Case 1:20-cv-00393-LMB-WEF Document 1462-11 Filed 04/05/23 Page 1 of 10 PageID#
`39646
`
`Exhibit 11
`Public Redacted
`Version
`
`

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`Case 1:20-cv-00393-LMB-WEF Document 1462-11 Filed 04/05/23 Page 2 of 10 PageID#
`EXECUTION COPY
`39647
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`CONFIDENTIAL
`
`a
`
`AMENDED AND RESTATED NGP DISTRIBUTION AGREEMENT
`
`BY AND BETWEEN
`
`PHILIP MORRIS INTERNATIONAL MANAGEMENTS.A.
`
`AND
`
`ALT RIA CLIENT SERVICES LLC
`
`July 15, 2015
`
`

`

`Case 1:20-cv-00393-LMB-WEF Document 1462-11 Filed 04/05/23 Page 3 of 10 PageID#
`39648
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`Facsimile: 888-532-0988; or
`
`Mail: Altria Client Services
`Post Office Box 6544
`Po1t land, OR 97228-6544
`
`Any invoice submitted to ALCS in an improper format or without the required documentation will
`be returned unpaid to PMI for correction and resubmission.
`
`5.4.
`
`Payment. All payments made hereunder shall be made in Dollars to accounts specified to ALCS
`or the applicable ALCS Affiliate by PMI reasonably in advance of such payments being due. ALCS
`will pay all undisputed portions of properly documented invoices within thirty (30) days after
`receipt of the invoice, or as otherwise agreed in writing by the Parties. If ALCS disputes any
`po1t ion of an invoice, ALCS will provide written notice to PMI within ten (10) days of receipt of
`the invoice indicating the reason ALCS is withholding any amount, and will pay the undisputed
`portion of the invoice. Neither the payments made to PMI, nor the method of those payments, will
`relieve PMI of its obligation to perform its obligations in compliance with the requirements in this
`Agreement. In addition, no payment by ALCS or any ALCS Affiliate of any invoice will be
`deemed ALCS's or the applicable ALCS Affiliate's acceptance of the NOP Products desciibed on
`the invoice.
`
`5.5.
`
`Late payment. If ALCS fails to make any payment to PMI hereunder on the due date for payment
`and the payment is not in dispute between the relevant Parties, or in the event of a dispute that has
`not been resolved, without prejudice to any other right or remedy available to PMI, PMI shall be
`entitled to charge ALCS interest (both before and after judgment) on the amount unpaid at the
`annual rate of twelve ( 12) months LIBOR plus two per cent (2%) calculated on a daily basis until
`payment in fu ll is made without prejudice to PMl's light to receive payment on the due date.
`
`6. INTELLECTUAL PROPERTY.
`
`6.1.
`
`NGP License.
`
`6.1.1. Subject to Section 8.3 below, PMI, for itself and on behalf of the PMI Affiliates, hereby grants to
`ALCS and the applicable ALCS Affiliate for the term of this Agreement on a NGP
`Product-by-NOP Product basis:
`
`(i) an exclusive (including with regard to PMI and PMI Affiliates) license under the _ _
`~ I n tellectual Prope1ty to Commercialize the NOP Products in the ALCS Territory, with
`the right to grant sublicenses for the sole purpose of Commercialization of NGP Products in the
`ALCS Tenitory by ALCS and the applicable ALCS Affiliate (for the avoidance of doubt, no
`sublicenses may be granted for the purpose of allowing Commercialization of NGP Products in
`the ALCS Te1Titory by or on behalf of any Person other than ALCS or an Affiliate);
`
`(ii) an exclusive (including with regard to PMI and PMI Affiliates except as otherwise provided in
`Article 9 of this Agreement) license and right of reference under the Regulatory Approvals and
`~
`y Documentation that PMI or PMI Affiliates may Possess with respect to
`- - - - as necessa1y for purposes of Commercializing
`in the
`ALCS Territory; and
`
`(iii) a non-exclusive, as to PMI and the PMI Affiliates, and otherwise exclusive, license and right of
`reference under the Regulatory Approvals a n d~ r y Documentation that PMI
`or PMI Affiliates may Possess with respect to 111111111111111 necessary for the pu1pose
`
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`of seeking Regulatory Approval for
`Article 9 and the other terms of this Agreement.
`
`in the ALCS Tenitory, subject to
`
`If FDA Autho1ization has not been obtained for any NGP Product
`of the date
`of submission of the relevant application or repo1t to the FDA or other competent U.S. Government
`Authority, ALCS's licenses as set out above, and PMl's exclusive supply obligations set out in
`Section 2.1 , shall expire; provided that such
`hall exclude any time periods
`commencing upon receipt of a written request by the FDA for additional information and ending
`upon delivery of such info1mation to the FDA. Notwithstanding the foregoing, in the event that
`PMI obtains FDA Autho1ization for
`after the licenses granted under this Section
`6.1.1 have expired pursuant to the preceding sentence as a result of the time required to obtain FDA
`Auth01ization, ALCS shall have an option to an exclusive license under the
`Intellectual Property on the terms outlined in this Section 6.1.1 and subject to the terms of this
`Agreement (including any extension of the term on account of a delay in obtaining FDA
`Authorization as provided in Section 12.1), which option shall last for
`following
`FDA Authorization. The foregoing option shall be exercisable by ALCS by sending written notice
`thereof to PMI.
`
`to (i)
`
`6.1.2. PMI hereby grants to ALCS a Right effective upon receipt of FDA Authotization for -
`an exclusive (including with regard to PMI and PMI Affiliates) license under the PMI -
`Intellectual Property to Commercialize- p roducts in the ALCS Tenitory, with the tight to
`grant sublicenses for the sole purpose of Commercialization of
`products in the ALCS
`Tenitory by ALCS and the applicable ALCS Affiliate (for the avoidance of doubt, no sublicenses
`may be granted for the purpose of allowing Commercialization of NGP Products in the ALCS
`Territory by or on behalf of any Person other than ALCS or an Affiliate); (ii) an exclusive
`(including with regard to PMI and PMI Affiliates) license and tight of reference under the
`Regulatory Approvals a~ other Regulato1y Documentation that PMI or PMI Affiliates may
`Possess with respect to - as necessary for purposes of Commercializing ~ roducts in
`the ALCS Territory, and (iii) a non-exclusive, as to PMI and the PMI Affiliates, and otherwise
`exclusive, license and 1ight of reference under the Regulatory Approvals ~ other Regulatory
`Documentation that PMI or PMI Affiliates may Possess with respect to-
`as necessary for
`pmposes of seeking Regulatory Approval f o r - i n the ALCS Territory, subject to Section 9
`and the other terms of this Agreement, in each case on financial terms to be agreed between the
`Pa1ties, but otherwise on the terms contained herein. Upon agreement of any such financial terms,
`shall be deemed an NGP Product hereunder and Schedule A hereto shall be amended
`accordingly.
`
`6.1.3.
`
`The license grants set forth in Section 6.1.1 and, if exercised, Section 6.1.2 shall be limited to the
`embodiments of NGP Products as delivered by PMI or a PMI Affiliate to ALCS or the applicable
`ALCS Affiliate for Commercialization in the ALCS Territory pursuant to Section 2.1 above.
`Nothing in this Agreement obligates PMI or its Affiliates to licens~ c h n o l o gy to
`ALCS or any ALCS Affiliate, other than the NGP Products, the 111111111111111 Intellectual
`Property, the PMI NGP Marketing Intellectual Property and, subject to Section 6.1.2, the -
`- n tellectual Property.
`
`6.1.4.
`
`The license grants set forth in Section 6.1.1 and 6.1.2 do not include the tight for ALCS to further
`develop, improve or modify any NGP Product.
`
`6.2.
`
`NGP Marketing Intellectual Property.
`
`6.2.1.
`
`Subject to Section 8.3 below, PMI hereby grants to ALCS a n~ b l e ALCS Affiliate an
`exclusive (including with regard to PMI and PMI Affiliates), - - license under the PMI
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`NGP Marketing Intellectual Property (excluding Trademark Rights within the PMI NGP
`Marketing Intellectual Property, which are separately addressed in Section 6.2.2 below), to the
`extent it has the equivalent rights in the ALCS TeITitory, to use the same for the purpose of
`Commercializing any NGP Product in the ALCS Tenitory, with the right to grant sublicenses to the
`sole extent necessary for the purpose of Commercialization of NGP Products in the ALCS
`Terdtory by ALCS and the applicable ALCS Affiliate (for the avoidance of doubt, no sublicenses
`may be granted for the purpose of allowing Commercialization of NGP Products in the ALCS
`Territory by or on behalf of any Person other than ALCS or an ALCS Affiliate).
`
`6.2.2. ALCS shall be under no obligation to use the PMI NGP Marketing Intellectual Property or any
`Trademark Rights within the PMI NGP Marketin Intellectual Pro ert in the Commercialization
`of NGP Products in the ALCS Tenitor .
`
`6.2.2.1
`
`6.2.2.2
`
`6.3.
`
`6.4.
`
`subject to Section 8.3 below, PMI hereby grants
`to ALCS an exclusive (including with regard to PMI and PMI Affiliates) license under the agreed
`Trademark Right(s) within the PMI NGP Marketing Intellectual Property to Commercialize NGP
`Products in the ALCS Territory, with the d ght to grant sublicenses for the sole purpose of
`Commercialization of NGP Products by ALCS and the applicable ALCS Affiliate in the ALCS
`Tenitory , subject to quality control requirements as determined by PMI in its sole reasonable
`discretion.
`
`ALCS hereby grants to PMI an exclusive (including with regard to ALCS and
`ALCS Affiliates) license under the agreed Trademark Right(s) Possessed by ALCS to
`Commercialize NGP Products in the PMI Territory, with the right to grant sublicenses for the sole
`purpose of Commercialization of NGP Products by PMI and PMI Affiliates in the PMI TeITitory,
`subject to quality control requirements as determined by ALCS in its sole reasonable discretion.
`
`Intellectual Prope1ty, the
`~ All right, title, and interest in and to the PMI
`. . . . . Intellectual Property and the PMI NGP Marketing Intellectual Property is and shall
`remain the sole and exclusive property of PMI. All 1ight, title, and interest in and to the ALCS
`·sand shall remain the sole and exclusive property of ALCS .
`
`IP Maintenance. PMI shall be solely responsible at its own cost and expense for the filing,
`prosecution, maintenance and/or defense of (i) the Patents forming part of the PM I - (cid:173)
`lntellectual Prope1ty and the -
`Intellectual Property (subject to Section 6.1.2) that it
`elects to seek and procure ("PMI Patent Rights"); and (ii) the Trademark Rights forming pait of
`the PMI NGP Marketing Intellectual Property and licensed to ALCS hereunder (the "PMI
`Trademarks") (together "PMI IP Rights") and will do so in the ALCS Temtory in accordance
`with the strategy that PMI reasonably devises. In collllection with the foregoing, PMI covenants
`for the term of this Agreement to
`
`provided that PMI shall not be under
`an obligation to file for such patents if PMI has a commercially reasonable basis for not making
`such filing, and (z) use commercially reasonable efforts to prosecute and/or defend and maintain
`the Patents and registered trademarks that Cover the NGP Products to be sold by ALCS or the
`applicable ALCS Affiliate hereunder in the ALCS Territory. PMI shall keep ALCS reasonably
`informed of all matelial developments in relation to PMI IP Rights and shall consider in good faith
`
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`any reasonable suggestions made by PMI in relation to the prosecution and maintenance of PMI IP
`Rights in the ALCS Territory.
`
`6.5.
`
`IP Enforcement.
`
`If either Party believes that an infiingement by a third party of the
`.
`Property, the
`ntellectual Property (subject to Section 6 .
`may be occunfog anywhere in the world ("IP
`In rmgement" , such Party shall disclose full details of the actual, alleged, threatened or potential
`infringement to the other Party.
`
`6.5.1.
`
`6.5.2.
`
`6.5.3. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any
`recovery realized as a result of such IP Infringement litigation described above (whether by way of
`settlement or otherwise) shall be first allocated to reimburse the Parties for their costs and expenses
`in making such recovery (which amounts shall be allocated pro rata if insufficient to cover the
`totalit of such ex enses).
`
`6.6.
`
`Additional Rights.
`
`6.6. l ALCS Right.
`
`6.6.1.1
`
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`6.6.1.2
`
`6.6.1.2.1
`
`6.6. 1.2.2
`
`6.6. 1.2.3
`
`6.6.1.2.4
`
`the exclusive licenses granted hereunder (to the extent ALCS has an exclusive license to the
`PMI
`Intellectual Property in the ALCS Territory at the time the Right is
`exercised), including under Sections 6.1 and 6.2, shall become non-exclusive only as to PMI,
`the PMI Affiliates, and their respective contract manufacturers and distributors, and shall
`otherwise remain exclusive within the ALCS TeITitory.
`
`the exclusive supply obligations hereunder (to the extent PMI has an exclusive supply
`obligation in the ALCS Tenitory at the time the Right is exercised), including in Section 2. 1,
`shall become non-exclusive only as to PMI, the PMI Affiliates, and their respective contract
`manufacturers and distributors, and shall otherwise remain exclusive within the ALCS
`Tenitory.
`
`PMI and the PMI Affiliates may, subject to the ALCS
`import,
`·
`·
`· ·
`e the acquired rights to a
`acquired
`which may include lntellectua
`be, in the ALCS Tenitory.
`
`sell, offer to sell,
`or the
`roperty , as t e case may
`
`6.6.1.2.5 Notwithstanding the other provisions of this Section 6.6.1, so long as ALCS makes genuine use
`of the licensed Trademark Rights within the PMI NGP Marketing Intellectual Property in the
`ALCS Territory, then ALCS's license to Trademark Rights within the PMI NGP Marketing
`Intellectual Prope1ty shall remain exclusive in the ALCS Teni tory.
`
`6.6.2 PMI Right.
`
`6.6.2.1
`
`

`

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`6.6.2.2
`
`7.
`
`7.1
`
`8.
`
`8.1
`
`8.2
`
`ALCS and the
`Intellectual Property, sell, offer to sell,
`ALCS Affiliates may, subject to the
`imp01t, distribute and otherwise use the acquired tights to
`or the
`
`COMMERCIALIZATION STRATEGY.
`
`COMMERCIALIZATION COMMITMENTS.
`
`ALCS or the applicable ALCS Affiliate shall launch each of the
`least
`on a product-by-product basis
`Authorization for the relevant product, subject to the supply to ALCS of sufficient volumes of such
`product meeting the Specifications under this Agreement.
`
`Subject to (i) having achieve
`the relevant product; and (ii.
`.
`.
`
`ii) FDA Autho1ization of
`mes of the relevant NGP
`
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`Case 1:20-cv-00393-LMB-WEF Document 1462-11 Filed 04/05/23 Page 9 of 10 PageID#
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`IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their
`duly authorized representatives as of the Effective Date.
`
`PHILIP MORRIS INTERNATIONAL
`MANAGEMENT S.A.
`
`ALTRIA CLIENT SERVICES LLC
`
`By: _ _ _ __ _ _ _ _ _ _ _ _
`
`Name: Peter Luongo
`Title: Vice President Treasury & Planning
`
`Date: I-!'; IJ', 2'?lr
`
`Name: Mark R. Cruise
`Title: Vice President, Applied Technology
`Date:
`
`PHILIP MORRIS INTERNATIONAL
`MANAGEMENTS.A.
`
`s--'~'------=--a.f-----(cid:173)
`By: _ _ _ _ _
`Name: Sedat Muderrisoglu
`Title: Managing Director R P & Adjacent Business
`Date: J"u.. \ ~ IS l CJ;.;) 1 ._r
`
`[Signature Page - Amended and Restated NGP Distribution Agreement]
`
`

`

`Case 1:20-cv-00393-LMB-WEF Document 1462-11 Filed 04/05/23 Page 10 of 10 PageID#
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`lNWilNESS WHEREOF, the Parties.have caused this Agreement to be executed by their
`duly authorized representatives as of the Effective Date.
`
`PHILIP MORRIS INTERNATIONAL
`MANAGEMENTS.A.
`
`ALTRIA CLIENT SERVICES LLC
`
`By: _ _ _ _ _ _ _ _ _ _ _ _
`
`By:_M_. -~ -
`
`· _ll._. ~-· _ ~ __ _
`
`Name: Peter Luongo
`Title: Vice President Treasury & Planning
`Date:
`
`Name: Mark R. Cruise
`Title: Vice President, Applied Technology
`Date: Jul:j 15 1 2015
`
`PHILIP MORRIS INTERNATIONAL
`MANAGEMENTS.A.
`
`By: _ _ _ _ _ _ _ _ _ _ _
`Name: Sedat Muderrisoglu
`Title: Managing Director RRP & Adjacent B usiness
`Date:
`
`[Signature Page - Amended and Restated NGP Distribution Agreement]
`
`