Common use of Material Submissions and Correspondence Clause in Contracts

Material Submissions and Correspondence. As between the Parties, each Pfizer Licensor and each Company Licensee shall have the sole right, but not the obligation, to control all regulatory matters with respect to its Licensed Products in its respective field of use in the Territory within the scope of its rights with respect thereto, including the preparation, submission, and maintenance of all regulatory submissions; provided that upon the applicable Pfizer Licensor’s reasonable request: 3.2.1 such Pfizer Licensor shall have the right to participate in all meetings with the Regulatory Authorities to the extent permitted by Applicable Law, and 3.2.2 such Company Licensee shall provide such Pfizer Licensor with a copy of any material communications from, and drafts of any material filings (including Regulatory Approval Applications) or responses to, any Regulatory Authorities reasonably prior to submission to allow such Pfizer Licensor an opportunity to review and comment thereon (and such material communications, filings and responses shall be subject to such Pfizer Licensor’s approval, not to be unreasonably withheld). Such Pfizer Licensor shall provide any comments with respect to such communications, filings and responses to such Company Licensee as soon as reasonably practicable and such Company Licensee shall incorporate all such comments made by or on behalf of such Pfizer Licensor. In the event of a dispute between such Company Licensee and such Pfizer Licensor regarding such comments, such Pfizer Licensor shall have final decision-making authority. 3.2.3 For purposes of this Section 3.2, the applicable Pfizer Licensor shall be deemed to have made a reasonable request if, at the time of such request, such Pfizer Licensor or any of its Affiliates is researching, developing, manufacturing or commercializing a compound or product that contains a compound in the same Compound Class as the compound that is contained in the applicable Licensed Product.

Material Submissions and Correspondence. As between the Parties, each Pfizer Licensor and each Company Licensee shall have the sole right, but not the obligation, to control all regulatory matters with respect to its Licensed Products in its respective field of use in the Territory within the scope of its rights with respect thereto, including the preparation, submission, and maintenance of all regulatory submissions; provided that upon the applicable Pfizer Licensor’s reasonable request: 3.2.1 such Pfizer Licensor shall have the right to participate in all meetings with the Regulatory Authorities to the extent permitted by Applicable Law, and 3.2.2 such Company Licensee shall provide such Pfizer Licensor with a copy of any material communications from, and drafts of any material filings (including Regulatory Approval Applications) or responses to, any Regulatory Authorities reasonably prior to submission to allow such Pfizer Licensor an opportunity to review and comment thereon (and such material communications, filings and responses shall be subject to such Pfizer Licensor’s approval, not to be unreasonably withheld). Such Pfizer Licensor shall provide any comments with respect to such communications, filings and responses to such Company Licensee as soon as reasonably practicable and such Company Licensee shall incorporate all such comments made by or on behalf of such Pfizer Licensor. In the event of a dispute between such Company Licensee and such Pfizer Licensor regarding such comments, such Pfizer Licensor shall have final decision-making authority. For clarity, such comments may include that submission of a Regulatory Approval Application should be delayed or is not permitted. 3.2.3 For purposes of this Section 3.2, the applicable Pfizer Licensor shall be deemed to have made a reasonable request if, at the time of such request, such Pfizer Licensor or any of its Affiliates is researching, developing, manufacturing or commercializing a compound or product that contains a compound in the same Compound Class compound as the compound that is contained in the applicable Licensed Product.

Material Submissions and Correspondence. As between the Parties, each Pfizer Licensor and each Company Licensee shall have the sole right, but not the obligation, to control all regulatory matters with respect to its Licensed Products in its respective field of use in the Territory within the scope of its rights with respect thereto, including the preparation, submission, and maintenance of all regulatory submissions; provided that upon the applicable Pfizer Licensor’s reasonable request: 3.2.1 such Pfizer Licensor shall have the right to participate in all meetings with the Regulatory Authorities to the extent permitted by Applicable Law, and 3.2.2 such Company Licensee shall provide such Pfizer Licensor with a copy of any (a) material communications fromfrom any Regulatory Authorities reasonably following receipt thereof, and (b) drafts of any material filings (including Regulatory Approval Applications) or responses to, to and communications with any Regulatory Authorities reasonably prior to submission to allow such Pfizer Licensor an opportunity to review and comment thereon (and such material communications, filings and responses shall be subject to such Pfizer Licensor’s 's prior written approval, not to be unreasonably withheld). Such Pfizer Licensor shall provide any comments with respect to such communications, filings and responses to such Company Licensee as soon as reasonably practicable and such Company Licensee shall incorporate all such comments made by or on behalf of such Pfizer Licensor. In the event of a dispute between such Company Licensee and such Pfizer Licensor regarding such comments, such Pfizer Licensor shall have final decision-making authority. For clarity, such comments may include that submission of a Regulatory Approval Application should be delayed or is not permitted. 3.2.3 For purposes of this Section 3.2, the applicable Pfizer Licensor shall be deemed to have made a reasonable request if, at the time of such request, such Pfizer Licensor or any of its Affiliates is researching, developing, manufacturing or commercializing a compound or product that contains a compound in the same Compound Class compound as the compound that is contained in the applicable Licensed Product.