Common use of Combination Product Clause in Contracts

Combination Product. If Roche or its Affiliates intend to sell a Combination Product, then the Parties shall meet approximately [***] prior to the anticipated First Commercial Sale of such Combination Product in the Territory to negotiate in good faith and agree to an appropriate adjustment to Net Sales to reflect the relative commercial value contributed by the components of the Combination Product (the “Relative Commercial Value”). If, after such good faith negotiations not to exceed [***], the Parties cannot agree to an appropriate adjustment, the dispute shall be initially referred to the executive officers of the Parties in accordance with Section 21.2. Should the Parties fail to agree [***] of such referral, then the Relative Commercial Value shall be determined by an Expert Committee under the procedures of this Section. If the Parties are unable to agree on the Relative Commercial Value, then Roche will select one (1) individual who would qualify as an Expert, Pieris will select (1) individual who would qualify as an Expert, and those two (2) individuals shall select one (1) individual who would qualify as an Expert and who shall be chairman of a committee of the three Experts (the “Expert Committee”), each with a single deciding vote. The Expert Committee will promptly hold a meeting to review the issue under review, at which it will consider memoranda submitted by each Party at least [***] before the meeting, as well as reasonable presentations that each Party may present at the meeting. The determination of the Expert Committee as to the issue under review will be binding on both Parties. The Parties will share equally in the costs of the Expert Committee. Unless otherwise agreed to by the Parties, the Expert Committee may not decide on issues outside the scope mandated under terms of this Agreement. Notwithstanding the foregoing, for any Combination Product that includes a Companion Diagnostic Product (i.e., not a Companion Diagnostic), the Relative Commercial Value of such Companion Diagnostic Product shall be [***]

Combination Product. If Roche or its Affiliates intend to sell a Combination Product, then the Parties shall meet approximately [***] prior to the anticipated First Commercial Sale of such Combination Product in the Territory to negotiate in good faith and agree to an appropriate adjustment to Net Sales to reflect the relative commercial value contributed by the components of the Combination Product (the “Relative Commercial Value”). If, after such good faith negotiations not to exceed [***], the Parties cannot agree to an appropriate adjustment, the dispute shall be initially referred to the executive officers of the Parties in accordance with Section 21.2. Should the Parties fail to agree [***] of such referral, then the Relative Commercial Value shall be determined by an Expert Committee under the procedures of this Section23.6. If the Parties are unable to agree on the Relative Commercial ValueValue , then Roche will select one (1) individual [***] who would qualify as an Expert, Pieris C4T will select (1) individual [***] who would qualify as an Expert, and those two (2) individuals [***] shall select one (1) individual [***] who would qualify as an Expert and who shall be chairman of a committee of the three Experts (the “Expert Committee”), each with a single deciding vote. The Expert Committee will promptly hold a meeting to review the issue under review, at which it will consider memoranda submitted by each Party at least [***] before the meeting, as well as reasonable presentations that each Party may present at the meeting. The determination of the Expert Committee as to the issue under review will be binding on both Parties. The Parties will share equally in the costs of the Expert Committee. Unless otherwise agreed to by the Parties, the Expert Committee may not decide on issues outside the scope mandated under terms of this Agreement. Notwithstanding the foregoing, for any Combination Product that includes a Companion Diagnostic Product (i.e., not a Companion Diagnostic), the Relative Commercial Value of such Companion Diagnostic Product shall be [***].

Combination Product. If Roche the Selling Party or its Affiliates intend to sell a Combination Product, then the Parties shall meet approximately [***] one (1) year prior to the anticipated First Commercial Sale of such Combination Product in the Territory to negotiate in good faith and agree to an appropriate adjustment to Net Sales to reflect the relative commercial value contributed by the components of the Combination Product (the “Relative Commercial Value”). If, after such good faith negotiations not to exceed [***]ninety (90) days, the Parties cannot agree to an appropriate adjustment, the dispute shall be initially referred to the executive officers of the Parties in accordance with Section 21.223.2. Should the Parties fail to agree [***] within sixty (60) days of such referral, then the Relative Commercial Value shall be determined by an the Expert Committee under the procedures of this Sectionset forth below. If the Parties are unable to agree on the Relative Commercial Value, then Roche will select one (1) individual who would qualify as an Expert, Pieris BPM will select (1) individual who would qualify as an Expert, and those two (2) individuals shall select one (1) individual who would qualify as an Expert and who shall be chairman of a committee of the three Experts (the “Expert Committee”), each with a single deciding vote. The Expert Committee will promptly hold a meeting to review the issue under review, at which it will consider memoranda submitted by each Party at least [***] fifteen (15) days before the meeting, as well as reasonable presentations that each Party may present at the meeting. The determination of the Expert Committee as to the issue under review will be binding on both Parties. The Parties will share equally in the costs of the Expert Committee. Unless otherwise agreed to by the Parties, the Expert Committee may not decide on issues outside the scope mandated under terms of this Agreement. Notwithstanding If the foregoing, for any Combination Product that includes Expert Committee is unable to come to a Companion Diagnostic Product determination within sixty (i.e., not a Companion Diagnostic)60) days of such meeting, the Relative Commercial Value of such Companion Diagnostic Product shall matter will be decided pursuant to Section 23.3. […***…]

Combination Product. If Roche or its Affiliates intend to sell a Combination Product, then the Parties shall meet approximately [***] * year prior to the anticipated First Commercial Sale of such Combination Product in the Territory to negotiate in good faith and agree to an appropriate adjustment to Net Sales to reflect the relative commercial value contributed by the components of the Combination Product (the “Relative Commercial Value”). If, after such good faith negotiations not to exceed [***], the Parties cannot agree to an appropriate adjustment, the dispute shall be initially referred to the executive officers Senior Officers of the Parties in accordance with Section 21.2. Should If the Parties fail are unable to agree [on the Relative Commercial Value within ***] * days of such referral, then the Relative Commercial Value shall be determined by an Expert Committee under the procedures of this Sectionfollowing procedure. If the Parties are unable to agree on the Relative Commercial Value, then Roche will select one (1) individual *** who would qualify as an Expert, Pieris Hookipa will select (1) individual *** who would qualify as an Expert, and those two (2) individuals *** shall select one (1) individual *** who would qualify as an Expert and who shall be chairman of a committee of the three Experts (the “Expert Committee”), each with a single deciding vote***. The Expert Committee will promptly hold a meeting to review the issue under review, at which it will consider memoranda submitted by each Party at least [***] * days before the meeting, as well as reasonable presentations that each Party may present at the meeting. The determination of the Expert Committee as to the issue under review will be binding on both Parties. The Parties will share equally in the costs of the Expert Committee. Unless otherwise agreed to by the Parties, the Expert Committee may not decide on issues outside the scope mandated under terms of this Agreement. Notwithstanding the foregoing, for any Combination Product that includes a Companion Diagnostic Product (i.e., not a Companion Diagnostic), the Relative Commercial Value of such Companion Diagnostic Product shall be [***].

Combination Product. If Roche the Selling Party or its Affiliates intend to sell a Combination Product, then the Parties shall meet approximately [***] one (1) year prior to the anticipated First Commercial Sale of such Combination Product in the Territory to negotiate in good faith and agree to an appropriate adjustment to Net Sales to reflect the relative commercial value contributed by the components of the Combination Product (the “Relative Commercial Value”). If, after such good faith negotiations not to exceed [***]ninety (90) days, the Parties cannot agree to an appropriate adjustment, the dispute shall be initially referred to the executive officers of the Parties in accordance with Section 21.223.2. Should the Parties fail to agree [***] within sixty (60) days of such referral, then the Relative Commercial Value shall be determined by an the Expert Committee under the procedures of this Sectionset forth below. ​ If the Parties are unable to agree on the Relative Commercial Value, then Roche will select one (1) individual who would qualify as an Expert, Pieris BPM will select (1) individual who would qualify as an Expert, and those two (2) individuals shall select one (1) individual who would qualify as an Expert and who shall be chairman of a committee of the three Experts (the “Expert Committee”), each with a single deciding vote. The Expert Committee will promptly hold a meeting to review the issue under review, at which it will consider memoranda submitted by each Party at least [***] fifteen (15) days before the meeting, as well as reasonable presentations that each Party may present at the meeting. The determination of the Expert Committee as to the issue under review will be binding on both Parties. The Parties will share equally in the costs of the Expert Committee. Unless otherwise agreed to by the Parties, the Expert Committee may not decide on issues outside the scope mandated under terms of this Agreement. Notwithstanding If the foregoing, for any Combination Product that includes Expert Committee is unable to come to a Companion Diagnostic Product determination within sixty (i.e., not a Companion Diagnostic)60) days of such meeting, the Relative Commercial Value of such Companion Diagnostic Product shall matter will be decided pursuant to Section 23.3. ​ […***]…] ​

Combination Product. If Roche Dermira or its Affiliates intend to sell a Combination Product, then the Parties shall meet approximately [*****] prior to the anticipated First Commercial Sale of such Combination Product in the Territory to negotiate in good faith [*****] and agree to an [*****] Certain portions denoted with an asterisk have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. appropriate adjustment to Net Sales to reflect the relative commercial value contributed by the components of the Combination Product (the “Relative Commercial Value”). If, after such good faith [*****] negotiations not to exceed [*****] ([*****]) days, the Parties cannot agree to an appropriate adjustment, the dispute shall be initially referred to the executive officers of the Parties in accordance with Section 21.2. Should the Parties fail to agree within [*****] ([*****]) days of such referral, then the Relative Commercial Value shall be determined by an Expert Committee under the procedures of this SectionSection 9.4. If the Parties are unable to agree on the Relative Commercial ValueValue under this Section, then Roche will select one (1) individual [*****] who would qualify as an Expert, Pieris Dermira will select (1) individual [*****] who would qualify as an Expert, and those two [*****] (2[*****]) individuals shall select one (1) individual [*****] who would qualify as an Expert and who shall be chairman of a committee of the three [*****] Experts (the “Expert Committee”), each with a single deciding vote. The Expert Committee will promptly hold a meeting to review the issue under review, at which it will consider memoranda submitted by each Party at least [*****] ([*****]) days before the meeting, as well as reasonable presentations that each Party may present at the meeting. The determination of the Expert Committee as to the issue under review will be binding on both Parties. The Parties will share equally in the costs of the Expert Committee. Unless otherwise agreed to by the Parties, the Expert Committee may not decide on issues outside the scope mandated under terms of this Agreement. Notwithstanding the foregoing, for any Combination Product that includes a Companion Diagnostic Product (i.e., not a Companion Diagnostic), the Relative Commercial Value of such Companion Diagnostic Product shall be [***].

Combination Product. If Roche or its Affiliates intend to sell a Combination Product, then the Parties shall meet approximately [*** * *] prior to the anticipated First Commercial Sale of such Combination Product in the Territory to negotiate in good faith and agree to an appropriate adjustment to Net Sales to reflect the relative commercial value contributed by the components of the Combination Product (the “Relative Commercial Value”). If, after such good faith negotiations not to exceed [*** * *], the Parties cannot agree to an appropriate adjustment, the dispute shall be initially referred to the executive officers of the Parties in accordance with Section 21.222.2. Should If the Parties fail are unable to agree on the Relative Commercial Value within [*** * *] of such referral, then the Relative Commercial Value shall be determined by an Expert Committee under the procedures of this Sectionfollowing procedure. If the Parties are unable to agree on the Relative Commercial Value, then Roche will select one (1) individual who would qualify as an Expert, Pieris Dicerna will select (1) individual who would qualify as an Expert, and those two (2) individuals shall select one (1) individual who would qualify as an Expert and who shall be chairman of a committee of the three Experts (the “Expert Committee”), each with a single deciding vote. The Expert Committee will promptly hold a meeting to review the issue under review, at which it will consider memoranda submitted by each Party at least [*** * *] before the meeting, as well as reasonable presentations that each Party may present at the meeting. As part of the Expert Committee’s consideration, the Parties agree that the Relative Commercial Value of the Lead Product within a Combination Product shall not be less than (a) [* * *] if the first Filing for Regulatory Approval is (or is planned to be, as applicable) for use with one additional Non-Compound Active Agent Controlled by Roche where such compound has a Valid Claim of the composition of matter with at least [* * *]remaining patent life in one or more countries in the Territory or (b) [* * *] if the condition in part (a) is not met. The determination of the Expert Committee as to the issue under review will be binding on both Parties. The Parties will share equally in the costs of the Expert Committee. Unless otherwise agreed to by the Parties, the Expert Committee may not decide on issues outside the scope mandated under terms of this Agreement. Notwithstanding the foregoing, for any A Hybrid Product shall not be treated as a Combination Product that includes a Companion Diagnostic Product (i.e.under this Section 11.4.4 with respect to the Lead Compound and Selected Target Compound, not a Companion Diagnostic), however the Relative Commercial Value of such Companion Diagnostic will be determined if there are other Combination Product shall be [***]components other than the Lead Compound and Selected Target Compound.