EXHIBIT 10.31
COLLABORATION AGREEMENT
between
PROCTER & ▇▇▇▇▇▇ PHARMACEUTICALS, INC.
and
REGENERON PHARMACEUTICALS, INC.
December 11, 1996
Execution Copy
COLLABORATION AGREEMENT
I. Definitions......................................................3
II. Scope; Joint Management Committee................................9
III. Research and Development........................................11
IV. Commercialization of Products...................................17
V. License Grants..................................................19
VI. Royalties and Accounting........................................21
VII. Patents and Infringement........................................24
VIII. Confidentiality.................................................27
IX. Representations, Warranties and Indemnification.................28
X. Term, Termination...............................................30
XI. Miscellaneous...................................................35
XII. Execution.......................................................39
COLLABORATION AGREEMENT
Made as of this 11th day of December, 1996, by and among
Procter & ▇▇▇▇▇▇ Pharmaceuticals, Inc., an Ohio corporation having its
principal offices at ▇▇▇ ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇
(hereinafter "Procter & ▇▇▇▇▇▇"), and
Regeneron Pharmaceuticals, Inc., a New York corporation having its
principal office at ▇▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
(hereinafter "Regeneron").
Whereas Regeneron and Procter & ▇▇▇▇▇▇ have conducted basic research in
the area of skeletal muscle; and
Whereas Procter & ▇▇▇▇▇▇ and Regeneron share a common vision and commit
to a true collaboration focused on discovering, developing, and commercializing
therapeutic agents in the Field in the Territory (both terms as defined herein);
and
Whereas Procter & ▇▇▇▇▇▇ and Regeneron intend fully to utilize their
capabilities, capitalize on each other's expertise, and put forth Commercially
Reasonable Efforts to achieve this objective, and recognize that each party is
contributing valuable technologies and capabilities to this effort and that the
combination of these compatible and complementary technologies and capabilities
creates the basis for a successful collaboration; and
Whereas the Parties have also entered into a Stock Purchase Agreement
and Stock Registration Agreement as of the date first written above as part of
this collaboration; so that
The Parties agree as follows:
Article I - Definitions
1.1. "Affiliate" means any entity that directly or indirectly Owns, is
Owned by, or is under common Ownership with a Party to this Agreement. In no
event will Amgen-Regeneron Partners, any legal entity that Regeneron forms with
Glaxo that relates to their July 1993 agreement, any legal entity that Regeneron
forms with Pharmacopeia, Inc. that relates to their October 1996 agreement, or
any legal entity that Regeneron forms with Procter & ▇▇▇▇▇▇ that relates to this
Agreement be deemed to be an Affiliate of Regeneron under this Agreement. "Owns"
or "Ownership" means direct or indirect possession of more than fifty percent
(50%) of the votes of holders of a corporation's voting securities or a
comparable equity interest in any other type of entity.
1.2. "Agreement" means the present agreement together with all
appendices.
1.3. "Allowable Expense" means Direct Costs to be reimbursed with
respect to a Compound that the JMC approves and authorizes (including without
limitation the nature, amount and calculation of such costs) prior to the time
when such expenses are incurred and shall consist of internal and/or Third Party
(as defined herein) costs incurred by each Party for the research, development,
commercialization, and marketing of Compounds. "Direct Costs" shall mean those
costs that are traceable to the approved activity based upon effort expended
and/or resources consumed to perform such activity; Direct Costs shall not
include without limitation any ▇▇▇▇-up or profit above actual costs. Allowable
Expenses will be recognized in accordance with GAAP.
1.4. "Anniversary" means the month and day of the Effective Date
during any year subsequent to the Effective Date.
1.5. "Article" means any article of this Agreement.
1.6. "Calendar Quarter" means each period of three (3) months
ending on 31 March or 30 June or 30 September or 31 December.
1.7. "Commercially Reasonable Efforts" means efforts and resources
commonly used in the research-based pharmaceutical industry for a product at a
similar stage of research, development or commercialization of similar market
potential, taking into account the establishment of the compound or product in
the marketplace, the cost-effectiveness of the efforts or resources while
optimizing profitability, the competitiveness of alternative products in
the marketplace, the proprietary position of the product, the likelihood of
regulatory approval given the regulatory structure involved, the profitability
of the product and alternative products and other relevant factors. Commercially
Reasonable Efforts shall be determined on a market by market basis for a
particular Compound, and it is anticipated that the level of effort will change
over time reflecting changes in the status of the Compound and the market
involved.
1.8. "Competing Product" means any compound, product, method or system
which is or may be used for a purpose or purposes that are the same or
substantially similar to those for which a Compound is or may be used in the
Territory. Competing Product shall not include the compounds ***.
1.9. "Compound" means a chemical entity, which is not Third Party
Technology, with research or commercial utility in the Field and which primary
site of action is skeletal muscle. Compound includes Research Compounds,
Development Compounds and Marketed Compounds that may be useful in methods of
research, diagnosis, treatment or prevention in the Field. Each Compound shall
also be deemed to include all indications (both inside and outside the Field),
formulations, line extensions, or modes of administration thereof. Compound
shall not include the compounds ***.
1.10. "Development Compound" means a Compound that the JMC has
determined has met Success Criteria and should undergo further development
pursuant to Section 3.3.
1.11. "Effective Date" means the date first written above.
1.12. "Exclusivity Term" means the period of time beginning on the
Effective Date of this Agreement to the end of the Tail Period.
1.13. "Field" means the diagnosis, prevention and/or treatment of
conditions in humans and animals associated with the promotion or protection of
skeletal muscle mass or function (including, without limitation, the diagnosis,
treatment or prevention of muscle atrophy).
1.14. "Fiscal Year" means the twelve (12) month period of time from
July 1 to June 30, except that the first Fiscal Year commences on the Effective
Date and ends on June 30, 1997.
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
1.15. "FTE" or "Full Time Equivalent" means one Effort Year of an
employee or class of employees. "Effort Year" means nineteen hundred and fifty
(1,950) hours of direct effort expended on approved activities during a Fiscal
Year.
1.16. "GAAP" means generally accepted accounting principles.
1.17. "Joint Discovery Research Term" means the period beginning on
and including the Effective Date and ending upon termination pursuant to
Section 3.2(c).
1.18. "Joint Management Committee" or "JMC" means the committee
described in Article II.
1.19. "Joint Non-discovery Research Term" means the period of time
after the termination of the Joint Discovery Research Term when the Parties are
performing research on Research Compounds pursuant to Section 3.2(d).
1.20. "J-V" means such collaborative relationship as may be established
pursuant to Section 3.8 of this Agreement. J-V may or may not be structured as a
separate legal entity, such as a corporation, partnership, LLC, or such other
form as the Parties may agree. In agreeing on the form of the collaborative
relationship, the Parties shall take appropriate account of, among other
factors, ease of administration and tax liabilities.
1.21. "Know-how" means the entire right, title and interest in trade
secret Technology. "P&G Know-how" shall mean the entire right, title and
interest in Know-how owned solely or jointly with a Third Party by P&G or an
Affiliate of P&G. "Regeneron Know-how" shall mean the entire right, title and
interest in Know-how owned solely or jointly with a Third Party by Regeneron or
an Affiliate of Regeneron.
1.22. "Major Country" means the ***.
1.23 "Marketed Compound" means a Compound which is sold in any
country in the Territory.
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
1.24. "Net Sales" means total gross realization less: (i) discounts,
including cash discounts and discounts for special purchases, rebates,
retroactive price reductions or allowances granted or incurred from the billed
amount, (ii) any sales or value added taxes or any other taxes measured by the
amount of sales or gross receipts, and (iii) credits or allowances actually
granted upon claims, rejections or returns, including recalls, regardless of the
party requesting such. As used herein, total gross realization means the list
price for a Compound multiplied by volume in units for units sold or otherwise
transferred by either Party or an authorized agent of either Party to a
customer, but excludes sales or transfers between and among the Parties, the
Parties' Affiliates, or an authorized agent or licensee of either Party, unless
such sale or other transfer is to a customer.
1.25. "Opting Out Party" means the Party that has elected not to
continue research, development and/or commercialization of a Compound either in
the entire Territory or in one or more specific countries therein.
1.26. "Party" means Regeneron or Procter & ▇▇▇▇▇▇.
1.27. "Patent" shall mean the entire right, title and interest in a
Valid Claim to Technology in a patent application, and all continuing and
divisional patent applications, continuations-in-part, reissue applications and
all other related patent applications claiming priority, indirectly and
directly, to such application, and all patents issuing therefrom, worldwide.
"P&G Patent Rights" shall mean the entire right, title and interest in a Patent
owned solely or jointly with a Third Party by P&G or an Affiliate of P&G.
"Regeneron Patent Rights" shall mean the entire right, title and interest in a
Patent owned solely or jointly with a Third Party by Regeneron or an Affiliate
of Regeneron.
1.28. "Proceeding Party" means that Party that is not an Opting Out
Party with respect to a Compound either in the entire Territory or in one or
more specific countries therein.
1.29. "Product Plan" means the annual compilation of objectives,
activities, resource allocations, Success Criteria, Allowable Expenses and
budgets regarding the development and commercialization of Development Compounds
and Marketed Compounds agreed to by the Joint Management Committee, as more
thoroughly described in Section 3.3(c).
1.30. "Research Compound" means a Compound that has not yet been
designated a Development Compound.
1.31. "Research Plan" means the annual compilation of objectives,
activities, resource allocations, Success Criteria, Allowable Expenses and
budgets regarding the Parties' collaborative research in the Field agreed to by
the JMC during the Joint Discovery Research Term and Joint Non-discovery
Research Term.
1.32. "Royalty Term" means the period from the first Net Sales in
the first country to the final payment of royalties in the last country
pursuant to Section 6.1.
1.33. "Section" means any section of this Agreement.
1.34. "Success Criteria" means specific criteria set forth in the
Research Plan that define the minimum technical and/or commercial requirements
for a Research Compound to be designated a Development Compound. For Development
Compounds being developed pursuant to a Product Plan, Success Criteria shall
mean the minimum technical and/or commercial requirements for a Development
Compound to become a commercially viable Marketed Compound.
1.35. "Sumitomo Compound" means any Compound which is claimed by a
Regeneron Patent and for which Sumitomo Chemical Company Limited has exercised
rights pursuant to its Technology Development Agreement with Regeneron executed
in March 1989.
1.36. "Tail Period" means the two (2) years immediately after the
end of the Joint Discovery Research Term.
1.37. "Technology" means all inventions, trade secrets and other
information, whether or not patentable, which is useful for the research,
development and/or commercialization of Compounds which are (a) conceived or
reduced to practice by a Party or acquired or licensed by a Party from a Third
Party prior to the Effective Date; (b) conceived or reduced to practice by a
Party or acquired or licensed by a Party from a Third Party during the Joint
Discovery Research Term; (c) conceived or reduced to practice by a Party during
the Tail Period; (d) conceived or reduced to practice by a Party as a result of
activities with respect to a Research Compound during the Joint Non-discovery
Research Term; or (e) a result of development or commercialization of a
Development Compound and/or Marketed Compound during the Term.
Technology may include, without limitation, research methods and materials
(including without limitation genetic materials, receptors, cell lines and
transgenic animals) useful in performing research, Compounds, formulations,
chemical synthesis and manufacturing processes, methods of diagnosis and methods
of treatment.
1.38. "Term" means the period of time beginning on the Effective Date
and unless terminated earlier pursuant to Sections 3.2 or 10.2, ending upon the
expiration of the Royalty Term.
1.39. "Territory" means the entire world, excluding Japan with
respect to any Sumitomo Compound and MuSK and Agrin. Japan shall be included in
the Territory except for Sumitomo Compounds and MuSK and Agrin. "MuSK" shall
mean the materials ***. "Agrin" shall mean the compounds ***.
1.40. "Third Party" means any entity other than Regeneron or
Procter & ▇▇▇▇▇▇ or their Affiliates or a J-V established in accordance with
this Agreement.
1.41. "Third Party Technology" means Technology owned solely by
Regeneron or its Affiliates in which a Third Party has rights pursuant to an
agreement between such Third Party and Regeneron or its Affiliates prior to the
Effective Date, as specifically set forth in Attachment 9.1.
1.42. "Valid Claim" shall mean any claim in a published and unexpired
application or patent included within a Patent which claim has not been held
unenforceable, unpatentable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or unappealed within
the time allowed for appeal, and which has not been finally abandoned or
admitted to be invalid or unenforceable through disclaimer.
1.43. "Year" means a calendar year beginning January 1 and ending
December 31, except that the first Year shall be deemed to begin on the
Effective Date and end on December 31, 1997.
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
Article II - Scope; Joint Management Committee
2.1. Scope.
(a) The Parties shall work together to research, develop and
commercialize Compounds pursuant to this Agreement in the Territory. During the
Term, neither Party may directly or indirectly develop or commercialize a
Competing Product. Additionally, during the Joint Discovery Research Term, the
Parties shall work together on an exclusive basis in the Field, so that neither
Party shall perform research, development and/or commercialization activities
independently or with a Third Party in the Field, except as agreed by the JMC,
or pursuant to the terms of this Agreement. The Parties shall use Commercially
Reasonable Efforts in performing their obligations under this Agreement.
(b) Notwithstanding anything to the contrary contained in this
Agreement, the Parties agree that the *** (hereinafter "Procter & ▇▇▇▇▇▇
Exclusion Compounds") or *** ("Regeneron Exclusion Compounds") shall not be
included within the scope of this Agreement. Procter & Gamble's rights to
research, develop or commercialize Procter & ▇▇▇▇▇▇ Exclusion Compounds shall
not be subject to the provisions of this Agreement. Regeneron's rights to
research, develop or commercialize Regeneron Exclusion Compounds shall not be
subject to the provisions of this Agreement.
2.2. Membership. The work under this Agreement shall be performed by the Parties
pursuant to the oversight of the JMC. In particular, the JMC shall have
authority to oversee the research, development and commercialization of
Compounds under this Agreement. The JMC will consist of six (6) members with
three (3) designated by each Party. A chairperson of the JMC will be nominated
alternately by Procter & ▇▇▇▇▇▇ and Regeneron to twelve (12) month terms. The
Parties will be free to change their respective representatives, on notice to
the other Party. The JMC will exist until the earlier of termination or
expiration of this Agreement or when one Party is an Opting Out Party with
respect to all Compounds in all countries, unless the Parties otherwise agree.
The JMC may delegate its responsibilities to other committees (e.g., Patent
Committee, Research Committee, Clinical Committee). The initial members of the
JMC shall be selected within fifteen (15) days after the Effective Date. The
first JMC meeting shall occur within thirty (30) days of the Effective Date.
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
2.3. Meetings. The JMC will meet at least two (2) times per Year and
may meet at additional times as the Parties shall agree. Either Party may call a
special meeting of the JMC, up to two (2) times per year, on fifteen (15) days'
written notice to the other Party. The chairperson shall send to all JMC members
notices of all regular meetings and agendas for such meetings. The Party
convening a special meeting shall send notices and agenda for such meeting.
Meetings will alternate between the offices of the Parties, or may be held via
teleconference, videoconference or such other place or manner as the Parties may
mutually agree. Members of the Committee shall have their right to participate
in and vote at meetings in person, by telephone, by videoconference or by proxy.
The Party hosting any meeting shall appoint a secretary to the meeting who will
record the minutes of the meeting which will be circulated to the members of the
JMC promptly following the meeting for review, comment, and adoption.
2.4. Decision-making Criteria. Subject to Sections 3.2(a) and
4.1, all decisions of the JMC shall be made by majority vote and in the exercise
of good faith. Such decisions shall adhere to the ethical and legal standards
for the research-based pharmaceutical industry and utilize Commercially
Reasonable Efforts to research, develop, and commercialize Compounds.
2.5. Dispute Resolution. Subject to Sections 3.2(a) and 4.1, if a
decision cannot be achieved by the JMC, the matter shall be referred to further
review and resolution by the Chairman or CEO of Regeneron and the President of
Procter & ▇▇▇▇▇▇ (the "CEOs"). If the CEOs cannot resolve the issue within
thirty (30) days, the CEOs shall mutually agree upon and appoint to the JMC a
"Temporary Member." "Temporary Member" means a person who is knowledgeable in
the research based pharmaceutical industry, possessing senior executive
experience and skills and not associated with either Party, an Affiliate of
either Party, or a competitor of either Party. If the CEOs cannot mutually agree
on the identity of such Temporary Member within fifteen (15) days of such thirty
(30) day period, the Parties shall request an arbitral panel composed in
accordance with Article XI, sitting in Boston, Mass., to, and such panel shall,
appoint to the JMC a Temporary Member. The JMC shall meet and resolve the
dispute within one week of such appointment of the Temporary Member. All
decisions with respect to the issue in dispute shall be made by majority vote of
the JMC. Such Temporary Member shall be appointed to the JMC until such time as
the CEOs mutually agree that the dispute or disputes have been resolved or until
one Party is deemed to be an Opting Out Party with respect to such Compound (and
country, if applicable) at issue, whichever is earlier. Such Temporary Member
shall be instructed to render his or her votes consistent with the stated
decision-making criteria of the JMC, as set forth in Section 2.4. The Parties
shall share equally in all costs associated with the appointment of the
Temporary Member.
2.6. Conduct of Work by Others. It is understood that each Party has
entered into this Agreement based on the specific experience and skill of the
other Party. Accordingly, it is anticipated that work under this Agreement will
be conducted primarily by the Parties. However, it may be commercially
reasonable for the Parties to enter into agreements with commercial or
non-commercial Third Parties to acquire Technology or conduct certain aspects of
such work (e.g., because the Third Party's work provides a favorable
cost/benefit vs. utilizing internal resources). Such agreements may include
(without limitation), acquisition of research methods, Compounds or intellectual
property rights (if applicable), consultation, conduct of certain research
tests, chemical synthesis and supply, safety testing, clinical testing and/or
marketing support. All such work by or acquisition from Third Parties shall be
conducted pursuant to the Research and/or Product Plan and shall be an Allowable
Expense and shall be performed pursuant to written agreements embodying
confidentiality, intellectual property rights and other terms consistent with
the terms set forth in this Agreement, such that the commercial or
non-commercial Third Parties are obligated to assign or exclusively license
without royalty obligations for any patents, patent applications or know-how in
the Field to the Parties or such other terms that are agreed by the Parties.
Information obtained by a Party from any Third Party shall be subject to Article
VIII of this Agreement. All Technology obtained from a Third Party pursuant to
this Section 2.6 shall be jointly owned by the Parties and shall be subject to
Articles V and VII.
2.7. Record-keeping. Subject to Section 3.4(d), the JMC shall appoint
one Party to keep complete and accurate records pertaining to the Parties'
activities hereunder. The other Party shall have the right to review such
records upon reasonable notice to the recordkeeping party and at reasonable
times. Such records shall be audited annually within a reasonable period after
the end of the Fiscal Year by the recordkeeping party's independent certified
public accountant and are subject to audit by the other Party pursuant to
Section 6.5. In addition, the recordkeeping party shall prepare quarterly
unaudited financials which shall be distributed to the Parties within thirty
(30) days of the end of such period.
Article III - Research and Development
3.1. Research Plan. The Parties have agreed to the draft Research Plan.
The JMC is authorized to finalize the draft Research Plan and amend the Research
Plan from time to time. The Research Plan shall include general goals of the JMC
relating to the Parties' research in the Field and the timing, nature and
priority of resources to be applied and will detail research tasks and goals,
Success Criteria, personnel allocation, outside services and costs, Allowable
Expenses, budgets, and such other matters deemed necessary to implement the
Research Plan in the Joint Discovery Research Term and Joint Non-discovery
Research Term. The Research Plan will include an annual budget and will be
updated by the JMC on at least an annual Fiscal Year basis. The timing and
calculations for the Research Plan budget are contained in Attachment 3.1.
3.2. Funding of Research Plan.
(a) During the Joint Discovery Research Term, Procter & ▇▇▇▇▇▇
shall fund fifteen (15) Regeneron FTEs per Year for Regeneron's work pursuant to
the Research Plan. Regeneron will fund and supply at least *** Regeneron FTEs
per Year for the same period of time that Procter & ▇▇▇▇▇▇ funds *** Regeneron
FTEs pursuant to this Section 3.2(a). For purposes of this Section only,
Regeneron's annual cost per FTE shall be *** (adjusted on a Fiscal Year basis,
starting for the quarter beginning July 1997, for inflation in the prior
calendar year based on changes in the Consumer Price Index for All Urban
Consumers as published by the U.S. Bureau of Labor Statistics). This funding
commitment shall commence on the Effective Date and be payable quarterly in
arrears, except for the first Calendar Quarter of the first Year, which shall be
payable in advance on the Effective Date, subject to Procter & Gamble's right to
terminate such payments, as provided in Section 3.2(c). ***.
(b) Regeneron shall use funding provided under this Section
3.2 solely for carrying out the Research Plan. Regeneron shall submit invoices
to Procter & ▇▇▇▇▇▇ within forty-five (45) days of the end of each Calendar
Quarter detailing the number of FTEs performing research and development
activities pursuant to the Research Plan, as well as a detailed description of
such activities. Invoices submitted to Procter & ▇▇▇▇▇▇ pursuant to this Section
are payable net thirty (30) days after receipt and are subject to Procter &
Gamble's audit pursuant to Section 6.5.
(c) Procter & ▇▇▇▇▇▇ shall provide the funding to Regeneron for
research pursuant to Section 3.2(a) for at least three (3) Years.
Thereafter, subject to Regeneron's funding
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
commitment in Section 3.2(a), Procter & ▇▇▇▇▇▇ shall continue to fund
Regeneron's *** FTEs pursuant to Section 3.2(a) until the earlier of (x)
termination by Procter & ▇▇▇▇▇▇ of the Joint Discovery Research Term with at
least *** days' notice prior to the beginning of the fourth, fifth or sixth
Years, or (y) upon designation of a Development Compound by the JMC prior to the
beginning of the sixth Year. The Parties shall equally fund Allowable Expenses
under the Research and/or Product Plans upon the earlier of (i) the beginning of
the fourth Year if the JMC has designated a Development Compound in any prior
Year, (ii) the JMC's designation of a Development Compound after the end of the
third Year, or (iii) the beginning of the sixth Year. Procter & ▇▇▇▇▇▇ may
terminate the Joint Discovery Research Term at the beginning of the fourth Year
or any Year thereafter with at least *** notice prior to the beginning of such
Year. Regeneron may terminate the Joint Discovery Research Term with at least
*** days' notice prior to the beginning of the sixth Year or any Year
thereafter.
(d) If a Research Compound is identified by either or both
Parties (x) during the Joint Discovery Research Term but has not been designated
a Development Compound prior to termination of the Joint Discovery Research
Term, or (y) during the Tail Period, the Parties shall meet within *** days of
the termination of the Joint Discovery Research Term in the case of (x) or
within *** days of such identification in the case of (y) to agree on a Research
Plan or other disposition (e.g., license to a Party or Third Party) of such
Research Compound. All funding for the Research Plan during the Joint
Non-discovery Research Term shall be shared equally by the Parties. The Joint
Non-discovery Research Term shall be terminated by the JMC's designation of such
Research Compound as a Development Compound, or as otherwise agreed by the
Parties.
3.3. Selection of Development Compounds.
(a) At the time that the Parties have performed sufficient
research and preclinical testing of a Research Compound and such testing shows
that the Research Compound may have utility in the Field and has met the
Research Plan's predetermined Success Criteria for such Research Compound to be
considered a Development Compound, so that the JMC reasonably determines that
the Research Compound should undergo safety assessment and other preclinical
development activities to determine whether to commence clinical studies with
respect thereto (and thereby such Research Compound being designated as a
Development Compound), then further research, development, and commercialization
of the Development Compound will be conducted in accordance with this Agreement.
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
(b) If the JMC agrees that the Research Compound meets the
Success Criteria but one Party elects to opt out of further development, then
the Party desiring not to proceed in developing the Research Compound shall be
deemed an Opting Out Party with respect to that Research Compound. The
Proceeding Party may develop the Research Compound only if such Research
Compound would not be a Competing Product with respect to other existing
Development Compounds and Marketed Compounds.
(c) Within *** after the designation of a Development Compound
by the JMC, the Parties shall meet and agree as to how such Development Compound
will be developed and commercialized and incorporate such agreements into the
Product Plan. The Product Plan shall include general goals of the Parties
relating to the development and commercialization of each Development Compound
and the timing, nature, and priority of resources to be applied and will detail
tasks and goals, personnel allocation, outside services and costs, Success
Criteria, Allowable Expenses, budgets, and such other matters deemed necessary
to implement the Product Plan. The Product Plan will include a spending forecast
through the end of clinical trials for the Development Compound and a budget for
the next Fiscal Year that will be updated by the JMC at least annually on a
Fiscal Year basis. Procter & ▇▇▇▇▇▇ is responsible for taking the lead in
proposing such budget with significant and timely input from Regeneron. The
timing and calculations for the typical Product Plan budget is contained in
Attachment 3.1 as an example. The JMC will have complete authority to adopt all
Product Plans.
3.4. Funding of Development Compounds and Marketed Compounds;
Opting Out.
(a) All Allowable Expenses for a Development Compound incurred
pursuant to the Product Plan by either Party will be shared equally by the
Parties, whether the JMC designated the Development Compound as such prior to or
after the end of Year 3. Nothing herein shall excuse or mitigate Procter &
Gamble's funding obligations under Section 3.2.
(b) During the development of a Compound, if one Party is unable to
fund its equal share of Allowable Expenses (the "Owing Party") and proceeds in
good faith to pursue financing for its share from a Third Party, such sum shall
be loaned to the Owing Party by the other Party, accruing interest at the rate
specified in Section 6.4, for a period not to exceed*** from the time the
funding for such Allowable Expenses was initially due ("Advances"). If the Owing
Party fails to timely repay the Advances along with any other Allowable Expenses
that may be payable at that time, the Owing Party shall be deemed to be an
Opting Out Party as of the
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
date such Advances were initially due. Advances for each Party shall be limited
to *** Advances per Compound and no more than *** Advances for all Compounds
during the same *** period. An example relating to Advances is outlined in
Attachment 3.4(b).
(c) If, at any time during a Compound's development or
commercialization, one Party, but not both, elects not to participate in the
further development and/or commercialization of such Compound, then such Party
shall be deemed an Opting Out Party with respect to that Compound, either in
total or on a country-by-country basis pursuant to Section 3.6. At that point,
the Proceeding Party may proceed to develop and/or commercialize such Compound
at its own expense. Unless the Parties otherwise agree, in no event, however,
may a Party opt out from or otherwise refuse to pay its share of Allowable
Expenses to which such Party has committed.
(d) If both Parties opt out, the Parties shall use
Commercially Reasonable Efforts to license the Compound, and each Party's
respective share of any income derived from such Compound shall be calculated
pursuant to Section 6.1(b).
(e) The Parties' equal funding of Allowable Expenses under the
Product Plan shall commence on the day the JMC designates the Development
Compound as such and be payable quarterly in arrears, based on justification of
Allowable Expenses incurred over the quarter. Regeneron and Procter & ▇▇▇▇▇▇
shall submit reports to each other within thirty (30) days of the end of each
Calendar Quarter detailing the number of FTEs performing research and
development activities pursuant to the Product Plan, Third Party costs and other
costs incurred in research, development and commercialization activities, as
well as a detailed description of such activities. Each Party shall review and
approve the other Party's reports within fifteen (15) days thereafter, subject
to the JMC's approval, if necessary. Procter & ▇▇▇▇▇▇ will then calculate the
amount that shall be paid by either Party to the other Party to equalize funding
and so advise Regeneron within seven (7) days. The Party to whom funds are owed
will issue an invoice for the corresponding amount, payable within thirty (30)
days. Costs incurred and paid pursuant to this Section are subject to audit
pursuant to Section 6.5.
3.5. Research, Development and Commercialization Communication. In
addition to Regeneron's reporting obligations under Section 3.2(b), Regeneron
and Procter & ▇▇▇▇▇▇ will submit reports to each other not less than two (2)
times per Fiscal Year presenting a meaningful summary of research, development
and commercialization activities performed under this Agreement. Regeneron and
Procter & ▇▇▇▇▇▇ will make presentations of such activities to each
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
other, beyond that made to the JMC, as reasonably requested by each other. All
Technology generated by the Parties shall be disclosed pursuant to Section 7.1.
Subject to Section 5.4, the Parties shall use their best efforts to communicate
information only in the Field. Regeneron and Procter & ▇▇▇▇▇▇ will also
communicate informally and through the JMC to inform each other of research and
development done under this Agreement. Regeneron and Procter & ▇▇▇▇▇▇ will
provide each other with raw data in original form or a photocopy thereof for any
and all work carried out under this Agreement as reasonably requested by the
other. Any information contained in such reports and as otherwise communicated
by Regeneron or Procter & ▇▇▇▇▇▇ is subject to Article VIII. If one Party is
deemed an Opting Out Party, the Proceeding Party shall annually report to the
Opting Out Party research, development and commercialization activities
performed for Compounds in the Territory for the prior Year sufficient to allow
the Opting Out Party to determine whether the Proceeding Party is utilizing
Commercially Reasonable Efforts.
3.6. Global Development. The Product Plan shall set forth commercially
reasonable development work (including without limitation clinical studies) to
support acceptable regulatory applications for marketing clearance in all Major
Countries. The costs associated with these activities shall be deemed "Global
Expenses". If either Party fails to pay its share of Global Expenses with
respect to a Compound, such Party shall be deemed an Opting Out Party with
respect to such Compound in the entire Territory. Either Party may opt out of
the commercialization of a Compound on a country-by-country basis provided it
funds its share of total Global Expenses, to the extent that funding of any
development and/or commercialization expenses is solely attributable to one
country and is not considered a Global Expense ("Country Expenses"). A Party
electing to opt out of such Country Expenses shall be deemed an Opting Out Party
with respect to such Compound in that particular country only.
3.7. J-V Formation. Commencing at the end of the first Year, the
Parties shall negotiate in good faith an agreement by the end of the third Year
that contains all of the terms and conditions of this Agreement, along with
other terms and conditions as the Parties may agree to develop and/or
commercialize Compounds ("J-V Agreement"). In the event that the Parties cannot
finalize such J-V Agreement prior to the end of the third Year, Procter & ▇▇▇▇▇▇
may terminate this Agreement pursuant to Section 3.2(c), elect to continue to
perform research, development and commercialization activities pursuant to this
Agreement until its termination, or negotiate such other arrangement as the
Parties may agree.
3.8. Sumitomo Compounds.
(a) ***
(b) ***
Article IV - Commercialization of Products
4.1. Marketing and Sales Strategy. ***.
4.2. Net Profits. The Parties, so long as neither Party is an
Opting Out Party with respect to such Marketed Compound either in the entire
Territory or in one or more specific countries, as appropriate, will share
equally in the Net Profits of each Compound sold. "Net Profits" mean Net Sales
less Allowable Expenses.
4.3. Exclusive Distributor. The JMC may appoint either Party or a Third
Party to act as its agent in connection with the marketing, sale and
distribution of Marketed Compounds, and the JMC and/or the Parties (as the case
may be) shall grant to such agent(s) appropriate authority to perform its or
their responsibilities hereunder. In connection with such marketing, sales and
distribution, the following principles shall apply:
(a) the business objective will be to maximize overall
profits; and
(b) in the event that a Third Party is appointed as the
Parties' agent with respect to the marketing, sale and distribution of the
Marketed Compound in a country, Regeneron and Procter & ▇▇▇▇▇▇ will each receive
equal shares of any revenue received from such Third Party, so long as neither
Party is an Opting Out Party with respect to such Marketed Compound in such
country.
4.4. Regeneron Co-Promotion Activities. Provided that Regeneron is not an Opting
Out Party with respect to the Compound, Regeneron will have an equal right and
opportunity, but not the obligation, to participate in the sales and marketing
efforts in any country in the Territory as to which it has not opted out by
supplying up to fifty percent (50%) of a Marketed Compound's sales and marketing
efforts with notice to Procter & ▇▇▇▇▇▇ within *** of the JMC's decision to
prepare a regulatory application for marketing clearance in the first Major
Country with respect to all Major Countries, then on a country-by-country basis
upon regulatory
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
filings in such countries other than Major Countries. Regeneron's and Procter &
Gamble's sales and marketing personnel costs shall be an Allowable Expense and
shall be calculated for both Parties on the same basis (e.g., the cost per
salesperson or sales call for Regeneron and Procter & ▇▇▇▇▇▇ shall be the same
per year). If Regeneron wants to discontinue or decrease its co-promotion
activities, it must give Procter & ▇▇▇▇▇▇ *** months' notice prior to such
discontinuation or decrease.
4.5. Trademarks; Packaging. After a Compound has been designated a
Development Compound, the Parties shall jointly develop a trademark for such
Development Compound. So long as it is not an Opting Out Party with respect to
such Compound in a country, Procter & ▇▇▇▇▇▇ shall file, prosecute and maintain
all trademark applications and registrations for such trademarks, and all
expenses in connection with such activities shall be deemed Allowable Expenses.
As long as neither Party is an Opting Out Party with respect to the Marketed
Compound, such Marketed Compound shall be sold under a single trademark which
shall be owned by Procter & ▇▇▇▇▇▇ or, if a legal entity is formed pursuant to a
J-V Agreement, the trademark shall be owned by such entity to the extent legally
permissible. If one Party is an Opting Out Party with respect to such Marketed
Compound, any trademarks shall be owned by the Proceeding Party. So long as
neither Party is an Opting Out Party, the label of the Marketed Compound will
contain the name of Regeneron and Procter & ▇▇▇▇▇▇, to the extent legally
permissible.
Article V - License Grants
5.1. Exclusivity. Procter & ▇▇▇▇▇▇ and its Affiliates will not make,
have made, use, import, or sell, or license Technology for use in the Field in
the Territory under Patents and Know-how owned by Procter & ▇▇▇▇▇▇ and its
Affiliates (including Procter & ▇▇▇▇▇▇ Patents, Procter & ▇▇▇▇▇▇ Know-how and
Patents and Know-how owned jointly by the Parties pursuant to Section 5.2)
except under, and in accordance with, the terms of this Agreement. Regeneron and
its Affiliates will not make, have made, use, import, or sell, or license
Technology for use in the Field in the Territory under Patents and Know-how
owned by Regeneron and its Affiliates (including Regeneron Patents, Regeneron
Know-how and Patents and Know-how owned jointly by the Parties pursuant to
Section 5.2) except under, and in accordance with, the terms of this Agreement.
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
5.2. Rights in Technology Developed During Agreement. Patents and
Know-how resulting from work by the Parties under this Agreement shall be owned:
(x) by Regeneron, for Technology conceived and reduced to practice solely by
employees of Regeneron or its Affiliates; (y) by Procter & ▇▇▇▇▇▇, for
Technology conceived and reduced to practice solely by employees of Procter &
▇▇▇▇▇▇ or its Affiliates; (z) jointly, for Technology conceived and/or reduced
to practice jointly by employees of Procter & ▇▇▇▇▇▇ or its Affiliates and
Regeneron or its Affiliates. Inventorship shall be determined according to the
laws of the United States. Filing, prosecution, maintenance and enforcement of
such Patents shall be handled pursuant to Article VIII.
5.3. Rights in Technology. Procter & ▇▇▇▇▇▇ hereby grants Regeneron the
Sole License to make, have made, use, import and sell Technology in the Field
under Procter & ▇▇▇▇▇▇ Patents and Procter & ▇▇▇▇▇▇ Know-how. Regeneron hereby
grants Procter & ▇▇▇▇▇▇ the Sole License to make, have made, use, import, and
sell Technology in the Field under Regeneron Patents and Regeneron Know-how. As
used herein, "Sole License" shall mean a non-exclusive, royalty free license in
the Territory under Know-how or a Patent, without the right to sublicense,
granted by a "Licensor Party" to the other "Licensee Party," wherein the
Licensor Party shall not grant any Third Party a license to Technology in the
Field under said Know-how or Patent.
5.4. Rights in Non-Field Inventions. Any compound, composition,
material or method (including without limitation genetic materials, receptors,
cell lines, transgenic animals, pharmaceutical actives, chemical processes,
methods of treatment and methods of diagnosis), which is not a Third Party
Technology and which is conceived of and/or reduced to practice by a Party as a
direct result of work under this Agreement during the Exclusivity Period, but
for which there is no utility in the Field known as of the end of the
Exclusivity Period (herein "Non-Field Invention"), shall be owned:
(x) by Regeneron, if conceived and reduced to practice solely by
employees of Regeneron or its Affiliates;
(y) by Procter & ▇▇▇▇▇▇, if conceived and reduced to practice
solely by employees of Procter & ▇▇▇▇▇▇ or its Affiliates; and/or
(z) jointly, if conceived and/or reduced to practice jointly by
employees of Procter & ▇▇▇▇▇▇ or its Affiliates and Regeneron or its Affiliates.
***
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
5.5. Rights upon Termination of Research. Upon expiration of the
Exclusivity Term and except as set forth in Sections 5.6 and 5.7 with respect to
Compounds under development or commercialization by one or both of the Parties
pursuant to this Agreement, the obligations of the Parties under Section 5.1
shall terminate and the Sole Licenses granted by the Parties under Section 5.3
shall terminate. In addition, Procter & ▇▇▇▇▇▇ shall grant Regeneron a
non-exclusive, royalty-free license under Procter & ▇▇▇▇▇▇ Know-how and Procter
& ▇▇▇▇▇▇ Patents, without the right to sublicense, to make, have made, and use
Technology for the purpose of discovering, developing and/or commercializing
Compounds (other than Compounds identified before the end of the Exclusivity
Term) in the Field. Regeneron shall ▇▇▇▇▇ ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇ a non-exclusive,
royalty-free license under Regeneron Know-how and Regeneron Patents, without the
right to sublicense, to make, have made, and use Technology for the purpose of
discovering, developing and/or commercializing Compounds (other than Compounds
identified before the end of the Exclusivity Term) in the Field.
5.6. Rights in Compounds under Research, Development and
Commercialization. Subject to Section 3.8, a Party shall not grant any license
to a Third Party in the Territory under any Patent or Know-how owned in whole or
in part by that Party to make, have made, use, import or sell any Compound
during the Term with respect to Compounds that are the subject of joint
research, development and/or commercialization by the Parties under this
Agreement or a J-V Agreement. The Parties shall grant licenses under Patents or
Know-how to each other, or to any jointly owned entity as may be established by
the Parties pursuant to a J-V Agreement, as may be necessary to facilitate
research, development and/or marketing of such Compounds.
5.7. Grant of License by Opting Out Party. In the event a Party becomes
an Opting Out Party with respect to the development and/or commercialization of
a Compound in its entirety or on a country-by-country basis, then that Opting
Out Party shall grant the Proceeding Party an exclusive license, with the right
to sublicense, to make, have made, use, import and sell such Compound under the
Patents , Know-how, trademarks and copyrights regarding that Compound owned by
the Opting Out Party. The license shall be in all countries of the Territory in
which opting out has been deemed to occur, and shall be subject to the royalty
set forth in Paragraph 7.1. The Opting Out Party shall comply with reasonable
requests for cooperation by the Proceeding Party, and the Proceeding Party shall
reimburse the Opting Out Party for reasonable out-of-pocket expenses incurred
with respect to such cooperation.
Article VI - Royalties and Accounting
6.1. Royalty Calculation.
(a) The Proceeding Party will pay to the Opting Out Party a
royalty on Net Sales of a Marketed Compound on a country-by-country basis, sold
by the Proceeding Party, its Affiliates, licensees and/or sublicensees in the
Territory at the applicable rate listed below multiplied by the Net Sales in
such country:
*** ***
--------- -------
*** ***
*** ***
*** ***
*** ***
Such royalty will be paid for a period of *** years from the date of first sale
to a customer of such Compound in a particular country, or for so long as the
manufacture, use, importation or sale of the Compound would, but for the
licenses granted herein, infringe a Valid Claim of a Patent in such country,
whichever is longer.
(b) If both Parties opt out with respect to a Compound in total or on a
country-by-country basis, opting out either simultaneously or sequentially, then
the Parties shall use Commercially Reasonable Efforts and cooperate with each
other to license the Compound to a Third Party. ***. Examples of the respective
percentages are outlined in Attachment 6.1(b). Reasonable out-of-pocket expenses
incurred in obtaining such licensee shall be shared equally by the Parties.
Notwithstanding the above, either Party may receive, without sharing with the
other Party, reimbursement from such licensee for reasonable, (*** to account
for indirect overhead) costs of research, development and/or commercialization
costs (whether internal or Third Party) to be incurred by such Party for work to
be conducted in the future on behalf of the licensee. Any amounts in excess of
such reimbursement shall be shared in the same proportion as calculated above in
this Section 6.1(b) All amounts from licensees received by either Party shall be
fully disclosed to the other Party and subject to audit (including without
limitation the calculation of Fully-Loaded costs) pursuant to Section 6.5.
(c) If the Proceeding Party elects to distribute or sublicense a
Compound in any country, and a license must be obtained from a Third Party to
manufacture and/or market such
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
Compound to avoid a non-frivolous claim of patent infringement, the Proceeding
Party shall offset the following portion of the Third Party license fee, royalty
or other similar payments ("Licensee Fees") against the Opting Out Party's
royalty:
*** ***
--------- -------
*** ***
*** ***
*** ***
*** ***
Any portion of Licensee Fees paid by the Proceeding Party that is to be
offset against the Opting Out Party's royalty but that exceeds the Opting Out
Party's royalty payable, shall be carried forward and accrue interest pursuant
to Section 6.4 and be offset against future royalties as such royalties become
payable.
6.2. Royalty Payment.
(a) Royalties payable under Section 6.1 will be paid not later
than sixty (60) calendar days following the end of each Calendar Quarter. All
payments shall be accompanied by a report in writing showing the Calendar
Quarter for which such payment applies, the amount billed to Third Parties for
Marketed Compounds sold during such Calendar Quarter, the deductions from the
amount billed to arrive at the Net Sales, the Net Sales for the Calendar
Quarter, and the royalties due on such Net Sales, such report being broken down
by Marketed Compound and country. All royalties will be paid in the currency
where Net Sales take place or, at the option of the payee, in US dollars at a
rate of exchange on the last business day of the Calendar Quarter as quoted in
The Wall Street Journal (or Citibank, N.A. if such rates are not available in
The Wall Street Journal).
(b) All royalties due under this Article VI will be deposited
in a bank chosen by the recipient by the date due. Any amounts or royalties
prohibited from export by a particular country will be deposited in a bank
chosen by the recipient in such country. Any deductions for withholding taxes
imposed by the country in which Net Sales take place will be withheld and
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
paid as required by law. The paying Party will provide promptly upon request any
receipts from the governmental or taxing authority evidencing payment of such
taxes and will assist the receiving Party in claiming relief from double
taxation.
6.3. Records. Procter & ▇▇▇▇▇▇ and Regeneron will maintain, and will
require their Affiliates and sublicensees to maintain, complete and accurate
records of Net Sales of Marketed Compounds sold subject to the royalty
provisions of Section 6.1 and the audit provisions of Section 6.5.
6.4. Interest Rate. Unless otherwise provided in this Agreement,
any payments past due will bear interest at the prime rate (such quoted in The
Wall Street Journal on the first day of the month of the accrual) plus two (2)
percentage points, compounded monthly.
6.5. Audit. Records shall be open for audit during reasonable business
hours for a period of three (3) years from creation of individual records for
examination not more often than once each year by an independent certified
public accountant ("CPA") selected by the payee and reasonably acceptable to the
payer for the sole purpose of verifying the correctness of payments to be made
under this Agreement. If the CPA finds a discrepancy of greater than ten (10)
percent of such payment, the CPA shall submit a detailed report regarding the
audit and such discrepancy to both Parties within thirty (30) days of commencing
the audit. The Parties shall attempt to resolve such discrepancy to their mutual
satisfaction during the next fifteen (15) days. If the Parties cannot resolve
the discrepancy, their CEOs shall meet within ten (10) days after such fifteen
(15) day time period. If the CEOs cannot resolve the dispute within five (5)
days, either Party may take such dispute to arbitration pursuant to Section
11.4. The calculation of such payment shall be deemed final (and not subject to
audit or dispute resolution) five (5) years after the period in which such
payment was due, unless arbitration pursuant to Section 11.4 is commenced prior
to such time. Out-of-pocket expenses incurred with respect to such CPA shall be
paid by the payee; however, the payer shall reimburse the payee for such CPA
expenses if the discrepancy is greater than ten (10%) percent, as such
discrepancy is determined by the CEOs or arbitrators.
Article VII - Patents and Infringement
7.1. Disclosure. Each Party will promptly disclose to the other
Party all Technology owned in whole or in part by that Party or in which
Technology such Party otherwise has rights.
7.2. Patent Applications. Regeneron and Procter & ▇▇▇▇▇▇ will discuss
and evaluate Technology disclosed pursuant to Section 7.1, and confer regarding
the advisability of filing patent applications to cover any Technology. The
Party (herein "Responsible Party") for the filing, prosecution and maintenance
of patent applications shall be: (x) Procter & ▇▇▇▇▇▇, if the subject invention
is made solely by employees of Procter & ▇▇▇▇▇▇; (y) Regeneron, if the subject
invention is made solely by employees of Regeneron; or (z) determined by
agreement of the Parties for all other inventions, taking into account the
nature of the invention and the relationship of the invention to inventions
claimed in other patents or applications. Regeneron and Procter & ▇▇▇▇▇▇ will
discuss with each other the advisability of filing Patent applications beyond
the priority country.
7.3. Filing and Prosecution of Patents. The Responsible Party shall
diligently file, prosecute, issue, and maintain patent applications according to
its own internal standards and for effectively covering other inventions made by
its employees or consultants. The Responsible Party will endeavor to ensure that
all patent applications are filed before any public disclosures so as to ensure
validity of patent applications filed outside of the United States. The
Responsible Party will submit a substantially complete draft of each patent
application to the other Party at least thirty (30) days prior to the
contemplated filing date and consider any comments of the other Party, provided
that in those circumstances where the Responsible Party believes time is of the
essence, the Responsible Party will endeavor to provide the other with such
advance notice as it reasonably can under the circumstances. Regeneron and
Procter & ▇▇▇▇▇▇ will confer with each other regarding the prosecution of such
Patent Applications and will copy each other with any official action and
submission in such Patent Applications.
7.4. Alternate Responsibility for Prosecution. Should Regeneron or
Procter & ▇▇▇▇▇▇ not wish to file, prosecute, maintain, or issue a Patent
Application or maintain a Patent covering an Invention at all or in a particular
country, any necessary authority will be granted to the other to file,
prosecute, maintain, and issue such a Patent Application or maintain such a
Patent, all at the expense of the other Party.
7.5. Infringement. Procter & ▇▇▇▇▇▇ and Regeneron shall promptly
notify the other in writing of any infringement of a Patent within the Patent
Rights licensed or to be licensed pursuant to Article V of which they become
aware.
7.6. Enforcement of Patents. Regeneron and Procter & ▇▇▇▇▇▇ may, but
shall not be required to, prosecute any alleged infringement or threatened
infringement of a Patent within
the Patent Rights of which they are aware or which is brought to their
attention. The prosecuting Party shall act in its own name and at its own
expense unless the other Party at its option pays fifty percent (50%) of all
reasonable out-of-pocket costs. Regeneron and Procter & ▇▇▇▇▇▇ shall cooperate
fully with each other including, if required to bring such action, the
furnishing of power of attorney. Any recovery obtained shall belong to the
prosecuting Party unless the other Party has paid fifty percent (50%) of said
costs in which case each Party will receive fifty percent (50%) of any recovery.
7.7. Alternate Responsibility for Enforcement. If Regeneron or Procter
& ▇▇▇▇▇▇ has failed to prosecute under Section 7.6 with respect to alleged or
threatened infringement of one of its Patents (i) three (3) months after it has
been notified in writing by the other of such alleged infringement or (ii) one
(1) month before the time limit, if any, set forth in the appropriate laws and
regulations for the filing of such actions, whichever comes first, the other
may, but shall not be required to, prosecute any alleged infringement or
threatened infringement of the Patent. Such prosecuting Party shall act in its
own name and at its own expense. In such event, both Parties shall cooperate
fully with each other at their own expense, including if required in order to
bring such an action, the furnishing of a power of attorney. Any recovery
obtained shall belong to the prosecuting Party.
7.8. Trademark Infringement and Enforcement. Procter & ▇▇▇▇▇▇ and
Regeneron shall promptly notify the other in writing of any infringement of a
trademark under Section 4.5 of which they become aware. The owner of the
trademark application or registration may, but shall not be required to,
prosecute any such alleged infringement or threatened infringement. The
prosecuting Party shall act in its own name (unless joinder of the other Party
is required by law in which case it shall be joined) and at its own expense
unless the other Party at its option pays fifty percent (50%) of all reasonable
out-of-pocket costs. Regeneron and Procter & ▇▇▇▇▇▇ shall cooperate fully with
each other in such action. Any recovery obtained shall belong to the prosecuting
Party unless the other Party has paid fifty percent (50%) of the costs in which
case each party will receive fifty percent (50%) of any recovery.
7.9. Alternate Responsibility for Trademark Enforcement. If the owner of
the trademark application or registration has failed to prosecute under Section
7.8 with respect to an alleged or threatened infringement of a trademark (i)
three (3) months after it has been notified in writing by the other of such
alleged infringement or (ii) one (1) month before the time limit, if any, set
forth in the appropriate laws and regulations for the filing of such actions,
whichever comes first, the other Party may, but shall not be required to,
prosecute any alleged infringement
or threatened infringement of the trademark. Such prosecuting Party shall act in
its own name and at its own expense. In such event, both Parties shall cooperate
fully with each other at their own expense. Any recovery obtained shall belong
to the prosecuting Party.
Article VIII - Confidentiality
8.1. Confidentiality and Non-Use Obligations. Each Party shall
maintain in confidence all information (herein "Information") which is:
(a) Technology disclosed to it by the other Party pursuant to
Section 7.1;
(b) Technology developed by the Party during the Exclusivity
Term; or
(c) other information ("Other Information") disclosed by the
other Party which is considered confidential by the other Party, and so
designated as confidential in writing when first disclosed or within thirty (30)
days after disclosure if the first disclosure is oral.
The Party shall take all reasonable precautions to:
(d) prevent disclosure of such Information to Third Parties, except as
set forth in Section 2.6, Section 8.3 and Section 11.10, or as may be necessary
for the filing or prosecution of patent applications pursuant to Article VII;
(e) use Know-how pursuant to the rights and obligations of the
Party pursuant to Article V; and
(f) use Other Information only for the purposes of this Agreement.
These restrictions upon disclosure and use of Information shall
terminate ten (10) years after the date such Information is developed or
disclosed as set forth above, but shall not apply to any specific portion of
Information which:
(i.) is Other Information already in the possession of a Party at
the time of disclosure by the other Party;
(ii.) is or later becomes available to the public other than by
default by the Party;
(iii.) is received from a Third Party having no obligation of
confidentiality to the other Party;
(iv.) is Other Information developed by the Party entirely without
reference or use of Information, as established by probative documentary
evidence; or
(v.) is required to be disclosed by law or government regulation.
8.2. Prior Confidentiality Agreements. The "Confidential
Disclosure Agreement" dated October 8, 1996 between Regeneron Pharmaceuticals,
Inc. and Procter & ▇▇▇▇▇▇ has
separately been rendered void and all Information to be kept confidential under
such agreement as of the Effective Date will be subject to the terms of Section
8.1 as if disclosed under this Agreement.
8.3. Research Manuscripts and Abstracts. It is understood the Parties
may wish to publish or otherwise disclose Technology to a Third Party for
publication in a reputable scientific forum (for example, as an abstract, poster
presentation, lecture, article, book, or any other means of dissemination to the
public). Such disclosures may be made to a Third Party regarding (x) preclinical
research; (y) clinical research disclosing only data that have been locked, if
disclosure presents no significant risk to regulatory filings and serves a
compelling business reason for publication; and (z) other work by the Parties,
upon approval by the JMC. No such disclosure shall be made to a Third Party
until a patent application has been filed adequately describing and claiming any
patentable Technology embodied in such disclosure, pursuant to Article VI. A
Party wishing to make any such disclosure shall submit a complete written draft
of the disclosure to the other Party at least thirty (30) days prior to
submission for the disclosure to a Third Party. The Party shall consider any
comments from the other Party. Any disputes regarding the appropriateness and
content of any such disclosure shall be resolved by the JMC.
Article IX - Representations, Warranties and Indemnification
9.1. Patents.
(a) Each Party and their respective Affiliates warrant that,
as of the Effective Date, it has no actual knowledge of any information
rendering invalid or unenforceable any Patent licensed to the other Party under
Article V or VII. Each Party will promptly inform the other Party immediately if
it obtains such information after the Effective Date.
(b) Each Party and their respective Affiliates warrant that it
is has no actual knowledge of any patents or Know-how owned by a Third Party
that might prevent, inhibit, or limit the Parties from conducting the research,
development and commercialization activities under this Agreement. Each Party
and their respective Affiliates warrant that, except as disclosed in Attachment
9.1, it has not entered into any agreement with a Third Party that might
prevent, inhibit, or limit the Parties from conducting the research, development
and commercialization activities under this Agreement. Regeneron and its
Affiliates warrant that Attachment 9.1 is a complete list of Third Party
Technology existing as of the Effective Date.
9.2. No Guarantee. The Parties understand that the research and
development work to be conducted pursuant to this Agreement will involve
untested, experimental, and currently undeveloped technology and that neither
Regeneron nor Procter & ▇▇▇▇▇▇ guarantees the safety or usefulness of any
Compound. Except as expressly set forth in this Agreement, the Parties disclaim
all warranties of any nature, express or implied.
9.3. Indemnification.
(a) Indemnification Regarding Joint Activities, General. Any
and all liability, damage, loss, cost (including without limitation reasonable
attorneys' fees) and expense resulting from any suits, claims, actions, demands,
liabilities, expenses and/or loss ("Losses") relating to the joint development,
manufacture, use, storage, distribution or sale of any Compound ("Joint
Activities") will be shared equally. Each Party shall indemnify and hold
harmless the other Party for such Party's respective share of such liability;
provided, however, that the portion of Losses due to the gross negligence or
willful or intentional misconduct of either or both Party(ies) shall be governed
by Section 9.3(b).
(b) Indemnification by the Parties. Each Party shall indemnify
and hold the other Party harmless from and against that portion of any and all
Losses due to the gross negligence or willful or intentional misconduct of such
indemnifying Party, as well as any Losses that were not caused by Joint
Activities.
(c) Indemnification by the Proceeding Party. The Proceeding
Party agrees to save, defend and hold the Opting Out Party harmless from and
against any and all Losses to the extent that such factual allegations forming
the primary basis for such Losses occurred after the Party became an Opting Out
Party with respect to that Compound and/or country. Both Parties shall provide
prompt notice to the other of such potential Losses. The Proceeding Party shall
assume control of the defense of the potential Losses (including without
limitation the right to settle the claim). The Opting Out Party shall provide
reasonable cooperation to the Proceeding Party, and the Proceeding Party shall
reimburse the Opting Out Party its reasonable out-of-pocket expenses.
(d) Indemnification Procedure. In the event that either Party
receives notice of potential Losses, such Party shall immediately inform the
other Party and the JMC. The JMC shall decide the manner in which to respond to
and handle the claim. If the JMC cannot decide on how to respond to the claim
prior to five (5) days before the answer is due, the Party receiving the notice
shall answer the claim and take reasonably necessary actions to defend itself,
and the other Party may appoint its own counsel at its own expense, until the
JMC agrees on how to handle the claim.
Article X - Term, Termination
10.1. Term. Unless terminated earlier pursuant to Sections 3.2,
10.2 or by mutual agreement, this Agreement shall expire at the end of the
Royalty Term.
10.2. Default. Failure by either Party (the "Defaulting Party") to
comply with any of the material obligations contained in this Agreement, the
Stock Purchase Agreement, the Stock Registration Agreement or any J-V Agreement
shall entitle the other Party (the "Nondefaulting Party") to give to the
Defaulting Party notice specifying the nature of the default and requiring it to
cure such default. If the Defaulting Party disagrees with the existence, extent
or nature of the default, the Parties shall use good faith efforts to resolve
the dispute within thirty (30) days. If (i) such default is not cured with such
thirty (30) day period after the receipt of such notice or (ii) the Parties have
not otherwise resolved the dispute during such thirty (30) day period, the
Nondefaulting Party shall be entitled to initiate arbitration under Section 11.4
and at its sole discretion suspend performance under this Agreement.
10.3. Change of Control.
(a) In the event of a Change in Control, as that term is
defined in Section 10.5(a), of either the Parties or their respective Affiliates
that have responsibilities or obligations under this Agreement (each
collectively or individually then referred to as the "Acquired Company") and the
Acquired Company is not an Opting Out Party with respect to all Compounds in all
countries under this Agreement, then the Party affiliated with the Acquired
Company shall notify the other Party of any such Change in Control as soon as
the Change in Control may publicly be announced. Upon receipt of any such
notification, the other Party or an Affiliate thereof (the "Electing Company")
shall have the unilateral right to give notice to the Acquired Company within
*** days after its next regularly scheduled board meeting, but in no event
longer than *** days, after receipt of the Acquired Company's notification that
the Electing Company:
(i) elects not to continue the research,
development and commercialization collaboration, whether or not a J-V has been
formed (the "Option"), in which case a determination of the License Fee pursuant
to Section 10.6 will be made, and within ***
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
following such License Fee determination will make the further election either
to purchase the entire interest of the Party affiliated with the Acquired
Company under this Agreement or any J-V Agreement ("Acquired Company Interest")
or offer the Acquired Company the option to purchase the entire interest of the
Electing Company under this Agreement or any J-V Agreement ("Electing Company
Interest") at the License Fee (but in the event that the Acquired Company does
not desire to purchase the Electing Company Interest, the interests of the
Parties shall be disposed of by sale, license, or other commercially reasonable
arrangement for a price that maximizes value for both Parties, paid by a Third
Party or a Party, and each Party shall have the right to receive half of the
consideration thus obtained less any Advances plus accrued interest payable), or
(ii) desires to continue the collaboration for a
period of up to *** from the date of the Change in Control (the "Trial Period")
upon the express condition that the ultimate parent of the entity acquiring
control of the Acquired Company within *** days thereafter agrees in writing to
such Trial Period and otherwise agrees to be bound by the provisions of this
Agreement, the Stock Registration Agreement, the Stock Purchase Agreement and
any J-V Agreement. If the ultimate parent of the acquiring entity accepts these
conditions, the collaboration shall continue, and the Option shall expire unless
the Electing Company exercises the Option within*** days prior to the expiration
of the Trial Period. If the ultimate parent of the acquiring entity fails to
give notice within the required period that it will be bound by the provisions
of such aforementioned Agreements, the Electing Company shall be deemed to have
exercised the Option as of the expiration of such *** day period and the Parties
shall then follow the procedures set forth in this Section 10.3.
10.4. Substantial Stock Accumulation.
(a) In the event of a Substantial Stock Accumulation, as that
term is defined in Section 10.5(b), of either the P&G Parent or the Regeneron
Parent (the "Affected Company"), at any time after the Substantial Stock
Accumulation, the Party affiliated with the Affected Company may, but is not
obligated to, inform the other Party in writing that the Party affiliated with
the Affected Company regards such Substantial Stock Accumulation as being not in
the best interests of the collaboration. This notice shall be separate from and
in addition to the notice required under Sections 10.3 and 10.4(b). Upon receipt
of any such notification stating that the Substantial Stock Accumulation is not
in the best interests of the collaboration, the other Party or its Affiliates
(the "Purchasing Company") shall have the option, at its election and upon
notice to
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
the Affected Company within *** days after receipt of the Affected Company's
notification of a Substantial Stock Accumulation, to purchase the Acquired
Company Interest at the License Fee.
(b) In the event of a Substantial Stock Accumulation in either
the P&G Parent or the Regeneron Parent, as soon as the Party affiliated with the
Affected Company has knowledge of the Substantial Stock Accumulation, it shall
give prompt notice to the other Party. Such notice shall be separate from and in
addition to the notice provided for in Sections 10.3 and 10.4(a) and must be
given regardless of whether the Party affiliated with the Affected Company
regards the Substantial Stock Accumulation as being not in the best interest of
the collaboration. From the date on which the Party affiliated with the Affected
Company has notice of the Substantial Stock Accumulation, the following
provisions shall become effective and remain effective until the Substantial
Stock Accumulation is eliminated, unless otherwise agreed:
(i) If the Party that is not affiliated with
the Affected Company reasonably determines in good faith that the person or
entity making the Substantial Stock Accumulation is a competitor of such Party
or its Affiliates, such Party may so inform the other Party in writing. Promptly
after receipt of such notice, the Party affiliated with the Affected Company
shall establish a procedure whereby no director or executive employee of the
Affected Company who was not a director or employee of the Affected Company
prior to the Substantial Stock Accumulation, and who was previously a director
or employee of the person or entity making the Substantial Stock Accumulation (a
"Tainted Director or Executive"), shall receive any of the following: (x)
confidential information of the other Party and its Affiliates; and (y)
confidential information of the collaboration, except that any such Tainted
Director or Executive can be given information as to actual and projected sales
and profits of the collaboration.
(ii) If the Party that is not affiliated with
the Affected Company does not give notice pursuant to this Section 10.4, the
Party affiliated with the Affected Company shall establish a procedure whereby
no Tainted Director or Executive shall receive confidential information of the
other Party and its Affiliates but need not place any restrictions on
confidential or other information of the collaboration.
(iii) In the event of a material violation of
this Section 10.4, the non-breaching Party may, without resort to the dispute
resolution procedure set forth in Articles II and XI, bring an immediate court
action or enjoin such violation and to recover any damages that it may have
incurred by reasons of such violation.
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
10.5. Definitions.
(a) For purposes of this Agreement, a "Change in Control" of a
company shall be deemed to have occurred in the event of (i) a merger,
consolidation, reorganization, recapitalization, the purchase of substantially
all of the company's assets, or other transaction in which or as result of which
the common stock of the company, or a successor entity having the same ownership
as the company, shall cease (except temporarily) to be a publicly traded
security; or (ii) the acquisition by any individual, firm, corporation, or
entity (other than any profit sharing or other employee benefit plan of the
company or any Affiliate, or any employee or group of employees or former
officers an/or directors of the company or its Affiliates) of beneficial
ownership, directly or indirectly, of securities of the company representing
more than *** of the combined voting power of the company's then outstanding
voting securities. Notwithstanding the foregoing, The Procter & ▇▇▇▇▇▇ Company
directly or indirectly must have at least *** percent of the combined voting
power of Procter & Gamble's outstanding voting securities, otherwise there shall
be a Change of Control of Procter & ▇▇▇▇▇▇.
(b) A "Substantial Stock Accumulation" of a company shall be
deemed to have occurred in the event of the accumulation by any individual,
firm, corporation, or entity (other than any profit sharing or other employee
benefit plan of the company or any Affiliate, or any employee or group of
employees or former officers an/or directors of the company or its Affiliates)
of beneficial ownership, directly or indirectly, of securities of the company
representing more than *** of the combined voting power of the company's then
outstanding voting securities. Notwithstanding the foregoing, ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇,
M.D., Ph.D., the present President and Chief Executive Officer of Regeneron, may
accumulate more than *** percent of Regeneron's or Regeneron's Parent's combined
voting power of its outstanding securities and no Substantial Stock Accumulation
for Regeneron shall be deemed to have occurred. For the purposes of this Section
10.5(b), ▇▇. ▇▇▇▇▇▇▇▇▇'▇ ownership of securities of Regeneron or Regeneron's
Parent shall be deemed to be his direct or indirect ownership of capital shares
or options to purchase such capital shares of Regeneron or Regeneron's Parent
and the direct or indirect ownership of such shares by members of his family
living in his household to the extent that ▇▇. ▇▇▇▇▇▇▇▇▇ retains voting control,
the power to exercise such options, and the right to dispose of such shares, and
shall not include any other shares over which he does not possess Beneficial
Ownership, as defined in the Securities and Exchange Act of 1934, as amended.
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
10.6. The "License Fee" for purposes of Sections 10.3 and 10.4
shall be determined as follows:
(a) License Fee has two components: a Valuation (as
defined herein) of the Parties' interest in the Agreement or J-V Agreement with
respect to Compounds to which neither Party has opted out in total and a running
royalty on Net Sales of any Compound for which neither Party has opted out, such
rate and term being calculated as per Section 6.1 ("Running Royalty"). Each
Party shall designate an investment banking firm of its choice, and each
investment banking firm will be asked to prepare an appraisal as to the fair
market value of the collaboration as a going concern that would be received in
cash from a Third Party if a sale of the collaboration were made to a Third
Party, taking into account any contractual obligation of either Party or its
Affiliates to refrain from manufacturing or marketing a product competitive with
the Products in the Territory for any period, the value of the information,
Patents and Know-how, and other assets being licensed and the potential market
for such Compounds in the Territory ("Fair Market Value"). The Fair Market Value
shall not include Compounds in specific countries or in the entire Territory for
which either Party is an Opting Out Party, as such royalty shall continue to be
governed pursuant to Section 6.1, regardless of a Change of Control. *** The
investment bankers will be asked to submit their Valuations within thirty (30)
days after the Purchase Date. In the event of a Party's failure to obtain an
investment banking firm's Valuation within thirty (30) days after the Purchase
Date, the Valuation will be the Valuation determined by the investment banking
firm appointed by the other Party. An example of the operation of the License
Fee is set forth in Attachment 10.6(a).
(b) If the difference between the lower Valuation and the
higher Valuation is not more than *** of the higher Valuation, or if the
Valuations are equal, the final Valuation shall be the average of the
Valuations. If the difference between the *** Valuations is more than *** of the
higher Valuation, the investment bankers will select a third investment banking
firm from those known as major bracket investment banking firms, and that firm
shall also prepare a Valuation. The third investment banking firm will not have
access to the Valuations prepared by the other investment banking firms. The ***
Valuations that are the closest in value then shall be averaged, and the
resulting average shall be the final Valuation.
(c) The purchase of the interest shall thereafter be
consummated by payment of the Valuation and the obligation to pay the Running
Royalty within *** days after receipt of all investment bankers' valuations or
such later date upon which all necessary regulatory
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
approvals have been obtained and/or regulatory waiting periods have expired.
Advances (if applicable) shall be first subtracted from or added to (as the case
may be) the Valuation, then any excess Advance shall be immediately payable by
the Owing Party.
(d) Each Party shall bear the expense of obtaining the
Valuation of the investment bankers selected by such Party, and if a third
investment banker is selected, the expense of obtaining its Valuation shall be
borne equally by the Parties.
(e) Unless otherwise agreed in writing by the Parties, the
License Fee for a license under Sections 10.3, 10.4 and 10.5 shall be calculated
as of the date of the Electing Company's notice that it elects to exercise the
Option under Sections 10.3 or 10.4 or the Purchasing Company's notice that it
desires to license the interest of the Party affiliated with the Affected
Company under Section 10.3 (such date shall be referred to as the "Purchase
Date").
(f) During the pendency of the Option election and valuation
process, the Parties shall continue to perform their customary activities under
this Agreement or any J-V Agreement.
Article XI - Miscellaneous
11.1. Force Majeure. Neither Party shall lose any rights hereunder or
be liable to the other Party for damages or loss on account of failure of
performance by the Defaulting Party if the failure is occasioned by government
action, war, fire, explosion, flood, strike, lockout, embargo, act of God, or
any other similar cause beyond the reasonable control of the Defaulting Party,
provided that the Party claiming force majeure has exerted all reasonable
efforts to avoid or remedy such force majeure and given prompt notice to the
other Party.
11.2. Notices. Any notices or communications provided for in this
Agreement to be made by either of the Parties to the other shall be in writing,
in English, and shall be made by prepaid air mail with return receipt addressed
to the other at its address set forth above. Any such notice or communication
may also be given by hand or facsimile to the appropriate designation with
confirmation of receipt. Either Party may by like notice specify an address to
which notices and communications shall thereafter be sent. Notices sent by mail
shall be effective upon receipt; notices given by hand shall be effective when
delivered.
Notices for Regeneron shall be sent to:
Regeneron Pharmaceuticals, Inc.
Attn: Corporate Secretary
▇▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
With copy to:
Regeneron Pharmaceuticals, Inc.
Attn: General Counsel
▇▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Notices for Procter & ▇▇▇▇▇▇ shall be sent to:
Procter & ▇▇▇▇▇▇ Pharmaceuticals, Inc.
Attn: President
▇▇▇ ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇
With copy to:
Procter & ▇▇▇▇▇▇ Pharmaceuticals, Inc.
Attn: Associate General Counsel
Blue Ash Office Center
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
11.3. Governing Law. This Agreement shall be governed by the laws of
the State of Delaware, as such laws are applied to contracts entered into and to
be performed within such state. Any claim or controversy arising out of or
related to this Agreement or any breach hereof shall be submitted to arbitration
pursuant to Section 11.4. The United Nations Convention on Contracts for the
International Sale of Goods will not apply to this Agreement.
11.4. Arbitration. Subject to Sections 2.5 and 10.4(b)(iii),
disagreements under this Agreement shall be settled by arbitration in accordance
with the commercial arbitration rules of the American Arbitration Association.
The parties further agree that each such disagreement be
submitted to a panel of three (3) impartial arbitrators with each Party
selecting one (1) arbitrator within fifteen (15) days of a request for
arbitration and the two (2) selected arbitrators selecting a third arbitrator
who is experienced in the United States pharmaceutical industry within thirty
(30) days after the request. Any arbitration hereunder shall commence within
thirty (30) days after appointment of the third arbitrator and shall be held in
Boston, Mass., U.S.A. Upon reasonable notice and prior to any hearing, the
Parties will allow document discovery and will disclose all materials relevant
to the subject matter of the dispute. The arbitrators shall make final
determinations as to any discovery disputes. The decision of the arbitrators
shall be rendered no later than sixty (60) days after commencement of
arbitration. The costs of arbitration shall be split by the parties unless the
arbitrators decide otherwise. Any judgment or decision rendered by the panel
shall be binding upon the Parties and shall be enforceable by any court of
competent jurisdiction.
11.5. Non-waiver of Rights. Except as specifically provided for herein,
the waiver from time to time by any of the parties of any of their rights or
their failure to exercise any remedy shall not operate or be construed as a
continuing waiver of same or of any other of such Party's rights or remedies
provided in this Agreement.
11.6. Severability. If any term, covenant, or condition of this
Agreement or the application thereof to any Party or circumstance shall, to any
extent, be held to be invalid or unenforceable, then (i) the remainder of this
Agreement, or the application of such term, covenant or condition to Parties or
circumstances other than those as to which it is held invalid or unenforceable,
shall not be affected thereby and each term, covenant, or condition of this
Agreement shall be valid and be enforced to the fullest extent permitted by law
and (ii) the Parties hereto covenant and agree to renegotiate any such term,
covenant, or application thereof in good faith in order to provide a reasonably
acceptable alternative to the term, covenant, or condition of this Agreement or
the application thereof that is invalid or unenforceable, and in the event that
the Parties are unable to agree upon a reasonably acceptable alternative, then
the Parties agree that a submission to arbitration shall be made in accordance
with Section 11.4 to establish an alternative to such invalid or unenforceable
term, covenant, or condition of this Agreement or the application thereof, it
being the intent that the basic purposes of this Agreement are to be
effectuated.
11.7. Entire Agreement. This Agreement sets forth all the covenants,
promises, agreements, warranties, representations, conditions, and
understandings between the Parties hereto in the Field, with the exception of
any agreements by the Parties executed at an even date
hereof, and supersedes and terminates all prior agreements and understanding
between the parties in the Field. No subsequent alteration, amendment, change,
or addition to this Agreement shall be binding upon the Parties hereto unless
reduced to writing and signed by the respective authorized officers of the
Parties.
11.8. Survival. Sections 5.4, 5.5 and 8.1 shall survive the
termination of this Agreement for to the extent specified therein. Section 9.3
and any accrued obligations under this Agreement shall survive termination of
this Agreement without limit as to time.
11.9. Assignment.
(a) Procter & ▇▇▇▇▇▇ and Regeneron may assign any of their
rights or obligations under this Agreement in any country of the Territory to
any Affiliates; provided, however, that such assignment shall not relieve the
assigning Party of its responsibility for performance of its obligations under
this Agreement.
(b) The Parties recognize that each may perform some of its
obligations hereunder through Affiliates; provided, however, that Procter &
▇▇▇▇▇▇ and Regeneron shall remain responsible and be guarantors of such
performance by their Affiliates and shall cause their Affiliates to comply with
the provisions of this Agreement in connection with such performance.
(c) Procter & ▇▇▇▇▇▇ and Regeneron may only assign their
rights under this Agreement in any country of the Territory to a Third Party
with written permission of the other Party, which permission will only be given
at its sole discretion.
11.10. Publicity.
(a) Procter & ▇▇▇▇▇▇ and Regeneron will jointly discuss and
promptly agree, based on the principles of Section 11.10(b), on any press
releases and any other public statements regarding the execution and the subject
matter of this Agreement, the research to be conducted under this Agreement or
any other aspect of this Agreement, subject in each case to disclosure otherwise
required by law or regulation.
(b) In the discussion and agreement of Section 11.10(a), the
principles observed by Procter & ▇▇▇▇▇▇ and Regeneron will be accuracy, the
requirements for confidentiality under Article IX, the advantage a competitor of
Procter & ▇▇▇▇▇▇ or Regeneron may gain from any statement under Section
11.10(a), the requirements of disclosure under any securities laws or
regulations of the United States, including those associated with SEC and
regulatory filings and public offerings, the restrictions imposed by the Federal
Food, Drug and
Cosmetic Act, and the standards and customs in the pharmaceutical
industry for such disclosures by companies comparable to Procter & ▇▇▇▇▇▇ and
Regeneron.
11.11. Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one in the same instrument.
11.12. No Solicitation. During the Term of this Agreement, the
Parties shall not directly or indirectly solicit the other Party's employees for
employment or other consulting arrangements.
Article XII - Execution
12.1. In witness whereof the Parties have executed this Agreement in
duplicate originals by their proper officers as of the date and year first
written above.
Procter & ▇▇▇▇▇▇ Pharmaceuticals, Inc.
By:
------------------------------
G. ▇▇▇▇▇▇▇ ▇▇▇▇▇
President
Regeneron Pharmaceuticals, Inc.
By:
------------------------------------
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, M.D., Ph.D.
President and Chief Executive Officer
Attachment 3.1
Timing and Calculation of Research and/or Product Plan Budgets
Budget Process
1) ***
2) ***
3) ***
Attachment 3 cont.
Budget Cost Development
1) ***
Attachment 3 cont.
2) ***
Attachment 3.4(b) -- Example of Advances Operation
FUNDING OF DEVELOPMENT CANDIDATES
***
Attachment 6.1(b)
Each Party's Share of Royalties or Other Income
When Both Parties Opt Out
***
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.
Attachment 9.1 - Agreements Relating to Third Party Technology
Technology Development Agreement dated as of March 20, 1989, between Sumitomo
Chemical Company, Limited and Regeneron Pharmaceuticals, Inc.
Collaboration Agreement dated as of August 31, 1990, between Amgen Inc. and
Regeneron Pharmaceuticals, Inc.
Collaboration Agreement dated as of July 22, 1993, between Glaxo Group Limited
and Regeneron Pharmaceuticals, Inc.
Research Development Agreement dated as of June 2, 1994, between Sumitomo
Pharmaceuticals Company, Ltd., and Regeneron Pharmaceuticals, Inc.
Collaboration Agreement dated as of October 9, 1996, between Pharmacopeia, Inc.,
and Regeneron Pharmaceuticals, Inc.
Attachment 10.6(a)
Example of License Fee Operation
Scenario License Fee Operation
***
*** Certain material has been omitted from this section pursuant to a request
for confidential treatment and has been filed separately with the S.E.C.