Common use of Development Expenses Clause in Contracts

Development Expenses. (a) Subject to Section 4.5(b), all Development Expenses incurred by the Parties under the Development Plan in the Territory shall be shared between the Parties at a ratio of 75:25 (Biogen Idec:Portola) as determined according to the provisions of the Financial Exhibit. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. (b) On a Product-by-Product basis, Portola shall have the option (the “Opt-Out Option”) to opt-out of its co-funding of the Development of such Product under this Section 4.5, which option shall be exercisable by providing Biogen Idec with written notice within ninety (90) days after the earlier of either: (i) receiving from the FDA the minutes (or other correspondence) regarding the first EOP2 Meeting with the FDA, at which the Parties present their proposed protocol for, and obtain the FDA’s advice regarding, a Phase III Clinical Trial (or other pivotal trial) in the first Indication for such Product that is not a Niche Indication; or (ii) receiving from Biogen Idec a written notice confirming that Biogen Idec is committed to commence and conduct a Phase III Clinical Trial for such Product for an Indication that is not a Niche Indication, after the JSC makes a decision to commence and conduct such Phase III Clinical Trial. Upon Portola’s exercise of the Opt-Out Option notwithstanding anything herein to the contrary: (A) Portola’s obligation to share Development Expenses for such Product under this Section 4.5 shall terminate with respect to all Development Expenses incurred after such date and the Parties shall prepare a Reconciliation Statement for the fractional Calendar Quarter ending upon such date and payment(s) between the Parties shall be made accordingly and pursuant to the Financial Exhibit; (B) subject to Section 11.4, Biogen Idec shall thereafter be responsible for one hundred percent (100%) of the Development Expenses for such Products incurred by either Party after such date; (C) for as long as Portola continues to conduct Portola Development Activities for such Product under the Development Plan, Portola shall provide Biogen Idec with reports of its Development Expenses for such Product on a quarterly basis in accordance with the quarterly close process outlined in the Financial Exhibit; (D) Portola shall no longer share any Collaboration Operating Profit (or Loss) for such Products under Section 8.3 in the Profit Share Territory but shall instead receive royalties for such Products throughout the Royalty Territory under Section 8.4; (E) notwithstanding Article 3, each of the JSC and JDC shall meet on a semi-annual basis (or more frequently as the Parties otherwise agree) until the First Commercial Sale of the first Product in a Major Indication in a Major Territory, thereafter all committees, including the JSC, JDC, and if applicable the JCC, shall disband and the consequence set forth in Section 3.7 shall apply; provided, however, that (x) if a Certain Change of Control Event subsequently occurs, all committees, including the JSC, JDC and JCC shall immediately be disbanded and the consequence set forth in Section 3.7 shall apply; and (y) if Development of the applicable Product is subsequently discontinued for Major Indications in favor of a Back-Up Compound for which Portola has not exercised its Opt-Out Option, the provisions of this subsection (E) shall not apply unless and until Portola exercises its Opt-Out Option with respect to such Back-Up Compound; (F) notwithstanding Section 3.4, while the JSC is still in place, in the event the Parties’ representatives on the JSC cannot agree on a matter, Biogen Idec’s representative at the JSC shall have the right to make the final decision on such matter without the need for further escalation; (G) Portola shall no longer have the right to continue any Development activities with respect to such Product in any Major Indication or any Niche Indication without the approval of the JSC (but Portola may complete any on-going clinical trials under Portola Initiated Niche Development at Portola’s expense); (H) Portola shall retain the commercialization rights set forth in Section 7.2(b) but shall otherwise no longer have the right to continue any other commercialization activities with respect to any Product in any Major Indication or any Niche Indication without the approval of the JSC, provided that if a Certain Change of Control Event subsequently occurs, such commercialization rights under Section 7.2(b) shall immediately lapse; and provided, further that, the Parties may nonetheless agree on Portola’s continuing involvement in certain activities related to the Development and commercialization of the Products, including Product containing Back-Up Compounds, such as the conduct of certain Development activities, interaction with Regulatory Authorities, participation in key opinion leader activities, and interaction with medical affairs professionals; provided that in such event, the Parties may agree on additional regular or ad hoc meetings of the JSC and/or JDC to facilitate the collaboration between the Parties on such activities, and provided, further, that if a Certain Change of Control Event subsequently occurs, all such rights of involvement shall immediately lapse.

Development Expenses. (a) Subject The Parties shall share any and all Development Expenses as follows: Takeda shall bear the initial fifty million Dollar ($50,000,000) of total Development Expenses; any Development Expenses in excess of such amount shall thereafter be borne seventy percent (70%) by Takeda and thirty percent (30%) by Affymax. For clarity, the Development expenses incurred in connection with the ROW Development shall not be included in the Development Expenses; provided, that if the JSC determines that the Parties will use any results of the ROW Development to Section 4.5(b)support the Regulatory Approval of the Product in the U.S., then, Affymax shall without delay reimburse Takeda for thirty percent (30%) of the external expenses incurred by Takeda on and after January 1, 2007 for the applicable ROW Development. (i) Each Party shall calculate and maintain records of all relevant Development Expenses incurred by the Parties under it for the Development Plan of the Product, in the Territory shall accordance with procedures to be shared agreed upon between the Parties. The Parties at understand and agree that Internal Expenses shall not be shared, subject to Section 3.4(a)(iv). (ii) Within ten (10) Business Days following the end of each calendar quarter, Takeda shall submit to Affymax a ratio written report setting forth in reasonable detail the Development Expenses it has incurred in such calendar quarter. Within ten (10) Business Days following the end of 75:25 each calendar quarter, Affymax shall submit to Takeda a written report setting forth in reasonable detail the Development Expenses it has incurred in such calendar quarter. (Biogen Idec:Portolaiii) Within twenty (20) Business Days following the end of each calendar quarter, Takeda shall submit to Affymax a written report setting forth in reasonable detail the detailed calculation of all Development Expenses for the Product, and the calculation of any net amount owed by Affymax to Takeda or by Takeda to Affymax, as determined according the case may be, in order to ensure the appropriate sharing of Development Expenses in accordance with the provisions of Section 3.4(a). The net amount payable shall be paid by Takeda or Affymax to the Financial Exhibitother Party, as the case may be, within twenty-five (25) Business Days following the end of each calendar quarter; provided, that, in the event of a dispute, any amounts not in dispute shall be paid and the disputing Party shall provide written notice without undue delay after receipt of the written report in question to the other, specifying such dispute and explaining the basis of the dispute. [*] = Certain confidential information contained Affymax and Takeda shall promptly thereafter meet and negotiate in good faith a resolution to such dispute and, promptly upon resolution of such dispute, the applicable Party shall make the agreed-upon payment. If such dispute is not resolved within forty-five (45) days after delivery of a notice of dispute with respect thereto to the other Party, the disputing Party may audit the other Party in accordance with the provisions of Section 8.11. For clarity, nothing in this document, marked by brackets, has been omitted Section 3.4(a)(iii) shall serve to limit a Party's ability to seek recourse for billing errors discovered after payment is made. (iv) The Parties acknowledge and filed separately agree that Internal Expenses shall not be reimbursed or shared except as set forth in this Section 3.4(a)(iv). In connection with the Securities U.S. Development, either Party may refer to the Finance Subcommittee to provide certain specified Development activities using internal resources and Exchange Commission pursuant to Rule 406 include such Internal Expenses as the Development Expenses to be shared hereunder. Any such referral shall include a sufficiently detailed description of the Securities Act proposed Development activities, the associated Internal Expenses, and, where possible, the costs and expenses to be paid to Third Party contractors if the same Development activities were contracted out to them. If the JSC approves (which approval shall not be unreasonably withheld) the proposal of 1933the Finance Subcommittee to include such Internal Expenses as the Development Expenses, then the proposing Party shall obtain reimbursement as amendedthe Development Expenses for the Internal Expenses actually incurred (in an amount not to exceed any approved amount) in performing such Development activities for the Product. (b) On a Product-by-Product basis, Portola Takeda shall have the option (the “Opt-Out Option”) to opt-out of its co-funding of the Development of such Product under this Section 4.5, which option shall be exercisable by providing Biogen Idec with written notice within ninety (90) days after the earlier of either: (i) receiving from the FDA the minutes (or other correspondence) regarding the first EOP2 Meeting bear all costs and expenses associated with the FDAROW Development, at which the Parties present their proposed protocol for, and obtain the FDA’s advice regarding, a Phase III Clinical Trial (or other pivotal trial) in the first Indication for such Product that is not a Niche Indication; or (ii) receiving from Biogen Idec a written notice confirming that Biogen Idec is committed to commence and conduct a Phase III Clinical Trial for such Product for an Indication that is not a Niche Indication, after the JSC makes a decision to commence and conduct such Phase III Clinical Trial. Upon Portola’s exercise of the Opt-Out Option notwithstanding anything herein to the contrary: (A) Portola’s obligation to share Development Expenses for such Product under this Section 4.5 shall terminate with respect to all Development Expenses incurred after such date and the Parties shall prepare a Reconciliation Statement for the fractional Calendar Quarter ending upon such date and payment(s) between the Parties shall be made accordingly and pursuant to the Financial Exhibit; (B) subject to Section 11.4, Biogen Idec 3.4(a). (c) Any reimbursement payments made pursuant to this Section 3.4 shall thereafter be responsible for one hundred percent (100%) of subject to the Development Expenses for such Products incurred by either Party after such date; (C) for as long as Portola continues to conduct Portola Development Activities for such Product under the Development Plan, Portola shall provide Biogen Idec with reports of its Development Expenses for such Product on a quarterly basis in accordance with the quarterly close process outlined in the Financial Exhibit; (D) Portola shall no longer share any Collaboration Operating Profit (or Loss) for such Products under Section 8.3 in the Profit Share Territory but shall instead receive royalties for such Products throughout the Royalty Territory under Section 8.4; (E) notwithstanding Article 3, each of the JSC and JDC shall meet on a semi-annual basis (or more frequently as the Parties otherwise agree) until the First Commercial Sale of the first Product in a Major Indication in a Major Territory, thereafter all committees, including the JSC, JDC, and if applicable the JCC, shall disband and the consequence general payment procedures set forth in Section 3.7 shall apply; providedSections 8.7 through 8.11, however, that (x) if a Certain Change of Control Event subsequently occurs, all committees, including the JSC, JDC and JCC shall immediately be disbanded and the consequence set forth in Section 3.7 shall apply; and (y) if Development of the applicable Product is subsequently discontinued for Major Indications in favor of a Back-Up Compound for which Portola has not exercised its Opt-Out Option, the provisions of this subsection (E) shall not apply unless and until Portola exercises its Opt-Out Option with respect to such Back-Up Compound; (F) notwithstanding Section 3.4, while the JSC is still in place, in the event the Parties’ representatives on the JSC cannot agree on a matter, Biogen Idec’s representative at the JSC shall have the right to make the final decision on such matter without the need for further escalation; (G) Portola shall no longer have the right to continue any Development activities with respect to such Product in any Major Indication or any Niche Indication without the approval of the JSC (but Portola may complete any on-going clinical trials under Portola Initiated Niche Development at Portola’s expense); (H) Portola shall retain the commercialization rights set forth in Section 7.2(b) but shall otherwise no longer have the right to continue any other commercialization activities with respect to any Product in any Major Indication or any Niche Indication without the approval of the JSC, provided that if a Certain Change of Control Event subsequently occurs, such commercialization rights under Section 7.2(b) shall immediately lapse; and provided, further that, the Parties may nonetheless agree on Portola’s continuing involvement in certain activities related to the Development and commercialization of the Products, including Product containing Back-Up Compounds, such as the conduct of certain Development activities, interaction with Regulatory Authorities, participation in key opinion leader activities, and interaction with medical affairs professionals; provided that in such event, the Parties may agree on additional regular or ad hoc meetings of the JSC and/or JDC to facilitate the collaboration between the Parties on such activities, and provided, further, that if a Certain Change of Control Event subsequently occurs, all such rights of involvement shall immediately lapseinclusive.

Development Expenses. (a) Subject to Section 4.5(b), The Parties shall share any and all Development Expenses incurred by as follows: Takeda shall bear the Parties under the initial fifty million Dollar ($50,000,000) of total Development Plan in the Territory shall be shared between the Parties at a ratio of 75:25 (Biogen Idec:Portola) as determined according to the provisions of the Financial Exhibit. [*Expenses; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. any Development Expenses in excess of such amount shall thereafter be borne seventy percent (70%) by Takeda and thirty percent (30%) by Affymax. For clarity, the Development expenses incurred in connection with the ROW Development shall not be included in the Development Expenses; provided, that if the JSC determines that the Parties will use any results of the ROW Development to support the Regulatory Approval of the Product in the U.S., then, Affymax shall without delay reimburse Takeda for thirty percent (30%) of the external expenses incurred by Takeda on and after January 1, 2007 for the applicable ROW Development. (i) Each Party shall calculate and maintain records of all relevant Development Expenses incurred by it for the Development of the Product, in accordance with procedures to be agreed upon between the Parties. The Parties understand and agree that Internal Expenses shall not be shared, subject to Section 3.4(a)(iv). (ii) Within ten (10) Business Days following the end of each calendar quarter, Takeda shall submit to Affymax a written report setting forth in reasonable detail the Development Expenses it has incurred in such calendar quarter. Within ten (10) Business Days following the end of each calendar quarter, Affymax shall submit to Takeda a written report setting forth in reasonable detail the Development Expenses it has incurred in such calendar quarter. (iii) Within twenty (20) Business Days following the end of each calendar quarter, Takeda shall submit to Affymax a written report setting forth in reasonable detail the detailed calculation of all Development Expenses for the Product, and the calculation of any net amount owed by Affymax to Takeda or by Takeda to Affymax, as the case may be, in order to ensure the appropriate sharing of Development Expenses in accordance with the provisions of Section 3.4(a). The net amount payable shall be paid by Takeda or Affymax to the other Party, as the case may be, within twenty-five (25) Business Days following the end of each calendar quarter; provided, that, in the event of a dispute, any amounts not in dispute shall be paid and the disputing Party shall provide written notice without undue delay after receipt of the written report in question to the other, specifying such dispute and explaining the basis of the dispute. Affymax and Takeda shall promptly thereafter meet and negotiate in good faith a resolution to such dispute and, promptly upon resolution of such dispute, the applicable Party shall make the agreed-upon payment. If such dispute is not resolved within forty-five (45) days after delivery of a notice of dispute with respect thereto to the other Party, the disputing Party may audit the other Party in accordance with the provisions of Section 8.11. For clarity, nothing in this Section 3.4(a)(iii) shall serve to limit a Party’s ability to seek recourse for billing errors discovered after payment is made. (iv) The Parties acknowledge and agree that Internal Expenses shall not be reimbursed or shared except as set forth in this Section 3.4(a)(iv). In connection with the U.S. Development, either Party may refer to the Finance Subcommittee to provide certain specified Development activities using internal resources and to include such Internal Expenses as the Development Expenses to be shared hereunder. Any such referral shall include a sufficiently detailed description of the proposed Development activities, the associated Internal Expenses, and, where possible, the costs and expenses to be paid to Third Party contractors if the same Development activities were contracted out to them. If the JSC approves (which approval shall not be unreasonably withheld) the proposal of the Finance Subcommittee to include such Internal [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Expenses as the Development Expenses, then the proposing Party shall obtain reimbursement as the Development Expenses for the Internal Expenses actually incurred (in an amount not to exceed any approved amount) in performing such Development activities for the Product. (b) On a Product-by-Product basis, Portola Takeda shall have the option (the “Opt-Out Option”) to opt-out of its co-funding of the Development of such Product under this Section 4.5, which option shall be exercisable by providing Biogen Idec with written notice within ninety (90) days after the earlier of either: (i) receiving from the FDA the minutes (or other correspondence) regarding the first EOP2 Meeting bear all costs and expenses associated with the FDAROW Development, at which the Parties present their proposed protocol for, and obtain the FDA’s advice regarding, a Phase III Clinical Trial (or other pivotal trial) in the first Indication for such Product that is not a Niche Indication; or (ii) receiving from Biogen Idec a written notice confirming that Biogen Idec is committed to commence and conduct a Phase III Clinical Trial for such Product for an Indication that is not a Niche Indication, after the JSC makes a decision to commence and conduct such Phase III Clinical Trial. Upon Portola’s exercise of the Opt-Out Option notwithstanding anything herein to the contrary: (A) Portola’s obligation to share Development Expenses for such Product under this Section 4.5 shall terminate with respect to all Development Expenses incurred after such date and the Parties shall prepare a Reconciliation Statement for the fractional Calendar Quarter ending upon such date and payment(s) between the Parties shall be made accordingly and pursuant to the Financial Exhibit; (B) subject to Section 11.4, Biogen Idec 3.4(a). (c) Any reimbursement payments made pursuant to this Section 3.4 shall thereafter be responsible for one hundred percent (100%) of subject to the Development Expenses for such Products incurred by either Party after such date; (C) for as long as Portola continues to conduct Portola Development Activities for such Product under the Development Plan, Portola shall provide Biogen Idec with reports of its Development Expenses for such Product on a quarterly basis in accordance with the quarterly close process outlined in the Financial Exhibit; (D) Portola shall no longer share any Collaboration Operating Profit (or Loss) for such Products under Section 8.3 in the Profit Share Territory but shall instead receive royalties for such Products throughout the Royalty Territory under Section 8.4; (E) notwithstanding Article 3, each of the JSC and JDC shall meet on a semi-annual basis (or more frequently as the Parties otherwise agree) until the First Commercial Sale of the first Product in a Major Indication in a Major Territory, thereafter all committees, including the JSC, JDC, and if applicable the JCC, shall disband and the consequence general payment procedures set forth in Section 3.7 shall apply; providedSections 8.7 through 8.11, however, that (x) if a Certain Change of Control Event subsequently occurs, all committees, including the JSC, JDC and JCC shall immediately be disbanded and the consequence set forth in Section 3.7 shall apply; and (y) if Development of the applicable Product is subsequently discontinued for Major Indications in favor of a Back-Up Compound for which Portola has not exercised its Opt-Out Option, the provisions of this subsection (E) shall not apply unless and until Portola exercises its Opt-Out Option with respect to such Back-Up Compound; (F) notwithstanding Section 3.4, while the JSC is still in place, in the event the Parties’ representatives on the JSC cannot agree on a matter, Biogen Idec’s representative at the JSC shall have the right to make the final decision on such matter without the need for further escalation; (G) Portola shall no longer have the right to continue any Development activities with respect to such Product in any Major Indication or any Niche Indication without the approval of the JSC (but Portola may complete any on-going clinical trials under Portola Initiated Niche Development at Portola’s expense); (H) Portola shall retain the commercialization rights set forth in Section 7.2(b) but shall otherwise no longer have the right to continue any other commercialization activities with respect to any Product in any Major Indication or any Niche Indication without the approval of the JSC, provided that if a Certain Change of Control Event subsequently occurs, such commercialization rights under Section 7.2(b) shall immediately lapse; and provided, further that, the Parties may nonetheless agree on Portola’s continuing involvement in certain activities related to the Development and commercialization of the Products, including Product containing Back-Up Compounds, such as the conduct of certain Development activities, interaction with Regulatory Authorities, participation in key opinion leader activities, and interaction with medical affairs professionals; provided that in such event, the Parties may agree on additional regular or ad hoc meetings of the JSC and/or JDC to facilitate the collaboration between the Parties on such activities, and provided, further, that if a Certain Change of Control Event subsequently occurs, all such rights of involvement shall immediately lapseinclusive.

Development Expenses. (a) Subject to Section 4.5(b), Nycomed shall bear all Development Expenses incurred by the Parties under after the Effective Date, and shall pay to Micromet on or before the first day of each calendar quarter the amount of Development Expenses budgeted to be incurred by Micromet in such calendar quarter as set forth in the applicable Development Plan. Nycomed shall pay all such amounts to an account established by Micromet which is exclusively used for the coverage of the Development Plan Expenses. Any interest received from the deposited amount on the account shall be credited against the Development Expenses. Micromet shall provide Nycomed with quarterly reports containing a detailed account of development activities performed and Micromet’s Development Expenses incurred during the preceding calendar quarter. The Parties shall work together to reconcile, in a timely fashion, the Development Expenses set forth in the Territory reports presented by Micromet with Nycomed’s payments for such quarter. If the Parties determine that such payments exceed Micromet’s reported Development Expenses, then the amount of such excess shall be shared between credited against the next payment of Development Expenses by Nycomed hereunder (or, if no such payment is anticipated, refunded by Micromet to Nycomed within [***] days of such determination). If the Parties at a ratio of 75:25 (Biogen Idec:Portola) as determined according determine that Micromet’s reported Development Expenses exceed the amount paid by Nycomed, then Nycomed shall pay the excess amount to the provisions of the Financial Exhibit. Micromet within [***] = days of such determination but no later than the next quarterly advance payment made by Nycomed under this Section 3.3. All *** Certain confidential information contained in this document, marked by brackets, document has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. (b) On a Product-by-Product basis, Portola shall have the option (the “Opt-Out Option”) to opt-out of its co-funding of the Development of such Product under this Section 4.5, which option shall be exercisable by providing Biogen Idec with written notice within ninety (90) days after the earlier of either: (i) receiving from the FDA the minutes (or other correspondence) regarding the first EOP2 Meeting with the FDA, at which the Parties present their proposed protocol for, and obtain the FDA’s advice regarding, a Phase III Clinical Trial (or other pivotal trial) in the first Indication for such Product that is not a Niche Indication; or (ii) receiving from Biogen Idec a written notice confirming that Biogen Idec is committed to commence and conduct a Phase III Clinical Trial for such Product for an Indication that is not a Niche Indication, after the JSC makes a decision to commence and conduct such Phase III Clinical TrialCommission. Upon Portola’s exercise of the Opt-Out Option notwithstanding anything herein to the contrary: (A) Portola’s obligation to share Development Expenses for such Product under this Section 4.5 shall terminate Confidential treatment has been requested with respect to all the omitted portions. such Development Expenses incurred after such date and the Parties shall prepare a Reconciliation Statement for the fractional Calendar Quarter ending upon such date and payment(s) between the Parties shall be made accordingly and pursuant paid to the Financial Exhibit; (B) subject to Section 11.4, Biogen Idec shall thereafter be responsible for one hundred percent (100%) of extent made or incurred in conjunction with an approved budget line item in the Development Expenses for such Products incurred Plan as approved and revised from time to time by either Party after such date; (C) for the JSC as long as Portola continues to conduct Portola Development Activities for such Product under the Development Plan, Portola set forth below. The JSC shall provide Biogen Idec with reports of its Development Expenses for such Product monitor and review on a quarterly basis the actual expenses incurred by the Parties in accordance with conducting development activities under the quarterly close process outlined in Development Plan and each Party shall promptly notify the Financial Exhibit; (D) Portola JSC if it reasonably expects that its Development Expenses during any calendar period shall no longer share any Collaboration Operating Profit (or Loss) exceed by [***] percent [***] the then-current budgeted amount for such Products under Section 8.3 in the Profit Share Territory but shall instead receive royalties for such Products throughout the Royalty Territory under Section 8.4; (E) notwithstanding Article 3, each of the JSC and JDC shall meet on a semi-annual basis (or more frequently as the Parties otherwise agree) until the First Commercial Sale of the first Product in a Major Indication in a Major Territory, thereafter all committees, including the JSC, JDC, and if applicable the JCC, shall disband and the consequence set forth in Section 3.7 shall apply; provided, however, that (x) if a Certain Change of Control Event subsequently occurs, all committees, including the JSC, JDC and JCC shall immediately be disbanded and the consequence set forth in Section 3.7 shall apply; and (y) if Development of the applicable Product is subsequently discontinued for Major Indications in favor of a Back-Up Compound for which Portola has not exercised its Opt-Out Option, the provisions of this subsection (E) shall not apply unless and until Portola exercises its Opt-Out Option with respect to such Back-Up Compound; (F) notwithstanding Section 3.4, while the JSC is still in place, in the event the Parties’ representatives on the JSC cannot agree on a matter, Biogen Idec’s representative at the JSC shall have the right to make the final decision on such matter without the need for further escalation; (G) Portola shall no longer have the right to continue any Development activities with respect to such Product in any Major Indication or any Niche Indication without the approval of the JSC (but Portola may complete any on-going clinical trials under Portola Initiated Niche Development at Portola’s expense); (H) Portola shall retain the commercialization rights set forth in Section 7.2(b) but shall otherwise no longer have the right to continue any other commercialization activities with respect to any Product in any Major Indication or any Niche Indication without the approval of the JSC, provided that if a Certain Change of Control Event subsequently occurs, such commercialization rights under Section 7.2(b) shall immediately lapse; and provided, further that, the Parties may nonetheless agree on Portola’s continuing involvement in certain activities related to the Development and commercialization of the Products, including Product containing Back-Up Compounds, such as the conduct of certain Development activities, interaction with Regulatory Authorities, participation in key opinion leader activities, and interaction with medical affairs professionals; provided that in period. In such event, the Parties may agree on additional regular JSC shall in good faith consider and review a corresponding amendment to either the applicable budget or ad hoc meetings the scope of development activities to be performed consistent with the JSC and/or JDC to facilitate the collaboration between the Parties on such activities, and provided, further, that if a Certain Change of Control Event subsequently occurs, all such rights of involvement shall immediately lapseParties’ obligations under this Agreement.

Development Expenses. (a) Subject to Section 4.5(b)The Parties shall share any and all Development Expenses as follows: (i) During the First Step, all expenses and activities are the responsibility of *, as per the Development Plan described in Exhibit D, and subsequent activities required to complete the First Step; (ii) After the First Step, total Development Expenses shall be borne based on each Parties P/L Share Percentage; The initial P/L Share Percentages of the Parties are as follows: TGTX: * % NOVIMMUNE: * % If either party fails to pay their proportionate share of Development Expenses and Commercial Expenses prior to First Commercial Sale, then the P/L Share Percentages shall be adjusted as set forth herein in Sections 3.3(a)(vi). The adjustment of such Party’s P/L Share Percentages shall be the sole remedy for such failure. (iii) Each Party shall calculate and maintain records of all relevant Development Expenses incurred by the Parties under it for the Development Plan of the Product, in the Territory shall accordance with procedures to be shared agreed upon between the Parties. The Parties at understand and agree that Internal Expenses shall not be shared, subject to Section 3.3(a)(vii). (iv) Within * (* ) Business Days following the end of each calendar quarter, * shall submit to * a ratio written report setting forth in reasonable detail the Development Expenses it has incurred in such calendar quarter. Within * (* ) Business Days following the end of 75:25 each calendar quarter, * shall submit to * a written report setting forth in reasonable detail the Development Expenses it has incurred in such calendar quarter. (Biogen Idec:Portolav) Within * ( * ) Business Days following the end of each calendar quarter, * shall submit to * a written report setting forth in reasonable detail the calculation of all Development Expenses for the Product, and the calculation of any net amount owed by NOVIMMUNE to TGTX or by TGTX to NOVIMMUNE, as determined according the case may be, in order to ensure the appropriate sharing of Development Expenses in accordance with the provisions of Section 3.3(a) (ii). The net amount payable shall be paid to the Financial Exhibitother Party, as the case may be, within * ( * ) days following the receipt of the written report; provided, that, in the event of a dispute, any amounts not in dispute shall be paid and the disputing Party shall provide written notice without undue delay after receipt of the written report in question to the other, specifying such dispute and explaining the basis of the dispute. [*] = Certain confidential information contained The Parties shall promptly thereafter meet and negotiate in good faith a resolution to such dispute and, promptly upon resolution of such dispute, the applicable Party shall make the agreed-upon payment. If such dispute is not resolved within * ( * ) days after delivery of a notice of dispute with respect thereto to the other Party, the disputing Party may audit the other Party in accordance with the provisions of Section 8.7. For clarity, nothing in this documentSection 3.3(a) (v) shall serve to limit a Party’s ability to seek recourse for billing errors discovered after payment is made. (vi) If hereunder, marked either Party fails to contribute their portion of the Development Expenses or Commercial Expenses, such Party’s P/L Share Percentage shall be reduced pro rata to the extent of the Development Expenses or Commercial Expenses that they do not fund as a percentage of the cumulative Development Expenses and Commercial Expenses to date, however, in no event shall NOVIMMUNE’S P/L Share Percentage be reduced below * %. In the event of failure to pay allocated Development Expenses or Commercial Expenses on time as set forth above, each party shall be afforded * ( * ) months to make a catch-up payment. However, upon receipt of Pivotal Data for the Product and any time thereafter, no catch-up payments will be allowed by bracketseither Party. (vii) The Parties acknowledge and agree that Internal Expenses * be reimbursed or shared except as set forth in this Section 3.3(a). However, has been omitted and filed separately in connection with the Securities Development, either Party may refer to the JSC to provide certain specified Development activities using internal resources as opposed to out-sourcing such activity to a Third Party and Exchange Commission pursuant to Rule 406 include such Internal Expenses as the Development Expenses to be shared hereunder. Any such referral shall include a sufficiently detailed description of the Securities Act of 1933proposed Development activities, the associated Internal Expenses, and, where possible, the costs and expenses to be paid to Third Party contractors if the same Development activities were contracted out to them. If the JSC approves (which approval shall not be unreasonably withheld) such Internal Expenses as amendedthe Development Expenses, then the proposing Party shall obtain reimbursement as the Development Expenses for the Internal Expenses actually incurred (in an amount not to exceed any approved amount) in performing such Development activities for the Product. (b) On a Product-by-Product basis, Portola shall have the option (the “Opt-Out Option”) Any reimbursement payments made pursuant to opt-out of its co-funding of the Development of such Product under this Section 4.5, which option 3.3 shall be exercisable by providing Biogen Idec with written notice within ninety (90) days after the earlier of either: (i) receiving from the FDA the minutes (or other correspondence) regarding the first EOP2 Meeting with the FDA, at which the Parties present their proposed protocol for, and obtain the FDA’s advice regarding, a Phase III Clinical Trial (or other pivotal trial) in the first Indication for such Product that is not a Niche Indication; or (ii) receiving from Biogen Idec a written notice confirming that Biogen Idec is committed to commence and conduct a Phase III Clinical Trial for such Product for an Indication that is not a Niche Indication, after the JSC makes a decision to commence and conduct such Phase III Clinical Trial. Upon Portola’s exercise of the Opt-Out Option notwithstanding anything herein subject to the contrary: (A) Portola’s obligation to share Development Expenses for such Product under this Section 4.5 shall terminate with respect to all Development Expenses incurred after such date and the Parties shall prepare a Reconciliation Statement for the fractional Calendar Quarter ending upon such date and payment(s) between the Parties shall be made accordingly and pursuant to the Financial Exhibit; (B) subject to Section 11.4, Biogen Idec shall thereafter be responsible for one hundred percent (100%) of the Development Expenses for such Products incurred by either Party after such date; (C) for as long as Portola continues to conduct Portola Development Activities for such Product under the Development Plan, Portola shall provide Biogen Idec with reports of its Development Expenses for such Product on a quarterly basis in accordance with the quarterly close process outlined in the Financial Exhibit; (D) Portola shall no longer share any Collaboration Operating Profit (or Loss) for such Products under Section 8.3 in the Profit Share Territory but shall instead receive royalties for such Products throughout the Royalty Territory under Section 8.4; (E) notwithstanding Article 3, each of the JSC and JDC shall meet on a semi-annual basis (or more frequently as the Parties otherwise agree) until the First Commercial Sale of the first Product in a Major Indication in a Major Territory, thereafter all committees, including the JSC, JDC, and if applicable the JCC, shall disband and the consequence general payment procedures set forth in Section 3.7 shall apply; provided, however, that (x) if a Certain Change of Control Event subsequently occurs, all committees, including the JSC, JDC Sections 8.5 and JCC shall immediately be disbanded and the consequence set forth in Section 3.7 shall apply; and (y) if Development of the applicable Product is subsequently discontinued for Major Indications in favor of a Back-Up Compound for which Portola has not exercised its Opt-Out Option, the provisions of this subsection (E) shall not apply unless and until Portola exercises its Opt-Out Option with respect to such Back-Up Compound; (F) notwithstanding Section 3.4, while the JSC is still in place, in the event the Parties’ representatives on the JSC cannot agree on a matter, Biogen Idec’s representative at the JSC shall have the right to make the final decision on such matter without the need for further escalation; (G) Portola shall no longer have the right to continue any Development activities with respect to such Product in any Major Indication or any Niche Indication without the approval of the JSC (but Portola may complete any on-going clinical trials under Portola Initiated Niche Development at Portola’s expense); (H) Portola shall retain the commercialization rights set forth in Section 7.2(b) but shall otherwise no longer have the right to continue any other commercialization activities with respect to any Product in any Major Indication or any Niche Indication without the approval of the JSC, provided that if a Certain Change of Control Event subsequently occurs, such commercialization rights under Section 7.2(b) shall immediately lapse; and provided, further that, the Parties may nonetheless agree on Portola’s continuing involvement in certain activities related to the Development and commercialization of the Products, including Product containing Back-Up Compounds, such as the conduct of certain Development activities, interaction with Regulatory Authorities, participation in key opinion leader activities, and interaction with medical affairs professionals; provided that in such event, the Parties may agree on additional regular or ad hoc meetings of the JSC and/or JDC to facilitate the collaboration between the Parties on such activities, and provided, further, that if a Certain Change of Control Event subsequently occurs, all such rights of involvement shall immediately lapse8.6.