Exhibit 10.1
CROSS LICENSE
AGREEMENT
This License Agreement (this
“Agreement”) is made effective as of June 30, 2009
(the “Effective Date”) by and among Alphatec Spine,
Inc., a Delaware corporation with a principal place of business at
5818 El Camino Real, Carlsbad, California 92008
(“Alphatec”), International Spinal Innovations, LLC, a
limited liability company organized under the laws of the state of
Connecticut, with an address at 97 Balfour Drive, West Hartford, CT
06117 (“ISI”), and, for purposes of Sections 4.1, 4.4,
7.3, and 11.15 hereof only, Alphatec Holdings, Inc., a Delaware
corporation with a principal place of business at 5818 El Camino
Real, Carlsbad, California 92008 (“Holdings”). Alphatec
and ISI are each hereafter referred to individually as a
“Party” and together as the
“Parties”.
WHEREAS, ISI is the owner of, or
otherwise controls, certain proprietary Licensed ISI Patents
(hereinafter defined);
WHEREAS, Alphatec is the owner of,
or otherwise controls, certain proprietary Licensed Alphatec
Patents (hereinafter defined);
WHEREAS, Alphatec desires to obtain
a license from ISI to the Licensed ISI Patents to develop and
commercialize Licensed Alphatec Products (hereinafter
defined);
WHEREAS, ISI desires to obtain a
license from Alphatec to the Licensed Alphatec Patents to develop
and commercialize Licensed ISI Products (hereinafter defined);
and
WHEREAS, ISI and Alphatec each
desire to cross-license the other on the terms and subject to the
conditions of this Agreement.
NOW, THEREFORE, in consideration of
the mutual covenants contained herein, and for other good and
valuable consideration, the receipt and adequacy of which are
hereby acknowledged, the Parties hereby agree as
follows:
1. DEFINITIONS
Whenever used in this Agreement with
an initial capital letter, the terms defined in this Article 1
shall have the meanings specified.
1.1 “ Affiliate
” shall mean any company, corporation, partnership, limited
liability company, trust, or other business entity that directly or
indirectly controls, is controlled by, or is under common control
with a designated person or entity, and for such purpose
“control” shall mean the possession, direct or
indirect, of the power to direct or cause the direction of the
management and policies of the entity, whether through the
ownership of voting securities, by contract or
otherwise.
1
Portions of this Exhibit were
omitted, as indicated by [***], and have been filed
separately
with the Secretary of the
Commission pursuant to the Registrant’s application
requesting
confidential treatment under Rule
24b-2 of the Securities Exchange Act of 1934, as
amended.
1.2 “ Common
Stock ” shall mean the common stock of Holdings,
which trades on Nasdaq under the symbol ATEC and any securities
into which such common stock may hereafter be reclassified,
converted or exchanged.
1.3 “ Confidential
Information ” shall mean with respect to a Party (the
“Receiving Party”), all information which is disclosed
by the other Party (the “Disclosing Party”) to the
Receiving Party hereunder or to any of its employees, consultants,
Affiliates, licensees or sublicensees, except to the extent that
the Receiving Party can demonstrate by written record or other
suitable physical evidence that such information, (a) as of
the date of disclosure is known to the Receiving Party or its
Affiliates other than by virtue of a prior confidential disclosure
to the Receiving Party or its Affiliates; (b) as of the date
of disclosure is in, or subsequently enters, the public domain,
through no fault or omission of the Receiving Party; (c) is
obtained from a Third Party having a lawful right to make such
disclosure free from any obligation of confidentiality to the
Disclosing Party; or (d) is independently developed by or for
the Receiving Party without reference to or reliance upon any
Confidential Information of the Disclosing Party.
1.4 “ Guarantee and
Agreement ” shall mean the guarantee and agreement of
Holdings set forth in Section 11.15 hereof.
1.5 “ Alphatec
Inventions ” shall mean any enhancement, invention or
discovery created or identified, owned or controlled by Alphatec
that does not fall within the Licensed ISI Patents. Alphatec
Inventions shall not include any invention conceived in whole or in
part before or after the Effective Date by ISI or any of its
agents, employees, consultants, or representatives except as
provided for in Section 3.1.1 of this Agreement.
1.6 “ ISI
Inventions ” shall mean any enhancement, invention or
discovery created or identified, owned or controlled by ISI that
does not fall within the Licensed Alphatec Patents. ISI Inventions
shall not include any invention conceived in whole or in part
before or after the Effective Date by Alphatec or any of its
agents, employees, consultants (including when ISI acts as a
consultant for Alphatec) or representatives.
1.7 “ ISI
Indemnitees ” and “ Alphatec
Indemnitees ” (each individually an “
Indemnitee ”) shall have the meaning given in
Section 8.1.
1.8 “ Licensed
Field ” shall mean [***] .
1.9 “ Licensed ISI
Patents ” shall mean the patents and patent
applications described in Schedule A attached hereto, and
all divisional, continuation, continuation-in-part (to the extent
that the continuation-in-part is entitled to the priority date of
an initial patent or patent application which is the subject of
this Agreement), reissue, reexamination, registration, renewal, or
extension, or any patent issuing therefrom or any supplementary
protection certificates related thereto, and all foreign
counterparts to any of the foregoing.
2
Portions of this Exhibit were
omitted, as indicated by [***], and have been filed
separately
with the Secretary of the
Commission pursuant to the Registrant’s application
requesting
confidential treatment under Rule
24b-2 of the Securities Exchange Act of 1934, as
amended.
1.10 “ Licensed Alphatec
Patents ” shall mean the patents and patent
applications described in Schedule B attached hereto, and
any divisional, continuation, continuation-in-part (to the extent
that the continuation-in-part is entitled to the priority date of
an initial patent or patent application which is the subject of
this Agreement), reissue, reexamination, registration, renewal, or
extension, or any patent issuing therefrom or any supplementary
protection certificates related thereto, and any foreign
counterparts to any of the foregoing.
1.11 “ Licensed Alphatec
Product ” shall mean any product sold by Alphatec,
its affiliates, or Sublicensees that, absent the license provided
in this Agreement, would infringe a Valid Claim of the Licensed ISI
Patents.
1.12 “ Licensed ISI
Product ” shall mean [***] made, used, offered
for sale, or sold by ISI, its affiliates, or Sublicensees that,
absent the license provided in this Agreement, would infringe a
Valid Claim of the Licensed Alphatec Patents.
1.13 “ Net Sales
” shall mean the gross amount invoiced or otherwise payable
to Alphatec, its Affiliates, or Sublicensees on account of sales or
other transfers of a Licensed Alphatec Product anywhere in the
Territory during a designated period, less (to the extent otherwise
then or previously included in amounts invoiced for such Licensed
Product and in respect of which no previous deduction was
taken):
1.13.1 trade, cash and quantity
discounts or rebates actually allowed or taken on Licensed Alphatec
Products, including discounts or rebates to governmental or managed
care organizations;
1.13.2 credits or allowances
actually given or made for rejection of, and for uncollectible
amounts (except to the extent later collected) on, or return of
previously sold Licensed Alphatec Products;
1.13.3 sales commissions paid to a
Third-Party;
1.13.4 any charges for insurance,
freight, and other transportation costs directly related to the
delivery of Licensed Alphatec Product to the extent included in the
gross invoiced sales price;
1.13.5 any tax, tariff, duty or
governmental charge levied on the sales, transfer, transportation
or delivery of a Licensed Alphatec Product (including any tax such
as a value added or similar tax or government charge), other than
franchise or income tax of any kind whatsoever; and
1.13.6 any import or export duties
or their equivalent borne.
In addition, should Alphatec be
required, in order to lawfully exercise its rights as to a Licensed
Alphatec Product, to obtain additional rights in a country to
patents of any Third Parties which are not Affiliates of Alphatec,
which patents are (i) pending or
3
Portions of this Exhibit were
omitted, as indicated by [***], and have been filed
separately
with the Secretary of the
Commission pursuant to the Registrant’s application
requesting
confidential treatment under Rule
24b-2 of the Securities Exchange Act of 1934, as
amended.
issued on the Effective Date, and
(ii) required for Alphatec to practice the inventions
described in the Licensed ISI Patents, then Alphatec may also
deduct from Net Sales with respect to a designated period the
amount of the royalty Alphatec is required to pay to such Third
Party or Parties for such necessary rights to such patents with
respect to such Licensed Alphatec Product.
“Net Sales” shall not
include amounts invoiced to or otherwise payable by Alphatec, any
of its Affiliates and/or any Sublicensees for Licensed Alphatec
Products sold or otherwise transferred to Alphatec or any of its
Affiliates and/or its Sublicensees, unless the Licensed Alphatec
Product is consumed by the invoiced entity.
1.14 “ Shares
” shall have the meaning set forth in Paragraph 4.1.1(a)
hereof.
1.15 “ Alphatec
Sublicensee ” shall mean any Third Party to whom
Alphatec grants a sublicense of some or all of the rights granted
to Alphatec under this Agreement.
1.16 “ ISI
Sublicensee ” shall mean any Third Party to whom ISI
grants a sublicense of some or all of the rights granted to ISI
under this Agreement.
1.17 “
Technology ” shall mean all of the following
intangible legal rights, whether or not filed, perfected,
registered or recorded, applicable to the Licensed Field:
(i) inventions, patents, patent disclosures, patent rights,
including any and all continuations, continuations-in-part,
divisionals, reissues, re-examinations, utility models, industrial
designs and design patents or any extensions thereof,
(ii) rights associated with works of authorship, including
without limitation, copyrights, copyright applications and
copyright registrations and (iii) any and all proprietary
ideas, inventions, discoveries, Confidential Information, data,
results, formulae, designs, specifications, methods, processes,
techniques, ideas, know-how, technical information (including,
without limitation, structural and functional information), process
information, pre-clinical information, clinical information, and
any and all proprietary control and manufacturing data and
materials, whether or not patentable.
1.18 “ Term
” shall have the meaning given in
Section 9.1.
1.19 “ Territory
” shall mean all countries and jurisdictions of the
world.
1.20 “ Third
Party ” shall mean any person or entity other than
Alphatec, ISI and their respective Affiliates.
1.21 “ Valid
Claim ” shall mean a claim indicated as allowable in
an issued, unexpired patent or in a pending patent application
within the Licensed ISI Patents and Licensed Alphatec Patents that
(a) has not been finally cancelled, withdrawn, abandoned or
rejected by any administrative agency or other body of competent
jurisdiction, (b) has not been revoked, held invalid, or
declared unpatentable or unenforceable in a decision of a court or
other body of competent jurisdiction that is unappealable or
unappealed within the time allowed for appeal, (c) has not
been rendered unenforceable through disclaimer or otherwise, and
(d) is not lost through interference proceedings.
4
Portions of this Exhibit were
omitted, as indicated by [***], and have been filed
separately
with the Secretary of the
Commission pursuant to the Registrant’s application
requesting
confidential treatment under Rule
24b-2 of the Securities Exchange Act of 1934, as
amended.
1.22 “ First Commercial
Sale ” shall mean the date of the first transaction,
transfer or disposition for value by or on behalf of Alphatec or
any Affiliate or Sublicensee of Alphatec to a Third Party of a
Licensed Alphatec Product.
2. GRANT OF RIGHTS
2.1 License Grant to
Alphatec .
2.1.1 ISI Grant of License to
Alphatec . ISI hereby grants to Alphatec an exclusive (even as
to ISI, but subject to the limitations set forth in Subsection
2.1.2) royalty-bearing license, including the right to grant
sublicenses, to the Licensed ISI Patents to make, have made,
import, export, use, offer for sale or sell Licensed Alphatec
Products in the Territory, and to conduct research and development
in support of the aforementioned licensed uses, in all cases,
subject to the terms and conditions of this Agreement. The license
granted in this subsection shall entitle Alphatec to sell and
market Licensed Alphatec Products through Third-Party
distributors.
2.1.2 Limitation of ISI’s
License Grant to Alphatec . With respect to any laterally
delivered multi-shaft interbody implant, ISI’s license grant
to Alphatec in Subsection 2.1.1 is non-exclusive, and shall only be
sublicensable in accordance with Subsection 6.2.
2.2 License Grant to
ISI . Alphatec hereby grants to ISI a non-exclusive,
fully-paid, royalty-free license including the right to grant
sublicenses, provided that such sublicense shall only be granted in
accordance with Subsection 6.2, to the Licensed Alphatec Patents to
make, have made, import, export, use, offer for sale or sell a
Licensed ISI Product in the Territory, and to conduct research and
development in support of the aforementioned licensed uses, in all
cases, subject to the terms and conditions of this Agreement. The
license granted in this subsection shall entitle ISI to sell and
market ISI Products through Third-Party distributors.
3. DEVELOPMENT AND
COMMERCIALIZATION OF LICENSED ALPHATEC PRODUCTS.
3.1 Commercialization
.
3.1.1 Responsibility . From
and after the Effective Date, Alphatec shall have full control and
authority over the development and commercialization of Licensed
Alphatec Products in the Licensed Field in the Territory. Alphatec
shall own all Alphatec Inventions. Alphatec shall own all
Technology resulting from (i) the joint efforts of the agents,
Affiliates and employees of ISI and Alphatec during the term of
this Agreement, or (ii) any efforts performed by ISI pursuant
to Section 3.2.
5
Portions of this Exhibit were
omitted, as indicated by [***], and have been filed
separately
with the Secretary of the
Commission pursuant to the Registrant’s application
requesting
confidential treatment under Rule
24b-2 of the Securities Exchange Act of 1934, as
amended.
3.1.2 Diligence . After the
Effective Date, Alphatec will exercise commercially reasonable
efforts to develop a Licensed Alphatec Product, such commercially
reasonable efforts to take into account the competitiveness of the
marketplace, the proprietary position of the Licensed Alphatec
Product, the relative potential safety and efficacy of the Licensed
Alphatec Product, the cost of goods and availability of capacity to
manufacture and supply the Licensed Alphatec Product at commercial
scale, the profitability of the applicable Licensed Alphatec
Product, and other relevant factors including, without limitation,
technical, legal, scientific or medical factors.
3.2 ISI Assistance . ISI
shall transfer to Alphatec all drawings, prototypes and other
related materials in its possession or control as of the Effective
Date that relate to a single-shaft Licensed Alphatec Product (the
“Prototype Transfer”). As consideration for the
Prototype Transfer, within ten (10) business days of the
receipt of an invoice from ISI, Alphatec shall reimburse ISI for
all expenses incurred as of the Effective Date in connection with
the creation of the materials that are the subject of the Prototype
Transfer; provided that such payment shall not exceed [***]
. In addition, upon Alphatec’s reasonable request, ISI will
provide commercially reasonable assistance to develop
Alphatec’s first Licensed Alphatec Product. Alphatec will pay
ISI for such assistance [***] plus reasonable travel and
out-of-pocket expenses.
4. PAYMENTS AND
ROYALTIES
4.1 Initial Payment; Milestone
Payments; Royalty Payments; Royalty Rates; and Minimum Quarterly
Royalty .
4.1.1 Initial Payment Upon
the terms and subject to the conditions contained herein, Alphatec
shall issue and transfer with full title guaranteed, two hundred
sixty thousand (260,000) shares (the “Shares”) of
Common Stock (the “Share Payment”). ISI’s license
grant to Alphatec constitutes full consideration for the Share
Payment. The Share Payment shall be due and payable within twenty
(20) business days of the Effective Date. The payment
described in this Subsection 4.1.1 shall not be credited against or
otherwise reduce any other amounts payable hereunder.
4.1.2 Milestone Payments .
Alphatec shall pay milestone payments to ISI (each such payment a
“Milestone Payment”) as specified below no more than
thirty (30) days after the occurrence of the corresponding
event designated below, unless this Agreement has been terminated
prior to such due date. No Milestone Payments described in this
Subsection 4.1.2 shall be credited against or otherwise reduce any
other amounts payable hereunder.
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6
Portions of this Exhibit were
omitted, as indicated by [***], and have been filed
separately
with the Secretary of the
Commission pursuant to the Registrant’s application
requesting
confidential treatment under Rule
24b-2 of the Securities Exchange Act of 1934, as
amended.
4.1.3 Royalty Payments .
During the Term of this Agreement, Alphatec shall pay to ISI within
thirty (30) days of the end of each calendar quarter royalties
of [***] of Net Sales of Licensed Alphatec Products. Only
one royalty shall be payable to ISI pursuant to this
Section 4.1.3 for each sale of a Licensed Alphatec Product,
notwithstanding that more than one patent or patent claim reads
upon such Licensed Alphatec Product.
4.1.4 Minimum Royalty Payment
. In accordance with the chart set forth in this Subsection 4.1.4,
Alphatec shall pay ISI a minimum annual royalty amount. No
minimum annual royalty described in this Subsection 4.1.4 shall be
credited against or otherwise reduce any other amounts payable
hereunder. For a particular year, in the event that the sum of
the earned royalties on Net Sales paid pursuant to Subsection 4.1.3
above with respect to such calendar is less than the minimum annual
royalty for such year designated below, the obligation to pay the
difference to ISI shall accrue on the last day of such year and be
payable by Alphatec no later than forty-five (45) days
following the end of such year:
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4.2 Payment, Conversion and
Withholding .
4.2.1 Payment . All payments
hereunder shall originate in the United States and be made in
United States dollars.
4.2.2 Conversion . Conversion
of foreign currency to United States dollars shall be made at the
conversion rate existing in the United States (as reported in
The Wall Street Journal ) on the last business day of the
quarter immediately preceding the applicable calendar quarter. If
The Wall Street Journal ceases to be published, then the
rate of exchange to be used shall be that reported in such other
business publication of national circulation in the United States
as the Parties reasonably agree.
4.2.3 Tax Withholding;
Restrictions on Payment . All taxes, assessments and fees of
any nature levied or incurred on account of any payments from
Alphatec to ISI accruing under this Agreement, by national, state
or local governments, will be assumed and paid by Alphatec, except
taxes levied thereon as income to ISI and if such taxes are
required by applicable law to be withheld by Alphatec they will be
deducted from payments due to ISI and will be timely paid by
Alphatec to the proper taxing authority for the account of ISI, a
receipt or other proof of payment therefore secured and sent to ISI
as soon as practicable. Alphatec shall remit all payments to ISI
hereunder from within the United States.
7
Portions of this Exhibit were
omitted, as indicated by [***], and have been filed
separately
with the Secretary of the
Commission pursuant to the Registrant’s application
requesting
confidential treatment under Rule
24b-2 of the Securities Exchange Act of 1934, as
amended.
4.3 Records Retention;
Review .
4.3.1 Record Retention .
Alphatec shall keep accurate books and accounts of the computation
of the number of Licensed Alphatec Products sold and the Net Sales
of Alphatec, its Affiliates and Sublicensees of Licensed Alphatec
Products, and shall cause such Affiliates and Sublicensees to keep
such records of their respective sales of Licensed Alphatec
Products and Net Sales of Licensed Alphatec Products, in sufficient
detail to permit accurate determination of all figures necessary
for verification of payments required to be paid hereunder, which
books and accounts shall be maintained for at least three
(3) years from the end of the calendar year to which they
pertain.
4.3.2 Review . At the request
of ISI, which shall not be made more frequently than once per
calendar year during the Term, on a business day designated by ISI
upon at least thirty (30) days’ prior written notice to
Alphatec, Alphatec shall permit, under confidentiality obligations
with terms substantially the same as those hereunder, an
independent certified public accountant reasonably selected by ISI
and reasonably acceptable to Alphatec to inspect (during regular
business hours) the relevant records required to be maintained by
Alphatec under Subsection 4.3.1. In the event such inspection
reveals an underpayment, such underpayment shall be due and payable
by Alphatec within thirty (30) days of the date of such
inspection, together with interest thereon from the date the amount
due but unpaid was first due until the date paid, at the lower of
[***] per annum or the maximum rate permitted by applicable law.
Such inspection shall be at the expense of ISI unless there is an
underpayment that differs by greater than [***] from the amount
that was otherwise due, in which event Alphatec shall pay the
reasonable costs of the inspection. The foregoing is without
prejudice to the right of Alphatec to dispute the conclusion of the
accountant, but such dispute shall not relieve Alphatec of its
obligation to pay interest and, under the circumstances described,
costs of inspection as to amount actually due.
4.4 Matters Related to the
Issuance of Common Stock .
4.4.1 Representations, Warranties
and Certain Covenants of Alphatec and of Holdings . Alphatec
and Holdings, each separately and jointly represent, warrant, and
covenant that:
(a) Assuming the covenant of ISI
contained in Subsection 4.4.2 of this Agreement is complied with,
the issuance to ISI of each Share will be in compliance with all
applicable federal and state securities laws in connection with the
offer, issuance and sale of the securities.
(b) The execution, delivery and
performance of this Agreement by Holdings, the issuance and sale of
the Shares and the consummation by Holdings of the other
transactions by it contemplated hereby do not and will not on the
date of the
8
Portions of this Exhibit were
omitted, as indicated by [***], and have been filed
separately
with the Secretary of the
Commission pursuant to the Registrant’s application
requesting
confidential treatment under Rule
24b-2 of the Securities Exchange Act of 1934, as
amended.
issuance and sale of the Shares
(i) conflict with or violate any provision of Holdings’
or any of its subsidiaries certificates or articles of
incorporation, bylaws or other organizational or charter documents,
or (ii) conflict with, or constitute a default (or an event
that with notice or lapse of time or both would become a default)
under, result in the creation of any lien or encumbrance upon any
of the properties or assets of Holdings or any of its subsidiaries,
or give to others any rights of termination, amendment,
acceleration or cancellation (with or without notice, lapse of time
or both) of, any agreement, credit facility, debt or other
instrument or other understanding to which Holdings or any of its
subsidiaries is a party or by which any property or asset of
Holdings or any such subsidiary is bound or affected, in each case
with respect to this Subsection (ii), to a degree that would have a
material adverse effect on the assets or results of operations of
Holdings or its subsidiaries when considered as a whole (a
“Material Adverse Effect”), or (iii) conflict with
or result in a violation of any law, rule, regulation, order,
judgment, injunction, decree or other restriction of any court or
governmental authority to which Holdings or any such subsidiary is
subject (including federal and state securities laws and
regulations), or by which any property or asset of Holdings or any
such subsidiary is bound or affected, in each case with respect to
this Subsection (iii), to a degree that would have a Material
Adverse Effect.
(c) Prior to the issuance of the
Shares, Holdings shall obtain all consents, approvals, orders,
authorizations or registrations, qualifications, designations,
declarations, and make all filings or registrations with any court
or other federal, state, local or other governmental authority or
other person that is required in order to issue the
Shares.
(d) The Shares, when issued in
accordance herewith, will be (i) duly authorized,
(ii) duly and validly issued, (iii) fully paid and
nonassessable, and (iv) free and clear of all liens or
encumbrances imposed by Holdings, other than restrictions on
transfer provided for herein.
(e) At all times prior to the second
anniversary of the last issuance of the Shares during which there
are Shares outstanding which have not been previously (i) sold
or transferred to or through a broker or dealer or underwriter in a
public distribution, or (ii) sold or transferred in a
transaction exempt from the registration and prospectus delivery
requirements of the Securities Act of 1933, as amended (the
“Securities Act”), in the case of either Subsection
(i) or Subsection (ii) in such a manner that, upon the
consummation of such sale or transfer, all transfer restrictions
and restrictive legends with respect to such Shares upon the
consummation of such sale or transfer and Holdings shall use its
commercially reasonable efforts to: (1) comply with the
requirements of Rule 144(c) under the Securities Act with respect
to current public information about Holdings, and (2) furnish
to ISI such non-publicly available reports and documents of
Holdings as ISI may reasonably request to avail itself of Rule 144
of the Securities Act, or any similar rule or regulation of the
United States Securities Exchange Commission allowing ISI to sell
the Shares without registration.
4.4.2 Representations and
Warranties of ISI . ISI represents and warrants that
(i) it is an “accredited investor” as that term is
defined in Rule 501(a) of Regulation D of the Securities Act;
(ii) it is acquiring the Shares for investment for ISI’s
own
9
Portions of this Exhibit were
omitted, as indicated by [***], and have been filed
separately
with the Secretary of the
Commission pursuant to the Registrant’s application
requesting
confidential treatment under Rule
24b-2 of the Securities Exchange Act of 1934, as
amended.
account and not as a nominee or agent, and not
with a view to the resale or distribution of any part thereof,
without prejudice, however, to ISI’s right to at all times to
sell or otherwise dispose of any or all of the Shares so issued in
compliance with applicable federal and state securities laws and
(iii) it does not have any contract, undertaking, agreement or
arrangement with any person to sell, transfer or grant
participation to such person or to any third pers