Sublicense Fees In partial consideration of the License and subject to Sections 3.7 and 3.8, Company will pay to Penn:
(i) [CONFIDENTIAL TREATMENT REQUESTED] /*/ percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%) of sublicensing royalties actually received by Company and its Affiliates in consideration of sublicenses of the License for Licensed Products Sold by sublicensees for use in the Field of Use while covered in the country of Sale of expected use by a Valid Claim of the Penn Patent Rights that is licensed to Company under the License, provided that, such amounts payable to Penn with respect to such sublicensing royalties for such Sales of such Licensed Products shall not be less than [CONFIDENTIAL TREATMENT REQUESTED] /*/ percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%) of Net Sales of such Licensed Products made by sublicensees (as such Net Sales definition is applied to sublicensees, and applying Section 3.8 to such sublicensees’ Net Sales); and
(ii) [CONFIDENTIAL TREATMENT REQUESTED] /*/ percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%) of all other sublicensing fees and payments and other consideration actually received by Company in consideration of sublicenses under the License granted by Company or its Affiliates, excluding for this clause (ii) (1) sublicensing royalties addressed by clause (i) above, (2) equity investments to the extent not in excess of fair market value made by sublicensees in Company or its Affiliates, (3) payments by sublicensees to Company or Affiliates for payment or reimbursement of patent prosecution, defense, enforcement and maintenance and/or other related expenses, and (4) payments by sublicensees to Company or its Affiliates for future research, development or commercialization activities (including pre-clinical or clinical studies) undertaken by or for Company or its Affiliates (including payments for FTEs), and further provided that if Company pays to Penn a milestone payment under Section 3.2 for achieving a milestone for which Company receives from a sublicensee a payment for achieving the same milestone subject to this Section 3.5(ii), then the amount of the Company’s payment to Penn under Section 3.2 shall be deducted from such sublicensee’s payment for purposes of this Section 3.5(ii) and shall not be subject to such [CONFIDENTIAL TREATMENT REQUESTED] /*/ percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%) share.
Manufacturing Technology Transfer Except as the Committee ------------ --------------------------------- may otherwise agree in writing, in order to effectuate an orderly transition of the uninterrupted availability of Product to LILLY for purposes contemplated under this Agreement, MEGABIOS, at least ninety (90) days prior to completion of the Project or completion of Phase I Clinical Trials, whichever is earlier, shall transfer to LILLY all information and instructions concerning the manufacturing process and related matters in MEGABIOS' possession which may be necessary for LILLY to manufacture Product (including information regarding obtaining necessary Lipids related thereto) for clinical trials and commercialization as contemplated hereunder including, but not limited to, analytical and manufacturing methods. MEGABIOS shall also provide assistance (in the form of consultation) to LILLY with respect to manufacturing matters for a period of [ * ] months after completion of the initial transfer of information and instructions as provided below. Such transfer and assistance by MEGABIOS will be referred to herein as the "Manufacturing Transfer." All such information, methods and instructions transferred to LILLY under this Section 4.3 shall be referred to herein as the "Manufacturing Information," and shall be maintained in confidence by LILLY pursuant to Section 7.1, except that LILLY's obligation to maintain in confidence such Manufacturing Information shall survive for ten (10) years following expiration or termination of this Agreement. LILLY agrees that it will use all such transferred Manufacturing Information only for the manufacture of the Products and shall not disclose or transfer such Manufacturing Information to any third party manufacturer except as provided in Section 2.10. MEGABIOS shall provide, and bear its costs for, up to [ * ] FTEs for a period of up to [ * ] months [ * ] in aggregate) to accomplish the Manufacturing Transfer. Such FTEs, at LILLY's request, shall include visits to LILLY's facilities by MEGABIOS personnel including up to [ * ] from MEGABIOS' head of manufacturing. MEGABIOS shall furnish any additional reasonable assistance beyond the assistance described above regarding manufacturing matters that LILLY may request and that MEGABIOS is able to provide, for up to [ * ] after the initial transfer of Manufacturing Information, providing that LILLY [ * ] incurred with respect to such additional assistance.
For clarity the time allowances provided in clause 2.10 shall operate to reduce the maximum timetabled classroom teaching time specified in clause 4.2 of this agreement.
Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.
Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.
Development Milestone Payments Pfizer shall make the payments set forth below within [**] days (or [**] days after [**] following the first occurrence of each event described below for a Licensed Product Covered by a Valid Claim that achieves such milestone (each event a “Development Milestone” and each payment a “Development Milestone Payment”). Development Milestone Development Milestone Payment [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]. The Development Milestone Payment in clause (2) of this Section 3.3 may become payable as set forth in Section 4.6. Whether or not the Development Milestone in clause (2) of this Section 3.3 is achieved, the Development Milestone Payment in clause (2) shall, pursuant to Section 4.6, in all cases become payable prior to the time the Development Milestone Payment in clause (3) of this Section 3.3 becomes payable. With respect to the Development Milestone in clause (3) of this Section 3.3, in the case of a [**] that is determined to have become [**], such Development Milestone, if achieved based on such [**], shall be achieved upon [**]; provided, however, if either [**], such Development Milestone shall be deemed to have been met on the date of such determination. With respect to the Development Milestone in clause (8) of this Section 3.3, such Development Milestone will be paid in [**], provided that if such Licensed Product [**]. (For the avoidance of doubt, all payment [**] that became payable prior to such [**] shall continue to be payable and there shall be [**] of the [**] Development Milestone Payment will be deemed to have been achieved and payable on [**], and will be paid by Pfizer within [**] days thereafter, until the earlier of [**]. For example, [**] of such Development Milestone, such Development Milestone Payment would be paid [**] of the Development Milestone [**]. For the avoidance of doubt: (a) except for (i) the Development Milestone Payment set forth in clause (6) of this Section 3.3 [**], (ii) the Development Milestone Payment set forth in clause (8) of this Section 3.3 [**] and (iii) the Development Milestone Payment set forth in clause (9) of this Section 3.3 [**], each Development Milestone Payment shall be payable only once upon achievement of the applicable Development Milestone and only on the first occurrence of the corresponding Development Milestone regardless of the number of Licensed Products and (b) satisfaction of a Development Milestone by an Affiliate or by a sublicensee or assignee of, or Third Party retained by, Pfizer or its Affiliates shall be deemed to have been satisfied by Pfizer for the purposes of this Section 3.3.
Sublicense Requirements Any Sublicense:
(A) is subject to this Agreement;
(B) will reflect that any sublicensee will not further sublicense;
(C) will prohibit sublicensee from paying royalties to an escrow or other similar account;
(D) will expressly include the provisions of Sections 8, 9, and 10 for the benefit of Stanford; and
(E) will include the provisions of Section 4.4 and require the transfer of all the sublicensee’s obligations to *****, including the payment of royalties specified in the Sublicense, to Stanford or its designee, if this Agreement is terminated. If the sublicensee is a spin-out from *****, ***** must guarantee the sublicensee’s performance with respect to the payment of Stanford’s share of Sublicense royalties.
DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK
Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Milestone Payments (a) In partial consideration of the license rights granted by Marina Bio under this Agreement, MirnaRx shall pay to Marina Bio a milestone payment upon the first achievement by MirnaRx (independently of work done by or in collaboration with a Sublicensee) of the applicable milestone event set forth in the table below, such payments to be in the listed amounts for the applicable Milestone Event:
(i) For each Licensed Product: [***] [***]
(ii) For each Additional Indication for the Licensed Product, up to total of [***] Additional Indications:
(1) [***] [***]
(b) For clarity, each of the above milestone payments shall be paid only once for a particular Licensed Product, regardless if any such Milestone Event is achieved more than once, except that [***]. Further, if a particular Licensed Product achieves a particular Milestone Event under subclause (i) of the above table without having achieved a previous Milestone Event in such subclause (i), then such previous Milestone Event shall be deemed also achieved, and the Milestone Payment associated with such Milestone Event shall then be paid with the achievement of the subsequent Milestone Event. For illustrative purposes only, if the [***] Milestone Event as set forth in (i)(3) in the table above is not achieved for a Licensed Product but the [***] Milestone Event as set forth in (i)(4) above is achieved for such Licensed Product, then the Milestone Payment for achievement of the Milestone Event in clause (i)(3) [***] will be paid when the Milestone Payment for (i)(4) is paid. The total amount of milestone payments payable for a particular Licensed Product under the above shall not, in any event, exceed $6,000,000 under subclause (i) of the above table and $10,000,000 in total. For additional clarity, if MirnaRx (or its Affiliate) enters into a sublicense Agreement under which the applicable Sublicensee is granted sublicense rights to Commercialize a Licensed Product, then achievement of any of the above Milestone Events by such Sublicensee, or by MirnaRx or its Affiliate working in collaboration with such Sublicensee under the sublicense agreement, shall not create a Milestone Payment obligation, but instead MirnaRx shall have the obligation to share Sublicense Revenues received under such sublicense agreement as provided in Section 5.6 below.
(c) Notwithstanding Sections 5.3(a) and 5.3(b) and the milestone table above, (i) no Milestone Payment for achievement of [***] of the milestone table above, and (ii) no [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Milestone Payments for [***] of the milestone table above, shall be payable with respect to any Licensed Product containing or incorporating miR-34. For clarity, Sections 5.3(a) and 5.3(b) and the milestone table above shall apply in full to all Licensed Products other than any Licensed Product containing or incorporating miR-34, unless the Parties mutually agree otherwise in writing.
1.7. The Parties acknowledge and agree that as of the Amendment Effective Date, the Milestone Payment for the achievement of the Milestone Event [***] of the milestone table above has been paid in full by MirnaRx [***].
1.8. Section 5.4 shall be amended and restated in its entirety with the following: