Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.
Distribution Agreement This Agreement has been duly authorized, executed and delivered by the Company and constitutes a valid and binding obligation of the Company. The transactions contemplated by this Agreement have been duly authorized by the Company.
Collaboration Agreement The Collaboration Agreement shall not have been terminated in accordance with its terms and shall be in full force and effect.
Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.
Pharmacovigilance Agreement Within [***] after the Effective Date, BMS and the Company (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being in connection with the use of the Licensed Compound(s) until such time that all pharmacovigilance responsibilities have transferred from BMS to Company. These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Licensed Compound(s). Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. Until such guidelines and procedures are set forth in a written agreement between the Parties (hereafter referred to as the “Pharmacovigilance Agreement”), the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound(s) subject to all applicable regulations and guidelines. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled. Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Marketing Agreement The Company shall have entered into, ------------------- executed and delivered the Marketing Agreement.
Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.
Transitional Services Agreement Seller shall have executed and delivered the Transitional Services Agreement.
Xxxxxx Agreement Xxxx Agreement contains the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior agreement, written or oral, with respect thereto.
Distribution Agreements Subject to compliance with applicable provisions of the 1940 Act, the Board of Trustees may enter into a contract or contracts with one or more Persons to act as underwriters and/or placement agents whereby the Trust may either agree to sell Shares of the Trust, any Series or Class to the other party or parties to the contract or appoint such other party or parties its sales agent or agents for such Shares. In either case, the contract shall be on such terms and conditions as the Board of Trustees may in its discretion determine, not inconsistent with the provisions of this Section 5.12 or the By-laws; and such contract may also provide for the repurchase or sale of Shares of the Trust, any Series or Class by such other party as principal or as agent of the Trust and may provide that such other party may enter into selected dealer agreements with registered securities dealers and brokers and servicing and similar agreements with Persons who are not registered securities dealers to further the purposes of the distribution or repurchase of such Shares.