Updates and Meetings Sample Clauses

Updates and Meetings. During the GAN Option Period and any Option Negotiation Period with respect to the GAN Option, within [***] Taysha shall (a) deliver to Astellas a written report containing a summary of all material research, development, manufacturing and commercialization activities conducted with respect to GAN Products during such calendar month (if any); provided that if at any time during the GAN Option Period and any Option Negotiation Period with respect to the GAN Option, Taysha becomes aware of any new information related to the 120 GAN Product that is reasonably likely to materially impact the development or commercialization of the 120 GAN Product, Taysha shall promptly provide such information to Astellas, but in any event in no more than [***] after Taysha becomes aware of such information; and (b) promptly notify Astellas of any meeting with the FDA related to the 120 GAN Product and, [***]. During the GAN Option Period and any Option Negotiation Period with respect to the GAN Option, at Astellas’ reasonable written request, Taysha shall promptly (i) meet with Astellas to discuss the contents of any such report and any activities with respect to any GAN Product; or (ii) deliver to Astellas any additional information reasonably requested by Astellas with respect to any GAN Product; provided that such information is Controlled by Taysha or any of its Affiliates, including any data generated in any such research, development, manufacturing or commercialization activities.
Sample 1
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Updates and Meetings. During the Rett Option Period and any Option Negotiation Period with respect to the Rett Option, [***] Taysha shall (a) deliver to Astellas a written report summarizing Xxxxxx’s progress with respect to the Rett Development Plan and Rett Budget, which report shall include all material research, development, manufacturing and commercialization activities conducted with respect to Rett Products during such calendar quarter, as well as the results of any clinical studies or material non-clinical studies; provided that if at any time during the Rett Option Period and any Option Negotiation Period with respect to the Rett Option, Xxxxxx becomes aware of any new information related to the 102 Rett Product that is reasonably likely to materially impact the development or commercialization of the 102 Rett Product, Taysha shall promptly provide such information to Astellas[***] after Xxxxxx becomes aware of such information; and (b) promptly notify Astellas of any meeting with the FDA related to the 102 Rett Product and, to the extent allowed by applicable law and unless otherwise not possible based on the requested timing from the FDA[***]. During the Rett Option Period and any Option Negotiation Period with respect to the Rett Option, at Astellas’ reasonable written request, Taysha shall promptly (i) meet with Astellas to discuss the contents of any such report and any activities with respect to any Rett Product; or (ii) deliver to Astellas any additional information reasonably requested by Astellas with respect to any Rett Product; provided that such information is Controlled by Taysha or any of its Affiliates, including any data generated in any such research, development, manufacturing or commercialization activities.
Sample 1
Updates and Meetings. During the Option Election Period and any Option Negotiation Period, within [***], Perspective shall (a) deliver to Lantheus a written report summarizing Perspective’s progress with respect to the Development Plan and Development Budget, which report shall include all material research, development, manufacturing and commercialization activities conducted with respect to the VMT-α-NET Product during such calendar quarter, as well as a summary of interim data or results from the Phase I/IIa Study; provided that if at any time during the Option Election Period and any Option Negotiation Period, Perspective becomes aware of any new information related to any VMT-α-NET Product that is [***], Perspective shall [***] provide such information to Lantheus, but in any event in no more than [***] after Perspective becomes aware of such information; and (b) [***]notify Lantheus of any meeting with the FDA related to the VMT-α-NET Product and, to the extent allowed by applicable law and unless otherwise not possible based on the requested timing from the FDA, allow [***]of Lantheus to participate in such meeting as observers only (without the right to speak or otherwise participate in such meeting). During the Option Election Period and any Option Negotiation Period, at Lantheus’ reasonable written request, Perspective shall, within [***], (i) make available members of its executive leadership team and appropriate other employees to meet with Lxxxxxxx to discuss the contents of any such report and any activities with respect to the VMT-α-NET Product; or (ii) deliver to Lantheus any additional information reasonably requested by Lxxxxxxx with respect to the VMT-α-NET Product; provided that such information is Controlled by Perspective or any of its Affiliates, including any data generated in any such research, development, manufacturing or commercialization activities.
Sample 1
Updates and Meetings. With respect to each Preclinical Development Program as to which Lantheus exercises its Program Preclinical Co-Funding Option, commencing upon the date of such option exercise until the Program Option Data Package Delivery Date for the Lead Candidate (the “Pre-IND Development Period”), within [***] after the end of each calendar quarter during such period, Perspective shall deliver to Lantheus a written report (a) summarizing Perspective’s progress with respect to the Program Preclinical Development Plan which report shall include all material preclinical development activities conducted with respect to the Lead Candidate during such calendar quarter, as well as a summary of any interim data generated in the performance of such activities and the results thereof, and including a high-level description of the preclinical development activities anticipated to be conducted in the subsequent calendar quarter; provided that if at any time during such period, Perspective becomes aware of any new information related to the Lead Candidate or such Preclinical Development Program that is reasonably likely to materially impact the development, manufacturing or commercialization of such Lead Candidate, Perspective shall promptly provide such information to Lantheus, but in any event in no more than [***] after Perspective becomes aware of such information and (b) detailing the development costs incurred to date against the preclinical Development Budget set forth in the Program Preclinical Development Plan. Additionally, during the Pre-IND Development Period, Perspective shall promptly notify Lantheus of any meeting with the FDA related to the Lead Candidate or such Preclinical Development Program and, to the extent allowed by applicable law and unless otherwise not possible based on the requested timing from the FDA, allow at least [***] of Lantheus to participate in such meeting as observers only (without the right to speak or otherwise participate in such meeting). During the Pre-IND Development Period, at Lantheus’ reasonable written request, Perspective shall, within [***], (i) make available members of its executive leadership team and appropriate other employees to meet with Lxxxxxxx to discuss the contents of any such report or activities described therein; or (ii) deliver to Lantheus any additional information reasonably requested by Lxxxxxxx with respect to the Lead Candidate or such Preclinical Development Program; provided that such information is Controll...
Sample 1

Related to Updates and Meetings

  • Reports and Meetings A. Sub-adviser shall furnish to the Board or Adviser, or both, as appropriate, such information, reports, evaluations, analyses and opinions as are required by law or that the Board or Adviser, as appropriate, may reasonably require, including, without limitation: compliance reporting and certification with respect to:

  • AMENDMENTS AND MEETINGS 35 Section 11.1. Amendments............................................................................35 Section 11.2. Meetings of the Holders of Securities; Action by Written Consent......................36

  • JSC Meetings The JSC will meet at least [**], or more or less frequently as mutually agreed by the Parties, at such times as may be agreed to by the Parties. The JSC will determine its meeting locations, and whether to conduct a meeting in-person, by teleconference, or videoconference. Each Party is responsible for all costs and expenses incurred by it in connection with its participation in the meetings of the JSC. Each Party shall have the right to call a special meeting of the JSC at any time as necessary or desirable to address disputes or other matters within the scope of the JSC’s responsibilities by providing the other Parties with written notice to that effect. The JSC Chairs shall schedule and convene such special JSC meeting as soon as practicable following such notice. Each Party may, from time-to-time and with prior written notice to the JSC members of the other Parties, invite Project Team members and/or others of its employees, consultants or agents to attend relevant portions of a JSC meeting as necessary. The Sponsoring Party shall notify the other Parties in writing in the event that it wishes to invite a Third Party to attend a JSC meeting. Any such notice shall be provided at least [**] business days prior to the relevant JSC meeting and shall identify the relevant Third Party and briefly describe the reasons that the Sponsoring Party wishes to include the Third Party in the meeting. The attendance and participation of such Third Party shall be subject to the prior written consent of the Parties receiving such notice (such consent not to be unreasonably withheld). Any such consent granted by a Party shall be conditioned upon the consultant or contractor being bound by a written confidentiality and non-use agreement that is reasonably acceptable to the consenting Party. In the event the Sponsoring Party requires the attendance of such Third Party at subsequent JSC meetings, approval shall not be required for any Third Party who was previously approved by the other Parties and remains bound by an appropriate written confidentiality and non-use agreement at the time of the Project Team meeting, provided that the Sponsoring Party gives the other Parties prior notice of such attendance and the other Parties do not revoke their consent. The Parties’ respective JSC Chairs (as defined below) shall be responsible for ensuring compliance with the foregoing.

  • Regulatory Meetings The Regulatory Lead Party shall provide the other Party with notice of all meetings, conferences, and discussions (including FDA advisory committee meetings and any other meeting of experts convened by the FDA concerning any topic relevant to a Product, as well as Product labeling and post-Regulatory Approval Product labeling discussions with the FDA) scheduled with the FDA concerning any pending Drug Approval Application or any material regulatory matters relating to a Product within [****]* after the Regulatory Lead Party receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the other Party a reasonable opportunity to participate in such meetings, conferences and discussions). The other Party shall be entitled to be present at, and to participate in, all such meetings, conferences or discussions. PDL’s and BMS’ respective members of the JDC shall use reasonable efforts to agree in advance on the scheduling of such meetings and on the objectives to be accomplished at such meetings, conferences, and discussions and the agenda for the meetings, conferences, and discussions with the FDA. The Regulatory Lead Party shall also include the other Party in any unscheduled, ad-hoc meetings, conferences and discussions with the FDA concerning any pending IND, Drug Approval Application or any material regulatory matters relating to a Product. * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions.

  • Meetings Meetings of the Trustees shall be held from time to time upon the call of the Chairman, if any, or the President or any two Trustees. Regular meetings of the Trustees may be held without call or notice at a time and place fixed by the By-Laws or by resolution of the Trustees. Notice of any other meeting shall be given by the Secretary and shall be delivered to the Trustees orally not less than 24 hours, or in writing not less than 72 hours, before the meeting, but may be waived in writing by any Trustee either before or after such meeting. The attendance of a Trustee at a meeting shall constitute a waiver of notice of such meeting except where a Trustee attends a meeting for the express purpose of objecting to the transaction of any business on the ground that the meeting has not been properly called or convened. Any time there is more than one Trustee, a quorum for all meetings of the Trustees shall be one-third, but not less than two, of the Trustees. Unless provided otherwise in this Declaration and except as required under the 1940 Act, any action of the Trustees may be taken at a meeting by vote of a majority of the Trustees present (a quorum being present) or without a meeting by written consent of a majority of the Trustees. Any committee of the Trustees, including an executive committee, if any, may act with or without a meeting. A quorum for all meetings of any such committee shall be one-third, but not less than two, of the members thereof. Unless provided otherwise in this Declaration, any action of any such committee may be taken at a meeting by vote of a majority of the members present (a quorum being present) or without a meeting by written consent of all of the members. With respect to actions of the Trustees and any committee of the Trustees, Trustees who are Interested Persons in any action to be taken may be counted for quorum purposes under this Section and shall be entitled to vote to the extent not prohibited by the 1940 Act. All or any one or more Trustees may participate in a meeting of the Trustees or any committee thereof by means of a conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other; participation in a meeting pursuant to any such communications system shall constitute presence in person at such meeting.

  • Meetings and Minutes The JGC shall meet [***] or as otherwise agreed to by the Parties, with the location of in-person meetings alternating between a location designated by Morphic and a location designated by AbbVie, with AbbVie designating the place of the first meeting. The chairperson of the JGC shall be responsible for calling meetings of the JGC on no less than [***] notice unless exigent circumstances require shorter notice. Each Party shall make all proposals for agenda items at least [***] in advance of the applicable meeting and shall provide all appropriate information with respect to such proposed items at least [***] in advance of the applicable meeting; provided, that under exigent circumstances requiring input by the JGC, a Party may provide its agenda items to the other Party within a shorter period of time in advance of the meeting or may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents to such later addition of such agenda items or the absence of a specific agenda for such meeting (which consent shall not be unreasonably conditioned, withheld or delayed). The chairperson of the JGC shall prepare and circulate for review and approval of the Parties minutes of each meeting within [***] after the meeting. The CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. Parties shall agree on the minutes of each meeting promptly, but in no event later than the next meeting of the JGC, and such approved minutes shall be signed by each Alliance Manager.

  • Board Meetings Unless otherwise restricted by applicable law, the Certificate of Incorporation or these Bylaws, members of the Board or any committee thereof may participate in a meeting of the Board or any committee thereof by means of conference telephone or other communications equipment by means of which all persons participating in the meeting can hear each other. Such participation in a meeting shall constitute presence in person at the meeting, except where a person participates in the meeting for the express purpose of objecting to the transaction of any business on the ground that the meeting was not lawfully called or convened.

  • Conference Telephone Meetings Directors or members of any committee of the Board may participate in a meeting of the Board or such committee by means of conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other, and such participation in a meeting shall constitute presence in person at such meeting.

  • Voting Power and Meetings Except as provided in the next sentence, regular meetings of the Shareholders for the election of Trustees and the transaction of such other business as may properly come before the meeting shall be held, so long as Shares are listed for trading on the New York Stock Exchange, on at least an annual basis, on such day and at such place as shall be designated by the Trustees. In the event that such a meeting is not held in any annual period if so required, whether the omission be by oversight or otherwise, a subsequent special meeting may be called by the Trustees and held in lieu of such meeting with the same effect as if held within such annual period. Special meetings of the Shareholders or any or all classes or series of Shares may also be called by the Trustees from time to time for such other purposes as may be prescribed by law, by the Declaration of Trust or by these Bylaws, or for the purpose of taking action upon any other matter deemed by a majority of the Trustees and a majority of the Continuing Trustees to be necessary or desirable. A special meeting of Shareholders may be held at any such time, day and place as is designated by the Trustees. Written notice of any meeting of Shareholders, stating the date, time, place and purpose of the meeting, shall be given or caused to be given by a majority of the Trustees and a majority of the Continuing Trustees at least seven days before such meeting to each Shareholder entitled to vote thereat by leaving such notice with the Shareholder at his or her residence or usual place of business or by mailing such notice, postage prepaid, to the Shareholder’s address as it appears on the records of the Trust. Such notice may be given by the Secretary or an Assistant Secretary or by any other officer or agent designated for such purpose by the Trustees. Whenever notice of a meeting is required to be given to a Shareholder under the Declaration of Trust or these Bylaws, a written waiver thereof, executed before or after the meeting by such Shareholder or his or her attorney thereunto authorized and filed with the records of the meeting, shall be deemed equivalent to such notice. Notice of a meeting need not be given to any Shareholder who attends the meeting without protesting prior thereto or at its commencement the lack of notice to such Shareholder. No ballot shall be required for any election unless required by a Shareholder present or represented at the meeting and entitled to vote in such election. Notwithstanding anything to the contrary in this Section 10.2, no matter shall be properly before any annual or special meeting of Shareholders and no business shall be transacted thereat unless in accordance with Section 10.6 of these Bylaws.

  • Member Meetings (a) There shall be no meetings of the Members unless called by the Board or as otherwise specifically required by the Delaware Act. No Members or group of Members, acting in its or their capacity as Members, shall have the right to call a meeting of the Members.

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