Exhibit 10.29
FEASIBILITY, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This Feasibility, Development and Commercialization Agreement (this
"Agreement") is made as of July 22, 2002, by and between Voyager Pharmaceutical
Corporation, a Delaware corporation with its principal place of business at 0000
Xxxxxxxxx Xxxxxx Xxxxx, Xxxxxxx, XX 00000 ("Voyager"), and Southern Biosystems,
Inc., an Alabama corporation with its principal place of business at 000 Xxx
Xxxxxx Xxxxx, Xxxxxxxxxx, Xxxxxxx 00000 ("SBS").
RECITALS
WHEREAS, Voyager is the owner of United States Patent No.
6,242,421, covering the treatment and prevention of Alzheimer's disease;
WHEREAS, SBS is in the business of developing, commercializing
and manufacturing biodegradable polymers, biomedical devices and
controlled-release products for biomedical and nonbiomedical applications
including products based on the DURIN(TM) System;
WHEREAS, Voyager desires to develop and commercialize a
pharmaceutical product that implements Voyager's patented Alzheimer's Disease
treatment methodology;
WHEREAS, Voyager desires to obtain certain rights to use SBS's
proprietary drug delivery technology in connection with the development and
commercialization of such a pharmaceutical product, and SBS desires to grant
Voyager such rights, all on the terms and conditions set forth herein; and
WHEREAS, Voyager desires that SBS assist it in the development
and commercialization of such a pharmaceutical product by performing certain
feasibility, development, regulatory and manufacturing activities relating to
such a product, and SBS desires to perform such activities, all on the terms and
conditions set forth herein.
AGREEMENT
NOW, THEREFORE, in consideration of the recitals and the
mutual covenants and promises contained herein, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
parties hereto, intending to be legally bound, do hereby agree as follows:
ARTICLE I. DEFINITIONS
Section 1.1 "Active Agent" shall mean leuprolide acetate.
Section 1.2 "Affiliate" of a Person shall mean any other Person that
directly, or indirectly through one or more intermediaries, controls, is
controlled by or is under common control with such first Person. "Control" and,
with correlative meanings, the terms "controlled by" and "under common control
with" shall mean ownership of shares
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
of stock having at least 50% of the voting power entitled to vote for the
election of directors in the case of a corporation and at least 50% of the
interest in profits in the case of a business entity other than a corporation.
Section 1.3 "Agreement" shall have the meaning set forth in the preamble
hereto.
Section 1.4 "Applicable Law" shall mean the applicable laws, rules,
regulations, including any rules, regulations, guidelines, or other requirements
of the Regulatory Authorities, that may be in effect from time to time in the
Territory.
Section 1.5 "Chair" shall have the meaning set forth in Section 6.1.
Section 1.6 "Clinical Milestone Target Date" shall have the meaning set
forth in Section 4.2(a).
Section 1.7 "Clinical Trial Plan" shall have the meaning set forth in
Section 4.2(a).
Section 1.8 "Clinical Trials" shall mean Phase I, Phase II, Phase III and
such other tests and studies in human subjects or patients that are required by
the Regulatory Authorities from time to time in connection with the Product
pursuant to Applicable Law or otherwise.
Section 1.9 "CMC Data" shall mean any and all information contained in, as
well as data supporting, the Chemistry, Manufacturing and Control section of an
IND or NDA for the Product, and any similar information or data required with
respect to any other Regulatory Approval.
Section 1.10 "Commercially Reasonable Efforts" shall mean, with respect to
the research, development, Manufacture or commercialization of the Product,
efforts and resources commonly used in the research-based pharmaceutical
industry for a product of similar commercial potential at a similar stage in its
lifecycle, taking into consideration its safety and efficacy, its cost to
develop, the competitiveness of alternative products, its proprietary position,
the likelihood of regulatory approval, its profitability, and all other relevant
factors. Commercially Reasonable Efforts shall be determined on a
market-by-market basis in the Territory. Commercially Reasonable Efforts with
respect to Voyager's diligence in conducting Clinical Trials and pursuing
Marketing Authorization with respect to the Product in the United States will be
evaluated in view of, among other factors, Voyager's timely achievement of
Clinical Milestone Target Dates (as changed from time to time in accordance with
Section 4.2(a)) and Voyager and SBS's timely satisfaction of their respective
obligations hereunder.
Section 1.11 "Confidential Information" shall mean (a) any and all
information or material that, at any time before or after the date hereof, has
been or is provided or communicated to the Receiving Party by or on behalf of
the Disclosing Party pursuant to this Agreement or in connection with the
transactions contemplated hereby or any
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discussions or negotiations with respect thereto; any data, ideas, concepts or
techniques contained therein; and any modifications thereof or derivations
therefrom and (b) the existence and terms of this Agreement. Confidential
Information may be disclosed either orally, visually, in writing, by delivery of
materials containing Confidential Information or in any other form now known or
hereafter invented.
Section 1.12 "Deposit" shall have the meaning set forth in Section 7.1.
Section 1.13 "Development Activities" shall have the meaning set forth in
Section 3.2.
Section 1.14 "Development Costs" shall have the meaning set forth in
Section 7.1.
Section 1.15 "Development Evaluation Materials" shall have the meaning set
forth in Section 3.6.
Section 1.16 "Development Formulations" shall mean the various Product
prototypes developed by SBS in connection with performing the Development
Activities and provided to Voyager for evaluation in accordance with the
Development Plan.
Section 1.17 "Development Plan" shall have the meaning set forth in Section
3.2.
Section 1.18 "Disclosing Party" shall mean the party disclosing
Confidential Information.
Section 1.19 "Effective Date" shall mean the date first above written.
Section 1.20 "Exploit" shall mean to make, have made, import, use, sell,
offer for sale or otherwise dispose of a product or process, including the
research, development, registration, modification, enhancement, improvement,
Manufacture, storage, formulation, optimization, export, transport,
distribution, promotion or marketing of a product or process.
Section 1.21 "FDA" shall mean the United States Food and Drug
Administration and any successor agency thereto.
Section 1.22 "Feasibility Activities" shall mean all tests, studies and
other activities that are performed in connection with the Feasibility Program,
including the preparation of the Final Report.
Section 1.23 "Feasibility Evaluation Materials" shall have the meaning set
forth in Section 2.3.
Section 1.24 "Feasibility Plan" shall mean the detailed program set forth
in Exhibit 1.24 for developing a formulation of the Product that meets the
Product
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Specifications and evaluating the feasibility of such formulation, as the same
shall be amended from time to time in accordance with Section 6.1.
Section 1.25 "Feasibility Program" shall have the meaning set forth in
Section 2.1.
Section 1.26 "FFDCA" shall have the meaning set forth in Section 5.4.
Section 1.27 "Final Report" shall mean the detailed analysis and evaluation
of the Feasibility Program which shall (a) describe the methodology employed and
the results achieved by SBS in conducting the Feasibility Program, (b) provide
recommendations for additional development of the Product, and (c) be in such
form and include such other information as set forth in the Feasibility Plan.
Section 1.28 "Firm Order" shall have the meaning set forth in Section 5.2.
Section 1.29 "First Commercial Sale" shall mean the first sale for use or
consumption by the general public of the Product in a country in the Territory
after Regulatory Approval for the marketing and sale of the Product has been
obtained in such country.
Section 1.30 "GAAP" shall mean United States generally accepted accounting
principles consistently applied.
Section 1.31 "GLP" shall mean the current good laboratory practices
applicable from time to time pursuant to Applicable Law.
Section 1.32 "GMP" shall mean the current good manufacturing practices
applicable from time to time to the Manufacturing of the Product or any
intermediate thereof pursuant to Applicable Law.
Section 1.33 "IND" shall mean an investigational new drug application filed
with the FDA for authorization to commence human clinical trials, and its
equivalent in other countries or regulatory jurisdictions in the Territory.
Section 1.34 "Indemnification Claim Notice" shall have the meaning set
forth in Section 12.3.
Section 1.35 "Indemnified Party" shall have the meaning set forth in
Section 12.3.
Section 1.36 "Indemnifying Party" shall have the meaning set forth in
Section 12.3.
Section 1.37 "Invention" shall mean any discovery, improvement, process,
formula, data, invention, know-how, trade secret, procedure, device, marketing
study or other intellectual property, whether or not patentable, including any
enhancement in the manufacture, formulation, ingredients, preparation,
presentation, means of delivery,
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dosage or packaging of a product or any discovery or development of a new
indication for a product.
Section 1.38 "Joint Development Team" shall have the meaning set forth in
Section 6.1.
Section 1.39 "Joint Inventions" shall have the meaning set forth in Section
8.1.
Section 1.40 "Losses" shall have the meaning set forth in Section 12.1.
Section 1.41 "Major Market" shall mean each of Canada, France, Germany,
Italy, Japan, the United Kingdom and the United States.
Section 1.42 "Manufacture" and "Manufacturing" shall mean, with respect to
the Product, the manufacturing, processing, formulating, packaging, labeling,
holding and quality control testing of such Product.
Section 1.43 "Manufacturing Cost" shall have the meaning set forth in
Section 5.3.
Section 1.44 "Manufacturing Process" shall mean any process or step thereof
that is necessary or useful for Manufacturing the Product or any intermediate
thereof.
Section 1.45 "Marketing Authorization" shall mean an approved New Drug
Application as defined in the FFDCA and the regulations promulgated thereunder,
or any corresponding foreign application, registration or certification,
necessary or reasonably useful to market the Product in countries or regulatory
jurisdictions in the Territory other than the United States, including
applicable pricing and reimbursement approvals.
Section 1.46 "Minimum Royalty" shall have the meaning set forth in Section
7.3.
Section 1.47 "Net Sales" shall mean, with respect to any Person for any
period, the gross amount invoiced by such Person and its Affiliates and
sublicensees for the sale of the Product to unrelated third Persons in bona fide
arms' length transactions, less deductions, in their normal and customary
amounts for: (a) normal and customary trade, quantity and cash discounts and
sales returns and allowances, including (i) those granted on account of price
adjustments, billing errors, rejected goods, damaged goods, returns and rebates,
(ii) administrative and other fees and reimbursements and similar payments to
wholesalers and other distributors, buying groups, pharmacy benefit management
organizations, health care insurance carriers and other institutions, (iii)
allowances, rebates and fees paid to distributors and (iv) chargebacks; (b)
freight, postage, shipping and insurance expenses to the extent that such items
are included in the gross amount invoiced; (c) customs and excise duties and
other duties related to the sales to the extent that such items are included in
the gross amount invoiced; (d) rebates and similar payments made with respect to
sales paid for by any governmental or regulatory authority such as, by way of
illustration and not in limitation of the parties' rights hereunder,
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federal or state Medicaid, Medicare or similar state programs or any equivalent
programs of a country other than the United States; (e) sales and other taxes
and duties directly related to the sale or delivery of the Product (but not
including taxes assessed against the income derived from such sale); (f)
distribution expenses to the extent that such items are included in the gross
amount invoiced; and (g) any such invoiced amounts that are not collected by
such Person or its Affiliates or sublicensees. Any of the deductions listed
above that involves a payment by such Person or its Affiliates or its
sublicensees shall be taken as a deduction in the calendar quarter in which the
payment is accrued by such entity. Deductions pursuant to subsection (g) above
shall be taken in the calendar quarter in which such sales are no longer
recorded as a receivable. For purposes of determining Net Sales, (x) the Product
shall be deemed to be sold when invoiced and a "sale" shall not include
transfers or dispositions for charitable, promotional, pre-clinical, clinical,
regulatory or governmental purposes, (y) sales between or among such Person, its
Affiliates and sublicensees shall be excluded from the computation of Net Sales
and (z) Net Sales shall include the portion of the price charged for separate
products sold along with or for use in connection with the Product which is in
excess of the fair market value of such products if they were not sold along
with or in connection with the Product as reasonably determined by such Person.
Net Sales shall include any amounts received by such Person, its Affiliates or
sublicensees in connection with the transfer of Product to an unrelated third
Person to the extent any such amounts are prepayments of, or can be offset or
credited against, Product sales to such unrelated third Person. If the Product
is transferred or delivered by or for such Person to a third Person but no
invoice is delivered, Net Sales shall be determined based on the average gross
selling price invoiced by such Person for the Product during the three (3) month
period immediately preceding such transfer or delivery.
Section 1.48 "Person" shall mean an individual, sole proprietorship,
partnership, limited partnership, limited liability partnership, corporation,
limited liability company, business trust, joint stock company, trust,
unincorporated association, joint venture or other similar entity or
organization, including a government or political subdivision, department or
agency of a government.
Section 1.49 "Phase I" shall mean all tests and studies in subjects that
are required by the Regulatory Authorities from time to time pursuant to
Applicable Law or otherwise to obtain sufficient data of safety, metabolism and
pharmacokinetic properties and clinical pharmacology to permit initiation of
Phase II for the Product, including the trials referred to in 21 C.F.R. ss.
312.21(a), as amended.
Section 1.50 "Phase II" shall mean all tests and studies in subjects that
are required by the Regulatory Authorities from time to time pursuant to
Applicable Law or otherwise, in addition to Phase I, to obtain sufficient data
as to efficacy and dosing to permit initiation of Phase III for the Product,
including the trials referred to in 21 C.F.R. ss. 312.21(b), as amended.
Section 1.51 "Phase III" shall mean all tests and studies using an
extensive patient base (other than Phase I and Phase II) that are intended to
provide substantial evidence of efficacy and safety in support of Marketing
Authorization for the Product,
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including all tests and studies that are required by the FDA from time to time,
pursuant to Applicable Law or otherwise, as Phase III tests and studies for the
Product.
Section 1.52 "Product" shall mean a biodegradable polymeric implant [* * *]
for the treatment of Alzheimer's Disease in humans that utilizes the SBS
Technology or the SBS Improvements and contains the Active Agent.
Section 1.53 "Product Specifications" shall mean the written specifications
and quality control testing procedures for the Product determined by Voyager and
amended, modified or supplemented from time to time in accordance with Section
5.8.
Section 1.54 "Project Information and Inventions" shall have the meaning
set forth in Section 8.1.
Section 1.55 "Receiving Party" shall mean the party receiving Confidential
Information.
Section 1.56 "Recipients" shall have the meaning set forth in Section 10.1.
Section 1.57 "Regulatory Approval" shall mean any and all approvals
(including pricing and reimbursement approvals), licenses, registrations or
authorizations of any Regulatory Authority, necessary for the Exploitation of
the Product in a country in the Territory, including any (a) approval of the
Product, including any IND, Marketing Authorization and supplements and
amendments thereto; (b) pre- and post-approval marketing authorizations
(including any prerequisite Manufacturing approval or authorization related
thereto); (c) labeling approval; and (d) technical, medical and scientific
licenses.
Section 1.58 "Regulatory Authority" shall mean any applicable
supra-national, federal, national, regional, state, provincial or local
regulatory agencies, departments, bureaus, commissions, councils or other
government entities regulating or otherwise exercising authority with respect to
the Exploitation of the Product in the Territory.
Section 1.59 "SBS" shall have the meaning set forth in the preamble hereto.
Section 1.60 "SBS Improvements" shall mean any and all Inventions created,
developed or acquired as a result of or in connection with the Agreement,
including the Feasibility Activities, the Development Activities or SBS's
Manufacturing of the Product hereunder that relate (i) solely to the SBS
Technology including implant and accessory devices used in connection therewith
or (ii) the application of the SBS Technology to or the combination of the SBS
Technology with agents, features or processes.
Section 1.61 "SBS Indemnified Parties" shall have the meaning set forth in
Section 12.2.
Section 1.62 "SBS Technology" shall mean any and all proprietary technical
information, formulations, processes, know-how, data, specifications, methods of
manufacture or use, characterization methods, characterization results, and
other
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proprietary information to the extent not generally known, whether or not
patentable, owned by SBS relating to its proprietary bioerodable polymeric
implant technology (DURIN(TM) Biodegradable Implants) for imparting controlled
release or other performance-enhancing qualities to products, including any
patents (issued, pending, or subsequently filed and including all divisionals,
continuations, continuations-in-part or other related United States and foreign
applications).
Section 1.63 "Terminated Country" shall have the meaning set forth in
Section 4.2.
Section 1.64 "Territory" shall mean all countries of the entire world
except any Terminated Countries.
Section 1.65 "Test Formulations" shall mean the various Product prototypes
developed by SBS in connection with performing the Feasibility Activities and
provided to Voyager for evaluation in accordance with the Feasibility Plan.
Section 1.66 "Testing Laboratory" shall have the meaning set forth in
Section 5.6.
Section 1.67 "Third Party Claim" shall have the meaning set forth in
Section 12.3.
Section 1.68 "Unique Dose Product" shall mean a controlled release
pharmaceutical product that delivers the Active Agent and with respect to which
[***].
Section 1.69 "Voyager" shall have the meaning set forth in the preamble
hereto.
Section 1.70 "Voyager Patents" shall mean any and all patents, patent
applications, and other intellectual property owned or controlled by Voyager
related to the treatment and prevention of Alzheimer's disease, including United
States Patent No. 6,242,421.
Section 1.71 "Voyager Development Recommendations" shall have the meaning
set forth in Section 3.6.
Section 1.72 "Voyager Feasibility Recommendations" shall have the meaning
set forth in Section 2.3.
Section 1.73 "Voyager Indemnified Parties" shall have the meaning set forth
in Section 12.1.
ARTICLE II. FEASIBILITY PROGRAM
Section 2.1 Conduct of Feasibility Program. SBS shall conduct and complete
all tests, studies and other activities set forth in, or required in order to
obtain the information set forth in, the Feasibility Plan (the "Feasibility
Program"); provided that SBS may, at its sole discretion, elect to have selected
Feasibility Activities be performed
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by its Affiliates and further may subcontract standard tasks and services to
third Person providers of such services; provided that SBS shall be responsible
for ensuring that the performance of all Feasibility Activities by its
Affiliates or third Persons complies with the terms of this Agreement and in no
event shall any such delegation or subcontract release SBS from any of its
obligations under this Agreement. SBS shall use Commercially Reasonable Efforts
to complete the Feasibility Program in accordance with the timeline set forth in
the Feasibility Plan. SBS represents, warrants and covenants that it shall
perform the Feasibility Program in good scientific manner and in compliance in
all material respects with all Applicable Laws and good, professional clinical
and laboratory practices (but not under GLP), and shall endeavor to achieve the
objectives of the Feasibility Program efficiently and expeditiously. Moreover,
SBS shall proceed diligently with the Feasibility Program by allocating
sufficient time, effort, equipment, and skilled personnel to complete the
Feasibility Program successfully and promptly. Notwithstanding the foregoing,
the parties acknowledge and agree that there can be no assurances that the
objectives of the Feasibility Program can be achieved, or that they can be
achieved in the time set forth in the Feasibility Plan.
Section 2.2 Costs and Expenses.
(a) Subject to Section 7.1 and except as provided in Section 2.2(b),
SBS shall be solely responsible for all costs and expenses incurred in
connection with the performance of the Feasibility Activities, including costs
and expenses of personnel, laboratory facilities and equipment, chemicals (other
than the Active Agent) and other supplies.
(b) SBS shall obtain, from a vendor approved by Voyager and at
Voyager's expense, all Active Agent necessary to complete the Feasibility
Activities. SBS estimates that approximately [***] of Active Agent will be
required for the completion of the Feasibility Activities.
Section 2.3 Test Formulations. SBS shall from time to time provide
Voyager with (a) sufficient quantities of the various Test Formulations of the
Product as the same are developed during the performance of the Feasibility
Program and (b) such technical and other information regarding such Test
Formulations as Voyager may reasonably require, in each case to enable Voyager
to evaluate the scientific and commercial viability of such Test Formulations
(collectively, the "Feasibility Evaluation Materials"). Voyager may evaluate the
Test Formulations received from SBS and provide recommendations to the Joint
Development Team for changes to the Feasibility Program (the "Voyager
Feasibility Recommendations"), including the development of the Product. Any
Test Formulations provided by SBS will be used by Voyager for research purposes
only and shall not be used in humans.
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Section 2.4 Reporting Requirements.
(a) At approximately the midpoint of the completion of the Feasibility
Program, SBS shall provide Voyager with a written progress report which shall
describe the Feasibility Activities that SBS has performed to date and evaluate
the work performed in relation to the goals of the Feasibility Plan
(b) Within forty-five (45) days after completion of the Feasibility
Program, SBS shall provide Voyager with the Final Report. Within thirty (30)
days of Voyager's receipt of the Final Report, the parties shall meet, at such
time and place as the parties may agree, to review the Final Report, including
the results of the Feasibility Program contained therein.
(c) In addition to the written reports specified in clauses (a) and
(b) above, SBS shall provide such other information as may be reasonably
requested by Voyager relating to the Feasibility Program from time to time.
Section 2.5 Rights and Remedies. If SBS defaults in the performance of any
of its material obligations under this Article II, which default has not been
cured by SBS within sixty (60) days after receiving written notice thereof from
Voyager, then Voyager may, in its sole discretion, terminate (a) the rights and
obligations of the parties under Article II, Article III, Article V or Article
VI on an Article-by-Article basis, or under all such Articles (in which event
the license granted pursuant to Section 8.2(a) shall also terminate) or (b) the
rights and obligations of the parties under Section 4.2(c) (in which event the
license granted pursuant to Section 8.2(c) shall also terminate), in each case
by providing immediate written notice to SBS, in which event Voyager shall have
the right to perform or have performed by a third Person all feasibility,
development, regulatory or Manufacturing activities related to the Product
previously allocated to SBS under the terminated provisions. The rights and
remedies provided in this Section 2.5 shall be cumulative and in addition to any
other rights or remedies that may be available to Voyager.
Section 2.6 [***] Technology. The parties acknowledge and agree that
Voyager is currently in discussions with [***] regarding the use or acquisition
of certain data and technology that may be relevant to the Product and that may
accelerate, or eliminate the necessity for, the performance of certain
Feasibility Activities and Development Activities. In the event that Voyager
acquires the right to use such data and technology, the parties shall negotiate
in good faith amendments to the terms of this Agreement that provide for the
acceleration or elimination of such Feasibility Activities and Development
Activities; provided that in no event shall the method for calculating
Development Costs or Manufacturing Costs, the royalties payable by Voyager
pursuant to Section 7.3, or, except as expressly set forth in the succeeding
proviso, the milestone payments payable by Voyager pursuant to Section 7.2 be
amended or changed as a result of the use of such data and technology; provided
further, however, that in the event that the use of such data and technology
obviates the need for performance of Phase I trials for the Product, Voyager
shall pay the $[***] milestone otherwise payable pursuant to
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Section 7.2(a) within [***] days after receipt by Voyager of written
notification from FDA that Phase I trials for the Product are not required.
ARTICLE III. DEVELOPMENT ACTIVITIES
Section 3.1 Election to Proceed. Voyager shall notify SBS in writing,
within [ * * * ] days after SBS's submission to Voyager of the Final Report,
whether Voyager elects to proceed with further development of the Product. If
Voyager notifies SBS that it does not wish to proceed with further development,
or if Voyager does not deliver notice within such [ * * * ] day period, then
this Agreement shall be deemed to have been terminated pursuant to Section
11.2(a) as of the time of delivery of such notice or the end of such [ * * * ]
day period, as the case may be.
Section 3.2 Development Plan.
(a) Upon the election by Voyager to proceed with development of the
Product pursuant to Section 3.1, the parties shall consult to develop as soon as
reasonably practicable a written plan (the "Development Plan") that sets forth
(i) further development activities with respect to the Product that are
necessary or desirable to enable Voyager to commence Clinical Trials for the
Product (including Manufacturing Process development as required and the
production by SBS of Product formulations for preclinical, toxicology and other
studies) (the "Development Activities"), (ii) the party responsible for
performing each Development Activity, and (iii) an estimated timeline for
completion of critical development milestones in accordance with Section 3.3(b).
In the event of any dispute between the parties with respect to the contents of
the Development Plan, such dispute will be submitted to the Joint Development
Team and resolved by the Joint Development Team in accordance with Section 6.1.
The Development Plan may be amended from time to time by the Joint Development
Team in accordance with Section 6.1.
(b) Prior to commencing any Development Activities, SBS shall provide
Voyager with a good faith, non-binding estimate of the total amount of
Development Costs required to complete the Development Activities.
Section 3.3 Conduct of Development Activities.
(a) Each of SBS and Voyager shall provide funding, conduct and
complete all tests, studies and other activities set forth in, or required in
order to obtain the information set forth in, the Development Plan for which it
is assigned responsibility; provided that SBS may, at its sole discretion, elect
to have selected Development Activities allocated to it under the Development
Plan be performed by its Affiliates and further may subcontract standard tasks
and services to third Person providers of such services; provided that SBS shall
be responsible for ensuring that the performance of all Development Activities
by its Affiliates or third Persons complies with the terms of this Agreement and
in no event shall any such delegation or subcontract release SBS from any of its
obligations under this Agreement. Each of SBS and Voyager represents, warrants
and covenants that it shall perform the Development Activities for which it is
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assigned responsibility in good scientific manner and in compliance in all
material respects with all requirements of Applicable Laws and good clinical and
laboratory practices and under such regulatory standards (for example GLP or
GMP) as shall be specified in the Development Plan, and shall endeavor to
achieve the objectives of the Development Plan efficiently and expeditiously.
Moreover, each of SBS and Voyager shall proceed diligently with the Development
Plan by allocating sufficient time, effort, equipment, and skilled personnel to
complete the Development Activities for which it is assigned responsibility
successfully and promptly.
(b) The Development Plan will include good faith estimates for
critical development milestones, such as completion of a GLP toxicity study,
package development, trocar development, manufacturing of an initial batch of
clinical materials under GMP, and preparation of documentation for submission of
an IND (toxicity, CMC, and initial stability).
Section 3.4 Costs and Expenses.
(a) Subject to Section 7.1 and except as provided in Section 3.4(b),
SBS shall be solely responsible for all costs and expenses incurred in
connection with the performance of the Development Activities for which it is
assigned responsibility, including costs and expenses of personnel, laboratory
facilities and equipment, chemicals (other than the Active Agent) and other
supplies.
(b) SBS shall obtain, from a vendor approved by Voyager and at
Voyager's expense all Active Agent necessary to complete the Development
Activities for which SBS is assigned responsibility.
Section 3.5 Reporting Requirements.
(a) Within thirty (30) days after the end of each calendar quarter in
which Development Activities are performed, SBS shall provide to Voyager a
written progress report, which shall describe the Development Activities it has
performed during such calendar quarter, evaluate the work performed in relation
to the goals of the Development Plan, and provide such other information as may
be reasonably requested by Voyager with respect to the Development Activities.
(b) In addition to the written reports specified in subsection (a)
above, SBS shall provide such other information as may be reasonably requested
by Voyager relating to the Development Activities from time to time.
Section 3.6 Development Formulations. SBS shall from time to time provide
Voyager with (a) sufficient quantities of the various Development Formulations
as the same are developed during the performance of the Development Activities
and (b) such technical and other information regarding such Development
Formulations as Voyager may reasonably require, in each case to enable Voyager
to evaluate the scientific and commercial viability of such Development
Formulations (collectively, the "Development Evaluation Materials"). Voyager may
evaluate the Development Formulations received
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such material has been filed separately with the SEC
from SBS and provide recommendations to the Joint Development Team for changes
to the Development Plan (the "Voyager Development Recommendations").
Section 3.7 Regulatory Records. SBS shall maintain records of all
Feasibility Activities and Development Activities conducted by it in sufficient
detail and in good scientific manner appropriate for patent and regulatory
purposes, which shall be substantially complete and materially accurate and
shall reflect all work done and results achieved in the performance of the
Feasibility Activities and Development Activities, and which shall be retained
by SBS for at least five (5) years after the termination of this Agreement, or
for such longer period as may be required by Applicable Law. Voyager shall have
the right, during normal business hours and upon reasonable notice, to inspect
and copy any such records.
Section 3.8 Rights and Remedies. If SBS defaults in the performance of any
of its material obligations under this Article III, which default has not been
cured by SBS within sixty (60) days after receiving written notice thereof from
Voyager, then Voyager may, in its sole discretion, terminate (a) the rights and
obligations of the parties under Article III, Article V or Article VI on an
Article-by-Article basis or under all such Articles (in which event the license
granted pursuant to Section 8.2 (a) shall also terminate) or (b) Section 4.2(c)
(in which event the license granted pursuant to Section 8.2(c) shall also
terminate), in each case by providing immediate written notice to SBS, in which
event Voyager shall have the right to perform or have performed by a third
Person all development, regulatory and Manufacturing activities related to the
Product previously allocated to SBS under the terminated provisions. The rights
and remedies provided in this Section 3.8 shall be cumulative and in addition to
any other rights or remedies that may be available to Voyager.
ARTICLE IV. REGULATORY APPROVALS
Section 4.1 Regulatory Approvals. Within ninety (90) days following the
completion of the Development Activities, Voyager shall notify SBS in writing in
the event that Voyager elects to commence Clinical Trials with respect to the
Product. If Voyager notifies SBS that it does not wish to proceed with Clinical
Trials, or if Voyager does not deliver notice within such ninety (90) day
period, then this Agreement shall be deemed to have been terminated pursuant to
Section 11.2(a) as of the time of delivery of such notice or the end of such
ninety (90) day period, as the case may be. Voyager shall have the sole right to
develop the appropriate strategy for obtaining and maintaining Regulatory
Approvals in the Territory. All INDs, Marketing Authorizations and other
filings, applications or requests pursuant to or in connection with the
Regulatory Approvals shall be made in the name of, and shall be owned solely by,
Voyager or its designee. Voyager shall have the sole right to conduct all
communications with the Regulatory Authorities with regard to the Product.
Section 4.2 Voyager Diligence.
(a) If Voyager elects to proceed with Clinical Trials for the Product,
Voyager shall use Commercially Reasonable Efforts to conduct all required
Clinical
13
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such material has been filed separately with the SEC
Trials and obtain the Regulatory Approvals necessary to Exploit the Product in
the United States as soon as reasonably practicable. Voyager shall use
Commercially Reasonable Efforts to commercialize the Product in the United
States during the term of this Agreement commencing as soon as reasonably
practicable after receipt of required Regulatory Approvals. At the same time as
Voyager provides SBS with written notice of its intent to conduct Clinical
Trials pursuant to Section 4.1, Voyager shall provide SBS with a written outline
of its Clinical Trial strategy and timeline to support Regulatory Approval in
the United States (the "Clinical Trial Plan"). The Clinical Trial Plan will
include Voyager's good faith estimate as to the target dates for (i) IND filing,
(ii) start of Phase III and (iii) NDA filing to support Regulatory Approval in
the United States (each, a "Clinical Milestone Target Date"). Voyager shall
review the Clinical Trial Plan at least on a quarterly basis and may in its
reasonable discretion change such plan and any Clinical Milestone Target Date
therein at any time. Voyager promptly shall notify SBS in writing in the event
of any material change to the Clinical Trial Plan or in the event that any
Clinical Milestone Target Date is delayed by one calendar quarter or more. At
SBS's request, Voyager shall provide SBS the reasons for such change. If Voyager
defaults in the performance of any of its material obligations under this
Section 4.2(a), which default has not been cured by Voyager within sixty (60)
days after receiving written notice thereof from SBS, then SBS may, in its sole
discretion, terminate this Agreement by providing immediate written notice to
Voyager.
(b) If Voyager has not applied for Regulatory Approval in (i) each
other Major Market within [***] after obtaining Regulatory Approval for the
Product in the United States or (ii) in each country in the Territory other than
a Major Market within [***] after obtaining Regulatory Approval for the Product
in the United States, or has not made the First Commercial Sale in any country
[***] after receipt of Regulatory Approval in such country, then SBS may, upon
[***] days prior written notice to Voyager (unless Voyager applies for such
Regulatory Approval or makes such First Commercial Sale within such [***] day
period), terminate the rights granted to Voyager under Section 8.2 with respect
to such country (each, a "Terminated Country").
(c) SBS may elect, at its sole discretion, to Exploit the Product in
any Terminated Country by providing [***] days prior written notice to Voyager.
(d) The remedies set forth in this Section 4.2 shall be exclusive and
in lieu of any other remedies that may be available to SBS pursuant to any
statutory or common law or equity with respect to any Losses of any kind or
nature suffered by SBS directly or indirectly resulting from or arising out of
any failure by Voyager to perform its obligations under this Section 4.2 .
Section 4.3 Cooperation of SBS. SBS shall cooperate with any and all
reasonable requests for assistance from Voyager with respect to the development
and commercialization of the Product and obtaining and maintaining Regulatory
Approvals for the Product, including by:
(a) making its employees, consultants and other scientific staff
available upon reasonable notice during normal business hours at their
respective places of
14
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such material has been filed separately with the SEC
employment to consult with Voyager on issues arising during such development and
commercialization;
(b) making its employees, consultants and other scientific staff
available upon reasonable notice during normal business hours to attend meetings
with Regulatory Authorities concerning the Product;
(c) disclosing and making available to Voyager, in whatever form
Voyager may reasonably request, all biological, chemical, pharmacological,
toxicological, pharmaceutical, physical and analytical, clinical, safety,
Manufacturing and quality control data and other information related to the
Product, the Manufacturing Process and the SBS Technology owned or controlled by
SBS as is necessary or desirable to prepare, file, obtain and maintain any
Regulatory Approval; and
(d) SBS shall prepare and provide to Voyager all CMC Data with respect
to the Product necessary to obtain and maintain Regulatory Approvals and in a
form suitable for filing by Voyager with Regulatory Authorities.
Section 4.4 Review of Filings. Voyager shall provide SBS with the
opportunity for a timely review and comment on all regulatory filings proposed
to be made with respect to the Product prior to their submission to a Regulatory
Authority and will promptly provide SBS with copies of all communications to or
from any Regulatory Authority with respect to the Product. SBS shall perform
such review promptly after such filings are provided by Voyager.
Section 4.5 Rights and Remedies. If SBS defaults in the performance of any
of its material obligations under this Article IV, which default has not been
cured by SBS within [***] days after receiving written notice thereof from
Voyager, then Voyager may, in its sole discretion, terminate (a) the rights and
obligations of the parties under Section 4.3, 4.4 or Article V on a case-by-case
basis or under all such provisions (in which event the license granted pursuant
to Section 8.2(a) shall also terminate) or (b) the rights and obligations of the
parties under Section 4.2(c) (in which event the license granted pursuant to
Section 8.2(c) shall also terminate), in each case by providing immediate
written notice to SBS, in which event Voyager shall have the right to perform or
have performed by a third Person all regulatory and Manufacturing activities
related to the Product previously allocated to SBS under the terminated
provisions. The rights and remedies provided in this Section 4.5 shall be
cumulative and in addition to any other rights or remedies that may be available
to Voyager.
ARTICLE V. MANUFACTURING
Section 5.1 Supply Obligations. SBS shall supply Voyager with, and Voyager
shall purchase from SBS, (a) all of Voyager's clinical requirements of the
Product and placebos necessary in connection with Clinical Trials and (b) all of
Voyager's commercial requirements of the Product; provided that SBS shall not be
required to supply a number of units of Product in any calendar quarter that
exceeds the reasonable maximum quarterly manufacturing capacity of SBS's
manufacturing facility in
15
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such material has been filed separately with the SEC
Birmingham, Alabama on the date of this Agreement unless SBS otherwise agrees.
These supply and purchase obligations shall continue until the earlier to occur
of (i) the effective date of SBS's election to discontinue supply of Voyager's
commercial requirements of Product, which effective date shall be specified in a
written notice delivered by SBS to Voyager not less than [ * * * ] prior to such
effective date; provided that in no event may SBS elect to terminate its supply
obligations prior to [ * * * ] the First Commercial Sale of the Product in the
Territory, (ii) the termination of this Agreement and (iii) the termination of
these supply and purchase obligations with respect to the Product in accordance
with Sections 2.5, 3.8, 4.5 and 5.6. SBS may, in its sole discretion,
subcontract with a qualified contract manufacturer in order to fulfill SBS's
supply obligations to Voyager hereunder; provided that in no event shall any
such subcontract release SBS from any of its obligations under this Agreement,
including its obligation to deliver Product that complies with the warranty set
forth in Section 5.4.
Section 5.2 Forecasting, Order and Delivery of Products.
(a) Forecasting. Within ninety (90) days of Voyager's election to
commence Clinical Trials with respect to the Product, Voyager shall submit an
estimate of the quantities of the Product (and placebos, if any) that Voyager
expects to purchase from SBS during the succeeding [***] calendar quarters.
Thereafter, on or before the thirtieth (30th) day of each following calendar
quarter, Voyager shall submit an updated forecast of its requirements of the
Product from SBS for the succeeding [***] calendar quarters. These forecasts
shall be non-binding and shall be used by SBS for planning purposes only.
(b) Firm Orders. Not later than ninety (90) days prior to commencement
of each calendar quarter, Voyager shall submit to SBS a purchase order for such
quantities of the Product (and placebos, if any) as Voyager commits to purchase
from SBS during such calendar quarter, with a statement of the dates on which
delivery shall be required and shipping instructions therefore (a "Firm Order").
SBS shall confirm to Voyager in writing, within five (5) days after receipt
thereof, the receipt by SBS of each Firm Order submitted in accordance with this
Section 5.2, and shall be obligated to deliver the specified quantity of the
Product (and placebos) in accordance with the delivery schedule set forth in
such Firm Order. SBS shall exercise its best efforts to comply with changes to a
Firm Order that Voyager may request after receipt by SBS of such Firm Order but
shall not be liable for its inability to do so. Firm Orders may be amended by
mutual agreement of the parties. In the event that the terms of any Firm Order
are not consistent with this Agreement, the terms of this Agreement shall
prevail.
(c) Delivery and Risk of Loss. SBS shall deliver the quantities of the
Product (and placebos) set forth in each Firm Order on the delivery date
specified therein, to a location designated in writing by Voyager, FOB (as
defined in the UCC) SBS's facility in Birmingham, Alabama. Title to the Products
shall pass to Voyager at the time of delivery.
(d) Invoice and Payment. SBS shall promptly invoice Voyager for all
quantities of the Product delivered in accordance herewith. Invoices shall be
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**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
accompanied by a certificate of analysis and a certificate of compliance with
the warranty set forth in Section 5.4 for each invoiced batch of the Product, in
such form as is reasonably acceptable to Voyager. Subject to Section 5.6,
payment with respect to a shipment shall be due thirty (30) days after receipt
by Voyager of such shipment of the Product and the invoice and certificates with
respect thereto; provided, however, that if Voyager rejects such shipment
pursuant to Section 5.6, then payment shall be due within sixty (60) days after
receipt by Voyager of notice from the Testing Laboratory that the invoiced
Product is conforming or, subject to Section 5.6, receipt by Voyager of
replacement Product, as the case may be. In the event of any inconsistency
between an invoice and this Agreement, the terms of this Agreement shall
control. All payments shall be made in accordance with Section 7.4.
Section 5.3 Price. The parties hereby agree that the price (the
"Manufacturing Cost") for Voyager's requirements of:
(a) clinical supplies of the Product (and placebos) shall be equal to
[***] in accordance with all Applicable Laws calculated in accordance with
Exhibit 5.3.
(b) commercial supplies of the Product shall be equal to [***].
SBS shall notify Voyager in advance of any material increase in Manufacturing
Cost.
Section 5.4 Warranty. SBS warrants that, at the time of delivery of the
Product to Voyager: (a) such Product will have been Manufactured, held and
shipped in accordance with the Regulatory Approvals for the Product, applicable
GMP and all other Applicable Law; (b) such Product will have been Manufactured
in accordance, and be in conformity, with the Product Specifications and will
conform with the certificate of analysis provided pursuant to Section 5.2; (c)
such Product will not be adulterated or misbranded under the Federal Food, Drug,
and Cosmetic Act, as amended (the "FFDCA"), and similar provisions of the laws
of other countries as to which Regulatory Approvals have been granted with
respect to the Product; (d) title to such Product will pass to Voyager as
provided herein free and clear of any security interest, lien or other
encumbrance; (e) such Product will have been Manufactured in facilities that are
in material compliance all Applicable Laws at the time of such Manufacture
(including applicable inspection requirements of FDA and other Regulatory
Authorities); and (f) such Product may be introduced into interstate commerce
pursuant to the FFDCA.
Section 5.5 Non-Conforming Product. SBS shall not deliver to Voyager any
Product that fails to conform in any respect to the warranty set forth in
Section 5.4. In the event that any Product shall fail to pass the quality
control testing conducted by SBS, (i) SBS shall notify Voyager thereof within
one (1) business day, (ii) SBS shall not release the batch from which such
Product was taken, and (iii) the parties shall agree upon appropriate corrective
steps to be taken. Voyager, at its option, may investigate the cause of such
failure, or require SBS to do so, in which case SBS shall provide Voyager with a
written report summarizing the results of the SBS's investigation, all at the
expense of SBS.
17
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
Section 5.6 Failure or Inability to Supply Product.
(a) Notification of Inability to Supply. In the event that SBS, at any
time during the term of this Agreement, shall have reason to believe that it
will be unable to supply Voyager with the full quantity of the Product
forecasted to be ordered or actually ordered by Voyager in a timely manner and
in conformity with the warranty set forth in Section 5.4 (whether by reason of
force majeure or otherwise), SBS shall promptly notify Voyager thereof. Promptly
thereafter, the parties shall meet to discuss how Voyager shall obtain such full
quantity of conforming Product. Compliance by SBS with this Section 5.6 shall
not relieve SBS of any other obligation or liability under this Agreement,
including any obligation or liability under clause (b) or (c) below.
(b) Failure to Supply Conforming Product. In the event that Voyager
reasonably determines, within thirty (30) days after delivery thereof by SBS,
that any Product supplied by SBS does not conform to the warranty set forth in
Section 5.4, Voyager shall give SBS notice thereof (including a sample of such
Product). SBS shall undertake appropriate testing of such sample and shall
notify Voyager whether it has confirmed such non-conformity within thirty (30)
days after receipt of such notice from Voyager. If SBS notifies Voyager that it
has not confirmed such non-conformity, the parties shall submit the disputed
batch to an independent testing laboratory mutually acceptable to the parties
(the "Testing Laboratory") for testing. The findings of the Testing Laboratory
shall be binding on the parties, absent manifest error. The expenses of the
Testing Laboratory shall be borne by SBS if the testing confirms the
non-conformity and otherwise by Voyager. If the Testing Laboratory or SBS
confirms that a batch of Product does not conform to the warranty set forth in
Section 5.4, SBS shall promptly (i) supply Voyager with a conforming quantity of
the Product at SBS's expense or (ii) reimburse Voyager for all reasonable costs
Voyager may have directly incurred with respect to such non-conforming Product,
including any Manufacturing Cost paid by Voyager with respect to such Product,
which costs Voyager shall have the right to offset against any payments owed by
Voyager to SBS under this Agreement. The rights and remedies provided in this
clause shall be cumulative and in addition to any other rights or remedies that
may be available to Voyager.
(c) Rights and Remedies.
(i) If SBS fails [***] or more times within any [***] consecutive
month period to supply the full quantity of Product specified in a Firm Order by
the delivery date specified therein and in conformity with the warranty set
forth in Section 5.4, Voyager may, in its sole discretion, terminate (A) the
rights and obligations of the parties under Article V (in which event the
license granted Section 8.2(a) shall also terminate) or (B) the rights and
obligations of the parties under Section 4.2(c) (in which event the license
granted pursuant to Section 8.2(c) shall also terminate), in each case by
providing immediate written notice to SBS, and thereafter Voyager may
Manufacture Product itself or purchase its requirements for Product from a third
Person. The rights and remedies provided in this Section 5.6 shall be cumulative
and in addition to any other rights or remedies that may be available to
Voyager.
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**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
Section 5.7 Costs and Expenses. SBS shall be solely responsible for all
costs and expenses incurred in connection with the Manufacture of supplies of
the Product pursuant to this Article V, including costs and expenses of
personnel, testing, including quality control and stability, Manufacturing
facilities and equipment, the Active Agent, raw materials, excipients, labeling,
packaging materials and all other supplies of any kind used in connection with
Manufacturing the Product (and placebos), which costs shall be included in the
calculation of Manufacturing Costs in accordance with Section 5.3; provided,
however, that Voyager (i) shall reimburse to SBS, within 30 days after receipt
of an invoice and reasonable supporting documentation therefor, the cost of any
piece of Manufacturing equipment or other fixed asset procured by SBS after the
date hereof and required to Manufacture the Product hereunder; provided that the
cost of such equipment or asset is [ * * * ] or less, and (ii) may, if it so
determines in its sole and absolute discretion, purchase (and retain title to)
and make available for use by SBS any other piece of Manufacturing equipment or
other fixed asset that SBS requests for use in connection with the Manufacture
of the Product; provided further, that Voyager, in its sole discretion but upon
reasonable advance notice to SBS, may from time to time, at its cost, supply to
SBS materials (including the Active Agent) to be used in the Manufacture of the
Product, in which event the cost of such materials shall not be included in
calculating Manufacturing Cost for the Products for which they were used.
Section 5.8 Amendment of Product Specifications and Manufacturing Process.
(a) Rights and Limitations. Voyager reserves the right to amend,
modify or supplement the Product Specifications or the Manufacturing Process
unilaterally and in its sole discretion for the purpose of complying with the
Regulatory Approvals, GMP, other Applicable Law, or, upon ninety (90) days prior
notice, for any other reasonable business purpose. Voyager shall promptly supply
SBS with appropriate documentation relating to any such changes to the Product
Specifications or Manufacturing Process to the extent that such changes affect
SBS's Manufacturing of the Product hereunder. In the event that SBS cannot
reasonably implement or comply with such changes to Product Specifications (it
being acknowledged and agreed by SBS that increase in Manufacturing Cost shall
not constitute a valid justification for failure to implement or comply with
such changes), then SBS shall not be required to implement or comply with such
changes. SBS may not amend, modify or supplement the Product Specifications or
the Manufacturing Process for the Product in any respect without the prior
written consent of Voyager, which consent shall not be unreasonably withheld or
delayed.
(b) Amendment to Regulatory Approvals; Costs and Expenses. In the
event that Voyager amends, modifies or supplements the Product Specifications or
the Manufacturing Process for the Product, or consents to any such amendment,
modification or supplement by SBS, SBS shall provide to Voyager any such
documentation or other information with respect thereto as Voyager may
reasonably request in order to obtain or maintain any Regulatory Approval or
comply with GMP or Applicable Law. Voyager shall reimburse SBS for reasonable
costs that are actually incurred by SBS in connection with any such change
requested by Voyager, including reasonable costs of capital equipment and
process upgrades, obsolescence of raw materials, goods-in-process,
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**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
packaging materials and supplies and finished goods not suitable for use in the
business or operations of SBS or any of its Affiliates; provided, however, that
Voyager's liability for such reimbursement shall be limited to levels of
inventory that are customary in pharmaceutical manufacturing operations. SBS
shall be solely responsible for any and all costs and expenses incurred by it or
Voyager and its Affiliates and sublicensees as a result of any amendment,
modification or supplementation of the Product Specifications or the
Manufacturing Processes by SBS not requested by Voyager, or requested by Voyager
as a result of SBS's failure to Manufacture Product in conformity with the
warranty set forth in Section 5.4, which costs shall not be included in the
Manufacturing Costs.
Section 5.9 Testing, Assays, Stability and Quality Assurance.
(a) Testing Requirements. With respect to the Product or any
intermediate thereof Manufactured or supplied by SBS, SBS shall be responsible
for the performance of and compliance with all Product testing required by the
Product Specifications, the Manufacturing Processes and Regulatory Approvals for
the Product and all Applicable Law. SBS agrees to implement and maintain such
processing control procedures as Voyager may reasonably request, including the
assignment of identification numbers to each lot of Product and the maintenance
of production records, quality control records, batch records and related
information.
(b) Retention of Samples. SBS shall take and retain, for such period
as may be required by Applicable Law or such longer period as otherwise
reasonably required by Voyager, samples of Product (i) sufficient to satisfy
SBS's obligations under this Agreement, GMP and Applicable Law with respect to
its Manufacturing of the Product, (ii) sufficient to perform quality control
testing and stability testing in accordance with this Agreement, the Regulatory
Approvals for the Product, GMP and all other Applicable Law, and (iii) as
otherwise reasonably required by Voyager, and in each case shall specify the
control number and the date of Manufacture thereof. Further, SBS shall submit to
Voyager, upon Voyager's written request, such samples, materials and quality
control records as Voyager may reasonably request.
(c) Stability Testing. SBS shall perform stability testing of the
Product in accordance with the Product Specifications, the Manufacturing
Process, the Regulatory Approvals, GMP and other Applicable Law, and such other
requirements and processes as Voyager shall reasonably determine from time to
time. If SBS confirms a stability failure with respect to the Product, SBS shall
notify Voyager thereof within twenty-four (24) hours and the parties shall
discuss in good faith appropriate corrective action. SBS shall promptly
implement any such corrective action.
(d) Maintenance of Facilities. SBS shall ensure, that any and all
necessary licenses, registrations, and Regulatory Authority approvals have been
obtained in connection with any facilities and equipment used in connection with
the Manufacture of the Product by SBS. SBS shall maintain such facilities and
equipment in a state of repair and operating efficiency consistent with the
requirements of the Product Specifications, the Regulatory Approvals, the
Manufacturing Processes, GMP and all
20
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
other Applicable Law. Prior to each use of any equipment in Manufacturing the
Product, SBS shall implement a cleaning validation protocol with respect to such
equipment, including the cleaning and maintenance thereof, in accordance with
any procedures reasonably established by Voyager and notified to SBS, the
Product Specifications, the Regulatory Approvals and the Manufacturing
Processes, GMP and all other Applicable Law. SBS shall maintain in such
facilities adequate and segregated (if required) holding accommodations for the
Product, the Active Agent, and the excipients, packaging components, and other
items used in Manufacturing the Product in accordance with the Product
Specifications, the Regulatory Approvals and the Manufacturing Process, GMP and
all other Applicable Law. If required under Applicable Law, all Product shall be
held by SBS in a separate segregated area until delivery to Voyager.
(e) Quality Assurance Procedures. Without limitation of the foregoing,
SBS agrees to implement, in connection with the Manufacture of the Product,
quality assurance and quality control procedures, including validation
protocols, process change procedures and methods of statistical analysis for
cleaning validation that are reasonably satisfactory to Voyager.
Section 5.10 Inspection by Voyager. SBS agrees that Voyager and its agents
shall have the right, upon reasonable prior notice to SBS, to inspect any
facility at which the Product or any intermediate thereof is Manufactured as
well as the Manufacturing of the Product and any intermediates thereof, as
applicable, including inspection of (a) the materials used in the Manufacture of
the Product, (b) the holding facilities for such materials, (c) the equipment
used in the Manufacture of the Product, and (d) all records relating to such
Manufacturing and each such manufacturing facility. Following such audit,
Voyager shall discuss its observations and conclusions with SBS and corrective
actions shall be agreed upon by Voyager and SBS within thirty (30) days
thereafter. SBS shall implement such corrective action within sixty (60) days
after the parties reach such agreement, unless otherwise agreed in writing by
the parties.
Section 5.11 Notification of Inspections; Communications. SBS shall notify
Voyager by telephone within one (1) business day, and in writing within five (5)
business days, after learning thereof, of any proposed or unannounced visit or
inspection of any facility at which the Product, or any intermediate thereof, is
Manufactured, or of any Manufacturing Process used in connection with the
Manufacture of the Product, by any Regulatory Authority, and shall permit
Voyager or its agents to be present and participate in such visit or inspection.
SBS shall provide to Voyager a copy of any report and other written
communications received from such Regulatory Authority in connection with such
visit or inspection, and any written communications received from such
Regulatory Authority relating to the Product or any facility or Manufacturing
Process used in connection with the Manufacture of the Product, within three (3)
business days after receipt thereof, and shall consult with Voyager concerning
the response of SBS to each such communication. SBS shall provide Voyager with a
copy of all draft responses for comment as soon as possible and all final
responses for review and approval, which shall not be unreasonably withheld or
delayed, within five (5) business days prior to submission thereof.
21
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
Section 5.12 Manufacturing Records. SBS shall maintain, or cause to be
maintained, (i) all records necessary to comply with GMP and all other
Applicable Law relating to the Manufacture of the Product, (ii) all
Manufacturing records, standard operating procedures, equipment log books, batch
records, laboratory notebooks and all raw data relating to the Manufacturing of
the Product, and (iii) such other records as Voyager may reasonably require in
order to ensure compliance by SBS with the terms of this Agreement. All such
material shall be retained for such period as may be required by GMP and all
other Applicable Law or for such longer period as Voyager may reasonably
require; provided, however, that all records relating to the Manufacturing,
stability and quality control of each batch of the Product shall be retained at
least until the first anniversary of the end of the approved shelf life for all
Product from such batch.
Section 5.13 Labeling. Voyager shall specify all labeling to be used on the
Product and the packaging thereof. SBS agrees to use such labeling (and only
such labeling) on the Product, and not to use such labeling on any other
product. To the extent permissible under Applicable Law, at SBS's request (and
expense if compliance with such request increases any costs related to the
Product), Voyager shall cause the packaging of the Product to display, in a
manner reasonably acceptable to SBS and Voyager, the name and logo of SBS (or an
Affiliate) and to identify SBS as a developer or such Product. SBS shall grant
Voyager appropriate licenses in order to fulfill its obligations under this
Section 5.13.
ARTICLE VI. JOINT DEVELOPMENT TEAM
Section 6.1 Joint Development Team. Upon initiation of the Feasibility
Program, the parties shall establish a joint development team (the "Joint
Development Team") which shall consist of two (2) representatives appointed by
each party. The chairperson of the Joint Development Team shall be a
representative of Voyager (the "Chair"). Each party may, from time to time,
change one or more of its representatives by written notice to the other party.
The Joint Development Team shall be responsible for and establish procedures for
the management of the Feasibility and Development Programs in accordance with
the Feasibility and Development Plans and shall serve as points of contact
between the parties to coordinate activities and ensure that the parties perform
their respective obligations (if any) diligently in accordance with the
Feasibility Plan and the Development Plan. The Joint Development Team shall meet
at least once per month (either by telephone or in person, as agreed to by SBS
and Voyager) to review the planning and the progress of the Feasibility and
Development Programs and to consider recommendations regarding, and to make
changes to, the Feasibility and Development Plans and performance of the
Feasibility and Development Programs. In performing its functions, the Joint
Development Team shall attempt to reach all decisions by consensus. However, if
the members cannot reach consensus with respect to any decision within a
reasonable time period (which shall not be more than thirty (30) days) after
careful consideration, the matter shall be referred to the chief executive
officers of Voyager and SBS for review and discussion. In the event the CEOs of
Voyager and SBS cannot reach agreement within a reasonable time period (which
shall not be more than thirty (30) days), then the Chair shall make the final
decision, which shall be final and
22
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
binding on the parties. Notwithstanding the foregoing, nothing herein, and no
decision made under this Section, shall be deemed to modify or supersede the
express terms or conditions of this Agreement, or any decision or
decision-making authority otherwise expressly provided for in this Agreement.
ARTICLE VII. PAYMENTS
Section 7.1 Development Costs.
(a) Voyager shall pay SBS's fully allocated development cost
calculated in accordance with Exhibit 7.1 (the "Development Costs") for all
Feasibility Activities, Development Activities and activities under and pursuant
to Article IV, in each case performed by SBS.
(b) The estimated total Development Costs necessary to complete all
Feasibility Activities is set forth in the Feasibility Plan, although the actual
Development Costs therefor may differ. Completion of the Feasibility Plan with
less effort than estimated may result in lower charges; however, additional
effort from unexpected results or changes requested by Voyager may result in
higher charges. SBS will not exceed the estimated costs without prior written
approval from Voyager.
(c) Voyager shall pay to SBS [***] upon execution of this Agreement
(the "Deposit").
(d) SBS shall submit to Voyager, not later than twenty (20) business
days after the end of each month during the term of this Agreement in which
Development Costs are incurred, an invoice which shall set forth the actual
amount of Development Costs incurred during the prior month. Voyager, within
thirty (30) days of receipt of each such invoice, (i) shall pay the amount
specified in such invoice, less twenty (20) percent of such invoiced amount
until such time as the Deposit has been fully credited, and (ii) thereafter
shall pay the full amount of each such invoice. Charges for reimbursement of
purchases of Active Agent by SBS in connection with the performance of the
Feasibility Activities and the Development Activities shall be invoiced
separately from time to time and shall be paid by Voyager within thirty (30)
days of receipt thereof. All invoices shall be sent to Voyager at the address
specified in Section 13.1 unless Voyager designates otherwise in writing to SBS.
23
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
Section 7.2 Milestone Payments. Voyager shall make the milestone payments
specified below to SBS within thirty (30) days following achievement of the
corresponding milestone event, except that in the case of the Approval of first
NDA (or equivalent) milestone event, payment shall be paid by Voyager within
sixty (60) days following achievement of such milestone event:
Milestone Event Milestone Payment
--------------- -----------------
(a) [ * * * ] [ * * * ]
(b) [ * * * ] [ * * * ]
(c) [ * * * ] [ * * * ]
(d) [ * * * ] [ * * * ]
Section 7.3 Voyager Royalties.
(a) Subject to the terms and conditions of this Section 7.3, Voyager
shall pay to SBS the following royalties based on aggregate Net Sales of the
Product by Voyager, its Affiliates and sublicensees in the Territory during each
calendar year (or part thereof):
[***] of Net Sales for that portion of aggregate
Net Sales in such calendar year that is less than or
equal to [***];
[***] of Net Sales for that portion of aggregate
Net Sales in such calendar year that exceeds [***]
but is less than or equal to [***]; and
[***] of Net Sales for that portion of aggregate
Net Sales in such calendar year that exceeds
[***];
provided that Voyager shall pay SBS at least [***] in royalties annually
(the "Minimum Royalty") commencing with the year in which the First Commercial
Sale in any country in the Territory is made. In the event that the First
Commercial Sale is made at some time other than the beginning of a calendar
year, the Minimum Royalty for such first year shall be prorated.
(b) Voyager's royalty payment obligations under this Section 7.3 shall
commence with the First Commercial Sale of the Product and shall terminate on
the termination of this Agreement. To the extent that royalties may not be
collected in a certain country in the Territory under Applicable Law for the
full royalty term hereunder, then the royalty due on sales in such country shall
terminate after the maximum period under which royalties may be collected under
Applicable Law without effect on the royalties due hereunder with respect to
sales made in other countries in the Territory.
24
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
(c) Royalties shall be payable on a quarterly basis, within sixty (60)
days after the end of each calendar quarter, based upon the Net Sales during
such calendar quarter (or a ratable portion of the Minimum Royalty, if greater),
commencing with the calendar quarter in which the First Commercial Sale of the
Product is made by Voyager. Royalties shall be calculated in accordance with
GAAP and with the terms of this Section 7.3. Only one royalty payment will be
due on Net Sales even though the Manufacture, sale or use of a Product may be
covered by more than one SBS Technology or SBS Improvement in a country. The
amount paid by Voyager as a Minimum Royalty with respect to any quarter shall be
fully creditable against royalties due based on Net Sales of Product for any
other quarter during the same calendar year.
(d) Each royalty payment hereunder shall be accompanied by a statement
showing (a) Net Sales during the applicable calendar quarter, (b) the number of
units of the Product sold by Voyager on a country-by-country basis during the
applicable calendar quarter, and (c) the amount of royalties due hereunder.
(e) In the event that a court or a governmental agency of competent
jurisdiction requires Voyager or a Voyager Affiliate or sublicensee to grant a
compulsory license to a third Person permitting such third Person to make and
sell the Product in a jurisdiction in the Territory despite Voyager having
exerted all reasonable efforts to oppose the granting of such compulsory
license, then all Net Sales by such compulsory sublicensee shall be excluded
from the royalty calculations set forth in Section 7.3(a) and the royalty rate
to be paid by Voyager on such Net Sales by such compulsory sublicensee shall be
the lesser of (i) the applicable royalty rate provided in Section 7.3(a) with
respect to such Net Sales, and (ii) [***] of the royalty rate under such
compulsory license, during the time period when such compulsory license is in
effect and being exercised.
Section 7.4 Method of Payment. All payments to SBS under this
Agreement shall be made by deposit of United States Dollars in the requisite
amount to such bank account as SBS may from time to time designate by notice to
Voyager. With respect to sales outside the United States, payments shall be
calculated based on currency exchange rates for the calendar quarter for which
remittance is made for royalties. For each currency, such exchange rate shall
equal the arithmetic average of the daily exchange rates (obtained as described
below) during the calendar quarter; each daily exchange rate shall be obtained
from the The Xxxx Xxxxxx Xxxxxxx, Xxxxxxx Xxxxxx Xxxxxx Edition, or, if not so
available, as otherwise agreed by the parties.
Section 7.5 SBS Royalties.
(a) If SBS elects to Exploit the Product in any Terminated Countries
pursuant to Section 4.2(c), subject to the terms and conditions of this Section
7.5, SBS shall pay to Voyager the following royalties based on aggregate Net
Sales of the Product by SBS, its Affiliates and licensees in all Terminated
Countries during each calendar year (or part thereof):
[***] of Net Sales for that portion of aggregate
Net Sales in such calendar year that is less than or
equal to [***];
25
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
[***] of Net Sales for that portion of aggregate
Net Sales in such calendar year that exceeds [***]
but is less than or equal to [***]; and
[***] of Net Sales for that portion of aggregate
Net Sales in such calendar year that exceeds [***].
(b) SBS's royalty payment obligations under this Section 7.5 shall
commence with the first commercial sale of the Product in any Terminated Country
and shall terminate on the termination of this Agreement. To the extent that
royalties may not be collected in a certain Terminated Country under Applicable
Law for the full royalty term hereunder, then the royalty due on sales in such
country shall terminate after the maximum period under which royalties may be
collected under Applicable Law without effect on the royalties due hereunder
with respect to sales made in other Terminated Countries.
(c) Royalties shall be payable on a quarterly basis, within sixty (60)
days after the end of each calendar quarter, based upon the Net Sales during
such calendar quarter, commencing with the calendar quarter in which the first
commercial sale of the Product is made by SBS, its Affiliates or sublicensees in
any Terminated Country. Royalties shall be calculated in accordance with GAAP
and with the terms of this Section 7.5.
(d) Each royalty payment hereunder shall be accompanied by a statement
showing (a) Net Sales during the applicable calendar quarter, (b) the number of
units of the Product sold by SBS, its Affiliates and sublicensees in the
Terminated Countries on a country-by-country basis during the applicable
calendar quarter, and (c) the amount of royalties due hereunder.
(e) All payments to Voyager under this Agreement shall be made by
deposit of United States Dollars in the requisite amount to such bank account as
Voyager may from time to time designate by notice to SBS. With respect to sales
outside the United States, payments shall be calculated based on currency
exchange rates for the calendar quarter for which remittance is made for
royalties. For each currency, such exchange rate shall equal the arithmetic
average of the daily exchange rates (obtained as described below) during the
calendar quarter; each daily exchange rate shall be obtained from The Xxxx
Xxxxxx Xxxxxxx, Xxxxxxx Xxxxxx Xxxxxx Edition, or, if not so available, as
otherwise agreed by the parties.
26
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
Section 7.6 Recordkeeping and Audit.
(a) SBS shall keep, or shall cause to be kept, complete and accurate
books and records of all information necessary, and in sufficient detail, to
determine all Development Costs, Active Agent costs, and Manufacturing Costs
payable by Voyager to SBS pursuant to this Agreement and Net Sales in the
Terminated Countries (if any) and the royalties payable by SBS to Voyager
pursuant to this Agreement for the previous seven (7) calendar years.
(b) Voyager shall keep, or shall cause to be kept, complete and
accurate books and records of all information necessary, and in sufficient
detail, to determine Net Sales in the Territory and the royalties payable by
Voyager to SBS pursuant to this Agreement for the previous seven (7) calendar
years.
(c) Voyager shall have the right, no more than once during any twelve
(12) consecutive month period during the term of this Agreement and the twelve
(12) months following the termination hereof, to have the books and records kept
by SBS pursuant to Section 7.6(a) (and all related work papers and other
information and documents) examined by an independent accounting firm of
national standing reasonably acceptable to SBS to verify SBS's calculations of
the amounts of Development Costs, Active Agent costs, and Manufacturing Costs
invoiced by SBS to Voyager hereunder and the accuracy of the information
contained in the reports delivered by SBS pursuant to Section 7.5(d) and SBS's
calculation of the royalties payable hereunder. If Voyager shall dispute any
such calculation, Voyager promptly shall notify SBS and Voyager and SBS shall
use good faith efforts to resolve such dispute. If Voyager and SBS are unable to
resolve such dispute within [ * * * ] days after Voyager notifies SBS of such
dispute, then an independent accounting firm mutually agreed to by Voyager and
SBS shall resolve such dispute and such accountant's resolution shall be final
and binding on the parties. Each party shall cooperate with such accountant's
investigation. If, and only if, it shall be determined pursuant to the
procedures set forth in this clause (c) that (i) SBS invoiced Voyager an amount
greater than [ * * * ] of the total amount actually owed by Voyager or (ii) SBS
paid Voyager an amount less than [ * * * ] of the total royalty amount actually
owed by SBS, then in each case SBS shall reimburse Voyager for all of its costs
related to such examination and shall pay all costs and expenses of the mutually
agreed accountant, if any; otherwise Voyager shall bear all of its costs related
to such examination and shall pay all costs and expenses of the mutually agreed
accountant, if any.
(d) SBS shall have the right, no more than once during any twelve (12)
consecutive month period during the term of this Agreement and the twelve (12)
months following the termination hereof, to have the books and records kept by
Voyager pursuant to Section 7.6(b) (and all related work papers and other
information and documents) examined by an independent accounting firm of
national standing reasonably acceptable to Voyager to verify the accuracy of the
information contained in the reports delivered by Voyager pursuant to Section
7.3(d) and Voyager's calculation of the royalties payable hereunder. If SBS
shall dispute any such information or calculation, SBS promptly shall notify
Voyager and SBS and Voyager shall use good faith efforts to
27
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
resolve such dispute. If SBS and Voyager are unable to resolve such dispute
within [***] days after SBS notifies Voyager of such dispute, then an
independent accounting firm mutually agreed to by SBS and Voyager shall resolve
such dispute and such accountant's resolution shall be final and binding on the
parties. Each party shall cooperate with such accountant's investigation. If,
and only if, it shall be determined pursuant to the procedures set forth in this
clause (d) that Voyager paid SBS an amount less than [***] of the total
royalty amount actually owed by Voyager, then Voyager shall reimburse SBS for
all of its costs related to such examination and shall pay all costs and
expenses of the mutually agreed accountant, if any; otherwise SBS shall bear all
of its costs related to such examination and shall pay all costs and expenses of
the mutually agreed accountant, if any.
(e) If, as a result of the procedures set forth in clause (c) or (d)
above, any amount paid by a party pursuant to the terms hereof shall be found to
have been incorrectly calculated, the appropriate party promptly shall pay to
the other party the amount necessary to correct such payment error.
(f) All financial books and records maintained by the parties pursuant
hereto shall be maintained in accordance with GAAP.
ARTICLE VIII. INTELLECTUAL PROPERTY
Section 8.1 Ownership
(a) SBS shall own all right, title and interest in and to the SBS
Technology and the SBS Improvements. Voyager shall, and shall cause its
Affiliates, sublicensees and subcontractors hereunder to, promptly disclose in
writing to SBS the development, making, conception or reduction to practice of
any SBS Technology and the SBS Improvements and shall and does hereby, and shall
cause its Affiliates, sublicensees and subcontractors to, assign to SBS any and
all right, title or interest Voyager or its Affiliates, sublicensees or
subcontractors may have in or to the SBS Technology and the SBS Improvements.
Voyager hereby appoints, and shall cause its Affiliates, sublicensees and
subcontractors to appoint, SBS as their attorney-in-fact for the purpose of
executing such documents in their respective names as may be necessary or
desirable to carry out the purposes of this subsection.
(b) Voyager shall own all right, title and interest in and to (i) the
Voyager Patents and (ii) any and all Inventions and other intellectual property
created, developed or acquired as a result of or in connection with the
Agreement including the Feasibility Activities, the Development Activities or
SBS's Manufacturing of the Product hereunder, relating to clinical uses of the
Active Agent (whether for treatment of Alzheimer's Disease or otherwise) (the
"Project Information and Inventions"); provided, however, that the Project
Information and Inventions shall not include any right, title or interest,
express or implied, in or to the SBS Technology or the SBS Improvements. SBS
shall, and shall cause its Affiliates, sublicensees and subcontractors to,
promptly disclose in writing to Voyager the development, making, conception or
reduction to practice of any Project Information and Inventions and shall and
does hereby, and shall cause its
28
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
Affiliates, sublicensees and subcontractors to, assign to Voyager any and all
right, title or interest SBS or its Affiliates, sublicensees and subcontractors
may have in or to the Project Information and Inventions. SBS hereby appoints,
and shall cause its Affiliates, sublicensees and subcontractors to appoint,
Voyager as their attorney-in-fact for the purpose of executing such documents in
their respective names as may be necessary or desirable to carry out the
purposes of this subsection.
(c) Any Inventions and other intellectual property created, developed
or acquired as a result of or in connection with the Feasibility Activities, the
Development Activities or SBS's Manufacturing of the Product hereunder
(including any data or information generated as a result of or in connection
with the Feasibility Activities and Development Activities, regardless of
whether such data or information is included in any report or information
delivered by SBS to Voyager hereunder), other than the Inventions owned by
either SBS or Voyager exclusively as set forth in Section 8.1(a) and (b), shall
be jointly owned by the parties ("Joint Inventions"). Except as otherwise set
forth herein or agreed upon in writing by the parties, each party shall have all
the rights and privileges of a joint owner under the patent laws of the United
States with respect to the Joint Inventions, including the right to exploit and
grant licenses and sublicenses to patents covering Joint Inventions, without
accounting to the other party. Each party shall, and shall cause its Affiliates
to, promptly disclose in writing to the other party the development, making,
conception or reduction to practice of any Joint Invention. Additionally, each
party agrees to cooperate with and provide reasonable assistance to the other
party in filing, prosecuting and perfecting patent and other intellectual
property rights covering Inventions related to the subject matter of this
Agreement owned by the other party at the other party's expense.
(d) It is understood and agreed that, except as expressly provided in
Section 8.2 hereof, nothing contained in this Agreement or otherwise shall be
construed to mean that one party will obtain any rights, by implication or
otherwise, in or to any proprietary right of the other party. In particular, SBS
will not obtain any right, title or interest in or to the Voyager Patents and
Project Information and Inventions and Voyager will not obtain any right, title
or interest in or to the SBS Technology and SBS Improvements, except as provided
in Section 8.2 hereof.
(e) Any and all information or material related to an Invention
assigned to a party pursuant to the terms of this Agreement shall constitute
Confidential Information of such party which shall be deemed the Disclosing
Party with respect to such Confidential Information.
Section 8.2 License Grants.
(a) Voyager hereby grants to SBS a limited, royalty-free, nonexclusive
license, without right to sublicense (except to the extent, and only to the
extent, necessary to permit a qualified contract manufacturer to Manufacture
Product in accordance with Section 5.1), under the Voyager Patents and Project
Information and Inventions solely to perform its obligations under Article II,
Article III and Article V, which grant shall expire
29
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
on the termination of this Agreement for any reason or otherwise in accordance
with Sections 2.5, 3.8, 4.5 or 5.6.
(b) SBS hereby grants to Voyager a worldwide, royalty-bearing,
exclusive (including with regard to SBS and its Affiliates) license, with right
to sublicense (subject to Section 8.2(d)), under the SBS Technology and the SBS
Improvements, to Manufacture, have Manufactured, import, use, sell, offer for
sale and otherwise Exploit the Product in the Territory, which grant shall
expire on the termination of this Agreement for any reason.
(c) In the event that SBS has the right and elects to Exploit the
Product in any Terminated Country pursuant to Section 4.2(c), Voyager hereby
grants to SBS in such Terminated Country a royalty bearing, exclusive license,
with the right to sublicense (subject to Section 8.2(e)) under the Voyager
Patents and Project Information and Inventions, and the right to use all
regulatory filings, Clinical Trial data and CMC data and all other intellectual
property owned by Voyager, in each case to the extent solely related to the
Product, and the right to cross-reference any and all regulatory filings with
respect to the Product, solely for purposes of Exploiting the Product in such
Terminated Country, which grant shall expire on the termination of this
Agreement for any reason or otherwise in accordance with Section 2.5, 3.8, 4.5
or 5.6.
(d) Voyager may sublicense its rights under Section 8.2(b), subject to
the following conditions: (i) such sublicense shall be subject to the terms and
conditions of this Agreement; and (ii) the rights of SBS under this Agreement
shall not be prejudiced, reduced or limited in any way as a result of such
sublicense of rights. Additionally, if Voyager sublicenses its rights to develop
or commercialize the Product (other than ordinary distributor arrangements), it
shall: (1) provide SBS with a copy of the proposed sublicense agreement in a
time frame that reasonably permits SBS to review and comment on the sublicense
agreement and a final copy of the sublicense agreement; and (2) the sublicense
agreement shall be subject to the approval of SBS which shall not be
unreasonably withheld or delayed.
(e) SBS may sublicense its rights under Section 8.2(c), subject to the
following conditions: (i) such sublicense shall be subject to the terms and
conditions of this Agreement; and (ii) the rights of Voyager under this
Agreement shall not be prejudiced, reduced or limited in any way as a result of
such sublicense of rights. Additionally, if SBS sublicenses its rights to
develop or commercialize the Product (other than ordinary distributor
arrangements), it shall: (1) provide Voyager with a copy of the proposed
sublicense agreement in a time frame that reasonably permits Voyager to review
and comment on the sublicense agreement and a final copy of the sublicense
agreement; and (2) the sublicense agreement shall be subject to the approval of
Voyager which shall not be unreasonably withheld or delayed.
Section 8.3 Prosecution and Maintenance of Intellectual Property Rights.
The responsibility for preparing, filing and prosecuting patent applications and
for maintaining patents and other intellectual property rights (and for managing
any interference proceedings relating to the foregoing) covering any Invention
owned by a
30
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
party, and all costs related thereto, shall be the responsibility of such
party. The parties shall by mutual agreement prepare, file and prosecute patent
applications and maintain patents and other intellectual property rights (and
manage any interference proceedings relating to the foregoing) covering any
Joint Invention, and all costs related thereto, shall be shared equally between
the parties.
Section 8.4 Third Person Litigation.
(a) Regarding SBS Technology and Improvements. In the event that
during the term of this Agreement any Person institutes against SBS or Voyager
any action that alleges that the use of the SBS Technology or the SBS
Improvements in connection with the Exploitation of the Product in the Territory
in accordance with the terms hereof infringes the intellectual property rights
held by such Person, then, as between SBS and Voyager, SBS, at its sole expense,
shall have the sole obligation to contest, and assume direction and control of
the defense of, such action, including the right to settle such action on terms
determined by SBS; provided that in no event shall SBS enter into any settlement
that adversely affects the interests of Voyager or its Affiliates, whether under
this Agreement or otherwise, without Voyager's prior written consent, which
shall not be unreasonably withheld or delayed. Voyager, at SBS's expense, shall
use all reasonable efforts to assist and cooperate with SBS as reasonably
requested by SBS in such action. If, as a result of any such action, a judgment
is entered by a court of competent jurisdiction from which no appeal can be
taken or from which no appeal is taken within the time permitted for appeal, or
a settlement is entered into by SBS, such that any SBS Technology or the SBS
Improvements cannot be used in connection with the Exploitation of the Product
in the Territory without infringing the intellectual property rights of such
Person, then Voyager shall have the right either to (i) terminate this Agreement
immediately or (ii) take such actions as it deems necessary to protect its
interests, including the right to obtain a license from such Person and to
offset the cost of such license against any amounts owed to SBS hereunder;
provided that the amount offset by Voyager shall not exceed [***] of the
royalty rate then payable by Voyager pursuant to Section 7.3.
(b) Regarding the Voyager Patents. In the event that during the term
of this Agreement any Person institutes against SBS any action that alleges that
the use of the Voyager Patents in connection with the Exploitation of the
Product in the Territory in accordance with the terms hereof infringes the
intellectual property rights held by such Person, then, as between SBS and
Voyager, Voyager, at its sole expense, shall have the sole obligation to
contest, and assume direction and control of the defense of, such action,
including the right to settle such action on terms determined by Voyager;
provided that in no event shall Voyager enter into any settlement that adversely
affects the interests of SBS or its Affiliates, whether under this Agreement or
otherwise, without SBS's prior written consent, which shall not be unreasonably
withheld or delayed. SBS, at Voyager's expense, shall use all reasonable efforts
to assist and cooperate with Voyager as reasonably requested by Voyager in such
action. If, as a result of any such action, a judgment is entered by a court of
competent jurisdiction from which no appeal can be taken or from which no appeal
is taken within the time permitted for appeal, or a
31
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
settlement is entered into by Voyager, such that Voyager cannot develop or
commercialize the Product in a country in the Territory, then SBS shall have the
right to terminate the rights granted to Voyager under Section 8.2 with respect
to such country.
Section 8.5 Exclusivity.
(a) During the term of this Agreement and, in the event of termination
of this Agreement by Voyager pursuant to Section 11.2(b) or (c), for a period of
[***] after termination hereof, SBS shall not, and shall cause its Affiliates
not to, (a) conduct any activity, either on its own or through its Affiliates,
or with, for the benefit of, or sponsored by any Person, that has as its goal or
intent discovering, identifying, Exploiting or otherwise commercializing any
Unique Dose Product, or (b) grant any license or other rights to any Person to
utilize any intellectual property owned or controlled by SBS or its Affiliates
(including the SBS Technology, SBS Improvements or Joint Inventions) for the
purpose of discovering, identifying, Exploiting or otherwise commercializing any
Unique Dose Product, in each case other than as expressly provided in this
Agreement.
(b) SBS acknowledges and agrees that the restrictions set forth in
clause (a) above are reasonable and necessary to protect the legitimate
interests of Voyager and that Voyager would not have entered into this Agreement
in the absence of such restrictions, and that any violation or threatened
violation of any provision of clause (a) above will result in irreparable injury
to Voyager. SBS also acknowledges and agrees that in the event of a violation or
threatened violation of any provision of clause (a) above, Voyager shall be
entitled to preliminary and permanent injunctive relief, without the necessity
of proving irreparable injury or actual damages and without the necessity of
having to post a bond, as well as to an equitable accounting of all earnings,
profits and other benefits arising from any such violation. The rights provided
in the immediately preceding sentence shall be cumulative and in addition to any
other rights or remedies that may be available to Voyager. Nothing in this
Section 8.5 is intended, or should be construed, to limit Voyager's right to
preliminary and permanent injunctive relief or any other remedy for a breach of
any other provision of this Agreement.
(c) Voyager acknowledges and agrees that SBS may develop and
commercialize, either for itself, its Affiliates, or for third parties,
products, other than Unique Dose Products during the period specified in clause
(a) above, which contain the Active Agent intended for uses other than for
treatment of Alzheimer's Disease but which may be used or prescribed in a manner
similar to the Product without authorization from SBS, and that SBS may have no
control over such use or prescription.
Section 8.6 Technology Transfer. If (a) necessary to permit Voyager to
exercise its rights pursuant to Sections 2.5, 3.8, 4.5, or 5.6(c), or (b) SBS is
unable or unwilling to supply Voyager with all of its commercial requirements
for Product, or (c) SBS elects not to continue supply of Voyager's commercial
requirements pursuant to Section 5.1(i), then in any such case SBS shall (i)
promptly disclose to Voyager or its designee such SBS Technology and SBS
Improvements and any know-how related thereto as is necessary or useful for
Voyager or such designee to develop, Manufacture and commercialize the Product,
and (ii) from time to time thereafter, as reasonably requested by Voyager, have
32
**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
its representatives meet with representatives of Voyager or its designee to
enable Voyager or such designee to develop, Manufacture and sell the Product;
provided that SBS may require any designee of Voyager to enter into a reasonable
and customary confidentiality agreement with SBS that requires that Confidential
Information communicated to such designee by SBS pursuant to this Section 8.6
shall be kept confidential and used only in performance of such designee's
obligations to Voyager, and provided further that Voyager shall be responsible
for the compliance by any designee that is not approved in advance by SBS (which
approval shall not be unreasonably withheld or delayed) with the terms and
conditions of such confidentiality agreement. Voyager shall reimburse SBS for
any reasonable expenses incurred by SBS in connection with any transfer pursuant
to clause (b) or (c) above.
ARTICLE IX. REPRESENTATIONS AND WARRANTIES
Section 9.1 Representations and Warranties of Each Party. Each party hereby
represents, warrants and covenants to the other party as follows:
(a) Such party (i) is duly incorporated and in good standing under the
laws of the jurisdiction of its incorporation, (ii) has full power and authority
to own its property and assets and to carry on its business as it is now being
conducted and as it is contemplated to be conducted by this Agreement, (iii) has
the power and authority and the legal right to enter into this Agreement and
perform its obligations hereunder, and (iv) has taken all necessary action on
its part required to authorize the execution and delivery of this Agreement and
the performance of its obligations hereunder. This Agreement has been duly
executed and delivered on behalf of such party and constitutes a legal, valid
and binding obligation of such party and is enforceable against it in accordance
with its terms subject to the effects of bankruptcy, insolvency or other laws of
general application affecting the enforcement of creditor rights and judicial
principles affecting the availability of specific performance and general
principles of equity, whether enforceability is considered a proceeding at law
or equity.
(b) Such party is not aware of any pending or threatened litigation
(and has not received any communication) that alleges that such party's
activities related to this Agreement have violated, or that by conducting the
activities contemplated herein such party would violate, any of the intellectual
property rights of any other Person.
(c) All necessary consents, approvals and authorizations of all
regulatory and governmental authorities and other Persons required to be
obtained by such party in connection with the execution and delivery of this
Agreement and the performance of its obligations hereunder have been obtained.
(d) The execution and delivery of this Agreement and the performance
of such party's obligations hereunder (i) do not and will not conflict with or
violate any requirement of applicable law or regulation or any provision of the
articles of incorporation or bylaws of such party and (ii) do not and will not
conflict with, violate, or breach, or constitute a default or require any
consent under, any contractual obligation or court or administrative order by
which such party is bound.
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such material has been filed separately with the SEC
Section 9.2 Additional Representations of SBS. SBS represents, warrants and
covenants to Voyager as follows:
(a) SBS owns all right, title and interest in and to the SBS
Technology and the SBS Technology is not subject to any lien, encumbrance or
claim of ownership by any third Person.
(b) To SBS's knowledge and belief, the SBS Technology has not and does
not infringe upon, misappropriate or otherwise violate the patent or
intellectual property rights of any other Person.
(c) There is no claim, litigation, judgment or settlement pending or
existing, or to SBS's knowledge and belief threatened, with or against SBS
relating to the SBS Technology.
(d) To SBS's knowledge and belief, there is no pre-clinical or
clinical data or information concerning the SBS Technology that suggests that
there may exist quality, toxicity, safety or efficacy concerns that could
reasonably be expected to impair the utility or safety of the Product.
(e) Neither SBS nor any of its Affiliates has been debarred or is
subject to debarment and neither SBS nor any of its Affiliates will use in any
capacity, in connection with the services to be performed under this Agreement,
any Person who has been debarred pursuant to Section 306 of the FFDCA, or who is
the subject of a conviction described in such section. SBS agrees to inform
Voyager in writing immediately if it or any Person who is performing services
hereunder is debarred or is the subject of a conviction described in Section
306, or if any action, suit, claim, investigation or legal or administrative
proceeding is pending or, to the best of SBS's knowledge, is threatened,
relating to the debarment or conviction of SBS or any Person performing services
hereunder.
Section 9.3 Additional Representations of Voyager. Voyager represents,
warrants and covenants to SBS as follows:
(a) Voyager owns all right, title and interest in and to the Voyager
Patents and the Voyager Patents are not subject to any lien, encumbrance or
claim of ownership by any third Person.
(b) To Voyager's knowledge and belief, the Voyager Patents have not
and do not infringe upon, misappropriate or otherwise violate the patent or
intellectual property rights of any other Person.
(c) There is no claim, litigation, judgment or settlement pending or
existing, or to the best of Voyager's knowledge and belief threatened, with or
against Voyager relating to the Voyager Patents.
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such material has been filed separately with the SEC
(d) To Voyager's knowledge and belief, there is no pre-clinical or
clinical data or information concerning the Active Agent that suggests that
there may exist quality, toxicity, safety or efficacy concerns that could
reasonably be expected to impair the utility or safety of the Product.
Section 9.4 Disclaimer of Other Warranties. EXCEPT AS SET FORTH IN
THIS AGREEMENT, THE PARTIES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF
ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF
QUALITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT
ARTICLE X. CONFIDENTIALITY
Section 10.1 Confidential Information. Except to the extent expressly
permitted by this Agreement and subject to the provisions of Sections 10.2 and
10.3, at all times during the term of this Agreement and for ten (10) years
following the termination hereof, the Receiving Party (a) shall keep completely
confidential and shall not publish or otherwise disclose any Confidential
Information furnished to it by the Disclosing Party, except to those of the
Receiving Party's employees, Affiliates, sublicensees, subcontractors or
consultants who have a need to know such information (collectively,
"Recipients") to perform such Party's obligations hereunder (and who shall be
advised of the Receiving Party's obligations hereunder and who are bound by
confidentiality obligations with respect to such Confidential Information no
less onerous than those set forth in this Agreement) and (b) shall not use
Confidential Information of the Disclosing Party directly or indirectly for any
purpose other than performing its obligations or exercising its rights
hereunder. The Receiving Party shall be jointly and severally liable for any
breach by any of its Recipients of the restrictions set forth in this Agreement.
Section 10.2 Exceptions to Confidentiality. The Receiving Party's
obligations set forth in this Agreement shall not extend to any Confidential
Information of the Disclosing Party:
(a) that is or hereafter becomes part of the public domain by public
use, publication, general knowledge or the like through no wrongful act, fault
or negligence on the part of a Receiving Party or its Recipients;
(b) that is received from a third party without restriction and
without breach of any agreement between such third party and the Disclosing
Party;
(c) that the Receiving Party can demonstrate by competent evidence was
already in its possession without any limitation on use or disclosure prior to
its receipt from the Disclosing Party;
(d) that is generally made available to third parties by the
Disclosing Party without restriction on disclosure; or
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such material has been filed separately with the SEC
(e) that the Receiving Party can demonstrate by competent evidence was
independently developed by the Receiving Party.
Section 10.3 Disclosure
(a) Each party may disclose Confidential Information to the extent
that such disclosure is:
(i) made in response to a valid order of a court of competent
jurisdiction or other governmental body of a country or any political
subdivision thereof of competent jurisdiction; provided, however, that the
Receiving Party shall first have given notice to the Disclosing Party and given
the Disclosing Party a reasonable opportunity to quash such order and to obtain
a protective order requiring that the Confidential Information and/or documents
that are the subject of such order be held in confidence by such court or
governmental body or, if disclosed, be used only for the purposes for which the
order was issued; and provided further that if a disclosure order is not quashed
or a protective order is not obtained, the Confidential Information disclosed in
response to such court or governmental order shall be limited to that
information which is legally required to be disclosed in such response to such
court or governmental order; or
(ii) otherwise required by law or regulation, in the opinion of
outside legal counsel to the Receiving Party, which shall be provided to the
Disclosing Party at least 24 hours prior to the Receiving Party's disclosure of
the Confidential Information pursuant to this Section 10.3;
(b) Voyager may disclose Confidential Information to the extent that
such disclosure is:
(i) made to the Regulatory Authorities as required in
connection with any filing, application or request for Regulatory Approval;
provided, however, that reasonable measures shall be taken to assure
confidential treatment of such information;
(ii) made to third Persons as may be necessary or useful in
connection with the Exploitation of the SBS Technology and SBS Improvements
licensed to Voyager hereunder, including subcontracting and sublicensing
transactions in connection therewith, provided that Voyager shall in each case
obtain from the proposed third Person recipient a written confidentiality
undertaking containing confidentiality obligations no less onerous than those
set forth in this Article X; or
(iii) a disclosure of the existence and terms of this Agreement
to existing or potential securityholders of Voyager; provided, however, that
reasonable measures shall be taken to assure confidential treatment of such
information.
Section 10.4 Notification. The Receiving Party shall notify the
Disclosing Party immediately, and cooperate with the Disclosing Party as the
Disclosing Party may
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such material has been filed separately with the SEC
reasonably request, upon the Receiving Party's discovery of any loss or
compromise of the Disclosing Party's Confidential Information.
Section 10.5 Remedies. Each party agrees that the unauthorized use or
disclosure of any information by the Receiving Party in violation of this
Agreement will cause severe and irreparable damage to the Disclosing Party. In
the event of any violation of this Article X, the Receiving Party agrees that
the Disclosing Party shall be authorized and entitled to obtain from any court
of competent jurisdiction injunctive relief, whether preliminary or permanent,
without the necessity of proving irreparable harm or monetary damages, as well
as any other relief permitted by applicable law. The Receiving Party agrees to
waive any requirement that the Disclosing Party post bond as a condition for
obtaining any such relief.
Section 10.6 Use of Names. Neither party shall mention or otherwise use the
name, insignia, symbol, trademark, trade name or logotype of the other party (or
any abbreviation or adaptation thereof) in any publication, press release,
promotional material or other form of publicity without the prior written
approval of such other party in each instance. The restrictions imposed by this
Section 10.6 shall not prohibit either party from making any disclosure
identifying the other party that is required by Applicable Law. Further, Voyager
and its Affiliates and sublicensees shall have the right to use the name of SBS
and its Affiliates to the extent necessary in connection with the Exploitation
of the SBS Technology and SBS Improvements as contemplated by this Agreement,
including subcontracting and sublicensing transactions in connection therewith.
Section 10.7 Press Releases. Except as expressly provided in Section 10.3,
neither party shall make a press release or other public announcement regarding
this Agreement, the terms hereof or the transactions contemplated hereby without
the prior written approval of the other party. Each party shall provide the
other with the proposed text of any such press release or public announcement
for review and approval, which approval shall not be unreasonably withheld, as
early as possible, but in no event less than five (5) business days in advance
of the publication, communication or dissemination thereof; provided, however,
that the receiving party shall be deemed to have approved any such press release
or public announcement if it fails to notify the proposing party in writing of
any objections to such press release or public announcement within four (4)
business days of receipt by the receiving party of the text of such public
announcement.
ARTICLE XI. TERM AND TERMINATION
Section 11.1 Term. This Agreement shall commence as of the Effective Date
and shall remain in force until the terminated in accordance with this Article
XI.
Section 11.2 Termination. In addition to any other provision of this
Agreement expressly providing for termination of this Agreement, this Agreement
may be terminated as follows:
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such material has been filed separately with the SEC
(a) Voyager may terminate this Agreement at any time for any reason by
giving SBS [***] days' prior written notice.
(b) Voyager may terminate this Agreement pursuant to Section 8.4 in
accordance with the terms thereof.
(c) This Agreement may be terminated at any time by either party:
(i) to the extent permissible under Applicable Law, immediately
upon written notice if the other party shall file in any court or agency,
pursuant to any statute or regulation of any state or country, a petition in
bankruptcy or insolvency or for reorganization or for an arrangement or for the
appointment of a receiver or trustee of that party or of its assets, or if the
other party proposes a written agreement of composition or extension of its
debts, or if the other party shall be served with an involuntary petition
against it, filed in any insolvency proceeding, and such petition shall not be
dismissed within [***] days after the filing thereof, or if the other party
shall propose or be a party to any dissolution or liquidation, or if the other
party shall make an assignment for the benefit of its creditors,
(ii) in the event of any default by the other party in the
performance of any of its material obligations herein contained, including a
party's failure to pay the other amounts when due, which default has not been
cured by the defaulting party within [***] days after receiving written notice
thereof from the nondefaulting party, or
(iii) pursuant to Section 13.2.
Section 11.3 Effect of Termination.
(a) The termination of this Agreement shall be without prejudice to
any rights or obligations of the parties that may have accrued prior to such
termination, and the provisions of Sections 3.7, 5.5, 5.12, 7.6, 8.1, 8.3, 8.5,
Articles I, IX, X, XII and XIII, and this Section 11.3 shall survive the
termination of this Agreement. Except as otherwise expressly provided herein,
termination of this Agreement in accordance with the provisions hereof shall not
limit remedies that may otherwise be available in law or equity.
(b) Upon termination of this Agreement, (i) each party, at the request
of the other, shall return all data, files, records and other materials in its
possession or control containing or comprising the other party's Inventions or
other Confidential Information except one copy of which may be retained for
archival purposes and (ii) all licenses and other rights granted by each party
to the other under Section 8.2 shall terminate.
(c) Upon termination of this Agreement by Voyager pursuant to Section
11.2(a), Voyager shall pay SBS in accordance with the terms hereof, to the
extent such amount exceeds any uncredited amount of the Deposit at the time of
such termination, for
38
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such material has been filed separately with the SEC
all activities performed by SBS under this Agreement through the date of
termination and for all costs not refundable to SBS or otherwise useable by SBS
or its Affiliates in respect of which SBS reasonably made commitments in
connection with the performance of its obligations hereunder before the date of
delivery of such notice of termination, and Voyager shall have no other
liability or obligation to SBS in respect of such termination.
(d) SBS shall have the right to retain any portion of the Deposit
uncredited at the time of termination of this Agreement unless this Agreement is
terminated by Voyager pursuant to Section 11.2(b) or (c), or upon termination of
the parties' rights and obligations under Article II pursuant to Section 2.5, in
which event SBS promptly shall refund to Voyager the balance of the Deposit, if
any, uncredited at the time of such termination.
Section 11.4 Rights in Bankruptcy. All rights and licenses granted under or
pursuant to this Agreement by SBS are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of the United States Bankruptcy Code, licenses of
right to "intellectual property" as defined under Xxxxxxx 000 xx xxx Xxxxxx
Xxxxxx Bankruptcy Code. The parties agree that Voyager, as licensee, and SBS, as
licensor, of such rights under this Agreement, shall retain and may fully
exercise all of its rights and elections under the United States Bankruptcy
Code. The parties further agree that, in the event of the commencement of a
bankruptcy proceeding by or against SBS under the United States Bankruptcy Code,
Voyager shall be entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property and all embodiments of such
intellectual property, which, if not already in Voyager's possession, shall be
promptly delivered to it (a) upon any such commencement of a bankruptcy
proceeding upon Voyager's written request therefor, unless the party subject to
such proceeding elects to continue to perform all of its obligations under this
Agreement or (b) if not delivered under (a) above, following the rejection of
this Agreement by or on behalf of SBS upon written request therefor by Voyager.
The parties further agree that, in the event of the commencement of a bankruptcy
proceeding by or against Voyager under the United States Bankruptcy Code, and an
assignment of this Agreement is made for the benefit of creditors of Voyager,
then the rights and obligations of Voyager under this Agreement may be
transferred and assigned only to another Person engaged in the business of
developing and commercializing pharmaceutical products that would reasonably be
capable of performing the obligations set forth in this Agreement.
ARTICLE XII. INDEMNIFICATION
Section 12.1 SBS Indemnification. SBS shall indemnify Voyager, its
Affiliates and their respective directors, officers, employees and agents (the
"Voyager Indemnified Parties"), and defend and save each of them harmless, from
and against any and all claims, lawsuits, losses, damages, liabilities,
penalties, costs and expenses (including reasonable attorneys' fees and
disbursements) (collectively, "Losses") incurred by any of them in connection
with, arising from or occurring as a result of (i) the breach by SBS of any of
its obligations under this Agreement, (ii) the breach or inaccuracy of any
representation or warranty made by SBS in this Agreement, (iii) any Third Party
Claim made by any Person relating to the use of the SBS Technology or the SBS
Improvements
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**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
by Voyager, its Affiliates or sublicencees, including any claim of infringement
or misappropriation of the patent, trademark or other intellectual property
rights of such Person; or (iv) the enforcement by Voyager of its rights under
this Section 12.1, except, in each case, for those Losses for which Voyager has
an obligation to indemnify SBS Indemnified Parties pursuant to Section 12.2, as
to which Losses each party shall indemnify the other to the extent of their
respective liability for the Losses.
Section 12.2 Voyager Indemnification. Voyager shall indemnify SBS, its
Affiliates and their respective directors, officers, employees and agents (the
"SBS Indemnified Parties"), and defend and save each of them harmless, from and
against any and all Losses incurred by any of them in connection with, arising
from or occurring as a result of (i) the breach by Voyager of any of its
obligations under this Agreement, (ii) the breach or inaccuracy of any
representation or warranty made by Voyager in this Agreement, (iii) any Third
Party Claim made by any Person relating to the use of the Voyager Patents by
SBS, including any claim of infringement or misappropriation of the patent,
trademark or other intellectual property rights of such Person, (iv) any Third
Party Claim made by any Person relating to death, personal injury or property
damage arising out of or resulting from the Exploitation of the Product (unless
such Third Party Claim arises or results from the breach or inaccuracy of any
representation or warranty made by SBS herein or any breach by SBS of any of its
obligations hereunder), or (v) the enforcement by SBS of its rights under this
Section 12.2, except, in each case, for those Losses for which SBS has an
obligation to indemnify Voyager Indemnified Parties pursuant to Section 12.1, as
to which Losses each party shall indemnify the other to the extent of their
respective liability for the Losses.
Section 12.3 Indemnification Procedure.
(a) Notice of Claim. The indemnified party (the "Indemnified Party")
shall give the indemnifying party (the "Indemnifying Party") prompt written
notice (an "Indemnification Claim Notice") of any Losses or discovery of facts
upon which such Indemnified Party intends to base a request for indemnification
under Section 12.1 or 12.2, but in no event shall the Indemnifying Party be
liable for any Losses that result from any delay in providing such notice. Each
Indemnification Claim Notice must contain a description of the claim and the
nature and amount of such Loss (to the extent that the nature and amount of such
Loss are known at such time). The Indemnified Party shall furnish promptly to
the Indemnifying Party copies of all papers and official documents received in
respect of any Losses.
(b) Third Party Claims. The obligations of an Indemnifying Party under
this Article XII with respect to Losses arising from claims of any third Person
that are subject to indemnification as provided for in Section 12.1 or 12.2 (a
"Third Party Claim") shall be governed by and be contingent upon the following
additional terms and conditions:
(i) Control of Defense. At its option, the Indemnifying Party may
assume the defense of any Third Party Claim by giving written notice to the
Indemnified Party within thirty (30) days after the Indemnifying Party's receipt
of an Indemnification
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**Material has been omitted pursuant to a request for confidential treatment and
such material has been filed separately with the SEC
Claim Notice. The assumption of the defense of a Third Party Claim by the
Indemnifying Party shall not be construed as an acknowledgment that the
Indemnifying Party is liable to indemnify any Indemnified Party in respect of
the Third Party Claim, nor shall it constitute a waiver by the Indemnifying
Party of any defenses it may assert against any Indemnified Party's claim for
indemnification. Upon assuming the defense of a Third Party Claim, the
Indemnifying Party may appoint as lead counsel in the defense of the Third Party
Claim any legal counsel selected by the Indemnifying Party which shall be
reasonably acceptable to the Indemnified Party. In the event the Indemnifying
Party assumes the defense of a Third Party Claim, the Indemnified Party shall
immediately deliver to the Indemnifying Party all original notices and documents
(including court papers) received by any Indemnified Party in connection with
the Third Party Claim. Subject to clause (ii) below, if the Indemnifying Party
assumes the defense of a Third Party Claim, the Indemnifying Party shall not be
liable to the Indemnified Party for any legal expenses subsequently incurred by
such Indemnified Party in connection with the analysis, defense or settlement of
the Third Party Claim. In the event that it is ultimately determined that the
Indemnifying Party is not obligated to indemnify, defend or hold harmless an
Indemnified Party from and against the Third Party Claim, the Indemnified Party
shall reimburse the Indemnifying Party for any and all costs and expenses
(including attorneys' fees and costs of suit) and any Losses incurred by the
Indemnifying Party in its defense of the Third Party Claim with respect to such
Indemnified Party.
(ii) Right to Participate in Defense. Without limiting Section
12.3(b)(i), any Indemnified Party shall be entitled to participate in, but not
control, the defense of such Third Party Claim and to employ counsel of its
choice for such purpose; provided, however, that such employment shall be at the
Indemnified Party's own expense unless (A) the employment thereof has been
specifically authorized by the Indemnifying Party in writing, (B) the
Indemnifying Party has failed to assume the defense and employ counsel in
accordance with Section 12.3(b)(i) (in which case the Indemnified Party shall
control the defense), or (C) the interests of the Indemnified Party and the
Indemnifying Party with respect to such Third Party Claim are sufficiently
adverse to prohibit the representation by the same counsel of both parties under
applicable law, ethical rules or equitable principles
(iii) Settlement. With respect to any Losses relating solely to
the payment of money damages in connection with a Third Party Claim and that
will not result in the Indemnified Party's becoming subject to injunctive or
other relief or otherwise adversely affect the business of the Indemnified Party
in any manner, and as to which the Indemnifying Party shall have acknowledged in
writing the obligation to indemnify the Indemnified Party hereunder, the
Indemnifying Party shall have the sole right to consent to the entry of any
judgment, enter into any settlement or otherwise dispose of such Loss, on such
terms as the Indemnifying Party, in its sole discretion, shall deem appropriate.
With respect to all other Losses in connection with Third Party Claims, where
the Indemnifying Party has assumed the defense of the Third Party Claim in
accordance with Section 12.3(b)(i), the Indemnifying Party shall have authority
to consent to the entry of any judgment, enter into any settlement or otherwise
dispose of
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such material has been filed separately with the SEC
such Loss provided that it obtains the prior written consent of the Indemnified
Party (which consent shall not be unreasonably withheld or delayed). The
Indemnifying Party shall not be liable for any settlement or other disposition
of a Loss by an Indemnified Party that is reached without the written consent of
the Indemnifying Party. Regardless of whether the Indemnifying Party chooses to
defend or prosecute any Third Party Claim, no Indemnified Party shall admit any
liability with respect to, or settle, compromise or discharge, any Third Party
Claim without the prior written consent of the Indemnifying Party (which consent
shall not be unreasonably withheld or delayed).
(iv) Cooperation. Regardless of whether the Indemnifying Party
chooses to defend or prosecute any Third Party Claim, the Indemnified Party
shall cooperate in the defense or prosecution thereof and shall furnish such
records, information and testimony, provide such witnesses and attend such
conferences, discovery proceedings, hearings, trials and appeals as may be
reasonably requested in connection therewith. Such cooperation shall include
access during normal business hours afforded to the Indemnifying Party to, and
reasonable retention by the Indemnified Party of, records and information that
are reasonably relevant to such Third Party Claim, and making employees and
agents available on a mutually convenient basis to provide additional
information and explanation of any material provided hereunder, and the
Indemnifying Party shall reimburse the Indemnified Party for all its reasonable
out-of-pocket expenses in connection therewith.
(v) Expenses. Except as provided above, the reasonable and
verifiable costs and expenses, including fees and disbursements of counsel,
incurred by the Indemnified Party in connection with any Third Party Claim shall
be reimbursed on a calendar quarter basis in arrears by the Indemnifying Party,
without prejudice to the Indemnifying Party's right to contest the Indemnified
Party's right to indemnification and subject to refund in the event the
Indemnifying Party is ultimately held not to be obligated to indemnify the
Indemnified Party.
Section 12.4 Insurance. Commencing not later than thirty (30) days prior to
the first use in humans of the Product and thereafter for at least five (5)
years after the expiration or termination of this Agreement, each party shall
obtain from a licensed and reputable insurer, and maintain on an on-going basis,
products liability insurance with at least [***] in coverage for each
occurrence. Coverage shall be on a per occurrence rather than a claims made
basis. The policy shall name the other party to this Agreement and its
Affiliates as an additional insured. The policy shall provide that each of the
parties will be notified of the cancellation or any restrictive amendment of the
policy at least thirty (30) days prior to the effective date of such
cancellation or amendment. None of the parties shall violate, or permit to be
violated, any conditions of such insurance policy, and each of the parties shall
at all times satisfy the requirements of the insurance company writing said
policy. At either party's request, the other party shall provide the requesting
party with a certificate of such policy within 15 days of the request.
Section 12.5 Limitation on Damages. EXCEPT WITH RESPECT TO THE GROSS
NEGLIGENCE OR INTENTIONAL MISCONDUCT OF A PARTY, SUCH PARTY SHALL NOT BE LIABLE
TO THE OTHER, WHETHER
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such material has been filed separately with the SEC
PURSUANT TO THE FOREGOING INDEMNIFICATION OBLIGATIONS OR OTHERWISE, FOR
SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, INCLUDING BUSINESS INTERRUPTION OR
LOST PROFITS, OR PUNITIVE DAMAGES; PROVIDED, HOWEVER, THIS EXCLUSION IS NOT
INTENDED TO, NOR SHALL, EXCLUDE ACTUAL OR COMPENSATORY DAMAGES OF THE AFFECTED
PARTY, INCLUDING SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES OWED TO THIRD
PARTIES AS A RESULT OF A THIRD PARTY CLAIM.
ARTICLE XIII.MISCELLANEOUS
Section 13.1 Notices. All notices, requests and other communications
hereunder must be in writing and will be deemed to have been duly given only if
delivered personally against written receipt or by facsimile transmission with
answer back confirmation or mailed (postage prepaid by certified or registered
mail, return receipt requested) or by overnight courier to the parties at the
following addresses or facsimile numbers:
If to Voyager to: Voyager Pharmaceutical Corporation
0000 Xxxxxxxxx Xxxxxx Xxxxx
Xxxxx 000
Xxxxxxx, XX 00000
Attention: Xxxxx Xxxxxxxx, Esq.
Facsimile: (000) 000-0000
With a copy to: Xxxxxxxxx & Xxxxxxx
0000 Xxxxxxxxxxxx Xxxxxx, XX
Xxxxxxxxxx, XX 00000
Attention: Xxxxxxxxx Xxxxxxxx Xxxxxxxxxx, Esq.
Facsimile: (000) 000-0000
If to SBS to: Xx. Xxxxxxx X. Xxxxx
President
Southern BioSystems, Inc.
000 Xxx Xxxxxx Xxxxx
Xxxxxxxxxx, XX 00000-0000
Facsimile: (000) 000-0000
With a copy to: Xxxx Xxx
Vice President & General Counsel
DURECT Corporation
00000 Xxxx Xxxx
Xxxxxxxxx, XX 00000
Facsimile: (000) 000-0000
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such material has been filed separately with the SEC
All such notices, requests and other communications will (a) if delivered
personally to the address as provided in this Section, be deemed given upon
receipt, (b) if delivered by facsimile to the facsimile number as provided in
this Section, be deemed given upon receipt by sender of the answer back
confirmation and (c) if delivered by mail in the manner described above or by
overnight courier to the address as provided in this Section, be deemed given
three (3) business days after deposit with the postal service or one (1)
business day after acceptance by the overnight courier service (in each case
regardless of whether such notice, request or other communication is received by
any other Person to whom a copy of such notice, request or other communication
is to be delivered pursuant to this Section). Any party from time to time may
change its address, facsimile number or other information for the purpose of
notices to that party by giving notice specifying such change to the other
parties hereto.
Section 13.2 Force Majeure. Neither party shall be liable for delay in
delivery or nonperformance in whole or in part, nor shall the other party have
the right to terminate this Agreement except as otherwise specifically provided
in this Section 13.2, where delivery or performance has been affected by a
condition beyond a party's reasonable control, including fires, floods,
embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be
declared or not), terrorism, insurrections, riots, civil commotion, strikes,
lockouts or other labor disturbances, acts of God or acts, omissions or delays
in acting by any governmental authority; provided that the party affected by
such a condition shall, within ten days of its occurrence, give notice to the
other Party stating the nature of the condition, its anticipated duration and
any action being taken to avoid or minimize its effect. The suspension of
performance shall be of no greater scope and no longer duration than is
reasonably required and the nonperforming party shall use its best efforts to
remedy its inability to perform; provided, however, that in the event the
suspension of performance continues for sixty (60) days after the date of the
occurrence, and such failure to perform would constitute a material breach of
this Agreement in the absence of such force majeure event, the nonaffected Party
may terminate this Agreement immediately by written notice to the other party.
Section 13.3 Entire Agreement; Amendment. This Agreement, including the
Exhibits hereto, embodies all the terms and conditions and obligations of the
contract between the parties hereto and supersedes and cancels all previous
agreements and understandings, whether oral or in writing, in respect of the
subject matter hereof and may not be amended or modified except by an express
declaration in writing signed on behalf of Voyager and SBS by duly authorized
officers and referring specifically to this Agreement.
Section 13.4 Further Assurances. Each party shall duly execute and deliver,
or cause to be duly executed and delivered, such further instruments and do and
cause to be done such further acts and things, including the filing of such
assignments, agreements, documents and instruments, as may be necessary or as
the other party may reasonably request in connection with this Agreement or to
carry out more effectively the provisions and purposes hereof, or to better
assure and confirm unto such other party its rights and remedies under this
Agreement.
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Section 13.5 Successors and Assigns. The terms and provisions hereof shall
inure to the benefit of, and be binding upon, Voyager, SBS and their respective
successors and permitted assigns.
Section 13.6 Governing Law. This Agreement shall be governed and
interpreted in accordance with the law of the State of Delaware excluding any
conflicts or choice of law rule or principle that might otherwise refer
construction or interpretation of this Agreement to the substantive law of
another jurisdiction.
Section 13.7 Assignment. Except as expressly provided herein, neither party
may, without the prior written consent of the other party, sell, transfer,
assign, delegate, pledge, or otherwise dispose of, whether voluntarily,
involuntarily, by operation of law or otherwise, this Agreement or any of its
rights or duties hereunder; provided, however, that either may, without such
consent, assign this Agreement and its rights and obligations hereunder to an
Affiliate, to the purchaser of all or substantially all of its assets related to
a Product or its business, or to its successor entity or acquiror in the event
of a merger, consolidation or change in control of such. Any attempt to assign,
transfer, subcontract or delegate any portion of this Agreement in violation of
this Section shall be null and void. All validly assigned and delegated rights
and obligations of the parties hereunder shall be binding upon and inure to the
benefit of and be enforceable by and against the successors and permitted
assigns of Voyager or SBS, as the case may be. In the event either party assigns
or delegates its rights or obligations to another party in accordance with the
terms hereof, the assignee or transferee shall assume all obligations of its
assignor or transferor under this Agreement and the performance of such
obligations shall be guaranteed in writing by the assignor or transferor.
Section 13.8 Waiver. Any term or condition of this Agreement may be waived
at any time by the party that is entitled to the benefit thereof, but no such
waiver shall be effective unless set forth in a written instrument duly executed
by or on behalf of the party waiving such term or condition. No waiver by any
party hereto of any term or condition of this Agreement, in any one or more
instances, shall be deemed to be or construed as a waiver of the same or any
other term or condition of this Agreement on any future occasion.
Section 13.9 Severability. If any provision of this Agreement is held to be
illegal, invalid or unenforceable under any present or future law, and if the
rights or obligations of any party under this Agreement will not be materially
and adversely affected thereby, (a) such provision shall be fully severable, (b)
this Agreement shall be construed and enforced as if such illegal, invalid or
unenforceable provision had never compromised a part hereof, (c) the remaining
provisions of this Agreement shall remain in full force and effect and shall not
be affected by the illegal, invalid or unenforceable provision or by its
severance herefrom, and (d) in lieu of such illegal, invalid or unenforceable
provision, there shall be added automatically as a part of this Agreement a
legal, valid and enforceable provision as similar in terms to such illegal,
invalid or unenforceable provision as may be possible and reasonably acceptable
to the parties herein.
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Section 13.10 Independent Contractors. The status of the parties under this
Agreement shall be that of independent contractors. Nothing in this Agreement is
intended or shall be deemed to constitute a partnership, agency, employer,
employee, or joint venture relationship between the parties. Neither party shall
have the right to enter into any agreements on behalf of the other party, nor
shall it represent to any Person that it has any such right or authority.
Section 13.11 Construction. Unless the context of this Agreement otherwise
requires: (a) words of any gender include each other gender; (b) words using the
singular or plural number also include the plural or singular number,
respectively; (c) the terms "hereof," "herein," "hereby" and derivative or
similar words refer to this entire Agreement; (d) the terms "Article,"
"Section," "Exhibit" or "clause" refer to the specified Article, Section,
Exhibit or clause of this Agreement; (e) the term "or" has, except where
otherwise indicated, the inclusive meaning represented by the phrase "and/or";
and (f) the term "including" or "includes" means "including without limitation"
or "includes without limitation." Whenever this Agreement refers to a number of
days, such number shall refer to calendar days unless business days are
specified. The captions of this Agreement are for convenience of reference only
and in no way define, describe, extend, or limit the scope or intent of this
Agreement or the intent of any provision contained in this Agreement. The
language of this Agreement shall be deemed to be the language mutually chosen by
the parties and no rule of strict construction shall be applied against either
party hereto.
Section 13.12 Remedies. The remedies provided hereunder and under the
governing law are cumulative and not exclusive.
Section 13.13 Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be deemed to be an original, and all of which,
taken together, shall constitute one and the same instrument.
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IN WITNESS WHEREOF, the parties hereto have executed this
Agreement on the day and year first above written.
VOYAGER PHARMACEUTICAL CORPORATION SOUTHERN BIOSYSTEMS, INC.
By:___________________________ By:___________________________
Name:_________________________ Name: ________________________
Title:__________________________ Title:__________________________
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EXHIBIT 5.3
MANUFACTURING COSTS
"Manufacturing Costs" shall mean [ * * * ]
Examples of Manufacturing Costs
A. [ * * * ]
B. [ * * * ]
C. [ * * * ]
- [ * * * ]
- [ * * * ]
- [ * * * ]
- [ * * * ]
- [ * * * ]
- [ * * * ]
- [ * * * ]
- [ * * * ]
- [ * * * ]
- [ * * * ]
- [ * * * ]
[ * * * ]
[ * * * ]
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EXHIBIT 7.1
DEVELOPMENT COSTS
"Development Costs" are the sum of: [ * * * ]
Examples of Development Costs
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
[ * * * ]
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