Development Committee. The PARTIES agree to work together in good faith in the collaboration under this Agreement and to keep each other reasonably informed of its activities hereunder. Additionally, and in support of the foregoing, promptly after the Effective Date, the PARTIES will form a four-member committee (the “DEVELOPMENT COMMITTEE”), equally represented by EAGLE and ▇▇▇▇▇▇, for the management of the development of the PRODUCTS, which will consist of the Chief Executive Officer and Chief Scientific Officer of each of EAGLE and ▇▇▇▇▇▇. Each Party shall have the right, from time to time, to substitute new members, on a permanent or temporary basis, for any of its previously designated members of the DEVELOPMENT COMMITTEE. Each Party shall bear its own costs associated with participation in the DEVELOPMENT COMMITTEE. 4.1.1 The DEVELOPMENT COMMITTEE shall generally oversee and facilitate the development of the PRODUCTs. Each party shall promptly provide the other and the DEVELOPMENT COMMITTEE with a copy of any FDA correspondence within 48 hours of receipt thereof and it will be the responsibility of EAGLE, with the oversight and approval of the DEVELOPMENT COMMITTEE, to create an appropriate response thereto. 4.1.2 During the Term, the DEVELOPMENT COMMITTEE shall meet at least once each calendar quarter or at such other frequency as the DEVELOPMENT COMMITTEE determines. The PARTIES shall meet on a date and time and at a location determined by the DEVELOPMENT COMMITTEE; the PARTIES anticipate alternating meetings between the Party’s respective sites. Upon written notice by either Party to the other that a meeting is required or requested, a meeting will be held within thirty (30) calendar days of such notice on a date and time and at a location to be agreed upon by the PARTIES, or sooner if warranted by the circumstances. Notices requesting such a meeting shall include adequate information describing the activity to be reviewed. Any meetings of the DEVELOPMENT COMMITTEE may be held in person at a location to be agreed to by the PARTIES, or by videoconference to teleconference. 4.1.3 In the event of the PRODUCT FAILURE, the DEVELOPMENT COMMITTEE shall select a REPLACEMENT PRODUCT within one hundred eighty (180) days of such failure. In the event the DEVELOPMENT COMMITTEE fails to select the REPLACEMENT PRODUCT within such period, EAGLE shall be entitled to a refund in accordance with Section 3.1.2. 4.1.4 The DEVELOPMENT COMMITTEE shall have no power or authority to amend this Agreement or to otherwise change any of the responsibilities or obligations of a Party under this Agreement, except as expressly agreed to in writing by such Party. Each member of the Development and Commercialization Committee will be entitled to one (1) vote and all decisions of the Development and Commercialization Committee shall be by a unanimous vote in favor of such decision. In the event that a majority of the members cannot agree, then the chief executive officer or president of each PARTY shall jointly agree.
Appears in 4 contracts
Sources: Development and License Agreement (Eagle Pharmaceuticals, Inc.), Development and License Agreement (Eagle Pharmaceuticals, Inc.), Development and License Agreement (Eagle Pharmaceuticals, Inc.)
Development Committee. The PARTIES agree to work together in good faith in the collaboration under this Agreement and to keep each other reasonably informed of its activities hereunder. Additionally, and in support of the foregoing, promptly after the Effective Date, the PARTIES will form a four-member committee (the “DEVELOPMENT COMMITTEE”), equally represented by EAGLE and ▇▇▇▇▇▇, for the management of the development of the PRODUCTS, which will consist of the Chief Executive Officer and Chief Scientific Officer of each of EAGLE and ▇▇▇▇▇▇. Each Party shall have the right, from time to time, to substitute new members, on a permanent or temporary basis, for any of its previously designated members of the DEVELOPMENT COMMITTEE. Each Party shall bear its own costs associated with participation in the DEVELOPMENT COMMITTEE.
4.1.1 The DEVELOPMENT COMMITTEE shall generally oversee and facilitate the development of the PRODUCTs. Each party shall promptly provide the other and the DEVELOPMENT COMMITTEE with a copy of any FDA correspondence within 48 hours of receipt thereof and it will be the responsibility of EAGLE, with the oversight and approval of the DEVELOPMENT COMMITTEE, to create an appropriate response thereto.
4.1.2 During the Term, the DEVELOPMENT COMMITTEE shall meet at least once each calendar quarter or at such other frequency as the DEVELOPMENT COMMITTEE determines. The PARTIES shall meet on a date and time and at a location determined by the DEVELOPMENT COMMITTEE; the PARTIES anticipate alternating meetings between the Party’s respective sites. Upon written notice by either Party to the other that a meeting is required or requested, a meeting will be held within thirty (30) calendar days of such notice on a date and time and at a location to be agreed upon by the PARTIES, or sooner if warranted by the circumstances. Notices requesting such a meeting shall include adequate information describing the activity to be reviewed. Any meetings of the DEVELOPMENT COMMITTEE may be held in person at a location to be agreed to by the PARTIES, or by videoconference to teleconference. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
4.1.3 In the event of the PRODUCT FAILURE, the DEVELOPMENT COMMITTEE shall select a REPLACEMENT PRODUCT within one hundred eighty (180) days of such failure. In the event the DEVELOPMENT COMMITTEE fails to select the REPLACEMENT PRODUCT within such period, EAGLE shall be entitled to a refund in accordance with Section 3.1.2.
4.1.4 The DEVELOPMENT COMMITTEE shall have no power or authority to amend this Agreement or to otherwise change any of the responsibilities or obligations of a Party under this Agreement, except as expressly agreed to in writing by such Party. Each member of the Development and Commercialization Committee will be entitled to one (1) vote and all decisions of the Development and Commercialization Committee shall be by a unanimous vote in favor of such decision. In the event that a majority of the members cannot agree, then the chief executive officer or president of each PARTY shall jointly agree.
Appears in 1 contract
Sources: Development and License Agreement
Development Committee. 2.1 With effect from the Commencement Date the Parties shall establish and run a Development Committee ("DC") as follows:
2.1.1 the DC shall comprise two (2) persons as voting members ("Members") and Ardana and Columbia respectively shall be entitled to appoint one (1) Member and to replace the Member appointed by it. The PARTIES agree initial Members shall be appointed by each Party prior to work together in good faith the first DC meeting. Ardana and Columbia respectively shall each notify the other of any change in the collaboration under this Agreement and to keep each other reasonably informed identities of its activities hereunder. Additionally, and in support of the foregoing, promptly after the Effective Date, the PARTIES will form a four-member committee (the “DEVELOPMENT COMMITTEE”), equally represented by EAGLE and ▇▇▇▇▇▇, for the management of the development of the PRODUCTS, which will consist of the Chief Executive Officer and Chief Scientific Officer of each of EAGLE and ▇▇▇▇▇▇. Each Party shall have the right, their Member from time to time, . Both sides shall use reasonable endeavours to substitute new members, on a permanent or temporary basis, for keep an appropriate level of continuity in representation. Members may be represented at any of its previously meeting by another person designated members [***]A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. by the absent Member. Meetings of the DEVELOPMENT COMMITTEE. Each Party DC shall bear its own costs associated with participation in the DEVELOPMENT COMMITTEE.
4.1.1 The DEVELOPMENT COMMITTEE shall generally oversee and facilitate the development of the PRODUCTs. Each party shall promptly provide the other and the DEVELOPMENT COMMITTEE with a copy of any FDA correspondence within 48 hours of receipt thereof and it will be the responsibility of EAGLE, with the oversight and approval of the DEVELOPMENT COMMITTEE, to create an appropriate response thereto.
4.1.2 During the Term, the DEVELOPMENT COMMITTEE shall meet at least once each calendar quarter or at such other frequency as the DEVELOPMENT COMMITTEE determines. The PARTIES shall meet on a date and time and at a location determined co-chaired by the DEVELOPMENT COMMITTEE; the PARTIES anticipate alternating meetings between the Party’s respective sites. Upon written notice by either Party to the other that a meeting is required or requested, a meeting will be held within thirty (30) calendar days of two Members and such notice on a date and time and at a location to be agreed upon by the PARTIES, or sooner if warranted by the circumstances. Notices requesting such a meeting co-chairpersons shall include adequate information describing the activity to be reviewed. Any meetings of the DEVELOPMENT COMMITTEE may be held in person at a location to be agreed to by the PARTIES, or by videoconference to teleconference.
4.1.3 In the event of the PRODUCT FAILURE, the DEVELOPMENT COMMITTEE shall select a REPLACEMENT PRODUCT within one hundred eighty (180) days of such failure. In the event the DEVELOPMENT COMMITTEE fails to select the REPLACEMENT PRODUCT within such period, EAGLE shall only be entitled to a refund in accordance with Section 3.1.2.
4.1.4 The DEVELOPMENT COMMITTEE shall have no power or authority to amend this Agreement or to otherwise change any of the responsibilities or obligations of a Party under this Agreement, except as expressly agreed to in writing by such Party. Each member of the Development and Commercialization Committee will be entitled to exercise one (1) vote each as Members at the DC and all shall not have any right to a veto or casting vote;
2.1.2 the quorum for meetings of the DC shall be the two (2) Members. Conclusions and decisions of the Development and Commercialization Committee DC shall be made by a unanimous vote in favor of such decision. In the event that a majority agreement of the members canMembers present wherever possible and shall be minuted by or upon behalf of the Chairpersons. Both Parties will use their reasonable efforts to build consensus. If the DC does not agree, then reach unanimous agreement regarding any matter such matter shall be referred for resolution to the chief executive officer or president Chief Executive Officer of each PARTY Party;
2.1.3 the venue for meetings not held by teleconference shall jointly agree.alternate between the offices of Ardana in Edinburgh, Scotland and the offices of COB in Livingston, New Jersey or such other venue as may be agreed. Each Party shall be responsible for its own expenses including travel and accommodation costs incurred in connection with DC meetings;
2.1.4 notwithstanding that each Party shall have only one Member of the DC the Parties acknowledge that other individuals may attend from either Party which additional attendees may change according to the subject matter of DC meeting. Each Party shall give the other reasonable advance notice of the identity of any such additional attendees which it intends to participate in the DC meeting in question. For the avoidance of doubt it is agreed that such persons shall not be Members and shall not have a right to vote or participate in the decision making process of the DC; and
Appears in 1 contract
Sources: Development and License Agreement (Columbia Laboratories Inc)
Development Committee. 8.1 The PARTIES agree Participants will, as soon as is practicable after the commencement of the Feasibility and Development Phase, establish a Development Committee for the JV Property consisting initially of three members and up to work together three alternate members representing Lonmin and two members and up to two alternate members representing, collectively, the Optionors, unless there is only one Optionor remaining in good faith which case such Optionor shall be entitled to one member and one alternative member on the Development Committee. At such time as Lonmin has earned an additional 10% Interest in the collaboration under this Agreement and JV Property in accordance with section 4.3 by delivery of a Full Feasibility Study to keep each other reasonably informed of its activities hereunder. Additionally, and in support of the foregoing, promptly after the Effective Date, the PARTIES will form a four-member committee (the “DEVELOPMENT COMMITTEE”Development Committee pursuant to section 8.11(b), equally represented by EAGLE and ▇▇▇▇▇▇, for the management of the development of the PRODUCTS, which will consist of the Chief Executive Officer and Chief Scientific Officer of each of EAGLE and ▇▇▇▇▇▇. Each Party shall have the right, from time to time, to substitute new members, on a permanent or temporary basis, for any of its previously designated members of the DEVELOPMENT COMMITTEE. Each Party shall bear its own costs associated with participation in the DEVELOPMENT COMMITTEE.
4.1.1 The DEVELOPMENT COMMITTEE shall generally oversee and facilitate the development of the PRODUCTs. Each party shall promptly provide the other and the DEVELOPMENT COMMITTEE with a copy of any FDA correspondence within 48 hours of receipt thereof and it will be the responsibility of EAGLE, with the oversight and approval of the DEVELOPMENT COMMITTEE, to create an appropriate response thereto.
4.1.2 During the Term, the DEVELOPMENT COMMITTEE shall meet at least once each calendar quarter or at such other frequency as the DEVELOPMENT COMMITTEE determines. The PARTIES shall meet on a date and time and at a location determined by the DEVELOPMENT COMMITTEE; the PARTIES anticipate alternating meetings between the Party’s respective sites. Upon written notice by either Party to the other that a meeting is required or requested, a meeting will be held within thirty (30) calendar days of such notice on a date and time and at a location to be agreed upon by the PARTIES, or sooner if warranted by the circumstances. Notices requesting such a meeting shall include adequate information describing the activity to be reviewed. Any meetings of the DEVELOPMENT COMMITTEE may be held in person at a location to be agreed to by the PARTIES, or by videoconference to teleconference.
4.1.3 In the event of the PRODUCT FAILURE, the DEVELOPMENT COMMITTEE shall select a REPLACEMENT PRODUCT within one hundred eighty (180) days of such failure. In the event the DEVELOPMENT COMMITTEE fails to select the REPLACEMENT PRODUCT within such period, EAGLE Lonmin shall be entitled to a refund fourth member on the Development Committee. A representative of Lonmin will be the chairman of the Development Committee for the JV Property during the Feasibility and Development Phase. The Development Committee will have the rights, powers and obligations specified in this section 8 and section 7 during the Feasibility and Development Phase.
8.2 A Participant may from time to time revoke in writing the appointment of its member(s) to the Development Committee and appoint in writing another in his place. A Participant may from time to time in writing appoint one alternate member for a member theretofore appointed by such Participant. Alternate members may attend meetings of the Development Committee, and in the absence of a member, his alternate may vote and otherwise act in his stead and place. Whenever any member or alternate member votes or acts, his votes or actions will for all purposes of this agreement be considered the actions of the Participant whom he represents. The Participants will give written notice to each other from time to time as to names, addresses and telephone numbers of their respective members and alternates on the Development Committee.
8.3 Meetings of the Development Committee will be held as required but in any event not less frequently than every three months. A meeting of the Development Committee may take place by means of conference telephones or other communication facilities by which means both Participants or their alternates participating in the meeting can hear each other provided the Development Committee meets in person not less than twice per Fiscal Year. The persons participating in a meeting in accordance with Section 3.1.2this section will be deemed to be present at the meeting and to have so agreed and will be counted in the quorum therefor and be entitled to speak and vote thereat.
4.1.4 8.4 The DEVELOPMENT COMMITTEE shall have no power Manager and Operator will consult freely with the Development Committee during the Feasibility and Development Phase and the members thereof, and keep them advised of all material developments and results.
8.5 Voting by the Development Committee may be conducted by verbal, written, electronic or authority facsimile ballot. A resolution in writing approving a matter to amend this Agreement or to otherwise change any be acted upon by the Development Committee, signed by all the members of the responsibilities Development Committee or obligations their alternates, is as valid as if it had been passed at a meeting of the Development Committee. Electronic and facsimile signatures are expressly consented to.
8.6 A quorum of any meeting of the Development Committee will consist of not less than two members, two alternate members or one member and one alternate member, representing both Lonmin and collectively the Optionors. If a Party under this Agreementquorum is not present within 120 minutes after the time fixed for holding any such meeting, except as expressly agreed the meeting will be adjourned to the next following day at the same time and place. At the adjourned meeting the members or alternate members present in writing by such Party. person (which may be only one person) will form a quorum and may transact the business for which the meeting was originally convened.
8.7 Each member of the Development and Commercialization Committee will be entitled to one (1) vote and on all decisions of the Development and Commercialization Committee.
8.8 Subject to section 8.12 (b), all decisions of the Development Committee shall will be by a unanimous the affirmative vote in favor of such decision. In the event that a majority of the votes represented by voting members in attendance. During the Feasibility and Development Phase, in the event of a vote which results in an equal number of votes for a matter and against a matter, the chairman of the Development Committee appointed pursuant to section 8.1 shall have the deciding vote.
8.9 Meetings of the Development Committee may be called by either Participant or the Manager by giving 14 days' notice to the other Participant. The Participants may agree to abridge this notice period and any member of the Development Committee attending a meeting called with less than 14 days' notice shall be deemed to have waived the notice requirement unless such member states that their sole purpose for attending such meeting is to object to the lack of adequate notice. Notice of any Development Committee meeting will be given at least ten days prior to the date fixed for such meeting, unless otherwise agreed by both Participants. All meetings will be held at such place as may be determined by the Operator. The reasonable costs of not more than four representatives of Lonmin and not more than two members in total from the Optionors in preparing for and attending meetings of the Development Committee shall be charged to Development Costs and funded in the manner contemplated by section 7.6. There will be included with a notice of meeting the proposed agenda and such material and data as may be reasonably required to enable the members of the Development Committee to determine the position they should take in respect of any vote or election to be made at such meeting. If a Full Feasibility Study is to be considered by the Development Committee then such material shall be provided to the members at least 30 days prior to the meeting. At such meeting, the Participants may make suggestions for any revisions or amendments to the proposed Full Feasibility Study. The Manager and the Operator shall give such suggestions due consideration but shall be under no obligation to adopt them into the Full Feasibility Study.
8.10 The Manager and Operator will have the responsibility of preparing and distributing notices and agendas of meetings and keeping records of the proceedings at such meetings and distributing such records to the Non-Operator Participants unless a Non-Operator Participant called such meeting in which case the Non-Operator Participant who called such meeting shall have the responsibility to distribute the notice and the agenda and the Manager shall have the responsibility of keeping records of the proceedings. Draft minutes of meetings of the Development Committee shall be distributed within five business days after any meeting. If a member has any material comments or suggested material revisions to the draft minutes they shall be sent to the Manager within ten business days of the receipt of the draft minutes. The Manager shall recirculate revised minutes within five business days thereafter. If a member of the Development Committee does not provide material comments on draft minutes or revised minutes within ten days then such member shall be deemed to have approved such minutes.
8.11 During the Feasibility and Development Phase the Development Committee will, without limiting any of its powers as specified elsewhere in this agreement, have the exclusive right, power and authority to:
(a) approve, modify, or reject or request the revision of any Scope of Work and Budget proposed by the Operator and to request additional information in connection with same;
(b) receive a completed Full Feasibility Study from Lonmin prior to the Feasibility Deadline;
(c) receive, approve, modify, reject or request the revision of a Full Feasibility Study;
(d) approve a form of accounting procedure for all Costs to be charged to the Participants, such procedure to be consistent with those attached as Schedule G attached hereto;
(e) determine to commence activity associated with any Scope of Work and Budget to develop a mine to Commercial Production, in relation to the JV Property or a portion thereof it being understood that such determination by the Development Committee will be subject to the approval of the board of directors of Lonmin. Lonmin will seek such approval within 60 days of such decision by the Development Committee; and
(f) determine to develop a mine to Commercial Production.
(a) Notwithstanding anything else in this agreement, the approval by the Development Committee of the Full Feasibility Study is subject to the approval of the board of directors of Lonmin. Lonmin agrees to use its reasonable best efforts to seek such approval within 60 days of the approval by the Development Committee and shall notify the Development Committee of such approval as soon as practical thereafter.
(b) Notwithstanding anything else in this agreement, a Full Feasibility Study which contemplates average annual production of 50,000 ounces or less of platinum group metals and gold under steady state conditions following the commencement of the Commercial Production shall require the unanimous approval of the Development Committee. The Participants will use their reasonable best efforts to reach unanimous consensus on such a Full Feasibility Study, and if the matter is put to a vote and is not so approved, the matter will be voted on again at a meeting of the Development Committee to be held not more than 30 days after the meeting of the Development Committee at which unanimous approval was not achieved. If unanimous approval is not achieved at such meeting, each Participant shall nominate an executive director who is not a member of the Development Committee and who shall use their reasonable efforts to resolve the matter. During any such period when a consensus cannot be reached only the Costs essential to keep the JV Property in good standing shall be incurred and all timeframes or deadlines set out in this agreement shall be suspended.
(c) Any Full Feasibility Study other than a Full Feasibility Study described in section 8.12(b) is subject to approval as described in section 8.8.
8.13 Following the approval by the Development Committee of the Full Feasibility Study, the Development Committee may consider and approve a Scope of Work and Budget and the terms of the Development Finance and make a decision to develop a mine to Commercial Production. Such approval is subject to the approval of the board of directors of Lonmin and Lonmin will seek such approval within 120 days of such approval by the Development Committee. Subject to section 8.14, if a Scope of Work and Budget have not been approved or if the activity described in an approved Scope of Work and Budget has not commenced by the date which is four years following the approval by the Development Committee of the Full Feasibility Study, as a result of an act or a failure to act of Lonmin, Lonmin shall prepare an offer to sell its Interest in the JV Property to PFN and Freegold USA, pro rata to their Interest or in such other proportion as PFN and Freegold may agree, for an amount of cash equal to the Costs incurred by Lonmin on the JV Property multiplied by 2.5. If PFN and Freegold USA both notify Lonmin within 60 days that such terms are acceptable to it, Lonmin shall transfer its Interest in the JV Property, pro rata to their Interest, to PFN and Freegold USA on such terms as were specified in the notice and each Participant shall execute such documents as are reasonably necessary to complete such transfer which must close within 60 days of the acceptance notice being sent by the latter of Freegold USA and PFN. If only one of PFN or Freegold USA notify Lonmin that such terms are acceptable to it within 60 days then Lonmin shall transfer its entire Interest to such Participant on such terms as were specified in the chief executive officer notice. If the transfer does not close within 60 days of the acceptance notice being sent by the latter of Freegold USA and PFN, Lonmin may transfer its Interest in the JV Property to a third party on terms not less favourable to Lonmin than those specified in the offer to PFN or president Freegold USA. If Lonmin is unsuccessful in finding a third party buyer on such terms within 60 days, Lonmin shall prepare an offer to sell its Interest to Freegold USA and PFN, pro rata to their Interest or in such other proportion as PFN and Freegold USA may agree, on terms more favourable to PFN and Freegold USA than the original offer. Freegold and PFN shall have 30 days to determine if they will purchase Lonmin's Interest on such terms. If either Freegold or PFN notify Lonmin that they will purchase Lonmin's Interest on such terms such purchase shall close within 30 days of each PARTY the latter of such acceptance notices being delivered. If only one of PFN and Freegold USA send such notice, Lonmin's entire Interest will be transferred to such Participant and if both PFN and Freegold USA send such notice then Lonmin shall jointly agreetransfer its Interest to PFN and Freegold USA pro rata to their Interest. If the purchase does not close within 30 days of such acceptance notices being given or if both Freegold USA or PFN determine not to purchase Lonmin's Interest in the first 30 days, Lonmin may sell its Interest to a third party on terms no less favourable to Lonmin than those described in the revised offer. If Lonmin is unable to sell its Interest by the date which is one year following the date Lonmin sent a notice to PFN and Freegold USA offering to sell its Interest for the Costs incurred by Lonmin on the JV Property multiplied by 2.5, Lonmin shall receive a 2.5% Net Smelter Royalty over the JV Property in exchange for all its Interest and its other rights and obligations under their agreement. Lonmin's right to receive this Net Smelter Royalty shall survive the termination of this Agreement and the Optionors obligation to pay such Net Smelter Royalty shall be joint and several.
8.14 The four year period referred to in section 8.13 shall be temporarily suspended during any period in which the results of the Full Feasibility Study would not reasonably recommend that the JV Property be put into Commercial Production due to changes in anticipated financial performance because the assumptions in the Full Feasibility Study including those relating to interest rates, metal prices and exchange rates used in the Full Feasibility Study were not those prevailing in the market place during such suspended period instead of those actually used.
Appears in 1 contract