Candidates The Superintendent or designee shall invite all current candidates for the office of Board member to attend:
Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.
Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.
Product Testing No later than [**] prior to a scheduled Delivery ARIAD US shall send to ARIAD SWISSCO the Delivery Documents for review. Following such review, unless within [**] of receipt of the Delivery Documents ARIAD SWISSCO gives written notice of rejection of the Product to be delivered, stating the reasons for such rejection, the Delivery shall proceed, and both Parties shall organize the same. Upon arrival at ARIAD SWISSCO nominated site it shall visually inspect the shipment of the Product to identify any damage to the external packaging. ARIAD SWISSCO may reject any shipment (or portion thereof) of the Product that is damaged by providing to ARIAD US reasonable evidence of damage within [**] after Delivery of such Product. If ARIAD SWISSCO does not so reject any shipment (or portion thereof) of the Product within [**] of Delivery of such Product, ARIAD SWISSCO shall be deemed to have accepted such shipment of the Product; provided, however, that in the case of the Product having any Latent Defect, ARIAD SWISSCO shall notify ARIAD US promptly once it becomes aware that a Product contains a Latent Defect and subsequently may reject such Product by giving written notice to ARIAD US of ARIAD SWISSCO’s rejection of such Product and shipping a representative sample of such Product or other evidence of Non-Conformance to ARIAD US within [**] after becoming aware of such Latent Defect, which notice shall include a description of the Latent Defect.
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.
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.
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.
New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.
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.
RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.