NOTE: Portions
of this Exhibit are the subject of a Confidential Treatment Request
by the Registrant to the Securities and Exchange Commission. Such
portions have been redacted and are marked with a “[*]”
in place of the redacted language.
RESEARCH AND COMMERCIAL LICENSE
OPTION AGREEMENT
This Research and Commercial License
Option Agreement (the “Agreement”) is made
and entered into as of October 1, 2005 (the “Effective
Date”) by and between Sangamo BioSciences, Inc., a
Delaware corporation having its principal place of business at
Point Richmond Tech Center, 501 Canal Boulevard, Suite A100,
Richmond, California 94804 (“Sangamo”), and
Dow AgroSciences
LLC, a Delaware limited liability company having its
principal place of business at 9330 Zionsville Road, Indianapolis,
Indiana 46268 (“DAS”). Sangamo and DAS are sometimes
referred to herein individually as a “Party” and
collectively as the “Parties.”
A.
Sangamo has expertise in, and proprietary technology relating to,
zinc finger proteins and their use to alter the genomes and/or
protein expression capabilities of organisms and cells, including
plants and plant cells.
B.
DAS has expertise in the use of genetically modified and
traditionally bred plants and plant cell cultures for agricultural
and industrial purposes as well as for the production of vaccines
and therapeutic products for human and/or animal health.
C.
DAS desires an exclusive license option under Sangamo’s
expertise and proprietary technology as applied to plant cells,
plants, and plant cell cultures, and Sangamo desires to grant such
an option, and both DAS and Sangamo desire to establish a research
collaboration to validate and optimize the application of such
Sangamo expertise and technology to plants, plant cells and plant
cell cultures for agricultural, industrial, and vaccine and
therapeutic product production purposes.
Now, Therefore, the Parties
agree as follows:
1.
1.1
“Affiliate” means, with respect to a particular
Party, a person, corporation, partnership, or other entity that
controls, is controlled by or is under common control with such
Party. For the purposes of the definition in this Section 1.1,
the word “control” (including, with correlative
meaning, the terms “controlled by” or “under the
common control with”) means the actual power, either directly
or indirectly through one or more intermediaries, to direct the
management and policies of such entity, whether by the ownership of
at least fifty percent (50%) of the voting stock of such entity, or
by contract or otherwise.
1.2
“Animal Health Product” a Licensed Product that is
used for diagnosis, treatment or prophylaxis of a disease or
medical condition in a non-human animal, for reducing or
eliminating pathogens in a non-human animal, or for nutritional
supplements or food additives for nutritional enhancements in a
non-human animal.
1.3
“Annual FTE Rate” means (a) for each year of
the Initial Research Term (i.e., until the third anniversary of the
Effective Date), $ *** per FTE and (b) for each year of the
Subsequent Research Term, $ *** per FTE plus an additional four percent (4%),
compounded annually, as a cost of living adjustment.
1.4
“Average Net Unit Return of the Trait” or
“ANURT” shall be calculated using the following
formula:
R is the DAS
reference price, which reference price shall in each case be equal
to the Net Unit Return for a unit of the germplasm into which the
applicable ZFP Trait was inserted or created. In the event the pure
germplasm is not sold in sufficient volume to establish a
reference
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***
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Certain
information on this page has been omitted and filed separately with
the Commission pursuant to a request for Confidential
Treatment.
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2.
price, then the
Net Unit Return for the nearest competitive germplasm will be used
as the reference price, and if substantially all of the competitive
germplasm is marketed with a particular Other Trait (referred to
hereinafter as an “embedded” Trait – an example
is glyphosate tolerance in soybeans), the reference price will be
for germplasm with the embedded Trait.
ANURP is the Net
Unit Return price for a unit of the germplasm of the resulting Crop
Product containing such ZFP Trait;
N is the number of
separate and commercially distinguishable Traits (both ZFP Traits
and Other Traits) in such Crop Product (excluding any embedded
Trait present in the reference germplasm); and
TPTR is the
royalties, if any, paid by DAS to a Third Party with respect to the
ZFP Trait in such Crop Product.
1.5
“CEO” shall have the meaning assigned to it in
Section 3.5(d).
1.6
“Collaboration” means all activities performed by
or on behalf of Sangamo or DAS in the course of performing the
activities described in, or fulfilling of their obligations
pursuant to, this Agreement.
1.7
“Confidential Information” shall have the meaning
assigned to it in Section 10.1.
1.8
“Contract Manufacturer” means a Third Party
contractor capable of carrying out the Manufacture of ZFP Products
at a quantity level and volume sufficient to supply Sangamo and DAS
for their activities under this Agreement and Sublicensees in
accordance with the terms of their Technology Licenses or their
research licenses granted by DAS pursuant to
Section 2.1(a)(ii).
1.9
“Control” means, with respect to an item of
Information or intellectual property right, that a Party owns or
has a license to such item or right and has the ability to disclose
such item and/or grant a license or sublicense as provided for in
this Agreement under such item or right without violating the terms
of any agreement or other arrangement with any Third
Party.
3.
1.10
“Core Patents” means (a) the United States
Sangamo Patents listed in Exhibit B; (b) any
non-provisional applications, additions, continuations,
continuations-in-part, divisions and substitutes thereof; and
(c) any reissue, re-examination, extension or patent term
extension of any such patent.
1.11
“Crop Product” means a Licensed Product that is a
human or animal food, human or animal food ingredient, or is used
to produce a human food, human food ingredient, or is a fiber.
Notwithstanding the foregoing, Crop Product shall not include any
Animal Health Product, Human Health Product or Industrial
Product.
1.12
“DAS Improvements” means (a) Improvements
(other than Joint Improvements) that are made by one or more
employees, consultants, or independent contractors of DAS or any
DAS Affiliate; and (b) Improvements made by Sublicensees
pursuant to research licenses granted by DAS pursuant to
Section 2.1(a)(ii), to the extent owned or controlled by DAS
or any DAS Affiliate.
1.13
“DAS Improvement Patent” means any Improvement
Patent that claims a DAS Improvement.
1.14
“DAS Product” means any Licensed Product arising
from DAS’s or its Affiliate’s activities in the Field
(a Licensed Product arising solely from a Sublicensee’s
activities in the Field is not included in DAS Product).
1.15
“DAS Program Inventions” means (a) Program
Inventions (other than Joint Program Inventions) that are made by
one or more employees, consultants, or independent contractors of
DAS or any DAS Affiliate, and (b) Program Inventions made by
Sublicensees, to the extent owned or controlled by DAS or any DAS
Affiliate.
1.16
“DAS Program Patent” means a Program Patent that
claims a DAS Program Invention.
1.17
“DAS ZFP Trait ” means a ZFP Trait arising from
DAS’s activities in the Field.
1.18
“Diligent Efforts” means the carrying out of
obligations or tasks in a sustained manner consistent with the
efforts a Party devotes to a product or a research, development
or
4.
marketing
project of similar market potential, profit potential or strategic
value resulting from its own research efforts, based on conditions
then prevailing. Diligent Efforts requires that the Party:
(a) promptly assign responsibility for such obligations to
specific employee(s) who are held accountable for progress and
monitor such progress on an on-going basis, (b) set and
consistently seek to achieve specific and meaningful objectives for
carrying out such obligations, and (c) consistently make and
implement decisions and allocate resources designed to advance
progress with respect to such objectives.
1.19
“Field” means gene targeting and/or gene regulation
using a ZFP Product to modify the genome of a plant cell, plant, or
plant cell culture (in each case, whether constituting or derived
from a vascular or non-vascular plant), or alter the nucleic acid
or protein expression in a plant cell, plant, or plant cell
culture. For the purpose of this Agreement,
“non-vascular” plants shall include but not be limited
to algae, moss, and fungi. Explicitly excluded from the Field are
delivery of any ZFP Product into a human or animal for diagnostic,
therapeutic or prophylactic purposes, and products intended to
result in such delivery.
1.20
“Field Specific Sangamo Patent” means any Sangamo
Patent in which all claims are directed to methods that are solely
useful in the Field, or to compositions of matter or methods of
manufacture of ZFP Products that are solely useful in the Field.
Exhibit A may be amended from time to time to identify and
update identification of Field Specific Sangamo Patents.
1.21
“Food Safety Product” means an Animal Health
Product for reducing or eliminating pathogens in non-human animals
that may be used to produce human food.
1.22
“FTE” means the equivalent of one employee or
consultant of Sangamo working full time for one twelve
(12) month period.
1.23
“Full-scale Product Launch” means commercial
offering of a product for an entire national market or for an
entire targeted market geography, as opposed to test
marketing.
1.24
“Generally Applicable Sangamo Patents” means all
Sangamo Patents (other than Field Specific Sangamo Patents) that
claim compositions of matter or methods that are reasonably
necessary or useful in the Field. Exhibit A may be amended
from time to time to
5.
identify and
update identification of Generally Applicable Sangamo
Patents.
1.25
“GMO Product” means any Crop Product that is a DAS
Product and is not a Non-GMO Product.
1.26
“Human Health Product” means any Licensed Product
(a) that is intended for the diagnosis, treatment or
prophylaxis of a disease or medical condition in a human or
(b) that is extracted from plant material and intended to be
ingested by or topically applied or otherwise delivered or
administered to humans, food, and food ingredients (e.g. oils),
including without limitation nutraceuticals, vitamins, nutritional
supplements, food additives, shampoo, soap, sunscreen, and
cosmetics.
1.27
“Improvement” means any enhancement, modification,
or improvement to the Sangamo Technology, whether patentable or
not, made during the term of the Agreement by one or more
employees, consultants, or independent contractors of DAS, a DAS
Affiliate, or a Sublicensee, but excluding any Product Specific
Invention. A “Joint Improvement” is an Improvement made
by one or more employees, consultants, or independent contractors
of both Parties.
1.28
“Improvement Patent” means any patent or patent
application in the United States or any foreign jurisdiction
claiming an Improvement.
1.29
“Industrial Product” means a Licensed Product that
is (a) a raw material for construction, textiles, or
industrial applications (e.g. biomaterials, biofeedstocks,
alternative raw materials), (b) a plant or plant part that
produces or is used as a product described in (a), or
(c) germplasm, seeds or other plant-derived material capable
of propagating a plant described in (b). Notwithstanding the
foregoing, Industrial Product shall not include any Animal Health
Product or Human Health Product.
1.30
“Information” means information, results and data
of any type whatsoever, in any tangible or intangible form
whatsoever, including without limitation, databases, inventions,
practices, methods, techniques, specifications, formulations,
formulae, knowledge, know-how, skill, experience, test data
including pharmacological, biological, chemical, biochemical,
toxicological and clinical test data, analytical and quality
control data, stability data, studies and
6.
procedures, and
patent and other legal information or descriptions.
1.31
“Infringement” shall have the meaning set forth in
Section 9.6(a).
1.32
“Initial Research Term” means the period of time
commencing on the Effective Date and continuing, unless the
Agreement is earlier terminated pursuant to Article 11, until
the third anniversary of the Effective Date.
1.33
“Joint Inventions” means inventions, whether
patentable or not, that are made by one or more employees,
consultants, or independent contractors of both Parties. Joint
Program Inventions are Joint Inventions that are Program
Inventions. For clarity, Joint Inventions shall include Joint
Improvements, but shall exclude jointly made Product Specific
Inventions.
1.34
“Joint Patent” means a patent or patent application
that claims a Joint Invention. “Joint Program Patent”
means a Joint Patent that claims a Joint Program Invention.
“Joint Improvement Patent” means a Joint Patent that
claims a Joint Improvement.
1.35
“Joint Research Team” or “JRT” means the
committee described in Sections 3.4 and 3.6.
1.36
“Joint Steering Committee” or “JSC” means
the committee described in Sections 3.4 and 3.5.
1.37
“Licensed Product ” means any product, other than a
ZFP Product, that is created or produced directly or indirectly
through use of Sangamo Technology in the Field by DAS or its
Affiliates or its Sublicensees. For clarity it is reiterated that
the Field explicitly excludes products intended to deliver into a
human or an animal any ZFP Product for diagnostic, therapeutic or
prophylactic purposes; therefore Licensed Product also excludes
such products.
1.38
“Licensing Program” means the program under which
DAS grants Technology Licenses to Sublicensees, as described in
more detail in Article 5.
1.39
“Major Crop” means one of the following six crops:
corn, cotton, canola oil/oil seed rape, rice, wheat, and
soybean.
7.
1.40
“Manufacture” or “Manufacturing ” means
the design, optimization, construction, production, and testing of
ZFP Product.
1.41
“Minimum Annual Payment” means each payment
described in Section 8.7.
1.42
“Net Average Trait Value” means the Average Net
Unit Return of the Trait multiplied by the net volume sold of the
applicable DAS Product.
1.43
“Net Sales” means the amount invoiced or otherwise
billed by DAS or its Affiliate or sublicensee for sales or other
commercial disposition of a DAS Product to a Third Party purchaser,
less the following to the extent included in such billing or
otherwise actually allowed or incurred with respect to such sales:
(i) discounts, including cash, trade and quantity discounts,
price reduction programs, retroactive price adjustments with
respect to sales of a product, charge-back payments and rebates
granted to trade customers; (ii) credits or allowances
actually granted upon rejections or returns of DAS Products,
including for replants, recalls or damaged goods; (iii) freight,
postage, shipping and insurance charges actually allowed or paid
for delivery of DAS Products, to the extent billed;
(iv) customs duties, surcharges and other governmental charges
incurred in connection with the exportation or importation of a DAS
Product; (v) bad debts relating to sales of DAS Products that
are actually written off by the seller in accordance with generally
accepted accounting principles, consistently applied, during the
applicable royalty calculation period; and (vi) taxes, duties
or other governmental charges levied on, absorbed or otherwise
imposed on sale of DAS Products, including without limitation
value-added taxes, or other governmental charges otherwise measured
by the billing amount, when included in billing, as adjusted for
rebates and refunds, but specifically excluding taxes based on net
income of the seller; provided that all of the foregoing deductions
are calculated in accordance with generally accepted accounting
principles consistently applied throughout the selling
party’s organization.
Notwithstanding
the foregoing, if any DAS Product is sold under a bundled or
capitated arrangement with other products, then, solely for the
purpose of calculating Net Sales for royalty purposes hereunder,
any discount on such DAS Products sold under such an arrangement
shall be no greater, on a percentage basis based on the gross
selling price prior to discount, than the largest percentage
discount applied on any other product sold within such bundled
arrangement
8.
for the
applicable accounting period. In case of any dispute as to the
applicable discount numbers under the preceding sentence, the
determination of same shall be calculated and certified by the
selling party’s independent public accountants, whose
decision shall be binding.
For sake of
clarity and avoidance of doubt, sales by DAS, its Affiliates or
sublicensees of a DAS Product to a Third Party distributor of such
DAS Product in a given country shall be considered a sale to a
Third Party customer.
1.44
“Net Unit Return” means Net Sales divided by the
net number of units sold.
1.45
“Non-GMO Designation” means that consultation with
relevant regulatory authorities in the United States, European
Union, Japan, and Canada has confirmed that Regulatory Approval for
a particular Crop Product is not required in any of
them.
1.46
“Non-GMO Product” means a Crop Product that is a
DAS Product and for which the criteria of Non-GMO Designation have
been satisfied.
1.47
“Option Exercise Notice” means DAS’s notice
pursuant to Section 2.2.
1.48
“Option Period” means the period commencing on the
Effective Date of this Agreement and ending on Sangamo’s
timely receipt of the Option Exercise Notice and the option fee set
forth in Section 8.6.
1.49
“Other Trait” means a Trait that is introduced,
enhanced, modified, deleted or otherwise altered through methods
that do not involve the use of ZFP Products.
1.50
“Product Specific Invention” means an invention,
whether patentable or not, that (a) is made by
(i) Sangamo in carrying out the Research Program or
Manufacturing ZFP Products for DAS or Sublicensees pursuant to
Section 7.1 or (ii) DAS or its Affiliates or Sublicensees
under this Agreement and (b) is specific to (i) a ZFP
Product that is directed to a particular DNA sequence in a plant
and solely useful for modifying the sequence or expression of a
gene in such plant related to such DNA sequence, or (ii) the
modified form of such DNA sequence (or the modified protein encoded
by such modified DNA sequence) as found in the resulting Licensed
Product.
9.
1.51
“Program Inventions” means inventions, other than
Improvements and Product Specific Inventions, that are
(a) made by the Parties (or any Affiliates or Third Parties
conducting Research Program activities on behalf of a Party) in
carrying out the Research Program, (b) otherwise arising from
DAS’s activities in the Field during the Option Period, or
(c) made by Sublicensees during the Option Period pursuant to
research licenses granted by DAS pursuant to
Section 2.1(a)(ii).
1.52
“Program Patent” means any patent or patent
application in the United States or any foreign jurisdiction that
claims a Program Invention.
1.53
“Regulatory Approval” means any and all approvals
(including supplements, amendments, pre- and post-approvals,
pricing and reimbursement approvals), licenses, registrations or
authorizations of any national, supra-national (e.g., the European
Commission or the Council of the European Union), regional, state
or local regulatory agency, department, bureau, commission, council
or other governmental entity, that are necessary for the
manufacture, distribution, use or sale of a DAS Product in a
regulatory jurisdiction, as well as applicable import approvals in
Japan and Canada. Regulatory Approval does not include a
confirmation by a regulatory agency that its approval is not
required.
1.54
“Research Budget” means the written budget prepared
by Sangamo and presented to the JSC for approval outlining a good
faith approximation of FTE expenditures and all other costs and
expenses that Sangamo expects to incur in carrying out the tasks
assigned to it under the Research Plan.
1.55
“Research Plan” means the written description of
the overall program for the conduct of the Research Program,
including an allocation of responsibilities between the Parties for
implementation, as amended or revised from time to time by the JSC
pursuant to Section 4.2. A preliminary Research Plan for the
Initial Research Term has been agreed upon by the Parties in a
separate side letter. The Research Plan shall include the Research
Budget.
1.56
“Research Program” means the collaborative research
program undertaken by the Parties to validate and optimize the
application of the Sangamo Technology to the Field.
1.57
“Research Term” means the Initial Research Term
plus the Subsequent Research
10.
1.58
“Sangamo Know-How” means all Information (other
than Sangamo Patents) that (a) is Controlled, during the term
of this Agreement, by Sangamo or by any entity that is a Sangamo
Affiliate during the Research Term and (b) is reasonably
necessary or useful in the Field; including any Sangamo Program
Invention. Sangamo Know-How shall not include any Information
licensed to Sangamo or a Sangamo Affiliate by a Third Party unless
such Information is licensed pursuant to a Third Party License and
meets the aforementioned criteria for Sangamo Know-How.
1.59
“Sangamo Patent” means (a) any patent or
patent application Controlled, during the term of this Agreement,
by Sangamo or by any entity that is a Sangamo Affiliate during the
Research Term, in the United States or any foreign jurisdiction,
that is reasonably necessary or useful in the Field or otherwise
claims the composition of matter, manufacture, or use of ZFP
Products; (b) any non-provisional application, addition,
continuation, continuation-in-part or division thereof or any
substitute application therefor; (c) any patents issuing on
any of the foregoing; (d) any reissue, re-examination,
extension or patent term extension of any such patent, and any
confirmation patent or registration patent or patent of addition
based on any such patent; and (e) any foreign equivalent of the
foregoing; including any Sangamo Program Patent. A patent or patent
application licensed to Sangamo or a Sangamo Affiliate by a Third
Party shall not be a Sangamo Patent unless such patent or patent
application is licensed pursuant to a Third Party License and meets
the aforementioned criteria for a Sangamo Patent. Sangamo Patents
identified as of the Effective Date are listed in Exhibit A,
which may be updated by Sangamo from time to time. Sangamo Patents
do not include DAS Improvement Patents, DAS Program Patents, or any
patents on Improvements made by Sublicensees. In Exhibit A,
each Sangamo Patent may be designated as a Field Specific Sangamo
Patent or Generally Applicable Sangamo Patent as mutually agreed
upon by the Parties.
1.60
“Sangamo Program Inventions” means Program
Inventions (other than Joint Program Inventions) that are made by
one or more employees, consultants, or independent contractors of
Sangamo or its Affiliates.
1.61
“Sangamo Program Patent” means any Program Patent
that claims a Sangamo
11.
1.62
“Sangamo Technology” means the Sangamo Patents and
the Sangamo Know-How.
1.63
“Stacking Crop Product” means a Crop Product that
(a) is a DAS Product, (b) is the direct or indirect
result of using one or more ZFP Products to produce a plant or
plant cell comprising Traits, where these Traits were each
available in separate plants or plant cells that could have been
crossed to produce a breeding stack of the two Traits, and
(c) is not the result of any other activity in the
Field.
1.64
“Sublicensee” means a Third Party that has entered
into a Technology License or received a research license granted by
DAS pursuant to Section 2.1(a)(ii).
1.65
“Sublicensing Revenues” means any cash
consideration that DAS receives from a Sublicensee in connection
with a Technology License, which may include (without limitation)
upfront license fees, annual license or maintenance payments,
milestone payments, royalties, credits against DAS’ future
expenses, or reductions in royalties or other payments otherwise
owed to the Sublicensee. Sublicensing Revenue also includes all
cash consideration received by DAS in connection with any research
license it grants pursuant to Section 2.1(a)(ii). Sublicensing
Revenue does not include the value of non-cash consideration
received by DAS, the Parties having expressly agreed that DAS is
not obligated to account to Sangamo for such
consideration.
1.66
“Subsequent Research Term” means the period of time
commencing on the expiration of the Initial Research Term and
continuing until it is terminated in accordance with
Section 4.1 or the Agreement is terminated pursuant to
Article 11, whichever is first.
1.67
“Technology License” means an executed and in-force
written agreement between DAS and a Third Party, wherein such Third
Party obtains a license under the Sangamo Technology to use ZFP
Products in the Field for the sole purpose of generating Licensed
Products and to use, make, have made, import, sell, and offer for
sale such Licensed Products. Technology License does not include a
Trait license granted by DAS to a Third Party to commercialize a
DAS Trait pursuant to Section 6.2, and does not include research
licenses
12.
granted by DAS
pursuant to Section 2.1(a)(ii).
1.68
“Third Party” means any entity other than
(i) Sangamo, (ii) DAS or (iii) an Affiliate of
either Party.
1.69
“Third Party License” shall mean (a) any of
the agreements set forth in Exhibit C and (b) any agreement
that is deemed to be a Third Party License in accordance with the
terms of Section 2.6(b).
1.70
“Trait” means a distinguishing characteristic or
quality of an organism resulting from (a) modified expression
of existing genes in the organism, (b) modification of the
coding sequence of an existing gene in the organism, or
(c) insertion of DNA sequences from a different
source.
1.71
“Trait Crop Product” means a Crop Product that is a
DAS Product but is not a Stacking Trait Product.
1.72
“ZFP Product” means a zinc-finger protein
(including a zinc-finger transcription factor or a zinc-finger
nuclease), or a nucleic acid encoding and capable of expressing
such protein in a cell or tissue.
1.73
“ZFP Trait” means a Trait that is introduced,
enhanced, modified, deleted or otherwise altered through activities
in the Field.
(a) Grants to DAS Effective upon Signing. S ubject to
the terms and conditions of this Agreement, Sangamo hereby grants
to DAS and its Affiliates the following licenses and rights under
Sangamo Technology:
13.
(i) a world-wide, co-exclusive (with Sangamo) research
license under Sangamo Technology to use ZFP Products in the Field
for research purposes and to make and test Licensed Products for
research purposes;
(ii) the exclusive right to grant research licenses to
Third Parties to use ZFP Products in the Field for research
purposes and to make and test Licensed Products for research
purposes; and
(iii) the exclusive right to grant to Sublicensees a
license (A) to use ZFP Products in the Field for the sole
purpose of generating Licensed Products and (B) to use, make,
offer to sell, sell, and import such Licensed Products, all
pursuant to Technology Licenses.
(b) Additional Grants to DAS Effective after Exercise of
Option. Subject to the terms and conditions of this Agreement,
Sangamo hereby grants to DAS and its Affiliates, effective upon
DAS’s exercise of the Option (which exercise shall include
timely provision of the Option Exercise Notice and timely payment
of the fee set forth in Section 8.6), the following additional
licenses and rights under Sangamo Technology:
(i) a royalty bearing, world-wide, exclusive license
to make, use, and import ZFP Products for use in the Field, which
DAS shall exercise for the sole purposes of
(1) generating DAS Products; or
(2) offering for sale and selling ZFP Products at cost
to Sublicensees for use in the Field for the sole purpose of
generating Licensed Products;
provided,
however, that with respect to the Manufacture of ZFP Products for
use in the Field, such license is co-exclusive with Sangamo and any
Contract Manufacturer, DAS shall not exercise such license until
Sangamo has transferred its Manufacturing technology to DAS
pursuant to Section 7.2, and Sangamo shall only use its
coexclusive rights in the Field with respect to Manufacture of ZFP
Products to fulfill its obligations under Section 7.1;
and
(ii) a royalty bearing, world-wide, exclusive license
to make, use, sell, offer for sale, and import DAS
Products.
14.
(c) Sublicensing . DAS shall not have the right to
sublicense its right to grant research licenses and Technology
Licenses under Section 2.1(a) nor sublicense its rights under
Section 2.1(b)(i), other than to a Contract Manufacturer selected
by DAS and approved by Sangamo for the sole purpose of
Manufacturing ZFP products in accordance with the terms of this
Agreement. The license set forth in Section 2.1(b)(ii) shall
be freely sublicensable. Sublicensees may be given the right to
further sublicense Licensed Products that they develop under
Technology Licenses, and Sublicensees may be given the right to
license Third Parties to make, use, offer to sell, sell, or import
products containing ZFP Traits that the Sublicensees develop under
Technology Licenses (i.e., license their Traits), provided that
licenses do not grant any sublicenses under or rights with respect
to Sangamo Technology.
(d) Non-exclusive rights for Animal Health Products and
Human Health Products . Notwithstanding anything to the
contrary in this Agreement, each of the licenses and rights granted
in 2.1(a) and 2.1(b) shall be non-exclusive with respect to Animal
Health Products and Human Health Products.
2.2 Option
Period. The Parties acknowledge and agree that the Research
Program is intended to provide DAS with an opportunity to evaluate
the Sangamo Technology and the utility of ZFP Products in the Field
for the generation of Licensed Products and to determine whether
DAS intends to exercise the Option. Accordingly, unless DAS
notifies Sangamo in writing on or before the third anniversary of
the Effective Date, that DAS desires to generate, develop and
commercialize DAS Products (such notice, the “Option Exercise
Notice”) and timely pays the fee set forth in Section 8.6,
this Agreement (including without limitation the licenses set forth
in Section 2.1) shall terminate in accordance with
Section 11.3. DAS hereby covenants that DAS and its Affiliates
will not practice the licenses set forth in Section 2.1(b)
during the Option Period.
(a) Manufacturing License. Subject to the terms and
conditions of this Agreement, DAS hereby grants to Sangamo and its
Affiliates a worldwide, fully paid, license under the Improvements,
DAS Program Inventions, and Joint Program Inventions (and any
patents or patent applications claiming the same) solely to
Manufacture ZFP Products for use in
15.
the Field by
DAS or its Sublicensees. Such license shall be sublicensable solely
to a Contract Manufacturer.
(b) Licenses under Improvements and Program Inventions.
Subject to the terms and conditions of this Agreement, DAS hereby
grants to Sangamo and its Affiliates a worldwide, fully paid,
perpetual, irrevocable (except pursuant to Section 11.2(e)),
exclusive license (with the right to sublicense) to practice the
DAS Improvements, Joint Improvements, DAS Program Inventions, and
Joint Program Inventions (and all patents and patent applications
claiming the same) for all purposes outside the Field.
2.4 Sangamo
Retained Rights.
(a) Notwithstanding anything to the contrary in this
Agreement, Sangamo shall retain the exclusive right to make and use
ZFP Products for uses outside the Field.
(b) Sangamo retains the right to use Sangamo Technology in
yeast and to grant Third Parties the right to use Sangamo
Technology in yeast. (It is intended that DAS has a non-exclusive
right to use Sangamo Technology in yeast in accordance with
Section 2.1.)
(a) DAS hereby covenants that it shall not use or practice,
nor shall it cause or permit any of its Affiliates or sublicensees
(including Sublicensees) to use or practice, directly or
indirectly, any Sangamo Technology for any other purposes other
than those expressly permitted by this Agreement.
(b) Sangamo hereby covenants that it shall not use or
practice, nor shall it cause or permit any of its any Affiliates or
sublicensees to, use or practice, directly or indirectly, any DAS
Improvement, DAS Program Invention, or Product Specific Invention
for any other purposes other than those expressly permitted by this
Agreement.
2.6 Third
Party Licenses.
(a) The licenses granted to DAS in Section 2.1 include
sublicenses under Sangamo Technology licensed to Sangamo pursuant
to Third Party Licenses. Such sublicenses
16.
are subject to
(i) the limitations set forth in the Third Party Licenses
(including without limitation any limitations on the scope and
exclusivity of the licenses granted to Sangamo thereunder and any
constraints on Sangamo’s ability to prosecute or enforce
Sangamo Patents licensed pursuant to such Third Party Licenses) and
(ii) DAS’s satisfaction of the non-financial terms and
conditions of the Third Party Licenses, including without
limitation those terms set forth on Exhibit D. DAS understands
and acknowledges that (1) the Collaborative Agreement between
Gendaq Limited and *** dated *** (the “ *** Agreement”)is not a Third Party License,
(2) the licenses granted to DAS under Section 2.1 do not
include sublicenses of any licenses received by Sangamo under
the ***
Agreement as a result of
Sangamo’s acquisition of Gendaq Limited, and (3) with
respect to any patents or patent applications included within the
Sangamo Patents that are addressed in the *** Agreement, the licenses granted to DAS in
Section 2.1 to such patents and patent applications are only
licenses under Sangamo’s ownership interest in such patents
and patent applications. DAS further understands and acknowledges
that, notwithstanding the fact that the Patent License Agreement
between ***
and Sangamo dated
*** , as amended, (the “
*** Agreement”) is a Third Party License,
(A) the licenses granted to DAS under Section 2.1 do not
include sublicenses under the patents and patent applications
licensed to Sangamo pursuant to the Fifth Amendment to the
*** Agreement (such amendment being dated
*** ) and (B) such patents and patent
applications are not Sangamo Patents.
(b) The licenses granted to DAS in Section 2.1 shall
only be expanded to include sublicenses under intellectual property
licensed to Sangamo by a Third Party after the Effective Date (and
the license agreement under which such intellectual property is
licensed to Sangamo shall only be deemed to be a Third Party
License) if:
(i) such intellectual property is reasonably necessary
or useful in the Field and Sangamo’s license thereto includes
the Field;
(ii) Sangamo discloses the substantive terms of such
agreement to DAS for review a reasonable amount of time in advance
of Sangamo’s anticipated entry into such a license agreement
(which Sangamo hereby covenants to do); and
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(iii) DAS provides Sangamo with written notice, prior
to Sangamo’s entry into such license agreement, in which
(1) DAS consents to adding such license agreement to the
definition of Third Party License, (2) DAS assumes the
obligations set forth in Section 8.11(b) with respect to such
license agreement as well as all other obligations of such license
agreement that are applicable to sublicensees thereunder, and
(3) DAS acknowledges in writing that its sublicense under such
license agreement is subject to the terms and conditions of such
license agreement.
(c) DAS hereby covenants (unless it receives prior written
consent from Sangamo, which Sangamo shall not unreasonably
withhold) that it shall not itself directly license from Third
Parties any intellectual property relating to ZFP Products without
first notifying Sangamo in writing of such Third Party intellectual
property and providing Sangamo with a reasonable opportunity to
obtain a license from such Third Party.
OVERVIEW AND MANAGEMENT OF THE
COLLABORATION
3.1 Overview
of the Collaboration. Sangamo and DAS will conduct a Research
Collaboration pursuant to the terms and conditions set forth in
this Agreement. They will also cooperate in carrying out the
Licensing Program. During the Option Period, DAS may conduct
research under its research license apart from the Research
Program, provided DAS shall disclose to Sangamo the general subject
matter (but not necessarily the specific targets) of all such
research, and shall disclose to Sangamo any Improvements or Program
Inventions arising from such research.
3.2 Research
Program. The goal of the Research Program will be to validate
and optimize the Sangamo Technology for use in the Field and enable
DAS to determine whether it wishes to exercise the
Option.
3.3 Licensing
Program. To the extent that DAS in its discretion decides to
pursue the Licensing Program, the Parties will cooperate to supply
ZFP Products to Sublicensees.
3.4 Overall
Management Structure . The management of the Collaboration
shall be
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vested in a
Joint Steering Committee (the “JSC”) and Joint Research
Team (the “JRT”), with responsibilities, as further
discussed in Sections 3.5 and 3.6, respectively.
3.5 Joint
Steering Committee.
(a) Membership. The JSC shall be composed of at least
four (4) members, two (2) members appointed by each
Party. The JSC will consist of senior members from each Party
authorized to make decisions with respect to matters including, but
not limited to, setting research goals, determining program
expansions, determining the criteria for the special research
milestone payments and when such criteria are met, resolving
disputes, and making strategic decisions. Promptly following the
Effective Date, each Party shall appoint its initial representative
to the JSC. Each Party may replace its JSC representatives at any
time upon written notice to the other Party. DAS will designate one
of its representatives as the Chairperson of the JSC. The
Chairperson shall be responsible for scheduling meetings, preparing
and circulating an agenda in advance of each meeting, preparing and
issuing minutes of each meeting within thirty (30) days
thereafter, revising such minutes to reflect timely comments
thereon, and overseeing the ratification of such revised
minutes.
(b) Meetings . During the Research Term, the JSC shall
meet a minimum of one (1) time every six (6) months.
After the Research Term has expired, the JSC shall meet at the
request of either Party, which request may be made by each Party
not more than once in each six (6) month period following the
end of the Research Term, unless otherwise agreed to by unanimous
consent of all members of the JSC. The Parties shall endeavor to
schedule meetings of the JSC at least six (6) months in advance.
Meetings for the JSC shall be held on an alternating basis in
Richmond, California (or such other location in the continental
United States as may be chosen by Sangamo) and Indianapolis,
Indiana (or such other location in the continental United States as
may be chosen by DAS). With the consent of the representatives of
each Party serving on a particular committee, other representatives
of each Party may attend meetings of that committee as non-voting
observers. A meeting of the JSC or a subordinate committee may be
held by audio or video teleconference with the consent of each
Party, provided that at least half of all meetings for that
committee in each calendar year shall be held in person. Meetings
of the JSC or a subordinate committee shall be effective only if at
least one
19.
representative
of each Party is present or participating. Each Party shall be
responsible for all of its own expenses of participating in the
committee meetings.
(c) Responsibilities . The JSC shall:
(i) Manage and direct the implementation of the
Agreement with the assistance of the Joint Research Team as
described in Section 3.6;
(ii) Establish the strategic direction of the Research
Program;
(iii) Oversee and direct the planning and execution of
the Research Plan;
(iv) Evaluate the progress of the Research
Program;
(v) Determine the completion of milestones set forth
in Sections 8.4 and 8.5;
(vi) Review, comment upon and approve any amendments
or modifications to the Research Plan (including, if applicable,
the Research Budget) within thirty (30) days of
receipt;
(vii) Have authority to establish one or more other
committees that report to the JSC and assist the JSC in managing
and directing the Research Program. Any committees formed beyond
the JSC shall be subordinate to the JSC, shall have such membership
and responsibilities as the JSC shall determine, and may be
disbanded by the JSC at any time. Each Party shall use good faith
and cooperative efforts to facilitate and assist the efforts of the
JSC and all additional committees established by the JSC. For
clarity, the JSC does not have any authority beyond the specific
matters set forth in this Agreement, and cannot in any way amend or
modify the terms or provisions of this Agreement;
(viii) Resolve, or attempt to resolve any disputes not
resolved by the Joint Research Team or any other subordinate
committees created by the JSC;
(ix) Perform such other functions as appropriate to
further the purposes
20.
of this
Agreement and as allocated to it in writing by the Parties;
and
(x) Critically review the results of the Research
Program during the first half of the eighth calendar quarter of the
Initial Research Term, to make a finding whether or not the results
have been so disappointing, based for example on consistent failure
to achieve the research milestones set forth in the Research Plan,
that exercise of the Option by DAS is highly unlikely.
(d) Decision Making; Authority. The JSC shall make its
decisions by consensus, with each Party’s representatives
collectively having one vote. If the JSC is unable to reach
consensus regarding a matter before it, the issue shall be
presented by the JSC to the Chief Executive Officer of each Party
(or his or her designee) ( “CEO” ) for
resolution. Once an issue has been presented to the CEOs, the CEOs
shall have fifteen (15) days to make a final determination
regarding the issue in dispute. In the event that the CEOs are
unable to reach a final determination within such fifteen
(15) day period, then the Parties shall present the issue to a
single arbitrator under the rules of the American Arbitration
Association applicable to expedited arbitrations. For clarity, the
foregoing shall only apply to issues remaining unresolved by the
JSC pursuant to this Section 3.5(d) and shall not apply to any
other dispute arising out of or relating to this Agreement
(including without limitation any disputes regarding a
Party’s alleged breach of this Agreement), which shall
instead be resolved pursuant to Section 8.17, 12.6(d) or 14.1.
The JSC does not have any authority beyond the specific matters set
forth in this Agreement, and cannot in any way amend or modify the
terms or provisions of this Agreement.
(a) Membership. The Joint Research Team
(JRT) shall consist of at least two (2) representatives from
each Party, with at least one (1) representative from each
Party being a scientist responsible in their respective
organizations for day-to-day management of the Research Program. No
more than one (1) member from each Party shall be a member of
both the JSC and the JRT.
(b) Responsibilities. The JRT shall report to and be
subordinate to the JSC. The JRT will manage implementation of the
Research Program, review results of the Research
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Program, and
suggest changes in the Research Plan or the Research Budget to the
JSC when such changes appear to be advisable to achieve the goals
of the Research Program. Upon expiration of the Research Term, the
JSC may dissolve the JRT.
(c) Meetings. The JRT shall meet at least quarterly,
and on a monthly basis shall confer by telephone conference or
video conference, or both, during the Research Term. Each Party
shall have (1) vote. Disputes shall be referred to the JSC,
and if they cannot be resolved at that level, will be resolved in
accordance with the procedure described in
Section 3.5(d).
3.7
Collaboration Guidelines.
(a) General. In all matters related to implementation
of the Agreement, the Parties shall be guided by standards of
reasonableness in economic terms and fairness to each of the
Parties, striving to balance the legitimate interests and concerns
of the Parties and further the Research Program.
(b) Independence. Subject to the terms of this
Agreement, the activities and resources of each Party shall be
managed by such Party, acting independently and in its individual
capacity. The relationship between Sangamo and DAS is that of
independent contractors and neither Party shall have the power to
bind or obligate the other Party in any manner, other than as is
expressly set forth in this Agreement.
4.1 Research
Term. The Research Program shall be conducted solely during the
Research Term. Each Party’s obligations under the Research
Plan and DAS’s research funding commitments set forth in
Section 8.3 shall remain in force during the Research Term and
shall terminate at the end of the Research Term. The Subsequent
Research Term shall end when the Parties agree in writing to
terminate it or are not able to agree upon additional work to
be
22.
performed under
the Research Plan.
4.2 Research
Plan. The Parties have agreed upon an initial Research Plan,
which is set forth in a separate side letter. Within one hundred
and twenty (120) days following the Effective Date, the JSC
shall update and finalize a new version of the Research Plan, which
will include a full description of the events calling for special
research milestone payments required by Section 8.4. During
the Research Term, the JSC shall review the Research Plan at least
semiannually and may generate revised versions of the Research Plan
that are consistent with the terms of this Agreement and the goals
of the Collaboration. Significant changes in the scope or direction
of the work and, any funding requirements exceeding one hundred
fifteen percent (115%) of the Research Budget must be approved by
the JSC. Without such approval, the most recently approved Research
Plan shall remain in effect. Once approved by the JSC, such revised
Research Plan shall replace the prior Research Plan. The Research
Plan shall allocate between the Parties responsibility for each of
the Research Program activities described therein in a manner
consistent with this Agreement. It is anticipated that Sangamo
shall be primarily responsible for the Manufacture of ZFP Products,
and that DAS shall be primarily responsible for the implementation
of the use of ZFP Products in plants.
4.3 Use of
Subcontractors. Either Party may subcontract portions of the
activities allocated to it under the Research Plan to any of its
Affiliates, or to a Third Party, provided that such Third Party
receives the prior approval of the JSC. Notwithstanding the
foregoing, the JSC may expressly waive this requirement with
respect to the subcontracting of certain Research Program
activities that both Parties agree should be within the sole
discretion of a Party.
4.4 Reports to
JSC. At each meeting of the JSC during the Research Term and
the six-month period following the end of the Research Term, each
Party shall submit to the JSC a written progress report summarizing
the work performed under the Research Plan since the last
meeting.
4.5 Conduct of
Research Program. The Parties shall use Diligent Efforts to
conduct their respective tasks assigned pursuant to the Research
Plan and to attempt to achieve the objectives of the Research
Program efficiently and expeditiously. Each Party shall conduct its
portion of the Research Program in good scientific manner, and in
compliance in all material
23.
respects with
the requirements of applicable laws, rules and regulations and all
applicable good laboratory practices.
4.6 Research
Funding. DAS shall be solely responsible for supporting the
costs of its own efforts under the Research Plan, including but not
limited to all costs and expenses associated with DAS personnel.
DAS shall support Sangamo’s efforts under the Research Plan
in the ways described in Section 8.3.
5.1
General. DAS shall have the right, but not the obligation for
marketing ZFP Products to Third Parties for use in the Field and
for negotiating Technology Licenses with such Third Parties, all of
which shall be carried out at DAS’s sole expense. DAS shall
keep Sangamo reasonably informed regarding all Technology License
negotiations. DAS shall provide Sangamo with a copy of each
executed Technology License within thirty (30) days after
execution. DAS shall also provide Sangamo with copies of research
licenses that it grants pursuant to Section 2.1(a)(ii) within
thirty (30) days after execution. With respect to any
Technology License or research license that includes a sublicense
under a Third Party License that requires Sangamo to provide to the
applicable Third Party licensor a copy of any Technology License or
research license or a summary of the terms of such Technology
License or research license, Sangamo shall be permitted to provide
such Third Party licensor with such copy or summary.
5.2 Technology
Licenses. DAS shall ensure that all Technology Licenses comply
with the following requirements:
(a) No Technology License shall obligate (or purport to
obligate) Sangamo, without Sangamo’s express prior written
consent, to any obligation other than Manufacture of ZFP Products
under the terms and conditions set forth in
Article 7.
(b) Each Technology License granted during the Option Period
shall require the relevant Sublicensee to pay milestones and
royalties to DAS that are no less than DAS’s
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milestone and
royalty obligations to Sangamo, as set forth in Sections 8.9
and 8.10, for the corresponding products arising from such
Sublicensee’s activities in the Field.
(c) Each Technology License shall include provisions
permitting DAS, upon termination of this Agreement, to assign its
rights and obligations to Sangamo (or, in the case of Manufacturing
obligations, a Contract Manufacturer, as the case may be) in a
manner consistent with the relevant sections of
Article 11.
(d) Each Technology License shall require the relevant
Sublicensee to:
(i) disclose in a timely fashion to DAS any
Improvement(s) made, conceived, or reduced to practice by the such
Sublicensee in its activities under the Technology License;
and
(ii) grant to Sangamo a fully paid, world-wide,
irrevocable license under any such Improvements that is exclusive
for uses outside the Field and is fully sublicensable.
(e) Each Technology License shall identify Sangamo as a
third party beneficiary with respect to the license set forth in
Section 5.2(d)(ii).
(f) Each Technology License shall require that the relevant
Sublicensee (i) assume the obligations set forth in
Section 8.11(c) and Exhibit D (as if such Sublicensee
were DAS) with respect to each Third Party License sublicensed
thereunder, and (ii) acknowledge that the Technology License
is subject to the terms and conditions of each such Third Party
License.
5.3 DAS
Discretion. In recognition of DAS’s Minimum Annual
Payment obligation pursuant to Section 8.7, the Parties agree
that:
(a) DAS has no obligation to seek Sublicensees,
and
(b) following payment of the Option Fee specified in
Section 8.6, DAS will have the right to enter into Technology
Licenses and grant research licenses pursuant to
Section 2.1(a)(ii), each on terms that it chooses, subject to
the requirements of Sections 5.2 and 5.4, respectively; and
will have no obligation to account to Sangamo for non-cash
compensation
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received from
Sublicensees pursuant to Technology Licenses or research licenses
pursuant to Section 2.1(a)(ii).
5.4 Research
Licenses . DAS shall ensure that all research licenses it
grants pursuant to Section 2.1(a)(ii) comply with the
following requirements:
(a) ownership of any ZFP Product supplied to the Sublicensee
shall remain in DAS (as between DAS and such Sublicensee) and the
ZFP Product will be treated as confidential by such
Sublicensee;
(b) the Sublicensee will not transfer any ZFP Product to any
other person or entity without prior written approval of DAS and
without such other person or entity entering into a material
transfer agreement with DAS that contains substantially similar
terms to those in the research license with such Sublicensee (and
such material transfer agreement shall be considered a research
license granted by DAS pursuant to
Section 2.1(a)(ii));
(c) the Sublicensee’s use of any ZFP Product supplied
to it will be limited strictly to evaluation purposes in the
Field;
(d) commercialization of any products resulting from use of
ZFP Products will be prohibited in the absence of a Technology
License;
(e) Each Research License shall require the relevant
Sublicensee to:
(i) disclose in a timely fashion to DAS all
Improvement(s) and Program Inventions made, conceived, or reduced
to practice by the such Sublicensee in its activities under the
Research License to permit consideration of patent strategy by DAS
and Sangamo;
(ii) with respect to any Sublicensee that is an
academic or not-for-profit institution, grant to Sangamo a fully
paid, world-wide, irrevocable non-exclusive license under any such
Improvements and Program Inventions for uses outside the Field that
is fully sublicensable, with an exclusive option to negotiate an
exclusive commercial license for uses outside the Field;
and
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(iii) with respect to any Sublicensee that is not an
academic or not-for-profit institution, grant to Sangamo a fully
paid, world-wide, irrevocable exclusive license under any such
Improvements and Program Inventions for uses outside the Field that
is fully sublicensable;
(f) Each Research License shall identify Sangamo as a third
party beneficiary with respect to the licenses set forth in
Sections 5.3(e)(ii) and 5.3(e)(iii);
(g) DAS will have at least thirty (30) days to review,
comment on and request removal of confidential information from any
proposed publication reporting results of work with ZFP Products
supplied to a Sublicensee and DAS shall not have the authority,
without Sangamo’s prior written consent, to approve any
proposed publication that contains Sangamo Confidential
Information;
(h) such research license shall not obligate (or purport to
obligate) Sangamo, without Sangamo’s express prior written
consent, to any obligation other than Manufacture of ZFP Products
under the terms and conditions set forth in
Article 7;
(i) no ZFP Products to which a Third Party License under
Section 8.11(b) is applicable will be supplied to a
Sublicensee unless the applicable research license requires that
the Sublicensee (i) assume the obligations set forth in
Sections 8.11(c) and 8.11(d) and Exhibit D (as if such
Sublicensee were DAS) with respect to each such Third Party License
sublicensed thereunder, and (ii) acknowledge that the research
license is subject to the terms and conditions of each such Third
Party License.
(j) such research license shall terminate upon the
termination of this Agreement for any reason or the termination of
the Licensing Program pursuant to Section 11.5.
DEVELOPMENT AND COMMERCIALIZATION
OF LICENSED PRODUCTS
6.1 DAS
Products. Sangamo shall have no responsibility for any costs or
expenses incurred by DAS, its Affiliates, or any sublicensees in
undertaking development or
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commercialization of DAS Products.
6.2 Trait
Sublicensing. DAS may license Third Parties to commercialize
DAS ZFP Traits or DAS Products provided that (a) such Third
Party does not have the right to use ZFP Products apart from such
use that is inherent in the ZFP Trait, (b) the applicable
agreement with the Third Party does not obligate (or purport to
obligate) Sangamo in any way, and (c) such licenses do not
grant any sublicenses or rights with respect to Sangamo
Technology.
7.1 Supply of
ZFP Products. Subject to Section 7.2, Sangamo shall be
obligated to Manufacture and supply ZFP Products for use by the
Parties and for use by Sublicensees. Quantities and delivery
schedules for all ZFP Products to be used in the Research Program
shall be set forth in the Research Plan. For ZFP Products to be
used by Sublicensees, DAS shall negotiate quantities and delivery
schedules for such ZFP Products on a case-by-case basis, provided,
however, that such quantities and delivery schedules are reasonable
and further provided that under normal circumstances (wherein at
least ***
of relevant target sequence is
provided) Sangamo will deliver ZFP Products within
*** ( *** )
weeks of request. For the supply of ZFP Products to DAS and
Sublicensees, Sangamo will directly charge DAS or Sublicensees (as
applicable) a transfer price reflecting solely (i) the cost of
time and materials expended in Manufacturing such ZFP Products, and
(ii) a reasonable allocation of overhead expenses and other
indirect costs, where such overhead and indirect costs shall be no
greater than charged in similar circumstances to other customers.
The Parties agree that a reasonable estimate for the cost of a ZFP
Product as of the Effective Date is $ *** and the cost is expected to go down. DAS,
however, acknowledges and agrees that the time, effort, and cost
associated with Sangamo’s Manufacturing efforts is likely to
vary significantly from ZFP Product to ZFP Product and that, as a
result, Sangamo cannot, as of the Effective Date, commit to any
particular price, quantity, or delivery schedule for the supply of
ZFP Products. However, Sangamo will work collaboratively with DAS
to establish a structured pricing platform for the supply of ZFP
Products.
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7.2 Transfer
of Manufacturing Technology. At any time following the end of
the Option Period, DAS may request that Sangamo transfer the
Manufacturing technology either to DAS or to a Contract
Manufacturer selected by DAS and approved by Sangamo. Sangamo shall
not unreasonably withhold approval of a Contract Manufacturer
selected by DAS. Sangamo shall transfer to DAS or such Contract
Manufacturer, as the case may be, all Information Controlled by
Sangamo that is related to the Manufacturing of ZFP Products for
use in the Field and is reasonably necessary or useful to enable
DAS or such Contract Manufacturer (as appropriate) to Manufacture
ZFP Products. It is anticipated that such transfer of Information
will be complete within one (1) year after Sangamo’s
receipt of DAS’s request, and Sangamo shall use commercially
reasonable efforts to meet this deadline. The costs and expenses
incurred by Sangamo in carrying out such transfer shall be
reimbursed by DAS at the then-current Annual FTE rate.
7.3 Technology
Escrow . Within ninety (90) days of the Effective Date,
the Parties agree to establish, at DAS’ sole expense, a
technology escrow that will ensure that computer media containing
the protocols and procedures for Manufacture of ZFP Products that
are identified in Section 12.5(a) will be available to DAS
upon occurrence of any of the following events:
(a) the adjudication of Sangamo as a bankrupt by any court
of competent jurisdiction;
(b) the appointment of a trustee or receiver (or similar
official) of all or a substantial part of the property of Sangamo
under the federal Bankruptcy Act or any state court receivership
proceedings, whether voluntary or involuntary, which appointment,
if involuntary, is not removed within sixty
(60) days;
(c) the liquidation of Sangamo or its failure to continue in
business (except in the event that such business has been acquired
or assumed by another entity);
(d) the filing by Sangamo of a voluntary petition in
bankruptcy, or the consent to, or failure to dismiss within the
time prescribed by law, of any bankruptcy proceedings instituted
against it; or
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(e) Refusal by Sangamo to allocate resources to Manufacture
of ordered ZFP Products for a period of 90 consecutive days or more
(unless a Contract Manufacturer is Manufacturing ZFP
Products).
Sangamo will
provide written confirmation upon completion of the deposit with
the escrow agent. The technology escrow shall end, and the
aforementioned computer media shall be returned to Sangamo upon the
earlier of termination of this Agreement or completion of the
Manufacturing technology transfer described in
Section 7.2.
8.1 License
Fee . In consideration for the licenses to Sangamo’s
patents and know-how set forth in Article 2 and access to
Sangamo’s archives of ZFP Products, DAS shall pay Sangamo a
license fee of seven and a half million dollars ($7,500,000) within
thirty (30) days of the Effective Date. The license fee
payment made by DAS to Sangamo pursuant to this Section 8.1
shall be noncreditable and nonrefundable.
8.2 Stock
Purchase . Upon Sangamo’s request, DAS or a DAS Affiliate
will participate in Sangamo’s next financing by purchasing up
to four million dollars ($4,000,000) of Sangamo common stock (but
in no event greater than *** percent ( *** %) of the total round), subject to the terms of
a separate stock purchase agreement and other agreements and
related documents executed pursuant thereto. This obligation is
further contingent on the following conditions:
(a) The financing must close no later than October 1,
2006; and
(b) The total round must be a minimum of 15 million
dollars ($15,000,000).
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30.
(a) DAS shall provide six million dollars ($6,000,000) in
research support to Sangamo for research projects carried out by
Sangamo pursuant to the Research Plan during the Initial Research
Period; however, this commitment is contingent upon (i) the
JSC being able to agree upon research projects that are
commercially and scientifically reasonable and (ii) the
Agreement not terminating pursuant to Section 11.2. DAS will
pay Sangamo against invoices for work actually carried out by
Sangamo (based on the current Annual FTE Rate) and expenses
incurred by Sangamo that were included in the Research Budget or
otherwise authorized by the JSC in carrying out the Research
Program; however, during the first eight quarters of the Initial
Research Term (contract quarters will correspond to calendar
quarters, ending on December 31, March 31, June 30,
and September 30), DAS will advance to Sangamo a minimum of
five hundred thousand dollars ($500,000) per quarter, totaling four
million dollars ($4,000,000) for the first eight quarters. More
specifically, at the beginning of each of the first eight quarters,
Sangamo will invoice DAS for an advance of five hundred thousand
dollars ($500,000), and DAS will pay such amount within thirty
(30) days of receiving the invoice. The second and subsequent
six invoices will each be accompanied with a description of the
services provided and expenses incurred by Sangamo in the previous
quarter in reasonable detail demonstrating the specific basis for
the charges. During the eighth quarter, the JSC will conduct a
review of the Research Program pursuant to Section 3.5(c)(x).
Unless DAS terminates this Agreement pursuant to Section 11.2,
Sangamo will submit invoices at the end of the eighth and
subsequent quarters, which will each be accompanied with a
description of the services provided and expenses incurred by
Sangamo in that quarter in reasonable detail demonstrating the
specific basis for the charges, and DAS will pay Sangamo within
thirty (30) days of receiving the invoice. If the amount
advanced by DAS exceeds the services provided and expenses incurred
by Sangamo during the first eight quarters, then the balance will
be applied against subsequent invoices. However, if DAS terminates
this Agreement pursuant to Section 11.2, Sangamo will not be
required to refund any excess of the Research Funding advanced by
DAS during for the first eight quarters of the Research
Term.
(b) During the last quarter of the third contract year, and
during the last quarter of the contract year for each subsequent
year for so long as the Subsequent Research
31.
Term continues,
the JSC will determine whether the Subsequent Research Term will be
extended for an additional year. DAS shall provide up to one
million dollars ($1,000,000) in research support to Sangamo during
each year of the Subsequent Research Term, however, this commitment
is contingent upon the JSC being able to agree upon research
projects that are commercially and scientifically
reasonable.
(c) Sangamo shall track and calculate the number of Sangamo
FTEs involved in the Research Program using the then-current Annual
FTE Rate and in accordance with Sangamo’s then-current
accounting methodology. In no event shall Sangamo be required
during the Research Term to incur more expenses (including
FTE-based expenses calculated at the then-current Annual FTE Rate)
in the course of performing its obligations under the Research Plan
than the amount that DAS is obligated to pay Sangamo pursuant to
this Section 8.3.
(d) All research support payments made by DAS to Sangamo
pursuant to this Section 8.3 shall be noncreditable and
nonrefundable.
8.4 Special
Research Milestone Payments . Within ninety (90) days of
the Effective Date, the JSC will define events which when achieved
will entitle Sangamo to receive a total of four million dollars
($4,000,000) in special research milestone payments. These event
definitions will be incorporated into the Research Plan. DAS will
pay all such special research milestone payments to Sangamo within
thirty (30) days after the earlier of (a) determination
by the JSC that the corresponding event set forth in the Research
Plan has been achieved and (b) Sangamo’s receipt of the
Option Exercise Notice. Within thirty (30) days of a request
by either Party, the JSC shall hold a meeting by audio or video
conference to make such a determination. In no event will the total
amount of special research milestone payments paid by DAS pursuant
to this Section 8.4 exceed four million dollars ($4,000,000).
If the special research milestone payments made by DAS prior to
Sangamo’s receipt of the Option Exercise Notice total less
than four million dollars ($4,000,000), then the balance will be
paid to Sangamo thirty (30) days after Sangamo’s receipt
of the Option Exercise Notice. All special research milestone
payments made by DAS to Sangamo pursuant to this Section 8.4
shall be noncreditable and nonrefundable.
32.
8.5
***
Milestone Payments
.
(a) Within thirty (30) days after the first
satisfaction of a *** for a DAS Product, DAS shall pay Sangamo one
million dollars ($1,000,000). This is a one time payment, and DAS
shall in no case be obligated to make this payment more than
once.
(b) On the first anniversary of the first Full-scale Product
Launch for a DAS Product that satisfies a *** ,
DAS shall pay Sangamo two million dollars ($2,000,000). This is a
one time payment and DAS shall in no case be obligated to make this
payment more than once
(c) All *** milestone payments made by DAS to Sangamo
pursuant to this Section 8.5 shall be noncreditable and
nonrefundable.
(d) The payments called for in this Section 8.5 are in
lieu of the Product Milestone Payments called for in
Section 8.9(b) for the first *** .
8.6 Option
Fee . DAS shall pay Sangamo an option fee of six million
dollars ($6,000,000) within thirty (30) days after it provides
the Option Exercise Notice. The option fee payment made by DAS to
Sangamo pursuant to this Section 8.6 shall be noncreditable
and nonrefundable.
8.7 Minimum
Annual Payments .
(a) If DAS exercises the Option, then DAS shall pay to
Sangamo within thirty (30) days of each anniversary of the
Effective Date starting with the third anniversary of the Effective
Date, the Minimum Annual Payment obligation set forth in this
Section 8.7 for the calendar year in which such anniversary
occurs. The Minimum Annual Payment obligation for the calendar
years in which the 3 rd through 6 th anniversaries occur are as follows:
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Anniversary of
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Minimum Annual Payment
Obligation
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***
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***
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***
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***
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Certain
information on this page has been omitted and filed separately with
the Commission pursuant to a request for Confidential
Treatment.
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33.
The Minimum
Annual Payment Obligation for each calendar year in which the
seventh and subsequent anniversaries of the Effective Date occur,
until the earlier of (i) DAS’s termination of the
Licensing Program pursuant to Section 11.5, (ii) the
expiration of this Agreement pursuant to Section 11.1, or
(iii) the termination of this Agreement pursuant to
Section 11.4 or 11.6, shall be *** dollars (US $ *** )
(b) In each calendar year in which DAS has a Minimum Annual
Payment Obligation, it will pay Sangamo, an amount equal to the
applicable Minimum Annual Payment Obligation, less any Sublicensing
Revenues paid to Sangamo for Sublicensing Revenues received by DAS
during the first two quarters of the calendar year in which the
Minimum Annual Payment is due. The amount due will be invoiced by
Sangamo as of October 1st, and DAS shall pay Sangamo within thirty
(30) days of receiving the invoice. Each payment made by DAS
pursuant to this Section 8.7 is referred to as a Minimum
Annual Payment.
(c) Each Minimum Annual Payment made by DAS to Sangamo
pursuant to this Section 8.7 shall be nonrefundable but fully
creditable against the following:
(i) the Sublicensing Revenue payments pursuant to
Section 8.8 due for the third and fourth quarters of the
calendar year in which such Minimum Annual Payment was made;
and
(ii) the DAS Product Royalties pursuant to
Section 8.10 due to Sangamo for the calendar ye
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