Common use of Expanded Access Clause in Contracts

Expanded Access. Eiger shall use commercially reasonable efforts to make the Licensed Progeria Product available in the Field as an investigational drug for treatment use (a) in the United States in a manner consistent with all applicable laws, rules and regulations, as each such law, rule or regulation is then in effect and (b) outside the United States, in accordance with “named patient” programs in countries where they are available and delivery by or for Eiger is permitted under applicable law without unreasonable cost, expense or risk of liability, in each case (a) and (b), [ * ]; provided that, with respect to (a) and (b), the aggregate net cost to Eiger for making the Licensed Progeria Product available as an investigational drug for treatment use under this Section 8 shall not in the aggregate exceed [ * ]. For the avoidance of doubt, such [ * ] excludes the costs of manufacturing the Licensed Progeria Product. Eiger shall notify PRF promptly in writing if the aggregate costs of making the Licensed Progeria Product available in the Field as an investigational drug for treatment use pursuant to the foregoing clauses (a) and (b) will exceed such [ * ]. If Eiger in good faith believes that (i) it is not commercially reasonable to make the Licensed Progeria Product available in the Field as an investigational drug for treatment use pursuant to the foregoing clauses (a) or (b) or (ii) making the Licensed Progeria Product available in the Field as an investigational drug for treatment use pursuant to the foregoing clause (b) will subject Eiger to an unreasonable cost, expense or risk of liability, then the Parties shall discuss in good faith potential alternatives. For purposes of this Section 8, “commercially reasonable efforts” shall be deemed met if Eiger spends, excluding the costs of manufacturing the Licensed Progeria Product, [ * ] to make the Licensed Progeria Product available as an investigational drug for treatment use in accordance with the foregoing clauses (a) and (b).

Appears in 1 contract

Sources: Collaboration and Supply Agreement (Eiger BioPharmaceuticals, Inc.)

Expanded Access. Eiger shall use commercially reasonable efforts to make the Licensed Progeria Product available in the Field as an investigational drug for treatment use (a) in the United States in a manner consistent with all applicable laws, rules and regulations, as each such law, rule or regulation is then in effect and (b) outside the United States, in accordance with “named patient” programs in countries where they are available and delivery by or for Eiger is permitted under applicable law without unreasonable cost, expense or risk of liability, in each case (a) and (b), [ * ]; provided that, with respect to (a) and (b), the aggregate net cost to Eiger for making the Licensed Progeria Product available as an investigational drug for treatment use under this Section 8 shall not in the aggregate exceed [ * ]. For the avoidance of doubt, such [ * ] excludes the costs of manufacturing the Licensed Progeria Product. Eiger shall notify PRF promptly in writing if the aggregate costs of making the Licensed Progeria Product available in the Field as an investigational drug for treatment use pursuant to the foregoing clauses (a) and (b) will exceed such [ * ]. If Eiger in good faith believes that (i) it is not commercially reasonable to make the Licensed Progeria Product available in the Field as an investigational drug for treatment use pursuant to the foregoing clauses (a) or (b) or (ii) making the Licensed Progeria Product available in the Field as an investigational drug for treatment use pursuant to the foregoing clause (b) will subject Eiger to an unreasonable cost, expense or risk of liability, then the Parties shall discuss in good faith potential alternatives. For purposes of this Section 8, “commercially reasonable efforts” shall be deemed met if Eiger spends, excluding the costs of manufacturing the Licensed Progeria Product, [ * ] to make the Licensed Progeria Product available as an investigational drug for treatment use in accordance with the foregoing clauses (a) and (b).. [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 179161731 v1

Appears in 1 contract

Sources: Collaboration and Supply Agreement (Eiger BioPharmaceuticals, Inc.)