Decision Making. 4.4.1 With respect to decisions of the JSC, the representatives of each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, at least one (1) representative of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensus. 4.4.2 If the JSC is unable to reach a consensus with respect to a dispute for a period in excess of [***] days, then the dispute shall be submitted to the Chief Executive Officers of Alnylam and MedCo for resolution. 4.4.3 If such escalated dispute cannot be resolved for a period in excess of [***] days, then: (a) [***]; and (b) [***]. 4.4.4 Notwithstanding the foregoing, MedCo may not exercise its final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take or decline to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or (v) to expand or narrow the responsibilities of the JSC.
Appears in 3 contracts
Samples: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.), License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.), License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Decision Making. 4.4.1 With respect 3.4.1 Subject to decisions the terms of the JSCthis Section 3.4, the representatives of each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, at least one (1) representative of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting. Action on any matter may be taken at a meeting, will take action by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensus.
4.4.2 If the JSC is unable to reach a consensus with respect to a dispute for a period in excess of [***] dayswith each Party having [***], irrespective of the number of representatives actually in attendance at a meeting, or by a written resolution signed by the designated representatives to the JSC of each of the Parties. The JSC members shall use good faith efforts to reach agreement on any and all matters submitted to it. If the JSC fails to reach unanimous consent on a particular matter within thirty (30) days of a Party having requested a formal vote on such matter (or, if such matter is urgent, within seven (7) days of such request), then such dispute will be subject to the resolution procedures described in Section 3.4.2.
3.4.2 In the event of any dispute shall be submitted in the JSC that is not resolved pursuant to the terms of Section 3.4.1, either Party may provide written Notice of such failure (a “Notice of Disagreement”) to the other Party in order to refer such dispute to the Chief Executive Officer of Reata and the Chief Operating Officer or Kyowa Kirin for potential resolution. Following any such Notice of Disagreement, the Chief Executive Officer of Reata and the Chief Operating Officer of Kyowa Kirin will meet at least once in person or by means of live telecommunication (telephone, video, or web conferences) to discuss the matter on which the JSC failed to reach unanimous consent and use their good faith efforts to resolve the matter within thirty (30) days after receipt of the Notice of Disagreement by the applicable Party. If any such disagreement is not resolved by the Chief Executive/Operating Officers of Alnylam and MedCo for resolution.
4.4.3 If or their designees within such escalated dispute cannot be resolved for a period thirty (30) day period, then, subject to the restrictions in excess of Section 3.4.4 below, [***] dayswill have the final decision-making authority with respect to any such disagreement relating to any Commercialization in the Territory. In making any such final decision, then:
(a) [***]; and
(b) ] shall reasonably consider, in good faith, any issues raised by [***] concerning risks that such decision could have a material adverse effect on [***].
4.4.4 3.4.3 Notwithstanding this Section 3.4, any dispute regarding the foregoinginterpretation of this Agreement, MedCo may the performance or alleged nonperformance of a Party’s obligations under this Agreement, or any alleged breach of this Agreement will be resolved in accordance with the terms of ARTICLE XVI and shall not exercise its be subject to the JSC decision-making.
3.4.4 With respect to any and all JSC decisions regarding clinical studies for Licensed Products within the Field by Kyowa Kirin, the following shall apply:
(a) For clinical studies within the protocols already established in studies by Reata (subject to variations in dose and dosing within the parameters of subsections (i) and (ii) below) and related to the development of Licensed Product for the treatment of chronic kidney disease (“CKD”), [***] shall have final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo conduct any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “such clinical studies that [***]”;
(b) For clinical studies for the Indication of CKD, but outside of the protocols and parameters described in Section 3.4.4(a), Kyowa Kirin shall provide summaries of such clinical studies and their proposed protocols to Reata. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this AgreementUpon review, (iii) if Reata reasonably believes those studies have the potential to adversely affect the safety profile of the Licensed Compound or to adversely impact patient safety, then Reata shall have the right to require Alnylam an independent panel of medical and scientific reviewers evaluate the proposed study (the “Technical Review Panel”), at Reata’s expense. The Technical Review Panel shall be comprised of three unaffiliated, independent members, and will act by majority vote. The members of the Technical Review Panel will be appointed as follows: (i) within [***] days of Reata’s request for a Technical Review Panel, each Party shall designate (in its sole discretion) an expert with technical expertise in the relevant area to take or decline be a member of the Technical Review Panel; (ii) within [***] days of each Party making their member designation, those designated members shall designate another expert with technical expertise in the relevant area to take any action be the third member of the Technical Review Panel, who will serve as the chairman of the panel. Within [***] days of the designation of the entire three-member Technical Review Panel, each Party shall submit a written statement detailing its positions with respect to the safety concerns of Reata that would result in prompted the request for a violation review by the Technical Review Panel. Promptly after the submission of any Law or any agreement with any Third Party or each Party’s written statements, the infringement of intellectual property rights of Third Technical Review Panel shall deliver to the Parties, in writing, the Technical Review Panel’s conclusions regarding the safety concerns of Reata, and its recommendations (ivif any) in a manner that excuses MedCo from for modification of Kyowa Kirin’s proposed protocol to address such safety concerns (taking into consideration the requirements for Commercialization Regulatory Approval). In the event the Technical Review Panel agrees with Reata’s safety concerns, [***].
(c) For any of its obligations specifically enumerated under this Agreementanimal studies proposed by Kyowa Kirin, or (v) to expand or narrow the responsibilities and for all proposed Kyowa Kirin clinical studies outside of the JSCCKD indication, Kyowa Kirin shall provide summaries of such clinical studies and their proposed protocols to Reata. Upon review, Reata has final authority to veto the studies if Reata determines, in its sole but reasonable discretion, that Reata has a reasonable basis to believe that the proposed studies present a risk of adversely affecting the safety profile of the Licensed Compound or adversely impacting patient safety.
Appears in 2 contracts
Samples: Exclusive License and Supply Agreement (Reata Pharmaceuticals Inc), Exclusive License and Supply Agreement (Reata Pharmaceuticals Inc)
Decision Making. 4.4.1 With respect Action by the JSC on matters to decisions of be determined by the JSC, the representatives of each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, at least one (1) representative of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensus.
4.4.2 If the require unanimous approval, with Licensor JSC is unable to reach a consensus with respect to a dispute for a period in excess of Members collectively having [***] daysand Licensee JSC Members collectively having [***]. In the event that the JSC does not unanimously approve any action, the JSC shall take no action on the matter at issue. In the event the JSC fails to reach unanimous agreement with respect to a particular matter within its authority, then the dispute shall be submitted either Party may, by written notice to the Chief Executive Officers other Party, have such matter referred to a senior executive officer of Alnylam each party who is senior in rank and MedCo for resolution.
4.4.3 If authority to such escalated dispute cannot be resolved for party’s JSC representatives, holds a period in excess title of at least [***] days, then:
and has the authority to resolve the dispute (a) “Senior Executive(s)”). The Senior Executives shall meet promptly (and in no event more than [***]; and
] days after a Party notifies the other Party of the referral of the dispute to the Senior Executives) and negotiate in good faith to resolve the dispute. If, despite such good faith efforts, the Senior Executives are unable to resolve such dispute (beach, a “Committee Dispute”), then: (a) [***].
4.4.4 Notwithstanding to the foregoingextent such Committee Dispute relates to operational matters related solely to the Development, MedCo may not exercise its Manufacture or Commercialization of the Licensed Products in the Territory, then Licensee will have final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, such Committee Dispute (iiib) to require Alnylam the extent such Committee Dispute relates to take operational matters related solely to the Development, Manufacture or decline to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or (v) to expand or narrow the responsibilities Commercialization of the JSCLicensed Products outside of the Territory, then Licensor will have final decision-making authority with respect to such Committee Dispute and (c) all other Committee Disputes shall be escalated to the dispute resolution mechanism procedures set forth in Section 12.11.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Cullinan Oncology, LLC), License and Collaboration Agreement (Cullinan Oncology, LLC)
Decision Making. 4.4.1 With respect to decisions of the JSC, the representatives of each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, at least one (1) representative of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensus.
4.4.2 If the JSC is unable to reach a consensus with respect to a dispute for a period in excess of [***] days, then the dispute shall be submitted to the Chief Executive Officers of Alnylam and MedCo for resolution.
4.4.3 If such escalated dispute cannot be resolved for a period in excess of [***] days, then:
(a) : [***]; and
(b) [***].
4.4.4 Notwithstanding the foregoing, MedCo may not exercise its final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take or decline to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or (v) to expand or narrow the responsibilities of the JSC.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Medicines Co /De), License and Collaboration Agreement (Medicines Co /De)
Decision Making. 4.4.1 With respect (a) Subject to the remainder of this Section 3.4, decisions of the JSCJSC shall be made by unanimous vote, the representatives of each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, with at least one (1) representative of from each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate participating in each JSC meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensusvote.
4.4.2 If (b) In the event that the JSC is unable to do not reach a consensus with respect to a dispute for a period in excess of [***] days, then particular matter within five (5) business days after the dispute shall be matter is submitted to the JSC, then either Party may, by written notice to the other Party, have such matter referred to (i) Bioprojet’s Chief Executive Officers Officer on the part of Alnylam Bioprojet and MedCo for resolution(ii) Partner’s Chief Executive Officer on the part of Partner (collectively, “Senior Executives”) who shall meet promptly and negotiate in good faith to attempt to resolve the dispute.
4.4.3 If (c) If, despite such escalated good faith efforts, the Senior Executives are unable to resolve such dispute cannot be resolved for a period in excess of [***] daysduring such meeting, then:
(a) [***]; and
(b) [***].
4.4.4 Notwithstanding the foregoing, MedCo may not exercise its final decision-making authority (i) if such dispute relates to require Alnylam the Commercialization Plan (other than with respect to undertake obligations beyond those for matters that relate to any proposed reduction of the level of resources to be committed by Partner under the Commercialization Plan, including the number of deployed sales representatives and the marketing and promotional spending, which it is responsiblematters shall be subject to clause (iv) below), the labeling of the Product (including negotiations with the FDA related thereto), regulatory activities or forgo any rightsmedical affairs strategies and activities in the Territory, under this Agreement, Partner shall have the right to cast the deciding vote on such matter;
(ii) if such dispute relates to cause Alnylam the price/branding positioning strategy of the Product, Partner shall have the right to incur cast the deciding vote on such matter, provided that any Costs above the then-applicable Development Costs Cap change shall be duly justified by Partner by a significant market change;
(iii) if such dispute relates to plans for any Clinical Study with respect to which MedCo has the Product (including any IST), such Clinical Study will not otherwise agreed be conducted without Bioprojet’s vote, unless such Clinical Study is required by any Regulatory Authority in the Partner Territory so as to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take or decline to take maintain any action that would result Regulatory Approval in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, Partner Territory;
(iv) in for any other matters to be decided by the JSC, including for clarity matters pertaining to any reduction to the overall level of resources to be committed by Partner under the Commercialization Plan, no such matters shall be implemented without unanimous consent of the Parties.
(d) For clarity, neither Party shall have the right to cast a manner that excuses MedCo deciding vote to excuse itself from any of its obligations specifically enumerated under this Agreement, or (v) to expand or narrow the responsibilities of the JSC.
Appears in 2 contracts
Samples: License and Commercialization Agreement (Harmony Biosciences Holdings, Inc.), License and Commercialization Agreement (Harmony Biosciences Holdings, Inc.)
Decision Making. 4.4.1 With 7.1 All resolutions of the General Meeting of Shareholders shall be taken with a simple majority of the votes cast, provided that a resolution shall only be validly taken if a simple majority of the votes cast on the A-Shares and B-shares in a meeting in which at least the majority of the A-Shares and B-Shares is present or represented also votes in favour of the resolution.
7.2 The following resolutions require the approval of each of the Shareholders A and B:
a) The appointment, suspension and dismissal of the Managing Directors (to the extent allowed under applicable law and if not so allowed, with a maximum qualified majority as shall be allowed);
b) The adoption of the AOPB proposed by the CEO pursuant to Article 9.2 insofar as it is, as a whole, inconsistent with the previously adopted AOPB with respect to matters such as (but not limited to) target markets, the number of co-location sites, the number of lines, revenue, EBITDA and products offered;
c) The following decisions insofar as not contemplated by the AOPB:
i. issuance of Shares;
ii. the amendment of the Articles of Association;
iii. the dissolution or liquidation of VersaPoint;
iv. the declaration or payment of any dividend or the repurchase by VersaPoint of any of its outstanding Shares;
v. approval of decisions of the JSC, Management Board pursuant to article 7.4;
vi. the representatives appointment of each Party shall have collectively one vote on behalf auditors of such Party. For each meeting VersaPoint.
7.3 The decisions of the JSC, at least one Management Board (1) representative of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensus.
4.4.2 If the JSC is unable to reach a consensus either with respect to a dispute for a period the management of VersaPoint or in excess its capacity as authorised corporate body of [***] days, then VersaPoint as shareholder of its subsidiaries) that require the dispute shall be submitted to prior approval of the Chief Executive Officers of Alnylam and MedCo for resolution.
4.4.3 If such escalated dispute cannot be resolved for a period in excess of [***] days, thenSupervisory Board are the following:
(a) [***]; andAdoption of the Employee Stock Option Plan and the distribution of options pursuant thereto other than to Managing Directors;
(b) [***].Decisions not contemplated by the AOPB but otherwise relating to matters within the scope of the Permitted Business involving an amount not exceeding 5 million Euro individually or 15 million Euro in the aggregate;
4.4.4 Notwithstanding c) The following decisions contemplated by the foregoingAOPB:
i. To make any investment or other expenditure that is contemplated by the AOPB and exceeding the amount of 5 million Euro;
ii. To grant a loan other than granting credit facilities in the ordinary course of business, MedCo may not exercise its final decision-making authority to (i) to require Alnylam to undertake obligations beyond those for which it is responsiblecustomers, or forgo any rights, under this Agreement, and (ii) to cause Alnylam to incur Subsidiaries of VersaPoint;
iii. Taking out any Costs above loan or the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreemententering into any other financial arrangement for an amount exceeding 5 million Euro, (iii) to require Alnylam to take or decline to take any action that would result in a violation other than the withdrawal of any Law amounts pursuant to a credit facility for which approval has already been obtained in accordance with this provision;
iv. Entering into a suretyship, guarantee agreement or any agreement with any Third Party otherwise accepting liability for the debts of a Person by VersaPoint or a Subsidiary of VersaPoint;
v. To purchase, transfer, rent, lease or encumber assets involving an amount exceeding 1 million Euro individually or 3 million Euro in the infringement aggregate;
vi. The entering into or terminating agreements regarding the granting of licenses and/or transfer of intellectual property rights owned or licensed by VersaPoint or its Subsidiaries involving an amount exceeding 1 million Euro individually or 3 million Euro in the aggregate;
d) Unless the urgency of Third Partiesthe matter requires immediate action and prior approval of the Supervisory Board cannot reasonably be obtained, the entering into legal proceedings or settlements involving an amount exceeding 1 million Euro individually or 3 million Euro in the aggregate;
e) Appointed or dismissal of member of the management board of a Subsidiary of VersaPoint and determining or amending the employment conditions of the members of the Management Team or the management board of a Subsidiary of VersaPoint (ivsubject to approval of the relevant member of the Management Team or the management board of a Subsidiary of VersaPoint);
f) The entering into or terminating of any long term agreements (other than a joint venture or partnership) with a Person;
g) Other items as notified to the Management Board by the combined meeting of holders of A-Shares and B-Shares.
7.4 The decisions of the Management Board (either with respect to the management of VersaPoint or in its capacity as authorised corporate body of VersaPoint as shareholder of its Subsidiaries) that require the prior approval of the General Meeting of Shareholders are the following:
a) Decisions not contemplated by the AOPB involving an amount exceeding 5 million Euro individually or 15 million Euro in the aggregate or otherwise relating to matters outside the scope of the Permitted Business;
b) the issuance of shares, delegation of the power to issue shares, granting rights to acquire shares by a Subsidiary of VersaPoint;
c) the acquisition of its own shares, reducing its share capital, the issuance of debt instruments by a Subsidiary of VersaPoint;
d) to file a petition for involuntary liquidation or suspension of payments or similar status in another jurisdiction for VersaPoint or a Subsidiary of VersaPoint;
e) the amendment of the articles of association of a Subsidiary of VersaPoint;
f) the dissolution of a Subsidiary or otherwise causing a Subsidiary of VersaPoint to cease to exist;
g) the entering into or terminating a joint-venture or partnership with a Person;
h) entering into or terminating arrangements whereby VersaPoint or a Subsidiary of VersaPoint takes over the management control of other companies (not being VersaPoint or a Subsidiary of VersaPoint);
i) to acquire any interest (in whole or in part) in any company (whether a manner that excuses MedCo from any of its obligations specifically enumerated under this AgreementSubsidiary or another company), or (vto expand the business either by establishing a new branch or otherwise insofar as not contemplated by the AOPB, by VersaPoint or a Subsidiary of VersaPoint;
j) to expand dispose of any interest (in whole or narrow in part) in any company (whether a Subsidiary of VersaPoint or another company), by VersaPoint or a Subsidiary of VersaPoint;
k) a material change in the responsibilities business or strategy of VersaPoint or a Subsidiary of VersaPoint insofar as not contemplated by the AOPB;
l) ceasing or disposing all or a substantial part of the JSCbusiness of VersaPoint or a Subsidiary of VersaPoint;
m) to determine or amend the principle underlying the preparation of the annual accounts of VersaPoint and its Subsidiaries;
n) the entering into, amending or terminating agreements or other transactions of any kind by VersaPoint or a Subsidiary of VersaPoint with a group company, a Shareholder or its group companies, a Managing Director, Supervisory Director, or a company in which a Shareholder, Managing Director or Supervisory Director has an interest in the management board, supervisory board or as a shareholder;
o) the transfer or encumbrance of shares and exercising voting rights on shares in the capital of a Subsidiary of VersaPoint;
p) a proposal for a legal merger or split-up (demerger) of VersaPoint or a Subsidiary of VersaPoint;
q) the distribution of options to Managing Directors pursuant to the Employee Stock Option Plan.
7.6 The Parties hereby agree that the procedures required in the Articles of Association or this Agreement regarding the approval of decisions of the Management Board also apply if it pertains to such decisions of (bodies of) Subsidiaries of VersaPoint, such that the Supervisory Board or the General Meeting of Shareholders shall be able to decide on any such matters affecting a Subsidiary of VersaPoint in the same manner it would be when such matter would affect VersaPoint. The Parties agree to use their best endeavours to accomplish this, either by providing management instructions to the management board of the Subsidiaries of VersaPoint, by amending the articles of association of such Subsidiaries, or by any other means possible under the laws applicable to the relevant Subsidiary.
Appears in 2 contracts
Samples: Shareholder Agreement (Versatel Telecom International N V), Shareholder Agreement (Versatel Telecom International N V)
Decision Making. 4.4.1 With respect 2.6.1 Subject to decisions the terms of this Section 2.6, each Committee will take action by unanimous vote with each Party having a single vote, irrespective of the JSC, the number of representatives of each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, at least one (1) representative of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate actually in each JSC meeting. Action on any matter may be taken attendance at a meeting, by teleconference, videoconference or by a written agreementresolution signed by the designated representatives of each of the Parties. The If a Committee fails to reach unanimous consent on a particular matter within thirty (30) days of a Party having requested a formal vote on such matter (such unresolved matter a “Disagreement”), then: (a) any Disagreement arising in the JDC or JCC will be referred to the JSC shall attempt for resolution, and (b) any Disagreement arising in the JSC will be subject to resolve any and all disputes before it for decision by consensusthe resolution procedures described in Section 2.6.2 below.
4.4.2 If 2.6.2 In the JSC is unable to reach event of a consensus with respect to Disagreement arising in the JSC, either Party may provide written notice of such Disagreement (a dispute for a period in excess “Notice of [***] days, then the dispute shall be submitted Disagreement”) to the Chief Executive Officer of the other Party. The Chief Executive Officers of Alnylam each of the Parties will meet at least once in person or by means of telecommunication (telephone, video, or web conferences) to discuss the matter on which the JSC failed to reach unanimous consent and MedCo for resolutionuse their good faith efforts to resolve the Disagreement within thirty (30) days after receipt of the Notice of Disagreement by the applicable Chief Executive Officer of a Party.
4.4.3 2.6.3 If any such escalated dispute canDisagreement is not resolved by the Chief Executive Officers within such thirty (30) day period, then the Disagreement will be resolved for a period in excess of [***] days, thenas follows:
(a) [the Chief Executive Officer of * * * will have the authority, subject to Section 2.6.3(b) below, to finally resolve any Disagreement relating to (i) * * *, and (ii) * * **]; and;
(b) [***].
4.4.4 Notwithstanding the foregoing, MedCo may not exercise its final decision-making Chief Executive Officer of * * * will have the authority to finally resolve any Disagreement relating to (i) to require Alnylam to undertake obligations beyond those for which it is responsible* * *, or forgo any rights, under this Agreement, and (ii) * * *;
2.6.4 Neither Party will exercise its right to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap finally resolve a dispute at a committee in accordance with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take or decline to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) Section 2.6 in a manner that excuses MedCo such Party from any of its obligations specifically enumerated under this Agreement.
2.6.5 Notwithstanding this Section 2.6, any dispute regarding the interpretation of this Agreement or (v) to expand or narrow any alleged breach of this Agreement will be resolved in accordance with the responsibilities terms of the JSCSection 16.4.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Kos Pharmaceuticals Inc), Collaboration and License Agreement (Kos Pharmaceuticals Inc)
Decision Making. 4.4.1 With respect (i) Subject to this Section 3.4, decisions of the JSC, Joint Commercialization Committee shall be made by agreement between the representatives of Valeant, and the representatives of Zogenix, with each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, at least having one (1) representative vote. No decision of the Joint Commercialization Committee shall be valid unless each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting. Action on any matter may be taken is represented by at a meeting, by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensus.
4.4.2 If the JSC is unable to reach a consensus with respect to a dispute for a period in excess of least [***] days, then ([***]) members at the dispute meeting at which the decision is made. The Parties shall be submitted cause their respective representatives on the Joint Commercialization Committee to the Chief Executive Officers of Alnylam and MedCo for resolutionuse their good faith efforts to resolve all matters appropriately presented to them in an expeditious manner.
4.4.3 If such escalated (ii) In the event that the Joint Commercialization Committee is unable to resolve a dispute cannot be resolved for or make a period in excess decision due to a lack of required unanimity within [***] days, then:
(a) [***]; ) days following *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. consideration of the dispute or the decision by such committee, then either Party may submit the matter to the Commercial Officers for a joint decision. The Commercial Officers shall diligently and in good faith attempt to resolve the referred dispute expeditiously and
, in any event, within [***] (b) [***]) days of receiving such written notification, or within such other time as mutually agreed upon in writing between such officers (and if the officers resolve the dispute, such resolution shall be deemed to be a decision of the Joint Commercialization Committee). In the event that the Commercial Officers are unable to reach a resolution of the dispute within such time period, then such disputes shall be resolved pursuant to Section 15.6 below.
4.4.4 Notwithstanding the foregoing(iii) For clarity, MedCo may not exercise its final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap dispute with respect to which MedCo whether a Party has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam breached its obligations under this AgreementAgreement is not subject to the escalation procedures set forth in this Section 3.4, (iii) but either Party may refer such a dispute for resolution pursuant to require Alnylam to take or decline to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or (v) to expand or narrow the responsibilities of the JSCSection 15.6.
Appears in 2 contracts
Samples: Co Promotion Agreement, Co Promotion Agreement (Zogenix, Inc.)
Decision Making. 4.4.1 With respect to decisions For those matters set forth in Section 4.1.3 (Duties of the JSC) that the JSC is only to review and discuss (and not approve), the JSC will review and discuss such matters at the next JSC (or appropriate Working Group meeting, if applicable), [***] the JSC (or appropriate Working Group, if applicable) will serve as a forum for communication, input, and discussion, but will not prevent a Party from taking action if such Party has final decision making authority and operational control with respect to such matters and such matter was brought before the JSC in accordance with Section 4.2.1 (Resolution of JSC Matters), but such matter will not be escalated pursuant to Section 4.2.2(b) (Escalation). For clarity, Kiniksa shall have decision making authority and operational control with respect to all matters pertaining to the Development or Commercialization of the Product in the Kiniksa Field in the Territory, including the implementation of the Development Plan or Commercial Plan without escalation pursuant to Section 4.2.2(b) (Escalation), subject to certain matters over which the JSC has an approval right, which matters shall be governed by Section 4.2.2(b) (Escalation) in the event that the JSC is unable to agree thereon. For those matters set forth in Section 4.1.3 (Duties of the JSC) that the JSC is to determine whether to approve, the JSC shall operate by consensus and for such matters, the representatives of each Party shall have collectively one (1) vote on behalf of such Party. For each ; provided that no such vote taken at a meeting of the JSC, at least one (1) shall be valid unless a representative of each Party shall constitute a quorum is present and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate participates in each JSC meetingthe vote. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensus.
4.4.2 If the JSC is unable to reach a consensus with respect to a dispute for a period in excess of [***] days, then the dispute shall be submitted to the Chief Executive Officers of Alnylam and MedCo for resolution.
4.4.3 If such escalated dispute cannot be resolved for a period in excess of [***] days, then:
(a) [***]; and
(b) [***].
4.4.4 Notwithstanding the foregoing, MedCo each Party, in its sole discretion, by written notice to the other Party (which notice may be provided via email), may choose not to have representatives on the JSC, and in such case, the JSC to representatives of the other Party will make decisions on behalf of the JSC. The JSC must exercise its final decision-making authority (i) in good faith and in a commercially reasonable manner for the purpose of optimizing the commercial potential of, and financial returns from, the Product in the Kiniksa Field in the Territory consistent with Commercially Reasonable Efforts. The Parties acknowledge and agree that the JSC will not have the power to require Alnylam to undertake obligations beyond those for which it is responsible, amend any of the terms of this Agreement or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take or decline to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or (v) to expand or narrow the responsibilities of the JSC, in each case, other than by agreement of the Parties as set forth in Section 17.5 (Amendments).
Appears in 2 contracts
Samples: License Agreement (Kiniksa Pharmaceuticals, Ltd.), License Agreement (Kiniksa Pharmaceuticals, Ltd.)
Decision Making. 4.4.1 With respect The PARTIES shall endeavor to decisions reach agreement by consensus on matters presented to the BOARD. Each CO-CHAIR may introduce matters for review and decision-making by the BOARD. Each PARTY, regardless of the JSCnumber of its representatives who attend a meeting, the representatives of each Party shall have collectively one vote on behalf of such Partyvote, which shall be cast by its CO-CHAIR. For each If the Parties are unable to reach agreement within 10 (TEN) days following a meeting of the JSCBOARD, at least one the matter shall promptly (1but not later than 10 (ten) representative of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(sdays following the aforementioned 10 (ten) participate in each JSC meeting. Action on any matter may day period) be taken at a meeting, presented by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensus.
4.4.2 If the JSC is unable to reach a consensus with respect to a dispute for a period in excess of [***] days, then the dispute shall be submitted CO-CHAIRS to the Chief Executive Officers Officer of Alnylam IROKO (“CEO”), with a summary of the PARTIES’ respective positions, and MedCo for resolution.
4.4.3 If such escalated dispute canthe CEO shall then promptly and finally decide the matter (the “TIE-BREAKING VOTE”); provided, however, that the following matters shall not be resolved presented to the CEO but shall instead require the unanimous consent of the BOARD: (i) other than the BUDGET for a period each of the first three (3) years of this AGREEMENT, approval of the BUDGET and (ii) any new, incremental spend in excess of [***] daysUS$200,000.00 (TWO HUNDRED THOUSAND UNITED STATES DOLLARS) above the previous year’s approved BUDGET. For the avoidance of doubt, then:
(i) in the event the PARTIES are unable to reach agreement on the BUDGET for the first three (3) years of this AGREEMENT, the matter shall be presented to the CEO to cast the TIE-BREAKING VOTE; (ii) the TIE-BREAKING VOTE shall not apply to the MANUFACTURE, PACKING and/or supply of the PRODUCTS (all of which being the subject matter of the WORLDWIDE MANUFACTURING AND SUPPLY AGREEMENT); (iii) the TIE-BREAKING VOTE shall not apply to any regulatory (including without limiting the generality of the aforegoing, technical transfer), issues or matters relevant to this AGREEMENT to the extent that the implementation or giving effect thereto may (a) [***]result in a breach of the APPLICABLE LAWS; and
and/or (b) [***].
4.4.4 adversely impact upon ASPEN and/or its AFFILIATES’ reputation and/or relationship with any AGENCY. (In the given circumstances IROKO shall, in its own name, be entitled to implement or give effect to its decision and/or determination and the costs associated therewith shall be deemed to be REGULATORY COSTS); (iv) the TIE-BREAKING VOTE shall not apply to any decision or determination taken by IROKO which is influenced by any factor extraneous to the terms and conditions of this AGREEMENT in circumstances where the implementation or giving effect to such a decision or determination may materially prejudice ASPEN and/or its AFFILIATES under this AGREEMENT. (By way of example, where IROKO takes a decision or makes a determination influenced by factors relevant to the MANUFACTURE, PACKAGING and/or COMMERCIALISATION of the PRODUCTS outside of the TERRITORY, in circumstances where such a decision and/or determination may prejudice ASPEN and/or its AFFILIATES); (v) the TIE-BREAKING VOTE shall not apply to or extend over any issues or matters relevant to new formulations (as defined in clause 23.4); and/or (vi) the TIE-BREAKING VOTE shall not apply to or extend over the COMMERCIALISATION of the PRODUCTS in that part of the TERRITORY which does not constitute the PRIORITY COUNTRIES. Notwithstanding the foregoing, MedCo may not exercise its final decisionif there shall have occurred a change of CONTROL of IROKO, the CEO shall no longer have a TIE-making authority (i) BREAKING VOTE. In that case, either PARTY shall be entitled to require Alnylam to undertake obligations beyond those refer the matter for which it is responsibledetermination by an independent expert appointed by agreement of the PARTIES, or forgo any rightsfailing such agreement within 5 (FIVE) days after either PARTY has requested such referral, under this Agreement, appointed by the then President (iior his successor-in-title) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take or decline to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or (v) to expand or narrow the responsibilities his designee of the JSCAmerican Arbitration Association (if Aspen requests the appointment) or by the then President (or his successor-in-title) or his designee of the South African Institute of Chartered Accountants (if Iroko requests the appointment). The expert shall have significant expertise as a businessperson in the international pharmaceutical industry, including in the AREA or AREAS that are the subject of the dispute/deadlock between the PARTIES. The expert shall act in his or her capacity as a business expert and not as on arbitrator and his or her decision shall be final and binding on the PARTIES. He or she shall render his/her decision, in writing, including the rationale thereof, within 45 (FORTY FIVE) days following his/her appointment. The fees and expenses of the expert and of the appointing authority shall be borne equally by the PARTIES.
Appears in 1 contract
Samples: Exclusive Sub License Agreement (Iroko Pharmaceuticals Inc.)
Decision Making. 4.4.1 With respect to decisions (i) Each of the JSC, the representatives of each Party VERTEX and NOVARTIS shall have collectively one vote on behalf of such Partythe JRC. For each meeting The objective of the JSCJRC shall be to reach agreement by consensus on all matters within the scope of the Research Plan. However, at least one in the event of a deadlock with respect to any action (1) representative of each Party which shall constitute a quorum and each Party shall use Commercially Reasonable Efforts be deemed to have its representative(soccurred if either party shall request a vote of the JRC on a matter and that vote shall either not be taken within thirty (30) participate days of the request or if taken shall result in each JSC meeting. Action on a tie vote) and subject to the procedure set forth in subsection (ii) below as to certain matters, the vote of VERTEX, rendered after reasonable and open discussion among the members of the JRC, shall be final and controlling.
(ii) Notwithstanding the foregoing, with respect to JRC decisions (x) as to the nature and extent of any matter additional Development Candidate Criteria referenced in Section 2.5.3 hereof, any disagreement between the parties that cannot be resolved within forty-five (45) days by the JRC (as that period may be taken at extended under (iii) below) shall be referred to the JSC for resolution and if not resolved within seven (7) business days after referral, shall be referred for final resolution in good faith by the Chief Executive Officer of VERTEX and the Chief Executive Officer of NOVARTIS, and failing final resolution, there will be no change to the Development Candidate Criteria; or (y) as to whether or not Development Candidate Information provided by VERTEX, pursuant to subsection (iii) below, is complete or as to whether or not a meetinggiven Compound proposed by VERTEX as a Development Candidate meets the Development Criteria, by teleconferencethe matter shall be referred as provided in subsection (x) above to the JRC and the JSC and, videoconference or by written failing agreement. The JSC , the matter shall attempt to resolve any and all disputes before it be referred for decision by consensusfinal resolution under the provisions of Section 11.2(b) of this Research Agreement.
4.4.2 If (iii) In the JSC is unable to reach a consensus event that NOVARTIS's representatives on the JRC reasonably believe that the Development Candidate Information with respect to a dispute particular Development Candidate proposed by VERTEX to the JRC is incomplete, NOVARTIS shall provide written notice thereof to VERTEX within fifteen (15) business days after receipt of the Development Candidate Information, and VERTEX shall undertake reasonable efforts to furnish the requested additional Development Candidate Information within fifteen (15) business days after receipt of NOVARTIS's notice hereunder. The 45-day period provided for a period action by the JRC under subsection (ii) above shall be extended by the amount of time required for VERTEX to provide the requested information, but in any event not in excess of [***] thirty (30) days, then the dispute shall be submitted to the Chief Executive Officers of Alnylam and MedCo for resolution.
4.4.3 If such escalated dispute cannot be resolved for a period in excess (iv) Notwithstanding any of [***] days, then:
(a) [***]; and
(b) [***].
4.4.4 Notwithstanding the foregoing, MedCo may not exercise its final decision-making authority (i) to require Alnylam to undertake obligations beyond those for if VERTEX and NOVARTIS deadlock on any other matters being considered by the JRC which it is responsible, or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING might have a CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this AgreementREQUESTED significant impact on the time or likely success of the Research Program, (iii) the matter shall be referred to require Alnylam to take or decline to take any action that would result the JSC for resolution in a violation of any Law or any agreement accordance with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or Section 2.6 hereof.
(v) Each party shall retain the rights, powers, and discretion granted to expand it under this Research Agreement, and the JRC shall not be delegated or narrow vested with any such rights, powers or discretion except as expressly provided in this Research Agreement. The JRC shall not have the responsibilities of the JSCpower to amend or modify this Research Agreement, which may only be amended or modified as provided in Section 12.15.
Appears in 1 contract
Samples: Research and Early Development Agreement (Vertex Pharmaceuticals Inc / Ma)
Decision Making. 4.4.1 With respect to decisions (a) The JSC will take action on matters within its power by unanimous consent of the members of the JSC, the representatives of with each Party shall have collectively one vote on behalf of such Party. For each meeting having a single vote, irrespective of the JSC, at least one (1) representative number of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate JSC members in each JSC meeting. Action on any matter may be taken attendance at a meeting, by teleconference, videoconference or by a written agreement. The JSC shall attempt to resolve any and all disputes before it for decision resolution signed by consensusthe Co-Chairs.
4.4.2 (b) If the JSC is unable to reach unanimous consent on a consensus particular matter, then either Party may provide written notice of such unresolved matter to the Alliance Managers who will try to facilitate the resolution of such issue. If the JSC is unable to resolve such matter within thirty (30) days after a Party provided written notice to the Alliance Managers, then the matter will be escalated, by written notice, to the respective Executive Officers of each Party. The Executive Officers (or his or her designee, who must be a member of the Party’s senior management with respect appropriate decision-making authority, but who is not a member of the JSC, JPT or the Alliance Manager) of each Party will meet at least once in person to discuss such matter and use their good faith efforts to resolve the unresolved matter within thirty (30) days after the matter has been escalated by written notice to the Executive Officers. If the Executive Officers (or their designees) cannot reach agreement on how to resolve such matter within the thirty (30) day time period, the Executive Officer of [***]. Without limiting the generality of the foregoing [***] (a) to designate a dispute [***], (b) to designate a [***] for further development [***], and (c) to approve [***] for a period Product, in excess each case subject to [***].
(c) Notwithstanding the terms of Section 2.1.5(b), the Executive Officer of [***] days, then the dispute shall be submitted to the Chief Executive Officers of Alnylam and MedCo for resolution.
4.4.3 If such escalated dispute cannot be resolved for a period in excess of [***] days, then:
that would (ai) [***]; and
or (bii) [***].
4.4.4 (d) Notwithstanding the foregoingterms of Sections 2.1.5(b) and (c) above, MedCo may not exercise its final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo any rights, under if the matter concerns a dispute regarding the interpretation of this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take performance or decline to take any action that would result in alleged nonperformance of a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its Party’s obligations specifically enumerated under this Agreement, or (v) to expand or narrow any other alleged breach of this Agreement, such matter will be resolved in accordance with the responsibilities terms of the JSCSection 17.4.
Appears in 1 contract
Samples: Collaboration and License Agreement (Micromet, Inc.)
Decision Making. 4.4.1 With respect 3.3.1 The JSC will make good faith efforts to make all decisions on matters before it by consensus. Subject to the terms of this Section 3.3, actions to be taken by the JSC, the JSC shall be taken only following a unanimous vote with each Party’s representatives of each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, at least having one (1) representative of vote (for clarity, with each Party shall constitute having only one (1) vote). If the JSC fails to reach unanimous consent on a quorum and each particular matter within [ * ] days of a Party shall use Commercially Reasonable Efforts having requested a formal vote on such matter (or, if such matter is urgent, within [ * ] days of such request), then either Party may submit such matter for resolution to have its representative(s) participate the Executive Officers pursuant to Section 15.2, except as provided in each JSC meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensusSection 3.3.2.
4.4.2 3.3.2 If the JSC is unable to reach a consensus decision by unanimous vote pursuant to Section 3.3.1, then the Party listed below shall have the final say on the following matters:
3.3.2.1 Versartis shall have final decision making authority with respect to the Development of Licensed Products in the Territory until the final clinical study report that is required for submission of the MAA for the Initial Indication in the Territory is completed.
3.3.2.2 Teijin will have final decision making authority with respect to the Development of Licensed Products in the Territory following the period of Versartis’ final say under Section 3.3.2.1.
3.3.2.3 Teijin will have final decision making authority with respect to Commercialization of Licensed Products in the Territory.
3.3.2.4 Notwithstanding the foregoing or any other term of this Agreement, in the event that Versartis reasonably believes that there is a dispute for reasonable likelihood that Teijin’s intended activity or conduct with respect to the Development or Commercialization of any Licensed Product could have a period in excess of [***] daysmaterial adverse effect on Versartis’ Development or Commercialization activities with respect to Licensed Products outside the Territory, then the dispute shall such issue will be submitted to the Chief Executive Officers of Alnylam and MedCo for resolutionattempted resolution pursuant to Section 15.2. If the Executive Officers are unable to resolve any such dispute, Versartis shall have final decision making authority with respect to such dispute.
4.4.3 If such escalated 3.3.3 For the avoidance of doubt, any dispute cannot be resolved for a period in excess regarding the interpretation of [***] days, then:
(a) [***]; and
(b) [***].
4.4.4 Notwithstanding the foregoing, MedCo may not exercise its final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take performance or decline to take any action that would result in alleged nonperformance of a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its Party’s obligations specifically enumerated under this Agreement, or (v) any alleged breach of this Agreement will be resolved in accordance with the terms of ARTICLE XV and shall not be subject to expand or narrow the responsibilities of the JSC’s decision-making authority.
Appears in 1 contract
Samples: Exclusive License and Supply Agreement (Versartis, Inc.)
Decision Making. 4.4.1 With respect to decisions Each Party’s representatives on the JSC will [*] on all matters within the scope of the JSC, the representatives of each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, at least one (1) representative of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement’s responsibilities. The JSC shall attempt JSC’s members will use [*] to resolve reach agreement on any and all disputes before it for decision by consensus.
4.4.2 JSC matters. If the JSC is unable to reach a consensus with respect to a dispute particular matter for a period in excess of which it is responsible within [*] after the matter is first presented to the JSC, then, at either Party’s request, the matter will be escalated for consideration by Executive Officers pursuant to Section 12.1(b). If Executive Officers do not reach mutual agreement with respect to such matter within [**] days], then the dispute shall matter will be submitted decided in accordance with the following: [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the Chief Executive Officers of Alnylam and MedCo for resolutioncompany if publicly disclosed.
4.4.3 If such escalated dispute cannot be resolved for a period in excess of [***] days, then:
(ai) [**];
(ii) subject to clause (i) above, [*]; and
(biii) subject to clause (i) and clause (ii) above, [*]; provided that, in each case ((ii) and (iii)), notwithstanding anything to the contrary set forth in this Agreement, neither Party will have the authority to make any final decision that: (1) [***].
4.4.4 Notwithstanding the foregoing, MedCo may not exercise its final decision-making authority ; or (i2) would reasonably be expected to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take or decline other Party to take any action that the other Party reasonably believes would result in a violation require the other Party to (x) violate any Applicable Law, including the requirements of any Law Regulatory Authority, (y) breach or otherwise violate any agreement with any Third Party entered into by the other Party (including, with respect to Xxxxxx, the UCSF License), or the infringement of (z) infringe or misappropriate any intellectual property rights of any Third PartiesParty. In addition, (iv) and notwithstanding anything to the contrary in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or (v) the JSC will not have the right to expand or narrow decide matters that are not expressly within the responsibilities authority of the JSC, including the right to resolve disputes involving the breach or alleged breach of diligence obligations (which will be instead resolved in accordance with Article 12), modifications to final decision-making rights of the JSC, or amendments to this Agreement (other than amendments to the Study Plan in accordance with this Agreement).
Appears in 1 contract
Samples: Evaluation Agreement (Fibrogen Inc)
Decision Making. 4.4.1 With respect (a) The JDC shall attempt to make decisions by consensus of the JSCrepresentatives present, with each Party having a single vote irrespective of the number of representatives of each such Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, in attendance or by a written resolution signed by at least one (1) representative appointed by each Party.
(b) If the JDC cannot, or does not, reach consensus on an issue which has been discussed during a meeting of each Party the JDC within ten (10) Business Days after the matter has first been discussed by the JDC, or any shorter term which is required by specific circumstances, then such issue shall constitute be referred to the respective Executive Officers of the Parties. Such Executive Officers shall meet for attempted resolution by good faith negotiations within thirty (30) days after such issue is referred to them. If the Executive Officers are not able to resolve such disputed issue within this thirty (30)-day period, and the disputed matter relates solely to the Product for the Indication in the Territory or, subject to Section 3.4(c), the Compound in connection with any Adverse Regulatory Determination as defined below, then ALFASIGMA shall have the final decision making authority as to such disputed matter; provided, that ALFASIGMA’s final decision making authority shall not (i) alter, amend or modify this Agreement, (ii) impose an additional obligation on IPI, (iii) be used to determine whether ALFASIGMA has used Commercially Reasonable Efforts to undertake its obligations under this Agreement, or (iv) materially adversely affect the right of IPI under Section 2.1(b). Any activity that requires JDC approval shall not be undertaken unless and until the matter has been resolved pursuant to this Section 3.4(b).
(c) Without prejudice to the generality of Section 3.4(b), if a quorum Regulatory Authority imposes or threatens to impose an obligation or requirement on ALFASIGMA relating to the Compound and each Party such obligation or requirement is reasonably likely to adversely affect the ability of ALFASIGMA to obtain Marketing Approval for the Product (an “Adverse Regulatory Determination”), then ALFASIGMA shall promptly notify IPI of the Adverse Regulatory Determination. The Parties shall, within ten (10) Business Days of IPI’s receipt of notice of an Adverse Regulatory Determination, meet in-person, or telephonically to determine, in good faith, a response to the applicable Regulatory Authority that addresses the Adverse Regulatory Determination. In connection with the Parties activities pursuant to the preceding sentence, (i) the Parties shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting. Action eliminate, mitigate or otherwise minimize the effect of the Adverse Regulatory Determination on any matter may be taken at a meetingALFASIGMA, by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensus.
4.4.2 If the JSC is unable to reach a consensus with respect to a dispute for a period in excess of [***] days, then the dispute shall be submitted to the Chief Executive Officers of Alnylam and MedCo for resolution.
4.4.3 If such escalated dispute cannot be resolved for a period in excess of [***] days, then:
(a) [***]; and
(b) [***].
4.4.4 Notwithstanding the foregoing, MedCo may not exercise its final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo any rights, under this Agreement, and/or (ii) at ALFASIGMA’s request, IPI shall, in coordination with ALFASIGMA, attend any Regulatory Authority meeting, interact with the Regulatory Authority and provide documentary information to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap Regulatory Authority; provided, that ALFASIGMA shall bear the documented reasonable costs of IPI in connection with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam its activities under this Agreement, (iii) to require Alnylam to take or decline to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or (v) to expand or narrow the responsibilities of the JSCSection 3.4(c).
Appears in 1 contract
Samples: Exclusive License Agreement (Innovation Pharmaceuticals Inc.)
Decision Making. 4.4.1 With respect to (a) The JSC shall make decisions and take action (1) by consensus of the JSCmembers present at a meeting, the representatives of with each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, at least having one (1) representative vote irrespective of the number of representatives of such Party in attendance, or (2) by a written resolution signed by at least both co-chairpersons appointed by each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(sParty.
(b) participate in each If, despite using reasonable efforts, the JSC meeting. Action does not reach consensus on any matter within its decision-making authority (a "Deadlocked Matter") within a period of twenty-one (21) days (or such other period as the Parties may be taken at a meetingagree in writing) after it has met and attempted to reach such consensus, then either Party may, by teleconferencewritten notice to the other Party, videoconference or by written agreement. The JSC refer the Deadlocked Matter to the Executive Officers; provided, however, that, if the Executive Officers do not reach agreement on such Deadlocked Matter within thirty (30) days after such Deadlocked Matter is referred to the Executive Officers, then such Deadlocked Matter shall attempt be decided as provided below:
(i) prior to resolve any and all disputes before it for decision by consensus.
4.4.2 If the JSC is unable to reach a consensus Opt-In Date, Theravance shall have the final decision-making right with respect to a dispute for a period any Deadlocked Matter, considering Xxxxxxx'x comments and suggestions in excess of [***] days, then the dispute shall be submitted to the Chief Executive Officers of Alnylam and MedCo for resolution.
4.4.3 If such escalated dispute cannot be resolved for a period in excess of [***] days, then:
(a) [***]good faith; and
(bii) [after the Opt-In Date, Xxxxxxx shall have the final decision-making right with respect to any Deadlocked Matter, considering Theravance's comments and suggestions in good faith.
(iii) Except as set forth in Section 6.3(c), neither Party shall have the final decision-making right, pursuant to this Section 3.2, with respect to any matter outside of the JSC's decision-making authority, or with respect to whether to effect any Fundamental Development Plan Change, and in the event of a failure to agree with respect ***]CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. to a Fundamental Development Plan Change, the Parties shall proceed under the then-current Clinical Development Plan having last been approved by both Parties.
4.4.4 Notwithstanding the foregoing(iv) Except as set forth in Section 6.3(c), MedCo neither Party may not exercise its final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) a Deadlocked Matter to require Alnylam to take or decline cause the other Party to take any action that would result in a violation of applicable Laws or that, in such other Party's reasonable determination, is a risk to patients or clinical trial subjects or is otherwise contrary to GCP and ethics or such other Party's compliance policies, or require or cause the other Party to bear any Law costs other than its agreed upon share of those set forth in then-current Phase 2 Budget, or any agreement with any Third Phase 3 Development Budget, or to commit additional employee or other resources to conduct Collaboration Activities. Notwithstanding the foregoing, except as set forth in Section 6.3(c), a Party or the infringement of intellectual property rights of Third Parties, (iv) may not exercise such final decision making authority in a manner that excuses MedCo from would increase the financial obligations of the other Party, and Theravance shall have the right to decide, in its sole discretion, whether to participate in the Commercialization of the Product in the U.S.
(c) The JSC shall have only such powers as are specifically delegated to it hereunder, and for clarity the JSC shall not have any authority or ability to: (1) resolve or conclude any disputes regarding a Party's performance or non-performance of its obligations specifically enumerated under this Agreement; (2) modify, amend or waive the terms or conditions of this Agreement; or (v3) bind either Party to expand act or narrow the responsibilities of the JSCrefrain from acting in any manner.
Appears in 1 contract
Samples: License and Collaboration Agreement (Theravance Biopharma, Inc.)
Decision Making. 4.4.1 With (a) The Joint Steering Committee may make decisions with respect to any subject matter that is subject to the Joint Steering Committee’s decision-making authority and functions as set forth in Section 3.1.3. Except as specified in Section 3.1.5(b), all decisions of the JSCJoint Steering Committee shall be made by consensus, with the representatives of from each Party shall have collectively one vote presenting a unified position on behalf of such Party. For each meeting of the JSC, at least one (1) representative of each Party shall constitute a quorum and each Party The Joint Steering Committee shall use Commercially Reasonable Diligent Efforts to have resolve the matters within its representative(s) participate in each JSC meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference roles and functions or by written agreement. The JSC shall attempt otherwise referred to resolve any and all disputes before it for decision by consensusit.
4.4.2 If the JSC is unable to reach a consensus with (b) With respect to a dispute for a period in excess of [***] daysany issue, if the Joint Steering Committee cannot reach consensus within ten (10) Business Days after the matter has been brought to the Joint Steering Committee’s attention, then the dispute such issue shall be submitted referred to the Chief Executive Officers Officer of Alnylam Theravance and MedCo the Chairman of R&D of GSK (collectively, the “Officers”) for resolution.
4.4.3 If . The Parties accept that the use of the Officers for resolution of any unresolved issues will be on an exceptional basis. In the event that the use of the Officers occurs on more than two occasions in any consecutive twelve (12) month period and such escalated dispute candisputes are not be resolved for a period in excess of [***] days, then:
(a) related to [***]; and
(b) , then GSK will from then on retain the final vote within the Joint Steering Committee for all issues [***].
4.4.4 Notwithstanding . If the foregoingOfficers are unable to reach consensus within thirty (30) days after the matter has been referred to them, MedCo may not exercise its the final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsibledecision on such disputed issue will reside with GSK; provided, or forgo any rightshowever, under this Agreement, (ii) to cause Alnylam to incur any Costs above that if the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “disputed issue involves [***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take or decline to take any action that would result in then the final decision will be made by a violation of any Law or any agreement with any mutually acceptable Third Party or mediator. Either Party can initiate such mediation on 30 days written notice to the infringement of intellectual property rights of Third Parties, (iv) in other Party. The Parties will use best efforts to agree on a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or (v) to expand or narrow the responsibilities mediator within such 30-day period. Such mediation will occur as promptly as practicable following selection of the JSCmediator and will be held in New York, New York. The decision of the mediator will be final and binding on the Parties; provided that either party shall retain all rights to bring an action against the other for damages and other monetary relief related to or arising out of the issue decided by the mediator.
Appears in 1 contract
Decision Making. 4.4.1 With respect Actions to decisions of be taken by the JSCJRC will be taken only following unanimous vote, the representatives of with each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, at least having one (1) representative vote representing the views of each Party shall constitute its members. If the JRC fails to reach unanimous agreement on a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensus.
4.4.2 If the JSC is unable to reach a consensus with respect to a dispute for a period in excess of [***] days**, then either Party may submit the dispute shall be submitted matter in writing to the Chief other, and the Parties will refer such dispute to the designated executive officer of Licensor and the designated executive officer of Licensee (or their respective designees) (the “Executive Officers of Alnylam and MedCo Officers”) for resolution.
4.4.3 If such escalated dispute cannot be resolved for a period resolution in excess of [***] days, then:
(a) [***]; and
(b) [***].
4.4.4 Notwithstanding accordance with the foregoing, MedCo may not exercise its final decision-making authority (i) procedures described in Section 14.2; provided, however, that the following disputes will not be submitted for resolution pursuant to require Alnylam to undertake obligations beyond those Section 14.2 and instead will be decided as follows: for which it is responsible, or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above dispute regarding an increase in operational responsibility of a Party greater than the then-applicable Development Costs Cap with respect to which MedCo has not otherwise operational responsibilities of such Party as previously agreed to CERTAIN by the Parties, the JRC members for the Party whose operational THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS OF HAVE BEEN OMITTED FROM THIS EXHIBIT WERE OMITTED EXHIBIT, AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934COMMISSION. reimburse Alnylam OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”. responsibility would be increased will make the final decision; provided, further, the foregoing proviso does not apply to the establishment of a Collaboration Research Plan. Each Party retains the rights, powers, and discretion granted to it under this AgreementAgreement and neither Party will delegate to or vest in any such rights, (iii) to require Alnylam to take powers, or decline to take any action that would result discretion in a violation the JRC, unless such delegation or vesting of any Law or any agreement with any Third Party rights is expressly provided for in this Agreement or the infringement of intellectual property rights of Third Parties, (iv) Parties expressly so agree in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or (v) to expand or narrow the responsibilities of the JSCwriting.
Appears in 1 contract
Samples: Research Collaboration, Option and License Agreement (Exicure, Inc.)
Decision Making. 4.4.1 With respect 3.4.1 Subject to decisions the terms of the JSCthis Section 3.4, the representatives of each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, at least one (1) representative of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting. Action on any matter may be taken at a meeting, will take action by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensus.
4.4.2 If the JSC is unable to reach a consensus with respect to a dispute for a period in excess of [***] dayswith each Party having [***], irrespective of the number of representatives actually in attendance at a meeting, or by a written resolution signed by the designated representatives to the JSC of each of the Parties. The JSC members shall use good faith efforts to reach agreement on any and all matters submitted to it. If the JSC fails to reach unanimous consent on a particular matter within thirty (30) days of a Party having requested a formal vote on such matter (or, if such matter is urgent, within seven (7) days of such request), then such dispute will be subject to the resolution procedures described in Section 3.4.2.
3.4.2 In the event of any dispute shall be submitted in the JSC that is not resolved pursuant to the terms of Section 3.4.1, either Party may provide written Notice of such failure (a “ Notice of Disagreement ”) to the other Party in order to refer such dispute to the Chief Executive Officer of Reata and the Chief Operating Officer or Kyowa Kirin for potential resolution. Following any such Notice of Disagreement, the Chief Executive Officer of Reata and the Chief Operating Officer of Kyowa Kirin will meet at least once in person or by means of live telecommunication (telephone, video, or web conferences) to discuss the matter on which the JSC failed to reach unanimous consent and use their good faith efforts to resolve the matter within thirty (30) days after receipt of the Notice of Disagreement by the applicable Party. If any such disagreement is not resolved by the Chief Executive/Operating Officers of Alnylam and MedCo for resolution.
4.4.3 If or their designees within such escalated dispute cannot be resolved for a period thirty (30) day period, then, subject to the restrictions in excess of Section 3.4.4 below, [***] dayswill have the final decision-making authority with respect to any such disagreement relating to any Commercialization in the Territory. In making any such final decision, then:
(a) [***]; and
(b) ] shall reasonably consider, in good faith, any issues raised by [***] concerning risks that such decision could have a material adverse effect on [***].
4.4.4 3.4.3 Notwithstanding this Section 3.4, any dispute regarding the foregoinginterpretation of this Agreement, MedCo may the performance or alleged nonperformance of a Party’s obligations under this Agreement, or any alleged breach of this Agreement will be resolved in accordance with the terms of ARTICLE XVI and shall not exercise its be subject to the JSC decision-making.
3.4.4 With respect to any and all JSC decisions regarding clinical studies for Licensed Products within the Field by Kyowa Kirin, the following shall apply:
(a) For clinical studies within the protocols already established in studies by Reata (subject to variations in dose and dosing within the parameters of subsections (i) and (ii) below) and related to the development of Licensed Product for the treatment of chronic kidney disease (“CKD”), [***] shall have final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo conduct any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “such clinical studies that [***]”;
(b) For clinical studies for the Indication of CKD, but outside of the protocols and parameters described in Section 3.4.4(a), Kyowa Kirin shall provide summaries of such clinical studies and their proposed protocols to Reata. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this AgreementUpon review, (iii) if Reata reasonably believes those studies have the potential to adversely affect the safety profile of the Licensed Compound or to adversely impact patient safety, then Reata shall have the right to require Alnylam an independent panel of medical and scientific reviewers evaluate the proposed study (the “ Technical Review Panel ”), at Reata’s expense. The Technical Review Panel shall be comprised of three unaffiliated, independent members, and will act by majority vote. The members of the Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]. Technical Review Panel will be appointed as follows: (i) within [***] days of Reata’s request for a Technical Review Panel, each Party shall designate (in its sole discretion) an expert with technical expertise in the relevant area to take or decline be a member of the Technical Review Panel; (ii) within [***] days of each Party making their member designation, those designated members shall designate another expert with technical expertise in the relevant area to take any action be the third member of the Technical Review Panel, who will serve as the chairman of the panel. Within [***] days of the designation of the entire three-member Technical Review Panel, each Party shall submit a written statement detailing its positions with respect to the safety concerns of Reata that would result in prompted the request for a violation review by the Technical Review Panel. Promptly after the submission of any Law or any agreement with any Third Party or each Party’s written statements, the infringement of intellectual property rights of Third Technical Review Panel shall deliver to the Parties, in writing, the Technical Review Panel’s conclusions regarding the safety concerns of Reata, and its recommendations (ivif any) in a manner that excuses MedCo from for modification of Kyowa Kirin’s proposed protocol to address such safety concerns (taking into consideration the requirements for Commercialization Regulatory Approval). In the event the Technical Review Panel agrees with Xxxxx’s safety concerns, [***].
(c) For any of its obligations specifically enumerated under this Agreementanimal studies proposed by Kyowa Kirin, or (v) to expand or narrow the responsibilities and for all proposed Kyowa Kirin clinical studies outside of the JSCCKD indication, Kyowa Kirin shall provide summaries of such clinical studies and their proposed protocols to Reata. Upon review, Xxxxx has final authority to veto the studies if Reata determines, in its sole but reasonable discretion, that Reata has a reasonable basis to believe that the proposed studies present a risk of adversely affecting the safety profile of the Licensed Compound or adversely impacting patient safety.
Appears in 1 contract
Samples: Exclusive License and Supply Agreement (Reata Pharmaceuticals Inc)
Decision Making. 4.4.1 With respect to decisions Each Party’s representatives on the JSC will [*] on all matters within the scope of the JSC, the representatives of each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, at least one (1) representative of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement’s responsibilities. The JSC shall attempt JSC’s members will use [*] to resolve reach agreement on any and all disputes before it for decision by consensus.
4.4.2 JSC matters. If the JSC is unable to reach a consensus with respect to a dispute particular matter for a period in excess of which it is responsible within [*] after the matter is first presented to the JSC, then, at either Party’s request, the matter will be escalated for consideration by Executive Officers pursuant to Section 12.1(b). If Executive Officers do not reach mutual agreement with respect to such matter within [**] days], then the dispute shall matter will be submitted to decided in accordance with the Chief Executive Officers of Alnylam and MedCo for resolution.
4.4.3 If such escalated dispute cannot be resolved for a period in excess of [***] days, thenfollowing:
(ai) [**];
(ii) subject to clause (i) above, [*]; and
(biii) subject to clause (i) and clause (ii) above, [*]; provided that, in each case ((ii) and (iii)), notwithstanding anything to the contrary set forth in this Agreement, neither Party will have the authority to make any final decision that: (1) [***].
4.4.4 Notwithstanding the foregoing, MedCo may not exercise its final decision-making authority ; or (i2) would reasonably be expected to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take or decline other Party to take any action that the other Party reasonably believes would result in a violation require the other Party to (x) violate any Applicable Law, including the requirements of any Law Regulatory Authority, (y) breach or otherwise violate any agreement with any Third Party entered into by the other Party (including, with respect to Fortis, the UCSF License), or the infringement of (z) infringe or misappropriate any intellectual property rights of any Third PartiesParty. In addition, (iv) and notwithstanding anything to the contrary in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or (v) the JSC will not have the right to expand or narrow decide matters that are not expressly within the responsibilities authority of the JSC, including the right to resolve disputes involving the breach or alleged breach of diligence obligations (which will be instead resolved in accordance with Article 12), modifications to final decision-making rights of the JSC, or amendments to this Agreement (other than amendments to the Study Plan in accordance with this Agreement). [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
Appears in 1 contract
Samples: Evaluation Agreement (Fibrogen Inc)
Decision Making. 4.4.1 With respect to (a) All decisions of the JSCeach Committee shall be made by unanimous vote, with each Party’s representatives collectively having one (1) vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before a Committee, the representatives of each Party shall have collectively one vote on behalf of the Parties cannot reach an agreement as to such Party. For each meeting of the JSC, at least one (1) representative of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensus.
4.4.2 If the JSC is unable to reach a consensus with respect to a dispute for a period in excess of within [***] daysBusiness Days after such matter was brought to such Committee for resolution or after such matter has been referred to such Committee, then such disagreement shall, upon the dispute shall written request of either Party, be submitted referred to the Chief Executive ESC (in the case of disagreement of the JRC, GDC, JCC or other joint subcommittees of the ESC), the Designated Senior Officers (in the case of Alnylam and MedCo disagreement of the ESC) for resolution.
4.4.3 , or the JRC, GDC or JCC, as applicable (in the case of disagreement of a * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission subcommittee of the JRC, GDC or JCC), in each case, to discuss such matter in good faith for resolution. If such escalated dispute the Designated Senior Officers cannot be resolved for a period in excess of resolve such matter within [***] daysdays after such matter has been referred to them, thenthen such matters shall be finally and definitively resolved as set forth in Section 2.9(b) and Section 2.9(c) or otherwise by consensus.
(b) Subject to Section 2.9(a) and Section 2.9(d), at the Designated Senior Officer level, MyoKardia shall have the right to decide the following matters in good faith and based on reasonable scientific, clinical and regulatory judgment and in light of regulatory guidance, Applicable Law and commercial potential, and consistent with applicable diligence requirements hereunder:
(ai) amendments to the Research Plan, including the incorporation or use of any technology covered by any Patent Right or other intellectual property of a Third Party into a Compound, Product or any activities in each case under the Research Plan, except that MyoKardia shall not have the right to increase Sanofi’s obligations (both financial and otherwise) to perform Sanofi Research Activities under this Agreement without Sanofi’s written consent;
(ii) the designation of the Development Candidates;
(iii) subject to MyoKardia’s obligations under Section 4.1, whether to develop an HCM1 Compound or HCM2 Compound for an Expanded Use;
(iv) the Manufacture of the Compounds and Products, except for (A) the Manufacturing of DCM1 Products under the Registration Program Plan therefor; and (B) the Manufacturing of the Compound and Product for use in the Commercialization of the Products in the Licensed Territory, in each case ((A) and (B)), which may be conducted by Sanofi if elected by Sanofi in which case MyoKardia shall supply appropriate quantities of Compound or bulk Product pursuant to a reasonable supply agreement to be executed by the Parties within an appropriate time frame;
(v) subject to Section 2.9(c)(i)(C) and Section 2.9(c)(ii), the Development of each Product through completion of POC Studies for such Product, including the content of the POC Development Plans (such as the regulatory strategy and the design, enrollment criteria, endpoints and protocols of the clinical trials included in such POC Development Plans, the strategy for the EOP2 Meetings and the EOP2 Packages), except that MyoKardia shall not, without Sanofi’s written consent, (A) increase Sanofi’s obligations to perform Sanofi POC Activities or (B) discontinue Development of a DCM1 Product after Initiation of the first clinical trial of such DCM1 Product following submission of an IND to the FDA, EMA or other applicable Regulatory Authority in a Major Market Country;
(vi) the research and development of a companion diagnostic for HCM1 Products and HCM2 Products, including whether and when to pursue the development of such companion diagnostic, but subject to the Parties’ mutual agreement on the activities to be conducted by the Parties to research and develop the companion diagnostic, the allocation of costs between the Parties for such activities and the financial terms pertaining to such companion diagnostic;
(vii) the Development of each XXX0 Xxxxxxxx, XXX0 Product, HCM2 Compound and HCM2 Product (including, subject to Section 4.8(b) and Section 4.8(c), any Expanded Use Compound and Expanded Use Product) following completion of POC Studies for such Compound or Product, including (A) whether to commence the Registration Program with a particular HCM1 Product or HCM2 Product, (B) the content of the applicable Registration Program Plans (such as the regulatory strategy (but not regulatory implementation in the Licensed Territory as provided in Section 2.9(c)(ii)), scope of the Registration Program, countries in which clinical trial sites will be located for the Registration Program for the US and EMA, and the design, enrollment criteria, endpoints and protocols of the clinical trials included in such Registration Program Plans); (C) as a decision that involves development or regulatory strategy (including whether to seek orphan drug designation), whether to file for and the content of a filing for exclusive rights conferred by any Regulatory Authority with respect to an HCM1 Product or an HCM2 Product; (D) whether to incorporate in any HCM1 Product or HCM2 Product any Know-How of a Third Party or technology covered by any Patent Right of a Third Party (e.g., as the formulation of, manufacturing process for, device for use with and/or companion diagnostics for such Product); and (E) as a decision that involves commercial strategy, whether to file for and the content of a filing for exclusivity rights conferred by any Regulatory Authority in the Retained Territory with respect to an HCM1 Product or an HCM2 Product other than patents, including, without limitation, new chemical entity exclusivity, data exclusivity, and pediatric exclusivity; except that MyoKardia shall not have the right to increase Sanofi’s financial obligations under the Registration Program Plans or to require Sanofi to conduct any particular activity under the Registration Program Plans without Sanofi’s prior written consent; * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission
(c) Subject to Section 2.9(a) and Section 2.9(d), at the Designated Senior Office level, Sanofi shall have the right to decide on the following matters in good faith and based on reasonable scientific, clinical and regulatory judgment and in light of regulatory guidance, Applicable Law and commercial potential, and consistent with applicable diligence requirements hereunder:
(i) the Development of each DCM1 Compound and DCM1 Product following completion of POC Studies for such Compound or Product, including (A) whether to commence the Registration Program with a particular DCM1 Product, (B) the content of the applicable Registration Program Plans (such as the regulatory strategy and regulatory implementation matters and the design, enrollment criteria, endpoints and protocols of the clinical trials included in such Registration Program Plans), (C) the strategy for the EOP2 Meeting and the EOP2 Package, in each case for the DCM1 Compounds and DCM1 Products, (D) the research, development and commercialization of a companion diagnostic for DCM1 Products (including with regard to engaging one or more Third Party diagnostic companies for such purpose, and including any such companion diagnostic activities conducted prior to completion of POC Studies for the applicable DCM1 Product so long as Sanofi bears all costs for such activities), but, unless Sanofi elects to perform all activities related to the research and development of the companion diagnostic for DCM1 Products on its own and at its sole expense, subject to the Parties’ mutual agreement on the activities to be conducted by the Parties to research and develop the companion diagnostic, the allocation of costs between the Parties for such activities and the financial terms pertaining to such companion diagnostic, (E) as a decision that involves development or regulatory strategy (including whether to seek orphan drug designation), whether to file for and the content of a filing for exclusive rights conferred by any Regulatory Authority with respect to DCM1 Product; and (F) whether to incorporate in any DCM1 Product any Know-How of a Third Party or technology covered by any Patent Right of a Third Party (e.g., as the formulation of, manufacturing process for, device for use with and/or companion diagnostics for such Product);
(ii) the regulatory implementation matters for the HCM1 Products, HCM2 Products and Expanded Use Products, in each case in the Licensed Territory, which matters consist of: (A) the countries other than the Major Market Countries in the Licensed Territory in which Sanofi shall submit a Marketing Approval Application (for clarity, clause (A) does not create a diligence obligation of Sanofi to Develop any Product for any countries other than as described in Section 5.6), (B) the timing and sequence of filing Marketing Authorization Applications in countries in the Licensed Territory, (C) the content of any Marketing Authorization Application for a country in the Licensed Territory (but not the Development activities that generate content for such applications), (D) the content of any interactions with Regulatory Authorities that support obtaining Marketing Approval in the Licensed Territory, and (E) as a decision that involves commercial strategy, whether to file for and the content of a filing for exclusivity rights conferred by any Regulatory Authority in the Licensed Territory with respect to an HCM1 Product or an HCM2 Product other than patents, including, without limitation, new chemical entity exclusivity, data exclusivity, and pediatric exclusivity;
(iii) the Manufacturing of DCM1 Products under the Registration Program Plan therefor and the Manufacturing of the Compounds and Products for use in the Commercialization of the Products in the Licensed Territory;
(iv) pricing and reimbursement approval for Products in the Licensed Territory, including any Required Phase 4 Studies for Pricing and Reimbursement conducted in support of such approvals; and
(bv) [***]the Commercialization of Products, and companion diagnostics for such Products, in the Licensed Territory.
4.4.4 Notwithstanding (d) Each Party’s final decision making authority described in Section 2.9(b) and Section 2.9(c) shall be subject to the foregoingfollowing:
(i) MyoKardia’s final decision making authority over the Development of HCM1 Products and HCM2 Products under the applicable Registration Program will be subject to Section 5.2(d);
(ii) any change in the HCM1 Criteria, MedCo HCM2 Criteria and/or DCM1 Criteria, including any applicable MOA, shall be based on scientific and clinical evidence, regulatory judgment and commercial potential and shall be subject to the mutual consent of the ESC after receiving the proposal from the JRC; provided that any disagreement at the ESC shall be referred to the Chief Executive Officer of MyoKardia and the Global President of R&D of Sanofi for final resolution without any further escalation in accordance with Section 2.9(a) (for clarity, if the Designated Senior Officers cannot reach a final resolution on a change to the HCM1 Criteria, HCM2 Criteria and/or DCM1 Criteria, as applicable, the criteria, including any applicable MOA, most recently approved by the mutual consent of the Parties and documented in this Agreement (including by way of an amendment) shall continue to be in effect); provided further that neither Party shall unreasonably withhold consent of a change to the HCM1 Criteria, HCM2 Criteria and/or DCM1 Criteria, as applicable, including any applicable MOA, unless such change broadens the scope of the applicable criteria or MOA (in which case such consent may not be withheld in the Party’s sole discretion); provided further that any such change in the HCM1 Criteria, HCM2 Criteria and/or DCM1 Criteria, including any applicable MOA, upon the approval of the ESC or the agreement of the applicable Designated Senior Officers, as the case may be, shall be documented as an amendment to this Agreement duly executed by the Parties in accordance with Section 15.8;
(iii) neither Party shall have the right to exercise its final decision-decision making authority to impose an obligation on the other Party to Manufacture Compounds or Products for supply to the Party making such decision, and MyoKardia shall not have the right to exercise its final decision making authority to obligate Sanofi to Manufacture any Compounds or Products for use under the Research Plan and/or the POC Development Plans;
(iiv) MyoKardia shall not use its final decision making authority to require Alnylam incorporate: (A) any formulation technology that is proprietary to undertake obligations beyond those for which it Sanofi in any HCM1 Product or HCM2 Product; (B) any diagnostic technology that is responsible, or forgo proprietary to Sanofi in any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap companion diagnostic with respect to which MedCo has not otherwise agreed any HCM1 Product or HCM2 Product; or (C) any manufacturing process technology that is proprietary to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take or decline to take any action that would result Sanofi in a violation the manufacturing process of any Law HCM1 Product or any agreement with any Third Party or HCM2 Product, in each case without the infringement prior written consent of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or Sanofi; and
(v) MyoKardia shall not use its final decision making authority to expand incorporate any device that is proprietary to Sanofi in any Combination Product with any HCM1 Compound or narrow HCM2 Compound without the responsibilities prior written consent of Sanofi and without the JSCagreement by the Parties with respect to either (A) supply arrangement for such device and/or (B) the amount and duration of any commercially reasonable royalties payable by MyoKardia to Sanofi applicable to the portion of Net Sales of such HCM1 Product or HCM2 Product, as applicable, allocable to such device component in accordance with Section 1.133, applied mutatis mutandis.
Appears in 1 contract
Samples: License and Collaboration Agreement (MyoKardia Inc)
Decision Making. 4.4.1 With respect to decisions (a) The JSC will take action on matters within its power by unanimous consent of the members of the JSC, the representatives of with each Party shall have collectively one vote on behalf of such Party. For each meeting having a single vote, irrespective of the JSC, at least one (1) representative number of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate JSC members in each JSC meeting. Action on any matter may be taken attendance at a meeting, by teleconference, videoconference or by a written agreement. The JSC shall attempt to resolve any and all disputes before it for decision resolution signed by consensusthe Co-Chairs.
4.4.2 (b) If the JSC is unable to reach unanimous consent on a consensus particular matter, then either Party may provide written notice of such unresolved matter to the Alliance Managers who will try to facilitate the resolution of such issue. If the JSC is unable to resolve such matter within thirty (30) days after a Party provided written notice to the Alliance Managers, then the matter will be escalated, by written notice, to the respective Executive Officers of each Party. The Executive Officers (or his or her designee, who must be a member of the Party’s senior management with respect appropriate decision-making authority, but who is not a member of the JSC, JPT or the Alliance Manager) of each Party will meet at least once in person to a dispute for a period in excess discuss such matter and use their good faith efforts to resolve the unresolved matter within thirty (30) days after the matter has been escalated by written notice to the Executive Officers. If the Executive Officers (or their designees) cannot reach agreement on how to resolve such matter within the thirty (30) day time period, the Executive Officer of [***] dayswill have the authority to [***] a [***] on the matter in lieu of the [***] of the [***] . Without limiting the generality of the foregoing [***] will have the [***] (a) to designate a [***] as a [***] , then (b) to designate a [***] as a [***] for further development as a [***] , and (c) to approve the dispute shall be submitted to the Chief Executive Officers of Alnylam and MedCo for resolution.
4.4.3 If such escalated dispute cannot be resolved for a period in excess filing of [***] daysfor a Product, then:in each case subject to [***] obligations under this Agreement. *** 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 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(ac) Notwithstanding the terms of Section 2.1.5(b), the Executive Officer of [***] will not have the authority to make a [***] that would (i) [***]] the [***] of [***] of [***] , or [***] or [***] obligations under the [***] ; and
or (bii) [***].
4.4.4 Notwithstanding the foregoing, MedCo may not exercise its final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo ] any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under ] or [***] during the [***] ( [***] ) [***] following the [***] that materially [***] the [***] of the [***] from that described in the [***] attached as [***] .
(d) Notwithstanding the terms of Sections 2.1.5(b) and (c) above, if the matter concerns a dispute regarding the interpretation of this Agreement, (iii) to require Alnylam to take the performance or decline to take any action that would result in alleged nonperformance of a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its Party’s obligations specifically enumerated under this Agreement, or (v) to expand or narrow any other alleged breach of this Agreement, such matter will be resolved in accordance with the responsibilities terms of the JSCSection 17.4.
Appears in 1 contract
Samples: Collaboration and License Agreement (Micromet, Inc.)
Decision Making. 4.4.1 With respect to decisions (i) Each of the JSC, the representatives of each Party VERTEX and NOVARTIS shall have collectively one vote on behalf of such Partythe JRC. For each meeting The objective of the JSCJRC shall be to reach agreement by consensus on all matters within the scope of the Research Plan. However, at least one in the event of a deadlock with respect to any action (1) representative of each Party which shall constitute a quorum and each Party shall use Commercially Reasonable Efforts be deemed to have its representative(soccurred if either party shall request a vote of the JRC on a matter and that vote shall either not be taken within thirty (30) participate days of the request or if taken shall result in each JSC meeting. Action on a tie vote) and subject to the procedure set forth in subsection (ii) below as to certain matters, the vote of VERTEX, rendered after reasonable and open discussion among the members of the JRC, shall be final and controlling.
(ii) Notwithstanding the foregoing, with respect to JRC decisions (x) as to the nature and extent of any matter additional Development Candidate Criteria referenced in Section 2.5.3 hereof, any disagreement between the parties that cannot be resolved within forty-five (45) days by the JRC (as that period may be taken at extended under (iii) below) shall be referred to the JSC for resolution and if not resolved within seven (7) business days after referral, shall be referred for final resolution in good faith by the Chief Executive Officer of VERTEX and the Chief Executive Officer of NOVARTIS, and failing final resolution, there will be no change to the Development Candidate Criteria; or (y) as to whether or not Development Candidate Information provided by VERTEX, pursuant to subsection (iii) below, is complete or as to whether or not a meetinggiven Compound proposed by VERTEX as a Development Candidate meets the Development Criteria, by teleconferencethe matter shall be referred as provided in subsection (x) above to the JRC and the JSC and, videoconference or by written failing agreement. The JSC , the matter shall attempt to resolve any and all disputes before it be referred for decision by consensusfinal resolution under the provisions of Section 11.2(b) of this Research Agreement.
4.4.2 If (iii) In the JSC is unable to reach a consensus event that NOVARTIS's representatives on the JRC reasonably believe that the Development Candidate Information with respect to a dispute particular Development Candidate proposed by VERTEX to the JRC is incomplete, NOVARTIS shall provide written notice thereof to VERTEX within fifteen (15) business days after receipt of the Development Candidate Information, and VERTEX shall undertake reasonable efforts to furnish the requested additional Development Candidate Information within fifteen (15) business days after receipt of NOVARTIS's notice hereunder. The 45-day period provided for a period action by the JRC under subsection (ii) above shall be extended by the amount of time required for VERTEX to provide the requested information, but in any event not in excess of [***] thirty (30) days, then the dispute shall be submitted to the Chief Executive Officers of Alnylam and MedCo for resolution.
4.4.3 If such escalated dispute cannot be resolved for a period in excess (iv) Notwithstanding any of [***] days, then:
(a) [***]; and
(b) [***].
4.4.4 Notwithstanding the foregoing, MedCo may not exercise its final decision-making authority (i) if VERTEX and NOVARTIS deadlock on any other matters being considered by the JRC which might have a significant impact on the time or likely success of the Research Program, the matter shall be referred to require Alnylam to undertake obligations beyond those the JSC for which it is responsible, or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap resolution in accordance with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take or decline to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or Section 2.6 hereof.
(v) Each party shall retain the rights, powers, and discretion granted to expand it under this Research Agreement, and the JRC shall not be delegated or narrow vested with any such rights, powers or discretion except as expressly provided in this Research Agreement. The JRC shall not have the responsibilities of the JSCpower to amend or modify this Research Agreement, which may only be amended or modified as provided in Section 12.15.
Appears in 1 contract
Samples: Research and Early Development Agreement (Vertex Pharmaceuticals Inc / Ma)
Decision Making. 4.4.1 With respect (i) Subject to decisions the provisions of this Section 6.4(b), actions to be taken by the JSC and each of the JSCsubcommittees shall be taken only following a unanimous vote, the representatives of with each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, at least having one (1) representative of each Party shall constitute vote. If any subcommittee fails to reach unanimous agreement on a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensus.
4.4.2 If the JSC is unable to reach a consensus with respect to a dispute for a period in excess of [***] thirty (30) days, then the dispute matter shall be submitted referred to the Chief Executive Officers of Alnylam and MedCo for resolutionJSC.
4.4.3 (ii) If such escalated dispute cannot be resolved the JSC fails to reach unanimous agreement on a matter before it for decision for a period in excess of [***] thirty (30) days, then:either Party may elect to submit such issue to the Parties’ Senior Officers and the JSC will submit in writing the respective positions of the Parties to their respective Senior Officers. Such Senior Officers will use good faith efforts, in compliance with this Section 6.4(b)(ii), to resolve promptly such matter, which good faith efforts will include at least one meeting between such Senior Officers within fifteen (15) days after the JSC’s submission of such matter to them. If the Senior Officers are unable to reach unanimous agreement on any such matter within thirty (30) days of such matter being referred to them, the matter will be decided in accordance with Section 6.4(b)(iii).
(aiii) [***]If the Parties’ Senior Officers are unable to reach unanimous agreement in accordance with Section 6.4(b)(ii), then (A) Company shall have final decision-making authority with respect to any and all matters (i) relating to Development of the Products, but excluding Licensed Territory-Required Development Activities, and (ii) subject to Section 3.1(d), relating to the inclusion of Company Confidential Information in any Regulatory Materials and/or Regulatory Data submitted to Regulatory Authorities in the Licensed Territory; and
(bB) [***].
4.4.4 Licensee shall have final decision-making authority with respect to any and all matters (i) relating to the conduct of Licensed Territory-Required Development Activities, except as provided for in this Section 6.4(b)(iii)(A)(ii), (ii) relating solely to Commercialization of the Products in the Field in the Licensed Territory (but excluding for clarity, approval of any form of Commercialization Reports or other reports), (iii) and Medical Affairs Activities for a Product in the Field in the Licensed Territory; and (C) neither Party shall have final decision-making authority with respect to Collaboration Proposals, Collaboration Plans, Collaboration Budgets or Collaboration Activities conducted thereunder. Notwithstanding anything to the foregoingcontrary, MedCo (X) no exercise of a Party’s final decision-making authority on any such matters may, without the other Party’s prior written consent, result in a material decrease or increase in the other Party’s or its Affiliates’ obligations, costs or expenses under this Agreement, any Development Plan or Commercialization Plan or require the other Party to perform additional activities not contemplated by this Agreement; and (Y) no exercise of a Party’s final decision-making authority on any such matters may not exercise conflict with or amend this Agreement without both Parties’ prior written consent, In exercising its final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo any rights, under this AgreementSection 6.4(b)(iii), (ii) to cause Alnylam to incur any Costs above each Party shall consider in good faith the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take or decline to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or (v) to expand or narrow the responsibilities interests of the JSCother Party.
Appears in 1 contract
Samples: License Agreement (Melinta Therapeutics, Inc. /New/)
Decision Making. 4.4.1 5.5.1 With respect to decisions of the JSC, the representatives of each Party shall have collectively one vote on behalf of such Party. For each meeting of the JSC, at least one (1) representative [**] representatives of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meetingquorum. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. The JSC shall attempt to resolve any and all disputes before it for decision by consensus.
4.4.2 5.5.2 If the JSC is unable to reach a consensus with respect to a dispute for a period in excess of [***] days, then the dispute shall be submitted to the Chief Executive Officers Officers, or his or her designee (any such designee to be a senior member of the designating Chief Executive Officer’s management team), of Alnylam and MedCo Genzyme for resolution.
4.4.3 5.5.3 If such escalated dispute cannot be resolved for a period in excess of [***] daysdays following escalation, then:
(a) [***]subject to Section 5.5.4, the Chief Executive Officer of Genzyme or his or her designee shall have the deciding vote on any matter involving the Development or Commercialization of Licensed Products in the Field in the Genzyme Territory, including the Genzyme Territory Development Plan and the Genzyme Territory Commercialization Plan; and
(b) [***]subject to Section 5.5.4, the Chief Executive Officer of Alnylam or his or her designee shall have the deciding vote on any matter involving the Development or Commercialization of Licensed Products in the Field in the Alnylam Territory, including the Alnylam Territory Development Plan and the Alnylam Territory Commercialization Plan, and on any matter involving the content of the Global Branding Strategy.
4.4.4 Notwithstanding 5.5.4 Neither Party shall have the foregoingdeciding vote on, MedCo may and the JSC shall not exercise its final have decision-making authority regarding, any of the following matters:
(i) the allocation of milestone payments to require Third Parties under Future Alnylam In-Licenses pursuant to Section 7.4.3.2;
(ii) the imposition of any requirements on the other Party to undertake obligations beyond those for which it is responsible, or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above Agreement or the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, Supply Agreements;
(iii) any matters that would cause a material increase in costs that the other Party is required to require Alnylam to expend, as determined in the reasonable discretion of such other Party;
(iv) the imposition of any requirements that the other Party take or decline to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, ;
(ivv) in a manner any matters that excuses MedCo would excuse such Party from any of its obligations specifically enumerated under this Agreement, Agreement or the Supply Agreements; or
(vvi) modifying the terms of this Agreement or any Supply Agreement or taking any action to expand or narrow the responsibilities of the JSC.
Appears in 1 contract
Samples: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Decision Making. 4.4.1 5.4.1 Any decisions of the JOC shall be made by unanimous vote. With respect to decisions of the JSCJOC, the representatives of each Party shall have collectively one vote (1) vote, exercised through its representatives on the JOC on behalf of such Party. For each meeting of the JSCJOC, a quorum exists so long as there is at least one (1) representative of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC present at the meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreementconsent. The JSC JOC shall attempt to resolve any and all disputes before it for decision by consensus.
4.4.2 5.4.2 If the JSC JOC is unable to reach unanimous agreement after working in good faith to reach a consensus and taking into account all reasonable medical, scientific, and clinical considerations and considering each Party’s comments or requests on such matters that would adversely impact the safety, commercial value or reputation of the Licensed Products, with respect to a dispute relating to a JOC responsibility described in Section 5.1.2 other than those set forth Sections 5.1.2(h) and 5.1.2(i) for a period in excess of [**], then the dispute shall be submitted to the Executive Officers for resolution. If the JOC is unable to reach unanimous agreement after working in good faith to reach a consensus and taking into account all reasonable medical, scientific, and clinical considerations and considering each Party’s comments or requests on such matters that would adversely impact the safety, commercial value or reputation of the Licensed Products, with respect to a dispute relating to a JOC responsibility set forth Sections 5.1.2(h) or 5.1.2(i) for a period in excess of [**], then the dispute shall be reviewed by a Working Group (as defined below) designated by the JOC, which shall within [**] submit to the JOC a written analysis of the dispute and recommendations for resolving the dispute. If the Working Group fails to timely submit such analysis and recommendations or if the JOC is unable to reach unanimous agreement with respect to such dispute for a period in excess of [***] daysfollowing the receipt of such analysis and recommendation, then the dispute shall be submitted to the Chief Executive Officers of Alnylam and MedCo for resolution.
4.4.3 5.4.3 If such escalated dispute cannot be resolved for a period in excess of [***] daysfollowing the escalation to the Executive Officers, then, such dispute shall be subject to this Section 5.4.3:
(a) [***]Subject to Section 5.4.4 and 5.4.5, Ono shall have the deciding vote with respect to any aspects of such matter relating to the Ono Territory, including the Ono Development Plan; andprovided that, any and all deciding votes shall be in good faith, and after good faith consideration of Karyopharm’s comments or requests on such matters that would adversely impact the safety, commercial value or reputation of the Licensed Products, and with due regard for the impact of such deciding vote on Development and Commercialization of the Licensed Products in the Karyopharm Territory and consistency in all material respects with the terms of this Agreement.
(b) [***]Subject to Section 5.4.4 and 5.4.5, Karyopharm shall have the deciding vote with respect to any aspects of such matter relating to the Karyopharm Territory, as well as any amendment to a Global Clinical Development Plan; provided that, any and all deciding votes shall be in good faith, and after good faith consideration of Ono’s comments or requests on such matters that would adversely impact the safety, commercial value or reputation of the Licensed Products, and with due regard for the impact of such deciding vote on Development and Commercialization of the Licensed Products in the Ono Territory and consistency in all material respects with the terms of this Agreement.
4.4.4 Notwithstanding 5.4.4 Neither Party shall have the foregoingdeciding vote on, MedCo may and the JOC shall not exercise its final have decision-making authority regarding, any of the following matters, which shall be mutually agreed to by the Parties:
(ia) to require Alnylam any matter that would materially adversely impact the safety, commercial value or reputation of a Licensed Product in the Ono Territory;
(b) the imposition of any requirements on the other Party to undertake obligations beyond those for which it is responsible, or to forgo any of its rights, under this Agreement, ;
(iic) to cause Alnylam to incur the imposition of any Costs above requirements that the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to other Party take or decline to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of any Third Parties, Party;
(ivd) in a manner any matters that excuses MedCo would excuse such Party from any of its obligations specifically enumerated under this Agreement, ; or
(e) modifying the terms of this Agreement or (v) taking any action to expand or narrow the responsibilities of the JSCJOC.
5.4.5 Notwithstanding anything to the contrary set forth herein,
(a) the decision-making Party shall make its decision in good faith, subject to the terms and conditions of this Agreement;
(b) in no event may the decision-making Party unilaterally determine that it has fulfilled any obligations hereunder or that the non-deciding Party has breached any obligations hereunder; and
(c) Ono may not make a decision that would cause Karyopharm to be in breach of a provision of a Karyopharm Third Party Agreement.
Appears in 1 contract
Decision Making. 4.4.1 With (a) The Joint Steering Committee may make decisions with respect to any subject matter that is subject to the Joint Steering Committee's decision-making authority and functions as set forth in Section 3.1.3. Except as specified in Section 3.1.5(b), all decisions of the JSCJoint Steering Committee shall be made by consensus, with the representatives of from each Party shall have collectively one vote presenting a unified position on behalf of such Party. For each meeting of the JSC, at least one (1) representative of each Party shall constitute a quorum and each Party The Joint Steering Committee shall use Commercially Reasonable Diligent Efforts to have resolve the matters within its representative(s) participate in each JSC meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference roles and functions or by written agreement. The JSC shall attempt otherwise referred to resolve any and all disputes before it for decision by consensusit.
4.4.2 If the JSC is unable to reach a consensus with (b) With respect to a dispute for a period in excess of [***] daysany issue, if the Joint Steering Committee cannot reach consensus within ten (10) Business Days after the matter has been brought to the Joint Steering Committee's attention, then the dispute such issue shall be submitted referred to the Chief Executive Officers Officer of Alnylam Theravance and MedCo the Chairman of R&D of GSK (collectively, the "Officers") for resolution.
4.4.3 If . The Parties accept that the use of the Officers for resolution of any unresolved issues will be on an exceptional basis. In the event that the use of the Officers occurs on more than two occasions in any consecutive twelve (12) month period and such escalated dispute candisputes are not be resolved for a period in excess of related to [*], then GSK will from then on retain the final vote within the Joint Steering Committee for all issues [*]. If the Officers are unable to reach consensus within thirty (30) days after the matter has been referred to them, the final decision on such disputed issue will reside with GSK; provided, however, that if the disputed issue involves [*], then the final decision will be made by a mutually acceptable Third Party mediator. Either Party can initiate such mediation on [*] days, then:
(a) to the other Party. The Parties will use best efforts to agree on a mediator within such [**]. Such mediation will occur as promptly as practicable following selection of the mediator and will be held in [*]; and
(b) [***].
4.4.4 Notwithstanding the foregoing, MedCo may not exercise its final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. reimburse Alnylam under this Agreement, (iii) to require Alnylam to take or decline to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or (v) to expand or narrow the responsibilities The decision of the JSCmediator will be final and binding on the Parties; provided that either party shall retain all rights to bring an action against the other for damages and other monetary relief related to or arising out of the issue decided by the mediator.
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