development or product life as TYMLOS, taking into account, without limitation, issues of safety and efficacy, market potential, anticipated pricing and reimbursement rates, costs, expected profitability (including development costs, intellectual property defense costs, distribution and logistics and all other costs associated with TYMLOS), labeling, pricing reimbursement, methods of distribution, the competitiveness of alternative products in the marketplace or under development, market exclusivity (including the patent, regulatory and other proprietary position of TYMLOS), the applicable regulatory environment and relevant commercial, financial, technical, legal, scientific and/or medical factors; provided, however, that the potential payment of the Milestone Payment Amount under this Agreement shall not be taken into account by Parent in determining the level of efforts to be asserted to achieve the Milestone. For the avoidance of doubt, Commercially Reasonable Efforts will not mean that a party guarantees that it will actually achieve the Milestone, and a failure to achieve the Milestone may still be consistent with Commercially Reasonable Efforts.
CVRs means the rights of Holders to receive contingent cash payments pursuant to the Merger Agreement and this Agreement.
CVR Register has the meaning set forth in Section 2.3(b).
DTC means The Depository Trust Company or any successor thereto.
Governmental Body means any federal, state, provincial, local, municipal, foreign or other governmental or quasi-governmental authority, including, any arbitrator or arbitral body, mediator and applicable securities exchanges, or any department, minister, agency, commission, commissioner, board, subdivision, bureau, agency, instrumentality, court or other tribunal of any of the foregoing.
Holder means a person in whose name a CVR is registered in the CVR Register at the applicable time.
Independent Accountant means an independent certified public accounting firm of nationally recognized standing designated either (i) jointly by the Acting Holders and Parent, or (ii) if such parties fail to make a designation, jointly by an independent public accounting firm selected by Parent and an independent public accounting firm selected by the Acting Holders.
Milestone means the achievement of the sum of (A) Net Sales of TYMLOS in the United States and (B) either (i) royalty payments based on sales of TYMLOS in Japan or (ii), if and at such time that no such royalty payments are owed, supply payments based on the supply of TYMLOS for sale in Japan that together exceed $300 million during any consecutive 12-month period beginning on the date hereof and ending on or prior to December 31, 2025.
Milestone Notice has the meaning set forth in Section 2.4(a).
Milestone Payment Amount means $1.00 per CVR, if, prior to the end of calendar year 2025, the Milestone is achieved.
Milestone Payment Date has the meaning set forth in Section 2.4(b).