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.
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.
Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).
Establishment of Committee The Province may, at its sole discretion, require the establishment of a committee to oversee the Agreement (the “Committee”).
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 Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.
Committee Composition The Redeployment Committee shall be comprised of equal numbers of representatives of the Hospital and of the Union. The number of representatives will be determined locally. Where for the purposes of HTAP (the Ontario Hospital Training and Adjustment Panel) there is another hospital-wide staffing and redeployment committee created or in existence, Union members of the Redeployment Committee shall serve on any such hospital-wide staffing committee established with the same or similar terms of reference, and the number of Union members on such committee will be proportionate to the number of its bargaining unit members at the particular Hospital in relation to other staff groups. Meetings of the Redeployment Committee shall be held during normal working hours. Time spent attending such meetings shall be deemed to be work time for which the representative(s) shall be paid by the Hospital at his or her regular or premium rate as may be applicable. Each party shall appoint a co-chair for the Redeployment Committee. Co-chairs shall chair alternative meetings of the Committee and will be jointly responsible for establishing the agenda of the Committee meetings, preparing minutes and writing such correspondence as the Committee may direct.
Patent Term Extensions The Parties shall use reasonable efforts to obtain all available supplementary protection certificates, patent term restorations, and other extensions (collectively, “Extensions”) of the Acceleron Patent Rights and Joint Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shire.
Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
Development Program RWJPRI shall be [**] and have [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following:
(i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and
(ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT.
(iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION;
(iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.
