Regulatory Responsibilities Subject to the terms and conditions of this Agreement, Licensee will be responsible, at its sole cost and expense, for all regulatory activities related to Development activities, as described in Section 4.1, including the preparation of Regulatory Materials and communications and interactions with Regulatory Authorities in the Territory with respect to the same. Each Party shall use Commercially Reasonable Efforts to carry out its regulatory obligations for the Specialty Product in accordance with the strategy for obtaining Regulatory Approval of the Specialty Product in the Territory as set forth in the Development Plan or otherwise approved by the JSC pursuant to Section 3.33.3. Licensee, directly or through its Affiliates, shall use Commercially Reasonable Efforts to obtain Regulatory Approval in the Territory. Notwithstanding the foregoing, Licensee shall be the Party responsible for achieving the regulatory milestones set forth on Exhibit G (the “Regulatory Milestones”). If Licensee fails to achieve any Regulatory Milestone with the time periods allotted for such Regulatory Milestone in Exhibit G, other than for reasons, being judged by the commonly accepted standards or practices in pharmaceutical industry of Territory, that are commercially impracticable or outside Licensee’s control, then Teva shall have the option in its sole discretion upon written notice to Licensee to: (i) extend the time period allotted for the achievement of the applicable Regulatory Milestone; or (ii) convert the exclusive rights granted to Licensee in Section 2.1(a) with respect to the given Specialty Product into nonexclusive rights, provided however, that Teva has called for the consultation(s) on such failure to achieve any Regulatory Milestone but both Parties are still unable to reach a solution within three (3) months as from the date of the first consultation. All Regulatory Approvals and other Regulatory Materials relating to the Licensed Products in the Territory shall be submitted in the name of, and shall be owned by, Teva or its Affiliate1. Bidding. Licensee shall be responsible for bidding activities for all Licensed Products in the Territory. Licensee shall keep Teva informed (through the Alliance Managers, the JDC or other means of communication) of any material issues concerning bidding process for all Licensed Products in the Territory, including updates of any discussion and correspondence with any Regulatory Authority with respect thereto. Licensee shall reasonably consider Teva’s comments with respect to Licensee’s or its Affiliate’s bidding activities for all Licensed Products in the Territory and shall promptly notify Teva of bidding result for all Licensed Products in the Territory.
No Advisory or Fiduciary Responsibility In connection with all aspects of each transaction contemplated hereby (including in connection with any amendment, waiver or other modification hereof or of any other Loan Document), the Borrower acknowledges and agrees that: (i) (A) the arranging and other services regarding this Agreement provided by the Lenders are arm’s-length commercial transactions between the Borrower and its Affiliates, on the one hand, and the Lenders and their Affiliates, on the other hand, (B) the Borrower has consulted its own legal, accounting, regulatory and tax advisors to the extent it has deemed appropriate, and (C) the Borrower is capable of evaluating, and understands and accepts, the terms, risks and conditions of the transactions contemplated hereby and by the other Loan Documents; (ii) (A) each of the Lenders and their Affiliates is and has been acting solely as a principal and, except as expressly agreed in writing by the relevant parties, has not been, is not, and will not be acting as an advisor, agent or fiduciary for the Borrower or any of its Affiliates, or any other Person and (B) no Lender or any of its Affiliates has any obligation to the Borrower or any of its Affiliates with respect to the transactions contemplated hereby except, in the case of a Lender, those obligations expressly set forth herein and in the other Loan Documents; and (iii) each of the Lenders and their respective Affiliates may be engaged in a broad range of transactions that involve interests that differ from those of the Borrower and its Affiliates, and no Lender or any of its Affiliates has any obligation to disclose any of such interests to the Borrower or its Affiliates. To the fullest extent permitted by law, the Borrower hereby waives and releases any claims that it may have against each of the Lenders and their Affiliates with respect to any breach or alleged breach of agency or fiduciary duty in connection with any aspect of any transaction contemplated hereby.
