EX-10.4 5 xoma-ex104_177.htm EX-10.4 xoma-ex104_177.htm

 

Exhibit 10.4

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ASSET PURCHASE AGREEMENT


by and among


NANOTHERAPEUTICS, INC.


and


XOMA (US) LLC




Dated as of November 4, 2015

 

 

 

 

 


 

TABLE OF CONTENTS

 

 

Page

ARTICLE I DEFINITIONS

1

 

 

Section 1.1

Definitions

1

Section 1.2

Interpretation

7

Section 1.3

Currency

8

 

 

 

ARTICLE II SALE AND PURCHASE OF PURCHASED ASSETS

8

 

 

Section 2.1

Purchase and Sale

8

Section 2.2

Purchased Assets

8

Section 2.3

Option.

9

Section 2.4

Assumption of Certain Liabilities and Obligations

9

Section 2.5

Non-Assignability

10

 

 

 

ARTICLE III PURCHASE PRICE

11

 

 

Section 3.1

Purchase

11

Section 3.2

Allocation of Purchase Price

11

Section 3.3

Transfer Taxes

11

 

 

 

ARTICLE IV THE CLOSING

12

 

 

Section 4.1

Closing Date

12

Section 4.2

Closing Deliveries

12

Section 4.3

Transfer of Title; Insurance

13

 

 

 

ARTICLE V REPRESENTATIONS AND WARRANTIES OF SELLER

14

 

 

Section 5.1

Seller’s Organization; Good Standing

14

Section 5.2

Authority; Execution and Delivery

14

Section 5.3

Consents; No Violation, Etc.

14

Section 5.4

Title to Purchased Assets

14

Section 5.5

Intellectual Property

14

Section 5.6

Litigation

15

Section 5.7

Regulatory Issues

15

Section 5.8

Compliance with Laws

15

Section 5.9

No Brokers

15

Section 5.10

Inventory

15

Section 5.11

Exclusive Representations and Warranties

15

 

 

 

ARTICLE VI CERTAIN COVENANTS AND AGREEMENTS OF SELLER

16

 

 

Section 6.1

Conduct of Business

16

i

 


 

 

Page

Section 6.2

Manufacturing Documents; XOMA Know-How

16

 

 

 

ARTICLE VII REPRESENTATIONS AND WARRANTIES OF BUYER

17

 

 

Section 7.1

Buyer’s Organization; Good Standing

17

Section 7.2

Authority; Execution and Delivery

17

Section 7.3

Consents; No Violations, Etc.

17

Section 7.4

Litigation

17

Section 7.5

No Brokers

17

Section 7.6

Availability of Funds

18

Section 7.7

Capital Stock

18

Section 7.8

As-Is Sale

18

 

 

 

ARTICLE VIII CERTAIN COVENANTS AND AGREEMENTS OF BUYER

18

 

 

Section 8.1

Assumption of Regulatory Commitments

18

Section 8.2

Adverse Event Data

19

 

 

 

ARTICLE IX OTHER COVENANTS AND AGREEMENTS

19

 

 

Section 9.1

Transfer of the DMFs

19

Section 9.2

Maintenance of the DMF Pending Completion of Transfer

19

Section 9.3

Assignment of XOMA License Agreements. .

19

Section 9.4

Press Releases

19

Section 9.5

Employment Matters

20

Section 9.6

Novation Assistance

20

Section 9.7

RO1 Award..

20

 

 

 

ARTICLE X

21

 

 

 

Section 10.1

Conditions of Performance by Seller and Buyer

21

Section 10.2

Buyer’s Conditions

21

Section 10.3

Seller’s Conditions

21

 

 

 

ARTICLE XI INDEMNIFICATION

22

 

 

Section 11.1

Survival

22

Section 11.2

Indemnification by Seller.

22

Section 11.3

Indemnification by Buyer

23

Section 11.4

Reductions

24

Section 11.5

Insurance

24

Section 11.6

Mitigation

24

Section 11.7

Procedure

24

 

 

 

ARTICLE XII TERMINATION

25

ii

 


 

 

Page

 

 

Section 12.1

Termination

25

Section 12.2

Effect of Termination

26

 

 

 

ARTICLE XIII GENERAL PROVISIONS

26

 

 

Section 13.1

Expenses

26

Section 13.2

Further Assurances and Actions

26

Section 13.3

Notices

26

Section 13.4

Waiver and Amendments

27

Section 13.5

Headings

27

Section 13.6

Severability

27

Section 13.7

Counterparts

27

Section 13.8

Entire Agreement; No Third Party Beneficiaries

28

Section 13.9

Relationship of the Parties

28

Section 13.10

Governing Law; Jurisdiction

28

Section 13.11

Specific Performance

28

Section 13.12

Waiver of Jury Trial

28

Section 13.13

Binding Effect; Assignment

29

Section 13.14

Disclosure Schedule

29

 

EXHIBITS

 

Exhibit A

Assumption Agreement

Exhibit B

Bill of Sale

Exhibit C

Nanotherapeutics License Agreement

Exhibit D

Allocation of Purchase Price

Exhibit E-1

Seller’s Letters to the FDA

Exhibit E-2

Buyer’s Letters to the FDA

Exhibit E-3

Letters of Reference

Exhibit F

Warehouse License Agreement

Exhibit G

NIAID Subcontract

Exhibit H

SAFC Authorization Letter

Exhibit I

GIBCO Authorization Letter

Exhibit J

Transition Services Agreement

 

 

iii

 


 

ASSET PURCHASE AGREEMENT

THIS ASSET PURCHASE AGREEMENT, dated as of the Fourth day of November, 2015 (this “Agreement”), is made by and among Nanotherapeutics, Inc., a Delaware corporation (“Buyer”), and XOMA (US) LLC, a Delaware limited liability company (“Seller”).

WHEREAS, Seller has been developing therapeutic treatments for botulinum poisoning, including the antibody product designated as XOMA 3AB (the “BOT Business”).  

WHEREAS, Seller desires to sell, transfer, and convey to Buyer, and Buyer desires to purchase from Seller, those certain assets related to the BOT Business, and Buyer desires to assume the Assumed Liabilities (as defined herein), all upon the terms and subject to the conditions hereinafter set forth; and

WHEREAS, in connection with the sale, transfer, and conveyance of those certain assets related to the BOT Business, the Seller, Buyer, and/or their respective Affiliates desire to enter into the Ancillary Agreements (as defined herein);

NOW, THEREFORE, in consideration of the mutual covenants herein contained and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the parties hereto hereby agree as follows:

ARTICLE I  
DEFINITIONS

Section 1.1Definitions. As used in this Agreement, the following terms have the meanings set forth below:

Affiliate” means, with respect to any Person, any other Person that directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, such Person. When used in this Agreement, “control” (including, with correlative meanings, the terms “controlling,” “controlled by” and “under common control with”), as used with respect to any Person, shall mean the possession, directly or indirectly, of a majority of the equity interests or the power to elect a majority of the board of directors (or Persons performing similar functions) of such Person, whether through the ownership of voting securities, status as a general partner, by contract, or otherwise. The parties acknowledge that in the case of certain entities organized under the Laws of certain countries outside of the United States, the maximum percentage ownership permitted by Law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence; provided that such foreign investor has the power to direct the management and policies of such entity.

Agreement” has the meaning set forth in the recitals.

Alternative Triggering Award” has the meaning set forth in Section 2.3.

Allocation” has the meaning set forth in Section 3.2.

 


 

Ancillary Agreements” means, collectively, the Transition Services Agreements, Nanotherapeutics License Agreement, the Bill of Sale, the Assumption Agreement, the Letter of Reference, and the Confidentiality Agreement.

Assumed Liabilities” has the meaning set forth in Section 2.4(a).

Assumption Agreement” means an assumption agreement to be executed at Closing by Buyer and Seller, substantially in the form attached hereto as Exhibit A.

Bill of Sale” means a bill of sale and assignment to be executed at Closing by Buyer and Seller, substantially in the form attached hereto as Exhibit B.

Business” means developing, manufacturing, selling, marketing, distributing, and commercializing the Products.

Business Day” means any day other than a Saturday, Sunday, or other day on which banks in San Francisco, California are required or authorized to be closed by Law or regulation.

Buyer” has the meaning set forth in the recitals.

Buyer Indemnified Parties” has the meaning set forth in Section 11.2(a).

Closing Date” has the meaning set forth in Section 4.1.

Common Stock” means common stock of Buyer.

Confidentiality Agreement” means that certain Confidentiality Agreement, dated as of July 30, 2015, by and between Buyer and Seller.

Contracts” means contracts, licenses, agreements, and all other legally binding arrangements, whether in existence on the date hereof or subsequently entered into, including all amendments thereto.

Deductible” has the meaning set forth in Section 11.2(b).

DMF” means those certain Drug Master Files, as such term is described in the United States Food, Drug, and Cosmetics Act, identified as DMF #024117 and DMF #024156.

DTRA Contract” means that certain contract issued by the Defense Threat Reduction Agency designated as #HDTRA1-15-C0012.

DTRA Triggering Award” has the meaning set forth in Section 2.3.

Eligible Employees” means those employees of Seller listed on Schedule 9.5(d).

Encumbrance” means any mortgage, charge, lien, security interest, pledge or encumbrance of any nature whatsoever.

Excluded Assets” has the meaning set forth in Section 2.2(b).

2


 

Excluded Liabilities” has the meaning set forth in Section 2.4(b).

Exhibits” means, collectively, the Exhibits referred to throughout this Agreement.

FDA” means the United States Food and Drug Administration.

GIBCO Authorization Letter” means a letter substantially in the form set forth on Exhibit I.

 

Governmental Entity” means any court, agency, authority, department, legislative, or regulatory body or other instrumentality of any government or country or of any national, federal, state, provincial, regional, county, city, or other political subdivision of any such government or any supranational organization of which any such country is a member or quasi-governmental authority or self-regulatory organization of competent authority.

Governmental Order” means any consent, authorization, approval, order, license, certification, or permit of or from, or declaration or filing with, any Governmental Entity, including any required filing with any Governmental Entity and the subsequent expirations of any required waiting period under any antitrust law.

Indemnified Party” has the meaning set forth in Section 11.7(a).

Indemnifying Party” has the meaning set forth in Section 11.7(a).

Initial Closing” has the meaning set forth in Section 4.1.

Knowledge” of Seller means the actual knowledge of the following employee of Seller: Diane Wilcock, solely in her capacity as Director of Seller and not in her personal capacity.

Law” means any statute, law, ordinance, regulation, rule or code of a Governmental Entity.

Letters of Reference” means the letters, in the form set forth as Exhibit E-3, providing a right of reference to Seller and its Affiliates under the DMFs.

Liabilities” means any and all debts, liabilities, and obligations, whether accrued or fixed, absolute or contingent, matured or unmatured, or determined or determinable, including product liability, and, more generally, those arising under any Law, action, or Governmental Order and those arising under any contract, agreement, arrangement, commitment, or undertaking, or otherwise.

Loss” or “Losses” means, collectively, any and all damages, losses, Liabilities, judgments, penalties, costs, and expenses (including reasonable attorneys’ fees and litigation expenses); provided, however, that Losses shall not include punitive, consequential, indirect, incidental, exemplary, punitive, or special damages, lost profits, lost revenue, diminution in value, or opportunity costs, and shall not be calculated by using or taking into account any multiple of earnings, cash flow, revenue, or other similar measure.

3


 

Manufacturing Documentation” means any and all of the following documents that are owned or controlled by Seller and that are specific to and necessary for the manufacture of each of the Products: manufacturing process validation reports, validation reports of analytical equipment, manufacturing instructions, batch records, manufacturing standard operating procedures, specifications and test methods for the products, raw materials, and stability, standard operating procedures, and specifications for packaging, manufacturing and packaging instructions, master formula, validation reports (analytical, packaging, and cleaning), stability data, and approved supplier lists.

Material Adverse Effect” means an event, change, or effect which is materially adverse to the Purchased Assets, taken as a whole, other than events, changes, or effects: (i) occurring generally in the U.S. economy; (ii) occurring generally in the healthcare industry; (iii) resulting from legislation or regulation, whether proposed or instituted, in the healthcare industry, including the biodefense sector; (iv) resulting from the execution and delivery of this Agreement, the transactions contemplated by this Agreement, or the announcement to Third Parties or the public of the transactions contemplated by this Agreement; or (v) resulting from changes in applicable Laws.  

Nanotherapeutics License Agreement” means a license agreement between Buyer and Seller, substantially in the form set forth on Exhibit C.

NIAID Contract” means Contract No. HHSN272201100031C, effective as of September 30, 2011, by and between the National Institutes of Health, National Institute of Allergy and Infectious Diseases and XOMA (US) LLC.

NIAID Subcontract” means a contract substantially in the form set forth on Exhibit G.

Option” has the meaning given in Section 2.3.

Option Closing” has the meaning given in Section 4.1.

Option Exercise” has the meaning given in Section 2.3.

Option Period” has the meaning given in Section 2.3.

Optioned Assets” means the Product Inventory.

Permitted Encumbrance” means (i) any Encumbrance disclosed on Schedule 1.1; (ii) any Encumbrance for Taxes, assessments, and other governmental charges that are not yet due and payable or that may thereafter be paid without penalty, or that are being contested in good faith by appropriate proceedings; (iii) with respect to Contracts, any restrictions, obligations, limitations, or other Encumbrances contained in such Contract or existing at Law or under the regulatory regime; (iv) any rights of the United States government (e.g., licenses, march-in rights, domestic manufacturing restrictions) in or in connection with the XOMA Patents, the UCSF Licensed Patents, the XOMA General Know-How, XOMA BOT Know-How, and any other intellectual property which may be included in the Purchased Assets; and (v) any imperfection of title or other Encumbrance that, individually or in the aggregate with other such imperfections and Encumbrances, would not have a Material Adverse Effect.

4


 

Person” means any individual, corporation, partnership, limited liability company, joint venture, firm, trust, business association, organization, Governmental Entity, or other entity.

Physical Assets” means those items set forth on Schedule 1.1.

Precursor Materials” means those quantities of the master cell banks, vectors and other precursor materials relating to the Products as are set forth on Schedule 1.1.

Product or Products” means, collectively, the antibody therapeutics for the treatment of botulinum toxin poisoning as described in further detail on Schedule 1.1.

 

Product Inventory” means Seller’s inventories of bulk drug product and finished clinical product relating to the Products owned by the U.S. Government and held by Seller incident to the NIAID Contract, as set forth on Schedule 1.1.

Purchase Price” has the meaning set forth in Section 3.1.

Purchased Assets” has the meaning set forth in Section 2.2(a).

SAFC Authorization Letter” means a letter substantially in the form set forth on Exhibit H.

Schedules” means, collectively, the Schedules referred to throughout this Agreement.

Seller” has the meaning set forth in the recitals.

Seller’s Cap” has the meaning set forth in Section 11.2(b).

Seller Indemnified Parties” has the meaning set forth in Section 11.3.  

Seller Plans” means each employee benefit plan, as defined in Section 3(3) of ERISA sponsored, contributed to, or maintained by Seller immediately prior to the Closing Date in which an Eligible Employee participates.

Seller Welfare Benefit Plans” means all of the Seller Plans which are welfare benefit plans and in which an Eligible Employee participates, including medical, dental, life insurance, and short- and long-term disability.

Survival Period” has the meaning set forth in Section 11.1.

Tax” means all Federal, state, local, and foreign taxes and assessments, including all interest, penalties, and additions with respect thereto.

Tax Return” means any report, return, election, notice, estimate, declaration, information statement, and other forms and documents (including all schedules, exhibits, and other attachments thereto) relating to and filed or required to be filed with a taxing authority in connection with any Taxes (including estimated Taxes).

Third Party” means any Person other than Seller or Buyer or their respective Affiliates.

5


 

Third Party Claim” has the meaning set forth in Section 11.7(b).

Transfer Taxes” has the meaning set forth in Section 3.3.

Transferred Contracts” means those certain Contracts set forth in Schedule 1.1.

Transferred Employees” has the meaning set forth in Section 9.5(a).

Transition Services Agreement” means the Transition Services Agreement to be executed at Closing by Seller and Buyer, substantially in the form attached as Exhibit J.

UCSF Licensed Patents” means the patents and patent applications which are the subject of the XOMA License Agreements.

U.S. Government Contracts” means those certain Transferred Contracts set forth in Schedule 1.1 under the heading “U.S. Government Contracts.”

Warehouse License Agreement” means that a license agreement between XOMA Corporation and Buyer substantially in the form attached as Exhibit F.

XOMA BOT Know-How” means all tangible and intangible techniques, information, technology, practices, trade secrets, inventions (other than those disclosed in a XOMA Patent), methods, processes, knowledge, know-how, conclusions, standard operating procedure, test data and results (including pharmacological, toxicological, manufacturing, and clinical test data and results), regulatory documentation, analytical and quality control data, and results or descriptions, in each case (i) owned or controlled by Seller or any of its Affiliates, and (ii) relating directly to the Products, as set forth in Schedule 6.2 under the heading, “XOMA BOT Know-How.”  For the avoidance of doubt, XOMA BOT Know-How includes the Manufacturing Documentation.

XOMA Co-Formulation Patents” means those certain patents and patent applications as set forth in Schedule 1.1, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, all letters patent granted thereon, and all reissues, re-examinations and extensions thereof, and all foreign counterparts of any of the foregoing.

XOMA Derived Product” means any product the discovery, manufacture, use, sale, offer for sale or importation of which (i) would, in the absence of ownership of or a license under any of the XOMA Patents or UCSF Licensed Patents, infringe a claim of any of the XOMA Patents or UCSF Licensed Patents, or (ii) involve any XOMA General Know-How or XOMA BOT Know-How.

XOMA’s Government Contract Liabilities” has the meaning set forth in Section 11.2(a)(iv).

XOMA General Know-How” means all tangible and intangible techniques, information, technology, practices, trade secrets, inventions (other than those disclosed in a XOMA Patent), methods, processes, knowledge, know-how, conclusions, standard operating procedure, test data and results (including pharmacological, toxicological, manufacturing, and

6


 

clinical test data and results), regulatory documentation, analytical and quality control data, and results or descriptions, in each case (i) owned or controlled by Seller or any of its Affiliates, and (ii) relating directly to the Products, as set forth in Schedule 6.2, under the heading “XOMA General Know-How.

XOMA License Agreements” means those certain Transferred Contracts set forth in Schedule 1.1 under the heading “XOMA License Agreements.”

XOMA Patents” means the XOMA Co-Formulation Patents and the XOMA Vector Patents, collectively.

XOMA Vector Patents” means those certain patents and patent applications set forth in Schedule 1.1, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, all letters patent granted thereon, and all reissues, re-examinations and extensions thereof, and all foreign counterparts of any of the foregoing.

Section 1.2Interpretation.

(a)“includes” and “including” shall mean, respectively, includes and including without limitation;

(b)a party includes its permitted assignees and/or the respective successors in title to substantially the whole of its undertaking;

(c)words denoting the singular shall include the plural and vice versa and words denoting any gender shall include all genders;

(d)references to Sections and Schedules are to Sections and Schedules of this Agreement unless otherwise specified;

(e)the headings in this Agreement are for information only and shall not be considered in the interpretation of this Agreement;

(f)any reference to “writing” or “written” includes faxes and any legible reproduction of words delivered in permanent and tangible form (but does not including email);

(g)the words “hereof”, “herein”, and “hereunder” and words of like import used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement;

(h)references to any agreement or contract are to that agreement or contract as amended, modified, or supplemented from time to time in accordance with the terms hereof and thereof; and

(i)the parties agree that the terms and conditions of this Agreement are the result of negotiations between the parties and that this Agreement shall not be construed in favor of or against any party by reason of the extent to which any party participated in its preparation.

7


 

Section 1.3Currency. All currency amounts referred to in this Agreement are in U.S. Dollars unless otherwise specified.

ARTICLE II  
SALE AND PURCHASE OF PURCHASED ASSETS

Section 2.1Purchase and Sale. Upon the terms and subject to the conditions of this Agreement, on the Initial Closing Date, Seller will severally sell, assign, transfer, convey, and deliver to Buyer, and Buyer will purchase, acquire, and accept, all right, title, and interest of Seller in, to, and under the Purchased Assets held by Seller. Upon the terms and subject to the conditions of this Agreement, on the Option Closing Date, Seller will severally sell, assign, transfer, convey, and deliver to Buyer, and Buyer will purchase, acquire, and accept, all right, title, and interest of Seller in, to, and under the Optioned Assets held by Seller.

Section 2.2Purchased Assets

.

(a)The term “Purchased Assets” means the following assets and rights of whatever kind and nature, tangible or intangible, other than the Excluded Assets, of Seller existing on the Closing Date:

 

(i)

the Precursor Materials;

 

(ii)

the DMFs;

 

(iii)

the Transferred Contracts; and

 

(iv)

the Physical Assets.

(b)Seller and Buyer expressly agree and acknowledge that Buyer is not acquiring any right, title, or interest in or to any of the assets of Seller which are not specifically identified in Section 2.2(a) (the “Excluded Assets”). For the avoidance of doubt, such Excluded Assets include, but are not limited to, the following:

 

(i)

any and all intellectual property of the Seller or any of its respective Affiliates, except as set forth in the Nanotherapeutics License Agreement;

 

(ii)

the accounts receivable, pre-paid expenses, and any cash or cash equivalents of Seller or any of its Affiliates relating to the Products or the Purchased Assets for the period prior to the Closing Date;

 

(iii)

any real property or leaseholds (together with all fixtures and fittings related to any property), physical plant, machinery, equipment, supplies (except the Precursor Materials expressly included in the Purchased Assets above), laboratories, or office equipment of the Seller or any of its respective Affiliates;

8


 

 

(iv)

any rights under Seller’s insurance policies or self-insurance that are related to the Products; and

 

(v)

any books and records, general books of account, and books of original entry.

(c)Buyer acknowledges and agrees that Seller may retain one copy of all or any part of the documentation that they deliver to Buyer hereunder.  Buyer also acknowledges and agrees that Seller is retaining certain quantities of assets which are otherwise the subject of the Purchased Assets, including quantities of certain master cell banks and vectors.

Section 2.3Option. Commencing upon the Closing and extending until the eighteenth monthly anniversary thereof (the “Option Period”), Buyer shall have an exclusive option to acquire the Optioned Assets (the “Option”).  In the event that, during the Option Period, Buyer obtains an award from the Defense Threat Reduction Agency on terms substantially similar to the terms which were set forth in that certain contract designated as #HDTRA1-15-C0012 (the “DTRA Triggering Award”), Buyer may exercise the Option by giving notice to Seller during the Option Period.  Further, in the event that Buyer does not obtain a DTRA Triggering Award, but obtains an award, funding or contractual commitment that Buyer believes will allow Buyer to advance the development of the Products in a manner comparable to the DTRA Triggering Award (an “Alternative Triggering Award”), Buyer may notify Seller that it desires to exercise the Option (the “Option Exercise”) by delivering to Seller, during the Option Period, a copy of the Alternative Triggering Award and a proposed set of alternative milestone payments in replacement of those set forth in the Nanotherapeutics License Agreement.  Upon receipt of such notice, Buyer and Seller shall discuss, in good faith, whether the Alternative Triggering Award would allow Buyer to advance the development of the Products in a manner comparable to the DTRA Triggering Award and appropriate alternative milestone payments in replacement of those set forth in the Nanotherapeutics License Agreement.  If (i) Seller, in its reasonable judgment agrees that the Alternative Triggering Award will allow Buyer to advance the development of the Products in a manner comparable to the DTRA Triggering Award, and (ii) Buyer and Seller agree upon, each in their sole discretion, alternative milestone payments and execute an amendment to this Agreement, within the Option Period, providing for alternative milestone payments to replace those set forth in the Nanotherapeutics License Agreement. Buyer may exercise the Option by giving notice to Seller during the Option Period.  

Section 2.4Assumption of Certain Liabilities and Obligations

.

(a)Buyer will assume, be responsible for, and pay, perform, and discharge when due the following (collectively, the “Assumed Liabilities”):

 

(i)

any Liabilities arising from any product liability or patent or trademark infringement claim or lawsuit first brought by any Third Party, the FDA, or any other Governmental Entity on or after the Closing Date to the extent identified as arising from any of the Products;

9


 

 

(ii)

any Liabilities that Buyer expressly assumes or agrees to assume under this Agreement, including Liabilities under the XOMA License Agreements;

 

(iii)

any Liabilities arising from Seller’s guarantee of Buyer’s performance of the U.S. Government Contracts under a novation agreement between Seller, Buyer and the U.S. Government;

 

(iv)

any Liabilities arising from, or relating to, the performance of the U.S. Government Contracts on or after the Closing Date, regardless of whether such Liabilities relate to events that took place before, on or after the Closing Date; and

 

(v)

except as otherwise provided in this Agreement, all other Liabilities, to the extent arising following the Closing from any of the following actions taken by or on behalf of Buyer, following the Closing: the development, manufacture, marketing, sale, export, distribution, or use of any of the Products and XOMA Derived Products.

(b)Except for the Assumed Liabilities, Buyer will not assume or be liable for any Liabilities arising in connection with any of the Products or any other Purchased Asset (collectively, the “Excluded Liabilities”).

Section 2.5Non-Assignability.Notwithstanding anything to the contrary contained in this Agreement, to the extent that the sale, assignment, sublease, transfer, conveyance or delivery or attempted sale, sublease, assignment, transfer, conveyance or delivery to Buyer of any asset that would be a Purchased Asset or any claim or right or any benefit arising thereunder or resulting therefrom is prohibited by any applicable Law or would require any governmental or third party authorizations, approvals, consents or waivers, and such authorizations, approvals, consents or waivers shall not have been obtained prior to the Closing, the Closing shall proceed without the sale, assignment, sublease, transfer, conveyance or delivery of such asset unless such failure causes a failure of any of the conditions to Closing set forth in Article 10, in which event the Closing shall proceed only if the failed condition is waived by the party or parties entitled to the benefit thereof.  In the event that the failed condition is waived and the Closing proceeds without the transfer, sublease or assignment of any such asset, then following the Closing, the parties shall use their reasonable best efforts, and cooperate with each other, to obtain promptly such authorizations, approvals, consents or waivers; provided, however, that none of Seller or Buyer or any of their respective Affiliates shall be required to pay any consideration therefor other than filing, recordation or similar fees which shall be paid by Buyer.  Pending such authorization, approval, consent or waiver, the parties shall cooperate with each other in any mutually agreeable, reasonable and lawful arrangements designed to provide to Buyer the benefits of use of such asset and to Seller the benefits, including any indemnities, that they would have obtained had the asset been conveyed to Buyer at the Closing.  Once authorization, approval, consent or waiver for the sale, assignment, sublease, transfer, conveyance or delivery of any such asset not sold, assigned, subleased, transferred, conveyed or delivered at the Closing

10


 

is obtained, Seller shall assign, transfer, convey and deliver such asset to Buyer at no additional cost.  To the extent that any such asset cannot be transferred or the full benefits of use of any such asset cannot be provided to Buyer following the Closing pursuant to this Section 2.5, then Buyer and Seller shall enter into such arrangements (including subleasing, sublicensing or subcontracting) to provide to the parties hereto the economic (taking into account Tax costs and benefits) and operational equivalent, to the extent permitted, of obtaining such authorization, approval, consent or waiver and the performance by Buyer of the obligations thereunder, which shall include, with respect to the NIAID Contract, entering into the NIAID Subcontract and transferring possession from Seller to Buyer of the Product Inventory.  Seller shall hold in trust for and pay to Buyer promptly upon receipt thereof, all income, proceeds and other monies received by Seller in connection with its use of any asset (net of any Taxes and any other costs imposed upon Seller) in connection with the arrangements under this Section 2.5.  

ARTICLE III  
PURCHASE PRICE

Section 3.1Purchase Price.  As additional consideration for the transfer of the Purchased Assets, Buyer shall deliver to Seller a certificate representing Twenty-Three Thousand and Eight (23,008) shares of Common Stock within three (3) Business Days of the execution of the DTRA Contract (the “Purchase Price”).

Section 3.2Allocation of Purchase Price. As soon as practicable following the Option Closing Date, Seller shall deliver to Buyer an allocation of the Purchase Price among the Purchased Assets and the Optioned Assets prepared in accordance with applicable Law (the “Allocation”).  Seller shall prepare the Allocation in a manner consistent with the methodology set forth on Exhibit D.  For purposes of preparing the Allocation, Seller shall be entitled to determine, in its sole discretion, the fair market value of the Common Stock comprising the Purchase Price based on its determination of the value per share of such Common Stock.  Seller will give Buyer reasonable opportunity to review and comment on the Allocation and Seller will consider in good faith any comments that Buyer has with respect to the Allocation.  If Buyer does object to such Allocation within fifteen (15) days of receiving such Allocation, Seller and Buyer shall seek in good faith for thirty (30) days thereafter to resolve any disagreements between them with respect to such draft Allocation.  If Seller and Buyer are unable to agree on the Allocation, then such Allocation shall not be binding on Seller, Buyer or their Affiliates.  If Seller and Buyer agree on the Allocation, Seller, Buyer and their Affiliates shall report and file all Tax Returns in all respects and for all Tax purposes consistent with such agreed-to Allocation and none of Buyer, Seller or their Affiliates shall take any Tax position (whether in audits, Tax Returns or otherwise) that is inconsistent with such agreed-to Allocation unless required to do so by applicable Law.

Section 3.3Transfer Taxes. All transfer, sales, value added, stamp duty, and similar Taxes payable in connection with the transactions contemplated hereby (collectively, the “Transfer Taxes”) will be borne by Buyer. The party responsible for filing any Tax Return with respect to such Taxes shall properly and promptly file such Tax Return.  Seller and Buyer shall cooperate with each other and use their reasonable efforts to minimize the Transfer Taxes attributable to the transfer of the Purchased Assets and shall use commercially reasonable efforts to obtain any exemption or other similar certificate from any Governmental Entity as may be necessary to mitigate such Taxes. Buyer shall reimburse Seller for any Transfer Taxes paid by Seller on Buyer’s behalf.

11


 

ARTICLE IV  
THE CLOSING

Section 4.1Closing Dates.  Subject to the satisfaction or waiver of all the conditions set forth in this Article IV and subject to Article X, the initial closing of the transactions contemplated by this Agreement (the “Initial Closing”) shall take place at the offices of Morrison & Foerster LLP, 425 Market Street, San Francisco, CA 94105 at 10:00 a.m. (local time) as soon as practicable (and in no event later than the fifth (5th) Business Day) after all the conditions set forth in this Article IV are satisfied or waived, or earlier as mutually agreed to by the parties. The Option closing shall take place at the offices of Morrison & Foerster LLP, 425 Market Street, San Francisco, CA 94105 at 10:00 a.m. (local time) as soon as practicable (and in no event later than the fifth (5th) Business Day) after the Option Exercise (“Option Closing”).  “Closing Date” means the date upon which the Initial Closing and/or the Option Closing occurs, as applicable.

Section 4.2Closing Deliveries.

(a)Initial Closing.  Contemporaneously with the Initial Closing, each party agrees on its own behalf, as applicable, to deliver such instruments of conveyance, assignment, transfer, and assumption, in form and substance reasonably satisfactory to Buyer and Seller, as may be necessary in order to consummate the transaction contemplated hereby, including the following:

 

(i)

Deliveries by Seller or its Affiliates to Buyer:

(1)a duly executed Bill of Sale with respect to the Purchased Assets;

(2)a duly executed Nanotherapeutics License Agreement;

(3)all necessary instruments relating to the assignment of the DMFs in accordance with the FDA guidance provided in Drug Master Files:  Guidelines, September 1989, Section VII.E.; and

(4)all other instruments necessary, in Buyer’s reasonable opinion, to transfer the Purchased Assets; provided that Buyer shall give reasonable notice of the need for such instruments prior to the Initial Closing.

 

(ii)

Deliveries by Buyer or its Affiliates to Seller:

(1)a duly executed Assumption Agreement with respect to the Purchased Assets;

(2)a duly executed Nanotherapeutics License Agreement; and

12


 

(3)all other instruments necessary, in Seller’s reasonable opinion, for Buyer to assume the Assumed Liabilities; provided that Seller shall give reasonable notice of the need for such instruments prior to the Initial Closing.

(b)Option Closing.  Contemporaneously with the Option Closing, each party agrees on its own behalf, as applicable, to deliver such instruments of conveyance, assignment, transfer, and assumption, in form and substance reasonably satisfactory to Buyer and Seller, as may be necessary in order to consummate the transaction contemplated hereby, including the following:

 

(i)

Deliveries by Seller or its Affiliates to Buyer:

(1)a duly executed Bill of Sale with respect to the Optioned Assets;

(2)all other instruments necessary, in Buyer’s reasonable opinion, to transfer the Optioned Assets; provided that Buyer shall give reasonable notice of the need for such instruments prior to the Option Closing.

 

(ii)

Deliveries by Buyer or its Affiliates to Seller:

(1)a duly executed Assumption Agreement with respect to the Optioned Assets;

(2)all other instruments necessary, in Seller’s reasonable opinion, for Buyer to assume the Assumed Liabilities; provided that Seller shall give reasonable notice of the need for such instruments prior to the Option Closing.

Buyer shall be responsible for the recording and registration of all assignments and instruments referred to in Section 4.2(a)(i) and Section 4.2(b)(i) above, and in any property covered by such assignments and instruments.

Section 4.3Transfer of Title; Insurance. Title and risk of loss or damage to the Purchased Assets shall pass to Buyer on the Closing Date at the place established for Closing in Section 4.1. As of the Closing Date, the Purchased Assets shall cease to be insured by Seller’s insurance policies or by Seller’s self-insurance, as the case may be, and Buyer shall have no right or obligation with respect to any such policy.

13


 

ARTICLE V  
REPRESENTATIONS AND WARRANTIES OF SELLER

Seller hereby severally represents and warrants to Buyer as of the date of this Agreement and as of the Closing Date as follows:

Section 5.1Seller’s Organization; Good Standing. Seller is either a limited liability company or a company organized under the laws of its jurisdiction of organization or formation. Seller has the requisite power and authority to own the Purchased Assets owned by Seller and to carry on its business as currently conducted. Seller is duly qualified to conduct business as a foreign corporation and is in good standing in each jurisdiction where the nature of the business conducted by it makes such qualification necessary, except where the failure to so qualify or be in good standing would not have a Material Adverse Effect.

Section 5.2Authority; Execution and Delivery. Seller has the requisite company power and authority to enter into this Agreement and to consummate the transactions contemplated hereby. The execution and delivery of this Agreement by Seller and the consummation of the transactions contemplated hereby have been duly and validly authorized by all requisite corporate action on the part of Seller. This Agreement has been duly executed and delivered by Seller and, assuming the due authorization, execution and delivery of this Agreement by Buyer, will constitute the legal, valid, and binding obligation of Seller, enforceable against it in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent transfer, and other similar laws affecting creditors’ rights generally from time to time in effect and to general principles of equity (including concepts of materiality, reasonableness, good faith, and fair dealing) regardless of whether considered in a proceeding in equity or at law.

Section 5.3Consents; No Violation, Etc. Except as set forth on Schedule 5.3, the execution and delivery of this Agreement do not, and the consummation of the transactions contemplated hereby and the compliance with the terms hereof will not, (a) result in any violation of or default (or an event which, with notice or lapse of time or both, would constitute a default) under (i) any Law or Governmental Order applicable to Seller or the Purchased Assets held by Seller, (ii) any provision of the certificate of incorporation or by-laws (or similar organizational document) of Seller or (iii) any material Contract of Seller which would result in an Encumbrance on any of the Purchased Assets sold by Seller; or (b) give rise to any approval, authorization, consent, license, filing, or registration with any court, arbitrator or Governmental Entity or Third Party; provided, however, that no representation or warranty is made in the foregoing clauses (a)(i), (a)(iii), or (b) with respect to matters that, individually or in the aggregate, would not result in a Material Adverse Effect.

Section 5.4Title to Purchased Assets. Except as set forth on Schedule 5.4, Seller has good and valid title to all of the Purchased Assets held by Seller free and clear of all Encumbrances (other than Permitted Encumbrances).

Section 5.5Intellectual Property. Except as set forth on Schedule 5.5, Seller and its Affiliates are the sole and exclusive owner of the XOMA Patents and hold all right, title, and interest in XOMA Patents free and clear of all Encumbrances (other than Permitted Encumbrances).

14


 

Section 5.6Litigation. Except as disclosed on Schedule 5.6, as of the date hereof, (a) there is no litigation proceeding that has been served on Seller that remains pending and relates primarily to the Products; and (b) to the Knowledge of Seller, there is no claim threatened or investigation pending or threatened against Seller that relates to the Products or otherwise relates to the Purchased Assets which (i) if adversely determined would result in a Material Adverse Effect; or (ii) challenges or seeks to prevent or enjoin the transactions contemplated by this Agreement. To the Knowledge of Seller, the U.S. Government inquiry into NIAID contract HHSN272200800028C, as disclosed on Schedule 5.6, relates to Seller’s billing practices and not with regard to the Products.

Section 5.7Regulatory Issues. Except as set forth on Schedule 5.7, or as would not have a Material Adverse Effect, during the two (2) years immediately prior to the date of this Agreement, with respect to each of the Products only, Seller has not received or been subject to: (i) any FDA Notices of Adverse Findings/FDA 483 Observations relating to any of the Products; or (ii) any warning letters or other written correspondence from the FDA concerning any of the Products in which the FDA asserted that the operations of Seller were not in compliance with applicable Laws, Governmental Orders or guidelines with respect to any of the Products.

Section 5.8Compliance with Laws. Except as set forth on Schedule 5.8, Seller is in compliance in all material respects with all Laws and Governmental Orders applicable to it which relate primarily to the Products or the Purchased Assets, except where the failure to so comply would not have a Material Adverse Effect. Except as set forth on Schedule 5.8 or excepts as would not have a Material Adverse Effect, Seller has not received any written notice within the past two (2) years (a) of any asserted violation of any Law or Governmental Orders; or (b) that any investigation or review by any Governmental Entity with respect to the Purchased Assets held by Seller is pending.

Section 5.9No Brokers. Seller has not entered into any agreement, arrangement, or understanding with any Person or firm which will result in the obligation to pay any finder’s fee, brokerage commission, or similar payment in connection with the transactions contemplated hereby.

Section 5.10Inventory. All bulk product and finished Product Inventory was manufactured, packaged, labeled, tested, stored, and handled in accordance with the Good Manufacturing Practices as defined under 21 U.S.C. § 351 (a)(2)(B) as applicable and in effect on the date such action was taken.  Buyer acknowledges that the Product Inventory is not owned by Seller.

Section 5.11Exclusive Representations and Warranties. Other than the representations and warranties set forth in this Article V, Seller is not making any other representations or warranties, express or implied, with respect to any of the Products or the Purchased Assets. Seller hereby disclaims any other express or implied representations or warranties, including regarding any financial projections or other forward-looking statements provided by or on behalf of Seller.

15


 

ARTICLE VI  
CERTAIN COVENANTS AND AGREEMENTS OF SELLER

Section 6.1Conduct of Business. From and after the date of this Agreement up to the Closing Date, Seller will conduct the Business in the ordinary course of business consistent with past practice; and use commercially reasonable efforts to preserve, in all material aspects, the good relations of Seller with respect to the Products with Governmental Entities. Without limiting the generality of the foregoing, Seller will not, without the prior written consent of Buyer (such consent not to be unreasonably withheld or delayed):

(a)dispose of or transfer any asset which would form part of the Purchased Assets, except in the ordinary course of business;

(b)enter into any licenses of intellectual property, or any other material leases, licenses, contracts, or commitments, relating to the Purchased Assets, except as required under the U.S. Government Contracts;

(c)create any indebtedness or obligation which would be or would reasonably be expected to become an Encumbrance on any Purchased Asset;

(d)except as provided in Schedule 6.1(d), settle, or offer or propose to settle, (i) any litigation, investigation, arbitration, proceeding, or other claim involving or the Products; or (ii) any litigation, arbitration, proceeding, or dispute that relates to the transactions contemplated hereby; or

(e)agree, resolve or commit to do any of the foregoing.

Section 6.2Manufacturing Documents; XOMA Know-How.

(a)On or prior to the Closing, Seller shall have electronically delivered to Buyer one copy of the XOMA BOT Know-How and the XOMA General Know-How, in each case as are listed on or contained in Schedule 6.2. Within five (5) days following the Closing Date, Seller shall deliver a DVD copy of the electronic data room maintained by Ansarada.

(b)To the extent that Buyer discovers following the Closing that it requires any documents that constitute Manufacturing Documentation, and such documents were not so provided to Buyer at Closing, Buyer shall provide written notice to Seller requesting the delivery thereof.  To the extent that such Manufacturing Documentation is in existence and is owned or controlled by Seller, and to the extent Seller is permitted to provide such Manufacturing Documentation to Buyer, Seller shall make commercially reasonable efforts to locate and deliver or make available to Buyer, either electronically or on paper, one copy of such Manufacturing Documentation.

16


 

ARTICLE VII  
REPRESENTATIONS AND WARRANTIES OF BUYER

Buyer hereby represents and warrants to Seller as of the date of this Agreement and as of the Closing Date as follows:

Section 7.1Buyer’s Organization; Good Standing.  Buyer is a corporation duly organized, validly existing and in good standing under the laws of Delaware. Buyer has all requisite corporate power and authority to carry on its business as it is currently being conducted. Buyer is duly qualified to conduct business as a foreign corporation and is in good standing in every jurisdiction where the nature of the business conducted by it makes such qualification necessary, except where the failure to so qualify or be in good standing would not prevent or materially delay the consummation of the transactions contemplated hereby.

Section 7.2Authority; Execution and Delivery.  Buyer has the requisite corporate power and authority to enter into this Agreement and to consummate the transactions contemplated hereby. The execution and delivery of this Agreement by Buyer and the consummation of the transactions contemplated hereby have been duly and validly authorized by all requisite corporate, shareholder and Board of Directors action on the part of Buyer. This Agreement has been duly executed and delivered by Buyer and, assuming the due authorization, execution and delivery of this Agreement by Seller, constitutes the legal, valid, and binding obligation of Buyer, enforceable against Buyer in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent transfer, and other similar laws affecting creditors’ rights generally from time to time in effect and to general principles of equity (including concepts of materiality, reasonableness, good faith, and fair dealing) regardless of whether considered in a proceeding in equity or at law.

Section 7.3Consents; No Violations, Etc.  The execution and delivery of this Agreement do not, and the consummation of the transactions contemplated hereby and the compliance with the terms hereof will not, (a) result in any violation of or default (or an event which, with notice or lapse of time or both, would constitute a default) under (i) any Law or Governmental Order applicable to Buyer; (ii) any provision of the certificate of formation or operating agreement (or similar organizational document) of Buyer; or (iii) any material Contract to which Buyer is a party or otherwise bound; or (b) give rise to any approval, authorization, consent, license, filing or registration with any court, arbitrator or Governmental Entity; provided, however, that no representation or warranty is made in the foregoing clauses (a)(i), (a)(iii), or (b) with respect to matters that, individually or in the aggregate, would not prevent or materially delay Buyer’s performance of its obligations hereunder.

Section 7.4Litigation.  As of the date hereof, there is no suit, claim, action, investigation, or proceeding pending or, to the knowledge of Buyer, threatened against Buyer or any of its Affiliates which if adversely determined would prevent or materially delay the ability of Buyer to perform its obligations hereunder.

Section 7.5No Brokers.  Buyer has not entered into any agreement, arrangement, or understanding with any Person or firm which will result in the obligation to pay any finder’s fee, brokerage commission, or similar payment in connection with the transactions contemplated hereby.

17


 

Section 7.6Availability of Funds.  Buyer has cash available that is sufficient to enable it to make payment of the Purchase Price and any other amounts to be paid by it hereunder without the necessity of any Third Party financing.

Section 7.7Capital Stock.  Immediately prior to Closing, Two Million Two Hundred Seventy-Seven Thousand Seven Hundred Sixty-One (2,277,761) shares of Common Stock are issued and outstanding.   The Common Stock issued to Seller will be duly and validly issued, fully paid, and nonassessable, and will be free of restrictions on transfer other than restrictions on transfer under applicable state and federal securities laws.  

Section 7.8As-Is Sale. BUYER ACKNOWLEDGES AND AGREES THAT, EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT: (A) IT HAS BEEN FURNISHED WITH OR GIVEN ADEQUATE ACCESS TO THE INFORMATION ABOUT THE PRODUCTS AND PURCHASED ASSETS AS IT HAS REQUESTED; (B) IT HAS CARRIED OUT AN APPROPRIATE DUE DILIGENCE INVESTIGATION CONCERNING THE INFORMATION GIVEN BY SELLER ON THE PRODUCTS AND PURCHASED ASSETS AND IS TAKING FULL RESPONSIBILITY FOR MAKING ITS OWN INDEPENDENT EVALUATION OF THE PRODUCTS AND PURCHASED ASSETS; (C) EXCEPT IN THE CASE OF FRAUD, IT WILL NOT ASSERT ANY CLAIM AGAINST SELLER OR ANY OF ITS EMPLOYEES, AGENTS, STOCKHOLDERS, AFFILIATES, OR ANY REPRESENTATIVES OR HOLD SELLER OR ANY SUCH PERSONS LIABLE FOR ANY INACCURACIES, MISSTATEMENTS, OR OMISSIONS WITH RESPECT TO INFORMATION FURNISHED BY SELLER, ITS AFFILIATES, OR REPRESENTATIVES (EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES CONTAINED IN ARTICLE V OF THIS AGREEMENT OR THE ANCILLARY DOCUMENTS); (D) SELLER MAKES ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, AT LAW OR IN EQUITY, IN RESPECT OF ANY OF THE PRODUCTS OR THE PURCHASED ASSETS, INCLUDING WITH RESPECT TO MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR ANY PARTICULAR PURPOSE OR USE, AND ANY SUCH OTHER REPRESENTATIONS OR WARRANTIES ARE HEREBY EXPRESSLY DISCLAIMED; (E) SELLER MAKES ANY REPRESENTATION OR WARRANTY WITH RESPECT TO THE ACCURACY AND COMPLETENESS OF ANY ESTIMATES, PROJECTIONS, FORECASTS, PLANS, BUDGETS, OR ANY FINANCIAL STATEMENTS MADE AVAILABLE BY SELLER TO BUYER; AND (F) BUYER IS PURCHASING THE PURCHASED ASSETS ON AN “AS-IS, WHERE-IS” BASIS. THIS SECTION 7.8 SHALL SURVIVE ANY CLOSING AND ANY TERMINATION OF THIS AGREEMENT.

ARTICLE VIII  
CERTAIN COVENANTS AND AGREEMENTS OF BUYER

Section 8.1Assumption of Regulatory Commitments. Except for the Excluded Liabilities, from and after the Closing Date, Buyer will assume control of, and responsibility for all costs, obligations, and Liabilities arising from or related to, any commitments or obligations to any Governmental Entity arising under applicable U.S. Law, Governmental Order, or regulation and involving any of the Products.

18


 

Section 8.2Adverse Event Data. Buyer agrees to share safety and adverse event data generated after the Closing Date with Seller and its Affiliates in the event such data is necessary or useful to in any regulatory submission, product registration, or dossier filed or to be filed by Seller or any of its Affiliates.

ARTICLE IX  
OTHER COVENANTS AND AGREEMENTS

Section 9.1Transfer of the DMFs. As soon as practicable following the Closing and in any event within three (3) weeks following the Closing Date, Seller shall deliver to Buyer one copy of the DMFs.  The parties hereto agree to use their reasonable efforts to take any other actions required by the FDA to effect the transactions contemplated hereby.  Promptly following, but in no event later than five (5) Business Days following the Closing Date, Seller will transmit letters substantially in the form attached as Exhibit E-1 hereto to the FDA and Buyer will transmit letters substantially in the form attached as Exhibit E-2 hereto to the FDA, and each of the parties will take any other actions necessary to effect the transfer of the DMF from the applicable Seller to Buyer.  Simultaneous with the transmission of the letters in the form attached as Exhibits E-1 and E-2 to the FDA, Buyer shall grant a right of reference to Seller and its Affiliates by executing and delivering the Letter of Reference.  Except as otherwise expressly provided for herein, each party will bear its own costs related thereto.

Section 9.2Maintenance of the DMF Pending Completion of Transfer.

(a)Maintenance. Until the completion of the transfer of the DMF to Buyer (or its Affiliates), Seller shall make commercially reasonable efforts to maintain the DMF.

(b)Costs. Buyer, or its Affiliates, shall bear any Third Party fees levied by the relevant Governmental Entity and any other relevant cost for the maintenance of the DMFs and for the transfer to Buyer (or its Affiliates) after the Closing.

Section 9.3Assignment of XOMA License Agreements.  In the event that (i) Buyer does not exercise its Option in accordance with Section 2.3, on or before the end of the Option Period or (ii) Buyer notifies Seller that it will not exercise the Option, Seller may request that Buyer assign to Seller the XOMA License Agreements. Within five (5) Business Days of such a request by Seller, Buyer shall assign the XOMA License Agreements to Seller. 

Section 9.4Press Releases. Buyer and Seller shall not at any time (and Buyer and Seller shall not permit at any time their respective Affiliates to) publicly disclose the execution, delivery, or contents of this Agreement, other than (a) with the prior written consent of the other parties hereto or (b) as required by any applicable Law or Governmental Order, any Governmental Entity, or any applicable securities exchange upon prior notice to the other parties hereto. Buyer and Seller shall agree with each other as to the form, timing, and substance of any press release or public disclosure related to this Agreement or the transactions contemplated hereby; provided, however, that nothing contained herein shall prohibit Buyer or Seller (or its respective Affiliates), following notification and consultation with the other party, from making any disclosure if required by any applicable Law or Governmental Order, any Governmental Entity, or any applicable securities exchange.

19


 

Section 9.5Employment Matters.  

(a)Offer of Employment for Eligible Employees.  On or prior to the Closing, Buyer shall have offered each Eligible Employee a position with Buyer on terms which are comparable, taken as a whole, to those set forth on Schedule 9.5(d), such offer contingent upon completion of the Closing.  Buyer shall notify Seller as to which Eligible Employees accept such offers of employment from the Buyer (referred to herein as “Transferred Employees”).  Seller shall terminate the employment of each Transferred Employees no later than five (5) Business Days after receipt of such notice from Buyer.  

(b)No Continued Employment.  Seller nor its Affiliates shall, directly or indirectly, solicit the continued employment of any Eligible Employee  or the employment of any Transferred Employees after the Closing (unless and until (i) Buyer has informed Seller in writing that the particular Eligible Employee has declined the offer of employment from Buyer, or (ii) three (3) months after the Closing, whichever occurs first).

(c)No On-Going Employment Commitment.  It is understood and agreed that (a) Buyer's extension of offers of employment as set forth in this section shall not constitute any commitment, contract or understanding (expressed or implied) of any obligation on the part of Buyer to a post-Closing employment relationship of any fixed term or duration or upon any terms or conditions other than those that Buyer may establish pursuant to individual offers of employment, and (b) employment offered by Buyer is "at will" and may be terminated by Buyer or by an employee at any time for any reason (subject to any written commitments to the contrary made by Buyer or an employee and pursuant to Law).  Nothing in this Agreement shall be deemed to prevent or restrict in any way the right of Buyer to terminate, reassign, promote or demote any of the Transferred Employees after the Closing or to change adversely or favorably the title, powers, duties, responsibilities, functions, locations, salaries, other compensation or terms or conditions of employment of such employees.

(d)Employee Information. Schedule 9.5(d) sets forth a list of Eligible Employees, each such Eligible Employee’s job title and duties at Seller, base salary or hourly rate (as applicable) at Seller, bonus and retention pay and date of hire at Seller, the Seller Plans in which such Eligible Employee is eligible to participate, the primary geographic location of his or her employment with Seller as of the date hereof, and the Eligible Employee’s status at Seller broken down into the following categories: (i) active, (ii) inactive on leave of absence with re-employment rights and (iii) on short-term disability under Seller’s short-term disability policy.

Section 9.6Novation Assistance.  Upon Seller’s request, Buyer shall use commercially reasonable efforts to assist Seller and its Affiliates in obtaining novations of the Transferred Contracts, including providing such information and executing such documents as reasonably required to support or effectuate such novations.

Section 9.7RO1 Award.  Following Closing, Buyer shall (i) use commercially reasonable efforts to assist Seller in obtaining the assignment to Buyer of that certain grant award and related contracts made by The National Institutes of Health and designated as Grant Number 1R01AI104579-01, and (ii) shall accept such assignment.

20


 

ARTICLE X  

CONDITIONS PRECEDENT

Section 10.1Conditions of Performance by Seller and Buyer. The obligations of the parties to consummate the transactions contemplated by this Agreement are subject to the fulfillment (or waiver where permissible) prior to the Closing of the following conditions:

(a)NIAID Subcontract.  The National Institute of Allergies and Infectious Diseases shall have consented in writing to Seller and Buyer entering into the NIAID Subcontract and transferring possession from Seller to Buyer of the Product Inventory.

(b)No Injunctions; Actions. There shall not: (i) be in effect any Law or Governmental Order which makes illegal or enjoins or prevents in any respect the consummation of the transactions contemplated by this Agreement; or (ii) have been commenced, and shall be continuing, an action or proceeding by any Governmental Entity which seeks to prevent or enjoin in any material respect the transactions contemplated hereby or making the consummation of such transactions illegal and which in the reasonable judgment of Seller or Buyer is reasonably likely to result in the issuance of such an injunction.

Section 10.2Buyer’s Conditions. Buyer’s obligation to consummate the transactions contemplated by this Agreement is further subject to the fulfillment at or prior to the Closing of each of the following conditions, any of which may be waived by Buyer in its sole discretion:

(a)all representations and warranties of Seller contained in this Agreement shall be true and correct as of the Closing except for such representations and warranties that address matters as of a particular date which need be true only as of the particular date specified therein, except where the failure of such representations and warranties of Seller to be true and correct would not have a Material Adverse Effect;

(b)Seller shall have performed or complied in all material respects with all covenants and agreements required to be performed or complied with by them hereunder on or prior to the Closing and shall have tendered the required documents at the Closing as set forth in Section 4.2(a); and

(c)Buyer shall have received a certificate signed by an executive officer of the Seller certifying as to the satisfaction of the conditions set forth in Section 10.2(a) and Section 10.2(b).

Section 10.3Seller’s Conditions. Seller’s obligation to consummate the transactions contemplated by this Agreement is further subject to the fulfillment of each of the following conditions, any of which may be waived by Seller in writing in their sole discretion:

(a)all representations and warranties of Buyer contained in this Agreement shall be true and correct in all material respects (in the case of any representation or warranty without any materiality qualification) or in all respects (in the case of any representation or warranty containing any materiality qualification) on the date hereof and as of the Closing, except for the warranties that address matters as of a particular date which need be true in all material respects (in the case of any representation or warranty without any materiality qualification) or in all respects (in the case of any representation or warranty containing any materiality qualification) only as of the particular date specified therein;

21


 

(b)Buyer shall have performed or complied in all material respects with all covenants required to be performed or complied with by it hereunder on or prior to the Closing and shall have tendered the cash and required documents at the Closing as set forth in Section 4.2(a)(ii); and

(c)Seller shall have received a certificate signed by an executive officer of Buyer certifying as to the satisfaction of the conditions set forth in Section 10.3(a) and Section 10.3(b).

ARTICLE XI  
INDEMNIFICATION

Section 11.1Survival.  All representations and warranties of Seller and Buyer contained herein or made pursuant hereto will survive the Closing Date for a period of twelve (12) months after the Closing Date, the covenants and agreements of the parties hereto contained in this Agreement will survive until the later of twelve (12) months following the Closing Date or until fully performed, and the indemnification obligations contained in Section 11.2(a)(iii) will survive the Closing Date indefinitely (as applicable, the “Survival Period”). Any right of indemnification pursuant to this Article XI hereof with respect to a claimed breach of a representation, warranty, or covenant will expire on the last day of the applicable Survival Period of the representation, warranty, or covenant claimed to be breached, unless on or prior to such date the party from whom indemnification is sought will have received notice of a good faith claim in accordance with the provisions of Section 11.7 hereof.

Section 11.2Indemnification by Seller.

(a)From and after Closing, Seller hereby agrees to indemnify Buyer and its Affiliates and their respective officers, directors, and employees (the “Buyer Indemnified Parties”) against, and agrees to hold them harmless from, any Loss incurred or suffered by such Buyer Indemnified Party to the extent such Loss arises from the following:

 

(i)

any breach by Seller of any representation or warranty made by it contained in this Agreement (or any Ancillary Agreement) that results in a Loss relating to the Purchased Assets;

 

(ii)

any breach by Seller of any of its covenants contained in this Agreement (or any Ancillary Agreement);

 

(iii)

any Excluded Liability; or

 

(iv)

any Liabilities arising from, or relating to, the performance of the U.S. Government Contracts to the extent such Liabilities relate to events that took place before the Closing Date (“XOMA’s Government Contract Liabilities”).

22


 

(b)Notwithstanding the foregoing, the indemnifications in favor of the Buyer Indemnified Parties contained in Section 11.2(a)(i) above shall be subject to the following limitations: (i) in no event shall the Buyer Indemnified Parties be entitled to receive payment for indemnification for claims made pursuant to Section 11.2(a)(i), except to the extent that the Buyer Indemnified Parties (collectively) have actually incurred Losses under Section 11.1 that exceed in the aggregate Two Hundred Fifty Thousand Dollars ($250,000.00) (the “Deductible”), in which event the Buyer Indemnified Parties will be entitled to reimbursement for Buyer claims solely to the extent such Buyer claims are in excess of the Deductible; provided, however, that no Losses may be claimed by a Buyer Indemnified Party and no Losses shall be included in calculating the aggregate Losses set forth in this clause (i) other than Losses in excess of One Hundred Thousand Dollars ($100,000.00) resulting from any single claim or series of related claims; and (ii) the Buyer Indemnified Parties shall be entitled to reimbursement for the amount of Losses incurred under Section 11.2(a)(i) in the aggregate solely up to One Million Five Hundred Thousand Dollars ($1,500,000.00) (the “Seller’s Cap”) and Seller will thereafter have no further obligations or liabilities with respect to any such Losses under Section 11.2(a)(i) in excess of the Seller’s Cap; provided further, that the Deductible and the Seller’s Cap shall not apply with respect to the XOMA’s Government Contract Liabilities.

(c)Buyer acknowledges and agrees that the indemnification provided in this Article XI and the indemnification provided in any of the Ancillary Agreements will be the sole and exclusive remedy for all Losses related to or arising at Law, under any statute, or in equity or otherwise out of this Agreement or the Ancillary Agreements or the transactions contemplated hereby or thereby (other than claims of or causes of action arising from fraud) and, in furtherance thereof, Buyer waives, from and after the Closing, to the fullest extent permitted under applicable Law, any and all rights, claims, actions, or causes of action (other than claims or causes of action arising from fraud) it may have against Seller or any of its respective Affiliates relating to the subject matter of this Agreement or any of the Ancillary Agreements, other than the remedies provided in this Article XI, or any other provision of this Agreement or contained in any Ancillary Agreement; provided, however, that Buyer shall be entitled to seek temporary or permanent injunctive relief in order to enforce its rights under this Article XI, or under any other provision of this Agreement or as provided under any of the Ancillary Agreements. Notwithstanding the foregoing, nothing shall prohibit Buyer from seeking specific performance pursuant to Section 13.11 hereof or pursuant to any Ancillary Agreement to the extent provided for therein.

Section 11.3Indemnification by Buyer.  Buyer hereby agrees to indemnify Seller and its respective Affiliates and their respective officers, directors, and employees (the “Seller Indemnified Parties”) against, and agrees to hold them harmless from, any Loss incurred or suffered by Seller Indemnified Party to the extent such Loss arises from or in connection with the following:

 

(i)

 

(i)

any breach by Buyer of any representation or warranty made by it contained in this Agreement (or any Ancillary Agreement);

23


 

 

(ii)

any breach by Buyer of any of its covenants contained in this Agreement (or any Ancillary Agreement); or

 

(iii)

any Assumed Liability.

Section 11.4Reductions.  The amount of any Loss for which indemnification is provided under this Article XI will be net of (a) any amounts recovered or recoverable by the Indemnified Party under insurance policies or other Third Party indemnification proceeds with respect to such Loss; and (b) any tax benefit realized by the Indemnified Party arising from the incurrence or payment of any such Losses.

Section 11.5Insurance.  The Indemnified Party agrees to pursue and to use its commercially reasonable efforts to collect on any recovery available with respect to any Losses subject to an indemnification claim under insurance policies. In determining the amount of Losses with respect to any claim for indemnification, there shall be deducted from such amount the amount of any proceeds actually received from insurance or from any other Person responsible for Losses by the Indemnified Party (or by any other Buyer Indemnified Party or Seller Indemnified Party, as applicable) in relation to such claim. If the Indemnified Party receives any amounts under applicable insurance policies or from any other Person responsible for Losses, subsequent to an indemnification payment by the Indemnifying Party, then such Indemnified Party shall promptly reimburse the Indemnifying Party for any payment made or expense incurred by such Indemnifying Party in connection with providing such indemnification up to the amount actually received by the Indemnified Party, net of any reasonable expenses incurred by such Indemnified Party in collecting such amount.

Section 11.6Mitigation. The Indemnified Party making a claim hereunder shall use its commercially reasonable efforts to mitigate any Losses that such Indemnified Party asserts pursuant to this Article XI.

Section 11.7Procedure.

(a)In order for an indemnified party under this Article XI (an “Indemnified Party”) to be entitled to any indemnification provided for under this Agreement, such Indemnified Party will, promptly following the discovery of the matters giving rise to any Loss, notify the indemnifying party under this Article XI (the “Indemnifying Party”) in writing of its claim for indemnification for such Loss, specifying in reasonable detail the nature of such Loss and the amount of the liability estimated to accrue therefrom; provided, however, that failure to give such prompt notification will not affect the indemnification provided hereunder except to the extent the Indemnifying Party will have been actually prejudiced as a result of such failure (except that the Indemnifying Party will not be liable for any expenses incurred during the period in which the Indemnified Party failed to give such notice). Thereafter, the Indemnified Party will deliver to the Indemnifying Party, within five (5) Business Days after the Indemnified Party’s receipt of such request, all information and documentation reasonably requested by the Indemnifying Party with respect to such Loss.

24


 

(b)If the indemnification sought pursuant hereto involves a claim made by a Third Party against the Indemnified Party (a “Third Party Claim”), the Indemnifying Party will be entitled to participate in the defense of such Third Party Claim and, if it so chooses, to assume the defense of such Third Party Claim with counsel selected by the Indemnifying Party. Should the Indemnifying Party so elect to assume the defense of a Third Party Claim, the Indemnifying Party will not be liable to the Indemnified Party for any legal expenses subsequently incurred by the Indemnified Party in connection with the defense thereof. If the Indemnifying Party assumes such defense, the Indemnified Party will have the right to participate in the defense thereof and to employ counsel, at its own expense, separate from the counsel employed by the Indemnifying Party, it being understood that the Indemnifying Party will control such defense. The Indemnifying Party will be liable for the reasonable fees and expenses of counsel employed by the Indemnified Party for any period during which the Indemnifying Party has not assumed the defense thereof (other than during any period in which the Indemnified Party will have failed to give notice of the Third Party Claim as provided above). If the Indemnifying Party chooses to defend or prosecute a Third Party Claim, all of the parties hereto will cooperate in the defense or prosecution thereof. Such cooperation will include the retention and (upon the Indemnifying Party’s request) the provision to the Indemnifying Party of records and information that are reasonably relevant to such Third Party Claim, and making employees available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder. If the Indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnifying Party will not settle, compromise, or discharge such Third Party Claim, to the extent that it involves any agreement, performance, or observance by the Indemnified Party, without the Indemnified Party’s prior written consent (which shall not be unreasonably withheld, conditioned, or delayed). Whether or not the Indemnifying Party will have assumed the defense of a Third Party Claim, the Indemnified Party will not admit any liability with respect to, or settle, compromise, or discharge, such Third Party Claim without the Indemnifying Party’s prior written consent (which shall not be unreasonably withheld, conditioned, or delayed).

ARTICLE XII  
TERMINATION

Section 12.1Termination. This Agreement may be terminated:

(a)by the mutual written agreement of Seller and Buyer;

(b)by Seller or Buyer upon written notice to the other if there shall be in effect any Law, or any Governmental Order which shall have become binding and nonappealable, in the United States which makes illegal or permanently prohibits or enjoins the consummation of the transactions contemplated by this Agreement; or

(c)by Seller or Buyer upon notice to the other if the Closing shall not have occurred on or before December 15, 2015; provided, however, that the right to terminate this Agreement pursuant to this Section 12.1(c) shall not be available to such party whose failure to fulfill any obligation under this Agreement has caused, or resulted, in the failure of the Closing to occur on or before such date.

25


 

Section 12.2Effect of Termination. Upon any termination of this Agreement pursuant to Section 12.1, no party shall thereafter have any further Liability but no such termination shall relieve either party of any Liability to the other party for any breach of this Agreement or fraud prior to the date of such termination. The provisions of this Section 12.2 and Article XII shall survive any termination of this Agreement pursuant to Section 12.1.

ARTICLE XIII  
GENERAL PROVISIONS

Section 13.1Expenses. Except as otherwise specified in this Agreement, all costs and expenses, including fees and disbursements of counsel, financial advisors, and accountants, incurred in connection with this Agreement and the transactions contemplated hereby will be paid by the party incurring such costs and expenses.

Section 13.2Further Assurances and Actions. Each of the parties hereto, upon the request of the other party hereto and without further consideration, will do, execute, acknowledge, and deliver, or cause to be done, executed, acknowledged, or delivered, all such further acts, deeds, documents, assignments, transfers, conveyances, powers of attorney, and assurances as may be reasonably necessary to effect complete consummation of the transactions contemplated by this Agreement. Seller and Buyer agree to execute and deliver such other documents, certificates, agreements, and other writings and to take such other actions as may be reasonably necessary in order to consummate or implement expeditiously the transactions contemplated by this Agreement.

Section 13.3Notices. All notices, requests, demands, waivers, and communications required or permitted to be given under this Agreement shall be in writing and shall be deemed to have been duly given if delivered by hand (including by reputable overnight courier):

(a)if to Buyer, to:

Nanotherapeutics, Inc.
13859 Progress Blvd., Suite 300
Alachua, FL  32615
Telephone: 386-462-9663

Attn:  James Talton

 

with a copy to:

Nanotherapeutics, Inc.
13859 Progress Blvd., Suite 300
Alachua, FL  32615
Telephone: 386-462-9663

Attn:  Andy Cziotka, Esq.

 

26


 

(b)if to Seller, to:

XOMA (US) LLC
c/o XOMA Corporation
2910 Seventh Street
Berkeley, CA 94710
(510) 204-7200
Attn: General Counsel

with a copy to:

Morrison & Foerster LLP
425 Market Street
San Francisco, CA 94105
Attn: Van W. Ellis
Telephone: (202) 887-8776

or to such other person or address as any party shall specify by notice in writing to the other party. All such notices, requests, demands, waivers and communications shall be deemed to have been given (i) on the date on which so hand-delivered; and (ii) on the date on which faxed and confirmed.

Section 13.4Waiver and Amendments. The failure of any party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other parties. No waiver shall be effective unless it has been given in writing and signed by the party giving such waiver. No provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives of each party.

Section 13.5Headings. The table of contents and headings contained in this Agreement are for reference purposes only and will not affect in any way the meaning or interpretation of this Agreement.

Section 13.6Severability. If any term or other provision of this Agreement is invalid, illegal, or incapable of being enforced under any Law or public policy, all other terms and provisions of this Agreement will nevertheless remain in full force and effect so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to any party. Upon such determination that any term or other provision is invalid, illegal, or incapable of being enforced, the parties hereto will negotiate in good faith to modify this Agreement so as to effect the original intent of the parties hereto as closely as possible in an acceptable manner in order that the transactions contemplated hereby are consummated as originally contemplated to the greatest extent possible.

Section 13.7Counterparts. This Agreement may be executed in one or more counterparts, all of which will be considered one and the same agreement and will become effective when one or more counterparts have been signed by each of the parties hereto and delivered to the other parties hereto, it being understood that all parties hereto need not sign the same counterpart.

27


 

Section 13.8Entire Agreement; No Third Party Beneficiaries. This Agreement (together with the schedules, annexes and exhibits attached hereto) and the Ancillary Agreements constitute the entire agreement and supersede all prior agreements and understandings, both written and oral, between or among the parties hereto with respect to the subject matter hereof. Except as specifically provided herein, this Agreement is not intended to confer upon any Person other than the parties hereto any rights or remedies hereunder.

Section 13.9Relationship of the Parties. Nothing contained in this Agreement shall be deemed to constitute a partnership, joint venture, or legal entity of any type between Seller and Buyer, or to constitute one as the agent of the other. Moreover, each party agrees not to construe this Agreement, or any of the transactions contemplated hereby, as a partnership for any tax purposes.

Section 13.10Governing Law; Jurisdiction. This Agreement will be governed by and construed in accordance with the laws of the State of California, without regard to the conflict of law principles thereof. Each of the parties irrevocably agrees that any legal action or proceeding arising out of or relating to this Agreement brought by any other party or its successors or assigns shall be brought and determined in state or federal court sitting in California, and each of the parties hereby irrevocably submits to the exclusive jurisdiction of the aforesaid courts for itself and with respect to its property, generally and unconditionally, with regard to any such action or proceeding arising out of or relating to this Agreement and the transactions contemplated hereby. Each of the parties agrees not to commence any action, suit, or proceeding relating thereto except in the courts described above in California, other than actions in any court of competent jurisdiction to enforce any judgment, decree or award rendered by any such court. Each of the parties further agrees that notice as provided herein shall constitute sufficient service of process and the parties further waive any argument that such service is insufficient. Each of the parties hereby irrevocably and unconditionally waives, and agrees not to assert, by way of motion or as a defense, counterclaim, or otherwise, in any action or proceeding arising out of or relating to this Agreement or the transactions contemplated hereby, (a) any claim that it is not personally subject to the jurisdiction of the courts described herein for any reason; (b) that it or its property is exempt or immune from jurisdiction of any such court or from any legal process commenced in such courts (whether through service of notice, attachment prior to judgment, attachment in aid of execution of judgment, execution of judgment, or otherwise); and (c) that (i) the suit, action, or proceeding in any such court is brought in an inconvenient forum; (ii) the venue of such suit, action, or proceeding is improper; or (iii) this Agreement, or the subject matter hereof, may not be enforced in or by such courts.

Section 13.11Specific Performance. The parties hereto agree that irreparable damage would occur in the event any provision of this Agreement were not performed in accordance with the terms hereof and that the parties hereto will be entitled to specific performance of the terms hereof, in addition to any other remedy at law or in equity, without the necessity of demonstrating the inadequacy of monetary damages and without the posting of a bond.

Section 13.12Waiver of Jury Trial. EACH OF THE PARTIES HERETO IRREVOCABLY AND UNCONDITIONALLY WAIVES TRIAL BY JURY IN ANY LEGAL ACTION OR PROCEEDING RELATING TO THIS AGREEMENT, THE AGREEMENTS, INSTRUMENTS AND DOCUMENTS CONTEMPLATED HEREBY, OR THE TRANSACTIONS CONTEMPLATED HEREBY AND FOR ANY COUNTERCLAIM THEREIN.

28


 

Section 13.13Binding Effect; Assignment.

(a)This Agreement shall inure to the benefit of and be binding upon the parties hereto and the respective successors and permitted assigns of the parties and such Persons. This Agreement may not be assigned by any party hereto without the prior written consent of each of the other parties; provided, however, that any Party may assign its rights hereunder to one or more of its Affiliates so long as such Affiliate agrees in writing to become a party to this Agreement and be bound to the terms and conditions of this Agreement, and the transferring party shall remain liable for the performance of all obligations of itself and its Affiliated transferees under this Agreement.

Section 13.14Disclosure Schedule. Concurrently with the execution and delivery of this Agreement by the parties hereto, the Seller delivered or caused to be delivered to the Buyer the Schedules. The Schedules are hereby incorporated by reference into, and forms an integral part of, this Agreement. The information and disclosures contained in each Schedule shall be deemed to be disclosed and incorporated by reference in each of the other Schedules (whether or not specific cross-references are made therein). The inclusion of any matter, information or item in the Schedule shall not be deemed to constitute an admission of any liability by the Seller to any Third Party or otherwise imply that any such matter, information, or item is material or creates a measure for materiality for the purposes of this Agreement.

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be signed by their respective representatives thereunto duly authorized, all as of the date first written above.

 

NANOTHERAPEUTICS, INC.

 

By:

 

 

Name:

 

 

Title:

 

 

 

XOMA (US) LLC

 

By:

 

 

Name:

 

 

Title:

 

 

 

 

29


 

Exhibit A

ASSIGNMENT AND ASSUMPTION AGREEMENT

ASSIGNMENT AND ASSUMPTION AGREEMENT

This Assignment and Assumption Agreement (the “Assignment and Assumption”) is made and entered into as of  [_______], 2015, by and among XOMA (US) LLC, a Delaware limited liability company (“Assignor”), and Nanotherapeutics, Inc., a Delaware corporation (“Assignee”).

WHEREAS, Assignor and Assignee are parties to that certain Asset Purchase Agreement dated as of November 4, 2015 (the “Purchase Agreement”), pursuant to which Assignee has agreed to purchase from Assignor the Purchased Assets (as defined in the Purchase Agreement); and

WHEREAS, pursuant to the Purchase Agreement, Assignor has agreed to assign certain rights and agreements to Assignee, and Assignee has agreed to assume certain obligations of Assignor, as set forth herein, and this Assignment and Assumption is contemplated by Section 2.4(a) of the Purchase Agreement;

NOW, THEREFORE, for and in consideration of the premises and the mutual covenants contained herein, and for other good and valuable consideration, the receipt, adequacy and legal sufficiency of which are hereby acknowledged, the parties do hereby agree as follows:

1.Capitalized Terms.  Capitalized terms used but not defined herein shall have the meanings for such terms that are set forth in the Purchase Agreement.

2.Assignment and Assumption.  Effective as of ______:______ ______.m.  (______ time) on ______, 20______ (the “Effective Time”), Assignor hereby assigns, sells, transfers and sets over (collectively, the “Assignment”) to Assignee all of Assignor’s right, title, benefit, privileges and interest in and to, and all of Assignor’s burdens, obligations and liabilities in connection with, each of the Assumed Liabilities. Assignee hereby accepts the Assignment and assumes and agrees to observe and perform all of the duties, obligations, terms, provisions and covenants, and to pay and discharge all of the liabilities of Assignor to be observed, performed, paid or discharged from and after the Closing, in connection with the Assumed Liabilities. Assignee assumes no Excluded Liabilities, and the parties hereto agree that all such Excluded Liabilities shall remain the sole responsibility of Assignor.

3.Terms of the Purchase Agreement.  The terms of the Purchase Agreement, including but not limited to Assignor’s representations, warranties, covenants, agreements and indemnities relating to the Assumed Liabilities, are incorporated herein by this reference. Assignor acknowledges and agrees that the representations, warranties, covenants, agreements and indemnities contained in the Purchase Agreement shall not be superseded hereby but shall remain in full force and effect to the full extent provided therein. In the event of any conflict or inconsistency between the terms of the Purchase Agreement and the terms hereof, the terms of the Purchase Agreement shall govern.

A-1


 

4.Further Actions.  Each of the parties hereto covenants and agrees, at its own expense, to execute and deliver, at the request of the other party hereto, such further instruments of transfer and assignment and to take such other action as such other party may reasonably request to more effectively consummate the assignments and assumptions contemplated by this Assignment and Assumption.

IN WITNESS WHEREOF, the parties have executed this Assignment and Assumption Agreement as of the date first above written.

 

ASSIGNOR

 

ASSIGNEE

XOMA (US) LLC,

 

Nanotherapeutics, Inc.,

a Delaware limited liability company

 

a Delaware corporation

 

 

 

 

 

 

 

By:

 

 

 

By:

 

 

Its:

 

 

 

Its:

 

 

 


A-2


 

Exhibit B

BILL OF SALE

GENERAL ASSIGNMENT AND BILL OF SALE

1.Sale and Transfer of Purchased Assets and Contract Rights.  For good and valuable consideration, the receipt, adequacy and legal sufficiency of which are hereby acknowledged, and as contemplated by Section 4.2(a)(i) of that certain Asset Purchase Agreement dated as of November 4, 2015 (the “Purchase Agreement”), to which XOMA (US) LLC, a Delaware limited liability company (the “Seller”), and Nanotherapeutics, Inc., a Delaware corporation (the “Buyer”), are parties, Seller hereby sells, transfers, assigns, conveys, grants and delivers to Purchaser and its successors and assigns, effective as of ______:______ ______.m. (______ time) on ______,  2015 (the “Effective Time”), all of Seller’s right, title and interest in and to all of the Purchased Assets (as defined in the Purchase Agreement).

2.Further Actions.  Seller covenants and agrees to warrant and defend the sale, transfer, assignment, conveyance, grant and delivery of the Purchased Assets hereby made against all persons whomsoever, to take all steps reasonably necessary to establish the record of Buyer’s title to the Purchased Assets and, at the request of Buyer, to execute and deliver further instruments of transfer and assignment and take such other action as Purchaser may reasonably request to more effectively transfer and assign to and vest in Buyer each of the Purchased Assets, all at the sole cost and expense of Seller.

3.Power of Attorney.  Without limiting Section 2 hereof, Seller hereby constitutes and appoints Buyer the true and lawful agent and attorney in fact of Seller, with full power of substitution and resubstitution, in whole or in part, in the name and stead of Seller but on behalf and for the benefit of Buyer and its successors and assigns, from time to time:

(a)to demand, receive and collect any and all of the Purchased Assets and to give receipts and releases for and with respect to the same, or any part thereof;

(b)to institute and prosecute, in the name of Seller or otherwise, any and all proceedings at law, in equity or otherwise, that Buyer or its successors and assigns may deem proper in order to collect or reduce to possession any of the Purchased Assets and in order to collect or enforce any claim or right of any kind hereby assigned or transferred, or intended so to be; and

(c)to do all things legally permissible, required or reasonably deemed by Buyer to be required to recover and collect the Purchased Assets and to use Seller’s name in such manner as Buyer may reasonably deem necessary for the collection and recovery of same,

Seller hereby declaring that the foregoing powers are coupled with an interest and are and shall be irrevocable by Seller.

B-1


 

4.Terms of the Purchase Agreement.  The terms of the Purchase Agreement, including but not limited to Seller’s representations, warranties, covenants, agreements and indemnities relating to the Purchased Assets, are incorporated herein by this reference.  Seller acknowledges and agrees that the representations, warranties, covenants, agreements and indemnities contained in the Purchase Agreement shall not be superseded hereby but shall remain in full force and effect to the full extent provided therein.  In the event of any conflict or inconsistency between the terms of the Purchase Agreement and the terms hereof, the terms of the Purchase Agreement shall govern.

IN WITNESS WHEREOF, Seller has executed this General Assignment and Bill of Sale as of ____________, 2015.

 

XOMA (US) LLC,

a Delaware limited liability company

 

By:

 

 

Its:

 

 

 


 

B-2


 

Exhibit C

FORM OF NANOTHERAPEUTICS LICENSE AGREEMENT

 

 

 

 

 

 

NANOTHERAPEUTICS LICENSE AGREEMENT,

BY AND BETWEEN

XOMA (US) LLC

and

NANOTHERAPEUTICS, INC.

____________ __, 2015

C-1


 

NANOTHERAPEUTICS LICENSE AGREEMENT

 

This NANOTHERAPEUTICS LICENSE AGREEMENT (this “Agreement”) is entered into as of [______] [__], 2015 (the “Effective Date”) by and between XOMA (US) LLC, a Delaware limited liability company (“Licensor), and Nanotherapeutics, Inc., a Delaware Corporation (“Licensee”).  Each of Licensor and Licensee is sometimes referred to individually herein as a “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, simultaneously with the execution of this Agreement, Licensor and Licensee have entered into that certain Asset Purchase Agreement (the “APA”) relating to the BOT Business (as defined in the APA).

WHEREAS, Licensor desires to retain ownership of the XOMA Co-Formulation Patents, XOMA Vector Patents, XOMA BOT Know-How, and XOMA General Know-How (each defined in the APA and which were not included within the Purchased Assets (as defined in the APA) acquired by Licensee under the APA) and Licensee desires to license the XOMA Co‑Formulation Patents, XOMA Vector Patents, XOMA BOT Know‑How, and XOMA General Know-How for all uses within the Field and Licensor agrees to grant such license.

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the Parties hereto, intending to be legally bound, hereby agree as follows:

1.DEFINITIONS

Whenever used in this Agreement with an initial capital letter, the terms defined in this Article 1 shall have the meanings specified herein and therein.  Capitalized terms not defined herein shall have the meanings set forth in the APA.

“Bankruptcy Code” has the meaning given in Section 6.14.

Calendar Quarter” means each three month period commencing on January 1, April 1, July 1, and October 1.

Field” means sales to the U.S. Government for counter-terrorism and warfare applications.

Net Sales” means the gross amounts invoiced by Buyer, its Affiliates, and any of its or their licensees or collaborators (each, a “Selling Party”) for the sale, transfer or other distribution of XOMA Derived Products to Third Parties, less the following deductions to the extent reasonable and customary and actually incurred, allowed, paid, accrued or specifically allocated in its financial statements, for:

(a)discounts (including trade, quantity and cash discounts), cash and non-cash coupons, retroactive price reductions, and charge-back payments and rebates granted to any Third Party (including to governmental entities or agencies, purchasers, reimbursers, customers, distributors, wholesalers, and group purchasing and managed care organizations or entities (and other similar entities and institutions));

C-2

 


 

(b)credits or allowances, if any, on account of price adjustments, recalls, claims, damaged goods, rejections or returns of items previously sold (including Product returned in connection with recalls or withdrawals) and amounts written off by reason of uncollectible debt, provided that if the debt is thereafter paid, the corresponding amount shall be added to the Net Sales of the period during which it is paid; and

(c)rebates (or their equivalent), administrative fees, chargebacks and retroactive price adjustments and any other similar allowances granted by a Selling Party (including to governmental authorities, purchasers, reimburses, customers, distributors, wholesalers, and managed care organizations and entities (and other similar entities and institutions)) which effectively reduce the selling price or gross sales of the Product.

If non-monetary consideration is received by a Selling Party for any Product in a given country, Net Sales will be calculated based on the average price charged for such Product in such country, as applicable, during the preceding royalty period, or in the absence of such sales, transfers or other distributions, the fair market value of the Product in such country, as applicable, as determined by the Parties in good faith.  If the Parties are unable to reach such an agreement, the Parties shall refer such matter to a jointly selected Third Party with expertise in the pricing of pharmaceutical products that is not, and has not in the past five (5) years been, an employee, consultant, legal advisor, officer, director or stockholder of, and does not have any conflict of interest with respect to, either Party for resolution.  Net Sales shall be determined on, and only on, the first sale, transfer or other distribution by a Selling Party to a Third Party that is not a Selling Party.

Term” has the meaning given in Section 4.1.

Territory” means worldwide.

2.LICENSES

2.1XOMA Co-Formulation Patents. Licensor hereby grants Licensee an exclusive, royalty-free, fully paid-up, freely sublicensable and transferable, license under the XOMA Co‑Formulation Patents for all uses and applications in the Field in the Territory, including to make, have made, use, sell, offer for sale, import, export, manufacture, develop and commercialize products for use in the Field and in the Territory.

2.2XOMA Vector Patents. Licensor hereby grants Licensee a non-exclusive, royalty-free, fully paid-up, freely sublicensable and transferable, license under the XOMA Vector Patents for all uses and applications in the Field in the Territory, including to make, have made, use, sell, offer for sale, import, export, manufacture, develop and commercialize products for use in the Field and in the Territory.

2.3XOMA BOT Know-How. Licensor hereby grants Licensee an exclusive, royalty-free, fully paid-up, freely sublicensable and transferable, license to the XOMA BOT Know-How for all uses and applications in the Field in the Territory, including to make, have made, use, sell, offer for sale, import, export, manufacture, develop and commercialize products for use in the Field and in the Territory.

C-3

 


 

2.4XOMA General Know-How. Licensor hereby grants Licensee a non-exclusive, royalty-free, fully paid-up, freely sublicensable and transferable, license to the XOMA General Know-How for all uses and applications in the Field in the Territory, including to make, have made, use, sell, offer for sale, import, export, manufacture, develop and commercialize products for use in the Field and in the Territory.

3.PAYMENTS

3.1In consideration of the licenses granted in Article 2, Licensee shall make the payments set forth below in this Section 3.1:

(a)One Million, Five Hundred Thousand Dollars ($1,500,000), payable in four equal, consecutive Calendar Quarter payments, with the first such payment being due at the end of the Calendar Quarter in which the Defense Threat Reduction Agency executes the DTRA Contract;

(b)Two Million Dollars ($2,000,000) within three (3) Business Days of the exercise by DTRA exercise of Option 1 in the DTRA Contract;

(c)One Million Dollars ($1,000,000), payable in four equal, consecutive Calendar Quarter payments, with the first such payment being due at the end of the Calendar Quarter in which the Defense Threat Reduction Agency makes an award in conjunction with its exercise of Option 1 in the DTRA Contract; and

(d)Quarterly Royalty Payments of Fifteen Percent (15%) of Net Sales of XOMA Derived Products.

3.2Payment of Milestone and Royalty Amounts; Accounting and Records.  

3.2.1Payment of Royalties Licensee shall pay Licensor the royalty payments set forth in Section 3.1(d) for each Calendar Quarter in which there are Net Sales, within thirty (30) days after the end of each such Calendar Quarter.

3.2.2Royalty Reports.  Licensee shall provide, at the same time each payment is made pursuant to Section 3.1(d), a report showing: (a) the gross sales of each XOMA Derived Product by country; (b) the amount of deductions, by category of permitted deduction, from gross sales to determine Net Sales; and (c) a calculation of the amount of royalty due to Licensor.

3.2.3Mode of Payment.  All payments made pursuant to Section 3.1 shall be made in immediately available funds by wire transfer to a United States based account to be identified by Licensor.

3.2.4Currency of Payments.  All payments made pursuant to Section 3.1 shall be made in United States dollars. When calculating the Net Sales of any XOMA Derived Product that occur in currencies other than the U.S. dollars, Licensee shall convert the amount of such sales into U.S. dollars using the applicable exchange rate reported in the Wall Street Journal for the last day of the applicable reporting period.

C-4

 


 

3.2.5Late Payments.  To the extent any payments made pursuant to Section 3.1 are not paid within the specified time period, such outstanding payments shall accrue interest from the date due, at the one year LIBOR rate on the last Business Day of the applicable calendar quarter prior to the date on which such payment was due, plus seven (7) percentage point, calculated on the basis of a 360-day year, or, if lower, the maximum rate permitted by law. 

3.2.6Blocked Currency.  If, at any time, legal restrictions prevent Licensee from remitting part or all of a royalty payment due under Section 3.1(d) when due with respect to any country where XOMA Derived Products are sold, Licensee shall promptly notify Licensor in writing and shall continue to provide Net Sales reports for such royalty payments within thirty (30) days after the end of each such Calendar Quarter.  Such royalty payments shall continue to accrue in such country, and Licensee shall deposit such payment in local currency in such country to the credit of Licensor in a recognized banking institution designated by Licensor in writing.

3.2.7Withholding Tax.  If Laws require withholding of income or other taxes imposed upon any royalty payments made by Licensee to Licensor under this Agreement, Licensee shall (i) make such withholding payments as may be required, (ii) subtract such withholding payments from such payments, (iii) submit appropriate proof of payment of the withholding taxes to Licensor within a reasonable period of time, and (iv) promptly provide Licensor with all official receipts with respect thereto.  Licensee shall provide reasonable assistance in order to allow Licensor to obtain the benefit of any present or future treaty against double taxation which may apply to such payments.

3.2.8Records.  Licensee shall keep, and shall require each Selling Party to keep, full, true and accurate books of account containing all particulars that may be necessary for the purpose of calculating all royalty payment amounts payable under Section 3.1(d).

3.2.9Audits.  Upon timely request and at least thirty (30) days’ prior written notice from Licensor, Licensor may have an independent public accountant reasonably acceptable to Licensee perform, on behalf of Licensor, an audit of such books and records of the Selling Parties that are reasonably necessary for Licensor’s independent public accountant to report on Net Sales of XOMA Derived Products for the then current calendar year and the two (2) most recently completed calendar years prior to the date of such request and the correctness of any Net Sales report or royalty payment made during such period.  Such audit shall be conducted during regular business hours in such a manner as to not unnecessarily interfere with the Licensee’s normal business activities.  Such audit shall not be performed more frequently than once per calendar year nor more frequently than once with respect to records covering Net Sales of any Product during any give period of time.  Such audits shall be conducted at the expense of Licensor, unless such audit identifies an underpayment of royalty payments of five percent (5%) or more for any XOMA Derived Product over any calendar year, in which case Licensee shall reimburse Licensor for all expenses incurred by Licensor to conduct such audit.

3.2.10Underpayment.  If the audit reveals an underpayment to Licensor, Licensee shall pay the shortfall amount to Licensor within thirty (30) days after the completion of the audit together with the applicable late payment interest amount.

C-5

 


 

4.TERM AND TERMINATION

4.1Term.  This Agreement shall commence on the Effective Date and shall continue in full force and effect, unless otherwise terminated pursuant to Section 4.2, until the expiration of the last valid claim of the XOMA Patents in all countries in the Territory (the Term”).  Upon the expiration of the Term, the licenses granted to Licensee shall be retained as fully paid-up, worldwide, perpetual and irrevocable licenses.

4.2Termination. This Agreement may be terminated as follows:

4.2.1Termination for Convenience.  Licensee may terminate this Agreement at any time upon sixty (60) days’ prior written notice to Licensor.

4.2.2Termination for Breach.  If a Party materially breaches any of its obligations under this Agreement, the non-breaching Party may provide the breaching Party with a written notice specifying the nature of the breach, and stating its intention to terminate this Agreement if such breach is not cured.  If the material breach is not cured within thirty (30) days after the receipt of such notice, the non-breaching Party shall be entitled, without prejudice to any of its other rights under this Agreement, and in addition to any other remedies available to it by law or in equity, to terminate this Agreement by providing written notice to the other Party.

4.2.3Termination for Failure of Exercised Option.  In the event that (i) Buyer does not exercise its Option in accordance with Section 2.3 of the APA, on or before the end of the Option Period or (ii) Buyer notifies Seller that it will not exercise the Option, this Agreement will automatically terminate.

4.3Surviving Provisions.  Termination or expiration of this Agreement for any reason shall be without prejudice to the rights and obligations of the Parties that have accrued prior to the termination or expiration. The following provisions shall survive early termination: Section 3.2 and Articles 4 and 5.

4.4Cumulative Rights.  The rights and remedies provided to each Party in this Article 3 are cumulative and in addition to any other rights and remedies available to such Party at law or in equity.  

5.NO WARRANTIES; LIMITATION OF LIABILITIES

5.1Warranty Disclaimer.  EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY WITH RESPECT TO ANY KNOW-HOW, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND EACH PARTY HEREBY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT.

5.2Limited Liability.  NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR ANY SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING LOST PROFITS OR LOST REVENUES, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH

C-6

 


 

DAMAGES.  NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 5.2 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE LIABILITY OF EITHER PARTY FOR THE BREACH OF ITS OBLIGATIONS UNDER THE CONFIDENTIALITY AGREEMENT.

6.GENERAL PROVISIONS

6.1Expenses. Except as otherwise specified in this Agreement, all costs and expenses, including fees and disbursements of counsel, financial advisors, and accountants, incurred in connection with this Agreement and the transactions contemplated hereby will be paid by the party incurring such costs and expenses.

6.2Further Assurances and Actions. Each of the parties hereto, upon the request of the other party hereto and without further consideration, will do, execute, acknowledge, and deliver, or cause to be done, executed, acknowledged, or delivered, all such further acts, deeds, documents, assignments, transfers, conveyances, powers of attorney, and assurances as may be reasonably necessary to effect complete consummation of the transactions contemplated by this Agreement. Licensor and Licensee agree to execute and deliver such other documents, certificates, agreements, and other writings and to take such other actions as may be reasonably necessary in order to consummate or implement expeditiously the transactions contemplated by this Agreement.

6.3Notices. All notices, requests, demands, waivers, and communications required or permitted to be given under this Agreement shall be in writing and shall be deemed to have been duly given if delivered by hand (including by reputable overnight courier):

6.3.1if to Licensor, to:

XOMA (US) LLC
c/o XOMA Corporation
2910 Seventh Street
Berkeley, CA 94710
(510) 204-7200
Attn: General Counsel

with a copy to:

Morrison & Foerster LLP
425 Market Street
San Francisco, CA 94105
Attn: Van W. Ellis
Telephone: (202) 887-8776

 

6.3.2if to Licensee, to:

Nanotherapeutics, Inc.
13859 Progress Blvd., Suite 300
Alachua, FL  32615
Telephone: 386-462-9663

Attn:  James Talton

 

C-7

 


 

with a copy to:

Nanotherapeutics, Inc.

13859 Progress Blvd., Suite 300

Alachua, FL  32615

Telephone: 386-462-9663

Attn:  Andy Cziotka, Esq.

 

or to such other person or address as any party shall specify by notice in writing to the other party. All such notices, requests, demands, waivers and communications shall be deemed to have been given (i) on the date on which so hand-delivered; and (ii) on the date on which faxed and confirmed.

6.4Waiver and Amendments

The failure of any party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other party. No waiver shall be effective unless it has been given in writing and signed by the party giving such waiver. No provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives of each party.

6.5Headings

The headings contained in this Agreement are for reference purposes only and will not affect in any way the meaning or interpretation of this Agreement.

6.6Severability

If any term or other provision of this Agreement is invalid, illegal, or incapable of being enforced under any Law or public policy, all other terms and provisions of this Agreement will nevertheless remain in full force and effect so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to any party. Upon such determination that any term or other provision is invalid, illegal, or incapable of being enforced, the parties hereto will negotiate in good faith to modify this Agreement so as to effect the original intent of the parties hereto as closely as possible in an acceptable manner in order that the transactions contemplated hereby are consummated as originally contemplated to the greatest extent possible.

6.7Counterparts

This Agreement may be executed in one or more counterparts, all of which will be considered one and the same agreement and will become effective when one or more counterparts have been signed by each of the parties hereto and delivered to the other parties hereto, it being understood that all parties hereto need not sign the same counterpart.

6.8Entire Agreement; No Third Party Beneficiaries

This Agreement (together with the schedules, annexes and exhibits attached hereto), the APA, and the Ancillary Agreements constitute the entire agreement and supersede all prior agreements and understandings, both written and oral, between or among the parties hereto with respect to the subject matter hereof. Except as specifically provided herein, this Agreement is not intended to confer upon any Person other than the parties hereto any rights or remedies hereunder.

6.9Relationship of the Parties

Nothing contained in this Agreement shall be deemed to constitute a partnership, joint venture, or legal entity of any type between Licensor and

C-8

 


 

Licensee, or to constitute one as the agent of the other. Moreover, each party agrees not to construe this Agreement, or any of the transactions contemplated hereby, as a partnership for any tax purposes.

6.10Governing Law; Jurisdiction

This Agreement will be governed by and construed in accordance with the laws of the State of California, without regard to the conflict of law principles thereof. Each of the parties irrevocably agrees that any legal action or proceeding arising out of or relating to this Agreement brought by any other party or its successors or assigns shall be brought and determined in state or federal court sitting in California, and each of the parties hereby irrevocably submits to the exclusive jurisdiction of the aforesaid courts for itself and with respect to its property, generally and unconditionally, with regard to any such action or proceeding arising out of or relating to this Agreement and the transactions contemplated hereby. Each of the parties agrees not to commence any action, suit, or proceeding relating thereto except in the courts described above in California, other than actions in any court of competent jurisdiction to enforce any judgment, decree or award rendered by any such court. Each of the parties further agrees that notice as provided herein shall constitute sufficient service of process and the parties further waive any argument that such service is insufficient. Each of the parties hereby irrevocably and unconditionally waives, and agrees not to assert, by way of motion or as a defense, counterclaim, or otherwise, in any action or proceeding arising out of or relating to this Agreement or the transactions contemplated hereby, (a) any claim that it is not personally subject to the jurisdiction of the courts described herein for any reason; (b) that it or its property is exempt or immune from jurisdiction of any such court or from any legal process commenced in such courts (whether through service of notice, attachment prior to judgment, attachment in aid of execution of judgment, execution of judgment, or otherwise); and (c) that (i) the suit, action, or proceeding in any such court is brought in an inconvenient forum; (ii) the venue of such suit, action, or proceeding is improper; or (iii) this Agreement, or the subject matter hereof, may not be enforced in or by such courts.

6.11Specific Performance

The parties hereto agree that irreparable damage would occur in the event any provision of this Agreement were not performed in accordance with the terms hereof and that the parties hereto will be entitled to specific performance of the terms hereof, in addition to any other remedy at law or in equity, without the necessity of demonstrating the inadequacy of monetary damages and without the posting of a bond.

6.12Waiver of Jury Trial

EACH OF THE PARTIES HERETO IRREVOCABLY AND UNCONDITIONALLY WAIVES TRIAL BY JURY IN ANY LEGAL ACTION OR PROCEEDING RELATING TO THIS AGREEMENT, THE ANCILLARY AGREEMENTS, INSTRUMENTS AND DOCUMENTS CONTEMPLATED HEREBY, OR THE TRANSACTIONS CONTEMPLATED HEREBY AND FOR ANY COUNTERCLAIM THEREIN.

6.13Binding Effect; Assignment

This Agreement shall inure to the benefit of and be binding upon the parties hereto and the respective successors and permitted assigns of the parties and such Persons. This Agreement may not be assigned by any party hereto without the prior written consent of each of the other parties; provided, however, that any Party may assign its rights hereunder to one or more of its Affiliates so long as such Affiliate agrees in writing to become a party to this Agreement and be bound to the terms and conditions of this Agreement,

C-9

 


 

and the transferring party shall remain liable for the performance of all obligations of itself and its Affiliated transferees under this Agreement.

Section 365(n) of the Bankruptcy Code.  All rights and licenses granted pursuant to any Section of this Agreement are, and shall be deemed to be, rights and licenses to “intellectual property” (as defined in Section 101(35A) of title 11 of the United States Code and of any similar provisions of applicable Laws under any other jurisdiction (the “Bankruptcy Code”)).  Each Party agrees that the other Party, as a Licensee of rights and licenses under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code.  The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party under the Bankruptcy Code or analogous provisions of applicable Law outside the United States, the other Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any intellectual property licensed to such Party and all embodiments of such intellectual property, which, if not already in such Party’s possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon such Party’s written request therefor, unless the Party in the bankruptcy proceeding elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under clause (a), following the rejection of this Agreement by the Party in the bankruptcy proceeding upon written request therefor by the other Party.


C-10

 


 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives.

 

 

 

XOMA (US) LLC

 

 

 

 

 

 

 

By:

 

 

 

 

Name:

 

 

 

 

Title:

 

 

 

 

 

 

 

 

 

NANOTHERAPEUTICS, INC.

 

 

 

 

 

 

 

By:

 

 

 

 

Name:

 

 

 

 

Title:

 

 


 

C-11

 


 

Exhibit D

ALLOCATION OF PURCHASE PRICE

 

 

 

 

 

Tax Purchase Price Allocation

 

 

 

 

 

Asset Classes

 

Total Purchase Price allocated by Asset Class

 

 

 

 

 

Class I (cash and general deposit accounts (including savings and checking accounts) other than certificates of deposit held in banks, savings and loan associations, and other depository institutions)

 

[Dollar value as set forth on the closing balance sheet = A]

 

 

 

 

 

 

Class II (actively traded personal property within the meaning of Code § 1092(d)(1) and Treas. Reg. § 1.1092(d)-1 (determined without regard to Code § 1092(d)(3)) and certificates of deposit and foreign currency even if not actively traded property, but excluding stock of target affiliates, whether or not actively traded, other than actively traded stock described in Code § 1504(a)(4); examples of Class II assets include U.S. government securities and publicly traded stock)

 

[Dollar value as set forth on the closing balance sheet = B]

 

 

 

 

 

 

Class III (assets that the taxpayer marks to market at least annually for federal income tax purposes and debt instruments (including accounts receivable), but not including (i) debt instruments issued by persons related at the beginning of the day following the acquisition date to the target under Code §§ 267(b) or 707, (ii) contingent debt instruments subject to Treas. Reg. §§ 1.1275-4 and 1.483-4, or Code § 988, unless the instrument is subject to the noncontingent bond method of Treas. Reg. § 1.1275-4(b) or is described in Treas. Reg. § 1.988-2(b)(2)(i)(B)(2), and (iii) debt instruments convertible into the stock of the issuer or other property)

 

[Dollar value as set forth on the closing balance sheet = C]

 

 

 

 

 

 

Class IV (stock in trade of the taxpayer or other property of a kind that would properly be included in the inventory of taxpayer if on hand at the close of the taxable year, or property held by the taxpayer primarily for sale to customers in the ordinary course of its trade or business)

 

[Dollar value as set forth on the closing balance sheet = D]

 

 

 

 

 

 

Class V (all assets other than Class I, II, III, IV, VI, and VII assets – for example fixed assets and machinery)

 

[Dollar value as set forth on the closing balance sheet = E]

 

 

 

 

 

 

 

 

 

 

 

Class VI and Class VII (goodwill and going concern value)

 

[Remainder = F = Purchase Price -(Sum of A+B+C+D+E)]

D-1


 

Total Value

 

 

 

Sum total of above

 

 

 

 

 

*For purposes of this allocation schedule, the amount set forth on the closing balance sheet shall be determined based on an interim closing of the books as of the Option Closing Date.

 

D-2


 

Exhibit E-1

SELLER’S LETTERS TO THE FDA

Drug Master File Staff

Food and Drug Administration

Center for Drug Evaluation and Research

Central Document Room

5901-B Ammendale Road

Beltsville MD 20705-1266

 

Date:  [Enter the date of this Submission]

 

DMF#:  024117

 

Holder: XOMA (US) LLC

 

Subject (Title): XOMA 3AB

 

RE: Submission Information: General Information/Administrative/Change in Holder: Transfer to New Holder

 

New Holder Name:  Nanotherapeutics, Inc. [Name of entity receiving DMF to be confirmed.]

 

Dear DMF Staff:

 

With this letter, we wish to provide notice that XOMA (US) LLC has transferred all rights to the above-referenced Drug Master File (“DMF”) to Nanotherapeutics, Inc. (“Nanotherapeutics”), with an address at 13859 Progress Blvd #300, Alachua, FL 32615 [Address of entity receiving DMF to be confirmed.], effective as of [***].  The responsible official at Nanotherapeutics is Doris Snow, and she may be reached by telephone at (386) 462-9663 Ext. 7216 or by email at dsnow@nanotherapeutics.com.  Nanotherapeutics has received a complete copy of the existing DMF.  

 

If you have any questions for XOMA Corporation regarding this letter, please contact me by telephone at (510) 541-5034 or by email at cafaro@xoma.com.

 

Sincerely,

 

Daniel P. Cafaro

Vice President, Regulatory Affairs and Compliance

XOMA (US) LLC

(510) 541-5034

cafaro@xoma.com

E-1-1


 

Drug Master File Staff

Food and Drug Administration

Center for Drug Evaluation and Research

Central Document Room

5901-B Ammendale Road

Beltsville MD 20705-1266

 

Date:  [Enter the date of this Submission]

 

DMF#:  024156

 

Holder: XOMA (US) LLC

 

Subject (Title): NONCLINICAL (PHARMACOLOGY, PHARMACOKINETICS, AND TOXICOLOGY) FOR XOMA 3AB

 

RE: Submission Information: General Information/Administrative/Change in Holder: Transfer to New Holder

 

New Holder Name:  Nanotherapeutics, Inc. [Name of entity receiving DMF to be confirmed.]

 

Dear DMF Staff:

 

With this letter, we wish to provide notice that XOMA (US) LLC has transferred all rights to the above-referenced Drug Master File (“DMF”) to Nanotherapeutics, Inc. (“Nanotherapeutics”), with an address at 13859 Progress Blvd #300, Alachua, FL 32615 [Address of entity receiving DMF to be confirmed.], effective as of [***].  The responsible official at Nanotherapeutics is Doris Snow, and she may be reached by telephone at (386) 462-9663 Ext. 7216 or by email at dsnow@nanotherapeutics.com.  Nanotherapeutics has received a complete copy of the existing DMF.  

 

If you have any questions for XOMA Corporation regarding this letter, please contact me by telephone at (510) 541-5034 or by email at cafaro@xoma.com.

 

Sincerely,

 

Daniel P. Cafaro

Vice President, Regulatory Affairs and Compliance

XOMA (US) LLC

(510) 541-5034

cafaro@xoma.com

 

 

 

E-1-2


 

Exhibit E-2

BUYER’S LETTERS TO THE FDA

Drug Master File Staff

Food and Drug Administration

Center for Drug Evaluation and Research

Central Document Room

5901-B Ammendale Road

Beltsville MD 20705-1266

Date:  [Enter the date of this Submission]

DMF#:  024117

Holder: XOMA (US) LLC

Subject (Title): XOMA 3AB

Submission Information: General Information/Administrative/Change in Holder: Acceptance by New Holder

New Holder Name:  Nanotherapeutics, Inc. [Name of entity to be confirmed.]

Dear DMF Staff:

With this letter, Nanotherapeutics, Inc. (“Nanotherapeutics”) wishes to acknowledge its acceptance of the above-referenced Drug Master File (“DMF”), which has been transferred to Nanotherapeutics from XOMA (US) LLC, effective as of [***].  Nanotherapeutics has an address at 13859 Progress Blvd #300, Alachua, FL 32615 [Address of entity receiving DMF to be confirmed.].  The responsible official at Nanotherapeutics is Doris Snow, and she may be reached by telephone at (386) 462-9663 Ext. 7216 or by email at dsnow@nanotherapeutics.com.      

Nanotherapeutics states that DMF 024117 is current and Nanotherapeutics will comply with the statements made within it.  Nanotherapeutics will notify FDA through an amendment to DMF 024117 of any addition, change, or deletion of information in the DMF.  [Nanotherapeutics will also notify in writing [AUTHORIZED PARTY OR PARTIES] that an addition, change, or deletion of information has been made to the DMF.]  Nanotherapeutics takes full responsibility for all the information in the DMF and for all the processes and testing performed by the manufacturer.

Nanotherapeutics hereby confirms that it has received a complete copy of the DMF.

[Include a statement explaining any change in manufacturing site, if applicable.]

E-2-1


 

Sincerely,

James D. Talton

President & CEO

Nanotherapeutics, Inc.

(386) 462-9663

(386) 462-2087 Fax

jtalton@nanotherapeutics.com

E-2- 2


 

[Please confirm the DMF is held in CDER, not the Center for Biologics Evaluation and Research]

Drug Master File Staff

Food and Drug Administration

Center for Drug Evaluation and Research

Central Document Room

5901-B Ammendale Road

Beltsville MD 20705-1266

 

Date:  [Enter the date of this Submission]

DMF#:  024156

Holder: XOMA (US) LLC

Subject (Title): NONCLINICAL (PHARMACOLOGY, PHARMACOKINETICS, AND TOXICOLOGY) FOR XOMA 3AB

Submission Information: General Information/Administrative/Change in Holder: Acceptance by New Holder

New Holder Name:  Nanotherapeutics, Inc. [Name of entity to be confirmed.]

Dear DMF Staff:

With this letter, Nanotherapeutics, Inc. (“Nanotherapeutics”) wishes to acknowledge its acceptance of the above-referenced Drug Master File (“DMF”), which has been transferred to Nanotherapeutics from XOMA (US) LLC, effective as of [***].  Nanotherapeutics has an address at 13859 Progress Blvd #300, Alachua, FL 32615 [Address of entity receiving DMF to be confirmed.].  The responsible official at Nanotherapeutics is Doris Snow, and she may be reached by telephone at (386) 462-9663 Ext. 7216 or by email at dsnow@nanotherapeutics.com.      

Nanotherapeutics states that DMF 024156 is current and Nanotherapeutics will comply with the statements made within it.  Nanotherapeutics will notify FDA through an amendment to DMF 024156 of any addition, change, or deletion of information in the DMF.  [Nanotherapeutics will also notify in writing [AUTHORIZED PARTY OR PARTIES] that an addition, change, or deletion of information has been made to the DMF.]  Nanotherapeutics takes full responsibility for all the information in the DMF and for all the processes and testing performed by the manufacturer.

Nanotherapeutics hereby confirms that it has received a complete copy of the DMF.

[Include a statement explaining any change in manufacturing site, if applicable.]

E-2- 3


 

Sincerely,

James D. Talton

President & CEO

Nanotherapeutics, Inc.

(386) 462-9663

(386) 462-2087

jtalton@nanotherapeutics.com

 

 

 

 

E-2- 4


 

Exhibit E-3

LETTERS OF REFERENCE

Drug Master File Staff

Food and Drug Administration

Center for Drug Evaluation and Research

Central Document Room

5901-B Ammendale Road

Beltsville MD 20705-1266

Date:  [Enter the Submission date of the LOA]

DMF#:  024117

Holder: Nanotherapeutics, Inc. [Entity name to be confirmed.]

Subject (Title): XOMA 3AB

RE: Letter of Authorization for: DMF 024117

Dear DMF Staff:

Nanotherapeutics, Inc. (“Nanotherapeutics”) hereby authorizes XOMA Corporation and its affiliates, including XOMA (US) LLC (collectively, “XOMA”), to incorporate by reference any information of whatever nature in DMF 024117 into any Biologics License Application (BLA), Investigational New Drug Application (IND), New Drug Application (NDA), New Animal Drug Application (NADA), Abbreviated New Drug Application (ANDA), or another DMF, in each case filed by XOMA.  We also authorize the FDA to review any portion of the aforementioned DMF 024117 when considering any BLA, IND, NDA, NADA, ANDA, or another DMF, in each case filed by XOMA.

The authorization provided hereby applies with respect to the entirety of DMF 024117, including any amendments or supplements made to such DMF after the date of this letter.

Nanotherapeutics states that DMF 024117 is current and Nanotherapeutics will comply with the statements made within it.  Nanotherapeutics will notify FDA through an amendment to DMF 024117 of any addition, change, or deletion of information in the DMF.   Nanotherapeutics will also notify in writing XOMA that an addition, change, or deletion of information has been made to the DMF.

E-3-1


Sincerely,

James D. Talton

President & CEO

Nanotherapeutics, Inc.

(386) 462-9663

(386) 462-2087 Fax

jtalton@nanotherapeutics.com

 

 


E-3- 2


Drug Master File Staff

Food and Drug Administration

Center for Drug Evaluation and Research

Central Document Room

5901-B Ammendale Road

Beltsville MD 20705-1266

Date:  [Enter the Submission date of the LOA]

DMF#:  024156

Holder: Nanotherapeutics, Inc. [Entity name to be confirmed.]

Subject (Title): NONCLINICAL (PHARMACOLOGY, PHARMACOKINETICS, AND TOXICOLOGY) FOR XOMA 3AB

RE: Letter of Authorization for: DMF 024156

Dear DMF Staff:

Nanotherapeutics, Inc. (“Nanotherapeutics”) hereby authorizes XOMA Corporation and its affiliates, including XOMA (US) LLC (collectively, “XOMA”), to incorporate by reference any information of whatever nature in DMF 024156 into any Biologics License Application (BLA), Investigational New Drug Application (IND), New Drug Application (NDA), New Animal Drug Application (NADA), Abbreviated New Drug Application (ANDA), or another DMF, in each case filed by XOMA.  We also authorize the FDA to review any portion of the aforementioned DMF 024156 when considering any BLA, IND, NDA, NADA, ANDA, or another DMF, in each case filed by XOMA.

The authorization provided hereby applies with respect to the entirety of DMF 024156, including any amendments or supplements made to such DMF after the date of this letter.

Nanotherapeutics states that DMF 024156 is current and Nanotherapeutics will comply with the statements made within it.  Nanotherapeutics will notify FDA through an amendment to DMF 024156 of any addition, change, or deletion of information in the DMF.   Nanotherapeutics will also notify in writing XOMA that an addition, change, or deletion of information has been made to the DMF.

E-3- 3


Sincerely,

James D. Talton

President & CEO

Nanotherapeutics, Inc.

(386) 462-9663

(386) 462-2087 Fax

jtalton@nanotherapeutics.com

 

 

E-3- 4


 

Exhibit F

WAREHOUSE LICENSE AGREEMENT

 

LICENSE AGREEMENT

This LICENSE AGREEMENT (this “Agreement”) is made and entered into as of [____] [●], 2015 (the “Effective Date”), by and between XOMA CORPORATION, a Delaware corporation (“Licensor”), and NANOTHERAPEUTICS, INC., a Delaware corporation (“Licensee”), with reference to the following facts:

RECITALS

WHEREAS, by a Lease dated February 13, 2013 (the “Prime Lease”), 7th Street Properties II (“Landlord”) leases to Licensee, as tenant, a portion of the building located at 804 Heinz Avenue, Berkeley, California 94710-2737 (the “Building”), which leased portion is comprised of approximately 35,000 square feet of rentable area (the “Premises”), at the rent and upon and subject to the terms and conditions set forth in the Prime Lease, a copy of which was provided to Licensee prior to the Effective Date.

WHEREAS, Licensor and Licensee have entered into an Asset Purchase Agreement, dated as of November 4, 2015 (“APA”), which provides, among other things, for Licensee’s acquisition of certain assets related to the BOT Business and certain related transactions, on the terms set forth in the APA and the Ancillary Agreements.  Capitalized terms used but not defined in this Agreement shall have the meaning ascribed to such terms in the APA.

WHEREAS, Licensee desires to license from Licensor, and Licensor desires to license to Licensee, the Licensed Premises (as defined below), all on the terms and conditions contained in this Agreement.

NOW, THEREFORE, in consideration of the mutual covenants herein contained and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the parties hereto hereby agree as follows:

1.Licensed Premises; Licensed FF&E.  

 

(a)Licensor does hereby grant to Licensee a temporary license to use, upon the conditions hereinafter provided, approximately 3,000 square feet of area in the Building (the “Licensed Premises”).  The Licensed Premises is shown on the floor plan attached hereto as Exhibit A.  Licensor also does hereby grant to Licensee temporary license to use, upon the conditions hereinafter provided, the fixtures, furniture and equipment more particularly described on Exhibit B attached hereto (the “Licensed FF&E”).  Licensee shall have access to, and use of, the conference rooms, pantries, restrooms and the other common areas of the Premises (collectively, the “Common Areas”).

 

(b)Licensee accepts the Licensed Premises and Licensed FF&E in their “as-is, where-is” condition, with all faults, and without any representation, warranty or obligation on the part of Licensor to pay any improvement allowance to Licensee with respect to the Licensed

F-1

 

 


 

Premises, to modify, improve or otherwise prepare the Licensed Premises for Licensee’s occupancy other than the construction of a demising wall generally in the location noted on Exhibit A, or as to the quality of the Licensed FF&E or whether or not it is functional or can be used by Licensee for any purpose.

  

(c)Licensee shall have no right to enter, and shall prevent its employees, agents, contractors, licensees and invitees from entering, any portions of the Premises other than the Licensed Premises and the portion of the Premises used for ingress and egress to and from the Licensed Premises.  

 

(d)Each party shall use commercially reasonable efforts to prevent its agents, employees or contractors from discovering or otherwise coming into contact with confidential information of the other party, and shall treat in whole such information confidentially in accordance with the Confidentiality Agreement.    

 

(e)This Agreement does not and shall not be deemed to constitute a lease or a conveyance of the Licensed Premises or the Licensed FF&E by Licensor to Licensee, or to confer upon Licensee any right, title, estate or interest in the Licensed Premises or the Licensed FF&E.  This Agreement grants to Licensee only a personal privilege to use and occupy the Licensed Premises and use the Licensed FF&E for the License Term on and subject to the terms and conditions set forth herein.  

 

2.Term.  

 

(a)Subject to and upon the covenants, agreements and conditions set forth in this Agreement, the term of this License (the “License Term”) shall commence on the Closing and expire at 5:59 PM Pacific Time on December 31, 2016, subject to termination as set forth in Section 2(b) below.  

 

(b)Licensor shall have the right, at any time, to terminate this Agreement for cause, which shall be deemed to exist (i) in the event Licensee has defaulted in the performance of any obligations, duties and responsibilities under this Agreement and has not cured the default within ten days after receiving written notice thereof from Licensor (or such lesser cure period as might be practicable under the circumstances in the event of an emergency); or (ii) in the event of Licensee’s bankruptcy, insolvency, receivership or liquidation.  Any such termination shall be effective five Business Days following Licensee’s receipt of written notice of termination from Licensor or in the event of a termination under clause (ii), upon the commencement of such event, regardless whether the event is later terminated.  If the Prime Lease is terminated or cancelled for any reason, then this Agreement shall terminate simultaneously.

 

3.Use.  Licensee shall use and occupy the Licensed Premises and use the Licensed FF&E solely for the conduct of the BOT Business and incidental office and administrative uses in accordance with this Agreement and the Prime Lease, and for no other use.

 

F-2

 

 


 

4.Legal and Contractual Compliance.  

 

(a)Licensee, at its sole cost and expense, shall comply with all present and future laws, rules, orders, ordinances, regulations, of all governmental authorities now existing or hereafter created, and of any applicable fire rating bureau, or other body exercising similar functions, which are applicable to Licensee’s use and occupancy of the Licensed Premises and use of the Licensed FF&E (the “Requirements”).  

 

(b)This Agreement is subject to the Prime Lease and to all underlying leases and mortgages now or hereafter affecting the real property of which the Licensed Premises is a part and to all renewals, modifications, consolidations, replacements and extensions of such leases and mortgages.  Licensee shall obtain the prior written consent of Licensor and Landlord with respect to any act which, if performed by Licensor, would require Landlord’s approval under the Prime Lease, and Licensor may withhold its consent if Landlord’s consent is not obtained.  Each provision under the Prime Lease in which Licensor is required to (i) indemnify, release or waive claims against Landlord and/or (ii) execute and deliver documents or notices to Landlord, shall be binding on Licensee as to the Licensed Premises as if incorporated fully in this Agreement and shall run from Licensee to both Landlord and Licensor (provided, however, all such notices and documents shall be delivered to Licensor).  Licensee shall have no right to contact Landlord directly for any reason whatsoever.  This Section 4(b) is self-operative.

 

(c)Licensee will keep the Licensed Premises and Licensed FF&E in clean, safe, sanitary and operating condition, will take good care thereof, and will suffer no waste or injury thereto.  Licensee shall not do or permit anything to be done in, about or with respect to the Licensed Premises that would (i) injure the Building or the Licensed Premises or the Licensed FF&E; (ii) vibrate, shake, overload, or impair the efficient operation of the Premises or the building systems located therein; (iii) cause the Prime Lease or the rights of Licensor, as tenant thereunder, to be canceled, terminated or forfeited or which would make Licensor liable for any damages, claim or penalty; or (iv) otherwise violate the Prime Lease.  Licensee shall comply with all reasonable rules and regulations promulgated from time to time by Licensor.

 

(d)Licensee shall not, without the prior written consent of Licensor, use, store, transport or dispose of any Hazardous Materials in or about the Licensed Premises except in compliance with applicable Requirements.  Licensee, at its sole cost, shall comply with all laws relating to its use of Hazardous Materials.  If Hazardous Materials stored, used, disposed of, emitted or released by Licensee or its agents, employees or contractors result in contamination of the Licensed Premises or the Building in which the Licensed Premises are situated or the water or soil thereunder, then Licensee shall promptly take any and all action necessary to clean up such contamination as required by law.  “Hazardous Materials” shall mean any material or substance that is now or hereafter designated by any applicable governmental authority to be, or regulated by any applicable governmental authority as, radioactive, toxic, hazardous or otherwise a danger to health, reproduction or the environment.

 

F-3

 

 


 

5.License Fee and Security Deposit.  

 

(a)Licensee is granted this License to use the Licensed Premises and Licensed FF&E during the License Term in consideration of a license fee (“License Fee”) of $9,528.58 per month from the Effective Date through April 30, 2016, and $9,814.44 per month, from May 1, 2016 through December 31, 2016, payable in advance on the 1st of each calendar month by wire transfer to such bank account as Licensor shall notify Licensee of from time to time.  License Fees for any partial month shall be properly prorated on a daily rate basis based on the number of days in the applicable month.  

 

(b)If Licensee fails to pay any payment of License Fee as and when due under this Agreement, then such outstanding payments shall accrue interest from the date due, at the one year LIBOR rate on the last Business Day of the applicable calendar quarter prior to the date on which such payment was due, plus seven percentage points, calculated on the basis of a 360-day year, or, if lower, the maximum rate permitted by law.

 

(c)Upon execution of this Agreement, Licensee shall pay to Licensor funds in the amount of $11,718.95 as security for Licensee’s full and timely performance of all of the provisions hereof.  Licensor may (but shall not be required to) use such security deposit (or any portion thereof), together with any interest earned thereon, to cure any default under this Agreement or to compensate Licensor for any damage Licensor incurs as a result of Licensee’s failure to perform any of its obligations under this Agreement.  In such event, and upon written notice specifying the amount of the security deposit so utilized by Licensor and the particular use for which such amount was used, Licensee shall immediately deposit with Licensor an amount sufficient to return the security deposit to an amount equal to the full amount specified, failing which Licensor shall have the same rights and remedies as for the non‑payment of the License Fee.  If Licensee is not in default at the expiration or termination of this Agreement, Licensor shall return to Licensee the security deposit or the balance thereof then held by Licensor, together with any interest earned thereon.

 

6.Assignment or Other Occupants.  Licensee will not assign or otherwise transfer this License, or permit occupancy or use by another party of the Licensed Premises or Licensed FF&E, or any part thereof.

 

7.Alterations.  Except as set forth on Exhibit C to this Agreement, Licensee shall make no alterations, installations, additions or improvements in or to the Licensed Premises or the Building without Licensor’s prior written consent, which consent may be granted or withheld in Licensor’s sole discretion.  Licensee shall bear all of the costs of any alterations, installations, additions, or improvements.  Except as Licensor otherwise may permit in writing, Licensee shall remove, at Licensee’s sole cost and expense, all alterations, installations, additions, or improvements that Licensee installs in the Licensed Premises.

 

8.Surrender.  Nothing contained in this Agreement will be deemed to permit Licensor to retain possession of the Licensed Premises after the expiration or earlier termination the License Term.  At the expiration or other termination of the License term, except as provided in Section 7 above, Licensee will surrender the Licensed Premises and the Licensed FF&E in the same order

F-4

 

 


 

and condition in which it was on the Effective Date, ordinary wear and tear and damage due to casualty or condemnation excepted.  If Licensor fails to deliver vacant possession of the Licensed Premises in the manner required under this Agreement on or prior to the expiration or earlier termination of the License Term, such failure will not be deemed to extend the License Term and Licensee shall be deemed to be a trespasser and shall pay to Licensor promptly upon demand therefor, for each day or portion thereof during which Licensee retains possession of the Licensed Premises after such expiration or earlier termination, an amount equal to $490.72 per day (in addition to all other amounts set forth herein).  The provisions of this Section 8 will not be deemed to limit or constitute a waiver of any other rights or remedies provided herein or at law or in equity, including Licensor’s right to immediately remove Licensee, Licensee’s property and the Licensed FF&E from the Licensed Premises.  Licensee shall additionally indemnify and hold Licensor harmless from and against all loss, liability, costs and expenses of any kind or nature (including, without limitation, reasonable attorneys’ fees and disbursements) resulting from or arising out of Licensee’s failure to comply with the provisions of this Section 8.  If any of Licensee's property remains in the Licensed Premises at the expiration or earlier termination of the License Term, such property shall be deemed Licensor’s property and Licensee shall be liable to Licensor for all costs of storage and/or removal of such property.  The provisions of this Section 8 will survive the expiration or earlier termination of the License Term.

 

9.Signage.  No sign, advertisement or notice shall be inscribed, painted, affixed or displayed on any part of the Licensed Premises, including window displays, without Licensor's prior written approval.

 

10.Services and Repairs.  Except as set forth in the Transition Services Agreement, Licensee acknowledges and agrees the Licensor has no obligation under this Agreement to provide work, services, utilities, access, repairs or restoration with respect to the Licensed Premises, the Licensed FF&E or any other portion of the Building that are the obligations of Landlord to provide under the Prime Lease or to perform any other obligations of Landlord under the Prime Lease, and that Licensor’s sole obligation with respect to any of the foregoing is to promptly, following the written request of Licensee, request that Landlord perform its obligations under the Prime lease.  Licensor shall in no event be liable to Licensee nor shall the obligations of Licensee under this Agreement be impaired or the performance thereof abated, reduced or excused because of any failure or delay on the Landlord’s part in performing or providing any of the foregoing.  Any and all injury, breakage or damage to the Licensed Premises or the Building of which they are a part, arising from any cause, done by Licensee or its agents, contractors, or employees, shall be repaired by Licensee at Licensee’s sole expense, to the reasonable satisfaction of Licensor.

 

11.Indemnification.  Licensee agrees to indemnify, protect, defend and save harmless Licensor and Licensor’s partners, officers, directors, contractors, agents and employees form and against any and all liability (statutory or otherwise), claims, suits, demands, damages, judgments, costs, fines, penalties, interest and expenses (including, without limitation, reasonable counsel and other professional fees and disbursements incurred in connection therewith) to which Licensor and/or any such partner, officer, director, contractor, agent or employee may be subject or suffer arising from, or in connection with: (a) any liability or claim for any injury to, or death of, any person or persons, or damage to property (including any loss of use thereof), occurring in

F-5

 

 


 

or about the Licensed Premises; (b) the use and occupancy of the Licensed Premises or use of the Licensed FF&E, or from any work, installation or thing whatsoever done or omitted (other than by Licensor or its agents or employees) in or about the Licensed Premises during the License Term; (c) any breach by Licensee of any of its representation, warranties or obligations set forth in this Agreement; and/or (d) any act, omission, carelessness, negligence or misconduct of Licensee or Licensee’s agents, employees, contractors or visitors.

 

12.Insurance.  Licensee shall obtain and keep in full force and effect during the License Term, at Licensee’s own cost and expense, (i) commercial general liability insurance naming Licensee, Licensor, Landlord and any other persons designated by Licensor as insured, in a combined single limit amount of not less than $5,000,000 in the aggregate, with a deductible not in excess of $10,000; and (ii) all-risk property insurance in an amount sufficient to cover Licensee’s property located within the Licensed Premises.  The company or companies writing the insurance that Licensee is required to carry and maintain or cause to be carried or maintained pursuant to this License as well as the form of such insurance shall at all times be subject to Licensor’s approval and any such company or companies shall be licensed to do business in the jurisdiction in which the Building is located.  Licensee’s commercial general liability insurance policy and certificates evidencing such insurance shall name Licensor as additional insured and shall also contain a provision by which the insurer agrees that such policy shall not be canceled except after 30 days’ written notice to Licensor.  Licensee agrees to provide to Licensor, prior to commencing its use of the Licensed Premises, the certificates evidencing such insurance.  Any insurance carried or to be carried by Licensee under this Agreement shall be primary over any policy that might be carried by Licensor.  If Licensee fails to perform any of its obligations regarding the acquisition and maintenance of insurance, Licensor may perform the same and the reasonable, direct, out-of-pocket cost of same shall be payable to Licensor upon Licensee’s receipt of written demand therefor accompanied by an invoice showing in reasonable detail such costs.  Each party shall include in each of its policies insuring against loss, damage or destruction by fire or other casualty, a waiver of the insurer’s right of subrogation against the other party.  Each party hereby releases the other party with respect to any claim (including a claim for negligence) which it might otherwise have against the other party for loss, damage or destruction with respect to its property (including rental value or business interruption), occurring during the License Term to the extent to which such party is insured under a policy containing a waiver of subrogation or naming the other party as an additional insured, as provided in this Section.  Both parties shall secure waiver of subrogation endorsements from their respective insurance carriers as to the other party.

 

13.Access and Parking.  Licensor and its representatives (and Landlord and its representatives) shall have the right, from time to time throughout the License Term, to enter any portion of the Licensed Premises at all reasonable times during normal business hours to examine the same, to show the same to prospective purchasers, mortgagees or lessees of the Building or any space therein, and to make such repairs and alterations as Licensor or Landlord may deem necessary or desirable to the Licensed Premises or any other portion of the Building.  Licensor shall use reasonable efforts to give notice prior to Licensor entering, and to minimize any interference Licensor may cause with Licensee’s use of, the Licensed Premises.  Licensee shall have access to the Licensed Premises on a 24/7 basis.  Access to the Licensed Premises shall be controlled by a card key system maintained by [Landlord].  Licensee shall be given [●]

F-6

 

 


 

card keys.  If Licensee requires additional card keys, the Licensee shall promptly reimburse Licensor for Licensor’s costs therefor.  Licensee’s right to use the parking areas serving the Building shall be in accordance with the provisions of the Prime Lease regarding parking.

 

14.Default and Remedies.  If Licensee shall default in fulfilling any of its covenants or obligations under this Agreement, Licensor may exercise any rights and remedies available to Licensor at law or equity, including terminating this Agreement and the License after first giving (a) not less than five Business Days’ written notice to Licensee in the event of any default in the payment of any monetary obligations under this Agreement; and (b) not less than 20 days’ written notice in the event of any non-monetary default.  In the event of such termination, Licensee shall however remain liable to Licensor for all money and other damages arising from such default.

 

15.WAIVER OF JURY TRIAL.  Licensor and Licensee hereby waive trial by jury in any action, proceeding or counterclaim brought by either of the parties hereto against the other on or in respect of any matter whatsoever arising out of or in any way connected with this License, the relationship of Licensor and Licensee under THIS AGREEMENT, Licensee's use of the Licensed Premises AND/OR LICENSED FF&E, and/or any claim of injury or damage.

 

16.Liability.  It is expressly agreed by the parties hereto that Licensor shall not be liable to Licensee, or to any of its employees, customers, or business invitees, for any damage, injury, loss, compensation or claim, including but not limited to claims for the interruption of or loss to Licensee's business, based on, arising out of, or resulting from any cause whatsoever.  All personal property of Licensee, its employees, agents, or invitees, in and on the Licensed Premises or any part of the Building, shall be and remain therein under any and all circumstances at the sole risk of said parties and Licensor shall in no event be liable to any such person or party for any damage to, or loss thereof.  Licensor shall not be liable for any personal injury to Licensee, Licensee's employees, agents, business invitees, customers, clients, family members, guests or trespassers arising from the use and condition of the Licensed Premises, the Licensed FF&E, or any part of the Building.

 

17.Relationship.  Licensor and Licensee acknowledge and agree that this Agreement does not and will not create any landlord-tenant relationship, licensor-licensee relationship or any privity of contract of any type between Landlord and Licensee.  Further the parties agree that Landlord’s consent to this Agreement does not act as a waiver of any of Landlord’s rights under the Prime Lease.

 

18.Broker.  Licensor and Licensee each represent and warrant one to another that neither of them has employed any broker in carrying on the negotiations, or had any dealings with any broker, relating to this License.  

 

19.Landlord’s Consent.  This License is subject to the prior consent of Landlord, and Licensee shall pay not later than 10 days’ following receipt of written invoice therefor any and all consent fees that Landlord imposes upon Licensor in connection with the request for Landlord’s consent.

 

F-7

 

 


 

20.Miscellaneous Provisions.  

 

(a)This License, including Exhibit A attached to this Agreement and made a part hereof, constitutes the entire agreement between the parties concerning the subject matter of this License and supersedes all prior or contemporaneous representations, negotiations, conditions, communications and agreements, whether oral or written, between the parties relating to the subject matter of this License and all past courses of dealing or industry custom.  No amendment, modification or waiver of any provision of this License shall be effective unless in writing and signed by duly authorized signatories of both parties.

 

(b)The waiver by either party of a default under any provision of this License shall not be construed as a waiver of any subsequent default under the same or any other provision of this License, nor shall any delay or omission on the part of either party to exercise or avail itself of any right or remedy that it has or may have under this Agreement operate as a waiver of any right or remedy.

 

(c)In the event that any of the provisions of this License shall be held by a court or other tribunal of competent jurisdiction to be invalid or unenforceable, the remaining portions hereof shall remain in full force and effect and such provision shall be enforced to the maximum extent possible so as to effect the intent of the parties and shall be reformed to the extent necessary to make such provision valid and enforceable.  If necessary, the valid and enforceable provision(s) shall be negotiated by the parties and substituted therefore to accomplish the intent of the severed provision(s) as nearly as practicable.

 

(d)Any and all matters in dispute between the parties to this agreement, whether arising from or relating to the agreement itself, or arising from alleged extra-contractual facts prior to, during, or subsequent to the agreement, including, without limitation, fraud, misrepresentation, negligence or any other alleged tort or violation of the contract, shall be governed by, construed, and enforced in accordance with the laws of the State of California, regardless of the legal theory upon which such matter is asserted and without regard to the principles of conflict of laws.  The parties submit to the jurisdiction and venue of the courts within the State of California.  If either party files suit in any court of competent jurisdiction to enforce its rights under this Agreement, then the prevailing party shall be entitled to recover from the other party all costs of such action or suit, including, but not limited to, investigative costs, court costs and reasonable attorneys' fees (including expenses incurred to collect those expenses).  

 

(e)All notices, consents, demands and requests, required or permitted to be given under this License, shall be given in writing and addressed to the Party to whom the notice is to be given at the following address:  (i) if to Licensor, at XOMA Corporation, 2910 Seventh Street, Berkeley, CA 94710, Attention: General Counsel, with a copy to Morrison & Foerster LLP, 425 Market Street, San Francisco, CA 94105, Attention: Van W. Ellis; and (ii) if to Licensee at Nanotherapeutics, Inc., 13859 Progress Blvd., Suite 300, Alachua, FL 32615, Attention: James Talton, with a copy to Nanotherapeutics, Inc., 13859 Progress Blvd., Suite 300, Alachua, FL 32615, Attention: Andy Cziotka.  Any notice or demand required or allowed under this License shall be in writing and shall be delivered by (1) registered or certified mail, return

F-8

 

 


 

receipt requested; (2) personal delivery by a reputable delivery service with signature required therefor or refusal noted thereon; (3) facsimile if the notice address includes a facsimile number with hard copy to follow by delivery by method (1), (2), or (5) of this Section; (4) electronic mail if the notice address includes an electronic mail address with hard copy to follow by method (1), (2), or (5) of this Section; or (5) overnight delivery such as Federal Express or other similarly reputable carrier.  Notice given by counsel to a party shall be considered notice given by a party.  Any notice or demand shall be deemed to have been given upon actual delivery (or refusal of delivery).  Any party may change its address for notices under this License by giving formal written notice to the other party in accordance with this Section upon at least 30 days’ prior written notice, specifying that the purpose of the notice is to change the party’s address.

 

(f)This Agreement shall be binding upon and inure to the benefit of the parties and their respective successors and permitted assigns.

 

(g)The paragraph headings of this Agreement are for the convenience of reference only, and do not form a part hereof and do not in any way modify, interpret, or construe the intentions of the Parties.  Each party has read and agreed to the specific language of this Agreement and no conflict, ambiguity, or doubtful interpretation shall be construed against the drafter.  All defined terms include the plural as well as the singular, as the context may require.  All of the recitals contained in this Agreement are hereby incorporated in this Agreement by reference.

 

(h)Licensee represents and warrants that this License has been duly authorized, executed and delivered by and on behalf of Licensee, and constitutes the valid and binding agreement of Licensee in accordance with the terms hereof.  Licensor represents and warrants that this License has been duly authorized, executed and delivered by and on behalf of Licensor, and constitutes the valid and binding agreement of Licensor in accordance with the terms hereof.

 

(g)This License may be executed by facsimile, electronic communication in portable document format (.pdf) or duplicate originals, and the Parties agree that their electronically transmitted signatures shall have the same effect as manually transmitted signatures.  This License may be executed in one or more counterparts, each of which shall constitute an original, but all of which when taken together shall constitute one and the same instrument for effective execution.

 

 

 

[Signatures on following page.]

F-9

 

 


 

 

IN WITNESS WHEREOF, Licensor and Licensee have caused this License to be executed and delivered as their act and deed, intending to be legally bound by its terms and provisions.

 

LICENSOR:

 

XOMA CORPORATION, a Delaware corporation

 

By:

 

 

Name:

 

 

Title:

 

 

 

LICENSEE:

 

NANOTHERAPEUTICS, INC., a Delaware corporation

 

By:

 

 

Name:

 

 

Title:

 

 

 

LICENSE CONSENTED TO:

 

7TH STREET PROPERTIES II, a California limited partnership

 

By:

 

 

Name:

 

 

Title:

 

 

 


 

F-10

 

 


 

EXHIBIT A

Licensed Premises

XOMA 4, First Floor, Nano CA (Yellow)

F-11

 

 


 

EXHIBIT B

Licensed FF&E

Desks

Chairs

Phones

F-12

 

 


 

EXHIBIT C

Licensee Alterations

1.  Construction of building standard demising walls for the offices and cubicle areas in the locations shown on Exhibit A.

 

 

 

F-13


 

Exhibit G

 

NIAID SUBCONTRACT

 

ADMINISTRATIVE SUBCONTRACT

 

This ADMINISTRATIVE SUBCONTRACT (this “Agreement”) dated as of [____] _____, 2015 (the “Effective Date”), is made and entered into between (i) Nanotherapeutics, Inc., a Delaware corporation (“Subcontractor”) and (ii) XOMA (US) LLC, a Delaware limited liability company (“Contractor”).  Contractor and Subcontractor are sometimes individually referred to herein as a “Party” and collectively as the “Parties.”  Capitalized terms used in this Agreement and not otherwise defined in this Agreement shall have the meanings given to them in the Asset Purchase Agreement (which is defined below).

R E C I T A L S

A.The National Institutes of Health, National Institute of Allergy and Infectious Diseases (“NIAID”) awarded Contract No. HHSN272201100031C to Contractor effective September 30, 2011.  A copy of the original contract, and all amendments thereto (together the “NIAID Contract”), is attached hereto as Exhibit A.

B.Contractor and Subcontractor entered into an Asset Purchase Agreement, dated November 4, 2015 (the “Purchase Agreement”), whereby Subcontractor will purchase from Contractor certain assets, including those assets to be used in performing the NIAID Contract, along with Contractor’s rights and obligations in the NIAID Contract.

C.Contractor and Subcontractor, as part of the Purchase Agreement, have agreed to request that the NIAID Contracting Officer, on behalf of the United States Government (the “Government”) approve and enter into a Novation Agreement that will formally transfer and assign all of the Contractor’s rights and obligations in the NIAID Contract to Subcontractor (the “Novation Request”).

D.Pending Government approval of the Novation Request, the Parties desire to enter into a subcontract arrangement whereby Subcontractor is obligated to meet all of the objectives, perform all of the tasks and technical requirements, timely provide all of the deliverables, and comply with all of the terms and legal obligations in the NIAID Contract to the same extent as if the NIAID Contract had been awarded to Subcontractor.

E.This Agreement supplements, and does not supersede, Section 2.5 of the Purchase Agreement.

NOW, THEREFORE, for valuable consideration received, Contractor and Subcontractor agree as follows:

1.The NIAID Contract in its entirety, and all contract documents relating thereto, including but not limited to delivery orders, supplements, schedules, amendments, and change orders issued and to be issued by the Government, are hereby incorporated by reference into this Agreement.

G-1

 


2.Subcontractor shall assume all of Contractor’s obligations and liabilities relating to the NIAID Contract arising after the Effective Date and shall be bound by all of the requirements and obligations in the NIAID Contract as if Subcontractor were the original party to the NIAID Contract.  In addition, Subcontractor shall comply with all applicable Laws governing the performance of the NIAID Contract.

3.During the period between the Effective Date and the earlier of (1) the date on which the Government approves the Novation Request and enters into a Novation Agreement, (2) cancellation of this Agreement due to the Government’s failure to approve the Novation Request (collectively, the “Interim Period”), or (3) expiration of the NIAID Contract, Subcontractor shall meet all of the objectives, perform all of the tasks and technical requirements, file all necessary reports, and timely provide all of the deliverables set forth in the NIAID Contract and the associated Statement of Work dated [___], as amended, which is incorporated into the NIAID Contract by reference.

4.All payments, expenses, cost reimbursements, fees, and other similar payments (collectively, the “Payments”) attributable to performance of the NIAID Contract are to be for the account of Subcontractor during the Interim Period.  

5.Subcontractor shall indemnify and hold Contractor harmless against any and all claims, losses, or liabilities arising in connection with Subcontractor’s performance (including any omission or failure to act by the Subcontractor, or its employees, agents or Affiliate(s)) of the NIAID Contract, subject to the time limitations listed in Section 2.

6.Any of the following shall be prepared by Subcontractor in the name of Contractor and submitted for approval to (and, if required, certification by) Contractor:

 

(i)

Correspondence directed to the Government regarding performance of the NIAID Contract;

 

(ii)

Invoices;

 

(iii)

Bids or proposals for new or additional work;

 

(iv)

Requests for equitable adjustment(s);

 

(v)

Cost claims;

 

(vi)

Requests or approval for a contract modification; and

 

(vii)

Requests for final decisions from the Government.

 

If approved, any such request will be signed or certified by Contractor and shall be submitted by Contractor to the Government.

7.Contractor has designated KAREN THOMAS as Contractor’s Contract Representative to receive and execute any documents related to Subcontractor’s performance under the NIAID Contract, and Subcontractor has designated JOANNE BROWN as Subcontractor’s Contract Representative to submit such documents to, and receive such documents from, the Contractor’s Designated Contract Representative.  Either Party may change its Designated Contract Representative by written notice to the other.  

G-2


All notices under this Agreement shall be given to the other Party’s Designated Contract Representative by (a) registered or certified mail, return receipt requested; (b) personal delivery by a reputable delivery service with signature required therefor or refusal noted thereon; (c) facsimile or email (in either case with a hard copy to follow by delivery by method (a), (b), or (d) of this Section); or (d) overnight delivery such as Federal Express or other similarly reputable carrier. Any notice or demand shall be deemed to have been given upon actual delivery.  

8.To the extent permitted by law, Contractor shall cause Payments received from the Government by Contractor for Subcontractor’s performance of the NIAID Contract to be to be deposited into a bank account in the name of Subcontractor within five (5) business days after the Contractor’s date of receipt.

9.Upon Government approval of the Novation Request, this Agreement shall be automatically terminated without any further action by the Parties; provided, however, that (i) Subcontractor shall continue to be responsible for all obligations and liabilities relating to the NIAID Contract arising during the term of this Agreement; and (ii) the Parties’ duties under Sections 2-7, 10-12, 14-16, 18, and 23 of this Agreement shall survive such termination.

10.During the Interim Period, any Subcontractor dispute (or any dispute arising from Subcontractor’s lower tier subcontractors or suppliers) originally derived or resulting in any way from any act, obligation, omission, directive, or actual or constructive change by the Government that is not disposed of by agreement may be drafted and properly prepared by Subcontractor for presentation to the Contractor.  Subject to Contractor’s prior approval, which shall not be unreasonably withheld, the Contractor will present the dispute or claim to the Government for a final decision pursuant to the applicable FAR Disputes clause.  If the Government’s final decision has an adverse effect on the Subcontractor, then Subcontractor shall have the right to assert Contractor’s right of appeal in the name of Contractor to the appropriate Board of Contract Appeals or to the U.S. Court of Federal Claims and to prosecute such appeal under the applicable Disputes clause, subject to Contractor’s prior approval.  Contractor agrees to give Subcontractor prompt notice of any decision relating to Subcontractor’s dispute.  Subcontractor shall have full responsibility for preparing and presenting documents related to any Subcontractor dispute with the Government and shall bear all expenses, including attorneys’ fees, in connection therewith and any appeal shall be at no cost to Contractor.  Contractor and Subcontractor shall be equally bound by the decision of the Board of Contract Appeals or Court of Federal Claims on any appeal pursuant to this paragraph.

11.If, prior to the expiration of the NIAID Contract, the Government refuses to allow Subcontractor to perform the NIAID Contract during the Interim Period, or has not acted on the Novation Request within eighteen (18) months from the Effective Date of this Agreement, or refuses to approve the Novation Request under substantially the same terms and conditions in effect at the time of the Closing, Contractor and Subcontractor shall for a period of thirty (30) days consult in good faith on how to proceed.

12.Each Party to this Agreement represents and warrants to the other Party that (a) this Agreement constitutes a valid and binding obligation of such Party, enforceable against it in accordance with its terms and (b) the execution, delivery and performance of this Agreement by such Party will not violate any of its organizational documents or any agreement, judgment, order, decree, or other obligation or legal requirement to which such Party is subject or by which it is bound.

G-3


13.All Federal Acquisition Regulation (“FAR”) clauses set forth or incorporated in the NIAID Contract that are by their terms required to be included in subcontracts are incorporated in this Agreement with the same force and effect as if set forth in full text.  This Agreement will be deemed to incorporate the same version of each FAR clause that is incorporated into the NIAID Contract, and all other clauses required by applicable Law.

14.The Parties agree that a breach of any of the terms, conditions, or other obligations under this Agreement may result in irreparable harm to the non-breaching Party.  The failure of either Party to perform any of the terms, conditions, and obligations established by this Agreement shall give rise to a right in the non-breaching Party to seek enforcement of this Agreement in a court of equity by a decree of specific performance or injunction.  Except as otherwise provided in this Agreement, this remedy shall be cumulative and in addition to any other remedies the Parties may have.

15.This Agreement is governed by and shall be interpreted and enforced in accordance with the laws of the State of California, without reference to its choice of law rules, except that all questions of interpretation of any agency regulation, FAR provision, or applicable federal law shall be interpreted according to the federal common law of government contracts as enunciated and applied by federal boards of contracts appeals and courts.

16.Each Party irrevocably consents and agrees that any action, suit or proceeding (except a dispute arising under Section 10) arising in connection with this Agreement (for purposes of this Section 16, a “Legal Dispute”) shall be subject to the exclusive jurisdiction of the courts of the State of California or the federal courts located therein and consents to personal jurisdiction within the courts of the State of California or the federal courts located therein.  Each Party waives, and agrees not to assert, as a defense in any Legal Dispute, that it is not subject to the jurisdiction of the courts of the State of California or the federal courts located therein.  Each Party agrees that a final judgment in any action, suit or proceeding described in this Section 16 after the expiration of any period permitted for appeal and subject to any stay during appeal shall be conclusive and may be enforced in other jurisdictions.

17.Subcontractor’s relationship with Contractor will be that of an independent contractor and nothing in this Agreement should be construed to create a partnership, agency, joint venture, or employer-employee relationship.

18.Neither this Agreement nor any interest herein may be assigned by Subcontractor, in whole or in part, without the prior written consent of Contractor (such consent not to be unreasonably withheld, conditioned or delayed), other than to an Affiliate of Subcontractor that assumes Subcontractor’s obligations under this Agreement, in which case no consent of Contractor would be required.

19.This Agreement and the Purchase Agreement, together with the schedules and attachments annexed thereto, constitute the entire agreement between the Parties with respect to the subject matter hereof and supersede all past contracts, representations, and agreements with respect to the subject matter of this Agreement.  This Agreement will not be deemed or construed to be modified, amended, rescinded, canceled or waived in whole or in part except by written amendment that refers specifically to the applicable section(s) of this Agreement and that is signed by the Parties and, to the extent necessary, approved by the Government.

G-4


20.Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid.  If any provision of this Agreement is found invalid, such provision will be ineffective only to the extent of such invalidity, without invalidating the remainder of this Agreement.

21.The Parties may execute this Agreement in counterparts, including electronic mail/PDF or other electronic counterparts, each of which shall be an original and all of which together shall constitute one and the same instrument.

22.This Agreement shall be binding upon and inure solely to the benefit of the Parties and permitted successors and assigns, and nothing in this Agreement is intended to confer upon any other person any rights or remedies of any nature.

23.The failure of a Party to exercise any right or remedy shall not be deemed to constitute a waiver of such right or remedy in the future.  No waiver shall be deemed to constitute a waiver of any other provision, nor shall any waiver constitute a continuing waiver unless otherwise expressly provided.

[The next page is the signature page.]


G-5


IN WITNESS WHEREOF, the Parties have duly executed this Agreement as of the Effective Date.

 

SUBCONTRACTOR:

 

Nanotherapeutics, Inc.

 

By:

 

 

Name:

 

 

Title:

 

 

 

CONTRACTOR:

 

XOMA (US) LLC

 

By:

 

 

Name:

 

 

Title:

 

 

 

 

G-6


 

Exhibit A

 

 

G-7

 


 

Exhibit H

SAFC AUTHORIZATION LETTER

XOMA (US) LLC (“XOMA”) hereby authorizes SAFC BIOSCIENCES, INC. to supply the materials listed in Annex A (“Materials”) hereto below to NANOTHERAPEUTICS, INC. (“Nanotherapeutics”) for use by Nanotherapeutics solely to the extent permitted by, and subject to the confidentiality obligations of, the Asset Purchase Agreement entered into by and between Nanotherapeutics and XOMA effective as of November 4, 2015.

 

XOMA (US) LLC

 

 

 

 

 

 

 

By:

 

 

 

 

Name:

 

 

 

 

Title:

 

 

 

 

Date:

 

 

 

 

 

Acknowledged and Agreed

 

 

 

 

 

 

 

NANOTHERAPEUTICS, INC.

 

 

 

 

 

 

 

By:

 

 

By:

 

Name:

 

 

Name:

 

Title:

 

 

Title:

 

Date:

 

 

Date:

 

 

SAFC BIOSCIENCES, INC.

 

 

 

 

 

 

 

By:

 

 

 

 

Name:

 

 

 

 

Title:

 

 

 

 

Date:

 

 

 

 

 


H - 1


Annex A

Cell Culture Media & Feed for XOMA 089

 

Material

Characteristic

Supplier

Product Number

 

XJEM Medium

Powder/ Granular

SAFC

68294C

XJEM Feed

( without NaCL)

Granular Powder

SAFC

68293C

XS 11  Feed

Powder

SAFC

68133C

 

 

 

H- 2


 

Exhibit I

GIBCO AUTHORIZATION LETTER

XOMA (US) LLC (“XOMA”) hereby authorizes THERMOFISHER SCIENTIFIC INC. to supply the materials listed in Annex A (“Materials”) hereto below to NANOTHERAPEUTICS, INC. (“Nanotherapeutics”) for use by Nanotherapeutics solely to the extent permitted by, and subject to the confidentiality obligations of, the Asset Purchase Agreement entered into by and between Nanotherapeutics and XOMA effective as of November 4, 2015.

 

 

XOMA (US) LLC

 

 

 

 

 

 

 

By:

 

 

 

 

Name:

 

 

 

 

Title:

 

 

 

 

Date:

 

 

 

 

 

Acknowledged and Agreed

 

 

 

 

 

 

 

NANOTHERAPEUTICS, INC.

 

 

 

 

 

 

 

By:

 

 

By:

 

Name:

 

 

Name:

 

Title:

 

 

Title:

 

Date:

 

 

Date:

 

 

THERMOFISHER SCIENTIFIC INC.

 

 

 

 

 

 

 

By:

 

 

 

 

Name:

 

 

 

 

Title:

 

 

 

 

Date:

 

 

 

 

 


I - 1


Annex A

Cell Culture Media & Feed for XOMA 089

 

Material

Characteristic

Supplier

Product Number

 

XPM -6 AGT Medium

Powder

GIBCO

A15064

 

 

 

I - 2

 


 

Exhibit J

TRANSITION SERVICES AGREEMENT

This TRANSITION SERVICES AGREEMENT (this “Agreement”) is dated as of [______] [__], 2015, by and between XOMA (US) LLC, a Delaware limited liability company (the “Seller”) and Nanotherapeutics, Inc., a Delaware corporation (the “Buyer”).

RECITALS

WHEREAS, as set forth in the Asset Purchase Agreement, dated November 4, 2015, between Buyer and Seller (the “Purchase Agreement”), Buyer has agreed to purchase from Seller and Seller has agreed to sell, transfer, assign and deliver to Buyer the Purchased Assets (as such term and each other capitalized term used herein without definition is defined in the Purchase Agreement) against delivery of the Purchase Price set forth in the Purchase Agreement;

WHEREAS, the Purchase Agreement provides that Seller shall enter into a transition services agreement with Buyer pursuant to which Seller shall provide certain transitional services to Buyer with respect to the BOT Business following the Closing Date for a limited period of time to facilitate the transfer of the Purchased Assets; and

WHEREAS, the parties desire hereby to set forth the terms and conditions upon which Seller shall provide such services to Buyer.

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereby agree as follows:

1.Provision of Services; Standard of Performance.

1.1Commencing on the date hereof, Seller shall provide or, cause one or more of its Affiliates or third parties to provide to Buyer the services (each, a “Service” and collectively, the “Services”) specified on an applicable service schedule or schedules attached hereto as Exhibit A, (each such schedule, a “Service Schedule”) for the period of time specified thereon, unless a Service is earlier terminated or extended in accordance with the terms hereof.  Each Service shall become subject to this Agreement upon execution of a Service Schedule related thereto.  With respect to each Service to be performed by Seller hereunder, the parties shall set forth the following information in the applicable Service Schedule: (i) the time period during which the Service will be provided; (ii) a summary and description of the Service to be provided; (iii) the Fees (as defined in Section 2.1), or estimated Fees, if any, for the Service; and (iv) any other terms applicable thereto or such other information with respect to the Service as the parties may agree.

1.2Unless a different Performance Standard (as defined in Section 1.4) is set forth in the applicable Service Schedule, Seller agrees to use commercially reasonable efforts to provide Services in substantially the same manner and at substantially the same level as such Services were performed by Seller and/or its Affiliates for the BOT Business immediately prior to the date hereof.

J - 1


 

1.3The Services shall be used by Buyer only for the purposes of conducting the BOT Business and operating the Purchased Assets substantially in the manner that they were conducted and operated, or proposed to be conducted or operated by Seller immediately prior to the Closing Date, and shall not be used for any other purposes, except as may be otherwise agreed to by Seller in writing.  Unless otherwise mutually agreed by the parties, with respect to any Service, Seller shall not be required to provide a level of service which is higher than the level of service provided by Seller with respect to the BOT Business or the Purchased Assets as of the Closing Date.

1.4Seller shall provide to Buyer a monthly report setting forth the Services performed during the preceding month with reference to any performance standards described on any Service Schedule (the “Performance Standards”) and containing such additional information as may, from time to time, be reasonably requested by Buyer with respect to any Additional Services (as defined in Section 3.3 below).

1.5Seller shall use commercially reasonable efforts to provide to Buyer reasonable notice of any scheduled interference with Seller’s operating or other systems, including downtime for network maintenance, which is reasonably likely to interrupt the performance of or the availability of equipment necessary for the provision of any Service.

2.Payment.

2.1Buyer shall pay each month to Seller the fee specified for each Service rendered during such month as set forth on the applicable Service Schedule (the “Fees”).

2.2On the last day of each calendar month, Seller shall invoice all Fees owed by Buyer for the Services provided for such month.  Unless contesting in good faith the Fees set forth on the invoice, Buyer shall pay such Fees within thirty (30) days of receipt of the invoice by check drawn on good funds or wire transfer of immediately available funds.  The invoice shall be accompanied by reasonable documentation supporting such Fees owed and shall set forth the Services or Additional Services provided, the Fees payable for each Service or Additional Service and invoices for Services provided by Seller’s Affiliates or third parties, if any.

2.3Seller shall notify Buyer of any payment obligations with respect to payroll, accounts payable, royalty and other payments, as applicable, owing from week to week by Buyer, if any.  Buyer shall within ten (10) days of receipt of the notice remit to Seller, by check drawn on good funds or wire transfer of immediately available funds, an amount equal to the total amount of Buyer’s obligations (from week to week) as specified by Seller to Buyer.

2.4Except as provided in the applicable Service Schedule for a specific Service, Seller shall not be obligated to: (i) hire any additional employees or create new or additional employee or independent contractor positions; (ii) maintain the employment of any specific employee; (iii) purchase, lease, license or otherwise acquire any new or additional assets, equipment or software; (iv) pay any costs related to the transfer or

J - 2


 

conversion of Buyer’s data to Seller or to any alternate supplier of Services after the term; (v) engage any alternate supplier of Services; or (vi) modify, alter or amend any existing Seller specifications and policies, in order to perform or complete performance of any Service.  Any such costs incurred by Seller to take any of the above actions at the request of Buyer in connection with the performance of any Service shall be borne by Buyer, except as set forth on the applicable Service Schedule, and shall be invoiced as Fees pursuant to Section 2.2.

2.5In the event that the provision of the Services or the relationship created between the parties hereunder gives rise to any Tax (other than a Tax based on income), such Tax shall be the responsibility of Buyer.

3.Term; Addition and Reduction of Services.

3.1Subject to the terms of this Section 3 and of Section 7, the provision of the Services shall commence on the date hereof and, with respect to each Service, shall terminate upon one (1) year from the Closing Date, unless a different period is set forth on the applicable Service Schedule.

3.2Buyer may terminate any Service by giving thirty (30) days’ prior written notice to Seller.  Any requested termination of a Service pursuant to this Section 3.2 shall become effective at the end of such thirty (30) day notice period.  Seller shall thereafter no longer be obligated to provide such Service and Buyer shall thereafter no longer be obligated to pay for such Service (except with respect to any Fees incurred up to such date).  The applicable Service Schedule shall thereafter be amended to reflect the termination of the Service.

3.3If Buyer desires to extend the term of any Service (or any part thereof) or add any additional service (collectively, the “Additional Services”) arising out of or relating to the Services, Buyer shall give Seller thirty (30) days’ prior written notice, which notice shall include reasonable details relating to such request.  Seller shall not have any obligation to extend any term or provide any Additional Service.  Upon execution of such amendment or new Service Schedule, any Additional Service shall be deemed to be a “Service” for all purposes hereunder.

3.4Seller shall reduce the quantity of any Service provided hereunder upon thirty (30) days’ prior written notice from Buyer.  Any requested reduction of a Service pursuant to this Section 3.4 shall become effective at the end of such thirty (30) day notice period.  The Fees payable with respect to such Service shall be reduced proportionately in accordance with the fee schedule set forth on the applicable Service Schedule with respect to such Service, provided that Buyer shall be obligated to reimburse Seller for any reasonable out-of-pocket expenses or costs attributable to such reduction.  The applicable Service Schedule shall thereafter be amended to reflect the reduction of such Service.

J - 3


 

3.5Seller shall not be required to provide any of the Services to the extent that the performance of such Services becomes materially more expensive for Seller unless Buyer agrees to pay for the additional cost.

4.Cooperation; Records; Access.

4.1The parties agree to fully cooperate in good faith with each other in connection with the provision of the Services and the matters related to or arising hereunder, including, without limitation, Seller’s cooperation with Buyer to enable Buyer to establish its own infrastructure to perform the Services independently of Seller as soon as practicable after the Closing Date; provided, however, that nothing in this Section 4 or elsewhere in this Agreement shall require Seller to incur any out-of-pocket cost in connection with rendering its cooperation to Buyer as hereby contemplated.

4.2Each of the parties shall create and maintain full and accurate books in connection with the provision of the Services.  For a period of no less than two (2) years following the expiration or earlier termination of this Agreement, the parties will maintain, in accordance with their standard document retention procedures, documentation supporting the information relevant to cost calculations contained in the Service Schedules and cooperate with each other in making such information available as needed in the event of a U.S. Tax audit.

4.3Subject to Buyer’s third party confidentiality and data protection obligations, Buyer shall make available during regular business hours (or otherwise upon reasonable prior notice) to Seller or its agents (i) all personnel designated by Buyer to receive or oversee the Services; and (ii) all books and records maintained by Buyer in connection with this Agreement and all other information or materials reasonably requested by Seller to facilitate Seller’s performance of this Agreement; provided, however, that any such requests do not unreasonably interfere with the operation of the day-to-day business affairs of Buyer.

4.4Subject to Seller’s third party confidentiality and data protection obligations, Seller shall make available during regular business hours (or otherwise upon reasonable prior notice) to Buyer or its agents (i) all personnel designated by Seller to provide the Services; (ii) all books and records maintained by Seller in connection with this Agreement and all other information or materials reasonably requested by Buyer for the purpose of exercising general oversight and monitoring of the performance of the Services; and (iii) on Seller’s premises, all records that Seller has prepared or maintained in providing the Services in order for Buyer to verify the accuracy of the Fees and the proper performance of Services; provided, however, that any such requests do not unreasonably interfere with the operation of the day-to-day business affairs of Seller.

4.5Each party shall cooperate with and assist the other party in obtaining any third party consents necessary for the performance of the Services, including, without limitation, any required consent under any intellectual property license or real property license or other occupancy agreement.  The out-of-pocket costs and expenses of obtaining any such consents shall be borne by Buyer.  In the event that the parties are unable to obtain any required consent, the parties shall negotiate in good faith reasonable modifications of the Services so that such consents are not required.

J - 4


 

4.6For any work performed on Buyer’s premises, Seller shall comply with all security, confidentiality, safety and health policies of Buyer.  Seller shall take all necessary precautions to prevent, and shall be responsible for, any injury to any Persons (including, without limitation, employees of Buyer) or damage to property (including, without limitation, Buyer’s property) arising from or relating to Seller’s performance of the Services or the use by Seller of any Buyer equipment, tools, facility or other property, whether or not such claim is based upon its condition or on the alleged negligence of Buyer in permitting its use.

5.Management Process.

5.1On the Closing Date, each party shall designate a project manager (a “Project Manager”) to report and discuss issues with respect to the provision of the Services.  The Project Managers shall meet (either in person or by electronic means) to discuss the performance of the Services as often as reasonably necessary to ensure the orderly provision of the Services, and shall have authority to address and remedy problems related to the provision of the Services.  Each party shall designate successor Project Managers in the event that a designated individual is not available to perform such role hereunder.

5.2In the event that any dispute arises under this Agreement, the parties agree to negotiate in good faith to resolve such dispute prior to seeking relief in accordance with Sections 3.10 and/or 3.11 of the Purchase Agreement.  Either party may at any time deliver a notice to the other party that it wishes to refer a dispute to the Project Managers.  Following receipt of such notice, the Project Managers shall negotiate in good faith to resolve such dispute within a period of ten (10) days (or such longer period of time as such Project Managers may agree in writing).  If at the end of such period, the Project Managers have not fully resolved the dispute, the Project Managers shall within ten (10) days appoint one expert satisfactory to both parties to mediate the dispute and shall share equally the costs thereof.  If within twenty (20) days following the appointment of such mediator the parties have not fully resolved the dispute, either party may seek relief in accordance with Sections 3.10 and/or 3.11 of the Purchase Agreement.

6.Intellectual Property.

6.1As used herein, “Work Product” shall include, without limitation, all Intellectual Property Rights (as defined in this Section 6.1) and any related work-in-progress, improvements or modifications to any Intellectual Property Rights that are created, developed or conceived (alone or with others) in connection with the Services. “Intellectual Property Rights” means any invention or discovery, whether patentable or nonpatentable, or copyrightable or non-copyrightable, to the extent that it is conceived or reduced to practice in performing the Services.

6.2Buyer agrees that all Work Product arising during the term of this Agreement (excluding any Confidential Information (as defined in the Confidentiality Agreement) of Buyer) shall be the property of Seller and hereby assigns all its rights in such Work Product and in all related Intellectual Property Rights to Seller.  Buyer

J - 5


 

acknowledges that Seller, in its sole discretion, shall have the right to license such Work Product or any portion thereof, and/or incorporate such Work Product or any portion thereof into products or services, for use by other licensees or customers of Seller.  At Seller’s request and expense, Buyer shall assist and cooperate with Seller in all reasonable respects and shall execute documents, give testimony and take further acts as reasonably requested by Seller to acquire, transfer, maintain and enforce Intellectual Property Rights and other legal protection for such Work Product.

6.3Subject to Buyer’s performance of its obligations hereunder, Seller hereby grants to Buyer a worldwide, non-exclusive, non-transferable license during the term of this Agreement to use, within Buyer’s enterprise only, the Work Product solely for Buyer’s internal business purposes.

6.4Buyer hereby disclaims all warranties of any kind, whether express, implied, statutory or otherwise, with respect to any Confidential Information of Buyer or other information or materials supplied by Buyer to Seller hereunder, including, without limitation, any warranties with respect to any specifications for the Work Product or other deliverables required hereunder.

6.5Except as otherwise expressly provided herein, nothing in this Agreement shall be deemed to grant, directly or by implication, estoppel or otherwise, any right or license with respect to any technology or other Intellectual Property Rights, and each party retains all right, title and interest in and to their respective technologies and other Intellectual Property Rights.

6.6Buyer hereby agrees to comply with all export laws and regulations of the U.S. Department of Commerce and all other U.S. Government Agencies, including, without limitation, the Export Administration Regulations of the U.S. Department of Commerce Bureau of Export Administration, and further agrees not to export, or allow the export or re-export of, any Confidential Information of Seller in violation of such laws and/or regulations, or without all required consents.

7.Termination.

7.1Subject to the terms of this Section 7, this Agreement shall terminate on the date on which the provision of all Services have been terminated pursuant to Section 3.

7.2This Agreement may be terminated by either party in advance of the termination date pursuant to Section 7.1 above:

(a)upon written notice to the other party if the other party shall default in the performance of any of its material obligations under this Agreement and such default shall continue and not be remedied for a period of ten (10) days after receipt of prior written notice stating that a default has occurred;

J - 6


 

(b)upon written notice to the other party if the other party has filed against it any involuntary petition in bankruptcy or similar proceeding seeking its reorganization, liquidation or the appointment of a receiver, trustee or liquidator for all or substantially all of its assets, whereupon such petition shall not be dismissed within sixty (60) days after the filing thereof, or if the other party shall (A) apply for or consent in writing to the appointment of a receiver, trustee or liquidator of all or substantially all of its assets; (B) file a voluntary petition or admit in writing its inability to pay its debts as they become due; (C) make a general assignment for the benefit of creditors; (D) file a petition or an answer seeking reorganization or an arrangement with creditors or take advantage of any insolvency law; or (E) file an answer admitting the material allegations of a petition filed against it in any bankruptcy, reorganization, insolvency proceedings or similar proceedings; or

(c)upon written notice to the other party if any Force Majeure Event (as defined in Section 9 hereof) occurs and any Services or obligations required to be performed hereunder are interrupted or interfered with for a period in excess of sixty (60) days.

7.3Upon the termination of this Agreement pursuant to this Section 7, Seller shall no longer be obligated to provide any Services and Buyer shall no longer be obligated to pay for any Services (except with respect to any Fees incurred up to the date of such termination).

7.4The provisions of Sections 6.3, 7, 9, 10, and 11 shall survive any termination of this Agreement.

8.Liability.

8.1Subject to Article 11 of the Purchase Agreement, Seller shall, to the extent permitted by law, indemnify and hold harmless Buyer and its agents and Affiliates from and against all Losses incurred or sustained by Buyer where such Losses result from the breach of any representation or covenant contained in this Agreement by Seller.  Seller’s aggregate liability to Buyer for Losses in connection with this Agreement shall not exceed the aggregate Fees paid by Buyer to Seller pursuant to this Agreement.  Except as provided above, Seller shall have no liability whatsoever to Buyer for any error, act or omission in connection with the Services to be rendered hereunder, and Seller’s sole responsibility to Buyer with respect to the Services shall be as follows:  (i) in the event of Seller’s error or omission in connection with the Services, to furnish correct information and to provide any necessary adjustment in the Services at no additional cost or expense to Buyer; and (ii) in the event of Seller’s failure to deliver any Service because of a Force Majeure Event, to use reasonable efforts, to make the Services available and/or to resume performing the Services as promptly as reasonably practicable.

8.2Subject to Article 11 of the Purchase Agreement, Buyer shall, to the extent permitted by law, indemnify and hold harmless Seller and its agents and Affiliates from and against all Losses incurred or sustained by Seller where such Losses result from the breach of any representation or covenant contained in this Agreement by Buyer.

J - 7


 

8.3Notwithstanding anything contained herein to the contrary, neither party shall have any liability to the other party hereunder for compensatory, punitive, special, incidental or consequential Losses (including loss of profits), regardless of the circumstances under which such Losses arose, even if advised of the possibility of such Losses.

9.Force Majeure.  Neither party shall be liable for any delay or failure to perform any obligations (other than payment obligations) hereunder resulting from any cause, condition or event beyond the reasonable control of the party affected, including, but not limited to, acts of God, fire, flood, earthquake, war, terrorism, riot, government action, strike, labor trouble or shortage, curtailment of business (including scheduled or unscheduled shutdowns of any manufacturing facility) or inability to obtain material, utilities, equipment or transportation (a “Force Majeure Event”).  The party claiming the benefit of this provision shall promptly notify the other party of a Force Majeure Event and attempt in good faith to resume performance as soon as commercially reasonable.  Neither party shall be obligated to settle a dispute or otherwise take any action which is not commercially reasonable to terminate a Force Majeure Event.

10.Confidential Information.

10.1Without the prior written consent of the other party, each party agrees not to (i) disclose Confidential Information to any third party or (ii) use any Confidential Information except as necessary to perform its obligations under this Agreement.  Any Confidential Information disclosed prior to the date hereof shall be protected by the terms of this Section 10.  Each party shall use no less than reasonable care in protecting any Confidential Information received.  Each party is and shall remain the sole owner of all right, title and interest in and to its respective Confidential Information.  Neither party shall possess any right, title or interest in or any lien on Confidential Information of the other party.  All Confidential Information disclosed hereunder shall be on an “AS IS” basis with no warranties, express or implied.

10.2Each party shall limit disclosure of Confidential Information to its agents and Affiliates who have a bona fide need for Confidential Information to carry out the purposes of this Agreement and who have agreed to observe the terms of this Section 10. Each party shall be responsible for any breaches of this Section 10 by its agents and Affiliates.  Seller agrees to consult with Buyer and to use commercially reasonable efforts to put in place adequate procedures and make appropriate personnel assignments, in each case as of the Closing Date, in order to ensure that Confidential Information of Buyer is not used by Seller for the benefit of its business or otherwise misused.

10.3Upon the earlier to occur of (i) the termination of this Agreement, (ii) such time as any Confidential Information ceases to be required by the party receiving such Confidential Information to perform or receive the Services or (iii) a reasonable request of a party, all Confidential Information of a party (and any copies thereof) shall be returned to that party and any such Confidential Information of a party (and any copies thereof) stored in computer or other electronic archival systems shall be deleted or erased, in each case within fifteen (15) days following such termination or request.  Upon the request of a party, the other party shall certify in writing that all such Confidential Information has been returned or destroyed.

J - 8


 

11.Licenses, Permits and Third Party Consents.  Each party shall obtain and maintain all permits, approvals and licenses and other applicable Governmental Orders, and shall obtain any third party consents, necessary or appropriate to perform its obligations hereunder and shall at all times comply with the terms and conditions of such permits, approvals and licenses or consents.  Unless otherwise provided in the applicable Service Schedule, the costs of obtaining any permits, approvals, licenses, sublicenses or approvals and third party consents, shall be borne by Seller.

12.Independent Contractor.  Each of Buyer and Seller shall be an independent contractor in the performance of its respective obligations hereunder.  Nothing in this Agreement shall create or be deemed to create a partnership, joint venture or a relationship of principal and agent or of employer and employee between Buyer and Seller, or between any of the agents, contractors or suppliers of Buyer, on the one hand, and of Seller, on the other hand.

13.Notices.  Any notices authorized to be given hereunder shall be in writing and deemed given, if delivered personally or by overnight courier, on the date of delivery if a Business Day, or if not a Business Day, on the first Business Day following delivery, or if mailed, three days after mailing by registered or certified mail, return receipt requested, and in each case, addressed, as follows:

If to Buyer to:

with a copy to:

Nanotherapeutics, Inc. 


Attn:  James Talton


13859 Progress Blvd, Suite 300

Alachua, FL 32615


Telephone:  386-462-9663

Nanotherapeutics, Inc. 


Attn:  Andy Cziotka, Esq.


13859 Progress Blvd, Suite 300


Alachua, FL 32615

Telephone:  386-462-9663

If to Seller to:

with a copy to:

XOMA (US) LLC

c/o XOMA Corporation

2910 Seventh Street

Berkeley, CA 94710


Attn:  General Counsel

Telephone:  (510) 204-7200


Morrison & Foerster LLP

425 Market Street


San Francisco, CA 94105


Attn:  Van W. Ellis

Telephone:  (202) 887-8776

 

or if delivered by telecopier, on a Business Day before 5:30 PM local time of addressee on transmission confirmed electronically, or if at any other time or day, on the first Business Day succeeding transmission confirmed electronically, to the facsimile numbers provided above or to such other address or telecopy number as any party shall specify to the other pursuant to the foregoing notice provisions.

J - 9


 

14.Severability.  No invalidity or unenforceability of any section of this Agreement or any portion thereof shall affect the validity or enforceability of any other section or the remainder of such section.

15.Counterparts.  This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, and all of which together shall constitute one and the same instrument.

5.Governing Law.  This Agreement shall be governed by and construed in accordance with the laws of the State of California without giving effect to any choice or conflict of law provision or rule (whether the State of California or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of California.  Any controversy or claim arising out of or relating to this Agreement shall be settled in accordance with the applicable provisions of the Purchase Agreement.

16.Succession; Third Party Beneficiaries.  This Agreement shall be binding upon and inure to the benefit of the parties named herein and their respective successors and permitted assigns.  Nothing herein, express or implied, is intended to or shall confer upon any other Person any legal or equitable right, benefit or remedy of any nature under this Agreement.

17.Assignment.  No party may assign either this Agreement or any of its rights, interests or obligations hereunder without the prior written approval of the other party, which approval shall not be unreasonably withheld; provided, however, that Seller may (i) assign any or all of its rights and interests hereunder to one or more of its Affiliates and (ii) designate one or more of its Affiliates or another third party to perform its obligations hereunder (in any or all of which cases Seller nonetheless shall remain responsible for the performance of all of its obligations hereunder).

18.Entire Agreement; Amendment.  This Agreement, together with the Purchase Agreement and the other Ancillary Agreements, constitutes the entire understanding and agreement between the parties hereto and supersedes any and all written or oral, prior or contemporaneous representations, understandings and agreements between or among Buyer and Seller with respect to the subject matter hereof, all of which are merged herein and therein.  This Agreement may not be canceled, altered, modified, amended or waived, in whole or in part, in any way, except by an instrument in writing signed by all of the parties hereto.  All amendments or modifications of this Agreement shall be binding upon the parties even in the absence of consideration so long as the same shall be in writing and executed by the parties hereto.

19.Controlling Agreement.  In the event of a conflict between the terms and conditions set forth in this Agreement and the terms and conditions set forth in the Purchase Agreement, or the interpretation and application thereof, the terms and conditions set forth in the Purchase Agreement shall prevail, govern and control in all respects.

J - 10


 

20.Disclaimer.  EXCEPT AS OTHERWISE EXPRESSLY PROVIDED HEREIN, SELLER MAKES NO WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY, AS TO THE SERVICES, INCLUDING, WITHOUT LIMITATION, THE ACCURACY OF THE SERVICES OR THEIR SUITABILITY FOR THE BUSINESS, AND SELLER HEREBY EXPRESSLY DISCLAIMS ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE AND NON-INFRINGEMENT OF THIRD PARTY RIGHTS AND TITLE.

21.Contractual Statute of Limitations.  Except for actions for nonpayment or breach of Buyer’s proprietary rights in the Work Product, no action, regardless of form, arising out of this Agreement may be brought by either party more than two (2) years after the cause of action has accrued.

[Remainder of page intentionally left blank]

 

 

J - 11


 

IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first above written.

 

 

 

NANOTHERAPEUTICS, INC.

 

 

 

 

 

 

 

By:

 

 

 

 

Name:

 

 

 

 

Title:

 

 

 

 

 

 

 

 

 

XOMA (US) LLC

 

 

 

 

 

 

 

 

By:

 

 

 

 

Name:

 

 

 

 

Title:

 

 

 

 

J - 12


 

EXHIBIT A

Form of Service Schedule __ to Transition Services Agreement

1.Schedule #:                                (To be inserted by responsible individual or department.)  

2.Functional Area:                               

3.Start/End Date:  The Services start on the Closing Date of the Transition Services Agreement between Seller and Buyer to which this Service Schedule is attached and end after a period of [________] from such Closing Date, unless otherwise indicated below.  

Indicate below if alternate start/end date:

Start Date:                                

End Date:                                    

If Start and End dates vary by Service [and/or country], please indicate in Section 5.

4.Summary of Services:  (Describe the Service to be provided in appropriate detail.)  

Service Name

Description

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5.Performance Standards:  (State minimum performance expected for each Service, if applicable.)

6.Estimated Total Fees:  (Attach separate Fee schedule as appropriate.)

7.Describe the process by which the cost of the Services and the Fees will be adjusted in case of an increase/decrease in the Services provided: (Describe on an individual service basis if necessary).

Upon execution of this Service Schedule by both parties, it shall be deemed incorporated into and made part of that certain Transitional Services Agreement.

 

NANOTHERAPEUTICS INC., Buyer,

XOMA (US) LLC, Seller

 

 

By:

 

 

By:

 

 

 

(Authorized Signature)

 

 

 

(Authorized Signature)

Date:

 

 

Date:

 

 

Name:

 

 

Name:

 

 

Title:

 

 

Title:

 

 

Address:

 

 

Address:

 

 

 

 

J - 13


 

Schedule 1.1

 

Permitted Encumbrances

 

None


Schedule 1.1 - 1


Physical Assets

 

 

Eight (8) computers and the desks and chairs located on the date hereof in the space covered by the Warehouse License Agreement.


Schedule 1.1 - 2

 


Products

GMP/Non-GMP

 

NX02

 

NX01

 

XC44

 

XB23

 

NX11

 

XC41

 

XC84

 

XC42

 

XE06

 

XE02

 

XB10

 

XE17

 

XB18

 

XOMA 3B

 

XOMA 3E

 

XOMA 3AB

 

Non-GMP

 

XOMA 4CD

 

XOMA ABE

 

Critical Reports

 

“Domains”

 

“Derivatives of domains” (BioAnalytical/Analytical Development; Modified for use)

 

“All domains and derivatives generally used for these products”

 

 

 

 

Schedule 1.1 - 3

 


 

Precursor Materials

Antibody

MCB vials

WCB vials

NX01

100

100

NX02

100

100

NX11

100

100

XB10

100

100

XB18

100

100

XB23

100

0 (not produced)

XE02

100

100

XE06

100

100

XE17

100

100

XC41

100

0 (not produced)

XC42

100

0 (not produced)

XC44

100

0 (not produced)

XC84

100

0 (not produced)

 

XOMA 4CD Bioanalytical Reagent Inventory List

 

Serum Drug Concentration Assay

 

 

 

Reagent

Lot No

Conc.

Quantity

Comments

4C4 Domain

020415

1.11 mg/mL

24 mg

Unlabel domain

4C10 Domain

030415

1.67 mg/mL

35 mg

Unlabel domain

8DC4 M8V6 Domain

Exp-15-CAO527

1.53 mg/mL

63 mg

Unlabel domain

Anti-Id XC42

 

 

 

Producing at Antibody Solutions. Available Nov to Dec. 2015

b-4C4 domain

R-LC20150521B

310 µg/mL

2.8 mg

Biotinylated domain for SDC assay

ru-4C4 domain

R-LC20150521A

308 µg/mL

2.8 mg

Ruthenylated domain for SDC assay

b-4C10 domain

R-LC20150511C

316 µg/mL

2.8 mg

Biotinylated domain for SDC assay

ru-4C10 domain

R-LC20150511D

311 µg/mL

2.2 mg

Ruthenylated domain for SDC assay

b-8DC4 M8V6 domain

R-LC20150612D

258 µg/mL

0.9 mg

Biotinylated domain for SDC assay

ru-8DC4 M8V6 domain

R-LC20150612C

282 µg/mL

1.0 mg

Ruthenylated domain for SDC assay

 

 

 

 

 

Immunogenicity Assay

 

 

 

 

Reagent

Lot No

Conc.

Quantity

Comments

Rabbit Ig purified Ab (XC41)

PR150811A

1.05 mg/mL

29 mg

ADA for positive control

Rabbit Ig purified Ab (XC42)

PR150811B

0.964 mg/mL

38 mg

ADA for positive control

Rabbit Ig purified Ab (XC44)

PR150811C

1.01 mg/mL

66 mg

ADA for positive control

Rabbit Ig purified Ab (XC84)

PR150811D

1.56 mg/mL

49 mg

ADA for positive control

Reagent

Lot No

Conc.

Quantity

Comments

ru-XC41

R-JC20150929A

198 µg/mL

1.9 mg

Drug labeling for ADA assay

Schedule 1.1 - 4


 

ru-XC42

R-JC20150929B

209 µg/mL

2.0 mg

Drug labeling for ADA assay

ru-XC44

R-JC20150929C

182 µg/mL

1.8 mg

Drug labeling for ADA assay

ru-XC84

R-JC20150929D

201 µg/mL

2.0 mg

Drug labeling for ADA assay

b-XC41

R-JC20150930A

194 µg/mL

1.9 mg

Drug labeling for ADA assay

b-XC42

R-JC20150930B

201 µg/mL

2.0 mg

Drug labeling for ADA assay

b-XC44

R-JC20150930C

204 µg/mL

2.0 mg

Drug labeling for ADA assay

b-XC84

R-JC20150930D

211 µg/mL

2.1 mg

Drug labeling for ADA assay

 

 

 

Schedule 1.1 - 5

 


 

Product Inventory

 

 

Description

P/N

L/N

Building

Freezer

Shelf/Box

MCB

WCB

Date Stored

Vials

Released

Quarantined

NX02

103350

1662204

X4

XC06292

3B

 

X

12/5/2005

46

X

 

NX02

103350

1662204

X4

XC06292

3C

 

X

12/5/2005

58

X

 

NX02

103338

1652380

X4

XC06292

3F

X

 

11/17/2005

48

X

 

NX02

103338

1652380

X4

XC06292

3G

X

 

11/17/2005

45

X

 

NX01

103349

1661858

X4

XC06292

4B

 

X

11/30/2005

83

X

 

NX01

103349

1661858

X4

XC06292

4C

 

X

11/30/2005

19

X

 

NX01

103337

1652483

X4

XC06292

4F

X

 

11/18/2005

86

X

 

NX01

103337

1652483

X4

XC06292

4G

X

 

11/18/2005

20

X

 

XC44

103832

NN10500

X4

XC06292

5B

X

 

7/31/2013

81

X

 

XC44

103832

NN10500

X4

XC06292

5C

X

 

7/31/2013

48

X

 

XB23

103804

NK10500

X4

XC06292

5E

X

 

1/17/2012

53

X

 

XB23

103804

NK10500

X4

XC06292

5F

X

 

1/17/2012

67

X

 

NX11

103339

1732062

X4

XC06292

5G

X

 

2/8/2006

47

X

 

NX11

103351

1748206

X4

XC06292

5H

 

X

2/23/2006

57

X

 

XC44

103832

NN10500

X4

XC06292

5J

X

 

7/31/2013

79

X

 

XC41

103889

NS10501

X4

XC06292

6B

X

 

7/22/2014

79

 

X

XC41

103889

NS10501

X4

XC06292

6C

X

 

7/22/2014

80

 

X

XC41

103889

NS10501

X4

XC06292

6D

X

 

7/22/2014

55

 

X

XC84

103869

NQ10500

X4

XC06292

6H

X

 

4/29/2014

60

 

X

XC84

103869

NQ10500

X4

XC06292

6I

X

 

4/29/2014

76

 

X

XC84

103869

NQ10500

X4

XC06292

6J

X

 

4/29/2014

65

 

X

XC42

103848

NP10500

X4

XC06292

7B

X

 

9/12/2013

65

X

 

XC42

103848

NP10500

X4

XC06292

7C

X

 

9/12/2013

68

X

 

XE06

103782

NJ10500

X4

XC06292

7D

X

 

5/26/2011

70

X

 

XE06

103782

NJ10500

X4

XC06292

7E

X

 

5/26/2011

55

X

 

Schedule 1.1 - 6


 

Description

P/N

L/N

Building

Freezer

Shelf/Box

MCB

WCB

Date Stored

Vials

Released

Quarantined

XE06

103783

NJ10501

X4

XC06292

7G

 

X

6/14/2011

81

X

 

XE06

103783

NJ10501

X4

XC06292

7H

 

X

6/14/2011

58

X

 

XC42

103848

NP10500

X4

XC06292

7I

X

 

9/12/2013

79

X

 

XE02

103758

NH10502

X4

XC06292

8C

 

X

2/12/2011

71

X

 

XE02

103758

NH10502

X4

XC06292

8D

 

X

2/12/2011

80

X

 

XE02

103759

NH10501

X4

XC06292

8F

X

 

2/1/2011

68

X

 

XE02

103759

NH10501

X4

XC06292

8G

X

 

2/1/2011

81

X

 

XB10

103714

NE10500

X4

XC06292

10C

X

 

3/20/2010

81

X

 

XB10

103714

NE10500

X4

XC06292

10D

X

 

3/20/2010

70

X

 

XB10

103716

NE10501

X4

XC06292

10G

 

X

4/6/2010

78

X

 

XB10

103716

NE10501

X4

XC06292

10H

 

X

4/6/2010

76

X

 

XE17

103740

NG10500

X4

XC06292

11B

X

 

9/14/2010

81

X

 

XE17

103740

NG10500

X4

XC06292

11C

X

 

9/14/2010

31

X

 

XE17

103741

NG10501

X4

XC06292

11E

 

X

10/12/2010

66

X

 

XE17

103741

NG10501

X4

XC06292

11F

 

X

10/12/2010

81

X

 

XB18

103722

NF10500

X4

XC06292

12C

X

 

6/29/2010

80

X

 

XB18

103722

NF10500

X4

XC06292

12D

X

 

6/29/2010

71

X

 

XB18

103721

NF10501

X4

XC06292

12F

 

X

7/17/2010

77

X

 

XB18

103721

NF10501

X4

XC06292

12G

 

X

7/17/2010

75

X

 

NX11

103351

1748206

X5

XC08765

6C

 

X

2/23/2006

47

X

 

XB23

103804

NK10500

X5

XC08765

6D

X

 

1/17/2012

31

X

 

NX11

103339

1732062

X5

XC08765

6E

X

 

2/8/2006

59

X

 

XE06

103782

NJ10500

X5

XC08765

1A

X

 

5/26/2011

31

X

 

XE06

103783

NJ10501

X5

XC08765

1B

 

X

6/14/2011

72

X

 

XB10

103714

NE10500

X5

XC08765

8C

X

 

3/20/2010

6

X

 

XB10

103716

NE10501

X5

XC08765

8D

 

X

4/6/2010

43

X

 

XB18

103722

NF10500

X5

XC08765

8E

X

 

6/29/2010

3

X

 

XB18

103721

NF10501

X5

XC08765

8F

 

X

7/17/2010

58

X

 

XE17

103740

NG10500

X5

XC08765

8G

X

 

9/14/2010

45

X

 

Schedule 1.1 - 7

 


 

Description

P/N

L/N

Building

Freezer

Shelf/Box

MCB

WCB

Date Stored

Vials

Released

Quarantined

XE17

103741

NG10501

X5

XC08765

8H

 

X

10/12/2010

56

X

 

XE02

103759

NH10501

X5

XC08765

8I

X

 

2/1/2011

8

X

 

XE02

103758

NH10502

X5

XC08765

8J

 

X

2/12/2011

48

X

 

 

 

 

Schedule 1.1 - 8

 


 

Transferred Contracts

 

Master Project Agreement, effective as of July 12, 2010, by and between Fisher BioServices, Inc. and XOMA (US) LLC

Lease Agreement, effective as of September 21, 2010, by and between Thermo Fisher Financial Services, Inc. and XOMA (US) LLC

Lease Agreement, effective as of June 24, 2011, by and between Thermo Fisher Financial Services, Inc. and XOMA (US) LLC

Lease Agreement, effective as of January 31, 2012, by and between Thermo Fisher Financial Services, Inc. and XOMA (US) LLC

Commercial Supply Agreement (Cell Culture Media and Reagents), effective as of July 1, 2011, by and between SAFC Inc. and XOMA (US) LLC

Subcontract for Services, effective as of July 12, 2012, by and between SRI International and XOMA (US) LLC

Master Laboratory Services Agreement, effective as of August 3, 2012, by and between Covance Laboratories Inc. and Covance Bioanalytical Services LLC, and XOMA (US) LLC

 

Amended and Restated Laboratory Services and Confidentiality Agreement, effective as of March 1, 2015, by and between Charles River Laboratories, Inc. and XOMA (US) LLC

 

XOMA License Agreements

License Agreement for Anti-Botulinum Neurotoxin Antibodies, UC Case Nos. SF98‑A13, SF05‑A14, SF07‑080, effective as of December 10, 2007, by and between The Regents of the University of California and XOMA Technology Ltd.

First Amendment to Exclusive License Agreement for Anti-Botulinum Neurotoxin Antibodies, UC Case Nos. SF98‑A13, SF05‑A14, SF07‑080, effective as of October 7, 2008, by and between The Regents of the University of California and XOMA Technology Ltd.

Second Amendment to Exclusive License Agreement for Anti-Botulinum Neurotoxin Antibodies, UC Case Nos. SF98‑A13, SF05‑A14, SF07‑080, effective as of September 13, 2011, by and between The Regents of the University of California and XOMA Technology Ltd.

Third Amendment to Exclusive License Agreement for Anti-Botulinum Neurotoxin Antibodies, UC Case Nos. SF98‑A13, SF05‑A14, SF07‑080, SF09‑140, effective as of August 23, 2012, by and between The Regents of the University of California and XOMA Technology Ltd.

Schedule 1.1 - 9


Fourth Amendment to Exclusive License Agreement for Anti-Botulinum Neurotoxin Antibodies, UC Case Nos. SF98‑A13, SF05‑A14, SF07‑080, SF09‑140 effective as of April 15, 2013, by and between The Regents of the University of California and XOMA Technology Ltd.

 

Fifth Amendment to Exclusive License Agreement for Anti-Botulinum Neurotoxin Antibodies, UC Case Nos. SF98‑A13, SF05‑A14, SF07‑080, SF09‑140, effective as of July 1, 2015, by and between The Regents of the University of California and XOMA Technology Ltd.

 

U.S. Government Contracts

Contract No. HHSN272201100031C, effective as of September 30, 2011 (“Contract No. HHSN272201100031C”), by and between the National Institutes of Health, National Institute of Allergy and Infectious Diseases and XOMA (US) LLC

Amendment 1 to Contract No. HHSN272201100031C, effective as of March 15, 2013, by and between the National Institutes of Health, National Institute of Allergy and Infectious Diseases and XOMA (US) LLC

Amendment 2 to Contract No. HHSN272201100031C, effective as of December 23, 2013, by and between the National Institutes of Health, National Institute of Allergy and Infectious Diseases and XOMA (US) LLC

Amendment 3 to Contract No. HHSN272201100031C, effective as of January 23, 2014, by and between the National Institutes of Health, National Institute of Allergy and Infectious Diseases and XOMA (US) LLC

Amendment 4 to Contract No. HHSN272201100031C, effective as of February 26, 2014, by and between the National Institutes of Health, National Institute of Allergy and Infectious Diseases and XOMA (US) LLC

Amendment 5 to Contract No. HHSN272201100031C, effective as of February 25, 2015, by and between the National Institutes of Health, National Institute of Allergy and Infectious Diseases and XOMA (US) LLC


Schedule 1.1 - 10

 


XOMA Co-Formulation Patents

1.

Title:

Antibody Coformulations

 

Inventor:

Susan Joyce Babuka, Chin-Yi Huang and Mingxiang Li

 

Assignee:      

XOMA (US) LLC

(Coformulations)

COUNTRY

APPLICATION

FILE DATE

PATENT/PUBLICATION

 

US Provisional

61/240,155

09/04/09

 

 

PCT

PCT/US10/47753

09/02/10

WO 2011/028962 A2

 

US

12/875,083

09/02/10

20110059079 A1

 

US Con

14/705,713

05/06/15

 

 

Europe

10814532.7

09/02/10

2473191 A1

 

 

 

2.

Title:

Anti-Botulism Antibody Coformulations

 

Inventor:

Susan Joyce Babuka, Mingxiang Li

 

Assignee:      

XOMA (US) LLC

(Coformulations BoNT)

COUNTRY

APPLICATION

FILE DATE

PATENT/PUBLICATION

 

US Provisional

61/240,149

04/09/09

 

 

PCT

PCT/US10/47752

09/02/10

WO 2011/028961 A2

 

US

12/875,065

09/02/10

8,821,879 B2

 

 

 


Schedule 1.1 - 11

 


XOMA Vector Patents

 

1.

Title:

Methods and materials for transient expression of a recombinant protein

 

Inventor:

Masahisa Handa, Arnold H. Horwitz, Robyn Cotter, Eddie Bautista

 

Assignee:      

XOMA (US) LLC

  (Transient Expression)

COUNTRY

APPLICATION

FILE DATE

PATENT/PUBLICATION

 

US Provisional

60/633,056

12/03/04

 

 

PCT

PCT/US05/043922

12/05/05

WO 2006/060769

 

US

11/831,691

07/31/07

7,794,976 B2

 

 

 

 

 

 

 

2.

Title:

METHODS AND MATERIALS FOR INCREASING EXPRESSION OF RECOMBINANT POLYPEPTIDES

 

Inventor:

Arnold Horwitz

 

Assignee:      

XOMA (US) LLC

(2 Gene Vector)

COUNTRY

APPLICATION

FILE DATE

PATENT/PUBLICATION

 

US Provisional

60/368,530

03/29/02

 

 

PCT

PCT/US03/010154

03/31/03

WO 04/033693

 

US

10,404,724

03/31/03

7,192,737 B2

 

US

11/673,539

02/09/07

7,993,915 B2

 

US

13/205,448

08/08/11

8,497,096 B2

 

Australia

2003 300588

03/31/03

2003 300588 B2

 

Canada

2,492,008

03/31/03

2,492,008

 

EUROPE:

03808015.6

03/31/03

1492874 B1

 

Belgium

03808015.6

03/31/03

1492874 B1

 

Denmark

03808015.6

03/31/03

1492874 B1

 

France

03808015.6

03/31/03

1492874 B1

 

Germany

03808015.6

03/31/03

603 35 794.6-08

 

Great Britain

03808015.6

03/31/03

1492874 B1

 

Ireland

03808015.6

03/31/03

1492874 B1

 

Netherlands

03808015.6

03/31/03

1492874 B1

 

Sweden

03808015.6

03/31/03

1492874 B1

 

Switzerland

03808015.6

03/31/03

1492874 B1

 

EUROPE:

10011422.2

09/29/10

2311962 B1

 

France

10011422.2

09/29/10

2311962 B1

 

Germany

10011422.2

09/29/10

2311962 B1

 

Great Britain

10011422.2

09/29/10

2311962 B1

 

Ireland

10011422.2

09/29/10

2311962 B1

 

Netherland

10011422.2

09/29/10

2311962 B1

 

Sweden

10011422.2

09/29/10

2311962 B1

 

Switzerland

10011422.2

09/29/10

2311962 B1

 

Japan

2004-543182

03/31/03

4554370

 

 

 

 

 

Schedule 1.1 - 12

 


 

Schedule 5.3

Consents

 

 

Master Project Agreement, effective as of July 12, 2010, by and between Fisher BioServices, Inc. and XOMA (US) LLC

 

Lease Agreement, effective as of September 21, 2010, by and between Thermo Fisher Financial Services, Inc. and XOMA (US) LLC

 

Lease Agreement, effective as of June 24, 2011, by and between Thermo Fisher Financial Services, Inc. and XOMA (US) LLC

 

Lease Agreement, effective as of January 31, 2012, by and between Thermo Fisher Financial Services, Inc. and XOMA (US) LLC

 

Commercial Supply Agreement (Cell Culture Media and Reagents), effective as of July 1, 2011, by and between SAFC Inc. and XOMA (US) LLC

 

Subcontract for Services, effective as of July 12, 2012, by and between SRI International and XOMA (US) LLC

 

Master Laboratory Services Agreement, effective as of August 3, 2012, by and between Covance Laboratories Inc. and Covance Bioanalytical Services LLC, and XOMA (US) LLC

 

Amended and Restated Laboratory Services and Confidentiality Agreement made as of December 31, 2008 by and between Charles River Laboratories, Inc. and XOMA (US) LLC

 

Amended and Restated Laboratory Services and Confidentiality Agreement, effective as of March 1, 2015, by and between Charles River Laboratories, Inc. and XOMA (US) LLC extending term to May 6, 2018

 

 

 

 

Schedule 5.3 - 1

 


 

Schedule 5.4

Title to Purchased Assets

 

None

 

Schedule 5.4 - 1

 


 

Schedule 5.5

XOMA Patents – Encumbrances

 

None

 

 

Schedule 5.5 - 1


 

Schedule 5.6

Litigation

 

Department of Public Integrity Inquiry into NIAID Contracts:  

 

On January 14, 2014, the Division of Program Integrity (DPI) in the Office of Management Assessment at the National Institutes of Health sent a letter to XOMA requesting information in connection with its review of allegations of misuse of NIH funds under contract HHSN272200800028C.  DPI is continuing its review of an allegation of misuse by XOMA of funds awarded under a contract with NIAID.  However, DPI has not informed XOMA that it has reached any conclusion about liability on the part of XOMA or the amount of funds that may be at issue. 

DPI’s request for information sought accounting, administration, and labor charge-related records in connection with the NIAID contract.  XOMA provided records to DPI in February, March, and April 2014.  XOMA has not received any substantive communication from DPI since producing records.

To XOMA’s Knowledge, the inquiry pertains solely to billing practices and not with regard to the Products.

 

 

 

Schedule 5.6 - 1


 

Schedule 5.7

Regulatory Issues

 

None

 

 

Schedule 5.7 - 1


 

 

Schedule 5.8

Compliance with Laws

 

None

Schedule 5.8 - 1


 

Schedule 6.1(d)

Settlements

 

None

 

 

Schedule 6.1(d) - 1


 

Schedule 6.2

 

XOMA BOT Know-How

 

 

Relevant NIAID Standard Operating Procedures

 

 

010.03.15 Evaluation and Maintenance of Chromatography Resins and Columns  

 

010.03.29_Cleaning,_Packing,_and_Efficiency_Testing_for_Chromatography_Columns  

 

010.03.37_Purification_Column_Regeneration.pdf  

 

010.03.38_Operation_and_Maintenance_of_Chromatography_Columns.pdf  

 

010.06.78_Purification_Buffer_Preparation.pdf  

 

010.08.34_Operation_of_the_2FRM3-500-01 Disposable Fermenter (Xcellerex_XDR-500_Disposable_Bioreactor).pdf  

 

010.08.35_Fermenter_Monitoring.pdf  

 

010.08.36_Standardization_of_DO2_for_2FRM3-500-01_Bioreactor.pdf  

 

010.08.37_Standardization_of_pH_for_2FRM3-500-01_Bioreactor.pdf  

 

010.10.02_Hydrophobic_Interaction_Chromatography_Processing_in_Manufacturing_at_XOMA.pdf  

 

010.10.03_Q_Sepharose_Processing_for_Manufacturing_at_XOMA.pdf  

 

010.10.04_Protein_A_Processing_for_Manufacturing_at_XOMA.pdf  

 

010.10.05__Viral_Filtration_for_Manufacturing XOMA.pdf  

 

020.01.01 Filter Integrity Testing  

 

020.01.83__Determining_Total_and_Viable_Cell_Counts_in_Cell_Suspensions.pdf  

 

040.01.87_Calibration_of_DO2_for_2FRM3-500-01_Bioreactor.pdf  

 

040.01.88 Calibration of pH for 2FRM3-500-01 Bioreactor.pdf  

 

040.03.33_Qualification_of_Chromatography_Columns.pdf  

 

090.01.10._Requirement_for_Validation_of_Assays_Supporting_GLP_Toxicology_and_Clinical_Studies.pdf  

 

090.01.11_Qualification_of_Analytical_Assays_in_Bioanalytical_Development.pdf  

 

090.02.51 Operation, Maintenance and Calibration Check of the Molecular Devices Microplate Reader in Bioanalytical Development.pdf  

 

090.03.16 Measurement of Human Engineered NX11 in Rat Serum by ECLA on the MSD Platform  

 

090.03.17_Measurement_of_Human_Engineered_NX01_in_Rat_Serum_by_ECLA_on_the_MSD_Platform.pdf  

 

090.03.18_Measurement_of_Human_Engineered_NX02_in_Rat_Serum_by_ECLA_on_the_MSD_Platform.pdf  

 

100.09.75_Installation,_operation,_storage,_and_maintenance_of_the_Wave_Bioreactor_System_20_50_used_in_XOMA_5.pdf  

 

100.21.07 Operation, Maintenance and Calibration of the Hiac/Royco Liquid Particle Counter, Model 9703  

 

100.22.01 Operation of the Microliter Pipets  

 

100.24.02 Operation of Masterflex and Watson-Marlow Peristaltic and ChemTec Pumps  

Schedule 6.2 - 1


 

100.24.08 Operation and Maintenance of Centrifugal, Positive Displacement, and Rotary Lobe Pumps  

 

100.28.06 Operation and Maintenance of the Molecular Devices Microplate Readers  

 

100.28.12_Operation_and_Maintenance_of_the_Shimadzu_Model_UV_-_1601_UV_Spectrophotometer.pdf  

 

100.31.06_Operation_Maintenance_Calibration_of_MSD_Sector_Imager_2400_6000.pdf  

 

100.35.03_Operation,_Standardization_and_Maintenance_of_QC_Conductivity_Meters.pdf  

 

100.37.31_Operation_of_the_Advanced_Micro-Osmometer,_Models_3300 and 3320.pdf  

 

100.37.48 Operation, Maintenance and Calibration of the Molecular Devices Total DNA Threshold System  

 

105.03.19_Measurement_of_Human_Engineered_NX11_in_Cyno_Serum_by_ECLA_on_the_MSD_Platform.pdf  

 

105.03.20_Measurement_of_Human_Engineered_NX02_in_Cynomolgus_Monkey_Serum_by_ECLA_on_the_MSD_Platform.pdf  

 

105.03.21__Measurement_of_Human_Engineered_NX01_in_Cynomolgous_Monkey_Serum_by_ECLA_on_the_MSD_Platform.pdf  

 

105.03.22_Guidance_for_Pharmacokinetic_Method_Validation--Ligand_Binding_Assays--Bioanalytical_Development  

 

105.03.29_Material Bridging, Qualification and Expiration Date Extension.pdf  

 

105.03.31_Operation,_Maintenance,_Cleaning_of_the_Microplate_Shaker_Bioanalytical Development.pdf  

 

105.03.32_Guidance_for_Immunogenicity_Method_Validation_in_Bioanalytical_Development.pdf  

 

105.03.33_Labeling_of_Proteins_with_Biotin_or_Ruthenium_in_Bioanalytical_Development.pdf  

 

900.02.01_Determination_of_Botulinum_Toxin_E_LD50_in_Female_CD-1_Mice.pdf  

 

900.02.02_Determination_of_XOMA_3E_Potency_by_Survival_Assay_in_Female_CD-1_Mice.pdf  

 

900.02.03_Determination_of_Individual_Antibody_Potency_Against_Botulinum_Toxin_E.pdf  

 

900.02.04_XOMA_4CD_Potency.pdf  

 

Relevant NIAID Program Batch Records

 

 

BR1001 XJEM Selective Medium with Geneticin and Histidinol  

 

BR1002 XJEM Fermentation Medium  

 

BR1031_85mM_Butyrate,_(XOMA_2).pdf  

 

BR1033 0.02 N Hydrochloric Acid Solution, (XOMA 2)  

 

BR1046_Q_Sepharose_Column_Regeneration.pdf  

 

BR1050_20_mM_Tris,1M_Sodium_Chloride,_pH_8.5.pdf  

 

BR1051_20mM_Tris_pH_8.5.pdf  

 

BR1067_20mM_Tris_150mM_Sodium_Chloride_250mM_sodium_sulfate_pH7.0.pdf  

 

BR1093 Cell Bank Media Fill  

Schedule 6.2 - 2


 

BR1102_50mM_Tris_150mM_sodium_Chloride,_pH_7.5_(XOMA_2)..pdf  

 

BR1103_0.2M_Hydrochloric_Acid.pdf  

 

BR1104_100mM_Acetic_Acid_pH 2.8.pdf  

 

BR1125_50mM_Sodium Hydroxide 1M Sodium Chloride.pdf  

 

BR1126 10mM Sodium Phosphate 150 mM Sodium Chloride 20 percent Ethanol, Ph 7.0.pdf  

 

BR1127_10mM_Sodium_Phosphate_150_mM_Sodium_Chloride_pH_7.0_pdf  

 

BR1134_NX11_Master_Cell_Bank_.pdf  

 

BR1135_NX02_Master_Cell_Bank.pdf  

 

BR1136_NX01_Master_Cell_Bank.pdf  

 

BR1141_NX11_Manufacturings_Working_Cell_Bank.pdf  

 

BR1142_NX02_Manufacturings_Working_Cell_Bank.pdf  

 

BR1143_NX01_Manufacturings_Working_Cell_Bank.pdf  

 

BR1145_300mM_Arginine 100mM_Glycine_pH_3.0.pdf  

 

BR1167__50_mM_Sodium_Citrate_0.1__M_Sodium_Sulfate_pH_6.0  

 

BR1168_50_mM_Sodium_Citrate_055_M_Sodium_Sulfate_pH_6.0.pdf  

 

BR1169__50_mM_Sodium_Citrate_2.0_M_Sodium_Sulfate_pH_6.0.pdf  

 

BR1170 25mM Sodium Citrate 1M Sodium Chloride pH_.pdf  

 

BR1172_Hydrophobic_Interaction_Chromatography__HIC__Column.pdf  

 

BR1174_10_mM_Succinate Succinic Acid,_142_mM_L Arginine HCI,_pH_6.0.pdf  

 

BR1176_XJEM_selective_medium_with_geneticin.pdf  

 

BR1191_Sterile_Antifoam_C_solution.pdf  

 

BR1199_10mM_L-Histidine,_142mM_L-Arginine_Hydrochloride,_pH_6.0.pdf  

 

BR1203_200_mM_Sodium_Butyrate.pdf  

 

BR1217_100_mM_Glycine,_100_mM_Arginine,_pH_3.5.pdf  

 

BR1245_200_mM_Arginine,_100_mM_Glycine,_pH_7.0.pdf  

 

BR1246_10_mM_Sodium_Phosphate,_300_mM_Arginine,_100_mM_Glycine,_pH_7.0.pdf  

 

BR1249_Fortified_XJEM_Selective_Medium_with_Geneticin_and_Histidinol.pdf  

 

BR1250_NX01_Scaleup,_NIAID 2.pdf  

 

BR1252_Concentrated_XJEM_Feed_Solution.pdf  

 

BR1254_Fortified_XJEM_Fermentation_Medium.pdf  

 

BR1255_NX01_Harvest,_NIAID_2.pdf  

 

BR1258_NX02_Scaleup_NIAID 2.pdf  

 

BR1260_NX02_Harvest,_NIAID_2.pdf  

 

BR1262_Chromatography_Column_Cleaning.pdf  

 

BR1263__Concentrated_XJEM_Feed_Solution_with_Amino_Acids_and_Ethanolamine.pdf  

 

BR1264_Fermentation_of_NX02_Antibodies_in_Production_Fermenter_130_L,_NIAID_2.pdf  

 

BR1275_NX11_Wave_Inoculation,_NIAID_2.pdf  

 

BR1276 NX11 Scaleup NIAID 2.pdf  

 

BR1314_NX11_Vial_Thaw,_NIAID_2.pdf  

 

BR1315_NX01_Vial_Thaw,_NIAID_2.pdf  

Schedule 6.2 - 3


 

BR1316_NX01_Wave_Inoculation_NIAID_2.pdf  

 

BR1317_Inoculation_of_NX01_Antibodies_in_Production_Fermenter_(130_L)_NIAID_2.pdf  

 

BR1318_NX02_Vial_Thaw_NIAID_2.pdf  

 

BR1319_NX11_Harvest,_NIAID_2.pdf  

 

BR1320_Fermentation_of_NX11_Antibodies_in_Production_Fermenter_130_L,_NIAID_2.pdf  

 

BR1321_Fermentation_of_NX01_Antibodies_in_Production_Fermenter_130_L,_NIAID_2.pdf  

 

BR1322_NX02_Wave_Inoculation_NIAID_2.pdf  

 

BR1323_Inoculation_of_NX02_Antibodies_in_Production_Fermenter_(130_L)_NIAID_2.pdf  

 

BR1324_Inoculation_of_NX11_Antibodies_in_Production_Fermenter_(130_L),_NIAID_2.pdf  

 

BR1326_Pressure_Test_and_SIP_For_130_L_ABEC_Fermenter-_Pilot_Plant.pdf  

 

BR1328_Protein_A_Chromatography_NX11,_NIAID_2.pdf  

 

BR1329_Q_Sepharose_FF_Chromatography_NX11,_NIAID_2.pdf  

 

BR1330_Butyl_650M_Chromatography_for_NX11,_NIAID_2.pdf  

 

BR1331_NX11_Viral_(NFP)_Filtration,_NIAID_2.pdf  

 

BR1332_Formulation,_NX11_Drug_Substance__5g_L_,_NIAID_2.pdf  

 

BR1333_Protein_A_Chromatography for_NX02,_NIAID_2.pdf  

 

BR1334_Q_Sepharose_FF_Chromatography for_NX02,_NIAID_2.pdf  

 

BR1335_Butyl_650 Hydrophobic Interaction_Chromatography_(HIC) for_NX02,_NIAID_2.pdf  

 

BR1336_NX02_Viral_(NFP)_Filtration.pdf  

 

BR1337_Formulation,_NX02_Drug_Substance_(5g_L),_NIAID_2.pdf  

 

BR1338_Protein_A_Chromatography_NX01,_NIAID_2.pdf  

 

BR1339_Q_Sepharose_FF_Chromatography for_NX01,_NIAID 2_.pdf  

 

BR1340_Butyl_650M_Hydrophobic Interaction Chromatography_(HIC) for_NX01,_NIAID_2.pdf  

 

BR1341_NX01_Viral_(NFP)_Filtration,_NIAID 2.pdf  

 

BR1342_Formulation,_NX01_Drug_Substance_(5g_L),_NIAID_2.pdf  

 

BR1355_Formulation_NX11_Drug_Substance_5_g_L_without_Tween_80_NIAID_2.pdf  

 

BR1356_Formulation, NX02 Drug Substance (5 g/L) without Tween 80 NIAID 2.pdf  

 

BR1357_Formulation,_NX01_Drug_Substance_5_gL_without Tween_80_NIAID_2.pdf  

 

pdf  

 

BR1368_XJEM_Fermentation_Medium_with_Additional_5g_per_L_Glucose.pdf  

 

BR1441_XB10_Preparation_of_Vial_Thaw_for_Master_Cell_Bank.pdf  

 

BR1442_XB10_Scaleup_for_Master_Cell_Bank.pdf  

 

BR1443_XB10_Master_Cell_Bank_Vial_Freeze.pdf  

 

BR1444_XB10_Preparation_of_Vial_Thaw_for_Manufacturers_Working_Cell_Bank_(MWCB).pdf  

 

BR1445_XB10_Scaleup_for_Manufacturers_Working_Cell_Bank_(MWCB).pdf  

Schedule 6.2 - 4


 

BR1446_XB10_Manufacturer_s_Working_Cell_Bank_(MWCB)_Vial_Freeze.pdf  

 

BR1448_XB18_Preparation_of_Vial_Thaw_for_Master_Cell_Bank.doc.pdf  

 

BR1449_XB18_Scaleup_for_Master_Cell_Bank.doc.pdf  

 

BR1450_XB18_Master_Cell_Bank_Vial_Freeze.pdf  

 

BR1451_XB18_Preparation_of_Vial_Thaw_for_Manufacturer_s_Working_Cell_Bank_(MWCB).pdf  

 

BR1452_XB18_Scaleup_for_Manufacturer_s_Working_Cell_Bank_(MWCB).pdf  

 

BR1453_XB18_Manufacturer_s_Working_Cell_Bank_(MWCB)_Vial_Freeze.pdf  

 

BR1454_2x_Concentrate_of_XJEM_Fermentation_Medium_with_Additional_5_g_L_Glucose.pdf  

 

BR1460_XE17_Preparation_of_Vial_Thaw_for_Master_Cell_Bank.pdf  

 

BR1461_XE17_Scaleup_for_Master_Cell_Bank.doc.pdf  

 

BR1462_XE17_Master_Cell_Bank_Vial_Freeze.pdf  

 

BR1463_XE17_Preparation_of_Vial_Thaw_for_Manufacturer_s_Working_Cell_Bank_(MWCB).pdf  

 

BR1464_XE17_Scaleup_for_Manufacturers_Working_Cell_Bank_(MWCB).pdf  

 

BR1465_XE17_Manufacturers_Working_Cell_Bank_(MWCB)_Vial_Freeze.pdf  

 

BR1470_XB10_Vial_Thaw.pdf  

 

BR1471_XB10_Scaleup.pdf  

 

BR1472_XB10_50_L_Wave_Inoculation,_NAIID_3.pdf  

 

BR1473_Inoculation_of_XB10_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1474_Fermentation_of_XB10_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1475_XB10_Harvest.pdf  

 

BR1476_Protein_A_Chromatography_XB10.pdf  

 

BR1477_Q_Sepharose_FF_Chromatography_for_XB10.pdf  

 

BR1478_Butyl_650M_Chromatography_XB10.pdf  

 

BR1479_XB10_Viral_(NFP)_Filtration_XB10.pdf  

 

BR1480__Formulation_XB10_Drug_Substance,_(5_gL).pdf  

 

BR1481_XB10_Process_Yield.pdf  

 

BR1483_Preparation_of_Disposable_TFF_Cassettes.pdf  

 

BR1485_XB18_Vial_Thaw.doc.pdf  

 

BR1486_XB18_Scaleup.pdf  

 

BR1487_XB18_50_L_Wave_Inoculation.pdf  

 

BR1488_Inoculation_of_XB18_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1489_Fermentation_of_XB18_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1490_XB18_Harvest.doc.pdf  

 

BR1491_XB10_Drug_Substance_Storage_Freeze.pdf  

 

BR1492_Protein_A_Chromatography_for_XB18.pdf  

 

BR1493_Q_Sepharose_FF_Chromatography_for_XB18.pdf  

 

BR1494_Butyl_650M_Chromatography_XB18.pdf  

 

BR1495_XB18_Viral_(NFP)_Filtration.pdf  

 

BR1496_Formulation_XB18_Drug_Substance,_(5_gL).pdf  

 

BR1497_XB18_Process_Yield.pdf  

 

BR1498_100mM_Argininge_100mM_Glycine_pH3.8.pdf  

Schedule 6.2 - 5


 

BR1499_50mM_Tris_50mM_Sodium_Chloride_pH7.8.pdf  

 

BR1500_0.1M_Sodium_Phosphate_0.54M_Sodium_Sulfate_pH7.50.pdf  

 

BR1501_0.1M_Sodium_Phosphate_0.2M_Sodium_Sulfate_pH7.5.pdf  

 

BR1507_XE02_Preparation_of_Vial_Thaw_for_Master_Cell_Bank.pdf  

 

BR1508_XE02_Scaleup_for_Master_Cell_Bank.pdf  

 

BR1509_XE02_Master_Cell_Bank_Vial_Freeze.pdf  

 

BR1510_XE02_Preparation_of_Vial_Thaw_for_Manufacturer_s_Working_Cell_Bank_(MWCB).pdf  

 

BR1511_XE02_Scaleup_for_Manufacturers_Working_Cell_Bank_(MWCB).pdf  

 

BR1512_XE02_Manufacturers_Working_Cell_Bank_(MWCB)_Vial_Freeze.pdf  

 

BR1513_XB18_Drug_Substance_Storage_Freeze.pdf  

 

BR1519_XE17_Vial_Thaw.pdf  

 

BR1520_XE17_Scaleup.pdf  

 

BR1521_XE17_50_L_Wave_Inoculation.pdf  

 

BR1522_Inoculation_of_XE17_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1523_Fermentation_of_XE17_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1524_XE17_Harvest.pdf  

 

BR1525_Protein_A_Chromatography_for_XE17.pdf  

 

BR1526_Q_Sepharose_FF_Chromatography_for_XE17.pdf  

 

BR1527_Phenyl_650M_Chromatography_XE17.pdf  

 

BR1528_Viral_(NFP)_Filtration_for_XE17.pdf  

 

BR1529_Formulation_of_XE17_Drug_Substance_5g-L.pdf  

 

BR1530_XE17_Drug_Substance_Filtration.pdf  

 

BR1531_XE17_Process_Yield.pdf  

 

BR1532_Bio_Rad_Pack_in_Place_Column_Cleaning.pdf  

 

BR1533_XE17_Drug_Substance_Storage_Freeze.pdf  

 

BR1534_XE06_Preparation_of_Vial_Thaw_for_Master_Cell_Bank.pdf  

 

BR1535_XE06_Scaleup_for_Master_Cell_Bank.pdf  

 

BR1536_XE06_Master_Cell_Bank_Vial_Freeze.pdf  

 

BR1537_XE06_Preparation_of_Vial_Thaw_for_Manufacturer_s_Working_Cell_Bank_(MWCB).pdf  

 

BR1538_XE06_Scaleup_for_Manufacturers_Working_Cell_Bank_(MWCB).pdf  

 

BR1539_XE06_Manufacturers_Working_Cell_Bank_(MWCB)_Vial_Freeze.pdf  

 

BR1540_XE02_Vial_Thaw.pdf  

 

BR1541_XE02_Scaleup.pdf  

 

BR1542_XE02_50_L_Wave_Inoculation.pdf  

 

BR1543_Inoculation_of_XE02_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1544_Fermentation_of_XE02_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1545_XE02_Harvest.pdf  

 

BR1546_HIC_Column_Regeneration_Using_the_Pall_PK50_Automated_Chromatography_Skid.pdf  

 

BR1547_Q_Sepharose_Fast_Flow_(QSFF)_Column_Regeneration_Using_the_Pall_PK50_Automated_Chromatography_Skid.pdf  

Schedule 6.2 - 6


 

BR1548_Protein_A_Column_Regeneration_Using_the_Pall_PK50_Automated_Chromatography_Skid.pdf  

 

BR1549_Protein_A_Chromatography_for_XE02.pdf  

 

BR1550_Q_Sepharose_FF_Chromatography_for_XE02.pdf  

 

BR1551_Butyl_650_M_Hydrophobic_Interaction_Chromatography_(HIC)_for_XE02.pdf  

 

BR1552_Viral_(NFP)_Filtration_for_XE02.pdf  

 

BR1553_Formulation_of_XE02_Drug_Substance_5g-L.pdf  

 

BR1554_XE02_Drug_Substance_Filtration.pdf  

 

BR1555_XE02_Process_Yield.pdf  

 

BR1556_XE02_Drug_Substance_Storage_Freeze.pdf  

 

BR1557_0_1M_Sodium_Citrate_0_60M_Sodium_Sulfate_pH6_0.pdf  

 

BR1558_0_1M_Sodium_Citrate_0_31M_Sodium_Sulfate_pH6_00.pdf  

 

BR1559_XE06_Vial_Thaw.pdf  

 

BR1560_XE06_Scaleup.pdf  

 

BR1561_XE06_50_L_Wave_Inoculation.pdf  

 

BR1562_Inoculation_of_XE06_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1563_Fermentation_of_XE06_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1564_XE06_Harvest.pdf  

 

BR1565_Protein_A_Chromatography_for_XE06.pdf  

 

BR1566_Q_Sepharose_FF_Chromatography_for_XE06.pdf  

 

BR1567_Phenyl_Sepharose_HP_Hydrophobic_Interaction_Chromatography_(HIC)_for_XE06.pdf  

 

BR1568_Viral_(NFP)_Filtration_for_XE06.pdf  

 

BR1569_Formulation_of_XE06_Drug_Substance_5g-L.pdf  

 

BR1570_XE06_Drug_Substance_Filtration.pdf  

 

BR1571_XE06_Process_Yield.pdf  

 

BR1572_XE06_Drug_Substance_Storage_Freeze.pdf  

 

BR1573_50mM_Tris_37mM_Sodium_Chloride_pH8.8.pdf  

 

BR1574_0.1M_Sodium_Citrate_1.2M_Sodium_Sulfate_pH6.0.pdf  

 

BR1575_0.1M_Sodium_Citrate_0.7M_Sodium_Sulfate_pH6.0.pdf  

 

BR1576_0.1M_Sodium_Citrate_0.325M_Sodium_Sulfate_pH6.0.pdf  

 

BR1577_Column_Packing_with_Phenyl_Sepharose_High_Performance_Resin.pdf  

 

BR1578_Column_Efficiency_Testing_Using_the_Pall_PK50_Automated_Chromatography_Skid.pdf  

 

BR1579_XB23_Preparation_of_Vial_Thaw_for_Master_Cell_Bank.pdf  

 

BR1580_XB23_Scaleup_for_Master_Cell_Bank.pdf  

 

BR1581_XB23_Master_Cell_Bank_Vial_Freeze.pdf  

 

BR1582_Column_Packing_Using_the_Pall_PK50_Automated_Chromatography_Skid.doc.pdf  

 

BR1583_NX01_Process_Yield.pdf  

 

BR1584_NX11_Process_Yield.pdf  

 

BR1585_NX02_Process_Yield.pdf  

 

BR1586_XB23_Vial_Thaw.pdf  

Schedule 6.2 - 7


 

BR1587_XB23_Scaleup.pdf  

 

BR1588_XB23_50_L_Wave_Inoculation.pdf  

 

BR1589_Inoculation_of_XB23_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1590_Fermentation_of_XB23_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1591_XB23_Harvest.pdf  

 

BR1592_Protein_A_Chromatography_for_XB23.doc.pdf  

 

BR1593_Q_Sepharose_FF_Chromatography_for_XB23.pdf  

 

BR1594_Butyl_650_M_Hydrophobic_Interaction_Chromatography_(HIC)_for_XB23.pdf  

 

BR1595_Viral_(NFP)_Filtration_for_XB23.pdf  

 

BR1596_Formulation_of_XB23_Drug_Substance,_5_gL.pdf  

 

BR1597_XB23_Drug_Substance_Filtration.pdf  

 

BR1598_XB23_Process_Yield.pdf  

 

BR1599_XB23_Drug_Substance_Storage_Freeze.pdf  

 

BR1601_0.1M_Sodium_Phosphate_0.59M_Sodium_Sulfate_pH7.50.pdf  

 

BR1603_0.1M_Sodium_Phosphate_0.325M_Sodium_Sulfate_pH7.50.pdf  

 

BR1604__XS-11_Fermentation_Medium.pdf  

 

BR1605_XMetA_Preparation_of_Vial_Thaw_for_Master_Cell_Bank.pdf  

 

BR1619_XC44_Preparation_of_Vial_Thaw_for_Master_Cell_Bank.pdf  

 

BR1620_XC44_Scaleup_for_Master_Cell_Bank.pdf  

 

BR1621_XC44_Master_Cell_Bank_Vial_Freeze.pdf  

 

BR1622_XC42_Preparation_of_Vial_Thaw_for_Master_Cell_Bank.pdf  

 

BR1623_XC42_Scaleup_for_Master_Cell_Bank.pdf  

 

BR1624_XC42_Master_Cell_Bank_Vial_Freeze.pdf  

 

BR1675_XC84_Preparation_of_Vial_Thaw_for_Master_Cell_Bank.pdf  

 

BR1676_XC84_Scaleup_for_Master_Cell_Bank.pdf  

 

BR1677_XC84_Master_Cell_Bank_Vial_Freeze.pdf  

 

BR1678_XOMA_247_Bulk_Placebo_Storage_Freeze.pdf  

 

BR1679_XC44_Vial_Thaw.pdf  

 

BR1680_XC44_Scaleup.pdf  

 

BR1681_XC44_50_L_Wave_Inoculation.pdf  

 

BR1682_Inoculation_of_XC44_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1683_Fermentation_of_XC44_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1685_XC44_Harvest_Clarification.pdf  

 

BR1686_XC44_Protein-A_Chromatography.pdf  

 

BR1687_XC44_SE_Hicap_Chromatography.pdf  

 

BR1688_XC44_Mustang_Q_Chromatography.pdf  

 

BR1689_Viresolve_Pro_Plus_Filtration,_XC44.pdf  

 

BR1690_Formulation,_XC44_Drug_Substance_5_gL.pdf  

 

BR1691_XC44_Drug_Substance_Filtration.pdf  

 

BR1692_XC44_Drug_Substance_Storage_Freeze.pdf  

 

BR1693_XC44_Process_Yield.pdf  

 

BR1694_Placebo_for_XC_Antibodies.pdf  

 

BR1715_XC44_Virus_Inactivation_Of_Protein-A_Chromatography_Pools.pdf  

Schedule 6.2 - 8


 

BR1716_XOMA_089_Bulk_Placebo_Storage_Freeze.pdf  

 

BR1717_XC42_Vial_Thaw.pdf  

 

BR1718_XC42_Scaleup.pdf  

 

BR1719_XC42_50_L_Wave_Inoculation.pdf  

 

BR1720_Inoculation_of_XC42_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1721_Fermentation_of_XC42_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1722_Placebo_for_XC_Antibodies_Storage_Freeze.pdf  

 

BR1723_Harvest_Clarification,_XC42.pdf  

 

BR1724_Protein-A_Chromatography,_XC42.pdf  

 

BR1725_XC42_Virus_Inactivation_Of_Protein-A_Chromatography_Pools.pdf  

 

BR1726_SE_Hicap_Chromatography,_XC42.pdf  

 

BR1727_Mustang_Q_Chromatography,_XC42.pdf  

 

BR1728_Viresolve_Pro_Plus_Filtration,_XC42.pdf  

 

BR1729_Formulation,_XC42_Drug_Substance_5_gL.pdf  

 

BR1730_XC42_Drug_Substance_Filtration.pdf  

 

BR1731_XC42_Process_Yield.pdf  

 

BR1732_XC42_Drug_Substance_Storage_Freeze.pdf  

 

BR1733_50_mM_Arginine_100_mM_Glycine,_pH_3.5.pdf  

 

BR1734_25mM_HEPES,_29.1_mM_NaCl,_pH_7.5.pdf  

 

BR1735_25mM_HEPES,_42.8_mM_NaCl,_pH_7.5.pdf  

 

BR1736_XC41_Master_Cell_Bank_Vial_Freeze.pdf  

 

BR1737_XC41_Preparation_of_Vial_Thaw_for_Master_Cell_Bank.pdf  

 

BR1738_XC41_Scaleup_for_Master_Cell_BanK.pdf  

 

BR1743_XC41_Vial_Thaw.pdf  

 

BR1744_XC41_Scaleup.pdf  

 

BR1745_XC41_50L_Wave_Inoculation.pdf  

 

BR1746_Inoculation_of_XC41_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1747_Fermentation_of_XC41_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1748_Harvest_Clarification_XC41.pdf  

 

BR1749_Protein-A_Chromatography_XC41.pdf  

 

BR1750_XC41_Virus_Inactivation_Of_Protein-A_Chromatography_Pools.pdf  

 

BR1751_SE_Hicap_Chromatography_XC41.pdf  

 

BR1752_NatriFlo_HD-Q_Chromatography_XC41.pdf  

 

BR1753_Viresolve_Pro_Plus_Filtration_XC41.pdf  

 

BR1754_Formulation_XC41_Drug_Substance_5_gL.pdf  

 

BR1755_XC41_Drug_Substance_Filtration.pdf  

 

BR1756_XC41_Process_Yield.pdf  

 

BR1757_XC41_Drug_Substance_Storage_Freeze.pdf  

 

BR1761_XC84_Vial_Thaw.pdf  

 

BR1762_XC84_Scaleup.pdf  

 

BR1763_XC84_50_L_Wave_Inoculation.pdf  

 

BR1764_Inoculation_of_XC84_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1765_Fermentation_of_XC84_Antibody_in_the_2FRM3-500-01_Fermenter.pdf  

 

BR1766_Harvest_Clarification,_XC84.pdf  

Schedule 6.2 - 9


 

BR1768_Protein-A_Chromatography_XC84.pdf  

 

BR1769_XC84_Virus_Inactivation_Of_Protein-A_Chromatography_Pools.pdf  

 

BR1770_SE_Hicap_Chromatography_XC84.pdf  

 

BR1771_NatriFlo_HD-Q_Chromatography,_XC84.pdf  

 

BR1772_Viresolve_Pro_Plus_Filtration,_XC84.pdf  

 

BR1773_Formulation,_XC84_Drug_Substance_5_gL.pdf  

 

BR1774_XC84_Drug_Substance_Filtration.pdf  

 

BR1775_XC84_Process_Yield.pdf  

 

BR1776_XC84_Drug_Substance_Storage_Freeze.pdf  

 

BR1777_25mM_Hepes,_28.2_mM_NaCl,_pH_8.0.pdf  

 

BR1778_25mM_Hepes,_58.2_mM_NaCl,_pH_8.0.pdf  

 

BR246 0.83 M Glucose 0.21 M Glutamine Feed Solution  

 

BR247 Dulbeccos Phosphate Buffered Saline  

 

BR252 EX-CELL 301 Selective Medium without Fetuin for Cell Bank Preparation  

 

BR324 EX-CELL 301 Selective Medium Without Fetuin for Inoculum Preparation  

 

BR721 85 mM Butyrate  

 

BR751 Protein A Column Sanitization and Storage  

 

BR752 SP Sepharose Column Sanitization and Storage  

 

BR753 Q Sepharose Column Sanitization Storage  

 

BR755 UF DF Sanitization and Storage  

 

BR757 1.0 N Sodium Hydroxide  

 

BR815 5.0M Sodium Chloride  

 

BR942 Chromatograhy Column Packing  

 

Relevant - NIAID SPECIFICATIONS

 

General Files

 

TM101 Visual Inspection

 

TM101 TSS Visual Inspection

 

TM101 TSS Visual Inspection Raw Material

 

TM102 Potentiometric Measurement

 

TM102 TSS Potentiometric Measurement

 

TM102201 Ex-Cell 301 Medium (Modified)

 

TM103 Bioburden Testing

 

TM103 TSS Bioburden Testing

 

TM103 TSS Raw Material Bioburden Testing

 

TM107 Particle counting in Liquids by HIAC.Royco 9703

 

TM107 TSS Liquid particle count testing

 

TM111 Osmolality by vapor pressure

 

TM111 TSS Osmolality by vapor pressure

 

TM119 XOMA product identity tests

 

TM121 TSS Vial Integrity Testing of stability samples

 

TM121 Vial integrity testing of stability samples

 

TM5004 Immuno assay for anti-NXO2 in human sera by ECLA on MSD

Schedule 6.2 - 10


 

TM5004 TSS Immuno assay for anti-NXO2 in human sera by ECLA on MSD

 

TM5007 Measurement of NX11 in Human Serum by ECLA on the MSD Platform.pdf

 

TM5007 TSS Measurement of NX11 in Human Serum by ECLA on the MSD Platform.pdf

 

TM5008 Measurement of NX02 in Human Serum by ECLA on the MSD Platform.pdf

 

TM5008 TSS Measurement of NX02 in Human Serum by ECLA on the MSD Platform.pdf

 

TM5009 Measurement of NX01 in Human Serum by ECLA on the MSD Platform.pdf

 

TM5009 TSS Measurement of NX01 in Human Serum by ECLA on the MSD Platform.pdf

 

TM5010 TSS Immunoassay for the Screening of Antibodies to NX02 in Human Serum by ECLA on MSD.pdf

 

TM5010 Immunoassay for Antibodies to NX02 in Human Serum by ECLA on MSD Platform.pdf

 

TM5011 Immunoassay for Antibodies to NX01 in Human Serum by ECLA on MSD Platform.pdf

 

TM5011 TSS Test Summary Sheet for Immunoassay for the Screening of Antibodies to NX01 in Human.pdf

 

TM5012 Immunoassay for Antibodies to NX11 in Human Serum by ECLA on MSD Platform.pdf

 

TM5012 TSS Test Summary Sheet for Immunoassay for the Screening of Antibodies to NX11 in Human.pdf

 

TM5013 Immunoassay for the Confirmation of Antibodies to NX01 in Human Serum by ECLA on MSD.pdf

 

TM5013 TSS Immunoassay Confirmation of Antibodies to NX01 in Human Serum ECLA on MSD.pdf

 

TM5014 Immunoassay for Endpoint Titer of Antibodies to NX02 in Human Serum by ECLA on MSD.pdf

 

TM5014 TSS Immunoassay Endpoint Titer of Antibodies NX02 in Human Serum by ECLA on MSD.pdf

 

TM5015 Immunoassay endpoint Titer of Antibodies to NX01 in Human Serum by ECLA--MSD.pdf

 

TM5015 TSS Immunoassay endpoint Titer of Antibodies to NX01 in Human Serum by ECLA--MSD.pdf

 

TM5016 Immunoassay for the Confirmation of Antibodies to NX11 in Human Serum by ECLA on MSD.pdf

 

TM5016 TSS Immunoassay Confirmation of Antibodies to NX11 in Human Serum ECLA on MSD.pdf

 

TM5017 Immunoassay Endpoint Titer of Antibodies to NX11 in Human Serum by ECLA--MSD.pdf

 

TM5017 TSS Immunoassay Endpoint Titer of Antibodies to NX11 in Human Serum by ECLA--MSD.pdf

 

TM5044  of XB10 Drug Concentration in Rat Serum by ECLA on the MSD .pdf  

 

TM5044 TSS  of XB10 in Rat Serum by ECLA on the MSD .pdf  

 

TM5045  of XB18 in Rat Serum by ECLA on the MSD .pdf  

Schedule 6.2 - 11


 

TM5045 TSS  of XB18 in Rat Serum by ECLA on the MSD  Draft.pdf  

 

TM5046  of XB23 in Rat Serum by ECLA on the MSD .pdf  

 

TM5046 TSS  of XB23 in Rat Serum by ECLA on the MSD  Draft.pdf  

 

TM5047  of XE02 in Rat Serum by ECLA on the MSD  Watson YE20131213A.pdf  

 

TM5047 TSS  of XE02 in Rat Serum by ECLA on the MSD  YE20131213A.pdf  

 

TM5048  of XE06 in Rat Serum by ECLA on the MSD  YE20131213A.pdf  

 

TM5048 TSS  of XE06 in Rat Serum by ECLA on the MSD  Watson YE20131213A.pdf  

 

TM5049  of XE17 in Rat Serum by ECLA on the MSD  YE20131213A.pdf  

 

TM5049 TSS  of XE17 in Rat Serum by ECLA on the MSD  YE20131213A.pdf  

 

TM5050 Immunoassay for Antibodies to XOMA 3B in Rat Serum by ECLA on MSD .pdf  

 

TM5050 TSS Immunoassay for Antibodies to XOMA 3B in Rat Serum by ECLA on MSD .pdf  

 

TM5051 Immunoassay for Confirmation of Antibodies to XOMA 3B in Rat Serum by ECLA on MSD .pdf  

 

TM5051 TSS Immunoassay for Confirmation of Antibodies to XOMA 3B in Rat Serum by ECLA on MSD .pdf  

 

TM5052 Immunoassay for Titer of Antibodies to XOMA 3B in Rat Serum by ECLA on MSD .pdf  

 

TM5052 TSS Immunoassay for Titer of Antibodies to XOMA 3B in Rat Serum by ECLA on MSD .pdf  

 

TM5053 Immunoassay for Antibodies to XOMA 3E in Rat Serum by ECLA on MSD .pdf  

 

TM5053 TSS Immunoassay for Antibodies to XOMA 3E in Rat Serum by ECLA on MSD .pdf  

 

TM5054 Immunoassay for the Confirmation of Antibodies to XOMA 3E in Rat Serum by ECLA on MSD .pdf  

 

TM5054 TSS Immunoassay for the Confirmation of Antibodies to XOMA 3E in Rat Serum by ECLA on MSD .pdf  

 

TM5055 Immunoassay for Titer Determination of Antibodies to XOMA 3E in Rat Serum by ECLA on MSD .pdf  

 

TM5055 TSS Immunoassay for Titer Determination of Antibodies to XOMA 3E in Rat Serum by ECLA on MSD .pdf

 

TM730 Residual Host Cell Protein ELISA

 

TM789 Determination of Residual DNA Content of Anti-Botulinum Toxin Antibody by ELISA

 

TM892 Measurement of NIAID Antibody Oxidation by HIC-HPLC method

 

TM729 Total Protein Determination using BCA Assay  

 

TM730 Quantitation of CHO Host Cell Protein by ELISA  

 

TM730 TSS Quantitation of CHO Host Cell Protein by ELISA  

 

TM741 Pro-inflammatory activity by IL-6 induction.pdf  

 

TM759 Growth and Productivity Test for Recombinant CHO Cell Banks.pdf  

 

TM759 TSS Growth and Productivity Test for Recombinant CHO Cell Lines.pdf  

 

TM782 Tryptic Map, NX02.pdf  

Schedule 6.2 - 12


 

TM783 TSS IEC Analysis of NX01.pdf  

 

TM783 Ion Exchange Chromatography Analysis of NX01 Containing Samples.pdf  

 

TM784 Spectrophotometric Determination of Protein Concentration, NX01 Containing Samples.pdf  

 

TM784 TSS Spectrophotometric Determination of Protein Concentration, NX01 Containing Samples.pdf  

 

TM789 Residual Protein A Content of anti-Botulinum Toxin Antibody by ELISA for NX01, NX02, NX11.pdf  

 

TM791 Tryptic Map, NX01.pdf  

 

TM793 Capillary Electrophoresis - Sodium Dodecyl Sulfate CE SDS Analysis NX01 Containing Samples  .pdf  

 

TM793 TSS Capillary Electrophoresis - Sodium Dodecyl Sulfa.pdf  

 

TM794 Spectrophotometric Determination of Protein Concentration, NX02 Containing Samples.pdf  

 

TM794 TSS Spectrophotometric Determination of Protein Conc.pdf  

 

TM796 TSS Ion Exchange Chromatography Analysis of NX02 Cont.pdf  

 

TM796 Ion Exchange Chromatography Analysis of NX02 Containing Samples.pdf

 

TM797 Capillary Electrophoresis - Sodium Dodecyl Sulfate (CE-SDS) Analysis, NX02 Containing Samples.pdf  

 

TM797 TSS Capillary Electrophoresis - Sodium Dodecyl Sulfa.pdf  

 

TM798 Capillary Electrophoresis - Sodium Dodecyl Sulfate (CE-SDS) Analysis, NX11 Containing Samples.pdf  

 

TM798 TSS Capillary Electrophoresis - Sodium Dodecyl Sulfa.pdf  

 

TM799 Ion Exchange Chromatography Analysis of NX11 Containing Samples.pdf  

 

TM799 TSS Ion Exchange Chromatography Analysis of NX11 Containing Samples.pdf  

 

TM800 Size Exclusion Chromatography Analysis of NX11.pdf  

 

TM800 TSS SEC Analysis of NX11.pdf  

 

TM801 Spectrophotometric Determination of Protein Concentration, NX11 Containing Samples.pdf  

 

TM801 TSS Spectrophotometric Determination of Protein Conc.pdf  

 

TM802_Tryptic_Map NX11.pdf  

 

TM806 Growth and Productivity Test for XJEM Modified Medium and XJEM Feed  

 

TM806 TSS Growth and Productivity Test for XJEM Modified Medium and XJEM Feed

 

TM820_Residual DNA Content Threshold Analysis, Sodium Iodide Extraction.pdf

 

TM829 Clarity, Opalescence and Color

 

TM829 TSS Clarity and Opalescence

 

TM829 TSS Color of Solution  

 

TM860 Spectrophotometric Determination of Protein Concentration, XOMA 3AB, XOMA 3B, and XOMA 3E.pdf  

 

TM860 TSS OD280 Analysis XOMA 3AB, 3B and 3E.pdf  

 

TM861 Capillary Electrophoresis - Sodium Dodecyl Sulfate (CE-SDS) Analysis, XOMA 3AB.pdf  

 

TM861 TSS CE-SDS, XOMA 3AB.pdf  

 

TM864 Size Exclusion Chromatography Analysis, 3XMAb-BoNT A.pdf  

Schedule 6.2 - 13


 

TM868 Ion Exchange HPLC Method, XOMA 3AB.pdf  

 

TM869 Determination of XOMA 3AB Binding by ELISA.pdf

 

TM880 Quantitation of Total DNA by PicoGreen.pdf  

 

TM886  Quantitation of Residual CHO Host Cell Protein on the MSD Platform.pdf  

 

TM891 Quantitation of Residual Protein A on the MSD Platform.pdf  

 

TM892 Oxidation Assay by Hydrophobic Interaction Chromatography for BoNT-A Antibodies.pdf  

 

TM893 Capillary Electrophoresis - Sodium Dodecyl Sulfate (CE-SDS) Analysis, XB10.pdf  

 

TM894 Capillary Electrophoresis--Sodium Dodecyl Sulfate (CE-SDS) Analysis, XB18.pdf  

 

TM895 Size Exclusion Chromatography Analysis, XB10.pdf  

 

TM896 Size Exclusion Chromatography Analysis, XB18.pdf  

 

TM897 Ion Exchange HPLC Method, XB10 Antibody.pdf  

 

TM898 Ion Exchange HPLC Method, XB18.pdf  

 

TM899 Tryptic Map, XB10.pdf

 

TM900 Tryptic Map Analysis, XB18.pdf

 

TM886 Residual CHO Host Cell Protein

 

TM891 Residual Protein A on MSD Platform

 

TM901 Oxidation Assay for XB10 Antibody by Reversed-Phase Chromatography.pdf

 

TM902 XB18 Oxidation Assay.pdf  

 

TM903 Determination of XB10 Binding to LCHN by ELISA.pdf  

 

TM904 Determination of XB18 binding to LCHN by ELISA.pdf  

 

TM905 Spectrophotometric Determination of Protein Concentration, Bo-NT B and E Containing Samples.pdf  

 

TM905 TSS OD280 Analysis Bo-NT B and E.pdf  

 

TM907 Capillary Electrophoresis - Sodium Dodecyl Sulfate (CE-SDS) Analysis XE17.pdf  

 

TM908 Size Exclusion Chromatography Analysis XE17.pdf  

 

TM909 Iion Exchange HPLC Method of XE17.pdf  

 

TM910 for Tryptic Map XE17.pdf  

 

TM911 Oxidation Assay for XE17 Antibody by Reversed-Phase  Chromatography.pdf  

 

TM912 Determination of XE17 binding to LCHN by ELISA.pdf  

 

TM913 Growth and Productivity Test for CD-CHO Medium.pdf  

 

TM913 TSS Growth and Productivity For CDCHO Medium Invitrogen.pdf  

 

TM915 Tryptic Map Analysis, XE02.pdf  

 

TM916 Ion Exchange HPLC Method, XE02 Antibody.pdf  

 

TM917 Determination of XE02 binding to LCHN by ELISA.pdf  

 

TM918 Size Exclusion Chromatography Analysis--XE02.pdf  

 

TM919 Measurement of the XE02 Antibody Oxidation by Reversed-Phase Chromatography.pdf  

 

TM920  Capillary Electrophoresis--Sodium Dodecyl Sulfate (CE-SDS) Analysis--XE02.pdf  

 

TM Quantitation Residual XOMA CHO K1 Host Cell Proteins on MSD Platform.pdf  

Schedule 6.2 - 14


 

TM922 Determination of XE06 Binding to LCHN by ELISA.pdf  

 

TM923 Tryptic Map Analysis, XE06.pdf  

 

TM924 Oxidation Assay for XE06 Antibody by Reversed-Phase  Chromatography.pdf  

 

TM925 Ion Exchange HPLC Method, XE06 Antibody.pdf  

 

TM926 Size Exclusion Chromatography Analysis, XE06.pdf  

 

TM927 Capillary Electrophoresis--Sodium Dodecyl Sulfate (CE-SDS) Analysis, XE06--dated.pdf  

 

TM928 Residual DNA Content by PCR.pdf  

 

TM931 Tryptic Map Analysis, XB23.pdf  

 

TM932 Determination of XB23 Binding to LCHN by ELISA.pdf  

 

TM933 IEC for XB23.pdf  

 

TM934 Capillary Electrophoresis - Sodium Dodecyl Sulfate (CE-SDS) Analysis XEB23.pdf  

 

TM935 Oxidation  Assay  for  XB23 Antibody by Reversed-Phase Chromatography.pdf  

 

TM936 Size Exclusison Chromatography Analysis, XB23.pdf  

 

TM937 Size Exclusison Chromatography Analysis, XOMA 3E Drug Product.pdf  

 

TM938 Determination of XOMA 3EB Binding by ELISA R00.pdf  

 

TM939 Capillary Electrophoresis - Sodium Dodecyl Sulfate (CE-SDS) Analysis XOMA 3E.pdf  

 

TM940 Ion Exchange HPLC Method XOMA 3E.pdf  

 

TM943 Size Exclusion Chromatography Analysis, XOMA 3B.pdf  

 

TM944 Determination of XOMA 3B Binding by ELISA.pdf  

 

TM945 Ion Exchange HPLC Method, XOMA 3B.pdf  

 

TM946 Capillary Electrophoresis - Sodium Dodecyl Sulfate (CE-SDS) Analysis XOMA 3B.pdf  

 

TM947 Growth and Productivity Test for XPM Medium.doc.pdf  

 

TM947 TSS Growth and Productivity For XPM Medium.pdf

 

TM953 Size Exclusion Chromatography Analysis, XC44.pdf  

 

TM954 Determination of XC (Monoclonal antibody) Binding to Specific BoNT C D domain by ELISA.pdf  

 

TM955 Ion Exchange HPLC, XC44.pdf  

 

TM956 Capillary Electrophoresis - Sodium Dodecyl Sulfate (CE-SDS) Analysis XC44.pdf  

 

TM957 Tryptic Map Analysis, XC44.pdf TM954 XC Binding to Specific BoNT CD Domain by ELISA  

 

TM965 Size Exclusion Chromatography Analysis, XC42.pdf  

 

TM966 Ion Exchange HPLC Method, XC42.pdf  

 

TM967 Capillary Electrophoresis - Sodium Dodecyl Sulfate (CE-SDS) Analysis XC42.pdf  

 

TM969 Tryptic Map Analysis, XC42 Antibody.pdf  

 

TM971 TSS Bacterial Endotoxin Determination for Water Samples.pdf  

 

TM971 TSS Test for Bacterial Endotoxin.pdf  

 

TM971 Bacterial Endotoxin Determination.pdf  

 

TM974 Ion Exchange HPLC, XC84.pdf  

Schedule 6.2 - 15


 

TM975 Tryptic Map Analysis, XC84.pdf  

 

TM976 Capillary Electrophoresis - Sodium Dodecyl Sulfate (CE-SDS) Analysis XC84.pdf  

 

TM977 Size Exclusion Chromatography Analysis, XC84.pdf  

 

TM980 (XC41 SEC Method).pdf  

 

TM981 Ion Exchange HPLC Method,XC41.pdf  

 

TM982 Capillary Electrophoresis - Sodium Dodecyl Sulfate (CE-SDS) Analysis XC41.pdf  

 

TM983 Tryptic Map Analysis, XC41 Antibody.pdf

 

TM991 TSS OD280 Analysis.pdf  

 

TM991 spectrophotometric Determination of Protein Concentration  XOMA 4CD.pdf

 

Product Specific Files

 

NIAID 2 FILES:

 

1.

NX01

 

a.

NX01 Drug Substance

 

b.

TM783 Ion Exchange HPLC

 

c.

TM783 TSS Ion Exchange HPLC

 

d.

TM784 Determination of Protein Concentration

 

e.

TM784 TSS Determination of Protein Concentration

 

f.

TM791 Tryptic Map

 

g.

TM793 Capillary Electrophoresis

 

h.

TM793 TSS Capillary Electrophoresis

 

 

2.

NX02

 

a.

NX02 Drug Substance

 

b.

TM782 Tryptic Map

 

c.

TM794 Determination of Protein Concentration

 

d.

TM794 TSS Determination of Protein Concentration

 

e.

TM796 Ion Exchange Chromatography

 

f.

TM796 TSS Ion Exchange Chromatography

 

g.

TM797 Capillary Electrophroresis

 

h.

TM797 TSS Capillary Electrophroresis

 

 

3.

NX11

 

a.

NX11 Drug Substance

 

b.

TM798 Capillary Electrophroresis

 

c.

TM798 TSS Capillary Electrophroresis

 

d.

TM799 Ion Exchange

 

e.

TM799 TSS Ion Exchange

 

f.

TM800 SEC Analysis

 

g.

TM800 TSS SEC Analysis

 

h.

TM801 Determination of Protein Concentration

Schedule 6.2 - 16


 

i.

TM801 TSS Determination of Protein Concentration

 

j.

TM802 Tryptic Map

NIAID 3 Specific TM Files:

 

1.

XB10

 

a.

XB10 Drug Substance

 

b.

TM820 Residual DNA Content Threshold Analysis

 

c.

TM893 Capillary Electrophoresis

 

d.

TM895 SEC Analysis

 

e.

TM897 Ion Exchange HPLC

 

f.

TM899 Tryptic Map

 

g.

TM901 Oxidation Assay

 

h.

TM903 Binding to LCHN by ELISA

 

 

2.

XB18

 

a.

XB18 Drug Substance

 

b.

TM820 Residual DNA Content Threshold Analysis

 

c.

TM894 Capillary Electrophoresis

 

d.

TM896 SEC Analysis

 

e.

TM898 Ion Exchange HPLC

 

f.

TM900 Tryptic Map

 

g.

TM902 Oxidation Assay

 

h.

TM904 Binding to LCHN by ELISA

 

 

3.

XB23

 

a.

XB23 Drug Substance

 

b.

TM928 Residual DNA Content by PCR

 

c.

TM931 Tryptic Map

 

d.

TM932 Binding to LCHN by ELISA

 

e.

TM933 Ion Exchange HPLC

 

f.

TM934 Capillary Electrophoresis

 

g.

TM935 Oxidation Assay

 

h.

TM936 SEC Analysis

 

 

4.

XE02

 

a.

XE02 Drug Substance

 

b.

TM820 Residual DNA Content Threshold Analysis

 

c.

TM915 Tryptic Map

 

d.

TM916 Ion Exchange HPLC

 

e.

TM917 Binding to LCHN by ELISA

 

f.

TM918 SEC Analysis

 

g.

TM919 Oxidation Assay

 

h.

TM920 Capillary Electrophoresis

 

Schedule 6.2 - 17


 

5.

XE06

 

a.

TM820 Residual DNA Content Threshold Analysis

 

b.

TM922 Binding to LCHN by ELISA

 

c.

TM923 Tryptic Map

 

d.

TM924 Oxidation Assay

 

e.

TM925 Ion Exchange HPLC

 

f.

TM926 SEC Analysis

 

g.

TM927 Capillary Electrophoresis

 

 

6.

XE17

 

a.

XE17 Drug Substance

 

b.

TM820 Residual DNA Content Threshold Analysis

 

c.

TM907 Capillary Electrophoresis

 

d.

TM908 SEC Analaysis

 

e.

TM909 Ion Exhange HPLC

 

f.

TM910 Tryptic Map

 

g.

TM911 Oxidation Assay

 

h.

TM912 Binding to LCHN by ELISA

NIAID 4 Specific TM Files:

 

1.

XC41

 

a.

TM980 SEC Analysis

 

b.

TM981 Ion Exchange HPLC

 

c.

TM982 Capillary Electrophoresis

 

d.

TM983 Tryptic Map

 

e.

XC41 Bulk Drug Substance

 

 

2.

XC42

 

a.

TM965 SEC Analysis

 

b.

TM966 Ion Exchange HPLC

 

c.

TM969 Tryptic Map

 

d.

TM967 Capillary Electrophoresis

 

e.

XC42 Bulk Drug Substance

 

 

3.

XC44

 

a.

TM953 SEC Analysis

 

b.

TM955 Ion Exchange HPLC

 

c.

TM956 Capillary Electrophoresis

 

d.

TM957 Tryptic Map

 

e.

XC44 BDS

 

 

4.

XC84

 

a.

TM974 Ion Exchange HPLC

 

b.

TM975 Tryptic Map

Schedule 6.2 - 18


 

c.

TM976 Capillary Electrophoresis

 

d.

TM977 SEC Analysis

 

e.

XC84 Bulk Drug Substance


Schedule 6.2 - 19


 

XOMA General Know-How

 

XOMA Standard Operation Procedures (Know How)

 

 

010.02.14 Bulk Drug Substance Container Closure Following Final Filtration  

 

010.02.18_Cell_Bank_Media_Fill_Procedure.pdf  

 

010.03.14 Flow Rate Determination  

 

010.06.11 General Surface and Manual Cleaning of Equipment  

 

010.06.71 Hazardous Chemical Waste Disposal  

 

010.06.73 Manufacturing Checklist  

 

010.06.77 Manufacturing Department Labeling Requirement.pdf  

 

010.06.81_WFI_Use_and_Expiration_in_X2.pdf  

 

010.06.87_Creation_and_Reconciliation_of_labels_for_Bulk_Drug_Substance_Master_Cell_Bank_Master_Working_Cell_Bank.pdf  

 

010.08.05 Clean Up of Spills in the Manufacturing Area  

 

010.08.19 Preparation of Tubing Assemblies for Autoclaving  

 

010.09.01_Handling_and_Storage_of_Temperature_Sensitive_Material.pdf  

 

010.10.06_Operation_of_the_3M_Zeta_Plus_Encapsulated_System.pdf  

 

020.01.96 Qualification and Control of Product Reference Standards  

 

030.01.100Preparation_of_Reagents_and_Chemical_Inventory_in_Analyticall_Development  

 

030.01.102_Labeling_aCHO_K1_Antibody_with_SulfoTAG.pdf  

 

030.01.99 Preparation of Chemical Solutions in the Quality Control Laboratory.pdf  

 

030.02.01_Initiation_and_Control_of_Interim_and_Development_Standards_.pdf  

 

040.01.02 The Calibration of Scales and Balances  

 

040.01.04 Calibration of Chart Recorders  

 

040.01.08 Calibration of Thermometers  

 

040.01.22 Volume Checks, Calibration, and Maintenance of Microliter Pipettes  

 

040.01.25 Certification and Maintenance of HEPA Filters, Laminar Air Flow Benches, Fume Hoods, Walk-in Hoods and Biological Safety Cabinets  

 

040.01.63_Calibration_of_the_Shimadzu_UV-1601_Spectrophotometer.pdf  

 

040.01.81_Rosemount_Solucomp_DO2_Transmitter_Calibration.pdf  

 

040.01.82_Mass_Flow_Controller_Calibration.pdf  

 

040.01.83_Agitator_Calibration.doc.pdf  

 

040.01.86_calibration_of_the_shimadzu_uv-1800_spectrophotometer.pdf  

 

040.02.01 Controlled Temperature Chamber and Walk-In Cold Room Thermal Mapping Studies  

 

040.03.01 Instrument and Equipment Calibration Program  

 

040.03.09 Validation Program  

 

040.03.14 Log of Use, Maintenance, and Cleaning  

 

040.03.15 Backup and Recovery of Computerized Systems  

 

040.03.17 Volume Checks of Multichannel Pipets  

Schedule 6.2 - 20


 

040.03.19_Analytical_Method_Qualification,_Validation,_and_Transfer_in_Quality_Control.pdf  

 

040.03.22 Security Procedure for Computer Applications and Databases  

 

040.03.23 Re-validation of Controlled Systems and Equipment at XOMA Berkeley  

 

040.03.24 Calibration of the Molecular Devices VersaMax Plate Reader  

 

040.03.26 Qualification of Analytical Instruments and Laboratory Equipment  

 

040.03.30_Analytical_Method_Qualification_in_Pharmaceutical_Development.pdf  

 

050.01.32_Environmental_Monitoring_Program_for_XOMA_4,_XOMA_5,_and_XOMA_6.pdf  

 

060.01.39 Qualification of Microbiological Media and Solutions By Growth Promotion Testing.pdf  

 

060.01.41 Autoclaving Supplies Used in Quality Control Sample Collection and Processing  

 

070.01.02 Control of Cell Banks  

 

090.02.21 Check-In of Bioanalytical Development Non-Clinical GLP and Clinical Study Samples  

 

090.02.30 Assay Quality Control in Bioanalytical Development  

 

090.02.31 Use of Quality Control Samples in Bioanalytical Development  

 

090.02.37 Labeling Practices for GLP Chemical and Biological Reagents in Bioanalytical Development  

 

090.02.55 Management of Preclinical and Clinical Studies in Bioanalytical Development.pdf  

 

090.02.56 Deviation Reporting and Resolution in GLP Studies.pdf  

 

100.03.27 Operation of Balances Scale and Weighing Measuring Components by Process and Manufacturing Sciences and Quality  

 

100.03.29_Operation_Maintenance_Calibration_of_OHAUS_Balance_in_Pharmaceutical_Development.pdf  

 

100.05.02 Maintenance and Calibration of Centrifuges and Orbital Shakers  

 

100.06.37_Installation,_Operation_and_Maintenance_of_the_Vi-CELL_Cell_Viability_Analyzer.pdf  

 

100.08.01_Specification,_Purchasing--Purchase,_Commissioning--Equipment,_Instruments,_Software--GxP_Use.pdf  

 

100.08.02 Visual Inspection of Production Equipment  

 

100.08.03 Cleaning Check-Out for Equipment Prior to First-Time Use  

 

100.08.05 Commissioning of Facilities and Equipment for GMP Use.pdf  

 

100.09.36 Sampling of Manufacturing Bioreactors  

 

100.09.46 Operation of the Terumo Sterile Tube Welder  

 

100.09.59 Standardization and Operation of Conductivity Meter for Manufacturing  

 

100.09.65 Maintenance of Fermentors and Control Skids  

 

100.12.01 Operation and Maintenance of the Fyrite CO2 Analyzer  

 

100.14.03 Operation of Laminar Air Flow Work Stations  

 

100.15.01 Operation and Maintenance of XOMA Quality Control High Pressure Liquid Chromatography (HPLC) Systems  

Schedule 6.2 - 21


 

100.15.07_Operation_and_Maintenance_of_the_Agilent_1100_and 1200 High-Pressure_Liquid_Chromatography_(HPLC)_Systems.pdf  

 

100.15.09_Operation_and_Maintenance_of_the_Beckman_Coulter_Proteome_Lab_PA_800_Protein_Characterization_System.pdf  

 

100.15.10_HPLC_Column_Conditioning_Procedure_for_New_Quality_Control_Analytical_Columns.pdf  

 

100.16.14_Operation_of_the_Forma_Orbital_Shake.pdf  

 

100.16.15_Operation_and_Maintenance_of_the_MaxQ_2000_Orbital_Shaker.pdf  

 

100.17.10_Operation,_Calibration_and_Maintenance_of_the_Fisher_Scientific_Accumet_XL20_pH_Meter.pdf  

 

100.23.03 Operation of Power Supplies  

 

100.28.16 Operation, Maintenance, and Calibration of the Shimadzu PharmaSpec UV-1700 UV Spectrophotometer  

 

100.28.18_Operation_and_Maintenance_of_the_Shimadzu_Model_UV-1800_UV_Spectrophotometer--dated.pdf  

 

100.28.19_Operation,_Maintenance,_Calibration_of_Spectramax_M2_Microplate_Reader.pdf  

 

100.30.11_Preparation_of_Disposable_TFF_Cassettes.pdf  

 

100.31.03_Operation_and _Calibration_of_Electronic_Balances_in_Bioanalytical_Development.pdf  

 

100.33.07 Operation and Maintenance of Controlled Temperature Chambers  

 

100.34.09 Vapor Testing  

 

100.37.39 Operation and Maintenance of Quality Control Water Baths, Ovens, and Furnaces  

 

100.37.50 Analytical Equipment Calibration and Preventative Maintenance  

 

100.37.63 Operation and Maintenance of the Cell and Analytical Development (AD) GxP Water Baths  

 

100.37.64_Operation_of_the_Nova_Biomedical_Bioprofile_400_Analyzer.pdf  

 

100.37.80_Operation_and_Maintenance_of_Water_Baths_in_Bioanalytical_Development.pdf  

 

105.01.01_Master_Schedule_Maintenance.pdf  

 

105.01.02_GLP_Organizational_Chart.pdf  

 

105.01.03_GLP_Management_Roles_and_Responsibilities.pdf  

 

105.01.04_Definitions_of_GLP_Terminology.pdf  

 

105.01.05 QAU GLP Protocol Review and Copy Maintenance  

 

105.01.07_Preparation_of_a_GLP_Phase_Study_Report_by_Preclinical_Research.pdf  

 

105.01.09_Overview_of_Procedures_Followed_which_Support_GLP_Nonclinical_Laboratory_Studies.pdf  

 

105.02.00_GLP_QAU_Phase_and_Report_Inspections.pdf  

 

105.02.01_QAU_Roles_and_Responsibilites.pdf  

 

105.02.02 Test Article Fabrication and Characterization for GLP Use  

 

105.03.01_Glossary_of_GLP_Terminology_Used_in_Bioanalytical_Development.pdf  

 

105.03.05_Determination_of_Bulk_Drug_Substance_and Drug Product Homogenity.pdf  

 

105.03.06_Bioanalytical_Development_Assay_Transfer.pdf  

Schedule 6.2 - 22


 

105.03.07_Operation_and_Cleaning_of_Laminar_Air_Flow_Work_Stations in Bioanalytical Development.pdf  

 

105.03.13_Maintenance_of_Instrument_Records_in_Bioanalytical_Development.pdf  

 

105.03.15_Chain_of_Custody_Data_Handling_in_Bioanalytical_Development.pdf  

 

105.03.16_Incurred_Sample_Reproducibility_Evaluation_of_GLP_Study_Samples_for_Pharmacokinetic_Analysis.pdf  

 

105.03.37_Laboratory_Housekeeping_and_Maintenance_Checklist_Procedure_in_Bioanalytical_Development.pdf  

 

105.03.38_Installation,_Operation,_and_Maintenance_of_the_Vi-Cell_XR_Viability_Analyzer_in_Bioanalytical_Development.pdf  

 

105.03.39_Instructions_Clinical_Pharmacokinetic,_Immunogenicity_Study_Sample_Collection_Processing, Shipping to Bio Dev.pdf  

 

105.03.44_WinNonlin_Pharmacokinetic_Analysis_System.pdf  

 

105.03.45_Data_Storage_for_GLP_Studies_in_the_Pharmacokinetic_Department.pdf  

 

105.03.46_Bioanalysis,_Samples_and_Data_Handling_and_Data_Release_for_Double-Masked_(Double-Blinded)_Clinical_Trials.pdf  

 

105.04.00_GLP_Study_Sample_Long Term Storage_in_Bioanalytical_Development.pdf  

 

105.04.01_GLP_Archivist_and_Archiving.doc.pdf  

 

105.06.00_GLP_Compliance_Assessment_Procedure_for_GLP_Nonclinical_Laboratory_Studies.pdf  

 

105.06.01_Roles_and_Responsibilities_for_Sponsor_Representatives_who_Support_GLP_Nonclinical_Laboratory_Studies.pdf  

 

105.06.03_Roles_and_Responsibilities_for_Prinicpal_Investigators_who_Support_GLP_Nonclinical_Laboratory_Studies.pdf  

 

110.01.01_Pharmaceutical_Worker_Hygiene_and_Health_Requirements.pdf  

 

120.01.05 Functions and Responsibilities of the Quality Unit.  

 

120.01.08_Quality_Risk_Management  

 

120.02.01 Inspection Policy  

 

120.03.02 Evaluating Invalid, Unexpected and Out of Specification and Out of Trend Test Results.  

 

120.03.07 Deviation Reporting and Resolution  

 

120.03.08 Technology Transfer  

 

120.03.09 Data Recording Rules  

 

120.03.11 Expiration Date Policy  

 

120.03.12 Outside Contractors Policy and Procedure  

 

120.03.16 Document Change Control Procedure  

 

120.03.18 Planned Change Request  

 

120.03.19 Corrective And Preventive Action (CAPA) Program  

 

120.03.20 QA Guidance on Regulatory Department Approval of DCRs and ECRs  

 

120.03.30 XOMA Policy on Manufacturing Process and Analytical Method Technology Transfer to Outside Parties.pdf  

 

120.04.02_Product_Specification_File_Requirements.pdf  

 

120.05.01 Vendor Qualification - Certificate of Analysis  

 

120.05.02_Quality_Agreement_Procedure.pdf  

Schedule 6.2 - 23


 

120.06.02 Vendor Audit Program  

 

120.06.03 Internal and Third Party Audit Program  

 

120.06.08 Qualifying Contract Testing Laboratories  

 

130.01.02 Assigning Numbers to Controlled Documents  

 

130.01.04 Master Signature List  

 

130.02.04 Reporting Results - Use of Significant Figures and Rounding Rules  

 

130.03.03 Laboratory Notebook Issuance and Archiving  

 

130.04.02 Assigning Validation Document Numbers and Archiving Validation Documents  

 

130.05.15 Labeling Practices Within Quality Control  

 

130.06.01 Submission of Files to the Document Control Archives  

 

130.06.03 Security and Policy of the Document Control Archives  

 

130.07.01 Storing Documents with an Off Site Facility.pdf  

 

130.36.16_Operation_and_Maintenance_of_the_AquaMax_2000_Microplate_Washer_.doc.pdf  

 

140.01.03 Reserve Samples  

 

140.01.06 Raw Material Release, Requalification, and Expiration Date Policy  

 

140.01.07 Using the USP/NF CD-ROM version in the Quality Department  

 

140.01.08 Handling Temperature Sensitive Materials in the Event of a Temperature Monitor Alarm  

 

140.02.11 Quality Control Material Receiving - Request, Receipt, Inspection, and Materials Distribution in the Laboratory  

 

140.02.12 Storage and Inventory Control of Reference Standards.pdf  

 

140.03.08 Materials Safety Evaluation per USP and EP  

 

140.03.10_Raw_Materials_Process_Flow.pdf  

 

140.04.01 Warehouse Receiving  

 

140.05.02 Destruction of Raw Materials, Intermediates and Final Products  

 

140.06.07_Part_Number_Requests_and_GMP Ordering Procedure Sourcing Part Numbered Items.pdf  

 

140.06.11 Returning Material to a Vendor From Inspection or Stock  

 

150.01.05 Product Stability Studies and Expiration Dating  

 

160.01.01 XOMA GMP Training Program  

 

160.01.16 XOMA Core SOPs (Standard Operating Procedures)  

 

160.01.18 XOMA OJT (On-the-Job Training) and Training Binder Management  

 

160.01.18 XOMA Qualification Form FORM C.pdf  

 

160.01.19 XOMA GLP Training Program  

 

170.01.06 Operation and Maintenance of the XOMA Card Access System.pdf  

 

170.06.27_Cleaning_and_Sanitization_of_Classified_and_Controlled_Areas.doc  

 

170.06.30 Laboratory Housekeeping and Maintenance Checklist Procedure  

 

170.07.01 Pest Control Program  

 

170.08.01 Building Security  

 

170.11.06_Maintenance_of_Fermentation_Equipment.pdf  

 

170.11.07 Maintenance of Purification Equipment  

 

170.11.20 Housekeeping and Maintenance of Quality Control/IQA Laboratories.pdf  

Schedule 6.2 - 24


 

170.11.24_Preventive_Maintenance_Procedure_for_the_Xcellerex_Disposable_Reactor_System.doc.pdf  

 

190.01.01 Shipping Request Procedure  

 

190.01.01A_Shipping_Request_Form.pdf  

 

190.01.02 Shipment Execution Procedure  

 

190.01.03_Cold_Chain_Temptale_Monitor_Management.pdf  

 

190.01.10 Shipping Biomedical Materials  

 

190.03.08._Preparing_Cold_Packs_for_Shipments of GxP Materials.pdf  

 

200.01.01 Sampling Raw Materials  

 

200.01.02 Visual Inspection of Final Product In Unlabeled Containers  

 

210.01.02 QC Data Review Procedure  

 

210.01.03 Evaluation of Outlying Analytical Data  

 

210.01.04 Trend and Control Charts Used in Quality Control  

 

210.01.05 Investigation of Product Bioburden.pdf  

 

210.02.01 Use of USP-NF CD-ROM version for Training QC Analysts  

 

210.04.05 Stability Interim Reports.pdf  

 

210.04.07_Backup_and_Recovery_of_Quality_Control_Laboratory_Computers.doc  

 

210.04.09_Use_of_MINITAB_Software_in_the_Quality_Control_Department.pdf  

 

210.04.10_Change_Control_in_the_Quality_Control_Departments.pdf  

 

210.05.01 Quality Control Test Summary Sheet and Run Log Distribution, Use and Archival  

 

210.05.25 TSS Test Summary Sheets of Outside Testing Laboratory Used for Quality Control Tests  

 

210.05.25 Test Summary Sheets of Outside Testing Laboratory Used for Quality Control Tests  

 

220.01.11_Sample_Submission,_Accountability_and_Result_Reporting.pdf  

 

220.01.12_Receipt_and_Distribution_of_Samples_from_CMOs.pdf  

 

240.01.01 Product Complaints  

 

260.00.01 Documentation of Contact with Regulatory Agencies  

 

260.00.02 Review and Approval of Regulatory Submissions  

 

260.01.07 SOP for Preparation and Archiving of Regulatory Documents  

 

270.01.01 XOMA Security Policy Computer and Network Systems  

 

270.01.02 XOMA Compliance Policy for Computerized Systems  

 

270.01.65_Manual_Time_Synchronization_of_GMP_Manufacturing_Equipment_in_X-2.pdf  

 

270.01.68_System_Owner_and_Business_Owner_review_procedure_for_SOX_and_GXP_Systems_in_Service_Desk.pdf  

 

 

Schedule 6.2 - 25


 

Schedule 9.5(d)

Eligible Employees

 

 

Employee Name

Job Title

Base Salary

Bonus Target

2015 Equity (Target)
NQ Options
(# of shares)

2015 Equity (Target)
RSUs
(# of shares)

Date of Hire

Tomic, Milan

Sr. Director, Quality

$231,825

25%

14,152

10,248

4/26/1999

Ferrell, Christina

Project Manager

$115,000

15%

0

6,333

1/5/2015

Rangel-Fonseca, Maria

Manager, Quality Control

$114,056

10%

0

2,600

5/20/2013

Cleary, Erica

Sr Associate 1

$88,825

8%

0

2,333

7/15/2013

Wong, Lily

Sr Research Associate 2, Cell Screening

$93,613

10%

0

2,600

4/14/2008

Espinoza, Yero

Sr Research Associate 2, Cell Screening

$105,165

10%

0

4,333

1/11/2005

 

 

 

 


Schedule 9.5(d) - 1


Terms of Employment

 

Management Incentive Compensation Plan
(As Amended and Restated February 20, 2002)

Calculation of Individual Incentive Awards

Company and individual performance objectives will be weighted depending upon participant level. A 20% judgment factor will be included as an individual performance measurement for all participants in the Plan.

Company and individual performance goals for participants in the Plan are to be weighted as follows:

Participant Level

Company Objectives

Individual Objectives

Performance Objectives

Officer

50%

30%

20%

Senior Director

40%

40%

20%

Director

40%

40%

20%

Manager and Discretionary Participant

30%

50%

20%”

 

 

The bonus opportunity ranges for participants in the Plan expressed as a percentage of Base Salaries are as follows:

Participant Level

Minimum

Target

Maximum

Officer

12.5%

25%

37.5%

Director

7.5%

15%

22.5%

Manager

5%

10%

15%

Discretionary Participant

3.5%

7%

10.5%”

 


Schedule 9.5(d) - 2


Medical and Prescription Drugs

Medical Services

CIGNA HDHP PPO —January 1, 2015

 

In-Network

Out-of-Network

XOMA Funded HRA:

 

 

- Individual

$2,250

- Family

$3,500

Medical Plan Deductible

 

 

- Individual

$3,250

$6,500

- Family

$4,500

$9,000

Out-of-Pocket Max

 

 

- Individual

$3,250

$6,500

- Family

$4,500

$13,000

Co-Insurance

Plan pay 90% after deductible

Plan pays 70% after deductible

Office Visits:

 

 

- Primary Care

Plan pays 90%, after deductible

Plan pays 70%, after deductible

- Specialist

Plan pays 90%, after deductible

Plan pays 70%, after deductible

- Preventive Care

Plan pays 100%, no deductible

Plan pays 70%, after deductible

Hospitalization

Plan pays 90%, after deductible

Plan pays 70%, after deductible

Outpatient Surgery

Plan pays 90%, after deductible

Plan pays 70%, after deductible

Diagnostic Lab & X-ray

Plan pays 90%, after deductible

Plan pays 70%, after deductible

Emergency Room

Plan pays 90%, after deductible

Plan pays 90% after deductible

Prescription Drugs:

$250 Individual / $750 Family

 

When patient requests brand drug, patient pays the generic copay plus the difference between the brand and generic drugs p to the cost of the brand name drug.

Deductible (Brand)

Not Covered

Retail (30 day supply)

 

 

- Generic

$35 Co-pay

 

- Preferred Brand

$50 Co-pay

 

- Non-Preferred Brand

$65 Co-pay

 

Home Delivery (90 day supply)

 

 

- Generic

$88 Co-pay

 

- Preferred Brand

$125 Co-pay

 

- Non-Preferred Brand

$163 Co-pay

 

 

Employee Only                          $155.45

Monthly Premium

Employee + 1                             $337.93

 

Employee + 2 or more                $498.42

Member Services

www.mycigna.com

1.800.CIGNA24(1.800.244.6224)

 

Schedule 9.5(d) - 3


Services

Kaiser Permanente HMO — January 1, 2015

Deductible

- Individual

- Family

None

Out-of-Pocket Max - Individual - Family

$3,000

$6,000

Co-Insurance

Plan pays 100%

Office Visits:

- Primary Care

- Specialist

- Preventive Care

$30 Co-pay

$30 Co-pay

100%

Hospitalization

Plan pays 100%, after $500 co-pay per day

Outpatient Surgery

Plan pays 100%, after $250 co-pay per procedure

Diagnostic Lab & X-ray

Plan pays 100%, after $10 co-pay per encounter

(Note: Advanced imaging such as MRI, CT and PET scans are a $50 co-pay)

Emergency Room

Plan pays 100%, after $150 co-pay per visit

Prescription Drugs:

 

Retail (30 day supply)

- Generic

- Brand

 

Home Delivery (100 day supply)

- Generic

- Brand

$10 Co-pay

$30 Co-pay

 

 

$20 Co-pay

$60 Co-pay

Monthly Premium

Employee Only                      $155.45

Employee + 1                        $337.93

Employee + 2 or more           $498.42

Member Services

www.members.kp.org

 

1.800.464.4000

 

Schedule 9.5(d) - 4


Dental

Our Dental PPO plan through Unum is designed to encourage preventative care by paying 100% of the reasonable and customary costs for participating employees’ preventative services and to help pay a portion of the charges for their general & major services as outlined in the plan description.

The dental coverage also applies to “out-of-network” dentists at a reimbursement level of 90th percentile of usual and customary reimbursements for dentists in that local area Services

Services

Unum Dental PPO

 

In-Network

Out-of-Network

Deductible (waived for preventive)

- Individual

- Family

$50 $150

$50 $150

Annual Maximum

$2,000

Preventive Services

Exam Cleanings, 4 per calendar

year

X-rays

100%

100% of UCR

Basic Services

Fillings

Simple Extractions

Endodontics

General Anesthesia

80%

80% of UCR

Major Services

Crowns

Prosthetics

Implants

50%

50% of UCR

Orthodontia (Adult & Child)

50%

50% of UCR

Lifetime Orthodontic Maximum

$1,500

Monthly Premium

Employee Only                       $13.98

Employee + 1                          $25.18

Employee + 2 or more            $42.69

Member Services

www.unumdental.com

1.888.222.2685

 

 


Schedule 9.5(d) - 5


Vision

Our Vision plan through Cigna is provides routine vision exams for a $20 copay, and preferred pricing on a large selection of brand-name, designer frames, lenses, and lens options.

Benefit

In-Network

Out-of-Network

Exam Copay

$20 copay

N/A

Exam Allowance*

Covered 100% after copay

Up to $45

Materials Copay

$20 copay

N/A

Eyeglass Lenses*

100% after copay

Single vision

Up to $32

Bifocal

Up to $55

Trifocal

Up to $65

Leticular

Up to $80

Frames*

Up to $130

Up to $71

Contact Lens*

(in lieu of lenses and frame)

 

- Elective

- Therapeutic

Up to $130

100%

Up to $105

Up to $210

*Frequency

The frequency period for the is once per plan year (calendar year basis)

Monthly Premium

Employee Only$1.65

Employee + 1$3.30

Employee + 2 or more$4.95

Member Services

www.mycigna.com

1.877.478.7557

 

Schedule 9.5(d) - 6


Basic Life and AD&D

XOMA provides benefit eligible employees with Basic Term Life and AD&D coverage through Unum.

Schedule of Benefits

Life/AD&D

Eligibility

Class 1: CEO & VP

Class 2: All Other Eligible Employees

Life Benefit Amount

Class 1: 2x Salary to $700,000 Class 2: 1x Salary to $500,000

AD&D Benefit Amount

100% of Life Benefit to $500,000

Guarantee Issue

$500,000

Age Reduction

To 65% at 65To 50% at 70

Value Add

Unum’s Life Financial Planning resources are part of the basic life benefit and encompasses objective financial planning, legal information and emotional support.

Cost:

100% Employer Paid (All employees pay taxes on benefits in excess of $50,000)

Member Services

www.unum.com

1.800.421.0344

 

Voluntary Life

XOMA provides benefit eligible employees the option of electing and paying the premium for additional Life coverage through post-tax payroll deduction.

Schedule of Benefits

Voluntary Life

Employee:

- Benefit

- Maximum

- Guarantee Issue

Units of $10,000
$500,000
$170,000

Spouse/Domestic Partner:

- Benefit

- Maximum

- Guarantee Issue

Units of $5,000 $500,000

(not to exceed 100% of employee’s election)

$25,000

Child:

- Benefit

- Maximum

- Guarantee Issue

Units of $2,000

$10,000

$10,000

(The maximum benefit for a child between the ages of live birth and 6 months is $1,000)

 

Schedule 9.5(d) - 7


Voluntary AD&D

XOMA provides benefit eligible employees the option of electing and paying the premium for additional AD&D coverage through post-tax payroll deduction.

Schedule of Benefits

Voluntary Life

Employee:

- Benefit

- Maximum

Units to 5x salary in increments of $10,000

$500,000

Spouse/Domestic Partner:

- Benefit

- Maximum

50% of employee’s amount of coverage

Up to $250,000

Child:

- Benefit

Flat $10,000

(The maximum benefit for a child between the ages of live birth and 6 months is $1,000)

 

Voluntary Long-Term Care Insurance

XOMA Corporation provides benefit eligible employees with a base long-term care plan through Unum. The base plan and buy-up options are described below:

Base Plan

Unum Long-Term Care

Monthly Facility Benefit

$3,000

Elimination Period (one per lifetime)

90 days

Lifetime Maximum

$108,000

Facility Benefit Duration

3 Years

Home Care Level

50% of facility benefit amount

Member Services

www.unum.com

800.227.4165, option 2

 

Voluntary Buy-Up Option(s)

 

Guarantee Issue Limits:

 

•   Base Facility monthly benefit not to exceed $6,000 per month

•   Base duration not exceed 6 year duration

•   Family home care benefits (paid at 50% of facility benefit amount

•   5% Compound uncapped inflation protection

Additional Options:

   Monthly benefit amounts greater than $6,000

   Lifetime duration

   75% and 100% home care level Additional Options:

   Community case and immediate family member care

 

Spouses, Domestic Partners, Adult Children over 18 years of age,

Siblings, Parents(in-law) and Grandparents(in-law) are eligible for the same plan design and rate tables (based on their own age) and require medical underwriting for all options chosen.

Schedule 9.5(d) - 8


Prudential 401(k)

XOMA matching contributions vest over a period of 4 years. Employees have the opportunity to divest their unvested match at anytime.

Years of Service Less than 1

Vested Percentage

Less than 1

0%

1 but less than 2

25%

2 but less than 3

50%

3 but less than 4

75%

4 or more years

100%

 

Schedule 9.5(d) - 9