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.
FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.
Commercialization Plan At such times as the JGC will deem appropriate, the JGC will direct the Parties to mutually prepare a Worldwide Commercialization Plan, and the JGC will review and approve such initial Worldwide Commercialization Plan. Thereafter, the JGC will have one or the other Party (or both) update the Worldwide Commercialization Plan each calendar year, and the JGC will review and approve any such update or any other amendment to the Worldwide Commercialization Plan. Notwithstanding anything in this CCPS Agreement to the contrary, the Parties acknowledge and agree that (i) Bluebird may decline to perform any Commercialization activity proposed to be conducted by Bluebird in the Worldwide Commercialization Plan (other than Manufacturing of Vectors and associated Payloads), and (ii) the Worldwide Commercialization Plan will not include, and Bluebird will have no obligation to perform, any such Commercialization activity that Bluebird has declined to perform, provided that once Bluebird has agreed to perform a Commercialization activity, it will be obligated to perform, and cannot decline to perform, such activity. In addition, either Party may request at any time that the JGC consider and approve other updates to the Worldwide Commercialization Plan. Further:
(a) The JGC will set the required form and contents of the Worldwide Commercialization Plan. The Worldwide Commercialization Plan will reflect a singular marketing and sales approach worldwide, and will specify, among other things, the number of sales reps in the U.S. for each Party, allocation of regions in the U.S. for each Parties’ sales force, creation of marketing materials, planning for conferences, and other marketing activities. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(b) Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will take any material action regarding the Commercialization of Licensed Product unless described in the Worldwide Commercialization Plan or approved by the JGC.
(c) All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the JGC and as part of the U.S. Development & Commercialization Program.
(d) Celgene will have final decision making authority for all Commercialization activities worldwide, including timing of launch and pricing and the Worldwide Development Plan.
Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.
Manufacturing Standards All forest products except poles, produced and sold under this contract will be manufactured to maximize the amount of logs meeting preferred log lengths and to achieve the average log length listed. 97318 3 WS "WS" indicates that west side scaling rules apply. Minimum trim is 8 inches per scaling segment for west side scaling rules. "ES" indicates that east side scaling rules apply. Minimum trim is 4 inches per scaling segment for east side scaling rules. Poles produced under this contract will be manufactured to ANSI specifications (American National Standard Specifications and Dimensions for Wood Poles), in force at the time of signing this contract.
a. Sweep will be limited to within the bole of the log as measured using a tape stretched between the centers of each end of the log.
b. Logs approved by the state for peelers shall be chuckable with no more than a 2 inch diameter area of rot within a 5 inch diameter circle located at the center of either end of the log.
c. Limbs and knots shall be cut flush, with no more than 15 percent of a log having limbs or knots over 2 inches in diameter extending more than 2 inches above the surface of the log.
Joint Commercialization Committee (i) The JCC shall oversee Commercialization of JAK Licensed Products in the Field worldwide. As soon as practicable following the Effective Date (but in no event more than thirty (30) days following the Effective Date), each Party shall designate its initial three (3) representatives on the JCC. The JCC shall be composed of appropriate and key executives of Novartis together with an equal number of appropriate and key executives from Incyte. Novartis and Incyte shall each appoint a person from among its representatives on the JCC to serve as the co-chairperson of the JCC. The co-chairpersons shall not have any greater authority than any other representative on the JCC and shall conduct the following activities of the JCC: (A) calling meetings of the JCC; (B) preparing and issuing minutes of each such meeting within thirty (30) days thereafter; (C) preparing and circulating an agenda for the upcoming meeting; and (D) ensuring that any decision-making delegated to the JCC is carried out in accordance with Section 3.5.
(ii) The JCC shall be responsible for: (A) overseeing, reviewing and coordinating the Commercialization of JAK Licensed Products in the Field worldwide; (B) developing and overseeing the Global Branding Strategy; (C) setting overall strategic objectives and plans related to Commercialization of JAK Licensed Products in the Field worldwide; (D) reviewing, commenting on and approving the Promotional Plan; (E) reviewing Commercialization issues for JAK Licensed Products in the Field in the Novartis Territory that will have an impact on Commercialization of JAK Licensed Products in the Field in the Incyte Territory; (F) reviewing Commercialization issues for JAK Licensed Products in the Field in the Incyte Territory that will have an impact on Commercialization of JAK Licensed Products in the Field in the Novartis Territory; (G) providing a forum for the Parties to discuss the Commercialization of JAK Licensed Products in the Field worldwide; and (H) such other responsibilities as may be assigned to the JCC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.
Board Composition (a) On the date of this Agreement, the Company shall cause the Person(s), if any, listed on Schedule B to be designated as Minority Shareholder Observers (as defined below) with all rights set forth in Section 2.1(d) (it being understood that at any time after the date hereof until the date that the Minority Shareholder Observer(s) are appointed to the Board as directors pursuant to the immediately following sentence, the Company shall, promptly upon receipt of a written request from the Minority Shareholder Representative, cause any Person(s) named in such written request to be designated as Minority Shareholder Observer(s); provided, that there may be no more than two Minority Shareholder Observers at any one time). As soon as reasonably practicable following receipt of the Company Shareholder Approval and in any case within one Business Day thereafter, the Board shall increase the size of the Board by two directors and cause such persons to be appointed to the Board as directors; provided, that if the Company Shareholder Approval is not obtained by the date that is 30 days prior to the Designation Date for the Next Annual Meeting, (i) the Company shall take all commercially reasonable actions necessary to cause the election of two Minority Shareholder Observers to the Board as directors at the Next Annual Meeting or (ii) if the Minority Shareholders no longer beneficially own, in the aggregate, 66% or more of the Minority Shares, the Company shall take all commercially reasonable actions necessary to cause the election of one Minority Shareholder Observer, designated by the Minority Shareholder Representative on behalf of the Minority Shareholders, to be elected to the Board as director at the Next Annual Meeting; in each case, the Company’s obligations to take all commercially reasonable actions necessary to cause the election of such Minority Shareholder Observers to the Board as directors shall include the obligation of the Company to take all actions to cause such Minority Shareholder Observers to be nominated by the Board, including the Governance Committee, for election at the Next Annual Meeting. Thereafter, and for so long as (i) the Minority Shareholders continue to beneficially own, in the aggregate, 66% or more of the Minority Shares (the “Two Designee Threshold”), the Minority Shareholder Representative on behalf of the Minority Shareholders shall have the right to designate two directors for election to the Board and (ii)(x) the Minority Shareholders continue to beneficially own, in the aggregate, 10% or more of the then outstanding Equity Securities, or (y) the Minority Shareholders beneficially own, in the aggregate, less than 10% of the then outstanding Equity Securities but such Minority Shareholders continue to beneficially own, in the aggregate, 33% or more of the Minority Shares (“One Designee Threshold”), then the Minority Shareholder Representative on behalf of the Minority Shareholders shall have the right to designate one director for election to the Board (each such director nominee, including such initial nominees, a “Minority Shareholder Designee”), such percentages in each case calculated on a fully diluted basis giving effect to any securities, warrants, options or other rights convertible into or exchangeable or exercisable for equity securities of the Company, whether or not subject to contingencies or passage of time, or both; provided, that, if the Minority Shareholders’ beneficial ownership, in the aggregate, of Equity Securities (x) falls below the Two Designee Threshold, then one Minority Shareholder Designee, designated by the Minority Shareholder Representative on behalf of the Minority Shareholders, shall resign from the Board as promptly as practicable upon the Minority Shareholder Representative becoming aware of the Minority Shareholders falling below such threshold, or (y) falls below the One Designee Threshold, then the Minority Shareholder Designee shall resign from the Board as promptly as practicable upon the Minority Shareholder Representative becoming aware of the Minority Shareholders falling below such threshold. So long as the Minority Shareholder Representative, on behalf of the Minority Shareholders, has the right to designate at least one director for election to the Board, one Minority Shareholder Designee designated by the Minority Shareholder Representative on behalf of the Minority Shareholders shall be entitled to serve on each committee of the Board except as prohibited by applicable law or stock exchange requirements; provided, that if such Minority Shareholder Designee is so prohibited, such Minority Shareholder Designee shall nonetheless have the right to participate as a non-voting observer on such committee (any such observer, a “Committee Observer”). In each case, the Company shall take all commercially reasonable actions necessary to cause the appointment of such Minority Shareholder Designee(s) (x) to the Board (including taking all actions to cause such Minority Shareholder Designee(s) to be nominated by the Board, including the Governance Committee, for election at each annual meeting of the shareholders of Company (or at any special shareholder meeting of the Company at which the Board is to be elected)) and (y) to the applicable committee of the Board (including taking all actions to cause such Minority Shareholder Designee(s) to be elected by the Board to serve on such committee of the Board).
(b) Each Minority Shareholder Designee shall comply in all respects with the Company’s corporate governance guidelines as in effect from time to time, in each case as determined by the Board’s Corporate Governance and Nominating Committee (the “Governance Committee”); provided, that the Company hereby acknowledges and agrees that the initial Minority Shareholder Designees comply with such corporate governance guidelines. The Minority Shareholder Representative shall notify the Company of any proposed Minority Shareholder Designee in writing no later than the latest date on which shareholders of the Company may make nominations to the Board in accordance with the Code of Regulations (such date, the “Designation Date”), together with all information concerning such nominee required to be delivered to the Company by the Code of Regulations and such other information reasonably requested by the Company; provided, that the Company shall give the Shareholder Representative 30 days written notice of the Designation Date; provided, further, that that in the event the Minority Shareholder Representative fails to provide any such notice, the Minority Shareholder Designees shall be the person(s) then serving as the Minority Shareholder Designees as long as the Minority Shareholder Representative provides such information to the Company promptly upon request by the Company.
(c) In the event of the death, disability, resignation or removal of a Minority Shareholder Designee, the Board will promptly elect to the Board a replacement director designated by the Minority Shareholder Representative, subject to the fulfillment of the requirements set forth in first sentence of Section 2.1(b), to fill the resulting vacancy, and such individual shall then be deemed a Minority Shareholder Designee for all purposes under this Agreement. In the event the Minority Shareholder Representative fails to designate a replacement director to fill any such vacancy, such Board seat shall remain vacant until the Minority Shareholder Representative designates such replacement director to fill such vacancy.
(d) So long as the Minority Shareholder Representative on behalf of the Minority Shareholders has the right to designate any Minority Shareholder Designee for election to the Board pursuant to Section 2.1(b), the Minority Shareholder Representative on behalf of the Minority Shareholders shall have the right to designate a non-voting observer to the Board in lieu of, or as a replacement for, any Minority Shareholder Designee (any such observer, a “Minority Shareholder Observer”). Each Minority Shareholder Observer shall be entitled to (x) attend all meetings of the Board and each applicable committee of the Board except as prohibited by applicable law or stock exchange requirements and (y) receive all materials with respect to such meetings. The Minority Shareholder Representative on behalf of the Minority Shareholders shall have the right to remove or replace any Minority Shareholder Observer at any time from time to time, subject to compliance with the first sentence of Section 2.1(b). The Company shall (x) notify each Minority Shareholder Observer of all meetings of the Board (and the applicable committees thereof) using the same form of communication used to notify the directors on the Board and (y) provide each Minority Shareholder Observer with copies of all notices, minutes, consents and other materials provided to the directors on the Board no later than the time that such materials are provided to the directors. Each Minority Shareholder Observer shall be entitled to reimbursement for reasonable out-of-pocket expenses incurred in attending meetings of the Board (and the applicable committees thereof) to the same extent as directors on the Board.
(e) If a Committee Observer is designated pursuant to Section 2.1(a), such Committee Observer shall be entitled to (x) attend all meetings of each committee of the Board except as prohibited by applicable law or stock exchange requirements and (y) receive all materials with respect to such meetings. The Company shall (x) notify each Committee Observer of all meetings of the committees of the Board using the same form of communication used to notify the members of such committee and (y) provide each Committee Observer with copies of all notices, minutes, consents and other materials provided to the members of such committee no later than the time that such materials are provided to the members. Each Committee Observer shall be entitled to reimbursement for reasonable out-of-pocket expenses incurred in attending meetings of the committees of the Board to the same extent as members of such committees.
Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.
Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.