Product Sampling. (a) Schering may provide sampling for the Product for use in the treatment of chronic hepatitis C in a country within the Territory, in reasonable quantities comparable to the sampling conducted for its other anti-viral and/or oncology products in that country; provided, however, that subsequent to commercial launch of the Product in any country, the amount of such sampling in such country shall be limited to [REDACTED]. The free use of Product prior to commercial launch for the treatment of chronic hepatitis C in (i) pre-marketing programs (where permitted by applicable law) and compassionate programs, and (ii) other marketing and Phase IV studies, shall all be deemed sampling of the Product. All samples of the Product shall be purchased at a price equal to [REDACTED]. (b) Subsequent to commercial launch of the Product by ICN in any country, the amount of sampling in such country by ICN shall be limited to [REDACTED]. If the amount of such sampling by ICN in any such country exceeds [REDACTED], then ICN shall pay to Schering an amount equal to the [REDACTED], determined in accordance with the provisions of Section 6.2. (c) The distribution of Product by Schering during the [REDACTED] preceding the date on which Schering reasonably expects to receive Regulatory Approval shall be consistent with the Research and Development Plan set forth as Exhibit D and with Schering's previous historical compassionate use programs for ribavirin in connection with the treatment of chronic hepatitis C. Schering shall not engage in pre-approval distribution of the Product (other than for clinical trials, which are those with protocols and case report forms) in a manner that could reasonably be expected to compromise the distribution by ICN of the Product in the EU following Regulatory Approval.
Appears in 7 contracts
Samples: Exclusive License and Supply Agreement (Ribapharm Inc), Exclusive License and Supply Agreement (Icn Pharmaceuticals Inc), Exclusive License and Supply Agreement (Icn Pharmaceuticals Inc)