Joint Development Committee. (a) Upon the Effective Date, the Parties shall establish a joint committee dedicated to overseeing Licensee’s Development of the Licensed Products in the Field in the Territory (the “Joint Development Committee” or the “JDC”). Each Party shall appoint [***] representatives who possess a general understanding of Development matters to act as its representatives on the JDC. Each Party shall designate one of its representatives as a co-chair of the JDC. Each co-chair shall serve as the primary single point of communication within the respective Party’s organization with respect to JDC activities, confer with the co-chair of the other Party regarding JDC logistics and issues and disputes to be raised during JDC meetings, and ensure each Party’s compliance with the rules governing the JDC. Each Party may replace one or more of its representatives (including the co-chair), in its sole discretion, effective upon written notice to the other Party of such change. Each Party’s representatives on the JDC, and any replacement for any such representative, shall be bound by the obligations of confidentiality set forth in Article 6. Each Party shall be responsible for all of its own expenses incurred in connection with participating in all such meetings. (b) The JDC shall, consistent with the terms and conditions set forth in this Agreement: i. review and promptly comment on the initial Development Plan for the Second Product for obtaining Regulatory Approval in the Territory (to the extent Licensee exercises the option under Section 2.2 and the Second Product becomes a Licensed Product); ii. review and promptly comment on any material updates or amendments to the Development Plan; iii. keep Lipocine reasonably informed, at each JDC meeting, as to the progress of Licensee’s material Development activities under the Development Plan; iv. review and promptly comment on material Development activities not otherwise included in the Development Plan, including any Phase 4 Trials and other Clinical Trials to be conducted by Licensee to amend the label for a Licensed Product such as to change in dosage forms, strengths, indications or other modifications; v. keep the other Party reasonably informed of any Licensee Improvements, Lipocine Improvements or Joint Improvements; vi. subject to Section 4.5 and solely to the extent necessary to effectuate Section 4.5, keep the other Party reasonably informed of the creation of any new Licensee Data or New Lipocine Data generated by a Party or its Representatives (but for clarity, this Section 4.2(b)(vi) shall not permit any access to any Licensee Data or New Lipocine Data by the non-Data Generating Party, which access shall be subject to the terms and conditions of Section 4.5); review and promptly comment on material Regulatory Documentation and material amendments thereto for the Licensed Products prior to submission by Licensee to FDA; vii. review and approve any material aspects of Clinical Trials in accordance with Section 4.4(b); viii. perform any and all tasks and responsibilities that are otherwise expressly attributed to the JDC under the Agreement; and ix. perform such other functions as the Parties may mutually agree in writing. For the avoidance of doubt, should Licensee determine that JDC review and comment in accordance with this Section 4.2(b) is materially hindering its Development activities hereunder (e.g., review is taking an unreasonably long time) due to Lipocine’s representative(s)’s action, inaction or omission, Licensee may proceed with its planned Development activities prior to receipt of comment from the JDC, provided that Licensee’s decision to proceed is consistent with its obligations to use Commercially Reasonable Efforts with respect to Development hereunder. Notwithstanding the foregoing, nothing in this Section 4.2, shall prevent Licensee from taking action to address a safety concern. (c) To the extent Licensee exercises the option under Section 2.2 and the Second Product becomes a Licensed Product, the JDC shall meet at least (i) [***] per Calendar Quarter until Regulatory Approval of the Second Product and (ii) for the remainder of the Term, at least [***] per Calendar Year. If the First Product is the only Licensed Product, the JDC shall meet at least [***] per Calendar Year during the Term. The location of JDC meetings shall alternate between locations designated by Lipocine and locations designated by Licensee. The co-chairs of the JDC shall be responsible for calling meetings on reasonable prior notice. Each Party shall use reasonable efforts to make all proposals for agenda items and to provide all appropriate information with respect to such proposed items reasonably in advance of the applicable meeting. The co-chairs may suggest topics for the agenda for JDC meetings and prepare and circulate to the JDC for review and approval of the Parties’ minutes of each meeting within [***] days of a JDC meeting. The Parties shall agree on the minutes of each meeting as promptly as practicable following receipt of the initial draft minutes of such meeting. Representatives of the Parties on the JDC may attend meetings by telephone, videoconference or in person; provided that each participant in any meeting held by telephone or videoconference can hear what is said by, and be heard by, all other participants. Until Regulatory Approval of the Second Product (if applicable), at least [***] (1) JDC meeting per year shall be held in person, unless by reason of a Force Majeure Event, travel or in-person meeting cannot reasonably occur. A quorum of the JDC shall exist whenever there is present at a meeting at least [***] representative appointed by each Party. As appropriate, and upon at least [***]business days’ prior written notice to the other Party, a Party may allow its other employees or a Third Party to attend JDC meetings as observers; provided, however, that a Party shall not allow a Third Party to attend a JDC meeting without the other Party’s prior written consent, not to be unreasonably withheld, conditioned or delayed; and provided further, however, that each such additional attendee (i) shall not participate in the decision-making process of the JDC and (ii) shall agree in writing to be bound by obligations of confidentiality and non-disclosure consistent with those set forth in Article 6. Each Party may also call for special meetings of the JDC with reasonable prior written notice to the other Party (it being agreed that at least [***] business days shall constitute reasonable notice) to resolve particular matters requested by such Party and within the decision-making responsibility of the JDC. Each Party shall be responsible for all of its own expenses incurred in connection with participating in all such meetings. (d) Each Party shall provide the JDC such material information as required under this Agreement or as otherwise reasonably requested by the other Party and reasonably available to such Party to enable the other Party to perform its material obligations under this Agreement, in each case relating to the progress of material activities under the Development Plan and other agreed upon material activities with respect to each Licensed Product. (e) If a dispute arises that cannot be resolved by the JDC through good faith discussions, the co-chair of either Party may cause such dispute to be referred to their respect Party’s respective Executives for resolution. Such Executives (or their designees) will in good faith seek to resolve the matter within [***] days after the matter has been referred to them, or within such longer time period as the Parties may mutually agree upon. In the event that consensus cannot be reached with respect to a decision after a meeting of the Executives, then Licensee shall have the final decision-making authority for all Development activities, provided that Licensee’s decision is consistent with its obligations to use Commercially Reasonable Efforts with respect to Development hereunder. (f) The JDC shall not have any authority beyond the authority with respect to the matters expressly set forth in this Agreement nor any power to amend, modify or waive compliance with this Agreement. In furtherance thereof, each Party shall retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion shall be delegated or vested in the JDC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing.
Appears in 1 contract
Sources: License Agreement (Lipocine Inc.)
Joint Development Committee. (a) Upon Within ten (10) days after the Effective Date, the Parties shall establish a joint committee dedicated to overseeing Licensee’s Development of the Licensed Products in the Field in the Territory (the “Joint Development Committee” or the Committee (“JDC”)) shall be established with the responsibilities and authority set forth in this Section 3.4. The JDC shall consist of six (6) members, three (3) members to be appointed by each of Premas and Licensee. Each Party shall appoint [***] representatives who possess a general understanding may, with notice to the other, substitute any of Development matters to act its members serving on the JDC and may invite ad hoc non-voting members as its representatives desired. The Parties may also, by mutual agreement, increase or decrease the number of members serving on the JDC; provided that the number of members representing each Party remains equal. Each Party shall designate Licensee will have the right to appoint one of its representatives as a co-chair members to be the chairperson of the JDC. Each co-chair shall serve as The JDC will be in place until the primary single point earlier of communication within the respective Party’s organization with respect to JDC activities, confer with the co-chair (i) expiration and/or termination of the other Party regarding JDC logistics and issues and disputes Development Period or (ii) there is a written agreement between the Parties to be raised during JDC meetings, and ensure each Party’s compliance with the rules governing disband the JDC. Each Party may replace one or more of its representatives (including the co-chair), in its sole discretion, effective upon written notice to the other Party of such change. Each Party’s representatives on the JDC, and any replacement for any such representative, shall be bound by the obligations of confidentiality set forth in Article 6. Each Party shall be responsible for all of its own expenses incurred in connection with participating in all such meetings.
(b) The JDC shall, consistent with shall have the terms responsibility and conditions set forth authority to: (i) provide a forum for exchange of information related to the development of Products in this Agreement:
i. the Field in the Territory; (ii) review and promptly comment on the initial Development Plan for the Second Product for obtaining Regulatory Approval in the Territory (to the extent Licensee exercises the option under Section 2.2 and the Second Product becomes a Licensed Product);
ii. review and promptly comment on discuss any proposed material amendments or updates or amendments to the Development Plan;
; (iii. keep Lipocine reasonably informed, at each JDC meeting, as to ) oversee the implementation of the Development Plan; (iv) monitor the progress of Licensee’s material Development activities under the Development Plan;
iv. review and promptly comment on material Development activities not otherwise included in Plan against the Development Plan, including any Phase 4 Trials and other Clinical Trials metrics agreed to be conducted by Licensee to amend the label for a Licensed Product Parties (such as to change in dosage forms, strengths, indications or other modifications;
v. keep the other Party reasonably informed of any Licensee Improvements, Lipocine Improvements or Joint Improvements;
vi. subject to Section 4.5 timeline and solely to the extent necessary to effectuate Section 4.5, keep the other Party reasonably informed of the creation of any new Licensee Data or New Lipocine Data generated by a Party or its Representatives (but for clarity, this Section 4.2(b)(vi) shall not permit any access to any Licensee Data or New Lipocine Data by the non-Data Generating Party, which access shall be subject to the terms and conditions of Section 4.5costs); review and promptly comment on material Regulatory Documentation and material amendments thereto for the Licensed Products prior to submission by Licensee to FDA;
vii. review and approve any material aspects of Clinical Trials in accordance with Section 4.4(b);
viii. (iv) perform any and all tasks and responsibilities that are otherwise expressly attributed to the JDC under the Agreement; and
ix. perform such other functions as the Parties may mutually agree in writing. For the avoidance of doubt, should Licensee determine that JDC review and comment in accordance with this Section 4.2(b) is materially hindering its Development activities hereunder (e.g., review is taking an unreasonably long time) due to Lipocine’s representative(s)’s action, inaction or omission, Licensee may proceed with its planned Development activities prior to receipt of comment from the JDC, provided that Licensee’s decision to proceed is consistent with its obligations to use Commercially Reasonable Efforts with respect to Development hereunder. Notwithstanding the foregoing, nothing in this Section 4.2, shall prevent Licensee from taking action to address a safety concern.
(c) To the extent Licensee exercises the option under Section 2.2 and the Second Product becomes a Licensed Product, the The JDC shall meet at least hold meetings as mutually agreed by the Parties, but in no event less than quarterly unless Licensee and Premas mutually agree in writing (iwhich may include email), no later than thirty (30) [***] per Calendar Quarter until Regulatory Approval of the Second Product and (ii) for the remainder of the Term, at least [***] per Calendar Year. If the First Product is the only Licensed Product, the JDC shall meet at least [***] per Calendar Year during the Term. The location of JDC meetings shall alternate between locations designated by Lipocine and locations designated by Licensee. The co-chairs of the JDC shall be responsible for calling meetings on reasonable prior notice. Each Party shall use reasonable efforts to make all proposals for agenda items and to provide all appropriate information with respect to such proposed items reasonably days in advance of any meeting following the applicable meeting. The co-chairs may suggest topics for the agenda for JDC meetings and prepare and circulate to the JDC for review and approval initial meeting of the Parties’ minutes of each JDC, that no new business has transpired that would require a meeting within [***] days of a JDC meeting. The Parties shall agree on the minutes of each meeting as promptly as practicable following receipt of the initial draft minutes of such meetingJDC. Representatives of the Parties on the JDC Meetings may attend meetings by telephone, videoconference or in person; provided that each participant in any meeting be held by telephone or videoconference can hear what is said by, and be heard by, all other participants. Until Regulatory Approval of video conference as agreed by the Second Product (if applicable), at least [***]
(1) JDC meeting per year shall be held in person, unless by reason of a Force Majeure Event, travel or in-person meeting cannot reasonably occur. A quorum of the JDC shall exist whenever there is present at a meeting at least [***] representative appointed by each Party. As appropriate, and upon at least [***]business days’ prior written notice to the other Party, a Party may allow its other employees or a Third Party to attend JDC meetings as observers; provided, however, that a Party shall not allow a Third Party to attend a JDC meeting without the other Party’s prior written consent, not to be unreasonably withheld, conditioned or delayed; and provided further, however, that each such additional attendee (i) shall not participate in the decision-making process of the JDC and (ii) shall agree in writing to be bound by obligations of confidentiality and non-disclosure consistent with those set forth in Article 6. Each Party may also call for special meetings of the JDC with reasonable prior written notice to the other Party (it being agreed that at least [***] business days shall constitute reasonable notice) to resolve particular matters requested by such Party and within the decision-making responsibility of the JDC. Each Party shall be responsible for all of its own expenses incurred in connection with participating in all such meetingsParties.
(d) Each Party The quorum for JDC meetings shall provide be four (4) members, provided there are at least two (2) members from each of Licensee and Premas present. The JDC will render decisions by unanimous vote. The members of the JDC such material information as required under this Agreement or as otherwise reasonably requested by the other Party shall act in good faith to cooperate with one another and reasonably available to such Party to enable the other Party to perform its material obligations under this Agreement, in each case relating to the progress of material activities under the Development Plan and other agreed upon material activities reach agreement with respect to each Licensed Productissues to be decided by the JDC.
(e) If Disagreements among the JDC will be resolved via good-faith discussions; provided, that in the event of a dispute arises disagreement that cannot be resolved by the JDC through good faith discussions, the co-chair of either Party may cause such dispute to be referred to their respect Party’s respective Executives for resolution. Such Executives within thirty (or their designees30) will in good faith seek to resolve the matter within [***] days after the date on which the disagreement arose, the matter has been referred to them, or within such longer time period shall be resolved as the Parties may mutually agree upon. In the event that consensus cannot be reached with respect to a decision after a meeting of the Executives, then Licensee shall have the final decision-making authority for all Development activities, provided that requested by Licensee’s decision is consistent with its obligations to use Commercially Reasonable Efforts with respect to Development hereunder.
(f) The At each JDC shall not have any authority beyond meeting, Premas will keep the authority JDC informed regarding the progress and results of development activities with respect to the matters expressly set forth in this Agreement nor any power to amend, modify or waive compliance with this Agreement. In furtherance thereof, each Party shall retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion shall be delegated or vested Products in the JDC unless such delegation or vesting of rights is expressly provided for Territory in this Agreement or the Parties expressly so agree in writingField.
Appears in 1 contract
Sources: License and Development Agreement (Akers Biosciences, Inc.)
Joint Development Committee. (a) Upon Promptly following the Effective Date, the Parties shall establish a joint committee dedicated Joint Development Committee to overseeing Licensee’s Development of oversee, coordinate and review the Licensed Products in activities to be conducted under the Field in the Territory Research Plan and this Agreement (the “Joint Development Committee” or the “JDC”). The JDC shall be comprised of at least two (2) members from each Party with appropriate relevant expertise (each, a “Member”). Each Party shall appoint [***] representatives who possess a general understanding of Development matters may replace any appointed Member at any time upon written notice to act as its representatives on the JDCother Party. Each Party shall designate one (1) of its representatives Members as a co-chair chairperson of the JDC. Each of the co-chair chairpersons shall serve as be responsible, on an alternating basis, with the primary single point of communication within the respective Party’s organization Kite co-chairperson having responsibility with respect to JDC activitiesthe initial meeting, confer for working with the co-chair Alliance Managers to schedule meetings, prepare and circulate an agenda in advance of each meeting. Any JDC member may add topics to the draft agenda. The following shall apply to the JDC and its members:
(a) During the Research Term, the JDC shall meet at least once every Calendar Quarter at times mutually agreed upon by the Parties, or more frequently as the Parties deem appropriate. At least two (2) such meetings per Calendar Year shall be held in person, and all other such meetings may be held by teleconference or videoconference. The location of the meetings to be held in person shall alternate between sites designated by each Party, or as otherwise mutually agreed upon;
(b) The presence of at least two (2) CDL Members and two (2) Kite Members shall be required to constitute a quorum at any meeting of a committee. No business shall be transacted at any meeting of a committee unless a quorum of the members of such committee is present at the time when the meeting proceeds to business;
(c) In addition to its Members, the Parties’ Alliance Managers shall attend and the Parties shall have the right to invite observers to each meeting of a committee. For meetings of the JDC, a Party must provide the other Party regarding JDC logistics and issues and disputes to be raised during JDC meetings, and ensure each Party’s compliance with the rules governing the JDC. Each Party may replace one or more of its representatives (including the co-chair), in its sole discretion, effective upon advance written notice to the other Party of such changeobservers. Each Party’s representatives on the JDC, Such observers shall not have any voting rights and any replacement for any such representative, shall be bound by the written obligations of confidentiality set forth in Article 6. and non-use, either by virtue of his or her employment by such Party or by a separate written agreement; and
(d) Each Party shall be responsible for all of travel and related costs and expenses for its own expenses incurred in connection with participating in all such meetings.
(b) The JDC shallMembers and other representatives to attend meetings of, consistent with the terms and conditions set forth in this Agreement:
i. review and promptly comment on the initial Development Plan for the Second Product for obtaining Regulatory Approval in the Territory (to the extent Licensee exercises the option under Section 2.2 and the Second Product becomes a Licensed Product);
ii. review and promptly comment otherwise participate on any material updates or amendments to the Development Plan;
iii. keep Lipocine reasonably informed, at each JDC meeting, as to the progress of Licensee’s material Development activities under the Development Plan;
iv. review and promptly comment on material Development activities not otherwise included in the Development Plan, including any Phase 4 Trials and other Clinical Trials to be conducted by Licensee to amend the label for a Licensed Product such as to change in dosage forms, strengths, indications or other modifications;
v. keep the other Party reasonably informed of any Licensee Improvements, Lipocine Improvements or Joint Improvements;
vi. subject to Section 4.5 and solely to the extent necessary to effectuate Section 4.5, keep the other Party reasonably informed of the creation of any new Licensee Data or New Lipocine Data generated by a Party or its Representatives (but for clarity, this Section 4.2(b)(vi) shall not permit any access to any Licensee Data or New Lipocine Data by the non-Data Generating Party, which access shall be subject to the terms and conditions of Section 4.5); review and promptly comment on material Regulatory Documentation and material amendments thereto for the Licensed Products prior to submission by Licensee to FDA;
vii. review and approve any material aspects of Clinical Trials in accordance with Section 4.4(b);
viii. perform any and all tasks and responsibilities that are otherwise expressly attributed to the JDC under the Agreement; and
ix. perform such other functions as the Parties may mutually agree in writing. For the avoidance of doubt, should Licensee determine that JDC review and comment in accordance with this Section 4.2(b) is materially hindering its Development activities hereunder (e.g., review is taking an unreasonably long time) due to Lipocine’s representative(s)’s action, inaction or omission, Licensee may proceed with its planned Development activities prior to receipt of comment from the JDC, provided that Licensee’s decision to proceed is consistent with its obligations to use Commercially Reasonable Efforts with respect to Development hereunder. Notwithstanding the foregoing, nothing in this Section 4.2, shall prevent Licensee from taking action to address a safety concerncommittee.
(c) To the extent Licensee exercises the option under Section 2.2 and the Second Product becomes a Licensed Product, the JDC shall meet at least (i) [***] per Calendar Quarter until Regulatory Approval of the Second Product and (ii) for the remainder of the Term, at least [***] per Calendar Year. If the First Product is the only Licensed Product, the JDC shall meet at least [***] per Calendar Year during the Term. The location of JDC meetings shall alternate between locations designated by Lipocine and locations designated by Licensee. The co-chairs of the JDC shall be responsible for calling meetings on reasonable prior notice. Each Party shall use reasonable efforts to make all proposals for agenda items and to provide all appropriate information with respect to such proposed items reasonably in advance of the applicable meeting. The co-chairs may suggest topics for the agenda for JDC meetings and prepare and circulate to the JDC for review and approval of the Parties’ minutes of each meeting within [***] days of a JDC meeting. The Parties shall agree on the minutes of each meeting as promptly as practicable following receipt of the initial draft minutes of such meeting. Representatives of the Parties on the JDC may attend meetings by telephone, videoconference or in person; provided that each participant in any meeting held by telephone or videoconference can hear what is said by, and be heard by, all other participants. Until Regulatory Approval of the Second Product (if applicable), at least [***]
(1) JDC meeting per year shall be held in person, unless by reason of a Force Majeure Event, travel or in-person meeting cannot reasonably occur. A quorum of the JDC shall exist whenever there is present at a meeting at least [***] representative appointed by each Party. As appropriate, and upon at least [***]business days’ prior written notice to the other Party, a Party may allow its other employees or a Third Party to attend JDC meetings as observers; provided, however, that a Party shall not allow a Third Party to attend a JDC meeting without the other Party’s prior written consent, not to be unreasonably withheld, conditioned or delayed; and provided further, however, that each such additional attendee (i) shall not participate in the decision-making process of the JDC and (ii) shall agree in writing to be bound by obligations of confidentiality and non-disclosure consistent with those set forth in Article 6. Each Party may also call for special meetings of the JDC with reasonable prior written notice to the other Party (it being agreed that at least [***] business days shall constitute reasonable notice) to resolve particular matters requested by such Party and within the decision-making responsibility of the JDC. Each Party shall be responsible for all of its own expenses incurred in connection with participating in all such meetings.
(d) Each Party shall provide the JDC such material information as required under this Agreement or as otherwise reasonably requested by the other Party and reasonably available to such Party to enable the other Party to perform its material obligations under this Agreement, in each case relating to the progress of material activities under the Development Plan and other agreed upon material activities with respect to each Licensed Product.
(e) If a dispute arises that cannot be resolved by the JDC through good faith discussions, the co-chair of either Party may cause such dispute to be referred to their respect Party’s respective Executives for resolution. Such Executives (or their designees) will in good faith seek to resolve the matter within [***] days after the matter has been referred to them, or within such longer time period as the Parties may mutually agree upon. In the event that consensus cannot be reached with respect to a decision after a meeting of the Executives, then Licensee shall have the final decision-making authority for all Development activities, provided that Licensee’s decision is consistent with its obligations to use Commercially Reasonable Efforts with respect to Development hereunder.
(f) The JDC shall not have any authority beyond the authority with respect to the matters expressly set forth in this Agreement nor any power to amend, modify or waive compliance with this Agreement. In furtherance thereof, each Party shall retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion shall be delegated or vested in the JDC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing.
Appears in 1 contract
Sources: Research Collaboration and License Agreement (Kite Pharma, Inc.)
Joint Development Committee. (a) Upon Promptly following the Original Effective Date, the Parties shall establish a joint development committee dedicated to overseeing Licensee’s Development of oversee, coordinate and review the Licensed Products in . activities to be conducted under the Field in Research Plan during the Territory Collaboration Term (the “Joint Development Committee” or the “JDC”). The JDC shall be comprised of at three (3) members from each Party with appropriate relevant expertise (each, a “Member”). Each Party shall appoint [***] representatives who possess a general understanding of Development matters may replace any appointed Member at any time upon written notice to act as its representatives on the JDCother Party. Each Party shall designate one (1) of its representatives Members as a co-chair chairperson of the JDC. Each of the co-chair chairpersons shall serve as be responsible, on an alternating basis, with the primary single point of communication within the respective Party’s organization Allogene co-chairperson having responsibility with respect to JDC activitiesthe initial meeting, confer for working with the co-chair of the other Party regarding JDC logistics and issues and disputes Alliance Managers to be raised during JDC schedule meetings, prepare and ensure circulate an agenda in advance of each Party’s compliance with the rules governing the JDCmeeting. Each Party Any JDC member may replace one or more of its representatives (including the co-chair), in its sole discretion, effective upon written notice add topics to the other Party of such changedraft agenda. Each Party’s representatives on the JDC, and any replacement for any such representative, The following shall be bound by the obligations of confidentiality set forth in Article 6. Each Party shall be responsible for all of its own expenses incurred in connection with participating in all such meetings.
(b) The JDC shall, consistent with the terms and conditions set forth in this Agreement:
i. review and promptly comment on the initial Development Plan for the Second Product for obtaining Regulatory Approval in the Territory (to the extent Licensee exercises the option under Section 2.2 and the Second Product becomes a Licensed Product);
ii. review and promptly comment on any material updates or amendments to the Development Plan;
iii. keep Lipocine reasonably informed, at each JDC meeting, as to the progress of Licensee’s material Development activities under the Development Plan;
iv. review and promptly comment on material Development activities not otherwise included in the Development Plan, including any Phase 4 Trials and other Clinical Trials to be conducted by Licensee to amend the label for a Licensed Product such as to change in dosage forms, strengths, indications or other modifications;
v. keep the other Party reasonably informed of any Licensee Improvements, Lipocine Improvements or Joint Improvements;
vi. subject to Section 4.5 and solely to the extent necessary to effectuate Section 4.5, keep the other Party reasonably informed of the creation of any new Licensee Data or New Lipocine Data generated by a Party or its Representatives (but for clarity, this Section 4.2(b)(vi) shall not permit any access to any Licensee Data or New Lipocine Data by the non-Data Generating Party, which access shall be subject to the terms and conditions of Section 4.5); review and promptly comment on material Regulatory Documentation and material amendments thereto for the Licensed Products prior to submission by Licensee to FDA;
vii. review and approve any material aspects of Clinical Trials in accordance with Section 4.4(b);
viii. perform any and all tasks and responsibilities that are otherwise expressly attributed apply to the JDC under the Agreement; and
ix. perform such other functions as the Parties may mutually agree in writing. For the avoidance of doubt, should Licensee determine that JDC review and comment in accordance with this Section 4.2(b) is materially hindering its Development activities hereunder (e.g., review is taking an unreasonably long time) due to Lipocine’s representative(s)’s action, inaction or omission, Licensee may proceed with its planned Development activities prior to receipt of comment from the JDC, provided that Licensee’s decision to proceed is consistent with its obligations to use Commercially Reasonable Efforts with respect to Development hereunder. Notwithstanding the foregoing, nothing in this Section 4.2, shall prevent Licensee from taking action to address a safety concern.members:
(ca) To During the extent Licensee exercises the option under Section 2.2 and the Second Product becomes a Licensed ProductCollaboration Term, the JDC shall meet at least (i) [***] per once every Calendar Quarter until Regulatory Approval of at times mutually agreed upon by the Second Product and Parties, or more frequently as the Parties deem appropriate. At least one (ii1) for the remainder of the Term, at least [***] per Calendar Year. If the First Product is the only Licensed Product, the JDC shall meet at least [***] such meeting per Calendar Year during the Term. The location of JDC meetings shall alternate between locations designated by Lipocine and locations designated by Licensee. The co-chairs of the JDC shall be responsible for calling meetings on reasonable prior notice. Each Party shall use reasonable efforts to make all proposals for agenda items and to provide all appropriate information with respect to such proposed items reasonably in advance of the applicable meeting. The co-chairs may suggest topics for the agenda for JDC meetings and prepare and circulate to the JDC for review and approval of the Parties’ minutes of each meeting within [***] days of a JDC meeting. The Parties shall agree on the minutes of each meeting as promptly as practicable following receipt of the initial draft minutes of such meeting. Representatives of the Parties on the JDC may attend meetings by telephone, videoconference or in person; provided that each participant in any meeting held by telephone or videoconference can hear what is said by, and be heard by, all other participants. Until Regulatory Approval of the Second Product (if applicable), at least [***]
(1) JDC meeting per year shall be held in person, unless and all other such meetings may be held by reason of a Force Majeure Event, travel teleconference or in-person meeting cannot reasonably occurvideoconference. A quorum The location of the JDC meetings to be held in person shall exist whenever there is present at a meeting at least [***] representative appointed alternate between sites designated by each Party. As appropriate, and upon or as otherwise mutually agreed upon.
(b) The presence of at least [***]business days’ prior written notice one Notch Member and one Allogene Member shall be required to the other Party, constitute a Party may allow its other employees or a Third Party to attend JDC meetings as observers; provided, however, that a Party shall not allow a Third Party to attend a JDC quorum at any meeting without the other Party’s prior written consent, not to be unreasonably withheld, conditioned or delayed; and provided further, however, that each such additional attendee (i) shall not participate in the decision-making process of the JDC and JDC.
(iic) shall agree in writing In addition to be bound by obligations of confidentiality and non-disclosure consistent with those set forth in Article 6. Each Party its Members, the Parties’ Alliance Managers may also call for special meetings of the JDC with reasonable prior written notice to the other Party (it being agreed that at least [***] business days shall constitute reasonable notice) to resolve particular matters requested by such Party and within the decision-making responsibility attend any meeting of the JDC. Each Party shall be responsible for all may invite other of its own expenses incurred in connection relevant employees or consultants to a JDC meeting as non-voting observers, provided that (i) such Party must provide the other Party with participating in all advance written notice identifying each such meetingsobserver and such other Party has no reasonable objection to such observers, and (ii) such Party shall ensure that such observers are bound by written obligations relating to confidentiality and intellectual property that are consistent with this Agreement.
(d) Each Party shall provide the JDC such material information as required under this Agreement or as otherwise reasonably requested by the other Party be responsible for all travel and reasonably available to such Party to enable the other Party to perform related costs and expenses for its material obligations under this Agreement, in each case relating to the progress of material activities under the Development Plan Members and other agreed upon material activities with respect representatives to each Licensed Product.
(e) If a dispute arises that cannot be resolved by the JDC through good faith discussionsattend meetings of, and otherwise participate on, the co-chair of either Party may cause such dispute to be referred to their respect Party’s respective Executives for resolution. Such Executives (or their designees) will in good faith seek to resolve the matter within [***] days after the matter has been referred to them, or within such longer time period as the Parties may mutually agree upon. In the event that consensus cannot be reached with respect to a decision after a meeting of the Executives, then Licensee shall have the final decision-making authority for all Development activities, provided that Licensee’s decision is consistent with its obligations to use Commercially Reasonable Efforts with respect to Development hereunderJDC.
(f) The JDC shall not have any authority beyond the authority with respect to the matters expressly set forth in this Agreement nor any power to amend, modify or waive compliance with this Agreement. In furtherance thereof, each Party shall retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion shall be delegated or vested in the JDC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing.
Appears in 1 contract
Sources: Collaboration and License Agreement (Allogene Therapeutics, Inc.)
Joint Development Committee. The Parties recognize that it is in both of their interests to (ai) Upon ▇▇▇▇▇▇ the Effective Datedevelopment of the Licensed Product in the Territory, including regulatory submissions; (ii) minimize the time to First Commercial Sale of the Licensed Product in the Territory during the term of this Agreement; and (iii) coordinate the activities of both Parties with respect to the development and time to First Commercial Sale of the Licensed Product in the Territory.
3.2.1 Accordingly, the Parties shall hereby establish a joint development committee dedicated to overseeing Licensee’s Development made up of the Licensed Products an equal number of representatives of each Party set forth in the Field in the Territory Schedule B hereto (the “Joint Development Committee” or the “JDC”). Each Party Both Parties shall appoint [***] representatives who possess have the right from time to time to substitute individuals, on a general understanding of Development matters to act as its representatives on the JDC. Each Party shall designate one permanent or temporary basis, for any of its representatives as a co-chair previously designated members of the JDC. Each coThe members appointed by each Party shall be vested with appropriate decision-chair making authority and power by such Party. Either Party shall serve have the right to engage Third Parties to assist as the primary single point members of communication within the respective Party’s organization with respect to JDC activities, confer with the co-chair of the other Party regarding JDC logistics and issues and disputes to be raised during JDC meetings, and ensure each Party’s compliance with the rules governing the JDC. Each Party may replace one or more of its representatives (including the co-chair), in its sole discretion, effective upon written notice to the other Party of such change. Each Party’s representatives on the JDC, and any replacement for any such representativeprovided, shall be bound by however, (i) said Third Party agrees to protect the obligations confidential information of confidentiality set forth in Article 6. Each Party shall be responsible for all of its own expenses incurred in connection with participating in all such meetings.
(b) The JDC shall, both Parties consistent with the terms and conditions set forth provisions of Section 10; and (ii) the applicable Party obtains the prior written approval of the other Party of said Third Party, such approval not to be unreasonably withheld or delayed.
3.2.2 The JDC shall meet: (i) once every six months prior to the First Commercial Sale, or more often as needed, on a date and at a location to be agreed to by the JDC, and (ii) upon written notice by either Party to the other that a meeting is required or requested, in this Agreement:which case a meeting will be held within fourteen (14) calendar days of such notice on a date and at a location to be agreed to by the Parties. After the First Commercial Sale the JDC shall meet on an as needed basis. Notice requesting a meeting shall include adequate information describing the activity to be reviewed. Any meetings of the JDC may be held in person at a location to be agreed to by the Parties, or by videoconference or teleconference. Other representatives of the Parties may attend JDC meetings as participants. The Parties shall agree, at the first meeting of the JDC, upon procedures for maintaining meeting minutes.
i. review 3.2.3 The purpose of the JDC is to serve as an advisory committee and promptly comment on to make recommendations and to coordinate the initial Development Plan for development and clinical study efforts of the Second Parties with respect to the development effort of the Licensed Product for obtaining Regulatory Approval in the Territory (and to minimize the time to First Commercial Sale thereof. Accordingly, the JDC shall discuss and resolve, to the extent Licensee exercises possible, any issues that arise under this Agreement including, without limitation, the option under Section 2.2 and following:
(a) Review of the Second Product becomes a Licensed Product);
ii. review and promptly comment on any material updates or amendments to the Development Plan;
iii. keep Lipocine reasonably informed, at each JDC meeting, as to the progress of Licensee’s material Development activities under the Development Plan;
iv. review and promptly comment on material Development activities not otherwise included in the Development Plan, including any Phase 4 Trials and other Clinical Trials to be conducted by Licensee to amend the label for a Licensed Product such as to change in dosage forms, strengths, indications or other modifications;
v. keep the other Party reasonably informed of any Licensee Improvements, Lipocine Improvements or Joint Improvements;
vi. subject to Section 4.5 and solely to the extent necessary to effectuate Section 4.5, keep the other Party reasonably informed of the creation of any new Licensee Data or New Lipocine Data generated by a Party or its Representatives (but for clarity, this Section 4.2(b)(vi) shall not permit any access to any Licensee Data or New Lipocine Data by the non-Data Generating Party, which access shall be subject to the terms and conditions of Section 4.5); review and promptly comment on material Regulatory Documentation and material amendments thereto development plan for the Licensed Products prior Product, including clinical study requirements and protocol needed for FDA approval ;
(b) Determining the analytical methods, validation, and stability of Licensed Product to submission be provided by Licensee to FDA;
vii. review and approve any material aspects of Clinical Trials for use in accordance with Section 4.4(b);
viii. perform any and all tasks and responsibilities that are otherwise expressly attributed to the JDC under the AgreementTerritory; and
ix. perform such other functions as the Parties may mutually agree in writing. For the avoidance of doubt, should Licensee determine that JDC review and comment in accordance with this Section 4.2(b) is materially hindering its Development activities hereunder (e.g., review is taking an unreasonably long time) due to Lipocine’s representative(s)’s action, inaction or omission, Licensee may proceed with its planned Development activities prior to receipt of comment from the JDC, provided that Licensee’s decision to proceed is consistent with its obligations to use Commercially Reasonable Efforts with respect to Development hereunder. Notwithstanding the foregoing, nothing in this Section 4.2, shall prevent Licensee from taking action to address a safety concern.
(c) To Determining the extent Licensee exercises the option under Section 2.2 optimal concentration of Licensed Product and the Second Product becomes a Licensed Product, the JDC shall meet at least (i) [***] per Calendar Quarter until Regulatory Approval packaging of the Second Licensed Product and (ii) in preparation for First Commercial Sale.
3.2.4 In the remainder of the Term, at least [***] per Calendar Year. If the First Product is the only Licensed Product, the JDC shall meet at least [***] per Calendar Year during the Term. The location of JDC meetings shall alternate between locations designated by Lipocine and locations designated by Licensee. The co-chairs of the JDC shall be responsible for calling meetings on reasonable prior notice. Each Party shall use reasonable efforts to make all proposals for agenda items and to provide all appropriate information with respect to such proposed items reasonably in advance of the applicable meeting. The co-chairs may suggest topics for the agenda for JDC meetings and prepare and circulate to the JDC for review and approval of the Parties’ minutes of each meeting within [***] days event of a JDC meeting. The Parties shall agree on the minutes of each meeting as promptly as practicable following receipt of the initial draft minutes of such meeting. Representatives of the Parties on the JDC may attend meetings by telephone, videoconference or in person; provided that each participant in any meeting held by telephone or videoconference can hear what is said by, and be heard by, all other participants. Until Regulatory Approval of the Second Product (if applicable), at least [***]
(1) JDC meeting per year shall be held in person, unless by reason of a Force Majeure Event, travel or in-person meeting cannot reasonably occur. A quorum of the JDC shall exist whenever there is present at a meeting at least [***] representative appointed by each Party. As appropriate, and upon at least [***]business days’ prior written notice to the other Party, a Party may allow its other employees or a Third Party to attend JDC meetings as observers; provided, however, that a Party shall not allow a Third Party to attend a JDC meeting without the other Party’s prior written consent, not to be unreasonably withheld, conditioned or delayed; and provided further, however, that each such additional attendee (i) shall not participate in the decision-making process of the JDC and (ii) shall agree in writing to be bound by obligations of confidentiality and non-disclosure consistent with those set forth in Article 6. Each Party may also call for special meetings of the JDC with reasonable prior written notice to the other Party (it being agreed that at least [***] business days shall constitute reasonable notice) to resolve particular matters requested by such Party and within the decision-making responsibility of the JDC. Each Party shall be responsible for all of its own expenses incurred in connection with participating in all such meetings.
(d) Each Party shall provide the JDC such material information as required under this Agreement or as otherwise reasonably requested by the other Party and reasonably available to such Party to enable the other Party to perform its material obligations under this Agreement, in each case relating to the progress of material activities under the Development Plan and other agreed upon material activities with respect to each Licensed Product.
(e) If a dispute arises that cannot be resolved by the JDC through good faith discussionsotherwise resolved, the co-chair of either Party may cause such dispute to be referred to their respect PartyLicensee’s respective Executives for resolution. Such Executives (or their designees) will in good faith seek to resolve the matter within [***] days after the matter has been referred to them, or within such longer time period as the Parties may mutually agree upon. In the event that consensus cannot be reached with respect to a decision after a meeting of the Executives, then Licensee President shall have the final decision-making authority. That authority for all Development activitiesmay be exercised in Licensee’s President’s discretion, provided that Licensee’s decision it is consistent with its obligations to use Commercially Reasonable Efforts with respect to Development hereunder.
(f) The JDC shall not have any authority beyond the authority with respect to the matters expressly set forth in this Agreement nor any power to amend, modify or waive compliance with terms of this Agreement. In furtherance thereof, each Party shall retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion shall be delegated or vested in the JDC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing.
Appears in 1 contract
Joint Development Committee. (a) Upon the Effective Date, the The Parties shall will also establish a joint committee dedicated to overseeing Licensee’s Development of the Licensed Products in the Field in the Territory (the “Joint Development Committee” or the Committee (“JDC”). Each , composed of three representatives of each Party shall appoint [***] representatives who possess a general understanding selected by the Parties that have knowledge and expertise in the development of products similar to Product to oversee the Development matters to act as its representatives on the JDC. Each Party shall designate one of its representatives as a co-chair of the JDCProduct hereunder and to coordinate the global development of Product. Each co-chair The initial JDC chairperson shall be appointed by Norgine and shall serve in such capacity for one (1) year. Thereafter, the member of the JDC who shall serve as the primary single point of communication within the respective Party’s organization with respect to JDC activities, confer with the co-chair of the other Party regarding JDC logistics and issues and disputes to chairperson shall be raised during JDC meetings, and ensure designated alternately by each Party’s compliance , with the rules governing the JDCeach chairperson serving for a period of one (1) year. Each Party may replace one or more of its JDC representatives (including the co-chair), in its sole discretion, effective upon by written notice to the other Party. The role of the JDC shall be:
(i) to facilitate the exchange of Information between the Parties under this Agreement with respect to their Product-related activities (including activities conducted in the Licensed Territory and the Retained Territory), including as and to the extent necessary for each Party of such change. Each Party’s representatives to perform its obligations under this Agreement;
(ii) to develop, review and comment on the JDCDevelopment Plan (and associated budget) and all amendments and updates thereto, and any replacement to submit such plan (and associated budget) to the JSC for any approval (it being understood that the JDC shall submit such representativeplan (and associated budget) with sufficient time for the JSC to review and approve such plan); and
(iii) to establish such working teams or subcommittees and to perform such other functions as appropriate to further the purposes of this Agreement, shall be bound as determined by the obligations of confidentiality set forth Parties in Article 6. Each Party shall be responsible for all of its own expenses incurred in connection with participating in all such meetingswriting.
(b) The JDC shall, consistent with the terms and conditions set forth in this Agreement:
i. review and promptly comment on the initial Development Plan for the Second Product for obtaining Regulatory Approval in the Territory (to the extent Licensee exercises the option under Section 2.2 and the Second Product becomes a Licensed Product);
ii. review and promptly comment on any material updates or amendments to the Development Plan;
iii. keep Lipocine reasonably informed, at each JDC meeting, as to the progress of Licensee’s material Development activities under the Development Plan;
iv. review and promptly comment on material Development activities not otherwise included in the Development Plan, including any Phase 4 Trials and other Clinical Trials to be conducted by Licensee to amend the label for a Licensed Product such as to change in dosage forms, strengths, indications or other modifications;
v. keep the other Party reasonably informed of any Licensee Improvements, Lipocine Improvements or Joint Improvements;
vi. subject to Section 4.5 and solely to the extent necessary to effectuate Section 4.5, keep the other Party reasonably informed of the creation of any new Licensee Data or New Lipocine Data generated by a Party or its Representatives (but for clarity, this Section 4.2(b)(vi) shall not permit any access to any Licensee Data or New Lipocine Data by the non-Data Generating Party, which access shall be subject to the terms and conditions of Section 4.5); review and promptly comment on material Regulatory Documentation and material amendments thereto for the Licensed Products prior to submission by Licensee to FDA;
vii. review and approve any material aspects of Clinical Trials in accordance with Section 4.4(b);
viii. perform any and all tasks and responsibilities that are otherwise expressly attributed to the JDC under the Agreement; and
ix. perform such other functions as the Parties may mutually agree in writing. For the avoidance of doubt, should Licensee determine that JDC review and comment in accordance with this Section 4.2(b) is materially hindering its Development activities hereunder (e.g., review is taking an unreasonably long time) due to Lipocine’s representative(s)’s action, inaction or omission, Licensee may proceed with its planned Development activities prior to receipt of comment from the JDC, provided that Licensee’s decision to proceed is consistent with its obligations to use Commercially Reasonable Efforts with respect to Development hereunder. Notwithstanding the foregoing, nothing in this Section 4.2, shall prevent Licensee from taking action to address a safety concern.
(c) To the extent Licensee exercises the option under Section 2.2 and the Second Product becomes a Licensed Product, the JDC shall meet at least once per quarter, unless otherwise specified by the JSC, at times mutually agreed upon by the Parties. At least two (i2) such meetings per calendar year must be held in person, and all other such meetings may be held by teleconference or videoconference. The location of the JDC meetings shall alternate between sites designated by each Party, with the first such meeting of the JDC to be held in person to be at Tranzyme’s offices. A unanimous vote of all the members of the JDC is required to make decisions. In the event of a disagreement among members of the JDC, the committee members shall use good PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO AN APPICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [***] per Calendar Quarter until Regulatory Approval of the Second Product DENOTES OMISSIONS. faith efforts to discuss and (ii) for the remainder of the Term, at least [***] per Calendar Yearresolve expeditiously such disagreement. If the First Product is the only Licensed Product, the JDC shall meet at least [***] per Calendar Year during the Term. The location of JDC meetings shall alternate between locations designated by Lipocine and locations designated by Licensee. The co-chairs a disagreement among members of the JDC shall be responsible remains unresolved for calling meetings on reasonable prior notice. Each Party shall use reasonable efforts to make all proposals for agenda items and to provide all appropriate information with respect to such proposed items reasonably in advance of the applicable meeting. The co-chairs may suggest topics for the agenda for JDC meetings and prepare and circulate to the JDC for review and approval of the Parties’ minutes of each meeting within [***] days of a JDC meeting. The Parties shall agree on the minutes of each meeting as promptly as practicable following receipt of the initial draft minutes of such meeting. Representatives of the Parties on the JDC may attend meetings by telephone, videoconference or in person; provided that each participant in any meeting held by telephone or videoconference can hear what is said by, and be heard by, all other participants. Until Regulatory Approval of the Second Product more than thirty (if applicable), at least [***]
(130) JDC meeting per year shall be held in person, unless by reason of a Force Majeure Event, travel or in-person meeting cannot reasonably occur. A quorum of the JDC shall exist whenever there is present at a meeting at least [***] representative appointed by each Party. As appropriate, and upon at least [***]business days’ prior written notice to the other Party, a Party may allow its other employees or a Third Party to attend JDC meetings as observers; provided, however, that a Party shall not allow a Third Party to attend a JDC meeting without the other Party’s prior written consent, not to be unreasonably withheld, conditioned or delayed; and provided further, however, that each such additional attendee (i) shall not participate in the decision-making process of the JDC and (ii) shall agree in writing to be bound by obligations of confidentiality and non-disclosure consistent with those set forth in Article 6. Each Party may also call for special meetings of the JDC with reasonable prior written notice to the other Party (it being agreed that at least [***] business days shall constitute reasonable notice) to resolve particular matters requested by such Party and within the decision-making responsibility of the JDC. Each Party shall be responsible for all of its own expenses incurred in connection with participating in all such meetings.
(d) Each Party shall provide the JDC such material information as required under this Agreement or as otherwise reasonably requested by the other Party and reasonably available to such Party to enable the other Party to perform its material obligations under this Agreement, in each case relating to the progress of material activities under the Development Plan and other agreed upon material activities with respect to each Licensed Product.
(e) If a dispute arises that cannot be resolved by the JDC through good faith discussions, the co-chair of either Party may cause such dispute to be referred to their respect Party’s respective Executives for resolution. Such Executives (or their designees) will in good faith seek to resolve the matter within [***] days after the committee first addresses such matter has been referred to them, (or within such longer time period as the Parties may mutually agree upon), such disagreement shall be submitted to the JSC for resolution under Section 3.2. In the event that consensus cannot be reached with respect to a decision after a meeting of the Executives, then Licensee shall have the final decision-making authority for all Development activities, provided that Licensee’s decision is consistent with its obligations to use Commercially Reasonable Efforts with respect to Development hereunder.
(f) The JDC shall not have any authority beyond the authority with respect to the matters expressly set forth in this Agreement nor any no power to amend, modify amend or waive compliance with this Agreement. In furtherance thereof, each Party shall retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion shall be delegated or vested in the JDC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing.
Appears in 1 contract
Sources: License Agreement (Tranzyme Inc)
Joint Development Committee. (a) Upon Promptly after the Effective Date, the Parties shall establish form a joint committee dedicated to overseeing Licensee’s Development of the Licensed Products in the Field in the Territory (the “Joint Development Committee” or Committee (the “JDC”)) to oversee the Combined Therapy Studies conducted under this Agreement. Each Party The JDC shall appoint consist of [***] representatives who possess a general understanding of Development matters to act as its representatives on the JDC. Each Party shall designate one of its representatives as a co-chair of the JDC. Each co-chair shall serve as the primary single point of communication within the respective Party’s organization with respect to JDC activities, confer with the co-chair of the other Party regarding JDC logistics and issues and disputes to be raised during JDC meetings, and ensure each Party’s compliance with the rules governing the JDC. Each Party may replace one or more of its representatives (including the co-chair), in its sole discretion, effective upon written notice to the other Party of such change. Each Party’s representatives on the JDC, and any replacement for any such representative, shall be bound by the obligations of confidentiality set forth in Article 6]. Each Party shall be responsible for all determining the qualifications and substitutions of its own expenses incurred JDC members. It is anticipated that each Party’s representatives may include experts in connection with participating in all such meetings.
(b) clinical development, patient safety and regulatory affairs. The JDC shall, consistent with the terms and conditions set forth in this Agreement:
i. review and promptly comment on the initial Development Plan for the Second Product for obtaining Regulatory Approval in the Territory (to the extent Licensee exercises the option under Section 2.2 and the Second Product becomes a Licensed Product);
ii. review and promptly comment on any material updates or amendments to the Development Plan;
iii. keep Lipocine reasonably informed, at each JDC meeting, as to the progress of Licensee’s material Development activities under the Development Plan;
iv. review and promptly comment on material Development activities not otherwise included in the Development Plan, including any Phase 4 Trials and other Clinical Trials to be conducted by Licensee to amend the label for a Licensed Product such as to change in dosage forms, strengths, indications or other modifications;
v. keep the other Party reasonably informed of any Licensee Improvements, Lipocine Improvements or Joint Improvements;
vi. subject to Section 4.5 and solely to the extent necessary to effectuate Section 4.5, keep the other Party reasonably informed of the creation of any new Licensee Data or New Lipocine Data generated by a Party or its Representatives (but for clarity, this Section 4.2(b)(vi) shall not permit any access to any Licensee Data or New Lipocine Data by the non-Data Generating Party, which access shall be subject to the terms and conditions of Section 4.5co-chaired with one co-chairperson designated by each Party (each, a “Co-Chair”); review and promptly comment . The JDC shall meet on material Regulatory Documentation and material amendments thereto for the Licensed Products prior to submission by Licensee to FDA;
vii. review and approve any material aspects of Clinical Trials in accordance with Section 4.4(b);
viii. perform any and all tasks and responsibilities that are otherwise expressly attributed to a Quarterly basis, or more or less frequently as the JDC under the Agreement; and
ix. perform such other functions as the Parties agrees (and it may mutually agree in writing. For the avoidance of doubt, should Licensee determine that JDC review and comment in accordance with this Section 4.2(b) is materially hindering its Development activities hereunder (e.g., review is taking an unreasonably long time) due appoint subteams to Lipocine’s representative(smeet more frequently)’s action, inaction or omission, Licensee may proceed with its planned Development activities prior to receipt of comment from the JDC, provided that Licensee’s decision to proceed is consistent with either Party through its obligations to use Commercially Reasonable Efforts with respect to Development hereunder. Notwithstanding the foregoing, nothing in this Section 4.2, shall prevent Licensee from taking action to address Co-Chair may request a safety concern.
(c) To the extent Licensee exercises the option under Section 2.2 and the Second Product becomes a Licensed Product, the JDC shall meet at least (i) [***] per Calendar Quarter until Regulatory Approval of the Second Product and (ii) for the remainder of the Term, at least [***] per Calendar Year. If the First Product is the only Licensed Product, the JDC shall meet at least [***] per Calendar Year during the Term. The location of JDC meetings shall alternate between locations designated by Lipocine and locations designated by Licensee. The co-chairs meeting of the JDC shall be responsible for calling meetings on reasonable prior notice. Each Party shall use reasonable efforts to make all proposals for agenda items and to provide all appropriate information with respect to such proposed items reasonably in advance of (or the applicable meeting. The coCo-chairs may suggest topics for the agenda for JDC meetings and prepare and circulate to the JDC for review and approval of the Parties’ minutes of each meeting within Chairs only) at any time upon [***] days of a JDC meeting. The Parties shall agree on the minutes of each meeting as promptly as practicable following receipt of the initial draft minutes of such meeting. Representatives of the Parties on the JDC may attend meetings by telephone, videoconference or in person; provided that each participant in any meeting held by telephone or videoconference can hear what is said by, and be heard by, all other participants. Until Regulatory Approval of the Second Product (if applicable), at least [***]
(1) JDC meeting per year shall be held in person, unless by reason of a Force Majeure Event, travel or in-person meeting cannot reasonably occur. A quorum of the JDC shall exist whenever there is present at a meeting at least [***] representative appointed by each Party. As appropriate, and upon at least [***]business days’ prior written notice to the other Party, with the understanding that the other Party will use reasonable efforts to comply with such request but such other Party will not be in breach of this Agreement in the event that it is unable to comply with such request but is using reasonable efforts to conduct a JDC meeting as promptly as practicable. Upon request by either Party, such meetings will be held by audio or video teleconference, provided that face-to-face meetings shall occur at least semi-annually. No fewer than [*] prior to each meeting, and in any event as soon as reasonably practicable, each Party shall use good faith efforts to disclose to the other Party any proposed agenda items together with appropriate supporting information. The Co-Chairs shall alternate responsibility for preparing and circulating the final agendas for, and the definitive minutes of each meeting of the JDC, and may conduct such activities through their designees. Such minutes shall provide a description, in reasonable detail, of the discussions at the meeting, a list of material actions and decisions made by the JDC, a list of action items made by the JDC and a list of material issues not resolved by the JDC. The JDC Co-Chair who drafts the minutes (or his or her designee) shall provide the other Co-Chair and each Party’s Alliance Managers with the initial draft meeting minutes, who shall return the draft with any proposed changes, and this process shall be repeated until a final version of the meeting minutes is agreed upon and signed (or acknowledged as final via email) by each of the Co-Chairs. The Parties shall reasonably cooperate to complete and agree upon a final version of meeting minutes within [*] from the date of the relevant meeting. The final version of the meeting minutes shall be signed (or acknowledged as final via email) by the two Co-Chairs, and each Party shall be provided with a copy of the final version of the meeting minutes for its safekeeping. To the extent relevant to the agenda, a reasonable number of additional representatives of a Party may allow its other employees or a Third Party to attend JDC meetings as observers; provided, however, that a Party shall not allow a Third Party to attend a JDC meeting without the other Party’s prior written consent, not to be unreasonably withheld, conditioned or delayed; and provided further, however, that each such additional attendee (i) shall not participate in the decision-making process of the JDC and (ii) shall agree in writing to be bound by obligations of confidentiality and non-disclosure consistent with those set forth in Article 6. Each Party may also call for special meetings of the JDC in advisory capacity with reasonable the prior written notice consent of the other Party. All representatives to the other Party (it being agreed that JDC or attending JDC meetings shall be subject to confidentiality and nonuse restrictions at least [***] business days shall constitute reasonable notice) to resolve particular matters requested by such Party and within the decision-making responsibility of the JDC. Each Party shall be responsible for all of its own expenses incurred in connection with participating in all such meetings.
(d) Each Party shall provide the JDC such material information as required under this Agreement or restrictive as otherwise reasonably requested by the other Party and reasonably available to such Party to enable the other Party to perform its material obligations under this Agreement, in each case relating to the progress of material activities under the Development Plan and other agreed upon material activities with respect to each Licensed Product.
(e) If a dispute arises that cannot be resolved by the JDC through good faith discussions, the co-chair of either Party may cause such dispute to be referred to their respect Party’s respective Executives for resolution. Such Executives (or their designees) will in good faith seek to resolve the matter within [***] days after the matter has been referred to them, or within such longer time period as the Parties may mutually agree upon. In the event that consensus cannot be reached with respect to a decision after a meeting of the Executives, then Licensee shall have the final decision-making authority for all Development activities, provided that Licensee’s decision is consistent with its obligations to use Commercially Reasonable Efforts with respect to Development hereunder.
(f) The JDC shall not have any authority beyond the authority with respect to the matters expressly those set forth in this Agreement nor any power to amend, modify or waive compliance with this Agreement. In furtherance thereof, each Party shall retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion shall be delegated or vested in the JDC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writingherein.
Appears in 1 contract
Sources: Master Clinical Trial Collaboration Agreement (Compugen LTD)