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 [*** * *] 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.

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 21.2. 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 [***] Portions of the exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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 or its Affiliates intend to sell In the event a Licensed Product is a Combination Product, then the Parties shall meet approximately [***] prior to the anticipated First Commercial Sale of such Combination Product in the Territory to will negotiate in good faith and agree to in writing upon an appropriate adjustment to allocation of the proportion or part of the actual Net Sales for such Combination Product that fairly reflects the added value of the Achillion Single API(s) therein to reflect the relative commercial value contributed by the components of actual Net Sales, taking into account relevant factors such as average prices in relevant countries where other APIs that are not Single Agents included in the Combination Product (the “Relative Commercial Value”). Ifare sold separately or in other combinations, after and actual Net Sales less such good faith negotiations not to exceed [***], the Parties cannot agree to an appropriate adjustment, the dispute agreed-upon proportion/part of actual Net Sales shall be initially referred to treated as the executive officers Net Sales royalty base for purposes of the Parties in accordance with determining royalties due under 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 Section8.4.1. If the Parties are unable to agree on the Relative Commercial Valuesuch allocation, then Roche will the allocation shall be determined by a neutral expert as follows. Upon the failure of the Parties to agree upon the allocation, the JSC shall notify each Party thereof and the Parties shall thereafter confer and attempt in good faith to mutually select one (1) individual who would qualify as an Expertand engage a single external expert to resolve the allocation issue. Such expert shall be neutral and independent of both Parties and all of their respective Affiliates, Pieris will select (1) individual who would qualify as an Expertshall have significant experience and expertise in the pharmaceutical industry and appropriate for determining a fair allocation. If the Parties cannot agree on such single expert within [**] days of the JSC notice, and those two (2) individuals then each Party shall select one (1) individual who would qualify as an Expert such expert and who the two (2) experts selected by the Parties shall appoint a third expert, and the decision shall be chairman rendered by the 3-expert panel, provided that all such three (3) experts must meet the foregoing criteria and shall be mutually engaged by the Parties under a written contract acceptable to both Parties within [**] days of a committee of each expert’s selection or appointment. Within [**] days after the three Experts expert(s) is/are selected or appointed (as the “Expert Committee”case may be), each Party will deliver to the expert(s) and the other Party a written memorandum setting forth its proposed allocation, relevant information and supporting arguments or rationale (each a “Proposed Resolution” of the applicable Party), such memorandum not to exceed [**] pages in length (with double-spaced typeface of least [**] point font). The Parties will also provide the expert(s) with a single deciding votecopy of this Agreement, as may be amended at such time. The Expert Committee will promptly hold a meeting to review Within [**] days after receipt of the issue under reviewother Party’s Proposed Resolution, at which it will consider memoranda submitted by each Party may submit to the expert(s) (with a copy to the other Party) a response to the other Party’s Proposed Resolution, such response not to exceed [**] pages in length (with double-spaced type face of at least [**] point font). Neither Party may have any other communications (either written or oral) with any expert(s) other than as expressly permitted in this Section 8.4.3(b), provided that the expert(s) may convene a hearing if the expert(s) so choose(s) to ask questions of the Parties. Within [**] before the meeting, as well as reasonable presentations that each Party may present at the meeting. The determination days after appointment or selection 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 Diagnosticrequired expert(s), the Relative Commercial Value expert(s) will render a written decision selecting one of such Companion Diagnostic Product the proposed allocations set forth in the Proposed Resolutions (without modification unless the Parties mutually agree). The decision of the expert(s) shall be [***]final and memorialized in writing, and the Parties shall share equally the out-of-pocket costs incurred in engaging the expert(s).