Common use of Manufacture and Supply of Product Clause in Contracts

Manufacture and Supply of Product. (a) The Compound, Development Plan Carriers and Product will be manufactured by Novartis or a Third Party manufacturer of Novartis’ sole choice, the selection of which shall not be unreasonably withheld by Emisphere unless Emisphere can reasonably demonstrate that the selected Third Party manufacturer is considered a technological competitor of Emisphere and Emisphere would suffer commercially from such selection for such reason alone. Emisphere may raise objection to a maximum of one Third Party manufacturer as proposed by Novartis. (b) Any chemical (not including the Commercial Carrier) or formulation components required by Novartis for its own manufacture of the Product, Development Plan Carriers or Compound for the purposes of this Agreement shall be procured by Novartis at its own expense. Novartis shall ensure that supplies of the Product(s) are produced as diligently as any of its products of similar commercial importance. Novartis shall be responsible for the packaging, labeling, distribution and sale of the Product. The manufacture and distribution of supplies of Product for use in clinical studies or as samples in a country shall be carried out in the same manner. Novartis shall have the right to manufacture any Development Plan Carrier during Development and Commercialization. (c) From the fifth anniversary of the Launch of the Product, subject to the following sentence, Emisphere may itself manufacture up to a maximum of ***% of Novartis’ needs for the Commercial Carrier only if Emisphere is able to produce the Commercial Carrier to the same standards of quality and consistency as Novartis and at a cost acceptable to Novartis. If Emisphere quotes a verifiable price that is ***% of the Novartis Fully Burdened Manufacturing Cost with the same standard of quality and consistency as Novartis, then Emisphere shall be permitted to manufacture up to ***% of the Novartis Commercial Carrier needs.

Manufacture and Supply of Product. (a) The Compound, Development Plan Carriers and Product will be manufactured by Novartis or a Third Party manufacturer of Novartis’ sole choice, the selection of which shall not be unreasonably withheld by Emisphere unless Emisphere can reasonably demonstrate that the selected Third Party manufacturer is considered a technological competitor of Emisphere and Emisphere would suffer commercially from such selection for such reason alone. Emisphere may raise objection to a maximum of one Third Party manufacturer as proposed by Novartis. (b) Any chemical (not including the Commercial Carrier) or formulation components required by Novartis for its own manufacture of the Product, Development Plan Carriers or Compound for the purposes of this Agreement shall be procured by Novartis at its own expense. Novartis shall ensure that supplies of the Product(s) are produced as diligently as any of its products of similar commercial importance. Novartis shall be responsible for the packaging, labeling, distribution and sale of the Product. The manufacture and distribution of supplies of Product for use in clinical studies or as samples in a country shall be carried out in the same manner. Novartis shall have the right to manufacture any Development Plan Carrier during Development and Commercialization. *** - indicates material omitted pursuant to a Confidential Treatment Request and filed separately with the Securities and Exchange Commission. (c) From the fifth anniversary of the Launch of the Product, subject to the following sentence, Emisphere may itself manufacture up to a maximum of ***% of Novartis’ needs for the Commercial Carrier only if Emisphere is able to produce the Commercial Carrier to the same standards of quality and consistency as Novartis and at a cost acceptable to Novartis. If Emisphere quotes a verifiable price that is ***% of the Novartis Fully Burdened Manufacturing Cost with the same standard of quality and consistency as Novartis, then Emisphere shall be permitted to manufacture up to ***% of the Novartis Commercial Carrier needs.

Manufacture and Supply of Product. (a) The Compound, Development Plan Programme Carriers and Product will be manufactured by Novartis or a Third Party manufacturer of Novartis’ sole choice, the selection of which shall not be unreasonably withheld by Emisphere unless Emisphere can reasonably demonstrate that the selected Third Party manufacturer is considered a technological competitor of Emisphere and Emisphere would suffer commercially from such selection for such reason alone. Emisphere may raise objection to a maximum of one Third Party manufacturer as proposed by Novartis. (b) Any chemical (not including the Commercial Carrier) or formulation components required by Novartis for its own manufacture of the Product, Development Plan Programme Carriers or Compound for the purposes of this Agreement shall be procured by Novartis at its own expense. Novartis shall ensure that supplies of the Product(s) are produced as diligently as any of its products of similar commercial importance. Novartis shall be responsible for the packaging, labeling, distribution and sale of the Product. The manufacture and distribution of supplies of Product for use in clinical studies or as samples in a country shall be carried out in the same manner. Novartis shall have the right to manufacture any Development Plan Programme Carrier during Development and Commercialization. *** - indicates material omitted pursuant to a Confidential Treatment Request and filed separately with the Securities and Exchange Commission. (c) From the fifth anniversary of the Launch of the Product, subject to the following sentence, Emisphere may itself manufacture up to a maximum of ***% * of Novartis’ needs for the Commercial Carrier only if Emisphere is able to produce the Commercial Carrier to the same standards of quality and consistency as Novartis and at a cost acceptable to Novartis. If Emisphere quotes a verifiable price that is ***% * of the Novartis Fully Burdened Manufacturing Cost with the same standard of quality and consistency as Novartis, then Emisphere shall be permitted to manufacture up to ***% * of the Novartis Commercial Carrier needs.