited to [***]
percent ([***]%) on that portion of [***] Hana Net Sales up to, and
including, [***] Dollars ($[***]), and increased to [***] percent ([***]%)
on that portion of [***] Hana Net Sales in excess of [***] Dollars
($[***]);
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(c)
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With
respect to Licensee/Sublicensee Net Sales of Sphingosomal Vinorelbine in
the United States, a royalty equal to the lesser of (1) [***] percent
([***]%) of the royalty received by Hana on Licensee/Sublicensee Net Sales
in the United States pursuant to a License Agreement and/or Sublicense, as
applicable, and (2) the royalty rate set forth in Section 3.2.2(a) above
with respect to Hana Net Sales in the United States as applied to
Licensee/Sublicensee Net Sales of Sphingosomal Vinorelbine in the United
States; and
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(d)
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With
respect to Licensee/Sublicensee Net Sales of Sphingosomal Vinorelbine in
each country of the Territory other than the United States, a royalty
equal to the lesser of (1) [***] percent ([***]%) of
the royalty received by Hana on Licensee/Sublicensee Net Sales
pursuant to a License Agreement and/or Sublicense, as applicable, in each
country of the Territory other than the United States, and (2) the royalty
rate set forth in Section 3.2.2(b) above with respect to Hana Net Sales in
each country of the Territory other than the United States as applied to
Licensee/Sublicensee Net Sales of Sphingosomal Vinorelbine in each country
of the Territory other than the United
States.
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INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.
7.3 Sections
3.2.3 and 3.2.4 of the Restated Agreement is amended in its entirety to read as
follows:
3.2.3 Generic
Competition
If,
during a given calendar year, there is sale of a generic Sphingosomal
Vinorelbine or sale of an approved equivalent to Sphingosomal Vinorelbine
(collectively, “Approved
Sphingosomal Vinorelbine Equivalents”) in any country in the Territory,
then, for such country, the total amount of royalties payable to TEKMIRA for the
Hana Net Sales of Sphingosomal Vinorelbine in such country during such calendar
year will be reduced to [***] percent ([***]%) of the royalties payable to
TEKMIRA pursuant to Section 3.2.2(a) and 3.2.2(b) for such calendar year, in
such country.
3.2.4 Deductions:
Notwithstanding
the schedule of royalty payments set forth in Sections 3.2.2(a) and 3.2.2(b),
Hana shall be entitled to deduct from such Sphingosomal Vinorelbine royalty
obligations owed by Hana to TEKMIRA set forth in Sections 3.2.2(a) and 3.2.2(b),
an amount equal to [***] percent ([***]%) of the research and development
expenses Hana incurs in connection with the Development of Sphingosomal
Vinorelbine (the “Sphingosomal
Vinorelbine R&D Expenses”); provided however, that such deduction
shall not exceed the lesser of:
(a) [***]
Dollars ($[***]); or
(b) [***]
Dollars ($[***]) per patient treated in a Registrational Clinical
Trial;
provided
further, however, that such deduction for Sphingosomal Vinorelbine R&D
Expenses shall not exceed [***] percent ([***]%) of the royalty amount otherwise
payable by Hana to TEKMIRA for Sphingosomal Vinorelbine set forth in Section
3.2.2(a) or 3.2.2(b), as applicable, in each calendar year, provided that Hana
shall be entitled to carry over into succeeding years any amount of Sphingosomal
Vinorelbine R&D Expenses that were ineligible for deduction as a result of
such limitation. All Sphingosomal Vinorelbine R&D Expenses shall be subject
to audits by TEKMIRA using reasonable and customary audit procedures in order to
verify the amounts thereof.
7.4 The
milestone payment set forth in Section 3.3.1(a) shall be deleted and Section
3.3.1 of the Restated Agreement is amended in its entirety to read as
follows:
3.3.1 Milestone
Payments:
Hana
shall pay to TEKMIRA milestones payments in respect of Sphingosomal Topotecan as
follows:
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(a)
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Deleted.
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(b)
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[***]
Dollars ($[***]) within ten (10) days following the FDA’s acceptance for
review of an NDA submission by Hana relating to Sphingosomal Topotecan
(the “Sphingosomal
Topotecan
NDA”),
which payment shall be satisfied by Hana issuing to TEKMIRA a number of
additional shares of Common Stock determined by dividing [***] Dollars
($[***]) by the FMV as of the Sphingosomal Topotecan NDA filing date;
provided however, if a Regulatory Submission equivalent to an NDA is
accepted in any of the Designated EU States before the Sphingosomal
Topotecan NDA is accepted, then [***] ([***]) the milestone payment due
under this Section 3.3.1(b) will be paid by Hana to TEKMIRA immediately
upon the acceptance of that equivalent filing in any of the Designated EU
States, and the remaining balance will be paid by Hana to TEKMIRA
immediately upon the acceptance of the Sphingosomal Topotecan NDA by the
FDA; and
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INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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(c)
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[***]
Dollars ($[***]) upon the approval by the FDA of a Sphingosomal Topotecan
NDA, which payment shall be made by Hana issuing to TEKMIRA a number of
additional shares of Common Stock determined by dividing [***] Dollars
($[***]) by the FMV as of the date of such FDA approval; provided however,
if a Regulatory Submission equivalent to an NDA is approved in any of the
Designated EU States before an NDA relating to Sphingosomal Topotecan is
approved by the FDA, [***] the milestone due under this Section 3.3.1(c)
will be paid by Hana to TEKMIRA immediately upon approval of that
equivalent filing and the remaining balance will be paid by Hana to
TEKMIRA immediately upon the approval of an NDA relating to Sphingosomal
Topotecan by the FDA.
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7.5 Section
3.3.2 of the Restated Agreement is amended in its entirety to read as
follows:
3.3.2 Royalties
Hana
shall pay to TEKMIRA royalty payments based on [***] Net Sales of Sphingosomal
Topotecan as follows:
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(a)
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With
respect to Hana Net Sales of Sphingosomal Topotecan in the United States,
a royalty no greater than [***] percent ([***]%) of Hana Net Sales
comprised of the sum of one or more of the following percentages: (i)
[***] percent ([***]%) of Hana Net Sales in consideration of Patents if
the Product sold is embraced within any Valid Claim under the Patents in
the United States; (ii) [***] percent ([***]%) of Hana Net Sales in
consideration of, and during any period of Product exclusivity provided by
the laws of the United States of America, including but not limited to
marketing exclusivity in the form of data exclusivity, pediatric
exclusivity, and orphan drug designation exclusivity; and (iii) [***]
percent ([***]%) of Hana Net Sales in consideration
of Technology; provided, however, that the total royalty paid
shall be limited to [***] percent ([***]%) on that portion of [***] Hana
Net Sales up to, and including, [***] Dollars ($[***]), and limited to
[***] percent ([***]%) on that portion of [***] Hana Net Sales exceeding
[***] Dollars ($[***]);
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(b)
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With
respect to Hana Net Sales of Sphingosomal Topotecan in each country of the
Territory other than the United States, a royalty of [***] percent
([***]%) of Hana Net Sales in consideration of Patents and Technology;
provided, however, that the total royalty paid shall be limited to [***]
percent ([***]%) on that portion of [***] Hana Net Sales up to, and
including, [***] Dollars ($[***]), and increased to [***] percent ([***]%)
on that portion of [***] Hana Net Sales in excess of [***] Dollars
($[***]);
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(c)
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With
respect to Licensee/Sublicensee Net Sales of Sphingosomal Topotecan in the
United States, a royalty equal to the lesser of (1) [***] percent ([***]%)
of the royalty received by Hana on Licensee/Sublicensee Net Sales in the
United States pursuant to a License Agreement and/or Sublicense, as
applicable, and (2) the royalty rate set forth in Section 3.3.2(a) above
with respect to Hana Net Sales in the United States as applied to
Licensee/Sublicensee Net Sales of Sphingosomal Topotecan in the United
States; and
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INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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(d)
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With
respect to Licensee/Sublicensee Net Sales of Sphingosomal Topotecan in
each country of the Territory other than the United States, a royalty
equal to the lesser of (1) [***] percent ([***]%) of the royalty received
by Hana on Licensee/Sublicensee Net Sales pursuant to a License Agreement
and/or Sublicense, as applicable, in each country of the Territory other
than the United States, and (2) and the royalty rate set forth in Section
3.3.2(b) above with respect to Hana Net Sales in each country of the
Territory other than the United States as applied to Licensee/Sublicensee
Net Sales of Sphingosomal Topotecan in each country of the Territory other
than the United States.
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7.6 Sections
3.3.3 and 3.3.4 of the Restated Agreement is amended in its entirety to read as
follows:
3.3.3 Generic
Competition
If,
during a given calendar year, there is sale of a generic Sphingosomal Topotecan
or sale of an approved equivalent to Sphingosomal Topotecan (collectively,
“Approved Sphingosomal
Topotecan Equivalents”) in any country in the Territory, then, for such
country, the total amount of royalties payable to TEKMIRA for the Hana Net Sales
of Sphingosomal Topotecan in such country during such calendar year will be
reduced to [***] percent ([***]%) of the royalties payable to TEKMIRA pursuant
to Section 3.3.2(a) and 3.3.2(b) for such calendar year, in such
country.
3.3.4 Deductions:
Notwithstanding
the schedule of royalty payments set forth in Sections 3.3.2(a) and 3.3.2(b),
Hana shall be entitled to deduct from such Sphingosomal Topotecan royalty
obligations owed by Hana to TEKMIRA set forth in Sections 3.3.2(a) and 3.3.2(b),
an amount equal to [***] percent ([***]%) of the research and development
expenses Hana incurs in connection with the Development of Sphingosomal
Topotecan (the “Sphingosomal
Topotecan R&D Expenses”); provided however, that such deduction shall
not exceed the lesser of:
(a) [***]
Dollars ($[***]); or
(b) [***]
Dollars ($[***]) per patient treated in a Registrational Clinical
Trial;
provided
further, however, that such deduction for Sphingosomal Topotecan R&D
Expenses shall not exceed [***] percent ([***]%) of the royalty amount otherwise
payable by Hana to TEKMIRA for Sphingosomal Topotecan set forth in Section
3.3.2(a) or 3.3.2(b), as applicable, in each calendar year, provided that Hana
shall be entitled to carry over into succeeding years any amount of Sphingosomal
Topotecan R&D Expenses that were ineligible for deduction as a result of
such limitation. All Sphingosomal Topotecan R&D Expenses shall be subject to
audits by TEKMIRA using reasonable and customary audit procedures in order to
verify the amounts thereof.
8. Sections
3.6.1, 3.6.2 and 3.6.3 of the Restated Agreement are amended in their entirety
to read as follows:
3.6.1 Hana
shall pay to Tekmira a percentage of Sphingosomal Vincristine
Licensing/Sublicensing Revenue as follows:
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.
(a) [***]
percent ([***]%) of Licensing/Sublicensing Revenue received by Hana or its
Affiliate as initial license fees (an “Upfront Payment”) for any
Sphingosomal Vincristine Product Licensed or Sublicensed by Hana or its
Affiliate to a Third Party; and
(b) [***]
percent ([***]%) of Licensing/Sublicensing Revenue, other than Upfront
Payment(s) (“Milestone
Payments”), for any Sphingosomal Vincristine Product Licensed or
Sublicensed by Hana or its Affiliate to a Third Party.
3.6.2 Hana
shall pay to Tekmira a percentage of Sphingosomal Vinorelbine
Licensing/Sublicensing Revenue as follows:
(a) [***]
percent ([***]%) of Upfront Payment(s) for any Sphingosomal Vinorelbine Product
Licensed or Sublicensed by Hana or its Affiliate to a Third Party;
and
(b) [***]
percent ([***]%) of Milestone Payments for any Sphingosomal Vinorelbine Product
Licensed or Sublicensed by Hana or its Affiliate to a Third Party.
3.6.3 Hana
shall pay to Tekmira a percentage of Sphingosomal Topotecan
Licensing/Sublicensing Revenue as follows:
(a) [***]
percent ([***]%) of Upfront Payment(s) for any Sphingosomal Topotecan Product
Licensed or Sublicensed by Hana or its Affiliate to a Third Party;
and
(b) [***]
percent ([***]%) of Milestone Payments for any Sphingosomal Topotecan Product
Licensed or Sublicensed by Hana or its Affiliate to a Third Party.
9. Section
3.6.4 shall be amended to read in its entirety as follows:
3.6.4 Notwithstanding
anything to the contrary contained in this Section 3.6, Hana shall have no
obligation to pay to TEKMIRA its respective share of any such
Licensing/Sublicensing Revenue unless and until Hana actually receives such
Licensing/Sublicensing Revenue from its Licensee or Sublicensee. For
clarity, the payments made by Hana to TEKMIRA pursuant to Sections 3.6.1, 3.6.2
and 3.6.3 shall be in lieu of, and not in addition to, the milestone payments
described in subparagraphs 3.1.1, 3.2.1 and 3.3.1 above, such that Hana shall
owe TEKMIRA the milestone payments pursuant to Sections 3.1.1, 3.2.1 and 3.3.1
if Hana has not entered into a License/Sublicense Agreement and itself achieves
the milestones set forth in Sections 3.1.1, 3.2.1 and 3.3.1 with respect to a
Product OR Hana
shall owe TEKMIRA the milestone payments pursuant to Section 3.6.1, 3.6.2 and
3.6.3 if Hana has entered into a License/Sublicense Agreement with respect to a
Product. By way of non-limiting example, if Hana has entered into a
License or Sublicense with respect to Sphingosomal Vinorelbine (a “Vinorelbine
Sublicense”), and pursuant to such Vinorelbine Sublicense Hana receives a
milestone payment of $[***] upon approval by the FDA of an NDA relating to
Sphingosomal Vinorelbine (the “NDA Approval
Milestone”) and such milestone payment is considered
Licensing/Sublicensing Revenue pursuant to this Agreement, Hana would not owe
TEKMIRA the $[***] milestone payment set forth in Section 3.2.1(c) in addition
to the $[***] of Licensing/Sublicensing Revenue owed pursuant to Section 3.6.2
above ([***]% of the milestone Hana receives as Licensing/Sublicensing Revenue
pursuant to the applicable License/Sublicense Agreement), but instead would owe
TEKMIRA only $[***] with respect to the NDA Approval
Milestone. Similarly, if Hana has entered into a Vinorelbine
Sublicense, and pursuant to such Vinorelbine Sublicense Hana does receive an NDA
Approval Milestone, Hana would not owe TEKMIRA the $[***] milestone payment set
forth in Section 3.2.1(c), but instead would owe TEKMIRA [***]% of the milestone
payment received by Hana for such NDA Approval Milestone from the Licensee or
Sublicensee, as applicable, under the Vinorelbine Sublicense and falling within
the definition of Licensing/Sublicensing Revenue generated pursuant to such
Vinorelbine Sublicense.
10. A
new Section 10.2.3 shall be added and shall read in its entirety as
follows:
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.
10.2.3 Nondisclosure of
Terms. Except for either Party’s right to disclose the terms
of this Agreement to the University of British Columbia and to [***], each of
the Parties hereto agrees not to disclose the terms of this Agreement to any
Third Party without the prior written consent of the other party hereto;
provided that a Party may disclose the terms of this Agreement without such
consent to such party’s attorneys, advisors or investors on a need to know
basis, to Third Parties in connection with due diligence or similar
investigations by such Third Parties, and to potential Third Party investors in
confidential financing documents; in each case, under circumstances that
reasonably ensure the confidentiality and appropriately restricted use thereof,
or to the extent required by law.
11. A
new sentence shall be added at the end of Section 14.4.1 and shall read in its
entirety as follows:
Notwithstanding
the forgoing, in the event of a dispute with respect to the existence of a
breach and/or default under this Agreement, the cure periods set forth in this
Section 14.4.1 shall be tolled until such time as the dispute is resolved
pursuant to Article 13 hereof.
12. Section
15.2 of the Restated Agreement is amended in its entirety to read as
follows:
15.2 Assignment. Neither
Party may assign this Agreement in whole or in part without the prior written
consent of the other Party, provided that, (i) either Party may assign this
Agreement in whole or in part to an entity that is an Affiliate so long as such
entity is an Affiliate at the time of such assignment, without such
consent, and
(ii) either Party may assign this Agreement, without such consent, to an
entity that acquires all or substantially all of the business or assets of such
Party to which this Agreement pertains (whether by merger, reorganization,
amalgamation, acquisition, sale or otherwise), and agrees in writing to be bound
by the terms and conditions of this Agreement. The terms and
conditions shall be binding on and inure to the benefit of the permitted
successors and assigns of the Parties. Any permitted assignee
shall assume all obligations of its assignor under this Agreement. No
assignment shall relieve any Party of responsibility for the performance of any
accrued obligation that such Party then has under this Agreement. If
either Party is acquired by another entity, the intellectual property rights of
the acquiring entity shall not be included in the technology licensed to the
other Party hereunder.
13. Covenant.
12.1 As
of the date hereof, the Parties have entered into that certain Acknowledgement
Agreement (the “Acknowledgement”)
with UBC regarding an amendment to the UBC Sublicense Agreement, which amendment
shall (a)conform the provisions of the UBS Sublicense Agreement to those set
forth in this Amendment, and (b) clarify that Tekmira shall be entitled to
receive from Hana milestone payments, a percentage of Licensing/Sublicensing
Revenue and royalties, as applicable, pursuant to either the Agreement, as
amended hereby, or the UBC Sublicense, but in no event shall Hana be required to
make duplicate payments under both agreements with respect to any transaction
triggering such payment. The Parties agree that within thirty (30)
days of the Amendment No. 1 Effective Date, (a) the Parties shall execute an
amendment of the UBC Sublicense Agreement as contemplated by this Amendment and
the Acknowledgement, and (b) the Parties and UBC shall execute a new tripartite
consent agreement by and among UBC, Hana and Tekmira consenting to such
amendment to the UBC Sublicense.
12.2 The
Parties further acknowledge that, pursuant to this Amendment No. 1, Hana has no
obligation to Tekmira to make the payment to Tekmira as set forth in Section
3.3.1(a) of the Restated Agreement.
14. Miscellaneous. Except
as specifically modified or amended hereby, the Restated Agreement shall remain
in full force and effect and, as modified or amended, is hereby ratified,
confirmed and approved. Notwithstanding the foregoing, to the extent
any terms of this Amendment No. 1 conflict with the terms of the Restated
Agreement, the terms of this Amendment shall govern. No provision of
this Amendment No. 1 may be modified or amended except expressly in a writing
signed by both Parties nor shall any terms be waived except expressly in a
writing signed by the Party charged therewith.
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.
IN
WITNESS WHEREOF, the Parties have executed this Amendment No. 1 in duplicate
originals by their duly authorized representatives as of the Amendment No. 1
Effective Date.
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HANA BIOSCIENCES,
INC.
|
TEKMIRA PHARMACEUTICALS
CORPORATION
|
||||
| By: | /s/ Xxxxxx X. Xxxxxxxx | By: |
/s/ Xxx Xxxxxxxx
|
||
|
Name:
|
Xxxxxx X. Xxxxxxxx
|
Name:
|
Xxx Xxxxxxxx
|
||
|
Title:
|
President and Chief Executive
Officer
|
Title:
|
Chief Financial Officer
|
||
|
TEKMIRA
PHARMACEUTICALS CORPORATION
|
|||||
| By: |
/s/
Xxxx X. Xxxxxx
|
|
|||
|
Name:
|
Xxxx X. Xxxxxx
|
|
|||
|
Title:
|
President and Chief Executive
Officer
|
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