Example ContractsClausesGeneric Competition
Generic Competition
Generic Competition contract clause examples

Generic Competition. Royalties payable following establishment of Generic Competition with respect to the sale by a Third Party of a product that is a Biosimilar Biologic Product to such Allogene Licensed Product in such country will be payable at ​ of the otherwise applicable rate prior to application of this Section 5.2.2(a). “Generic Competition” means, with respect to a given Calendar Year with respect to an Allogene Licensed Product in any country, that during such Calendar Year, one (1) or more Third Parties have received Regulatory Approval to sell in such country a Biosimilar Biologic Product, such Biosimilar Biologic Product(s) will be commercially available in such country and such Biosimilar Biologic Product(s) will have, in the aggregate. A product will be a “Biosimilar Biologic Product” with respect to an Allogene Licensed Product if such product # has been licensed as a biosimilar or interchangeable product by FDA pursuant to Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)), as may be amended, or any subsequent or superseding law, statute or regulation, # has been licensed as a similar biological medicinal product by EMA pursuant to Directive 2001/83/EC, as may be amended, or any subsequent or superseding law, statute or regulation, or # has otherwise achieved analogous Regulatory Approval from another applicable Regulatory Authority.

Generic Competition”. Generic Competition means, with respect to a Product in any Region of the Territory in a given Calendar Quarter, that, during such Calendar Quarter, one or more Generic Products shall be commercially available in such Region and sold by a Third Party not authorized by Newsoara or any of its Affiliates, and such Generic Products shall have a market share of at least ​ of the aggregate market share of Products and Generic Products (based on data provided by IMS International, or if such data is not available, such other reliable data source as reasonably determined by Newsoara in consultation with vTv) as measured by unit volume.

Generic Competition”. Generic Competition means, with respect to a Product in any Region of the Territory in a given Calendar Quarter, that, during such Calendar Quarter, one or more Generic Products shall be commercially available in such Region and sold by a Third Party not authorized by Huadong or any of its Affiliates, and such Generic Products shall have a market share of at least ​ of the aggregate market share of Products and Generic Products (based on data provided by IMS International, or if such data is not available, such other reliable data source as reasonably determined by Huadong in consultation with vTv) as measured by unit volume.

Generic Competition. In the event that, in a country, a Generic Version of the Licensed Product has been approved for commercialization in such country, Janssen may reduce the royalty rate for calculating royalties payable to Arrowhead based on Janssen’s and ​ = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Generic Competition. Subject to [Section 5.5.3(e)] (Cumulative Reductions Floor), if in any Calendar Year during the Royalty Term for a given Licensed Product in a country the Generic Competition Percentage in such country is greater than or equal to ​, then commencing in the next Calendar Year, and thereafter during each Calendar Quarter, the aggregate Net Sales of such Licensed Product in such country during each Calendar Quarter will be reduced by ​.

Reduction for Generic Competition. Subject to [Section 6.4.4(d)] (Cumulative Adjustments), on a Product-by-Product basis, in the event of Loss of Market Exclusivity with respect to a Product in a country, as from the first Calendar Quarter this [Section 6.4.4(b)] (Reduction for Generic Competition) applies, the applicable Royalty Rate pursuant to Section 6.4 (Royalty Rate) for annual Net Sales of such Product otherwise due in such country will be reduced by ​ where there is a Loss of Market Exclusivity for such Product in such Calendar Quarter in such country.

Adjustment for Generic Competition. With respect to Products resulting from the TIGIT Research Program, on a country-by-country and Product-by-Product basis, if during a calendar quarter for which royalties are being calculated hereunder for a particular Product, one or more products being sold in a particular country are Generic Products with respect to such Product, and the market penetration (based on sales of units of such Product and such Generic Product(s) in the aggregate, as reported by IMS International, or if such data are not available, such other reliable data source as reasonably agreed by the Parties) of such Generic Product exceeds ​, then the royalty rate otherwise applicable to the Net Sales of the Product in such country during such quarter and thereafter (for as long as such Generic Products are sold in such country) will be reduced to ​ of Net Sales in such country. For the avoidance of doubt, such reduction will only apply for those calendar quarters in which the market penetration exceeds ​.

Reduction for Generic Competition. In the event that one or more Generic Products with respect to a Licensed Product are commercially available in a given country in the Territory (“Generic Competition”) in a given Calendar Quarter, then Licensee shall be entitled to deduct ​ from the Royalty due to [[AstraZeneca:Organization]] with respect to such Licensed Product in such country if Net Sales of such Licensed Product in such country in such Calendar Quarter ​, such deduction to be made in such Calendar Quarter and thereafter in each Calendar Quarter during the Royalty Term in which there is Generic Competition with respect to such Licensed Product in such country.

Reduction for Generic Competition. If during the Royalty Term, the Generic Competitors have achieved a Generic Market Share of more than ​ within the Licensee Territory, in lieu of the royalty rate specified in Article 6.4(a) above, the royalty rate applicable to Annual Royalty Bearing Net Sales of the Product shall be reduced to ​ percent (​), irrespective of the level of Net Sales.

Royalty Adjustment for Generic Competition. In the event that there is Generic Competition (as defined below) with respect to an Orphazyme Product in any country during the Royalty Term, then the Royalties payable for Net Sales in respect of such Orphazyme Product in such country shall be reduced by ​ following the first occurrence of Generic Competition in such country and for long as Generic Competition prevails in such country. In this Section, “Generic Competition” means the initiation of commercial sales of a generic version of an Orphazyme Product in a country.

Next results

Draft better contracts
faster with AllDrafts

AllDrafts is a cloud-based editor designed specifically for contracts. With automatic formatting, a massive clause library, smart redaction, and insanely easy templates, it’s a welcome change from Word.

And AllDrafts generates clean Word and PDF files from any draft.