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Exhibit 10.34
***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2
COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License
Agreement (the " Agreement ") is made and entered into
effective as of December 3, 2004 (the " Effective Date
") by and between Micromet AG , having its principal place
of business at Staffelseestrasse 2, 81477, Munich, Germany ("
Micromet "), and Ares Trading S.A. , having its
principal place of business at Zone Industrielle de
l’Ouriettaz, CH-1170 Aubonne, Switzerland (" Serono
"). Micromet and Serono each may be referred to herein individually
as a " Party ," or collectively as the " Parties
."
Recitals
A. Micromet is
developing a pharmaceutical product comprising a human antibody of
IgG-1 subtype binding to EpCAM.
B. Serono is a
pharmaceutical company with experience in the development and
commercialization of pharmaceutical products.
C. Micromet and
Serono desire to collaborate on the development of the Product (as
defined below), to obtain marketing approval of the Product, and
thereafter to have one or both Parties commercialize the
Product.
In consideration of the foregoing
premises and the mutual promises and covenants contained herein and
other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the Parties hereby agree as
follows:
Agreement
1. Definitions
When used in this Agreement,
capitalized terms will have the meanings as defined below and
throughout the Agreement.
1.1 "Additional
Indication" means any of the following Indications: [***].
1.2 " Affiliate "
means a legal entity that controls, is controlled by, or is under
common control with a Party. For purposes of this definition only,
"control" and, with correlative meanings, the terms "controlled by"
and "under common control with" means (a) the possession,
directly or indirectly, of the power to direct the management or
policies of a legal entity, whether through the ownership of voting
securities or by contract relating to voting rights or corporate
governance, or (b) the ownership, directly or indirectly, of
more than fifty percent (50%) of the voting securities or other
ownership interest of a legal entity; provided ,
however , that if local law restricts foreign ownership,
control will be established by direct or indirect
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ownership of the maximum ownership percentage that may, under
such local law, be owned by foreign interests.
1.3 " Applicable
Law " means the laws, rules, and regulations, including any
statutes, rules, regulations, guidelines, or other requirements,
that may be in effect from time to time and apply to the
development, manufacture, registration, and marketing of the
Product in the countries of the Territory, including any such
statutes, rules, regulations, guidelines, or other requirements of
the FDA or the EMEA.
1.4 "Assignment Agreement"
means the Assignment Agreement ("Übertragungs Vertrag")
between Micromet GmbH and [***] and [***] entered into on
[***].
1.5 "BI" means Boehringer
Ingelheim Pharma GmbH & Co. KG.
1.6 " BI Process
Development Agreement " means the Process Development Agreement
between Micromet and BI dated as of December 15, 2003.
1.7 "BI Process License
Agreement" means the Process License Agreement between Micromet
and BI entered into on December 15, 2003.
1.8 " BLA " means a
Biologics License Application filed with the FDA in conformance
with Applicable Law.
1.9 " CAT Agreement
" means the Non-Exclusive Product License Agreement between
Micromet and Cambridge Antibody Technology Limited entered into on
September 3, 2003.
1.10 " Clinical Trial
Materials " means the Product formulated in accordance with
applicable specifications, and placebo of such formulations, for
administration to healthy volunteers or patients in clinical
trials.
1.11 " Collaboration
Technology " means Joint Collaboration Technology, Micromet
Collaboration Technology, and Serono Collaboration Technology.
1.12 " Combination
Study " has the meaning as defined in Section 3.1.5.
1.13 "
Commercialization " means the marketing, promotion,
advertising, selling or distribution of the Product in a country
after all Marketing Approvals have been obtained in such country.
The term " Commercialize " has a correlative meaning.
1.14 " Commercially
Reasonable Efforts " means those diligent efforts consistent
with the exercise of prudent scientific and business judgment, as
applied by a Party to the development and commercialization of its
own pharmaceutical products at a similar stage of development and
with similar market potential.
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1.15 "Confidential
Information" has the meaning as defined in
Section 9.1.
1.16 " Control "
and, with correlative meaning, the term " Controlled ",
means, with respect to a Party and any Patent, Know-How, or other
intellectual property right, the ability to grant the other Party
access, a license or a sublicense (as applicable) or right to use
such Patent, Know-How, or intellectual property right as provided
in this Agreement without violating the terms of any agreement or
other arrangement with any Third Party existing at the time such
Party would be required under this Agreement to grant the other
Party such access, license, sublicense or right of use.
1.17 " Co-Promotion
Option " has the meaning as defined in Section 5.1.
1.18 " Co-Promotion
Option Period " has the meaning as defined in
Section 5.1.
1.19 " Co-Promotion
Period " has the meaning as defined in Section 5.2.
1.20 " Co-Promotion
Territory " means the territory of the United States or Europe
or both, with respect to which Micromet has exercised the
Co-Promotion Option.
1.21 " Development
Activities " means any activities to be performed pursuant to a
Development Plan in connection with the development of the Product,
including any in vitro or in vivo preclinical
studies, clinical studies in humans, the preparation and filing of
the BLA or MAA, the development of a commercial scale manufacturing
process for the Product, and the manufacture of Clinical Trial
Materials for use in clinical trials performed prior to the first
Marketing Approval or as a condition of receiving such Marketing
Approval.
1.22 " Development
Expenses " means, with respect to a Party, all direct and
indirect costs and expenses incurred by such Party in carrying out
Development Activities, calculated in accordance with generally
accepted accounting principles consistently applied and such
Party’s cost accounting systems, including (a) the cost
of such individuals performing Development Activities by or on
behalf of such Party calculated at the FTE Rate;
(b) reasonable out-of-pocket expenses not included in the FTE
Rate, as set forth in a Development Plan (such as expenses for
dedicated equipment, reagents, etc.); (c) the Fully Burdened
CTM Manufacturing Cost of, or purchase price paid for, Clinical
Trial Materials manufactured or purchased for the performance of
the Development Activities; and (d) manufacturing process
development and other services provided by Third Parties in
connection with the performance of the Development Activities.
Development Expenses will not include [***].
1.23 " Development
Plan " means either or both of the Micromet Program Plan or the
Serono Program Plan.
1.24 " Development
Program " means either or both of the Micromet Program or the
Serono Program.
1.25 " Dyax
Agreement " means the License Agreement between Micromet and
Dyax Corporation entered into on October 30, 2000.
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1.26 " EMEA " means
the European Medicines Evaluation Agency, or any successor agency
thereof.
1.27 " EpCam "
means the whole or part of the human epithelial cell adhesion
molecule EpCAM identified by the SWISS-PROT entry name TTD1_HUMAN
and accession number P16422.
1.28 " Europe "
means (a) those countries that, as the Effective Date, are
member states of the European Union, and (b) any country not
included within the foregoing that, as of the date of first
commercial sale of the Product following the receipt of the first
Marketing Approval in a member state of the European Union, is a
member state of the European Union, and in each case any successor
states comprising the territory of such member states.
1.29 " FDA " means
the United States Food and Drug Administration, or any successor
agency thereof.
1.30 " Field "
means the treatment of human diseases, disorders and
conditions.
1.31 " Final Study
Report " has the meaning as defined in Section 3.1.
1.32 " FTE " means
[***] hours of scientific or technical work per year on or directly
related to the execution or implementation of a Development Program
carried out by a qualified individual by or on behalf of a Party.
Scientific or technical work can include, but is not limited to,
research, experimental laboratory work, developing manufacturing
processes for the Product, conducting pre-clinical and clinical
development of the Product, recording and writing up results,
reviewing literature and references, holding scientific
discussions, preparing and filing a BLA or MAA for the Product, and
managing and directing scientific or technical staff.
1.33 " FTE Rate "
means (a) € [***] per FTE per annum for FTEs performed outside of the
United States, and (b) US$[***] per FTE per annum for FTEs
performed in the United States, which amounts described in each of
the foregoing subsections include laboratory supplies and equipment
(excluding items provided for separately under the applicable
Development Program), equipment maintenance costs, utilities, waste
removal, and a pro rata allocation of general and
administrative expenses plus facilities expenses.
1.34 "Fully Burdened CTM
Manufacturing Cost" means the consolidated fully burdened cost
incurred by Serono or on its behalf in the manufacture of Clinical
Trial Materials, including (a) direct labor and material costs;
(b) product quality assurance/control costs, to the extent
allocable to the Clinical Trial Materials; (c) facility and
equipment depreciation costs; (d) facility and equipment validation
and control costs; (e) costs of transport, customs, clearance
and storage of the Clinical Trial Materials (if necessary), duty,
and insurance; and (f) applicable overhead reasonably
allocable to the Clinical Trial Materials, in each case as
determined in accordance with International Accounting Standards as
applied by Serono consistently across its products. Fully-Burdened
CTM Manufacturing Cost will exclude [***] and any [***]
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1.35 " GCP " means
the standards, practices and procedures set forth in the
International Conference on Harmonization (ICH) guidelines
entitled "Guidance for Industry E6 Good Clinical Practice:
Consolidated Guidance," including related regulatory requirements
imposed by the FDA, and equivalent foreign regulations or
standards, as applicable.
1.36 " GLP " means
good laboratory practices regulations promulgated by the FDA,
published at 21 C.F.R. § 58, as such regulations may be
amended from time to time, and equivalent foreign regulations or
standards, as applicable.
1.37 " IND " means
an Investigational New Drug Application filed with the FDA, and the
equivalent application in jurisdictions outside the United
States.
1.38 " Indication "
means a cancer of [***] or any [***] thereof, including [***],
[***], [***], [***], [***], [***], [***], [***], [***], [***],
[***], [***], [***], [***], [***], [***], and [***]. Any [***] that
are clinically or pathologically distinct will be considered [***]
(e.g. [***] and [***] are [***] and for the purpose of this
definition [***], or [***] are cancers [***] and for the purpose of
this definition [***]).
1.39 " Interim Study
Report " has the meaning as defined in Section 3.1.
1.40 " JCC " has
the meaning set forth in Section 5.4.2.
1.41 " Joint
Collaboration Technology " means any Patents and Know-How made,
conceived or developed jointly by employees, agents or independent
contractors of both Parties or their Affiliates during the course
of, in furtherance of, and as a direct result of such employees,
agents or independent contractors performing an activity pursuant
to this Agreement.
1.42 " Know-How "
means (a) any scientific or technical information, results and
data of any type whatsoever, in any tangible or intangible form
whatsoever, that is not in the public domain or otherwise publicly
known, including databases, practices, methods, techniques,
specifications, formulations, formulae, knowledge, know-how, skill,
experience, test data including pharmacological, medicinal
chemistry, biological, chemical, biochemical, toxicological and
clinical test data, analytical and quality control data, stability
data, studies and procedures, and manufacturing process and
development information, results and data, and (b) any
biological, chemical, or physical materials that are not in the
public domain or otherwise available to the public; all to the
extent not claimed or disclosed in a Patent.
1.43 " Licensed
Know-How " means any Know-How Controlled by Micromet as of the
Effective Date or during the Term that is made, conceived or
developed by employees, agents or independent contractors of
Micromet or its Affiliates and that is necessary or useful for the
manufacture, use, or sale of the Product; but excluding any
Know-How within the Micromet Collaboration Technology or Joint
Collaboration Technology.
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1.44 " Licensed
Patents " means the Micromet Patents and the Third Party
Patents.
1.45 " Licensed
Technology " means the Licensed Know-How, the Licensed Patents,
the Micromet Collaboration Technology, and Micromet’s rights
and interest in the Joint Collaboration Technology.
1.46 " MAA " means
a marketing approval application filed with the EMEA, and any
corresponding applications in countries or territories other than
the European Union or the United States.
1.47 " Major Market
" means the [***], the [***], [***], [***], [***], [***] and
[***].
1.48 " Marketing
Approval " means the approval of a BLA or MAA, or any
supplement thereof, and any pricing and reimbursement approvals to
the extent required by Applicable Law prior to the sale of
pharmaceutical products in a country or territory.
1.49 " Marketing
Costs " has the meaning as defined in Exhibit F
.
1.50 " Micromet
Collaboration Technology " means any Patents and Know-How made,
conceived or developed solely by employees, agents or independent
contractors of Micromet or its Affiliates during the course of, in
furtherance of, and as a direct result of such employees, agents or
independent contractors performing an activity pursuant to this
Agreement.
1.51 "Micromet
Contribution" has the meaning as defined in
Section 5.3.1.
1.52 " Micromet
Patents " means the Patents listed on Exhibit A and
any other Patents Controlled by Micromet as of the Effective Date
or during the Term that are made, conceived or developed by
employees, agents or independent contractors of Micromet or its
Affiliates and are necessary or useful for the manufacture, use, or
sale of the Product; but excluding any Patents within the Micromet
Collaboration Technology or Joint Collaboration Technology,
1.53 " Micromet
Program " has the meaning as defined in Section 3.1.
1.54 " Micromet Program
Plan " has the meaning as defined in Section 3.1.
1.55 " MT201 "
means a human antibody of IgG-1 subtype binding to EpCAM with the
sequence set forth in Exhibit B .
1.56 " Net Profits
" has the meaning as defined in Exhibit F .
1.57 " Net Sales "
means the gross amount invoiced by Serono, its Affiliates or
Sublicensees for sales of the Product to any Third Party (other
than any Sublicensee), less deductions with respect to:
(a) normal trade, cash and quantity discounts allowed by
Serono, its Affiliates or Sublicensees, including charge backs;
(b) credits, allowances or adjustments
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allowed by Serono, its Affiliates or Sublicensees, including
amounts allowed for returned or defective products;
(c) insurance and transportation charges paid by Serono, its
Affiliates or Sublicensees; (d) custom duties, value added
taxes (VAT), sales taxes or other governmental charges paid by
Serono, its Affiliates or Sublicensees in connection with such
sales (but excluding what is commonly known as income taxes);
(e) amounts debited by Serono, its Affiliates or Sublicensees
on account of bad debts with respect to Net Sales previously
invoiced; and (f) rebates or reimbursements actually granted
by Serono, its Affiliates or Sublicensees to managed health care
organizations, federal, state, or local governments (or their
agencies), including Medicaid rebates. In the event any amounts
debited on account of bad debts are subsequently recovered by
Serono, its Affiliates or Sublicensees, such amounts will be added
to Net Sales for the calendar quarter in which such recovery
occurred.
If a Combination Product (as defined below) is sold, then for
the purpose of calculating royalties owed under this Agreement on
sales of the Combination Product, Net Sales will be calculated as
follows: first, Serono will determine the actual Net Sales of such
Combination Product (calculated using the above described
deductions) and then such amount will be multiplied by the fraction
A/(A+B), where A is the weighted (by sales volume) average invoice
price of the actual Product component of such Combination Product,
and B is the weighted (by sales volume) average invoice price of
the other active ingredient(s) or functional device of such
Combination Product. If the invoice price of either the Product or
the other active ingredient(s) or functional device of such
Combination Product cannot be determined, Net Sales of such
Combination Product will be equitably determined by the Steering
Committee with unanimous agreement of all members and without
application of the dispute resolution procedures set forth in
Section 2.1.5. "Combination Product" means (a) a Product
consisting of MT201 and one or more other active ingredients, or
(b) a Product where MT201 (alone or with one or more other
active ingredients) is contained in or otherwise administered to a
patient by a functional device proprietary to Serono, an Affiliate
of Serono or a Third Party; but in all cases excluding any inert
ingredients or packaging materials.
Notwithstanding the foregoing, any amounts received on account
of transfers of Product between Serono, its Affiliates or
Sublicensees will be excluded from the calculation of Net Sales,
and Net Sales will be calculated based on the final sale of such
transferred product by Serono, its Affiliates or Sublicensees to
any Third Party (who is not a Sublicensee). Further, transfers or
dispositions of the Product for charitable or promotional purposes
or for preclinical, clinical, manufacturing, regulatory or
governmental purposes will not be deemed to be "sales."
1.58 " Ongoing
Trial " has the meaning as defined in Section 3.1.
1.59 " Opt-Out
Option " has the meaning as defined in Section 5.5.
1.60 " Patents "
means (a) all patents and patent applications in any country
or supranational jurisdiction, and (b) any provisionals,
substitutions, divisions, continuations, continuations in part,
reissues, renewals, registrations, confirmations, patents of
addition, reexaminations, extensions, supplementary protection
certificates and the like, of any such patents or patent
applications.
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1.61 " Pivotal
Trial " means a clinical trial that is of appropriate size and
design to establish that a pharmaceutical product is safe and
effective for its intended use, to define warnings, precautions and
adverse reactions that are associated with the pharmaceutical
product in the dosage range to be prescribed, and is required to
support Marketing Approval of such pharmaceutical product or label
expansion of such pharmaceutical product.
1.62 " Product "
means a product consisting of or comprising MT201.
1.63 " Project Team
" has the meaning as defined in Section 2.2.
1.64 " Project Team
Leader " has the meaning as defined in Section 2.2.
1.65 " Rejected
Indication " has the meaning set forth in
Section 3.3.5.
1.66 " Serono
Collaboration Technology " means any Patents and Know-How that
are necessary or used for the manufacture, use, or sale of the
Product and that are made, conceived or developed solely by
employees, agents or independent contractors of Serono or its
Affiliates during the course of, in furtherance of, and as a direct
result of such employees, agents or independent contractors
performing an activity pursuant to this Agreement.
1.67 " Serono
Program " has the meaning as defined in Section 3.3.
1.68 " Serono Program
Plan " has the meaning as defined in Section 3.3.
1.69 " Steering
Committee " has the meaning as defined in
Section 2.1.1.
1.70 " Sublicensee
" means a Third Party that is developing or Commercializing the
Product pursuant to a license agreement with Serono or any of its
Affiliates.
1.71 " Technology
Acquisition Agreement " means any agreement entered into before
or after the Effective Date between a Party and a Third Party under
which such Party is granted a license to or is assigned any of such
Third Party’s Patents or Know-How that claim or cover the
Product or the development, manufacture or Commercialization
thereof.
1.72 " Technology
Acquisition Payments " means any license fees, milestone
payments, royalties, or other cash payments made or payable by a
Party to a Third Party under any Technology Acquisition Agreement
in connection with the execution of such agreement or the
development, manufacture or Commercialization of the Product.
1.73 " Term " has
the meaning as defined in Section 11.1.
1.74 " Territory "
means all countries and territories of the world.
1.75 " Third Party
" means any entity other than Micromet, Serono or their respective
Affiliates.
1.76 " Third Party
Patents " means the Patents licensed to Micromet pursuant to
the Dyax Agreement and the CAT Agreement, and any other Patents of
a Third Party Controlled by
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Micromet as of the Effective Date that are necessary or useful
for the manufacture, use, or sale of the Product.
1.77 " United
States " means the United States of America, its territories
and possessions, including the Commonwealth of Puerto Rico.
1.78 " Valid Claim
" means: [***].
2. Collaboration Governance
2.1 Steering
Committee.
2.1.1 Establishment. Within thirty (30) days following
the Effective Date, the Parties will establish a steering committee
(the " Steering Committee ") to oversee the development of
the Product under this Agreement. Each Party will appoint three
(3) employees to serve as their representatives on the
Steering Committee. From time to time, Micromet and Serono each may
replace any of its representatives on the Steering Committee upon
written notice to the other Party. One member of the Steering
Committee will be designated as the " Chairperson ."
Micromet will designate the Chairperson for the period prior to the
commencement of the Serono Program, and Serono will designate the
Chairperson for the period following the commencement of the Serono
Program. Subject to the provisions of this Section 2, the
Steering Committee will establish its own procedural rules for its
operation.
2.1.2 Tasks of the Steering Committee. The Steering
Committee will: (a) determine Indications to be pursued in the
development of the Product; (b) review and approve, in its
discretion, any updates or amendments to the Micromet Program Plan
and accompanying budget for Development Expenses proposed by the
Project Team; (c) develop the strategy for the Serono Program;
(d) review and approve, in its discretion, the Serono Program
Plan (including the allocation of Development Activities therein)
and any updates or amendments thereto proposed by the Project Team;
(e) monitor the progress of the activities undertaken by the
Parties pursuant to the Development Program; (f) review the product
lifecycle plans of the Parties for the Product, including
indication and label expansions, new dosage forms, and new
formulations
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or delivery systems; (g) agree upon a communication
strategy for the Product; (h) attempt to resolve disputes
among the members of the Project Team and (i) take such other
actions as are expressly delegated to the Steering Committee in
this Agreement. The Steering Committee will not have any power to
amend this Agreement and will have only such powers as are
specifically delegated to it under this Agreement.
2.1.3 Steering Committee Meetings. The Steering Committee
will meet not less than once every calendar quarter until
completion of the Ongoing Trials; thereafter, the Steering
Committee will meet not less than semi-annually. Meetings may be
held in person or by means of telecommunication (telephone, video,
or web conferences); provided that at least one meeting per year
will be held in person. At least four (4) members of the
Steering Committee will constitute a quorum for any meeting,
provided that at least two (2) representatives from each Party
are present. The Steering Committee may meet more frequently by
agreement of the Parties or upon the request of either Party. The
Chairperson will be responsible for organizing the meetings of the
Steering Committee and for distributing the agenda of the meetings,
which will include any report received from the Project Team
Leaders, but will have no additional powers or rights beyond those
held by the other representatives to the Steering Committee. The
Chairperson will include on the agenda any item within the scope of
the responsibility of the Steering Committee that is requested to
be included by a Party, and will distribute the agenda to the
Parties no less than seven (7) days before any meeting of the
Steering Committee. Each Party may, in its discretion, invite
non-voting employees, consultants or advisors (which consultants
and advisors will be under an obligation of confidentiality no less
stringent than the terms set forth in Section 9) to attend any
meeting of the Steering Committee. Each Party will bear its own
costs associated with holding and attending Steering Committee
meetings.
2.1.4 Meeting Minutes. Minutes will be kept of all Steering
Committee meetings by the hosting Party and sent to all members of
the Steering Committee for review and approval within fourteen
(14) days after each meeting. If the meeting is held by means
of telecommunication, Micromet will be deemed to be the hosting
Party during the Micromet Program, and Serono will be deemed to be
the hosting Party during the Serono Program. Minutes will be deemed
approved unless any member of the Steering Committee objects to the
accuracy of such minutes by providing written notice to the other
members of the Steering Committee within fourteen (14) days of
receipt of the minutes. In the event of any such objection that is
not resolved by mutual agreement of the Parties, such minutes will
be amended to reflect such unresolved dispute.
2.1.5 Decision Making.
(a) Unless expressly otherwise set forth in this
Agreement, the Steering Committee will take action by unanimous
consent of the Parties, with each Party having a single vote,
irrespective of the number of representatives actually in
attendance at a meeting, or by a written resolution signed by the
designated representatives of each of the Parties.
(b) If the Steering Committee is unable to reach
unanimous consent on a particular matter within thirty
(30) days of a formal vote requested by either Party on such
matter, then either Party may provide written notice of such
dispute to the Chief Executive
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Officer of the other Party; provided, however , that no
such referral to the Chief Executive Officers will occur, and [***]
will have the casting vote, with respect to matters relating to the
[***].
(c) The Chief Executive Officers (or their respective
designees, who will not be members of the Steering Committee or
Project Team) of each of the Parties will meet at least once in
person to discuss the dispute and use their good faith efforts to
resolve the dispute within [***] after submission of such dispute
to such officers.
(d) If any such dispute is not resolved by the Chief
Executive Officers or their designees within [***] after submission
of such dispute to such officers, then the Chief Executive Officer
of [***] will have the authority to finally resolve such dispute
(reasonably taking into consideration the position of [***]);
provided, however , [***].
2.2 Project Team.
2.2.1 Establishment of the Project Team. At its first
meeting, the Steering Committee will establish a joint project team
consisting of an adequate number of employees of both Parties that
will be responsible for managing the execution of Development
Activities (the " Project Team "). The Project Team may
change its number of representatives from time to time by mutual
consent of its members. Each Party will designate one of its
Project Team members as the co-leader of the Project Team (each, a
" Project Team Leader "). The Project Team Leaders may, in
their discretion, create sub-teams of the Project Team for the
purpose of carrying out specific tasks provided for in this
Agreement. From time to time, Micromet and Serono each may replace
any of its representatives on the Project Team upon written notice
to the other Party. The Project Team Leaders will alternate serving
as the Chairperson of the Project Team, with each Project Team
Leader acting as Chairperson for a period of one year. Micromet
will designate the first Chairperson. The Chairperson will be
responsible for administering Project Team meetings and circulating
the agenda prior to each meeting, but will have no additional
powers or rights beyond those held by the other representatives to
the Project Team. Subject to the provisions of this Section 2,
the Project Team will establish its own procedural rules for its
operation.
2.2.2 Tasks of the Project Team. The Project Team will:
(a) propose any appropriate updates or amendments to the
Micromet Program Plan or the accompanying budget for Development
Expenses; (b) propose the Serono Program Plan (including the
allocation of Development Activities therein) and the accompanying
budget for Development Expenses as well as any appropriate updates
or amendments thereto; (c) coordinate the activities
undertaken by the Parties pursuant to the Development Program; and
(d) take such other actions as are expressly delegated to
Project Team by the Steering Committee. The Parties acknowledge and
agree that certain portions of the Micromet Program Plan in the
form attached to this Agreement as Exhibit G contain
references to potential changes to the Micromet Program Plan or the
studies to be performed pursuant to such plan, and that any such
potential changes will become part of
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the Micromet Program Plan only upon unanimous consent of the
Parties pursuant to the decision making processes set forth in
Section 2.2.5 and 2.1.5.
2.2.3 Meeting . The Project Team will meet not less than
once every calendar quarter. Meetings may be held in person or by
means of telecommunication (telephone, video, or web conferences);
provided that at least one meeting per year will be held in person.
At least four (4) members of the Project Team will constitute
a quorum for any meeting, provided that at least two
(2) representatives from each Party are present. The Project
Team may meet more frequently by agreement of the Parties or upon
the request of either Party. Each Party will bear its own costs
associated with holding and attending Project Team meetings.
2.2.4 Minutes. Minutes will be kept of all Project Team
meetings by the hosting Party and sent to all members of the
Project Team for review and approval within fourteen (14) days
after each meeting. If the meeting is held by means of
telecommunication, Micromet will be deemed to be the hosting Party
during the Micromet Program, and Serono will be deemed to be the
hosting Party during the Serono Program. Minutes will be deemed
approved unless either Project Team Leader objects to the accuracy
of such minutes by providing written notice to the other Project
Team Leader within fourteen (14) days of receipt of the
minutes. In the event of any such objection that is not resolved by
mutual agreement of the Parties, such minutes will be amended to
reflect such unresolved dispute.
2.2.5 Decision Making. The Project Team will take action by
unanimous consent of the Parties, with each Party having a single
vote, irrespective of the number of representatives actually in
attendance at a meeting or by a written resolution signed by both
Project Team Leaders. If the Project Team is unable to reach
unanimous consent on a particular matter within thirty
(30) days of a formal vote requested by either Party on such
matter, either Project Team Leader may refer such matter to the
Steering Committee for resolution.
2.2.6 Reporting. Within thirty (30) days after the end
of each calendar quarter and at least one week prior to any
Steering Committee meeting, the Project Team Leaders will provide
to the Steering Committee a written progress report, which will
describe the progress made in the performance of Development
Activities since the last such report. In addition to the progress
reports provided hereunder, it is contemplated that the Parties
will maintain informal communications through the Project Team
Leaders on their day-to-day activities under this Agreement.
2.2.7 Dissolution. If Micromet does not exercise the
Co-Promotion Option described in Section 5.1, then the Project Team
will be disbanded upon the expiration of the Co-Promotion Option
Period.
3. Development Program
3.1 Micromet Program.
Subject to the terms and conditions of this Agreement, Micromet
will perform the following activities (collectively, the "
Micromet Program ") following the Effective Date, all as
described in further detail in the plan attached to this Agreement
as Exhibit G , which plan will include the development
timelines and a budget of
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Development Expenses to be incurred pursuant to the Micromet
Program (the " Micromet Program Plan "):
3.1.1 Ongoing Trial . Completion of the following Phase II
clinical trials of the Product being conducted by Micromet as of
the Effective Date: MT201-201 (prostate cancer) and MT201-202
(metastatic breast cancer) (each, an " Ongoing Trial ");
3.1.2 Interim Study Report . Compilation of initial
statistical analysis of each Ongoing Trial (each, an " Interim
Study Report "), to be performed [***] weeks after registration
of the last patient in the applicable Ongoing Trial;
3.1.3 Final Study Report . Preparation of a final
study report for each Ongoing Trial (each, a " Final Study
Report "), to be performed following database lock ([***] weeks
after registration of the last patient) and completion of the
applicable Ongoing Trial;
3.1.4 BI Process Development Agreement . Management of
Micromet’s collaboration relating to the development and
scale-up of a manufacturing process for the Product pursuant to the
BI Process Development Agreement;
3.1.5 Combination Study . Performance of a Phase I clinical
trial designed to demonstrate the safety of a combination of the
Product with docetaxel (the " Combination Study "); and
3.1.6 Ongoing Preclinical Work . Performance of certain
additional preclinical activities relating to Product.
3.2 Conduct of the Micromet
Program .
3.2.1 Efforts and Standards . Micromet will use Commercially
Reasonable Efforts to conduct the Micromet Program, either itself
or with or through Affiliates or Third Party contractors. Micromet
will use or retain personnel with sufficient skills and experience
as are required to accomplish efficiently and expeditiously the
activities of the Micromet Program as set forth in the Micromet
Program Plan in a good scientific manner and in compliance in all
material respects with all Applicable Laws including GLP and GCP.
Micromet will commit such amount of FTEs to conduct the Micromet
Program as are necessary to accomplish the Micromet Program in a
timely manner, and in any event no smaller amount of FTEs than are
specified by the Micromet Program Plan. Serono will not be
obligated to reimburse Micromet for any Development Expenses
incurred by or on behalf of Micromet for the Micromet Program in
excess of the total Development Expenses budgeted in the Micromet
Program Plan, unless otherwise agreed in writing by Serono.
3.2.2 Records . All preclinical work conducted by or on
behalf of Micromet in the Micromet Program will be completely and
accurately recorded, in sufficient detail and in good scientific
manner, in separate laboratory notebooks distinct from other work
being conducted by Micromet. Micromet will also retain all clinical
trial records required by
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Applicable Law to be maintained. On reasonable notice, and at
reasonable intervals but not more than [***], Serono will have the
right to audit Micromet’s compliance with this
Section 3.2.2.
3.3 Serono Program.
3.3.1 Scope. Promptly after receipt by Serono of the Interim
Study Reports for both Ongoing Trials, the Steering Committee will
develop a strategy for the development of the Product and the
further Development Activities through Marketing Approval of the
Product, other than the Development Activities included in the
Micromet Program (the " Serono Program ").
3.3.2 Serono Program Plan.
(a) During and promptly following the formulation of
the Serono Program, the Project Team will prepare a plan describing
the Development Activities to be performed during the Serono
Program to enable the filing of BLAs and MAAs and the receipt of
Marketing Approval for the Product in the Territory (the "
Serono Program Plan "), including a budget of Development
Expenses to be incurred pursuant to the Serono Program Plan and the
procedures for the timely transfer to Serono of any preclinical and
clinical analytical assays and clinical data, regulatory filings,
and any other Licensed Know-How, materials, or data relating to the
Product.
(b) Within [***] days after receipt by Serono of the
Final Study Reports for both Ongoing Trials, the Project Team will
review and update the draft Serono Program Plan, if necessary, and
present the Serono Program Plan to the Steering Committee for
review and approval. Within [***] days of its receipt, the Steering
Committee will approve the Serono Program Plan, after, if
necessary, making any revisions thereto to render such Plan
approvable.
3.3.3 Commencement. The Serono Program will commence upon
approval by the Steering Committee of the initial Serono Program
Plan pursuant to Section 3.3.2 above.
3.3.4 Responsibilities.
(a) If Micromet has exercised the Co-Promotion Option
with respect to both the United States and Europe, then the
Parties, [***], will [***]. Subject to the foregoing, the Steering
Committee will define the development strategy for each such
Indication and approve the allocation of the Development Activities
of the Serono Program Plan between the Parties in its discretion
and the Project Team will coordinate the Development Activities
undertaken by each Party for each such Indication.
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(b) If Micromet has not exercised the Co-Promotion
Option, or has exercised it with respect to the United States or
Europe only, then the Steering Committee will approve the
allocation of the Development Activities of the Serono Program Plan
between the Parties in its discretion; provided, however ,
that notwithstanding anything in this Agreement to the contrary,
any Development Activities allocated to Micromet will be subject to
Micromet’s written consent.
(c) Each Party will be responsible for the performance
of such Development Activities as may be allocated to it under the
Serono Program Plan pursuant to subsections (a) and
(b) above. In any event, the Serono Program Plan will provide
that Serono is responsible for performing all activities relating
to Chemistry, Manufacturing and Controls (CMC) pursuant to the
BI Process Development Agreement.
3.3.5 Additional Indications.
(a) At any time during the Co-Promotion Period,
Micromet may submit to the Steering Committee a written proposal to
add to the Serono Program any Indication from the list of
Additional Indications that is not then included in the Serono
Program. If the Steering Committee approves the inclusion of such
Indication in the Serono Program, then the Serono Program Plan will
be updated to include the Development Activities to be performed by
the Parties in connection with such Indication. If the Steering
Committee does not approve the inclusion of any such Indication in
the Serono Program (each such Indication, a " Rejected
Indication "), then, notwithstanding anything in this Agreement
to the contrary, Micromet will have the right, at its own option
and expense, to plan and conduct the development of the Product for
each such Rejected Indication; provided, however, that
Micromet may not conduct development of the Product for more than
[***] Rejected Indications simultaneously; and provided further,
however , that Micromet may not conduct development of the
Product for any Rejected Indication if such Indication has not been
approved pursuant to Section 2.1.5 for inclusion in the Serono
Program based on a determination made in good faith, on the basis
of substantiated medical or scientific rationale, that conducting
the development of the Product for such Indication could present
safety issues that could compromise the Serono Program. Micromet
agrees and acknowledges that if and for so long as the Product is
being developed as part of the Serono Program for the [***].
(b) As Serono is responsible following the completion
of the Micromet Program for conducting meetings and discussions
related to the Product with regulatory authorities, including the
FDA, Micromet will not, in the course of developing the Product for
a Rejected Indication, conduct any such meetings or discussions
without Serono’s participation or its prior written consent,
which consent will not be unreasonably withheld. In addition,
Micromet will not send any written materials to the FDA or any
other regulatory authority regarding the Product unless such
written materials have been reviewed and approved by Serono, which
approval will not be unreasonably withheld. If Micromet receives
any written or oral communications from the FDA or any other
regulatory authority relating to the Product, Micromet will
promptly notify Serono and provide a copy to Serono of any
written
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communication, or notes of any oral communication. The Parties
will confer regarding any response to such written or oral
communication prior to its transmission by Serono to the FDA or
other regulatory authority. Micromet will provide to Serono any
safety data resulting from any clinical trials conducted of the
Product in the Rejected Indication in accordance with Applicable
Law and the safety reporting and data exchange agreement executed
by the Parties pursuant to Section 3.8. Serono will be
responsible pursuant to such safety reporting and data exchange
agreement for reporting safety data to the FDA or other regulatory
authorities.
(c) At any time during which Micromet is developing
the Product for a Rejected Indication, Micromet will provide to
Serono a copy of any INDs, any interim analyses and final reports
of clinical trials performed of the Product for such Rejected
Indication, and will otherwise provide updates at the meetings of
the Project Team and Steering Committee regarding the development
of the Product for the Rejected Indication, including a detailed
description of the development costs incurred by Micromet to date
with respect to such development. Serono will have the right, not
more than [***], to review source data of the clinical trials of
the Product for the Rejected Indication that are available to
Micromet. Micromet will conduct any clinical studies of the Product
in the Rejected Indication in compliance in all material respects
with all Applicable Laws including GCP. Serono may at any time
during the period Micromet is developing the Product for a Rejected
Indication elect to include such Rejected Indication as part of the
Serono Program. Upon such election, (i) the Serono Program
Plan will be updated to include the Development Activities to be
performed by the Parties in connection with such Indication;
(ii) Micromet will transfer to Serono any clinical data,
regulatory filings including INDs, and any other Know-How,
materials, or data that have been made, conceived or developed
during the development of the Product for the Rejected Indication
in an orderly fashion and in a manner such that the value of the
delivered information and materials is preserved in all material
respects; (iii) Micromet will assign or sublicense to Serono
any Technology Acquisition Agreement entered into by Micromet
pursuant to Section 6.3.1 with respect to the development of
the Product for such Rejected Indication; (iv) Serono will [***];
(v) such Indication will cease to be a Rejected Indication;
and (vi) Serono will [***].
(d) If Micromet has completed all Pivotal Trials of
the Product in a Rejected Indication that, as reasonably determined
in good faith in accordance with the decision making processes set
forth in Section 2.1.5, are required to support Marketing
Approval for the Product in such Rejected Indication, then such
Indication will cease to be a Rejected Indication and will be
deemed included in the Serono Program, and Micromet will transfer
to Serono any clinical data and any other Know-How, materials, or
data that have been made, conceived or developed during the
development of the Product for the Rejected Indication in an
orderly fashion and in a manner such that the value of the
delivered information and materials is preserved in all material
respects. Micromet will also assign or sublicense to Serono any
Technology Acquisition Agreement entered into by Micromet pursuant
to Section 6.3.1 with
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respect to the development of the Product for such Rejected
Indication. Serono will thereafter prepare and file a BLA or MAA
for the Product in such Rejected Indication. Within [***] days of
acceptance of such BLA or MAA by the relevant regulatory authority,
Serono will [***], and [***]. The Parties will update the marketing
plan developed pursuant to Section 5 to include such Rejected
Indication and will Commercialize the Product for such Rejected
Indication under the terms of this Agreement.
(e) If the BI Process Development Agreement and the BI
Process License Agreement have been assigned to Serono or Serono is
then manufacturing Clinical Trial Materials, Serono will supply to
Micromet Clinical Trial Materials required by Micromet for the
development of any Rejected Indication [***]. Serono will use
commercially reasonable efforts to ensure that capacity is
available at a Serono manufacturing facility or a BI manufacturing
facility to meet the foregoing obligation, provided that in the
event of any capacity limitations, the supply of Clinical Trial
Materials for the performance of the Serono Program or Product for
the Commercialization of the Product will take precedence over the
supply of Clinical Trial Materials required by Micromet for the
development of such Rejected Indications.
3.3.6 Records. All preclinical work conducted by or on
behalf of the Parties in the Serono Program will be completely and
accurately recorded, in sufficient detail and in good scientific
manner, in separate laboratory notebooks distinct from other work
being conducted by the applicable Party. Each Party will also
retain all clinical trial records required by Applicable Law to be
maintained in connection with the Serono Program or the development
of any Rejected Indication. During any period when either both
Parties are performing Development Activities under the Serono
Program or Micromet is developing a Rejected Indication, on
reasonable notice, and at reasonable intervals but not more than
[***] [***], each Party will have the right to audit the other
Party’s compliance with this Section 3.3.6.
3.4 Diligence in
Development.
3.4.1 By Serono . Serono, itself or through one or more
Affiliates, Sublicensees or other Third Parties, will use
Commercially Reasonable Efforts to develop and obtain Marketing
Approval for the Product in all Major Markets. Serono will perform
the Serono Program in a good scientific manner and in compliance in
all material respects with all Applicable Laws including GLP and
GCP. All efforts of Serono’s Affiliates, Sublicensees and
Third Party contractors will be considered efforts of Serono for
the purpose of determining Serono’s compliance with its
obligations under this Section 3.4.1. Serono’s
fulfillment of its obligations to use Commercially Reasonable
Efforts under this Section 3.4.1 will be conclusively
established at any given time if, during the preceding [***]
period, any one of the following situations applies: (a) with
respect to any [***] period falling within the first [***] from
the
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commencement of the Serono Program pursuant to
Section 3.3.3, Serono, its Affiliates or Sublicensees [***];
(b) with respect to any subsequent [***] period, Serono, its
Affiliates or Sublicensees [***]; (c) Serono, its Affiliates or
Sublicensees [***]; (d) Serono, its Affiliates or Sublicensees
[***]; or (e) the Parties collectively [***] with respect to [***]
(i) at least [***] during such [***] period, or (ii) at
least [***], in the aggregate, during such [***] period [***].
3.4.2 By Micromet. Micromet will use Commercially Reasonable
Efforts to perform its Development Activities under the Serono
Program in a good scientific manner and in compliance in all
material respects with all Applicable Laws including GLP and GCP.
All efforts of Micromet’s Affiliates will be considered
efforts of Micromet for the purpose of determining Micromet’s
compliance with its obligations under this Section 3.4.2.
3.5 Development
Expenses.
3.5.1 Obligation . Serono will bear all Development Expenses
incurred by the Parties; provided , however , that
(a) Serono will not have any obligation to make any payments
in excess of [***] Euros ( € [***]) with respect to the
Micromet Program as described in the plan attached to this
Agreement as Exhibit G ; (b) Serono will not have
any obligation to make any payments with respect to
Micromet’s FTEs for the management of the Ongoing Trials, and
(c) during the Co-Promotion Period, the allocation of
Development Expenses incurred by the Parties for the Serono Program
will be as set forth in Section 5.3.
3.5.2 Reports and Payment . Serono will pay to Micromet on
or before the first day of each calendar quarter the amount of
Development Expenses budgeted to be incurred by Micromet in such
calendar quarter as set forth in the applicable Development Plan.
Within thirty (30) days of the end of each calendar quarter,
Micromet will provide Serono with quarterly reports containing a
detailed account of Development Activities performed by Micromet
and Micromet’s Development Expenses incurred during the
preceding calendar quarter, including the number of individuals
that performed Development Activities, the number of FTE hours
worked by each such individual and the out-of-pocket expenses
incurred by Micromet. All reported charges will be in accordance
with the budget for Development Expenses for the applicable
Development Plan. Any such report will be considered Confidential
Information of Micromet, subject to the terms and conditions of
Section 9. The Development Expenses set forth in such reports
will be reconciled with Serono’s payments for such quarter.
If such payments are in excess of Micromet’s accumulated
Development Expenses, then the amount of such excess will be
credited against the next payment of Development Expenses due by
Serono hereunder (or, if no such payment is due, refunded by
Micromet to Serono within [***] days of such determination). If
Micromet’s accumulated Development Expenses exceed the amount
paid by Serono, then Serono will pay the excess amount to Micromet
within [***] days of the determination.
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3.6 Development Plan
Updates. In the course of the performance of the Development
Program, the Project Team will update the applicable Development
Plan as it deems necessary and appropriate. In addition, the
Project Team will update the budget for Development Expenses set
forth in the applicable Development Plan in order to reflect the
changes to the Development Plan. Any changes to a Development Plan,
including changes to the budget for Development Expenses, are
subject to approval by the Steering Committee.
3.7 Technology Transfer;
Assignment of BI Process Development Agreement and BI Process
License Agreement.
3.7.1 Technology Transfers . Upon commencement of the
Serono Program pursuant to Section 3.3.3, the Parties will
transfer the Licensed Know-How to Serono in accordance with the
Serono Program Plan. In addition, from time to time in connection
with the performance by the Parties of the Serono Program Plan, the
Parties will share any analytical assays and clinical data,
regulatory filings, and any other Know-How, materials, or data
relating to the Product that have not already been shared between
the Parties. The costs incurred by the transferring Party in
connection with any transfers made pursuant to this
Section 3.7.1 will be [***].
3.7.2 Assignment of BI Process Development Agreement and
BI Process License Agreement . Promptly following the Effective
Date, Micromet will use diligent efforts to obtain BI’s
consent to the assignment of the BI Process Development Agreement
and the BI Process License Agreement to Serono, and if Micromet has
received such consent, Micromet will assign the BI Process
Development Agreement and the BI Process License Agreement to
Serono [***] of the Serono Program pursuant to Section 3.3.3.
If such consent is not received by Micromet prior to the end of
such [***], the Parties will in good faith negotiate an alternate
arrangement under which Micromet will supply Clinical Trial
Materials and Product to Serono for Serono’s performance of
this Agreement or take any actions pursuant to the BI Process
Development Agreement and the BI Process License Agreement that
would permit Serono or its designee to manufacture Clinical Trials
Materials and the Product. If Micromet is supplying Clinical Trial
Materials or Product to Serono and Micromet is also developing the
Product for a Rejected Indication, then in the event of any
capacity limitations with respect to the manufacture of Clinical
Trial Materials or Product, the supply of Clinical Trial Materials
for the performance of the Serono Program or Product for the
Commercialization of the Product will take precedence over the
supply of Clinical Trial Materials required by Micromet for the
development of such Rejected Indication.
3.8 Regulatory Obligations
during the Development Program. During the Micromet Program,
Micromet will maintain a safety database with respect to any animal
studies or clinical trials conducted with the Product by or on
behalf of Micromet and will be responsible for maintaining INDs and
conducting any other regulatory activities required for the conduct
of the Micromet Program, including communicating and preparing and
filing all reports (including adverse drug experience reports) with
the FDA or other applicable regulatory authorities. If Micromet
receives any written or oral communications from the FDA or any
other regulatory
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authority relating to the Product, Micromet will promptly notify
Serono and provide a copy to Serono of any written communication,
or notes of any oral communication. The Parties will confer
regarding any response to such written or oral communication prior
to its transmission to the FDA or other regulatory authority. Upon
Micromet’s exercise of its Co-Promotion Option, the Parties
will execute a safety reporting and data exchange agreement
specifying safety reporting requirements and methods for exchange
of important safety information regarding the Product. Upon the
commencement of the Serono Program pursuant to Section 3.3.3,
the Parties will maintain a common safety database for animal
studies and clinical trials of the Product, which database will be
managed by Serono. Serono will thereafter be responsible for
maintaining INDs and conducting any other regulatory activities
required for the conduct of the Serono Program, including
communicating and preparing and filing all reports (including
adverse drug experience reports) with the FDA or other applicable
regulatory authorities.
3.9 Clinical Trial
Materials. Micromet will be responsible for purchasing any
additional Clinical Trial Materials from BI pursuant to the BI
Process Development Agreement that are required to conduct the
Ongoing Clinical Trials and the Combination Study. Serono will be
responsible for manufacturing or purchasing all Clinical Trial
Materials required to conduct the Serono Program. The costs of
manufacturing or purchasing Clinical Trial Materials for the
conduct of the Serono Program will be Development Expenses.
3.10 Progress Reports. The
Parties will inform each other of their Development Activities
through their interactions in the Project Team and through progress
reports submitted to the Steering Committee. To the extent not
otherwise provided for herein, upon request of a Party, the other
Party will provide the requesting Party copies of clinical trial
protocols, preliminary reports and final reports of any clinical
studies performed by it, and any other information or data
reasonably requested by the other Party.
4. Unilateral Commercialization by Serono
4.1 Principles of
Commercialization. Serono will be solely responsible for
Commercializing the Product in the Territory during the Term;
provided , however , that, during the Co-Promotion
Period, Section 5 will apply to the Parties’
co-promotion of the Product in the Co-Promotion Territory.
4.2 Regulatory Obligations
during Commercialization. Serono will own and maintain all
regulatory filings and Marketing Approvals for the Product
developed pursuant to this Agreement, including all INDs, BLAs and
MAAs (other than those INDs held by Micromet pursuant to the
Micromet Program prior to their transfer to Serono pursuant to
Section 3.7 and those INDs held by Micromet pursuant to
Section 3.3.5). As between the Parties, Serono will be solely
responsible for all activities in connection with maintaining
Marketing Approvals and other regulatory approvals required for the
Commercialization and manufacture of the Product in the Territory,
including communicating and preparing and filing all reports
(including adverse drug experience reports) with the applicable
regulatory authorities.
4.3 Regulatory Meetings.
Serono will promptly notify Micromet in writing and in advance of
any meeting with or inspection by any regulatory authority related
to the Product and provide copies of any written correspondence and
documentation relating thereto. At
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Micromet’s option, and subject to Serono’s approval,
which will not unreasonably be withheld, Micromet may have an
employee or Third Party consultant participate in such meeting or
inspection as an observer.
4.4 Diligence in
Commercialization. Serono will use Commercially Reasonable
Efforts to launch the Product in a country after receiving all
Marketing Approvals in such country, and thereafter will use
Commercially Reasonable Efforts to Commercialize the Product in
such country. Serono may sell the Product as part of a bundle with
other Serono products or offer package deals to customers that
include the Product, provided that for the calculation of Net
Sales, the gross amount invoiced for the Product so treated will be
deemed to be the weighted (by sales volume) average invoice price
in the preceding calendar quarter for Product sold separately and
the rebate or discount with respect to the Product may not exceed
the weighted average rebate or discount on all other products sold
as part of the bundle or package. Upon request of Micromet, Serono
will provide to the Steering Committee a copy of the launch and
annual marketing plans prepared by Serono with respect to the
Commercialization of the Product, and any amendments or updates
thereto.
4.5 Product Supply. Serono
will be responsible for manufacturing or purchasing all commercial
supplies of the Product in the Territory.
4.6 Branding, Trademarks,
Trade Dress, and Logos. Serono will be the owner of all
trademarks, trade dress, logos, slogans, designs and copyrights
developed for or used on or in connection with the
Commercialization of the Product in the Territory. Serono will
select the trademark or trademarks used to identify the Product
that will be Commercialized in the Territory pursuant to this
Agreement. Serono will oversee the filing, prosecution and
maintenance of all trademark registrations for the Product in the
Territory. Serono will be responsible for the payment of any and
all costs relating to filing, prosecution, and maintenance of the
trademark or trademarks for the Product in the Territory.
5. Joint Development and Commercialization
5.1 Option. Micromet will
have the right to elect to develop and Commercialize the Product in
the United States and in Europe jointly with Serono (the "
Co-Promotion Option ") pursuant to the provisions of this
Section 5.1. Within [***] days of commencement of the Serono
Program pursuant to Section 3.3.3 (the " Co-Promotion
Option Period "), Micromet may exercise the Co-Promotion Option
with respect to one or both of the United States and Europe by
providing written notice of such exercise to Serono designating the
territory or territories with respect to which Micromet desires to
exercise the option (such territory or territories, the "
Co-Promotion Territory "). Such exercise will be effective
immediately upon receipt of such notice by Serono. If Micromet does
not exercise the Co-Promotion Option during the Co-Promotion Option
Period, and Serono’s actual expenditures for Development
Expenses during the initial [***] following expiration of the
Co-Promotion Option Period do not equal at least [***] percent of
the amounts for Development Expenses for such period set forth in
the Serono Program Plan, then Serono will promptly so notify
Micromet. For [***] day period following such notice,
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Micromet may exercise its Co-Promotion Option (treating such
period as the Co-Promotion Option Period), upon written notice to
Serono and the payment of Micromet’s share (as described in
Section 5.3.1) of Development Expenses incurred by Serono to the
date of option exercise.
5.2 Co-Promotion Period.
The " Co-Promotion Period " will commence upon
Micromet’s exercise of the Co-Promotion Option and will
expire upon the earlier of: (a) if Micromet has exercised the
Opt-Out Option pursuant to Section 5.5 with respect to the
entire Co-Promotion Territory, the end of the period described in
Section 5.5.2 or (b) termination of the Parties’
development and Commercialization of the Product in the
Co-Promotion Territory.
5.3 Development Expenses
during Co-Promotion Period.
5.3.1 Split of Expenses . During the Co-Promotion Period,
the development of the Product will continue pursuant to the terms
of Sections 2, 3, and 4, subject to the terms and conditions
of this Section 5. Micromet will be responsible for and pay a
certain percentage, as set forth in Exhibit E , of the
Development Expenses incurred by the Parties in connection with the
development of the Product in the Co-Promotion Territory during the
Co-Promotion Period in accordance with the Serono Program Plan
(such amount, the " Micromet Contribution ").
5.3.2 Report of Development Expenses Incurred . Within [***]
days of the end of each calendar quarter during the Co-Promotion
Period during which Development Expenses have been incurred by
either Party in connection with the development of the Product in
the Co-Promotion Territory, each Party incurring such Development
Expenses will deliver a report to the other Party. Each such report
will contain a detailed account of Development Activities performed
and Development Expenses incurred during the preceding calendar
quarter, including the number of individuals that performed
Development Activities, the number of FTE hours worked by each such
individual and the [***] incurred. Any such report will be
considered Confidential Information of the Party submitting it,
subject to the terms and conditions of Section 9. All reported
charges will be in accordance with the budget for Development
Expenses for the Serono Program.
5.3.3 Reconciliation . Following receipt of such reports,
there will be a reconciliation of the Development Expenses incurred
during such calendar quarter by each Party, with a subsequent
payment by one Party to the other to the extent necessary so that
each Party bears its appropriate percentage share of such
Development Expenses. Such balancing payments by one Party to the
other to reimburse the other Party for the purposes of cost sharing
under this Agreement will be approved by the Project Team within
[***] ([***]) days of the end of each calendar quarter with respect
to which reports have been delivered hereunder and will be made
within [***] ([***]) days thereafter.
5.3.4 Grace Period . Notwithstanding the foregoing
provisions of Section 5.3, in the event that the budget for
the current calendar year in the Serono Program Plan most recently
approved by the Steering Committee [***] compared to the budget for
such calendar year in the last Serono Program Plan approved before
the start of such calendar year, then
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Micromet will have the right to delay the payment of its share
of the Development Expenses [***] of such prior approved budgeted
amount for [***]months following the end of the current calendar
year; provided, however , that any payments which are not
made on the date such payments would otherwise be due will bear
interest until paid at the lower of (a) [***] above the overnight
LIBOR rate in effect on the due date, or (b) the maximum rate
permitted by applicable law, calculated on the number of days such
payment is delayed.
5.4 Co-Promotion
Terms.
5.4.1 Co-Promotion Agreement . Within [***] days after
completion of the final study report for the first Pivotal Trial
for the Product anywhere in the Co-Promotion Territory, if such
completion occurs during the Co-Promotion Period, the Parties will
negotiate in good faith a co-promotion agreement governing the
co-promotion of Product by the Parties in the Co-Promotion
Territory that will include the provisions of this Section 5.4
and such other terms that are customary and appropriate for a
co-promotion arrangement (the " Co-Promotion Agreement ").
Until such Co-Promotion Agreement is negotiated, the Parties will
Commercialize the Product in the Co-Promotion Territory in
accordance with the provisions of this Section 5.4 and
Section 4.
5.4.2 Joint Commercialization Committee. The co-promotion of
the Product in the Co-Promotion Territory will be governed by a
Joint Commercialization Committee (the " JCC ") to be
established by the Parties. Each Party will have equal
representation on the JCC, which will meet at least once per
calendar quarter, at mutually agreeable times and locations, to
discuss and coordinate the launch of the Product in the
Co-Promotion Territory, the marketing and promotion of the Product
and the strategies and programs that should be developed to
maximize Net Profits generated with the Product. In addition, if
there is more than one territory within the Co-Promotion Territory,
the Parties will establish a regional commercialization committee
for each such territory, with each such committee having the
responsibilities allocated to such committee by the JCC. The JCC
will be responsible for issues relating to branding, labeling,
positioning, life cycle management and post-approval clinical
trials of the Product in the territories within the Co-Promotion
Territory. Any regional commercialization committee established for
a territory within the Co-Promotion Territory will be responsible
for any region-specific operational issues as the JCC may delegate,
will report to the JCC on a regular basis and will refer any
dispute to the JCC.
5.4.3 Dispute Resolution. The JCC will take action by
unanimous consent of the Parties, with each Party having a single
vote. If the JCC is unable to reach unanimous consent on a
particular matter within thirty (30) days of a formal vote
requested by either Party on such matter, either Party may
refer
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