Role and Responsibilities. Except as expressly set forth in this Agreement, both during and after the Collaboration Period, the DC’s role shall be primarily informational and advisory. The DC’s principal responsibility shall be to encourage and facilitate the exchange of Information and Materials, including the disclosure of Data and Inventions as required hereunder, between the Parties with respect to the Development of Compound and Products as contemplated by Article 3. Without limiting the generality of the foregoing, the DC shall: (a) During the Collaboration Period, provide a forum for each Party to disclose to the other on an ongoing basis all results, including Data, of Pre-POC Development Plan activities performed by such Party; (b) Periodically review the Development Plans, and consider and approve modifications thereto, provided that, during any period after the Option Exercise Date when Xencor is not sharing Development Costs pursuant to Section 6.3, Amgen shall have the sole authority to amend the Post-Exercise Development Plan, and the DC shall have no such authority; (c) Oversee and coordinate the technology transfer activities contemplated by Section 3.4 and, if applicable, Section 3.7; (d) Throughout its existence, provide a forum for each Party to keep the other Party informed regarding the progress and results of such Party’s Development efforts with respect to Compound and Products; (e) Provide a forum to allow Amgen prior to Option exercise, and Xencor after Option exercise, (i) to ask the other Party questions regarding, and discuss the progress and results of, the other Party’s Development and regulatory activities, and (ii) to make comments and suggestions to the other Party regarding Product Development and regulatory strategy; (f) Attempt in good faith to resolve misunderstandings and differences arising between the Parties arising in the course of the activities contemplated by Article 3; and (g) Perform such other duties as are specifically assigned to the DC in this Agreement or as otherwise agreed in writing by the Parties.
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Samples: Collaborative R&d, Licensing and Option Agreement, Collaboration and Option Agreement (Xencor Inc), Collaboration and Option Agreement (Xencor Inc)
Role and Responsibilities. Except The Supply Committee shall oversee all aspects of supply of Trospium Twice-Daily and Trospium Once-Daily under this Agreement and shall have as expressly set forth in this Agreement, both during and after its overall purpose the Collaboration Periodmanagement of the supply to Esprit of Finished Products and/or Samples prior to the Processing Assumption Date, the DC’s role transition of Processing Activities from Indevus to Esprit pursuant to the terms of this Agreement and, if Indevus exercises the Ex-US Supply Option, the management of the supply of Trospium Once-Daily solely for use outside the Territory either in (i) bulk capsule form prior to being in its finished, labeled and packaged form or (ii) finished, labeled and packaged form. In particular, the Supply Committee shall be primarily informational perform the following functions:
(i) Oversee all aspects of the supply of Trospium Twice-Daily prior to the NDA Transfer Date and advisory. The DC’s principal responsibility shall be Trospium Once-Daily prior to encourage the Processing Assumption Date;
(ii) Prepare a supply plan coordinating the entire supply chain to support all needs for Products in the Field within and facilitate outside the exchange Territory;
(iii) Oversee all Processing Activities;
(iv) Identify and propose actions to prevent potential interruptions of Information supply;
(v) Oversee audits of Third Party Manufacturers;
(vi) Propose new Third Party Manufacturers, subject to the terms and Materialsconditions of Indevus’ agreements with Third Party Manufacturers;
(vii) Oversee quality control and assurance, implementation process improvements, cost reduction initiatives, and logistics initiatives;
(viii) Coordinate the supply of Compound in sufficient quantities for Indevus to satisfy its obligations under Section 14.6(b);
(ix) Coordinate assumption by Esprit of Processing Activities, including the disclosure of Data and Inventions as required hereunder, between the Parties with respect to the Development of Compound and Products as contemplated by Article 3. Without limiting the generality of the foregoing, the DC shall:
(a) During the Collaboration Period, provide a forum for each Party to disclose to the other on an ongoing basis all results, including Data, of Pre-POC Development Plan activities performed by such Party;
(b) Periodically review the Development PlansTechnology Transfer, and consider recommend a timeline and approve modifications thereto, provided that, during any period after procedures for the Option Exercise Date when Xencor is not sharing Development Costs pursuant to Section 6.3, Amgen shall have the sole authority to amend the Post-Exercise Development Plan, and the DC shall have no such authority;
(c) Oversee and coordinate the technology transfer activities contemplated by Section 3.4 and, if applicable, Section 3.7;
(d) Throughout Technology Transfer in its existence, provide a forum for each Party to keep the other Party informed regarding the progress and results of such Party’s Development efforts with respect to Compound and Products;
(e) Provide a forum to allow Amgen prior to Option exercise, and Xencor after Option exercise, (i) to ask the other Party questions regarding, and discuss the progress and results of, the other Party’s Development and regulatory activities, and (ii) to make comments and suggestions to the other Party regarding Product Development and regulatory strategy;
(f) Attempt in good faith to resolve misunderstandings and differences arising between the Parties arising in the course of the activities contemplated by Article 3first meeting; and
(gx) Perform Have such other duties as are specifically assigned responsibilities and address any other matters delegated to the DC in Supply Committee under this Agreement or as otherwise may be mutually agreed upon in writing by the PartiesParties from time to time, as well as any other matters pertaining to each Party’s performance of its supply obligations under this Agreement.
Appears in 1 contract
Role and Responsibilities. Except The Supply Committee shall oversee all aspects of supply of Trospium Twice-Daily and Trospium Once-Daily under this Agreement and shall have as expressly set forth in this Agreement, both during and after its overall purpose the Collaboration Periodmanagement of the supply to Esprit of Finished Products and/or Samples prior to the Processing Assumption Date, the DC’s role transition of Processing Activities from Indevus to Esprit pursuant to the terms of this Agreement and, if Indevus exercises the Ex-US Supply Option, the management of the supply of Trospium Once-Daily solely for use outside the Territory either in (i) bulk capsule form prior to being in its finished, labeled and packaged form or (ii) finished, labeled and packaged form. In particular, the Supply Committee shall be primarily informational perform the following functions: Confidential treatment has been requested for portions of this document. This copy of the document filed as an Exhibit omits the confidential information subject to the confidentiality request. Omissions are designated by the symbol [...***...]. A complete version of this document has been provided separately to the Securities and advisory. The DC’s principal responsibility shall be Exchange Commission.
(i) Oversee all aspects of the supply of Trospium Twice-Daily prior to encourage the NDA Transfer Date and facilitate Trospium Once-Daily prior to the exchange Processing Assumption Date;
(ii) Prepare a supply plan coordinating the entire supply chain to support all needs for Products in the Field within and outside the Territory;
(iii) Oversee all Processing Activities;
(iv) Identify and propose actions to prevent potential interruptions of Information supply;
(v) Oversee audits of Third Party Manufacturers;
(vi) Propose new Third Party Manufacturers, subject to the terms and Materialsconditions of Indevus’ agreements with Third Party Manufacturers;
(vii) Oversee quality control and assurance, implementation process improvements, cost reduction initiatives, and logistics initiatives;
(viii) Coordinate the supply of Compound in sufficient quantities for Indevus to satisfy its obligations under Section 14.6(b);
(ix) Coordinate assumption by Esprit of Processing Activities, including the disclosure of Data and Inventions as required hereunder, between the Parties with respect to the Development of Compound and Products as contemplated by Article 3. Without limiting the generality of the foregoing, the DC shall:
(a) During the Collaboration Period, provide a forum for each Party to disclose to the other on an ongoing basis all results, including Data, of Pre-POC Development Plan activities performed by such Party;
(b) Periodically review the Development PlansTechnology Transfer, and consider recommend a timeline and approve modifications thereto, provided that, during any period after procedures for the Option Exercise Date when Xencor is not sharing Development Costs pursuant to Section 6.3, Amgen shall have the sole authority to amend the Post-Exercise Development Plan, and the DC shall have no such authority;
(c) Oversee and coordinate the technology transfer activities contemplated by Section 3.4 and, if applicable, Section 3.7;
(d) Throughout Technology Transfer in its existence, provide a forum for each Party to keep the other Party informed regarding the progress and results of such Party’s Development efforts with respect to Compound and Products;
(e) Provide a forum to allow Amgen prior to Option exercise, and Xencor after Option exercise, (i) to ask the other Party questions regarding, and discuss the progress and results of, the other Party’s Development and regulatory activities, and (ii) to make comments and suggestions to the other Party regarding Product Development and regulatory strategy;
(f) Attempt in good faith to resolve misunderstandings and differences arising between the Parties arising in the course of the activities contemplated by Article 3first meeting; and
(gx) Perform Have such other duties as are specifically assigned responsibilities and address any other matters delegated to the DC in Supply Committee under this Agreement or as otherwise may be mutually agreed upon in writing by the PartiesParties from time to time, as well as any other matters pertaining to each Party’s performance of its supply obligations under this Agreement.
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Samples: Merger Agreement (Allergan Inc)